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H50/H50P

Automated Glycohemoglobin Analyzer

Service Manual
© 2016-2020 Shenzhen Mindray Bio-medical Electronics Co., Ltd. All rights Reserved.
For this Operator’s Manual, the issued Date is 2020-12.

Intellectual Property Statement


SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. (hereinafter called Mindray) owns
the intellectual property rights to this Mindray product and this manual. This manual may refer to
information protected by copyright or patents and does not convey any license under the patent rights
or copyright of Mindray, or of others.

Mindray intends to maintain the contents of this manual as confidential information. Disclosure of the
information in this manual in any manner whatsoever without the written permission of Mindray is
strictly forbidden.

Release, amendment, reproduction, distribution, rental, adaptation, translation or any other derivative
work of this manual in any manner whatsoever without the written permission of Mindray is strictly
forbidden.

, are the trademarks, registered or otherwise, of Mindray in China


and other countries. All other trademarks that appear in this manual are used only for informational
or editorial purposes. They are the property of their respective owners.

Responsibility on the Manufacturer Party


Contents of this manual are subject to changes without prior notice.

All information contained in this manual is believed to be correct. Mindray shall not be liable for errors
contained herein nor for incidental or consequential damages in connection with the furnishing,
performance, or use of this manual.

Mindray is responsible for the effects on safety, reliability and performance of this product, only if:

◼ all installation operations, expansions, changes, modifications and repairs of this product are
conducted by Mindray authorized personnel.
◼ the electrical installation of the relevant room complies with the applicable national and local
requirements.

◼ the product is used in accordance with the instructions for use.

I
WARNING
⚫ It is important for the hospital or organization that employs this equipment
to carry out a reasonable service/maintenance plan. Neglect of this may
result in machine breakdown or injury of human health.

⚫ Be sure to operate the system under the situation specified in this manual;
otherwise, the system will not work normally and the analysis results will be
unreliable, which would damage the system components and cause personal
injury.

NOTE
⚫ This equipment must be operated by skilled/trained clinical professionals.

Repair Service
◼ Free Service:

Free service is provided for any product within the scope specified by Mindray warranty rules.

◼ Paid Service:

Mindray offers paid service for any product beyond the scope specified by Mindray warranty rules;
Even during the warranty period, only paid service is available if the need for service is caused by the
following reasons: artificial damage; improper use; grid voltage beyond the specified range of the
device; irresistible natural disasters; replacement with parts and consumables not authorized by
Mindray or service work by personnel not authorized by Mindray.

Return Procedure
In the event that it becomes necessary to return this product or part of this product to Mindray, the
following procedure should be followed:
Obtain return authorization: Contact the Mindray Service Department and obtain a Customer Service
Authorization (Mindray) number. The Mindray number must appear on the outside of the shipping
container. Returned shipments will not be accepted if the Mindray number is not clearly visible. Please
provide the model number, serial number, and a brief description of the reason for return.
Freight policy: The customer is responsible for freight charges when shipping the product to Mindray
for service (including customs charges).

II
Service Contact
Company Name: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Company Address: Mindray Building, Keji 12th Road South, High-tech Industrial Park,
Nanshan, Shenzhen, 518057, P. R. China
Website: www.mindray.com
E-mail Address: service@mindray.com
Tel: +86 755 81888998
Fax: +86 755 26582680

EC-Representative: Shanghai International Holding Corp. GmbH(Europe)

Address: Eiffestraβe 80, Hamburg 20537, Germany

Tel: 0049-40-2513175

Fax: 0049-40-255726

III
Table of Contents

Chapter 1 Mechanical System ............................................................................................. 1-1


1.1 Mechanical System Composition(Standalone Instrument) ................................. 1-1
1.2 Mechanical System Composition (Instrument in the Sample Processing System) .. 1-6
1.3 Debug Screen Introduction ...................................................................................1-12
1.4 Sample Probe Position Adjustment.......................................................................1-14
Sample Probe Upper Position Adjustment .....................................................1-15
Mixing Bath Upper Position Adjustment .........................................................1-15
Autoloading Piercing Position Adjustment .....................................................1-16
Closed-Tube Piercing Position Adjustment ....................................................1-19
1.5 Gripper Position Adjustment .................................................................................1-21
1.6 Built-in Barcode Scanner Adjustment ...................................................................1-25
1.7 Replacing the FRU...............................................................................................1-35
Sample Collection Assembly .........................................................................1-35
CT Probe Wipe .............................................................................................1-39
Piercing Probe ..............................................................................................1-40
Mix bath Assembly ........................................................................................1-41
Syringe Assembly .........................................................................................1-42
Auto Mix Assembly .......................................................................................1-43
Tube Clamp ..................................................................................................1-44
Plunger Pump Assembly ...............................................................................1-46
Plunger Pump ...............................................................................................1-48
Waste Pump Assembly (Standalone Instrument) ...........................................1-48
Waste Pump Assembly (Instrument in the Sample Processing System).........1-50
Degasser Assembly (Applicable to version before EHK011 (May 5th, 2016)) ..1-51
Degasser Assembly 2 (Applicable to EHK011 (May 5th, 2016) and Later Version)
.....................................................................................................................1-53
Pulse Damper ...............................................................................................1-54
Rotation Feeding Valve .................................................................................1-56
Cisterns (Standalone Instrument) ..................................................................1-57
Waste Cistern (Instrument in the Sample Processing System).......................1-58
Autoloader ....................................................................................................1-60
Sample Compartment Assembly ...................................................................1-62
Unload Unit...................................................................................................1-64
Temperature Control Assembly .....................................................................1-65
Filter Assembly (Standalone Instrument) .......................................................1-66

1
Table of Contents

Filter Assembly (Instrument in the Sample Processing System) .....................1-67


Top Left Cover Assembly (H50) .....................................................................1-73
Touchscreen .................................................................................................1-74
Pinch Roller Assembly (Instrument in the Sample Processing System) ..........1-75
Barcode Scanner Assembly (Instrument in the Sample Processing System)..1-76
1.8 List of FRUs for Replacement...............................................................................1-77
Chapter 2 Fluidic System..................................................................................................... 2-1
2.1 Introduction ........................................................................................................... 2-1
Sample Preparation Channel (Standalone Instrument) ................................... 2-2
Sample Preparation Channel (Instrument in the Sample Processing System) . 2-3
Chromatographic Channel (Standalone Instrument) ....................................... 2-4
Chromatographic Channel (Instrument in the Sample Processing System) ..... 2-5
Temperature Control Unit ............................................................................... 2-6
Reagent Management (Standalone Instrument) ............................................. 2-7
Reagent Management (Instrument in the Sample Processing System) ........... 2-9
Dynamic Sampling ........................................................................................2-10
2.2 Reagent System .................................................................................................. 2-11
2.3 Fluidic Components and Functions.......................................................................2-12
Degasser (Applicable to version before EHK011 (May 5th, 2016)) ..................2-12
Bubble Trap (Applicable to EHK011 (May 5th, 2016) and Later Version) ........2-13
Plunger Pump ...............................................................................................2-14
Pulse Damper ...............................................................................................2-15
Feeding Valve/Rotation Valve........................................................................2-17
Analytical Column .........................................................................................2-19
Filter and Filter Element ................................................................................2-20
Back Pressure Sensor ..................................................................................2-20
Temperature Control of the Analytical Column ...............................................2-21
Temperature Control of the Optical System ...................................................2-22
Other Fluidic Components ............................................................................2-23
2.4 Fluidic Sequences (Standalone Instrument) .........................................................2-34
Startup Sequence .........................................................................................2-34
Whole Blood Analysis Mode ..........................................................................2-37
Predilute Analysis Mode ................................................................................2-38
Probe Cleanser Maintenance Sequence .......................................................2-39
2.5 Fluidic Sequences (Instrument in the Sample Processing System) .......................2-42
Startup Sequence .........................................................................................2-42
Whole Blood Analysis Mode ..........................................................................2-44
Prediluted Analysis Mode ..............................................................................2-48

2
Table of Contents

Probe Cleanser Maintenance Sequence .......................................................2-49


Chapter 3 Optical System .................................................................................................... 3-1
3.1 Overview of Optical System Principle .................................................................... 3-1
3.2 Optical System Operating Principle ....................................................................... 3-1
3.3 Optical System Composition ................................................................................. 3-2
3.4 Optical System Status Determination .................................................................... 3-2
3.5 Maintenance and Replacement of the Optical System ........................................... 3-3
3.6 Optical System Status Verification after Maintenance or Replacement ................... 3-5
Adjusting gains of the channels ...................................................................... 3-5
Chapter 4 Hardware System ................................................................................................ 4-1
4.1 Structure of Hardware System............................................................................... 4-1
4.2 Hardware System Signal Flow Chart ..................................................................... 4-3
4.3 List of Hardware Major PCBA and Cables ............................................................. 4-4
Components of main boards .......................................................................... 4-4
Cables ........................................................................................................... 4-5
4.4 Distribution Diagram of Power Supplies................................................................. 4-7
4.5 Introduction to the Hardware Boards ..................................................................... 4-7
Main Control Board ........................................................................................ 4-7
Analog Drive Board.......................................................................................4-12
Autoloader Board ..........................................................................................4-17
Preamplification Board ..................................................................................4-21
LED Drive Board ...........................................................................................4-25
Liquid Pressure Detection Board ...................................................................4-28
Touch Screen Control Board .........................................................................4-29
Indicator Board .............................................................................................4-30
Power Patching Board ..................................................................................4-33
RFID Card Reader ........................................................................................4-34
Display Screen Assembly..............................................................................4-35
Key Board.....................................................................................................4-36
Power Supply Assembly................................................................................4-37
4.6 Service Instructions for Other Parts Closely-Related To Hardware ........................4-38
Sensors ........................................................................................................4-38
Hydraulic Sensor ..........................................................................................4-39
Temperature Sensors....................................................................................4-40
Degasser ......................................................................................................4-40
Rotary Feeding Valve....................................................................................4-40
Chapter 5 Software .............................................................................................................. 5-1
5.1 Introduction ........................................................................................................... 5-1

3
Table of Contents

5.2 Password .............................................................................................................. 5-1


User Access Level Definition .......................................................................... 5-1
Preset User Information ................................................................................. 5-3
Add user ........................................................................................................ 5-4
Delete user .................................................................................................... 5-4
5.3 Functions of Service Access Level ........................................................................ 5-5
Menu Structure Overview............................................................................... 5-5
Repeatability test ........................................................................................... 5-6
Carryover test ................................................................................................ 5-7
Fluidic Volume Calibration.............................................................................. 5-9
Temperature Calibration ................................................................................ 5-11
Pressure Calibration .....................................................................................5-13
Advanced Setup ...........................................................................................5-14
Empty/Prime .................................................................................................5-15
Self-Test .......................................................................................................5-16
HPLC Self-Test .............................................................................................5-21
Debug->Sample Probe .................................................................................5-24
Debug-> Barcode Scanner............................................................................5-26
Adjustment->Export Debug Data...................................................................5-27
Status ...........................................................................................................5-28
View vulnerable parts info. ............................................................................5-29
5.4 Analyzer Update ..................................................................................................5-29
Notes before Update .....................................................................................5-29
Update Steps ................................................................................................5-30
5.5 LIS Setup .............................................................................................................5-35
Function Entry ..............................................................................................5-35
Screen ..........................................................................................................5-35
5.6 Error Code ...........................................................................................................5-36
Chapter 6 H50/H50P Active Maintenance Report ................................................................ 6-1
6.1 Checking Basic Status .......................................................................................... 6-1
6.2 Verification ............................................................................................................ 6-3
Repeatability Test Result ................................................................................ 6-3
Chromatogram Verification............................................................................. 6-3
Appendix ................................................................................................................................... A-1

4
Chapter 1 Mechanical System

1.1 Mechanical System Composition (Old Standalone


Instrument)
On the front of the analyzer, you will find the autoloader, the screen, buttons, etc., inside the
autoloader; there is the sample compartment assembly. Open the left cover, you will find reagent
bags.

Figure 1-1 Front of the analyzer

No. Name No. Name


1 Touchscreen 5 Autoloader
2 Button 6 Sample compartment
3 Tube 7 Left cover (with reagent bags in it)
4 Tube rack 8 Power Switch

1-1
Mechanical System

On the back of the analyzer, you will find the AC input, waste outlet, USB and network interfaces.

Figure 1-2 Back of the analyzer

No. Name No. Name


1 AC input 4 USB interface 1
2 Waste sensor connector 5 USB interface 2
3 Waste outlet 6 Network interface

1-2
Mechanical System

Open the front cover of the analyzer, you will find the sample collection assembly, rotation valve
module, analytical column module, plunger pump module and autoloading module. Open the left
cover, you will find the reagent module.

Figure 1-3 Front of the analyzer (without front cover)

No. Name No. Name


1 Rotation valve module 4 Sample collection assembly
2 Column module 5 Autoloading module
3 Plunger pump 6 Reagent module

1-3
Mechanical System

Open the right cover, you will find the optical module, syringe module, bath assembly, waste pump
assembly, degasser assembly and mix assembly. The optical module is in the upper part of the
analyzer and the bath assembly is inside the right cover.

Figure 1-4 Right side of the analyzer (right door open)

No. Name No. Name


1 Optical module 4 Waste pump assembly
2 Syringe module 5 Degasser assembly
3 Bath assembly 6 Mixing assembly

1-4
Mechanical System

Open the back door of the analyzer, you will find the drive board PCB, autoloader board and the main
control board.

Figure 1-5 Back of the analyzer (back door open)

No. Name No. Name


1 Drive board PCB 3 Main control board
2 Autoloader board

1-5
Mechanical System

1.2 Mechanical System Composition (Instrument in the


Sample Processing System and New Standalone
Instrument)

Instrument in the Sample Processing System and New

Standalone Instrument
On the front of the analyzer, you will find the barcode scanner, the screen, buttons, etc., open the left
cover, you will find reagent bags.

4
5

Figure 1-6 Front of the analyzer

No. Name No. Name


1 Touch screen 2 Button
3 Scanner 4 Left cover (with reagent bags installed
inside)
5 Power switch

1-6
Mechanical System

On the back of the analyzer, you will find the AC input, waste outlet, USB and network interfaces.

5 4 3 2 1

Figure 1-7 Back of the analyzer

No. Name No. Name


1 AC input 4 USB port 1
2 Waste sensor socket 5 USB port 2
3 Waste connector 6 Network interface

1-7
Mechanical System

Open the front cover of the analyzer in the sample processing system, you will find the rotation valve
module, analytical column module, pincher roller assembly, plunger pump module, barcode scanner
assembly, and sampling assembly. Open the left cover, you will find the reagent module.

7
5

Figure 1-8 Front of the analyzer (without front cover)

No. Name No. Name


1 Rotation valve module 5 Barcode scanner assembly
2 Analytical column module 6 Sampling assembly
3 Pincher roller assembly 7 Reagent module
4 Plunger pump module

1-8
Mechanical System

Open the right cover, you will find the optical module, syringe module, bath assembly, waste pump
assembly, degasser assembly and mix assembly. The optical module is in the upper part of the
analyzer and the bath assembly is inside the right cover.

1 2

5 4

Figure 1-9 Right side of the analyzer (right door open)

No. Name No. Name


1 Optical system module 4 Waste pump assembly
2 Syringe module 5 Degasser assembly
3 Bath assembly module 6 Mix assembly

1-9
Mechanical System

Open the back door of the analyzer, you will find the drive board PCB, autoloader board and the main
control board.

Figure 1-10 Back of the analyzer (back door open)

No. Name No. Name


1 Drive board PCB 3 Main control board
2 Autoloader board

1-10
Mechanical System

The appearance of the analyzer is shown below (the bottom left cover of analyzer in sample
processing system and new standalone analyzer are different; the appearance of new standalone
analyzer and old standalone analyzer is the same).

1 2 3

Figure 1-11 Appearance of the analyzer in sample processing system

1 2 3

4
7

Figure 1-12 Appearance of new standalone analyzer main part

No. Name No. Name


1 Top left cover assembly (H50) 5 Bottom right cover assembly
2 Top cover 6 Bottom left cover
3 Top right cover assembly (H50) 7 Left cover (H50)
4 Right door (H50)

1-11
Mechanical System

New Standalone Instrument


The new standalone instrument is mainly composed of main unit, autoloader and other parts. And the
sample housing assembly is inside the autoloader. Please refer to 1.2.1 for the appearance of new
standalone instrument.

Figure 1-13 Appearance of new standalone analyzer

No. Name No. Name


1 Main unit 2 tube
3 Tube rack 4 autoloader
5 Sample housing assembly
The autoloader and the main unit of the new standalone analyzer are connected by connection board
and longitudinal beam of bearer.

1-12
Mechanical System

4
Figure 1-14 Connection between autoloader and main unit of new standalone analyzer

No. Name No. Name


1 Main unit 2 Autoloader
3 Connection board 4 longitudinal beam of bearer

1-13
Mechanical System

1.3 Debug Screen Introduction


If any part of the sampling assembly or the autoloader is replaced, it is necessary to check and adjust
the mechanical positions (Sample probe upper position, mixing bath upper position, autoloading
piercing position, closed-tube piercing position, and manipulator pinching position).
The adjustment can be completed on the "Debug" screen.
Tap "Menu → Service→ Debug → Sample Probe" to enter the "Debug" screen.

Note 1: after tapping "Start", the assembly should be at the default position instead of the adjusted
position, and the button changes into "Save". The adjustment only takes effect if you tap "Save" after
the adjustment. The "Check" button is used to simulate the actions in normal sample analysis process.
Remember to remove the fixtures as instructed.
Note 2: Select “Fine Adjust” or “Coarse Adjust” on the bottom of the screen. When "Fine Adjust” is
selected, it means the current state of motor adjustment is “Fine Adjust", the motor moves 2 steps by
one tap; when the button shows "Coarse Adjust", it means the current state of motor adjustment is
“Coarse Adjust", the motor moves 20 steps by one tap.
Note 3: in the horizontal movement of the sampling assembly, the stride of one step is 0.16mm; in
vertical movement, 0.04mm.

1.4 Sample Probe Position Adjustment


The adjustment of sample probe positions includes the following contents:
◼ Sample probe upper position (probe wipe position)

◼ Mixing bath upper position

◼ Autoloading piercing position


◼ Closed-tube piercing position

Note: the "Sample Probe Up Position" variation is included in the formula of autoloading and closed-

1-14
Mechanical System

tube piercing position step calculation. Therefore, sample probe up position adjustment is of the
first priority; if you adjust the autoloading/closed-tube piercing position first, further adjustment is
needed after the sample probe up position adjustment, since the change of the sample probe up
position will lead to the change of the autoloading and closed-tube piercing positions.
The adjustment tools include:

◼ Cross-headed screwdriver
◼ Ruler

◼ Fitting pin or sample probe up position fixture

Sample Probe Upper Position Adjustment


Adjustment: select "Sample Probe Adjustment →Sample Probe Upper Pos.", and then tap "Start".
Use the "Up" and "Down" buttons to adjust the sample probe tip to be level with the bottom surface
of the probe wipe.
Check: tap "Save", and then "Check". Use the sample probe wipe up position fixture to check the
adjusted position as instructed by the figures below:

Applicable to
Applicable to
closed-
open-sampling
sampling type
type

Since the aspirating aperture positions of the sample


probe are different between the open-sampling type
and closed-sampling type, the verification fixtures to
verify the sample probe upper position are also
different. Remember to distinguish the 2 fixtures.
The fixture has 2 ends, one is longer and the other is
shorter.

If the requirements are not met, adjust again using the "Up" and "Down" buttons.
If there is no fixture, use a ruler and a fitting pin to have a check. The probe tip should be 7.2 ± 0.2mm
from the bottom of the probe wipe.

Mixing Bath Upper Position Adjustment


Select "Sample Probe Adjustment →Mix Bath Upper Pos.", and then tap "Start" to make the sample
probe above the mixing bath. Make sure the sample probe is in the center of the mixing bath, and the
distance between the sample probe tip and the top of the mixing bath is 12 mm. If the sample probe
does not meet the requirement:

1-15
Mechanical System

1. Select "Sample Probe Adjustment →Mix Bath Upper Pos.", and then tap "Start". Then use the
"Forward" and "Backward" buttons to adjust the sample probe position in the front-to-back
position, use the “Upward” and “Downward” buttons to adjust the sample probe position in the
vertical direction. When the adjustment finishes, tap "Save", and then "Check", to confirm the
mixing bath sampling position.
2. Exit the “Debug” screen, put a 12X75 anticoagulant evacuated collection tube into the tube rack,
and run a count cycle. Make sure that the sample probe does not touch the bath during the
mixing.

Autoloading Piercing Position Adjustment


◼ Autoloader lengthwise and broadwise adjustment (mechanical method)

◼ Sample probe lengthwise adjustment (software method)

◼ Sample probe vertical adjustment (software method)


Where the first 2 steps influence the centering for piercing (deviated piercing), and step 3 influences
the minimum aspiration volume.
Detailed procedures are as follows:
1. Take a tube rack, and place a 12X75 evacuated blood collection tube in the rack. Load and feed
the tube rack on the “Autoloader” screen until the collection tube is at the autoloading piercing
position. For the standalone instrument, make sure the 2 tube rack pinch rollers seize the rack;
for the instrument in the sample processing system, make sure tightly fix the tube rack.
2. On the "Sample Probe Adjustment" screen, choose the “AL Piercing Pos.”, then tap the "Check"
button, then the sample probe starts piercing the evacuated blood collection tube in the rack.

Check if the pierced position is at the center of the tube cap (you can cover the tube cap with adhesive
tape for easier check) without obvious deviation. If it does not meet the requirement, tap "Return",
and the sample probe will withdraw from the tube. Adjust as instructed below:

1.4.3.1 Old Standalone Instrument


1) For deviation to left or right
a. Remove the 3 screws fixing the autoloader, and make the autoloader closely touches the
front plate. Move the autoloader to left/right, and secure the screws after the adjustment.

1-16
Mechanical System

Left Screw Middle Screw


Right screw

2) For deviation to front or back, check if the main unit front plate closely touches the
autoloader/track (mechanical method), then adjust the position of the sample probe using the
"Forward" and "Backward" buttons on the "Debug" screen.
3) After the adjustment, tap "Check" to check if the piercing position is at the center.
Remove the tube cap of the evacuated blood collection tube and put it back into the tube rack. On
the "Sample Probe Adjustment" screen, choose the “AL Piercing Pos.”, then tap the "Check" button,
then the sample probe starts piercing the evacuated blood collection tube in the rack. Put the
evacuated blood collection tube upward manually, and make the probe tip touch the bottom of the
tube. Check if the tube is 3-5mm higher (you can mark on the exterior wall of the tube)

1.4.3.2 New Standalone Instrument


1) For deviation to left or right: remove the 3 screws fixing the autoloader and the 2 screws fixing
the autosampler’s dowel assemblies, and make the autoloader closely touches the front plate.
Move the autoloader to front/back, and secure the 5 screws after the adjustment.

Left Screw Middle Screw


Right screw

1-17
Mechanical System

2 screws fixing the


autosampler s dowel
assembly
2) For deviation to front or back: check if the main unit front plate closely touches the
autoloader/track (mechanical method), then adjust the position of the sample probe using the
"Forward" and "Backward" buttons on the "Debug" screen.
3) After the adjustment, tap "Check" to check if the piercing position is at the center.
Remove the tube cap of the evacuated blood collection tube and put it back into the tube rack. On
the "Sample Probe Adjustment" screen, choose the “AL Piercing Pos.”, then tap the "Check" button,
then the sample probe starts piercing the evacuated blood collection tube in the rack. Put the
evacuated blood collection tube upward manually until the probe tip touch the bottom of the tube.
Check if the tube is 3-5mm higher (you can mark on the exterior wall of the tube).

1.4.3.3 Instrument on the Sample Processing System


1) For deviation to left/right: remove the 4 screws fixing the main unit locating piece. Move the main
unit locating piece to left/right, and secure the 4 screws after the adjustment.

1-18
Mechanical System

Mai n uni t
locating block

2) For deviation to front or back: check if the main unit front plate closely touches the
autoloader/track (mechanical method), then adjust the position of the sample probe using the
"Forward" and "Backward" buttons on the "Debug" screen.
3) After the adjustment, tap "Check" to check if the piercing position is at the center.
Remove the tube cap of the evacuated blood collection tube and put it back into the tube rack. On
the "Sample Probe Adjustment" screen, choose the “AL Piercing Pos.”, then tap the "Check" button,
then the sample probe starts piercing the evacuated blood collection tube in the rack. Put the
evacuated blood collection tube upward manually until the probe tip touch the bottom of the tube.
Check if the tube is 3-5mm higher (you can mark on the exterior wall of the tube).

Closed-Tube Piercing Position Adjustment


◼ Sample compartment broadwise and lengthwise adjustment (mechanical method)

◼ Sample probe lengthwise adjustment (software method)

◼ Sample probe vertical adjustment (software method)


Where the first 2 steps influence the centering for piercing (deviated piercing), and step 3 influences
the minimum aspiration volume.
Detailed procedures are as follows:
1. Place a 12X75 evacuated blood collection tube into the assorted 13X75 adapter.
2. On the "Sample Probe Adjustment" screen, choose the “CT Piercing Pos.”, then tap the "Check"
button, and the sample probe starts piercing the cap of the evacuated blood collection tube in
the adapter.

1-19
Mechanical System

Check if the pierced position is at the center of the tube cap (you can cover the tube cap with adhesive
tape for easier check) without obvious deviation. If it does not meet the requirement, tap "Return",
and the sample probe will withdraw from the tube. Adjust as instructed below:
1) For deviation to left or right, remove the 3 screws fixing the sample compartment, and check if
the distance between the center of the compartment and the front plate is 117.5mm, move the
compartment to left/right, and secure the screws after the adjustment.

Two screws on
One s crew on the right
the left

2) For deviation to front or back, check if the distance between the center of the compartment and
the front plate is 117.5 mm, and adjust the position of the sample probe using the "Forward" and
"Backward" buttons on the "Debug" screen.
3) After the adjustment, tap "Check" to check if the piercing position is at the center.
Remove the tube cap of the evacuated blood collection tube and put it back into the adapter. On
the "Sample Probe Adjustment" screen, choose the “CT Piercing Pos.”, then tap the "Check"
button, and the sample probe starts piercing the cap of the evacuated blood collection tube in
the adapter. Put the evacuated blood collection tube upward manually, and make the probe tip
touch the bottom of the tube. Check if the tube is 3-5mm higher (you can mark on the exterior
wall of the tube)

1-20
Mechanical System

1.5 Gripper Position Adjustment


1. The mixing assembly position needs to be confirmed and adjusted again after being removed or
installed.
◆ Mixing assembly installation and adjustment (mechanical)
◆ Manipulator position adjustment (software: left/right, front/back, up/down)
2. If the mixing gripper is removed or installed, the mixing assembly position also needs to be
confirmed and adjusted again
◆ Gripper position adjustment (mechanical)
◆ Gripper position adjustment (software: left/right, front/back, up/down)
Detailed procedures are as follows:
1. Get a tube rack, and transport it manually until the 2 tube rack pinch rollers seize the rack.
2. On the "Sample Probe Adjustment" screen, select "Mix Mechanism", and then tap "Initialize →
X Forward". The manipulator moves out to the above of the tube rack. Check visually that the
gripper is aligned with the center of the tube position in the left-to-right and front-to-rear directions.
And make sure the gap between the gripper and the top surface of the tube rack is 2mm.

3. If position in the left-to-right direction does not meet the requirement, loosen the 4 M4X8 cross-
recessed pan head screws, and then move the mixing assembly to left/right until the manipulator
is aligned with the center of the tube position, and then secure the screws.

4 M4X8 cross-
recessed panhead
screws

Pin

Check visually that the


pincher is aligned with
the center of the tube

Note 1: prevent from deformation while moving the mixing assembly, and adjust the pin in the
assembly if necessary.
Note 2: after the screws are secured, the position of the mixing assembly may change, and you need

1-21
Mechanical System

to check the pincher position again.

4. If position in the front-to-back direction does not meet the requirement


a) For the new gripper assembly (115-064325-00), configuring the new rotation axis (longer,
no threaded hole in the front) and the old one (shorter, a threaded hole in the front, and two
sides of it are made flat) will use the same adjustment method. Tap the “Upward” button in
the “Manipulator Pos.” section, loosen the two M3X10 stainless-steel inner hexagon screws
used to fix the gripper, then move the gripper forward/backward until the manipulator is
aligned with the center of the tube position, and then secure the screws.

Loosen the 2 inner


The old rotation
hexagon screws.
axis, a threaded
The new rotation
hole in the front,
axis, no threaded
and two sides of it
hole in the front.
are made flat.

b) For the old gripper assembly (115-006303-00) and old rotation axis, use a retaining screw
on the top of the old tube clamp and a M3X10 stainless-steel inner hexagon screw in the
front of the rotation axis to fix them together. And the manipulator location can’t be adjusted
forward or backward.

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Mechanical System

An inner
hexagon screw
and a retaining
screw

c) Note: the old gripper assembly can’t be installed on the new rotation axis. Because the new
rotation axis is fixed with only one retaining screw, then the old gripper can’t be locked tightly.
5. If the vertical direction does not meet the requirement
On the “Manipulator Pos.” screen, tap the “Upward” or “Downward” buttons to adjust the manipulator
in the vertical direction. After the adjustment is completed and saved, go back to the “Mix Mechanism”
screen to confirm the height.

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Mechanical System

The gap between the


gripper and the top
surface of the tube
rack is 2mm

6. Select "X Backward", and place a 12X75 tube into the tube position the gripper aims at. Check
the relative state of the tube after it is placed back using the X direction, Z direction, and “Mix”
buttons. It is required there should be no interference in the tube pinching and mixing processes,
and all actions should be completed smoothly.

No interference, and
all actions are
completed smoothly. If
the manipulator
position is not correct,
adjust using the
buttons in the
"Manipulator Pos . "
area.

If the requirement is not met, adjust the manipulator position using the buttons in the "Manipulator
Pos." area. After the adjustment, go back to the "Autoloader" screen and check.
Make the underside of the gripper at least 2mm higher than the topside of the tube rack using the
“Upward” and “Downward” buttons.

1-24
Mechanical System

2mm

1.6 Built-in Barcode Scanner Adjustment

Old Standalone Instrument


1. Take a tube rack, load and feed the tube rack on the “Autoloader” screen. Make sure the 2 tube
rack pinch rollers seize the rack. Tap “Service -> Debug -> Scanner”, then tap “Scanner On”, and
the barcode scanner beams.

2. Place a piece of paper right before the tube rack, and observe the reflection of the beam on the

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Mechanical System

paper. The beam should be aligned with the center of the tube position notch.

3. If the requirement is not met, loosen the 2 M3X8 pan head screws, and manually adjust the
position of the beam. After the adjustment is successful, re-secure the screws. After the screws
are secured, re-check the position of the beam.

Loosen the two


screws to adjust
the position of the
built-in barcode
scanner.

New Standalone Instrument


1. Take a tube rack, load and feed the tube rack on the “Autoloader” screen. Make sure the 2 tube
rack pinch rollers seize the rack. Tap “Service -> Debug -> Scanner”, then tap “Scanner On”, and
the barcode scanner beams.

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Mechanical System

2. Place a piece of paper right before the tube rack, and observe the reflection of the beam on the
paper. The beam should be aligned with the center of the tube position notch.

3. If the requirement is not met, loosen the 4 screws fixing the scanner (the 2 M3X8 pan head
screws and the 2 M3X4 cross recess pan head screws), spacer of 3.2 mm in diameter and spring
washer of 3.1 mm in diameter. Manually adjust the position of the beam. After the adjustment is
successful, re-secure the screws. After the screws are secured, re-check the position of the beam.
Note: as the M3X4 screws and their spacer and spring washer are very small, and are not easy
to take out when they fall into the autoloader, don’t remove them from the built-in scanner.

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Mechanical System

Loosen the 4
screws to
adjust the
position of the
Built-in
barcode
scanner

Instrument in the Sample Processing System


1. Take a tube rack, load and feed Tube Racks. Make sure the 2 tube rack pinch rollers seize the
rack. Tap “Service>Debug>Sample Probe>Autoloader>Scanner Unit”, then tap “Scanner On”,
the barcode scanner beams.

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Mechanical System

2. Place a piece of paper right before the tube rack, and observe the reflection of the beam on the
paper. The beam should be aligned with the center of the tube position notch.

3. If the requirement is not met, loosen the 4 screws fixing the scanner (the 2 M3X8 pan head
screws and the 2 M3X4 cross recess pan head screws), spacer of 3.2 mm in diameter and spring
washer of 3.1 mm in diameter. Manually adjust the position of the beam. After the adjustment is
successful, re-secure the screws. After the screws are secured, re-check the position of the beam.
Note: as the M3X4 screws and their spacer and spring washer are very small, and are not easy
to take out when they fall into the autoloader, don’t remove them from the built-in scanner.

Loosen the 4
screws to
adjust the
position of the
Built-in
barcode
scanner

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Mechanical System

1.7 Pincher Roller Assembly (Instrument in Sample


Processing System)
Before adjustment, make sure the initial feed position of the track pusher, and the relative position of
sample probe and autoloader’s dowel pin hole meet the requirements.
1. Manually rotate the two driven wheels of the scanner assembly’s pincher roller and make sure
they can roll smoothly without any stoppage.

2. Put an empty tube into the tube rack and place the tube rack on the buffer area of the loading
tray.

3. Tap “Menu>Service>Debug>Sample Probe>Autoloader" to enter the “Autoloader" screen.

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Mechanical System

4. Tap “Initialize” on the “Autoloader” screen to initialize the autoloader. Tap “Load>Feed” to feed
the empty tube to the rotation scanning position. Tap “Press Tube Rack”.

5. Tap “Initialize” on the “Scanning Unit” screen to initialize the scanner unit position. Tap “Fix
Tube>Release Tube” repeatedly to check whether the tube is at the center of the scanner unit.
Note: do not release the tube rack in this process.

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Mechanical System

6. If the tube is not at the center of the scanner unit, loose the screws of the pincher roller assembly
and move the position of the pincher roller assembly. Then secure the screws of the pincher
roller.

Screws of
pincher roller

New Standalone Instrument


1. Take a tube rack, load and feed the tube rack on the “Autoloader” screen. Make sure the 2 tube
rack pinch rollers seize the rack. Tap “Service -> Debug -> Scanner”, then tap “Scanner On”, and
the barcode scanner beams.

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Mechanical System

2. Place a piece of paper right before the tube rack, and observe the reflection of the beam on the
paper. The beam should be aligned with the center of the tube position notch.

3. If the requirement is not met, loosen the 4 screws fixing the scanner ( the 2 M3X8 pan head
screws and the 2 M3X4 cross recess pan head screws), spacer of 3.2 mm in diameter and spring
washer of 3.1 mm in diameter. Manually adjust the position of the beam. After the adjustment is
successful, re-secure the screws. After the screws are secured, re-check the position of the beam.
Note: as the M3X4 screws and their spacer and spring washer are very small, and are not easy
to take out when they fall into the autoloader, don’t remove them from the built-in scanner.

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Mechanical System

Loosen the 4
screws to
adjust the
position of the
Built-in
barcode
scanner

Instrument on the Sample Processing System


1. Take a tube rack, load and feed Tube Racks. Make sure the 2 tube rack pinch rollers seize the
rack. Tap “Service -> Debug -> Scanner”, then tap “Scanner On”, and the barcode scanner
beams.

2. Place a piece of paper right before the tube rack, and observe the reflection of the beam on the
paper. The beam should be aligned with the center of the tube position notch.

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Mechanical System

3. If the requirement is not met, loosen the 4 screws fixing the scanner ( the 2 M3X8 pan head
screws and the 2 M3X4 cross recess pan head screws), spacer of 3.2 mm in diameter and spring
washer of 3.1 mm in diameter. Manually adjust the position of the beam. After the adjustment is
successful, re-secure the screws. After the screws are secured, re-check the position of the beam.
Note: as the M3X4 screws and their spacer and spring washer are very small, and are not easy
to take out when they fall into the autoloader, don’t remove them from the built-in scanner.

Loosen the 4
screws to
adjust the
position of the
Built-in
barcode
scanner

1.8 Replacing the FRU

Sample Collection Assembly


◼ Tools
NO.107 cross-head screwdriver
◼ Removal

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Mechanical System

1. Remove the right door;


2. Revolve to open the top left cover assembly.
3. Remove the 2 M4X8 screws that fix the bath integrating assembly and the front cover, revolve
and open the bath integrating assembly.
4. Take off the line connectors at the end of the drag chain.
5. Move the Y movement assembly horizontally to the center to reveal the 4 M4X8 screws.
6. Remove the 4 M4*8 screws.
7. Move the assembly horizontally until it is away from the pinholes, and then take it out from the
opening of the front cover.
8. Replace the sampling assembly and align the pinholes, and then mount the 4 M4*8 screws.

1 2 3

No. Name No. Name


1 Top left cover assembly 4 Bath integrating assembly
2 The M4X8 screw of the sample collection 5 Sample collection assembly
assembly
3 The M4X8 screw of the bath assembly

◼ Debug:

See the autoloader debug procedure for details.

1.8.1.1 Structure of the sample collection assembly


The sample collection assembly aspirates, dispenses and mixes sample, and drives the sample probe
to move on two directions.

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Mechanical System

Figure 1-15 Structure of the sample collection assembly

The X mechanism consists of the horizontal bracket, X guide rod, guide rod clamp, synchronous belt
and belt pulley, X initial-position sensor and motor. There are detecting notches in the horizontal
bracket, which correspond to the X direction sensors for position detection.

Figure 1-16 X mechanism of the sample collection assembly

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Mechanical System

Figure 1-17 Y mechanism of the sample collection assembly

The sample probe is driven by the pierce slide; rotation motion of the motor is transferred to rectilinear
motion of the pierce slide through the driving of the screw-nut pairs, and the pierce slide then drives
the Y direction motion of the sample probe, directed by the guiding shaft. The Y initial position sensor
is installed in the pierce bracket; the baffle structure of the pierce slide serves as sensor baffle to
realize Y direction positioning of the sample probe.

1-38
Mechanical System

CT Probe Wipe
◼ Tools

Tweezers

◼ Removal
1. Rise the piercing probe to the top until the probe wipe is almost away from the sample probe.
2. Remove the circlip above the probe wipe manually.
3. Move the probe wipe down to take it off the sample probe.
4. Take off the waste and diluent pipes from the pipe fixing seat, and pull out the pipes connecting
to the probe wipe with tweezers.
5. Replace the CT probe wipe, connect the waste and diluent pipes and install them back to the
pipe fixing seat, and then mount the probe wipe back to the piercing bracket and install the probe
wipe circlip.

1-39
Mechanical System

No. Name No. Name


1 Piercing probe 4 Piercing bracket
2 CT probe wipe 5 Pipe fixing seat
3 Probe wipe circlip

Piercing Probe
◼ Tools

NO.107 cross-head screwdriver

◼ Removal

1. Rise the piercing probe to the top until the probe wipe is almost away from the sample probe.
2. Remove the circlip above the probe wipe manually, and move the probe wipe down to take it off
the sample probe.
3. Remove the M3*8 screws in the fixing plate of the sample probe and take of the fixing plate.
4. Take out the piercing probe from the opening.
5. Replace the piercing probe, put the probe through the hole of the bracket, make sure the flat part
of the probe is align with the plane of the piercing slide, and then install the fixing plate back.
6. Install the CT probe wipe and its circlip back.

1-40
Mechanical System

No. Name No. Name


1 Piercing probe 4 Probe wipe circlip
2 Piercing bracket 5 Sample probe fixing plate
3 CT probe wipe 6 M3X8 composite screw

Mix bath Assembly


◼ Tools

M3 inner hexagon spanner, NO.107 cross-head screwdriver

◼ Removal

1. Remove the right door.


2. Remove the 2 M4X8 screws that fix the bath integrating assembly and the front cover, revolve
and open the bath integrating assembly.
3. Remove the M3*10 inner hexagon screws of the mix bath assembly, and take off the assembly.
4. Replace the mix bath assembly, align the screw to the pinhole in the partition and tighten the
screw.

1-41
Mechanical System

No. Name No. Name


1 Mix bath assembly 2 M3x10 inner hexagon screw

◼ Validation

Enter the "Service" →"Debug “→”Sample Probe Adjustment" screen, tap "Check" to see if the
sample probe is in the center of the mix bath; if not, further adjustment is needed.

Syringe Assembly
◼ Tools

NO.107 cross-head screwdriver, inner hexagon spanner, slot-headed screwdriver.

◼ Procedure

There are 2 syringe assemblies in the analyzer, which are the 100ul syringe assembly and 2.5ml
syringe assembly. The 2 syringe assemblies are both installed on the syringe mounting plate.
1. Remove the right door.
2. Remove the 2 M4 screws that fix the bath integrating assembly, revolve and open the bath
integrating assembly.
3. Disconnect all tubes connected to the syringe, remove the earthing screws (M3) and pinching
screws of the syringe with NO.107 cross-head screwdriver, pull the syringe outward a little and
disconnect the sensor motor lines at the back of the syringe, and the syringe can be removed
from the analyzer.
4. To replace the 2 syringes together, remove the screw of the syringe mounting plate with No. 107
cross-head screwdriver.

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Mechanical System

◼ Prime

1. After replacement, enter the software screen, tap “Setup→Empty/Prime” to prime the tubes.
2. Tap “HWS Channel” to perform the priming.

No. Name No. Name


1 M4 screw 5 M3X10 panhead screw
2 Syringe mounting plate 6 100ul syringe (lateral)
3 100ul syringe assembly 7 2.5ml Mindray syringe (fluororubber)
4 2.5ml syringe assembly

Auto Mix Assembly


◼ Tools

NO.107 cross-head screwdriver

◼ Procedure

1. Remove the right door.


2. Remove the 2 M4 screws that fix the bath integrating assembly, revolve and open the bath
integrating assembly.
3. Left revolve to open the top left cover assembly, and right revolve to open the top right cover
assembly.
4. Remove the 2 M4*8 screws in the bottom right cover with NO.107 cross-head screwdriver to
take off the bottom right cover.
5. Remove the 4 M4*8 screws with the NO.107 cross-head screwdriver.
6. Move the auto mix assembly away from the pinhole and take it out from the right side of the
analyzer; while taking it out, do not scrap other components.

1-43
Mechanical System

1 2 3 4 5

Figure 1-18 Standalone HbA1c analyzer

1 2 3 4

Figure 1-19 HbA1c analyzer in the sample processing system

No. Name No. Name


1 Top left cover assembly 4 M4*8 screw of the lower right cover
2 M4*8 screw of the auto mix 5 Top right cover assembly
assembly
3 Bottom right cover

◼ Validation

Enter the "Service “→ ”Self-test" screen, tap "Syringes and Sampling Mechanism", and then tap on
each syringe to perform self-test to check if the movement motors and sensors are working as normal.

Tube Clamp
◼ Tools
M2.5 inner hexagon spanner
◼ Procedure

1-44
Mechanical System

1. Left revolve to open the top left cover assembly.


2. Enter the software interface, go to “Service” -> “Debug” -> “Mix Mechanism”, then click “X
Forward” -> “Z Upward”.
3. Replace and install a new clamp.
a) For the new tube clamp (115-064325-00), configuring the new rotation axis (longer, no
threaded hole in the front) and the old one (shorter, a threaded hole in the front, and two
sides of it are made flat) will use the same adjustment method. Click the “Up” button in the
“Manipulator” section, loosen the two M3X10 stainless-steel inner hexagon screws used to
fix the tube clamp, then move the clamp forward/backward until the manipulator is aligned
with the center of the tube position, and then secure the screws.

Loosen the 2 inner


The old rotation
hexagon screws.
axis, a threaded
The new rotation
hole in the front,
axis, no threaded
and two sides of it
hole in the front.
are made flat.

b) For the old tube clamp (115-006303-00) and old rotation axis, use a retaining screw on the
top of the old tube clamp and a M3X10 stainless-steel inner hexagon screw in the front of
the rotation axis to fix them together. And the clamp location can’t be adjusted forward or
backward.

1-45
Mechanical System

An inner
hexagon screw
and a retaining
screw

c) Note: the old tube clamp can’t be installed on the new rotation axis. Because the new
rotation axis is fixed with only one retaining screw, then the old tube clamp can’t be locked
tightly.

◼ Validation

1. Enter the "Service"→"Debug"→"Autoloader" screen. Put a tube rack onto the autoloader, tap
"Init" and "X Load" in turn to push the tube rack forward, and tap "Y Feed" 3 times to send the
second tube position of the rack to the pinch position of the manipulator.
2. Select "Mix Mechanism", and then click "Init→X Forward". The manipulator moves out to be on
top of the tube rack. Check visually that the clamp is aligned with the center of the tube position.
Click “X Backward”, put a tube into the tube position, then click “X Forward”, “Z Upward”, and “Z
Downward” one by one. Make sure the tube is not tilted or crashed when the clamp moves the
tube upward or downward.

Plunger Pump Assembly


◼ Tools
NO.107 cross-head screwdriver

1-46
Mechanical System

◼ Procedure

1. Right revolve to open the top right cover assembly.


2. Remove the 2 M4*8 screws in the bottom right cover with NO.107 cross-head screwdriver to
take off the bottom right cover.
3. Remove the 2 M3 screws by the front side of the plunger pump assembly with NO.107 cross-
head screwdriver, and pull the assembly forward to take it off.
4. Replace and install a new plunger pump assembly. Make sure the slot of the bottom vibration
damper plate fits into the grab of the supporting seat.

No. Name No. Name


1 Top right cover assembly 3 M4*8 screw
2 Plunger pump assembly 4 Bottom right cover assembly
5 Bottom vibration damper 6 Supporting seat
plate

1-47
Mechanical System

Plunger Pump
◼ Tools

NO.107 cross-head screwdriver

◼ Procedure

1. Take out the plunger pump assembly.


2. Loosen the 8 M3*8 screws under the plunger pump assembly with NO.107 cross-head
screwdriver, and take off the plunger pumps.
3. Replace the plunger pumps and install the assembly back.
◼ Fluidic volume setup

1. Enter the software screen, tap “Service→Fluidic Volume” to enter the plunger pump fluidic
volume calibration screen.
2. Enter the “Plunger Pump Flow Rate by Step” and the “Plunger Pump Return Difference” for both
plunger pumps of Eluent A and Eluent B.
◼ Prime

1. After replacement, enter the software screen, tap “Setup→Empty/Prime” to prime the tubes.
2. If pump A was replaced, tap “Eluent A Channel” to perform the priming; if pump B was replaced,
tap ”Eluent B Channel” to perform the priming.

2
1

No. Name No. Name


1 Plunger pump assembly 2 M3*8 screw

Waste Pump Assembly (Standalone Instrument)


◼ Tools
NO.107 cross-head screwdriver
◼ Procedure

1-48
Mechanical System

1. Remove the right door.


2. Remove the 2 M4 screws that fix the bath integrating assembly, revolve and open the bath
integrating assembly.
3. Loosen the 2 M4*8 screws under the waste pump assembly with NO.107 screwdriver.

No. Name No. Name


1 M4 screw 2 Waste pump assembly

No. Name No. Name


1 M4 screw 2 The entire FRU

The waste pump assembly is consisted of the following 3 FRUs, which shall be replaced together.
3001-10-07252 Rotation diaphragm pump
047-012739-00 Pump assembly label (P1)
3101-20-68592 Pump connecting line

1-49
Mechanical System

Waste Pump Assembly (Instrument in the Sample

Processing System)
◼ Tools
NO.107 cross-headed screwdriver
1. Procedure
2. Remove the right door.
3. Remove the 2 M4 screws fixing the bath integrating assembly, revolve and open the bath
integrating assembly.

4. Disconnect the cables and tubes on the waste pump.

5. Loosen the 2 fixing screws on the waste pump assembly, push the waste pump assembly

towards the middle plate, then lift it up.

6. Remove the rain coat of pump.


7. Use the NO.107 cross-head screwdriver to loosen the 8 M4*8 screws on the bottom of the waste
pump assembly. Then remove the waste pump.

No. Name No. Name


1 M4 screw 2 Waste pump assembly

1-50
Mechanical System

No. Name No. Name


1 Pump 1bar 300ml/min DC12V 2 M4 screw
3 The rain coat of pump

The following FRUs of the waste pump assembly should be replaced.


3001-10-07252 Pump 1bar 300ml/min DC12V
047-019022-00 the rain coat of pump

Degasser Assembly (Applicable to version before EHK011

(May 5th, 2016))


◼ Tools

NO.107 cross-head screwdriver


◼ Procedure

1. Remove the right door.


2. Remove the 2 M4 screws that fix the bath integrating assembly, revolve and open the bath
integrating assembly.
3. Loosen the 4 M4*8 screws under the degasser assembly with NO.107 screwdriver.

1-51
Mechanical System

No. Name No. Name


1 M4 screw 2 Degasser assembly

◼ Tools

NO.107 cross-head screwdriver


◼ Procedure

1. Take off the degasser assembly.


2. Remove the 2 M3 screws that fix the degasser cover with NO.107 cross-head screwdriver and
take the cover off.
3. Loosen the 2 M3*8 screws under the degasser with NO.107 screwdriver.
4. Remove the degasser.

◼ Prime

1. After replacement, enter the software screen, tap “Setup→Empty/Prime” to prime the tubes.
2. Tap “Eluent A Channel” and “Eluent B Channel” to perform the priming.
082-001943-00 Degasser, 2 channels, 285ul/channel
009-004752-00 Degasser connecting line

1-52
Mechanical System

No. Name No. Name


1 Degasser pinboard 4 M3 screw
2 M3*8 screw 5 Degasser cover
3 Degasser

Degasser Assembly 2 (Applicable to EHK011 (May 5th, 2016)

and Later Version)


◼ Tools

NO.107 cross-headed screwdriver


◼ Procedure

1. Remove the right door.


2. Remove the 2 M4 screws fixing the bath integrating assembly, revolve and open the bath
integrating assembly.
3. Use the NO.107 cross-head screwdriver to remove the 4 M3*8 screws on the bottom of the
degasser assembly.
4. Enter the software screen, tap “Setup→Empty/Prime” to prime the tubes.
5. Disconnect the cables and tubes on the degasser assembly, then take out the degasser
assembly 2.

1-53
Mechanical System

No. Name No. Name


1 M4 screw 2 Degasser assembly 2

Pulse Damper
◼ Tools
NO.107 cross-head screwdriver

◼ Procedure

1. Remove the right door.


2. Remove the 2 M4 screws that fix the bath integrating assembly, revolve and open the bath
integrating assembly.
3. Open the top right cover.
4. Remove the 2 M3*8 screws at the back of the pulse damper with the NO.107 cross-head
screwdriver.
5. Take out the pulse damper from the front.

1-54
Mechanical System

1 2

No. Name No. Name


1 Front of the pulse damper 3 M3 screw
2 Top right cover 4 Back of the pulse damper
5 Bath integrating assembly

◼ Pressure setup

1-55
Mechanical System

1. On the software, tap “Service→Pressure” to enter the column pressure calibration screen.
2. Enter the pressure value displayed on the pulse damper to the edit box of “K”.
3. Before you perform this procedure, make sure there is no residue pressure from previous
pressure build-up procedure.

Enter the pressure value


displayed on the pulse
damper to the edit box of
“K”.
Then adjust the value of
b to make sure the
“ Column Pressure” is
zero.

◼ Prime
1. After replacement, enter the software screen, tap “Maintenance→Empty/Prime” to prime the
tubes.
2. Tap “Eluent A Channel” to perform the priming.
Note: Now the H50 standalone analyzer is delivered with old board (051-001765-00 A1c
AnalogDrv PCBA) and old pulse damper (082-002127-00 Pulse damper 2Mpa 0.2mL); the H50
analyzer used in the sample processing system after EHK015 is delivered with new board (051-
001765-01 A1c AnalogDrv (NEW) PCBA) and new pulse damper (115-040825-00 Pulse
Damper).

Rotation Feeding Valve


◼ Tools

NO.107 cross-head screwdriver


◼ Procedure

1. Open the top right cover.


2. Loosen the connector of the rotation feeding valve.
3. Remove the 2 M3 screws that fix the rotation feeding valve from the side of the front cover.
◼ Prime

1. After replacement, enter the software screen, tap “Setup→Empty/Prime” to prime the tubes.
2. Tap “Eluent A Channel” to perform the priming.

1-56
Mechanical System

No. Name No. Name


1 Rotation feeding valve 3 M3 screw
2 Connector 4 Top right cover

Cisterns (Standalone Instrument)


115-027283-00 HWS cistern
115-027284-00 Eluent A cistern
115-027285-00 Eluent B cistern
115-018614-00 Short cistern

◼ Tools

NO.107 cross-head screwdriver

◼ Procedure

1. Remove the right door.


2. Enter the software screen, tap “Setup→Empty/Prime” to empty the cistern(s) as needed.
3. Remove the 2 M4 screws that fix the bath integrating assembly, revolve and open the bath
integrating assembly.
4. Loosen the M4 screws that fix the cisterns with NO.107 screwdriver.

◼ Prime
1. After replacement, enter the software screen, tap “Setup→Empty/Prime” to prime the tubes.
2. Tap “Eluent A Channel”, “Eluent B Channel” or “HWS Channel” as necessary to perform the
priming.

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Mechanical System

No. Name No. Name


1 Short cistern 5 Eluent B cistern
2 HWS cistern 6 Air filter
3 M4 screw 7 Isolation chamber
4 Eluent A cistern

The air filter shall be installed at the angle as indicated by the arrow in the following figure.

Waste Cistern (Instrument in the Sample Processing System)


115-027283-00 HWS cistern
115-027284-00 Eluent A cistern
115-027285-00 Eluent B cistern
115-069975-00 Waste bath assembly

1-58
Mechanical System

◼ Tools

NO.107 cross-headed screwdriver

◼ Procedure

1. Remove the right door.


2. Remove the 2 M4 screws fixing the bath integrating assembly, revolve and open the bath
integrating assembly.
3. Use the NO. 107 cross-head screwdriver to loosen the M4 screws fixing the cisterns.
4. Install the new cisterns.
5. Enter the software screen, tap “Setup→Empty/Prime” to prime the tubes..

No. Name No. Name


1 Waste Cisterns 5 Eluent B cistern
2 HWS cistern 6 Air filter
3 M4 screw 7 Isolation chamber cylinder
4 Eluent A cistern

The air filter should be installed in the direction pointed by the arrow.

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Mechanical System

Autoloader
Note: the analyzer in the sample processing system is not equipped with the autoloader.
◼ Tools

NO.107 cross-head screwdriver


◼ Procedure

1. Remove the right door with NO.107 cross-head screwdriver.


2. Remove the bottom left plate with NO.107 cross-head screwdriver.
3. Remove the autoloader cover assembly with NO.107 cross-head screwdriver.
4. Loosen the M4 screws that fix the autoloader with NO.107 cross-head screwdriver.
5. Take off the autoloader.

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Mechanical System

No. Name No. Name


1 Bottom left plate 4 M4 screw
2 Autoloader 5 Right door
3 Autoloader cover assembly

1.8.18.1 Autoloader assembly structure

4
5

3
2 Y X

8 7 6

Figure 1-20 Autoloader

1-61
Mechanical System

1 --- Reflection sensor 2 --- Unload unit


3 --- Loading counter 4 --- Tube detection assembly
5 --- Microswitch 6 --- Vertical feed unit(X load)
7 --- Horizontal load unit(Y feed) 8 --- Sample compartment assembly

Figure 1-21 Autoloader (hide the cover to reveal sensor position)

1 --- X load initial sensor 2 --- X load end sensor


3 --- Tube detection position counting sensor 4 --- Tube pierce position counting sensor
5 --- Y feed initial sensor 6 --- Unload sensor
Note: The sample compartment assembly sensor is not marked in the figure above.

◼ Debug

Refer to 1.4.3 Autoloading Piercing Position Adjustment

Sample Compartment Assembly


Note: the analyzer in the sample processing system is not equipped with the autoloader.

◼ Tools

NO.107 cross-head screwdriver

◼ Procedure

1. Take out the autoloader.


2. Remove the 3 M4*8 screws in the bottom plate of the sample compartment assembly with the
NO.107 cross-head screwdriver.
3. Lift the sample compartment assembly (3106) up to take it out.

1-62
Mechanical System

No. Name No. Name


1 Sample compartment assembly 3 Bottom plate of the assembly
2 M4*8 screw

1.8.19.1 Inner structure of the sample compartment

Figure 1-22 Sample compartment assembly

1 --- Bracket 2 --- Tension spring


3 --- Sensor 4 --- Sensor baffle
5 --- Torsion spring 6 ---Damper gear

◼ Debug

See the autoloader adjustment procedure for details.

1-63
Mechanical System

Unload Unit
Note: the analyzer in the sample processing system is not equipped with the autoloader.

◼ Tools

NO.107 cross-head screwdriver


◼ Procedure

1. Take out the autoloader.


2. Remove the 2 M4*8 screws in the bottom plate of the sample compartment assembly with the
NO.107 cross-head screwdriver.
3. Take the unload unit up.

1.8.20.1 Tube detection assembly

Figure 1-23 Tube detection assembly

◼ Tools

NO.107 cross-head screwdriver

◼ Procedure

1. Open the top right cover.


2. Remove the 2 M3*8 screws in the tube detecting and scanning bracket with NO.107 cross-head
screwdriver.
3. Lift the tube detection assembly up to take it out.

1-64
Mechanical System

No. Name No. Name


1 Tube detection assembly 3 M3*8 screw
2 Tube detecting and scanning bracket

Temperature Control Assembly


◼ Tools

M3 inner hexagon spanner


◼ Procedure

1. Open the top right cover.


2. Disconnect the tubes and wires connected to the temperature control assembly.
3. Remove the 4 M4 screws in the front cover with M3 inner hexagon spanner.
4. Take out the temperature control assembly.

◼ Prime

1. After replacement, enter the software screen, tap “Setup→Empty/Prime” to prime the tubes.
2. Tap “Eluent A Channel” to perform the priming.

1-65
Mechanical System

No. Name No. Name


1 M4 inner hexagon screw 2 Temperature control assembly

Filter Assembly (Applicable to Old Standalone Instrument

version before EHK016)


◼ Tools
NO.107 cross-head screwdriver

◼ Procedure

1. Open the top right cover.


2. Disconnect the tubes and wires connected to the filter assembly.
3. Remove the 2 M3 screws in the front cover with NO.107 cross-head screwdriver.
4. Take out the filter assembly.

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Mechanical System

No. Name No. Name


1 M3 screw 2 Filter assembly

Filter Assembly (Applicable to Instrument in the Sample

Processing System and new Standalone Instrument after

EHK016)
◼ Tools
NO.107 cross-headed screwdriver

◼ Procedure

NOTE
⚫ The filter may touch the blood. Wear gloves when you replace the filter.

1. Preparation

1) Tap Menu -"Maintenance" > “Consumables” > “Filter” to enter the filter
replacement screen.

2) Tap the "Replace" button on the screen; the analyzer prepares for replacement.

1-67
Mechanical System

2. Remove the old filter


When the analyzer preparation completes, the “Remove the old filter” screen
displays.

1) Open the front cover of the analyzer.

1-68
Mechanical System

2) Remove the tube fitting connecting to the filter by rotating it counterclockwise.

3) Remove the upper part of the filter by rotating it counterclockwise, then remove
the filter element.

1-69
Mechanical System

4) Tap "OK" when you complete, or tap "Cancel" to cancel the replacement.

3. Install a new filter

After you remove the old filter and tap “OK” on the screen. The following screen
displays.

1) Place a new filter element into the lower part of the filter.

1-70
Mechanical System

2) Tightly screw up the upper part back to the filter clockwise.

3) Connect and tightly secure the tube fitting to the upper part of the filter
clockwise.

4) Tap "OK" when you complete, or tap "Cancel" to cancel the replacement.

1-71
Mechanical System

Leakage self-test
4. When you have installed a new filter element and tapped “OK” on the screen, the
following screen displays.

1) Tap “Prime” and make sure there is no liquid leakage.

NOTE
⚫ If you observe liquid leakage, tap “Stop” on the screen. Make sure
the fitting is tightly screwed , and repeat the step.

2) Tap “OK” when prime completes.

5. Complete replacement

1-72
Mechanical System

1) Wipe off the leaked liquid with a tissue, and close the two front covers of the
analyzer.
2) Tap “OK” on the screen. The new filter information displays.

Top Left Cover Assembly (H50)


◼ Tools
NO.107 cross-head screwdriver
◼ Procedure

1. Open the top left cover.


2. Remove the touchscreen connecting line connected to the top left cover.
3. Remove the M3 screws that fix the top left assembly (H50) to the front cover with NO.107 cross-
head screwdriver.
4. Take off the top left cover assembly (H50).

1-73
Mechanical System

No. Name No. Name


1 Top left cover assembly(H50) 3 M3 screw
2 Hinge R-45

Touchscreen
◼ Tools

NO.107 cross-head screwdriver

◼ Procedure

1. Take off the top left cover assembly (H50).


2. Remove the M3 screws in the touchscreen assembly with NO.107 cross-head screwdriver.
3. Take off the screen assembly and the touchscreen in turn.

1-74
Mechanical System

No. Name No. Name


1 Top left cover 3 Screen bracket
2 Touchscreen 4 M3 screw

Pinch Roller Assembly (Instrument in the Sample

Processing System)
◼ Tools

NO.107 cross-headed screwdriver

◼ Procedure

1. Open the top left cover assembly (H50) and top right cover assembly (H50).
2. Use the NO. 107 cross-head screwdriver to remove the 3 M4 installation screws.
3. Disconnect the cables of the motor and sensor, then remove the pinch roller assembly.

1-75
Mechanical System

No. Name No. Name


1 Temperature control module 3 Pincher roller assembly
2 M4 screw 4 Bottom right cover

Barcode Scanner Assembly (Instrument in the Sample

Processing System and New Standalone Instrument)


◼ Tools
NO.107 cross-headed screwdriver

◼ Procedure

1. Open the top left cover assembly (H50) and top right cover assembly (H50).
2. Use the NO. 107 cross-head screwdriver to remove the 3 M4 cross-recessed pan head screws
on the back of the right door (H50), then remove the right door (H50).
3. Use the NO. 107 cross-head screwdriver to remove the M4 cross-recessed pan head screw
(number 1 in the figure) and M4 cross-recessed countersunk screw (number 3 in the figure),
4. then remove the bottom right cover assembly.
5. Use the NO. 107 cross-head screwdriver to remove the M3 cross-recessed pan head screw
(number 5 in the figure).
6. Disconnect the cables on the barcode scanner assembly, then take out the barcode scanner
assembly.

No. Name No. Name


1 M4 cross-recessed pan head 4 Pincher roller assembly
screw
2 Bottom right cover assembly 5 M3 cross-recessed pan head screw
3 M4 cross-recessed 6 Barcode scanner assembly
countersunk screw

Scanner Assembly (Old Standalone Instrument)


◼ Tools

NO.107 cross-headed screwdriver

◼ Procedure

1-76
Mechanical System

1. Open the top left cover assembly (H50) and top right cover assembly (H50).
2. Use the NO. 107 cross-head screwdriver to remove the 3 M4 cross-recessed pan head screws
on the back of the right door (H50), then remove the right door (H50).
3. Use the NO. 107 cross-head screwdriver to remove the M4 cross-recessed pan head screw
(number 1 in the figure) and M4 cross-recessed countersunk screw (number 3 in the figure),
4. then remove the bottom right cover assembly.
5. Use the NO. 107 cross-head screwdriver to remove the M3 cross-recessed pan head screw
(number 5 in the figure).
6. Disconnect the cables on the barcode scanner assembly, then take out the barcode scanner
assembly.

4
6

No. Name No. Name


1 M4 cross-recessed pan head 4 M3 cross-recessed pan head screw
screw
2 Bottom right cover assembly 5 Tube detecting and scanning bracket
3 M4 cross-recessed countersu 6 Scanner assembly
nk screw

1.9 List of FRUs for Replacement


In the following table, the FRU code with “standalone instrument” means it is only applicable to the
HbA1c standalone analyzer, the FRU code with “instrument in the sample processing system” means
it is only applicable to the analyzer in the sample processing system, the FRU code without any notes
means it can be used by both standalone instrument and sample processing system.

Serial No. FRU Code Name


1 115-024960-00 Sampling assembly
2 041-001013-00 CT probe wipe
3 115-014677-00 Piercing probe
115-025076-00
4 (standalone Mix bath assembly
instrument)
5 115-039850-00 Mix pool assy(H50P)

1-77
Mechanical System

Serial No. FRU Code Name


(instrument in the
sample
processing
system)
2-way miniature electromagnetic valve (stub, new
6 115-010089-00
terminal)
7 115-025078-00 Syringe assembly
8 115-011898-00 100ul lead screw driving syringe assembly
9 115-012523-00 100ul syringe (lateral)
10 115-031800-00 2.5ml syringe assembly
11 0033-30-74613 2.5ml Mindray syringe (fluororubber)
12 115-013056-00 Fluidic valve. 3-way -75~250kPa DC12V
115-031984-00
13 (standalone Auto mix assembly
instrument)
115-069976-00
(instrument in the
14 sample mixing asm
processing
system)
15 115-006303-00 Spring tube pincher(5380)
16 115-025077-00 Plunger pump assembly
17 082-002128-00 Plunger pump 5Mpa 4.5mL/min 0.169uL/step
115-031854-00
18 (standalone Burkert valve
instrument)
115-024961-00
19 (standalone Waste pump assembly
instrument)
3001-10-07252
(instrument in the
20 Rotation diaphragm pump
sample processing
system)
047-012739-00
21 (standalone Pump assembly label (P1)
instrument)
22 3101-20-68592 Pump connecting line
115-027228-00
(applicable to
23 Degasser assembly
version before
EHK011)
082-001943-00
24 Degasser, 2 channels, 285ul/channel
(applicable to

1-78
Mechanical System

Serial No. FRU Code Name


version before
EHK011)
009-004752-00
(applicable to
25 Degasser connecting line
version before
EHK011)
115-037652-
00(applicable to
26 degasser assembly2
EHK011 and later
version)
082-002127-00
27 (standalone Pulse damper 2Mpa, volume 0.2mL
instrument)
115-040825-00
(applicable to
EHK015 and later
28 Pulse Damper
instrument in the
sample processing
system)
Rotation feeding valve, 2-position, 6-way, 41MPa
29 082-001931-00
24VDC
30 115-027283-00 HWS cistern
31 115-027284-00 Eluent A cistern
32 115-027285-00 Eluent B cistern
115-018614-00
33 (standalone Short cistern
instrument)
115-069975-00
(instrument in the
34 Assembly of waste pool
sample processing
system)
35 3003-20-34949 Isolation chamber (mold MR34949-01/MR34949-02)
36 082-001963-00 Air filter 0.1um 98mmX32mm 0.1Mpa
115-031985-00
37 (standalone Autoloader
instrument)
38 115-012506-00 Sample compartment assembly (3106)
3102-30-69247
39 (standalone Unload unit
instrument)
115-005375-00
40 (standalone Tube detection assembly
instrument)

1-79
Mechanical System

Serial No. FRU Code Name


41 115-024958-00 Power supply assembly
42 115-027265-00 Temperature control assembly
115-031986-00
43 (standalone Filter assembly
instrument)
115-070354-00
(instrument in the
44 Filter assembly
sample processing
system)
45 115-025527-00 Top left cover assembly (H50)
46 021-000058-00 Touchscreen, resistive, 8.4", 4-wire
47 115-025528-00 Screen assembly
115-037907-00
(instrument in the
48 wheel fixed asm
sample processing
system)
115-069977-00
(instrument in the
49 Scan Assembly
sample processing
system)

1-80
Chapter 2 Fluidic System

2.1 Introduction
The fluidic system of H50 Automated Glycohemoglobin Analyzer mainly consists of 4 parts, which are
reagent management, sample preparation, chromatography and temperature control. Their functions
are:
Reagent management: priming, replacing and detection of the hemolysis solution, eluent A and eluent
B.
Sample preparation: aspirating sample and sending sample to the sample loop.
Chromatography: sending sample to the column, eluting sample with the 2 types of eluent; the eluted
sample then goes onto the flow cell for concentration monitoring.
Temperature control: adjusting and controlling temperature of the column and flow cell.
Chromatographic
Reagent Management Module 1 2 1 2
separation Module
VA
C 6 3 6 3
5 4 5 4
Load(POSB) Inject(POSA)

Steel tube 3
Thermostatic
preheating Box
Detecor
Preheating steel tube 2

Thermostatic Chamber
EL_A EL_B Isolation chamber
Cistern Cistern PS1
OPEN
1 2

Colum preheating
HWS
Cistern Germproof filter 6 3 Column
C4 5 4
Eluate Eluate Hemolysis & 3

Box
INJ_PUMPB Column filter
B A Wash Solution Bubble Trap
ROT-V
Damper 1 2
6 3 Preheating steel tube 1
5 4
Pressure INJ-V
Bubble Trap INJ_PUMPA Transduser

Sample Loop 4 uL

Waste
cistern

Syringe 100uL

Probe wipe

Sample probe

Mix bath Wipe filter

Syringe 2.5mL
Mix bath
filter GP1
Waste
container
Waste pump
Sample preparation Module

Figure 2-1 Fluidic system (old standalone instrument)

2-1
Fluidic System

Chromatographic
Reagent Management Module
separation Module 1 2 1 2

VA
C 6 3 6 3
5 4 5Inject4
Load
(POSB) (POSA)

Steel tube 3
Thermostatic
preheating Box
Detecor
Preheating steel tube 2

GP1
EL_A Isolation chamber Thermostatic Chamber
Cistern EL_B PS
Cistern OPEN 5 6 1

Colum preheating
HWS
Cistern Germproof filter 4 1 Column
3 2
Eluate Eluate Hemolysis &

Box
INJ_PUMPB ROT-V
B A Wash Solution Bubble Trap Column filter

Damper 5 6
4 1
Preheating steel tube 1
3 2

Pressure Transduser INJ-V


Bubble Trap INJ_PUMPA
Sample Loop 40 uL

Waste Waste
cistern cistern 2

Syringe 100uL

Probe wipe

Sample probe

Mix bath Wipe filter


P2 Waste pump 2

Syringe Waste connector


2.5mL
Mix bath filter GP
1
P1 Waste
container
Sample preparation Module Waste pump 1

Figure 2-2 Fluidic system (new standalone instrument and instrument in the sample
processing system)

Sample Preparation Channel (Old Standalone Instrument)

1 2
HWS
6 3
Cistern 5 4
INJ-V

Sample Loop 4 uL

SV18 SV19

SV01
Syringe 100uL

SV04 SV03 SV02


Probe wipe

Sample probe

Mix bath Wipe filter

SV06 SV05

Syringe 2.5mL
Mix bath
filter GP1
Waste
container
SV15
Waste pump

Figure 2-3 Sample preparation channel

Reagent used: Hemolysis solution


The sample preparation channel collects, mixes and prepares sample; the channel consists of the
following 3 portions:
1. Whole blood sample collection: this channel consists of the 100ul syringe and sample probe; it
collects sample of the whole blood mode, aspirated 16ul of whole blood and dispensing 4ul of

2-2
Fluidic System

blood sample.
2. Predilute sample collection: this channel consists of the 2.5ml syringe, SV04, SV19, injection
valve, sample loop and sample probe; its major function is collecting samples of the predilute
mode, aspirating 160ul of the sample.
3. Mix bath: this channel consists of the 2.5ml syringe, SV04, SV02, mix bath, mix bath filter, SV15
and the waste pump; its major function is dispensing fluid into the mix bath, mixing sample,
cleaning the mix bath, and preparing 400ul of sample at the ratio of 1:100.
4. Sample preparation: this channel consists of the 2.5ml syringe, SV04, SV19, injection valve,
sample loop and sample probe; its major function is preparing sample, aspirating 160ul of sample.
5. Sample probe cleaning: this channel consists of the 2.5ml syringe, SV04, SV03, SV19, SV01,
probe wipe, injection valve, sample loop, probe wipe filter, SV06, waste pump, sample probe and
the probe wipe; its major function is cleaning sample preparation tubing, and the exterior and
interior walls of the sample probe, aspirating reagent from the HWS cistern (driven by the 2.5ml
syringe) to clean the components together with the valves, and collecting waste generated from
cleaning the sample probe.

Sample Preparation Channel (New Standalone Instrument

and Instrument in the Sample Processing System)

HWS 5 6
Cistern 4 1
3 2
INJ-V
Sample Loop 40 uL

Waste
SV18 SV19 cistern 2

SV01
Syringe 100uL

SV04 SV03 SV02


Probe wipe SV14

Sample probe

Mix bath Wipe filter

P2 Waste pump 2

SV06 SV05
Syringe Waste connector
2.5mL
Mix bath filter
GP1

P1 Waste
SV15
container
Waste pump 1

Figure 2-4 Sample preparation channel

Applied reagent: Hemolysis Solution


The sample preparation channel collects, mixes and prepares sample; the channel consists of the
following 3 portions:
1. Whole blood sample collection: this channel consists of the 100ul syringe and sample probe; it
collects sample of the whole blood mode, aspirating 16ul of whole blood and dispensing 4ul of
blood sample.
2. Predilute sample collection: this channel consists of the 2.5ml syringe, 100ul syringe, SV04,

2-3
Fluidic System

SV19, injection valve, sample loop and sample probe; its major function is collecting samples of
the predilute mode, aspirating 160ul of the sample.
3. Mix bath: this channel consists of the 2.5ml syringe, SV04, SV02, mix bath, HGB test light
assembly, mix bath filter, SV15 and the waste pump; its major function is dispensing fluid into
the mix bath, mixing sample, cleaning the mix bath, and preparing 400ul of sample at the ratio
of 1:100. In the meanwhile, add the HGB test light assemblies on both sides of the mix bath to
test the mix bath background and the voltage of the mixed samples.
4. Sample preparation: this channel consists of the 2.5ml syringe, 100ul syringe, SV04, SV19,
injection valve, sample loop and sample probe; its major function is preparing sample, aspirating
160ul of sample, then finishing the dynamic sampling according to the HGB concentration value
of samples.
5. Sample probe cleaning: this channel consists of the 2.5ml syringe, SV04, SV03, SV19, SV01,
probe wipe, injection valve, sample loop, probe wipe filter, SV06, waste pump 1, waste pump 2,
SV14, sample probe and probe wipe; its major function is cleaning sample preparation tubing,
and the exterior and interior walls of the sample probe, aspirating reagent from the HWS cistern
(driven by the 2.5ml syringe) to clean the components together with the valves, and collecting
the waste generated from cleaning the sample probe into the waste cistern 2 through the probe
wipe and waste pump 1, then discharging the waste through waste pump 2 into the waste
container or the waste direct discharge pipe.

Chromatographic Channel (Old Standalone Instrument)


The chromatographic channel mainly consists of the plunger pump A, plunger pump B, pulse pumper,
injection valve, rotation valve, column, flow cell and the waste cistern. See the following diagram for
its connection.

1 2 1 2

6 3 6 3
5 4 5 4
Load(POSB) Inject(POSA)

Steel tube 3

Preheating steel Detecor


tube 2

Thermostatic
Chamber
SV13 PS1
1 2
EL_B

6 3 Column
5 4

Bubble Trap INJ_PUMPB Column filter


ROT-V
EL_A

Damper 1 2
6 3 Preheating steel tube 1
SV17 5 4
Pressure INJ-V
Bubble Trap INJ_PUMPA Transduser

Sample Loop 4 uL

SV16
Waste
Sample probe

SV18 SV19 cistern

Syringe 2.5mL

Figure 2-5 Chromatographic channel

The plunger pump A (INJ_Pump A) provides feeding power of eluent A. The plunger pump B
(INJ_Pump B) provides feeding power of eluent B. SV16 and SV17 controls the on/off of the tubes of

2-4
Fluidic System

plunger pump A and B respectively. When the plunger pump works, the corresponding valve opens,
and vice versa.
The pulse damper is a passive fluid device, it is used to buffer the pressure pulsation generated by
the plunger pump. It also acts as a pressure sensor to record pressure over the tubes.
Injection valve 1 connects the sample preparation channel and chromatographic channel. When it is
at the load position, the sample preparation channel loads diluted blood sample to the sample loop;
and when it is at the inject position, the chromatographic channel sends sample to the column for
elution and separation.
The column is a critical component for chromatography. When blood sample is loaded to the column,
it is processed by eluent of the pre-defined low ionic strength and pH conditions. Due to different
charge strength and adsorption capacity with the stationary phase, the various types of hemoglobin
are eluted and separated.
Injection valve 2 is at position B during analysis, it shifts to position A only in certain maintenance
sequences.
The separated sample then goes through the flow cell to the waste cistern, and discharged from the
analyzer by the waste pump.

Chromatographic Channel (New Standalone Instrument and

Instrument in the Sample Processing System)

1 2 1 2

6 3 6 3
5 4 5 4
Load(POSB) Inject(POSA)

Steel tube 3

Preheating steel Detecor


tube 2

Thermostatic
Chamber
SV13 PS1
1 2
EL_B

6 3 Column
5 4

Bubble Trap INJ_PUMPB Column filter


ROT-V
EL_A

Damper 1 2
6 3 Preheating steel tube 1
SV17 5 4
Pressure INJ-V
Bubble Trap INJ_PUMPA Transduser

Sample Loop 4 uL

SV16
Waste
Sample probe

SV18 SV19 cistern

Syringe 2.5mL

Figure 2-6 Chromatographic channel

The plunger pump A (INJ_Pump A) provides feeding power of eluent A. The plunger pump B
(INJ_Pump B) provides feeding power of eluent B. SV16 and SV17 controls the on/off of the tubes of
plunger pump A and B respectively. When the plunger pump works, the corresponding valve opens,
and vice versa.
The pulse damper is a passive fluid device, it is used to buffer the pressure pulsation generated by
the plunger pump. It also acts as a pressure sensor to record pressure over the tubes.

2-5
Fluidic System

Injection valve 1 connects the sample preparation channel and chromatographic channel. When it is
at the load position, the sample preparation channel loads diluted blood sample to the sample loop;
and when it is at the inject position, the chromatographic channel sends sample to the column for
elution and separation.
The column is a critical component for chromatography. When blood sample is loaded to the column,
it is processed by eluent of the pre-defined low ionic strength and pH conditions. Due to different
charge strength and adsorption capacity with the stationary phase, the various types of hemoglobin
are eluted and separated.
Injection valve 2 is at position B during analysis, it shifts to position A only in certain maintenance
sequences.
The separated sample then goes through the flow cell to the waste cistern, and discharged into the
waste cistern 2 by the waste pump 1, finally discharged from the analyzer by the waste cistern 2 and
waste pump 2.

Temperature Control Unit


The temperature control unit consists of the column temperature-control box and the flow cell
temperature-control box. See the following figure for its fluidic connection.

Steel tube 3

Detecor
Preheating steel tube 2

Thermostatic Chamber

Column

Preheating steel tube 1

Figure 2-7 Connection of the temperature control unit

The column temperature-control box keeps constant temperature of the column and preheats blood
sample and reagent that enters the column. The heating membrane heats the thermal storage base
plate, its conductive base then heats the column to target temperature and preserves the temperature,
and its preheating steel tube heats the reagent to target temperature to ensure chromatographic effect.
The flow cell temperature-control box keeps constant temperature of the LED, light absorption
detector, and flow cell, and preheats blood sample that enters the flow cell. The heating membrane
heats the thermal storage base plate, its conductive base then heats the LED, light absorption

2-6
Fluidic System

detector and flow cell to target temperature and preserves the temperature, and its preheating steel
tube heats the reagent to target temperature to ensure stability of the chromatographic analysis.

Reagent Management (Old Standalone Instrument)

VAC

GV10

GV11

GV12

GP1
Isolation chamber
EL_A EL_B
Cistern Cistern OPEN SV13
HWS
Germproof
Cistern
filter

Eluate Eluate Hemolysis & Wash


B A Solution Bubble Trap

SV17

Bubble Trap

SV16

Figure 2-8 Connection of reagent tubes










Waste cistern

SV06 T70 SV05

T69 C48
T71
C49 GP1
T72 Waste
C50 T73 container
SV15
T105 T68 Waste pump

Figure 2-9 Connection of waste tubes

Reagent management involves the HWS hemolysis solution, Eluent A cistern, Eluent B cistern, waste
cistern and waste channel. See the figure below for the fluidic connection.
HWS cistern priming: the HWS cistern connects to atmospheric pressure through GV10 and the

2-7
Fluidic System

germproof filter. To prime the HWS cistern with reagent, the waste pump (GP1), GV10 and SV07 are
open to generate vacuum for the priming; when the priming finishes, the waste pump, GV10 and
SV07 are closed. When GV 10 is closed, pressure of the cistern restores to normal, during which air
enters the cistern from the germproof filter.
The priming of EL_A and Eluent B cistern is similar to the priming of the HWS cistern.
Emptying the HWS cistern: the 2.5mL syringe aspirates reagent from the HWS cistern, and dispense
it to the mix bath, and then the waste pump discharges the reagent from the mix bath to the waste
container. Each time 2mL of reagent is discharged, 60 discharges are required to empty the HWS
cistern. See the figure below.

HWS
Cistern

SV04 SV02

Mix bath

Syringe 2.5mL

Mix bath filter

C50 T73 废液桶


SV15
Waste pump

Figure 2-10 HWS cistern emptying channel

Emptying the Eluent A cistern: reagent in the cistern is driven through the rapid relief channel to the
waste cistern by plunger pump A, and then discharged to the waste container by the waste pump.
Emptying the Eluent B cistern: reagent in the cistern is driven through the rapid relief channel to the
waste cistern by plunger pump B, and then discharged to the waste container by the waste pump.
The waste cistern connects to atmospheric pressure through GV13. When performing certain
maintenance operations, the waste cistern forms a vacuum, for example, when the plunger pump is
exhausting air, SV13 closes to form a vacuum in the waste cistern together with SV05 and the waste
pump.
The waste pump turns on to collect waste together with SV05, SV06 and SV15.

2-8
Fluidic System

Reagent Management (New Standalone Instrument and

Instrument in the Sample Processing System)

SV09 GV10

SV08 GV11

SV07
GV12

EL_A
Cistern EL_B
Cistern OPEN
HWS
Cistern Germproof filter
Eluate Hemolysis &
A Wash Solution

Figure 2-11 Connection of reagent tubes

Waste Waste
cistern cistern 2

SV14

P2 Waste pump 2

SV06 SV05
Waste connector

GP1

P1 Waste
SV15
container
Waste pump 1

Figure 2-12 Connection of waste tubes

Reagent management involves the HWS hemolysis solution, Eluent A cistern, Eluent B cistern, waste
cistern and waste channel. See the figure for the fluidic connection.
HWS cistern priming: the HWS cistern connects to atmospheric pressure through GV10 and the
germproof filter. To prime the HWS cistern with reagent, the waste pump (GP1), GV10 and SV07 are
open to generate vacuum for the priming; when the priming finishes, the waste pump, GV10 and

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Fluidic System

SV07 are closed. When GV 10 is closed, pressure of the cistern restores to normal, during which air
enters the cistern from the germproof filter.
The priming of EL_A and Eluent B cistern is similar to the priming of the HWS cistern.
Emptying the HWS cistern: the 2.5mL syringe aspirates reagent from the HWS cistern, and dispense
it to the mix bath, and then the waste pump 1 discharges the reagent from the mix bath to the waste
cistern 2, finally the waste pump 2 discharges the reagent into the waste container or the waste direct
discharge pipe. Each time 2mL of reagent is discharged, 60 discharges are required to empty the
HWS cistern. See the figure below.

Waste cistern 2

HWS
Cistern

SV14

SV02 P2 Waste pump 2


SV04

Mix bath

Waste connector
Syringe 2.5mL

Mix bath filter

P1
SV15 Waste
Waste pump 1 container

Figure 2-13 HWS cistern emptying channel

Emptying the Eluent A cistern: reagent in the cistern is driven through the rapid relief channel to the
waste cistern by plunger pump A, and then discharged to the waste cistern 2 by the waste pump,
finally discharged to the waste container or waste direct discharge pipe through the waste pump 2.
Emptying the Eluent B cistern: reagent in the cistern is driven through the rapid relief channel to the
waste cistern by plunger pump B, and then discharged to the waste cistern 2 by the waste pump,
finally discharged to the waste container or waste direct discharge pipe through the waste pump 2.
The waste pump 1 turns on to collect the waste together with SV05, SV06 and SV15 into the waste
cistern 2, then the waste pump 2 turns on to discharge the collected waste together with SV14 to the
waste container or waste direct discharge pipe.

Dynamic Sampling (New Standalone Instrument and

Instrument in the Sample Processing System)


Dynamic sampling principle: adjust the sample feeding volume dynamically according to the HGB
concentration measurement results, to make sure the total area of each tested sample maintains a
stable range value. The dynamic sampling is used for the whole blood analysis mode. When the
operator uses the whole blood analysis mode, test the HGB concentration of the samples in the mix
bath before sample feeding, then choose the different sequence for the sample feeding volume
according to the HGB concentration value.
Refer to the figure below for the dynamic sampling method:

2-10
Fluidic System

column 1 2
EL_A
6 3
5 4

INJ_PUMP
INJ-V
Ta2

SV18

Syringe 2.5mL SV01


Syringe 100uL

SV03 SV02
Probe wipe

Sample probe
Mix bath Wipe
filter

Mix bath filter

2.2 Reagent System


The reagent system of H50 Automated Glycohemoglobin Analyzer consists of the hemolysis solution,
eluent A and eluent B. Their major functions are listed in the table below:

Reagent Function
Used for the pre-process of blood sample before the
HbA1c analysis. The hemolysis solution mixes with whole
blood sample to process blood cells, eliminating
Hemolysis solution
interference of cell particles to the ion-exchange-based
high-performance liquid chromatography (HPLC) method,
the processed sample is used for HbA1c analysis.
Used with the HbA1c analysis system to determine the
HbA1c percentage and substance content in the blood
samples. The eluent A and B works together for elution of
Eluent A for HbA1c
hemoglobin. The HbA1c in the sample, which hardly has
analysis
any positive charge, is the first being eluted with eluent of
Eluent B for HbA1c
the pre-defined low ionic strength and pH conditions; and
analysis
the positive charged HbA0 is eluted with the eluent of high
ionic strength. In this way, the analyzer builds up the Hb
chromatogram.

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Fluidic System

2.3 Fluidic Components and Functions

Degasser (Applicable to version before EHK011 (May 5th,

2016))
◼ Symbol

Degasser Unit

Figure 2-14 Degasser symbol

◼ Appearance:

Figure 2-15 Degasser

◼ Function:

Remove gas dissolved in reagent and remove part of the bubbles.

◼ Note:

1. The connector on the top left of the degasser is sealed by a white plug, while the connector on
the top right is connected to the atmosphere as shown in the figure below. Do not misplace the
plug.
2. Keep the board at the back of the degasser away from water.

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Fluidic System

Bubble Trap (Applicable to Old Standalone Instrument, New

Standalone Instrument and Instrument in the Sample

Processing System after EHK011 (May 5th, 2016))


◼ Symbol

Figure 2-16 Bubble trap symbol

◼ Appearance

Figure 2-17 Bubble trap

◼ Functions
Remove the bubbles in the eluent to avoid the measurement interference caused by these bubbles.

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Fluidic System

Plunger Pump
◼ Symbol

Figure 2-18 Plunger pump symbol

◼ Appearance

Figure 2-19 Plunger pump

◼ Function

The plunger pump is a flow drive component. With capacity change of the sealed cavity resulted from
the reciprocating motion of the plunger in the cylinder, it realizes aspirating and discharging of liquid.
A check valve is installed on both the inlet and outlet of the pump, when aspirating liquid, the check
valve of the outlet is closed, and when discharging liquid, the check valve of the inlet is closed. If the
fluid transmitted by the plunger pump is saline reagent, to avoid creep of the seal ring caused by
crystallization of reagent, the seal ring must be washed.

◼ Note

If some troubles occur caused by the low pressure during the pressure build-up process, follow the
instructions below to fix the problems. Firstly, make sure each tube connector is not leaking, then
perform several priming actions for Eluent A cistern and Eluent B cistern. If the problem continues,
test the check valve of the plunger pump referring to the following steps:
1. Prepare the syringe, connecting tube, and the connector applicable to the inlet of the plunger
pump as shown in the following figure.
2. Remove the check valve on the inlet: use a spanner to unscrew the check valve on the plunger
pump inlet (the check valve under the plunger pump). Aspirate some air (> 5mL) in the syringe,
then connect the syringe connector to the check valve and secure it.

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Fluidic System

3. Unblock the check valve on the inlet: make the check valve vertical, slowly push the syringe arm
until all the air enters into the check valve. Then unscrew the connector and aspirate some air in
the syringe again. Secure the connector and repeatedly push the air.
4. Install the check valve on the inlet: if the air can go through the check valve smoothly, then this
check valve is unblocked. Unscrew the syringe connector and install the inlet check valve back
to the plunger pump.
5. Remove the check valve on the outlet: use a spanner to unscrew the check valve on the plunger
pump outlet (the check valve above the plunger pump). Directly connect the syringe connector
to the outlet check valve and secure it.
6. Unblock the check valve on the outlet: make the check valve vertical, slowly pull the syringe arm
to the maximum range. Then unscrew the connector and push the syringe back to the original
position. Secure the connector and try again.
7. Install the check valve on the outlet: if the syringe can be pulled back without any strength, then
this check valve is unblocked. Unscrew the syringe connector and install the outlet check valve
back to the plunger pump.

Pulse Damper
◼ Symbol

Figure 2-20 Pulse damper symbol

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Fluidic System

◼ Appearance

Figure 2-21 Pulse damper-old standalone instrument (082-002127-00 Pulse damper 2Mpa
0.2mL)

Figure 2-22 Pulse damper-instrument-New Standalone Instrument and Instrument in the


sample processing system (115-040825-00 Pulse Damper)

◼ Functions

The pulse damper is a pressure vessel that is used to eliminate fluid pressure pulsation or flow
pulsation in tube. It can stabilize fluid pressure and flow, thus eliminating vibration of the tube. Its
cavity is filled with a special elastic material. When the pressure increases, the material is contracted
and fluid is stored in the cavity; and when the pressure decreases, the material restores with the fluid
released.

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Fluidic System

Besides, a hydraulic sensor is integrated to the pulse damper to measure pressure of the tube.

Feeding Valve/Rotation Valve


◼ Symbol

2 1 2 1

3 6 3 6

4 5 4 5
POSA POSB

Figure 2-23 Rotation valve symbol

◼ Appearance:

Figure 2-24 Rotation valve (V1.0)

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Fluidic System

Figure 2-25 Rotation valve (V2.0)

Figure 2-26 Rotation valve (V3.0)

2-18
Fluidic System

◼ Function:

The feeding valve and rotation valve share the same material. They are only different in function.
The feeding valve quantifies and feeds sample; the rotation valve mainly realizes maintenance
functions. By switching of the 2 valves, different channels are connected and the functions are
realized.
◼ Note:

1. The 6 ports shall be correctly connected with their corresponding tubes.


2. The board behind the valve shall be kept away from water, and the wire shall be correctly
connected.

Analytical Column
◼ Symbol

Column

Figure 2-27 Analytical column symbol

◼ Appearance

Figure 2-28 Analytical column

◼ Function

The analytical column consists of the column jacket and stationary phase; it is the key component for
chromatography. When blood sample is loaded to the column, it is processed by eluent of the pre-
defined low ionic strength and pH conditions. Due to different charge strength and adsorption capacity
with the stationary phase, the various types of hemoglobin are eluted and separated.
◼ Note:

Make sure the inlet and outlet of the analytical column are correctly connected during installation.

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Fluidic System

Filter and Filter Element


◼ Symbol:

Filter

Figure 2-29 Filter symbol

◼ Appearance:

Filter Filter element

Figure 2-30 Filter and filter element

◼ Function:

The major function of the filter is to keep particles in the processed sample blood from entering the
analytical column, so as to slow down the pressure increase of the column to increase its service life.
The filter mainly consists of the cover and filter element.

Back Pressure Sensor


◼ Symbol:

PS1

Figure 2-31 Back pressure sensor symbol

2-20
Fluidic System

◼ Appearance:

Figure 2-32 Back pressure sensor

◼ Function

The back pressure sensor is a relative pressure sensor, with steel tube at its back connecting to the
atmosphere. Its major function is to measure fluid pressure at the outlet of the flow cell. The pressure
signal is transferred to flow signal of the tubes, which is directly used to calculate the chromatography
area of the various types of hemoglobin.
Pay attention to direction of the sensor during installation (put the side with the marking hole
downward, it is the inlet) to avoid accumulation of bubbles in the cavity of the pressure sensor.
Otherwise, the measured pressure may be incorrect.

Temperature Control of the Analytical Column


◼ Symbol:
temperature-
control box

Column
C38 C37
Column

T84

C35 C36
Preheating
steel tube 1

Figure 2-33 Symbol of temperature control box of the analytical column

2-21
Fluidic System

◼ Appearance:

Figure 2-34 Temperature control box of the analytical column

◼ Function:
Preheat blood sample and reagent that enter the analytical column; 2. Heat the analytical column and
keep constant temperature.
◼ Note:

The column shall be firmly installed inside the black heat-conducting base. Make the arc surface in
the middle of the column fits into that of the heat-conducting base to ensure the heat-conducting effect.
After installing the analytical column, lock up the box to ensure the heating preserving effect.
Do not bend the steel tube of the box with heavy force to avoid block of the tube and the unexpected
change in flow and pressure.

Temperature Control of the Optical System


◼ Symbol

Flow cell C41


temperature- Steel tube 3

control box
Detecor
Preheating steel
tube 2
C40

C39
Thermostatic Chamber

Figure 2-35 Symbol of flow cell temperature control box

2-22
Fluidic System

◼ Appearance:

Figure 2-36 Flow cell temperature control box

◼ Function:

Preheat blood sample and reagent that enter the optical flow cell; 2. Heat the LED, light absorption
detector and flow cell, and keep constant temperature.

◼ Note:

After installing optical system components, lock up the box to ensure the heating preserving effect of
the optical system.
Do not bend the steel tube of the optical system with heavy force to avoid block of the tube and the
unexpected change in flow and pressure.

Other Fluidic Components

2.3.11.1 Mix Bath Filter


◼ Symbol:

Mix bath filter

Figure 2-37 Mix bath filter symbol

◼ Appearance:

Figure 2-38 Mix bath filter

2-23
Fluidic System

◼ Function:

Filter the waste discharged from the mix bath to protect downstream fluidic components.

◼ Note:

Pay attention to direction of the coupling during installation, the side with a gap is its outlet.

2.3.11.2 Joint
◼ Symbol:

◼ Appearance:

Figure 2-39 Joints

◼ Function:

Connect tubes and components.

◼ Note:
Pay attention to the direction of the coupling.

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Fluidic System

2.3.11.3 Germproof Filter


◼ Symbol:

Germproof
filter

Figure 2-40 Germproof filter symbol

◼ Appearance:

Figure 2-41 Germproof filter

◼ Function:

Prevent germs from entering the cistern.

◼ Note:

Pay attention to the direction of the filter, its inlet is connected to the atmosphere.

2.3.11.4 Probe Wipe Filter


◼ Symbol:

Probe wipe
filter

Figure 2-42 Probe wipe filter symbol

2-25
Fluidic System

◼ Appearance:

Figure 2-43 Probe wipe filter

◼ Function:

Filter the impurities in waste in the probe wipe to protect downstream fluidic components.

◼ Note:

Pay attention to the direction of the filter.

2.3.11.5 Valves
◼ Symbol:

Figure 2-44 Electromagnetic valve symbol

◼ Appearance:

SMC 3-way valve SMC 2-way valve

Mindray valve Burkert valve

Figure 2-45 Electromagnetic valves

2-26
Fluidic System

◼ Function:

2-way valve: connect and disconnect the channel. When the valve is not electrified, the tube between
its inlet and outlet is disconnected, and vice versa.
3-way valve: switching of channels. When the valve is not electrified, its COM is connected to the NO;
when the valve is electrified, its COM is connected to the NC.
◼ Note:

The operating voltage of Mindray valve is DC 12V, and its maximum pressure is 200KPa. The Mindray
valve works via the electromagnet, and restores using spring; it should not be electrified for long.
When the electromagnetic valve is electrified, the ejector rod of the valve presses down; when it is
not electrified, the ejector rod restores. By touching the rod with your hand, you can feel its movement
easily so as to judge its status.

2.3.11.6 Syringes
◼ Symbol:

Syringe 2.5mL Syringe 100uL

Figure 2-46 Syringe symbols

◼ Appearance:

Figure 2-47 100uL syringe and 2.5mL syringe

2-27
Fluidic System

◼ Function:

The 2.5mL syringe is used to aspirate and prepare sample, and clean the system in predilute mode.
The 100uL syringe is used to aspirate sample in whole blood mode.

◼ Note: /

2.3.11.7 Sample Probe


◼ Symbol:
/
◼ Appearance:

Figure 2-48 Sample probe

◼ Function:

The sample probe provides a corrosion resistant cavity for aspiration and dispensing of blood and
probe cleanser.

◼ Note:

The sample probe tip is designed tapered for its piercing function.

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Fluidic System

2.3.11.8 Probe Wipe


◼ Symbol:

Probe
wipe

Figure 2-49 Probe wipe symbol

◼ Appearance:

Figure 2-50 Probe wipe

◼ Function:

The probe wipe provides a cavity for cleaning of the sample probe with the effect of liquid flow, and
gathering of the waste produced.
◼ Note: /

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Fluidic System

2.3.11.9 Waste Pump (Standalone Instrument)


◼ Symbol:

Waste pump

Figure 2-51 Waste pump symbol

◼ Appearance:

Figure 2-52 Waste pump

◼ Function:

Emptying the probe wipe, waste cistern and mix bath, generating vacuum of the waste cistern and
priming reagent to the cisterns.

◼ Note:

Pay attention to the direction of the waste pump.

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Fluidic System

2.3.11.10 Waste Pump Assembly (New Standalone Instrument and Instrument


in the Sample Processing System)
◼ Symbol:

P1 P2 Waste pump
P2
Waste pump P1

Figure 2-53 Waste pump symbol

◼ Appearance:

Figure 2-54 Waste pump assembly

The waste pump 1 is used to empty the probe wipe, waste cistern and mix bath, generate vacuum of
the waste cistern and prime reagent to the cisterns. The waste pump 2 is used to empty the waste
cistern 2.
◼ Note:

Pay attention to the direction of the waste pump.

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Fluidic System

2.3.11.11 Bath and Cisterns


◼ HWS cistern: stores hemolysis solution;

Figure 2-55 HWS cistern

◼ Eluent A cistern: stores eluent A;

Figure 2-56 EL_A cistern

◼ Eluent B cistern: stores eluent B;

Figure 2-57 EL_B cistern

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Fluidic System

◼ HbA1c mix bath-old standalone instrument: provides the site for sample mixing and reaction, and
feeds processed sample.

Figure 2-58 Mix bath-old standalone instrument

◼ HbA1c mix bath-new standalone instrument and instrument in the sample processing system
(with HGB test light assembly): provides the site for sample mixing and reaction, and feeds
processed sample. The HGB test light assembly is used to test mix bath background and the
HGB value of samples.

Figure 2-59 Mix bath-new standalone instrument and instrument in the sample processing
system (with HGB test light assembly)

2-33
Fluidic System

◼ Waste cistern (old standalone instrument): stores waste and generates vacuum.

Figure 2-60 Waste cistern

◼ Waste cistern assembly (new standalone instrument and instrument in the sample processing
system)
Waste cistern: stores waste and generates vacuum.
Waste cistern 2: stores and empties the waste.

Figure 2-61 Waste cistern assembly

2.4 Fluidic Sequences (Old Standalone Instrument)

Startup Sequence
The general startup sequence applies to starting up the analyzer after normal shutdown.
Definition of normal shutdown: shut down the analyzer with normal analyzing function (without error)
according to the procedure stated in the Operator's Manual.

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Fluidic System

The analyzer is to be started up after normal shut down for a period not exceeding the specified period.
If the analyzer is to be idle for a longer period, the prepare-to-ship procedure shall be performed, and
the startup sequence after prepare-to-ship shutdown will be invoked.
Note:
After normal shutdown, the analyzer stops working, crystals may be produced in certain area due to
reagent evaporation, bubbles may be produced due to evolution of gas dissolved in reagent or air
permeability of tubes, and cross contamination may occur due to exposure to reagent, which all bring
negative impact to the analyzer.

2.4.1.1 Components Involved


All sensors, plunger pumps, waste pumps, electromagnetic valves, rotation valves, filters, waste
cisterns, other cisterns, the sample probe assembly, probe wipe, temperature-control assembly, the
analytical column, and flow cell.

2.4.1.2 Working Order


The general startup sequence consists of 3 phases:
1. Initialization
In this phase, the actions done include hardware initialization, software initialization, user login,
electromechanical system initialization and fluidic system initialization. Its procedure is shown in the
following diagram.

Start

Turn on
temperature
control

User login

Manufature/RD/
Skip
Yes Service access
initialization?
level?
Yes No
No
Electromechanical
System initialization

Startup finishes Fluidic Succeed? No


initialization
Troubleshooting
Yes

Next phase ERROR or


ATTENTION

Figure 2-62 Startup initialization process

2. Priming and cleaning


In this phase, cleaning operations of different strength are done according to the system idle period.
PUMP CLEAN mainly cleans the seal ring of the plunger pump to prevent the seal ring from being
worn out by reagent crystals; BUFFER PRIME replaces reagent in tubes of plunger pump A and B,
and empties bubbles in the tubes to maintain flow rate. WARMING UP cleans the sample preparation
channel (including the sample probe assembly and probe wipe), it also cleans the chromatography
channel to balance the analytical column, and waits until the temperature of the column and flow cell
meets requirement.

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Fluidic System

The previous phase

Cistern fluid
No Idle period≤72hr? No Idle period≤72hr?
discharge

Yes Yes

PUMP CLEAN-1
PUMP CLEAN-2
PUMP CLEAN-2
BUFFER PRIME-1

BUFFER PRIME-2
BUFFER PRIME-2
Temperature meets
requirement in specified No
period?
Temperature meets
requirement in specified No
period?
Temperature meets
Yes Yes
requirement in specified No
period?
Yes
WARMING UP-2
WARMING UP-1
WARMING UP-2

Temperature meets
No
requirement?

Yes Troubleshooting

ERROR or
Next phase
ATTENTION

Figure 2-63 Startup cleaning process

3. Ending startup
If the user enables the auto analysis after startup function, and there is tube rack on the autoloader
desk, the auto analysis procedure will be started after cleaning and priming. If not, the plunger pump
will be turned off, the startup sequence ends and the analyzer stands by.
The previous phase

Is there any
Analysis
Yes sample&&Auto
flow
analysis enabled?

No

Pump Stop sequence

End

Figure 2-64 Startup ending process

2-36
Fluidic System

Whole Blood Analysis Mode

2.4.2.1 Sample Preparation Channel


◼ 0~14s:

1. Sample probe pre-piercing and cleaning: the 2.5ml syringe works together with SV04, SV01,
SV03, waste pump and SV06;
2. Sample aspiration: the 100ul syringe aspirates 16ul of whole blood;
3. Cleaning after sample aspiration: the 2.5ml syringe, SV04, SV03, waste pump and SV06.

1 2
HWS 6 3
5 4
Cistern
INJ-V

Sample Loop 4 uL

SV18 SV19

SV01
Syringe 100uL

SV04 SV03 SV02


Probe wipe

Sample probe

Mix bath Wipe filter

SV06 SV05

Syringe 2.5mL
Mix bath
filter GP1
Waste
container
SV15
Waste pump

Figure 2-65 Work flow of sample preparation channel

◼ 14~24s:

1. Sample probe cleaning in mix bath: the sample probe moves to mix bath lower position, V15
opens to empty the mix bath;
2. Sample probe exterior wall cleaning: the 2.5ml syringe, SV04, SV03, waste pump and SV06
3. Adding hemolysis solution: the 2.5ml syringe, V02 opens to add 100ul hemolysis solution to the
mix bath;
4. Sample blood discarding by probe wipe: the 100ul syringe dispenses 6ul of blood to probe wipe;

◼ 24~34s:

1. Mix bath sample blood dispensing: the 100ul syringe dispenses 4ul of blood to mix bath;
2. Sample dilution and mixing: the 2.5ml syringe dispenses 300ul of hemolysis solution to the mix
bath to dilute and process sample blood, meanwhile the 2.5ml syringe mixes the sample by
aspirating and dispensing it 2 times, 100ul each time.
3. Sample probe exterior and interior wall cleaning: the 2.5ml syringe, SV04, SV03, SV01, waste
pump and SV06
◼ 34~52s:

Sample preparation: the 2.5ml syringe works together with SV04 and SV19 to aspirate 160ul of
sample to the inlet of the feeding valve, which by then switches to send the sample loop to sample

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Fluidic System

preparation channel. The 2.5ml syringe continues to aspirate 80~100ul of sample through the feeding
valve. The sample loop quantifies 4ul of sample. By the 52s, the feeding valve switches to finish
sample feeding.

1 2
6 3
5 4

Injection Valve
1

Sample Loop
4 uL

SV19

Figure 2-66 Sample preparation process

◼ 52~69s:
Tube cleaning and restoration: After sample feeding (the feeding valve switches after sample feeding),
the 2.5ml syringe works with SV04, SV01, SV19, waste pump, SV06, SV02 and SV15 to clean the
sample preparation tube and mix bath.

2.4.2.2 Chromatography Channel


◼ 0~99s

Plunger pump A works with stable flow, when the feeding valve moves to the load position, it sends
sample to the analytical column for elution.

◼ 99~104s

Plunger pump A stops working, and plunger pump B starts to work. It feeds eluent B with stable flow
to further elute sample in the analytical column.

◼ 104~124s

Plunger pump B stops working, and plunger pump A starts to work. It feeds eluent A with stable flow
to wash the analytical column and restore its balance.

Predilute Analysis Mode

2.4.3.1 Sample Preparation Channel


◼ 30~52s

Sample preparation: the 2.5ml syringe works together with SV04 and SV19 to aspirate 160ul of
sample to the inlet of the feeding valve, which by then switches to send the sample loop to sample
preparation channel. The 2.5ml syringe continues to aspirate 80~100ul of sample through the feeding
valve. The sample loop quantifies 4ul of sample. By the 22s, the feeding valve switches to finish
sample feeding.
◼ 52~72s
Tube cleaning and restoration: After sample feeding (the feeding valve switches after sample feeding),
the 2.5ml syringe works with SV04, SV01, SV19, waste pump, SV06, SV02 and SV15 to clean the

2-38
Fluidic System

sample preparation tube and mix bath.

2.4.3.2 Chromatography Channel


◼ 0~99s
Plunger pump A works with stable flow, when the feeding valve moves to the load position, it sends
sample to the analytical column for elution.
◼ 99~104s

Plunger pump A stops working, and plunger pump B starts to work. It feeds eluent B with stable flow
to further elute sample in the analytical column.
◼ 104~124s

Plunger pump B stops working, and plunger pump A starts to work. It feeds eluent A with stable flow
to wash the analytical column and restore its balance.

Probe Cleanser Maintenance Sequence


After long-term use, particles in blood sample may block the filter before the analytical column, which
causes pressure rise in tubing. The pressure may even rise to the maximum operating pressure.
Therefore probe cleanser maintenance shall be performed to the filter based on the quantity of
samples analyzed.
The maintenance flow is as follows:
Start

Software prompt asks the user to


put probe cleanser into the sample compartment

Open the
compartment door
Tap “Start”

Is the compartment
door closed?

Yes
Preparation before
maintenance
Probe Cleanser
maintenance
Reset after
maintenance
No

Reset times

Maintenance
performance self-test
Prompt for
calibration

End

Figure 2-67 Probe cleanser maintenance flow

2-39
Fluidic System

2.4.4.1 Preparation before maintenance


① Turn on the degasser; ② Prime all cisterns to make sure there will be enough reagent to support
the probe cleanser maintenance; ③ Switch the rotation valve to fast relief position to prevent
probe cleanser from entering the analytical column.
Note:
The analytical column may be damaged if probe cleanser enters the column. Should there be any
error during the preparation phase; the probe cleanser maintenance process will end instantly.

2.4.4.2 Probe cleanser maintenance


The maintenance flow consists of 2 phases:
① Probe cleanser soaking
Plunger pump A turns on to keep the pressure and flow of the tubing of eluent A stable;
The sample probe moves to the closed sample aspiration position, the 2.5 mL syringe aspirates 1 mL
of probe cleanser and cleans the outside of the sample probe;
The 2.5 mL syringe discharges the aspirated probe cleanser out of the analyzer through the probe
wipe and waste pump.
The sample probe moves to the closed sample aspiration position again, the 2.5mL syringe aspirates
670uL of probe cleanser and cleans the outside of the sample probe;
The syringe keeps on aspirating probe cleanser, which goes through the sample loop first. With
continuous switching of the feeding valve and driven by the plunger pump, the probe cleanser in the
sample loop goes to the filter and is discharged to the waste cistern then through the fast relief
channel.
When the probe cleanser goes to the filter, plunger pump A stops to reduce its flow rate so that it can
thoroughly soak the filter.
The steps above are performed twice in a row.

2-40
Fluidic System

废液池
Waste cistern

流通池
Detecor
柱塞泵
INJ_PUMPB
Column

ROT-V
Column filter

6 3
5 4

INJ-V

Ta2
Sample Loop 4 uL

SV19
Syringe2.5mL注射器
2.5mL

Probe wipe

Sample probe

Wipe filter

SV06

T69

GP1

SV15
P1 废液桶
Waste container
Waste pump

Figure 2-68 Probe cleanser soaking

② Probe cleanser cleaning


The purpose of probe cleanser cleaning is to remove residual probe cleanser in tubing to eliminate
its impact to blood sample and the chromatography system. The sample preparation channel and
chromatography channel are cleaned.
The 2.5mL syringe aspirates hemolysis solution from the HWS cistern, pulls and pushes the
hemolysis solution back and forth in the sample preparation channel to clean it, and then discharges
the solution to waste cistern through the sample probe and probe wipe. During the process, the
feeding valve switches between POS A and POS B repeatedly for thorough cleaning.
Cleaning of the chromatography channel is accomplished by the continuous and intermittent liquid
feeding of Plunger pump A, which soaks and cleans the downstream tubing so that it can restore its
normal state.

2.4.4.3 Restoration after maintenance


After probe cleanser cleaning, the state of the fluidic system shall be restored to normal. The
operations to be done include switching rotation valve, priming cisterns and turning off the degasser.

2.4.4.4 Maintenance performance self-test


After probe cleanser maintenance, self-test of the filter pressure and column pressure shall be
performed to see if the maintenance effect and filter performance are ok.

2-41
Fluidic System

2.5 Fluidic Sequences (New Standalone Instrument and


Instrument in the Sample Processing System)

Startup Sequence
The general startup sequence applies to starting up the analyzer after normal shutdown.
Definition of normal shutdown: shut down the analyzer with normal analyzing function (without error)
according to the procedure stated in the Operator's Manual.
The analyzer is to be started up after normal shut down for a period not exceeding the specified period.
If the analyzer is to be idle for a longer period, the prepare-to-ship procedure shall be performed, and
the startup sequence after prepare-to-ship shutdown will be invoked.
Note:
After normal shutdown, the analyzer stops working, crystals may be produced in certain area due to
reagent evaporation, bubbles may be produced due to evolution of gas dissolved in reagent or air
permeability of tubes, and cross contamination may occur due to exposure to reagent, which all bring
negative impact to the analyzer.

2.5.1.1 Components Involved


All sensors, plunger pumps, waste pump assemblies, electromagnetic valves, rotation valves, filters,
waste cistern assemblies, other cisterns, sample probe assembly, probe wipe, temperature-control
assembly, the analytical column, and flow cell.

2.5.1.2 Working Order


The general startup sequence consists of 3 phases:
1. Initialization
In this phase, the actions done include hardware initialization, software initialization, user login,
electromechanical system initialization and fluidic system initialization. Its procedure is shown in the
following diagram.

Start

Turn on
temperature
control

User login

Manufature/RD/
Skip
Yes Service access
initialization?
level?
Yes No
No
Electromechanical
System initialization

Startup finishes Fluidic Succeed? No


initialization
Troubleshooting
Yes

Next phase ERROR or


ATTENTION

Figure 2-69 Startup initialization process

2-42
Fluidic System

2. Priming and cleaning


In this phase, cleaning operations of different strength are done according to the system idle period.
PUMP CLEAN mainly cleans the seal ring of the plunger pump to prevent the seal ring from being
worn out by reagent crystals; BUFFER PRIME replaces reagent in tubes of plunger pump A and B,
and empties bubbles in the tubes to maintain flow rate. WARMING UP cleans the sample preparation
channel (including the sample probe assembly and probe wipe), it also cleans the chromatography
channel to balance the analytical column, and waits until the temperature of the column and flow cell
meets requirement.
The previous phase

Cistern fluid
No Idle period≤72hr? No Idle period≤72hr?
discharge

Yes Yes

PUMP CLEAN-1
PUMP CLEAN-2
PUMP CLEAN-2
BUFFER PRIME-1

BUFFER PRIME-2
BUFFER PRIME-2
Temperature meets
requirement in specified No
period?
Temperature meets
requirement in specified No
period?
Temperature meets
Yes Yes
requirement in specified No
period?
Yes
WARMING UP-2
WARMING UP-1
WARMING UP-2

Temperature meets
No
requirement?

Yes Troubleshooting

ERROR or
Next phase
ATTENTION

Figure 2-70 Startup cleaning process

3. Ending startup
If the user enables the auto analysis after startup function, and there is tube rack on the autoloader
desk, the auto analysis procedure will be started after cleaning and priming. If not, the plunger pump
will be turned off, the startup sequence ends and the analyzer stands by.
The previous phase

Is there any
Analysis
Yes sample&&Auto
flow
analysis enabled?

No

Pump Stop sequence

End

Figure 2-71 Startup ending process

2-43
Fluidic System

Whole Blood Analysis Mode

2.5.2.1 Sample Preparation Channel


◼ 0~14s:

1. Sample probe pre-piercing and cleaning: the 2.5ml syringe works together with SV04, SV01,
SV03, waste pump 1, SV06, waste pump 2, and SV14;
2. Sample aspiration: the 100ul syringe aspirates 16ul of whole blood;
3. Cleaning after sample aspiration: the 2.5ml syringe, SV04, SV03, waste pump 1, SV06, waste
pump 2, and SV14.
4. Background Voltage Test: the HGB test light assembly tests the background voltage of the mix
bath.

HWS 5 6
Cistern 4 1
3 2
INJ-V
Sample Loop 40 uL

Waste
SV18 SV19 cistern 2

SV01
Syringe 100uL

SV04 SV03 SV02


Probe wipe SV14

Sample probe

Mix bath Wipe filter

P2 Waste pump 2

SV06 SV05
Syringe Waste connector
2.5mL
Mix bath filter
GP1

P1 Waste
SV15
container
Waste pump 1

Figure 2-72 Work flow of sample preparation channel

◼ 14~24s:
1. Sample probe cleaning in mix bath: the sample probe moves to mix bath lower position, V15
opens to empty the mix bath;
2. Sample probe exterior wall cleaning: the 2.5ml syringe, SV04, SV03, waste pump 1, SV06, waste
pump 2, and SV14;
3. Adding hemolysis solution: the 2.5ml syringe, V02 opens to add 100ul hemolysis solution to the
mix bath;
4. Sample blood discarding by probe wipe: the 100ul syringe dispenses 6ul of blood to probe wipe;

◼ 24~36s:

1. Mix bath sample blood dispensing: the 100ul syringe dispenses 4ul of blood to mix bath;
2. Sample dilution and mixing: the 2.5ml syringe dispenses 300ul of hemolysis solution to the mix
bath to dilute and process sample blood, meanwhile the 2.5ml syringe mixes the sample by
aspirating and dispensing it 2 times, 100ul each time.
3. Sample probe exterior and interior wall cleaning: the 2.5ml syringe, SV04, SV03, SV19, waste

2-44
Fluidic System

pump 1, SV06, waste pump 2, and SV14.


4. Mixed sample voltage testing: HGB test light assembly testes the sample voltage in the mix bath.

◼ 36~52s:

Sample preparation: the 2.5ml syringe and 100ul syringe work together with SV04 and SV19 to
aspirate 160ul of sample, and 80ul~90ul of sample passes through the feeding valve, which by then
the feeding valve switches to send the sample loop to sample preparation channel. Then the 100ul
syringe controls the sample feeding according to the dynamic sampling sequence command. The
sample feeding volume varies with the HGB concentration value. By the 52s, the feeding valve
switches to finish sample feeding.

(1) Aspirate 160ul of sample

2-45
Fluidic System

(2) Aspirate the sample to the inlet of the feeding valve

(3) The feeding valve switches to the sampling position

2-46
Fluidic System

(4) 100ul syringe controls the sample feeding

(5) The feeding valve switches to the injection position

Figure 2-73 Sample preparation process

2-47
Fluidic System

1. Use the 2.5ml syringe to aspirate 160ul of sample.


2. The feeding valve is at the injection position. The 2.5ml syringe and 100ul syringe work together
to make certain volume of the sample pass through the feeding valve, to make sure the sample
blood in the left inlet is not diluted.
3. After the syringe stops moving, the feeding valve switches to the sampling position.
4. 100ul syringe controls the sample to go through the sample loop.
5. The feeding valve switches to the injection position, the sample blood in the sample loop goes
into the column with the Eluent driven by the plunger pump.

◼ 52~67s:
Tube cleaning and restoration: After sample feeding (the feeding valve switches after sample feeding),
the 2.5ml syringe works with SV04, SV01, SV19, waste pump 1, SV06, waste pump 2, SV14, SV02,
and SV15 to clean the sample preparation tube and mix bath.

2.5.2.2 Chromatography Channel


◼ 0~99s

Plunger pump A works with stable flow, when the feeding valve moves to the load position, it sends
sample to the analytical column for elution.

◼ 99~104s

Plunger pump A stops working, and plunger pump B starts to work. It feeds Eluent B with stable flow
to further elute sample in the analytical column.

◼ 104~124s

Plunger pump B stops working, and plunger pump A starts to work. It feeds Eluent A with stable flow
to wash the analytical column and restore its balance.

Prediluted Analysis Mode

2.5.3.1 Sample Preparation Channel


◼ 30~52s
Sample preparation: the 2.5ml syringe and 100ul syringe work together with SV04 and SV19 to
aspirate 160ul of sample, and 80ul~90ul of sample passes through the feeding valve, which by then
the feeding valve switches to send the sample loop to sample preparation channel. Then the 100ul
syringe feeds 4ul of sample. By the 52s, the feeding valve switches to finish sample feeding.
◼ 52~68s

Tube cleaning and restoration: After sample feeding (the feeding valve switches after sample feeding),
the 2.5ml syringe works with SV04, SV01, SV19, waste pump 1, SV06, waste pump 2, SV14, SV02,
and SV15 to clean the sample preparation tube and mix bath.

2.5.3.2 Chromatography Channel


◼ 0~99s
Plunger pump A works with stable flow, when the feeding valve moves to the load position, it sends
sample to the analytical column for elution.

2-48
Fluidic System

◼ 99~104s

Plunger pump A stops working, and plunger pump B starts to work. It feeds Eluent B with stable flow
to further elute sample in the analytical column.

◼ 104~124s

Plunger pump B stops working, and plunger pump A starts to work. It feeds Eluent A with stable flow
to wash the analytical column and restore its balance.

Probe Cleanser Maintenance Sequence


After long-term use, particles in blood sample may block the filter before the analytical column, which
causes pressure rise in tubing. The pressure may even rise to the maximum operating pressure.
Therefore probe cleanser maintenance shall be performed to the filter based on the quantity of
samples analyzed.
The maintenance flow is as follows:

Start

Software prompt asks the user to


put probe cleanser into the sample compartment

Open the
compartment door
Tap “Start”

Is the compartment
door closed?

Yes
Preparation before
maintenance
Probe Cleanser
maintenance
Reset after
maintenance
No

Reset times

Maintenance
performance self-test
Prompt for
calibration

End

Figure 2-74 Probe cleanser maintenance flow

2.5.4.1 Preparation before Maintenance

① Turn on the degasser; ② Prime all cisterns to make sure there will be enough reagent to support

the probe cleanser maintenance; ③ Switch the rotation valve to fast relief position to prevent probe

cleanser from entering the analytical column.


Note:
The analytical column may be damaged if probe cleanser enters the column. Should there be any
error during the preparation phase; the probe cleanser maintenance process will end instantly.

2-49
Fluidic System

2.5.4.2 Probe Cleanser Maintenance


The maintenance flow consists of 2 phases:
1. Probe cleanser soaking
Plunger pump A turns on to keep the pressure and flow of the tubing of Eluent A stable;
The sample probe moves to the closed sample aspiration position, the 2.5mL syringe aspirates 450uL
of probe cleanser and cleans the outside of the sample probe;
The syringe keeps on pushing probe cleanser, which goes into the sample loop first. With continuous
switching of the feeding valve and driven by the plunger pump, the probe cleanser in the sample loop
goes to the filter and is discharged to the waste cistern then through the fast relief channel.
When the probe cleanser goes to the filter, plunger pump A stops to reduce its flow rate so that it can
thoroughly soak the filter.
The steps above are performed twice in a row.
Waste cistern

Thermostatic Chamber

INJ_PUMP 5 6
4 1 Column
3 2

ROT-V
Column filter

5 6
4 1
Preheating steel tube 1
3 2

INJ-V

Sample Loop 40 uL

Waste
SV19 cistern 2
Syringe 2.5mL

SV14
Probe wipe

Sample probe

Wipe filter
P2 Waste pump 2

SV06 SV05
Waste connector

GP1

P1 Waste
SV15
container
Waste pump 1

Figure 2-75 Probe cleanser soaking

2. Probe cleanser cleaning


The purpose of probe cleanser cleaning is to remove residual probe cleanser in tubing to eliminate
its impact to blood sample and the chromatography system. The sample preparation channel and
chromatography channel are cleaned.
The 2.5mL syringe aspirates hemolysis solution from the HWS cistern, pulls and pushes the
hemolysis solution back and forth in the sample preparation channel to clean it, and then discharges
the solution to waste cistern through the sample probe and probe wipe. During the process, the
feeding valve switches between POS A and POS B repeatedly for thorough cleaning.
Cleaning of the chromatography channel is accomplished by the continuous and intermittent liquid
feeding of plunger pump A, which soaks and cleans the downstream tubing so that it can restore its
normal state.

2-50
Fluidic System

2.5.4.3 Restoration after Maintenance


After probe cleanser cleaning, the state of the fluidic system shall be restored to normal. The
operations to be done include switching rotation valve, priming cisterns and turning off the waste
pump.

2.5.4.4 Maintenance Performance Self-test


After probe cleanser maintenance, self-test of the filter pressure and column pressure shall be
performed to see if the maintenance effect and filter performance are OK.

2-51
Chapter 3 Optical System

3.1 Overview of Optical System Principle


The H50 optical system uses double wavelength colorimetric principle to measure the hemoglobin
solution eluted from the chromatography column real time, by measuring the absorbance curve
(chromatogram), concentration of the hemoglobin solution can be obtained. The measuring
wavelength is 415nm, while the reference wavelength is 500nm, which is used to offset temperature
drift and background interference to increase measuring accuracy.

3.2 Optical System Operating Principle


The following figure is the optical path top view of the H50 optical system.

10

9
OUT

1 2 3 4 6 7 8
IN

Figure 3-1 Optical path top view

1. Blue LED
2. Convergent lens
3. Encapsulated lens
4. Flow cell
5. Encapsulated lens
6. Dichroscope
7. 500nm interference filter
8. Detecting PD
9. 415nm interference filter
10. Detecting PD
The H50 optical system uses the blue LED (1) as optical source, which emits blue light beam whose
dominant wavelength is 460nm. The light beam is then converged by the convergent lens (2), and
then enters the flow cell (4) which is encapsulated by the two planoconvex quartz lenses (3, 5). The
emergent light is split into two beams by the dichroscope (6), the one whose wavelength is 500nm is
transmitted through the interference filter (7) and the received by the detecting PD (8), while the other
one whose wavelength is 415nm is reflected through the interference filter (9) and the received by
the detecting PD (10). Since hemoglobin has intensive absorption to the 415nm light beam, its
concentration can be calculated by measuring the absorbance. To increase the measuring accuracy
and reduce interference, the 500nm light beam to which hemoglobin has no absorption is used as a

3-1
Optical System

reference.

3.3 Optical System Composition


The following figure shows the assemblies of the H50 optical system.

1 2 3 4 5
8

7
6

Figure 3-2 Optical system composition

1. Detecting assembly 2. Flow cell assembly


3. Front optical assembly 4. Cover
5. Outlet pipe 6. Inlet pipe
7. Base plate assembly 8. Shielding case
The detecting assembly (1) is consisted of the dichroscope, 415nm and 500nm interference filters,
and detecting PDs. The flow cell assembly (2) is consisted the flow cell and encapsulated quartz
lenses. The flow cell assembly (2) is fixed to the detecting assembly (1). The front optical assembly
(3) includes the blue LED and aspheric focusing lens.
Part of the inlet pipe (6) is embedded in the base plate assembly (7) which is fitted with heating
membrane to adjust temperature of the sample that goes to the flow cell. The entire optical system is
encapsulated by the shielding case (8) to shield the impact of outside light, heat, vibration and
electromagnetic field.

3.4 Optical System Status Determination


The status of the H50 optical system can be determined by voltage and gain of the two optical

3-2
Optical System

channels in the Setup -> Gains screen.


First, run a background count under CT-WB mode. After the analysis,, check if the voltages of the
415nm and 500nm optical channels are within the range 3.800V~4.100V, and the gains are below
255 in the Setup -> Gains screen. See the following figure.

Figure 3-3 "Gains" screen

3.5 Maintenance and Replacement of the Optical System


If the optical system is not in its normal state, maintenance or replacement of the system is needed.
Based on the status determination, the possible causes and maintenance methods of the optical
system anomaly are:

◼ Cause 1: Optical intensity attenuation due to aging of the LED

Optical intensity of the LED attenuates due to its aging, which results in voltage drop of the PDs of
the 415nm and 500nm channels.
✓ Tool: No. 107 cross-head screwdriver
✓ Solution:
a) Adjust the gains of the 415nm and 500nm channels in the Setup -> Gains screen until the
voltages fall within the range 3.800-4.100V.
b) If the gains have been adjusted to the max, but the background voltages are still lower than the
required range, the H50 optical system must be replaced according to the following procedure.
i. Shut down the analyzer, and then disconnect the sockets that connect the 3 wires of the
optical system to the analyzer system (see the following figure). The signal wire is connected
to socket A42 and A45 of the drive board of the analyzer.

3-3
Optical System

Wire connecting the


Optical system temperature switch and
signal wire heating membrane

Temperature
sensor wire

Figure 3-4 Wires of the optical system

ii. Remove the 4 M3 cross-recessed panhead screws (2 in the back and 2 in the front) that fix
the optical system to the support plate of the analyzer, and unscrew the joints of the inlet
and outlet pipes. See the following figure.

Inlet pipe joint

Outlet pipe
joint

M3 screws on the
front

Figure 3-5 Connection of the optical system to the analyzer

iii. Replace the optical system and connect it back as shown in the 2 figures above. Be noted
that the temperature sensor wire of the base plate shall be connect to terminal T_OPT_HT,
and the temperature sensor wire of the flow cell shall be connected to terminal T_OPT_AIR;
and the inlet and outlet pipes shall be tightened to avoid leakage.
✓ Note:
➢ Before the adjustment, run a background count in the "Sample Analysis" screen to make
sure the flow cell is filled with liquid;
➢ After replacing the optical system, make sure the inlet and outlet pipes are tightened to
avoid leakage.

3-4
Optical System

◼ Cause 2: Failure of the LED drive board or the detecting assembly

✓ Tool: No. 107 cross-head screwdriver


✓ Solution:
If no change in voltage is observed when adjusting the gains of the optical channels, the LED drive
board or detecting assembly may be broken. As the LED drive board is fixed inside the optical system
shielding case, and the detecting assembly is fixed to the base plate and connected to the inlet and
outlet pipes as well, they can be difficult to be replaced, the workable solution is to replace the entire
H50 optical system. The replacing procedure has already been given in Cause 1, step b).

3.6 Optical System Status Verification after Maintenance


or Replacement
The following items shall be verified after maintaining or replacing the optical system.

Adjusting gains of the channels


See Cause 1, step a) of section 5.

◼ Verification with samples

After adjusting the gains, run analysis of a normal fresh blood sample. It is required that
chromatogram peak pattern of the sample is normal, without abnormal peak, as shown in the following
figure.

Figure 3-6 Chromatogram of a normal sample

3-5
Chapter 4 Hardware System

4.1 Structure of Hardware System


The hardware system mainly consists of 3 boards (namely main control board, drive board and
autoloader board) and 4 modules (namely autoloader module, driving sub-module, optical signal
detection module and main control module). The connection diagram is shown as follows:
Optical
Optical pre-
pre- Optical
Optical pre-
pre- Optical heating Optical system
Front amplification
amplification amplification
amplification membrane and temperature
cover board
board board
board protection switch sensor

LED
LED drive
drive board
board

009-004812-00 Optical
system Heating cable
009-005459-00
Cover sensor cable 009-004814-00 Optical system
temperature sensor cable

051-000218-00
051-000218-00 Liquid
Liquid pressure
pressure
detection
detection board(I)
board(I) 009-004813-00 Optical system
J4 signal cable
Column thermostatic
009-004754-00 Column
chamber heating
A38 A17 A5 A18 thermostatic chamber heating
A41,A45 membrane and
J69 J80 control cable
Touch screen protection switch
009-004817-00 009-004753-00 Column
control board J67 Column thermostatic
Touch screen touch thermostatic chamber
051-000881-00 A4 chamber
control cable
(F) temperature cable
Ambient
temperature
009-004818-00 009-004742-00
J4, A20 009-004748-00 Plunger
LED screen signal Communication M
J16 pump motor cable
cable J81 cable between A27
main control Plunger pump
A37 009-004749-00 Plunger pump
board and drive Plunger
Keyboard 051- sensor cable
009-004816-00 board pump
J78
001568-00(H) indicator board cable 009-004750-00 Rotary feedingsensor
051-001159-00
051-001159-00 Main
Main control
control board
board (B)
(B) A16
valve power cord 21
Indicator board 009-004751-00 Rotary feeding 34 56
A26
051-000675-00 (G) valve signal cable
009-004743-00
RFID reagent detection A12 Cable to the right
009-005582-00 J14
module door valve
Reagent RFID cable
(009-005588-00 RFID
009-004744-00
lead wire) *3
A13 Front horizontal
RFID reagent detection 051-001159-00
051-001159-00 Drive
Drive analog
analog board
board PCBA(B)
PCBA(B) plate valve cable
009-005583-00
module J9
Tube rack RFID cable
(009-005588-00 RFID A7 009-004745-00
wire) J68 Pump cable
J8
009-004746-00
A11 Cable to the middle
Connecting line of plate valve
data board and
autoloader board 009-004755-00 Fluid
serial port A6 pressure sensor cable

J12 J11 Fluid pressure sensor


A15
009-004752-00 Degasser
009-004756-00 Autoloading Degasser cable pump
Autoloader
mechanism and sensor extension J3,J14
board
cables ,J7,J8 009-004747-00 Floater sensor
A30
cable Floater
051-000393-00
051-000393-00 Autoloader
Autoloader board
board (B)
(B) A1
009-004811-00
Mix mechanism 009-004763-00 Mix mechanism motor A32 009-
J15,J16 Syringe sensor cable
and sensor connecting line 002604-00
,J6
Syringe
J5
M ground
(6P) A14 A33 A21 009-004810-00 Syringe
A22 motor cable cable
100uL syringe
2.5mL syringe
009-004739-00 Main
009-004740-00
control board cables 009-004741-00 Drive
Autoloader board 009-004809-00
to digital and drive board cables to digital
power cord Sample
board analog power and power circuit
circuit collection
assembly
sensor
connecting
J5 J7 J6 cable 009-002463-00
J3 M_SAMPLE_Y
(6P) (6P) (12P) (14P) Sample collection SEN_XPOS
220V/110V AC 009-004808-00 Joint assembly motor and SEN_YUP
Sample sensor patching line
Power
Power supply
supply module
module J2 collection
(12P)
assembly M
motor
connecting SAMPLE_X
051-001345-00
051-001345-00 Power
Power patching
patching board
board PCBA(C)
PCBA(C) cable

Figure 4-1 Hardware system connection diagram (standalone instrument)

4-1
Hardware System

Optical pre- Optical pre- Optical heating Optical system


Front amplificatio n amplificatio n membrane and temperature
cover boa rd boa rd protection switch sensor

LED drive board

009-004 812-00 Optical


system Heating ca ble
009-005 459-00
Cover sen sor cable 009-004 814-00 Optical system
temperature sensor cab le

051-000 218-00 Liqu id pressu re


detectio n b oard(I) 009-004 813-00 Optical system
J4 signal cable
Column th ermostatic
009-004 754-00 Column
chamber hea ting
A38 A17 A5 A18 thermostatic chambe r h eati ng
A41,A45 membrane an d
J69 J80 control cab le
Touch screen protection switch
009-004 817-00
control board 009-004 753-00 Column
Touch screen touch J67 Column th ermostatic
051-000 881-00 A4 thermostatic chambe r
control cab le chamber
(F) temperature cable
Ambien t
temperature
009-004 818-00 009-004 742-00
J4, A20 009-004 748-00 Plun ger
LED scree n signa l Commu nicatio n M
J16 pump moto r cabl e
cable J81 cable between A27
main co ntr ol Plun ger pump
A37 009-004 749-00 Plun ger pump
boa rd a nd drive Plun ger
Keyboa rd 051- sensor cab le
009-004 816-00 boa rd pump
J78
001 568-00(H) indi cator boar d cable 009-004 750-00 Rotary feedin gsensor
051-001 159-00 Main co ntr ol b oard (B) A16
valve power cord 2 1
Indicato r b oard 009-004 751-00 Rotary feedin g 34 56
A26
051-000 675-00 (G) valve signal cable
009-010600-00
RFID re agent detection A12 Cable to the right
009-005 582-00 J14
module doo r valve
Reage nt RFID cable
(009-005 588-00 RFID
009-004 744-00
lead wire) *3
A13 Front h orizontal
RFID re agent detection 051-001 159-00 Drive a nalog boa rd P CB A(B) plate va lve cable
009-005 583-00
module J9
Tube rack RFID cable
(009-005 588-00 RFID A7 009-009999-00
wire) J68 Pump cable
J12 J8
009-004 746-00
A11 Cable to the middle
Conne cting line of plate va lve
009-010 598-00 data board an d
Track
major & track wire autoloa der boa rd 009-007286-00 Fluid
serial port A6 pressure sensor cab le

J12 J11 Fluid pressure se nso r


A15 009-004 752-00 Degasser
009-009 969-00 Degasser cab le pump
Autoloa der 009-004 756-00 Autoloa ding J3,J14
boa rd Autoloa ding mechanism mechanism a nd sen sor 009-004 747-00 Floater sen so r
,J7,J8 A30 Floater
and sensor connection exte nsi on cab les cable
cable
051-000 393-00 Autoloa der board (B)
A1 A31 009-010602-00 Floater Floater
sensor cab le 2
Mix mechanism 009-004 763-00 Mix mechanism motor 009-
J15,J16 009-004 811-00
and sensor con nectin g lin e A32 002 604-00
,J6 Syringe sensor cable
Syringe
J5
M grou nd
(6P) A14 A21 009-004 810-00 Syringe
A2 A22 A33
motor cabl e
cable
100uL syri nge
2.5mL syri nge
009-004 739-00 Main
009-004 740-00
control board cables 009-004 741-00 Drive
Autoloa der board 009-004 809-00
to d igita l a nd drive boa rd cab les to d igital
power cord Sample
boa rd a nalog power and po wer circuit 009-006870-00
collecti on
circuit HGB wire assemb ly
sensor
connecting
J5 J7 J6 cable 009-002 463-00
J3 M_SAMPL E_Y
(6P) (6P) (12P) (14P) Sample collection SEN_XPO S
220V/110V AC Mixing bath 009-004 808-00 Joint assemb ly motor a nd SEN_YUP
Sam ple sensor patchi ng l ine
Power supply mo dule J2 collect ion
(12P)
ass embly M
motor
connec ting SAMPL E_X
051-001 345-00 Power patching boar d PCBA(C) cable

Figure 4-2 Hardware system connection diagram (instrument in the sample processing
system)

1. Main Control Board


The main control board provides the following functions:
1. FPGA configuration interface: use the SPI bus line for chip configuration and update;
2. USB port: the communication port supports 4 USB 2.0 devices;
3. UART interface: supports 7 channels of serial communication at most;
4. Network interface: 10M/100M Ethernet communication interface;
5. Touch screen control board uses I2C communication protocol to communicate with main control
board;
6. RFID interface: the RFID interface uses the RS232 voltage level standard, and send signals to
control the electrifying and de-electrifying of the RFID.
7. Indicator board: the indicator board acts as the prompter to the analyzer and communicates
with the main control board through common IO voltage level;
8. Autoloader communication: the serial port of autoloader board uses the RS422 voltage level;
9. Display interface: supports 18 bit display mode; and its backlight socket is controlled by the
switching between high and low voltage levels.

4-2
Hardware System

2. Drive Board
The drive board controls the movement of major mechanisms, performs pressure detection and drives
various components and parts. It mainly provides the following functions:
1. Driving stepping motors: drives 6 stepping motors
2. Sensor signal detection: detects the signals of 8 sensors;
3. Driving electromagnetic valves: drives 21 electromagnetic valves;
4. Air pressure detection: supports vacuum detection;
5. Fluid detection sensor: supports the floater sensor;
6. Analytical column pressure detection: detects the column pressure;
7. Drive of degasser: control the voltage switch of the degasser;
8. Temperature detection and control: use temperature sensors to detect temperature and
controls the heating of optical system and column.

3. Autoloader Board
The autoloader board controls the movement of the autoloader the mix mechanism. It mainly provides
the following functions:
1. Driving the stepping motors;
2. Sensor signal detection;
3. Mix mechanism tube detection;
4. Scanner control;
5. Control of the electromagnet valve to the sample compartment door.

4. Optical Signal Detection Module


The optical signal detection module consists of two pre-amplification boards and an LED drive board.
While the LED drive board provides constant current to drive the LED, the pre-amplification boards
support the optical signal detection of 415nm and 500 nm channels.
1. LED drive board: supports the constant drive of LED; the adjustment of the current is supported
by an adjustable potentiometer;
2. Optical pre-amplification board: the optical signal detection of both 415nm and 500nm channels.

4.2 Hardware System Signal Flow Chart


The main control board is the control center of the whole hardware system. Almost all the signals will
finally converge on the main control board.
1. Analog drive board components—>Analog drive board--→Main control board
2. Autoloader board components-→Autoloader board-→Main control board
3. Main control board components-→ Main control board

4-3
Hardware System

Hardware system Components

Indicator board LED drive board

Optical system
Optical pre- LED,415nm optical channel
Display screen
amplification board 1 PD: 500nm optical channel PD
assembly

Optical pre-
amplification board 2
Touch screen
control board Temperature detection: detection
of inside-analyzer temperature,
optical system temperature and
column temperature
Analog drive
USB interface board Heating control: temperature
control of the optical system and
the column
Main control board
Network interface
Sample collection assembly
motor control, sensor detection
Column pressure detection
Back pressure sensor
detection board AM335X Valves, pumps and floater
module Rotary feeding Rotary feeding valve
valve control board
RFID card reader1
Rotary feeding Feeding valve
valve control board
RFID card reader2

RFID card reader3


Autoloader (stepping motors,
Autoloader detection sensors, micro-switch,
RFID card reader4
board electromagnet)
Mix mechanism (stepping
motors, sensors)

Figure 4-3 H50/H50P hardware subsystem signal flow diagram

4.3 List of Hardware Major PCBA and Cables

Components of main boards


051-001062-00 Indicator board PCBA
LCD screen TFT 8.4"800*600 3.3v 450cd/m2 LED
021-000060-00
backlight
021-000058-00 Touch screen, electric resistance, 8.4", 4-lead
051-000881-00 6301 touch screen control board
051-001568-00 Printing module keypad PCBA
051-000393-00 Autoloader board PCBA
051-001345-00 Power patching board PCBA
051-001765-00 A1c AnalogDrv PCBA
051-001765-01 A1c AnalogDrv (NEW) PCBA
051-001944-01 A1c Master Borad PCBA
051-001983-00 System LED drive board PCBA
051-001982-00 Pre-amplification board PCBA
115-031818-01 RFID card reader
051-001277-00 Power board PCBA
051-000218-00 Clog detection board

4-4
Hardware System

Cables
No. Part No. Material description
1 009-004739-00 Main control board cables to digital and drive
board analog power circuit
2 009-004740-00 Autoloader board power cord
3 009-004741-00 Drive board cables to digital and power
circuit
4 009-004815-00 Communication cable of data board and
autoloader board serial port
5 009-004742-00 Communication cable of main control board
and drive board
6 009-004743-00 Cable to the right door valve
7 009-004744-00 Cable to the front plate valve
8 009-004745-00 Pump connecting cable
9 009-004746-00 Cable to the middle plate valve
10 009-004747-00 Floater sensor cable
11 009-004748-00 Plunger pump motor cable
12 009-004749-00 Plunger pump motor sensor cable
13 009-004750-00 Power cable to the rotary feeding valve
14 009-004751-00 Valve cable to the rotary feeding valve
15 009-004753-00 Column thermostatic chamber temperature
control cable
16 009-004754-00 Column thermostatic chamber heating
control cable
17 009-004755-00 Fluid pressure sensor cable
18 009-007286-00 Fluid pressure sensor cable
19 009-004756-00 Autoloading mechanism and sensor
extension cables
20 009-004808-00 Sample collection assembly motor
connecting cable
21 009-004809-00 Sample collection assembly sensor
connecting cable
22 009-004810-00 Syringe motor cable
23 009-004811-00 Syringe sensor cable
24 009-004812-00 Optical system heating module cable
25 009-004814-00 Optical system temperature sensor cable
27 009-005459-00 Cover sensor cable
28 009-005582-00 Reagent RFID cable
29 009-005583-00 Tube rack RFID cable
30 009-002604-00 Syringe earth wire
31 009-005259-00 LED cables
32 009-004813-00 Optical system signal line

4-5
Hardware System

No. Part No. Material description


33 009-004759-00 Autoloading mechanism motor and sensor
cables
34 009-002463-00 Sample collection assembly motor and
sensor patching line (CT models)
35 009-004763-00 Mix mechanism motor and sensor
connecting line
36 009-004752-00 Degasser connecting line
37 0020-20-12522 Power cord (GB/10A250V/2.5M)
38 009-004056-00 LIS system network connecting cable
39 009-004817-00 Touch screen control cable
40 009-004818-00 LCD screen signal cable
41 009-001198-00 Front cover protective earth wire
42 009-004816-00 Key board cable
43 009-010010-00 wire
44 009-009969-00 Autoloading mechanism and sensor
(instrument in the connection cable
sample
processing
system)
45 009-009999-00 Pump cable
(instrument in the
sample
processing
system)
46 009-010600-00 Cable to the right door valve
(instrument in the
sample
processing
system)
47 009-010602-00 Floater sensor cable 2
(instrument in the
sample
processing
system)
48 009-010598-00 major & track wire
(instrument in the
sample
processing
system)
49 009-006870-00 HGB wire

4-6
Hardware System

4.4 Distribution Diagram of Power Supplies


The power supply module outputs 3 types of power circuit: digital power circuit, analog power circuit
and power circuit. The circuits are input through the J1 socket on the power patching board and then
distributed to various boards through the rest sockets on the power patching board. The power
distribution diagram is shown as following:

051-001159-00 Main control board


A1(A12V,
AN12V)
D5V D12V(J68)
J2
(12P) 051-001159-00 Analog drive board
PCBA(B)
J6 A14(D5V D12V
J5 J7 (12P) P24V)
(6P) (6P) J3
051-001345-00 Power patching board PCBA(C)
(14P)
J5
(D5V
051-000393-00 Autoloader board (B)
P12V
P24V)

Figure 4-4 System power distribution diagram

4.5 Introduction to the Hardware Boards

Main Control Board

4.5.1.1 Function overview


As the control center of the analyzer, the main control sub-module regulates the running of the whole
system. It is the "central nervous system" of the analyzer. On the other hand, it also controls the man-
machine interaction functions (for example, the screen display, response to touch actions, and the
network interfaces). In this respect, it also can be seen as the "brain" of the analyzer.

4-7
Hardware System

Autoloader board
Display screen communication
board

Touch screen
Indicator board
control board
AM335X

Liquid pressure Main control


USB*4
detection board sub-module

Drive board FPGA


communication Network interface
socket

RFID*4

Figure 4-5 Main control sub-module structure

The main functions of the main control platform are as follows:


◆ support the TFT screen with display resolution of 800*600;
◆ provide touch screen interfaces;
◆ provide serial/SPI communication interface to the drive control platform;
◆ provide 4 USB 2.0 ports;
◆ provide 10M/100M network interface;
◆ support autoloader board communication;
◆ provide RFID communication interface.

4-8
Hardware System

4.5.1.2 Socket Description

Figure 4-6 Main control board structure

Table 4-1 Sockets on the main control board

No. Position no. Function Description


1 J78 Indicator board socket /
2 J81 Drive board communication /
socket
3 J8 Autoloader board /
communication socket
4 J80 Liquid pressure detection /
board communication socket
5 J69 Liquid pressure detection /
board power supply socket
6 J68 5V and 12V power sockets /

7 J9 Tube rack RFID /


communication socket
8 J16 Screen LVDS socket /

4-9
Hardware System

No. Position no. Function Description


9 J61 SD card socket Located at the back of the
board. Pay attention to the card
insert direction
10 J4 Display screen backlight socket /

11 J67 Touch screen socket /

12 J14 Reagent RFID communication /


socket
13 B1 Button cell port Insert the cell in accordance
with the "Top and Bottom" side
marks at the metal position of the
socket.
14 J1 Network socket /

15 J2 USB ports /
16 J3 USB ports /

4.5.1.3 Indicator Description


Table 4-2 Main board indicator

Position
No. Function Description
no.
1 D2 FPGA status indicator Blue LED, flicker at the frequency of
1Hz
2 D6 Ethernet connection status The indicator flickers when
indicator connected to the Ethernet
3 D7 10/100M Ethernet connection The indicator flickers when
status indicator connected to the 100M Ethernet
4 D40 USB status indicator
5 D42 USB status indicator
6 D44 Power conversion chip status Stay on under normal conditions
indicator
7 D1 Digital 3.3V voltage indicator
8 D5 (CPU Power conversion chip status Stay on under normal conditions
sub- indicator
module)

4-10
Hardware System

4.5.1.4 Test points


Table 4-3 Main board test points

Position
No. Function Normal voltage range (V) Description
no.
1 TP36 5V test point 4.75 ~ 5.25
2 TP37 12V test point 11.4~ 12.6
Digital circuit ground
3 TP2 3.3V test point 3.13 ~ 3.47
TP39 (GND)
4 TP1 1.8V test point 1.71~ 1.89
5 TP3 1.2V test point 1.14~ 1.26
Note: connect one end of the multimeter to the voltage test point, the other end to the corresponding
ground test point.

4.5.1.5 Troubleshooting
Table 4-4 Troubleshooting of main control board

No. Error description Troubleshooting


1 Display screen backlight does not light 1. Check whether the two ends of cable J4
are properly inserted
2. Measure the TP37 and TP2 voltages,
and see whether they are normal
3. If voltages measured at TP37 and TP2
are normal, and cable J4 is properly
connected and not damaged, then the
cause for the error may be that the boot
application is not burned into the CPU
sub-module, or the CPU sub-module is
damaged and need to be replaced.
2 The display screen backlight works Check whether the two ends of cable J16 are
properly, but the logon screen will not properly inserted.
display
3 The screen display stops on the logon Reconnect the SD card.
screen, the progress bar won't display
4 Software upgrade screen is prompted 1. Check whether the two connectors of
when the instrument is turned on J81 are properly connected;
2. Check whether the two connectors of J8
are properly connected;
3. Check whether the D2 indicator (blue) on
the main board is flickering at the
frequency of 1Hz;
When all above steps are performed but the
error remains, then the cables or the main

4-11
Hardware System

No. Error description Troubleshooting


board is damaged.
5 No report when error occurs 1. Check whether the status indicator board
is properly inserted (J78); try
reconnecting it;
2. Check whether the cables are damaged.
6 Touch screen does not respond 1. Check whether the touch screen control
cables are properly connected (A12); try
reconnecting the cables;
2. Check whether the cables are damaged.
3. Check whether the touch screen control
board has errors.
7 The touch screen does not response at the Log in at the service access level, re-
touched position calibrate the touch screen

Analog Drive Board

4.5.2.1 Function Overview


The analog drive board controls the motive power components (e.g. motors and valves) and monitors
the states of the sensors, fluid level and micro-switches. It also monitors the temperature, humidity
and voltages as required. Besides, as an important part of the hardware system, the analog drive
board also supports some communication functions.

Sensor *8 21 valves

Stepping Air pressure


motor*6 sensor
MCU

Liquid
Rotary pressure
feeding valve sensor

Main control FPGA EPCS16


board SPI Floater*5
communicatio
n socket UART

Temperature
Degasser
sensor

Figure 4-7 Drive sub-module structure

Above figure shows the analog drive board structure. The board can be divided into the following

4-12
Hardware System

functional units by different types of controlled components:


⚫ Main control unit: converts the control signals from the host system to corresponding action
commands; and executes the commands by controlling the moving parts movements and
monitoring sensor states.
⚫ Control unit: controls the movements of motors, valves and fans.
⚫ Monitoring unit: monitors the status of position sensors, analog sensors, micro-switches,
voltages and temperatures.
⚫ Power supply: provides constant and table power to the 24V, 5V and 3.3V power circuits, as well
as the other digital power circuit and reference power circuit.

4.5.2.2 Socket Description


Table 4-5 Sockets on the analog drive board

Position
No. Function Description
no.
1 A7 Waste pump socket /
2 A41 Optical pre-amplification board signal socket /

3 A45 Optical pre-amplification board and LED drive board socket /

4 A5 Optical flow cell temperature sensor socket /

5 A4 Column temperature sensor socket /

6 A1 Analog +12V/-12V power socket /

7 A6 Liquid pressure detection sensor socket /

8 A37 Plunger pump sensor socket /

9 A33 Sampling mechanism sensor socket


10 A32 Syringe sensor socket /

11 A31 Floater sensor socket /

12 A30 Floater sensor socket /

13 A27 Main control board communication socket /

14 A26 Rotary feeding valve drive socket /

15 A22 Sampling mechanism motor drive socket /


16 A21 Syringe motor drive socket /

17 A20 Plunger pump motor drive socket /

18 A18 Column thermostatic chamber heating socket /

19 A17 Optical system heating socket /

20 A16 Rotary feeding valve power socket /

21 A15 Degasser socket /

22 A14 Digital 5V, 12V/24V power sockets /

23 A13 Front horizontal plate valve drive socket /

4-13
Hardware System

Position
No. Function Description
no.
24 A12 Right plate valve drive socket /

25 A11 Middle plate valve drive socket /

4.5.2.3 Indicator Description


Table 4-6 Analog drive board indicator

Position
No. Function Description
no.
1 D94 FPGA operation indicator Flickers at the frequency of 1Hz after
analyzer initialization
2 D65 MCU operation indicator 1 Flickers at the frequency of 1Hz after
analyzer initialization
3 D66 MCU operation indicator 3 Stay on under normal conditions
4 D16 12V power supply indicator Stay on under normal conditions
5 D17 24V power supply indicator Stay on under normal conditions
6 D96 Digital 5V power indicator Stay on under normal conditions
7 D99 Digital 3.3V power indicator Stay on under normal conditions
8 D19 Analog -12V power supply indicator Stay on under normal conditions
9 D18 Analog +12V power supply indicator Stay on under normal conditions
10 D22 Analog +5V power supply indicator Stay on under normal conditions
11 D23 Analog -12V power supply indicator Stay on under normal conditions
12 D47 Motor channel1 indicator Stays on when not working; flickers
when working
13 D48 Motor channel2 indicator Stays on when not working; flickers
when working
14 D49 Motor channel3 indicator Stays on when not working; flickers
when working
15 D50 Motor channel4 indicator Stays on when not working; flickers
when working
16 D51 Motor channel5 indicator Lights off when the motor is not
working, flickers when working
17 D52 Motor channel6 indicator Lights off when the motor is not
working, flickers when working
18 D36 Column thermostatic chamber Lights on when heating, lights off when
heating indicator not heating
19 D37 Optical system heating indicator Lights on when heating, lights off when
not heating

4-14
Hardware System

4.5.2.4 Test points


Table 4-7 Analog drive board test points

Position Normal voltage


No. Function Description
no. range (V)
1 TP7 12V power test point 11.4~12.6 Power circuit ground
2 TP14 24V power test point 22.8~25.2 TP8/TP13

3 TP1 Digital 5V power test 4.75~5.25


point
4 TP3 Digital 3.3V power test 3.135~3.465
point Digital circuit ground
5 TP6 Digital 2.5V power test 2.375~2.625 TP2/TP4
point
6 TP5 Digital 1.2V power test 1.17~1.23
point
7 TP18 Digital +12V power test 11.4~12.6
point
8 TP19 Analog -12V power test -11.4~-12.6
point Analog circuit ground
9 TP21 Digital +5V power test 4.75~5.25 TP20
point
10 TP25 Analog -5V power test -4.75~-5.25
point
Note: connect one end of the multimeter to the voltage test point, the other end to the corresponding
ground test point.

4.5.2.5 Troubleshooting
Table 4-8 Troubleshooting of analog drive board

No. Error description Troubleshooting


1 Lots of motors and sensors show 1. Burned board: check whether the components
abnormal status on the board are burned or damaged; if yes,
investigate for possible causes and replace the
damaged board if necessary.
2. Power problem: check the power supply
indicators one by one and confirm whether the
supply voltages fall in rated ranges. If any
indicator works abnormally, then the board may
be damaged.
3. Cable problem: the cables of the analyzer

4-15
Hardware System

No. Error description Troubleshooting


generally run in bundles. Check whether there is
damage or short circuit problem between cables.
If yes, replace the cables. In addition, pay
attention if the cables get loose from where they
are inserted into the boards. If so, re-insert the
cables tightly.
2 One of the motor channels is abnormal 1. Check the powers: check the powers one by
one and see whether their indicators and voltages
work normally;
2. MCU and FPGA status: check whether the 3.3V
power works properly, and whether the MCU and
FPGA indicators normally flicker;
3. Logic run: check whether the indicators of the
motor channels work as expected;
4.Cables: check whether the cables are
damaged, broken or short circuited; check
whether the cables are tightly inserted into the
boards and the sockets of the motors;
5. Motors: when all the above checking points are
OK, replace the motor.
3 One of the sensors work abnormally 1. Check the powers: check the powers one by
one and see whether their indicators and voltages
work normally;
2. MCU and FPGA status: check whether the 3.3V
power works properly, and whether the MCU and
FPGA indicators normally flicker;
3. Logic run: check whether the indicators of the
motor channels work as expected;
4.Cables: check whether the cables are
damaged, broken or short circuited; check
whether the cables are tightly inserted into the
boards and the sockets of the motors;
5. Sensor problem: when all the above checking
points are OK, replace the sensor and check
again.
4 Abnormal communication to main When the power supply to the board is OK, and
control board the MCU and FPGA work properly, first check
whether the cables are damaged and if are tightly
inserted into the boards.
5 Temperature abnormal Check the temperature cables are properly
connected, whether they are damaged. If there is

4-16
Hardware System

No. Error description Troubleshooting


no such problem, check whether the temperature
sensor gets short-circuited.
6 ADC reads abnormal sensor values Check the temperature cables are properly
connected, whether they are damaged. If there is
no such problem, you may need to replace the
sensor.

Autoloader Board

4.5.3.1 Introduction
The autoloader board is mainly responsible for blood sample presentation, mixing and the reading of
the tube barcode.

4.5.3.2 Function
◼ Driving the stepping motors
The autoloader board controls the driving of the following 5 stepping motors:
Mix mechanism X direction motor
Mix mechanism Z direction motor
Mix motor
X direction loading motor
Y direction feeding motor
The stepping motors use the bipolar constant current half step driving method, with each stepping
motor having its own position sensor.

◼ Control function of electromagnets

The electromagnets control the open of sample compartment door (the door need to be closed
manually).
◼ Control of built-in scanner

The built-in scanner reads the barcodes of the tubes and tube racks. The autoloader board controls
the built-in scanner through the MCU. MCU realizes asynchronous serial communication (UART) with
built-in scanner through serial port 1.
◼ Status detection of position sensors and micro-switch

On the autoloader board seat 13 position sensors and a micro-switch. The FPGA detects the status
of position sensors and the micro-switch from time to time; and the MCU inquires the status data
stored in FPGA as needed.
◼ Parameter storage

You may need to adjust the start positions of the mix mechanism X direction motor and the mix motor
to remove processing and installment deviations. The position parameters after adjustment will be
saved to the autoloader.

4-17
Hardware System

4.5.3.3 Structure

Figure 4-8 Connections of the Autoloader board

4.5.3.4 Sockets
Table 4-9 The sockets on the autoloader board

Sockets Functions Pins Description


J3 Electromagnet socket 2 /
J5 Power socket 6
J6 Mix mechanism sensor socket 20
/
J7 Feeding mechanism sensor socket1 20
J8 Feeding mechanism sensor socket2 20
J11 MCU configuration socket 10 /

4-18
Hardware System

Sockets Functions Pins Description


J12 Communication socket 4 /
J14 Feeding mechanism motor socket 8 /
Socket to mix mechanism X motor /
J15 8
and Z motor
J16 Mix mechanism socket 4 /
P1 Built-in scanner socket 15 /

4.5.3.5 Indicators and test points


Table 4-10 Indicators on the autoloader board

Indicators Description
D3 12V power indicator, lights when the 12V power supply works properly
D4 5V power indicator, lights when the 5V power supply works properly
D5 3.3V power indicator, lights when the 3.3V power supply works properly
D25 MCU working indicator, flickers at the frequency of 0.5s when MCU works
properly
D26 FPGA working status indicator, flickers at the frequency of 0.5s when FPGA
works properly

Table 4-11 Autoloader board test points

No. Name Pins Description


1 TP1 Pin3 of X1 The output signal of 24.4545M crystal oscillator
clock, FPGA work clock
2 TP2 PIN 47 of U2 RD signal from MCU
3 TP3 PIN 62 of U2 WR signal from MCU
4 TP4 PIN 0 of U2 ALE signal from MCU
5 TP5 PIN 28 of U2 FPGA reset signal
6 TP6 PIN 5 of J1 FPGA configuration start signal
7 TP7 VCC +5VDC voltage (5±0.25V)
8 TP8 12V0 +12VDC voltage (+12±1.2V)
9 TP9 24V0 +24VDC voltage (+24±1.2V)
10 TP10 VDD +3.3VDC voltage (+3.3±0.15V)
11 TP11 GND
12 TP12 GND
13 TP13 1V5 +1.5VDC (1.5±0.05V)
14 TP15 TUBE Tube detection sensor output signal (> 0.4V when
blocked, < 0.2V when not blocked)
15 TP18 PIN 3 of X2 The output signal of 24.4545M crystal oscillator
clock, MCU work clock
16 TP21 PIN 12 of Feeding mechanism Y motor stepping pulse signal
U16
17 TP23 PIN 12 of Feeding mechanism X motor stepping pulse signal

4-19
Hardware System

No. Name Pins Description


U18
18 TP24 PIN 12 of Feeding mechanism Z motor stepping pulse signal
U22
19 PIN 12 of
TP25 Mix mechanism X motor stepping pulse signal
U23
20 PIN 12 of
TP26 Mix mechanism stepping pulse signal
U24

4.5.3.6 Troubleshooting
The autoloader board uses mature design and is very unlikely to break down. For the errors of the
board itself, refer to the troubleshooting of the drive board for solutions. Here we only list some
common errors occurred during the autoloading process and their corresponding troubleshooting
information.

Table 4-12 Troubleshooting for Autoloading Module

No. Error type Cause Troubleshooting Note

Use a multimeter to measure the


voltage between the black and white
wires at the sensor ends. When it is
powered on and the compartment
The position
door is closed, the voltage should be
sensor for the
larger than 3V; open the door
door When the
manually and measure the voltage
compartment compartment door
again, the value should be less than
door failed, or cannot open, it is
0.2V. If the voltages are out of such
Door open the most probably
1 ranges, the sensor is broken, please
error electromagnet caused by the failure
replace it.
encounters too of the door
When the sensor works properly,
much mechanism and the
press the [OPEN] key again, and
resistance and spring.
check whether the electromagnet
cannot be
moves. If the electromagnet moves
drawn out.
but still the compartment door won't
open, then the door mechanism has
failed. Remove and re-install the door
spring, or replace the spring.
Wrong Make sure current setting for the
scanner scanner (code system and digits) is in
Failed to settings; consistent with the used barcode;
2 scan the unqualified check whether the barcode is stuck at /
barcode barcode the proper position (at least 16mm
sticking; poor from the bottom of the tube); check
barcode whether the mirror on the scanner is

4-20
Hardware System

No. Error type Cause Troubleshooting Note

quality; blocked by dust or other objects;


scanner check the barcode quality, whether
installed at there is any stain or notch; or whether
wrong the contrast ratio is sufficient.
position.

Y-direction left
or right sensor
1. Check whether the sensor works
fails; the Y-
Y-direction properly;
direction
left or right 2. When the sensor works OK, then
3 sensor block /
sensor the error must be caused by the
sheet does not
error sensor block sheet. Adjust or replace
move correctly
the sensor block sheet.
with the tube
feeding.
The error is
reported when
1. Check whether the micro-switch is
the X-direction
pressed down;
loading should
2. When it is pressed down, check
X- have been in Pay special attention
whether the switch works effectively.
direction position but to the micro-switch
4 When the micro-switch is pressed
loading the system and its connection
down, the voltage between its two
failed cannot detect wires.
ends should be 0V; when it is not
the loading in-
pressed down, the voltage measured
position signal
should be larger than 3V.
from the micro-
switch.

Preamplification Board

4.5.4.1 Function overview


The preamplification board amplifies and quantifies the weak photoelectric signals produced by the
photodiode, and transfers them into digital signals for output. In this way, it realizes the measurement
of weak analog signals. The board is connected with the drive board, from which it was supplied with
power and to which it outputs the measurement results.

4.5.4.2 Structure
The preamplification board consists of the analog part and the digital part. Its structure is shown in
Figure 4-9:

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Hardware System

Figure 4-9 Preamplification board

Only one of the metallic oxide apertures (the one marked MH4 on the up left of Figure 4-9) is
connected to AGND.

4.5.4.3 Socket Description


The preamplification board has only one socket, whose pins are defined as below:

Table 4-13 Socket pins on the preamplification board

Position no. No. Functions Description


Digital circuit
J1 Enter
1 ground
Digital power
J1 2 Output 5V
circuit
J1 3 ADC output Output
J1 4 ADC clock Input
Digital circuit
J1
5 ground Input
ADC chip
J1 6
select Input
J1 7 Analog circuit Output 5V
Analog
J1 8
ground Input
J1 9 Not used NC
Analog
J1 10
ground Input
J1 11 Analog power Output -12V
J1 12 Analog power Output 12V

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Hardware System

4.5.4.4 Indicator Description


None

4.5.4.5 Test Points


Table 4-14 Test points on the preamplification board

Test
Definition Description
Points
ADC reference Reference range [4.9V, 5.1V]. Voltage out of that range
TP1
voltage indicates that the power chip AD586 may be damaged.
Square wave signal from the drive board, normally with a
frequency higher than 800KHz. When the signal
TP2 ADC clock signal frequency is too low, or there is no such signal received,
then the drive board or the drive chip
CY74FCT2245CTQCT may be damaged.
Analog signal test Reference range [4.9V, 5.1V]. Voltage out of that range
TP3
point indicates that the OPA chip may be damaged.
Analog signal test Reference range [-1V, 5V]. Voltage out of that range
TP4
point indicates that the OPA chip may be damaged.
Analog signal test Reference range [-1V, 5V]. Voltage out of that range
TP5
point indicates that the OPA chip may be damaged.
Analog signal test Reference range [-1V, 5V]. Voltage out of that range
TP6
point indicates that the OPA chip may be damaged.
Reference range [0.020V, 0.035V]. Voltage out of that
TP7 Reference voltage range indicates that the regulator chip
REF3033AIDBZTmay be damaged.
Square wave signal output from the preamplification
TP8 ADC output board. If no such output is detected, then the ADC may be
damaged.
Square wave signal from the drive board, normally with a
frequency higher than 300Hz. When the signal frequency
ADC chip select
TP9 is too low, or there is no such signal received, then the
input signal
drive board or the drive chip CY74FCT2245CTQCT may
be damaged.
Reference range [4.5V, 5.5V]. Voltage out of the range
TP10 ADC power indicates ADC damage or the short circuit of
preamplification board.
Reference range [-0.05V, 0.05V]. Voltage out of the range
TP11 Analog ground
indicates the short circuit of preamplification board.
Reference range [10V, 14V]. Voltage out of the range
TP12 12V analog circuit
indicates the short circuit of preamplification board.
-12V analog Reference range [-10V, 14V]. Voltage out of the range
TP13
circuit indicates the short circuit of preamplification board.

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Hardware System

Test
Definition Description
Points
Digital circuit Reference range [-0.05V, 0.05V]. Voltage out of the range
TP14
ground indicates the short circuit of preamplification board.
Digital power Reference range [4.5V, 5.5V]. Voltage out of the range
TP15
circuit indicates the short circuit of preamplification board.

4.5.4.6 Troubleshooting
Abnormal voltage
values on the "Gain"
screen

Yes
If the drive board
output voltage Drive board error
abnomral?

No

Perform background
or aging tests for 3
times

Yes
Error removed? Record

No

Yes
Check if the
Weld the MH6
welding spot MH6
spot
fell out?

No

Other errors

Figure 4-10 Troubleshooting of the preamplification board

The preamplification board rarely finds errors due to its simplified design; so before you start the
preamplification board troubleshooting procedure, check the analog circuits output by the drive board
(including ±12V, analog 5V and digital 5V) one by one against the information stated in above Table
1, and make sure there is no error with the drive board voltages.
While the drive board output voltages are all normal, but the "Gain" screen displays abnormally low
voltage (<1V), run background (or aging) tests for 3 times to remove any bubble in the flow cell, and
then check the voltage values on the "Gain" screen again to see if they are normal.
If the error remains after all above steps (the voltages displayed on the "Gain" screen are continuously
lower than 1V or keep jumping), check if the welding spot MH6 between the preamplification board
and the PD has fallen out by pressing the area near the spot. If the gain voltages shows sudden and
large change (>2V), then the MH6 spot needs to be welded again.
If the possibility of all above errors is excluded during the troubleshooting procedure, you need to find

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Hardware System

the error elsewhere.

LED Drive Board

4.5.5.1 Function Overview


The LED drive board transfers voltages to constant current and drives the LED to light. The board is
connected with the drive board. The drive board supplies power to the LED board and controls its
switching.

4.5.5.2 Structure

Figure 4-11 LED drive board

The metallic oxide aperture (see Figure 4-11) is connected to AGND.

4.5.5.3 Socket Description


The LED drive board has two sockets: J1 connects to the drive board, and J2 connects to the LED.

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Hardware System

Table 4-15 J1 socket pins on the LED drive board

Position no. No. Functions Description


J1 1 Analog power Output 12V
Switch control
J1 2 Input [0V-12V]
socket
J1 3 Analog ground Input

Table 4-16 J2 socket pins on the LED drive board

Position no. No. Functions Description


LED drive Negative
J2
1 socket terminal
LED drive Positive
J2 2
socket terminal

4.5.5.4 Indicator Description


N/A

4.5.5.5 Test Points


Table 4-17 LED drive board test points

Test
Definition Description
Points
When the LED is connected and the LED light is on, the
TP1 Switch test point voltage should be lower than 0.5V. Otherwise the
switch tube IRLML2502PBF may have error.
When the LED is switched on, the voltage detected at
Switch control this test point should be higher than 3V; and when the
TP2
test point LED is switched off, the voltage should be <0.5V.
Otherwise the drive board may be with error.
When the LED is switched on, the voltage should be
Reference within the range of [0V, 2.5V]. When it is out of the
TP3
voltage test point range, then the power chip ZR431F01TA may be
damaged.
Reference range [0V, 0.05V]. Voltage out of the range
TP4 Analog ground
indicates the short circuit of LED drive board.
When the LED is switched on, the voltage should be
Reference within the range of [0V, 2.5V]. When it is out of the
TP5
voltage test point range, then the power chip ZR431F01TA may be
damaged.
Reference range [11V, 13V]. Voltage out of the range
TP6 Analog circuit indicates the damage of the drive board or the short
circuit of LED drive board.

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Hardware System

Test
Definition Description
Points
When the LED is switched on, the voltage should be
Digital power within the range of [2.5V, 12V]. When it is out of the
TP7
test point range, then the power chip ZR431F01TA may be
damaged.

4.5.5.6 Troubleshooting

LED does not light

Yes
If drive board
Drive board
output voltage
error
abnormal

No

Short circuit TP1


and TP4

Drive board does


not send out
Yes
signals to switch
Error removed? on the LED, or the
switch tube
IRLML2502PBF
No is damaged

Adjust the
potentiometer to
its two extreme
values

Yes
Error removed? Record

No

Other errors

Table 4-18 Troubleshooting of the LED drive board

The LED drive board rarely finds errors due to its simplified design; so before you start the LED drive
board troubleshooting procedure, check the analog circuits output by the drive board one by one
against the information stated in above

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Hardware System

Table 4-15, and make sure the drive board voltages are all normal.
If all drive board output voltages are normal, short circuit TP1 and TP4. If doing this may make the
LED work properly, then either the drive board did not send out signals to switch on the LED, or the
switch tube is damaged. If the LED still does not light on, there is the possibility that the current
supporting the LED is too weak, and the LED light is too feeble to be recognized. Try adjusting the
potentiometer to its two extreme values.
If the possibility of all above errors is excluded during the troubleshooting procedure, find the error
elsewhere.

Liquid Pressure Detection Board

4.5.6.1 Function Overview


Liquid pressure detection board (clog detection board) detects the pressure around the flow cell,
which is then transmitted in the form of the liquid pressure signals to ADC through the liquid pressure
sensor. The signals are then transferred to digital signals and transmitted to data board through serial
port transmission.

Figure 4-12 Liquid pressure detection board structure

4.5.6.2 Socket Description


Position
No. Functions Description
no.
1 J1 The socket connects the liquid pressure /

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Hardware System

Position
No. Functions Description
no.
sensor which receives liquid pressure
signals
2 J4 The interface connects data board. It
supplies power and works as the serial
port to transmit the digital signals of
liquid pressure to data board.

4.5.6.3 Indicator Description


Indicators Definition functions
The LED indicator stays on under normal conditions When
D6 5V voltage indicator the indicator is off, the 5V voltage is abnormal, and you
need to check if the 12V voltage is OK.
The LED indicator stays on under normal conditions When
the indicator lights off, then the digital 12V power supply to
12V power supply the liquid pressure detection board is with error. Check
D7
indicator whether the cables connecting the liquid pressure
detection board and the data board are properly plugged,
or the digital 12V voltage of the data board is normal.

Touch Screen Control Board

4.5.7.1 Function Overview


The touch screen control board, by connecting to the digital main control board on one end, and to
the 4-wire resistive touch screen on the other end, can be seen as the bridge between the touch
screen and main control board. It converts the touch screen output signals to digital signals
recognizable by the main control board, and the digital signals later are transferred to position signals
by main control board CPU.

4.5.7.2 Structure

Table 4-19 Touch screen control board

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Hardware System

4.5.7.3 Sockets and indicators


Table 4-20 Sockets and indicators on the touch screen control board

No. Position no. Functions Description


1 J1 Touch screen socket Receive touch screen signals
2 J3 Communication socket to main Enable the communication
control board between the touch screen control
board power circuit and the main
control board
3 D5 3.3V power indicator \

4.5.7.4 Troubleshooting
Table 4-21 Troubleshooting of the touch screen control board

No. Error description Troubleshooting


1 The touch screen is damaged 1. Check whether the J1 and J4 cables are
properly inserted;
2. Check whether the D5 indicator stays on;
3. When the above two points are OK, unplug
and reconnect the J1 cable, and switch off
and re-electrify the touch screen control
board.
4. If the error remains, replace the touch screen
or the touch screen control board.

Indicator Board

4.5.8.1 Introduction
The indicator board connects to the digital main control board. It receives the control signals output
by the digital control board, indicates the whole device status and sends out sound alarms.

4.5.8.2 Functions
The indicator board has two major functions:
Status indication function: the indicator board uses the 3-color indication system (red, yellow and
green) to indicate different status of the whole device.
Sound alarm function: the buzzer on the indicator board will sound alarm when errors are detected.

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Hardware System

4.5.8.3 Structure

Table 4-22 Indicator board insert diagram (front)

Table 4-23 Indicator board insert diagram (back)

4.5.8.4 Sockets
There is one socket (J1) on the indicator board. It is defined as below:

Table 4-24 Definition of J1 socket

PIN Signals Description


It sends out signals to control the green indicator, which will
1 GREEN_LED light on when high level signals are received, and light off
when low level signals are received.
It sends out signals to control the yellow indicator, which will
2 YELLOW_LED light on when high level signals are received, and light off
when low level signals are received.
It sends out signals to control the red indicator, which will
3 RED_LED light on when high level signals are received, and light off
when low level signals are received.
4 GND Digital circuit ground
It sends out signals for the buzzer, which will sound when
5 BUZ_N high level signals are received, and remain silent when low
level signals are received.
6 GND Digital circuit ground
5V power circuit, supply power to the buzzer and the
7 VCC
indicators
8 \ Reserved design

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Hardware System

4.5.8.5 Indicators and test points


The test points on the indicator board are defined as below:

Table 4-25 Indicator board test points

Test Points Silk-screen Function Description Note

TP1 VCC Test point of 5V power Normal voltage range 4.75V-5.25V

TP2 GND Ground test point Normal voltage range 4.75V-5.25V

Green indicator control signal


TP3 / 3.3V TTL level
test point
Yellow indicator control signal
TP4 / 3.3V TTL level
test point
Red indicator control signal
TP5 / 3.3V TTL level
test point
When the indicator lights on, a low
Green indicator working electrical level should be detected,
TP6 /
status test point and when it lights off, a high level
of 5V should be detected.
When the indicator lights on, a low
Yellow indicator working electrical level should be detected,
TP7 /
status test point and when it lights off, a high level
of 5V should be detected.
When the indicator lights on, a low
Yellow indicator working electrical level should be detected,
TP8 /
status test point and when it lights off, a high level
of 5V should be detected.

4.5.8.6 Troubleshooting
There are two common errors often found with the indicator board:
◼ Indicators does not light properly

Possible causes: poor connection of the J1 cable to the J1 socket; or damage of the indicator;
To remove the error: unplug and re-connect the very cable; replace the cable; or replace the LED
indicator
◼ Buzzer does not work properly

Possible causes: poor connection of the J1 cable to the J1 socket; or damage of the buzzer;
To remove the error: unplug and re-connect the very cable; replace the cable; or replace the buzzer

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Hardware System

Power Patching Board

4.5.9.1 Function Overview


051-001345-00 power patching board distributes and monitors the power board-output-voltages to
various boards, and indicates the power board status through indicators.

Figure 4-13 Power patching board

4.5.9.2 Socket description

Position no. Functions


J1 Not used
J2 Output 5V and 12V digital power circuit for the main control board
Output ±12V analog power circuit for the analog drive board

J3 Supply power to the analog drive board


J4 Not used
J5 Supply power to the autoloader board
J6 Supply power to the analog drive board
J7 Supply power to the autoloader board

4-33
Hardware System

4.5.9.3 Indicator Description

No. Indicator position number Description

1 D1(D5V) Digital 5V indicator: when it lights on, the digital 5V


power circuit output by the power supply module
works OK; otherwise, it is with error.
2 D2(D12V) Digital 12V indicator: when it lights on, the digital 12V
power circuit output by the power supply module
works OK; otherwise, it is with error.
3 D3(P12V) Power 12V indicator: when it lights on, the power 12V
power circuit output by the power supply module
works OK; otherwise, it is with error.
4 D4(P24V) Power 24V indicator: when it lights on, the power 24V
power circuit output by the power supply module
works OK; otherwise, it is with error.
5 D5(A12V) Analog 12V indicator: when it lights on, the analog 12V
power circuit output by the power supply module
works OK; otherwise, it is with error.
6 D6(A12V_N) Analog -12V indicator: when it lights on, the analog -
12V power circuit output by the power supply module
works OK; otherwise, it is with error.
7 D7(A5V7) Analog 5.7V indicator: when it lights on, the
analog 5.7V power circuit output by the power supply
module works OK; otherwise, it is with error.

RFID Card Reader

4.5.10.1 Function Overview


023-000836-00 RFID card reader is the interface to the RFID label. It reads and writes into the RFID
label at the bottom level.

4-34
Hardware System

Figure 4-14 RFID card reader

4.5.10.2 Socket Description


Table 4-26 Sockets to the RFID card reader

Sockets Functions Note


J6 Communication socket to main control board /
J3 Power enable socket /

4.5.10.3 Indicator Description


There is only one red running indicator on the RFID card reader (as marked on above figure).
1. The indicator flickers only once when the card reader completes POST;
2. and stays on when the card is read or written into.

Display Screen Assembly

4.5.11.1 Function Overview


The display screen assembly mainly consists of the LCD display screen and the cables. It is the user
interactive interface.

4-35
Hardware System

4.5.11.2 Structure

Figure 4-15 Display screen assembly

4.5.11.3 Troubleshooting of common errors


Table 4-27 Troubleshooting of display screen assembly

No. Error description Troubleshooting


1 The display screen does not light on Check whether the connection between the
backlight socket and the screen signal
cable fells loose.
2 Touch screen displays poor color Check whether the connection between the
signal socket and the screen signal cable
fells loose.
3 The touch screen is damaged /
4 Compartment door cannot be opened Check whether the keyboard signal cable is
properly connected, or any of the keys is
damaged
5 Buzzer does not sound or indicator /
does not light

Key Board

4.5.12.1 Function Overview


When the key is pressed down, the switch is coupled; and when the main control board detects the

4-36
Hardware System

action, it sends out a command to open the compartment door. We re-use the same SM&S printing
module key board here. And the PCB is only for installation and for lead wires.

4.5.12.2 Structure

When the key board is pressed down, the two pins of J1 are connected.

4.5.12.3 Socket Description


Socket Function Note
J1 The socket connects to the main control board. When /
the key board is pressed down, the two pins of J1 are
connected.

Power Supply Assembly

4.5.13.1 Function Overview


The power supply assembly transfers AC circuit to DC circuit, and supplies power to the boards inside
the analyzer.

4.5.13.2 Structure
The power supply assembly mainly consists of the power input socket, the power switch, the power
supply and the radiator fan. The power input socket inputs and filters the power. The connecting and
disconnecting of power are completed through the power switch. Make sure you have unplugged all
power cords before you service the power supply.

4-37
Hardware System

Power
input Power
socket patching
board joint

GND

Power
switch

4.5.13.3 Service Instructions


The power supply assembly is always serviced and replaced as a whole.
1. When power supply assembly error is suspected, unplug all the cables to the power patching
board first. Check the indicators on the power patching board, or use a multimeter to measure
the voltages. If no voltage or abnormal voltage is detected, then the power patching board is
damaged. Replace the power supply assembly.
2. When the board is powered on, but the fan does not work, and there is no voltage output,
dissemble the power supply assembly and check whether the fan is connected correctly. Use a
multimeter to measure the voltage on power input socket and see if normal AC voltage can be
detected. If there is no such problem, replace the power supply assembly.

4.6 Service Instructions for Other Parts Closely-Related


To Hardware
Such parts include sensors, air pressure sensor, liquid pressure sensor, temperature sensor,
degasser and rotary feeding valves etc.

Sensors
The H50/H50P analyzer uses two outsourced transmissive sensors: the 4-wire transmissive sensor
(ID: 801-3003-00015-00) and the 3-wire sensor. The difference between the 4-wire sensor and 3-wire
sensor is that the power supply wire and signal wire of the 3-wire sensor share one earth wire, while
those of the 4-wire sensor have their own earth wires.

4-38
Hardware System

Figure 4-16 4-wire transmissive sensor 3-wire transmissive sensor

The 3-wire sensor has 3 wires: red, blue and black, while the red one is the power supply wire, black
the earth wire, and the blue one signal output wire. The voltage between the red wire and black wire
is fixed to be (4.75-5.25) V. When the optical path is blocked, the voltage between the blue wire and
black wire is about 3.3V, and when not blocked, the voltage will be less than 0.2V.
The 4-wire sensor has 4 wires: red, black, green and white, while the red one is the power supply
wire, the black one and green one are earth wires, and the white one signal output wire. The voltage
between the red wire and black wire is fixed to be (4.75-5.25) V. When the optical path is blocked, the
voltage between the white wire and green wire is about 3.3V, and when not blocked, the voltage will
be less than 0.2V.
Common errors related to digital output sensors include:
1. External light interference
Avoid direct exposure to sunlight; otherwise, the sensor may not work properly.
2. Connecting cable damaged
The connecting cable of the sensor may be damaged in the assembly process on the manufacture
site or in the first installation and adjustment. If the power supply wire or signal wire is damaged and
the earth wire is short-circuited, the sensor will lose efficacy. To remove this type of error, bind up the
breakage or replace with a new sensor cable.

Hydraulic Sensor
The H50/H50P analyzer has two hydraulic sensors, one of which is directly connected to the analog
drive board for liquid pressure detection; and the other is connected to the clog detection board, which
is then connected to the main control board, for back pressure detection.
Frequent errors found in liquid pressure detection:
1. Check whether the connecting cables of the liquid pressure detection board and the drive board
are damaged or broken. If yes, replace the cables;
2. The connection between the cables and the board end gets loose. Secure the connector;
3. Check whether the drive board is burnt;
If the error still remains after all above steps, the sensor may have error, replace the liquid pressure
sensor.
Frequent errors found in back pressure detection
1. Check whether the connecting cables of clog detection board and the main drive board are

4-39
Hardware System

damaged or broken. If yes, replace the cables.


2. The connection between the cables and the boards end gets loose. Secure the connector;
3. The connector on the clog detection board end gets corrosive by liquid leakage. Replace the
connector.
If the error still remains after all above steps, the sensor may have error, replace the liquid pressure
sensor.

Temperature Sensors
There are in all five temperature sensors. One is for ambient temperature detection, two for the
column thermostatic chamber temperature detection, and two for optical flow cell temperature
detection.
Abnormal ambient temperature: check whether the ambient temperature sensor or the cables are
broken;
Abnormal temperature of column thermostatic chamber and optical flow cell: when the temperature
screen displays 50℃, first check whether the cables are properly connected, and then check whether
the temperature sensor is short circuited; when the temperature screen displays 0℃, or the value
keeps jump violently, check whether the temperature sensor gets short-circuited, or the sensor and
the cables are broken.

Degasser
The degasser errors can be detected by degasser status register. When the degasser reports
abnormal status, first check whether the degasser status cable is properly connected. If yes, check if
the degasser is working, and if it is not working, check whether the power cord of the degasser is
connected. If the degasser is working but cannot reach the target pressure, check whether there is
any leakage on the degasser and the tubing. If the error remains after all above steps, replace the
degasser.

Rotary Feeding Valve


There are two major errors relating to rotary feeding valve.
1. The rotary feeding valve does not move: check whether the power and control cables are
properly connected. Unplug the power cord of the valve and reconnect it to see if it may move.
If not, then the valve is damaged.
2. The rotary feeding valve cannot rotate to target position: check whether the control cable of the
rotary feeding valve gets loose. Then unplug the power cord of the valve and reconnect it. If the
valve just clicks, it is OK; if it rotates for 1 or 2 seconds, then it is damaged.

4-40
Chapter 5 Software

5.1 Introduction
This chapter describes the operation methods of those software functions possibly used by the
service engineer when installing and maintaining the analyzer. (Those operations contained in
the user manual are excluded from this chapter.) This software should be operated with
reference to the service manual or production process of other technical teams (like hardware,
fluidics).
This chapter contains the following contents:
Part 1: Introduction
Part2: Password
Part3: Functions of “Service” access level
Part4: Analyzer Update
Part5: LIS Setup

5.2 Password

User Access Level Definition


There are 5 access levels: Operator, administrator, service engineer, manufacturer and R&D
engineer. Users in different levels are only allowed to access some particular functions.

Table 5-1 Functions of the Access Levels

Minimum
Functions of Level 1 Functions of Level 2
Authority
User Management
Add user administrator
Change Password Operator
Delete user administrator
Startup & Shutdown
Login Operator
Logout Operator
Shut Down the analyzer Operator
Packup & Shutdown administrator
Sample Analysis Operator
Results Review
Table Review Operator
Graph Review Operator
View Results Operator
Validate/Cancel Val. administrator
Delete sample administrator

5-1
Software

Minimum
Functions of Level 1 Functions of Level 2
Authority
Print Result Operator
Communicate Result Operator
Export Result Operator
Review special info. administrator
View patient information Operator
Edit patient information Operator
QC Analysis
View QC files Operator
Modify QC files administrator
Clear QC files administrator
View QC graph Operator
View QC table Operator
Delete QC sample administrator
Print QC result Operator
Communicate QC result Operator
Export QC result Operator
Analyzer Calibration
AL count calibration administrator
Adjust calibration factor administrator
View the calibration history administrator
Export the calibration history administrator
Touch screen calibration administrator
Performance test
Repeatability Test Service engineer
Carryover Test Service engineer
Aging test Manufacturer
Setup
Set up conditions of time-based administrator
maintenance
Set up System Time administrator
Set up Barcode Types administrator
Select Parameter Unit administrator
Set up Reference Ranges administrator
Select report parameter administrator
Set up Department and Shortcut administrator
code
Set up print parameters administrator
Set up communication administrator
parameters
Set up fluidic volume parameters Service engineer
(Fluidic Volume Calibration)

5-2
Software

Minimum
Functions of Level 1 Functions of Level 2
Authority
Set up temperature parameters Service engineer
(Temperature Calibration)
Set up Pressure parameters Service engineer
(Pressure Calibration)
Set Optical Channel Gains administrator
Set Analyzer Serial No. Service engineer
Set analyzer configuration Service engineer
Set up language Service engineer
Maintenance
View Logs administrator
Export Logs administrator
View Errors Operator
Remove Error Operator
Load column information administrator
Replace the reagents Operator
Wake up the analyzer Operator
Empty Service engineer
Prime Service engineer
Probe Cleanser maintenance Operator
Analyzer Debug
Self-test Service engineer
Adjustment Service engineer
Sequences debug R&D engineer
Export Debug Data Service engineer
View Status
View Analyzer Status during Operator
Sample Analysis
View Analyzer Run Status Service engineer
View vulnerable-parts statistics Service engineer
View version information Operator
Analyzer Update Service engineer

Preset User Information

Table 5-2 Preset User Information

User name Name Authority Password


Admin Administrator administrator Admin
service Null Service engineer Se s700
Pro*(Note 1) Null Manufacturer /
RD Null R&D engineer /

5-3
Software

Note1: * is the manufacturer code which should be input with the prefix Pro together. It consists
of 1~9 numbers.

Add user
This function allows you to add users. You may add up to 30 operators and 20 administrators.
The following user information can be edited:

Table 5-3 User Information

Inspection Type Specification


Item
User name character 1 to 12 characters in length, including letters, numbers
string and the following characters: ~@#%-_+={}[], not case
sensitive
Name character 0 to 20 characters in length, including letters, numbers
string and the following characters: : ~`!@#$%^&*()-
_+={}[]\|:;”’,./<>?, case sensitive
Password character 0 to 12 characters in length, including letters, numbers
string and the following characters: : ~`!@#$%^&*()-
_+={}[]\|:;”’,./<>?, case sensitive
Access level options Operator/Administrator

Table 5-4 Add user

Access level User types allowed to add


Operator N/A
administrator administrator, Operator
Service engineer administrator, Operator
Manufacturer administrator, Operator
R&D engineer administrator, Operator

Delete user
This function allows you to delete users. Particular types of users can be deleted except the
current user logged in.

Table 5-5 Delete User

Access level User types allowed to delete


Operator N/A
administrator administrator, Operator
Service engineer administrator, Operator
Manufacturer administrator, Operator
R&D engineer administrator, Operator

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5.3 Functions of Service Access Level

Menu Structure Overview

Table 5-6 Menu Structure

Level 1 menu Level 2 menu Level 3 menu


Sample Analysis
Table Review
QC Setup
Graph
Table
Calibrate Manual
Calibrator
Touch Screen Calibration
Performance Aging
Repeatability
Carryover
Setup Date/time
User Management
Parameter
Shortcut Code
Auxiliary
Maintenance
Barcode Setup
Print Setup
Communication
Gains
Advanced Setup
Maintenance Consumables Reagents
Analytical Column
Replacing Reagents
Empty and Prime
Fluidics
Sequences debug
Log
Service Temperature
Pressure
Fluidic Volume
Self-test
HPLC Self-Test
Debug Sample Probe
Barcode scanner

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Level 1 menu Level 2 menu Level 3 menu


Debug data export
Status Statistics
Sensor Floater
Sensors
Others
Temperature and
Pressure
Voltage
Version information
Logout
Shutdown

Repeatability test

5.3.2.1 Function Entry


Performance -> Repeatability

5.3.2.2 Screen

5.3.2.3 Instruction for Use


1. Load the PD Tube Rack and tap [Start].
2. The analyzer loads the PD Tube Rack and detects the tubes. When a sample is found, it
will begin to test.

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3. When a single sample test is finished, the analyzer will show the result of the repeatability
test sample. The latest test result will be showed preferentially.
4. The analyzer will automatically select those samples that meet the requirement of the
sample group of repeatability test, and update the number of the selected samples. When
the number of the selected samples reaches the minimum number required by the sample
group, the analyzer will show the repeatability index and test result. When the test result
is "FALL", the analyzer will highlight the result in red.
5. Use the navigation buttons to browse the samples of repeatability test in the list. You may
browse the previous/next sample, previous/next page or the first/last sample by tapping
the arrow buttons on the left of the screen.
6. Change the selected status of the samples.
7. The analyzer updates the number of the selected samples, the repeatability index and the
test result.

5.3.2.4 Note
When the analyzer detects non-AL PD Tube Rack, the prompt "Rack Type Error" will show up
and the test will be stopped.
When the number of the selected samples does not reach the minimum number required, the
analyzer will not perform the calculation of repeatability index, nor give the test result.
When the sample does not meet the sample group requirement of repeatability test, it cannot
be selected.

Carryover test

5.3.3.1 Function Entry


Performance -> Carryover

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5.3.3.2 Screen

5.3.3.3 Instruction for Use


1. Load the PD Tube Rack and tap [Start].
2. The Analyzer loads the PD Tube Rack and detects the tubes. When a sample is found, it
will begin to test.
3. When a single sample test is finished, the analyzer will show the results of the carryover
test samples according to the sample match sequence.
4. When the test of the carryover samples is finished, the analyzer will show the carryover
index and the test result. When the test result is "FALL", the analyzer will highlight the
result in red to remind the user.

5.3.3.4 Note
When the analyzer detects non-AL PD Tube Rack, the prompt "Rack Type Error" will show up
and the test will be stopped.
When the sample result cannot meet requirements, the analyzer will remind the user that the
result is invalid, and it will empty the test results of the carryover samples, and stop testing.

5.3.3.5 Test Rules


The judgment criterion of validity of the carryover test result:
a. Background Sample: The result is greater than or equal to 0.
b. Low value and high value sample: HbA1c% is within the linear range [3, 20], A0 peak area
is greater than or equal to 0.

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Fluidic Volume Calibration

5.3.4.1 Function Entry


Service-> Fluidic Volume

5.3.4.2 Screen

5.3.4.3 Instruction for Use


1. Enter the [Fluidic Volume] screen to set up fluidic volume parameters of the plunger pump.
2. The analyzer will check the validity of the input contents when you exit the screen. If valid,
the analyzer will remind you to save the settings.
3. Confirm and save the settings.
4. The analyzer saves and applies the settings.

5.3.4.4 Returned Data and Calibration Process


When the SA1c retention time is shorter than 29 s, return the following data if the plunger pump
needs to be re-calibrated.
1. Login to the software using service account (User name: Service, Password: Se s700).
2. Go to the “Table Review” screen, tap the “Export” button, then check “Chromatogram” and
export all the results tested last week.

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3. Go to the “Service->Debug Data” screen, check all the options as shown in the following
figure. Make sure choose “All Records” for the “Special Sample Information”.

4. Take a picture of the “Maintenance->Consumables->Column” screen to record the


information.
5. The customer support gets the information according to the above steps and transfer that
to the technical support.

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6. If the plunger pump parameters can be adjusted after evaluating the returned data, GTS
will reply the new parameters. Go to the “Service->Fluidic Volume” screen, input the new
plunger pump parameters then save.

7. Go to the “Maintenance-> Empty/Prime” screen, tap the “Fluidics” button to prime the
analyzer. Then test 5 new samples and make sure the SA1c retention time meets the
requirement.

Temperature Calibration

5.3.5.1 Function Entry


Service-> Temperature

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5.3.5.2 Screen

5.3.5.3 Instruction for Use


1. Enter the [Temperature] screen to set the resistance needed by temperature calibration,
and calibrate the temperature sensor.
2. After switching the edit box focus, the analyzer will apply the temperature calibration
settings.
3. When the analyzer temperature is steady, tap [Auto Set].
4. The Analyzer will automatically calculate and show the temperature setup results.
5. Switch the screen and confirm to save the settings.
6. The analyzer saves and applies the settings.

5.3.5.4 Note
N/A

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Pressure Calibration

5.3.6.1 Function Entry


Service-> Pressure

5.3.6.2 Screen

5.3.6.3 Instruction for Use


1. Enter the [Pressure] screen to finish setting.
2. After switching the edit box focus, the analyzer will apply the settings to show the calibrated
Column Pressure and Flow Cell Pressure.
3. The analyzer will check the validity of the input content when you exit the screen. If valid,
the analyzer will remind you to save the settings.
4. Confirm and save the settings.
5. The analyzer saves and applies the settings.

5.3.6.4 Note
N/A

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Advanced Setup

5.3.7.1 Function Entry


Setup-> Advanced Setup

5.3.7.2 Screen

5.3.7.3 Instruction for Use


1. Enter the [Advanced Setup] screen to finish setting.
2. The analyzer will check the validity of the input content when you exit the screen. If valid,

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the analyzer will remind you to save the settings.


3. Confirm and save the settings.
4. The analyzer saves the settings.

5.3.7.4 Note
When language is modified, you need to restart the analyzer according to the prompts to
validate the modification.

Empty/Prime

5.3.8.1 Function Entry


Maintenance-> Empty/Prime

5.3.8.2 Screen

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5.3.8.3 Instruction for Use


1. Select a certain fluidic component to empty or prime.
2. The Analyzer performs the operation and prompts that the operation is ongoing.
3. When the operation finishes, the analyzer will remind you it is done.

5.3.8.4 Note
N/A

Self-Test

5.3.9.1 Function Entry


Tap “Service-> Self-Test” to enter “Self-Test” screen.

5.3.9.2 Screen
◼ Valve

Tap “Valve” to enter the valve self-test” screen. Tap corresponding valve number or “All” to
confirm whether the selected valve beeps twice. Note: there is no No. 20 valve on the analyzer.
Each valve has a valve number nearby, so you can find the corresponding valve easily.

Valve self-test screen

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V7~V10

V11~V12

V1~V4

V16~V17

V14
V15

V18~V19
V5~V6、V13

Valve position diagram

◼ Syringes and Sampling Mechanism

Tap “Syringes and Sampling Mechanism”, and then tap the buttons in the "Syringes" and
"Sampling Mechan." area to check whether the motor and sensor work normally.

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Syringe and sampling mechanism self-test screen

Sampling

2.5ml syringe

100ul syringe

Sampling mechanism position diagram

◼ Autoloader Assembly and Manipulator


Tap “Autoloader Assembly” and then tap the buttons on this screen in turn to check whether
the motor and the sensor of the autoloader and each manipulator work normally. Note: there
is no autoloader on the instrument in sample processing system. Only the manipulator
needs to be self-tested.

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The button in this area for


instrument on the sample
processing system will be
gray by default, indicating
no need to be tested.

◼ Other parts

Tap “Others” on the self-test screen.

For standalone
instrument, only the
Waste Pump P1 needs
to be tested. The Waste
Pump P2 will be gray by
default.

For instrument in the


sample processing
system, as the barcode
scanner is not used, the
Barcode Scanner
column will be gray by
default.

Others self-test screen

Tap “Feeding Valve”. If it works normally, you can hear the action sound. Tap “Rotation Valve”,
If it works normally, you can hear the action sound.

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Rotation valve Feeding valve

Position of rotation valve and feeding valve


Tap “Waste Pump P1” or “Waste Pump P2”, the selected waste pump will start work and stop
in 5s. After the waste pump stops working, you can tap “Menu>Status>Temp.&Pressure” to
observe the pressure of the waste pump. The pressure decline of the waste pump shall not be
over 2Kpa within 10s. Otherwise, you need to check the waste pump channel for leakage.

P1 P2

Tap “Indicator” on the “Other” self-test screen, If there is no error, the red, green and orange
indicator on the analyzer screen will be on in turn and you will hear beeps. The software prompts
“Self-test completes successfully”.

Indicator

5.3.9.3 Instruction for Use


1. Tap “Service>Self -Test” to enter self-test screen. And then tap the corresponding
parts for self -test.
2. The self-test result will pop out when it completes.

5.3.9.4 Note
1. There is no No.20 valve on the analyzer. Each valve has a valve number nearby, so you
can find the corresponding valve easily.

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2. There is no autoloader on the instrument in sample processing system. Only the


manipulator needs to be self-tested.

HPLC Self-Test

5.3.10.1 Function Entry


Service-> HPLC Self-Test

5.3.10.2 Screen

5.3.10.3 Instruction for Use


1. Tap “Service -> HPLC Self-Test” to enter the HPLC Self-Test screen. Make sure the tubes
connected to the Eluent A cistern and Eluent B cistern are full of liquid. Operators should
execute the priming operation a few more times.
2. Tap the “Self-Test” button, the analyzer will prompt you to confirm a 2-way fitting is used
as a substitute for the column.

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Tap the “OK” button to execute the no column pressure self-test as shown in the following figure.

3. Use a customized aging tube to replace the 2-way fittings as shown in the figure below.
The removed connectors should be given to the FQC personnel for packing up.

082-001949-
00 PEEK
Union for 1/16"
OD Tubing

The removed connectors


should be given to the 1200mm
FQC personnel for 0.15PEEK
packing up. tube

Aging tube,
insert the tube
to the end
before
tightening it

4. Tap the “Acquire Steady Pressure” button, the analyzer prompts you to confirm the aging

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tube is installed as the following figure. Tap the “OK” button, then the analyzer starts the
plunger pump pressure build-up self-test. Make sure the self-test result is normal, that is
the stable pressure is above 1.80MPa.

5. Tap the “Rapid Compression” button, the analyzer prompts you to confirm the aging tube
is installed as the following figure. Tap the “OK” button, then the analyzer starts the plunger
pump compression self-test and records the result.

6. Tap the “Rapid Decompression” button, the analyzer prompts you to confirm the aging tube
is installed as the following figure. Tap the “OK” button, then the analyzer starts the plunger
pump decompression and records the result.

Fluidic Volume Check


1. Perform the “Prime” operation for the plunger pump.

2. Connect the plunger pump as shown in the following figure.

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Loosen the original


tube connected to
the plunger pump
outlet, then connect
the PEEK tube
(length is 410mm,
tube diameter is
0.15mm) to the
outlet end to be
tested, make sure
the connection is
secured.

3. Put one end of the 0.15mm PEEK tube into the test tube. Tap the “Dispense” button until
the liquid flows down into the test tube. The plunger pump will dispense 1.8 mL (the plunger
pump runs 60s, and the liquid is dispensed 30ul/s) liquid.

Debug->Sample Probe

5.3.11.1 Function Entry


Service->Debug->Sample Probe

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5.3.11.2 Screen

5.3.11.3 Instruction for Use


1. Select the corresponding item to debug.
2. When the performance is finished, the analyzer will show the result or report the error.

5.3.11.4 Note
Please refer to the chapter "Mechanical System" for details of the debug process.

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Debug-> Barcode Scanner

5.3.12.1 Function Entry


Service->Debug-> Barcode Scanner

5.3.12.2 Screen

5.3.12.3 Instruction for Use


1. Open or close the barcode Scanner.
2. The Analyzer performs the corresponding action.

5.3.12.4 Note
Please refer to the Production Process for details of the debug process.

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Adjustment->Export Debug Data

5.3.13.1 Function Entry


Service-> Debug Data

5.3.13.2 Screen

5.3.13.3 Instruction for Use


1. Select a certain content to perform exporting.
2. The analyzer performs the action and reminds you that it is exporting.
3. When the exporting is finished, the analyzer will prompt “Export succeeded”.

5.3.13.4 Note
When the analyzer is not connected to a USB flash drive, it will remind you to connect a USB
flash drive firstly.

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Status

5.3.14.1 Function Entry


Status Menu

5.3.14.2 Screen

5.3.14.3 Instruction for Use


1. Select a certain item under the Status menu.
2. The analyzer will show the current status of the selected item.

5.3.14.4 Note
N/A

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View vulnerable parts info.

5.3.15.1 Function Entry


Status->Statistics

5.3.15.2 Screen

5.3.15.3 Instruction for Use


1. Enter the Statistics screen to view the Used Times of the vulnerable parts; you may
initialize the Used Times.
2. When the Used Times of the vulnerable parts has reached the Max. Uses, the analyzer
will remind you the error of "Uses out of limit".

5.3.15.4 Note
N/A

5.4 Analyzer Update

Notes before Update

5.4.1.1 Update Times


It will take about 5~8 minutes to finish the complete software update.
It will take about 1~3 minutes to finish the complete hardware MCU and FGPA update.

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Please be patient to wait for the updating result. Although the progress bar may remain
immobile in a short time, do not turn off the power supply, otherwise the update may fail or the
analyzer cannot be started.

5.4.1.2 Troubleshooting in the Update Process


If the analyzer prompts the information of mount failure and the prompt “Connect the USB flash
drive", please insert the USB flash drive again and wait 10 seconds before restart the update.
You may try multiple times. If the prompt "Connect the USB flash drive" keeps showing, please
change another USB flash drive.
If the update package includes boot software, hardware MCU and FPGA, when the analyzer
prompts update failure, please do not restart the analyzer or turn off the power supply.
Ensure the correctness of the USB flash drive and update package before restart the update.
If unexpected power outage happens when updating other items, please power on the analyzer
again, and the updating module will run automatically when the analyzer is restarted.
Note: Under the circumstance of update unfinished or failed, the analyzer will automatically run
the update program after being restarted. Please do not tap the "Cancel" button to give up
update. Otherwise, even if the previous update operation has made the analyzer software in
an uncertain situation, the update program will not run again, and the analyzer cannot be started.

5.4.1.3 Do not pull off the USB flash drive during the update process

Update Steps
◼ Step 1: Update package preparation
1. Run the Windows operating system;
2. Insert the installation disk of the analyzer into the DVD ROM of the PC, and open the disk
in "My Computer";
3. Find "update.rar" in the disk, extract "update.rar" to the update folder, copy update folder
to the USB flash drive, and then insert the USB flash drive to the USB interface on the right
side of the analyzer.

◼ Step 2: Updating

1. Insert the SD card to the card slot of the analyzer, and then turn on the analyzer. When
the touch screen calibration is finished, you will enter the software screen, as the following
figure shows:

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Figure 5-1 Application Software Screen

2. Tap "Status->Version Info." in the menu bar to enter the update screen, as the following
figure shows:

Figure 5-2 Version Information Screen

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3. Tap "Start Update" button on the Version Information Screen to enter the Version Update
screen, as the following figure shows:

Figure 5-3 Update Screen

4. Tap "Upgrade" button to start the update process. Firstly the prompt box "Preparing for
Update" pops up, as the following figure shows:

Figure 5-4 Prompt Box of Preparing for Update

5. The preparing process for update generally lasts for 10 seconds or, at most 1 minute. On
the screen, “……”will keep showing up, please be patient. When the preparation is done,
the prompt box of update confirmation pops up, as the following figure shows:

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Figure 5-5 Prompt Box of project information and disk version (The actual version
information shall prevail.)

6. Tap "Yes" button to start the update process. Firstly, the prompt box of File Verification
pops up, as the following figure shows:

Figure 5-6 Prompt Box of File Verification

7. When the file verification is finished, the File Update Screen pops up. After the file update
is finished, the update of application software will get to start. After that, the update of
hardware driver will follow closely. The following figure shows the prompt box of application
software update.

Figure 5-7 Prompt Box of application software update

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Note: When updating the hardware drive, the prompt "Updating the drive board" will pop up. If
some item is not updated, the corresponding update prompt will not be displayed.
8. Data update will be performed then, as the following figure shows:

Figure 5-8 Prompt Box of Updating data

9. When the data update is finished, the prompt “Update succeeded!" pops up, as the
following figure shows:

Figure 5-9 Prompt Box of Updating success

10. Tap "OK" button, and the prompt "Please turn off the analyzer and restart" will pop up, as
the following figure shows:

Figure 5-10 Prompt Box of Restarting the analyzer

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11. Turn off the analyzer, pull off the USB flash driver and wait for a while, like 20 seconds,
and then turn on the analyzer again.

12. When the startup process is over, tap the Menu button on the upper left corner of the main
screen to display the submenus, and then tap "Status"--"Version Information" to check if
the updated version is correct.

5.5 LIS Setup

Function Entry
Setup -> Communication

Screen

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5.6 Error Code


0x01000101 Waste container full The waste container is full. Replace it with a new one.
Connect a floater even when the waste is discharged
directly.
0x01000102 No Eluent A When the error is reported, the user will be prompted
to install a new one; and the analyzer will stop
analysis if the user does not do so. If the analyzer still
does not respond after a new reagent is installed, try
to move the reagent bag a little.
0x01000103 No Eluent B When the error is reported, the user will be prompted
to install a new one; and the analyzer will stop
analysis if the user does not do so. If the analyzer still
does not respond after a new reagent is installed, try
to move the reagent bag a little.
0x01000104 No Hemolysis When the error is reported, the user will be prompted
Solution to install a new one; and the analyzer will stop
analysis if the user does not do so. If the analyzer still
does not respond after a new reagent is installed, try
to move the reagent container a little.
0x01000105 Please replace Eluent If the user has not installed a new reagent in 5
A minutes after the message appeared, the analyzer
will stop analysis.
0x01000106 Please replace Eluent If the user has not installed a new reagent in 5
B minutes after the message appeared, the analyzer
will stop analysis.
0x01000107 Please replace lyse If the user has not installed a new reagent in 5
minutes after the message appeared, the analyzer
will stop analysis.
0x01000108 Eluent A expired Eluent A is expired. The problem will not forbid the
user operation for the moment.
0x01000109 Eluent B expired Eluent B is expired. The problem will not forbid the
user operation for the moment.
0x0100010A Hemolysis Solution Hemolysis Solution is expired. The problem will not
expired forbid the user operation for the moment.
0x0100010B Hemolysis Solution The liquid level in the cistern is lower than the floater.
cistern is empty
0x0100010C Eluent A cistern is The liquid level in the cistern is lower than the floater.
empty
0x01000112 Replacing Eluent A The error will be reported when a valid RFID label is
failed detected, but the aspiration of the reagent fails due
to poor tube connections.
0x01000113 Replacing Eluent B The error will be reported when a valid RFID label is

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failed detected, but the aspiration of the reagent fails due


to poor tube connections.
0x01000114 Failed to replace The error will be reported when a valid RFID card is
Hemolysis Solution detected, but the aspiration of the reagent fails due
to poor tube connections.
0x01000150 Column information The error may occur during the installation. Install a
loading failed new column as instructed, and the error will be
removed.

0x01000151 Column expired The RFID card of the column bears the expiration
date and the "Use before" date of the column. The
problem will not forbid user operation for the moment.
0x01000152 Column uses out of The uses of the column exceeds the upper limit of
limit 3000 times, and further operation will be forbidden.
The use limit information is stored in the RFID card.

0x01000201 Column pressure If the analyzer keeps detecting high column


exceeds upper limit pressure, it will stop the analysis. When the error
appears, perform "Probe Cleanser Maintenance". If
the error still remains after that, replace the column.
0x01000202 Pressure out of upper When the error is reported, the analyzer will stop
limit analysis immediately. Check if there is any tubing
getting clogged.
0x01000203 Pressure out of lower When the error is reported, the analyzer will stop
limit analysis immediately. Check if any tube, especially
the fittings and tubes connected to the column get
loose.
0x01000204 Pressure building-up /
overtime error
0x01000210 Optical flow cell /
temperature out of
upper limit
0x01000211 Optical flow cell temp. Check if the cover of the optical system is closed
out of lower limit
0x01000212 Optical flow cell The temperature sensor of the optical system is
temperature reading damaged or not connected properly. The analyzer
error will stop the heating of the optical system.
0x01000220 Column temperature /
out of upper limit
0x01000221 Column temperature /
out of lower limit
0x01000222 Column temperature The temperature sensor of the column is damaged or
reading abnormal not connected properly. The analyzer will stop the
heating of the column.

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0x01000230 Front cover illegally The analysis will be stopped immediately. It takes a
opened long time and lots of reagent to remove the error.
0x01000240 415nm blank voltage The 415nm blank voltage signal out of upper limit.
signal out of upper Check if there is any bubble in the flow cell. If there
limit is not, reset the gains of the optical system.
0x01000241 415nm blank voltage The 415nm blank voltage signal out of lower limit.
signal out of lower limit Check if there is any bubble in the flow cell. If there
is not, reset the gains of the optical system.
0x01000250 500nm blank voltage The 500nm blank voltage signal out of upper limit.
signal out of upper Check if there is any bubble in the flow cell. If there
limit is not, reset the gains of the optical system.
0x01000251 500nm blank voltage The 500nm blank voltage signal out of upper limit.
signal out of upper Check if there is any bubble in the flow cell. If there
limit is not, reset the gains of the optical system.
0x01000260 Buffer cistern /
pressure abnormal

0x01000301 Tube rack info. The card-reader cable under the bottom cover on the
communication right side of the analyzer is not connected properly;
abnormal or the board card is damaged.
0x01000302 Tube rack info. The label on the tube rack is damaged
reading abnormal
0x01000303 Eluent A info. The Eluent A card-reader cable is not connected
communication properly; or the board card is damaged.
abnormal
0x01000304 Eluent A info. reading The Eluent A RFID card is damaged.
abnormal
0x01000305 Eluent B info. The Eluent B card-reader cable is not connected
communication properly; or the board card is damaged.
abnormal
0x01000306 Eluent B info. reading The Eluent B RFID card is damaged.
abnormal
0x01000307 Hemolysis Solution The Hemolysis Solution card-reader cable is not
info. communication connected properly; or the board card is damaged.
abnormal
0x01000308 Hemolysis Solution The Hemolysis Solution RFID card is damaged.
info. reading abnormal

0x01000401 Hemolysis Solution Syringe error. Check if the sensors are damaged, and
syringe failed to leave the motor may move smoothly.
home position
0x01000402 Lyse syringe failed to Syringe error. Check if the sensors are damaged, and
return to home the motor may move smoothly.
position

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0x01000403 Hemolysis Solution Syringe error. Check if the sensors are damaged, and
syringe failed to return the motor may move smoothly.
to sensor-blocked
area as expected
0x01000404 Hemolysis Solution Syringe error. Check if the sensors are damaged, and
syringe is in blocked the motor may move smoothly.
area
0x01000405 Lyse syringe Required aspirated volume + actual aspirated
command error volume > maximum aspirated volume;
Required dispensed volume > actual aspirated
volume;
The last action has not finished before the
initialization, self-test, and aspiration/dispensation
action.

0x01000501 Sampling syringe Sampling syringe error. Check if the sensors are
failed to leave home damaged, and the motor may move smoothly.
position
0x01000502 Sampling syringe Sampling syringe error. Check if the sensors are
failed to return to damaged, and the motor may move smoothly.
home position
0x01000503 Sampling syringe is Sampling syringe error. Check if the sensors are
not in blocked area damaged, and the motor may move smoothly.
0x01000504 Sampling syringe is in Sampling syringe error. Check if the sensors are
blocked area damaged, and the motor may move smoothly.
0x01000505 Sampling syringe Required aspirated volume + actual aspirated
command error volume > maximum aspirated volume;
Required dispensed volume > actual aspirated
volume;
The last action has not finished before the
initialization, self-test, and aspiration/dispensation
action.

0x01000601 Sample probe failed to /


leave home position in
vertical direction
0x01000602 Sample probe failed to /
return to home
position in vertical
direction
0x01000603 Sample probe failed to /
leave home position in
horizontal direction
0x01000604 Sample probe failed to /

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return to home
position in horizontal
direction
0x01000605 Sample probe failed to /
find notch
0x01000606 Sample probe arrived /
at wrong notch

0x01000701 Right edge of lyse /


position notch overrun
0x01000702 Left edge of lyse /
position notch overrun
0x01000703 Right edge of /
autoloading position
notch overrun
0x01000704 Left edge of /
autoloading position
notch overrun
0x01000705 Right edge of closed- /
tube position notch
overrun
0x01000706 Left edge of closed- /
tube position notch
overrun

0x01000801 Plunger pump A Check if the cable of the plunger pump on the right
initialization failed side is not connected properly. Check if there is liquid
in the sensor connector? (see silkscreen for plunger
pump type)
0x01000802 Plunger pump B Check if the cable of the plunger pump on the left side
initialization failed is not connected properly. Check if there is liquid in
the sensor connector? (see silkscreen for plunger
pump type)
0x01000803 Plunger pump A The sensor is not triggered during the movement.
movement failed
0x01000804 Plunger pump B The sensor is not triggered during the movement.
movement failed

0x01000901 Feeding valve The sensor is not triggered during the feeding valve
switching failed movement, the valve need to be executed self-test
again, and the current sample need to be retested.
0x01000902 Rotation valve The sensor is not triggered during the rotation valve
switching failed movement, the valve need to be executed self-test
again, and the current sample need to be retested.

5-40
Software

0x01000A01 Degasser off /


0x01000A02 Degasser pressure /
not in control range

0x01000B01 EEPROM write error EEPROM write error


0x01000B02 Action overtime Action overtime

Performing Hemolysis Solution Floater is damaged


sequence floater status
overtime abnormal
0x01000C02 Eluent A floater status Floater is damaged
abnormal
0x01000C03 Fluidic initialization not Some error has occurred during startup
performed

0x01000D01 Sample Probe uses Sample Probe uses out of the upper limit of 60,000
out of limit times
0x01000D02 Filter uses out of limit Filter uses out of limit (the upper limit has not been
decided yet)
0x01000D03 Time for Probe 600 analyses have been performed, time for Probe
Cleanser Cleanser maintenance
maintenance
0x01000D04 Probe Cleanser The Probe Cleanser maintenance has not
maintenance failed completed. Some functions including analysis will be
forbidden
0x01000D05 Filter failed The error is reported when the column pressure rises
too fast. The old filter must be replaced, or the
column life span will drop

0x01000E01 Data length abnormal /


0x01000E02 Optical signal /
abnormal

0x01005200 Loading motor busy Mix mechanism X direction motor action error
0x01005201 Manipulator pinch Mix Mechanism is working
motor busy
0x01005202 Manipulator pinch Mix mechanism X direction motor action failed1
motor failed to leave
home position
0x01005203 Manipulator pinch Mix mechanism X direction motor action failed2
motor failed to return
to home position

5-41
Software

0x01005204 Manipulator pinch Mix mechanism X direction motor action failed3


motor action forbidden
0x01005205 Manipulator pinch Mix mechanism X direction motor is not initiated
motor initialization
failed
0x01005206 Manipulator pinch Mix mechanism X direction motor action overtime
motor action overtime
0x01005207 Manipulator pinch Mix mechanism X direction motor action failed1
motor failed to leave
end position
0x01005208 Manipulator pinch Mix mechanism X direction motor action failed2
motor failed to return
to end position
0x01005209 Manipulator pinch Mix mechanism X direction sensor error
motor sensor
abnormal

0x01005400 Manipulator pinch Mix motor initialization error


motor initialization
forbidden
0x01005401 Manipulator elevation Mix Mechanism is working
motor busy
0x01005402 Manipulator elevation Mix mechanism Z direction motor action failed1
motor failed to leave
home position
0x01005403 Manipulator elevation Mix mechanism Z direction motor action failed2
motor failed to return
to home position
0x01005404 Manipulator elevation Mix motor Z direction motor current action forbidden
motor action forbidden
0x01005405 Manipulator elevation Mix mechanism Z direction motor is not initiated
motor initialization
failed
0x01005406 Manipulator elevation Mix mechanism Z direction motor action overtime
motor action overtime
0x01005407 Manipulator elevation Mix mechanism Z direction motor action failed1
motor failed to leave
end position
0x01005408 Manipulator elevation Mix mechanism Z direction motor action failed2
motor failed to return
to end position
0x01005409 Manipulator elevation Mix mechanism Z direction sensor error
motor sensor
abnormal

5-42
Software

0x01005500 Manipulator elevation Mix motor current action not allowed (no way to
motor forbids mix report this yet)
motor action
0x01005501 Mix motor busy Mix motor in action
0x01005502 Mix motor failed to Mix motor action error
leave home position
0x01005503 Mix motor failed to Mix motor action error
return to home
position
0x01005504 Mix motor action Mix motor action not allowed
forbidden
0x01005505 Mix motor initialization Mix motor not initialized
failed
0x01005506 Mix motor action Mix motor action overtime
overtime
0x01005507 Mix motor failed to Motor not supposed to be at the end position
leave end position
0x01005508 Mix motor failed to Motor supposed to be at the end position
return to end position

0x01005601 Mix mechanism busy Mix Mechanism is working


0x01005603 Mix mechanism action Mix mechanism action overtime
overtime
0x01005604 Mix time setting out of Mix time setting out of limit
limit
0x01005605 Mix mechanism Mix mechanism is not initiated
initialization failed
0x01005606 Mix mechanism Mix mechanism current action is forbidden
current action
forbidden

0x01005700 Feeding motor busy X-direction loading motor in action


0x01005701 Feeding motor home X-direction loading motor action error 1
position sensor error
0x01005702 Feeding position tube X-direction loading motor current action forbidden
rack error
0x01005703 Feeding motor end X-direction loading motor action error 2
position sensor error
0x01005704 Feeding motor sensor X-direction loading motor sensor error
error
0x01005705 Feeding motor loading X-direction loading motor loading error
error

5-43
Software

0x01005706 Feeding motor action X-direction loading motor action overtime


overtime
0x01005708 Feeding position Loading micro-switch error
micro switch error

0x01005801 Autoloader board Functional code error


functional code error
0x01005802 Autoloader board data Data length error
length error
0x01005803 Autoloader board Command identifier error
command identifier
error
0x01005804 Autoloader board Check code error
check code error
0x01005805 Autoloader board end End code error
code error
0x01005806 Autoloader board Identification code error
identifier error

0x01005900 Loading motor Y-direction loading motor in action


receiving command
error
0x01005901 Loading motor Y-direction motor initialization forbidden
initialization forbidden
0x01005902 Unloading tray full, Unloading action error
unloading forbidden
0x01005903 Loading motor home Y-direction loading motor action error
position sensor error
0x01005904 Loading motor Unloading position sensor error
unloading position
sensor error
0x01005905 Loading position right Y-direction right sensor error
sensor error
0x01005906 Loading position left Y-direction left sensor error
sensor error
0x01005907 Loading motor not Y-direction loading motor is not initialized
initialized
0x01005908 Loading motor feeding Y-direction loading motor feeding error
not at home position
0x01005909 Loading motor Y-direction loading motor unloading error
unloading not at home
position
0x0100590A Loading motor action Y-direction loading motor action overtime (no way to

5-44
Software

overtime report this yet)


0x0100590B Autoloader receiving Command cannot be executed
command error (not in
sampling mode)
0x0100590C Autoloader receiving Command cannot be executed
command error (not in
stop status)
0x0100590D Autoloader horizontal Y-direction left and right sensors cooperation error
loading sensor match
error
0x0100590E Unloading tray full Too many tubes are fed to the unloading tray during
when autoloader is autoloader initialization
initializing
0x0100590F Sensor blocked after Tube detection sensor is blocked after initialization.
autoloader
initialization
0x01005910 Autoloader horizontal Right sensor damaged, or unable to drag the tube
loading sensor rack
abnormal

0x01005a00 Autoloader board EEPROM data invalid


EEPROM chip error
0x01005a01 Failed to opening Opening sample compartment door failed
sample compartment
door
0x01005a02 Autoloader action All autoloader actions are currently forbidden when
forbidden when the autoloader is paused
autoloader is paused
0x01005a03 Autoloader adjust The autoloader is not at adjusting status, so all
forbidden when adjustment actions are forbidden
autoloader is not at
adjusting status
0x01005a04 Autoloader Adjustment parameter out of range
adjustment parameter
setting out of range
0x01005a05 Scanner read error Read scanner error
0x01005B00 Rotary scanning Rotary scanning mechanism is moving
mechanism action
error
0x01005B02 Rotary scanning The falling edge is not triggered during the
mechanism action initialization process of fixing mechanism
error
0x01005B03 Rotary scanning The rising edge is not triggered during the
mechanism action initialization process of fixing mechanism

5-45
Software

error
0x01005B04 Rotary scanning Sensor is not blocked during the initialization process
mechanism action of fixing mechanism
error
0x01005B05 Rotary scanning Sensor is blocked during the initialization process of
mechanism action fixing mechanism
error
0x01005B06 Rotary scanning Too many steps remain untaken after the tube fixing
mechanism action process
error
0x01005B07 Rotary scanning Sensor is not blocked during the tube fixing process
mechanism action
error
0x01005B08 Rotary scanning The falling edge is not triggered during the tube fixing
mechanism action process
error
0x01005B09 Rotary scanning The rising edge is not triggered during the tube
mechanism action releasing process
error
0x01005B0A Rotary scanning Sensor is not blocked during the tube releasing
mechanism action process
error

5-46
Chapter 6 H50/H50P Active Maintenance Report

6.1 Checking Basic Status


To check and confirm the analyzer state, customer support should record the analyzer state in
the following table when the analyzer is powered on normally.
Troubleshooting (Fill it
Measurement Measurement Pass or when the
Measurement item
standard results fail measurement result is
failed)
Ambient Pass
15℃~30℃
temperature Fail
Reagent residue Pass
Insufficient or not
volume Fail
Reagent expiration Pass
Expired or not
date Fail
Waste container Pass
Full or not
status Fail
Power cord,
Bent, damaged or Pass
network cable,
not Fail
reagent tubes
1. Connector is
firmly
connected.
2. Floater moves
Reagent container Pass
smoothly.
tube cap assembly Fail
3. The cap
surface is
clean without
obvious stain.
The mixing bath
inlet is clean Pass
Mixing bath
without any Fail
residue.
Probe wipe surface
is clean without any Pass
Probe wipe
blood stains or Fail
reagent crystals.
No foreign residue
Pass
Probe wipe filter and the filter screen
Fail
is not damaged.

6-1
H50/H50P Active Maintenance Report

Troubleshooting (Fill it
Measurement Measurement Pass or when the
Measurement item
standard results fail measurement result is
failed)
No leakage and Pass
Syringe assembly
reagent crystals. Fail
1. Door detection
sensor is clean
without any
dust.
2. The torsion
spring and
dowel of the
compartment
door are clean
Sample Pass
without any
compartment Fail
foreign objects.
3. The roller of
the
compartment
door is clean
without any
foreign objects,
the roller can
roll normally.
Sampling
assembly , Clean without any Pass
autoloader, mixing dust Fail
assembly sensors
The barcode can Pass
Barcode scanner
be recognized. Fail
Optical background Pass
[3.8, 4.1]V
voltage Fail
Mixing bath voltage Pass
[1.8, 2.2]V
(Only for H50P) Fail

NOTE
⚫ If the measurement result is a specific value, fill this value into the table; if
not, choose “Pass” or “Fail” in the table.

⚫ If the measurement results all pass, no action needs to be taken. Do the

6-2
H50/H50P Active Maintenance Report

troubleshooting if any result is failed.

6.2 Verification

Repeatability Test Result


Take enough fresh blood samples or high-level controls, test 10 times continuously on the
“Performance->Repeatability” screen.

Repeatability HbA1c
1
2
3
4
5
6
7
8
9
10
MEAN
SD
CV
CV≤ 1.0%
Conclusion

Chromatogram Verification
Select 5 normal fresh blood samples to run analysis under the “OV/AL-WB” mode. It is required
that chromatogram peak pattern of the sample is normal as shown in the following figure, and
the analyzer reports no alarm.

6-3
H50/H50P Active Maintenance Report

6-4
Appendix
A Fluidic Diagrams (Old Standalone Instrument)
1 2 3 4 5 6 7 8
REV DESCRIPTION DESIGN
MRSZ/R05N01.291.01(4.0)
6.0 ND-100-65 hose implace of E-3603 hose Yan Yufeng

7.0 Change the length of T109 Chen Jiajun

1 2 1 2
A
VAC
6 3 6 3
J22-T4-J3 5 4 5 4
C94 T116
T120 C98
GV10 T12 C3 Load(POSB) Inject(POSA)
T3(P4)-J19 T11
SV09 T17 C9
J23-T5-J4 C2 T18 T98-J17
C95 T117 T119 C97 T24
T21
GV11 T13 C4
T2(P3)-J20 T10 C42
SV08 T16 C8
T19 T109
C96 T118 C1 J6-T95
T6 T8 T20
T14 C5 Detecor
T7 T9
SV07 T30 T15 C7 Preheating steel tube 2
GV12 C40
(P7)T1(P2)-J21 T29 T28
T25 C6
T26 T97
B T31 T32 T33
T112
GP1 T27 C39
T23 Isolation chamber Thermostatic Chamber C84
C11
C13 T91
EL_A EL_B C67
C82 C60 C59
Cistern C15 Cistern OPEN SV13 T77 T80 PS1
T107 C26 1 2
HWS C81 T113
Germproof 6 3 T85 Column C85
Cistern
T34 filter C61 C64 C38 C37
T114 5 4
T90 C43 T96
C16 C91 C92 C93 C62 C63 T84
Eluate Eluate Hemolysis & Wash T79 T82
C14 T35 INJ_PUMPB T110 Column filter
B A Solution Bubble Trap ROT-V
C25
Ta3
C21 C22
T43 Damper C35 C36
J18 C27 1 2 C32
C17 J2-T39-J27 J28-T40 T78 Preheating steel tube 1
6 3
C24 C33 C34 C28 C31
T36 SV17 5 4
T115 Ta1-J16
C29 C30
C90 Pressure Transduser
INJ-V C65 C66
C18
Bubble Trap INJ_PUMPA
C C23 Ta2
C19 C20 C56 T99 T100
Sample Loop 4 uL
J7-T57-J13-T111
J1-T38-J25 J26-T41 T42
T47

T37 SV16 J8-T59-J14 C47

名称: Waste cistern


SV18 SV19 T92
C58 T60(P1)-J15
T94 T56 C52

T93 T76
C89 C86
T54 T58 T55
C46 C87 J9
C44 C51
T83 C45 SV01
T51 T52 T53
C83
Syringe 100uL
T108 T61 T62

D SV03 SV02
T81 SV04
Probe wipe T75
T44 T64
C88 T65

Sample probe

J10-T63
Mix bath T66 Wipe filter
T67
C53 C54
C79
T74
T103 SV06 T70 SV05 T87
Syringe 2.5mL T69 C48 C55
T71
Mix bath filter
E C49 GP1
T104
T72 Waste
C80 C50 T73 container
SV15
T105 T68 Waste pump

保密密级:机密
CONFIDENTIAL
TITLE 3300 Fluidic diagram
DOC No. A1-115-027230-00
F 保密:此图及其全部知识产权(含著作权)归深圳迈瑞生物医疗电子股份有限公司所有。未经深圳迈瑞生物医疗电子股份有限公司预先书面许可,严禁出于任何目的,对此图的全部或部分内容(包括但不限于图中信息、数据、运算结果等)泄露、使用、拷贝或复制。 DESIGN Niu Zihua REV. 7.0 /
Classified documents, This set of drawing(s) and all it's intellectual property rights (including copyright) subsisting herein are property of Shenzhen Mindray Bio-medical Electronics Co.,Ltd. No disclosure,use,copies or reproductions
should be made of this drawing or any part(s) thereof for whatever purpose nor shall any information, data, calculations, or other contents contained in this drawing be disseminated without prior written permission of Shenzhen Mindray P.CODE 3300 SIZE A3
Bio-medical Electronics Co.,Ltd Software & Rev:
SHEET 1 OF 12
Microsoft visio 2019
B List of Tubes and Connectors (Old Standalone Instrument)
1 2 3 4 5 6 7 8
MRSZ/R05N01.291.01(4.0)

A
Bill of Materials in 3300 Fluidic Diagram
N0. Name in Diagram Quantity Unit P/N Position Remark
1 T1 1990 mm 082-002199-00
2 T2 2100 mm 082-002199-00
3 T3 2060 mm 082-002199-00
4 T4 120 mm 082-000036-00 46-120
5 T5 90 mm 082-000036-00 46-90
6 T6 120 mm M90-100071--- 1-120
7 T7 50 mm 082-000314-00 6-50
8 T8 50 mm 082-000314-00 6-50
B 9 T9 180 mm M90-100071--- 1-180
10 T10 200 mm M90-100071--- 1-200
11 T11 240 mm M90-100071--- 1-240
12 T12 20 mm M90-100071--- 1-20
13 T13 20 mm M90-100071--- 1-20
14 T14 20 mm M90-100071--- 1-20
15 T15 20 mm M90-100071--- 1-20
16 T16 20 mm M90-100071--- 1-20
17 T17 20 mm M90-100071--- 1-20
18 T18 17 mm M90-100071--- 1-17
19 T19 17 mm M90-100071--- 1-17
20 T20 17 mm M90-100071--- 1-17
C 21 T21 17 mm M90-100071--- 1-17
22
23 T23 180 mm 082-000108-00 30-180
24 T24 690 mm 082-000108-00 30-690
25 T25 20 mm M90-100071--- 1-20
26 T26 330 mm 082-000108-00 30-330
27 T27 30 mm 082-000432-00 29-30
28 T28 55 mm M6G-020006--- 10-55
29 T29 55 mm M6G-020006--- 10-55
30 T30 55 mm M6G-020006--- 10-55
31 T31 25 mm 082-001276-00 40-25
32 T32 25 mm 082-001276-00 40-25
D
33 T33 25 mm M6G-020006--- 10-25
34 T34 50 mm 082-001276-00 40-50
35 T35 50 mm 082-001276-00 40-50
36 T36 60 mm 082-001276-00 40-60
37 T37 480 mm 082-000432-00 29-480
38 T38 800 mm M6G-020008--- 13-800
39 T39 900 mm M6G-020008--- 13-900
40 T40 150 mm M6G-020008--- 13-150
41 T41 150 mm M6G-020008--- 13-150
42 T42 280 mm M6G-020008--- 13-280
43 T43 320 mm M6G-020008--- 13-320
E 44 T44 50 mm 082-000432-00 29-50
45
46
47 T47 150 mm M90-100071--- 1-150
48

保密密级:机密
CONFIDENTIAL
TITLE 3300 Fluidic diagram
F 保密:此图及其全部知识产权(含著作权)归深圳迈瑞生物医疗电子股份有限公司所有。未经深圳迈瑞生物医疗电子股份有限公司预先书面许可,严禁出于任何目的,对此图的全部或部分内容(包括但不限于图中信息、数据、运算结果等)泄露、使用、拷贝或复制。
Classified documents, This set of drawing(s) and all it's intellectual property rights (including copyright) subsisting herein are property of Shenzhen Mindray Bio-medical Electronics Co.,Ltd. No disclosure,use,copies or reproductions DOC No. A1-115-027230-00
should be made of this drawing or any part(s) thereof for whatever purpose nor shall any information, data, calculations, or other contents contained in this drawing be disseminated without prior written permission of Shenzhen Mindray
Bio-medical Electronics Co.,Ltd P.CODE 3300 REV. 7.0 /
SHEET 2 OF 12 SIZE A3
1 2 3 4 5 6 7 8
MRSZ/R05N01.291.01(4.0)

A Bill of Materials in 3300 Fluidic Diagram


N0. Name in Diagram Quantity Unit P/N Position Remark
49
50
51 T51 15 mm 082-000432-00 29-15
52 T52 15 mm 082-000432-00 29-15
53 T53 15 mm 082-000432-00 29-15
54 T54 20 mm 3001-10-07069 2-20
55 T55 150 mm 082-000432-00 29-150
56 T56 20 mm M90-100071--- 1-20
57 T57 600 mm M90-100031--- 4-600
58 T58 40 mm 3001-10-07069 2-40
B 59 T59 280 mm M6G-020008--- 13-280
60 T60 640 mm M6G-020008--- 13-640 Quantify
61 T61 20 mm 3001-10-07069 2-20
62 T62 20 mm 3001-10-07069 2-20
63 T63 700 mm M6G-020008--- 13-700
64 T64 730 mm 3001-10-07069 2-730
65 T65 1420 mm M90-100071--- 1-1420
66 T66 220 mm M90-100071--- 1-220
67 T67 25 mm 3001-10-07069 2-25
68 T68 430 mm M90-100071--- 1-430
69 T69 30 mm M90-100071--- 1-30
C 70 T70 50 mm M90-100071--- 1-50
71 T71 20 mm M90-100071--- 1-20
72 T72 600 mm M90-100071--- 1-600
73 T73 80 mm 082-000314-00 6-80
74 T74 220 mm 082-000314-00 6-220
75 T75 40 mm M90-100071--- 1-40
76 T76 50 mm 082-001276-00 40-50
77 T77 150 mm 082-001942-00 45-150
78 T78 130 mm 082-001942-00 45-130
79 T79 450 mm 082-001942-00 45-450
80 T80 250 mm 082-001942-00 45-250
D 81 T81 20 mm 3001-10-07069 2-20
82 T82 160 mm 082-001941-00 44-160
83 T83 20 mm 3001-10-07069 2-20
84 T84 90 mm 082-001941-00 44-90
85 T85 180 mm 082-001941-00 44-180
86
87 T87 1500 mm M6G-020055--- 22-1500
88
89
90 T90 20 mm 082-001276-00 40-20
91 T91 20 mm 082-001276-00 40-20
E 92 T92 20 mm 082-001276-00 40-20
93 T93 880 mm 082-000432-00 29-880
94 T94 80 mm M90-100071--- 1-80
95 T95 380 mm M6G-020008--- 13-380
96 T96 120 082-001941-00 44-120

保密密级:机密
CONFIDENTIAL
TITLE 3300 Fluidic diagram
F 保密:此图及其全部知识产权(含著作权)归深圳迈瑞生物医疗电子股份有限公司所有。未经深圳迈瑞生物医疗电子股份有限公司预先书面许可,严禁出于任何目的,对此图的全部或部分内容(包括但不限于图中信息、数据、运算结果等)泄露、使用、拷贝或复制。
Classified documents, This set of drawing(s) and all it's intellectual property rights (including copyright) subsisting herein are property of Shenzhen Mindray Bio-medical Electronics Co.,Ltd. No disclosure,use,copies or reproductions DOC No. A1-115-027230-00
should be made of this drawing or any part(s) thereof for whatever purpose nor shall any information, data, calculations, or other contents contained in this drawing be disseminated without prior written permission of Shenzhen Mindray
Bio-medical Electronics Co.,Ltd P.CODE 3300 REV. 7.0 /
SHEET 3 OF 12 SIZE A3
1 2 3 4 5 6 7 8

MRSZ/R05N01.291.01(4.0)

A Bill of Materials in 3300 Fluidic Diagram


N 0 . N a m e i n D i a g r aQmu a n t i t y U n i t P/N Position Remark
97 T97 150 mm 082-001941-00 44-150
98 T98 1230 mm M6G-020008--- 13-1230
99 T99 30 mm 082-001276-00 40-30
100 T100 30 mm 082-001276-00 40-30
101
102
103 T103 20 mm 082-000314-00 6-20
104 T104 20 mm 082-000314-00 6-20
105 T105 80 mm 3001-10-07069 2-80
106
B
107 T107 50 mm 082-000314-00 6-50
108 T108 20 mm 3001-10-07069 2-20
109 T109 450 mm 082-001941-00 44-450
110 T110 120 mm 082-001941-00 44-120
111 T111 170 mm 082-002207-00 48-170
112 T112 500 mm 082-000108-00 30-500
113 T113 1000 mm 082-000108-00 30-1000
114 T114 75 mm M90-100071--- 1-75
115 T115 75 mm M90-100071--- 1-75
116 T116 20 mm M6G-020006--- 10-20
117 T117 20 mm M6G-020006--- 10-20
C 118 T118 20 mm M6G-020006--- 10-20
119 T119 20 mm M6G-020006--- 10-20
120 T120 20 mm M6G-020006--- 10-20
121 T121
122 T122
123 T123
124 T124
125 T125
126 T126
127 T127
D 128 T128
129 T129
130 T130
131 T131
132 T132
133 T133
134 T134
135 T135
136 T136
137 T137
138 T138
139 T139
E 140 T140
141 T141
142 T142
143 T143
144 T144

保密密级:机密
CONFIDENTIAL
TITLE 3300 Fluidic diagram
F 保密:此图及其全部知识产权(含著作权)归深圳迈瑞生物医疗电子股份有限公司所有。未经深圳迈瑞生物医疗电子股份有限公司预先书面许可,严禁出于任何目的,对此图的全部或部分内容(包括但不限于图中信息、数据、运算结果等)泄露、使用、拷贝或复制。
Classified documents, This set of drawing(s) and all it's intellectual property rights (including copyright) subsisting herein are property of Shenzhen Mindray Bio-medical Electronics Co.,Ltd. No disclosure,use,copies or reproductions DOC No. A1-115-027230-00
should be made of this drawing or any part(s) thereof for whatever purpose nor shall any information, data, calculations, or other contents contained in this drawing be disseminated without prior written permission of Shenzhen Mindray
Bio-medical Electronics Co.,Ltd P.CODE 3300 REV. 7.0 /
SHEET 4 OF 12 SIZE A3
1 2 3 4 5 6 7 8

MRSZ/R05N01.291.01(4.0)

Bill of Materials in 3300 Fluidic Diagram

N0. Name in Diagram Quantity Unit P/N Position Remark


A
1 J1 1 EA 0030-20-13339 28-20
2 J2 1 EA 0030-20-13339 28-20
3 J3 20 mm M6G-020006--- 10-20
4 J4 20 mm M6G-020006--- 10-20
5 J5 20 mm M6G-020006--- 10-20
6 J6 20 mm 082-000710-00 37-20
7 J7 25 mm M6G-020006--- 10-25
8 J8 20 mm 082-000710-00 37-20
9 J9 25 mm 082-000710-00 37-25
10 J10 20 mm 082-000710-00 37-20
B 11
12
13 J13 20 mm 082-000710-00 37-20
14 J14 20 mm 082-000710-00 37-20
15 J15 20 mm 082-000710-00 37-20
16 J16 20 mm 082-000710-00 37-20
17 J17 20 mm 082-000710-00 37-20
18 J18 30 mm M6G-020008--- 1 3-30
19 J19 20 mm M6G-020006--- 10-20
20 J20 20 mm M6G-020006--- 10-20
21 J21 20 mm M6G-020006--- 10-20
C 22 J22 20 mm M6G-020006--- 10-20
23 J23 20 mm M6G-020006--- 10-20
24
25 J25 30 mm 082-000710-00 37-30
26 J26 30 mm 082-000710-00 37-30
27 J27 30 mm 082-000710-00 37-30
28 J28 30 mm 082-000710-00 37-30
29 J29
30 J30
31 J31
D 32 J32
33 J33
34 J34
35 J35
36 J36
37 J37
38 J38
39 J39
40 J40
41 J41
42 J42
43 J43
E
44 J44
45 J45
46 J46
47 J47
48 J48

保密密级:机密
CONFIDENTIAL
TITLE 3300 Fluidic diagram
F 保密:此图及其全部知识产权(含著作权)归深圳迈瑞生物医疗电子股份有限公司所有。未经深圳迈瑞生物医疗电子股份有限公司预先书面许可,严禁出于任何目的,对此图的全部或部分内容(包括但不限于图中信息、数据、运算结果等)泄露、使用、拷贝或复制。
Classified documents, This set of drawing(s) and all it's intellectual property rights (including copyright) subsisting herein are property of Shenzhen Mindray Bio-medical Electronics Co.,Ltd. No disclosure,use,copies or reproductions DOC No. A1-115-027230-00
should be made of this drawing or any part(s) thereof for whatever purpose nor shall any information, data, calculations, or other contents contained in this drawing be disseminated without prior written permission of Shenzhen Mindray
Bio-medical Electronics Co.,Ltd P.CODE 3300 REV. 7.0 /
SHEET 5 OF 12 SIZE A3
1 2 3 4 5 6 7 8

MRSZ/R05N01.291.01(4.0)

A
Bill of Materials in 3300 Fluidic Diagram
N0. Name in Diagram Quantity Unit P/N Position Remark
1 P1 250 mm M90-100071--- 1-250
2 P2 15 mm 082-000314-00 6-15
3 P3 15 mm 082-000314-00 6-15
4 P4 15 mm 082-000314-00 6-15
5
6
7 P7 20 mm M6G-020006--- 10-20
8 P8
9 P9
B 10 P10
11 P11
12 P12
13 P13
14 P14
15 P15
16 P16
17 P17
18 P18
19 P19
20 P20
C 21 P21
22 P22
23 P23
24 P24
25 P25
26 P26
27 P27
28 P28
29 P29
30 P30
31 P31
D 32 P32
33 P33
34 P34
35 P35
36 P36
37 P37
38 P38
39 P39
40 P40
41 P41
42 P42
43 P43
E 44 P44
45 P45
46 P46
47 P47
48 P48

保密密级:机密
CONFIDENTIAL
TITLE 3300 Fluidic diagram
F 保密:此图及其全部知识产权(含著作权)归深圳迈瑞生物医疗电子股份有限公司所有。未经深圳迈瑞生物医疗电子股份有限公司预先书面许可,严禁出于任何目的,对此图的全部或部分内容(包括但不限于图中信息、数据、运算结果等)泄露、使用、拷贝或复制。
Classified documents, This set of drawing(s) and all it's intellectual property rights (including copyright) subsisting herein are property of Shenzhen Mindray Bio-medical Electronics Co.,Ltd. No disclosure,use,copies or reproductions DOC No. A1-115-027230-00
should be made of this drawing or any part(s) thereof for whatever purpose nor shall any information, data, calculations, or other contents contained in this drawing be disseminated without prior written permission of Shenzhen Mindray
Bio-medical Electronics Co.,Ltd P.CODE 3300 REV. 7.0 /
SHEET 6 OF 12 SIZE A3
1 2 3 4 5 6 7 8

MRSZ/R05N01.291.01(4.0)

Bill of Materials in 3300 Fluidic Diagram


A
N0. Name in Diagram Quantity Unit P/N Position Remark
1 C1 1 EA M90-100027---
2 C2 1 EA M90-100066---
3 C3 1 EA 082-001105-00
4 C4 1 EA 082-001281-00
5 C5 1 EA 082-001281-00
6 C6 1 EA 082-001281-00
7 C7 1 EA 082-001281-00
8 C8 1 EA 082-001281-00
9 C9 1 EA 082-001105-00
10 C10
B
11 C11 1 EA 043-000880-00
12
13 C13 1 EA 3001-10-07066
14 C14 1 EA 082-001960-00
15 C15 1 EA 082-001960-00
16 C16 1 EA M90-100027---
17 C17 1 EA M90-100027---
18 C18 1 EA M90-100027---
1 EA 0040-10-32304
19 C19
1 EA 0040-10-32305
1 EA 0040-10-32304
C 20 C20
1 EA 0040-10-32305
1 EA 0040-10-32304
21 C21
1 EA 0040-10-32305
1 EA 0040-10-32304
22 C22
1 EA 0040-10-32305
23 C23 1 EA 082-001952-00
24 C24 1 EA 082-001952-00
25 C25 1 EA 082-001952-00
26 C26 1 EA 082-001952-00
27 C27 1 EA 082-001954-00
28 C28 1 EA 082-001952-00
D 29 C29 1 EA 082-001954-00
30 C30 1 EA 082-001954-00
31 C31 1 EA 082-001952-00
32 C32 1 EA 082-001954-00
33 C33 1 EA 082-001952-00
34 C34 1 EA 082-001952-00
35 C35 1 EA 082-001949-00
36 C36 1 EA 082-001949-00
37 C37 1 EA 082-001952-00
38 C38 1 EA 082-001952-00
39 C39 1 EA 082-001949-00
E 1 EA 082-001947-00
40 C40
1 EA 082-001948-00
41 C41
42 C42 1 EA 082-001952-00

保密密级:机密
CONFIDENTIAL
TITLE 3300 Fluidic diagram
F 保密:此图及其全部知识产权(含著作权)归深圳迈瑞生物医疗电子股份有限公司所有。未经深圳迈瑞生物医疗电子股份有限公司预先书面许可,严禁出于任何目的,对此图的全部或部分内容(包括但不限于图中信息、数据、运算结果等)泄露、使用、拷贝或复制。
Classified documents, This set of drawing(s) and all it's intellectual property rights (including copyright) subsisting herein are property of Shenzhen Mindray Bio-medical Electronics Co.,Ltd. No disclosure,use,copies or reproductions DOC No. A1-115-027230-00
should be made of this drawing or any part(s) thereof for whatever purpose nor shall any information, data, calculations, or other contents contained in this drawing be disseminated without prior written permission of Shenzhen Mindray
Bio-medical Electronics Co.,Ltd P.CODE 3300 REV. 7.0 /
SHEET 7 OF 12 SIZE A3
1 2 3 4 5 6 7 8

MRSZ/R05N01.291.01(4.0)

Bill of Materials in 3300 Fluidic Diagram


A N 0 . N a m e i n D i a g r a mQ u a n t i t y Unit P/N Position Remark
43 C43 1 EA 082-001281-00
44 C44 1 EA 043-000880-00
45 C45 1 EA 043-000880-00
46 C46 1 EA 043-000880-00
47 C47 1 EA 043-000880-00
48 C48 1 EA 082-001281-00
49 C49 1 EA 082-001281-00
50 C50 1 EA 3001-10-07066
51 C51 1 EA M90-100027---
52 C52 1 EA 082-001960-00
B 53 C53 1 EA M90-100009---
54 C54 1 EA M90-100025---
55 C55 1 EA 3102-20-69219
56 C56 1 EA M90-100027-00
57 C57
58 C58 1 EA M90-100065---
59 C59 1 EA 082-001954-00
60 C60 1 EA 082-001952-00
61 C61 1 EA 082-001954-00
62 C62 1 EA 082-001952-00
63 C63 1 EA 082-001954-00
C 64 C64 1 EA 082-001952-00
65 C65 1 EA M90-100027---
66 C66 1 EA M90-100027---
67 C67 1 EA 082-001951-00
68

69

70

71
D
72

73

74

75

76

E 77

78
79 C79 1 EA M90-100027---
80 C80 1 EA M90-100027---

保密密级:机密
CONFIDENTIAL
TITLE 3300 Fluidic diagram
F 保密:此图及其全部知识产权(含著作权)归深圳迈瑞生物医疗电子股份有限公司所有。未经深圳迈瑞生物医疗电子股份有限公司预先书面许可,严禁出于任何目的,对此图的全部或部分内容(包括但不限于图中信息、数据、运算结果等)泄露、使用、拷贝或复制。
Classified documents, This set of drawing(s) and all it's intellectual property rights (including copyright) subsisting herein are property of Shenzhen Mindray Bio-medical Electronics Co.,Ltd. No disclosure,use,copies or reproductions DOC No. A1-115-027230-00
should be made of this drawing or any part(s) thereof for whatever purpose nor shall any information, data, calculations, or other contents contained in this drawing be disseminated without prior written permission of Shenzhen Mindray
Bio-medical Electronics Co.,Ltd P.CODE 3300 REV. 7.0 /
SHEET 8 OF 12 SIZE A3
1 2 3 4 5 6 7 8

MRSZ/R05N01.291.01(4.0)

A Bill of Materials in 3300 Fluidic Diagram


N0. Name in Diagram Quantity Unit P/N Position Remark
81 C81 1 EA M90-100027---
82 C82 1 EA M90-100027-00
83 C83 1 EA 082-001105-00
1 EA 082-000525-00
84 C84
1 EA 082-000526-00
1 EA 082-000525-00
85 C85
1 EA 082-000526-00
86 C86 1 EA 043-000892-00
87 C87 1 EA 043-000892-00
B 88 C88 1 EA 082-001105-00
89 C89 1 EA 043-000892-00
90 C90 1 EA 082-001627-00
91 C91 1 EA 082-001627-00
92 C92 1 EA 082-001952-00
93 C93 1 EA 082-001952-00
94 C94 1 EA 082-001105-00
95 C95 1 EA 082-001105-00
96 C96 1 EA 082-001105-00
97 C97 1 EA 082-001105-00
98 C98 1 EA 082-001105-00
C 99
100
101
102
103
104
105
106
107
108
109
110
D 111
112
113
114
115
116
117
118
119
120
121
122
E 123
124
125
126

保密密级:机密
CONFIDENTIAL
TITLE 3300 Fluidic diagram
F 保密:此图及其全部知识产权(含著作权)归深圳迈瑞生物医疗电子股份有限公司所有。未经深圳迈瑞生物医疗电子股份有限公司预先书面许可,严禁出于任何目的,对此图的全部或部分内容(包括但不限于图中信息、数据、运算结果等)泄露、使用、拷贝或复制。
Classified documents, This set of drawing(s) and all it's intellectual property rights (including copyright) subsisting herein are property of Shenzhen Mindray Bio-medical Electronics Co.,Ltd. No disclosure,use,copies or reproductions DOC No. A1-115-027230-00
should be made of this drawing or any part(s) thereof for whatever purpose nor shall any information, data, calculations, or other contents contained in this drawing be disseminated without prior written permission of Shenzhen Mindray
Bio-medical Electronics Co.,Ltd P.CODE 3300 REV. 7.0 /
SHEET 9 OF 12 SIZE A3
1 2 3 4 5 6 7 8

MRSZ/R05N01.291.01(4.0)

Bill of Materials in 3300 Fluidic Diagram


A
N0. Name in Diagram Quantity Unit P/N Position Remark
1 SV01 1 EA 115-011404-00
2 SV02 1 EA 115-011404-00
3 SV03 1 EA 115-011404-00
4 SV04 1 EA 115-013056-00
5 SV05 1 EA 115-033289-00
6 SV06 1 EA 115-033289-00
7 SV07 1 EA 115-034926-00
8 SV08 1 EA 115-034926-00
9 SV09 1 EA 115-034926-00
10 GV10 1 EA 115-034927-00
B
11 GV11 1 EA 115-034927-00
12 GV12 1 EA 115-034927-00
13 GV13 1 EA 115-033289-00
14 SV14
15 SV15 1 EA 115-033289-00
16 SV16 1 EA 115-033289-00
17 SV17 1 EA 115-033289-00
18 SV18 1 EA 115-034926-00
19 SV19 1 EA 115-034926-00
20 SV20
21
C
22
23
24
25
26
27
28
29
30
31
32
D 33
34
35
36
37
38
39
40
41
42
43
E 44
45
46
47
48

保密密级:机密
CONFIDENTIAL
TITLE 3300 Fluidic diagram
F 保密:此图及其全部知识产权(含著作权)归深圳迈瑞生物医疗电子股份有限公司所有。未经深圳迈瑞生物医疗电子股份有限公司预先书面许可,严禁出于任何目的,对此图的全部或部分内容(包括但不限于图中信息、数据、运算结果等)泄露、使用、拷贝或复制。
Classified documents, This set of drawing(s) and all it's intellectual property rights (including copyright) subsisting herein are property of Shenzhen Mindray Bio-medical Electronics Co.,Ltd. No disclosure,use,copies or reproductions DOC No. A1-115-027230-00
should be made of this drawing or any part(s) thereof for whatever purpose nor shall any information, data, calculations, or other contents contained in this drawing be disseminated without prior written permission of Shenzhen Mindray
Bio-medical Electronics Co.,Ltd P.CODE 3300 REV. 7.0 /
SHEET 10 OF 12 SIZE A3
1 2 3 4 5 6 7 8

MRSZ/R05N01.291.01(4.0)
Bill of Materials in 3300 Fluidic Diagram
N0. Name in Diagram Quantity Unit P/N Position Remark
1 HWS Cistern 1 EA 115-027283-00
A 2 EL_A Cistern 1 EA 115-027284-00
3 EL_B Cistern 1 EA 115-027285-00
4 Waste cistern 1 EA 115-018614-00
5 Syringe 2.5mL 1 EA 115-002531-00
6 Syringe 100uL 1 EA 115-011898-00
7 Mix bath 1 EA 043-006654-00
8 Probe wipe 1 EA 041-001013-00
9 Sample probe 1 EA 115-014677-00
10 Wipe filter 1 EA 115-011660-00
11 Mix bath filter 1 EA BA40-10-62025
12
B 13
14
15 Bubble Trap 2 EA 082-002198-00
16 INJ_PUMPA 1 EA 082-002128-00
17 INJ_PUMPB 1 EA 082-002128-00
18 Damper 1 EA 082-002127-00
19 Germproof filter 1 EA 082-001963-00
20 INJ-V 1 EA 115-037562-00
21 ROT-V 1 EA 115-037562-00
22 Column 1 EA 082-001913-00
23 Detecor 1 EA 115-027756-00
C 1 EA 3101-20-68325
24 Isolation chamber
1 EA 3003-20-34949
Preheating steel
25 1 EA 082-001966-00
tube 1
Preheating steel
26 1 EA 082-001965-00
tube 2
27
28 Waste pump 1 EA 3001-10-07252
Include length of T60,
29 Ta1 1290 mm 115-031856-00
Theoretical central value
30 Ta2 81 mm 115-031857-00 Theoretical central value
31 Ta3 400 mm 115-031858-00 Theoretical central value
D
32 PS1 1 EA 115-034455-00
1 EA 041-015897-00
33 Column filter
1 EA 041-015898-00
34 / 1 EA 115-027280-00
35 / 1 EA 115-027281-00
36 / 1 EA 115-027282-00
37 / 1 EA 115-013091-00
38 / 1 EA 082-002234-00
39
40
41
E
42
43
44
45
46

保密密级:机密
CONFIDENTIAL
TITLE 3300 Fluidic diagram
F 保密:此图及其全部知识产权(含著作权)归深圳迈瑞生物医疗电子股份有限公司所有。未经深圳迈瑞生物医疗电子股份有限公司预先书面许可,严禁出于任何目的,对此图的全部或部分内容(包括但不限于图中信息、数据、运算结果等)泄露、使用、拷贝或复制。
Classified documents, This set of drawing(s) and all it's intellectual property rights (including copyright) subsisting herein are property of Shenzhen Mindray Bio-medical Electronics Co.,Ltd. No disclosure,use,copies or reproductions DOC No. A1-115-027230-00
should be made of this drawing or any part(s) thereof for whatever purpose nor shall any information, data, calculations, or other contents contained in this drawing be disseminated without prior written permission of Shenzhen Mindray
Bio-medical Electronics Co.,Ltd P.CODE 3300 REV. 7.0 /
SHEET 11 OF 12 SIZE A3
C Fluidic Diagrams (New Standalone Instrument and Instrument in the Sample
Processing System)
1 2 3 4 5 6 7 8
MRSZ/R05N01.291.01(4.0) REV DESCRIPTION DESIGN
Syringe 100ul in charge of the injection、 Chen Jiajun
2.0 Quantitative Ring Change
Change the length of T1、T2、T3、T60 and T109,
3.0 Change the connector type of the C29,Change the Chen Jiajun
installation considerations
1 2 1 2
A
VAC
6 3 6 3
J22-T4-J3 5 4 5 4
C94 T116
T120 C98
GV10 T12 C3 Load(POSB) Inject(POSA)
T3(P4)-J19 T11
SV09 T17 C9
J23-T5-J4 C2 T18 T98-J17
C95 T117 T119 C97 T24
T21
GV11 T13 C4
T2(P3)-J20 T10 C42
SV08 T16 C8
T19 T109
C1 J6-T95
C96 T118 T6 T8 T20
T14 C5 Detecor
T9 Preheating steel tube 2
SV07 T30 T15 C7
T7 GV12 C40
(P7)T1(P2)-J21 T29 T28
T25 C6
T26 T97
C39
B T31 T32 T33
T23 T112
GP1 T27
Thermostatic Chamber
EL_A C11 Isolation chamber C84
C13 T91
Cistern EL_B C67
C82 C60 C59 PS1
C15 Cistern OPEN SV13 T77 T80
T107 C26 5 6
HWS C81 T113
Germproof 4 1 T85 Column Ta3 C85
Cistern
T34 filter C61 C64 C38 C37
T114 3 2
T90 C43 T96
C16 C91 C92 C93 C62 C63 T84
Eluate Eluate Hemolysis & Wash T79 T82
C14 T35 INJ_PUMPB T110 Column filter
B A Solution Bubble Trap ROT-V
C25
C21 C22
Damper C35 C36
T43 J18 C27 5 6 C32
C17 J2-T39-J27 J28-T40 T78 C31
1 Preheating steel tube 1
T36 C24 C33 C34 C28 4
SV17 3 2
T115
Pressure Transduser C29 C30
C90 INJ-V
J13-T111 J16-Ta4 C65 C66
C18
Bubble Trap INJ_PUMPA Ta5
C C20 C56
C23 C47
J8-T59-J14
Sample Loop 40 uL
C19 T99 T100
J7-T57-J15 T127
J1-T38-J25 J26-T41 T42
T47 C53
SV16 T48 C57
T37 T121
SV19 Waste cistern WC Waste cistern 2
名称:
SV186
T92
C58 T60(P1) C102 T124
T94 T56 C52 WC2
C103
T93 T76
C89 C86
T54 T58 T55
C87 J9 T126
C46 C51
T83 C44 C45 SV01
T51 T52 T53
C83 C104
Syringe 100uL
T108 T61 T62
T125
T123
D SV03 SV02
T81 SV04 SV14
Probe wipe T75 T122
T44 T64
C88 T65
C105
Sample probe T128

J10-T63 Mix bath Wipe filter


T66 P2 Waste pump 2
T67
C100
C79
C101
C99
T103 SV06 T70 SV05 T129
Waste connector
Syringe 2.5mL T69 C48 T87
T71
Mix bath filter
E C49 GP1
T104
T72
C80 C50 T73 P1
SV15 Waste
container
T105 T68 Waste pump 1

保密密级:机密
CONFIDENTIAL
TITLE 3300 Fluidic diagram
DOC No. A1-115-069964-00
F 保密:此图及其全部知识产权(含著作权)归深圳迈瑞生物医疗电子股份有限公司所有。未经深圳迈瑞生物医疗电子股份有限公司预先书面许可,严禁出于任何目的,对此图的全部或部分内容(包括但不限于图中信息、数据、运算结果等)泄露、使用、拷贝或复制。 DESIGN Chen Jiajun REV. 3.0 /
Classified documents, This set of drawing(s) and all it's intellectual property rights (including copyright) subsisting herein are property of Shenzhen Mindray Bio-medical Electronics Co.,Ltd. No disclosure,use,copies or reproductions
should be made of this drawing or any part(s) thereof for whatever purpose nor shall any information, data, calculations, or other contents contained in this drawing be disseminated without prior written permission of Shenzhen Mindray P.CODE 3300 SIZE A3
Bio-medical Electronics Co.,Ltd Software & Rev:
SHEET 1 OF 12
Microsoft visio 2019
D List of Tubes and Connectors (New Standalone Instrument and Instrument in the
Sample Processing System)
1 2 3 4 5 6 7 8
MRSZ/R05N01.291.01(4.0)

A Bill of Materials in 3300 Fluidic Diagram


N0. N a m e i n D i a gr a m Q u a n t i t y U n i t P/N Position Remark
1 T1 1855 mm 082-002199-00
2 T2 2030 mm 082-002199-00
3 T3 2005 mm 082-002199-00
4 T4 110 mm 082-000036-00 46-110
5 T5 50 mm 082-000036-00 46-50
6 T6 80 mm M90-100071--- 1-80
7 T7 30 mm 082-000314-00 6-30
8 T8 30 mm 082-000314-00 6-30
9 T9 60 mm M90-100071--- 1-60
B 10 T10 80 mm M90-100071--- 1-80
11 T11 100 mm M90-100071--- 1-100
12 T12 20 mm M90-100071--- 1-20
13 T13 15 mm M90-100071--- 1-15
14 T14 20 mm M90-100071--- 1-20
15 T15 15 mm M90-100071--- 1-15
16 T16 15 mm M90-100071--- 1-15
17 T17 20 mm M90-100071--- 1-20
18 T18 50 mm M90-100071--- 1-50
19 T19 40 mm M90-100071--- 1-40
20 T20 40 mm M90-100071--- 1-40
21 T21 50 mm M90-100071--- 1-50
C 22
23 T23 180 mm 082-000108-00 30-180
24 T24 690 mm 082-000108-00 30-690
25 T25 20 mm M90-100071--- 1-20
26 T26 330 mm 082-000108-00 30-330
27 T27 30 mm 082-000432-00 29-30
28 T28 55 mm M6G-020006--- 10-55
29 T29 55 mm M6G-020006--- 10-55
30 T30 55 mm M6G-020006--- 10-55
31 T31 25 mm 082-001276-00 40-25
32 T32 25 mm 082-001276-00 40-25
33 T33 25 mm M6G-020006--- 10-25
D 34 T34 50 mm 082-001276-00 40-50
35 T35 50 mm 082-001276-00 40-50
36 T36 60 mm 082-001276-00 40-60
37 T37 480 mm 082-000432-00 29-480
38 T38 800 mm M6G-020008--- 13-800
39 T39 900 mm M6G-020008--- 13-900
40 T40 150 mm M6G-020008--- 13-150
41 T41 150 mm M6G-020008--- 13-150
42 T42 280 mm M6G-020008--- 13-280
43 T43 320 mm M6G-020008--- 13-320
44 T44 50 mm 082-000432-00 29-50
45
E 46
47 T47 150 mm 3001-10-07069 2-150
48 T48 30 mm 3001-10-07069 2-30

保密密级:机密
CONFIDENTIAL
TITLE 3300 Fluidic diagram
F 保密:此图及其全部知识产权(含著作权)归深圳迈瑞生物医疗电子股份有限公司所有。未经深圳迈瑞生物医疗电子股份有限公司预先书面许可,严禁出于任何目的,对此图的全部或部分内容(包括但不限于图中信息、数据、运算结果等)泄露、使用、拷贝或复制。
Classified documents, This set of drawing(s) and all it's intellectual property rights (including copyright) subsisting herein are property of Shenzhen Mindray Bio-medical Electronics Co.,Ltd. No disclosure,use,copies or reproductions DOC No. A1-115-069964-00
should be made of this drawing or any part(s) thereof for whatever purpose nor shall any information, data, calculations, or other contents contained in this drawing be disseminated without prior written permission of Shenzhen Mindray
Bio-medical Electronics Co.,Ltd P.CODE 3300 REV. 2.0 /
SHEET 2 OF 12 SIZE A3
1 2 3 4 5 6 7 8
MRSZ/R05N01.291.01(4.0)

A
Bill of Materials in 3300 Fluidic Diagram
N0. Name in Diagram Quantity Unit P/N Position Remark
49
50
51 T51 15 mm 082-000432-00 29-15
52 T52 15 mm 082-000432-00 29-15
53 T53 15 mm 082-000432-00 29-15
54 T54 20 mm 3001-10-07069 2-20
55 T55 150 mm 082-000432-00 29-150
56 T56 20 mm 3001-10-07069 2-20
B 57 T57 550 mm M90-100031--- 4-550
58 T58 40 mm 3001-10-07069 2-40
59 T59 470 mm M6G-020008--- 13-470
60 T60 374 mm M6G-020008--- 13-374 Quantify
61 T61 20 mm 3001-10-07069 2-20
62 T62 20 mm 3001-10-07069 2-20
63 T63 700 mm M6G-020008--- 13-700
64 T64 730 mm 3001-10-07069 2-730
65 T65 1420 mm M90-100071--- 1-1420
66 T66 220 mm M90-100071--- 1-220
67 T67 25 mm 3001-10-07069 2-25
68 T68 430 mm M90-100071--- 1-430
C 69 T69 30 mm M90-100071--- 1-30
70 T70 50 mm M90-100071--- 1-50
71 T71 20 mm M90-100071--- 1-20
72 T72 600 mm M90-100071--- 1-600
73 T73 80 mm 082-000314-00 6-80
74
75 T75 40 mm M90-100071--- 1-40
76 T76 30 mm 082-001276-00 40-30
77 T77 150 mm 082-001942-00 45-150
78 T78 130 mm 082-001942-00 45-130
79 T79 450 mm 082-001942-00 45-450
80 T80 270 mm 082-001942-00 45-270
D 81 T81 20 mm 3001-10-07069 2-20
82 T82 140 mm 082-001941-00 44-140
83 T83 20 mm 3001-10-07069 2-20
84 T84 90 mm 082-001941-00 44-90
85 T85 180 mm 082-001941-00 44-180
86
87 T87 2500 mm 082-000531-00 33-2500
88
89
90 T90 20 mm 082-001276-00 40-20
91 T91 20 mm 082-001276-00 40-20
92 T92 20 mm 082-001276-00 40-20
E
93 T93 880 mm 082-000432-00 29-880
94 T94 80 mm 3001-10-07069 2-80
95 T95 380 mm M6G-020008--- 13-380
96 T96 100 mm 082-001941-00 44-100

保密密级:机密
CONFIDENTIAL
TITLE 3300 Fluidic diagram
F 保密:此图及其全部知识产权(含著作权)归深圳迈瑞生物医疗电子股份有限公司所有。未经深圳迈瑞生物医疗电子股份有限公司预先书面许可,严禁出于任何目的,对此图的全部或部分内容(包括但不限于图中信息、数据、运算结果等)泄露、使用、拷贝或复制。
Classified documents, This set of drawing(s) and all it's intellectual property rights (including copyright) subsisting herein are property of Shenzhen Mindray Bio-medical Electronics Co.,Ltd. No disclosure,use,copies or reproductions DOC No. A1-115-069964-00
should be made of this drawing or any part(s) thereof for whatever purpose nor shall any information, data, calculations, or other contents contained in this drawing be disseminated without prior written permission of Shenzhen Mindray
Bio-medical Electronics Co.,Ltd P.CODE 3300 REV. 2.0 /
SHEET 3 OF 12 SIZE A3
1 2 3 4 5 6 7 8
MRSZ/R05N01.291.01(4.0)

A
Bill of Materials in 3300 Fluidic Diagram
N0. Name in Diagram Quantity Unit P/N Position Remark
97 T97 180 mm 082-001941-00 44-180
98 T98 1230 mm M6G-020008--- 13-1230
99 T99 30 mm 082-001276-00 40-30
100 T100 30 mm 082-001276-00 40-30
101
102
103 T103 20 mm 082-000314-00 6-20
104 T104 20 mm 082-000314-00 6-20
105 T105 80 mm 3001-10-07069 2-80
B 106
107 T107 50 mm 082-000314-00 6-50
108 T108 20 mm 3001-10-07069 2-20
109 T109 450 mm 082-001941-00 44-450
110 T110 135 mm 082-001941-00 44-135
111 T111 280 mm 082-002207-00 48-280
112 T112 500 mm 082-000108-00 30-500
113 T113 1000 mm 082-000108-00 30-1000
114 T114 75 mm M90-100071--- 1-75
115 T115 75 mm M90-100071--- 1-75
116 T116 20 mm M6G-020006--- 10-20
117 T117 20 mm M6G-020006--- 10-20
C 118 T118 20 mm M6G-020006--- 10-20
119 T119 20 mm M6G-020006--- 10-20
120 T120 20 mm M6G-020006--- 10-20
121 T121 50 mm 082-001276-00 40-50
122 T122 540 mm M90-100071--- 1-540
123 T123 600 mm 082-000314-00 6-600
124 T124 20 mm 082-001276-00 40-20
125 T125 30 mm M90-100071--- 1-30
126 T126 80 mm 082-001276-00 40-80
127 T127 55 mm M6G-020006--- 10-55
128 T128 80 mm 082-000314-00 6-80
129 T129 200 mm 082-000314-00 6-200
D 130 T130
131 T131
132 T132
133 T133
134 T134
135 T135
136 T136
137 T137
138 T138
139 T139
140 T140
141 T141
E
142 T142
143 T143
144 T144

保密密级:机密
CONFIDENTIAL
TITLE 3300 Fluidic diagram
F 保密:此图及其全部知识产权(含著作权)归深圳迈瑞生物医疗电子股份有限公司所有。未经深圳迈瑞生物医疗电子股份有限公司预先书面许可,严禁出于任何目的,对此图的全部或部分内容(包括但不限于图中信息、数据、运算结果等)泄露、使用、拷贝或复制。
Classified documents, This set of drawing(s) and all it's intellectual property rights (including copyright) subsisting herein are property of Shenzhen Mindray Bio-medical Electronics Co.,Ltd. No disclosure,use,copies or reproductions DOC No. A1-115-069964-00
should be made of this drawing or any part(s) thereof for whatever purpose nor shall any information, data, calculations, or other contents contained in this drawing be disseminated without prior written permission of Shenzhen Mindray
Bio-medical Electronics Co.,Ltd P.CODE 3300 REV. 2.0 /
SHEET 4 OF 12 SIZE A3
1 2 3 4 5 6 7 8
MRSZ/R05N01.291.01(4.0)

Bill of Materials in 3300 Fluidic Diagram


N0. Name in Diagram Quantity Unit P/N Position Remark
1 J1 1 EA 0030-20-13339 28-20
2 J2 1 EA 0030-20-13339 28-20
3 J3 20 mm M6G-020006--- 10-20
4 J4 20 mm M6G-020006--- 10-20
5 J5 20 mm M6G-020006--- 10-20
6 J6 20 mm 082-000710-00 37-20
7 J7 25 mm M6G-020006--- 10-25
B 8 J8 20 mm 082-000710-00 37-20
9 J9 25 mm 082-000710-00 37-25
10 J10 20 mm 082-000710-00 37-20
11
12
13 J13 20 mm 082-000710-00 37-20
14 J14 20 mm 082-000710-00 37-20
15 J15 20 mm 082-000710-00 37-20
16 J15 20 mm 082-000710-00 37-20
17 J17 20 mm 082-000710-00 37-20
18 J18 30 mm M6G-020008--- 1 3-30
19 J19 20 mm M6G-020006--- 10-20
C 20 J20 20 mm M6G-020006--- 10-20
21 J21 20 mm M6G-020006--- 10-20
22 J22 20 mm M6G-020006--- 10-20
23 J23 20 mm M6G-020006--- 10-20
24
25 J25 30 mm 082-000710-00 37-30
26 J26 30 mm 082-000710-00 37-30
27 J27 30 mm 082-000710-00 37-30
28 J28 30 mm 082-000710-00 37-30
29 J29
30 J30
31 J31
D 32 J32
33 J33
34 J34
35 J35
36 J36
37 J37
38 J38
39 J39
40 J40
41 J41
42 J42
43 J43
E
44 J44
45 J45
46 J46
47 J47
48 J48

保密密级:机密
CONFIDENTIAL
TITLE 3300 Fluidic diagram
F 保密:此图及其全部知识产权(含著作权)归深圳迈瑞生物医疗电子股份有限公司所有。未经深圳迈瑞生物医疗电子股份有限公司预先书面许可,严禁出于任何目的,对此图的全部或部分内容(包括但不限于图中信息、数据、运算结果等)泄露、使用、拷贝或复制。
Classified documents, This set of drawing(s) and all it's intellectual property rights (including copyright) subsisting herein are property of Shenzhen Mindray Bio-medical Electronics Co.,Ltd. No disclosure,use,copies or reproductions DOC No. A1-115-069964-00
should be made of this drawing or any part(s) thereof for whatever purpose nor shall any information, data, calculations, or other contents contained in this drawing be disseminated without prior written permission of Shenzhen Mindray
Bio-medical Electronics Co.,Ltd P.CODE 3300 REV. 2.0 /
SHEET 5 OF 12 SIZE A3
1 2 3 4 5 6 7 8
MRSZ/R05N01.291.01(4.0)

Bill of Materials in 3300 Fluidic Diagram


N0. Name in Diagram Quantity Unit P/N P o s i t i on Remark
A 1 P1 250 mm M90-100071--- 1-250
2 P2 15 mm 082-000314-00 6-15
3 P3 15 mm 082-000314-00 6-15
4 P4 15 mm 082-000314-00 6-15
5
6
7 P7 20 mm M6G-020006--- 10-20
8 P8
9 P9
10 P10
B 11 P11
12 P12
13 P13
14 P14
15 P15
16 P16
17 P17
18 P18
19 P19
20 P20
21 P21
C
22 P22
23 P23
24 P24
25 P25
26 P26
27 P27
28 P28
29 P29
30 P30
31 P31
D 32 P32
33 P33
34 P34
35 P35
36 P36
37 P37
38 P38
39 P39
40 P40
41 P41
E 42 P42
43 P43
44 P44
45 P45
46 P46
47 P47
48 P48

保密密级:机密
CONFIDENTIAL
TITLE 3300 Fluidic diagram
F 保密:此图及其全部知识产权(含著作权)归深圳迈瑞生物医疗电子股份有限公司所有。未经深圳迈瑞生物医疗电子股份有限公司预先书面许可,严禁出于任何目的,对此图的全部或部分内容(包括但不限于图中信息、数据、运算结果等)泄露、使用、拷贝或复制。
Classified documents, This set of drawing(s) and all it's intellectual property rights (including copyright) subsisting herein are property of Shenzhen Mindray Bio-medical Electronics Co.,Ltd. No disclosure,use,copies or reproductions DOC No. A1-115-069964-00
should be made of this drawing or any part(s) thereof for whatever purpose nor shall any information, data, calculations, or other contents contained in this drawing be disseminated without prior written permission of Shenzhen Mindray
Bio-medical Electronics Co.,Ltd P.CODE 3300 REV. 2.0 /
SHEET 6 OF 12 SIZE A3
1 2 3 4 5 6 7 8
MRSZ/R05N01.291.01(4.0)

Bill of Materials in 3300 Fluidic Diagram


N0. N a m e i n D i a g r am Quantity Unit P/N Position Remark
1 C1 1 EA M90-100066---
A
2 C2 1 EA M90-100066---
3 C3 1 EA 082-001105-00
4 C4 1 EA M90-100028-03
5 C5 1 EA M90-100028-03
6 C6 1 EA 082-001281-00
7 C7 1 EA M90-100028-03
8 C8 1 EA M90-100028-03
9 C9 1 EA 082-001105-00
10 C10 1 EA
11 C11 1 EA 043-000880-00
B 12
13 C13 1 EA 3001-10-07066
14 C14 1 EA 082-001960-00
15 C15 1 EA 082-001960-00
16 C16 1 EA M90-100027---
17 C17 1 EA M90-100027---
18 C18 1 EA M90-100027---
1 EA 0040-10-32304
19 C19
1 EA 0040-10-32305
1 EA 0040-10-32304
20 C20
C 1 EA 0040-10-32305
1 EA 0040-10-32304
21 C21
1 EA 0040-10-32305
1 EA 0040-10-32304
22 C22
1 EA 0040-10-32305
23 C23 1 EA 082-001952-00
24 C24 1 EA 082-001952-00
25 C25 1 EA 082-001952-00
26 C26 1 EA 082-001952-00
27 C27 1 EA 082-001954-00
28 C28 1 EA 082-001952-00
D 29 C29 1 EA 082-001954-00
30 C30 1 EA 082-001954-00
31 C31 1 EA 082-001952-00
32 C32 1 EA 082-001954-00
33 C33 1 EA 082-001952-00
34 C34 1 EA 082-001952-00
35 C35 1 EA 082-001949-00
36 C36 1 EA 082-001949-00
37 C37 1 EA 082-001952-00
38 C38 1 EA 082-001952-00
E 39 C39 1 EA 082-001949-00
1 EA 082-001947-00
40 C40
1 EA 082-001948-00
41 C41

42 C42 1 EA 082-001952-00

保密密级:机密
CONFIDENTIAL
TITLE 3300 Fluidic diagram
F 保密:此图及其全部知识产权(含著作权)归深圳迈瑞生物医疗电子股份有限公司所有。未经深圳迈瑞生物医疗电子股份有限公司预先书面许可,严禁出于任何目的,对此图的全部或部分内容(包括但不限于图中信息、数据、运算结果等)泄露、使用、拷贝或复制。
Classified documents, This set of drawing(s) and all it's intellectual property rights (including copyright) subsisting herein are property of Shenzhen Mindray Bio-medical Electronics Co.,Ltd. No disclosure,use,copies or reproductions DOC No. A1-115-069964-00
should be made of this drawing or any part(s) thereof for whatever purpose nor shall any information, data, calculations, or other contents contained in this drawing be disseminated without prior written permission of Shenzhen Mindray
Bio-medical Electronics Co.,Ltd P.CODE 3300 REV. 2.0 /
SHEET 7 OF 12 SIZE A3
1 2 3 4 5 6 7 8
MRSZ/R05N01.291.01(4.0)

Bill of Materials in 3300 Fluidic Diagram


N0. Name in Diagram Quantity Unit P/N Position Remark
43 C43 1 EA 082-001281-00
A
44 C44 1 EA 043-000880-00
45 C45 1 EA 043-000880-00
46 C46 1 EA 043-000880-00
47 C47 1 EA 043-000880-00
48 C48 1 EA 082-001281-00
49 C49 1 EA 082-001281-00
50 C50 1 EA 3001-10-07066
51 C51 1 EA M90-100027---
52 C52 1 EA 082-001960-00
53 C53 1 EA M90-100027---
B 54
55
56 C56 1 EA M90-100027-00
57 C57 1 EA 043-000892-00
58 C58 1 EA 043-000880-00
59 C59 1 EA 082-001954-00
60 C60 1 EA 082-001952-00
61 C61 1 EA 082-001954-00
62 C62 1 EA 082-001952-00
63 C63 1 EA 082-001954-00
64 C64 1 EA 082-001952-00
C
65 C65 1 EA M90-100027---
66 C66 1 EA M90-100027---
67 C67 1 EA 082-001951-00
68

69

70

71
D

72

73

74

75

76
E
77

78
79 C79 1 EA M90-100027---
80 C80 1 EA M90-100027---

保密密级:机密
CONFIDENTIAL
TITLE 3300 Fluidic diagram
F 保密:此图及其全部知识产权(含著作权)归深圳迈瑞生物医疗电子股份有限公司所有。未经深圳迈瑞生物医疗电子股份有限公司预先书面许可,严禁出于任何目的,对此图的全部或部分内容(包括但不限于图中信息、数据、运算结果等)泄露、使用、拷贝或复制。
Classified documents, This set of drawing(s) and all it's intellectual property rights (including copyright) subsisting herein are property of Shenzhen Mindray Bio-medical Electronics Co.,Ltd. No disclosure,use,copies or reproductions DOC No. A1-115-069964-00
should be made of this drawing or any part(s) thereof for whatever purpose nor shall any information, data, calculations, or other contents contained in this drawing be disseminated without prior written permission of Shenzhen Mindray
Bio-medical Electronics Co.,Ltd P.CODE 3300 REV. 2.0 /
SHEET 8 OF 12 SIZE A3
1 2 3 4 5 6 7 8
MRSZ/R05N01.291.01(4.0)

Bill of Materials in 3300 Fluidic Diagram


N0. Name in Diagram Quantity Unit P/N Position Remark
81 C81 1 EA M90-100027---
A 1 EA M90-100027-00
82 C82
83 C83 1 EA 082-001105-00
1 EA 082-000525-00
84 C84
1 EA 082-000526-00
1 EA 082-000525-00
85 C85
1 EA 082-000526-00
86 C86 1 EA 043-000892-00
87 C87 1 EA 043-000892-00
88 C88 1 EA 082-001105-00
89 C89 1 EA 043-000892-00
B 90 C90 1 EA 082-001627-00
91 C91 1 EA 082-001627-00
1 EA 082-003555-00
92 C92
1 EA 082-003593-00
93 C93 1 EA 082-001952-00
94 C94 1 EA 082-001105-00
95 C95 1 EA 082-001105-00
96 C96 1 EA 082-001105-00
97 C97 1 EA 082-001105-00
98 C98 1 EA 082-001105-00
99 C99 1 EA 0040-10-32308
C
100 C100 1 EA M90-100069---
101 C101 1 EA 3100-20-41232
102 C102 1 EA M90-100030-
103 C103 1 EA 082-001960-00
104 C104 1 EA M90-100027---
105 C105 1 EA M90-100027---
106
107
108
109
D 110
111
112
113
114
115
116
117
118
119
120
E
121
122
123
124
125
126

保密密级:机密
CONFIDENTIAL
TITLE 3300 Fluidic diagram
F 保密:此图及其全部知识产权(含著作权)归深圳迈瑞生物医疗电子股份有限公司所有。未经深圳迈瑞生物医疗电子股份有限公司预先书面许可,严禁出于任何目的,对此图的全部或部分内容(包括但不限于图中信息、数据、运算结果等)泄露、使用、拷贝或复制。
Classified documents, This set of drawing(s) and all it's intellectual property rights (including copyright) subsisting herein are property of Shenzhen Mindray Bio-medical Electronics Co.,Ltd. No disclosure,use,copies or reproductions DOC No. A1-115-069964-00
should be made of this drawing or any part(s) thereof for whatever purpose nor shall any information, data, calculations, or other contents contained in this drawing be disseminated without prior written permission of Shenzhen Mindray
Bio-medical Electronics Co.,Ltd P.CODE 3300 REV. 2.0 /
SHEET 9 OF 12 SIZE A3
1 2 3 4 5 6 7 8
MRSZ/R05N01.291.01(4.0)

Bill of Materials in 3300 Fluidic Diagram


N0. Name in Diagram Quantity Unit P/N Position Remark
A 1 SV01 1 EA 115-011404-00
2 SV02 1 EA 115-011404-00
3 SV03 1 EA 115-011404-00
4 SV04 1 EA 115-013056-00
5 SV05 1 EA 115-033289-00
6 SV06 1 EA 115-033289-00
7 SV07 1 EA 115-033289-00
8 SV08 1 EA 115-033289-00
9 SV09 1 EA 115-033289-00
10 GV10 1 EA 115-033286-00
11 GV11 1 EA 115-033286-00
B 12 GV12 1 EA 115-033286-00
13 GV13 1 EA 115-033289-00
14 SV14 1 EA 115-033289-00
15 SV15 1 EA 115-033289-00
16 SV16 1 EA 115-033289-00
17 SV17 1 EA 115-033289-00
18 SV18 1 EA 115-011404-00
19 SV19 1 EA 115-011404-00
20
21
C 22
23
24
25
26
27
28
29
30
31
32
D 33
34
35
36
37
38
39
40
41
42
E 43
44
45
46
47
48

保密密级:机密
CONFIDENTIAL
TITLE 3300 Fluidic diagram
F 保密:此图及其全部知识产权(含著作权)归深圳迈瑞生物医疗电子股份有限公司所有。未经深圳迈瑞生物医疗电子股份有限公司预先书面许可,严禁出于任何目的,对此图的全部或部分内容(包括但不限于图中信息、数据、运算结果等)泄露、使用、拷贝或复制。
Classified documents, This set of drawing(s) and all it's intellectual property rights (including copyright) subsisting herein are property of Shenzhen Mindray Bio-medical Electronics Co.,Ltd. No disclosure,use,copies or reproductions DOC No. A1-115-069964-00
should be made of this drawing or any part(s) thereof for whatever purpose nor shall any information, data, calculations, or other contents contained in this drawing be disseminated without prior written permission of Shenzhen Mindray
Bio-medical Electronics Co.,Ltd P.CODE 3300 REV. 2.0 /
SHEET 10 OF 12 SIZE A3
1 2 3 4 5 6 7 8
MRSZ/R05N01.291.01(4.0)
Bill of Materials in 3300 Fluidic Diagram
N0. Name in Diagram Quantity Unit P/N Position Remark
1 HWS Cistern 1 EA 115-027283-00
2 EL_A Cistern 1 EA 115-027284-00
A 3 EL_B Cistern 1 EA 115-027285-00
4 Waste cistern 1 EA 115-069975-00
5 Syringe 2.5mL 1 EA 115-002531-00
6 Syringe 100uL 1 EA 115-011898-00
7 Mix bath 1 EA 043-006654-00
8 Probe wipe 1 EA 041-001013-00
9 Sample probe 1 EA 115-014677-00
10 Wipe filter 1 EA 115-011660-00
11 Mix bath filter 1 EA BA40-10-62025
12
13
14
B 15 Bubble Trap 2 EA 082-002198-00

16 INJ_PUMPA 1 EA 082-002128-00

17 INJ_PUMPB 1 EA 082-002128-00
18 Damper 1 EA 115-040825-00
19 Germproof filter 1 EA 082-001963-00
20 INJ-V 1 EA 115-035402-00
21 ROT-V 1 EA 115-035402-00
22 Column 1 EA 082-001913-00
23 Detecor 1 EA 115-027756-00
C 1 EA 3101-20-68325
24 Isolation chamber
1 EA 3003-20-34949
Preheating steel tube
25 1 EA 082-001966-00
1
Preheating steel tube
26 1 EA 082-001965-00
2
27
28 Waste pump 1 1 EA 115-069978-00
29 Waste pump 2 1 EA 115-069978-00
Include length of T60,
30 Ta4 619 mm 115-031856-00
Theoretical central value
D 31 Ta5 90 mm 115-031857-00 Theoretical central value
32 Ta3 400 mm 115-031858-00 Theoretical central value
33 PS1 1 EA 115-034455-00
1 EA 041-015897-00
34 Column filter
1 EA 041-015898-00
35 / 1 EA 115-027280-00
36 / 1 EA 115-027281-00
37 / 1 EA 115-027282-00
38 / 1 EA 115-046485-00
39 / 1 EA 115-007831-00
40 / 1 EA 082-002234-00
41 Waste cistern 2 1 EA 115-069975-00
E 42 Waste connector 1 EA 041-029940-00
43
44
45
46

保密密级:机密
CONFIDENTIAL
TITLE 3300 Fluidic diagram
F 保密:此图及其全部知识产权(含著作权)归深圳迈瑞生物医疗电子股份有限公司所有。未经深圳迈瑞生物医疗电子股份有限公司预先书面许可,严禁出于任何目的,对此图的全部或部分内容(包括但不限于图中信息、数据、运算结果等)泄露、使用、拷贝或复制。
Classified documents, This set of drawing(s) and all it's intellectual property rights (including copyright) subsisting herein are property of Shenzhen Mindray Bio-medical Electronics Co.,Ltd. No disclosure,use,copies or reproductions DOC No. A1-115-069964-00
should be made of this drawing or any part(s) thereof for whatever purpose nor shall any information, data, calculations, or other contents contained in this drawing be disseminated without prior written permission of Shenzhen Mindray
Bio-medical Electronics Co.,Ltd P.CODE 3300 REV. 2.0 /
SHEET 11 OF 12 SIZE A3
PN: 046-008090-00(7.0)

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