SP750 User Manual

Contents
Preface...................................................................................................................................1
Chapter 1 Brief Introduction.................................................................................................3
1.1 General............................................................................................................................3
1.2 Features...........................................................................................................................3
1.3 Technical specification....................................................................................................4
1.4 Introduction of pump parts and buttons..........................................................................5
1.5 Packing............................................................................................................................8
1.6 Symbols...........................................................................................................................8
Chapter 2 Installation..........................................................................................................10
2.1 Site requirements...........................................................................................................10
2.2 Installation for bracket..................................................................................................10
2.3 Preparation before operating.........................................................................................10
Chapter 3 Pump Operation..................................................................................................12
3.1 Selection for Power Mode.............................................................................................12
3.2 Run the pump................................................................................................................12
3.3 “Infusion will over!” and “KVO” state.........................................................................14
3.4 Air bubble alarm............................................................................................................14
3.5 Pressure (Occlusion) alarm...........................................................................................14
3.6 Door open alarm............................................................................................................15
3.7 Switch for Power Mode.................................................................................................16
Chapter 4 Start and Stop Infusing.......................................................................................17
4.1 Turn on the Pump..........................................................................................................17
4.2 Setting for Total Volume................................................................................................17
4.3 Setting for Infusion Rate...............................................................................................17
4.4 IV Set Type....................................................................................................................18
4.5 START/STOP the Pump................................................................................................18
4.6 Eliminate alarm.............................................................................................................19
4.7 “Infusion will over!” and “KVO” state.........................................................................22
Chapter 5 Infusion Function................................................................................................23
5.1 Clear infused volume....................................................................................................23
5.2 Accumulation of infused volume..................................................................................23
5.3 Change "TOTAL VOLUME" during Infusing..............................................................23
5.4 PURGE..........................................................................................................................23
5.5 Change Infusion Bottle during Infusing........................................................................24
5.6 Moving Patient..............................................................................................................24
5.7 Noise and Heat..............................................................................................................24
Chapter 6 System Setting....................................................................................................25
6.1 Pressure threshold.........................................................................................................25
6.2 Rate calibration.............................................................................................................26
6.3 Language.......................................................................................................................26
6.4 Button sound.................................................................................................................27
6.5 Reset..............................................................................................................................27
Chapter 7 Calibration for IV Set.........................................................................................28
7.1 Infusion Accuracy.........................................................................................................28
7.2 IV Set Requirements.....................................................................................................28
7.3 Selection of IV Set........................................................................................................28
7.4 Calibration for IV Set....................................................................................................29
Chapter 8 Maintenance........................................................................................................30
8.1 Cleaning and Disinfection.............................................................................................30
8.2 Periodic Maintenance....................................................................................................30
8.3 Non-pollution treatment and Recycling........................................................................31
8.4 Disposal and Recycling for the IV Set..........................................................................31
Chapter 9 Infusion Characteristics......................................................................................32
9.1 Accuracy Characteristics...............................................................................................32
9.2 Occlusion Response Characteristics..............................................................................38
9.3 Recommended IV Set and Infusion Component...........................................................39
Chapter 10 EMC Compatibility and Interference...............................................................40
Appendix I Explanation of system alarms..........................................................................42
Appendix II EMC Guidance and Manufacturer Declaration..............................................43
Preface
Important prompts
Before operating the pump, please read this manual carefully.
Please save this manual well for further use.
The User Manual is completely compiled in accordance with IEC60601-2-24-2012, IEC
60601-1:2012 and IEC 60601-1-8:2012. The information contained in this document is subject to
change without prior notice.
Owing to product updates, the device you received may not be totally consistent with the
description in this User Manual. We would sincerely regret for that.
About This Manual
This manual mainly introduces the following contents:
 Overview, function descriptions and technical specifications.
 Installation and test methods.
 Operation procedures for the pump and main menu, calibration procedures for IV set.
Safety Precautions
Warning
 The pump can not be operated by the person who is not familiar with it.
 The pump must be properly grounded.
 The pump can only be used for general infusion, avoid using for infusing blood or other
situations.
 It is required to use the specified IV set, or the infusion accuracy may be inaccurate.
 During using, please check the residual volume and IV set pipe regularly, and it is not
recommended to completely rely on the alarm functions.
 Avoid using the pump in alarm state, and eliminate the alarm before continuing to use.
 Do not reuse or disinfect the single-use infusion sets. Used infusion sets should be
disposed of following appropriate methods.
 Avoid using the pump in environment with flammable things.
 Operate the pump in the range of 120 cm of patient heart height.
 Only the components, connectors and disposable products complied with National
Standards can be used in the system. Please consult your dealer for relevant information.
 Infusion accuracy is not reliable if uncalibrated IV set is used.
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 The pump is a system that provides positive pressure, it can produce positive liquid
pressure to overcome the resistance occurred in actual process, including the resistance
produced by small catheters and filters, which is convenient for intravenous injection. As
using filters during infusing is not considered, the pump doesn't provide the function of
checking filter, and it does not alarm under the condition of using filters.
 Do not refit the device.
 Users should read the user manual carefully before use and follow the requirements to
operate.
 No parts of the infusion pump that shall be serviced or maintained while the infusion
pump is in use with the patient.
 The ME Equipment is CLASS I ME Equipment, to avoid the risk of electric shock, this
equipment must only be connected to a supply mains with protective earth. The internal
electrical power source should be used if the integrity of the protective earth conductor or
the protective earthing system in the installation is in doubt.
 The infusion pump should be connected to an appropriate power source when the internal
battery is in low battery state.
 All replacements, modifications and repairs must be performed by qualified service
engineers that authorized by manufacturer.
 When applying the infusion pump to neonates or children,Set the infusion rate strictly
following the doctor's advice.
Attention:
 Make sure that the pump is securely attached to the infusion pole to avoid risk of falling.
 Before operating, please make sure the IV set pipeline is unblocked and installed properly.
 Make sure that there is no air bubble in the IV set, otherwise use “ PURGE” mode or
manually remove bubbles.
 After starting the infusion, it is recommended to change the tube clamping position every
four hours to ensure accuracy, when the infusion duration reaches 24 hours, it is
recommended to replace the infusion set or move it to the sections not being squeezed.
 Don’t place the extruded pipeline among the ultrasound transducers, otherwise it may
mistakenly alarm for air bubble.
 The pump is calibrated for accuracy with distilled water, solution viscosity and proportion
may influence the infusion accuracy.
2
 The pump stops infusing under alarm conditions, except for "Infusion will over!", "KVO",
and "Low battery" alarms. Periodic monitoring must be performed to ensure that the pump
works as expected.
 It is recommended to set the infusion volume 15mL smaller than the actual liquid volume,
otherwise all liquid in the pipeline may be injected and the device alarms for air bubble.
 Before working with internal battery, check the battery to make sure it has sufficient
power. Charge the device if necessary.
 When the device is power supplied only by battery, a fully charged battery could provide
at least 5 hours continuous working with a medium speed of 25ml/h, or at least 4 hours
continuous working with a high speed of 699ml/h, but the working time cannot be
guaranteed if the battery is damaged or not fully charged. When the battery is low, please
keep the speed lower than 300ml/h, and timely connect with the mains power supply.
 If the pump runs abnormally, and the reason is not clear, please stop infusing and report
the error (including the information of the infusion components, infusion amount, infusion
rate, machine No, the type of the infused liquid, etc.) to the distributor or manufacturer
who sold the product to you.
 Our company can provide circuit diagrams, component lists, drawings, calibration
specification and other materials as requested to help qualified technical personnel for
device maintenance.
 Avoid inserting the power plug into the place where is difficult to disconnect.
 Do not maintain the device during using.
 The product is suitable for adults, children and neonates.
 Do not touch the peristaltic part during device working.
Chapter 1 Brief Introduction

1.1 General
The product is a volumetric Infusion Pump with high safety and long service life. It is easy
to operate. Its high-accuracy flow rate control and comprehensive alarm measures ensure
patient’s safety and satisfied treatment effect.
Intended use and Purpose:
3
The device is used with IV set, applicable for clinical drug intravenous infusion in medical
institutions when infusion volume and drug use are strictly controlled. The pump is electrically
driven and continuous, only used by medical staff.
Attention:
 To ensure the infusion accuracy, the IV sets used should meet the requirements of ISO
8536-8.
Intended patient populations:
The product is suitable for adults, children and neonates.
Intended Users:
Professional medical staff.
Contraindications:
Do not use it for blood transfusion, infusion of insulin, analgesics, chemotherapeutic drugs,
or epidural anesthesia drugs.
Clinical benefits:
Precise control medicine infusion flow rate and volume.
The device is applicable for use in medical institutions. The intravenous infusion to patients
is operated by medical staff.
Special safety measures include:
 IV set clamp prevents liquid free flow if the pump door opens accidentally.
 High-accuracy air bubble detector prevents air bubbles from entering patient's body.
 The pressure sensor can detect the blocking of downstream pipeline.
 When high-pressure blocking alarm appears, the A.B.S system stops infusing immediately,
and automatically eliminates the pressure in the IV set, to avoid sudden obstruction
disappearing causing transient high-dose injection.
 Infusion parameters during infusing are protected against being changed arbitrarily.
 When applying the infusion pump to neonates or children,Set the infusion rate strictly
following the doctor's advice.
1.2 Features
1) Two CPUs monitor the infusion situation in real time and have the mechanism to
independently stop the motor operation. In case of device failure, the device can
stop the infusion in time and make audible and visual alarms to prevent the device
from over-infusion and reversed-infusion; when the infusion tube is blocked, the
4
device can stop the infusion in time and make audible and visual alarms to prevent
the device from reversed-infusion.
2) High-accuracy fluid delivery, to achieve optimal infusion effect;
3) Compatible with multiple standard IV sets;
4) 2.8' LCD display;
5) Residual time can be displayed during infusing;
6) With remind function when start infusing;
7) Alarm for occlusion, air bubble, door open and motor abnormal;
8) Pressure alarm threshold can be adjusted by medical personnel;
9) IV set clamp prevents liquid flowing freely if the pump door opens accidentally;
10) A.B.S—ANTI BOLUS SYSTEM prevents sudden obstruction disappearing causing
transient high-dose injection;
11) Stop infusing automatically if alarms ( "Infusion will over!", "KVO" and "Low
battery" alarms are excluded);
12) Power supplied by both external AC power and built-in lithium battery.
1.3 Technical specification
Type Volumetric infusion pump
PURGE rate 699 mL/h
Range of infusion
1 mL/h～699 mL/h, increment 1 mL/h
rate
Preset volume range 1 mL～9999 mL, increment 1 mL

Accuracy 1)
±5%
KVO rate 1 mL/h
Display information ①Infusion rate ②Total volume ③Infused volume ④Residual time
①Infusing prompt ②Door open ③Occlusion ④Air bubbles

Alarms ⑤Motor failure ⑥Infusion will over! ⑦KVO state ⑧Low battery
** Expression is faulty **Battery exhausted
Occlusion pressure
100 kPa～300 kPa
detection
Safety classification Class I, type BF
Protection IPX2
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classification
Working mode Continuous operation
Power supply 100-240 V~, 50/60 Hz
Battery Rechargeable Li-Ion battery, 7.4 V/5000 mAh
When the pump is connected to AC power, the battery can be

Battery charging
charged automatically, and it takes 8 h~12 h for fully charged.
The device can continuously work at least 5 hours with a medium

Continuous operation
speed of 25ml/h, or at least 4 hours with a high speed of 699ml/h.
Maximum weight About 1.9 kg
Dimension 143.6 mm(L)×151.8mm(W)×195.3 mm(H)
① Temperature: +5 ℃~+40 ℃ ② Relative humidity: 20%～90%

Working environment
③ Atmospheric pressure: 860 hPa～1060 hPa
①Environment temperature: -30 ℃～+55 ℃ ②Relative humidity:

Storage environment 5%～96% ③Atmospheric pressure: 500 hPa～1060 hPa ④No
corrosive gas ⑤ Well-ventilated
The disposable pump infusion set manufactured by Shinva Ande

Applicable IV set
Healthcare Apparatus Co., Ltd.(BPQ-15)
Sensitivity of bubble
Not less than 20ul
sensor
1)
For the accuracy of the infusion rate, it is determined according to that one infusion pump
sample is tested based on relevant clauses in IEC 60601-2-24 for 7 different tests with new
administration set (IV set) for each test at ambient temperature 25℃.
2)
Warning: To avoid the risk of electric shock, this equipment must only be connected
to a supply mains with protective earth.
3)
Under single fault conditions, the maximum volume that may be infused by the device will be
±24.89% of the setting volume .
6
1.4 Introduction of pump parts and buttons
7 4
5
11
6
8 10
9
Figure 1-1 Front view
No. Name Description
1 Handle Convenient for carrying
Working state It is green when the pump runs normally, and red when alarm
2
indicator appears.
3 Pump door Fix the IV set.
In the menu on the bottom of screen, press it to execute the

4 Selection button
right side operation selection.
Cursor or number If you need to input numbers, press UP or DOWN button to

5
selection button select. In other times, it is used as cursor selection button.
6 Power and Indicate the power type:

charging indicator Yellow: when the pump works with battery only;
7
Green: when the pump works with external power;
Green (charging indicator): in charging state.
Enter/Alarm clear
7 Confirm current selection or clear the alarm
button
8 ON/OFF Press and hold it to turn on or off the pump
It is used for rinsing the IV set before infusing; This button is

prohibited to use during infusing process; When the infusion is
9 PURGE
suspended, press it to infuse fleetly with the infusion rate of
699mL/h.
10 START/STOP In main menu, press it to start or halt infusing.
Lock for pump

11 Open the pump door when lift it up.
door
Figure 1-2 Internal view for pump door
12 IV set slot Fix the IV set.
Finger peristaltic
13 Squeeze the IV set and control the flow rate.
pump
14 Door sensor Detect the pump door state (open or close) during infusing.
8
Detect whether there is occlusion in the downstream
15 Pressure sensor
pipeline during infusing.
Detect whether there is air bubble in the IV set during

16 Air bubble detector
infusing.
When the door is open, the clamp will tighten the IV set
immediately to prevent liquid flowing. When it is closed,
17 IV set clamp
the IV set clamp will open automatically, and the liquid can
flow.
19
18 20
Figure 1-3 Rear view
18 Power cord socket Connect with AC power cord
19 Speaker To make audible alarms
20 Multi-function interface 1)
for communication purpose
Note: 1) Additional equipment connected to medical electrical equipment through the

communication port must comply with the respective IEC or ISO standards (e.g. IEC 60950 or
IEC 62368 for data processing equipment). Furthermore all configurations shall comply with the
requirements for medical electrical systems (see clause 16 of the latest valid version of IEC
60601-1). Anybody connecting additional equipment to medical electrical equipment configures
a medical system and is therefore responsible that the system complies with the requirements for
9
medical electrical systems. If in doubt, consult your local representative or the technical service
department.
1.5 Packing
Standard configuration:
(1) One Infusion pump
(2) One power cord
(3) One user manual
Attention:
 If any part in packing is missing, please contact the dealer immediately.
1.6 Symbols
Symbol Description
Type BF applied part
IPX2 Degree of protection against ingress of liquid
Refer to instruction manual/booklet
WEEE (2012/19/EU)
This item is compliant with Directive 93/42/EEC of 14 june

1993 concerning medical devices; Including, at 21 march
2010, the amendments by Council Directive 2007/47/EC.
European Representative
Manufacturer
Date of manufacture
Serial number
Infusion liquid flow
10
Transport temperature limitation: -30 ℃～+55 ℃
Transport humidity limitation: 5%～96%
This way up
Fragile, handle with care
Keep dry
Stacking limit by number (8 layers)
Alternative current
Multi-function interface
11
Chapter 2 Installation
2.1 Site requirements
The power cord should be connected to a power socket with three-pin (one pin is Earth
wire), power supply is 100-240 V~, 50/60 Hz.The medical staff should keep the infusion pump
away from inflammable liquids or gases. The pump should be operated within a temperature
range of 5 ℃ to 40 ℃. Do not operate the pump near equipment that emits high frequency
electromagnetic radiation (such as high frequency surgical unit or cauterizing equipment), to
avoid false alarms.
Warning
Avoid opening the enclosure to adjust or maintain the pump under the condition of live,
necessary maintenance must be performed by qualified service engineers that authorized by
manufacturer.
2.2 Installation for bracket
The bracket enables the pump mounting on a special infusion pole. The installation location
is on the rear of the pump.
Warning
Before installing the pump to the infusion pole, the medical staff should check the stability of the
infusion pole.
2.3 Preparation before operating
1) Open the packing.
2) Install the pump on the mobile infusion pole or place it on a table.
3) Plug the power cord into a grounded AC socket.
4) Insert the IV set into the pump.
5) The drip chamber of IV set should be placed approximately 10cm above the pump,
and the roller clamp should be under the infusion pump.
Attention:
 If the pump is just received or it is not used for a long time, connect it with AC power, and
wait for 5 minutes before operating (the battery should be charged completely before
using battery as power supply).
 When the pump is carried from the environment where the temperature is below 0 ℃ to
the room, please operate it after 15 minutes.
12
 Do not position the infusion pump so that it is difficult to operate the disconnection
device.
2.3.1 Installation of IV set
The medical staff should follow the following steps to install the IV set:
1) Before installing the IV set, select the type of IV set according to the infusion pump.
2) Fix the pump to the bracket.
3) Prepare for the IV set and infusion bottle, hang the bottle on the infusion pole.
4) Inject liquid into the drip chamber to its one-third level.
5) Adjust the roller clamp to let the liquid flow, and discharge all air from the pipeline.
6) Adjust the roller clamp to stop free flow.
7) Lift up the door lock to open the pump door.
8) Make sure that the drip chamber locates above the pump, and the infusion direction
is liquid input, not output direction.
9) Press the IV set into the air bubble detector and the guide slot, and tightly clip the
IV set by the IV set clamp.
10) Close the pump door and lock it.
11) Open the roller clamp completely and verify that there is no liquid flow.
12) The fluid flow will be controlled by the infusion pump.
13) Use the PURGE function to drain the air from the tube, remove the protective cover
of the IV needle, and insert the needle into the vein.
Attention:
 Before starting the infusion, the total amount of infusion should be cleared to avoid
accumulation of previous infusion volume and causing alarms.
 To reduce the infusion error for long-term extrusion of the finger peristaltic pump,
the position of infusion pipeline should be changed about every one hour.
 The pump is calibrated by The disposable pump infusion set manufactured by
Shinva Ande Healthcare Apparatus Co., Ltd. If other types of infusion sets that
comply with national standard are used, please refer to User Manual for parameter
setting and Accuracy calibration before using.
 If pipeline is equipped with a sliding connector, it will result in loose connection.
 Infusion accuracy may be influenced by solution viscosity and proportion.
 Operate the pump in the range of 120 cm of patient heart height.
13
2.3.2 Disassembly of IV set
Steps are as below:
1) Close the roller clamp, then open the pump door.
2) Take out the IV set from the clamp, and close the pump door.
3) Turn off the pump.
14
Chapter 3 Pump Operation
3.1 Selection for Power Mode
Two modes of power supply are supported, which is convenient for use:
In general, you can use the AC100~240 V, 50/60 Hz as power supply. The internal battery
can provide you enough power for short-distance or short-time emergency use.
When the pump is connected to an external power supply, the internal lithium battery can be
charged no matter the device is turned on or not. We do not provide external charging equipment,
the lithium battery can only be charged inside the device. When using an external power supply,
in case of a sudden power failure, the system will automatically switch to the internal battery
power, so the pump can work without interruption.
No matter which mode you choose, our product can provide you an accurate infusion.
Attention:
 When the pump works with internal battery, and the battery power is lower than its one-
third ( ), please do not infuse with the rate of more than 300 mL/h. As the low-battery
may cause a lower actual infusion rate than the setting.
 Connect the device with mains power supply when the battery is low.
 The internal battery is an emergency backup power supply, the infusion rate under battery
power supply should be lower than 500 mL/h. In order to ensure the accuracy of normal
infusion, please use an external power supply.
 When the device is connected to supply mains, the reliable grounding of supply mains
ground wire shall be guaranteed. If any doubts, the device should be operated by an
internal power source.
3.2 Run the pump
Connect to the power
After connecting with AC power supply, the power indicator lights in green, which means
the device is under AC power supply state. Press ON/OFF button to turn on the pump, and it
enters the main menu, as shown in Figure 3-1:
15
Figure 3-1 Main menu
Set the infusion rate and total volume, and start infusing:
In the main menu, when the “Rate” is selected, press to enter its setting interface, as
shown in Figure 3-2:
Figure 3-2 Rate setting interface

Press LEFT or RIGHT button to select, and use UP or DOWN button to change the value.
After that, press to return to the main menu, or press to cancel the setting and
return to the main menu.
Press to start infusing process, the three working state indicators light alternately. As
the infusion volume increases, the remaining time shortens. Press START/STOP button again,
the infusion stops. As Figure 3-3:
16
Figure 3-3 Infusion interface
Memory function
If the pump stops or turns off during infusing, the infusion rate, volume and infused
volume will be memorized, when the device is restarted, it can continue to work.
3.3 “Infusion will over!” and “KVO” state
The KVO state refers to that, after the pump finishes infusing total volume (when the
infused volume is equal to the total volume), in order to keep the vein open, the pump still
continues the infusion at a very slow rate.
Three minutes before finishing infusing, the pump will give an alarm every 20 seconds, the
working state indicators keep lighting in green, and the message "Infusion will over!" and
appears on the screen.
After infusion is completed, the pump will switch to KVO state automatically, and the
message "Enter KVO mode" appears on the screen. The infusion rate under this state is the
preset KVO rate.
3.4 Air bubble alarm
1) Set the infusion rate to 500 mL/h.
2) Press to start infusing. Shake the IV set to make air bubbles artificially and
observe the device, the working state indicators should turn red and flicker, and the
message "Air bubble in IV tube!" and appear on the screen, the device makes
audible alarm and stops infusing automatically.
3) Long press to eliminate the alarm and return to the main menu.
17
Figure 3-4 Air bubble alarm
3.5 Pressure (Occlusion) alarm
1) Make sure that the drip chamber locates above the pump.
2) Set the infusion rate to 500 mL/h. Press to start infusing.

3) Close the roller clamp of the IV set (roller clamp should below the pump). This will
cause downstream occlusion.
4) After a few seconds, the working state indicators turn red and flicker, and the
message "The infusion tube is blocked!" and appear on the screen, the device
makes audible alarm and stops infusing automatically.
5) Open the roller clamp and long press to eliminate the alarm, and return to the
main menu.
Figure 3-5 Occlusion alarm

Attention:
18
 The lower infusion rate is, the longer time takes for occlusion detection.
3.6 Door open alarm
1) Press to run the pump.

2) Open the pump door, the working state indicators turn red and flicker, and the
message "The door open!" and appear on the screen, the device makes audible
alarm and stops infusing automatically.
3) Close pump door, long press to eliminate the alarm and return to the main
menu.
Figure 3-6 Door open alarm

3.7 Switch for Power Mode
1) Disconnect the power cord from the AC socket.
2) The power indicator turns to yellow, which indicates that the pump is working with
internal battery.
3) Insert the power cord into the AC socket again.
4) The power indicator turns to green, and the charging indicator becomes green
(charging) or does not light (battery is fully charged).
Attention:
 Volume of high-level continuous alarm is no less than 65dB(A).
 The device has low-battery alarm function, alarm interval is about 10s. The alarm
automatically turns off after 2 minutes, or connect the device with AC power to eliminate
it.
 Two conditions for battery alarm:
1) When working with internal battery, about within 30 minutes before the pump stops
19
infusing due to low battery, it gives an alarm every 20 seconds, and the working
state indicators turn yellow and are always light , message "Low battery, please
charge!" appears on the screen with audible alarm.
2) When working with internal battery, about 3 minutes before the battery runs out, the
working state indicators turn red and flicker, message "Battery exhausted, turn it
off!" appears on the screen, and the pump makes audible alarm and stops infusing
automatically.
3) When both the mains and internal power supply are dead, the backup battery of the
device will provide power for the internal CPU and the speaker to make a sustained
audible alarm for 3 minutes to indicate the power failure, and at the same time, the
LCD screen goes off, and the working state indicator flickers in red.
20
Chapter 4 Start and Stop Infusing
4.1 Turn on the Pump
1) Connect the pump to AC power supply.
2) Press ON/OFF to turn on the pump, and enter the main menu.
4.2 Setting for Total Volume
In main menu, press UP or DOWN button to select "Total", then press to enter its
setting interface, shown as Figure 4-1.
Figure 4-1 Total volume setting

The total volume value can be set from 1 mL to 9999 mL.
4.3 Setting for Infusion Rate
In main menu, press UP or DOWN button to select "Rate", then press to enter its
setting interface, shown as Figure 4-2.
21
Figure 4-2 Infusion rate setting
The infusion rate value can be set from 1 mL/h to 699 mL/h.
4.4 IV Set Type
In main menu, press UP or DOWN button to select "Type", then press to enter the
interface for inputting password, shown as Figure 4-3.
Figure 4-3 Password interface

After inputting the password "9999", the system will enter the interface for setting type,
shown as Figure 4-4.
22
Figure 4-4 Type setting interface
Press UP or DOWN button to select.
Attention:
 Password can only be accessed and kept by medical staff.
4.5 START/STOP the Pump
After setting the "Rate", "Total" and "Type", press to start infusing process. As the
infusion volume increases, the remaining time shortens. Press START/STOP button again, the
infusion stops, and system returns to the main menu.
4.6 Eliminate alarm
If alarm occurs, the pump makes audible alarm, and the reason for alarm is displayed on the
screen. Long press(about 2s) to eliminate the alarm; short press to pause the alarm,
after 2 minutes, the alarm sound continues.
The pump alarm includes two levels: high priority and low priority. High priority alarm,
which is the most serious alarm, means that patient is in life-threatening danger or the pump
occurs critical technical problem. Low priority alarm means general warning. The level of all
technical alarms and general alarms is default by the system, which can’t be changed by user.
Before use, the operator shall verify whether current alarm setting is suitable for every patient.
Once activated, the alarm will response immediately(within 1s) . Within the range of 4m away
from the pump, alarm indicator light can be seen and alarm sound can be heard.
Alarm list is shown as below:
Name Level Type Sound characteristic Light
23
characteristic
Sound mode: “beep-beep-beep---

Air bubble High Technical Indicator light
beep-beep, beep-beep-beep---
alarm priority alarm flickers in red
beep-beep”

Occlusion High Technical Indicator light
beep-beep”

Door open High Technical Indicator light
beep-beep”

Motor High Technical Indicator light
failure alarm priority alarm flickers in red
beep-beep”
Pressure Sound mode: “beep-beep-beep---

High Technical Indicator light
abnormal beep-beep, beep-beep-beep---
priority alarm flickers in red
alarm beep-beep”
Door Sound mode: “beep-beep-beep---

High Technical Indicator light
abnormal beep-beep, beep-beep-beep---
alarm beep-beep”

Infusion end High General Indicator light
beep-beep”
Battery Sound mode: “beep-beep-beep---

High General Indicator light
exhausted beep-beep, beep-beep-beep---
alarm beep-beep”

High General Indicator light
KVO alarm beep-beep, beep-beep-beep---
beep-beep”
Standby Low General Indicator light

Sound mode: “beep-beep-beep”
alarm priority alarm lights in yellow
Infusion will Low General Sound mode: “beep-beep-beep” Indicator light
24
over! priority alarm lights in yellow
Low battery Low General Indicator light

Sound mode: “beep-beep-beep”
alarm priority alarm lights in yellow
prompt —— —— Indicator light

Sound mode: “beep”
signal lights in yellow
Alarm Alarm
Alarm Alarm Light Alarm Alarm Duty
classifi sound
type level characteristic information level signal Cycle
cation interval
The indicator light 5
Air High Techni is flashing red. seconds White text

Red
bubble priority cal Flashing （±2 Red 50%
background
alarm alarm alarm frequency: 2.0 ± seconds background
0.6 Hz ）
High Techni is flashing red. seconds White text

Occlusio Red
priority cal Flashing （±2 Red 50%
n alarm background
alarm alarm frequency: 2.0 ± seconds background
0.6 Hz ）
Door High Techni is flashing red. seconds White text

Red
open priority cal Flashing （±2 Red 50%
background
0.6 Hz ）
Motor High Techni is flashing red. seconds White text

Red
failure priority cal Flashing （±2 Red 50%
background
0.6 Hz ）
Pressure High Techni The indicator light 5 White text Red 50%
abnorma priority cal is flashing red. seconds Red background
25
Flashing （±2
l alarm alarm alarm frequency: 2.0 ± seconds background
0.6 Hz ）
Door High Techni is flashing red. seconds White text

Red
abnorma priority cal Flashing （±2 Red 50%
background
l alarm alarm alarm frequency: 2.0 ± seconds background
0.6 Hz ）
5
The indicator light
Infusion High seconds White text
Genera is flashing red. Red
end priority （±2 Red 50%
l alarm Flashing background
alarm alarm seconds background
frequency:
）
2.0 ± 0.6 Hz

Battery High
Genera is flashing red. seconds White text Red
exhauste priority 50%
l alarm Flashing （±2 Red background
d alarm alarm
frequency: seconds background
2.0 ± 0.6 Hz ）

High
KVO Genera is flashing red. seconds Red
priority 50%
alarm l alarm Flashing （±2 White text background
alarm
frequency: seconds Red
2.0 ± 0.6 Hz ） background
20
Low The indicator light seconds Black text

Standby Genera Yellow
priority is always on in （±2 Yellow 100%
alarm l alarm background
alarm yellow. seconds background
26
20
Infusion Low The indicator light seconds Black text

Genera Yellow
will priority is always on in （±2 Yellow 100%
l alarm background
over! alarm yellow. seconds background
20
Low Low The indicator light seconds Black text

Genera Yellow
battery priority is always on in （±2 Yellow 100%
l alarm background
alarm alarm yellow. seconds background
10
The indicator light seconds Black text

prompt Yellow
—— —— is always on in （±2 Yellow 100%
signal background
yellow. seconds background
Attention:
 In any single area, the use of different alarm presets for the same or similar device is
potentially dangerous.
 If the infusion pump is restarted after power interruption, the settings of alarm system will
not be changed.
 When the syringe pump is powered on, the system will detect whether the alarm sound
and the function of the alarm light are normal.
When you start the machine, you can hear a "Dang" alarm sound, and the alarm light
flashes red once. The purpose of this function is to verify whether the alarm function of
the system is normal. Therefore, the user should observe the result when starting the
system. If the audio-visual alarm is abnormal, it means that the system can not monitor the
patient. Therefore, the user must contact the manufacturer and the maintenance center.
4.7 “Infusion will over!” and “KVO” state
The KVO state refers to that, after the pump finishes infusing total volume, in order to keep
27
the vein open, the pump still continues the infusion at a very slow rate.
1) Three minutes before finishing infusing, the pump will give an alarm every 20 seconds,
the working state indicators keep lighting in green, and the message "Infusion will over!"
appears on the screen.
2) After infusion is completed, the pump will switch to KVO state automatically, and the
message "Enter KVO mode" and appears on the screen. The working indicators flicker in
red, and the pump makes audible alarm.
3) Press to end the KVO state.
28
Chapter 5 Infusion Function
5.1 Clear infused volume
When the pump stops working, select "Clear" in main menu. After pressing button,
the message "Volume is XXXX.XX mL, clear zero?" appears on screen. Press to clear
infused volume, press to cancel. Shown as Figure 5-1:
Figure 5-1 Clear infused volume

5.2 Accumulation of infused volume
The pump is able to accumulate the amount that already infused. When the pump is used on
other patients or the medicine solution is changed, it accumulates previous volume that was
infused to the patient, and displays the total volume to be infused to current patient. If the infused
volume is non-0, press to start infusing, and the system will prompt "Volume is XXXX.XX
mL, clear zero?", press to clear infused volume, press to cancel; if the infused
volume is 0, the pump starts infusing normally.
5.3 Change "TOTAL VOLUME" during Infusing
Press to halt infusing, then the pump returns to the main menu, select "Total" to reset
the total volume, and press to save the setting. After the system back to the main menu,
press "START/STOP" to continue.
5.4 PURGE
In non-infusing state, short press once and long press it to clean the pipeline.
Warning
 Disconnect the IV set from the patient when cleaning pipeline.
29
In PURGE state, the air bubble detector is deactivated. (Do not use this function when
connecting the IV set to the patient.)
Attention:
 When the pump works with internal battery, avoid using this function in low battery state.
5.5 Change Infusion Bottle during Infusing
During infusing, press to halt infusing, unplug the IV set from the infusion bottle, and
insert it into a new one. In main menu, the liquid volume in new infusion bottle is accumulated
to total volume, press to confirm current total volume, and the system returns to the main
menu. Make sure the infusion rate is right, press START/STOP to continue infusion.
Attention:
 To keep clean, don't touch the bottle stopper puncture outfit with hands.
 During replacing the infusion bottle, medical personnel should check whether there is air
bubble in the pipeline. If found, please remove all air bubbles before infusion.
5.6 Moving Patient
If patient needs to move, infusion can be guaranteed during moving.
Disconnect the power cord, the pump will continuously work with internal battery. Make
sure that the pump, power cord and the IV set are securely fixed to the infusion pole, and move it
with patient.
Attention:
 Do not let the pump swing excessively during patient moving. Normally, the AC power
supply should be used, the internal battery is only suitable for short-time moving. When
the pump only works with internal battery and battery is low, please avoid to use high
speed or long-time infusion.
5.7 Noise and Heat
The motor generates slight noise when running.
When the temperature exceeds 30 ℃, the pump surface becomes hot after a long time
operation.
30
Chapter 6 System Setting
In main menu, press UP or DOWN to select "Sys Setting", press to enter its setting
interface. Input password firstly, refer to section 4.3 for details. The system settings include settings
of pressure threshold, rate calibration, language, button sound and reset, shown as Figure 6-1:
Figure 6-1 System setting interface

6.1 Pressure threshold
Pressure sensor is able to detect the liquid pressure in the downstream pipeline, and pressure
threshold can change the maximum allowable pressure of the pump. During infusion process, if
the downstream pipeline is blocked and pump’s pressure reaches to the preset threshold value,
the pump alarms and stops infusing.
To set the pressure threshold:
In the system setting interface, press UP or DOWN to select "Pressure", and press to
enter its setting interface.
Press UP or DOWN to set the pressure value. There are 3 levels (1~3) can be adjusted, as
shown in Figure 6-2:
31
Figure 6-2 Pressure threshold interface
Attention:
 The pump has been set to the optimal pressure threshold before leaving factory, if no
particular need, please don't change it. To avoid causing injury to patients, make sure the
value is not changed before infusing.
 Due to the temperature effect to the IV set and medicine solution, the actual alarm value of
pressure may become larger (smaller) when temperature drops (rises). According to the
specific needs and the degree of temperature dropping (rising), it is appropriate to
decrease (increase) the pressure threshold of alarm.
6.2 Rate calibration
In the system setting interface, press UP or DOWN to select "Calibration", and press
to enter its setting interface.The interface displays the IV set brand name, calibration speed
sections and speed offset, as shown in Figure 6-3:
Figure 6-3 Offset setting interface

Press UP or DOWN to select different items, and press LEFT or RIGHT to change the
32
value, then press to confirm the setting.
Attention:
 The IV set should be consistent with the current type in using. Calculation method of rate
offset refer to Chapter 7.
6.3 Language
In the system setting interface, press UP or DOWN to select "Language", and press to
enter its setting interface, as shown in Figure 6-4:
Figure 6-4 Language selection interface
Press UP or DOWN to select the language, and press to confirm the setting.
6.4 Button sound
In the system setting interface, press UP or DOWN to select "Volume". Then press UP or
DOWN to turn on or off the sound, and press to confirm the setting, as shown in Figure 6-
5:
Attention:
 Alarm sound is affected by the ON or OFF of button sound, it is always in “ON” state.
33
Figure 6-5 Button sound setting
6.5 Reset
In the system setting interface, press UP or DOWN to select "Reset", after pressing ,
the system prompts “Reset All?”, press to reset or press to cancel, as shown in Figure
6-6:
Figure 6-6 Rest interface
34
Chapter 7 Calibration for IV Set
The accuracy largely depends on the IV set. Materials and specifications chosen by different
manufacturers are different, so in order to ensure the accuracy, different brands of IV set have
their own infusion parameter. A new brand infusion set must be calibrated and it can not be used
until validated that its accuracy within the allowable error range.
The above work will be completed by the supplier or dealer.
Local suppliers have obligation to provide a database of IV set brands that commonly used
in local. Before purchasing the pump, users should inform the suppliers of the IV set brand that
they intended to use.
7.1 Infusion Accuracy
Infusion accuracy refers to the percentage of the difference between actual infusion volume
and preset infusion volume divided by the preset volume under the condition of preset infusion
rate, the formula is as below:
Infusion accuracy = (actual infusion volume - preset infusion volume) / preset infusion
volume × 100%
7.2 IV Set Requirements
External diameter: 3.5 mm~4.3 mm.
The IV set contained Silicon rubber: High flexibility, relative stable with physical
properties, and doesn't change with the changes in ambient temperature, the infusion accuracy
can be achieved to ± 5% after calibration.
Ordinary PVC (polyvinyl chloride): low flexibility, unable to exactly recover to the original
state after being extruded, its diameter will increase gradually with the extrusion frequency and
infusion time increasing, the accuracy is about ±(5~15)% after calibration.
Hard PVC (polyvinyl chloride): without flexibility, almost unable to recover to the original
state after being extruded, it is not recommended to use.
Attention:
7.3 Selection of IV Set
Each pump provides a specified IV set for use and one blank brand for selection. After
35
connecting to the power, press ON/OFF to turn on the pump, and then the current IV set
information appears on the screen. If the displayed brand is the same with the current using, you
needn't to reset. Otherwise, please see section 4.4 to reset the brand name.
Brand Model Specification
ANDE BPQ-15 Inner diameter 3mm
Attention:
 There are various infusion sets, and the models used in different hospitals are not the
same, the names of infusion set that listed in the “Type” are set based on user’s demand
before leaving factory. Before purchasing the pump, it would be better to inform the
supplier or manufacturer of the IV set brands that you are going to use, in order to input
the parameters of IV set into the pump system in advance.
 The selected name must be consistent with the current using type, otherwise the accuracy
may be inaccurate.
 If the IV set brand you want to calibrate is not in the selections, you can also directly
calibrate it in "A" channel without informing the dealer of its brand. This must be
calibrated. See section 7.4 for the calibration.

7.4 Calibration for IV Set
The pump sets infusion rate with "mL/h", also known as "volumetric mode" infusion, and
its calibration is called “infusion rate” calibration.
The method of calibrating a preset infusion rate (mL/h) is called “infusion rate” calibration.
Calibration steps:
In main menu, select the type of IV set to be calibrated. After inputting the password, enter
the system setting interface, select “Calibration” to enter rate calibration interface, which shows
the brand of IV set and its corresponding rate offsets.
Press UP or DOWN to select different items, and press LEFT or RIGHT to change the
offset value, the adjustment range is -20% to 20%.
Press to confirm the setting and return to system setting interface.

Offset adjustment principles:
36
Infusion rate offset (N %) can be calculated according to measurements and calculation.
Formula is as following:
N% = [(theoretical flow volume - measured flow volume) ÷ theoretical flow
volume]*100%........................... Formula 1
Calculate the value according to Formula 1, and directly edit the rate offset value in the
Offset interface.
Example:
Suppose the infusion rate of an infusion set is 50 mL/h, infusion measurement time is 60
minutes, and the actual measured volume is 56 mL. Let’s calculate the offset value (N%) and
complete the calibration operation.
The first step is to calculate the offset value: according to the conditions given above, the
“theoretical flow volume” during 60 minutes is: theoretical flow volume =50 mL/h×1 h = 50 mL.
Given actual measured volume is 56 mL, therefore, according to Formula 1, offset value (N%)=
[ (50 mL – 56 mL) ÷ 50 mL]% = -12%.
The second step is to input the offset value: According to the offset value calculated above,
in offset interface, press UP or DOWN to select the rate range, and press LEFT or RIGHT set the
offset value to “-12%”. Press to confirm, then the calibration is completed.
37
Chapter 8 Maintenance
Please use the pump carefully as it is a good designed equipment. Proper maintenance can
extend the service life of the device.
8.1 Cleaning and Disinfection
The patient contact parts (such as pump door, hook, etc) must be cleaned and disinfected
every month by medical personnel, the cleaning and disinfection methods are as following:
Cleaning: Clean the pump with a soft cloth soaked in soapy water, and use a dry cloth to
wipe dry.
Disinfection: Dip a soft cloth in “84” disinfectant solution (concentration: 25%), use it to
wipe the pump door, air bubble detection sensor and other parts, then wipe dry with a dry cloth.
8.2 Periodic Maintenance
8.2.1 Infusion rate inspection
1 ）When the pump is stored for 6 months or longer, before using, use a graduated cylinder
and stop watch to test the infusion rate.
2）For a normally used pump, the medical personnel should perform one infusion rate
inspection every six months by using a graduated cylinder and a stop watch. If its accuracy
exceeds the allowable range, it should be calibrated.
8.2.2 Inspection and Maintenance for Built-in Battery
When the battery is fully charged, the pump can work for more than 4 hours continuously at
the infusion rate of 25 ml/h with internal battery. When the pump is used for the first time or
after 3 months non-use, it is recommended to charge it at least 12 hours. It is better to keep the
battery in charging condition when the pump at non-working mode. If the pump is not used for a
long period, please charge it every 3 months until the charging indicator indicating it is fully
charged. When the pump is stored for a long time, it should be connected to the AC power
supply for 5 minutes before turning on.
Batteries belong to expendables. They must be replaced when reaching the service life. If
necessary, please contact your distributor or the manufacturer for battery replacement. Model:
Lithium polymer battery (7.4 V, 5000 mAh).
Warning:
The replacement of lithium batteries or fuel cells by inadequately trained personnel could result
in a hazard.
38
In order to ensure the battery performance and prolong its life, every month medical
personnel should take a test of battery running out until the pump automatically shut down.
Then, for future use, charge the pump until the charging indicator indicating it is fully charged.
Follow the steps below to check the battery every 4 months:
1) Connect to AC, charge the battery to fully charged;
2) Turn on the pump and install the infusion set;
3) Set the infusion rate to 25 mL/h, then start infusing;
4) Keep the pump working till it turns off for low battery.
 The battery is in good condition if, the pump takes more than 4 hours from starting
infusing to low battery (alarm); and, it takes more than 30 minutes from low battery
(alarm) to running out (alarm); and, more than 3 minutes from battery running out
(alarm) to automatic shutdown.
 If one or more of the above duration doesn’t meet the requirement, the battery is near
the end of its service life. Contact the dealer or manufacturer for battery
replacement.
5) After checking the battery, recharge the battery to fully charged for use next time.
Battery life depends on its use of frequency and time. The cycle life of the lithium battery in
this device is 300 times. If the number exceeds 300 times, it is recommended to replace the
battery or carry out above inspection every month. If the maintenance and storage of the battery
is appropriate, its service life will be about 3 years. While if used improperly, its service life may
be shortened. For the battery has been used over 3 years, we recommend to replace the battery or
carry out above inspection every month.
8.3 Non-pollution treatment and Recycling
The pump has normal life for Ten years, it needs to be discarded after reaching the service
life.
Please return the used battery to the dealer or manufacturer, or dispose them according to
applicable regulations. Do not disassemble the battery or throw it into fire, water or short circuit,
otherwise it will cause burning, explosion, leakage or risks of personal injury.
The dealer or our office will recycle the used pump.
Please contact manufacturer or dealer for more relevant information.
8.4 Disposal and Recycling for the IV Set
The IV set used with the pump is the disposable pump infusion set manufactured by Shinva
39
Ande Healthcare Apparatus Co., Ltd. It is disposable, and can not be used repeatedly. Please
dispose the used IV set according to local laws and regulations.
40
Chapter 9 Infusion Characteristics
9.1 Accuracy Characteristics
The infusion accuracy curve indicates the infusion change in a certain period after starting
infusing and the performance achieves a normal infusion volume. The curve adopts the brand of
the disposable pump infusion set manufactured by Shinva Ande Healthcare Apparatus Co.,
Ltd."(BPQ-15) for testing, which was used as an important symbol of the overall characteristics.
Test environment and condition
Temperature: +25 ℃~+30 ℃

Relative humidity: 20%~90%
Atmospheric pressure: 860 hPa~1060 hPa
Start Curve
It is drawn according to the data of two hours testing circle.

Sample interval: ∆t=0.5 minute infusion volume:Q/(ml/h) testing circle= 120 minutes
Figure 9-1 Accuracy characteristics curve
41
Figure 9-2 Start-up graph: Flow QI (1ml/h) against time (min) plotted from data
gathered during the first 2 h of the test period (Minimum)
-administration set: SHIVA ANDE BPQ-15
Figure 9-3 Start-up graph: Flow QI (25ml/h) against time (min) plotted from data gathered
during the first 2 h of the test period (Intermediate)- administration set: SHIVA ANDE BPQ-15
42
Figure 9-4 Start-up graph: Flow QI (25 ml/h) against time (min) plotted from data gathered
during the first 2 h of the test period (Intermediate) at back pressure of +13,33kPa-
administration set: SHIVA ANDE BPQ-15
during the first 2 h of the test period (Intermediate) at back pressure of -13,33kPa- administration
set: SHIVA ANDE BPQ-15
43
during the first 2h of the test period (Intermediate) when the supply container below the pump
mechanism at a distance of 0.5m -administration set: SHIVA ANDE BPQ-15
Horn-shaped curve
Short-term infusion volume error: ( p△t) Sample interval: △t=0.5 minute

Observation window duration: p△t=2, 5, 11, 19, 31 minutes
The total average percentage of measured infusion volume error: A (%)
The minimum testing error of observation window within given time: EP min (%)
The maximum testing error of observation window within given time: EP max (%)
Figure 9-7 Horn-shaped curve
44
Figure 9-8 Trumpet curve: Percentage variation Ep against observation window duration P (min)
and the overall mean percentage error A plotted from data gathered during the second hour of the
test period (Minimum) -administration set: SHIVA ANDE BPQ-15
Figure 9-9 Trumpet curve: Percentage variation Ep against observation window duration P (min)
and the overall mean percentage error B plotted from data gathered during the last hour of the
test period (Minimum)
45
Figure 9-10 Trumpet curve: Percentage variation Ep against observation window duration P
(min) and the overall mean percentage error A plotted from data gathered during the second hour
of the test period (Intermediate) - administration set: SHIVA ANDE BPQ-15
(min) and the overall mean percentage error B plotted from data gathered during the last hour of
the test period (Intermediate)- administration set: SHIVA ANDE BPQ-15
46
of the test period (Intermediate) at back pressure of +13,33kPa- administration set: SHIVA
ANDE BPQ-15
47
of the test period (Intermediate) at back pressure of -13,33kPa- administration set: SHIVA ANDE
BPQ-15
of the test period (Intermediate) when the supply container below the pump mechanism at a
distance of 0.5m
Attention:
 Infusion accuracy does not reflect the clinical standard, such as age, weight and other
drugs the patient uses.
 Infusion accuracy may be affected by environmental conditions (pressure, temperature,
the
IV set, etc.)
9.2 Occlusion Response Characteristics
Blocking alarm time is an important guideline of the occlusion response, the pump adopts the
brand of the disposable pump infusion set manufactured by Shinva Ande Healthcare Apparatus
Co., Ltd." for testing, its data only represents the conclusion of the current measurement.
Occlusion alarm time was influenced by infusion rate, IV set brand, IV set specification, infusion
solution, infusion pipeline length, external pressure, etc, temperature. The pump has been set to
48
the optimal characteristic before leaving factory, if no particular needs, please don't adjust the
pressure value.
Occlusion Pressure Occlusion Alarm

Rate(ml/h)
(kPa) Time
1 158 2h11min
Alarm Grade 1
25 143 5min02sec
Alarm Grade 1 218 2h40min

3 25 208 6min10sec
Occlusion Bolus dose
It produces about 1 .3ml bolus dose under the atmospheric pressure of 143kPa, and 2.4 ml bolus
dose under the atmospheric pressure of 208 kPa when running at 25mL/h(the result is the
average of measuring for many times, which is used for reference).
Occlusion pressure range
Level 1: 100-180kPa
Level 2: 120-260kPa
Level 3: 140-300kPa
Note: The above data are values tested under test conditions, the actual data varies with
different test conditions, please refer to the data tested by the product you have purchased. Under
the conditions of the same reference occlusion value and flow rate, the higher the tested pressure
value, the longer the alarm delay time.
warning ：
Select suitable occlusion alarm threshold since setting occlusion alarm threshold to extreme
values can affect the time for activation of the occlusion alarm.
9.3 Recommended IV Set and Infusion Component
The pump is calibrated by the disposable IV set manufactured by Shinva Ande Healthcare
Apparatus Co., Ltd. If you use other brands of the IV set, please refer to the User Manual for
calibrating the IV set parameter, or tell your IV set brand to the dealer who can help calibrate it.
49
Chapter 10 EMC Compatibility and Interference
The pump can prevent external interference, including high-intensity radio frequency
radiation, magnetic and electrostatic. However, user should avoid using the mobile phone within
0.5 meter away from the device.
Avoid using this pump with MRI (Magnetic Resonance Imaging) or analogous medical
equipment together, otherwise the electromagnetic interference will cause system failure or
50
system collapse.
Ensure that the environment in which the pump is used is not subject to any sources of
strong electromagnetic field, such as mobile telephones, etc. Otherwise the electromagnetic
interference will cause system failure or system collapse.
Note:
 The device is a class A equipment of radio interference protection conformed EN55011.
 The device requires special precautions for electromagnetic compatibility (EMC) and
requires qualified personnel to install and use in accordance with the EMC information
provided below.
 Electromagnetic fields can affect the performance of the device, so other equipment used
near the equipment must meet the appropriate EMC requirements. Mobile phones, X-rays,
or MRI devices are possible interference sources, as they emit high-intensity
electromagnetic radiation.
ESD Precautionary measures
In order to avoid the accumulation of electrostatic charge, it is recommended to store,
maintain and use the equipment at a relative humidity of 30% or more. The floor should be
covered with ESD dissipated carpets or similar materials. In the use of the components, non-
synthetic clothing should be wore. In order to prevent electrostatic discharging to the ESD-
sensitive parts of the device, the personnel should contact the metal frame of the components or
the large metal objects near the device. When using the device, especially when it is possible to
contact the ESD-sensitive parts of the device, the operator should wear a grounded bracelet
designed for ESD-sensitive devices.
ESD Precautionary procedure training
All potential users are advised to understand the ESD warning symbols and receive
training on ESD precautions. The most basic content of the ESD precautionary procedure
training should include an introduction to electrostatic charge physics, voltage level in the
conventional case, and damage to the electronic components when the operator with electrostatic
charge contacts them. In addition, the methods for preventing electrostatic buildup, and the
manner and reasons for the release of human body static electricity to the ground or equipment
frame or the use of a bracelet to connect the human body to the equipment or the ground before
establishing the connection should be described.
 The use of ACCESSORIES, transducers and cables other than those specified, with the
51
exception of transducers and cables sold by the MANUFACTURER of the ME
EQUIPMENT or ME SYSTEM as replacement parts for internal components, may result
in increased EMISSIONS or decreased IMMUNITY of the ME EQUIPMENT or ME
SYSTEM.
 Devices or systems should not be used when they are close to or stacked with other
equipment, if necessary, please observe and verify that they can operate normally in the
configurations.
 Devices or systems may still be interfered by other equipment, even if other equipment
meets the requirements of the corresponding national standard.
 Active medical devices are subject to special EMC precautions and they must be installed
and used in accordance with these guidelines.
 Portable and mobile RF equipment may affect the use of medical electrical equipment.
 Basic performance description: Working status can not be changed, infusion rate is set to
300mL/h, the allowable error is ±5%.
52
Appendix I Explanation of system alarms
Alarm Alarm level Reasons Solutions
Press START/STOP to stop infusing,
The preset infusion and the alarm is eliminated; in the
Infusion will Low priority
volume is main menu, clear the infused
over! alarm
completed. volume, and press START/STOP to
restart infusing.
1. Long press(about 2s) confirm
1. There is air button to eliminate the alarm;
bubble in the IV set. manually remove the air bubble, and
High priority 2. Incorrect press START/STOP to restart
Air bubble
alarm installation of IV infusing.
set. 2. Reinstall the IV set.
3. Sensor failure. 3. Contact with customer service
(manufacturer or supplier).
1. Long press confirm button to
1. Blocking occurs.
eliminate the alarm; remove the
2. Alarm system is
obstruction, and press START/STOP
High priority sensitive due to the
Blocking to restart infusing.
alarm blocking alarm limit
2. Refer to the user manual for the
is set too small.
pressure threshold.
3. Sensor failure.
3. Contact with customer service.
1. Battery is low.
1. Connect with AC power supply to
Low priority 2. Aging of battery
Low battery charge the battery.
alarm or battery charging
circuit is damaged.
1. Battery is
dead.
1. Connect with AC power supply
Battery High priority 2. Aging of
to charge the battery.
exhausted alarm battery or battery
charging circuit
is damaged.
1. Long press confirm button to
1. Wrong
eliminate the alarm; reinstall the
Motor High priority installation of IV
IV set, and press START/STOP to
abnormal alarm set.
restart infusing.
2. Motor failure.
53
Appendix II EMC Guidance and Manufacturer Declaration
The following cable types must be used to ensure that they comply with interference radiation
and immunity standards:
Name Cable length(m)
Power cord 1.8
Connection cable of potential
3.0
equalization terminal
Table 1: Electromagnetic emission
Guidance and manufacture’s declaration –electromagnetic emission
The device is intended for use in the environment specified below. Buyer or operator should
assure that it is used in such environment.
Emission test Compliance Electromagnetic environment-guidance
The device uses RF energy only for its internal

RF emissions function. Therefore, its RF emissions are very
Group 1
CISPR 11 low and are not likely to cause any interference
in nearby electronic equipment.
RF emissions
Class A
CISPR 11
Harmonic The device is suitable for use in all

emissions Not applicable establishments, other than domestic and those
IEC 61000-3-2 directly connected to a low voltage power
Voltage supply network which supplies buildings used
fluctuations/ for domestic purpose.

Not applicable
flicker emission
IEC 61000-3-3
54
Table 2: Electromagnetic immunity 1
Guidance and manufacture’s declaration-electromagnetic immunity
IEC60601 test Compliance Electromagnetic

Immunity test
level level environment-guidance
Electrostatic ±8kV contact ±8kV contact Floors should be wood,

discharge (ESD) ±15kV air ±15kV air concrete or ceramic tile. If
IEC 61000-4-2 floor is covered with
synthetic material, the
relative humidity should
be at least 30%.
±2kV for
±2kV for power Mains power quality
Electrical fast power supply
supply lines should be that of a typical
transient/burst lines
± 1 kV for I/O commercial or hospital
IEC 61000-4-4 ± 1 kV for I/O
line environment.
line
±1 kV lines to ±1 kV lines to Mains power quality

Surge earth earth should be that of a typical
IEC 61000-4-5 ±2 kV lines to ±2 kV lines to commercial or hospital
earth earth environment.
Voltage dips, short <5%UT(>95%dip <5%UT(>95%d Mains power quality
55
ip in UT) for
in UT) for 0.5 should be that of a typical
0.5 cycle
cycle commercial or hospital
40%
40% UT(60%dip environment. If the user
interruptions and UT(60%dip in
in UT) for 5 cycle requires continued
voltage vatiations UT) for 5 cycle
70%UT(30%dip operation during power
on power supply 70%UT(30%di
in UT) for 25 mains interruptions, it is
input lines p in UT) for 25
cycle recommended that the
IEC 61000-4-11 cycle
<5%UT(>95% device be powered from an
<5%UT(>95%
interrupt UT) for 5 uninterruptible power
interrupt UT)
sec supply or a battery.
for 5 sec
Power frequency 400 A/m 400 A/m Power frequency magnetic

(50 Hz) magnetic fields should be at levels
field characteristic of a typical
IEC 61000-4-8 location in a typical
commercial or hospital
environment.
NOTE: UT is the a.c. mains voltage prior to application of the test level.
Table 3: Electromagnetic immunity 2
Guidance and manufacture’s declaration-electromagnetic immunity
Immunity IEC60601 Compliance

Electromagnetic environment -guidance
test test level level
56
Portable and mobile RF communications
equipment should be used no closer to any
part of the device, including cables, than the
recommended separation distance calculated
3V
Conducted from the equation applicable to the frequency
(effective 3V
RF of the transmitter.
value) (effective
IEC61000 Recommended separation distance
150kHz～ value)
-4-3 d=1.2 P
80MHz
d=1.2 P 80MHz-800MHz
d=2.3 P 800MHz-2.5GHz
Where P is the maximum output power rating
of the transmitter in watts (W) according to
the transmitter manufacturer and d is the
recommended separation distance in meters
(m).
Radiated Field strengths from fixed RF transmitters, as

3 V/m
RF determined by an electromagnetic site survey,
80 MHz～ 3 V/m
IEC61000
a
should be less than the compliance level in
2.5 GHz
-4-3 each frequency range.b
Interference may occur in the vicinity of
equipment marked with the following symbol:
NOTE 1: At 80MHz and 800 MHz, the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.
a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV
broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic
environment due to fixed RF transmitters, an electromagnetic site survey should be
considered. If the measured field strength in the location in which the device or system is
used exceeds the applicable RF compliance level above, the device should be observed to
57
verify normal operation. If abnormal performance is observed, additional measures may be
necessary, such as adjusting the direction or location of the device.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Table 4: Recommended safety distance
Recommended separation distances between

portable and mobile RF communications equipment and the device
The device is intended for use in the electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the device can help prevent
electromagnetic interference by maintaining a minimum distance between portable and
mobile RF communications equipment (transmitters) and the device as recommended below,
according to the maximum output power of the communications equipment.
Separation distance according to power of transmitter (m)
Rated power of 150 k Hz – 80 MHz 80 MHz – 800 MHz 800 MHz – 2.5 GHz
transmitter(W) P P P
d=1.2 d=1.2 d=2.3
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
For transmitters rated at a maximum output power not listed above, the recommended
separation distanced in meters (m) can be estimated using the equation applicable to the
frequency of the transmitter, where P is the maximum output power rating of the transmitter
in watts (W) according to the transmitter manufacturer.
NOTE 1 At 80MHz and 800MHz, the separation distance for the higher frequency range
applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.
58
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Contents

 Do not touch the peristaltic part during device working.

Chapter 1 Brief Introduction

Type Volumetric infusion pump

PURGE rate 699 mL/h

Preset volume range 1 mL～9999 mL, increment 1 mL

KVO rate 1 mL/h

①Infusing prompt ②Door open ③Occlusion ④Air bubbles

Safety classification Class I, type BF

Working mode Continuous operation

Power supply 100-240 V~, 50/60 Hz

Battery Rechargeable Li-Ion battery, 7.4 V/5000 mAh

When the pump is connected to AC power, the battery can be

The device can continuously work at least 5 hours with a medium

Maximum weight About 1.9 kg

Dimension 143.6 mm(L)×151.8mm(W)×195.3 mm(H)

① Temperature: +5 ℃~+40 ℃ ② Relative humidity: 20%～90%

①Environment temperature: -30 ℃～+55 ℃ ②Relative humidity:

The disposable pump infusion set manufactured by Shinva Ande

Figure 1-1 Front view

No. Name Description

1 Handle Convenient for carrying

3 Pump door Fix the IV set.

In the menu on the bottom of screen, press it to execute the

Cursor or number If you need to input numbers, press UP or DOWN button to

6 Power and Indicate the power type:

8 ON/OFF Press and hold it to turn on or off the pump

It is used for rinsing the IV set before infusing; This button is

10 START/STOP In main menu, press it to start or halt infusing.

Lock for pump

Figure 1-2 Internal view for pump door

No. Name Description

12 IV set slot Fix the IV set.

Detect whether there is air bubble in the IV set during

Figure 1-3 Rear view

No. Name Description

18 Power cord socket Connect with AC power cord

19 Speaker To make audible alarms

Note: 1) Additional equipment connected to medical electrical equipment through the

Type BF applied part

IPX2 Degree of protection against ingress of liquid

Refer to instruction manual/booklet

This item is compliant with Directive 93/42/EEC of 14 june

Infusion liquid flow

Transport humidity limitation: 5%～96%

Fragile, handle with care

Stacking limit by number (8 layers)

Figure 3-2 Rate setting interface

2) Set the infusion rate to 500 mL/h. Press to start infusing.

Figure 3-5 Occlusion alarm

1) Press to run the pump.

Figure 3-6 Door open alarm

Figure 4-1 Total volume setting

Figure 4-3 Password interface

Name Level Type Sound characteristic Light

Sound mode: “beep-beep-beep---

Sound mode: “beep-beep-beep---

Sound mode: “beep-beep-beep---

Sound mode: “beep-beep-beep---