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IVD Global Technical Support Dept.

OTY-12001 (2.0)

CL-2000i&2200i
Chemiluminescence Immunoassay
Analyzer

MINDRAY CONFIDENTI AL

Installation Guidance

IVD Global Technical Support Department

Document No.: ZSH-13090-CL-2000i&2200i


IVD Global Technical Support Dept.
OTY-12001 (2.0)

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

Document No.: ZSH-13090-CL-2000i&2200i


IVD Global Technical Support Dept.
OTY-12001 (2.0)
3.7.3 Importing and Configuring Chemistry Parameters ............................................ 69
Chapter 4 System Performance Test .............................................................................................. 73
4.1 DCF Diagnosis .................................................................................................................... 73
4.2 System check ...................................................................................................................... 73
4.3 Other Tests .......................................................................................................................... 76
4.3.1 Repeatability Test ................................................................................................... 76
Chapter 5 LIS and Remote Help ....................................................................................................... 77
5.1 LIS Connection ................................................................................................................... 77
Appendix A Comparison of altitude and atmospheric pressure ............................................. 78

Document No.: ZSH-13090-CL-2000i&2200i


IVD Global Technical Support Dept.
OTY-12001 (2.0)

Chapter 1 Check before Installation

1.1 Installation Environment


 Altitude: -400-4,000m. (106kPa-63.2kPa. An external vacuum pump is required when the
instrument is used at an altitude between 2000m and 4000m)
 The system is for indoor use only.
 The bearing platform (or ground) should be level (with gradient less than 1/200).
 The bearing platform (or ground) should be able to support at least 750Kg weight.
 The installation site should be well ventilated.
 The installation site should be free of dust.
 The installation side should not be in direct sun.
 The installation site should be kept away from a heat or draft source.
 The installation site should be free of corrosive gas and flammable gas.
 The bearing platform (or ground) should be free of vibration.
 Operating temperature: 15°C-30°C with fluctuation <2°C/H. Provide air conditioning
equipment if the room temperature does not meet the requirements.
 Relative humidity: 35%-85% RH, without condensation.

1.2 Space and Accessibility Requirements for Unpacking


 Dimensions of whole unit after packing: 1707 mm (length) × 1191 mm (depth) × 1400 mm
(height)
 The space for unpacking the instrument should be over 2m wide and over 5m long.

CL-2000i
Chemiluminescence
Immunoassay Analyzer

2 3

1707mm 1100mm 1600mm

Figure 1 Space and accessibility requirements for unpacking the CL-2000i package

Document No.: ZSH-13090-CL-2000i&2200i


IVD Global Technical Support Dept.
OTY-12001 (2.0)

1.2.1 Space and Accessibility Requirements for Installation


 Dimensions of whole unit before packing: 1445mm (length) × 1016 mm (depth) × 1145mm
(height).
 Dimensions of SDM before packing: 1016mm(length)×705mm(depth)×920mm(height)
 It is better for the installation space to be over 5.6m×2.2m.
5625mm
Air switch

Power cable
Data cable
800mm
Waste tube

Waste tank
LIS server

PC
2467mm

UPS

CL-2000i SDM

1445mm 705mm

Figure 2 Space and accessibility requirements for installation of the CL-2000i

1.2.2 Power Supply and Noise


 Power supply: 220V-240V~ 50Hz, 220V/230V~ 60Hz. Voltage fluctuation: +/-10%. Line
frequency: +/-3Hz. Three-wire power cord with good grounding performance.

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.

Document No.: ZSH-13090-CL-2000i&2200i


IVD Global Technical Support Dept.
OTY-12001 (2.0)

1.2.3 Drainage Check (if draining water through a sewer)


 The waste tube should be 2m to 10m long.
 The waste outlet should be no less than 50mm wide.
 The waste outlet should be no higher than 50cm.

BIOHAZARD
Dispose of liquid waste according to the local regulations.

1.3 Recommended PC Configuration


Item Description
CPU At least Intel Dual Core, 3.0GHz
Random access memory (RAM) At least 4GB
The computer is connected to the analyzer through a network
adapter. If you are going to connect the computer with the LIS or
Network adapter
Internet, you should prepare another network adapter (Intel
gigabit network adapter)
The computer should provide an RS232 serial port, which is used
Serial port
to connect it with the SDM.
Install the operating system in the C drive and the operating
software of the instrument in the D drive.
Make sure that the C drive is over 30G and D drive over 100G,
Hard disk defragment and the disk file system is of NTFS format.
Deselect the two options at the bottom of the disk properties
window: “Compress drive to save disk space” and “Allow
Indexing Service to index this disk for fast file searching”.
The operating system installed on the computer must be an
Operating system
activated Microsoft Windows 10 (64 bits).
Except for the operating system, other application software
must not be installed or reserved on the computer. If an
Application software anti-virus application has been installed, then remove the
automatic scheduled scanning and add the operating software
and BSLOG to the trust list.
Screen saver and system Turn off the screen saver and BS Special Power Policy power
standby scheme, and then disable the hibernation option.
Set the screen resolution as 1280*1024 pixels and color quality
Screen display properties
as Highest.
Automatic synchronization Disable the Automatically synchronize with an Internet time
with Internet time server server option.
Automatic updates Turn off the automatic updates.
If you are going to use the auto startup function, perform
Auto startup setup necessary settings for BIOS and network adapters while referring
to their operation manuals.

Document No.: ZSH-13090-CL-2000i&2200i


IVD Global Technical Support Dept.
OTY-12001 (2.0)

1.4 Configuration Check


Table 1 Configuration list

• CL-2000i/CL-2200i Chemiluminescence Immunoassay Analyzer -------------------------- 1


• Sample Delivery Module (SDM) -------------------------------------------------------------------- 1
• Accessory kit ------------------------------------------------------------------------------------------- 1
• Computer (Prepare by distributor or user) ------------------------------------------------------- 1
• Display monitor (Prepare by distributor or user) ------------------------------------------------ 1
• Waste tank ---------------------------------------------------------------------------------------------- 2
• Accompanying reagents
Accompanying reagents ---------------------------------------------------------------------------- 1
Wash buffer -------------------------------------------------------------------------------------------- 2
• Optional modules
Printer --------------------------------------------------------------------------------------------------- 1
External vacuum pump------------------------------------------------------------------------------ 1
Store the reagent pack in the 2~8°C refrigerator.

Document No.: ZSH-13090-CL-2000i&2200i


IVD Global Technical Support Dept.
OTY-12001 (2.0)

Chapter 2 Instrument installation

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 Installation Procedure

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

Document No.: ZSH-13090-CL-2000i&2200i


IVD Global Technical Support Dept.
OTY-12001 (2.0)
Figure 4 Serial No. and 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.

Figure 5 Tilt warning label in normal conditions

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.

Document No.: ZSH-13090-CL-2000i&2200i


IVD Global Technical Support Dept.
OTY-12001 (2.0)

Figure 6 No screws on top of slope cover

Slope
board

Figure 7 Slope cover

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.

Document No.: ZSH-13090-CL-2000i&2200i


IVD Global Technical Support Dept.
OTY-12001 (2.0)

Figure 8 Open the front door

 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.

Figure 9 Screw down anchors before loosening horizontal screws

 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.

Document No.: ZSH-13090-CL-2000i&2200i


IVD Global Technical Support Dept.
OTY-12001 (2.0)

Figure 10 Lift anchors

6. Unpacking SDM: Untie the belts on the SDM package, and remove the upper cover
and side covers.

Figure 11 Unpack SDM

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.

Figure 12 Pushing direction of SDM

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

Document No.: ZSH-13090-CL-2000i&2200i


IVD Global Technical Support Dept.
OTY-12001 (2.0)
prevent scratches.
Note: If the transportation channel is narrow, please remove the rack transfer
unit and front door assembly of the analyzer before transport. Removing
wrapping film and locating analyzer and SDM: Remove the wrapping film, tapes
and sponge from the analyzer and SDM, and remove the power cords from the empty
chambers of the SDM. Locate the analyzer and SDM, and screw down the anchors to
prevent the analyzer and SDM from moving. (One person is required to screw down all
anchors manually so that they can be lifted to the same height.)
Check: Check if the following packaging materials have been removed:
 Foam for fixing the drawer

 Foam on the dispersion carousel

 Foam to protect the cuvette loader assembly

 Tapes for fixing the upward shift mechanism of the auto loader

Document No.: ZSH-13090-CL-2000i&2200i


IVD Global Technical Support Dept.
OTY-12001 (2.0)

 Tapes for fixing the tray bracket assembly

 Plugs of inlet and outlet

 Sealing tape on wash wells


 Tape for fixing the tube on probe arm

 Tape on scanning push-in part and scanning push-out part


 Protective tapes on panels
 Tapes on retrieval push-in part part

Document No.: ZSH-13090-CL-2000i&2200i


IVD Global Technical Support Dept.
OTY-12001 (2.0)

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.

2. Fix the network cable in


1. Connect the CL-2000i
the buckle at the lower
analyzer with an end of the bottom plate
operating computer which is at the top of the
through a network cable
rack

3. Schematic 1: Insert the


network cable connector
into the communication
adapter board at the back
end of the SDM.

Document No.: ZSH-13090-CL-2000i&2200i


IVD Global Technical Support Dept.
OTY-12001 (2.0)

3. Schematic 2: Insert the


network cable connector
into the communication
adapter board at the back
end of the SDM.

Figure 13 Analyzer connecting cable


2. Connect power supply cable:
Connect the power module of the analyzer as follows:
1) Connect SDM power supply wire: SDM is powered by the DC power supply board of the
analyzer. The cable is fixed with cable tie to the lower right of the analyzing unit and
connect the cable according to the number of the cable.

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

Document No.: ZSH-13090-CL-2000i&2200i


IVD Global Technical Support Dept.
OTY-12001 (2.0)

4. Note to check the cable marker:


CADB-LCB(0)-J2 5. Note to check the cable marker:
CADB-LCB(1)-J2

6. Plug in the power cable connectors as instructed by the


cable marker. There are three connectors.

MCB-LCB(1)-J6

MCB-LCB(1)-J2

CADB-LCB(0)-J2

Figure 14 SDM power connection

Document No.: ZSH-13090-CL-2000i&2200i


IVD Global Technical Support Dept.
OTY-12001 (2.0)
2) Connect the earthing wire

Connect the analyzer's earthing


wire to the SDM's one. (Screws
are placed in the accessory kit)

Figure 15 Analyzer earthing wire connection

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

Document No.: ZSH-13090-CL-2000i&2200i


IVD Global Technical Support Dept.
OTY-12001 (2.0)

1. Lead system
power cable
through cord
holes.

2. Observe the cable marker of the


power cable. The brown line is
live wire, with cable marker as
J1.1; the blue line is null line,
with cable marker as J1.2

3. Fix the brown live wire, J1.1, at


the upper end; and the blue null
line, J1.2, at the lower end.

Figure 16 System power cable connection

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.

Document No.: ZSH-13090-CL-2000i&2200i


IVD Global Technical Support Dept.
OTY-12001 (2.0)

Interconnecti
on cable

Figure 17 Interconnection 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.

Figure 18 Lead cable

Document No.: ZSH-13090-CL-2000i&2200i


IVD Global Technical Support Dept.
OTY-12001 (2.0)
Figure 19 Fix cable with cable ties

Figure 20 Connect cables of the front track (on upper board)

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.

Figure 21 Apply a track alignment tool

Document No.: ZSH-13090-CL-2000i&2200i


IVD Global Technical Support Dept.
OTY-12001 (2.0)

The gaps
between the
frames are even.

Figure 22 Check interconnection

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.

Figure 23 Connecting screws for analyzer and SDM

Document No.: ZSH-13090-CL-2000i&2200i


IVD Global Technical Support Dept.
OTY-12001 (2.0)

Figure 24 Install connecting screws

7. Connecting UPS (provided by the distributor): If configured, the UPS should be


connected to the analyzer by its supplier.

2.2.3 Installing Peristaltic Pump Tube


Follow the procedures below:
Make sure the blue buckle located in the blank slot and tighten the screws on the right.

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:

Document No.: ZSH-13090-CL-2000i&2200i


IVD Global Technical Support Dept.
OTY-12001 (2.0)
1. The eight buckle of the four pump tubes should be fixed in the slots without deviation.
2. Tighten the inner nut to its shoulder first and then tighten the second screw. Do not
tighten the two screws at the same time.

2.2.4 Removing Retaining Screws on the Reagent Carousel


For the new reagent carousel cover, the locations of the retaining screws are as follows:

Locations of retaining screws


on the reagent carousel

Figure 26 Locations of retaining screws on the new reagent carousel

Figure 27 After removing retaining screws from the new reagent carousel

Document No.: ZSH-13090-CL-2000i&2200i


IVD Global Technical Support Dept.
OTY-12001 (2.0)

2.2.5 Remove the drawer mounting plate of wash buffer


To prevent shipping damage, the wash buffer drawer needs to be fixed with a drawer mounting
plate at the factory. Therefore, the drawer mounting plate needs to be removed at the client's
site. Perform the operations in the following sequence:
1. Use a hexagon wrench to loosen two M3X10 screws on the drawer mounting plate and then
remove the drawer mounting plate.

Drawer mounting plate


Two M3X10
hexagon socket
screws

Figure 28 Remove two screws on the drawer mounting plate


2. Pull the handle of the drawer to check if it moves smoothly.

Figure 29 Install drawer handle


Note: The optical sensor is used to detect if the wash buffer tank is changed. Remind the user

Document No.: ZSH-13090-CL-2000i&2200i


IVD Global Technical Support Dept.
OTY-12001 (2.0)
of not changing the wash buffer tank unless it is used up.

2.2.6 Fluidic Connection


2.2.6.1 Connecting Waste Tubes
The waste tube provided with the CL-2000i chemiluminescence immunoassay analyzer is
ID12mm×OD18mm PVC tube. The service engineer should connect the waste tube and waste
sensor with the chemiluminescence immunoassay analyzer, and connect the other end of the
waste tube to the waste tank.

Figure 29 Connect the waste tank


If the waste can be discharged through sewer, follow the steps below:

CL-2000i Chemiluminescence
Immunoassay Analyzer
Sensor of
external vacuum
pump

23
1

Outlet

Figure 30 Waste discharge

Requirements for connecting waste tubes:


1. Insert the waste tube into the sewer, and make sure that the tube is about 2m~10m long.
2. Make sure that the waste outlet is no less than 50mm wide and less than 50cm high.
3. Ensure that the waste tube outlet is higher than the liquid level in the sewer in order to
prevent bubbles overflow.

Document No.: ZSH-13090-CL-2000i&2200i


IVD Global Technical Support Dept.
OTY-12001 (2.0)
4. Cover the waste outlet to eliminate noise and prevent bubbles overflow.
5. To prevent leaks, fix all tubes and connectors properly with the tube clamps in the
accessory kit.
6. When installing the tubes, prevent them from being bent, twisted, or pressed, and keep
them away from any sharp-edged objects or others that may scratch the tubes.
7. Ensure that all electric connectors are higher than and away from fluidic parts and prevent
fluidic connectors from facing electric components.

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.

2.2.6.2 Connect Wash buffer tank


1. Take out the wash buffer drawer and remove the tape and package bag of the cap
assembly of the wash buffer tank.

Fix the tape and


package bag of the cap
assembly of the wash
buffer tank.

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).

Document No.: ZSH-13090-CL-2000i&2200i


IVD Global Technical Support Dept.
OTY-12001 (2.0)

Fix the plug of the cap


assembly of the wash
buffer tank to the hanger
on the door

Figure 32 Fix the plug of the cap assembly of the wash buffer tank to the
hanger on the door to prevent contamination

3. Check if the plug of the cap assembly is tightened.


Check if the white compression nut at the lower end of the cap assembly of the wash buffer tank
is loose. If so, tighten it clockwise.

Figure 33 Screw tightening direction


4. Remove the cap of the wash buffer tank and place the cap assembly into the tank and
tighten the cap.

Document No.: ZSH-13090-CL-2000i&2200i


IVD Global Technical Support Dept.
OTY-12001 (2.0)

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

Document No.: ZSH-13090-CL-2000i&2200i


IVD Global Technical Support Dept.
OTY-12001 (2.0)
2.2.6.3 Final Connection Effects

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.

2.2.7 Connect the computer.


Connect the PC with analyzer
The connection of analyzer is shown in the following figure, 2 cables needed:
The serial port cable is used to connect SDM (set the serial port as COM1 in device manager of
PC).
The network cable is used to connect the analyzing unit. The IP of the network adapter on the
PC should be set as 192.168.23.3.

Document No.: ZSH-13090-CL-2000i&2200i


IVD Global Technical Support Dept.
OTY-12001 (2.0)

Figure 38 Connect serial cable of the analyzer with network cable

2.2.8 Check the connectors on both ends of substrate outlet valve


When the analyzer is installed, disassemble the front panel and check if the connectors at both
ends of the substrate outlet valve SV32 are loose. If loose, tighten them.
Preheating module

Substrate protection
tube assembly

Check
connector
Substrate bottle (1)

Substrate bottle (2)

Substrate
syringe

Document No.: ZSH-13090-CL-2000i&2200i


IVD Global Technical Support Dept.
OTY-12001 (2.0)

2.2.9 Connect external vacuum pump (Optional)


Due to the need in the plateau area, an external vacuum pump kit is optional. The current
external vacuum pump kit contains all sensor wiring and adapters and tubing required for an
external vacuum pump.
For the connection of the sensors, connect the sensors of the old model and of the cost
reduction phase I to J8 on the fluidics temperature control board. Connect the sensors of the
cost reduction phase II to J2 on the main control board.
Directly connect the outlet pipe of the external vacuum pump to the Y-type adapter inside the
analyzer via the adapter (115-051691-00), and perform pressure configuration after connection.
The adapter (115-051691-00) is also in the kit of the external vacuum pump and no separate
application is required.
The schematic diagram of the adapter is as follows:

Connect to the Adapter Connect to the tube


tube at the Y coming from the
connector of the external vacuum
analyzer pump

Document No.: ZSH-13090-CL-2000i&2200i


IVD Global Technical Support Dept.
OTY-12001 (2.0)

2.2.10 Software Installation


Complete the software installation according to the SetupGuide. The following are what you
should pay attention to.
1. After installation, check the configuration file.
Be sure to confirm the following configuration file after installation.

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.

Document No.: ZSH-13090-CL-2000i&2200i


IVD Global Technical Support Dept.
OTY-12001 (2.0)
2. When burning in the control software, no need to select instrument version any more.
The new software can identify automatically and match the software upgrade package. You
don't need to select it manually.

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.

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IVD Global Technical Support Dept.
OTY-12001 (2.0)

Chapter 3 Power on and alignment

3.1 Preparation for Powering On


 Load solid waste containers.
 Switch on the power supply of the drainage module (optional).
 Turn on the main power switch of the analyzer.
 See the figure below. The analyzer automatically fills the buffer tank with water. Generally,
the tank will be full in 10~15 minutes.

Figure 37 Auto prime of wash buffer

 Load at least 3 cuvette-installed trays (no more than 9).

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IVD Global Technical Support Dept.
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Pull out the


drawer and
load 3 cuvette
trays.

Figure 38 Load cuvette trays

3.2 Initial Startup


1. Start up the computer. The CL-2000i Operating Software is run automatically. See the
figure below.

Figure 39 Start up CL-2000i

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.

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IVD Global Technical Support Dept.
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Figure 40 Login window of CL-2000i

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.

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IVD Global Technical Support Dept.
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Figure 41 Select Vacuum Pressure Check

1 3

Figure 42 Configure atmospheric pressure

4. Confirm location and perform alignment


Note: The pressure configuration should match the local atmospheric pressure
otherwise insufficient vacuum may occur.

3.3 Main Unit Position Confirmation and Alignment


Since the instrument is not primed, the instrument status is stopped. But the it has no effect on
mechanical position confirmation and alignment of main unit.
The alignment items are shown in the following table. Refer to CL-2000i Alignment Guide for
specific steps and methods

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IVD Global Technical Support Dept.
OTY-12001 (2.0)
Table 2 List of alignments for installation (Analyzer)

Module Unit Alignment Affected parameters


Dispersion Carousel
Dispersion carousel position offset Unit-Cuvette Position
Offset -Stop Position
Dispersion Carousel
Reversed Rotary Stop Position Unit-Reversed Rotating
Compensation Stop Position
Dispersion
Compensation
Carousel
Dispensing
Unit
Dispense Station Vertical Position Module-Dispensing
Position
Aspirating Module
Dispense Station Vertical Position -Aspirate Position at
Cuvette Bottom
Substrate Vortex Speed alignment /
First Gripper Unit-Front
Operating Horizontal
Position on the Inner Ring
of Reaction Carousel
First Gripper Unit-Front
Operating Vertical Position
Main
on the Inner Ring of
unit
Reaction Carousel
First Gripper Unit-Front
Operating Horizontal
Position on the Middle
Ring of Reaction Carousel
First and First Gripper Unit-Front
Gripper Outside/Middle/Inside of
Second Operating Vertical Position
Reaction Carousel Horizontal
Gripper on the Inner Ring of
Reaction Carousel
First Gripper Unit-Front
Operating Horizontal
Position on the Outer Ring
of Reaction Carousel
First Gripper Unit-Front
Operating Vertical Position
on the Inner Ring of
Reaction Carousel
Second Gripper Unit-Back
operating horizontal
position on the Inner Ring

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of Reaction Carousel
Second Gripper Unit-Back
operating horizontal
position on the Middle
Ring of Reaction Carousel
Second Gripper Unit-Back
operating horizontal
position on the Outer Ring
of Reaction Carousel
First Gripper
Unit-Horizontal Reversed
Compensations
First Gripper Unit-Vertical
Forward/Reversed Compensations
Reversed Compensations
Second Gripper
Unit-Horizontal Reversed
Gap Compensations
Second Gripper Unit-Mixer
Mixing Position Horizontal Position
Horizontal Position
Second Gripper
Dispersion Carousel Horizontal Unit-Dispersion Carousel
Gripping Position Horizontal Gripping
Position
First Gripper Unit-Tray
Position (1, 1) # Horizontal
Position
First Gripper Unit-Tray
Position (1, 1) # Vertical
Position
First Gripper Unit-Tray
Position (9, 1) # Horizontal
Position
Gripper Tray Horizontal
First Gripper Unit-Tray
Position (9, 1) # Vertical
Position
First Gripper Unit-Tray
Position (1, 14) #
Horizontal Position
First Gripper Unit-Tray
Position (9, 1) # Vertical
Position
Reaction Carousel First Gripper Unit-Front
Inner/Middle/Outer Horizontal Operating Horizontal
Gripping Position Alignment Position on the Inner Ring

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of Reaction Carousel
First Gripper Unit-Front
Operating Vertical Position
on the Inner Ring of
Reaction Carousel
First Gripper Unit-Front
Operating Horizontal
Position on the Middle
Ring of Reaction Carousel
First Gripper Unit-Front
Operating Vertical Position
on the Middle Ring of
Reaction Carousel
First Gripper Unit-Front
Operating Horizontal
Position on the Outer Ring
of Reaction Carousel
First Gripper Unit-Front
Operating Vertical Position
on the Outer Ring of
Reaction Carousel
Second Gripper Unit-Back
Operating Horizontal
Position on the Inner Ring
of Reaction Carousel
Second Gripper Unit-Back
Operating Horizontal
Position on the Middle
Ring of Reaction Carousel
Second Gripper Unit-Back
Operating Horizontal
Position on the Outer Ring
of Reaction Carousel
First Gripper Unit-Sample
Positions Horizontal
First Gripper Unit-Sample
Positions Vertical
First Gripper Unit-Diluting
Dispense and #1/#2 Diluting
Position 1 Horizontal
Positions Horizontal
Position
First Gripper Unit-Diluting
Position 1 Vertical Position
First Gripper Unit-Diluting
Position 2 # Horizontal

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Position
First Gripper Unit-Diluting
Position 2 # Vertical
Position
First Gripper
Unit-Discarding Position 1
Horizontal
First Gripper
Unit-Discarding Position 1
Horizontal Discarding Position #1/#2 Vertical
Alignment First Gripper
Unit-Discarding Position 2
Horizontal
First Gripper
Unit-Discarding Position 2
Vertical
First Gripper Unit-Vertical
Gripping Position on the
Front Operating Position
on the Inner Ring of
Reaction Carousel
First Gripper Unit-Vertical
Gripping Position on the
Front Operating Position
on the Middle Ring of
Reaction Carousel
First Gripper Unit-Vertical
Gripping Position on the
Front Operating Position
Vertical Gripping Position Alignment on the Outer Ring of
on Reaction Carousel Reaction Carousel
Second Gripper
Unit-Vertical Gripping
Position on the Back
Operating Position on the
Inner Ring of Reaction
Carousel
Second Gripper
Unit-Vertical Gripping
Position on the Back
Operating Position on the
Middle Ring of Reaction
Carousel
Second Gripper

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Unit-Vertical Gripping
Position on the Back
Operating Position on the
Outer Ring of Reaction
Carousel
Mixing Position Vertical Gripping Second Gripper Unit-Mixer
Position Alignment Gripping Vertical Position
Second Gripper
Dispersion Carousel Vertical Gripping
Unit-Dispersion Carousel
Position Alignment
Vertical Gripping Position
First Gripper Unit-Vertical
Vertical Gripping Position Alignment
Gripping Position in
in Dispensing Position
Dispensing Position
Tray Gripper Vertical Position First Gripper Unit-Tray
Alignment Gripper Vertical Position
Reagent Carousel Unit -
Position Offset at 1st
Reagent Carousel's Position Offset at
Injection Port of the
1st Injection Port - Stop Position (Ra)
Reagent Probe - Stop
Position (Ra)
Reagent Carousel Unit -
Position Offset at 2nd
Reagent Carousel's Position Offset at
Injection Port of the
2nd Injection Port - Stop Position (Rb)
Reagent Probe - Stop
Position (Rb)
Reagent Carousel Unit -
Position Offset at 3rd
Reagent Carousel's Position Offset at
Reagent Injection Port of the
3rd Injection Port - Stop Position (Rc)
carousel Reagent Probe- Stop
Position (Rc)
Reagent Carousel Unit -
Position Offset at 4th
Reagent Carousel's Position Offset at
Injection Port of the
4th Injection Port - Stop Position (Rd)
Reagent Probe- Stop
Position (Rd)
Reagent Carousel Unit -
Reversed Rotary Stop Position
Reversed Rotary Stop
Compensation
Position Compensation
Reagent Carousel Unit -
Reagent Carousel Bar Code
Bar Code Scanning Offset
Scanning Position
- Stop Position
Reagent Probe Unit-Ra
Reagent Horizontal position for aspirating
Aspirate Position
probe unit Ra/Rb/Rc/Rd
Horizontal Position

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Reagent Probe Unit-Rb
Aspirate Position
Horizontal Position
Reagent Probe Unit-Rc
Aspirate Position
Horizontal Position
Reagent Probe Unit-Rd
Aspirate Position
Horizontal Position
Reagent Probe Unit -
Reagent probe horizontal wash
Horizontal Wash Position
position
(Initial Position)
Reagent Probe
Unit-Horizontal Reagent
Dispense Position on
Inner Ring
Reagent Probe
Horizontal Reagent Dispense
Unit-Horizontal Reagent
Position on Reaction Carousel
Dispense Position on
Inner/Middle/Outer Rings
Middle Ring
Reagent Probe
Unit-Horizontal Reagent
Dispense Position on
Outer Ring
Reagent Probe Unit -
Reagent probe horizontal
Horizontal Reversed
forward/reversed compensations
Compensation
Reagent Probe Vertical Wash Reagent Probe Unit -
Position Vertical Wash Position
Reagent Probe
Unit-Reagent Carousel
Vertical Extreme Position
Ra
Reagent Probe
Unit-Reagent Carousel
Vertical Extreme Position
Reagent Carousel Vertical Extreme
Rb
Position
Reagent Probe
Unit-Reagent Carousel
Vertical Extreme Position
Rc
Reagent Probe
Unit-Reagent Carousel
Vertical Extreme Position

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Rd
Reagent Probe
Unit-Reagent Dispense
Position Vertical Extreme
on Inner Ring
Reagent Probe
Reagent Dispense Position Vertical
Unit-Reagent Dispense
Extreme on Reaction Carousel
Position Vertical Extreme
Inner/Middle/Outer Rings
on Middle Ring
Reagent Probe
Unit-Reagent Dispense
Position Vertical Extreme
on Outer Ring
Sample probe wash position Sample Probe Unit-Wash
horizontal Position Horizontal
Sample Probe Unit-Wash
Position Horizontal
Sample Probe
Sample Probe Horizontal Dispense Unit-Diluting Position 1
and 1#/2# Diluting Positions Horizontal
Sample Probe
Unit-Diluting Position 2
Horizontal
Sample Probe
Sample Probe Horizontal
Unit-Horizontal Reversed
Forward/Reversed Compensations
Sample Compensation
Probe Unit Sample Probe Unit-Wash
Sample Probe Wash Position Vertical Position Vertical 1
Alignment Sample Probe Unit-Wash
Position Vertical 2
Sample Probe
Unit-Sample Position
Vertical Extreme
Sample Probe
Sample Dispense/#1 Diluting/#2
Unit-Diluting Position 1
Diluting Position Vertical Extreme
Vertical Extreme
Sample Probe
Unit-Diluting Position 2
Vertical Extreme

After the main position alignments are completed, power off the instrument and exit the
operating software.

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3.4 Installing Probe

3.4.1 Installing Sample Probe


1. Removing arm cover: Loosen one M3 cross pan head screw on each side of the arm
cover without removing them.

Figure 43 Retaining screws on arm cover

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.

Figure 44 Two spring guide posts

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.

Figure 45 Fluidic tubes

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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.

3.4.2 Installing Reagent Probes


Refer to the previous section to install the reagent probe.

3.4.3 Check after power-on


Connecting power supply: After installation, power on the analyzer, check if the No.D2 LED
indicator (orange) on the circuit board inside the sample probe/reagent probe arm is lit. If it is, it
indicates that the liquid level detection system is powered normally. Use a water-dipped cotton
swab to touch the probe tip and check if the No.D5 LED indicator (green) is lit. If it is, it indicates
that the liquid level detection board can function normally.

Figure 46 Sample level detection indicators

3.5 SDM Position Confirmation and Alignment


1. Keep the analyzer powered up, locate the SDMDemo.exe file in the
D:\Mindray\CL2000i\OperationSoft directory and double-click to open it.

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:

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IVD Global Technical Support Dept.
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Table 3 List of alignments for installation (SDM)

Module Unit Alignment Affected parameters


Connection SDM's horizontal position against
/
between front track
SDM and SDM's vertical position against
/
front track front track
Rack Supply Unit-Offset of
Offset of Position Switch for Rack
Position Switch for Rack
Supply Push-In Part
Supply Push-In Part
Sample Center and Scanning
/
Position
STAT Push-Back Part Half Rack Supply Unit-Half
Rack supply
Protrude for Rack Supply Push-In Protrude for Rack Supply
unit
Part Push-In Part
Scanning Push-In Part Moving to Rack Supply Unit-Scanning
Utmost End Push-In Part to Utmost End
Rack Supply Unit-Scanning
Scanning Push-Out Part Target
Push-Out Part to Utmost
Pos Adjustment
End
Rack retrieval unit-MCC1
Grid Aligning with Scanning
Channel
Grid aligning with scanning channel
SDM Rack retrieval unit-MCC2
Grid Aligning with Scanning
Channel
Rack retrieval unit-MCC1
Grid Aligning with Return
Lane
The grid aligning with return lane
Rack retrieval Rack retrieval unit-MCC2
unit Grid Aligning with Return
Lane
Rack retrieval unit-MCC1
Grid Aligning with Retrieval
Channel
Grid aligning with retrieval channel
Rack retrieval unit-MCC2
Grid Aligning with Retrieval
Channel
Retrieval Push-In Part Moving to Rack retrieval unit-In Part to
Rack Storage Unit Rack Storage Unit
Positioning Station Moving to Normal Lane(M1)-Offset for
Aspirate Point Aspirate Point
Normal unit
Sample Probe Rotary to Normal Sample probe unit-Normal
Lane Aspirate Position Horizontal

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Passing & Return
Positioning Station Moving to
Lane(M1)-Offset for
passing-return lane
Aspirate Point
Sample Probe Rotary to Passing Sample probe unit-Normal
Lane Aspirate Position Horizontal
Passing&Return
Return Push-Out Part Moving to
Lane(M1)-Return Push-Out
End Position
Part to Utmost End
Passing&Return
Lane(M1)-Steps for lane
Lane Change Part Home
change part to reach home
Non-normal position
Unit Passing&Return
Lane Change Part Moving from Lane(M1)-Lane Change
Passing Lane to Normal Lane Part from Passing Lane to
Normal Lane
Passing&Return
Lane Change from Return to Lane(M1)-Lane Change
Normal Part from Return Lane to
Normal Lane
Passing&Return
Lane Change Align with Return Lane(M1)-Lane Change
Lane Part Aligning with Return
Lane
After SDM Position Confirmation and Alignment is completed, start prime.

3.6 Fluidic Prime


Perform the following checks prior to fluidic prime:
 The wash buffer floater cables have been connected.
 The auto priming of wash buffer is normal.
The buzzing sound of the pump can be heard during the priming process. After priming, the
buzzing sound disappears and the wash buffer tank (2L) is full. Start the fluidic prime after
finishing the preparation.
Note: After the analyzer is installed, if the analyzer will not be activated within two weeks,
or the analyzer will not be activated before the current consumables run out according to
the feedback of the department, Empty Whole Unit must be performed.

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1. Wash Buffer Aspirating Tube Check and Prime


1) Select 7 Wash Buffer Aspirating Tube Check and Prime, and select Continue.

2) Select Continue (Restart is not required).

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3) Select OK directly.

4) Select Continue to end the wash buffer prime procedure.


5) Select 8 Wash Buffer Aspirating Tube Pressure Test.
Note: There is no priming operation in this step, and you only need to follow the prompts,
without testing the water pressure.

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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.

7) Finally, select Continue to end step 8.

2. Wash Buffer Prime


1) Select 9 Wash Buffer Prime, and select Continue.

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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.

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3) Select OK to continue after the priming is finished.

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.)

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5) Make sure the dispersion dispense probes have been removed and put in a proper
container, and then select Continue.

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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.

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7) After the priming is finished, select OK.

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.

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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.

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12) Select Continue to end the Probe Wash Tube Pressure Test process.

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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.

3. Clean Substrate Tubes


1) Select 3 Cleaning and Priming Substrate Tubes under Hydropneumatic Subsystem Check
and Calibration (see the figure below)

2) A Warning dialog box will pop up as shown in the figure below. Select OK directly.

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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.

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Note: the ultra-pure water is distilled water. Do not replace it with tap water, mineral
water or other unidentified liquid from hospital water dispenser. If the conditions do
not permit, you can use the Cestbon Pure Water instead.

6) Empty substrate tubes.


Remove the substrate bottles and select substrate 1 and 2 receptively. Input 50 times and
start substrate prime.

7) Use the acid wash solution to clean the substrate tubes.


Load acid wash solution in the positions of substrate 1 and 2, and input 50 times and select
Start.

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Note: There is 20ml acid wash solution in each substrate bottle. Manually add
ultra-pure water for dilution till the substrate bottle is full.

8) Use the acid wash solution to soak the substrate tubes


After prime, keep the acid wash solution in the substrate tube and soak the tube for 30
minutes.
9) Empty substrate tubes again.
Still on this screen. Remove the substrate bottles and select substrate 1 and 2 receptively.
Input 50 times and start substrate prime and empty the substrate tubes.

10) Use ultra pure water to clean the substrate tubes again.

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IVD Global Technical Support Dept.
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Still on this screen. Fill the clean substrate bottle with ultra pure water and load it into the
substrate 1 position and then select Substrate 1 on the software screen; input 100 times
and click Start to clean substrate path 1 with the ultra pure water.
Use the same method to clean substrate path 2.

11) Empty substrate tubes again.


Still on this screen. Remove the substrate bottles and select substrate 1 and 2 receptively.
Input 50 times and start substrate prime.
12) Perform Substrate Prime.
Still on this screen. Load an equilibrated substrate to substrate 1 after removing its
aluminum foil at the bottom. Select Substrate 1, input 50 times, select Start and perform
substrate prime. Prime substrate 2 in the same way.
NOTE:
A. The substrate must be well equilibrated.
B. Before loading substrate, remove the aluminum foil seal from the bottom of the substrate
bottle.
13) Install the substrate spike after prime and click Continue.

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IVD Product Global Technical Support Department

3.7 Setting up

3.7.1 Loading Special Reagents


1. Loading wash buffer:
Load wash buffer on the Reagent -> Special Reagent screen as shown in the figure below.

1
3
4
MINDRAY CONFIDENTI AL

5
2

Figure 47 Load wash buffer

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.

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Figure 48 Hand-held bar code reader


NOTE:
1 Before loading substrate, remove the aluminum foil seal from the bottom of the substrate bottle.
2 If the scanning fails, the bar code reader cannot read the bar code. Please perform "Add
and Enter Key" on the operation manual of the bar code reader, and check after scanning
3 bar codes.

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Figure 49 Scan bar code on substrate

Figure 50 Load substrate


3. Waste tank/Reaction cuvettes
Waste tank and reaction cuvettes have been loaded in the early operations. The software will
detect them automatically.
4. Wash Buffer
Load wash solution CD80 in the same way as wash buffer after finishing the system
performance test.
5. Diluent
Diluent is also known as sample diluent Load the sample diluent during clinical test. Once it is
loaded to the reagent carousel, the reagent bar code reader scans its bar code to calculate the
volume.

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Figure 51 Check the status of the consumables

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Figure 52 Reagent Carousel Status

3.7.2 Initial Maintenance Record


Perform the Home command (about 20 min. Wait for the temperature to become steady) to put
the system into Standby status. Select Utility -> Maintenance -> Maintenance, confirm all
scheduled maintenance procedures and set up start time for them. The maintenance
frequencies include Daily, Weekly, Monthly, Three-Month, Six-Month, and Other. Select the
Select All button on each maintenance frequency tab page, and then select OK. The current
date and time appears in the Date Performed column of each maintenance procedure as shown
in the figure below.

Figure 53 Initial maintenance record

3.7.3 Importing and Configuring Chemistry Parameters


Select Utility -> Chemistries -> Config F3.

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Figure 54 Chemistries screen

Select Options to display the Options window.

Figure 55 Chemistries screen

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

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Exit to close the window.

Figure 56 Import default chemistry parameters

Select Import and then select Exit. The default chemistry parameters are imported.

Figure 57 Select Import and Exit

Check the imported chemistries on the Chemistries screen.

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Figure 58 Check the imported chemistries

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OTY-12001 (2.0)

Chapter 4 System Performance Test

4.1 DCF Diagnosis


1. Enter Utility-Maintenance-Diagnostics- Photometer Diagnosis -DCF diagnosis.
2. Parameter settings: Set the Test Cycle as 20 and select Start to start the test.

3. Record the Relative Extreme Difference, which should be less than 1.5%.

Figure 59 DCF stability test

4.2 System check


Enter Utility-Maintenance-Diagnostics- System Diagnosis
Test index:
The system check should satisfy the following indices:
Item index
Substrate background SD<100
Sample Probe CV<1.5%
Reagent Probe CV<1.5%
Note: for system check, the index is Substrate background SD is smaller than 100,
reagent probe/sample probe CV<1.5%.

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Figure 60 System check


Select Background Test, Reagent Probe Test, and Sample Probe Test

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.

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Figure 62 Wait for results


The system starts the test automatically. The screen after test is as follows:

Figure 63 Result screen


In this case, substrate background SD=80<100, reagent probe repeatability 1.20%<1.5%, and
sample probe repeatability 0.96%<1.5%, all of which meet the requirements.

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4.3 Other Tests

4.3.1 Repeatability Test


Pick at least 1 item that will be test by user in the list below, finish the calibration at first.
Anti-Tg Anti-TPO LH HCG
HBsAg HIV Anti-TP Anti-HCV
Take a quality control as sample to perform 15 times repeatability test, the repeatability test
should satisfy the following indices:

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.

After the calibration test is completed, select this option again.

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Chapter 5 LIS and Remote Help

5.1 LIS Connection


The service engineer should assist the hospital in connecting the LIS software.

MINDRAY CONFIDENTI AL

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IVD Global Technical Support Dept.
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Appendix A Comparison of altitude and


atmospheric pressure

Altitude Atmospheric Pressure(kPa) Atmospheric Pressure(psi)


(m)
-400 105.9 15.4
-300 104.8 15.2
-200 103.6 15.0
-100 102.5 14.9
0 101.3 14.7
100 100.2 14.5
200 99.1 14.4
300 98.0 14.2
400 96.9 14.0
500 95.8 13.9
600 94.7 13.7
700 93.6 13.6
800 92.6 13.4
900 91.5 13.3
1000 90.5 13.1
1100 89.4 13.0
1200 88.4 12.8
1300 87.4 12.7
1400 86.4 12.5
1500 85.4 12.4
1600 84.4 12.2
1700 83.4 12.1
1800 82.4 12.0
1900 81.5 11.8
2000 80.5 11.7
2100 79.6 11.5
2200 78.6 11.4
2300 77.7 11.3
2400 76.8 11.1

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IVD Global Technical Support Dept.
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Altitude Atmospheric Pressure(kPa) Atmospheric Pressure(psi)


(m)
2500 75.9 11.0
2600 75.0 10.9
2700 74.1 10.7
2800 73.2 10.6
2900 72.3 10.5
3000 71.4 10.4
3100 70.6 10.2
3200 69.7 10.1
3300 68.9 10.0
3400 68.0 9.9
3500 67.2 9.7
3600 66.4 9.6
3700 65.6 9.5
3800 64.8 9.4
3900 64.0 9.3
4000 63.2 9.2
4100 62.4 9.0
4200 61.6 8.9
4300 60.8 8.8
4400 60.1 8.7
4500 59.3 8.6
4600 58.6 8.5
4700 57.8 8.4
4800 57.1 8.3
4900 56.4 8.2
5000 55.6 8.1

Document No.: ZSH-13090-CL-2000i&2200i

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