SK-600II 输液泵
Infusion Pump
维修手册
Service Manual
Intellectual Property Rights
The intellectual property right of this product and its Service Manual belongs to Shenzhen Shenke Medical
Instrument Technical Development Co., Ltd. (hereinafter short as Shenke).
Shenke reserves the right to final interpretation of this Service Manual. Without prior approval from Shenke
in writing, this Service Manual shall not be photocopied, modified or translated, fully or partially, by any
individual or organization.
,
and
are trademarks or registered trademarks of Shenke.
I
Foreword
Introduction
This Service Manual provides detailed introduction of the product and its components, as well as the
procedures for installation, removal, testing and troubleshooting, intended to help the service technicians solve the
common problems effectively. This Service Manual does not provide depth introduction on the product structure
and design principle. In case of any problems you cannot solve, please contact our After-sale Service Division.
This Service Manual describes the product based on most complete configurations, so that some parts might
be unsuitable to your product. If you have any questions, please contact our After-sale Service Division.
Before repairing the product, please read this Service Manual thoroughly until full understanding of the
contents herein, so as to ensure correct repair and avoid causing damage to the product or human body.
Target Readers
This Service Manual is intended for the biomedical engineers, authorized repairmen or service
representatives responsible for maintenance of this product.
Version Information
With the change of software or technical specifications, the version number of this Service Manual is subject
to updating without prior notice. Version information of this Service Manual is as follows:
■ Version: 1.0
■ Date Released: 2011-12
© 2011 All rights reserved. Shenzhen Shenke Medical Instrument Technical Development Co., Ltd.
II
Contents
Chapter 1 Safety ........................................................................................................................................................ 1
1.1
1.2
Safety Information ................................................................................................................................. 1
1.1.1
DANGER.................................................................................................................................... 2
1.1.2
WARNING ................................................................................................................................ 2
1.1.3
CAUTION ................................................................................................................................. 2
1.14
NOTES .......................................................................................................................................... 3
Symbols ................................................................................................................................................. 4
Chapter 2 Principle of Design.................................................................................................................................... 1
2.1
Overview ............................................................................................................................................... 1
2.2
System Breakdown ................................................................................................................................ 1
2.3
Hardware Configuration ........................................................................................................................ 3
.2.3.1
Mainboard .................................................................................................................................. 3
2.3.2
Pump Body ................................................................................................................................ 4
2.3.3
Power Board .............................................................................................................................. 5
2.3.4
Air Bubble Pressure Board ........................................................................................................ 6
2.3.5
Battery Cover Plate .................................................................................................................... 7
2.3.6
Door Opening Detection Board ................................................................................................. 7
2.3.7
Infusion Rate Sensor .................................................................................................................. 7
Chapter 3Test and Maintenance................................................................................................................................. 1
3.1
Introduction ........................................................................................................................................... 1
3.1.1
Test Report ................................................................................................................................. 1
3.1.2
Recommended Interval .............................................................................................................. 1
3.2
Visual Inspection ................................................................................................................................... 2
3.3
Power-On Self-Test (POST) .................................................................................................................. 2
3.4
Infusion Flow Test ................................................................................................................................. 3
3.5
Pressure Sensor Test .............................................................................................................................. 4
3.6
Battery Test ............................................................................................................................................ 5
3.7
Electrical Safety Test ............................................................................................................................. 5
3.7.1
Electric Leakage Test of Enclosure ............................................................................................ 6
3.7.2
Electric Leakage Test of Patient................................................................................................. 7
3.8
Cleaning and Sterilizing......................................................................................................................... 7
4.1
Overview ............................................................................................................................................... 1
4.2
Replacing Components .......................................................................................................................... 1
4.3
Technical Alarm and Diagnosis ............................................................................................................. 1
4.4
Troubleshooting Guideline .................................................................................................................... 3
4.4.1
Power-On / Power-Off Trouble .................................................................................................. 3
1
4.4.2
Screen Malfunction .................................................................................................................... 3
4.4.3
Alarm Fault ................................................................................................................................ 4
4.4.4
Keypad Fault .............................................................................................................................. 4
4.4.5
Motor Fault ................................................................................................................................ 4
4.4.6
Pressure Sensor Fault ................................................................................................................. 4
4.4.7
Air Bubble Sensor Fault ............................................................................................................ 4
4.4.8
Communication Error ................................................................................................................ 5
4.4.9
Power Source Fault .................................................................................................................... 5
4.4.10
Infusion Rate Sensor Fault ......................................................................................................... 6
chapter 5 Repair and Disassembly ............................................................................................................................. 1
5.1
Tools ...................................................................................................................................................... 1
5.2
Preparations for Disassembly ................................................................................................................ 1
5.3
Disassembly Steps ................................................................................................................................. 2
5.3.1
Separation of Front and Rear Enclosure .................................................................................... 2
5.3.2
Disassembly of Power Board ..................................................................................................... 4
5.3.3
Removal of Front Enclosure Set ................................................................................................ 4
5.3.4
Removal of Mainboard .............................................................................................................. 7
5.3.5
Removal of Pump Body............................................................................................................. 8
5.3.6
Removal of Battery Plug Set.....................................................................................................11
chapter 6 Components ............................................................................................................................................... 1
6.1
Machine Components ............................................................................................................................ 1
6.2
Pump Body Assembly............................................................................................................................ 3
2
Chapter 1 Safety
1.1 Safety Information
This chapter describes the basic safety considerations that the user must take notice and abide by when
repairing or operating the infusion pump. The same or similar safety information or other safety information
related to actual operation will appear in other chapters.
DANGER

To indicate immediate danger. If not avoided, it might cause death, severe
human injury or property loss.
WARNING

To indicate the potential hazard or unsafe operation. If not avoided, it might
cause death, severe human injury or property loss.
CAUTION

To indicate the potential hazard or unsafe operation. If not avoided, it might
cause slight human injury, product problem, damage or property loss.
NOTES

To emphasize the important considerations, provide description or explanation
for better repair of this product.
1.1.1 DANGER
DANGER

The infusion pipe must be flatly installed to the bottom of the groove on infusion
pump.
1.1.2 WARNING
WARNING




Only the service people authorized by Shenke are allowed to disassemble the
infusion pump. The repair or upgrading of the infusion pump must be done by
the repairmen that are trained and authorized by Shenke.
To avoid fire or explosion, do not use the infusion pump in an environment with
inflammable or explosive substances like anesthetics.
The infusion pump is of Class II electric protection. The PE end of the included
Class I power cord shall not be used for protective earthing or functional
earthing.
Disposal of packaging materials must comply with the local laws or the waste
treatment regulations of the hospital. The packaging materials must be put at a
place out of the children’s reach.
1.1.3 CAUTION
CAUTION




The electromagnetic field will affect the performance of infusion pump.
Therefore, the other devices near the infusion pump must comply with
associated EMC requirements. Mobile phone, X-ray or MRS device are possible
sources of interference, as they can emit electromagnetic radiation of high
intensity.
Avoid sterilizing the infusion pump at high pressure or exposing it to chemical
substances.
Before turning on the power supply of infusion pump, please confirm if the
power voltage and frequency comply with the specifications marked on the label
or defined in the Instruction Manual.
During repair, take care to prevent the infusion pump from damage caused by
falling, knock, severe vibration or other external forces.
2
1.14
NOTES
NOTES



For details on the use of infusion pump and other information, please refer to the Instruction
Manual.
This Service Manual describes the product based on the most complete configurations and
functions. Maybe your infusion pump does not have some configurations or functions.
Please do not insert the equipment not designated by Shenke into the data interface.
3
1.2 Symbols
Note! Check the Instruction Manual.
Class II equipment
IP21
Type BF applied part
Keep away from dropping water
Alternating current (AC)
Direct current (DC)
Production Batch No.
Machine Serial No.
Date of Production
Manufacturer
Pollution-free Treatment
Wireless
device
Up or number increment
Up or number decrement
Confirm
Set
Stop
receiving
/
emitting
Eliminate alarm
Start
Quick forward
Clear
Select
ON
OFF
Decimal point
Caution against
transport
Fragile! Handle with care during transport
Keep upright during transport
rain
during
At most 5 layers stacked on same
packaging
Device complies with EC Directive 93/42/EEC and the basic requirements in its Appendix I. So
it is registered with CE Mark.
4
Chapter 2 Principle of Design
2.1 Overview
This infusion pump is intended for accurate continuous infusion of the drug to a single elderly person, child
or newborn baby patient.
2.2 System Breakdown
The system is broken down by mechanical components, hardware and software. The composition diagram is
as below:
System
Mechanical Part
Hardware -
Software
Host Computer
Mainboard
System Software
Front Enclosure
Assembly
Power Board
Driver
Pump Body
Assembly
Rear Enclosure
Assembly
Infusion Rate Sensor
Air Bubble Pressure
Board
Battery Cover Plate
Door Opening Detection
Board
Infusion Rate Sensor
Air Bubble Pressure
Board Software
The system card connection diagram is as below:
Mainboard
CN3
Door Opening
Detection Board
Pressure sensor
FPC1
P_Gate
PYL_1
Flash2
1
Ultrasonic
emitting
P_RX1
Power Board
Qpyl
P_TX1
CN2
Air Bubble
Pressure Board
CN1
P1
PS52
Ultrasonic
receiving
Stepper Motor
P1
Battery Cover
Plate
2
Battery
Infusion
Rate
Sensor
2.3 Hardware Configuration
Schematic Diagram:
Stepper Motor
Battery
Battery
Cover
Plate
Power Board
AC
Serial
Communication
Mainboard
3.3V/5V Power
Supply
5V Power Supply
Serial Communication
Air Bubble
Pressure Board
The system core is mainboard and power board. LCD display and its power source are controlled by the
mainboard. The measuring and status information of each module is processed by the power board before sending
to the mainboard. Finally under the control of mainboard, the information is displayed on the screen. The
mainboard is also assigned to control the buzzer and status indicator. All modules are powered by the power board.
The power board is also assigned for driving of the motor, measuring of each sensor and processing of status
information.
.2.3.1 Mainboard
The mainboard serves for information integration of the whole system. It is designed to control the LCD and
the functions such as keypad input, buzzer sound and parameter saving.
3
2.3.1.1 Schematic Diagram
SRAM
MCU
Screen
Buzzer
Run_LED
Keypad
Logic Gate
Circuit
EEPROM
5V
3.3V
Serial Port 1: Power Board
Serial Port 2: ZIGBEE wireless module
2.3.1.2 Function Introduction
The mainboard communicates with the power board or ZIGBEE wireless module on power board via the
extended serial port of logic gate circuit.
The mainboard provides the display information to LCD and detects the key operation, realizing the user
interface；
The mainboard controls the buzzer for its alarm sound as well as the key stroke sound.
The mainboard controls the run indicator via adaption from power board.
SRAM supports the temporary storage of data and run of the program. EEPROM is used as the memory on
the machine.
2.3.2 Pump Body
The pump device is the provider of dynamic force to the whole system and it is the source of power to
deliver the liquid. During operation, the stepper motor drives the cam shaft to rotate, so that the pump impeller
reciprocates up and down by a specific sequence and rule as waves to squeeze the intravenous infusion pipe,
pushing the liquid in the infusion pipe to flow at a preset speed
4
Schematic Diagram
Infusion pipe
Pump impeller
2.3.3 Power Board
The power board receives the function information from air bubble pressure sensor and then sends it to the
mainboard. It also drives the stepper motor to run according to the information from the mainboard. The power
board is also assigned to convert the power supply (from city grid and battery) into the power required for each
board. It also supports battery charging.
5
2.3.3.1 Schematic Diagram
5V
3.3V
LDO
AC
Input
AC/DC
MCU
Power ON/OFF
12V
12V
Recharging
circuit
Voltage Rise
Circuit
Serial Port
5V Output
7.4V
Logic Gate Circuit
Motor
Test
Circuit
Battery
Drive circuit
Energizing
Circuit
18.9V
Stepper
Motor
18V Output
Enable Off
Enable input
2.3.3.2 Function Introduction
When AC power is input to the power board, 12V DC voltage is first obtained via a safety certified power
module. This DC voltage is used as the main input for DC/DC conversion and recharging circuit. In this case, we
can not only recharge the lithium battery, but also obtain 5V, 3.3V and 18.9V DV voltage via conversion by 5V
DC/DC, 3.3V LDO and 18.9V DC/DC circuit.
Except the power supply functions, the MCU on power board is also assigned for processing the
measurement and status information from the sensors before sending it to the mainboard. It also controls the run
of stepper motor according to the commands from the mainboard.
2.3.4 Air Bubble Pressure Board
The air bubble pressure board provides the functions to detect the air bubble, occlusion and door opening. It
detects the air bubble by checking the attenuation of ultrasonic wave in different materials, while it detects the
occlusion by using the pressure sensor.
6
Schematic Diagram
Ultrasonic generating
circuit
Ultrasonic receiving
circuit
To
Door opening detection
Power board
MCU
5V Input
Pressure amplifying circuit
Pressure information output
2.3.4.3 Function Introduction
The central processor on ultrasonic pressure board will process the signals from the ultrasonic circuit and
door opening sensor, and then send them to MCU on mainboard.
The pressure amplification circuit will amplify the weak voltage signals from pressure sensor before sending
them to the power board.
2.3.5 Battery Cover Plate
The main function of battery cover plate is to adapt the AC power cord. Connecting 2 pcs of 2A 250V fuse in
series on AC power cord can protect the downstream circuits.
2.3.6 Door Opening Detection Board
A micro switch is placed on the door opening detection board. Any change in handle status can affect the
closing of micro switch. In this case, we can know the status of handle from detecting the closing state of the
micro switch.
2.3.7 Infusion Rate Sensor
Schematic Diagram:
IR Emitting Circuit
IR Receiving Circuit
7
Power Board
The infusion rate sensor is fixed on the liquid filter. Measuring method: When the liquid droplet drips down
through the filter, it will impede the receiving of infrared light in the sensor. By applying the pulse signals
generated from the infrared light of different intensity, the dripping frequency of liquid drops is exchanged into
the flow rate of infusion. And by using this signal for feedback of actual infusion condition of the pump, we can
detect if there is any liquid leakage.
8
Chapter 3Test and Maintenance
3.1 Introduction
To ensure long reliable run of the infusion pump, the service people shall carry out periodical inspection,
maintenance and testing. This chapter provides the basic testing methods for infusion pump. In this chapter, we
have also recommended the suitable testing intervals and tools. The service people are required to repair and test
the infusion pump as needed, and select the suitable testing tools.
The testing and inspection methods provided in this chapter are mainly used for verifying if the infusion
pump reaches the performance requirements. If the testing result does not meet the requirements, it indicates that
some function module of the infusion pump is failed. In this case, immediate repair or replacement is required. If
you have any other questions, please contact our After-sale Service Division.
CAUTION



All the tests must be done by qualified service people.
Be sure to take care when setting or changing the contents in [Advanced Setting]
menu; otherwise it might cause loss of data.
Before testing, the service people shall ensure if the testing tools and connection
wires are suitable. The service people shall have good skills on use of these testing
tools.
3.1.1 Test Report
After finishing the test, our service people are required to complete the following test report and send it back
to the After-sale Service Division.
Test Equipment
Name
Model / Number
Effective Date
Test Point
Test Result
Tester:
Test Date:
Test Records
S/N
Test Item
1
2
Judgment
If OK:
3.1.2 Recommended Interval
Check / Maintenance Item
Interval
Visual Inspection
After the first installation or each reinstallation.
Power-On Self-Test (POST)
1.
2.
Infusion Flow Test
Every 6 months, by using the graduated cylinder and
stopwatch.
Pressure Sensor Test
1.
2.
3.
Battery Test
Electrical
Safety Test
1.
2.
Electric
Leakage
Test of Enclosure
After the first installation or each reinstallation.
After each repair or replacement of the pump
components.
When the user doubts the pressure is occluded or
the measurement is incorrect.
After each repair or replacement of the module.
Every 6 months
Every year
Before repair of infusion pump or when the user
doubts that the battery is cause of trouble
1. After repair or replacement of the power module
2. Every 2 years the shortest
Electric
Leakage
Test of Patient
Cleaning and Sterilizing
1. Every month recommended.
2.
Thorough cleaning of the pump surface required
before or after a long storage.
3.2 Visual Inspection
The visual inspection is intended for thorough inspection of the appearance of infusion pump. The infusion
pump passes the visual inspection if there is no obvious physical damage. The inspection items include:




If there is physical damage to the pump enclosure, screen or keypad.
If the AC power plug and cord are worn, and if the pins in the power socket are loose or twisted.
If the peripheral interface of infusion pump is loose or if the pin is twisted.
If the safety label and nameplate are clear and legible.
3.3 Power-On Self-Test (POST)
The POST is intended for determining if the infusion pump can be normally started to run. The infusion
pump passes the POST if it can complete the startup process according to the steps below：
1. Connect the infusion pump to AC power source.
2. Press
key. The infusion pump will give out “DI...” startup music.
3. The system gives outs a “DU” sound (indicating the alarm sound self-test is passed); all LEDs on the panel
light up and then the LED on top left is dark (indicating the alarm lamp self-test is passed).
2
4. The startup image disappears and the system enters into main interface, indicating the normal startup is
finished.
3.4 Infusion Flow Test
Make combination as per the infusion rate and preset volume below. When the infusion is started, use the
stopwatch to count the time and use the graduated cylinder to receive the liquid flowing out from the infusion
pump. Stop infusion when up to the specified time (30 min. recommended for measuring the low rate; and 6 min.
recommended for measuring the middle rate and highest rate. For the low rate, middle rate and high rate for
different models, see the description in a), b) and c) below). Record the time and read the graduated cylinder. Then,
calculate the flow rate as per the formula (1). The result shall comply with the requirements in 4.3.2.
Infusion rate = Infusion liquid volume / count time …………………………(1)
Select 5ml/h, 1000ml/h and 2000ml/h as the test points. Perform 3 measurements at each point and take the
maximum error.
Note: In the test a), b) and c) above, it is needed to adjust the position of pipe clamp on infusion set or replace the
infusion set before each test.
Liquid Level
Liquid Container (Open or foldable bag)
Drip kettle (if included)
Injection needle (18G, 1.2mm. See GB15811)
Connection
device
Input
Output
Electronic balance
Computer
3
3.5 Pressure Sensor Test
Testing tools:
 Infusion bottle
 Infusion pipe
 Precision pressure gauge: calibrated
Testing procedures:
1. Connect the infusion pump, infusion pipe and precision pressure gauge as shown below.
Precision pressure gauge
2.
Before infusion, the reading on pressure gauge shall be zero. If not zero, disconnect the liquid line to
reset the reading on pressure gauge to zero. After that, reconnect the liquid line properly.
3.
Under advanced setting mode, you may press
key (CLEAR) and
key (SET)at the same
time to enter the pressure calibration interface, as shown below.
Pressure calibration
±10
A
Flow rate: 100.0ml/h
Pressure: 100.0kPa
Pressure sensor: 54
Initial pressure: 0
Coefficient: 0.63
Stop
4.
Press
key (START) to start the infusion. Verify that the maximum error of the pressure sensor at
any pressure point within the measuring range shall not exceed ±20Kpa against the readings on pressure
gauge.
5. Use the infusion pump to infuse the pressure gauge until the pressure inside the gauge reaches 60kPa.
Then, repeat Step 4.
6. Use the infusion pump to infuse the pressure gauge until the pressure inside the gauge reaches 100kPa.
Then, repeat Step 4.
7. Use the infusion pump to infuse the pressure gauge until the pressure inside the gauge reaches 140kPa.
Then, repeat Step 4.
4
If one of the pressure errors exceeds ±20Kpa, please contact our technical support people.
3.6 Battery Test
The battery performance might be deteriorated with the time going on. It is suggested to recharge and
discharge the battery every 3 months, and check the battery performance periodically.
Please check the battery performance according to the steps below:
1. Connect the infusion pump to AC power source and recharge continuously for 8~14 hours.
2. Disconnect the AC power source. Then, continuously run the infusion pump at an infusion rate of
25ml/h, until the pump is stopped because the battery power is too low.
 If the time from start of infusion to stop of the infusion pump lasts 200 minutes or longer, it
indicates that the battery is in good condition.
 If the time from start of infusion to stop of the infusion pump lasts 60~200 minutes, it indicates
that the battery is close to the end of its service life.
 If the time from start of infusion to stop of the infusion pump lasts shorter than 60 minutes, it
indicates that the battery has reached the end of its service life and shall be replaced.
3. After finishing the battery inspection, it is needed to recharge the battery for next use.
NOTES


The battery might be damaged or have trouble if the lasting time of power
supply is too short after it is fully recharged. The lasting time of battery power
depends on the infusion pump configuration and operating frequency, e.g. long
use of LCD backlight.
The battery shall be replaced or properly recycled if there is obvious damage
(bulge, deformation or leakage) or the battery cannot store the electric power.
3.7 Electrical Safety Test
WARNING





The electrical safety testing is intended for finding out the abnormal electrical
hazards by using the accredited tester. Failure to discover these hazards might
cause injury to the patients or operators.
The electrical safety testing may be done by using the commercially provided
safety analyzer and other testing devices. The service people must guarantee the
suitability, functional integrity and safety of these testing devices, while having
good skills on their use.
The electrical safety testing shall be according to the latest version the following
standard: EN 60601-1.
Please also observe the local laws on electrical safety testing, if any.
In the patient ward, all the equipments that are powered by city grid and
5
connected to the medical instrument must comply with IEC 60601-1 standard.
Meanwhile, electrical safety testing must be done to these equipments according
to the testing interval of the tester.
The electrical safety testing is intended for finding the possible hazards that might cause electrical safety risk
to the patients, operators and repairmen. Please carry out the electrical safety testing under normal environment
(including: temperature, humidity and atmospheric pressure).
The electrical safety testing described in this chapter is based on 601 safety analyzer. Different safety
analyzers might be used in different regions. Please ensure the suitability of your electrical safety testing program.
The equipment connection schematic is as below:
Tested
Equipment
A: AC Power Source (Programmable
power source, frequency adjustable)
B: Isolation transformer on leakage
current testing tool
C: Safety tester
Testing tools:


Safety analyzer
Isolation transformer
3.7.1 Electric Leakage Test of Enclosure
1.
2.
Connect the 601 safety analyzer to 264 VAC/60 Hz power source.
Connect the applied part of the tested equipment by using the applied part connection tooling. The SUM
end of the connection tooling for applied part is connected to the RA end of the safety analyzer.
3.
4.
Via power cord, connect the tested equipment to the auxiliary power output port on 601 safety analyzer.
Connect one end of the red testing wire to the “Red input terminal” on the safety analyzer, and clip
another end tightly onto the metal foil on the surface of tested equipment enclosure.
5.
Turn on the power source of 601 safety analyzer and press “5－Enclosure leakage” on the panel of 601
safety analyzer to enter the enclosure leakage current testing interface.
6.
The enclosure leakage current shall not exceed 100μA under normal conditions and shall not exceed
300μA in event of a single fault.
6
3.7.2 Electric Leakage Test of Patient
1.
2.
Connect the 601 safety analyzer to 264 VAC/60 Hz power source.
Connect the applied part of the tested equipment by using the applied part connection tooling. The SUM
end of the connection tooling for applied part is connected to the RA end of the safety analyzer.
3.
4.
Via power cord, connect the tested equipment to the auxiliary power output port on 601 safety analyzer.
Turn on the power source of 601 safety analyzer and press “6－Patient leakage” on the panel of 601
safety analyzer.
5.
Keep pressing “APPLIED PART” key to select AC or DC measuring. If DC is selected, “DC" is
displayed behind the limit value.
6.
The patient leakage current shall not exceed 10μA under normal conditions and shall not exceed 50μA
in event of a single fault.
If the electrical safety testing is failed, please contact our technical support people.
3.8 Cleaning and Sterilizing
Always use the materials and methods listed in this chapter to clean or sterilize the infusion pump. We do
not provide warranty for the damage or accident caused by use of other materials or methods.
The chemicals or methods listed by us are only used as the means to control the infection. We will not
assume any liability for their effectiveness. For infection control method, please consult the infection
prevention department or epidemiological experts of the hospital.
Please ensure that the infusion pump and its accessories are placed in dust-free environment. To avoid
damage to the infusion pump, be sure to observe the following regulations:
 Dilute the cleanser and disinfectant as instructed by the manufacturer, or use them at a concentration as
low as possible.
 Never immerse the infusion pump into the liquid.
 Never pour the liquid onto the infusion pump or accessories.
 Never allow the liquid to enter the pump body.
 To avoid damage to the enclosure, never wash the infusion pump by using the abrasive materials (e.g.
steel wool or silver polish) or any solvent like xylene or acetone.
WARNING

Before cleaning the infusion pump, be sure to turn off the power source and
disconnect the power cord from the socket.
The infusion pump shall be cleaned periodically. The cleaning interval shall be shortened in the areas with
severe pollution or great sandy wind. Before cleaning, please consult or check the regulations for cleaning of
medical equipment.
7
Below are the cleansers and disinfectants available for use:







Warm water
Diluted soap water
Diluted ammonia water
Sodium hypochlorite (bleach for wash use)
Hydrogen peroxide (3%)
Ethanol (70%)
Isopropanol (70%)
Recommended steps for cleaning and sterilizing of the infusion pump:
1.
Turn off the power source and disconnect the power cord from socket.
2.
Wipe the surface of infusion pump with the soft cloth wetted by warm water.
3
You may sterilize the surface of infusion pump by wiping it with the tampons that have absorbed
75% ethanol.
4
After cleaning or sterilizing, put the infusion pump in a cool and well-ventilated place for natural
drying.
The above operations are for reference only. The sterilizing effect shall be verified through appropriate
approach.
CAUTION

Never sterilize the infusion pump by using the gas (EtO) or formaldehyde.
8
Chapter 4 Troubleshooting
4.1 Overview
This chapter provides categorized description of the infusion pump troubles by fault position and symptom.
When eliminating the trouble, please refer to the corresponding fault sheet and check, locate and eliminate the
fault by order.
The recommended methods in this chapter can help you solve most of the equipment troubles, but exclusive
of any problem that might occur. In case of any fault not described in this chapter, please contact our After-sale
Service Division.
4.2 Replacing Components
You may replace the circuit board set and other main components or parts of the infusion pump. Once you
have located the circuit board set with trouble, you may replace it according to the steps described in Chapter 5 –
Repair and Disassembly. Then, check if the trouble has been eliminated, or if the infusion pump can pass the
relevant testing. If the trouble is eliminated, it indicates that the original circuit board set is damaged. In this case,
please return it to our company for repair. If the trouble remains, please reinstall the original circuit board set and
try eliminating the trouble from other possible causes.
To know and obtain the components you need to replace, please refer to Chapter 6 – Components.
4.3 Technical Alarm and Diagnosis
Before troubleshooting, please check if there is technical alarm on the infusion pump. If any, please eliminate
the technical alarm first and then eliminate the trouble according to the description in 4.4 – Troubleshooting
Guideline, so as to avoid unnecessary disassembly of the equipment.

Alarm Message
Note: The column “A” means if the trouble can be fully eliminated; the column “B” means if the sound and light
can be cleared; and the column “L” refers to the alarm level.
Alarm
Message
“Air”
A
YES
B
No
L
High
Cause
Solution
There is air bubble in the
Press
key (STOP) to stop infusion and
infusion pipe
silence the alarm. After eliminating the air
bubble in the pipe, press
to restart infusion.
key (START)
Alarm
Message
A
B
L
Cause
Solution
Incorrect installation of Reinstall the infusion pipe correctly.
infusion pipe
Malfunction with the Refer to 4.4 – Troubleshooting Guideline.
infusion pump sensor
“Over”
YES
No
High
The volume
completed.
limit
is
Press
key (STOP) to stop infusion and
silence the alarm. Then, press
key
(CLEAR) to eliminate the accumulated
volume. After that, press
key (START)
to restart infusion.
“Occlusion” YES
No
High
Infusion loop occlusion
Press
key (STOP) to stop infusion and
silence the alarm. After eliminating the
occlusion in the loop, press
key
(START) to restart infusion.
The occlusion value is too Adjust the occlusion level higher.
sensitive
Malfunction with the Refer to 4.4 – Troubleshooting Guideline.
infusion pump sensor
Pipe
installation
error
YES
No
Low
Incorrect installation of Reinstall the infusion pipe correctly.
infusion pipe
Malfunction with the Refer to 4.4 – Troubleshooting Guideline.
infusion pump sensor
Abnormal 1 YES
No
Medium Data communication error Refer to 4.4 – Troubleshooting Guideline.
Abnormal 2 YES
No
High
Malfunction in the motor
Press
of the infusion pump.
key (STOP) to stop infusion and
silence the alarm. After that, press
key
(START) to restart infusion. If this alarm
occurs again, please refer to 4.4 –
Troubleshooting Guideline.
Infusion
YES
Rate Error
(infusion
rate sensor
required)
No
High
Incorrect
setting
of Reset the infusion rate correctly.
infusion rate parameters
Accuracy not calibrated
Recalibrate the accuracy of infusion pipe
Water droplet is adhered Shake off the water droplets on the wall of
on the wall of funnel pipe funnel pipe.
after a long period of run,
which affects the function
of infusion rate sensor.
Infusion pipe unsmooth
2
Eliminate the infusion loop occlusion.
Alarm
Message
A
B
L
Cause
Solution
Malfunction of infusion Refer to 4.4 – Troubleshooting Guideline.
rate sensor
No
power
supply
AC No
No
Low
No AC power supply Connect to AC power supply.
connected.
No
No
High
Battery power is low.
Low
Voltage
Connect AC power supply and recharge the
battery.
Battery
aging
or Refer to 4.4 – Troubleshooting Guideline.
malfunction in the battery
charging circuit.
Battery used No
up
No
High
Battery power too low
Connect AC power supply and recharge the
battery.
Battery
aging
or Refer to 4.4 – Troubleshooting Guideline.
malfunction in the battery
charging circuit.
Startup
Message
No
No
Low
The infusion pump is not
started within the preset
time
after
correction
installation of the infusion
pipe.
Start the infusion pump within the preset time
after correction installation of the infusion
pipe. For setting of the startup time, please
refer to the Instruction Manual.
4.4 Troubleshooting Guideline
4.4.1 Power-On / Power-Off Trouble
Symptom
Possible Cause
Troubleshooting
The
infusion
pump cannot be
started.
No AC power supply is
connected, or the battery power is
low
Check if the infusion pump is correctly connected to AC
power supply, or if the battery power is adequate.
Power board damaged
Replace the power board.
Malfunction of connection wire
1. Check if the wire from the power board to the
mainboard, and the plug from AC cable or battery wire to
the power board is properly inserted.
2. Check if the connection wire and plug are damaged.
Mainboard damaged
Replace the mainboard
4.4.2 Screen Malfunction
Symptom
Image disorder, black
screen or white screen
Possible Cause
Troubleshooting
Mainboard damaged
Replace the mainboard
3
4.4.3 Alarm Fault
Symptom
No alarm sound
Possible Cause
Troubleshooting
Mainboard damaged
Replace the mainboard
Power board damaged
Replace the power board.
4.4.4 Keypad Fault
Symptom
No reaction with
key pressed down
Possible Cause
Troubleshooting
Mainboard damaged
Replace the mainboard
4.4.5 Motor Fault
Symptom
Motor is abnormal.
Abnormal 2
Possible Cause
Troubleshooting
Motor belt is loosened.
Reinstall the motor belt correctly.
Malfunction of connection wire
1. Check if the plug from motor wire to the power
board is properly inserted.
2. Check if the connection wire and plug are
damaged.
Power board damaged
Replace the power board.
4.4.6 Pressure Sensor Fault
Symptom
Abnormal
pressure
value on display
Possible Cause
Troubleshooting
Pressure sensor damaged
Replace the pressure sensor.
Malfunction of connection wire
1. Check if the wire from air bubble pressure board
to the power board is properly connected.
2. Check if the connection wire and plug are
damaged.
Air bubble
damaged.
pressure
board
Potentiometer setting on air
bubble pressure board is incorrect
Replace the air bubble pressure board
Adjust the potentiometer (RW_YL1) on air bubble
pressure board to make the pressure valve within a
proper range.
4.4.7 Air Bubble Sensor Fault
Symptom
Incorrect air bubble
value on display
Possible Cause
Troubleshooting
Ultrasonic sensor damaged
Replace the ultrasonic sensor.
Malfunction of connection wire
1. Check if the wire from air bubble pressure board
4
to the power board is properly connected.
2. Check if the connection wire and plug are
damaged.
Air bubble
damaged.
pressure
board
Replace the air bubble pressure board
4.4.8 Communication Error
Symptom
Abnormal 1 Alarm
Possible Cause
Troubleshooting
Malfunction of connection wire
1. Check if the wire from the power board to
mainboard is properly connected.
2. Check if the connection wire and plug are
damaged.
Power board damaged
Replace the power board.
Mainboard damaged
Replace the mainboard
4.4.9 Power Source Fault
Symptom
Battery
unstable
voltage
Possible Cause
Troubleshooting
Battery damaged
Replace the battery
Malfunction of connection wire
1. Check if the wire from the battery to the power
board is properly connected.
2. Check if the connection wire and plug are
damaged.
Battery cannot be
recharged to full
capacity
Power board damaged
Replace the power board.
Battery damaged
Replace the battery
Malfunction of connection wire
1. Check if the wire from the battery to the power
board is properly connected.
2. Check if the connection wire and plug are
damaged.
Battery cannot be
recharged
Power board damaged
Replace the power board.
Battery damaged
Replace with a new battery for recharging. If this
battery can be normally recharged, it indicates that
the original battery is damaged.
Malfunction of connection wire
1. Check if the wire from the battery to the power
board is properly connected.
2. Check if the connection wire and plug are
damaged.
Power board damaged
Replace the power board.
5
NOTES
●
The modules and infusion rate sensor are powered by the power module. Fault with the power module
will cause many troubles to other components. Therefore, if the components cannot work normally,
take care to check if the working voltage of this component is normal. For the working voltage and
voltage testing point for each component, please refer to Chapter 2 – Principles of Design.
4.4.10
Infusion Rate Sensor Fault
Symptom
Fault with the LED
indicator
for
infusion rate sensor
Possible Cause
Troubleshooting
Infusion rate sensor damaged
Replace the infusion rate sensor
Power board damaged
Replace the power board.
Malfunction of connection wire
1. check if the wire from the infusion rate sensor
socket on rear enclosure to the power board is
properly connected, and if the welding from the
infusion rate sensor to the infusion rate sensor
socket on rear enclosure is properly connected.
2. Check if the connection wire and plug are
damaged.
The infusion rate
sensor does not
work
Infusion rate sensor damaged
Replace the infusion rate sensor
Power board damaged
Replace the power board.
Malfunction of connection wire
1. check if the wire from the infusion rate sensor
socket on rear enclosure to the power board is
properly connected, and if the welding from the
infusion rate sensor to the infusion rate sensor
socket on rear enclosure is properly connected.
2. Check if the connection wire and plug are
damaged.
Infusion rate mode
cannot be started
Incorrect installation of infusion rate
sensor
6
Ensure to install the infusion rate sensor correctly
onto the liquid filter. The locator of liquid filter
must be vertically inserted into the groove of
infusion rate sensor.
chapter 5 Repair and Disassembly
5.1 Tools
You might need the following tools during disassembly and replacement of the components:
■ Screwdriver (Size: 102)
■ Screwdriver (Size: 107)
■ Forceps
■ Sharp-nose pliers
■ Hex socket wrench 5.5mm
■
Wrist strap
5.2 Preparations for Disassembly
Before disassembly of the infusion pump, please stop infusion to the patients and shut down the infusion
pump, while disconnecting all the accessories and external equipments.
CAUTION

Please eliminate the static electricity before disassembly. To avoid damage to the components,
please wear personal protective equipment like wrist strap or electrostatic gloves when
disassembling some components with electrostatic sensitive label.

During reinstallation, take care to connect the wires properly and place them in good order, so as
to avoid the short circuiting due to damage of the connection wires.

Take care to select the appropriate screws during reinstallation. Forcible tightening of the
incorrect screws might cause damage to the equipment. And during use after reinstallation, the
screws or components might fall off, thus causing unpredictable damage or injury to the product
or human body.

Disassemble the equipment in correct order. Incorrect order and forcible assembly might cause
irreversible damage to the equipment.

Before separating the components, please be sure that all connections have been plugged off.
During separation, take care not to break the connection wire or damage the connector.

Please store the removed screws and other parts by category for easy reach during reinstallation.
And avoid dropping, contaminating or losing them.
5.3 Disassembly Steps
5.3.1 Separation of Front and Rear Enclosure
If the machine is installed with infusion rate sensor, please pull out the infusion rate sensor socket from the
rear enclosure.

As shown, use the screwdriver to remove 4 screws M4×30 fixing the rear enclosure.

As shown, open the front and rear enclosure.
NOTES
● As the mating joint is applied with waterproof adhesive, you might have to use a
strong force to open the front and rear enclosure. Please use force with care.

As shown, pull out AC power plug and battery plug.
2

As shown, separate the front and rear enclosures.
NOTES
● To avoid breaking the connecting wires or damaging the plug, please use
force with care when separating the front and rear enclosures.
3
5.3.2 Disassembly of Power Board
1.
First, unplug the wires connected to the power board. Then, pull out the power board slowly.
2.
Open the clamp and unplug the 14pin strip. Remove the power board.
5.3.3 Removal of Front Enclosure Set
1.
Tear off the surface film on the left of front enclosure by using the forceps or other similar
4
tools.
NOTES
● To avoid scratching the front enclosure, please use force with care when tearing off
the surface film.
2.
Tear off the keypad film on front enclosure.
3.
Use the screwdriver to remove 2 countersunk head screws M4×10 and 4 pan head screws
M4×8.
4.
Use the screwdriver to loosen 1 screw M4×12. Then, take out the screw with forces.
5
NOTES
● To avoid dropping the screws into pump body, please use force with care when
removing the screws.
5.
Remove the handle and sleeve with forceps.
6
6.
Remove the pump body assembly.
5.3.4 Removal of Mainboard
1.
Use the screwdriver and hex socket wrench 5.5. to remove 4 ST3×6 screws, 2 M3 X 10
countersunk head screws and 2 M3 nuts fixing the mainboard.
2
Remove the mainboard.
7
3
Open the pin holder of mainboard and remove 14pin strips.
5.3.5 Removal of Pump Body
1
Remove the liquid blockage seat.
8
2 Unplug the wires connected to the air bubble pressure board.
3
Use the screwdriver to loosen 2 pan head screws M3×6. Then, remove the air bubble pressure
board.
4
Use the screwdriver to loosen 2 pan head screws M2×5. Then, remove the handle detection
board.
9
5 Use the screwdriver to remove 2 pan head screws M3×6 with washer. Then, remove the
bracket.
6
Use the screwdriver to remove 1 pan head screws M4×25 with washer. Then, remove the
ultrasonic pressure set.
10
7
Use the screwdriver to loosen 2 pan head screws ST2.9×9.5. Then, remove the ultrasonic
module.
5.3.6 Removal of Battery Plug Set
First unplug the wires connected to the battery cover plate. Then, use the screwdriver to loosen 2 pan head screws
ST2×10. Remove the battery.
11
Blank Page
12
chapter 6 Components
6.1 Machine Components
Explosive View
Parts List
S/N
Part Number
Part Name & Spec.
1
60003090
600II front enclosure (C07)
1
2
60001018
Semi-finished 600II mainboard
1
3
\
600II pump body assembly
1
4
60001019
Semi-finished 600II power board
1
5
60003010
Rear cover (C07) assembly
1
6
80080013
Elastic washer 4
4
7
80080008
Pan head screw M4x30 with slot
4
8
50001014
Lithium battery
1
9
60001038
Circuit board SK600I Battery V1.2
1
10
80080005
Pan head tapping screw ST2.6x8 with slot
2
11
80080023
Pan head screw M3x12 with slot
1
12
80080069
Pan head tapping screw ST3x6 with slot
4
13
80080001
Nut M3
2
14
80080016
Plastic washer ￠3x￠7x3.5
1
15
60002001
Handle assembly
1
16
60003035
Plastic washer
1
17
80080012
Countersunk head screw M3x10.5 with slot
2
18
80080054
Countersunk head screw M4x10 with slot
1
19
80080006
Pan head screw M4x8 with slot
4
20
60004080
Right film
1
21
60004079
Left film
1
22
60003098
600II Chinese Lens
1
2
QTY
6.2 Pump Body Assembly
Explosive View
3
Parts List
S/N
Part Number
Part Name & Spec.
1
60003021
Pump Body
1
2
80080057
Jam nut M4
2
3
60003033
Driving synchronous impeller
1
4
60003008
Belt
1
5
60003092
Gear cover plate
1
6
60003032
Driven synchronous impeller
1
7
60002019
Magnet
2
8
80080052
Counter nut M4
1
9
60002023
Eccentric wheel shaft A
1
10
80080036
Countersunk head screw M3x6 with slot
4
11
60003027
Bearing cover
1
12
60002018
Bearing
1
13
60003025
Eccentric wheel pad
2
14
80080096
Clamp ring ￠4×0.8
2
15
60002021
Eccentric wheel A
5
16
60002022
Eccentric wheel B
5
17
60003026
Middle pad of eccentric wheel
1
18
60002024
Flange bearing
1
19
60003024
Pipe clamp
1
20
60003022
Pump impeller
10
21
60002028
Clamp of pipe clamp
2
22
60002032
Pressure plate of pipe clamp
1
23
80080059
Pan head tapping screw ST2x6 with slot
2
24
80080002
Nut M4
3
25
80080092
Gasket
1
26
80080119
Pan head flat-pointed tapping screw ST2.9x10.5 with slot
3
27
60003179
Pressure fixing seat
1
28
50001036
Pressure sensor B
1
4
QTY
29
60003178
Ultrasonic rod
1
30
80080062
Copper pillar C M3x9-M3x3.2
2
31
80080014
Plastic washer ￠3x￠6x1.2
2
32
80080010
Pan head screw M3x8 with slot
4
33
60003134
Sensor holder B
1
34
60002035
Support
1
35
60003038
Liquid blockage clamp
1
36
80060042
Circuit board 600I_KMJC_1.0_V1.1
1
37
50002031
Compression spring 2
1
38
80080076
Pan head screw M2x5 with slot
2
39
60001012
Stepper motor for high-speed pump
1
40
80080007
Pan head screw M4x16 with slot
2
41
80080013
Elastic washer 4
3
42
80080070
Washer 4
1
43
80080061
Pan head screw M4x25 with slot
1
44
60003096
Ultrasonic enclosure E
1
45
60002031
Cover Plate
1
46
60002025
Guide
2
47
60002029
Handle spring
4
48
60003031
Pressing plate
1
49
80080021
Pan head screw M3x12 with slot
6
50
60002026
Pull lever
1
51
60002077
Pipe compression spring (elevation)
4
52
60003030
Pipe compression block
1
53
60003029
Pipe compression slide
1
54
80080020
Pan head screw M3x6 with slot
2
55
60001020
Circuit board 600I_QPYLJC_44_04
1
5