BeneFusion VP5 Service Manual PDF

 

 

BeneFus BeneF usio ion n VP5 (This Instruction Manual may also be used for BeneFusion Be neFusion VP5 Ex Infu Infusion sion Pump.) 

Infusion nfus ion Pump

Serv rvic ice e Ma Manu nua al

 

 

 

 

Intellectual property rights The intellectual property rights for this Operator's Manual and corresponding product belong to the Shenzhen Shenke Medical Instrument Technical Development Co. Ltd. (hereinafter referred to as "Shenke Company"). Shenke Company is one of the group members of the Mindray Medical International. © 2012-2014 Shenzhen Shenke Medical Instrument Technical Development Co. Ltd. All rights reserved.

 No individual or organization may reproduce, modify or translate any part of this Operator's Manual without written consent from Shenke Company Company..

,

,

and

are registered trademarks or trademarks of the

Mindray company. Shenke Company is authorized to use the aforementioned registered trademarks or trademarks upon the approval of the Mindray company.

Statement Shenke Company possesses the final interpretation rights for this O Operator's perator's Manual.

Shenke Company has the right to modify the content of this user manual without prior notification. Any modified modified content will appear in a newly-published version of this user manual.

Shenke Company shall only bear responsibility for product safety, reliability, and performance when all the following requirements are satisfied:  

Assembly, expansion, readjustments, improvements, and maintenance must be carried out by professionals approved by Shenke Company;

 

All replacement parts used in repairs and accessories, and consumables used to form a complete set, must be Shenke Company originals (genuine originals) or approved by Shenke Company;

 

Related electrical equipment must comply with national standards and the requirements of this Operator's Manual.

 

The product is operated in accordance with this Operator's Manual.

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Foreword Introduction This Operator's Manual provides a detailed introduction of the hardware components, installation, dismantling, testing and troubleshooting of this product and its parts, which may effectively help repair staff handle commonly seen problems. It does not provide in-depth information on the structure and design of the product. If you experience problems that cannot be solved, please contact our after-sale service department.

Information in this Operator's Manual is based on a fully configured product, some of which may not be applicable to the product you're repairing. If you have any questions, please contact our after-sale service department.

Before carrying out any repair work, please ensure that you can properly repair the product by carefully reading and fully understanding the content of this Operator's Manual. This way, damage to the product or physical injuries may be avoided.

For use by Professional biomedical engineers responsible for the maintenance of this product, authorized repair staff or after-sale service representatives.

Version Information The version number of this Operator's Manual may be updated without notice at any time due to changes in software or technical specifications. The version information of this Operator's Manual is as follows. 

 

 

Version No.: 1.0 Time of Publication: 07-2014

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Contents Intellectual property rights ................................................................................................................ I Statement........................................................................................................................................... I  I  Chapter 1

Safety ............................................................................................................................ 1

1.1

Safety Information ........................................................................................................ 1

1.2

Dangers ......................................................................................................................... 2

1.3

WARNING .................................................................................................................... 2

1.4

CAUTION..................................................................................................................... 3

1.5

NOTE ............................................................................................................................ 3

1.6

Equipment Symbols ...................................................................................................... 4

Chapter 2 2.1

Design ........................................................................................................................... 5 Produc t Overview ......................................................................................................... 5 2.1.1

2.2

2.3 Chapter 3 3.1

Structural components and features .................................................................. 6

Product Exterior ............................................................................................................ 7 2.2.1

Front View ......................................................................................................... 7

2.2.2

Rear View .......................................................................................................... 9

2.2.3

Side View .......................................................................................................... 9

2.2.4

Side View with the Door Opened .................................................................... 10

2.2.5

Bottom View ................................................................................................... 11

Hardware Design......................................................................................................... 12 Te Testing sting and maintenance ............................................................................................. 22  Description .................................................................................................................. 22 3.1.1

Testing report .................................................................................................. 23

3.1.2

Re Recommended frequency ................................................................................ 23

3.2

Appearance inspection ................................................................................................ 24

3.3

Startup test................................................................................................................... 24

3.4

Accuracy Calibration .................................................................................................. 25

3.5

Pressure Calibration .................................................................................................... 27

3.6

Operation test .............................................................................................................. 29

3.7

Battery power test ....................................................................................................... 30

3.8

Electrical safety test .................................................................................................... 30 3.8.1

Housing leakage current test ........................................................................... 31

3.8.2

Ground leakage current test............................................................................. 31

3.8.3

Patient leakage current test .............................................................................. 32

 

 

3.9

Chapter 4

Cl C leaning and Disinfection ........................................................................................... 32 3.9.1

Cleaning .......................................................................................................... 32

3.9.2

Disinfection ..................................................................................................... 33

Troubleshooting .......................................................................................................... 34

4.1

Description .................................................................................................................. 34

4.2

Replacement of parts ................................................................................................... 34

4.3

Check infusion pump status ........................................................................................ 35

4.4

Fault Table ................................................................................................................... 36

Chapter 5

4.4.1

Alarm messages and alarm cancellation ......................................................... 36

4.4.2

Faulty machine ................................................................................................ 37

4.4.3

Faulty Display ................................................................................................. 38

4.4.4

Faulty operation and alarm.............................................................................. 38

4.4.5

Faulty Monitoring ........................................................................................... 39

Maintenance and Disassembly .................................................................................... 40

5.1

Tools ............................................................................................................................ 40

5.2

Preparation for disassembly ........................................................................................ 40

5.3

Disassembly procedures .............................................................................................. 41 5.3.1

Disassembly of the upper housing assembly ................................................... 41

5.3.2

Disassembly of the pump assem sembly and the housing base assembly .............. 43

5.3.3

Disassembly of the front/rear door housing assembly and pump transmission assembly..................................................................................... 46 

5.3.4

Disassembly of the alarm light plate, keyboard and display screen ..................... 49

5.3.5

Disassembly of the pressure sensor assembly, assembly, pump tablet installation assembly, li liquid cl clip as assembly an and p pu ump ul ultrasonic cch hip as assembly ............... 51

5.3.6 Chapter 6

Dissembly of the Main Board ......................................................................... 54

Components ................................................................................................................ 56

6.1

Description .................................................................................................................. 56

6.2

Host ............................................................................................................................. 57

6.3

6.4

6.2.1

Exploded view................................................................................................. 57

6.2.2

Parts List ......................................................................................................... 57

Upper housing assembly ............................................................................................. 58 6.3.1

Exploded view................................................................................................. 58

6.3.2

Parts List ......................................................................................................... 58

Pump components ....................................................................................................... 59 6.4.1

Exploded view................................................................................................. 59

6.4.2

Parts List ......................................................................................................... 59

 

 

6.5

6.6

6.7

6.8

6.9

6.10

6.11

Chapter 7

Pump transmission assembly ...................................................................................... 60 6.5.1

Exploded view................................................................................................. 60

6.5.2

Parts List ......................................................................................................... 60

Pump tablet installation assembly ............................................................................... 61 6.6.1

Exploded view................................................................................................. 61

6.6.2

Parts List ......................................................................................................... 61

VP5 cam & motor assembly ....................................................................................... 62 6.7.1

Exploded view................................................................................................. 62

6.7.2

Parts List ......................................................................................................... 62

VP5 liquid clip assembly ............................................................................................ 63 6.8.1

Exploded view................................................................................................. 63

6.8.2

Parts List ......................................................................................................... 63

VP5 front door housing assembly ............................................................................... 64 6.9.1

Exploded view................................................................................................. 64

6.9.2

Parts List ......................................................................................................... 65

VP5 rear door housing assembly................................................................................. 66 6.10.1

Exploded view................................................................................................. 66

6.10.2

Parts List ......................................................................................................... 67

VP5 housing base assembly ........................................................................................ 68 6.11.1

Exploded view................................................................................................. 68

6.11.2

Parts List ......................................................................................................... 68

Upgrade ....................................................................................................................... 70

7.1

Tools ............................................................................................................................ 70

7.2

Software upgrade ........................................................................................................ 70 7.2.1

 

Software burning method ................................................................................ 70

 

  FOR YOUR NOTES

 

 

Chapter 1  Safety 1.1  Safety Information The safety statements presented in this chapter refer to basic safety information that the operator must pay attention to and abide by when using the infusion pump. There are additional safety statements in other chapters or sections, which may be the same as or similar to the following, or specific to particular operations.

DANGERS  

Indicates an imminent hazard that, if not avoided, could result in death, serious injury or damage to product/property.

WARNING  

Indicates a potential hazard or unsafe practice that, if not avoided, could result in death, serious injury or damage to product/property.

CAUTION  

Indicates a potential hazard or unsafe practice that, if not avoided, could result in minor personal injury, product malfunction or damage to product/property.

NOTE  

Provides application tips or other useful information to ensure that you get the most out of the product.

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1.2  Dangers This Manual does not contain any information on Danger levels.

1.3  WARNING WARNING  

Device, cables and accessories must be inspected before use to guarantee their normal and safe operation.

 

This equipment can only be connected to the socket with ground protection. Please adopt a rechargeable battery instead of the socket as the power supply if the socket is not provided with a ground lead.

 

To prevent fire or explosion, do not operate the system in the presence of anesthetic, flammable or explosive materials.



 

Patients' actual clinical conditions and the working condition of the infusion pump must be closely monitored, and the volume and levels of alarm must be set according to the actual needs. Operation and performance relying solely on the auditory alarm system alone is not sufficient, and setting the alarm at a low volume may endanger the patient.

 

Please carefully install the power line and cables with various accessories to prevent the patient from choking or suffocation caused by entanglement of the cables or by electrical disturbance.

 

The packaging materials must be disposed of in compliance with local laws and regulations or the hospital policy on waste management. They must be kept out of the reach of children.

 

This equipment must be used with professional medical consumables, and its accuracy cannot be guaranteed when it is used with a syringe that is a non-standard consumable or a consumable without calibration.

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1.4  CAUTION CAUTION  

Use the accessories specified in this Operator’s Manual to guarantee the patient’s safety.

 

Electromagnetic fields may affect equipment performance. This makes it necessary for other equipment used in the vicinity of the pump to meet EMC standards. Mobile phones, X ray and MRI equipment are all potential interference sources because of their high-intensity electromagnetic radiation.

 

Before the equipment is connected to the power supply, check that the voltage and frequency of the power supply match the specifications on the label or in this Operator’s Manual.

 

Please install and carry the equipment properly to protect the equipment from damage from drops, impacts, violent shaking or other external mechanical forces.



   

Avoid direct sunshine, high temperatures and humidity. Check the built-in battery before use to make sure it has sufficient power. Recharge the battery if necessary. n ecessary. 

1.5  NOTE NOTE  

The software of the equipment is developed according to the IEC60601-1-4 standard, which can minimize the possibility of the risk caused by program error.

 

This Operator’s Manual describes the most complete functional configuration of the system. The product you are using may not have some of the settings or functions described herein.

 

Do not insert devices that are not specified by the manufacturer into the multifunction interfaces.

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1.6  Equipment Symbols The equipment you purchased may not provide you with all the following symbols.

 NOTE! ON/OFF

Refer to the accompanying document (This Manual) Alternating current power supply (AC) Alarms

Alarm Silence

Clear/Back

Start

Bolus

Confirm

Stop

Menu

Move up/Increase

Move down/Decrease

Move left

Move right

Wireless networking

Lock

Protected against solid foreign

IP23 

Battery

Protected against

objects with a diameter no less

defibrillation CF applied

than 12.5mm and protected

 parts

against spraying liquid water Date of manufacture

Manufacturer

Electronic equipment: dispose of separately to avoid polluting

Wireless transceiver

the environment Multifunction interface

Serial number

The European Union

CE mark

Representative Office Environmentally-friendly Environmentally-fr iendly use  periods of electronic products (20 years)

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Chapter 2  Design 2.1  Product Overview Infusion pump and infusion set are used together to control the flow of liquid into the patient's body; Suitable for adults, children and newborns in clinical departments of a hospital. The Infusion Pump is expected to be used in (but not limited to): outpatient departments, emergency rooms, general wards, postoperative recovery rooms, operating rooms, general intensive care units, clinics and nursing homes; The Infusion Pump primarily consists of a housing, a motor drive system, an input system, a memory system, a control system, a display system, a sensor-based monitor system and an alarm system. Since some parts are optional, the Infusion Pump you have purchased may not have such  parts and their corresponding corresponding functions.

This Infusion Pump has the following functions and characte characteristics ristics: Accurate control of flow rate, fluid volume and infusion time; real-time monitoring of speed and direction of a running stepper motor; prevention of over-current, under-current under-curre nt and inverse-current. inverse-current. Good linear flow; flow rate may be changed during infusion; historical records: Operation, infusion and alarm logs can be recorded and data can be exported. Drug Library and Operational Interface can display the name of the drug currently being infused; data storage can store at least 2000 historical records and 2000 drug names; memory function can memorize the last infusion parameters; automatic fast forward and manual fast forward functions; 5

 

 

standby function can retain parameters set prior to standby;  purge function, degassing degassing the line prior to starting infusion; infusion; dynamic pressure monitoring function, providing real-time testing of infusion tube  pressure and with a pressure pressure icon, indicating indicating pressure status (i.e. (i.e. normal pressure, close-to-obstruction close-to-obstruc tion alert or obstruction alert); a lert); automatic and manual lock-screen functions, preventing accidental operation and misuse;  pill dose release function, function, automatically releasing releasing line pressure after after obstruction; self-test on startup function; anti-defibrillation function; KVO function, leaving the patient's line open; super bright large LED display; Alarm: Various alerts such as light, sound and alert message are supported; alarm volume is adjustable;  Network  Netwo rk communic communication: ation: Wireless Wireless co communica mmunication tion with with our Centra Centrall Infu Infusion sion Monitorin Monitoring g Management System, Bedside Infusion Monitoring Management System and Mobile  Nursing  Nursi ng Station Station (BB (BB machine) machine) and da data ta export export and and on-line on-line upgrade upgrade via PC PC connection connection;; Various infusion modes available

2.1.1  Structural components and features The Infusion Pump primarily consists of a housing, a motor drive system, an input system, a memory system, a control system, a display system, a sensor-based monitor system and an alarm system. Optional wireless modules. Optional functions of the software include Rate Mode, Time Mode, Bodyweight Mode, Ramp Mode, Sequential Mode, Loading Dose Mode, Drug Library, Record and Anti-bolus Function.

Since some parts are optional, the Infusion Pump may not have such parts and their corresponding functions.

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2.2  Product Exterior 2.2.1  Front View

1.

Alarm indicator lamp

The alarm indicator lamp indicates different alarm levels in different colors and flash frequencies, for details please refer to the User's Manual . 2.

Display

Used for displaying infusion parameters and relevant information. 3.

Flow direction indicator

4.

AC power indicator lights

  On: The Infusion Pump is connected to an AC power supply. 

supply y.   Off: The Infusion Pump is not connected to an AC power suppl 5. Door latch Door opens when the latch is pulled. 6.

 

Used for adjusting value, change lines and pages. 7.

 

  Under non-setting status, indicate to returns to previous menu or operation.   Under the setting status, indicate to clear the current set or cancel the edit.

8.

 

Used for confirming input operation.

7

 

 

9.

 

Press this key to start infusion after properly installing infusion tube and setting infusion parameters. 10.   Press this key to stop infusion during infusion. In case of infusion stops caused by alarm (e.g. obstruction), press this key to cancel the alarm. 11.     During infusion, press this key to enter the Bolus Settings screen.   When the pump is stopped, press this key to enter the Purge Settings screen.

12.     During high level and mid-level alarms, press this key and the alarm will be silenced for

2 minutes. The alarm silencing will be canceled automatically if a new alarm is triggered within the 2 minutes.   For low-level alarms, press this key to cancel the alarm.

13.   Used for turning power on, entering in standby state and turning off operations. 14.     Under non-operation status, used for switching [Main Menu] interface and other interfaces.   Under operation status, press and hold this key to lock; in locked state, press and hold to

unlock. 15. Battery indicator   Steady green indicates that the battery is charging.   Flashing indicates that the battery is providing power.   Light off indicates that there is no battery or the equipment is turned off and not connected to

an AC power supply.

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2.2.2  Rear View

1.

Battery chamber

2.

Multi-channel pumps connect rail

Used for combining multi-channel pumps. 3.

Alternating current (AC) power supply port

Connected by three-core-type power cord and AC power source. 4.

Multi-functional port with the following port functions:

  Direct current (DC) power supply port   RS232 interface    Nurse call interface interface

2.2.3  Side View

1.

Chutes

2.

ledger

3.

Multi-channel pump hasp The multi-channel pumps are connected to secure the equipment.

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2.2.4  Side View with the Door Opened

1. 

Multi-channel pump chute

2. 

Liquid clip clasp

3. 

Bubble detection plate

4. 

Down pressure detection plate

5. 

Infusion tube slot

6. 

Pump tablet

7. 

Up pressure detection plate

8. 

Liquid clip

9. 

Door

10.  Door latch

10

 

 

2.2.5  Bottom View

1. 

Product label

2. 

Fixed mounting holes

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2.3  Hardware Design Architecture of VP5 hardware board is shown below: Control Board, Key Board, Pressure Detection Board and Bubble Detection Board etc.

1. 

Control Board

VP5 Control Board consists of three sections, namely Power, Control and Monitoring sections. Power section includes AC/DC conversion module, switch control circuit, DC power conversion circuit, power management CPU, standby sound and light alarm circuit, and battery charge and discharge management circuit. The AC/DC conversion module converts AC 100-240VAC 100-240VAC input, 50/60Hz to DC 15V output; Switch control circuit combines inputs from AC/DC, external DC and internal battery into VPC, with AC/DC and external DC having higher priority than internal battery; switch signal then converts VPC to VPP as output. While VPC is not controlled by switch signal, VPP output is controlled by switch signal. Via LDO circuit (U7 ZSR500GTA) VPC is bucked to VCCB (5V) and via LDO circuit (U3 SPX5205) VCCB is bucked to VBB (3.3V); Via Buck circuit (U12 TPS5410D) VPP is bucked to VCC (5V); via LDO circuit (U13 SPX1117M3) VCC is bucked to VDD (3.3V); via Boost circuit (U26 LT3757EMSE) VPP is boosted to VMM (+24V).

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Power management CPU is responsible for switch control, motor power-down protection under a single fault, battery charge status monitoring, various module power status detection, battery indicator control, and communication with the main control module CPU via serial ports. Power management CPU uses Cortex M0 core chip LPC1112 (U10) powered by VBB power supply. Once powered off, the CPU is in sleeping mode. After power switch on the keyboard is pressed, triggering wake-up mode, power-on and module power in-use signals, which leads to output of VCC, VDD and VMM in this order and the entire system is then powered on. Main control CPU is powered by VDD power supply. After the CPU is powered on, it outputs a boot lock signal,  preventing accidental shutdown shutdown of power management CPU. In case of a nor normal mal shutdown, power management CPU first sends a request via serial ports to main control CPU which then revokes the boot lock signal after confirming that shutdown is permitted. Finally shutdown is completed  by the power management management CPU and the system system then goes to sleeping mode again. again. Battery charge and discharge management circuit uses BQ24103RHLR, with off-mode charging current designed for 1300±100mA (charging (charging time is not more than 6 hours) and on-mode charging current designed for 650±50mA (charging time is not more than 12 hours); the battery is designed to be fully charged at a voltage of 8.4 ± 0.2V. Under the circumstance of the battery voltage being too low and the AC power being switched off, the standby sound and light alarm circuit triggers a buzzer which rings at a frequency of 2.73Hz ± 0.5V and a red alarm LED is continuously lit. When the power management CPU detects unusual power of the VDD or abnormal communication with the main control module CPU, the buzzer rings and the stepper motor's  power is then shut down.

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Key signal testing points: Tested by a multimeter D5 positive ground voltage (ACDC_IN) is about 14V-16V. Tested by a multimeter D6 positive ground voltage (EDC_IN) is about 10V-16V. Tested by a multimeter C154 terminal voltage (BAT_IN) is about 6.8V-8.4V. Tested by a multimeter TP65 (VPC) is about 6.4V-15.6V. Tested by a multimeter TP66 (VPP) is about 6.4V-15.6V. Tested by a multimeter TP60 (VCCB) is about 4.5V-5.2V. Tested by a multimeter TP61 (VBB) is about 3.0V-3.6V. Tested by a multimeter TP62 (VCC) is about 4.5V-5.5V. Tested by a multimeter TP1 (VDD) is about 3.0V-3.6V. Tested by a multimeter TP16 (VMM) is about 23V-25V.

Control section is responsible for LCD display driver, speaker alarm circuit, nurse call, Dock on-line detection and power CPU, key CPU, and adjunct CPU UART communication. Main control CPU uses Cortex M3 core chip STM32F103VE (U14), with Intel 8080 system bus interface as the display driver interface and Buffer chip U8 and U9 (SN74LVCR2245) protecting the main control CPU pin from being burned by external overshoot. Speaker alarm circuit consists of PWM wave modulation circuit and amplifier circuit; Q5, U19 and peripheral RC form the PWM wave modulation circuit; U18 is a voice amplifier chip and power supply is +5V. Nurse call is an extended function, which is connected to the hospital alarm system via a designated nurse call cable; Q4, Q6 and peripheral RC form the nurse call circuit. U16 is EEPROM with an I2C interface for storing information such as historical records and calibration data. U15 is Nor flash with a SPI interface for storing drug libraries, language libraries and picture resources etc. U28 is a Zigbee module connected to the main control CPU via UART, enabling external wireless communication. X2 is a 32.768KHz passive crystal oscillator, providing the RTC module of the main control CPU with a clock. Encoder detection circuit is used for real-time detection of the motor's speed by the master control block CPU and whether its direction is consistent with the setting (adjunct CPU also detects in real-time the motor's speed and direction). U6 is a RS232 level converter chip; external communication interface, nurse call signals and Dock on-line detection signals are all connected to the multi-functional interfaces JP3. Main control CPU communicates with power management CPU, key CPU, and adjunct CPU via UART. UART.

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Key signal testing points RP5-6 foot LCD_WR writes control signals; RP5-8 foot LCD_RS data / command selection signals; RP6-2 foot LCD_CS chip-select signals RP6-6 foot UART signals sent by the main control CPU to the key CPU RP6-8 foot UART signals received received by the main control CPU from the key CPU TP24 external serial UART signals signals sent by the main control CPU TP23 external serial UART signals received by the main control CPU TP40 UART signals received by the main control CPU from the power management CPU TP41 UART signals signals sent by the main control CPU to the power management CPU TP53 SDA signals with which the main control CPU communicates with EEPROM TP63 SCL signals with which the main control CPU communicates with EEPROM TP54 CS_F signals with which the main control CPU communicates with Flash R198 SCK_F signals with which the main control CPU communicates with Flash TP56 MISO_F signals with which the main control CPU communicates with Flash R197 MOSI_F signals with which the main control CPU communicates with Flash TP59 main control CPU reset signals TP5 UART signals received by the main control CPU C PU from the adjunct CPU TP7 UART signals sent by the main control CPU to the adjunct CPU

15

 

 

C90 terminal voltage

Dock on-line detection signals, low level valid

TP64 CALL control signals, high level valid TP27 Zigbee module UART signals received by the main control CPU TP28 Zigbee module UART signals sent by the main control CPU TP26 Zigbee module reset signals TP46 WAVE speaker control signals, 20KHZ square wave signals when the speaker sounds TP47 SAMPLE speaker control signals, 600HZ square wave signals when the speaker sounds TP49 voice chip in-use signals and high level valid TP21 motor detection of input signals of optocoupler 1, output pulse signals when the motor is running TP25 motor detection of input signals of optocoupler 2, output pulse signals when the motor is running

Monitoring module consists of adjunct CPU, stepper motor drive circuit, motor detection circuit, up pressure detection circuit, down pressure detection circuit, bubble detection circuit, liquid clip detection circuit, door detection circuit, drop number detection circuit and designated tube detection circuit. Adjunct CPU uses STM32F100C8 (U1); stepper motor drive circuit uses motor control chip TMC260-PA TMC260-PA (U2). Motor detection circuit uses dual optocoupler to determine the motor's direction by comparing the two pulse sequences and to determine the motor's speed by measuring the frequencies of the two pulse sequences.

Liquid clip detection circuit, designated tube detection circuit and motor detection circuit all use optocoupler. Up pressure detection circuit and down pressure detection circuit are located at up  pressure plate and down pressure plate respectively; bubble detection circuit, designated tube detection circuit and liquid clip detection circuit are located at bubble detection plate; door detection circuit uses a limit switch and motor detection circuit is located at motor detection plate. Key signal testing points: TP59 adjunct CPU reset signals 16

 

 

TP6 motor stall detection signals, high level valid TP13 S_NCS signals with which adjunct CPU communicates with U2 TP12 S_SCK signals with which adjunct CPU communicates with U2 TP11 S_SDI signals with which adjunct CPU communicates with U2 TP14 S_SDO signals with which adjunct CPU communicates with U2

17

 

 

TP10 in-sue signals with which adjunct CPU controls U2, low level valid TP9 signals with which adjunct CPU controls U2 direction, low level motor in forward rotation and high level motor in reversal rotation TP8 signals with which adjunct CPU controls U2 stepping, pulse signals at motor start MSD1 motor detection of input signals of optocoupler 1, output pulse signals when the motor is running MSD2 motor detection of input signals of optocoupler 2, output pulse signals when the motor is running TP15 SCL signals for up pressure detection TP17 SDA signals for up pressure detection TP72 SCL signals for down pressure detection TP67 SDA signals for down pressure detection TP20 signals for liquid clip detection, low level when the clip is closed and high level when open TP19 signals for designated tube detection, high level when the tube is on-line and low level when off-line RP5-4 foot in-use signals for ultrasonic sensor transmission, low level valid TP69 AD in-use signals for bubble detection, low level valid TP73 AD in-use signals for bubble detection, 0.4-1.6V when the circuit is filled with liquid, less than 0.3V when the circuit is filled with bubbles TP18 signals for door detection, high level when the door is open and low level when closed TP100 Tested by a multimeter, 5V power supply suppl y for drop number ssensor ensor is about 14V-16V 14V-16V.. TP101 in-use signals for drop number detection TP102 signals for drop number detection

2. 

Pressure plate

Pressure detection circuit consists of ADS1100 A DS1100 and SPX5205; SPX5205 converts +5V to +3.3V as output and +3.3V supplies power to ADS1100 and pressure sensor; ADS1100 converts analog input signals of the pressure sensor into digital signals and sends them to the adjunct CPU via an I2C interface. One pressure plate is used by both up and down pressure detections. 18

 

 

3. 

Keyboard

Key management CPU uses Cortex M0 core chip LPC11 LPC1112 12 (U4) responsible for functions such as key (a total of 12 keys, of which the power switch key is directly linked to the power module CPU and other keys are processed by the key management CPU) scanning process, alarm light drive, and LCD backlight control (8 adjustable levels). A white key backlight is placed near each of the keys; once a key is pressed, the key backlight will be lit by the key management CPU. Alarm lights are in red and yellow colors and the flash frequency of each color is independently adjusted  by software. Battery indicator is continuously lit during charging, flashes when powered by battery alone with the flash frequency being controlled by the power management CPU; AC indicator is continuously lit when AC power supply is normal and is off when AC is disconnected. LCD control signals use Intel 8080 system bus interface, all from the main CPU. Transmission drive circuit of the bubble detection ultrasonic sensor consists of U3 and peripheral circuits; control in-use signals are sent by the adjunct CPU and drive signals are connected to the ultrasonic transmitter chip via J1.

Key testing points Tested by a multimeter TP10 (VDD) is about 3.0V-3.6V. Tested by a multimeter TP11 (VCC) is about 4.5V-5.5V. Tested by a multimeter TP12 (VPP) is about 6.4V-15.6V. R20 BL_PWM signals for LCD backlight control, PWM signals or high level switching on backlight Tested by a multimeter TP2 LCD backlight power supply is about 18.6V-20.4V. TP20 signals for battery indicator TP20 signals for AC indicator TP15 in-use signals for ultrasonic sensor drive, low level valid TP5 signals for ultrasonic sensor driveUS_DR driveUS_DRV1 V1 TP6 signals for ultrasonic sensor drive US_DR US_DRV2 V2

19

 

 

4. 

Bubble detection plate

Bubble detection plate uses LMH6683MAX (U3) high-speed operational amplifier to amplify the weak ultrasonic signals received by the ultrasonic sensor. The received analog signals are sent to the adjunct CPU for determination of bubbles and bubble sizes. Optocoupler U1 and peripheral circuits complete liquid clip on-line detection, optocoupler U2 and peripheral circuits complete designated tube detection. Key testing points J1-1 output signals received by the ultrasonic sensor TP2 amplified ultrasonic signals, TP5 AD in-use signals for bubble detection, 0.4-1.6V when the circuit is filled with liquid, less than 0.3 when the circuit is filled with bubbles.

20

 

  FOR YOUR NOTES

21

 

 

Chapter 3  Testing and maintenance 3.1  Description To ensure long-term stability of the infusion pump, maintenance personnel must provide it with regular inspection, maintenance and testing. In this chapter You will understand the basic testing methods for the infusion pump as well as recommended testing frequency and testing tools. Maintenance personnel should choose proper testing tools and carry out inspection and testing according to the actual needs.

The tests and testing methods provided in this chapter are mainly used to verify whether the  performance of the infusion pump achieves its specifications. If test results do not meet the specifications, it is an indication that a functional module has failed, which must be repaired or replaced immediately. If you have any other questions, please contact our after-sale service department.

CAUTION  

All tests must only be performed performed by qualified q ualified maintenance personnel.

 

Prior to testing, maintenance personnel must ensure the applicability of the testing tools and connecting cables, and they should also be familiar with the use of these tools.

22

 

 

3.1.1  Testing report

Following tests performed by maintenance personnel approved by this Company, please make a record according to the following test report, and send it back to our service department.

Testing equipment

 Name

Model/Number

Valid until

Testing points

Te Test st results

Tester:

Test date:

Test record

 No.

Te Test st

1 2 3 4 5 Test verdict

Pass or No Pass:

3.1.2  Recommended frequency The following tasks must be conducted by professional maintenance personnel approved by the manufacturer.. Must clean and disinfect the device before the test or maintenance. manufacturer

Inspection/Maintenance Items

Frequency

Appearance inspection

First installation, or after each re-installation.

Startup test

1. 

First installation, or after each re-installation.

2. 

After each repair or replacement of host components.

At least once every two years, or when you use a new brand Calibration

of infusion set or when you doubt the accuracy of infusion flow rate.

Operation test

Battery power test

At least once every year, or when you have doubts about the infusion flow rate and/or abnormalities such as pressure alert. 1. 

At least once every year.

2. 

After repair of the infusion pump, or user suspects that the battery is the source of failure.

23

 

 

Inspection/Maintenance Items

Frequency

Housing leakage Electrical

current test

1. 

After the power module is repaired or replaced.

safety test

Patient leakage

2. 

At least once every two years.

1. 

Recommendation: once every month.

2. 

Thoroughly clean the infusion pump casing before or

current test

Cleaning and Disinfection

after long storage periods.

3.2  Appearance inspection 1)

Clean housing, housing, no scratches, fastened assembly and no residues when shaken.

2)

Good handling with the keys.

3)

Complete and correct markings.

4)

Complete standard configuration and fastened sockets.

5)

Perform vibration test before operation test.

3.3  Startup test 1)

Once powered powered on, the pump begins system self-test and and screen display is normal without any error messages;

2)

The speaker beeps once and the buzzer beeps twice;

3)

The red and y yellow ellow alarm lights flash flash in sequence during startup.

4)

Interface for memory mode parameter settings;

NOTE  

Six self-tests corresponding to the six startup self-test codes are as follows. 1. Speaker; 2. Internal flash and external flash; 3. Communication test (drives, power and keys); 4. Alarm lights and buzzers; 5. Pressure coefficient (drive eepROM), 24V power supply; 6. Up and down pressure eeprom (i.e. pressure sensor's EEPROM)

 

If the system self-test fails, press key C to enter the system.

24

 

 

3.4  Accuracy Calibration It is not necessary to perform daily accuracy calibration for the infusion pump. However, calibration should be performed when the pump is used for the first time, or it is replaced with a new brand of infusion set, or you suspect a great flow rate deviation.

Prepare the following materials before the calibration:  

One 5ml measuring cup

 

One 50ml measuring cup

 

One infusion set

The steps for calibration are as follows: 1. 

Connect the infusion set to the infusion bottle (bag) and install the set onto the infusion  pump.

2. 

Enter

the

[Accuracy

Calibration]

interface:

Select

[Main

Menu]→[System

Maintenance]→Input Manufacturer's Maintenance Password →[Accuracy Calibration].

3. 

Follow the prompts and select the brand for the infusion tube, prompts as shown in the diagram will appear on the interface.

4. 

Press and hold

to purge and then place the end of the infusion tube into a clean

5ml measuring cup. 5. 

Press

6. 

After calibration is completed, input the actual liquid volume into [Liquid Volume].

and the infusion pump starts automatic calibration.

25

 

 

7. 

Press

to confirm data and enter into the next calibration interface; place the end of

the infusion tube into a clean 50ml measuring cup.

8. 

Press

9. 

After calibration is completed, input the actual liquid volume into [ Liquid Volume] and  press

10.  Press

and the infusion pump starts automatic calibration.

, "Calibration Completed" prompt will appear on the screen..

to complete calibration and return to the main menu interface.

NOTE  

During accuracy calibration, please use medical normal saline solution, glucose solution or grade III water for experiments.

 

Please remove the needle portion of the infusion tube and do not place the end of the infusion tube above the liquid level in the cylinder.

 

During the installation of the infusion tube, please place the infusion tube flat to the appropriate position and do not bend or stretch it.

26

 

 

3.5  Pressure Calibration 1.  After startup, enter the [Accuracy Calibration] interface: Select [Main Menu]→[System Maintenance]→Input Manufacturer's Maintenance Password →[Pressure Calibration].

2.  Follow the prompts and select the brand for the infusion tube, prompts as shown in the diagram will appear on the interface.

3.  Connect the infusion set to the infusion bottle (bag) and install the set onto the infusion  pump. Connect the se sett to a pressure pressure measuring measuring tool (FLUKE (FLUKE IDA4 IDA4 PLUS PLUS recomme recommended). nded). 4.  Press the start key to begin pressure 1 calibration. Once the pressure reading on the manometer reaches 150mmHg, press the OK key to start collecting pressure values. 5.  After the reading on the manometer stabilizes, follow the prompt and input the pressure value. Press the

key to begin the next "pressure 2" calibration step.

6.  Press the start key to begin calibrating pressure 2. Once the pressure reading on the manometer reaches 500mmHg, press the OK key to start collecting pressure values.

27

 

 

7.  After the reading on the manometer stabilizes, follow the prompt and input the pressure value. Press the

8.  Press

key and "Calibration Completed" prompt will appear on the screen.

to complete calibration and return to the main menu interface.

WARNING  

The Pressure Calibration screen has no occlusion alarm. To avoid risk of serious harm to patients, do not perform infusion in this screen.

NOTE  

The pump cannot be b e switched off directly from the Pressure Calibration screen.

 

If you have doubts dou bts about the accuracy of obstruction alert pressure (pressure value exceeding the alarm threshold), you will need to perform a pressure calibration.

 

Only pressure measuring tools recommended and approved by this Company can be used for the th e pressure calibration. 28

 

 

3.6  Operation test General features:

1)

When various various keys keys are operated on, the Mindray pump shall perform or react react normally in accordance with the

User's Manual;

abnormal operation should not cause the machine

to crash. 2)

Operate the pump in accordance with the User's Manual. Check whether the sound and light alarm of various levels is normal, whether volume control is normal and whether alarm muting is working.

3)

In case of the alarm alarm is set off when the pump was operated in accordance with the User's Manual, check the

historical records and make sure operations and alarms were

 properly recorded. recorded. 4)

After infusion infusion parameters parameters are are properly properly set, press the start key to enter into the operational interface; the operation icon shows normal;

5)

During infusion, infusion, the operation icon, speed, speed, cumulative cumulative volume and pressure pressure value value show show normal;

Networking function (only for machines with wireless networking capabilities):

1)

Regardless of which one of the central station or the pump is powered powered on first, networking shall always work.

2)

Transmission of the infusion data to the central station is normal. normal.

3)

Information on the pump status, infusion parameters parameters and alarm alarm received received by the central central station is correct.

4)

After the network is disconnected at a certain link, central station can correctly correctly indicate the disconnection; when the link is reconnected, networking and work are back to normal.

29

 

 

3.7  Battery power test 1)

Battery on-line system system can give give a prompt when no battery is installed;

2)

After the battery depletion alarm alarm is set off, a pump in operation or a paused pum pump p during operation may not be started.

3.8  Electrical safety test WARNING  

To test the electrical safety of the infusion pump, p ump, the electrical safety test is designed to detect abnormal electrical hazards which, if not discovered, may cause injury to the patient or the operator.



 

Commercially available testing devices such as the safety analyzer may be used u sed for electrical safety tests. Please ask the maintenance personnel to ensure the applicability, functional integrity and safety of such devices as well as to familiarize themselves with the use of these devices.

 

Electrical safety tests shall follow the following standards: EN 60601-1.

 

If local regulations provide provisions otherwise, please follow the provisions when performing relevant electrical safety tests.

 

In the patient area, all devices that are connected to the mains supply as well as to medical equipment must comply with the IEC 60601-1 standards, and must be tested for electrical safety in accordance with the test interval for monitoring devices.

Electrical safety tests are used to detect hazards that may pose electrical safety threats to the  patients, operators and maintenance personnel. Please perform electrical safety tests in a normal environment (including temperature, humidity and atmospheric pressure). While the 601 safety analyzer is used as an example in the electrical safety test described in this chapter,, different safety analyzers may be used in different regions. Please ensure the applicability chapter of the electrical safety test you would like to conduct.

30

 

 

Device connection diagram is as follows:

Testing tools:

  Safety analyzer   Isolation transformer

3.8.1  Housing leakage current test 1. 

Connect the 601 safety analyzer to a power supply of 264VAC 264VAC and 60Hz.

2. 

Using the connection tooling of the application section, connect the application section of the tested device and connect the SUM end of the connection tooling of the application section to the RA end of the safety analyzer. analyzer.

3. 

Connect the tested device, via a power line, to the auxiliary power output jack of the 601 safety analyzer.

4. 

Connect one end of the red test lead to the “Red input terminal” of the safety analyzer and clip the other end to the metal foil attached to the surface of the housing of the tested device.

5. 

Power on the 601 safety analyzer, analyzer, press "5-Enclosureleakage” on the panel of the 601

6. 

safety analyzer, analyzer, starting the interface for the housing leakage current test. Housing leakage current is less than 100μA under normal condition and less than 300μA under single-fault condition.

3.8.2  Ground leakage current test 1. 

Connect the 601 safety analyzer to a power supply of 264VAC 264VAC and 60Hz.

2. 

Connect the application section of the tested device to the RA end of the safety analyzer. analyzer.

3. 

Connect the tested device, via a power line, to the auxiliary power output jack of the 601 safety analyzer.

4. 

Power on the 601 safety analyzer, analyzer, press "4-Earth leakage” on the panel of the 601 safety analyzer,, starting the interface for the ground leakage current test. analyzer

5. 

Housing leak age age current is less than 500μA under normal condition and less than 1000μA under single-fault single-fault condition. 31

 

 

3.8.3  Patient leakage current test 1. 

Connect the 601 safety analyzer to a power supply of 264VAC and 60Hz.

2. 

Using the connection tooling of the application section, connect the application section of the tested device and connect the SUM end of the connection tooling of the application section to the RA end of the safety analyzer.

3. 

Connect the tested device, via a power line, to the auxiliary power output jack of the 601 safety analyzer.

4. 

Power on the 601 safety analyzer, analyzer, press "Patient leakage” on the panel of the 601 safety analyzer.

5. 

Continuously press the "APPLIED PART" PART" key to select AC and DC measurements; “DC” is shown following the limit value of direct current.

6. 

Patient leakage current is less than 10μA under normal condition and less than 50μA under single-fault condition.

If the electrical safety test fails, please contact our technical support team.

3.9  Cleaning and Disinfection 3.9.1  Cleaning The pump should be cleaned regularly. If operating in dirty or sandy areas, cleaning should be more frequent. Before cleaning, please consult or refer to the hospital's specific regulations concerning medical device cleaning.

The following are detergents available for selection:   Warm water  

Dilute soapy water

 

Dilute aqua ammonia

 

Sodium hypochlorite (bleaching powder for washing)

 

Hydrogen peroxide (3%)

 

Ethanol (70%)

 

Isopropanol (70%)

32

 

 

When cleaning the device: 1.

Turn off the pump and disconnect the AC power line.

2.

Wipe the display screen screen afte afterr soft cotton cotton balls absorb absorb an appropriate amount of detergent.

3.

Use a piece of soft cloth which absor absorbs bs a modest amount amount of cleaning cleaning agent to wipe the surface of the device.

4.

When necessary, use a piece of ccloth loth to wipe off off any excess cleaning agents.

5.

Place the equipment equipment in a cool and ventilated environment to dry. dry.

3.9.2  Disinfection The operation of disinfection may cause certain damage to the infusion pump. You are recommended to disinfect only when it is necessary in your desired maintenance plan. Clean the equipment before disinfection.

Recommended disinfectants are ethyl (70% ethanol and 70% isopropanol) and aldehyde.

CAUTION  

Do not use ethylene oxide (EtO) gas or formaldehyde for disinfection.

 

Do not conduct high pressure or high temperature disinfection for the infusion pump and its accessories.

33

 

 

Chapter 4  Troubleshooting 4.1  Description In this chapter faults of infusion pump are classified according to the components and faulty  phenomena. Please refer refer to the relevant relevant Fault Table Table when troubleshoot and examine, identify and and troubleshoot the fault in sequence.

The recommended solutions should help you solve most of the equipment faults you will encounter but not all possible problems. In the case of a fault not covered in this chapter, chapter, please contact our after-sale after-sale service department.

4.2  Replacement of parts You may replace the circuit board components and other major components or parts of this infusion pump. Once you have identified the faulty circuit board component, you may follow the steps described in Chapter 5 Maintenance and Disassembly D isassembly to  to replace the circuit board component.Then you may check whether the fault has been eliminated or whether the infusion  pump will pass relevant tests. tests. If the fault has been been eliminated, which shows that the original circuit  board was faulty, faulty, then please return return the components of the original original circuit board to the Company for repair. If the fault remains, please reassemble the original circuit board and troubleshoot according to other possible causes.

If you would like to know about the replacement parts you need, please refer to to Chapter  Chapter 6 Parts. Parts.

34

 

 

4.3  Check infusion pump status Operation methods for AD value channels and the corresponding tests

1.

Operation method method for starting starting the AD AD value interface: System maintenance maintenance ----- enter the  password --- sensor sensor AD value

2.

AD value interface is as follows.

3.

The meaning meaning of each AD value represents is demonstrated demonstrated in the diagram diagram below. below. 3V value

Battery value

5V value

15V power

25V motor

module

voltage

5V gold

DC power

capacitor

supply and

voltage

multi-serial  port

Up pressure value

Down  pressure

Designated

value

tube status

Code disk detection of

Door

Code disk detection

optocoupler

detection

of steps

4.

Bubble value

Down indicates the output AD value by the down pressure sensor; when the down pressure sensor exerts pressure, this value should increase.

5.

Up indicates the output AD value by the up pressure pressure sensor; when the up pressure sensor exerts pressure, this value should increase.

35

 

 

6.

Code indicates the output output AD value by the code disk detection detection of optocoupler; under normal normal circumstances, this value should be changed among 1, 2 and 3 when the motor is running.

7.

Door's value value indicates indicates the AD value valuess of the door detection sensor and liquid clip detection sensor.

When the infusion pump door is open and the liquid clip is open, Door's value is 3; When the infusion pump door is open and the liquid clip is closed, Door's value is 1; When the infusion  pump door is closed and the liquid clip is closed, Door's Door's value is 0. 8.

Tube indicates designated designated tube on-line detect detection ion (only applicable to closed models models of consumables).

9.

Bubble indicates indicates the bubble sensor value which increases increases after after the tube is installed. Under Under normal circumstances, the value is greater than 700 when the tube is filled with water and less than 150 when the tube is empty. empty.

10. Steps indicates the code disk detection detection of steps, the more the operational operational steps, the gre greater ater the value.. value

4.4  Fault Table VP5 During transport, storage and use, there can be faults that may impact the normal use as a result of various factors (e.g. grid voltage instability, changes in ambient temperature, drop and shock and components aging). In such cases, professional personnel with certain experience of medical equipment maintenance shall carry out component level repair in accordance with the following Fault Classification. The so-called part level repair refers to the analysis, replacement, test-run and identification of the device's faulty part(s), such as power supply, main control section, monitoring section and/or LCD. The repair of parts, also known as component level repair, must  be carried out by the manufacturer's manufacturer's maintenance engineers engineers with rich experience, experience, using specialized equipment, in a specific environment and under specific conditions.

4.4.1  Alarm messages and alarm cancellation  BeneFusion usion V VP5 P5 User's User's Man Manual ual for details. Please refer to BeneF

36

 

 

4.4.2  Faulty machine Faulty phenomenon

Possible cause

Treatment Treatment methods

When external power

1.  Battery is dead;

1.  Battery replacement;

supply is not

2.  Bad connection of the battery

2.  Repair or replacement of the

connected, there is no display on startup,

interface with the wires; 3.  Bad connection of the

 battery indicator is not not

keyboard with the FPC

lit and buzzer does not

wires;

 battery interface interface with the wires; 3.  Re-installment or replacement of FPC wires; 4.  Replacement of the Control

sound.

4.  Faulty Control Board

When external power

1.  Faulty Display;

supply is not

2.  Short circuit

Board 1.  Treatment as with Faulty Display;

connected, there is no

2.  Further examination of the main

display on startup,

control board and other boards.

 battery indicator is lit and buzzer sounds. When external AC  power supply is connected, AC indicator is not lit.

1.  Bad connection of the keyboard with the FPC wires; 2.  Bad connection of the AC  power supply wires; wires; 3.  Faulty AC/DC module.

Self-test 3 not passed; alarm

1.  Bad connection of the keyboard with the FPC wires;

alarm

wires; 2.  Repair or replacement replacement of AC  power supply wires; wires; 3.  Repair or replacement replacement of AC/DC module; 1.  Repair or replacement of FPC wires; 2.  Replacement of the Control

2.  Faulty Control Board;

Self-test 5 not passed;

1.  Repair or replacement of FPC

Board;

3.  Faulty Keyboard

3.  Replacement of the Keyboard.

1.  Faulty power supply of the

1.  Replacement of the Control

main control board 2.  Short circuit of the board

Board 2.  Check each board whether there is short circuit.

Self-test 6 not passed; alarm

1.  Up pressure or down  pressure detection plate plate

1.  Replacement of the up pressure or down pressure detection plate

EEPROM error Unable to charge  properly

1.  Bad connection of the  battery interface interface with the wires;

3.  Replacement of the Control

3.  Faulty Control Board

or measurement measurement

 battery interface interface with the wires; 2.  Replacement of the battery;

2.  Faulty battery;

Failure of an operation

1.  Repair or replacement of the

1.  Damage to the main control  board or its parts

Board 1.  Further examination of the main control board and its parts

function 37

 

 

4.4.3  Faulty Display Faulty phenomenon

Possible cause

Treatment Treatment methods

Power supply normal

1.  Bad connection of the

1.  Repair or replacement of FPC

on startup, black or

keyboard with the FPC

white Display Screen;

wires

Black or white Display Screen during normal operation Error in displayed texts or images

wires; 2.  Replacement of the Display Screen

2.  Faulty Display Screen

3.  Replacement of Keyboard;

3.  Faulty Keyboard

4.  Replacement of the Control Board

4.  Faulty Control Board 1.  Error in burning resource files

1.  Burn resource files again 2.  Replacement of the Control Board

2.  Faulty Control Board

4.4.4  Faulty operation and alarm Faulty phenomenon

Possible cause

Treatment Treatment methods

Key failure

1.  Bad connection of the keyboard with the FPC

1.  Repair or replacement of FPC wires;

wires;

2.  Replacement of Keyboard

2.  Faulty Keyboard Buzzer sound failure

1.  Faulty Control Board

1.  Replacement of the Control Board

Speaker sound failure

1.  Faulty speaker;

1.  Repair of the wires or replacement

or hoarse sound

2.  Bad connection of the  battery interface interface with the

of the speaker's components; 2.  Repair or replacement of the  battery interface interface with the wires;

wires; 3.  Faulty alarm circuit of the speaker

3.  Further examination of the faulty circuit and replacement of the main control board

Failure of the red

1.  Faulty alarm light plate;

alarm light or yellow

2.  Bad connection of the

alarm light

keyboard with the FPC

 backlight

of the alarm light plate; 2.  Repair or replacement of FPC wires;

wires;

Failure of the key

1.  Repair of the wires or replacement

3.  Faulty Keyboard

3.  Replacement of the Keyboard

4.  Faulty Control Board

4.  Replacement of the Control Board

1.  Bad connection of the

1.  Repair or replacement of FPC

keyboard with the FPC wires;

wires; 2.  Replacement of the Keyboard;

2.  Faulty Keyboard; 3.  Faulty Control Board

38

3.  Replacement of the Control Board

 

 

4.4.5  Faulty Monitoring Faulty phenomenon

Possible cause

Tr Treatment eatment methods

Pressure value

1.  Failure of the down

1.  Replacement of the down pressure

unchanged Pressure value overrange False positive on the up obstruction False positive on the door open False positive on the  bubbles

 pressure detection plate 1.  Failure of the down  pressure detection plate 1.  Failure of the up pressure detection plate

detection plate 1.  Replacement of down pressure detection plate 1.  Replacement of the up pressure detection plate

1.  Loose or damaged door detection limit switch

1.  Repair or replacement of the limit switch 1.  Repair of the wires of the

1.  Loose wires of the ultrasonic transmitter chip

ultrasonic transmitter chip or

or damaged ultrasonic

replacement of the keyboard

transmitter circuit

2.  Repair of the wires of the

2.  Loose wires of the

ultrasonic receiver chip or

ultrasonic receiver chip or

replacement of the bubble

failure of the ultrasonic

detection plate

detection circuit

3.  Repair of the wires from the

3.  Loose wires from the  bubble detection plate to

 bubble detection plate to to the main control board

the main control board Motor Error

1.  Failure of the motor

1.  Replacement of the motor detection plate

detection plate; 2.  Bad connection of the

2.  Repair or replacement of the motor wires;

motor wires 3.  Faulty drive circuit for the stepper motor

3.  Replacement of the Control Board; 4.  Replacement of the motor;

4.  Motor error (Err2); Faulty liquid clip

1.  Replacement of the bubble

1.  Faulty liquid clip

detection plate

detection circuit 2.  Loose wires from the

Faulty designated tube

2.  Repair of the wires from the

 bubble detection plate to

 bubble detection plate to to the main

the main control board

control board

1.  Faulty designated tube

1.  Replacement of the bubble detection plate

detection circuit 2.  Loose wires from the

2.  Repair of the wires from the

 bubble detection plate to

 bubble detection plate to to the main

the main control board

control board

39

 

 

Chapter 5  Maintenance and Disassembly NOTE  

During maintenance and disassembly, an anti-static wrist strap should sh ould be worn at all times.

5.1  Tools During disassembly and replacement of parts, you may need the following tools.   Phillips screwdriver (PH1)   Tweezers    Needle-nose pliers pliers 

  Diagonal pliers   Anti-static wrist strap

5.2  Preparation for disassembly Before disassembly of the infusion pump, please stop infusion to the patient, turn off the infusion  pump, and disconnect all accessories accessories and external external equipment.

CAUTION  

Maintenance personnel should eliminate static prior to disassembly. During disassembly of the parts of certain static-sensitive devices, protective gears such as anti-static wrist strap or gloves should be worn to avoid damage to the parts.

 

During re-installation, please make sure the connection wires are plugged in and properly placed to avoid the wires being crushed which may cause a short circuit.

 

Note that suitable screws should be used during re-installation. If incorrect screws are screwed in by force, equipment damage may ensue; during the operation after re-installation, screws or parts may fall off and cause unpredictable damage to the product or personal injury.

 

A certain order must be followed during disassembly. d isassembly. Instead if the equipment is disassembled not in this order and is done forcibly, irreversible damage to the equipment may ensue.

 

When components are disassembled, please ensure that all connection conn ection wires are unplugged and avoid breakage or damage to the connectors.

40

 

 

CAUTION  

Please place the screws and other parts and components in separate places in order to find and use them during re-installation, meanwhile avoid falling, contamination or loss.

 

During disassembly, please retain and protect p rotect the waterproof seals which should not be forgotten or damaged during installation.

5.3  Disassembly procedures 5.3.1  Disassembly of the upper housing assembly  1.  Reverse the machine to the direction as indicated in the diagram. Unscrew and remove the 5 M3x8 Phillips pan head screws connecting the upper housing assembly to the housing base;

Phillips pan head screws and M3x8 dual pads

41

 

 

2.  Vertically and upwardly pull open the housing assembly as indicated in the following diagram;

Upper housing

3.  Unplug the wires of the battery adapter plate from the J3 connector on the battery adapter  plate PCBA as indicated in the following following diagram; J3 connector

4.   Now,  Now, the upper housing assembly can be removed from the host and disassembly of the upper housing assembly is completed.

42

 

 

5.3.2  Disassembly of the pump assembly and the housing base assembly 1.  Remove the 2 M3x8 dual padded screws from the patch wire cover at the bottom of the housing;

Phillips pan head screws and M3x8 dual pads 2.  Remove the patch wire cover as indicated in the diagram;

There are snaps at both ends.

43

 

 

3.  Lift the socket slots on both ends of the connector as indicated in the diagram and pull out the wire arrangement along the direction of the connector; Wire arrangement arrangement of the Display Screen

Lift the slots on both ends. 4.  Unplug the pressure sensor wires from the J5 socket on the main control board as indicated in the diagram and unplug the limit switch wires from J4;

Down pressure sensor

Limit switch wires

wires are plugged into the J5 socket.

are plugged into the J4 socket.

44

 

 

5.  Unplug the code disk detection wires from the JP8 socket on the main control board;

Plug the code disk detection wires into the JP8 socket on the main control  board.

6.  Unplug the motor connection wires from the JP7 socket on the main control board as indicated in the diagram and unplug the bubble detection connection wires from the J3 socket;

Plug the bubble detection wires into the JP3 socket on the main control board.

Plug the code motor wires into the JP7 socket on the main control board.

45

 

 

7.  Reverse the machine to the direction as indicated in the diagram. Unscrew and remove the 5 M3x8 Phillips pan head screws fixing the pump assembly to the housing base;

Phillips pan head screws and M3x8 dual pads

8.   Now  Now,, the pump assembly can be separated from the housing base. Disassembly of the pump assembly is completed.

5.3.3  Disassembly of the front/rear door housing assembly and pump transmission assembly 1.  After opening the infusion pump door, remove the 7 PT2.6×6 stainless steel self-tapping screws inside of the door;

PT2.6×6 stainless steel self-tapping screws, under which a transparent nylon pad (2.5×5×0.5) is placed

46

 

 

2.  Separate the front door housing from the rear door housing as indicated in the following diagram;

Clip

3.  Unplug the ultrasonic wires from the J1 socket on the keyboard and the front door housing assembly is separated from the pump assembly. Disassembly of the front door housing assembly is completed;

Unplug the ultrasonic wires from the J1 socket on the keyboard and plug

47

 

 

4.  Remove the door pivot connecting the rear door housing assembly and pump transmission assembly in the direction as indicated by the arrow in the diagram. Pump transmission assembly is separated from the rear door housing assembly. Remove the door buffer torsion spring and the disassembly of the rear door housing assembly and pump transmission assembly is completed.

Door buffer Door pivot

48

torsion spring  spring 

 

 

5.3.4  Disassembly of the alarm light plate, keyboard and display screen 1.  Unplug the alarm light wires from the JP3 socket on the keyboard and remove the alarm light  plate along the direction of the positioning column. Disassembly of the alarm light plate is completed.

SP5 alarm light  plate PCBA  PCBA 

JP3 connector on the keyboard

Positioning column

2.  Unplug the FPC wires on the display screen from the J5 connector on the keyboard; Plug the FPC wires on the display screen into the socket J5 on the keyboard

49

 

 

3.  Remove the 4 PT2.6×6 self-tapping screws by which the keyboard is fixed and remove the keyboard along the direction of the limiting column. Disassembly of the alarm light plate is completed; Limiting columns and spacing holes

Pan head thread cutting self-tapping screws PT2.6×6

4.  As indicated in the diagram, directly remove the display screen after the disassembly of the alarm light plate is completed. Disassembly of the display screen is completed.

Display   Display

50

 

 

5.3.5  Disassembly of the pressure sensor assembly, pump tablet installation assembly, liquid clip assembly and pump ultrasonic chip assembly 1.  Remove the 7 M3X8 dual padded screws by which the cam & motor assembly are fixed and the 4 M3X8 dual padded screws by which the pump tablet installation assembly is fixed as indicated in the following diagram; M3X8 dual padded screws (locking the pump tablet installation assembly)

M3X8 dual padded screws (locking the cam & motor assembly)

2.  Separate the VP5 cam & motor assembly from the pump transmission assembly; Positioning pin

VP5 cam & motor assembly

51

 

 

3.  Unplug the connection wires of the ultrasonic sensor and down pressure sensor from the J1 and J2 sockets respectively on the bubble pressure plate; Down pressure sensor connection wires are plugged into the J2 socket.

Plug the connection wires of the pump ultrasonic sensor into the J1 socket.

4.  Remove the 4 M3x8 self-tapping screws by which the up pressure sensor and down pressure sensor assemblies are fixed. Disassembly of the pressure sensor assemblies is completed;

M3x8 dual padded screws

52

 

 

5.  Remove the M3x14 Phillips pan head screw at the pump base by which the liquid clip assembly is fixed. Remove the liquid clip assembly along the direction of the arrow. Disassembly of the liquid clip assembly is completed;

Phillips pan head screws M3x14

6.  Remove the pump tablet installation assembly along the direction of the arrow as indicated in the diagram. Disassembly of the pump tablet installation assembly is completed;

VP5 pump tablet installation assembly 7.  Remove the pan head thread cutting self-tapping screws PT2.6×6 by which the pump ultrasonic clip assembly is fixed;

Pan head thread cutting self-tapping screws PT2.6×6

53

 

 

8.  Remove the pump ultrasonic clip assembly along the direction of the arrow as indicated in the diagram. Disassembly of the pump ultrasonic clip assembly is completed.

VP5 pump ultrasonic clip assembly

5.3.6  Dissembly of the Main Board  1.  Unplug the wires on the main board PCBA; 2.  Remove the 5 PT3×8 self-tapping screws and 2 M3X12 pan head dual padded screws by which the main board is fixed; PT3×8 self-tapping screws

M3X12 pan head dual padded screws

54

 

 

3.  Remove the AC socket bracket and main control board respectively along the direction of the mouth of the housing base and the limiting columns. Disassembly of the main control board is completed. Place the two limiting columns through the spacing hole of the main control board Align the AC socket  bracket with the mouth of the housing  base

55

 

 

Chapter 6  Components 6.1  Description In this chapter the exploded views of the main components of the infusion pump host and their material codes are listed to help the maintenance personnel identify the components during disassembly and replacement of parts. Structural system of the infusion pump host is indicated in the following diagram.

Host

Upper housing assembly 

Pump assembly 

Front door housing assembly 

Rear door housing assembly 

Pump Base 

Lower housing assembly 

Pump transmission assembly 

Pump tablet

Cam & motor

Liquid clip

installation

assembly 

assembly 

assembly 

Diagram 1 Structure and Composition

56

 

 

6.2  Host 6.2.1  Exploded view

Diagram 2 Exploded View of the Host

6.2.2  Parts List  No.

Sub-part code

Sub-part description

No.

1

115-024527-00

VP5 pump components

1

2

033-000460-00

VP5 snap hook

2

3 4

115-024511-00 043-004208-00 043-00420 8-00

VP5 housing base assembly Mindray Pump Stack Locking Snap (common-mode materials)

1 1

5

115-024510-00 115-024510-00

VP5 upper housing assembly

1

6

043-004180-00

Multifunction interface

1

7

049-000661-00

VP5 rubber stopper for the drop number interface

1

8

049-000664-00

Foot pad

4

9

043-004406-00

VP5 housing base patch wire cover

1

10

048-003782-00

SP5 compaction cotton for wire arrangements arrangements

2

11

030-000305-00

12

043-005155-00

Pan head thread screws assembly GB/ T9074.8 M3X8 nickel-plated VP5 pump tablet waterproof membrane assembly assembly Table 1 Host Parts List 57

12 1

 

 

6.3  Upper housing assembly 6.3.1  Exploded view

Diagram 3 Exploded View of the Upper Housing

6.3.2  Parts List  No.

Sub-part code

Sub-part description

No.

1

043-004426-00

VP5 host housing

1

2

051-001592-00

SP5 battery interface PCBA

1

3

M04-003105---

Pan head thread cutting self-tapping screws PT3×8 zinc-plated

3

4

048-003783-00

Mindray Pump battery adapter plate sponge

1

5

009-004119-00

Wire electronic electroni c wire 3P2 speaker assembly spacing 1.25mm

1

6

043-004209-00

SP5 speaker briquetting (common-mode (common-mode materials)

1

7

048-003941-00 048-00394 1-00

EVA EVA matte (8.8×4.5×3)

1

8

022-000161-00

Lithium battery Li-ion 7.4V 4800mAh SK04B9003

1

9

043-004182-00

Battery chamber snaps

1

10

043-004183-00

SP5 battery door

1

Table 2 Upper Housing Assembly Parts List 58

 

 

6.4  Pump components 6.4.1  Exploded view

Diagram 4 Exploded View of the Pump

6.4.2  Parts List  No.

Sub-part code

Sub-part description

No.

1 2

115-024516-00 115-024516-00 041-013053-00

Pump transmission assembly assembly VP5 door pivot

1 3

3

M04-003105---

4

041-010090-00

5

009-002714-00 009-002714 -00

Ties 3*150mm

1

6

115-021567-00 115-021567-00

SP5 cam detection support assembly

1

7

115-021568-00 115-021568-00

SP5 push box assembly

1

Pan head thread cutting PT2.6×6 stainless steel  passivation self-tapping self-tapping screws screws Pan head thread cutting PT2.6×6 stainless steel  passivation self-tapping self-tapping screws screws

Table 3 Pump Assembly Parts List

59

7 7

 

 

6.5  Pump transmission assembly 6.5.1  Exploded view

Diagram 5 Exploded View of the Pump Transmission

6.5.2  Parts List  No.

Sub-part code

Sub-part description

No.

1

043-004433-00-01

VP5 Pump Base

1

2

115-024517-00 115-024517-00

VP5 pump tablet installation assembly

1

3

041-013053-00

VP5 door pivot

2

4

041-016597-00

VP5 door sleeve ring

2

5

115-02 4523-00 115-024523-00

VP5 pump ultrasonic ultraso nic clip assembly

1

6

030-000284-00

Pan head thread cutting self-tapping screws PT3×8 zinc-plated

1

7

115-024524-00 115-024524-00

VP5 liquid clip assembly

1

8

M04-051016---

Pan head screws GB/T818-2000 M3X14 zinc-plated

1

9

115-024521-00

Cam & motor assembly

1

10

030-000305-00

11

115-024522-00

VP5 pressure sensor

2

12

049-000692-00

VP5 pressure detection silicone

2

Pan head thread screws assembly GB/ T9074.8 M3X8 nickel-plated

Table 4 Pum Pump p Transmission Assembly Parts List 60

15

 

 

6.6  Pump tablet installation assembly 6.6.1  Exploded view

Diagram 6 Exploded View of the Pump Tablet Tablet Installation

6.6.2  Parts List  No.

Sub-part code

Sub-part description

No.

1

043-005375-00 043-00537 5-00

VP5 Pump Tablet Installation Installat ion Base

1

2

041-016960-00

VP5 liquid clip pump tablet - after machine addition

2

3

041-016959-00

VP5 compression compression pump tablet - after machine addition

3

4

033-000333-00

VP5 pump tablet reset spring (ID7.6x13)

5

5

041-013054-00

VP5 pump tablet pin

5

6

032-000382-00

Deep groove ball bearings.3X8X3/MR83ZZ bearings.3X8X3/MR83ZZ stainless steel

5

7

M04-021060---

Open-ended ring GB/T896-1986 6 nickel-plated

5

Table 5 Pum Pump p Tablet Tablet Installation Assembly P Parts arts List

61

 

 

6.7  VP5 cam & motor assembly 6.7.1  Exploded view

Diagram 7 VP5 Exploded View of the Cam & Motor Assembly

6.7.2  Parts List  No.

Sub-part code

Sub-part description

No.

1

041-013055-00 041-013055 -00

VP5 Pump Base Pad Assembly

1

2

041-013057-00

VP5 camshaft camshaft support block

2

3

BA30-10-06606

Deep groove ball bearings.5X14X5/F605ZZ bearings.5X14X5/F605ZZSRL SRL

2

4

041-013056-00

VP5 camshaft camshaft

1

5

051-001597-00

VP5 motor detection plate PCBA

1

6

043-004416-00

VP5 camshaft code disk (common-mode (common-mode materials)

1

7

043-004420-00

Driven synchronous wheel 3Mx30 toothed

1

8

030-000305-00

9

031-000283-00

Synchronous belt 3M-135-6

1

10

115-024520-00 115-024520-00

VP5 motor assembly assembly

1

Pan head thread screws assembly GB/ T9074.8 M3X8 nickel-plated nickel-plated

Table 6 VP5 Cam & Motor Assembly Parts List

62

11

 

 

6.8  VP5 liquid clip assembly 6.8.1  Exploded view

Diagram 8 VP5 Exploded View of the Liquid Clip

6.8.2  Parts List  No.

Sub-part code

Sub-part description

No.

1

M04-003105---

Pan head thread cutting self-tapping screws PT3×8 zinc-plated

6

2

043-004423-00

VP5 liquid clip upper cover (common-mode (common-mode materials)

1

3

033-000334-00

VP5 liquid clip operating lever reset torsion spring (ID4.5x2.5)

1

4

115-024525-00 115-024525-00

VP5 liquid clip switch assembly

1

5

041-013059-00

VP5 liquid clip connecting shaft

2

6

044-000612-00

VP5 liquid clip execution lever and metal lever

1

7

043-004422-00

VP5 liquid clip base box (common-mode (common-mode materials)

1

8

051-001596-00

VP5 sensor PCBA

1

9

033-000335-00

VP5 liquid clip execution lever spring (ID5 x20)

1

Table 7 VP5 Liquid Clip Assembly Parts List

63

 

 

6.9  VP5 front door housing assembly 6.9.1  Exploded view

Diagram 9 VP5 Exploded View of the Front Door Housing

64

 

 

6.9.2  Parts List  No.

Sub-part code

Sub-part description

No.

1

043-004995-00-01 

VP5 front door housing assem assembly bly

1

2

049-000672-00 

Mindray pump silicone keys 

1

3 4

048-004308-00  047-012023-01 

compaction cotton for display screen Mindray pump display 

4 1

5

048-004491-00 

VP5 waterproof foam for alarm light

1

6

051-001591-01 

SP5 alarm light plate PCBA

1

7

048-004310-00

Mindray dust mat for pump display

1

8

021-000056-00

LCD screen TFT 3.5” 272*480 3.3V

1

9

051-001593-02

SP5 keyboard PCBA

1

10

048-004537-00

VP5 keyboard buffer foam

1

11

M04-051004--- 

12 13

009-004212-00  048-003782-00 

wire FPC electronic wire spacing 30P 1.0 different surface 

1 

SP5 compaction cotton for wire arrangements arrangements

3

14

048-003942-00 

Keyboard shading sponge

1

Pan head thread cutting self-tapping screws PT2.6X6 zinc-plated

Table 8 VP5 Front Door H Housing ousing Assembly Parts List

65

4

 

 

6.10  VP5 rear door housing assembly 6.10.1 Exploded Exploded view

Diagram 10 VP5 Exploded View of the Rear Door Housing

66

 

 

6.10.2 Parts Parts List  No.

Sub-part code

Sub-part description

No.

1

043-004411-00-01  

VP5 rear door housing

1

2

043-004408-00 

VP5 up pressure indenter (common-mode materials) 

1

3 4

043-004412-00  033-000332-00 

VP5 briquetting block VP5 pressure indenter spring (ID3x15) 

1 3

5

043-004410-00 

VP5 briquetting block indenter (common-mode (common-mode materials)

2

6

033-000330-00 

VP5 briquetting block liquid clip spring (ID5X12)

2

7

033-000328-00

VP5 briquetting block spring (ID6X12)

2

8

M04-051004---

9

042-011270-00

VP5 door reinforcing plate

1

10

043-004409-00

VP5 down pressure indenter (common-mode (common-mode materials)

1

11

115-024515-00

VP5 door ultrasonic clip assembly assembly

1

12 13

048-004517-00 048-003782-00

VP5 door reinforcing plate tape SP5 compaction cotton for wire arrangements arrangements

1 1

14

048-004060-00

VP5 waterproof foam for door assembly

1

15

048-004059-00 

VP5 briquetting block waterproof foam (ID6X12)

1

16

041-013051-00 

VP5 door snap 

2 

17

033-000329-00 

VP5 door latch torsion spring (ID4.5x6) ( ID4.5x6)

1

18

115-024514-00 

Door handle assembly assembly

1

Pan head thread cutting self-tapping screws PT2.6X6 zinc-plated

Table 9 VP5 Rear Door Housing Assembly Parts List

67

9

 

 

6.11  VP5 housing base assembly 6.11.1 Exploded Exploded view

Diagram 11 VP5 Exploded View of the Housing Base Assembly

6.11.2 Parts Parts List

 No.

Sub-part code

Sub-part description

No.

1 2

043-004428-00  M04-003105--- 

VP5 host base Pan head thread cutting self-tapping screws PT3×8 zinc-plated

1 6

3

051-001594-00 

VP5 main control board PCBA

1

4

030-000242-00 

M3x12 pan head screws

2

5

043-004215-00-01 043-004215-00-01

AC socket support (after plastic wrapping)

1

6

009-004532-00

Wire electronic wire 12P double-headed wire (with magnetic ring) spacing 2.0mm

Table 10 Cam Detection Support Assembly Parts List

1

68

 

 

FOR YOUR NOTES

69

 

 

Chapter 7  Upgrade 7.1  Tools During upgrade, you may need the following tools.   Multifunction serial line   PC   PC burning of tool software

7.2  Software upgrade This infusion pump supports software upgrade. The burning software can be directly run on a desktop PC or mobile PC. Through a multi-serial port, the infusion pump can be connected to a PC and upgrade the main program, driver software, power supply board software and key board software. (upgrades for the drug library and built-in infusion set brands will be available)

7.2.1  Software burning method 1.  Connect the multifunction serial line to the multi-functional port on the host as indicated in the diagram; Multifunction interface

Multifunction serial line

70

 

 

2.  The other end of the multifunction serial line is a standard BD9 serial port. Connect this end to the PC as indicated in the diagram;

3.  Without plugging into AC power supply, open the battery chamber and remove the lithium  batter; 4.  Meanwhile simultaneously press the "Start" and "Power" keys on the machine panel. And now  put the battery back; the machine enters enters into boot and the display screen shows BootL BootLoader oader as indicated in diagram 1.3.

71

 

 

5.  Open the PC burning tool (G-GCRJ-0004) as indicated in the diagram. At this time the "Upgrade" menu is not available and may not be selected;

"Upgrade" menu may not be used at this time. 6.  Click "Administrator Login" and login password dialog box pops up, as indicated in the diagram;

7.  Input password and now upgrade menu becomes available, as indicated in the digram;

"Upgrade" menu may

72

 

 

8.  Select "Upgrade" and an interface as shown in the diagram appears; Click here to import software.

9.  Under the upgrade interface, select "Browse" and choose the software package to be burnt, as indicated in the diagram; Package saving path

10.  Click "Upgrade" at the upper right corner of the PC burning tool software and the software starts burning; 11.  After the burning is completed, upgrade status indicates "Success" and upgrade progress indicates “100%”, as shown in the diagram;

12.  Remove the battery to switch off the machine and disconnect the multifunction serial line.  Now,, the software burning  Now burning is completed.

73