USER MANUAL

INFUSION PUMP
(AIP-1200V)
Preface
1 Application Scope
Applicable to AIP-1200V infusion pumps of our company.
This User Manual describes the product’s most complete configuration, accessories and functions
which may not exist in the product of the user, for more detailed information, please contact
manufacturer.

2 Applicable Object
It is applicable to professional trained nurse, doctor, and maintenance technician of this equipment.

3 Use Instructions
This User Manual covers the basic information on the safety and effectiveness of the product for
guiding the operator to correctly install, test, operate, use and maintain the product. Please read this
manual thoroughly before use and use the product in a correct way. Please carefully keep the User
Manual for future use.
Our company is responsible for the reliability and performance of the equipment only all following
conditions are met:
⚫ Use the equipment according to this User Manual.
⚫ The equipment can only be disassembled, assembled, replaced, tested, improved and repaired by
the professional technicians of our company.
⚫ All components and accessories as well as consumables for repairing are provided by
manufacturer.
● Relevant electric devices meet the international standard IEC/EN 60601-1 and this User Manual.

4 Paraphrase
【】 means mechanical button
『』 means touch button
() further Information
- means inapplicable
√ means accordant
→ means operation steps
Bolus: Infuse large volume of liquid in a short time.
KVO: Keep vein open, prevent blood back to the IV tube and needle blocked.
Anti-bolus: Motor automatically reverse while the IV tube with high pressure.
IrDA: infrared communication
Warning /Attention: it may possibly cause physical injury or death if the cautions covered in the
Warning are not obeyed.
Caution: it may possibly cause physical injury or property loss if the cautions are not obeyed.
Note: in case fails to follow the supplementary or prompt information on the operation instructions
may possibly cause physical injury the equipment fault or property loss if it is not obeyed.
Accessories: the optional components which are necessary and (or) suitable for using with the
equipment in order to achieve the expected purpose, or provide convenience for achieving the
expected purpose, or improve the expected purpose, or increase the additional functions of the
equipment.
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Content
Preface .................................................................................................................................................2

Chapter1 Safety Instructions .................................................................................................................5

1.1 Warnings.................................................................................................................................5

1.2 Cautions ..................................................................................................................................6

1.3 Dialogue window ....................................................................................................................7

1.4 Symbols ...................................................................................................................................7

Chapter2 Overview .................................................................................................................................8

2.1 Application Scope ..................................................................................................................8

2.2 Contraindications...................................................................................................................8

2.3 Working Principle ..................................................................................................................8

2.4 Structure and Performance ..................................................................................................8

2.5 Product Specification .............................................................................................................9

Chapter3 Appearance ...........................................................................................................................12

3.1 Front View ............................................................................................................................12

3.2 Operation Panel ...................................................................................................................13

3.3 Display Screen ......................................................................................................................14

3.4 Rear View..............................................................................................................................17

3.5 Drop sensor (optional) .........................................................................................................18

Chapter4 Installation ............................................................................................................................19

4.1 Unpacking and Checking ....................................................................................................19

4.2 Installation ............................................................................................................................19

Chapter5 Use Preparation and Cautions ............................................................................................21

5.1 Use Preparation....................................................................................................................21

5.2 Operation Cautions..............................................................................................................21

Chapter6 Basic Operation ....................................................................................................................22

6.1 Operation Flow ....................................................................................................................22

6.2 Infusion Operation...............................................................................................................22

Chapter7 Set Infusion Parameters ......................................................................................................26

7.1 Introduction to Infusion Parameters Setting.....................................................................26

7.2 Infusion Parameters Setting Range ....................................................................................26

7.3 Infusion Mode Setting .........................................................................................................27

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Chapter8 System Setting ......................................................................................................................29

8.1 Settings ..................................................................................................................................29

8.2 General..................................................................................................................................32

8.3 Patient ...................................................................................................................................34

8.4 Records .................................................................................................................................34

8.5 System ...................................................................................................................................38

8.6 Electronic Memory Function ..............................................................................................38

Chapter9 Alarm Prompt and Troubleshooting ..................................................................................39

9.1 Introduction to Alarm Level ...............................................................................................39

9.2 Multi-level Alarm Rules ......................................................................................................39

9.3 Alarm Handle .......................................................................................................................39

9.4 Malfunction Analysis and Solution.....................................................................................39

Chapter10 Maintenance .........................................................................................................................40

10.1 Cleaning, disinfecting and sterilizing .................................................................................40

10.2 Periodical maintenance .......................................................................................................40

10.3 Add new brand and Calibration .........................................................................................41

10.4 Repair....................................................................................................................................43

10.5 Equipment Components/Accessories .................................................................................43

10.6 Production Date ...................................................................................................................43

10.7 Recycling ...............................................................................................................................44

Chapter11 Battery ..................................................................................................................................45

11.1 Check the Battery Performance .........................................................................................45

11.2 Replaced the Battery ...........................................................................................................45

Chapter12 After Sale Service .................................................................................................................46

Chapter13 Appendix...............................................................................................................................47

Appendix A Start Up Graphs and Trumpet Curves .................................................................................47

Appendix B Occlusion Response Property ................................................................................................49

Appendix C Alarm and Solution ................................................................................................................50

Appendix D EMC Electro Magnetic Compatibility declaration .............................................................52

Appendix E Wireless Module Information ................................................................................................56

Appendix F Factory Default Data Set .....................................................................................................57

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 Chapter1 Safety Instructions
1.1 Warnings

⚫ Before using, please check the equipment, connecting wire and accessories to ensure that it can work
normally and safely. If there’s anything abnormal, immediately stop working and contact our after sale
service department. Additionally, the adhesion or intrusion of fluid/drug may possibly cause the
equipment fault and malfunction. Therefore, please clean the equipment after use, and store it correctly.
⚫ This equipment must be operated by trained professional medical care personnel.
⚫ It is not allowed to put and use the equipment in the environment with anesthetic and other inflammable
or explosive articles to avoid fire or explosion.
⚫ It is not allowed to store or use the equipment in the environment with active chemical gas (including gas
for disinfecting) and moist environment since it may influence the inside components of the infusion
pump and may possibly cause performance drop or damage of the inside components.
⚫ The operator shall guarantee that the set infusion parameters of this equipment are the same as the
medical advice before starting infusion.
⚫ Please correctly install the infusion apparatus according to the infusion indication direction of this
equipment, ensure that infusion tube smoothly and straightly cross the creep device. Otherwise, it may
possibly suck blood from the patient or fails to reach the expected performance.
⚫ Please do not only depend on information prompt during use, please periodically check it to avoid
accident.
⚫ Tightly fix this equipment on the infusion stand and ensure the stability of the infusion stand. Be careful
when moving the infusion stand and this equipment to avoid the equipment dropping and infusion stand
falling or knocking the surrounding objects.
⚫ If the infusion tube is twisted, or the filter or needle is obstructed, or blood in the needle which may
obstruct the infusion, the pressure in the infusion tube will rise. When removing such occlusion, it may
possibly cause “bolus injection” (temporary excess infusion) to the patient. The correct method is to
tightly hold or clamp the infusion tube near the puncturing position, then open the door to drop the
pressure in the infusion tube. Then loosen the infusion tube, solve the reason of occlusion, and restart
infusion. If infusion is restarted when the occlusion reason exists, then it may cause occlusion alarm
persistently, and the pressure in the infusion tube may keep rising, and may break or cut off the infusion
tube, or hurt the patient.
⚫ This equipment injects fluid/drug through extruding the infusion tube, but it can’t detect the leakage if the
infusion line is cut off or broken. Therefore, please periodically check it to avoid above fault during the
working period.
⚫ During infusion, please periodically check the dripping state of the fluid and the fluid/drug in the
intravenous infusion bag/container, so as to ensure the correct working during infusion. This equipment
doesn’t directly measure the quantity of infusion fluid, therefore, it is possible that this equipment can’t
detect the free infusion flow under the extremely special condition. Even the drop sensor is adopted, it is
possible that this equipment can’t detect the free infusion flow which is less than the specific value for the
demands of tolerance.
⚫ This equipment has the occlusion detection function for detecting and alarming when the infusion needle
deviates the position in the vein or the needle is not correctly punctured in the vein. However, it only
alarms when the occlusion pressure has reached certain numerical value, and the puncturing part may
possibly have become reddish, swelling or bleeding, additionally, it is possible that the device doesn’t
alarm for a long period if the actual occlusion pressure is lower than the alarm threshold value, therefore,
please periodically check the puncturing part. If there’s any abnormal phenomenon for the puncturing part,
5
 please timely take suitable measures, such as puncturing again.
⚫ Only those infusion apparatus, line, infusion needle and other medical components that meet the local
laws and regulations and the requirements covered in and this User Manual can be adopted, it is
suggested to adopt the infusion apparatus with same brand as this equipment. It can’t ensure the infusion
accuracy if the unsuitable infusion line is adopted.
⚫ It is not allowed to disassemble or refit this equipment or use it for other purposes except normal infusion.
⚫ No one is allowed to repair this equipment except our company or the authorized repair technician of our
company.
⚫ To avoid risk of electric shock,this equipment must only be connected to AC with Ground Protection.

1.2 Cautions

⚫ Before its first use after purchase, or this equipment is not used for a long period, please charge the
equipment with AC power supply. If it is not fully charged, under power failure, the equipment can’t
continue working with built-in battery power supply.
⚫ This equipment can not be used in the places with radiological installation or magnetic resonance
equipment as well as the places with high pressure oxygen therapy.
⚫ Other devices near this equipment must meet corresponding EMC requirements, otherwise, it may
influence the performance of this equipment.
⚫ Under general conditions, please use AC power supply as much as possible since it can prolong the
service life of the battery at a certain degree. When using AC power supply, ensure that the grounding
wire is reliably connected with the ground, and only the AC power wire attached with this equipment
shall be adopted. The built-in battery can only be used as the assistant power supply when the AC
power supply can’t reliably connected with the ground and is not under normal conditions (power
failure or moving infusion).
⚫ Before connecting this equipment with power supply, please keep the power socket and plug dry, and
the power voltage and frequency meet the requirements listed in the equipment label or this User
Manual.
⚫ The equipment is equipped with the audible and visual alarm system, and the red and yellow alarm
indicators will light on by turn to check if the alarm system can work normally, and the speaker makes
the “beep” sound.
⚫ Please keep the equipment away from the AC power socket for a certain distance to avoid fluid/drug
splashing or dropping in the socket, otherwise, it may possibly cause short circuit.
⚫ Please use the fluid/drug after it has reached or nearly reached room temperature. When the fluid/drug
is used at low temperature, the air which is dissolved in the fluid/drug may cause more air bubbles and
result in frequent air bubble alarm.
⚫ It is not allowed to press and operate the button with sharp object (such as pencil tip and nail),
otherwise, it may possibly cause early damage to button or surface film.
⚫ Please do not use the infusion tube for 8h at the same pumping position. Infusion tube may distort after
using for a long time and cause flow rate error. It is suggested to replace the pumping position or
directly replace the infusion tube every 8h.
⚫ Please tightly close the flow rate adjuster of the infusion apparatus before taking out the infusion
apparatus to avoid liquid leakage.
⚫ Under the condition of low flow rate infusion, please pay special attention on occlusion. The lower the
infusion flow rate, the longer the time of detecting occlusion, and it in turn may possibly cause a long
time infusion stop during this period.

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⚫ If the equipment suffered from dropping or impacting, please immediately stop using it, and contact
our after sale service department, because the inside components of the equipment may be possibly
damaged even the appearance is not damaged and abnormality is not occurred when working.

1.3 Dialogue window

Dialogue window mainly content include operation select, operation confirm etc. tips information. For
instance
(Drawing1.3-1: Operation select window) (Drawing1.3-2: Operation confirm window)

1.4 Symbols
Not all of the below symbols are existed in the equipment you have purchased.
Table 1.4-1
Marks Description Marks Description

Batch code Protective earth (ground)

Drip Proof(Degree of protection

Serial number IP24
against ingress of fluids)

Caution Alternating current

Defibrillation-proof type CF
Handle with harmless method
applied Part

Date of Manufacture Manufacturer

environment-friendly use Non-ionizing electromagnetic

period (20 a) radiation
Authorized Representative in Refer to instruction manual
the European Community /booklet

Unlock Lock

Input / output Input

This side up Fragile items

Keep dry Stacking level limit

CE-mark/Notified Body

7
 Chapter2 Overview
2.1 Application Scope

2.1.1 Expected Purpose

The infusion pump is used together with infusion set to control the dose of liquid infused into patient’s
body, for example intravenous infusion.

2.1.2 Expected Working Environment

The infusion pump is expected to be used in institutes or units with healthcare capability. Including but
not limited to: outpatient department, emergency department, General wards, ICU (intensive care unit),
NICU (neonate intensive care unit), operating room, observation room, clinics and nursing home.

2.1.3 Suitable object

Adult, child or neonate.

2.2 Contraindications
No.

2.3 Working Principle

This equipment is a kind of instrument which can drive the pump to extrude the infusion tube for
accurately control of the infusion drops or infusion flow rate with the motor, and is capable of
guaranteeing to convey drug fluid safely in the vein of patient with even rate and accurate dosage.

2.4 Structure and Performance

2.4.1 Structure and Performance

The infusion pump mainly composes of the main unit and built-in battery, and can be installed with the
drop sensor. Double CPU has been adopted to our pump to ensure infusion safety. This equipment
provides several infusion modes, such as ml/h mode, body weight mode, drip mode, loading dose mode,
sequence mode, ramp up/down mode and relay mode. Additionally, it also has functions such as history
records, drug library, Anti-bolus, and alarm and so on.

2.4.2 Accessories
Pole clamp , Power wire , Handle , Drop sensor (optional)

2.4.3 Description on Model

This equipment main function is shown in table below.
Function /Model AIP-1200V

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 ml/h mode √
Body -weight mode √
Drip mode √
Loading -dose mode √
Infusion mode
Ramp up/down mode √
Sequence mode √
Drug Library mode √
Relay mode √
Drug name display √
Drug Library Drug dose upper and lower limit √
Drug names 2000
IrDA Optional
IrDA and workstation communication Optional
WIFI module Optional
Occlusion alarm level 12 levels

This User Manual describes the most configuration and most complete functions, due to model
difference or optional components, not all functions are equipped in the product you purchased.

2.5 Product Specification

Safety Classification
Electric protection Type Class I
Electric protection Level Defibrillation proof type CF applied Part
Protection against fluid
IP24
ingress
Working mode Continuous operation
Classification Portable equipment, non-portable infusion pump
Specification Parameters
Infusion apparatus
10-60 drips/ml
specification
≥1ml/h，±5%
System Accuracy
<1ml/h，accuracy ±5% or ±0.005ml/h choosing the higher value
10-20 drips/ml specification infusion apparatus: 0.01-2000ml/h
Infusion Rate 21-40 drips/ml specification infusion apparatus: 0.01-800ml/h
41-60 drips/ml specification infusion apparatus: 0.01-400ml/h
10-20 drips/ml specification infusion apparatus: 0.1-2000ml/h
Bolus Rate 21-40 drips/ml specification infusion apparatus: 0.1-800ml/h
41-60 drips/ml specification infusion apparatus: 0.1-400ml/h
10-20 drips/ml specification infusion apparatus: 2000ml/h
Purge rate
21-40 drips/ml specification infusion apparatus: 800ml/h
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 41-60 drips/ml specification infusion apparatus: 400ml/h
KVO Rate 0.01-5.00ml/h
Micro mode setting range 100-1200ml/h
Minimum flow rate
0.01ml/h
increment
Bolus Volume Minimum 0.1ml, max 50ml
VTBI 0-9999ml, minimum step is 0.01ml
Total Volume Infused 0.01-9999.99ml, minimum step is 0.01ml
Time Range 1min-99hrs59min
Upstream occlusion range -100Kpa to -30Kpa
Fuse Type T2AL 250V
Dimensions 233.5(W)*99(D)*120(H) mm
Weight 1.8kg
Power Supply
AC power supply 100-240V 50/60Hz
Input power 50VA
DC power supply DC15V
Model: DC 203
Specification: 11.1V 2600mAh
Charging time: 5h (under OFF status)
Battery Specifications
Working time: ≥9h (after completely charging the new battery, when the
environment temperature is 25℃ and flow rate is 25ml/h, the constantly
working time)
Alarm
When the sound is set at lowest level, alarm signal sound pressure level
Alarm signal sound ≥50dB(A)
pressure level When the sound is set at highest level, alarm signal sound pressure level
≤80dB(A)
VTBI near end, VTBI infused, Pressure high, Check upstream, Battery
nearly empty, Battery empty, No battery inserted, No power supply,
Reminder alarm, Standby time expired, KVO finished, Drop sensor
Alarm information
connection, Drop error, Air bubble, Door Open Check IV Set installation,
Drop in pressure, Drug dose limits exceeded, system error, Cumulative
Bubble
Environment
Do not use it in the environment with inflammable anesthetic gas mixed
Non AP/APG type
with air, and inflammable anesthetic gas mixed with oxygen or nitrous
equipment
oxide
(1) temperature: 5-40℃
Operating
(2) humidity: 15-95%, non-condensable

10
 (3) atmospheric pressure: 57-106kPa
(1) temperature: -20-60℃
Transport & Storage (2) humidity: 10-95%, non-condensable
(3) atmospheric pressure: 50-106kPa
Safety Standard

IEC 60601-1:2005+A1:2012
Medical electrical equipment-Part 1: General requirements for basic safety and
essential performance
IEC 60601-1-2 :2014
Medical electrical equipment - Part 1-2: General requirements for basic safety
and essential performance - Collateral standard: Electromagnetic disturbances-
Requirements And Tests
IEC 60601-1-6 :2010 （BS EN 60601-1-6:2010+A1:2015）
Medical electrical equipment - Part 1-6: General requirements for basic safety
Main Safety Standards
and essential performance - Collateral standard: Usability
IEC 60601-1-8：2006+A1:2012
Medical electrical equipment –Part 1-8: General requirements for basic safety
and essential performance –Collateral Standard: General requirements, tests
and guidance for alarm systems in medical electrical equipment and medical
electrical systems
IEC 60601-2-24: 2012
Medical electrical equipment –Part 2-24: Particular requirements for the basic
safety and essential performance of infusion pumps and controllers

11
 Chapter3 Appearance
3.1 Front View

① Tubing guide

② Pump door

③⑥⑧ Pressure Plate

④ Door holder

⑤ Pressure sensor-UPSTREAM

⑦ Pump tablets

⑨ Pressure sensor-DOWNSTREAM

⑩ Anti-free flow clamp

⑪ Anti-free flow clamp button (for controlling the anti-free flow clamp)

⑫ Air–in-line sensor

⑬ Line clamp

12
3.2 Operation Panel

①【Door open】

②【Stop】

Stop infusion and operation

③【Start】

After setting all parameters, press start to begin infusion.

④ Alarm indicator

While pump alarms, indicator light glitters, with different frequency and color, more information

please refer to Chapter 9.1

⑤ 4.3 inches TFT(LCD) touch screen

⑥【Menu】

Enter system home page.

⑦【Bolus/Purge】

⑧【Power】

Pump power switch, press and hold , pump power off. Stand-by selection button.

⑨ AC indicator

When connecting with AC power supply, AC indicator lights on.

13
3.3 Display Screen
The display screen interface layout composes of title bar and typical interface.

3.3.1 Title Bar

Title bar displays real-time state information and is not touchable, the left upper corner displays the
name of current editing parameter.
Table3.3.1-1: Title Bar Icon
Icon Paraphrase Description
Infusion apparatus
Infusion apparatus indication icon
indication icon
It displays only the equipment has accessed the EN-D7 Smart
Workstation access
infusion workstation correctly, please refer to “infusion
icon
workstation User Manual” for details
Lock screen
Unlock state icon is
indication icon
WIFI indication icon Indicate WIFI connection state.
Display the pressure change of the current infusion line at real
time.
Pressure indication
When the infusion line pressure changes, the pointer turns
icon
clockwise, when the line pressure reaches or exceeds the set
occlusion level default pressure value, it alarms for occlusion.
Battery charging
Display the current battery charging state
indication icon
The percentage numerical or remaining time value at the left
side of the icon displays the remained battery.
Battery status
Since the remained battery may change, it may possibly show
indication icon
the following states:

3.3.2 Typical Interface

During pre-infusion and infusion, the typical interface will display the following: main interface,
working interface, alarm interface, prompt interface, control panel, parameters setting, input method,
standby interface etc.

3.3.2.1 Typical Interface Icon Paraphrase

14
 Table3.3.2.1-1
Icon Paraphrase Description

Start Click this icon, start infusion

Stop Click this icon, stop infusion

1. During infusion, it is『Bolus』function, click it to start fast
infusion
Bolus/Purge Button
2. Before infusion starting, it is『Purge』function, click it to exhaust
air from the infusion line

Menu Click this icon, return to the main interface

X/Y Page indication Arabic numerals mean, X is the current page, Y is the total page

Up Click this icon, return to the back page

Down Click this icon to enter into the next page

Return Click this icon, return to the back menu

In the infusion parameters setting interface, click this icon to turn

Left
to the left page
In the infusion parameters setting interface, click this icon to turn
Right
to the right page
Single selection box-1 Mean that this parameter is selected

ON Mean this function is ON

OFF Mean this function is OFF.

3.3.2.2 Input Method Interface

The input method interface composes of the title bar, input box, editing box.
1) Title bar: display the name of current editing parameter.
2) Input box: real-time display the input content.
3) Editing box: It composes of the main button area and function button area.
The main button area composes of the numerical value, letters and icons, click it continuously to
change the sequence.
The function button area composes of clear button, backspace button,『 』,『 』and『Shift』.

15
Icon Paraphrase Description

Clear button Click it to clear input

Backspace button Click it to backspace delete

Shift Shift button Click it to switch the capital and lowercase English letters

Cancel button Click it to cancel editing and exit

Enter button Click it to save the input and exit

16
3.4 Rear View

① Line clamp

Keep the IV line neat

② A/C Adapter Port

External 100-240V 50/60Hz AC power supply

③ Pole Clamp

Using for fixing the equipment on the infusion stand

④ IrDA

Using for communicating with EN-D7 Smart workstation(Optional)

⑤ USB Port

Port for software upgrade

⑥ USB Port for drop sensor

Only supporting external drop sensor made by our company

⑦ Loudspeaker

⑧ Battery Compartment

Built-in lithium-ion battery

17
3.5 Drop sensor (optional)

① Housing

② Slider

Push the slider to left direction to adjust the spacing, loosen the slider to automatically return

③ Cable

Connect to the equipment drop sensor port

④ Plug

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 Chapter4 Installation
4.1 Unpacking and Checking
1) Please check the appearance before unpacking, if broken, please contact the transportation
company or our after-sale service department quickly.
2) Please carefully open the package to avoid damaging the equipment and relevant accessories.
3) After unpacking, please check the objects according to the packing list, if there’re insufficient or
damaged accessories, please contact our company as soon as possible.
4) Please keep relevant accessories, User Manual.
5) Please keep the packing case and packing materials for future transportation or storage.

Warning: Please put the packing materials out of reach of children. Please obey local laws and
regulations or the hospital waste treatment system to handle the packing materials.

4.2 Installation
Warning:

⚫ This equipment shall be installed by the designated technicians of our company.

⚫ All devices that connect with this equipment must pass the designated IEC standards (for
example: IEC 60950 information technology equipment safety and IEC 60601-1 medical electric
device safety) certification, and all devices must be connected according to the valid version of
IEC 60601-1 system. The technician who takes charge of connecting to additional devices with
the equipment interface is responsible for meeting the IEC 60601-1 standard. Please contact our
company if you have any enquiry.
⚫ When connecting this equipment with other electric devices to form the combination with special
function, if the combination can’t be confirmed dangerous or not, please contact our company or
the electric expert of hospital to ensure that the necessary safety of all devices in the combination
won’t be destroyed.
⚫ This equipment must be used and stored in the environment regulated by our company.

4.2.1 Install the Infusion Pump

(1) Rotate the pole clamp screw(knob) and unscrew to leave the space.
(2) Lock the Pole Clamp on the infusion stand, adjust the position of the infusion pump, tighten the
pole clamp to fix the infusion pump on the infusion stand (shown in drawing below). Hold the
infusion pump when tightening the fixing clamp; loose it after tightening to avoid falling.
(3) The pole clamp supports the vertical pole at default state. To adjust the pole clamp direction,
please remove the bolt from the pole clamp screwdriver, take out the pole clamp and adjust the
direction, then tighten the bolt.

19
4.2.2 Install the Drop sensor
(1) Insert the drop sensor plug into the drop

sensor port of this equipment and ensure tight

connection.

(2) Drop start should be above the line①.

(3) Liquid level should be below the line②.

Warning:
● The fluid/drug volume in the murphy’s dropper must be
less than 1/3 of its volume.

● The drop sensor shall be vertical.

20
 Chapter5 Use Preparation and Cautions
5.1 Use Preparation
The new equipment, or reusing after storing for a period, or reusing after repair, please check it to
ensure before use:

⚫ The equipment appearance is clean and under good condition without crack and leakage.

⚫ The moving components are smooth and effective, for example: the pump door can be opened
and closed smoothly, the button is effective.

⚫ The touch screen can be operated smoothly and effectively.

⚫ The power wire is installed tightly and won’t be easily damaged when pulling.

⚫ Set and check the system time to ensure that the history records will be correctly recorded.

⚫ In case only built-in battery is adopted for supplying power, please charge it to full before using,
and ensure that the battery keeps at the effective working conditions.

⚫ Carefully read the Warnings, Cautions and Operation Steps listed in this User Manual.

5.2 Operation Cautions

Cautions:

⚫ Avoid direct sunlight, high temperature or high humidity.

⚫ The equipment shall be put at the position less than 1.2m to the heart of the patient.

⚫ The parameters can only be set or changed by the trained and professional personnel.

⚫ Avoid the equipment working with fault so as to avoid medical negligence, which may hurt the
health and even life of the patient.

⚫ It may possibly drop the infusion accuracy or abnormal work of the equipment if the working
environment temperature exceeds the designated range.

⚫ The viscosity and specific gravity of infusion fluid will influence the infusion accuracy.

21
 Chapter6 Basic Operation
6.1 Operation Flow
¤Mount the infusion pump on the IV stand

¤Power on

¤Install IV Set

¤Select infusion tube brand or add new brand

¤Select infusion mode

¤Set Infusion Parameters

¤Remove air bubble from the line

¤Connect the infusion line with the patient

¤Start infusion

¤Infusion finish

¤Remove the IV Set

¤Power off or Standby

6.2 Infusion Operation

6.2.1 Equipment Installation
Mounting the device on the infusion stand according to Chapter 4.2, connect with AC power supply，
check the AC indicator lights.

6.2.2 Starting and Self-test

1) Press , power on the equipment.
2) After power on, the system will automatically check the motor, sensor, battery, memorizer, CPU
communication, alarm indicator.
3) After passing self-test, pump enters into ml/h mode interface.

Warning: ● If self-test failed, pump cannot operate properly or damaged, it cannot used for
patient infusion, please contact the company actively.

6.2.3 Infusion Apparatus Installation

1) Connect the IV line with the infusion bottle.
2) Extrude the drip chamber, when the fluid has reached 1/2 position of the drip chamber, open
the roller clamp.
3) Fill fluid/drug to the injection needle to remove air, then close the roller clamp.
4) Click the door open button to open the door of pump.
5) Click the anti-free flow clamp button to open the anti-free flow clamp, install the infusion tube in

22
 the infusion tube slot according to Drawing below, press the middle line of the pump inwards to
make it attach the peristaltic pump. Ensure that items 1-6 shown in Drawing below are correctly
installed.

6) Click the anti-free flow clamp button, the anti-free flow clamp tightens the infusion tube.
7) Manually push the pump door to suitable position, the pump door automatically closes.
8) Click 『Settings』→ 『Commonly used tube brand』, select infusion apparatus brand.

Warning: ● It is suggested to use the infusion apparatus of the brand attached with this system.

● Please confirm that the infusion apparatus brand and specification displayed in the display screen is
accordant with the actual one.
● Although this equipment supports user-defined infusion apparatus function, in order to ensure the
infusion accuracy, the user is strongly suggested to contact our company, and ask the professional
technician of our company to set and test the user-defined infusion apparatus.
9) Install Drop sensor
Please install it according to Chapter 4.2.2. After installing, click 『Settings』→ 『Drop sensor』to
activate the drop sensor function.

Caution ● The default state of drop sensor function is OFF, this function can be manually
activated by the user when the drop sensor is adopted.

6.2.4 Set Infusion Parameters

Enter the 『modes』 interface, select infusion mode, then set infusion parameters.

6.2.5 Purge Air

Under the parameters setting interface, Press 【Bolus】button and hold on, Or touch the screen purge
icon ,eliminate the air bubble in the line .
The purge total volume is not calculated in the Total Volume Infused.

Cautions:

● Before purge air, pls. confirm the infusion line is not connected with the patient.
● Purge rate is the max rate of the syringe size, when purge volume ≥5ml, purge will automatically
stop.

6.2.6 Start Infusion

Connect IV tube with patient, confirm infusion parameters, Press【Start】button, or touch screen
『start』 icon ,start infusion.

23
6.2.7 Changing infusing parameters during infusion
Under running interface, click the currently rate number enter parameters setting interface, reset target
infusion rate.

Note: ●Only the ml/h mode, drip mode and Body weight mode support rate modification
function
Under running interface, click Menu to enter parameter setting interface, change VTBI, Time, and
Reset total volume during infusion.

Note: ●Only the ml/h mode support VTBI, Time, and Reset total volume during infusion.

6.2.8 Bolus Application

In operation, Bolus functions have two operation modes: Manual bolus and Automatic bolus.
(1) Manual bolus: press and hold the【Bolus】button, pump will work at bolus rate. release the button,
pump will back to the previous setting infusion rate.
(2) Automatic bolus: Under the running interface, click『Bolus』 , set two parameters among bolus
infusion volume, rate and time, click『Start』. After bolus infusion finished, the equipment back to the
previous setting rate.
A beep sound can be heard in every 1ml infusion under bolus status.

6.2.9 Infusion Completion

When infusion near completion, pump will alarm. If ignore it, the system will keep alarming until
finishing infusion.
After VTBI completed, it activates VTBI infused alarm, if KVO function is ON, the equipment
automatically starts KVO function, click 『OK』in the alarm interface to stop KVO and eliminate
alarm.
The default working time of the KVO system is 30min, after reaching the time, it will activate KVO
completion alarm and stop infusion.
Please refer Chapter 8.1.2 to set KVO rate.

6.2.10 Stop Infusion

During infusion or after infusion, click , infusion stop. The interface display Total Volume Infused
and adjustable parameters.

6.2.11 Remove the Infusion Apparatus

Disconnect the infusion tube assembly from the patient, click to open the pump door, click the
anti-free flow clamp button to open the anti-free flow clamp, and remove the infusion apparatus.

6.2.12 Power OFF or Standby

Method 1: hold the 【Power】Button till the screen is OFF, the equipment is OFF.
Method 2: press the 【Power】Button to enter into OFF interface.
(1) Turn off the equipment: click 『Power off』icon, the equipment is turned OFF.

24
(2) Standby: click 『Standby』icon to enter into standby time setting interface, set the standby time.
Standby time range: 1min - 99hrs59min
Under standby state, the screen brightness will be lowest, after standby, the screen brightness will be
recovered.
(3) Cancel: click『Cancel』, return to the interface before OFF setting.
(4) If no operation, the device will enter standby interface automatically.

Note:

● The equipment has standby function only under the non-working state.
● Before turning off the equipment, please confirm that the pump door is closed, otherwise, the pump
door can’t be closed after turning off the equipment.

6.2.13 Replace Infusion Line/Infusion Container

★ Please replace the infusion tube assembly according to the following steps:
- Close the flow rate adjuster of the infusion tube assembly, open the infusion pump door, and then
remove the infusion tube assembly.
- According to the manual Chapter 6.2.3, prefill and install the new infusion tube assembly.
- Operate to restart infusion according to the above infusion steps if needed.
★ Please replace the fluid/drug container according to the following steps:
- Close the flow rate adjuster of the infusion tube assembly, open the infusion pump door, and remove
the infusion tube assembly.
- Remove the fluid/drug container from the infusion tube assembly.
- Connect the infusion tube with the new fluid/drug container.
- Restart infusion according to the above steps of replacing infusion tube assembly.

Warning: ● The infusion tube will distort if it worked for a long period and may result in flow
rate error, it is suggested to replace the pump pressing position or infusion tube assembly after
working for 8h.

25
 Chapter7 Set Infusion Parameters
7.1 Introduction to Infusion Parameters Setting
(1) The drug information can be displayed in the infusion running interface only when the drug library
is under active state.
Click『Settings』 icon in the main interface to enter submenu, find 『Drug Library』 menu item, click
to enter and select drug(『None』indicate the drug library is off). Please refer to this User Manual
Chapter 8.1.1 for details.
(2) For both the rate set in infusion parameter and the rate calculated by the system, the range is the
system default flow rate of the current working infusion apparatus specification.
(3) If didn’t set VTBI (Volume to be infused), the infusion pump will work to complete the fluid/drug
in the infusion container.

7.2 Infusion Parameters Setting Range

Infusion
Infusion Parameter Parameter Range
Mode
VTBI 0.01-9999ml
10-20 drips/ml specification infusion apparatus:
0.01-2000ml/h
21-40 drips/ml specification infusion apparatus:
ml /h mode Rate
0.01-800ml/h
41-60 drips/ml specification infusion apparatus:
0.01-400ml/h
Time 1min-99hrs59min
Weight(Body weight) 0.1-300kg
Acti agentia(Drug
0.01-99999
mass)
Conc.unit(Concentrati ng/ml, ug/ml, mg/ml, g/ml, U/ml, kU/ml, IU/ml,
on unit) IE/ml, mmol/ml, mol/ml, kcal/ml
Volume(Fluid amount) 0.01-9999ml
Dose rate 0.01-9999
Body weight ng/min, ug/min, mg/min, g/min, U/min, KU/min,
mode IU/min, IE/min, mmol/min, mol/min, kcal/min, ng/h,
ug/h, mg/h, g/h, U/h, KU/h, IU/h, IE/h, mmol/h,
mol/h, kcal/h, ng/kg/min, ug/kg/min, mg/kg/min,
Dose unit g/kg/min, U/kg/min, KU/kg/min, IU/kg/min,
IE/kg/min, mmol/kg/min, mol/kg/min, kcal/kg/min,
ng/kg/h, ug/kg/h, mg/kg/h, g/kg/h, U/kg/h,
KU/kg/h,IU/kg/h,IE/kg/h,mmol/kg/h, mol/kg/h,
kcal/kg/h
VTBI The same as ml/h mode
Drip mode
Drop rate 1-666 drops/min
Loading dose VTBI The same as ml/h mode

26
 mode Maintain rate
Loading rate
Loading time
VTBI
Ramp
Rate
up/down The same as ml/h mode
Rise time
mode
Fall time
Sequence Rate
The same as ml/h mode
mode Time
Weight
Drug library Concentration
The same as body weight mode
mode Dose rate
VTBI

7.3 Infusion Mode Setting

After starting the equipment and self-test, the equipment automatically enters into the ml/h mode
parameters setting interface, to select other mode, click 『Menu』icon to enter into the main interface,
click『Modes』icon to enter into the mode selection menu interface, and select preset infusion mode.

7.3.1 ml/h Mode

Under this mode, it allows to set three parameters: Rate, VTBI (Volume to be infused) and Time, set
any two of the three parameters, and the system will automatically calculate the third parameter, if the
VTBI is 0, then the equipment works at the set rate till stop with alarm.

7.3.2 Body- weight Mode

Under this mode, set the Weight(body weight), Acti agentia(drug mass), Conc.unit(concentration unit),
Volume(fluid volume), Dose rate, Dose unit, VTBI.
The system will automatically calculate the flow rate from the specified dose rate (ug/kg/min,
mg/kg/min, ug/kg/h, mg/kg/h,…etc) according to related formula {dose rate × weight}/{Acti
agentia(drug mass)/Volume(fluid volume)}, and automatically calculate the time according to (VTBI)
/(flow rate).
Exmaple: the dose rate unit(ug/kg/min)
Dose rate(ug / kg / min)  Weight(kg)  Volume(ml )
flow rate (ml/h)=  60
Acti agentia(mg) 1000

Exmaple: the dose rate unit(mg/kg/h)

Dose rate(mg / kg / h)  Weight(kg)  Volume(ml )
flow rate (ml/h)=
Acti agentia(mg)

7.3.3 Drip Mode

Under this mode, set the VTBI and drop rate, and the system will automatically calculate the infusion
flow rate and time.

27
 Note: ● The flow rate under drip mode is calculated according to the specification of the current
infusion apparatus, before adopting the drip mode, please confirm that the specification of the current
infusion apparatus is accordant with the specification displayed in the interface title bar display, if it is
not accordant, please contact the equipment maintenance technician to modify, otherwise, it may
cause serious deviation of flow rate.

7.3.4 Loading- dose Mode

The Loading- dose mode means to infusion with the Loading flow rate according to the Loading time,
after reaching the Loading time, it works at the Maintain rate till complete the VTBI(Volume to be
infused).

Loading dose VTBI =Loading rate ×Loading time

Maintain time = (VTBI -Loading VTBI) /Maintain rate

Under this mode, set the VTBI, Maintain rate, Loading rate, Loading time, system automatically
calculate Loading dose VTBI and Maintain time.

Note: ● VTBI must be greater than the Loading dose VTBI otherwise, when setting exceeds the
limit, the excess part can’t be set.

7.3.5 Ramp up/down Mode

Ramp up/down mode means to automatically increase the flow rate till reaching stable flow rate
within the set rise time of the equipment through setting the rise time and fall time, after holding for a
period, it automatically drops the flow rate within the set fall time. The rising or falling stage is
implemented in 9 stages.
Under this mode, set VTBI, rate in the stable stage, rise time and fall time, the system will
automatically calculate the rising and dropping rate.

7.3.6 Sequence Mode

Sequence mode means to infusion according to the set sequence after setting the rate and time of
different sequence groups. At most 5 sequence can be set in this mode.

7.3.7 Relay Mode

This function is available with the infrared communication function after combining this equipment
with EN-D7 Smart infusion workstation made by our company. Please refer to our company “infusion
workstation User Manual” for details.

7.3.8 Drug Library Mode

『None』indicate the drug library mode is turned off. Click drug names and follow the instructions to
input infusion parameters.
DERS is applicable to this mode, drug dose rate will be limited. “Drug dose limits exceeded” alarm
will be triggered if accumulated dose in certain time exceed preset dose limits.

Note: ●This device support self defined or customized drug information edit function. If required,
please contact with authorized party

28
 Chapter8 System Setting
8.1 Settings
Click『Settings』icon in the main interface to enter into parameters setting interface.

8.1.1 Drug Library

Click『Settings』icon in the main interface to enter submenu, find 『Drug Library』 menu item, click
to enter then set the ON/OFF state of drug library and select drug.

8.1.1.1 Introduction to Drug library

AIP-1200V supports over 2000 drug names, which can be imported with external tool, and has the
functions such as upper and lower limit, concentration and so on.
Select drug and then import the drug parameters, the user may change the parameters including the
concentration and dosage rate, but the parameters won’t be saved.

8.1.1.2 Setting Drug library

Click the drug name with preset. The selected drug will be displayed in the infusion mode parameter.
Select this function ON/OFF.

8.1.2 KVO Rate

Click『KVO rate』, input the numerical value, after confirming, click .
Please refer to Chapter 2.5 for the adjustable KVO range.

Note: ● KVO will be closed if KVO rate is 0ml/h.

8.1.3 Bolus Rate

Click『Bolus rate』, input the numerical value, after confirming, click .
Please refer to Chapter 2.5 for the adjustable Bolus rate range.

8.1.4 Occlusion Pressure

Click『Occlusion pressure』to enter into occlusion pressure level setting interface, move the long box
to the preset level, after confirming, click『OK』.
The higher the level, the higher the occlusion level, it is suggested to select suitable occlusion
pressure according to actual requirement.
With DPS switch on, line pressure is graphically and dynamically visible during infusing status.

Warning:

● When adopting fluid/drug of high viscosity and the occlusion pressure is set at low level, it is
possible that the system will report occlusion alarm even when the line is not obstructed, under this
condition, please carefully observe the pressure indication icon in the display screen and infusion line,
and rise the occlusion pressure if needed.
● When the occlusion pressure is set at high level, it may possibly cause the patient uncomfortable,
after rising the occlusion pressure, please carefully observe the condition of the patient, and
29
immediately take measure if there’s any abnormality.
● Under the equipment fault state, the max pressure generated by the infusion line is 160kPa. Under
single fault state, the max infusion volume is 2ml.
● If not used for intravenous infusion, for example Intra-arterial infusion, TPN (Total Parenteral
Nutrition) or EN (Enteral Nutrition) treatment, occlusion level should be adjusted to higher levels.
(Table: Relation of Occlusion level and Pressure)

Applicable Model: AIP-1200V Occlusion Pressure Level: 12 levels

Leve Pressure Intensity Pressure Intensity Pressure Intensity Pressure Intensity
l (mmHg) (Kpa) (bar) (psi)
1 150 20 0.2 2.90
2 225 30 0.3 4.35
3 300 40 0.4 5.8
4 375 50 0.5 7.25
5 450 60 0.6 8.7
6 525 70 0.7 10.15
7 600 80 0.8 11.6
8 675 90 0.9 13.05
9 750 100 1 14.5
10 825 110 1.1 15.95
11 900 120 1.2 17.4
12 975 130 1.3 18.85

When the line occlusion activates occlusion alarm, the system will automatically trigger anti-bolus
function to drop the line pressure and avoid additional impact bolus to the patient after contacting the
occlusion. Liquid leakage will be less than 0.2ml, line pressure will be less than 300mmHg.

8.1.5 DPS (Dynamic Pressure System)

With DPS switch on, line pressure is graphically and dynamically visible during infusing status.
“Drop in Pressure” alarm will be triggered while pressure in line is dropped in sudden. This can be
caused by disconnect of extension line or patient side.

8.1.6 Bubbles Size

Click『Bubbles size』to enter into air bubble size setting interface, move the long box to the preset
level, confirm and then click『OK』.
The air bubble detector has 7 levels, when the volume of single air bubble in the line reach the preset
air bubble testing alarm threshold value, it will activate air bubble alarm. It is suggested to select
suitable level according to the actual requirement.

Air Bubble detector level Alarm Threshold Value

Level 1 50μl
Level 2 100μl
Level 3 200μl
Level 4 300μl
Level 5 450μl
Level 6 600μl

30
 Level 7 800μl

8.1.7 Cumulative Bubble

Click『 Cumulative Bubble 』to enter the interface of accumulative bubble setting, input the threshold
value of accumulative alarm, and click to confirm.
The accumulated bubble detection range is 100 ~ 1000μl/15 min. When the volume of cumulative
bubbles within 15min reach the preset alarm threshold , the accumulative bubble alarm is triggered.

8.1.8 Finish Pre-Alarm

Time for pre-alarm refers to the time of activating nearing completion alarm when the fluid/drug
infused volume is nearly reaching the preset value.
Click『Finish pre-alarm』to enter into the time for pre-alarm setting interface, select ON or OFF, click
the preset time option, then the corresponding icon of this option changes into
The adjustable range of time for pre-alarm is: 2min, 5min, 10min, 15min, 20min, 30min.

8.1.9 Reminder Alarm

Click 『Reminder alarm』to enter into the time for reminder alarm setting interface, select ON or OFF,
click the preset time option, then the corresponding icon of this option changes into . The
adjustable range of time for Reminder alarm is: 2min, 5min, 10min, 15min, 20min, 30min.
Reminder alarm means that the system will activate “Reminder alarm” if no button is operated within
the preset time for “Reminder alarm” when the equipment is under no infusion no alarm state.

8.1.10 Weight Unit

Click『Weight unit』to enter into the body weight unit setting interface, click preset body weight unit
option, then the corresponding icon of this option changes into .

Note: ● The current software version only support unit kg.

8.1.11 Pressure Unit

Click『Pressure unit』to enter into pressure unit select setting interface, four units are available: mmHg,
kPa, bar, psi, click the preset unit option.

Note: ● Please carefully confirm when changing the current pressure unit.

Unit Mark Unit Conversion

kPa 1 kPa=7.5mmHg=0.145psi=0.01bar
psi 1psi=51.724mmHg=6.897kpa=0.069bar

31
 bar 1bar=750mmHg=14.5psi=100kPa

8.1.12 Micro Mode

Click『Micro mode』 to select the micro mode to be turned on and off. Under the ON mode, the
infusion rate under any infusion mode is not allowed to exceed this limit.
Micro mode speed limit setting: Click『System』→ 『Maintenance』 → enter password 2341 →
『Micro mode setting』to enter the micro mode speed limit setting interface.

Warning: Speed setting requires department head nurse authority

8.1.13 Drop Sensor

Click『Drop sensor』to set ON or OFF.
The “Drop error “ alarm function is only available only when the drop sensor is installed.

Note: ● The default state for drop sensor function system is OFF, it can be manually turned on by
the user when the drop sensor should be adopted. If the function is ON when the drop sensor is not
installed, then the system will report “drop sensor connection” alarm.

8.1.14 Drop Sensor Level

Click『Drop sensor level』to choose different levels of drop sensor sensitivity.
Three different drop sensor levels available, the higher level, the more sensitive alarm.

8.1.15 Commonly used tube brand

For the built-in infusion apparatus brand of the system, after installing the infusion apparatus, click
『Commonly used tube brand』to enter into the infusion apparatus brand selecting interface, and click
the preset brand option.
For blood infusion, a disposable blood infusion set in accordance with ISO 1135-4 is
recommended.

● The infusion apparatus of different brand may possible cause flow rate deviation, when use,
please confirm if the displayed information in the interface is accordant with the actual working
infusion apparatus.

8.1.16 Reset Total Volume

Click『Reset total volume』, the interface displays the operation confirming prompt box, click 『Yes』
to confirm reset, otherwise, please click『No』

8.2 General
In the main interface, click『General』to enter into the equipment setting interface.

8.2.1 NetWork
This equipment supports wireless or wire interconnection, when it is equipped with wireless module

and connects with the internet through WIFI, the equipment screen displays icon.

Click『NetWork』in main interface to set the response.

32
This device support HL7 protocol. It can transfer UDP data to dedicated network system visa WiFi.
Data will include device serial No., device status, alarms, VTBI, accumulated volume,
remaining time, programed rate, pressure level, real time pressure, real time rate, patient information.

Note: ● This function shall be set by the professional equipment maintenance technician.

● After activating the interconnection function, the equipment can periodically transmit the equipment
data to outside, and the data is only for displaying and doesn’t provide any suggestion on therapy.
8.2.1.1 Connection Mode
The connection mode supports WLAN and serial port modes, please select according to the actual
requirement.

8.2.1.2 Relay
Set the Relay mode switch and Relay sequence number.

8.2.1.3 WLAN
When WIFI function is in use, turn on the WLAN switch of the equipment, set the name and
password of access point, and configure the TCP/IP parameters.

Note: ● The wireless access must be set by the professional technician recognized by our
company.
● The transmitted data of this equipment doesn’t provide any suggestion on therapy, and this data
shall not be used for calculating the therapeutic schedule.
● When the data is adopted by the third party’s equipment or software, it is only for displaying, and
shall not be used for alarming or calculating.

8.2.2 Sound
Click『Sound』to enter into the sound parameters setting interface, the volume has 10 levels. The
lowest volume is ≥50dB, and the highest volume is ≤80 dB. Move the long box to the preset level,
after confirming, click『OK』.

8.2.3 Date &Time

Click『Date &Time』to enter into the date and time setting interface. It allows to set the date, time and
format in this interface.
When setting date and time, directly input the numerical value in the input method interface. For
example, to preset one date “2015-08-31”, input “20150831”; to preset the time “13: 34”, input
“1334”.
The time is displayed in 24h format or 12h format, the date is displayed in British type, American
type or Chinese type, please set according to the requirement.

8.2.4 Screen Lock

Click『Screen lock』to enter into automatic lock screen setting interface, select ON or OFF.
Automatic lock screen time can be set at 15s, 30s, 1min, 2min, 5min, 10minor 30min and so on,
which means that the equipment will automatically lock the screen if it is not touched or the button is
pressed within corresponding time after starting. If the screen or keypad is locked, no operation can
33
be conducted.
After turn on 『Screen lock』function during infusing，press【Power】key to lock or unlock the device
manually.
Unlock: press any keypad, or click the screen, a reminder of unlock will be popped out, click 『OK』.

Note: ● The equipment will automatically unlock if there’s high Level alarm.

8.2.5 Brightness
Click 『Brightness』to enter into display brightness setting interface. The brightness has 10 levels.

8.2.6 Night Mode

Click 『Night mode』 to enter into night mode switch setting interface to set the start and end time of
the night mode and the night brightness, at night, the system automatically adjusts the brightness to
the User defined value.

8.2.7 Nurse Call

Click『Nurse call』to select function ON and OFF.

Note: ● The nurse call function must be used with special cable.

● The user shall not only depend to relay on the nurse call function as the main alarm notice mode,
and shall identify according to the equipment alarm and the patient state.

8.2.8 Nurse Call Alarm Level

Click『nurse call alarm level』to select different alarm levels.

8.2.9 Battery Capacity Display

Display of battery capacity under h:m or percentage status can be switched and title bar display
changes accordingly.

8.3 Patient
Click『Patient』in the main interface to enter into setting interface.

8.3.1 Patient Information

Click『Patient』to enter into the patient information setting interface and set bed number, MRN, name,
gender, age, body weight, height.

8.3.2 Prescription
Click『Patient』to enter into the patient information setting interface and enter the end of the sub menu,
find menu item『Prescription』and enter to set the medical advice ID, medical advice information, start
time and state.

8.4 Records
8.4.1 History entries
Click 『Records』in the main interface to enter submenu, click the “History entries” menu item into
history records query interface. The equipment supports to save over 5000 history records, and can
display the event name, event date and time. When it is full, the new records will cover the old
34
records by turn.

8.4.2 Last therapies

Click 『Records』in the main interface to enter submenu, click the “Last therapies” menu item into
medical records query interface.
(1) This interface displays the latest 20 medical records, user may directly select it as the current
infusion plan, after confirming the parameters, then start infusion.
(2) The system can save 20 medical records at most, when it is full, the new records will cover the old
records by turn.

8.4.3 Export history records

Log on the PC tool to connect this equipment with PC;
After the equipment has achieved communication with PC, the PC can automatically read the data in
this equipment;
Create the history record folder in the PC to export the data to the folder.

Note: ● Please do not export data when the equipment is working.

8.4.3.1 The tool ‘Tool’ running environment

32bit or 64bit WIN7 and below WIN7, and now WIN10 system is not supported.

8.4.3.2 Tool installation instructions.

Click ‘setup’, and run the file, then click ‘Next’ and ‘Install’ in order.

Finally, click ‘Finish’. Here, ‘tool’ is installed successfully.

35
8.4.3.3 Export historical data
（1）Power on infusion pump, then click 【Menu】, then enter this directory, 『Menu』->『Record』
->『Export history records』.
（2）Now infusion pump will display “Connect data line”，user need connect infusion pump to PC
with TYPE-C data line. And infusion pump will display “Data cable is connected” after connection
success.
（3）Open PC tool “Tool”，COM position will display green COM port number, and SN position will
display SN number. The result indicates that the serial port is opened successfully, and the historical
data can be exported.

36
（4） Export data, click software UI『query』 read the pump’s historical data, the infusion pump
button，
UI will display “Send Completed”.

（5）Data save，click software UI 『Save』button，we can save the historical data as excel file.

（6）Device exit historical export UI. After the data export, click the device button 『Clear』to exit the
historical data export UI, the system will release the serial port, and we can connect the next infusion
pump to export the historical data.

37
8.5 System
Click『System』under the menu interface, enter the system information setting interface

8.5.1 Language
This equipment supports simplified Chinese, English, Spanish etc. Click『Language』to change device
language.

8.5.2 SN(Serial Number)

Check the serial number of the equipment, and user can’t modify the serial number.

8.5.3 Version
Check the software version in this interface.

8.6 Electronic Memory Function

After turning off the equipment, the electronic memory function can be saved for 10 years at least.
When the power failure time is ≤30s, the alarm setting before power failure will be automatically
recovered.

38
 Chapter9 Alarm Prompt and Troubleshooting
9.1 Introduction to Alarm Level
During infusion preparation and infusion, this equipment will alarm when reaching or exceeding the
set alarm threshold value and prompt with sound, light and text. According to the importance of alarm
information as well as the emergency and safety, the alarm is divided into three levels: high, middle
and low. Please refer to table below for details:
Alarm Level Sound Signal Interval Light color /flash frequency
High alarm 10s Red indicator flashes /2.0±0.6Hz
Middle alarm 15s Yellow indicator flashes / 0.6±0.2Hz
Low alarm Once, not repeated Yellow indicator lights on

If there’s alarm, the system will display the alarm interface. Click『OK』to exit the alarm interface.
Click『Mute』to mute, if alarm is not eliminated, the alarm sound will be sent out 2min later.
Warning ● Some alarm threshold values of this equipment can be set by the user, for example:
occlusion pressure, air bubble alarm, reminder alarm, VTBI infused pre-alarm, alarm sound volume
and so on, the user shall confirm the parameters when set the alarm threshold value, otherwise, it may
possibly influence the alarm function or infusion safety.

9.2 Multi-level Alarm Rules

When there’re several alarms, the system will alarm according to the following rules:
Table9.2-1
Multilevel Alarm Rules
Several alarms of different Display the alarms of highest level with sound, light and text,
levels generate simultaneously report middle alarm after eliminating all alarms of highest level
Several alarms of same level
Alarm circularly by turns, the time interval is 3s
generate simultaneously

9.3 Alarm Handle

Warning ● When there’s alarm, please check the conditions of the patient, remove the reason of
alarm and then continue working.
Please refer to Appendix C for the alarm solution.

9.4 Malfunction Analysis and Solution

When there’s malfunction, the infusion pump screen will display the malfunction alarm information,
this item is the alarm of high level. Please eliminate the malfunction alarm according to the prompt. If
it can’t be eliminated, please stop the equipment, contact our company to repair and test the
equipment, do not put it into operation before the equipment has passed the inspection, otherwise, it
may possibly cause unpredictable harm if it works with malfunction.

If the equipment is on fire/burns for unknown reason, or has other abnormal conditions, the user shall
immediately cut off power supply and contact our customer service department.

⚫ Under single fault state, the max infusion volume is 2ml.

39
 Chapter10 Maintenance
10.1 Cleaning, disinfecting and sterilizing
Warning

● Please cut off power supply and unplug the DC /AC power wire before cleaning the equipment.
● During cleaning and disinfecting, please keep the equipment horizontal and upwards to protect the
equipment and accessories from fluid.

10.1.1 Cleaning
(1) The daily maintenance is mainly to clean the housing and pump body. It is inevitable that
fluid/drug may flow in the equipment during infusion. Some fluid drug may corrode the pump
and cause working fault. After infusion, please timely clean the equipment, wipe it with moist
and clean soft fabric, and then naturally dry it.
(2) When cleaning the equipment interface, please wipe it with dry and soft fabric, confirm the
interface is dry before using.
(3) Please do not soak the equipment in water. Although this equipment has certain waterproof
function, when fluid splashes on the equipment, please check if it works normally, perform
insulation and electric leakage test if needed.

10.1.2 Disinfecting
(1) Disinfecting may possibly cause harm of certain degree to the equipment, it is suggested to
disinfect the equipment if it is needed.
Please disinfect the equipment with common disinfecting agent such as 50% sodium hypochlorite,
cidex 2% glutaraldehyde + activating agent, 70% ethanol, 70% isopropyl alcohol and so on. Please
follow the instructions of the disinfecting agent.
(2) After disinfecting, wet the soft fabric with warm water, dry the fabric and then wipe the
equipment with it.
(3) Do not sterilize the equipment with high pressure steam sterilizer, do not dry the equipment with
dryer or similar product.

Warning: ● Please do not adopt Cidex OPA orthophthalaldehyde, methyl ethyl ketone or similar
solvent, otherwise, it may corrode the equipment.

10.2 Periodical maintenance

Notes: ● The medical mechanism shall set up complete maintenance plan, otherwise, it may
possibly cause the equipment malfunction or fault, and may possibly hurt the physical safety.
● In order to ensure the safe use and prolong the service life of the equipment, it is suggested to
periodically maintain and check it once every 6 months. Some items shall be maintained by the user,
and some items shall be maintained by the dealer of the equipment.

40
● Please timely contact our company if the equipment is found defective.

10.2.1 Check the Appearance

(1) The appearance of the equipment shall be clean and under good condition without crack and
water leakage.
(2) The buttons are flexible and effective without invalid phenomenon; the sensitivity of the
touch screen is normal,
(3) The infusion pump door can be smoothly opened and closed, the electric safety clamp switch
is under good condition.
(4) The power wire is under good condition and installed tightly.
(5) After connecting with external power supply, check if the AC indicator of the equipment AC
indicator lights on normally.
(6) Adopt the accessories designated by our company.
(7) The environment meets the requirements.

10.2.2 Performance Check

Self-test and normal infusion function.
Alarm function normal
Battery performance.

10.2.3 Maintenance Plan

The following check/maintenance items must be performed by the professional technician recognized
by our company. If the following maintenances are necessary, please contact our company. Please
clean and disinfect the equipment before testing or maintaining.
Maintenance Items Cycle
Once every 2 years, please check after replacing the
Safety check according to IEC
printed circuit board assembly or the equipment is
60601-1
dropped or knocked.
Preventive system maintenance Once every 2 years, when the occlusion alarm, air
items (pressure calibrate, sensor bubble alarm, or infusion accuracy is doubt to be
calibrate, pump) abnormal
Brand of user-defined infusion Using the equipment for the first time, infusion
apparatus, infusion accuracy apparatus brand using for the first time, reusing the
calibration equipment after stopping for a very long period.

10.3 Add new brand and Calibration

In the 『System』 submenu, click 『Brand maintenance』 to enter into brand setting interface, create
the consumables brand, delete and calibrate the brand.

Warning: ● It is suggested to contact our company or local dealer, and customize and calibrate it
by professional technician, otherwise, it can’t guarantee the infusion accuracy.

Note: ● The built-in brand of the system shall not be deleted.

41
(1) Add new brand

Note: ● If the actual using infusion apparatus brand is not listed in the system built-in brand,
please create the infusion apparatus brand in this interface.
Please follow the below steps to add a new brand:
Material preparation: Infusion pump, IV tube, measure cylinder, scale balance
1) Click『Brand』, Edit the name.

2) Press ，Page down , Click『Size』, Edit IV tube size

3) Install the IV tube.

4) Press【Bolus】to remove air bubble in the line, put the needle into the measuring cup for collecting
fluid.
5) Click『Start Calibrate』to start Calibrate
6) After 5mins, the equipment will automatically stop, then record the net weight of fluid by ml;
7) Click『Volume』, Input the net weight(ml).
8) Calibration completed.
(2) Delete
Enter into『Delete』interface, click it to delete user-defined infusion apparatus brand.
(3)Calibrate

Note

• When first time use pump need calibration

• When added new brand need calibration
• When accuracy is not good need calibration.
Please calibrate the infusion apparatus when using the built-in brand infusion apparatus for the first
time, or the first user-defined infusion apparatus brand, or after periodical maintenance.
Please prepare the following materials before calibrating:
One new and unused infusion apparatus, 20ml measuring cup or 20ml injector.
Calibrating Steps:
1) Select the brand name
2) Install the IV tube
3) Press【Bolus】to remove air bubble in the line, put the needle into the measuring cup for collecting
fluid
4) Click『Start Calibrate』to start Calibrate
5) After 5mins, the equipment will automatically stop, then record the net weight of fluid by ml;
6) Click『Volume』Input the net weight(ml).
7) Calibration completed.
42
 Note：

When the『Volume』is less than 10ml, the infusion rate is ≤1500ml / h.

When the『Volume』is less than 7.5ml, the infusion rate is ≤1000ml / h.

10.4 Repair
10.4.1 Normal Repair Process
Please contact our company or authorized service personnel to repair if there’s any fault, do not
disassemble and repair the equipment. After repair, please perform overall test for the equipment. Our
company may provide the circuit diagram and components list to the authorized repair technician if
needed.

10.4.2 Maintenance for Long Term Store

If the equipment won’t be used for a long period, please take out the battery, and pack it with the
equipment in the package, and store it in the shade, cool and dry place without direct sunlight.
The following operations are necessary for using it again:
1. Verify the flow rate accuracy to avoid unconformity between the infusion apparatus parameters in
the equipment and the actual parameters after it hasn’t be used for a long period or caused by other
reasons, otherwise, it may cause infusion error, influence the therapeutic effects and even cause
medical negligence.
2. Perform air bubble and occlusion alarm test.
3. Test the battery discharging and charging duration to confirm that the battery is also usable.

10.5 Equipment Components/Accessories

Warning: ● Only the components and accessories designated by our company shall be adopted,
otherwise, it may possibly damage the equipment or drop the equipment performance.
During the normal service life of the equipment, the battery is consumable, it is suggested to replace
them once every 2 years, please contact the dealer or our company to replace them.
Variety Name
Optional configuration Wifi module
IrDA module
Optional Accessories Drop sensor
Equipment Battery
Components Pole clamp
Power wire
Handle

10.6 Production Date

Please refer to the label of the product.

43
10.7 Recycling
The normal service life of this equipment is 10 years, and depends on the use frequency and
maintenance. The equipment must be rejected after reaching the service life, please contact the
manufacturer or the dealer to get more detailed information.
1. The obsolete equipment may be returned to the original dealer or manufacturer.
2. The used lithium-ion polymer battery has the same treatment method, or according to the
applicable laws and regulations.
3. Please handle according to the equipment rejecting flow of your medical mechanism.

44
 Chapter11 Battery
This equipment is equipped with rechargeable lithium-ion polymer battery to ensure the normal
infusion when the equipment is moved or the external power supply is cut off.

When connecting external power supply, no matter the equipment is power on or not, the battery is
charged. When charging, the equipment screen displays the battery charging indication icon . In
case only built-in battery is adopted for supplying power, and when the remained battery is less than
20%, please connect the equipment with external power supply to charge the battery.

Warning: ● Only the battery designated by our company shall be adopted.

11.1 Check the Battery Performance

The performance of the built-in battery may drop according to the using duration, it is suggested to
check the battery once a month.

(1) Disconnect the equipment from the patient, and stop all infusions.

(2) Supply public power to the equipment to charge the battery for 5h at least.

(3) Supply power to the infusion pump only with battery, infusion at the rate of 25ml/h, test the time
till the battery runs down and the equipment is turned off.

- If the infusion time exceeds 7h, the battery keeps at good status.

- If the infusion time exceeds 5h but less than 7h, the battery starts deterioration, but it can be used
temporarily.

- If the infusion time is less than 5h, the battery is reaching the service life, please replace the battery.

11.2 Replaced the Battery

It is recommended to replace the battery every 2 years, it is suggested to replace the battery by the
dealer or manufacturer.

The steps of replacing battery are shown as below:

⑴ Cut off the power supply of the equipment, disconnect the power cable. Open the cover of battery
chamber and take out the battery.

⑵ Push the new battery into the battery chamber, and insert in the battery fastener.

⑶ After replacing the battery, install the battery cover, and check the battery.

Warning: ● When replace the battery, please do not touch the 12V DC plug inside of the batter
Chamber.

45
 Chapter12 After Sale Service
This product offers 1-year free warranty after purchase. The warranty period is from the installation
date listed on the “Warranty Card”. The “Warranty Card” is the only voucher for calculating the
warranty period, in order to maintain your benefit, please carefully fill into and keep the “Warranty
Card”, and hand over the copy for the company to the installation technician.

The damages of the equipment caused by the following shall not enjoy free warranty service.

1. Fault caused by incorrect operation, unauthorized refitting or repair.

2. The damages caused by incorrect operation during the transportation process after purchase.

3. The fault and damages caused by fire, salt injury, toxic gas, earthquake, windstorm, flood,
abnormal voltage and other natural disasters.

For the damages or faults mentioned above, our company provides repair services but charge at
repair cost.

46
 Chapter13 Appendix
Appendix A Start Up Graphs and Trumpet Curves
Appendix A.1 Start-up Graphs
Brand and specification of infusion set: Jierui(20 drops)
Flow Rate: 1ml/h
Measurement Interval: ∆ t = 0.5min
Measurement duration: T = 2h

Graph 1 Start-up graph: Flow rate 1 (ml/h) against time (min) plotted from data gathered
during the first 2 h of the test period

Brand and specification of infusion set: Jierui (20 drops)

Flow Rate: 25ml/h
Measurement Interval: ∆ t = 0.5min
Measurement duration: T = 2h

Graph 2 Start-up graph: Flow rate 25 (ml/h)against time (min) plotted from data gathered
during the first 2 h of the test period

47
Appendix A.2 Trumpet Curves
Brand and specification of infusion set: Jierui (20 drops)
Flow Rate: 1ml/h
Measurement Interval: ∆ t = 0.5min
Measurement duration: T = 2h

Graph 3 Trumpet curve: Percentage variation Ep against observation window duration P (min)
and the overall mean percentage error A plotted from data gathered during the second hour of
the test period

Brand and specification of infusion set: Jierui (20 drops)

Flow Rate: 25ml/h
Measurement Interval: ∆ t = 0.5min
Measurement duration: T = 2h

Graph 4 Trumpet curve: Percentage variation Ep against observation window duration P (min)
and the overall mean percentage error A plotted from data gathered during the second hour of
the test period

48
Appendix B Occlusion Response Property

AIP-1200V Delay and Possible Dose

Occlusion
Flow Rate Max bolus
Pressure Time to occlusion alarm(min)
(ml/h) (ml)
(mmHg)
Low 150 0h6min40sec 0.008
1
High 975 0h50min27sec 0.143
Low 150 0h0min38sec 0.007
25
High 975 0h1min40sec 0.131

Notes: The alarm pressure intensity error for AIP-1200V is ±15% or ±100mmHg, the higher
value shall be taken;

Notes: ● Conditions for above testing data: infusion set brand Jierui.
● The occlusion alarm pressure, alarm delay time and bolus are influenced by the test
conditions.
● The above data is the typical value under the test conditions, please see the test data of
the product for the actual data, the data may be different if the test conditions are
different

49
Appendix C Alarm and Solution
Alarm Type Alarm Reason Solution
Level
VTBI
High The preset value infusion Completion. Press 【Stop】button to stop alarm.
infused
Manually solve the problem of
1. Line occlusion during infusion. occlusion, Press【Start】 button to
continue infusion.
2. Fluid/drug in the actual infusion line
Pressure high High Rise the alarm Level, Press【Start】
of high viscosity, while the system
button to restart infusion.
occlusion level is set too low.
Please contact the dealer or
3. The pressure sensor is damaged.
manufacturer for repair
The upper part of the line is obstructed Check if the rate regulating adjuster
Check during infusion, and in turn drops the or fluid stopping device is open at
High
upstream line pressure intensity. the upper part of the line, Press
【Stop】button to stop alarm.
When power is supplied by the built-in
Immediately connect with external
battery only, under low battery, the
Battery power supply.
High alarm duration is >30min.
empty
2. Battery aging or the equipment Please contact the dealer or
charging circuit is fault. manufacturer for repair.
KVO KVO working time reached 30min,
High Press【Stop】button to stop alarm
finished infusion pump stops working.
The angle of inclination of the drip cup Check the installation of drop sensor
is too big or drop sensor is installed or drip cup fluid level, Press【Stop】
lower than the drip cup fluid level. button to stop alarm.
Check if the infusion apparatus
Drop error High The specification of infusion apparatus
specification is accordant with
is not accordant with the specification
displayed parameters, if it is not
displayed in the interface, which
accordant, , it shall be modified by
causes drop rate error.
professional maintenance technician.

Press【Stop】button to stop alarm,

disconnect the line from the patient,
Air bubble High Air bubble in the infusion line. eliminate the air with purge function,
or open the infusion pump door to
manually remove the air bubbles.

Press the 【Stop】button to eliminate

When the bubbles in the infusion the alarm, separate the pipe from the
Cumulative
High pipeline within 15 minutes reach the patient, using the purge function to
Bubble
cumulative bubble alarm threshold remove the bubbles, or open the door
manually to remove bubbles.
During infusion, the infusion pump Close the infusion pump door to stop
Door Open High
door is opened. this alarm.
50
Alarm Type Alarm Reason Solution
Level
While using drugs in drug library to
Drug dose
infuse, alarm will be triggered if max
limits High Press 【Stop】button to stop alarm.
dose in certain time have exceeded the
exceeded
preset limits.
If system self check failed or internal Restart device to check whether
System error High fault, system error alarm will give with alarm is eliminated, if still exists,
code number. contact maintenance personnel.
During infusion, the remaining time
VTBI near This alarm can’t be eliminated, and
Middle reached or is less than the set nearing
end wait till infusion completes.
completion time.
Occlusion Line pressure close to preset occlusion Check if there is occlusion in line
Middle
pre alarm pressure level. and click OK to eliminate alarm.
pressure in line is dropped in sudden. Check extension line or patient
Drop in
Middle connection. Click OK to eliminate
pressure
alarm.
1. When power is supplied only with The alarm automatically eliminates
the built-in battery, under low battery, after connecting the external power
Battery
Middle the alarm duration is >30min supply.
nearly empty
2. Battery aging or the equipment Please contact the dealer or
charging circuit is fault. manufacturer for repair.
No battery Keep connecting with external
Middle Battery is removed.
inserted power supply, reinstall the battery.
After installing infusion tube , under
Reminder non-working or alarm state, it is not
Middle Click any button to stop.
alarm operated within the set time of the
system.

Standby time During standby, after reaching the

Middle Press【Stop】button to stop alarm.
expired standby time.
When turning on the drop sensor, the
Drop sensor Connect the drop sensor, or turn off
Low equipment is not connected with the
connection the drop sensor in the menu.
drop sensor.
Under ON state, AC power supply is The alarm automatically eliminates
No power
Low adopted, but the AC power wire is after connecting the external power
supply
dropped during the process. supply.

Notes: ● When alarm rings, click the 『Mute』icon on the screen to temporarily stop sound
alarm for 2min.

51
Appendix D EMC Electro Magnetic Compatibility declaration
This product needs special precautions regarding EMC and needs to be installed and put into service
according to the EMC information provided, and this unit can be affected by portable and mobile RF
communications equipment.

Cautions:
⚫ This unit has been thoroughly tested and inspected to assure proper performance and operation!
⚫ This machine should not be used adjacent to or stacked with other equipment and that if adjacent
or stacked use is necessary, this machine should be observed to verify normal operation in the
configuration in which it will be used.

Warnings:
The use of ACCESSORIES, transducers and cables other than those specified, with the exception of
transducers and cables sold by the MANUFACTURER of the Infusion pump as replacement parts for
internal components, may result in increased EMISSIONS or decreased IMMUNITY of the Infusion
pump.

Guidance and manufacture’s declaration – electromagnetic emission

The Infusion pump is intended for use in the electromagnetic environment specified below. The
customer or the user of the Infusion pump should assure that it is used in such an environment.

Emission s test Compliance Electromagnetic environment –

guidance

The Infusion pump uses RF energy

only for its internal function.
RF emissions Therefore, its RF emissions are very
Group 1
CISPR 11 low and are not likely to cause any
interference in nearby electronic
equipment.

RF emissions
Class A
CISPR 11 The Infusion pump is suitable for use
in all establishments, including
Harmonic emissions domestic establishments and those
Not applicable
IEC 61000-3-2 directly connected to the public
low-voltage power supply network
Voltage fluctuations/
that supplies buildings used for
flicker emissions Not applicable domestic purposes.
IEC 61000-3-3

52
 Guidance and manufacture’s declaration – electromagnetic immunity

The Infusion pump is intended for use in the electromagnetic environment specified below. The
customer or the user of the Infusion pump should assure that it is used in such an environment.

Immunity test IEC 60601 test level Compliance level Electromagnetic environment
- guidance
Electrostatic ±6 kV contact ±8 kV contact Floors should be wood, concrete
discharge (ESD) or ceramic tile. If floor are
±8 kV air ±15 kV air
covered with synthetic material,
IEC 61000-4-2
the relative humidity should be
at least 30%.

Electrical fast ±2 kV for power supply ±2kV for power Mains power quality should be
transient/burst lines supply lines that of a typical commercial or
hospital environment.
IEC 61000-4-4 +1 KV for input/output
lines

Surge ±1 kV line(s) to line(s) ±1 kV line(s) to Mains power quality should be

line(s) that of a typical commercial or
IEC 61000-4-5 +2 KV line(s)to earth
hospital environment.
+2 KV line(s)to
earth

<5% UT <5% UT
Voltage dips, Mains power quality should be
(>95% dip in UT) (>95% dip in UT)
short that of a typical commercial or
for 0.5 cycle for 0.5 cycle
interruptions and hospital environment. If the user
voltage variations 40% UT 40% UT of the Infusion pump requires
on power supply (60% dip in UT) (60% dip in UT) continued operation during
input lines for 5 cycles for 5 cycles power mains interruptions, it is
recommended that the Infusion
IEC 61000-4-11 70% UT 70% UT
pump be powered from an
(30% dip in UT) (30% dip in UT)
uninterruptible power supply or
for 25 cycles for 25 cycles
a battery.
<5% UT <5% UT
(>95% dip in UT) (>95% dip in UT)
for 5 sec for 5 sec

Power frequency Power frequency magnetic

(50Hz/60Hz) fields should be at levels
magnetic field 3 A/m 400A/m characteristic of a typical
IEC 61000-4-8 location in a typical commercial
or hospital environment.

NOTE UT is the a.c. mains voltage prior to application of the test level.

53
 Guidance and manufacture’s declaration – electromagnetic immunity

The Infusion pump is intended for use in the electromagnetic environment specified below. The
customer or the user of Infusion pump should assure that it is used in such an environment.

IEC 60601 Complia

Immunity test Electromagnetic environment - guidance
test level nce level
Portable and mobile RF communications equipment
should be used no closer to any part of the Infusion
3 Vrms pump, including cables, than the recommended
Conducted RF
150 kHz to 10 Vrms separation distance calculated from the equation
IEC 61000-4-6 applicable to the frequency of the transmitter.
80 MHz
Recommended separation distance

d = 1.167 P

d = 1.167 P 80 MHz to 800 MHz

d = 2.333 P 800 MHz to 2.5 GHz

Where P is the maximum output power rating of the
3 V/m transmitter in watts (W) according to the transmitter
Radiated RF manufacturer and d is the recommended separation
80 MHz to distance in meters (m).
IEC 61000-4-3 10 V/m
2.5 GHz Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey, a
should be less than the compliance level in each
frequency range.b
Interference may occur in the vicinity of equipment
marked with the following symbol:

NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.
a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV
broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic
environment due to fixed RF transmitters, an electromagnetic site survey should be
considered. If the measured field strength in the location in which the Infusion pump is used
exceeds the applicable RE compliance level above the 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 Infusion pump.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

54
 Recommended separation distances between
portable and mobile RF communications equipment and the Infusion pump .
The Infusion pump is intended for use in an electromagnetic environment in which radiated
RF disturbances are controlled. The customer or the user of the Infusion pump can help
prevent electromagnetic interference by maintaining a minimum distance between portable
and mobile RF communications equipment (transmitters) and the Infusion pump as
recommended below, according to the maximum output power of the communications
equipment.

Separation distance according to frequency of

transmitter (m)
Rated maximum output power of
transmitter 150 KHz to 80 80 MHz to 800 800 MHz to 2.5
MHz MHz GHz
(W)

d = 1.167 P d = 1.167 P d = 2.333 P

0.01 0.117 0.117 0.233

0.1 0.369 0.369 0.738

1 1.167 1.167 2.333

10 3.689 3.689 7.379
100 11.667 11.667 23.333
For transmitters rated at a maximum output power not listed above, the recommended
separation distance d in meters (m) can be estimated using the equation applicable to the
frequency of the transmitter, where P is the maximum output power rating of the transmitter
in watts (W) according to the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range
applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.

55
Appendix E Wireless Module Information
Parameter Name Parameter Value

Frequency Range 2.412GHz-2.482GHz

Modulating Type OFDM, CCK, DSSS

Effective Radiating Power <20dBm

56
Appendix F Factory Default Data Set
Parameters Default Setting Parameters Default Setting
KVO rate 1ml/h Sound 10%
Occlusion pressure 450mmHg Screen lock ON
Bubble size 100μl Cumulative Bubble 300μl /15 min
Finish pre-alarm 2min Brightness 100%
Reminder alarm 2min Night mode OFF
Pressure unit mmHg Nurse call OFF
Micro mode OFF Drug library None
Drop sensor OFF Relay mode OFF

57