Manual de Usuario

Statement
Beijing Aeonmed Co, Ltd. (Aeonmed for short) holds the copyrights to this
manual, which is non-public published, and reserves the rights to keep it as a
secure document. Refer to this manual when operating, maintaining and
repairing Aeonmed products only. Anyone other than Aeonmed may not
make it known to others.
Proprietary materials protected by the copyright law are included in this

manual. Any section of it cannot be reproduced, copied, or translated into
other languages without any prior written approval from Aeonmed who
reserves the copyright.
Everything written in this manual is considered to be correct. Aeonmed is not

legally responsible for any mistakes printed within and any damages caused
by incorrect installation and operation. Aeonmed does not supply privileges
endowed by the patent law to any other parties. Aeonmed is not legally
responsible for the results caused by patent law breaking and any rights of
the third party violating.
Refer to this manual before any Aeonmed product is used. The manual
includes operating procedures which must be performed with cautiously,
operations that may result in non-normal working conditions and the dangers
which may damage equipment or cause bodily harm. Aeonmed is not
responsible for the security, reliability and function of the equipments in case
that the dangers, damages and non-normal phenomenon mentioned in this
manual happen. Free repairs for these malfunctions will not be provided by
Aeonmed.
Aeonmed have the rights to replace any contents in this manual without
notice.
Manufacturer Responsibility
Aeonmed is responsible for the security ， reliability and function of the
equipments when following conditions are adhered to:
 Installation, adjustments, mending and repairs must be performed by

individuals authorized by Aeonmed;
i
Epump500D User Manual
 Necessary electrical equipment and the working environment must be
in accordance with the national standards, professional standards and
the requirements listed in this manual;
 Equipment must be used and maintained as instructed in the operating
instructions.
The paid theoretical framework diagram will be supplied according to
customer’s requirements by Aeonmed, plus calibrating method and other
information to help the customer, under the assistance of qualified
technicians, repair the equipment parts where can be done by customer
himself based on the stipulation by Aeonmed.
CAUTION This equipment is not for family use.
WARNING Malfunctioning equipment may become invalid and cause

bodily injury if a set of effective and approving repairing proposals cannot be
submitted by the institution which is responsible for using this equipment.
And the equipment shall not be serviced or maintained while in use with a
PATIENT
Warranty
Manufacturing techniques and materials:
For a period of one year from the date of original delivery, the components
and assemblies of this product is warranted to be free from defects
manufacturing techniques and materials, provided that the same is properly
operated under the conditions of normal use and regular maintenance. The
warranty period for other parts is three months. Expendable parts are not
included. Aeonmed’s obligation under the above warranties is limited to
repairing free of charge.
ii
Free Obligations
 Aeonmed’s obligation under the above warranties does not
include the freight and other fees;
 Aeonmed is not responsible for any direct, indirect or final product
broken and delay which result from improper use, alteration by
using the assemblies unratified and maintenance by anyone other
than Aeonmed;
 This warranty does not apply to the followings:
Improper use
Machines without maintenance or machines broken
The label of Aeonmed original serial number or mark is removed
or replaced
Other manufacturers’ product
Security, reliability and operating condition

Aeonmed is not responsible for the security, reliability and operating
condition of this product in case that:
 The assemblies are disassembled, extended and readjusted

 This product is not operated correctly in accordance with the
manual instruction.
 The operation or maintenance environment does not follow the
requirements in this manual.
iii
Return
Follow the steps in case that the product needs to be returned to Aeonmed:
1. Obtain the right of return

Contact with the customer service department of Aeonmed by informing us
the number and type of the product. The number is marked on the surface of
the product. Return is unacceptable if the number cannot be identified.
Enclose a statement of the number, type and the reason of return as well.
2. Transportation charges
Transportation and insurance charges must be paid by the user for
transporting the product to Aeonmed for repairing. (Custom charges are
added with regard to the products sold to non-Chinese mainland users).
NOTE:
Each Aeonmed product has a serial number, such as
Epump500D (E) xx xx xxx
Epump500D: machine model
(E): machine model for exporting
The first xx: the year of manufacturing
The second xx: the month
The third xxx: equipment number
Expect service life:
5 year for normal working
Environmental protection
The wasted product and accessories should reasonable processing, for
instance, send it to waste recycling station. do not irresponsibility discarded.
iv
Contents
Statement.......................................................................................................i
Manufacturer Responsibility........................................................................i
Warranty........................................................................................................ii
Free Obligations..........................................................................................iii
Return...........................................................................................................iv
NOTE:...........................................................................................................iv
Precautions for use.....................................................................................ix
1. Introduction............................................................................................1
1.1 Summary of Epump500D..............................................................1
1.2 Symbols..........................................................................................2
1.3 Terminology and Definitions.........................................................4
2. Epump500D structure.............................................................................5
2.1 System components.......................................................................5
2.2 Front view......................................................................................5
2.3 Side view......................................................................................11
2.4 Inside view...................................................................................13
2.5 Bottom view.................................................................................14
3. Epump500D Operating Guide..............................................................15
3.1 Epump500D quick operation.......................................................15
3.2 Startup and shut down..................................................................16
3.3 Infusion parameter settings..........................................................17
3.4 The setting of IV SET, PRIME/BOLUS, OCCLUSION and IV
specification..............................................................................................19
3.5 Setting of ID and Bed..................................................................22
3.6 MICRO mode...............................................................................23
3.7 Timeout alarm..............................................................................23
3.8 "Start" or "Stop" of infusion........................................................24
3.9 Use of PRIME and BOLUS.........................................................25
3.10 Silence..........................................................................................26
4. Epump500D Calibration.......................................................................27
4.1 Rate Calibration...........................................................................27
4.2 Air Bubble calibration..................................................................29
4.3 Occluded calibration....................................................................30
5. Preoperative Checkout.........................................................................31
6. Installation............................................................................................33
6.1 Unpack and check........................................................................33
6.2 Fix the pump................................................................................33
6.3 Pedestal assembly........................................................................34
6.4 Connecting power cord................................................................35
v
6.5 Install IV set.................................................................................35
6.6 Connect with patient....................................................................37
6.7 Replacing medicine liquid...........................................................37
6.8 Precautions for connecting...........................................................38
6.9 Pharmacologic reactions..............................................................42
7. Maintenance and Disinfection..............................................................43
7.1 Maintenance.................................................................................43
7.2 General cleaning..........................................................................44
7.3 Detergent......................................................................................45
7.4 Sterilizing.....................................................................................45
7.5 Disinfecting..................................................................................46
7.6 Battery maintenance.....................................................................47
8. Alarm and Troubleshooting..................................................................49
8.1 About alarm.................................................................................49
8.2 Reason and disposal of alarms.....................................................50
8.3 Troubleshooting...........................................................................52
9. Accessories&Ordering Information.....................................................55
9.1 Order............................................................................................55
9.2 Recommended IV SETS..............................................................55
10. Specifications...................................................................................57
10.1 Physical specification...................................................................57
10.2 Environment requirements...........................................................57
10.3 Environment safety......................................................................57
10.4 Evironment protection.................................................................58
10.5 System technical specification.....................................................59
10.6 Operation principle......................................................................61
10.7 Monitoring performance..............................................................62
10.8 Data retention...............................................................................64
10.9 Accuracy......................................................................................64
10.10 Electromagnetic Compatibility................................................71
vi
Foreword
Thank you for purchasing and utilizing Aeonmed equipment.
For using the apparatus rightly and effectively, please read the User Manual
thoroughly and carefully before use.
Any use of the apparatus requires full understanding and actually
implemented of these instructions.
The apparatus is only to be used for purpose specified here.
One who is not authorized by Aeonmed shall not be allowed to open and
dismantle the apparatus for maintaining, checking or repairing.
For further assistance contact Aeonmed, good service would be supplied.
Aeonmed have the rights to replace any specification without notice.
The theoretical framework diagram will be supplied to customer by Aeonmed
if necessary.
vii
Welcome to contact Aeonmed by the following information:
Manufacture: Beijing Aeonmed Co., Ltd.

Registered address: 11B2, Fengtai Science Park, Beijing, PEOPLE’S
REPUBLIC OF CHINA
Production 11B2, Fengtai Science Park, Beijing, PEOPLE’S
address: REPUBLIC OF CHINA
No.10, Chaobai St., Yanjiao Development Zone,
065201 Sanhe, Hebei Province, PEOPLE’S
REPUBLIC OF CHINA
European Shanghai International Holding Corp.GmbH
Representative: (Europe)
Address: Eiffestrasse 80, 20537 Hamburg Germany.
P.C.: 100070
Tel.: +8610-83681616
Fax: +8610-63718989
Web site: www.aeonmed.com
E-mail: [email protected]
viii
Precautions for use
1. This apparatus can only be used by professional.
2. Do not open up enclosure to avoid electric shock. Any servicing or

updating must only be performed by authorized by our company; the
maintenance must be performed according to this manual.
3. Perform the checking procedure and make sure the accessories are up
to the mustard before use.
4. Error may be generated by using unspecified IV sets.
5. The equipment interconnected with Epump500D should be

equipotential (protect earth line connection).
6. It must conform to doctor’s advice to use BOLUS function in the

process of infusion.
7. If there is more than one infusion way to the patient, error may be
generated for variable block-pressure in the pipes.
8. Do not use Epump500D in the flammability surroundings, such as

anaesthetic, to prevent detonability.
9. Do not use cell phone near Epump500D, Or else, interferer generated

from cell phone will affect infusion accuracy of Epump500D.
10. Avoid sharing the same electrical outlet or over-close distance with
high-power surgery apparatus. Avoid using this apparatus in the strong
electric/ magnetic field surroundings.
11. Operator must guarantee the patient safety when Epump500D operated
with other electrosurgery unit.
12. The waste package must be performed according to current waste

control rules and place it where the child can’t reach.
13. Make sure alarm system normal to prevent infusion danger occurs.
14. Make sure AC power protective earth line in good condition, if not, use
battery supply.
ix
15. As auxiliary apparatus for infusion, the management of medicament is
answered by medical personnel.
16. If apparatus and accessories mentioned in this manual is needing its

expiration date, must be performed according to the processing rules. If
you want more assistance, please contact with us.
17. Disconnect the outlet line to isolate equipment from SUPLY MAINS
when open the enclose.
x
1 Introduction
. Introduction
1.1 Summary of Epump500D
Epump500D infusion pump is a medical appliance that
combines the microcontroller and the precision machineries
and can realize the accurate control of transfusion velocity
and capacity. It takes the linear peristaltic pump as its power
source and uses the motor to drive the peristaltic pump and
compress the tube so that the medical liquid could flow
inside the tube and the medical liquid can be transfused into
the body of patient.
WARNING The user of Epump500D must be

professional and trained.
WARNING Epump500D is unsuitable for use in MRI

environment.
1.1.1 Indication
Epump500D infusion pump is designed for infusion of
medications or fluids requiring continuous delivery at
precisely-controlled infusion rates through intravenous. The
system is intended to use in operating room, emergency
department, ICU, CCU, anabiosis room and general
sickroom for infusion.
1.1.2 Contraindication
Epump500D infusion pump cannot be used to blood
transfusion and insulin infusion, cannot be used to
analgesia, chemotherapy and too viscous liquid.
1
Figure 1-1 Epump500D system appearance

1.2 Symbols
Warnings and Cautions indicate all the possible
dangers in case of violation of the stipulations in this
manual. Refer to and follow them.
WARNING indicates potential hazards to operators

or patients.
CAUTION indicates potential damage to equipment.
2
1 Introduction
Instead of illustrations, other symbols may also be utilized.

Not all of them may necessarily appear in the equipment
and manual. The symbols include:
Alternating
Type CF equipment
Current
Caution,
Direct Current consult accompanying
documents
Protectively earth SN Serial Number
Equipotential Date of manufacture
Refer to chapter Address of manufacture
Battery upward
fragile Water funk
Story limit Temperature
Himidity Atmosphere
Mute alarm Prime infusion
Start/stop menu
Clrar Infusion mode
Prevent splash
IPX3 water enter
DC outlet
Must read user

TUV certification
manual
power off Power on
3
1.3 Terminology and Definitions

AC Alternating Current
DC Direct Current
Hz Hertz
A Ampere
V Volt
mL/h Milliliter per hour
drop/min Drop per minute

PRIME Fast mode used to expel air bubble in the tube
BOLUS Fast infusing mode
MPa Mega-Pa
KVO Keep vein open
Panel alarm symbols:
AIR Air alarm
OCCL IV SET block alarm
FINISH Infusion finish alarm
Timeout Idle timeout alarm
FAULT System error
BATT. Battery low alarm
DOOR Door open alarm
Ext-Power Extern mains power disconnect alarm
4
2 Epump500D Structure
Epump500D structure
2.1 System components
1） Epump500D is composed of Main Unit, power cord and optional
accessories.
2） optional accessories: PMS modular.
2.2 Front view
1
3
4
5
Figure 2-1 Epump500D front view

1 Display screen 2 Product model
3 Indicators 4 Keypad
5 Door Wrench
5
4 Area
2.2.1 Display Screen
1Area 5 Area
2 Area 6 Area
3 Area
Figure 2-2 Display main menu

 Area 1: IV sets area
There are IV sets options, from: 1 to 9.
 Area 2: alarm message area
Display the current alarm message of the pump.
Include alarm message of fault, low battery, door, air, occlusion timeout
and finish.
When alarm occurs, the corresponding icon will be blinking to remind

operator to deal with alarm. More details refer to chapter 8.1.
6
 Area 3: parameters area

This part displays:
Accumulated volume;
Preset volume;
Residual volume;
ID and bed number.
This part displays:

Infusion velocity: mL/h or drop/min;
Infusion time;
I.V. specification
Figure 2-3 Parameters area

 Area 4:BOLUS / PRIME velocity area
Display BOLUS / PRIME velocity of the pump.
options are :100、200、300、400、500、600、700、800、900mL/h.
 Area 5:occluded pressure area
Display occluded pressure threshold.
Three levels: High, middle and low.
 Area 6: infusing status area
These are drops display from top to down, Indicates the pump is
infusing.
The characters and numbers of LCD flash period is 0.6 second and the ratio
of display’s time to hide is 2 to 1.
7
2.2.2 Indicators
When alarm occurs, the alarm indicator blinks
Alarm to remind operator to deal with it in time.
indicator Variable colors with red, yellow, green
( 10.6.1 and 10.6.2)
When the pump is connected to AC power, the
AC indicator is lit; when AC power is cut off, the
AC indicator
indicator turns off.
The Color is green
When the pump is powered by inner battery,
the battery indicator blinks; When the pump is
Battery
connected to AC power, the battery indicator is
indicator
lit (in charging state).
The Color is green
2.2.3 Keypad
Figure 2-4 Keypads
8
 In non-operating state, infusion parameters can be set up. ( 3.3)

 In idle state, press this key for 2 seconds to set ""IV","BOLUS / PRIME
velocity "," occluded pressure" and " IV set specification ".( 3.4)
"Menu"  In the shutdown state, press this key and turn power switch on to
key enter into calibration interface. ( 4.1)
 Press this key to eliminate current input in the process of parameters

settings.
"Clear" key  In idle state, press this key to eliminate Accumulated volume.
 when setting velocity, press this key to change mode among "mL/h",
"Drop/min" and " Time".( 3.3)
"mode" key
 In calibration state, press this key to save and turn to next menu.(
4.1)
 Start up and stop infusion.

"Start/
Stop" key
 Press this key to pause audio alarm.( 3.9)

"Silence" key
 Press this key and hold for 2 seconds, the pump shall be in
"Rapid/Point" BOLUS / PRIME infusing state. ( 3.9)
key
 In the setting state, press this key to input "0";

No. "0" key
 In the IV sets options, press this key to choose 1.
No. "1" key  In the Pressure options, press this key to choose low. ( 3.4)
9

No. "2" key  In the Pressure options, press this key to choose middle. ( 3.4)
 In the I.V. sets options, press this key to choose 3.
No. "3" key  In the Pressure options, press this key to choose high. ( 3.4)
 In the IV sets options, press this key to choose 4. ( 3.4)
No. "4" key  In idle state, ID can be set up. ( 3.5.1)
 In the IV sets options, press this key to choose 5. ( 3.4)
 In the infusing/idle state, press this key velocity unit can be switched
No. "5"key
between mL/h and drop/min.( 3.8)
No. "6" key  In idle state, BED can be set up. ( 3.5.2)
 In the infusing or idle state, press this key to display Preset volume. (
No. "7" key
3.8)

No. "8" key
 In the infusing/idle state, press this key to display Accumulated
volume. ( 3.8)

No. "9" key  In the infusing/idle state, press this key to display Residual volume. (
3.8)
10
2.3 Side view
Handle
Door
Prompt
Foot
Figure 2-5 Epump500D side view
11
Rear view
Handle
DC port
Power Equipotential
switch Terminal
Power
Socket
Figure 2-6 Epump500D rear view

See figure 2-6, the rear panel is consisted of the following components:
1） Power switch: startup or shutdown the pump;
2） Power socket: input power supply: 100-240VAC,
50Hz/60Hz;DC12V/20W
3） Equipotential terminal: connected to equipotential terminal in other
equipments with special cable, or connected to protective ground by
operator if the AC supply used without equipotential terminal;
4） wireless module(optional)：Used together with PISMS
12
2.4 Inside view
Air
sensor
Peristaltic
pump
Door
Pressure
sensor
Anti-free flow
clamp
Figure 2-7 Epump500D inside view
13
2.5 Bottom view
Battery
compartment
Figure 2-8 Epump500D bottom view
14
3 Epump500D Operating Guide
Epump500D Operating Guide
3.1 Epump500D quick operation
Fix the pump correctly
Connect the pump with AC power or use inner battery
Install the I.V. set correctly, make sure the I.V. set Inserted
from Top to bottom ,along with Air sensor, peristaltic pump,
pressure sensor and Anti-freeflow clamp
Turn the power switch on
The Speaker’s sound means self-testing is finished, then

you can set infusion parameters
Press “menu” key and keep 2 seconds or more, choose I.V.

set, BOLUS/PRIME rate and occluded pressure threshold
one after another
Press “menu” key, when the number blink, input

corresponding parameters .
Press “start/stop” key to start infusing, while infusion is

finished, repress the “start/stop” key.
15
3.2 Startup and shut down
Connect power cord to AC power。
Turn power switch on, the speaker’s sound means self-

testing has finished, the pump is startup.
Turn power switch off, the pump is shut down.
CAUTION When the pump is powered by inner battery only, the

Battery indicator will blink and the speaker sounds
continually after the pump is power on. Press the key
to pause audio alarm. Three minutes later the

audio alarm will turn off.
WARNING It is risk of using inner battery only; connect the AC
power if it’s available. Pay attention to the time battery
can use. For more detail about battery maintenance,
battery capacity and battery usage, please refer to
chapter7.6.
CAUTION For more detail about checking before use and

installation, please refer to chapter 5 and 6.
16
3Epump500D Operating Guide
3.3 Infusion parameter settings

Epump500D has V-R、V-T two setting mode：
 V-R mode:corresponding parameters are preset infusion volume
and infusion rate. rate unit(mL/h or drop/min).
 V-T mode:corresponding parameters are preset infusion volume
and preset infusion time.
Setting steps are as follows：
Press key , in the idle state.

Blink here!
Input "Preset volume"
 Press key : clear the number inputted;
 Press key : save current setting and go to next step.
17
Blink here!
Input "infusion velocity"

Continued on Next Page
 Press key , change mode among "mL/h", "Drop/min"

and "Time".
 press key , clear the number inputted;

 In V-T mode, enter "hh" and "min".
Example:
set:03:05:
press key:
set:00:15:
press key:
 In V-R mode and rate unit is mL/h, if rate<50 mL/h,

Epump500D shall enter into MICRO mode automatically.
(3.6)
 Press key: to save setting.
Epump500D parameters as follows：
Infusion parameters Setting range Increment
18
volume preset 1mL～9999mL 1mL
Infusion time 1min～99h 59min 1min
infusion MICRO mode 1.0 mL/h～49.9 mL/h 0.1 mL/h

velocity
(mL/h) Normal mode 50 mL/h～1200 mL/h 1 mL/h
infusion 20drop/mL 1 ～400 drop/min 1 drop/min

velocity
(drop/min) 60 drop/mL 1～1200 drop/min 1 drop/min
19
The relativity among "mL/h", "drop/min" and "time" are as follows:
unit1 unit12 relativity remark
mL/h drop/min 1 mL/h=3 drop/mL I.V. set:20 drop/mL
mL/h drop/min 1 mL/h=1 drop/mL I.V. set:60 drop/mL

infusion mL/h= volume preset /
mL/h —
time infusion time
WARNING Epump500D shall limit the setting of "infusion velocity"

(1.0 mL/h～1200mL/h)，and change the "infusion time"
by that limit automatically.
3.4 The setting of IV SET, PRIME/BOLUS,

OCCLUSION and IV specification
In the idle state, press key and hold for 2 seconds.

Blink here!
Input " I.V. set "
 setting range:1～9;
Press No. "1" key~ No. "9" key
 Press key , save current setting and quit.
 Press key , save current setting and go to next

step.
20
Blink here!
Input "Rapid velocity"
 setting range:100、200、300、400、500、600、700、800、
900 mL/h.
Press No. "1" key~ No. "9" key

step.
Blink here!
Input "occluded pressure threshold"
 setting : Press key ，select"low";
Press key ，select"middle";
Press key ，select"high".

step.
21
WARNING pressure threshold is higher the sensitivity is lower.
Blink here!
Input "IV Specification”
 setting : Press key ，select"20 drop/mL";
Press key ，select"60 drop/mL";
 Press key , save current setting and go to next step.
22
3.5 Setting of ID and Bed

3.5.1 Setting of ID
In idle state, press key and hold for 2 seconds.
Blink here!

 Input ID number;

3.5.2 Setting of Bed
In idle state, press key and hold for 2 seconds.
Blink here!
 Input Bed number;
WARNING ID and Bed have setting range:1～200.
23
3.6 MICRO mode

In setting mode, If rate unit is mL/h and rate<50 mL/h, Epump500D shall
enter into MICRO mode automatically.
Minimum increment is 0.1mL/h in MICRO mode.
3.7 Timeout alarm

Startup the Epump500D and without operation for more than 2minutes,
this alarm shall be activated.
press any key can relieve this alarm.
WARNING timeout alarm is absent in the calibration state.
24
3.8 "Start" or "Stop" of infusion

When parameters setting are finished and get ready, start or stop of
infusion should be controlled by pressing key .

Display screen:
5
1
2 6
4
7
Figure 3-1 Display screen of infusion
1 I.V. Number
2 Alarm message
3 accumulated infusion volume
4 Velocity and Infusion time
5 occluded pressure threshold
6 Infusing indicator
7 infusion velocity
25
Infusion operation of Epump500D in idle or infusing state:
When parameters setting are finished and get ready, start or

stop of infusion should be controlled by pressing this key.
In infusing state, press this key to display infusion volume.
In infusing state, press this key to display accumulated

infusion volume.
In infusing state, press this key to display residual infusion

volume.
Press this key to switch the infusion velocity unit between

mL/h and drop/min each other.
In idle state, press this key for more than 2 seconds to cancel
accumulated volume.
3.9 Use of PRIME and BOLUS

3.9.1 PRIME
Set PRIME/BOLUS rate.( 3.4)
In idle state, press key and hold this key to get into
PRIME state.
Release key to stop PRIME.

This function is to expel inner air from tube.
Accumulated infusion volume is countedfrom 0 in PRIME state.
WARNING In PRIME state, all alarms are enabled but these alarms
shall not disturb PRIME.
3.9.2 BOLUS
26
Set PRIME/BOLUS rate. ( 3.4)
In infusing state, press key and hold this key to get into
BOLUS state.
Release key to stop BOLUS.

Accumulated infusion volume is countednormally in BOLUS
state.
WARNING It must conform to doctor’s advice to use BOLUS.

CAUTIONAll alarms are available in BOLUS state.
3.10 Silence
Press key to pause audio alarm.
CAUTION silence state is not more than 2 minutes.
27
4 Epump500DCalibration
Epump500D Calibration
Non-recommended infusion set can be used in Epump500D, but
successful calibration is needed by the company's professional.
CAUTIONchoose a flexible infusion set; calibration fail may cause

alarm fail.
4.1 Rate Calibration
In shutdown state, presskey
and turn on the

Epump500D pump. After
hearing a long beep, It enters
into rate calibration interface.
CAUTION When “IV SET” number blinks (default 9), press number key to
set other “IV SET” number; Confirm the same IV number of calibration and
normal use state.
28
4Epump500D calibration
Install the IV set

correctly; expel inner
air from the set. The
transfusion system end
abreast nothing but
linking a measuring
cylinder, and keep the
cylinder in a horizontal
plane.
Figure 4-1 Rate Calibration
Press key to start

calibration; when the
liquid arrived at 10ml
line or calibration
marker, press key

to finish calibration,
then Epump500Dwill blink here ！
turn to normal working
state.
If the deviation of infusion accuracy still exists, repeat above

process.
29
4.2 Air Bubble calibration
In shutdown state,
pressing
And turn on the

Epump500Dpump.
After hearing a long a
beep, It enters into air

bubble calibration b
interface.
Open the pump door,

install the IV set
correctly and then close
the pump door.
"b" is starting to blink, input "b" with "b=a ÷3", press to save
calibration value.
Press key: to clear the number inputted.
WARNING IV set must be full of fluid and installed on the pump

correctly and the air bubble must be expelled.
CAUTIONRate calibration and Bubble calibration are needed before

the first use.
30
4Epump500D calibration
4.3 Occluded calibration
Firstly, choose the IV

set required to
calibrate.
Use a three-way
connector to connect
a pressure tester.
Connect an injector
filled with liquid to the
tube end.
Figure 4-2 Occluded Calibration
After air bubble
calibration, the pump
enters into occluded
calibration real time
value
automatically. Press
number key to set blink

“IV SET” number. here ！
Push the injector and observe pressure tester, record real-time

value of AD1 and AD2 when pressure indicates 0.03MPa,
0.06MPa respectively.
Calculate the value: AD=AD2-AD1.
Input AD, press to save calibration value.
Press "clear" key to clear the number inputted.

CAUTIONOccluded calibration is not necessary in normal condition;
user shall set suitable threshold according to actual situation.
31
5 Preoperative Checkout
Preoperative Checkout
 Check system fault alarm
Shutdown state → Connect power supply → start up → self-testing
→1ml transfusion →no system fault alarm occurs.
CAUTION When this alarm occurs, please restart. If the fault still exists,
contact with Aeonmed.
 Check bubble alarm
Shutdown state → Connect AC power→ install IV set with air → display
“air”→ install IV set without air →”air” disappear.
CAUTION keep IV set dry and no foreign matter in the testing process.
 Check occlusion alarm
Shutdown state → Connect AC power→ install IV set with liquid →
keep patient circuit open → start infusing → no occlusion alarm →close
patient circuit →occlusion alarm.
CAUTION when full alarm or no alarm all the time, please calibrate IV
set.
 Check door open alarm
Shutdown state → connect AC power→ close pump door → startup →
self- testing → no “DOOR” → open pump door→ display “DOOR”.
 Check leakage
Shutdown→ install IV set with liquid →open patient circuit → close the
pump door →no liquid outflow.
CAUTION It is normal that dripping occurs in the initial stages. That’s

gravity effect.
 Check alarm sound
Shutdown state → without AC power→ start up→ the self-test sound is
active.
when press silence key, the sound is disable.
32
5. Preoperative Checkout
CAUTION if there is no sound all the time or silence key cannot stop
the sound, please contact authorized engineer.
 Check alarm indicator
Shutdown state → without AC power→ startup→ the yellow alarm
indicator is active.
CAUTION if the yellow indicator doesn’t blink, please contact

authorized engineer.
 Check AC power indicator
Connect AC power, the power indicator is on.
CAUTION if the indicator is on/off all the time, please contact

authorized engineer.
 check noise
Shutdown state → connect AC power→install infusion set→ close pump
door → start up →running
In infusing state, the noise of pump is bellow 45dB.
33
6 Installation
Installation
6.1 Unpack and check
Check whether the parts are damaged.
Check whether all the parts are ready and accord with specification.
6.2 Fix the pump

To fix the pump, refer to follow steps: locate the pedestal at the special or
general dropping-bottle bracket for appropriate place, and then connect the
pump to pedestal.
CAUTION To avoid uncertainty, Make sure the bottom and side of

pedestal are both in a good screw.
Make sure the pump is 0.5 meters higher than the bed and 1.2 meters higher
than the floor. And make sure it’s no more than 0.5 miters when the pump is
lower than patient in special used.
34
6 Installation
6.3 Pedestal assembly
Twisted off screw by

hand to dismantle
pedestal.
Figure 6-1 Pedestal assembly-1
Pedestal is central-
fixed, that can be installed
in twoways.
Figure 6-2 Pedestal assembly-2
35
6.4 Connecting power cord
Make sure the power supply accord to: 100~240VAC, 50Hz/60Hz
Use accompanying power cord to connect AC power.
Connect equipotential line if it is necessary.
6.5 Install IV set

Steps for installing IV set:
1)Open the door
Pull door Wrench.
Figure 6-3 Open the door
36
6 Installation
2) Install infusion set
Firstly, make the

tube be filled with liquid
using gravity and then
turn off the knob.
Afterwards put a part of
tube in the trough from
top to down then insert it
to the aperture of pushed
Anti-freeflow clamp,
release the clamp.
Figure 6-4 Install infusion set

CAUTION keep the tube unwinding and in the right place.
3) Close door
Close door and push

door Wrench.
Figure 6-5 Close door

4) Observe
Loosen the knob of IV set and use PRIME infusion operation, observe
that liquid flowing from needlepoint, afterwards turn off the knob.
37
6.6 Connect with patient
1) Confirm there is no air bubble in the tube.
2) After the above installation finished, turn on the knob of IV set, and
then make sure that no liquid flow from needlepoint or drop from the
drip chamber; if there is liquid flow or drops, it indicates the
installation of IV set not good, except for machine fault, so refer to
section 4.3. If good, turn off the knob.
3) Make sure no air bubble in the IV tube, afterwards remove needle
case and insert the needle to patient vein, also check that the
insertion is safe. Lastly, turn on knob of IV set and press to
startup infusing.
WARNING
 If installation of IV set is wrong, for example, the tube bending, not
across air sensor or pressure sensor, that will lead to alarm occurs,
alarm failure, or infusion accuracy not satisfied requirement.
 Door open alarm message will be activated if the pump door not closed
completely.
 Do use the specified IV set, and conform instruction for use to install it.
 Change the position peristaltic pump compressing every 4 hours when
using the recommended IV set.
CAUTION disused material (infusion sets as well) should be reclaimed
According to relative law,
6.7 Replacing medicine liquid
When infusion reaches presetting volume, the audible and visible alarm is
activated, at the same time the pump turns to KVO state. To replace
medicine liquid, press to stop infusing, turn off the knob of IV set, and
observe liquid dripping to confirm dripping is stopped. Afterwards replace
new medicine liquid, and reset infusion mode together with relevant
parameters, then press to start infusing.
38
6 Installation
6.8 Precautions for connecting
6.8.1 Check for liquid leakage
Before use, fully fill the liquid into the IV line. After the IV set has been
installed onto the pump, before the needle is inserted into the vein and the
infusion is started, put the needle naturally downward. Check whether
medical liquid drips from the needle (as shown in Figure 6-6). If the
medical liquid drips, it means that medical liquid cannot be blocked when
infusion is stopped, in this instance, deal with it in time. The detailed
methods are shown in section 8.3.
Figure 6-6 Check for liquid leakage-1
After the installation of IV set onto the infusion pump and when the tube is
full of liquid, manually open the pump door (as shown in Figure 6-5) and
check whether medical liquid drips from the needle. If medical liquid drips, it
means that the liquid-stopping clamp has not clamped tightly and cannot
block the infusion of medical liquid when the door is open. In this instance,
deal with it in time. The detailed methods are shown in section 8.3.
39
Figure 6-7 Check for liquid leakage-2

6.8.2
6.8.3 Three-way infusion
When an IV set is connected with the three-way connector and carried out
the combined infusion with another way (as shown in Figure 6-8),
attentions must be paid to taboo at matching of two medicines or more.
Besides, since the liquid from another IV line may have a minor resistance
on the IV set on the infusion pump, the accuracy may exceed the
stipulated tolerance.
Figure 6-8 Three-way infusion
6.8.4 Large difference from the drop rate

40
6 Installation
The drop rate is often converted into ml/h in clinical application. If a large
difference from the actual preset flow rate appears, there are possible
reasons as follows:
1. The drop rate measurement device is not accurate;
2. The specifications of IV set do not satisfy the requirements on
Epump500D. The specifications of the IV set required by Epump500D is
20 drops = 1mL±0.1mL. The processing method is to replace it with
another single-use IV set that satisfies the requirements;
3. If the IV set with the same specifications is not recommend by
Aeonmed, errors may occur due to the differences of materials and
inside/outside diameters of IV set.
41
If the infusion error is caused by the abnormal operation of the apparatus
itself, the reasons are complicated. It can be dealt with in the following
methods: obtain physiological saline whose volume is not less than 150ml,
connect the test system in accordance with Figure 6-9, put the output
terminal of liquid in the measuring cup, and set the infusion velocity to
150mL/h (simplified as Va) and time 30 minutes. When the infusion velocity
is stable, count the number of drops for one minute. Then, multiply the
number by 3. The final result shall be the actual estimated flow velocity
(simplified as Vb). After 30 minutes have been counted, check the volume (V)
of liquid in the measuring cup. Divided it by 0.5, the actually-measured
average velocity Vc shall be obtained. Compare Va, Vb and Vc and deal with
them in light of different results:
If Va and Vc are close and Vb has a large difference, processing is
unnecessary, since it belongs to the count error.
If Vb and Vc are close and Va has a large difference, it belongs to the
apparatus problem of Epump500D. Contact the manufacturer in time to deal
with.
Figure 6-9 Drop rate test
42
6 Installation
6.9 Pharmacologic reactions
1. In the process of infusion, when the BOLUS function is used, it should

be confirmed that the rapid infusion of medical liquid into the human
body shall not bring about pharmacologic reactions;
2. The use of pressure-raising medicine or blood vessel expansion
medicine may bring about minor error of flow rate due to the minor
change of vein pressure. Epump500D has taken sufficient
consideration of it in design and can guarantee that the infusion error
shall not exceed the specified range in this case;
3. Due to the individual differences of patients, the setup of infusion
parameters in clinic shall take the feedback information of physiological
reactions of patients as the criterion. Epump500D is only used as the
auxiliary infusion apparatus for the medical personnel and cannot
replace the judgment of clinicians.
WARNING Aeonmed is not legally responsible for the pharmacologic

reaction of reuse infusion set with residual medication.
43
7.Maintenance and Disinfection
Maintenance and Disinfection
7.1 Maintenance
1) The follow check should done before first use or reuse after restored
long time
(1) Check the pump if there is any mechanical failure or looseness,
shake and bad contact.
(2) Check all of the exposed wires and accessories
(3) Check the pump and make sure it works well.
Refer to chapter 8.3 if there is any failure, and maintained by authorized
engineer or connect with Aeonmed.
2) Comprehensive detection, include function security detection, must
performed by individuals authorized by Aeonmed every 6-12 months or
after each repair.
3) Implement rate calibration according to repairing proposals and
Detection by eligibility individuals every 12 months at least.
4) Detection needs to open the apparatus must be done by eligibility
individuals, security and maintenance detection can be done by
Aeonmed also.
5) Clean the exposed surfaces by alcohol, airing dry, and disinfect with
ultraviolet radiation (refer to chapter 7.5). Remove the battery by
eligibility individuals.
WARNING
Use a cleaning and sterilizing schedule that conforms to your
institution’s sterilization and risk-management policies.
 Refer to the material safety data policy of each agent.
 Refer to the operating and maintaining manual of all the
sterilizing equipments.
 Wear safety gloves and safety goggles.
CAUTION To prevent damage:
44
7 Maintenance and Disinfection
 Refer to the data supplied by the manufacturer if there are any
questions about the agent.
 Never use any organic, halogenate or oil base solvent,
anesthetic,
glass agent, acetone or other irritant agents.
 Never use any abrasive agent to clean any of the components
(i.e.
Steel wool, silver polish or agent).
 Keep liquids far from the electrical components.
 Prevent liquid from entering the equipment.
 Do not immerse the synthetic rubber components more than 15
minutes: any longer will cause inflation, or accelerating aging.
 The PH value of the cleaning solution must be from 7.0 to 10.5.
 Please do not position the ME EQUIPMENT so that it is
difficult to disconnect the power cord from supply mains after use.
WARNING Check if there is damage in the components. Replace if

necessary.
7.2 General cleaning

Clean the pump using cloth dampened by mild soap water or with equivalent
cleaning solutions. Use water to rinse off chemical residue if necessary.
Forbidden acetic acid peroxide or formaldehyde steaming.
WARNING
 Shut down the pump and disconnect AC power before cleaning.
 Keep dust free.
 Cleaning shell and screen of pump with noncorrosive detergent,
such as soap or fresh water.
CAUTION
45
 Prevent infusion pump is damaged in cleaning.
 Do not use strong solvent such as acetone.
 It’s very important that most detergent must be diluted, according
to instructions of manufacturer.
 Never use any abrasive agent to clean any of the components (i.e.
steel wool or silver polish )
 Keep liquid from entering the equipment and never immerse any
components of Epump500 infusion system in the liquid.
 Keep detergent from remaining any components of Epump500
7.3 Detergent
Diluted ammonia
Diluted sodium hypochlorite (bleaching powder for washing)
CAUTION
 500ppm(bleaching powder diluted by 1:100) ~5000ppm(bleaching
powder diluted by 1:10) sodium hypochlorite is very efficient, the
concentration is depend on the how dirty the surface is.
 35~37% formaldehyde diluted
 3% hydrogen peroxide
 alcohol
 isopropyl alcohol
WARNING
 The surface and sensor can be swabbed with alcohol and air-dry
 Aeonmed is not legally responsible for the validity of these
chemicals using as epidemical control method, please refer to
your hospital’s epidemical control principal or epidemical expert.
46
7.4 Sterilizing
Sanitizing should only be implemented when it’s necessary according to your
maintenance schedule. And we suggest cleaning the pump before sanitizing.
Sanitizing materials we recommended: alcohol group and aldehyde group.
CAUTION
 Sanitizing materials should be diluted as manufacture’s
recommendations or as thin as possibly.
 Prevent any fluids entered the pump
 Do not immerse any part of the pump in any fluids or cleaning
solutions
 Do not dump any fluids on the pump in the process of sanitizing.
 Do not leave the sanitizing materials on the exposed surface after
sanitizing is finished, use mild cloth cleaning the pump at once
7.5 Disinfecting
Disinfecting should only be implemented when it’s necessary according to
your maintenance schedule. And we suggest cleaning the pump before
disinfecting.
For proper disinfecting of the pump, we recommend ultraviolet radiation, and
observe the following steps:
Clean the exposed surface using swabs saturated with alcohol, then wait
until the surface is dry.
Open the pump door and put the pump into the ultraviolet radiation
disinfector
CAUTION
 Time: not less than 2 hours
 Strength: not less than 70μw/cm2;
47
 Temperature: 15~40°C;
 Relative humidity: 50%.
CAUTION Do not use gas (ETO), electron beam, steam,

formaldehyde etc. to disinfect.
7.6 Battery maintenance

1) Battery specification:
Ni-MH 9.6V AA
2) Charging
The pump controls the process of battery charge automatically
whenever connecting to AC power.
The inner battery will be charged automatically while the pump supplied
by AC power. When the AC power is absent, the inner battery will be
the power source automatically.
For 10 hours continuous charged, the capacity can arrive at 75%.
3) Battery Capability:
A fully charged battery provides more than 5 hours of operation at
25ml/h.
CAUTION
 To prolong battery life, we recommend that operate the pump with
fully charged battery only until the battery run down, recharge the
battery, and repeat 2-3 times for the first use.
 The inner battery is Ni-MH battery. Change it after 500 times fully
charged and discharge.
 The renewal of batteries must be operate by professional person
48
4) Battery disassembly
Twisted off
screw by tool.
Figure 7-1 Battery disassembly-1
Pull out
Battery.
Figure 7-2 Battery disassembly-2
49
8.Alarm and Troubleshooting
Alarm and Troubleshooting
8.1 About alarm
Name Description
Air Bubble alarm message
 When bubble exists in the IV tube and detected by air
Air bubble sensor, the bubble alarm occurs, “AIR” blinks, accompanied
by audible and visible alarm. The pump stops infusing.
 If the bubble is dealt with, “AIR” will disappear.
Occluded alarm message
 When patient tube pressure is over limitation, the occluded
Occlusion alarm is activated, “OCCL.” blinks, accompanied by audible
and visible alarm, the pump stop infusing at the same time.
 If the occlude is dealt with,” OCCL.” will disappear.
FINISH alarm message
FINISH  When infusion finished, the pump turns to KVO state
automatically. The” FINISH” blinks.
Timeout alarm message
 In idle or pause state, without operation more than 2
Timeout
minutes, this alarm shall be activated.
 Press any key can relieve this alarm.
Fault alarm message
 When fault alarm activated, “FAULT” blinks, and
Fault
accompanied by audible and visible alarm.
 Must shutdown the pump and restart it.
battery alarm message
 When the pump is powered by battery only, and residual
Battery capacity cannot ensure the pump continuous operating, the
low battery alarm is activated, “BATT.” blinks and
accompanied by audible and visible alarm.
Door open alarm message
Door open  When the pump door is open, the door open alarm is
activated, “DOOR” blinks. Close pump door, the icon
disappears.
Details about indicator’s color, flash frequency and alarm sound please
refer to chapter10.6.1 and 10.6.2.
50
8 Alarm and Troubleshooting
8.2 Reason and disposal of alarms
Cause: The bubble monitored volume is more than 30×10 -3 ml
or air sensor fault etc. Result: the pump stops infusing.
Action: Remove the bubble in the tube by manual or PRIME. If
Air bubble the alarm still exists, contact with Aeonmed.
Note: Start infusion after removing air bubble.
The bubble alarm caused by incompatibility of IV set can be
solved via bubble calibration in general.
Cause: Pressure in the tube is over threshold or sensor fault
etc.
Result: the pump stops infusing.
Action: Check patient circuit. If the alarm still exists, contact
with Aeonmed.
Caution: when occluded alarm is cancelled, the pump will
Occlusion restore previous state automatically, for special medicine,
please pay attention to BOLUS.
Caution: The occluded alarm caused by incompatibility of IV
set can be solved via occluded calibration in general.
Caution: Make sure the infusion way open before changing
alarm threshold in the process of infusing.
Cause: The current infusion volume accumulated reaches the
volume preset.
FINISH Result: The pump stops infusing.
Action: Press can relieve this alarm.

Cause: idle or pause state, without operation more than 2
minutes, this alarm shall be activated.
Timeout
Result: indicate idle state.
Action: press any key can relieve this alarm.
Cause:
1 、 motor or peristaltic pump can’t operate abnormally or
sensor fault etc.
Fault 2、auxilary-MCU or main-MCU halt
Action: Shutdown and restart. If the fault still exists, contact
with Aeonmed.
51
Cause: the battery capacity lower. And there are 30 minutes at
least when low battery alarm activated before battery exhaust
resulted in infusion stop.
Result: system can infuse continuously.
Low battery Action: Connect to AC power. If the alarm still exists, contact
with Aeonmed.
Caution: When low battery alarm occurs, make sure that
infusion will be finished in short time or connected to outer
power supply within short term.
Cause: Using inner battery, and there are 3 minutes left before
battery exhaust.
Bat. Empty Result: system stops infusing.
Action: Connect to AC power. If the alarm still exists, contact
with Aeonmed.
Cause: door unclosed.
Door open
Action: close pump door correctly. If the alarm still exists,
contact with Aeonmed.
52
Troubleshooting
NO.1:Bubble alarm
Description Bubble alarm is still given even if no air bubble is available in
the transfusion pipe.
Reason 1. The IV line is too soft.
2. The IV line has not been clamped to the position of air
sensor.
Methods 1. Clean the internal side of air sensor in a gentle way with a
little distilled water.
2. Take out the pipe and clamp it well.
NO.2: No alarm is given even if there is air bubble.

Description No alarm is given even if there is air bubble in the pipe
Reason 1. The air sensor is defective.
2. The air bubble is too small. This apparatus can only test
those bubbles no less than 30×10-3mL.
3. The bubble enters the tube before clamping the tube and
located below the sensor.
Methods 1. Contact the manufacturer for replacement of sensor.
2. Confirm the air sensor is in good condition. Deal with the
bubble and continue the infusion. Pay attention to the pump.
3. Remove the IV set, deal with the bubble and continue the
infusion.
NO.3: Fault alarm

Description The screen displays Fault alarm, but no other alarm is
available.
Reason Blocking of rotation of motor.
Methods Contact the manufacturer.
NO.4:Blocking pressure
Description Alarm is given for pressure before infusion start but after the
tube is placed to its position.
Reason The tube doesn’t put correctly.
Liquid enters into the sensor or the sensor is defective.
53
Methods Adjust the position of tube.
Contact the manufacturer.
NO.5: The tube is blocked but the alarm is not given.

Description Alarm conditions are available but alarm is not given.
The tube is blocked but the alarm is not given.
Reason The sensor is defective.
The blocking pressure and time do not satisfy the alarm
conditions.
Normal state. No repair is necessary.
NO.6: There is a big difference between the drop velocity and the preset rate.
Description
Reason 1. The IV set is not the standard one appointed by the
manufacturer.
2. Operating error of pump.
Methods 1. Change the IV set appointed by manufacturer.
2. If no IV set appointed by the manufacturer is available, the
IV set made of highly-elastic PVC tube can be used
temporarily, but the manufacturer is not responsible for the
infusion accuracy or consequences incurred.
3. It is not allowed to use the IV set with ordinary plastic tube or
rubber tube.
4. Contact the manufacturer.
NO.7: Liquid drops before pump start

Description Liquid leaks from the needle when the IV set has been installed
and before the pump is started.
Reason The tube has not been pressed well by pump slice.
NO.8: Liquid drops after the door is opened.

Description After the installation of IV set or during the normal operation,
liquid leaks from the needle when the door is opened.
54
Reason The anti-free flow clamp has not clamped well.
Methods Check the condition of anti-free flow clamp before installation of
tube.
NO.9: Low battery alarm

Description Low battery alarm is indicated on the screen.
Reason Shortage of battery power.
Methods Connect the AC power;
If low battery alarm is still given when the battery has been
charged for a long time (not less than 8 hours), it is possible
that the battery is defective, contact the manufacturer.
NO.10: Door open alarm

Description Door open alarm is indicated on the screen.
Reason The door is not closed well.
Methods Close the door again.
55
9 Accessories&Ordering Information
Accessories&Ordering Information
Accessories appointed by the manufacturer are listed in the table below.
CAUTION other accessories may damage the pump.
Code Description Specification
21000159
European Power Cable
4
21000349
American Power Cable 2m,250V/10A
0
21000159
Asian Power Cable
5
21000017 T500mA,Φ5×20,0.5A(T
Fuse 250V/0.5A
3 )
13001220
User manual -----
4
9.1 Order
This chapter is about ordering information of IV set.
IV set (High flexibility PVC, single-use, 0.7*23(wall thickness*inner diameter),
20 drops = 1mL±0.1mL ) made of Shandong Qiao Co. Ltd is appointed by
the manufacturer.
This IV set used for all the test in this document.
9.2 Recommended IV SETS

1、LONGXIN,GUANGDONG,20drip/ml
2、XINHUA,SHANDONG,20drip/ml
3、QIAOPAI,SHANDONG,20drip/ml
4、KANGFU,CHENGDU,20drip/ml
5、FUERTE,BEIJING,20drip/ml
6、HONGDA,JIANGXI,20drip/ml
7、JIERUI,SHANDONG,20drip/ml
8、HANAHAO,TIANJIN,20drip/ml
56
10 Specifications
57
10 Specifications
Specifications
10.1 Physical specification
All specifications are approximately, maybe changed at any moment without
notice.
CAUTION Do not put Epump500D into the shock environment.
Dimensions: 169×95×210mm(D×W×H)
Weight: ≤2kg(packaging-free)
Screen LCD
Language English
10.2 Environment requirements

Operation: +5℃~+40℃ (standard I.V. set)
Temperature
Storage: -20℃~+55℃
Relative Operation: 20%~90%

humidity Storage: ≤93%
Atmospheric Operation: 80~106kPa

Pressure Storage: 50~106kPa
10.3 Environment safety

Following these:
1） Follow the environment condition specified in this manual.
2） Keep enough space to operate and connect lines for backboard.
3） Ensure enough air circulating.
58
10 Specifications
WARNING
 Under no circumstances should this medical device be operated in the
presence of flammable anesthetics or other volatile materials due to a
possible explosion hazard.
10.4 Evironment protection
59
10.5 System technical specification

10.5.1 Technical parameters
1.0mL/h～49.9mL/h(increment: 0.1mL/h)
infusion rate:
50mL/h～1200mL/h(increment: 1mL/h)
volume preset : 9999mL, increment: 1mL
volume
9999mL, increment: 1mL
accumulated:
±5% (verrify morethan five simaples) with recommend
Accuracy
SETS
BOLUS and 100～900mL/h, increment: 100mL
infusion rate:≥10mL/h,KVO rate:3mL/h;
KVO rate:
infusion rate:＜10mL/h,KVO rate:1mL/h
Occlusion alarm
High,middle,low
threshold:
Maximum infusion
0.16MP
pressure
Air Bubble Detect: ≥30x10-3mL
Longer than 5 hours (fully charged, rate: 25mL/h, 20°C)
Battery Capability: Longer than 2 hours (fully charged,rate:1100mL/h,
20°C)
10.5.2
10.5.3 KVO
1) KVO rate
infusion rate:≥10mL/h,KVO rate:3mL/h;
infusion rate:＜10mL/h,KVO rate:1mL/h.
2) KVO rate accuracy:±10%.
10.5.4 Classification
According to EN60601-2-24, Epump500D belongs to the following
60
10 Specifications
classifications:
 Class I equipment
 Type CF equipment
 General equipment
 With internal battery
 Operate continuously
 IPX3
10.5.5 Power supply
AC 100~240V、50/60Hz or power adapter: DC 12V、20W;
NiMH 9.6V longer than 5 hours (fully charged, rate: 25mL/h, 20°C,).
Power consumption: ≤20VA;
Warning
If loss of the power source would result in an unacceptable RISK,so
the equipment must be connected to an appropriate power source.
10.5.6 Maximum volume infused on single fault condition
maximum volume
No. single fault
infused
1 One protective earth line is absent zero
2 One power cable is absent ≤0.5ml
3 exotic voltage is exist on F-type applied part zero
4 Electrical part fault may cause danger ≤0.5ml
5 Mechanical part fault may cause danger ≤0.5ml
6 Liquid leakage ≤0.5ml
61
10.6 Operation principle

The simplified block diagram of Epump500D infusion pump is shown in
Figure 10-1. The liquid in the IV line first inspected by the air sensor
(the liquid flows inside IV line). If the individual air bubble volume is
bigger than 30×10-3 ml exists in the liquid, Epump500D will be stop
infusing and give out the audio and visual alarms. After the bubble dealt
with, press to restart the pump, then the peristaltic pump, which
composed of 12 pump slices, compress the IV set so that the liquid flow
to the direction of pressure sensor. The pressure sensor is used to
detect the pressure value of IV set. If the pressure value is more than
the preset threshold, Epump500D will stop infusing and give out the
audio and visual alarms. After handling on it, press to restart the
pump, the liquid can be transfused into the body of patient.
UI part Infusion
set
Air bubble sensor

Power Primary
Supply Control Peristaltic pump
part part
Pressure sensor
Internal sensor
Figure 10-1 Epump500D operation principle block diagram
62
10 Specifications
10.7 Monitoring performance

10.7.1 Definition of Alarm type and Alarm priority
Alarm type Alarm priority
Empty medium
occlusion high
Air bubble high
door open high
Low battery medium
Bat. Empty high
AC power medium
Fault high
timeout medium
10.7.2 Characteristics of alarm indicator lights
Alarm indicator
Alarm category Flashing Interpretation
Color
Frequency
High priority Red Fast CCC-CC
Medium priority Yellow Slow CCC
The volume of auditory ALARM SIGNALS are at least 65dB (A) in the
distance of 1m.
Note: the “Fault alarm” is especially, it continue beep as”CCC..”
10.7.3 Door monitoring
In the idle or pause state, Door open “DOOR” blinks.
In the infusing state, Door open “DOOR” blinks and concomitant with
audio and visual alarm.
10.7.4 Occlusion monitoring
Detail of Occlusion Alarm Pressure:
High： 105Kpa±25KPa
Middle： 75Kpa±25KPa
Low： 45Kpa±25KPa
63
trigger time
I.V. set
Low High
1 5 min 30 min
Rate(mL/h)
25 7s 58 s
BOLUS(mL)
Rate(mL/h) 1/25
0.07 0.35
(the result is tested with “qiao” IVSETS,PVC,about 1.3m long ,under 25℃;
other different IVSETS ‘s alarm trigger offset have a little difference,can be
ignored)
10.7.5 Air bubble monitoring
In the idle or pause state, if IV set is not installed correctly or inner air
bubble is not expel from the set, “AIR” blinks.
In the infusing state, when single air bubble volume is more than 30×10 -3
ml, “AIR” blinks and concomitant with audio and visual alarm.
10.7.6 FINISH monitoring
When infusion volume reaches the volume preset, “FINISH” blinks and
the system supply audio and visual alarm.
10.7.7 Fault monitoring
When drive mechanism fault, “FAULT” blinks and the system give out
audio and visual alarm.
10.7.8 Battery low monitoring
When using internal battery, and its capacity exhaust, “BATT.” blinks and
the system give out audio and visual alarm.
10.7.9 AC Power monitoring
When AC power is disconnected, “EX-POWER” blinks and the system
give out audio alarm for 3 minutes at least.
10.7.10 Timeout monitoring
64
10 Specifications
In idle or pause state, without operation more than 2 minutes, this alarm
shall be activated, “Timeout” blinks and concomitant with audio and visual
alarm.
10.8 Data retention

The programming option selection is retained until they are changed or
the pump is ruined.
10.9 Accuracy
Accuracy of Epump500D is described in this section. The information was
developed in accordance with IEC 60601-2-24: 2012, Sub-Clause 50.102.
Refer to this standard for detailed information.
The following graphs and curves were derived from usage of recommended
IV sets.
With occlusion monitor and program control,Epump500D can protect the
PATIENT from over-infusion and, where applicable, under-infusion resulting
from self-error or partial or total blockage of the IV SET.
10.9.1 Set rates: minimum rates 1mL/h
The figure 10-2 plots the actual flow Q i(mL/h) against time T0 for the first 2
hours of analysis period. The Qi is calculated according to equation (1) of
Sub-Clause 50.102 in sample intervals.
Figure 10-1 plotted from the data gathered during the first 2h
of the analysis period (setting rate: 1mL/h)
65
The figure 10-3 plots mean delivery rate error for the 2nd hour, and it also
presents maximum and minimum average delivery rate error. By the way, it’s
according to equation (2),(3) and (4) of Sub-Clause 50.102
Figure 10-2 Trumpet curve plotted from data gathered during the second
hour of the test period (setting rate: 1mL/h)
The figure 10-4 plots mean delivery rate error for the last hour, and it also
Figure 10-3 Trumpet curve plotted from data gathered during the last
66
10 Specifications
10.9.2 Inter-mediate rates 25mL/h

The figure 10-5 plots the actual flow Q i(mL/h) against time T0 for the first 2
Figure 10-4 plotted from data gathered during the first 2h

of the test period (setting rate: 25mL/h)
according to equation (2),(3) and (4) of Sub-Clause 50.102.
67
Figure 10-6 Trumpet curve plotted from data gathered during the last hour of
the test period (setting rate: 25mL/h)
10.9.3 rates 100mL/h

The figure 10-8 plots the actual flow Qi(mL/h) against time T0 for the first 2

68
10 Specifications
Figure 10-10 Trumpet curve plotted from data gathered during the last hour
10.9.4 rates 900mL/h

The figure 10-11 plots the actual flow Qi(mL/h) against time T0 for the first 2
69

70
10 Specifications
Figure 10-13 Trumpet curve plotted from data gathered during the last hour
71
10.10 Electromagnetic
Compatibility
Changing or reassembling this equipment without Aeonmed’s authorization

may cause electromagnetic compatibility problems. Contact with Aeonmed
for assistance. Designing and testing this equipment is in accordance with
the following stipulations.
WARNING using cell phone or other radio radiant equipment near this
product may cause malfunction. Closely monitor the working condition of this
equipment if there is any radio radiant supply nearby.
Using other electrical equipment in this system or nearby may cause
interference. Check if the equipment works normally in these conditions
before using on a patient.
Be careful of the following when Epump500D is connected:
Do not put any object which is not in accordance with EN60601-1 in the 1.5M
range of patients.
An isolated transformer must be used for alternating current supply (in
accordance with IEC60989), or additional protective ground wires are
equipped if all the devices (for medical or non-medical use) are connected to
Epump500D by using signal input/signal output cable.
If a portable all-purpose outlet is used as the alternating current supply, it
must be in accordance with EN60601-1-1 and cannot be put on the floor.
Using another portable all-purpose outlet is not recommended.
Do not connect the non-medical equipment directly to the alternating current
outlet on the wall. Only the alternating current supply of the isolated
transformer can be used. Otherwise, the surface leaking current may exceed
the range permitted by EN60601-1 under the normal conditions, and
misoperation may cause injury to patients or operators.
A complete system current leaking test (according to EN60601-1) must be
performed after any equipment is connected to these outlets.
WARNING medical electrical equipment operators contact non-

medical electrical equipment and patients at same time. It is dangerous of
patients or operators.
72
10 Specifications
Guidance and Manufacturer’s Declaration – Electromagnetic Emissions

The Epump500D is intended for use in the electromagnetic environment
specified below. The customer or user of the Epump500D should ensure that it
is used in such an environment.
Emissions Complian Electromagnetic Environment – Guidance

Test ce
RF Emissions Group 1 The Epump500D uses RF energy only for its
CISPR 11 internal function. Therefore, its RF emissions
are very low and are not likely to cause any
interference in nearby electronic equipment.
RF Emissions Class A The Epump500D is suitable for use in all
CISPR 11 establishments, other than domestic, and
Harmonics Class A those directly connected to the public low-
IEC 61000-3- voltage power supply network that supplies
2 buildings used for domestic purposes.
Voltage Complies
Fluctuations/
Flicker
IEC 61000-3-
3
73
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity

specified below. The customer or user of the Epump500D should ensure that it
is used in such an environment.
Immunity EN/IEC Compliance Electromagnetic

Test 60601 Test Level Environment – Guidance
Level
ESD ±6kV ±6kV Floors should be wood,
EN/IEC Contact Contact concrete or ceramic tile. If
61000-4-2 ±8kV Air ±8kV Air floors are synthetic, the r/h
should be at least 30%
EFT ±2kV Mains ±2kV Mains Mains power quality should
EN/IEC ±1kV I/Os ±1kV I/Os be that of a typical
61000-4-4 commercial or hospital
environment
Surge ±1kV ±1kV Mains power quality should
EN/IEC Differential Differential be that of a typical
61000-4-5 ±2kV ±2kV commercial or hospital
Common Common environment.
Voltage <5% UT <5% UT Mains power quality should
Dips/Dropout (>95% dip in (>95% dip in be that of a typical
EN/IEC UT) for 0.5 UT) for 0.5 commercial or hospital
61000-4-11 cycle cycle environment. If the user of
the Epump500D requires
40% UT 40% UT continued operation during
(60% dip in (60% dip in power mains interruptions, it
UT) for 5 UT) for 5 is recommended that the
cycles cycles Epump500D be powered
from an uninterruptible
70% UT 70% UT power supply or battery.
(30% dip in (30% dip in
UT) for 25 UT) for 25
cycles cycles
<5% UT <5% UT
(>95% dip in (>95% dip in
UT) for 5 sec UT) for 5 sec
Power 3A/m 3A/m Power frequency magnetic
Frequency fields should be that of a
50/60Hz typical commercial or
Magnetic hospital environment.
Field
EN/IEC
74
10 Specifications
61000-4-8
75
Guidance and manufacturer’s declaration – electromagnetic immunity

specified below. The customer or the user of the Epump500D should assure
that it is used in such an environment.
Immunity EN/IEC 60601 Compliance Electromagnetic Environment –

Test Test Level Level Guidance
Portable and mobile communications
equipment should be separated from
Epump500D by no less than the
distances calculated/listed below:
Conducte 3Vrms 3Vrms D=1.2√P

d RF 150 kHz to 80
EN/IEC MHz outside
61000-4-6 ISM bands
10Vrms 10Vrms D=1.2√P

150 kHz to 80
MHz in ISM
bands
Radiated 10V/m 80 MHz 10V/m D=1.2√P 80 to 800 MHz

RF to 2.5 GHz D=2.3√P 800 MHz to 2.5 GHz
EN/IEC
61000-4-3 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
meter (m).
Field strengths from fixed RF

transmitters, as determined by an
electromagnetic site survey, should be
less than the compliance level in each
frequency range.
Interference may occur in the vicinity of

equipment marked with the following
symbol:
76
10 Specifications
Recommended separation distances between portable and

mobile RF communications equipment and the Epump500D
The Epump500D is intended for use in an electromagnetic environment in
which radiated RF disturbances are controlled. The customer or the user of
the Epump500D can help prevent electromagnetic interference by maintaining
a minimum distance between portable and mobile RF communications
equipment (transmitters) and the Epump500D as recommended below,
according to the maximum output power of the communications equipment
Rated maximum Separation distance according to frequency of transmitter

output power of
transmitter m
150 kHz to 80 150 kHz to 80 MHz 80 MHz to 800 MHz to 2.5
MHz outside in 800 MHz GHz
W ISM bands ISM bands D=1.2√P D=2.3√P
D=1.2√P D=1.2√P
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
77
CE mark in this manual apply

only to product with CE mark.
Directive 93/42/EEC
concerning Medical
Devices
Epump500D infusion pump user manual
Edition 02.00
Mar, 2015
Beijing Aeonmed Co., Ltd.
78

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Statement

Proprietary materials protected by the copyright law are included in this

Everything written in this manual is considered to be correct. Aeonmed is not

 Installation, adjustments, mending and repairs must be performed by

CAUTION This equipment is not for family use.

WARNING Malfunctioning equipment may become invalid and cause

Security, reliability and operating condition

 The assemblies are disassembled, extended and readjusted

1. Obtain the right of return

Welcome to contact Aeonmed by the following information:

Manufacture: Beijing Aeonmed Co., Ltd.

2. Do not open up enclosure to avoid electric shock. Any servicing or

4. Error may be generated by using unspecified IV sets.

5. The equipment interconnected with Epump500D should be

6. It must conform to doctor’s advice to use BOLUS function in the

8. Do not use Epump500D in the flammability surroundings, such as

9. Do not use cell phone near Epump500D, Or else, interferer generated

12. The waste package must be performed according to current waste

16. If apparatus and accessories mentioned in this manual is needing its

WARNING The user of Epump500D must be

WARNING Epump500D is unsuitable for use in MRI

Figure 1-1 Epump500D system appearance

WARNING indicates potential hazards to operators

CAUTION indicates potential damage to equipment.

Instead of illustrations, other symbols may also be utilized.

Protectively earth SN Serial Number

Equipotential Date of manufacture

Refer to chapter Address of manufacture

fragile Water funk

Story limit Temperature

Mute alarm Prime infusion

Clrar Infusion mode

Must read user

power off Power on

1.3 Terminology and Definitions

mL/h Milliliter per hour

drop/min Drop per minute

KVO Keep vein open

Panel alarm symbols:

AIR Air alarm

OCCL IV SET block alarm

FINISH Infusion finish alarm

Timeout Idle timeout alarm

FAULT System error

BATT. Battery low alarm

DOOR Door open alarm

Ext-Power Extern mains power disconnect alarm

2.2 Front view

Figure 2-1 Epump500D front view

Figure 2-2 Display main menu

 Area 2: alarm message area

Display the current alarm message of the pump.

When alarm occurs, the corresponding icon will be blinking to remind

 Area 3: parameters area

This part displays:

Figure 2-3 Parameters area

Figure 2-4 Keypads

 In non-operating state, infusion parameters can be set up. ( 3.3)