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 copyrights or patents and
does not convey any license under the patent rights of Mindray, nor the rights of
others. Mindray does not assume any liability arising out of any infringements of
patents or other rights of third parties.
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, rent, adaption and translation of this
manual in any manner whatsoever without the written permission of Mindray is
strictly forbidden.
,,,,are the registered
trademarks or trademarks owned by Mindray in China and other countries. All
other trademarks that appear in this manual are used only for editorial purposes
without the intention of improperly using them. 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 safety, reliability and performance of this product only in
the condition that:
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.
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.
NOTE:
This equipment is to be operated only by medical professionals trained
and authorized by Mindray or Mindray-authorized distributors.
I
Warranty
THIS WARRANTY IS EXCLUSIVE AND IS IN LIEU OF ALL OTHER WARRANTIES,
EXPRESSED OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY
OR FITNESS FOR ANY PARTICULAR PURPOSE.
Exemptions
Mindray's obligation or liability under this warranty does not include any
transportation or other charges or liability for direct, indirect or consequential
damages or delay resulting from the improper use or application of the product or the
use of parts or accessories not approved by Mindray or repairs by people other than
Mindray authorized personnel.
This warranty shall not extend to:
any Mindray product which has been subjected to misuse, negligence or
accident;
any Mindray product from which Mindray's original serial number tag or product
identification markings have been altered or removed;
any product of any other manufacturer.
Return Policy
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:
1 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.
2 Freight policy: The customer is responsible for freight charges when this
product is shipped to Mindray for service (this includes customs charges).
3 Return address: Please send the part(s) or equipment to the address offered
Tests analyzed simultaneously: 48 (single-reagent) / 24 (double-reagent); if the
ISE unit (optional) is connected, 3 (Na, K and Cl included) or 4 (Na, K, Cl and Li
included) tests are added
Throughput: maximum 300tests/h; if the ISE (optional) is connected, maximum
420tests/h (Na, K and Cl included) or maximum 480 tests/h (Na, K, Cl and Li
included)
Specifications
−
-R, Cumulative sum check, Cumulative error,
1.2 Loading System Feature
Sample volume: 3µl~45µl; Precision: 0.5µl; for the ISE (optional), 70µl serum,
70µl plasma, 140µl diluted urine
Sample disk: general sample disk, including the inner circle and the outer circle
Sample tube position: 60 positions, including 6 calibrator positions, 3 control
positions, 5 for STAT sample positions; 5 virtual disks for maximum 300 samples
Sample probe: with a built-in level detector; equipped with auto safeguard;
capable of tracking sample level
Washing function: automatically washing interior and exterior of sample probe;
carryover no more than 0.1%
Pre-dilution: 4 ≤ dilution rate ≤ 150, taking reaction cuvettes as the container
Reagent volume: 30-450ul; Precision: 1ul
Reagent disk: including the inner circle and the outer circle
Reagent position number: 25/50 reagent positions. Each reagent position is
available for containing one Hitachi 7060 bottle, one Hitachi 7170 bottle, one
Mindray inner-circle bottle or one Mindray outer-circle bottle.
Reagent probe: One independent probe which has a built-in level detector; is
equipped with auto safeguard and capable of tracking reagent level
Washing function: automatically washing interiors and exteriors of reagent probes;
carryover no more than 0.1%
1-1
1-
Specifications
Mixing bar: for single-reagent tests, it functions after sample dispensing; for
double-reagent tests, it functions after the dispensing of the sample and the
second reagent.
Reaction liquid volume: 180-500µl
Max. reaction time: 20 minutes
Reaction temperature: 37±0.3℃ with fluctuation of ±0.1℃
1.4 Others
Operating system: Windows 2000 or Windows XP
Display: optional
System interface: RS-232
Printer: optional
Built-in bar code scanner: optional
ISE module: optional
1-2
2 System Installation
NOTE:
The analyzer should be installed or moved to another place by
Mindray-authorized personnel only.
2.1 Check before Installation
The user should provide the environment that meets the requirements mentioned in
the Operation Manual. Check if the environment meets the requirements before
installing the analyzer . Refer to the chapter 2 of the Operation Manual for details.
2.2 Installation Procedure
System Installation
1 Ensure available installation fields and environments in hospitals.
2 Confirm the reagents and calibrators.
3 Go to the installation field, and then check the delivery list for acceptance.
4 Install the four handles on the four angles of the analyzer. Move the analyzer
to the installation field, fix the casters, and then remove the handles.
5 Insta ll the computer, display and printer.
6 Open the front plate, and check whether cable connections are loose. Open
the top plate, check whether the probe assemblies, reagent disk and sample
disk are intact and in good performance.
7 Connect the communication cable, power cable, grounding wire, waste tank
and deionized water tank. Install the used-cuvette bucket, reagent probe,
sample probe and mixing bar.
8 Top up the deionized water tank with deionized water.
9 Put reaction cuvettes in the feeder. Remember to check whether the surfaces
of the cuvettes are smooth. In case of any bump, remove it before loading the
cuvette to the compartment. Do not touch the light transmission part of the
cuvette in which the colorimetric reading is taken.
10 Load acid and alkaline detergents to positions 46 and 47, and distilled water
to positions 49 on the reagent disk. Load distilled water to position 60 on the
sample disk.
11 Switch on the analyzer as follows: POWER → ANALYZING UNIT POWER
→display → computer → printer.
12 After Windows is started, double-click the icon of BS-300 on the desktop to
start the system software. The system program will automatically finish the
self-test, become online and warm up the reaction cuvettes within about 30
minutes.
13 Select the [System/Status] menu, and then observe the system status and
record it in the table below:
2-1
System Installation
Feeder status UnconnectedFull Half full Empty
Reaction disk
temperature
Reagent disk
temperature
Ambient temperature
Waste tank status Abnormal (full) Normal (not full)
Detergent status Abnormal (empty) Normal (available)
Printer status No printer Normal
Main control unit UnconnectedIdle Running
Reaction disk unit Unconnected
Reagent disk unit Unconnected
Sample disk unit Unconnected
Loading/unloading unit Unconnected
Temperature control
unit
Lamp
Unconnected
Network connection Unconnected
Wavelength Dark current Light source base
340
405
450
510
546
578
630
670
700
Reference light system
14 Select the [System/Maintenance]menu. Then select the Motion tab page,
and implement all sub-steps of each unit to see whether they are normal. In
case of any exception, adjust it.
15 Wash the interiors and exteriors of the sample probe, reagent probe and
mixing bar for several times to make the fluid circuit filled.
16 Set parameters for test, reagent and calibration under theParameters menu.
2-2
System Installation
17 Request for calibration and samples, run and then debug the results.
18 After debugging the results, fill them in the table below:
Test ALT CREABUN
Target value
2sd range
Test value 1
Test value 2
Test value 3
Test value 4
Test value 5
Test value 6
Test value 7
Test value 8
Test value 9
Test value 10
19 Training
Can the user complete daily tests? Yes □ No □
Is the user familiar with the analytical methods such as
kinetic, two-point, endpoint?
Is the user familiar with the daily, weekly and monthly
maintenance and relevant maintenance methods?
Is the user skilled in washing dust screens? Yes □ No □
Is the user skilled in cleaning and replacing the probes
and the mixing bar?
Is the user skilled in replacing the plunger assemblies
of syringes?
Is the user skilled in replacing the lamp? Yes □ No □
Is the user skilled in maintenance of built-in bar code
scanner?
Is the user skilled in maintenance of ISE unit? Yes □ No □
Does the user know the positions, roles and
preparation methods of distilled water and acid and
alkaline detergents?
Yes □ No □
Yes □ No □
Yes □ No □
Yes □ No □
Yes □ No □
Yes □ No □
2-3
3 System Descriptions
The BS-300 analyzer consists of the analyzing unit, operation unit and output unit.
The analyzing unit consists of the dispensing system, feeder, temperature control
system, photometric system and fluid system.
3.1 Dispensing System
The dispensing system consists of the probe assemblies (including the reagent
probe assembly, sample probe assembly and mixing bar assembly), reagent disk,
sample disk and reaction disk.
3.1.1 Probe assemblies
System Descriptions
Among the probe assemblies, the mixing bar assembly is the same as the reagent
probe assembly and the sample probe assembly, except that the knurled axis is
30cm shorter.
Every probe assembly has a horizontal photoelectric switch and a vertical
photoelectric switch. These switches are used for defining horizontal and vertical
3-1
System Descriptions
initial positions of probe assemblies. The horizontal and vertical step motors
precisely control the horizontal and vertical movements of the probe assemblies, and
the synchronizing belts serve as the gearing.
The shaft and the bushing must corporate with each other precisely, so they cannot
be used confusedly.
3.1.2 Disk assemblies
The three disk assemblies are different in their coders. The coder corresponds to the
position where disks should stop. There is an initial-position mark under every coder.
The three coders of the three disks have three coder transducers. Each transducer
has two photoelectric switches for inducing the rotation and initial position of the
disk.
The step motors control the disk assemblies, and the synchronizing belts serve as
the gearing.
3-2
System Descriptions
There is a build-in bar code scanner to the left of the sample disk. The scanner is
optional.
3.2 Feeder
The feeder consists of the feeder assemblies and the manipulator. It is designated to
send cuvette segments to the reaction disk, take out the used ones and abandon
them to the used-cuvette bucket.
3.2.1 Feeder assemblies
The feeder assemblies include the gearing assembly, cuvette compartment
assembly, cuvette-pushing assembly and no-cuvette detection assembly (see the
following figure).
The supporting plate of the feeder assemblies is a square piece of steel that is
connected to the analyzing unit by its four poles, which are secured by four nuts.
Unscrewing the nuts, you can disassemble the feeder assemblies from the analyzing
unit easily.
Sample probe assemblyBuild-in bar code scanner
3-3
System Descriptions
There are five transducers that are shown in the figure below.
The no-cuvette transducer is used to detect whetherthere is a cuvette segment at
the loading position. The insufficient-cuvette transducer is used for determine
whether there are less than 10 reaction cuvettes in the compartment or not. If yes,
the analyzer will give a prompt.
Pressure Transducer
No-Cuvette
Transducer
3.2.2 Manipulator
Two step motors (horizontal and vertical) supply power for horizontal and vertical
movements of the manipulator.
The upper finger and lower finger are same in their structures. They work together to
replace used cuvette segments with new ones.
The manipulator runs in a relatively complicated way. There are four transducers on
it: vertical transducer, horizontal transducer and two finger transducers.
Cuvette-Pushing
Limit Transducer
Insufficient-Cuvette
Transducer
Cuvette-taking limit
transducer
3-4
System Descriptions
3.3 Temperature Control System
3.3.1 Temperature control assembly
The temperature control assembly of the reaction disk consists of the
temperature-controlled pot, heat-insulating sheath/plate, top heater, bottom heater,
reaction disk/cuvettes, photoelectric seat, temperature transducer, fan and control
circuit.
3-5
System Descriptions
1: Temperature transducer and the support
2: Fan
3: photoelectric seat
4: Heat-insulating sheath
5: top heater
6: Cover
7: temperature-controlled pot
8: bottom heater
Upper heater: square in shape, 220/110VAC, 125W
Lower heater: ring in shape, 220/110VAC, 350W
Total power: 475W.
The function of heaters is to compensate the heat for incubating the reagent and for
maintaining the temperature of the temperature-controlled chamber .
Fans are used in series in the temperature-controlled chamber. It makes the air
circulating in the chamber, and enhances the convective heat exchange. There are
four fans in the chamber. All have the alarm function.
The temperature transducer feeds back the air temperature at the position several
millimeters from the bottom of the reaction cuvette.
The overheat protection switch is to switch off the power when the temperature
controller does work and the temperature-controlled chamber reaches 55℃, so as to
avoid overheat or fire. When the temperature-controlled chamber becomes 35℃,
this switch will automatically be reset.
3.3.2 Reagent preheating
The preheating assembly consists of two aluminum plates, a Te flon tube having nine
loop sections, heating components, transducer, temperature protection switch,
thermal conductive colloid, a section of tube and the reagent probe.
The temperature of the thermal source of the preheater is controlled at 45℃. The
initial temperature of the reagent is 4 ~ 10℃ when it is taken out of the refrigeration
3-6
System Descriptions
chamber. When the reagent passes the heater, its temperature increases to 35℃.
Then the reagent is added into the reaction cuvette and the preheating process is
finished.
Reagent preheating assembly
3.3.3 Reagent refrigeration
The refrigeration module consists of refrigeration cabin, PU heat-insulating sheath,
reagent disk, reagent bottle, temperature transducer, refrigeration flakes, heat
sinking component, fan and control circuit. The refrigeration module is shown in the
following figure.
The refrigeration assembly consists of fan, hot-end radiator, POM connector,
cold-end heat-conductive aluminum block, and PELTIER refrigeration flake. Each
analyzer has two such refrigeration assemblies, as shown in the figure below. The
cold-side of the refrigeration flake clings to the refrigeration compartment, and the
hot-side clings to the radiator (The side having letters should cling to the refrigeration
aluminum block).
3-7
System Descriptions
Each refrigeration flake corresponds to a heat-sinking block and a cooling fan. It
should be installed with the cold side upward.
3.4 Photometric System
The photometric system consists of a measurement photometric system and a
reference photometric system. The measurement photometric system provides 9
monochromatic lights to measure the absorbance of the reacting liquid in the rotating
reaction cuvettes. The reference photometric system compensates the
measurement photometric system to make the measurement more accurate.
Tungsten-halogen
lamp
卤钨灯聚光镜
Biconvex lens
3.5 Fluid System
The fluid system is shown in the following figure.
Main fiber
传光束
Plano
小透镜反应杯滤光片小透镜光电管
convex lens
Fibers
传光束小端
Cuvette Filter
Photodiode
convex lens
共路
光电管
Plano
参考光路
Reference light
Photodiode
测量光路
Measurement
.
.
.
lights
3-8
Sample syringe
System Descriptions
Reagent syringe
Mixing bar
As shown in the figure above, the fluid system consists of interior washing and
exterior washing.
The syringe assembly controls the aspiration volume by controlling the travel of the
sample/reagent syringe. It is the core part of the fluid system.
3-9
System Descriptions
3.6 ISE Module (optional)
The ISE module that is used to measure the concentration of K+, Na+, Cl- and Li+ in
serum, plasma and urine consists of ion-selective electrodes, peristaltic pumps and
calibrants.
ISE
Pump W
Calibrant B
Pump BPump A
Calibrant A
Waste
3-10
System Descriptions
3-11
4 Functions of Boards
The analyzer is integrated with the following boards:
Main control board
Power drive board
Sample level detection board
Reagent level detection board
A/D conversion board
Ten photoelectric conversion boards (340nm, 405nm, 450nm, 510nm, 546nm,
The main control board is the control center of the whole hardware system. It
consists of the control circuits of 6 functional units (including main control unit,
photoelectric unit, reagent unit, sample unit, loading/mixing unit, temperature control
unit). Each functional unit has an MCU. They communicate in the multi-unit mode
and thus compose the whole control system.
ISE module
PC
Main control board
Step motors
DC motors
Pumps, valves
Level detection boards
Transducers
Power drive board
Heaters of reaction
disk
Reagent pre-heater
Lamp
Reagent
refrigeration board
Peltiers
transducers
The functions of the main control board are:
communicating with the PC through the RS232, receiving and analyzing
instructions from the PC and sending data to the PC.
controlling photoelectric conversion through the interface with the A/D conversion
board, reading and saving data from the A/D conversion board.
outputting control signals of each unit through the interface with the power drive
board.
4-1
Functions of Boards
receiving signals of fluid level detection and bump collision through the interface
with the level detection boards.
detecting signals from temperature transducers and controlling temperature of the
reaction disk and reagent preheating.
receiving signals from position transducers, deionized water transducer and waste
transducer and controlling the transducers.
controlling the built-in sample bar code scanner, reading the data and sending it to
the PC.
controlling the ISE module, reading the results and sending them to the PC.
4.2 Power Drive Board
The main functions of the power drive board are to receive the control signals from
the main control board and control drive components. The block diagram of the
power drive board is shown in the figure below.
Control signals from
Main Control Board
to 13 step motorsto 2 DC motors
to 2 solenoid valvesto 3 pumps
to 2 heaters of
reaction disk
4.3 A/D Conversion Board
The 10 photoelectric conversion circuits convert the intensity signals of the lights
transmitting through the reaction cuvettes to electric signals, and then transmit them
to the A/D conversion board through a 5-core shielded cable. Photoelectric
conversion boards for different wavelengths have different gains and cannot be
replaced by each other.
The A/D conversion board filters and amplifies the 10 channels of electric signals
output from the photoelectric conversion boards, transmits them through the
multi-way gating switch to the A/D converter and then sends them to the main control
board for further processing.
to lamp power
to 2 magnets
to reagent
preheating
4.4 Reagent Refrigeration Board
The circuits of the reagent refrigeration board include the refrigeration circuit and the
fan circuit.
The refrigeration circuit is needed to work continuously, so it is powered separately.
The control objects of the reagent refrigeration board include:
Reagent refrigeration: 2 PELTIER components, 4 fans.
4-2
Heat sink system for the whole device: 3 lamp-cooling fans, 4 temperature control
fans of the reaction disk.
4.5 Level Detection Boards
The level detection boards that include sample level detection board and reagent
level detection board are used to detect the fluid level of sample and reagent
separately. When the analyzer aspirates reagents/samples, the probes dip into the
liquid to a specific depth, so as to avoid carryovers that have impacts on test results,
and to avoid air aspiration when the reagent/sample is insufficient.
4.6 Feeder Connection Board
The feeder connection board transfers the signals between the feeder transducer
and the main control board, and connects the power drive board and the loading
motor (DC).
Functions of Boards
Connections:
Connector Connected with
J91 Front transducer
J92 Back transducer
J93 Intermediate transducer
J94 No-cuvette transducer
J95 Pressure transducer
J96 Motor control wire (connected with the power drive board)
J97 Motor control wire (connected the motors)
J98 Cuvette-loading button
J99 Connection wire of the main control board
4.7 Manipulator Connection Board
The manipulator connection board transfers the signals between the manipulator
transducer and the main control board, and connects the power drive board and the
electromagnet.
Connections:
Connector Connected with
J101 Horizontal loading position transducer
J102 Vertical loading position transducer
J103 Electromagnet-closing transducer of the lower hand
4-3
Functions of Boards
Connector Connected with
J108 Electromagnet-closing transducer of the upper hand
J104 Drive wire of the electromagnet of the upper hand
J105 Drive wire of the electromagnet of the lower hand
J106 Drive wire of the electromagnet (connected with the power drive
board)
J107 Connection wire of the main control board
J109 Safeguard transducer (reserved)
J110 Safeguard transducer (reserved)
4.8 Probes Connection Board
The probes connection board transfers the signals between the sample/reagent level
detection board and the main control board, inputs the temperature signals, outputs
the reagent preheating signals, and transfers the signals between the power drive
board and the mixing motor (DC).
Connector Connected with
J200 Interface of the sample level detection board
J201 Interface of the reagent level detection board
J202 Interface of the mixing motor (DC)
J203 Sample detection signal interface of the main control board
J204 Reagent detection signal interface of the main control board
J205 Temperature control signal interface of the reaction disk
J206 Reagent preheating signal interface
J207 Interface of the power drive board
4.9 Power Supply Assembly
The power supply assembly consists of three boards: PFC board, 24V board,
12V&5V board and ISE (optional) power supply board.
The functions of the PFC board include:
AC/DC conversion;
Supplying the +390V and VDD voltage to the 24V board and the 12V&5V board;
Supplying stable 12V voltage for the lamp;
Supplying control signals of the analyzing unit switch to control the C12V, 5V and
24V outputs.
The 24V board converts the 390VDC current transmitted from the PFC board to the
separated 24VDC outputs through the forward converter.
4-4
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