XK-04-TE-0-044-2017

0197

IPA1 Series Infusion Pump

User Manual
(IPA111 IPA112)

Version：0

MEDEVO MEDICAL Co., Ltd.

September 2017
 Contents
1. EXPLANATION OF SYMBOLS AND WARNINGS...............................- 1 -

1.1 EXPLANATION OF SYMBOLS................................................................- 1 -

1.2 WARNINGS......................................................................................... - 1 -

2. TERMS AND DEFINITIONS.................................................................- 4 -

3. INTRODUCTION AND SCOPE OF APPLICATION.............................- 4 -

3.1 INTRODUCTION...................................................................................- 4 -

3.2 APPLICATION......................................................................................- 5 -

3.3 MODEL NAME.....................................................................................- 5 -

4. IMPORTANT PROPERTIES.................................................................- 5 -

5. BASIC PARAMETERS, MAIN FEATURES AND FUNCTIONS...........- 7 -

5.1 BASIC PARAMETERS...........................................................................- 7 -

5.2 MAIN FEATURES.................................................................................- 7 -

5.3 MAIN FUNCTIONS..............................................................................- 11 -

6. STRUCTURE AND OPERATION DISPLAY.......................................- 12 -

6.1 STRUCTURE......................................................................................- 12 -

6.2 DISPLAY AND OPERATION INTERFACE...............................................- 14 -

7. CLINICAL OPERATION......................................................................- 15 -

7.1 DEVICE FIXATION..............................................................................- 15 -

7.2 POWER ON.......................................................................................- 16 -

7.3 SETUP PARAMETERS........................................................................- 16 -

I
8. ALARM SIGNAL FUNCTION..............................................................- 25 -

8.1 DOOR OPEN ALARM.........................................................................- 26 -

8.2 OCCLUSION ALARM...........................................................................- 27 -

8.3 PAUSE OVERTIME ALARM.................................................................- 27 -

8.4 COMPLETION ALARM.........................................................................- 28 -

8.5 AIR-IN-LINE ALARM...........................................................................- 28 -

8.6 ERROR ALARM..................................................................................- 29 -

8.7 LOW BATTERY ALARM.......................................................................- 30 -

8.8 BATTERY EXHAUST ALARM...............................................................- 30 -

8.9 NEAR COMPLETION ALARM...............................................................- 31 -

8.10 POWER OFF ALARM........................................................................- 31 -

8.11 ALARM SYSTEM SECURITY..............................................................- 31 -

8.12 ALARM SOUND SIGNAL PAUSE STATE.............................................- 32 -

8.13 EXTERNAL POWER CONNECTION TOKEN........................................- 32 -

8.14 BATTERY CHARGING TOKEN...........................................................- 32 -

8.15 BATTERY CHARGING COMPLETION TOKEN.....................................- 33 -

8.16 LOW AMBIENT TEMPERATURE TOKEN.............................................- 33 -

9. IV SET DEBUGGING..........................................................................- 33 -

9.1 IV SET DEBUGGING PROCEDURE.....................................................- 33 -

9.2 IV SET CODE SELECTIONS...............................................................- 33 -

9.3 IV SET ACCURACY CALIBRATION......................................................- 34 -

10.PRECAUTIONS FOR INFUSION SET / IV SET...............................- 34 -

PAGE \* MERGEFORMATII
11.TECHNICAL PARAMETERS..............................................................- 35 -

12.INTERNAL BATTERY.........................................................................- 41 -

13.MAINTENANCE AND REPAIR...........................................................- 41 -

13.1MAINTENANCE AND REPAIR.............................................................- 41 -

13.2C LEANING / DISINFECTION...............................................................- 41 -

13.3 DROP SENSOR...............................................................................- 43 -

13.4 DISPLAY PANEL..............................................................................- 43 -

13.5 MAINTENANCE................................................................................- 43 -

13.6 PROTECTIVE EARTHING..................................................................- 43 -

13.7 BATTERY DISASSEMBLY & ASSEMBLY.............................................- 43 -

14.TRANSPORT AND STORAGE...........................................................- 44 -

15.WASTE TREATMENT.........................................................................- 44 -

15.1 BATTERY........................................................................................ - 44 -

15.2 INFUSION SET (IV SET )..................................................................- 44 -

15.3 INFUSION PUMP.............................................................................- 44 -

16.ELECTROMAGNETIC COMPATIBILITY (EMC)................................- 45 -

17.EMC STATEMENT..............................................................................- 52 -

18.PACKAGING AND ACCESSORIES...................................................- 54 -

III
PAGE \* MERGEFORMATII
1. Explanation of Symbols and Warnings

1.1Explanation of Symbols

Symbol Description
Attention！

Disconnection (used in part of the device

only)

Connection(used in part of the device only)

AC

DC

CF application part

Access to files

Production date

Discard prohibited

IPX4 IPX4 Ingress Protection Test Equipment

Lot number

1.2 Warnings

The device / pump must be operated by professional medical staff.

Please read the operating instructions before use to prevent accidents
due to mishandling
1
To prevent the pump from being affected during its operation,
it is not allowed to place any other device that may cause
malfunction of the pump due to external radio frequency
interference or electromagnetic radiation over the pump. If it is
necessary to place any other device over / near the pump, it
should be verified that the pump can run under normal operating
conditions.
Avoid using the pump in presence of flammable gases and
flammable anesthetic mixture with air, oxygen or nitrous oxide.
The device can be operated under the environment with no strong
shock and strong electromagnetic fields.
Not suitable for portable infusion.
Prohibited to be used, together with other infusion systems, in the
same infusion tube to the patient.
Be sure that the pump is kept at a distance of no more than
1m from the allowable installation height of IV set (i.e.
transfusion set) above or below the patient's heart.
All parts and accessories of the device must be the product of
specified model.
The device cannot be used to automatically identify the type of
IVset.
The operator/ user must ensure that the IVset is the
recommended type and select the corresponding gears.
The device should be maintained calibrated by a trained
professional.
The IVset without recommendation may cause the large
deviation of infusion accuracy or excess of specified flow rate
accuracy.
The device belongs to IPX4 Infusion Pump. Do not immerse the
device in water. Contact your authorized dealer for repair, in case of

2
any inflow of liquid into the device. Continued use of the device is
allowed only after the check by a trained professional.
If the device falls from a height or suffers from strong shock, it
is allowed to be used only after being checked by a trained
professional.
Prohibited to press the button with sharp object.
 The device has no function of liquid leak detection. The user should
confirm there is no liquid leak in the IV set before use, and stop using
it and contact your authorized dealer for repair in the case of
any leakage.
Infusion parameters must be set as determined by the doctor.
Improper dosage of infusion could harm patients.
If IVset is in continuous use, the user should change the extruded
position of IV set every 6 to 8 hours to maintain an accurate infusion
rate.
The user must turn off liquid blocking roller before the change of
mounting position of IV set, and turn it on after completion of mounting.
Press “off” button if there is a non-trouble alarm from the device,
press the “on” button to start the operation after the trouble shooting.
Same or similar devices used in any separate area, if used with
alarm presets, may pose potential hazard, such as ICU or operating
room.
Before opening the door for repairs, maintenance personnel must
remove power supply cord.
Except the transducer and cable which are used by the
manufacturer of device or system as the spare parts for internal

3
components, transducer and cable may result in device or system
emission increase or immunity decrease.
Untrained personnel are prohibited to open the door of pump,
otherwise they would be disqualified from the warranty.
Contact your authorized dealer for maintenance of the pump if its
device and accessories reach the end of their service life, which may
cause a malfunction of the pump.
 User should conduct periodical inspection of the pump. If any
irregularity and failure are detected during the normal operation,
stop operation of the pump immediately and contact your local
authorized dealer to replace with other infusion device or mode.

2. Terms and Definitions

Operator/ user: Trained medical personnel who obtain the

qualification of the device .
Keep vein open (KVO): When delivery volume is reached,
flow rate turns into a very low flow rate/K.V.O rate automatically
(almost no therapeutic effect), and the device continues to operate,
ensuring unobstructed vein and avoiding the regurgitation of blood.
Medium speed:: Infusion speed25ml/h
Minimum speed: Infusion speed 1ml/h
Free-flow: Self-flow; Liquid infusion, under the influence of
gravity, other than the device
Running state: After setting parameters for device, Press
[START] button to start the device.
Alarm status: Alarm system status in which identified potential or
actual danger exists

4
3. Introduction and Scope of Application

3.1 Introduction

The device, as auxiliary infusion device, equipped with

independent dual-core CPU, intelligently controls the whole process of
infusion. With peristaltic pump as power source, real-time monitoring
by multiple sensors, and multiple alarm functions, the device can meet
the requirements of infusion under various circumstances, overcome
the shortage of gravity infusion, meet the needs of clinical intravenous
infusion and improve the accuracy of intravenous infusion.

3.2 Application

Intended use: applicable to clinical intravenous infusion in

medical institutions.
Contraindications: Blood transfusion, insulin, analgesia,
chemotherapy and epidural anesthetics.

3.3 Model Name

Infusion pump platform code

5
4. Important Properties

Stored infusion parameters: Setup and storage of flow rate

accuracy of 5 types of IV sets
Adjustable scope of infusion flow rate: Infusion flow rate (adjustable
from 1ml/h to 1200ml/h) can meet the needs in different situations.
Operated with its internal battery: Don’t worry about
interruption of transfusion during patient transport or sudden power
outage. Batteries can be externally removed, easy for transportation and
maintenance.
Dual CPU structure: Reliable system architecture able to ensure the
security of system.
Ultrasonic air bubble detector: Ultrasonic detection technique
which ensures accurate air bubble detection, is applicable to various
liquids and IV sets.
 Tube occlusion test: Occlusion alarm pressure range: 3 levels, easier
to use
Dosage mode(Body weight mode)：Able to turn into a proper flow rate
of infusion automatically when body weight, drug and solution volume
are entered. (IPA112 model).
 Basic performance: Flow rate accuracy

6
5. Basic Parameters, Main Features and

Functions

5.1 Basic Parameters

Table 1 Basic parameter table of IPA1 infusion pump

Model
IPA111 IPA112
Parameter
a) Dimension 130mm×175mm×230mm
b) Weight 2.0 Kg
c) Power ～100V-240V 50Hz/60Hz
d) Infusion set
Refer to “10Precautions for (IV set)”
(IV set)
e) Service life 5years
Atmospheric pressure: 76KPa～106KPa
Temperature: +5℃～+40℃
Humidity : 20%～90%
f) Operational When using this pump, do not use equipment
environment nearby producing vibration and electromagnetic
fields. Avoid using the pump in presence of
flammable gases and flammable anesthetic
mixture with air, oxygen or nitrous oxide.

5.2 Main Features

Table 2 List of IPA1 Infusion Pump Features

Model IPA111 IPA112

7
 Performance index
Flow rate mode Flow rate mode
Flow rate -time mode Flow rate -time mode
a) Infusion mode Flow rate – volume Flow rate – volume mode
mode Time – volume mode
Time – volume mode Dosage mode
1-1200ml/h
b) Infusion speed set
Flow rate<100ml/h，Step value 0.1
range
Flow rate≥100ml/h，Step value 1
c) Mean flow rate
±5%
accuracy
d) Setup delivery 1-9999ml，<100 Step value 0.1，≥100 Step value
volume range 1
e) Setup delivery
±5%
volume accuracy
f) Setup delivery time
00:01-99:59 (hour : minute)
range

g) Fast discharge speed 1000 ml/h

h) Mean flow rate

accuracy of fast ±5%
discharge
i) Setup flow rate of 1-1200ml/h adjustable，Default 800ml/h，Step
BOLUS value 1
j) Mean flow rate of
±5%
BOLUS
k) Single BOLUS
Single BOLUS1.0-10ml adjustable, Default 3ml
volume
l) Single BOLUS
±5%
volume accuracy
m) Maximum infusion 120KPa

8
pressure

High 100KPa±20KPa
n) Warning
occlusion Medium 60 KPa±20KPa
threshold
Low 40 KPa±20KPa

o) Maximum trigger-
time of warning
occlusion, at minimum
operating speed and 55min
minimum
warning occlusion
threshold (pressure)
p) Maximum trigger-
time of warning
occlusion, at medium
operating speed and 1min30s
minimum
warning occlusion
threshold (pressure)
q) Maximum trigger-
time of warning
occlusion, at minimum
operating speed and 1h35min
minimum
warning occlusion
threshold (pressure)
r) Maximum trigger-time 2min55s
of warning occlusion, at
medium
operating speed and

9
 maximum
warning occlusion
threshold (pressure)
s) Bolus dose,
at medium
operating speed and
1.0ml
minimum
warning occlusion
threshold (pressure)
t) Bolus dose,
at medium
operating speed and
1.6ml
maximum
warning occlusion
threshold (pressure)
u) Maximum capacity
under single fault 1.0ml
condition
1.0-5.0ml/h adjustable，Default1ml/h，Step value
v)KVO flow rate 0.1
Mean flow rate accuracy±5%
Total infused volume / Accumulated infusion
w)Real-time display of
volume
infusion information
Flow rate

x)Alarm silence time 1min50s—2min

y) Pause timeout alarm

1min50s—2min
time
～100V-240V 50Hz/60Hz
z) Power / input power
30VA

10
 Operate continuously for 4h after recharge the
aa) Internal battery
internal battery fully.

ab)Enclosing class IPX4

Operate at the max flow rate on wooden desk,

ac) Buzzer level control the buzzer level below 50dB (A) at 1 m
distance from all sides
Occlusion, Air bubble detection, Door open,
Infusion completion, Nearly completion, Pause
timeout, Low battery, Battery exhausted, Flow
ad) Alarm function
error, Power off, Power connection, Recharge the
battery, Recharge the battery fully, low ambient
temperature

5.3 Main Functions

 Display and setup of flow rate, time, and preset value

 Remaining time display
 Infused volume display
 Quick discharge
 Bolus
 Bolus flow rate, and single bolus preset
 Occlusion alarm pressure range: 3 levels
 KVO function
 KVO flow rate preset
 Internal power supply unit（Internal battery）
 Store infusion parameters of 5 different IV sets
 Dosage mode(Body weight mode)
 Display mode display

11
 Alarm（See chapter 8）
 Alarm pause

6. Structure and Operation Display

6.1 Structure

The product series consist of control system, motor drive unit,

peristaltic squeeze, detection unit, alarm unit, input and display unit, shell
and its supporting structure.
Front view and rear view are referred to in Table 6-1, and Table 6-2.
Components as below:

1 Rubber root 7 IV set 13 Occlusion sensor

2 Numerical buttons 8 Bubble detector 14 Tubing clamp
3 LCD 9 Pressure plate 15 Fixing clamp
4 Power LED 10 Door hook 16 RS232 interface
5 Charging LED 11 Lock buckle 17 Battery cover
6 Alarm/operating LED 12 Peristaltic pump 18 AC power outlet

12
Table 6-1 Front view

13
 Table 6-2 Rear view

6.2 Display and Operation Interface

Display interface is as shown in Table 6-3, and keypad interface

as shown in Table 6-4.

Table 6-3 Display interface

14
 Table 6-4Keypad interface

7. Clinical Operation

IV set initially used in the device must be debugged. For debugging

method, see "9 IV set debugging".
Basic operation steps: Fix the unit/device→Turn on →Setup
parameters→IV set fit→Tube emptying→Start infusion→Infusion
completion→Turn off
Note: Before the infusion, make sure that IV set used can match the
gear selected.

7.1Device Fixation

As shown in Table 7-1, during fixing the device, first loosen the knob,
put the pole of infusion support into fixed stand, adjust the position, and

15
tighten the knob; Ensure fixed stand is placed horizontally, and pole of
infusion support and fixed stand are placed vertically. The
vertical tilt angle should not exceed 10 degrees if there is a tilt.
User/operator must ensure that the device is placed in a stable and
secure manner.

Table 7-1 Fix the device

7.2Power on

After power cord is connected, LCD on the front view lights on, press

button turning on.

Attention: Before connecting power to the pump, please check if

there are foreign bodies remained in power outlet (e.g. drug residues) to
avoid short-circuit.

7.3Setup Parameters

7.3.1 IV Set Gear Selection

16
 a) In standby mode, continue pressing key, IV set gear

number 1-5 can circularly display from 1 to 5.

b) Select the gear No. corresponding to the IV set according to
corresponding relation between gear No. and IV set in the data sheet.
c) When displaying the gear No. corresponding to the IV set,

loosen key, completing the selection. Selected gear No.

corresponding to the IV set is displayed on the interface.

d) If the IV set model remained unchanged, use the selected gear
directly and skip this setup step.

7.3.2 Occlusion Pressure Alarm Gear Selection

a) In standby mode, press key, for cyclic selection of alarm

pressure gear, and switch in a sequence of low>medium>high>low.

b) Different levels of logo/symbol indicate occlusion pressure

alarm level. Low-level pointer points to and displays 1 / 3 arc; Medium-

level pointer points to and displays 2 / 3 arc; High-level pointer points
to and displays 3 / 3 arc;
c) You can use the previous setup gear directly and skip this setup
step.
7.3.3 Infusion Parameter Setup

Infusion parameters set up by the user are divided into 5 modes :

flow rate mode, flow rate-total infused volume mode, flow rate-time
mode, time- total infused volume mode, dosage mode(body weight

17
mode);
In flow rate mode, set flow rate parameters only;
In flow rate-total infused volume mode, set up flow rate, and
preset 2 parameters;
In flow rate-time mode, set up flow rate, and 2 parameters for
time; In time-total infused volume mode, set up time, and preset 2
parameters;
In dosage mode, set up infusion flow rate parameter values
automatically generated under dosage mode, and set up time or preset
delivery volume.
a) In standby mode, press key, for cyclic selection of “drops>flow
rate>time>preset delivery volume>dosage mode>drops” parameters;
Cursor cyclically points to each parameter logo. The parameter
pointed indicates the parameter selected.
b) Enter the parameter value by pressing numerical button, clear

zero the input number by pressing key. Press key for the next

parameter setup after the current parameter is set up.

c) In dosage mode, press key to enter into dosage mode

parameter setup. Press key for cyclic setup of “mode serial number

> dosage>body weight of patient> drug mass> solution volume> mode

serial No.” parameters. Cursor cyclically points to each parameter
logo. The parameter pointed indicates the parameter selected enters
the value by numeric keypad.
The mode serial No. corresponds to the unit serial number specified
in the list of input mode unit according to the drug dosage unit used. The

18
parameter “body weight of patient” is not included in the dosage unit, and
there is no need to enter the parameter value of body weight.

After completion of all the parameters setup, press key to quit

dosage mode parameter set, and infusion flow rate parameter value is
generated automatically, then set up time or preset delivery volume.
Flow rate parameter value generated in dosage mode can’t be
modified, e.g. quit dosage mode by modifying device, and clear the
parameters in dosage mode zero. Flow rate parameter value generated
in dosage mode ≤1200.
d) Setting parameter of drop volume is equivalent to flow rate. These
two parameters are automatically converted according to the following
formula. Setting either drop volume or flow rate will be ok.
Formula:
d rip rate(dotp ⁄ min)=Flow rate(ml /h)∗drop volume per ml(drop/ml)/60

e) Set up time by taking “●” as delimiter for hour and minute. Input “●”
after setting “hour “parameter value, then input “minute “parameter value.

7.4Fitting and Replacement of IV set

7.4.1 Fitting of IV set

a) Pour drug solution into drip cup of IV set, reaching 1/2 level.
Open the door (of pump) by pulling the handle of lock; Fix, from top to
bottom, a tube into bubble detector slot and tube slot at the 10cm
below the drip cup.
b) Open tubing clamp, and thread IV set through bayonet of tubing
clamp, keeping IV set vertical.

19
 c) Close the door, and open the drop pause pulley of IV set.
7.4.2 IV set /Solution Container Replacement and Re-installation
a) If replacing IV set or fitting position, close the drop pause pulley
of IV set to avoid the solution gravitational flow.
b) Open the door and tubing clamp, take out IV set, re-install IV
set, then open the drop pause pulley of IV set after fitting.
c) Before replacing solution container, stop the operation,
draw out puncture outfit in IV set, and insert it into solution
container; after fixing the solution container, start the operation of the
device after checking.

7.5Removal of Air in Line(Tube)

a) In standby mode, double click of key, then the pump starts

the quick discharge function, and infusion according to default flow
rate.
b) During quick discharge, select flow rate parameter pointed by
the logo/symbol, displaying flow rate. RUN LED, at 2Hzfrequency, is
blinked in logo, alarming signal-sound cyclically.
c) After air in line (tube) of the patients removed, click key to
stop fast discharge, then logo is blank.

7.6Infusion Start

a) Confirming that IV set is removed and connected to the patient,

press key to start infusion.
b) RUN LED, at1Hzfrequency, flashes. Operation indicator lights
cyclically. IV set starts to accumulate infused volume.

20
7.7Infusion Completion

When the total infused volume reaches delivery volume, the

device will sound the alarm of setup delivery volume completion
and display “completion” logo in alarm instruction zone, with its
flow rate turning into K.V.O rate automatically and displaying

“K.V.O” logo. In case of alarm, turn the alarm off by pressing

button. Otherwise, the alarm will be automatically restored after 2

minutes.
Attention: KVO flow rate is not displayed on display window.

7.8Turning Off

a) After completing the infusion, stop the operation of the

pump by pressing key.

b) Remove IV set and accessories.

c) Turn off the power by pressing key for

3 consecutive seconds.

Attention: Prohibited to turn off the power when the device

is in normal operation, otherwise, it may cause infusion
interruption.

7.9Infusion Parameter Check

21
 a) Under normal status of infusion, press key for cyclic

check of all infusion parameters, and switch between parameters

in a sequence of flow rate>time>preset delivery volume>total infused
volume>remaining time> drops>flow rate ;
b) Select the logo pointed to the parameter logo, display the
value corresponding to parameter;

c) Under stop state, clear zero each parameter by pressing

key, and clear zero “total infused volume”, “remaining time” and

parameters by continuing pressing .

7.10 Bolus Infusion

During the infusion, if there is a need of increasing flow rate within

short time in a particular status, the user may initiate “bolus Infusion”
function of the pump.
a) Under the normal infusion state, double click of key, then
the pump will initiate “bolus Infusion” function, and start infusion
according to default flow rate.
b) During bolus infusion, select flow rate parameter directed by
logo, displaying flow rate value. For total infused volume, display bolus
infusion volume by taking 0.1as step value. A RUN LED flash at
2Hzfrequency, alarming signal-sound cyclically, and is lit in logo.
c) When bolus infusion volume is reached, press key to stop
infusing, then the pump will return to the normal infusion state
automatically continuing infusion, and logo is blank. Or, when
22
default single bolus infusion volume is reached, the pump will stop
bolus infusion automatically, and return to normal infusion state to
continue infusing and logo is blank.
User may set up default BOLUS flow rate and single BOLUS
infusion volume. Single BOLUS infusion volume ranges 1.0 to 10ml.
BOLUS infusion volume is recorded into total infused volume. Single
BOLUS infusion volume is stopped automatically under dual control
mechanism. Dosage mode is ON when BOLUS infusion is started. The
unit returns to dosage mode automatically after completing BOLUS
infusion.

7.11 Automatic Accumulation of Infused Volume

When preset delivery volume is reached, the device sounds the

alarm. After the device is turned off, set the delivery volume again.
When the device is turned on, infused volume will be automatically
accumulated to accumulative infusion volume, i.e. total infused volume
by the patient.
For example, at the 1st time when the drug solution “a” is injected
into the patient, and preset delivery volume is 1 ml, the device will
sound the alarm of “a” infusion completion when total infused volume
is displayed as 1ml; At the 2nd time when the drug solution “b” is
injected into the patient, and preset delivery volume is 2ml. the device
will start infusion without removing accumulative volume; When total
infused volume is displayed as 3ml, the device will sound the alarm of
“b” infusion completion. Thus, the patient is injected into 3ml drug
solution, including 1ml drug solution “a”, and 2ml drug solution “b”.

23
7.12 Night Mode

In night mode, the user may lower the luminance and sound in
decibels of the device, which can reduce the impact on the patient in
the night time.
a) Under the normal infusion state, the user may turn on night

mode by pressing key, and luminance and sound (in decibels) of

the device are lowered. Press key to exit night mode.

b) Under the pause state of infusion, the device exits night mode
automatically, and displays normally.
In standby mode, the device exits night mode automatically. When
the device is operated in night mode, it remains night mode after
entering the alarm state. After start of bolus infusion and check of
infusion parameters, the device during the operation will exit night
mode automatically, in case of modification of infusion parameters

7.13 User Setup

User may define some function switch and technical parameters

corresponding to application environments.

a) Continue pressing key，press key for power on.

b) After displayed as U000characters, loosen key.

c) Press key，U000-U021 is displayed cyclically in sequence.

d) U000-U021 stands for function (option). Select “setup” option,

24
and input corresponding parameters. Save the setup value with

button.

e) Select “U014” option. Quit by pressing key, and return to

standby display.
Table 3 Description for user function setup parameters
Function Default
Range Description
items value
U000 — IV set debugging interface —
U001 0,1 alarm volume setting 0=low，1=high 1
Retain memory
U002 0,1 1
0=off，1=on
Drop parameter display switch
U003 0,1 1
0=off，1=on
Run default parameter selection
U005 0,1,2 0=flow rate，1=time，2=preset 0
delivery volume
Default parameter selection
U006 0,1 0=accumulated infusion volume, 0
1= remaining time
IV set lock
U008 0,1 0
0=off，1=on
Key tone switch
U010 0,1 0
0=off，1=on
U011 1- Bolus default flow rate setting 800
1200m

25
 l/h
1.0-
U012 Single bolus maximum 3
10ml
1.0-
U013 5.0ml/ KVO flow rate 1
h
Return to standby display by
U014 — —
pressing OK key
U016 15-70 IV set parameter/ml 20
Alarm thresholds for
20-
U018 occlusion pressure of IV set at —
1999
various gears
Return to ex-factory parameters
U019 0,1 setting 0
0=off，1=on
U020 0-10 Nearly completion alarm time 0
Occlusion default alarm gears
U021 — 1
1= medium

8. Alarm Signal Function

The device gives sound, light and character alarm signals.

Alarm sound pressure is divided into two degrees, i.e. high sound
pressure>70 dB and low sound pressure> 65 dB. Artificial alarm is
used to verify whether the alarm system is in its normal status.
According to the design of alarm condition priority, alarm
classification of the device is as follows:

26
 Table 4 Alarm Classification Table
Priority Alarm classification
Door open, Occlusion, Completion, Air in line,
High priority
Error, Battery exhaust
Pause overtime, Low battery, Near completion,
Low priority
Power off
Latch-up / non-latch-up alarm signals of the device are defined
below: Latch-up alarm signals include Door open, Occlusion,
Completion, Air in line, Error, Near completion, Battery exhaust, and IV
set drop alarms (High precision supplies).
Non latch-up alarm signals include Pause timeout, Low battery,
and Power off alarms.
Tokens include external power connection, battery charging,
battery charging completion, and low temperature environment.

8.1 Door Open Alarm

a) In operating mode, in case of opening or accidental opening of

the door of pump, the device gives alarm of door open, and "Door"
character is displayed on the LCD, and the device stops operation.
b) When alarm goes off with “door open”, press button to hold
alarm sound for 2 minutes. Alarm sound goes off again 2 minutes later.
Alarm resets by pressing “stop“ button, and "Door“ character is blank,
and the device stops operation, entering“standby”mode.
c) Check accuracy of alarm: Flow rate by initial setup is high level;
Preset delivery volume is 5 ml; Operation is started; When the door is
opened, the device gives “door open” alarm, and “Door” is displayed
on the LCD, at the same time, the device stops operation, LED flashes

27
and alarm sounds continuously, which shows the accurate “door open”
alarm.

8.2 Occlusion Alarm

a) In operating mode, in case of occlusion in infusion tube, the

device gives alarm of occlusion, and “Occl.” character is displayed on
the LCD, and the device stops operation.
b) When alarm goes off with “occlusion”, press ] button to hold
alarm sound for 2 minutes. Alarm sound goes off again 2 minutes later.
Alarm resets by pressing “stop” button, and " Occl." character is blank,
and the device stops operation, entering“standby”mode.
c) Check if there is any bending and extrusion in the tube, and any
occlusion in filter needles; Restart the infusion after removing the
problem.
d) Check accuracy of alarm: Flow rate by initial setup is 25 ml/h;
Preset delivery volume is 5 ml; Operation is started; In case of artificial
interruption of drug infusion, the device gives “occlusion” alarm, and
“Occl.” is displayed on the LCD, at the same time, the device stops
operation, LED flashes and alarm sounds continuously, which shows
the accurate “occlusion” alarm.

8.3 Pause Overtime Alarm

a) When the device is in standby mode for above 2 minutes, the

device gives pause timeout alarm, and "Pause Overtime" character is
displayed on the LCD.
b) Alarm resets by pressing any button, and " Pause Overtime "
character is blank.

28
 c) Check accuracy of alarm: If nothing is done after turning it on,
the device gives “Pause Overtime” alarm 2 minutes later, and “Pause
Overtime” is displayed on the LCD, at the same time, the device
sounds the alarm, which shows the accurate “Pause Overtime” alarm.

8.4 Completion Alarm

a) In operating mode, when the total infused volume reaches

delivery volume, the device gives completion alarm, "Completion" and
“KVO” characters are displayed on the LCD, and the flow rate turns
into K.V.O. rate automatically.
b) When alarm goes off with “completion”, press button to hold
alarm sound for 2 minutes. Alarm sound goes off again 2 minutes later.
Alarm resets by pressing “Stop”, "Completion" and “KVO” characters
are blank, and the device stops operation, entering“standby”mode.
c) Check accuracy of alarm: Flow rate by initial setup is high level;
Preset delivery volume is 5 ml; Operation is started; When
accumulated window value reached 5, the device gives “door open”
alarm; At the same time, the device runs at K.V.O. flow rate, “KVO”
characters are displayed on the LCD, and LED flashes, which shows
the accurate “completion” alarm.

8.5 Air-in-Line Alarm

a) In operating mode, when it is detected that there is air in line

(tube) by the bubble detector (single bubble volume≥50uL),the device
gives air-in-line alarm, " Air” characters are displayed on the LCD, and
the device stops operation.
b) When alarm goes off with “Air in line”, press button to hold

29
alarm sound for 2 minutes. Alarm sound goes off again 2 minutes later.
Alarm resets by pressing “Stop” button, “ Air” characters are blank, and
the device stops operation, entering“standby”mode.
c) Check whether there is air in line, and whether the bubble
detector is clean, then re-install IV set and restart the infusion.
Attention:
In case of occlusion in the tube, the device gives air-in-line alarm..
After removal of the occlusion, the device restarts the infusion.
Drug solution attached to the bubble detector should be cleaned
immediately, to avoid the error in alarm caused by the bubble detector.
d) Check accuracy of alarm: Flow rate by initial setup is800ml/h;
Preset delivery volume is 5 ml; Operation is started; Create air bubble
no less than 5mm 30 seconds later. Running through the bubble
detector, the device gives “air-in-line” alarm, and “Air” is displayed on
the LCD, at the same time, the device stops operation, LED flashes
and alarm sounds continuously, which shows the accurate “air-in-line”
alarm.

8.6 Error Alarm

a) When the device goes wrong, “n” character is displayed on the

LCD, and the device stops operation. Error codes are shown below.

Table 5 List of Error Codes

Error codes Description
Error 1 Electronic motor
Error 2 Occlusion detection module
Error 3 Air bubble detection module

30
 Error 5 Communication failure
Error 6 Motor fault
Error 7 Battery
b) When alarm goes off with “Error”, press button to stop alarm
sound. Alarm resets by pressing “stop” button, and " Error n" character
is blank, and the device stops operation, entering“standby”mode.
c) Check whether the IV set fitting is correct, and restart infusion
after adjustment. Contact your local authorized dealer to replace with
new one if there remains error alarm in this device.

8.7 Low Battery Alarm

a) When internal battery level is low, the device gives low battery
alarm, and battery modules under the logo flash.
b) In case of low battery alarm, it means that the battery is nearly
exhausted, and the device should be connected to power or manual
infusion is adopted.
Attention:
In case of use of external power supply, power indicator should be
lit, otherwise, please check whether power cord is plugged into an
outlet.
Check accuracy of alarm: In case of battery under voltage alarm,
the device should be connected to external power.
c) Alarm stops in case of low battery,
and low battery sign warning on the display shows the charging state,
without alarm sound, and charging indicator is lit, which shows the
accurate low battery alarm.

8.8 Battery Exhaust Alarm

31
 a) When internal battery power is nearly exhausted, the device
gives low battery alarm, and outer frame of battery token blinks.
Battery exhaust alarm sound remains.
b) In case of battery exhaust alarm, the battery is nearly used up,
and the device stops operation and is power off within 10 mines, thus,
it should be powered from a external power supply.

8.9 Near Completion Alarm

a) When total infused volume reaches the delivery volume, the

device gives near completion alarm, "near completion” character is
displayed on the LCD, and the device continues operating.
b) When alarm goes off with “Near completion”, press
button to stop alarm sound. The alarm lasts until the infusion
completion.
c) Near completion alarm can prompt user to make preparation
before the infusion. The alarm offending time can be customized, setup
time range : 0-10 minutes, setup method referred to in the article 7.14.

8.10 Power off Alarm

a) When external power is off, the device gives power off alarm,
external power indicator lights out, the device continues operating,
turning into battery power supply automatically, and battery token
flashes.
b) When external power is off, check external power line status,
connect power plug into the device again, alarm resets, and battery
token stops flashing. Contact the manufacturer to replace with new
one if it is judged that device failure results in power disconnection.

32
8.11 Alarm System Security

a) This device provides the auditory signal of key tone and

external power connection warning tone, which is separated from
auditory alarm signal, are single pulse and non-repetitive signal sound,
and the alarm signal is no less than 2 pulse signal sound.
b) All alarm status and alarm limits of the device prohibit the
change of access.
c) Any delay in the alarm status should be less than 2 seconds.
d) If an alarm occurs, operator shall handle the alarm at a distance
of 30-50cm in front of the product.
e) Verify if the alarm system is functioning: Refer to the relevant
contents of the article 8.1 - 8.12 in this operating manual.
f) Alarm system of the device is technical alarm.
g) Air-in-line alarm during fast discharge is inhibited.
h) If power outage is less than 30s, alarm setting before the
outage
is automatically restored.

8.12 Alarm Sound Signal Pause State

If an alarm is given by the device, press button to stop alarm

sound, icon is lit, and sound is paused. Alarm sound goes off
again 1min50s to 2mins later. In the meantime, press button to
inactivate sound signal if there is a need of inactivation of sound

signal, and icon is blank.

8.13 External Power Connection Token

33
 When connected to external power supply, the device prompts the
user to adopt external power supply. External power indicator lights up,
with prompt sound produced.

8.14 Battery Charging Token

When battery is not fully charged, power automatic device is being

charged, battery charging indicator lights up, and filler fields inside the
battery token are lit according to electricity quantity.

8.15 Battery Charging Completion Token

When battery is fully charged, battery charging indicator goes out,

and filler fields inside the battery token light up.

8.16 Low Ambient Temperature Token

When ambient temperature is 15 ℃ below, the device displays

command prompt of low ambient temperature. Snowflake command
prompt lighting up and flashing, the device continues operation. When
ambient temperature is above 15 ℃, the low ambient temperature
command prompt resets automatically, and the prompt is blank
automatically.

9. IV Set Debugging

9.1 IV Set Debugging Procedure

Entering user setup mode, select “U000” option.

9.2 IV Set Code Selections

34
 a) Press key，IV set code lights up successively and

cyclically.

b) When code corresponding to IVset lights up, loosen

key.

9.3 IV Set Accuracy Calibrations

a) For fitting IV set to be calibrated, empty the air in line.

b) Press “initial start” button to start calibration, and collect liquid
into empty measuring cylinder.
c) When display window shows the figure above 10, press “Stop”
button to stop infusion.
d) Read milliliters(ml) of liquid in measuring cylinder (subject to
liquid concave)
e) Modify numeric value of display window, and ensure the
consistency with “ml “of liquid in measuring cylinder.
f) Press “OK” button until prompt sound is heard, and save
accuracy parameter.
g) Empty the liquid in measuring cylinder. Repeat the above 6

steps (for 1-2 times) until the consistency between display milliliters

and actual milliliters of liquid in measuring cylinder.

Note：“Consistency” above means the deviation within ±0.2 ml.

10.Precautions for Infusion Set / IV Set

It is recommended to use disposable infusion set for intravenous

35
transfusion. To ensure the infusion accuracy, change fitting position of
IV set after continuous use for 6 to 8 hours. Use of infusion set whose
brand is not recommended may lead to the deviation of infusion
accuracy out of the range of specified flow rate accuracy. The ambient
temperature should not be 5 ℃ below. Otherwise, accuracy of infusion
cannot be guaranteed.
In case of replacement of its components due to the pump
maintenance or flow rate accuracy in critical value range, the device
should be calibrated and debugged again, and methods referred to in
"9 IV set debugging".

Table 6 List of Recommended IV Sets

Applica
Accu
No. Brand Specification Manufacturer ble
racy
model
Disposable Shandong Wei
1 Jerry infusion set Gao Group Medical
with needle Polymer Co. Ltd.
IPA111
Disposable Shanghai Kindly ±5%
IPA112
infusion set Enterprise
2 Kindly
with needle/ Development Group
intake type Co., Ltd.
Note：
1) Accuracy guaranteed by the device is within the accuracy error
range after calibration of corresponding IV sets according to "9 IV set
debugging".
2) The above IV sets, regardless of general or lightproof infusion

36
sets, can be used.

11. Technical Parameters

a) Methods for bolus control before occlusion relief : Stepping

motor control method used to release the pressure in tube due to
occlusion, and control bolus.
b) Digital memory retaining time after shutdown: 10 years.
c) Measurement unit for calibration of device: ml.
d) Preventive measures for over current and undercurrent due to
failure: Motor operating state detection and tube replacement time
control.
e) Ascent curve of Jerry IV set at lowest flow rate in the first two
hours

Dotted portion in the above graph indicates the setup flow rate ( 1
ml / h herein). Solid line is continuous connection line of mean flow
rate value during the sampling period.
f) Ascent curves of Jerry IV set at medium flow rate in the first two
hours

37
 Dotted portion in the above graph indicates the setup flow rate
( 25 ml / h herein). Solid line is continuous connection line of mean
flow rate value during the sampling period.
g) Trumpet curves of Jerry IV set at lowest flow rate in the 2nd hour

Dotted portion of trumpet curves in the above graph indicates the

proximate accuracy error value; Solid line above the dotted portion
indicates the maximum positive deviation curve within the 2nd hour;
Solid line below the dotted portion indicates the maximum negative
deviation curve within the 2nd hour;
h) Trumpet curves of Jerry IV set at medium flow rate in the 2nd hour

38
 Dotted portion of trumpet curves in the above graph indicates the
proximate accuracy error value; Solid line above the dotted portion
indicates the maximum positive deviation curve within the 2nd hour;
Solid line below the dotted portion indicates the maximum negative
deviation curve within the 2nd hour;
i) Trumpet curves of Jerry IV set at lowest flow rate in the last one hour

j) Trumpet curves of Jerry IV set at medium flow rate in the last

one hour

39
 k) Ascent curve of Kindly IV set at lowest flow rate in the first two
hours

Dotted portion in the above graph indicates the setup flow rate ( 1
ml / h herein). Solid line is continuous connection line of mean flow
rate value during the sampling period.
l) Ascent curves of Kindly IV set at medium flow rate in the first
two hours

40
 Dotted portion in the above graph indicates the setup flow rate
( 25 ml / h herein). Solid line is continuous connection line of mean
flow rate value during the sampling period.
m) Trumpet curves of Kindly IV set at lowest flow rate in the 2nd
hour

Dotted portion of trumpet curves in the above graph indicates the

proximate accuracy error value; Solid line above the dotted portion
indicates the maximum positive deviation curve within the 2nd hour;
Solid line below the dotted portion indicates the maximum negative
deviation curve within the 2nd hour;
n) Trumpet curves of Kindly IV set at medium flow rate in the 2nd
hour

Dotted portion of trumpet curves in the above graph indicates the

proximate accuracy error value; Solid line above the dotted portion

41
indicates the maximum positive deviation curve within the 2nd hour;
Solid line below the dotted portion indicates the maximum negative
deviation curve within the 2nd hour;
o) Trumpet curves of Kindly IV set at lowest flow rate in the last
one hour

p) Trumpet curves of Kindly IV set at medium flow rate in the last

one hour

q) Sensitivity of air detector: air bubble ≥ 50uL can be detected.

12. Internal Battery

2200mAh/11.1V rechargeable lithium battery pack is used in the

device.
Internal battery charge management module automatically
controls the charging of battery. After external power supply is
interrupted, the pump system is automatically switched to internal
battery power supply, and can be operated with only its internal
42
battery. Lead wire of battery (in red) indicates positive electrode; Lead
wire of battery (in black) indicates negative electrode.
Continuous work at medium flow rate exceeds 4 hours. Make sure
battery level can reach the required time before use of internal battery.
Remove battery cover by use of cross screwdriver to fix screw;
Open battery cover, take out rechargeable battery and replace it with
new one, then re-install battery cover.
Note: Rechargeable battery is supplied by your authorized dealer /
supplier. Use of non-dedicated battery may cause failure or accident in
the device!

13.Maintenance and Repair

13.1Maintenance and Repair

Device which has not been used for a long time should be charged
once every 3 months to prevent battery damage, and charging time no
less than 24 hours.
Internal battery should be tested once a year. If working time of
medium flow rate battery is below 1 hr, it should be replaced with new
battery without delay. In order to ensure the safety of transfusion
process, it is recommended to replace the internal battery once every
2 years.

13.2Cleaning / Disinfection
The series ofbattery requires routine surface cleaning and
disinfection before being used between the patients.

It is prohibited to use the disinfectants in the following types:

 Disinfectants corrosive to the known metals, including diclo
sodiumcyanate (e.g. bleach pellets), hypochlorite (e.g. chlorasol),
acetaldehyde (e.g. glutaraldehyde), and anion surfactant (e.g.
benzalkonium chloride).
43
  Iodine (e.g.povidone iodine) causes discoloration of surface.
 Concentrated isopropanol in detergent corrodes plastic parts.
Do not use diluents or other organic solvents for cleaning. Do not
use high pressure steam for sterilization. Do not use desiccant or
similar products for drying. Do not immerse the product in water.
It is recommended to use the following cleaning / disinfection
methods. Disinfectants should be used in accordance with the
instructions
 Ultraviolet disinfection
 Ethylene oxide gas (EOG) disinfection : Placed in the ventilated
place for more than 8 hours after the disinfection
 Ozone disinfection
 Chlorine dioxide disinfectant surface wiping
Cleaning or sterile towel is used to wipe the surface of device.
Disconnect AC power outlet when cleaning or disinfecting to prevent
the detergent from soaking through the device. Dry the splashed liquid
in time.
Attention: Turn off infusion pump before cleaning, and disconnect
AC power; Prevent liquid from leaking out or soaking through the
device;
Avoid the accumulation of liquid on the pump; Avoid using strong
cleaning agent to avoid damage to outer surface.
Attention: Do not clean the pump in case of any visible cracks,
breaks, or damage to the cover of the pump. Stop the operation
immediately and arrange qualified maintenance personnel to inspect
the pump.

13.3 Drop Sensor

44
 Avoid scratching the bubble detector during the use and cleaning.
Clean it immediately if the solution is found on occlusion sensor and
bubble detector to avoid the false alarm due to reduced performance.

13.4 Display Panel

Display panel of the device is made of PVC materials. During the

use, avoid scratching the surface with sharp object, so as not to affect
display and check.

13.5 Maintenance

Contact your authorized dealer / supplier if the device can’t

operate properly. Disassembly and assembly without authorization
must be prohibited.
Statement: Trained medical unit with maintenance ability can be
provided the required technical materials by our company.

13.6 Protective Earthing

If you have any doubt about protective earth conductor, use

internal battery only.

13.7 Battery Disassembly & Assembly

Battery disassembly& assembly in accordance with the diagram

13-1

45
 13-1 Battery disassembly& assembly

14.Transport and Storage

Temperature range：-20℃~+55℃
Relative humidity：≤93%

15.Waste Treatment

15.1 Battery

Improper handling of batteries may cause burn, explosion, fires,

etc. Do not disassemble, squeeze or puncture short-circuit batteries, or
put them into water or fire. Dispose of the used batteries according to
local regulations, or consult authorized dealers about battery recycling.

15.2 Infusion Set (IV set)

Disposable infusion should be disposed in accordance with

medical waste treatment regulations.

15.3 Infusion Pump

46
 When infusion pump reaches its end of service life, it is suggested
that local electronic waste treatment unit should dispose of it after the
proper treatment.

16.Electromagnetic Compatibility (EMC)

Guidance and manufacturer’s declaration – electromagnetic emissions –

for all EQUIPMENT and SYSTEMS
Guidance and manufacturer’s declaration: Electro-Magnetic Emissions
The IPA1 series infusion pump is intended for use in the
electromagnetic environment specified below. the customer or the user of
the IPA1 series infusion pump should assure that it is used in such an
environment.
Emissions test Compliance Electro-magnetic environment-
guidance
The IPA1 series infusion pump
uses RF energy only for its internal
RF emissions function. Therefore its RF emissions
Group 1
CISPR11 are very low and are not likely to
cause any interference in nearby
electronic equipment
RF emissions The IPA1 series infusion pump
Class A
CISPR11 is suitable for use in all
Harmonic emissions Not establishments other than domestic
IEC61000-3-2 applicable and those directly connected to the
Voltage public low-voltage power supply
fluctuation/flicker Not network that supplies buildings used
emissions applicable for domestic purposes.
IEC61000-3-3

47
 Guidance and manufacturer’s declaration – electromagnetic immunity
–for all EQUIPMENT and SYSTEMS
Guidance and manufacturer’s declaration – electromagnetic immunity
The IPA1 series infusion pump is intended for use in the
electromagnetic environment specified below. The customer or the user of
the IPA1 series infusion pump should assure that it is used in such an
environment.：
IEC 60601 Compliance electro-magnetic
Immunity test
test level level environments: guidance
Floors should be wood,
±6KV
±8KVContact concrete or ceramic tile. If
Electrostatic Contact
discharge floors are covered with
discharge discharge
±15KV air synthetic material, the
IEC61000-4-2 ±8KV air
discharge relative humidity should
discharge
be at least 30 %.
±2KV ±2 KV Mains power quality
connected to connected to should be that of atypical
Electrical fast power lines power lines commercial or hospital
transient/burst ±1 KV environment.
IEC61000-4-4 connected to not
in/output applicable.
lines
±1 KV ±1 KV Mains power quality
differential- differential- should be that of atypical
Surge mode voltage mode voltage commercial or hospital
IEC61000-4-5 ±2 KV environment.
common- Not
mode voltage applicable
Voltage <5%UT, <5%UT, Mains power quality
sags, short lasting half a lasting half a should be that of atypical

48
 period period
(>UT, >95% (>UT, >95%
sags) sags)
commercial or hospital
40%UT, 40%UT,
environment. If the user
lasting five lasting five
of the IPA1 series
periods periods
interruptions infusion pump requires
（> UT，60% (>UT, 60%
and voltage continued operation
sags) sags)
Variations on during power
70%UT, 70%UT,
power supply mains interruptions, it is
lasting 25 lasting 25
input lines recommended
periods periods
IEC61000-4 that the IPA1 series
(>UT, 30% (>UT, 30%
-11 infusion pump be
sags) sags)
powered from an
<5%UT, <5%UT,
uninterruptible power
lasting 5 lasting 5
supply or a battery.
seconds seconds
(>UT, >95% (>UT, >95%
sags) sags)
Power Power frequency
frequency magnetic fields should be
magnetic at levels characteristic of
400A/m 400 A/m
field（50/60 atypical location in a
Hz） typical commercial or
IEC61000-4-8 hospital environment.
Note：UT is the a.c. mains voltage prior to application of the test level.
Guidance and manufacturer’s declaration – electromagnetic immunity
– for Life-supporting EQUIPMENT and SYSTEMS
Guidance and manufacturer’s declaration—electromagnetic immunity
The IPA1 series infusion pump is intended for use in the
electromagnetic environment specified below. The customer or the user of

49
 the IPA1 series infusion pump should assure that it is used in such an
environment.

IEC 60601 Complianc Electro-magnetic

Immunity
test level e level environments - guidance

Portable and mobile RF

communications
equipment should be used
no closer to any part of
Conduction RF theIPA1 series infusion
IEC61000-4-6 pump including cables.
Than the recommended
separation distance

3 Vrms 3V calculated from the

equation applicable to the
Radiation RF ( Effective Value)
frequency of the
GB/T 150 kHz to transmitter.
IEC61000-4-3 80MHz
Except Recommended

ISM bands separation distance

d=1.2
10 V150
kHz to
10V
80MHzin
ISM bands
d=1.2

10V/m

80MHz～ 10V/m
2.5GHz

50
 d=1.2 80 kHz to

800MHz

d=2.3 800MHz to

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). b

Field strengths from fixed

RF transmitters, as
determined by an
electromagnetic site
survey c, a should be less
than the compliance level
in each frequency range. d

Interference may occur in

the vicinity of equipment
marked with the following
symbol:

51
 NOTE1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE2 These guidelines may not apply in all situations. Electromagnetic
propagation is affected by absorption and reflection from structures,
objects and people.
a The ISM (industrial, scientific and medical) bands between 150 kHz
and 80 MHz are 6,765 MHz to 6,795 MHz; 13,553 MHz to 13,567 MHz;
26,957 MHz to 27,283 MHz; and 40,66 MHz to 40,70 MHz
b The compliance levels in the ISM frequency bands between 150 kHz
and 80 MHz and in the frequency range 80 MHz to 2,5 GHz are
intended to decrease the possibility that mobile/portable
communications equipment could cause interference if it is
inadvertently brought into patient areas. For this reason, an additional
factor of 10/3 is used in calculating the recommended separation
distance for transmitters in these frequency ranges.

c 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 theIPA1 series infusion pump is used exceeds the
applicable RF compliance level above, the IPA1 series infusion pump
should be observed to verify normal operation. If abnormal
performance is observed, additional measures may be necessary, such
as reorienting or relocating the IPA1 series infusion pump.
d Over the frequency range 150 kHz to 80 MHz, field strengths should be
less than 3 V/m.
52
 Recommended distances between portable and mobile RF
communications equipment and the EQUIPMENT or SYSTEM – for Life-
supporting EQUIPMENT and SYSTEMS.
Recommended separation distances between portable and mobile RF
communications equipment and the IPA1 series infusion pump
The IPA1 series infusion pump is intended for use in an
electromagnetic environment in which radiated RF disturbances are
controlled. The customer or the user of the IPA1 series infusion pump can
help prevent electromagnetic interference by maintaining a minimum
distance between portable and mobile RF communications equipment
(transmitters) and the IPA1 series infusion pump as recommended below,
according to the maximum output power of the communications
equipment.
Separation distance according to frequency of
transmitter/m
150kHz to 150kHz to 80MHz～ 800MHz～
Rated
80MHz 80MHz in 800MHz 2.5GHz
maximum
outside ISM d = 1.2 d = 2.3
output power
ISM bands
of
bands d = 1.2
transmitter/W
d = 1.2

0.01 0.12 0.12 0.12 0.23

0.1 0.38 0.38 0.38 0.73
1 1.2 1.2 1.2 2.3
10 3.8 3.8 3.8 7.3
100 12 12 12 23
For transmitters rated at a maximum output power not listed above,
the recommended separation distance d in meters (m) can be

53
 determined 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 80 MHz and 800 MHz, the separation distance for the
higher frequency range applies.
NOTE 2 The ISM (industrial, scientific and medical) bands between
150 kHz and 80 MHz are 6,765 MHz to 6,795 MHz; 13,553 MHz to
13,567 MHz; 26,957 MHz to 27,283 MHz; and 40,66 MHz to 40,70
MHz
NOTE 3 An additional factor of 10/3 is used in calculating the
recommended separation distance for transmitters in the ISM
frequency bands between 150 kHz and 80 MHz and in the frequency
range 80 MHz to 2.5 GHz to decrease the likelihood that
mobile/portable communications equipment could cause interference if
it is inadvertently brought into patient areas.
NOTE 4 These guidelines may not apply in all situations. Electromagnetic
propagation is affected by absorption and reflection from structures,
objects and people.

17.EMC Statement

IPA1 infusion pumps have been tested, and conformed with medical
equipment standard YY0505-2012.These restrictions are intended to
provide reasonable protection for typical medical devices, to prevent
harmful interference.
a) The device can transmit radio frequency. It may cause harmful
interference to other equipment nearby if the installation and use of the device
are not in accordance with the instructions. However, it can’t be guaranteed
that such interference will not occur in a particular device.

54
 The device can be used by the trained professional medical personnel
only.
If the device causes harmful interference, it can be determined by
turning on / off the device. The user is encouraged to resolve it by
adopting one or more of the following measures:
 Readjust the position of receiver
 Increase the distance between devices,
 Connect this device and etc. to power outlet of different circuits
 Consult manufacturer or on-site service technician
b) Take and install specific EMC precautions for medical electrical
devices, and provide service according to the EMC information provided.
Portable and mobile radio-frequency communication equipment may
affect the operation of medical electrical devices, thus medical electrical
devices should be used carefully.
Except the transducers and cables sold as part of internal
components of IPA1 infusion pump, use of accessories, transducers and
cables (other than those specified) may result in increased emission or
reduced radiated immunity for equipment or system.
It is not allowed to place any other device over IPA1 infusion
pump.
If it is necessary to place any other device over / near the
pump, it should be verified that the pump can run under normal
operating conditions.
c) Anti- electrostatic precautions
Do not contact with pins of connectors marked with electrostatic
discharge warning symbols. Do not connect to these connectors unless
electrostatic discharge precautions are adopted.

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 Warning: Basic contents of training in electrostatic discharge
precautions are prescribed as below:
1) We draw the attention of all the members to the followings:
Do not touch the connectors marked with electrostatic discharge
warning symbols with hands or tools, unless the following electrostatic
discharge precautions are adopted, including:
 Methods of preventing accumulation of static charge (such as air
conditioning, humidification, floor conductive coating, non-synthetic
clothing etc.
 Human body electrostatic discharge into the frame of device or
system, or into ground or metal object.
 Connect human body to the device or system by a wrist belt.
2) All personnel who may touch the connectors marked with
electrostatic discharge warning symbols, including clinical / biomedical
engineering and medical personnel should receive the instructions herein
and training.
Electrostatic discharge training shall include an introduction of physics
related to static charge, and damage to electronic components caused by
voltage amplitude that may be generated in normal practice, and an
operator associated with static electricity. More specifically, methods of
preventing accumulation of static charge, and why and how to prompt
human body electrostatic discharge into the frame of device or system, or
into ground or metal object, or methods of connecting themselves to the
device or system or earth by a wrist belt before starting work, should be
specified.

18.Packaging and Accessories

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 Name Model Qty
Infusion pump IPA111 or IPA112 1
User manual — 1
Power cord — 1

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 MEDEVO MEDICAL Co., Ltd.
Registration Address: Room 201, F/L 2, Unit 5, Building 10,
Courtyard 20,
KeChuang14th Street,Beijing Economic and Technological Development A
rea (BDA), Beijing
Manufacturing Address: F/L 2, Unit 5, Building 10, Courtyard 20,
KeChuang14th Street,Beijing Economic and Technological Development A
rea (BDA), Beijing
Tel：86-10-87227118
Web: www.medevomed.com
MedNet GmbH

Borkstrasse 10, 48163 Muenster, Germany

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