Mindray BeneFusion SP3 User manual

BeneFusion SP3
BeneFusion SP3 Ex
Syringe Pump
Service Manual

I
Intellectual Property Statement
Shenzhen Mindray Scientific Co., Ltd. holds the intellectual property rights to this
product and this manual. Shenzhen Mindray Scientific Co., Ltd. is a member of
Mindray Medical Group.
©2019 Shenzhen Mindray Scientific Co., Ltd. All rights reserved. No parts of this
Manual may be reproduced, modified or translated by any individual or organization
without the written consent of Shenzhen Mindray Scientific Co., Ltd.
, , , and are the
registered trademarks or trademarks of Mindray. With the consent of Mindray,
Shenzhen Mindray Scientific Co., Ltd., is authorized to use the above registered
trademarks or trademarks.
Statement
Shenzhen Mindray Scientific Co., Ltd. has the final right to interpret this service
manual.
Shenzhen Mindray Scientific Co., Ltd. is responsible for the safety, reliability and
performance of the product only if all of the following requirements are met:
Assembly operations, expansion, re-adjustment, improvement and repair are
performed by professionals recognized by Shenzhen Mindray Scientific Co.,
Ltd.
The parts to be replaced in all repairs, associated accessories and
consumables are original or approved by Shenzhen Mindray Scientific Co., Ltd.
The relevant electrical equipment complies with China national standards and
the requirements of this service manual.
Product operations are performed in accordance with this manual.

II
Preface
Description
This Service Manual presents detailed information on the hardware composition,
installation, disassembly, test and troubleshooting of the product and relevant
accessories to help service personnel effectively address common problems.
Comprehensive briefings on product structure and design principle are not included.
For issues that could not be addressed, contact our Customer Service Department.
The product introduction described in this Service Manual is based on a fully
configured product. Therefore, certain content may not be applicable to your product.
If you have any question, please contact us.
Please carefully read this Service Manual and fully understand the content before
performing product maintenance. Otherwise, incorrect operation may cause
personal injury or damage to product.
Intended Audience
This Service Manual is geared for professional biomedical engineers, authorized
service personnel and after-sales representatives responsible for product
maintenance.
Revision History
The version of this Service Manual is subject to update without notice due to
changes in software or technical specifications. The version information of this
Service Manual is as follows:
Version No.: 3.0
Issue date: 2020-07

1
Contents
1 Safety.....................................................................................................................1-1
1.1 Safety Information...............................................................................................1-1
1.1.1 DANGER .................................................................................................1-1
1.1.2 WARNING...............................................................................................1-2
1.1.3 CAUTION ................................................................................................1-3
1.1.4 NOTE.......................................................................................................1-4
1.2 Equipment Symbols ............................................................................................1-4
2 Overview................................................................................................................2-1
2.1 Product Introduction ............................................................................................2-1
2.1.1 Structure, Composition and Performance...............................................2-1
2.2 Main Unit .............................................................................................................2-1
2.2.1 Front View ...............................................................................................2-1
2.2.2 Rear View................................................................................................2-3
2.2.3 Side View.................................................................................................2-4
2.2.4 Bottom View ............................................................................................2-5
2.3 Description of Hardware Principle.......................................................................2-5
2.3.1 Control board...........................................................................................2-6
2.3.2 Sensor Board ....................................................................................... 2-10
2.3.3 Keypad board........................................................................................2-11
3 Test and Maintenance..........................................................................................3-1
3.1 Introduction..........................................................................................................3-1
3.1.1 Test Report..............................................................................................3-1
3.1.2 Preventative Maintenance.......................................................................3-2
3.1.3 Recommended Frequency......................................................................3-2
3.2 Overall Appearance Inspection...........................................................................3-3
3.3 Power-on test ......................................................................................................3-3
3.4 Calibration ...........................................................................................................3-4
3.4.1 Syringe calibration...................................................................................3-4
3.4.2 Pressure Calibration................................................................................3-6
3.4.3 Sensor Calibration...................................................................................3-7
3.5 Running Test........................................................................................................3-8
3.6 Electrical Safety Tests .........................................................................................3-9
3.6.1 Enclosure Leakage Current Test.......................................................... 3-10
3.6.2 Earth Leakage Current Test ..................................................................3-11
3.6.3 Patient Leakage Current Test................................................................3-11
3.7 Cleaning and Disinfection..................................................................................3-11
3.7.1 Cleaning ................................................................................................3-11
3.7.2 Disinfection........................................................................................... 3-12

2
4 Troubleshooting ...................................................................................................4-1
4.1 Overview..............................................................................................................4-1
4.2 Part Replacement................................................................................................4-1
4.3 Checking Syringe Pump Status ..........................................................................4-1
4.4 Fault List..............................................................................................................4-2
4.4.1 SP3 System Fault and Exception Code..................................................4-2
4.4.2 Other Faults.............................................................................................4-7
5 Repair and Disassembly......................................................................................5-1
5.1 Tools Preparation.................................................................................................5-1
5.2 Disassembly steps ..............................................................................................5-1
5.2.1 Disassembling Front and Rear Covers (Note: You should wear an
anti-static wristband throughout)......................................................................5-1
5.2.2 Removing the Push and Pull Box Assembly (Note: You should wear an
anti-static wristband throughout)......................................................................5-3
5.2.3 Removing the Pump Body Assembly (Note: You should wear an
anti-static wristband throughout)......................................................................5-5
5.2.4 Disassembling Front Cover Assembly (Note: You should wear an
anti-static wristband throughout)......................................................................5-7
5.2.5 Disassemling the Pump Body Assembly (Note: You should wear an
anti-static wristband throughout)................................................................... 5-10
5.2.6 Disassembling Rear Cover Assembly (Note: You should wear an
anti-static wristband throughout)................................................................... 5-13
6 Components..........................................................................................................6-1
6.1 Host .....................................................................................................................6-1
6.1.1 Exploded View.........................................................................................6-1
6.1.2 Host Parts List.........................................................................................6-1
6.2 Front Cover Assembly.........................................................................................6-2
6.2.1 Exploded View.........................................................................................6-2
6.2.2 Front Cover Assembly Parts List.............................................................6-3
6.3 Pump Module Assembly......................................................................................6-4
6.3.1 Exploded View.........................................................................................6-4
6.3.2 Pump Module Assembly Parts List .........................................................6-5
6.4 Rear Cover Assembly..........................................................................................6-6
6.4.1 Exploded View.........................................................................................6-6
6.4.2 Rear Cover Assembly Parts List .............................................................6-6
6.5 Others..................................................................................................................6-7
6.5.1 Others Parts List......................................................................................6-7
7 Upgrade.................................................................................................................7-1
7.1 Tools ....................................................................................................................7-1
7.2 Software Upgrade ...............................................................................................7-1
7.2.1 Software Burning Method........................................................................7-1
7.3 Brand Library Download......................................................................................7-5

1-1
1 Safety
1.1 Safety Information
This chapter lists basic safety information that users must be aware of and observe
when using the syringe pump. Other safety information that is the same, similar, or
related to the specific operation will appear in each chapter.
DANGER
Indicates an imminent hazard that, if not avoided, will result in death or
serious injury.
WARNING
Indicates a potential hazard or unsafe practice that, if not avoided, could
result in death or serious injury or property damage.
CAUTION
Indicates a potential hazard or unsafe practice that, if not avoided, could
result in minor personal injury or product/property damage.
NOTE
Provides application tips or other useful information to ensure that you
get the most from your product.
1.1.1 DANGER
There is no information classfied as danger in this manual.

1-2
1.1.2 WARNING
WARNING
Before use, users must check the equipment, cables and accessories to
ensure that they work properly and safely.
The equipment can
only be connected to a properly installed power
outlet with protective earth contacts. If a protective earth conductor is
not provided, do not use the outlet and use a rechargeable battery to
power the equipment.
To avoid explosion hazard, do not use the equipment in the presence of
flammable anaesthetics, vapours or liquids.
Do not open the enclosure of the equipment, otherwise there is a danger
of electric shock. Repairs or upgrades to the equipment must be
performed by service personnel trained and autho
rized by Shenzhen
Mindray Scientific Co., Ltd. and must be performed with AC power
disconnected. Maintenance by non-
manufacturer or unauthorized
personnel can have an impact on the safety, performance and
functionality of the product.
When the equipment is co-
used with electrosurgical equipment, the
patient's safety must be ensured.
Attention must be paid to the actual clinical condition of the patient and
the working condition of the syringe pump, and the alarm volume and
alarm limit must be set according
to the actual situation. Do not rely
solely on an audible alarm system to infuse a patient. If the alarm volume
is adjusted to a small volume, the patient may be at risk. When the alarm
volume is lower than the ambient volume, the operator may fail to
identify the alarm.
Carefully route the power cord and various accessory cables to prevent
the patient from being entangled or suffocated and prevent the cables
from being entangled or subject to electrical interference.
Dispose of package materials as per the
applicable waste control
regulations, and keep them out of children's reach.
During the infusion process, clogging due to tube knotting, filter clotting
or intubation can result in increased internal pressure in the syringe.
Eliminating the clogging at this time may result in excessive injection of
the drug into the patient, and appropriate precautions must be taken.
The syringe pump is used within a range of 100 cm above and below the
patient's heart. The smaller the height difference between the syringe
pump and the patient's heart, the more accurate the pressure detection

1-3
in the infusion line.
This equipment must use professional medical consumables. When the
syringe used is not a standard consumable or when an uncalibrated
consumable is used, the accuracy will not be guaranteed. Please contact
us for calibration service.

When the peripherals are connected through the signal I/O port, the
patient cannot be touched at the same time, so as to avoid the patient
leakage current exceeding the standard requirements.

During defibrillation, do not touch the patient and other
non-
defibrillation equipment to avoid electric shock. During
defibrillation, defibrillation will not affect the basic performance of the
equipment, such as infusion accuracy, alarm, signal transmission, etc.
The equipment uses a power plug to disconnect it from an AC power
source. Place the equipment in a location where the power outlet is
within easy reach.
1.1.3 CAUTION
CAUTION
To ensure patient safety, use the accessories specified in this manual.

When the equipment and its accessories are about to exceed their
lifespan, they must be disposed of in accordance with local regulations
or hospital systems.

Since electromagnetic fields can affect the performance of this
equipment, other equipment
used near this equipment must meet the
appropriate EMC requirements. Mobile phones, X-ray equipment or MRI
devices are possible sources of interference as they may emit higher
levels of electromagnetic radiation.
Before connecting the equipment to the pow
er line, check that the
voltage and frequency ratings of the power are the same as those
indicated on the equipment's label or in this manual.

Always install or carry the syringe pump properly to avoid damage
caused by drop, impact, strong vibration or oth
er mechanical force.
After the equipment drops, the user must confirm that the equipment
can work normally, otherwise the equipment cannot be used.
After the disposable accessories are used, they must be disposed of in
accordance with the relevant regulations of the hospital.

The syringe pump must be protected from direct sunlight, high
temperatures and humidity.

1-4
Before using the internal battery, check the battery to make sure it has
enough power. Recharge the battery when needed.
The syringe with a Luer c
onnector is recommended to effectively
prevent the patient from underflow due to the patient's tubing being
pulled off.
1.1.4 NOTE
NOTE

Install the equipment in a location where you can easily observe,
operate, and maintain it.
Keep this manual near the equipment so that it can be easily and timely
obtained when needed.
The software of this equipment was developed in accordance with the
requirements of the YY/T 0708 standard, minimizing the possibility of
risk due to program errors.
This manual describes the product in its most complete configurations
and features. The product you purchased may not have certain
configurations or features.
Please do not insert the equipment not specified by Shenzhen Mindray
Scientific Co., Ltd. into the multi-function interface.

During the infusion process, the syringe pump precisely controls the
infusion flow rate, infusion volume and infusion time, and monitors the
speed and direction of the stepper motor in real time to effectively
prevent overflow, underflow and backflush.
This equipment does not come into direct contact with the drug/patient.
Therefore no biocompatibility testing is required.
1.2 Equipment Symbols
The equipment you purchased does not necessarily have all of the symbols below.
Note! Read the document attached Power ON/OFF
AC Battery
AC/DC DC
Alarm Sound pause

1-5
Clear/Return
Start, the beginning of
the action
Fast forward
Confirm
Stop Menu
Move up/Increment Move
down/Decrement
Move left Move right
CE marking
EFUP of electronics
(20 years)
IP34 Against solid foreign
objects with a diameter
of not less than 2.5 mm,
and splash-proof
Night mode
The wireless module is
configured and
connected successfully. Anti-defib CF
application
Production date Recycling
Use a pollution-free
method for processing
Non-ionizing radiation
Input/Output Serial number
Upward Avoid rain
Fragile, handle with care Stacking layer limit
Atmospheric pressure
limit Humidity limit
Temperature limit

1-6
FOR YOUR NOTES

2-1
2 Overview
2.1 Product Introduction
2.1.1 Structure, Composition and Performance
The syringe pump product is mainly composed of a syringe pump main unit,
fastening clips and infusion monitoring management system (BeneFusion DS3).
The speed of the stepper motor is precisely controlled to drive the screw operate at
a set speed, thus controlling the flow of liquid injected into the patient's body by the
syringe. This product can be used for clinically accurate infusion of the drug to the
patient, and all of its components are suitable for the patient environment. The
syringe pump main unit can be equipped with a wireless module. The software
optional functions include speed mode, time mode, weight mode, drug library,
historical records, and Anti-bolus.
The application part of this equipment is a syringe. Since some parts and functions
are optional, the syringe pump you purchased may not have some parts and their
corresponding functions.
2.2 Main Unit
2.2.1 Front View
1. Alarm lamp
The alarm lamp indicates the alarm priority in different colors and flashing
frequencies.

2-2
2. LCD
Display infusion parameters and related contents.
3. <Menu Key>
Adjust the value and scroll up and down.
4. <Clear/Return Key>
In the editing status, press this key to set the parameter to 0.
When the edit value is 0, press this key to make the value return to the pre-edit
value.
In the non-editing status, press this key to return to the previous screen.
5. <OK Key>
Enter the editing status, determine the input operation and save the value.
6. <Start Key>
Install the syringe correctly, set the infusion parameters, and then press this key
to start the infusion.
In the Fast Forward Setup screen, after setting the fast forward parameter,
press this key to start automatic fast forward.
7. <Stop Key>
During the infusion process, press this key to stop the infusion. If the infusion is
stopped due to an alarm, such as blocking, etc., press this key to cancel the alarm.
8. <Fast Forward Key>
During the infusion process, press this key to enter the fast forward setup
screen.
In the non-operating status, press this key to enter the drainage prompt screen.
9. <Sound Pause Key>
Pause the alarm sound.
10. <Power Key>
Power on the equipment, enter the standby status and power off the equipment.
11. <Menu Key>
Enter the [Main Menu] screen.
In the operating status, long press this key to lock the equipment; after it is
locked, long press this key to unlock it.
12. AC/DC LED
On: The syringe pump has been connected to AC/DC power (Including
shutdown).
Off: The syringe pump is not connected to the AC/DC power supply.
13. Extender fixed block
Fix the extender.

2-3
14. Syringe fixed clamp
15. Battery LED
Always green, indicating that the battery is charging (Including shutdown).
Flashing green, indicating that the battery is working
Off, indicating shutdown and no charging.
16. Push-and-pull box
Fix the syringe and push the syringe piston and push rod
17. Handle
2.2.2 Rear View
1. Product label
2. Mounting holes of fastening clip (2)
3. AC Power input interface
Connect to AC power through a three-wire power cord.
4. Multi-function interface, which has the following interface functions:
DC power input interface
M02D connector
Nurse call interface

2-4
2.2.3 Side View
1. Gripper
2. Extender fixed block
1. Clamp
Clamp the syringe push handle.
2. Syringe fixed clamp
3. Slot
4. Handle clamp
Secure the syringe flange and clamp the syringe.
5. Push-and-pull box
Fix the syringe and push the syringe piston and push rod
6. Gripper
Control the opening and closing of the clamp and control the push and pull box.

2-5
2.2.4 Bottom View
1. Speaker hole
2.3 Description of Hardware Principle
The SP3 hardware boards are structured as shown in the following figure, which
mainly includes the control board, keypad board, sensor board, etc.
Keypad board
J1
Control board
J8
J4
J7J6
J5
J11
J12
J3
J2
J2
ACDC module
100-240VAC 50/60Hz
15V/1.33A
Battery Battery DB9 Stepper
motor
Speaker
Sensor adapter
board
J3
J4
J2
Slider adapter
board
Pressure
detection
board
J2
J1
Rotary
potentiometer
J5
Film
potentiometer
Pressure sensor
J1
J2
Architecture Block Diagram of SP3 Hardware Boards

2-6
2.3.1 Control board
The SP3 control board consists of three parts, the power supply part, the main
control part and the monitoring part.
The power supply part includes an ACDC conversion module, an on/off control
circuit, a DC power conversion circuit, a standby sound and light alarm circuit, and a
battery charge and discharge management circuit.
The ACDC conversion module converts the input AC power supply of 100-240VAC
and 50/60Hz to an output of DC 15V.
The on/off control circuit can combine three power inputs of ACDC input, external
DC input, and internal battery into VBUS, and the priorities of ACDC input and
external DC input are higher than that of internal battery; the on/off signal can
convert VBUS into VPP output.
VBUS is not controlled by the on/off signal, but VPP is controlled by the on/off signal.
VBUS is stepped down to VCCB (5V) through the LDO circuit (U9 TLV70450).
VCCB is stepped down to VBB (3.3V) through the LDO circuit (U13 SPX5205). VPP
is stepped down to VCC (5V) through the Buck circuit (U11 TPS5420D). VCC is
stepped down to VDD (3.3V) through the LDO circuit (U12 SPX1117M3). VPP is
boosted to VMM (+18.9V) through the Boost circuit (U6 TPS61175PWP).
The main control CPU controls on/off and provides motor power failure protection
under single fault condition. The monitoring CPU monitors the battery charging
status, detects the power status of each module, controls the battery LED, and
communicates with the CPU of the main control module through the serial port. After
being triggered by the on/off key from the keypad, the main control CPU and the
monitoring CPU simultaneously output the power-on lock signal and the module
power enable signal, so that VCC, VDD, and VMM are sequentially output, and the
entire system is powered on. When the normal shutdown is required, after the main
control CPU detects the shutdown signal, it notifies the monitoring CPU to cancel
the power-on lock signal through the serial port, and finally the main control CPU
completes the shutdown.
Battery charging and discharging management circuit adopts BQ24103RHLR. The
on/off charging current is designed to both 650±50mA (The charging time of the
single battery does not exceed 6 h. The charging time of the dual battery does not
exceed 12 h). The battery is at a voltage of 8.1±0.2V when fully charged.
When the battery voltage is too low and the AC power and external DC power are off,
the backup sound and light alarm circuit triggers the buzzer to sound at a frequency
of 2.73Hz±0.5V, and drives the red alarm lamp to be continuously illuminated.
When the monitoring CPU detects that the VDD power supply is abnormal or the
communication with the CPU of the main control module is abnormal, the buzzer
sounds and the power of the stepper motor is turned off.

2-7
CPU of main
control Monitoring
CPU
Monitoring CPU
DCDC
TPS61175 18.9V
On/Off control circuit
ACDC
15V/1.33A
锂电池
7.4V/1600mAh
DCDC
TPS5420 5V
Lithium battery
charging circuit
LDO
SPX1117M3-L-3.3
Motor drive
Speaker drive
System 3.3 V
主控CPU
Lithium batteriesx2
7.4V/1600mAh
Backup power supply
SPX5205M5-L-3.3/TR
RTC power supply
Backup alarm
circuit
VREF
ZR431
ADC calibration
LCD Backlight
Monitoring CPU
backup power supply
Backup power supply
TLV70450-5V
External DC input
10-16V/2-1.25A
VBUS
Block Diagram of Power System
Test points for key signals:
TP115 (ACDC_IN) is about 15V when tested with a multimeter.
TP113 (EDC_IN) is about 10V-16V when tested with a multimeter.
TP100 (BAT2) is about 6.8V-8.4V when tested with a multimeter (In dual battery
configuration).
TP99 (BAT1) is about 6.8V -8.4V when tested with a multimeter.
U14 PIN1 (VBUS) is about 6.4V-15.6V when tested with a multimeter.
TP108 (VPP) is about 6.4V-15.6V when tested with a multimeter.
TP91 (VCCB) is about 4.5V-5.2V when tested with a multimeter.
TP90 (VBB) is about 3.3V when tested with a multimeter.
TP92 (VCC) is about 5.0V when tested with a multimeter.
TP89 (VDD) is about 3.3V when tested with a multimeter.
TP57 (VMM) is about 18.9V when tested with a multimeter.
The main control part is responsible for functions such as LCD display driver,
speaker alarm circuit, nurse call, key management, and UARTcommunication of the
monitoring CPU. The main control CPU uses the Cortex M3 core chip
STM32F103RGT6 (U5), and uses the Intel 8080 system bus interface as the display
driver interface. The speaker alarm circuit is composed of PWM wave modulation
circuit and power amplifier circuit. Q13, U3 and peripheral resistance are composed
of PWM wave modulation circuit. U4 is a voice amplifier chip with +5V power supply.
The nurse call is an extended function, which is interconnected with the hospital
alarm system through a special nurse call cable. Q2, Q8 and peripheral resistance
components are composed of a nurse call circuit. U16 is an EEPROM that uses the
I2C interface for storing historical records, calibration data and other information.
U23 and U24 are nor flashes that use SPI interfaces for storing drug libraries,
language libraries, and image resources. X3 is a 32.768 KHz crystal that provides

2-8
clocking for the RTC module of the main control CPU. U19 is an RS232 level
conversion chip, and the external communication interface and the nurse call signal
are all connected to the multi-function interface J8. The main control CPU
communicates with the monitoring CPU through UART.
Key and LCD I/O
multiplex interface
Speaker
Alarm lamp
CPU of main
control
STM32F103RG
Wi-Fi serial port/
communication
interface
EEPROM Flash
RS-232 communication
On/Off control
Motor power control
Monitoring CPU serial
port communication
RTC
Nurse call
Block Diagram of Main Control Module
Test points for key signals:
TP56 UART signal sent by the main control CPU to the monitoring CPU
TP11 UART signal received by the main control CPU from the monitoring CPU
TP5 UART signal sent by main control CPU through an external serial port
TP10 UART signal received by main control CPU through an external serial port
TP19 Reset signal of the main control CPU
TP4 Nurse call control signal
TP75 and TP76 PWM modulation input signal
TP77 Enable signal of voice chip
The monitoring module is composed of a monitoring CPU, a stepper motor drive
circuit, a long potentiometer detection circuit, a pressure detection circuit, a syringe
specification detection circuit, and a syringe in-position detection circuit. The
monitoring CPU adopts STM32F030C8T6 (U15), and the stepper motor drive circuit
uses a motor control chip A4982 (U2). By detecting the input signal of the long
potentiometer, the monitoring module judges the direction and rotation speed of the
motor, and realizes the emptying detection at the same time. The syringe in-position
detection circuit is implemented by an optical coupler circuit in the flap in-position