USER MANUAL

INFUSION PUMP
(EN-V7 Smart, EN-V7)
Preface
1 Application Scope
Applicable to EN-V7/EN-V7 Smart infusion pumps of our company.

This User Manual describes the product’s most complete configuration, accessories and functions 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 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

1
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.

5 Description on Revision of User Manual

The copyright of this User Manual belongs to Shenzhen ENMIND Technology Co., Ltd. Without
permission any institute or individual are prohibited to copy, modify or translate the contents speculated in
this User Manual.

This User Manual will be revised subject to product improvement, laws updating or instructions improving
basing on the preconditions of meeting related laws and regulations, and all revised records will be stated in
the new version.

Version Revising Date Revised Content

V1.0 2015.8.21 First edition
V2.0 2017.2.8 Optimize the Menus and Icons, Updated UI English characters
V2.1 2017.5.9 Add Standby time range, Upstream occlusion range,drug library
mode. Correct description of marks
V2.2 2017.6.22 Add descriptions of DPS function, alarms

2
Content
Chapter1 Safety Instructions................................................................................................................. 7
1.1 Warnings ................................................................................................................................ 7
1.2 Cautions.................................................................................................................................. 9
1.3 Dialogue window.................................................................................................................. 11
1.4 Symbols ................................................................................................................................ 12
Chapter2 Overview .............................................................................................................................. 13
2.1 Application Scope ................................................................................................................ 13
2.1.1 Expected Purpose .................................................................................................................. 13
2.1.2 Expected Working Environment ........................................................................................... 13
2.1.3 Suitable object ....................................................................................................................... 13
2.2 Contraindications ................................................................................................................ 13
2.3 Working Principle ............................................................................................................... 13
2.4 Structure and Performance ................................................................................................ 13
2.4.1 Structure and Performance .................................................................................................... 13
2.4.2 Accessories ............................................................................................................................ 13
2.4.3 Description on Model ............................................................................................................ 14
2.5 Product Specification .......................................................................................................... 15
Chapter3 Appearance .......................................................................................................................... 17
3.1 Front View ............................................................................................................................ 17
3.2 Operation Panel ................................................................................................................... 18
3.3 Display Screen...................................................................................................................... 19
3.3.1 Title Bar ................................................................................................................................. 19
3.3.2 Typical Interface .................................................................................................................... 20
3.3.2.1 Typical Interface Icon Paraphrase ................................................................................. 20
3.3.2.2 Input Method Interface .................................................................................................. 21
3.4 Rear View ............................................................................................................................. 22
3.5 Drop sensor (optional) ......................................................................................................... 23
Chapter4 Installation ........................................................................................................................... 24
4.1 Unpacking and Checking .................................................................................................... 24
4.2 Installation ........................................................................................................................... 24
4.2.1 Install the Infusion Pump ...................................................................................................... 25
4.2.2 Install the Drop sensor ........................................................................................................... 25
Chapter5 Use Preparation and Cautions ........................................................................................... 26
5.1 Use Preparation ................................................................................................................... 26
5.2 Operation Cautions ............................................................................................................. 26
Chapter6 Basic Operation ................................................................................................................... 27
6.1 Operation Flow .................................................................................................................... 27
6.2 Infusion Operation .............................................................................................................. 28
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 6.2.1 Equipment Installation .......................................................................................................... 28
6.2.2 Starting and Self-test ............................................................................................................. 28
6.2.3 Infusion Apparatus Installation.............................................................................................. 28
6.2.4 Set Infusion Parameters ......................................................................................................... 29
6.2.5 Purge Air................................................................................................................................ 29
6.2.6 Start Infusion ......................................................................................................................... 29
6.2.7 Changing infusing parameters during infusion ..................................................................... 30
6.2.8 Bolus Application .................................................................................................................. 30
6.2.9 Infusion Completion .............................................................................................................. 30
6.2.10 Stop Infusion ......................................................................................................................... 31
6.2.11 Remove the Infusion Apparatus ............................................................................................ 31
6.2.12 Power OFF or Standby .......................................................................................................... 31
6.2.13 Replace Infusion Line/Infusion Container ............................................................................ 31
Chapter7 Set Infusion Parameters ...................................................................................................... 33
7.1 Introduction to Infusion Parameters Setting .................................................................... 33
7.2 Infusion Parameters Setting Range ................................................................................... 33
7.3 Infusion Mode Setting ......................................................................................................... 34
7.3.1 ml/h Mode ............................................................................................................................. 35
7.3.2 Body- weight Mode ............................................................................................................... 35
7.3.3 Drip Mode ............................................................................................................................. 36
7.3.4 Loading- dose Mode .............................................................................................................. 36
7.3.5 Ramp up/down Mode ............................................................................................................ 37
7.3.6 Sequence Mode ..................................................................................................................... 37
7.3.7 Relay Mode ........................................................................................................................... 38
7.3.8 Drug Library Mode ............................................................................................................... 38
Chapter8 System Setting ...................................................................................................................... 39
8.1 Settings ................................................................................................................................. 39
8.1.1 Drug Library .......................................................................................................................... 39
8.1.1.1 Introduction to Drug library .......................................................................................... 39
8.1.1.2 Setting Drug library ....................................................................................................... 39
8.1.2 KVO Rate .............................................................................................................................. 39
8.1.3 Bolus Rate ............................................................................................................................. 39
8.1.4 Occlusion Pressure ................................................................................................................ 40
8.1.5 DPS (Dynamic Pressure System) .......................................................................................... 41
8.1.6 Bubbles Size .......................................................................................................................... 41
8.1.7 Finish Pre-Alarm ................................................................................................................... 42
8.1.8 Reminder Alarm .................................................................................................................... 42
8.1.9 Weight Unit ........................................................................................................................... 42
8.1.10 Pressure Unit ......................................................................................................................... 42
8.1.11 Micro Mode ........................................................................................................................... 43
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 8.1.12 Drop Sensor ........................................................................................................................... 43
8.1.13 Drop Sensor Level ................................................................................................................. 43
8.1.14 Commonly used tube brand ................................................................................................... 43
8.1.15 Reset Total Volume ................................................................................................................ 43
8.2 General ................................................................................................................................. 44
8.2.1 NetWork ................................................................................................................................ 44
8.2.1.1 Connection Mode .......................................................................................................... 44
8.2.1.2 Relay.............................................................................................................................. 44
8.2.1.3 WLAN ........................................................................................................................... 44
8.2.2 Sound..................................................................................................................................... 45
8.2.3 Date &Time ........................................................................................................................... 45
8.2.4 Screen Lock ........................................................................................................................... 45
8.2.5 Brightness .............................................................................................................................. 46
8.2.6 Night Mode ........................................................................................................................... 46
8.2.7 Nurse Call .............................................................................................................................. 46
8.2.8 Nurse Call Alarm Level ......................................................................................................... 46
8.2.9 Battery Capacity Display....................................................................................................... 46
8.3 Patient................................................................................................................................... 46
8.3.1 Patient Information ................................................................................................................ 46
8.3.2 Prescription............................................................................................................................ 46
8.4 Records ................................................................................................................................. 47
8.4.1 History entries ....................................................................................................................... 47
8.4.2 Last therapies......................................................................................................................... 47
8.4.3 Export history records ........................................................................................................... 47
8.4.4 Clear all records .................................................................................................................... 47
8.5 System................................................................................................................................... 47
8.5.1 Language ............................................................................................................................... 47
8.5.2 Factory Default ...................................................................................................................... 47
8.5.3 SN(Serial Number) ................................................................................................................ 48
8.5.4 Version................................................................................................................................... 48
8.5.5 Maintenance .......................................................................................................................... 48
8.6 Electronic Memory Function.............................................................................................. 48
Chapter9 Alarm Prompt and Troubleshooting .................................................................................. 49
9.1 Introduction to Alarm Level ............................................................................................... 49
9.2 Multi-level Alarm Rules ...................................................................................................... 49
9.3 Alarm Handle ...................................................................................................................... 50
9.4 Malfunction Analysis and Solution .................................................................................... 50
Chapter10 Maintenance ......................................................................................................................... 51
10.1 Cleaning, disinfecting and sterilizing ................................................................................. 51
10.1.1 Cleaning ................................................................................................................................ 51
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 10.1.2 Disinfecting ........................................................................................................................... 51
10.2 Periodical maintenance ....................................................................................................... 52
10.2.1 Check the Appearance ........................................................................................................... 52
10.2.2 Performance Check ............................................................................................................... 52
10.2.3 Maintenance Plan .................................................................................................................. 52
10.3 Add new brand and Calibration ........................................................................................ 53
10.4 Repair ................................................................................................................................... 57
10.4.1 Normal Repair Process .......................................................................................................... 57
10.4.2 Maintenance for Long Term Store ......................................................................................... 57
10.5 Equipment Components/Accessories ................................................................................. 58
10.6 Production Date ................................................................................................................... 58
10.7 Recycling .............................................................................................................................. 58
Chapter11 Battery .................................................................................................................................. 59
11.1 Check the Battery Performance ......................................................................................... 59
11.2 Replaced the Battery ........................................................................................................... 59
Chapter12 After Sale Service ................................................................................................................ 60
Chapter13 Appendix .............................................................................................................................. 61
Appendix A Start Up Graphs and Trumpet Curves ................................................................................. 61
Appendix A.1 Start-up Graphs .............................................................................................................. 61
Appendix A.2 Trumpet Curves .............................................................................................................. 62
Appendix B Occlusion Response Property................................................................................................ 63
Appendix C Alarm and Solution ................................................................................................................ 64
Appendix D EMC Electro Magnetic Compatibility declaration ............................................................. 67
Appendix E Wireless Module Information ............................................................................................... 72
Appendix F Factory Default Data Set ....................................................................................................... 73

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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.

 This equipment is not applicable to blood transfusion.

 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.

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 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, 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.

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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 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.

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 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.

 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.

10
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)

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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

CE-mark/Notified Body

12
 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..
The infusion pump is suitable for adult, children, and newborns in various clinical departments.

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, 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
Drop sensor (optional)
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 2.4.3 Description on Model
This equipment has two models: EN-V7, EN-V7 Smart, the main function differences are shown in table
below.
Function /Model EN-V7 EN-V7Smart
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 30 2000
IrDA - Optional
IrDA and workstation communication - Optional
WIFI module Optional Optional
Occlusion alarm level 4 levels 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.

14
2.5 Product Specification
Safety Classification

Electric protection
Class I
Type
Electric protection
Defibrillation proof type CF applied Part
Level
Protection against
IP24
fluid ingress

Working mode Continuous

Classification Portable equipment, non-portable infusion pump

Specification Parameters
Infusion apparatus
20 drops, 60 drops and so on
specification

System Accuracy ≥1ml/h，±5%

20-drop specification infusion apparatus: 0.01-1200ml/h

Infusion Rate
60-drop specification infusion apparatus: 0.01-400ml/h
20-drop specification infusion apparatus: 0.1-1200ml/h
Bolus Rate 60-drop specification infusion apparatus: 0.1-400ml/h
Purge rate 20-drop specification infusion apparatus: 1200ml/h
60-drop specification infusion apparatus: 400ml/h
KVO Rate 0.01-5.00ml/h
Micro mode
100-1200ml/h
setting range
Minimum flow rate
0.01ml/h
increment

Bolus Volume Minimum 0.1ml, max 50ml

VTBI 0-9999ml, minimum step is 0.01ml

Total Volume
0.01-9999.99ml, minimum step is 0.01ml
Infused
Time Range 1min-99hrs59min
Upstream occlusion
-75 mmHg ～ - 600 mmHg ( -10Kpa ～ -80Kpa )
range
Fuse Type T2AL 250V
Dimensions 234(W)*99(D)*120(H) mm
Weight 1.6kg
Power Supply

AC power supply 100-240V 50/60Hz

Input power 50VA

15
DC power supply DC 15V
Model: DC 203
Specification: 11.1V 2600mAh
Battery Charging time: 5h (under OFF status)
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 em
pty, Battery empty, No battery inserted, No power supply, Reminder alarm, Stand
Alarm information by time expired, KVO finished, Drop sensor connection, Drop error, Air bubble,
Door Open, Check IV Set installation, Drop in pressure, Drug dose limits
exceeded, system error

Environment

Non AP/APG type Do not use it in the environment with inflammable anaesthetic gas mixed with
equipment air, and inflammable anaesthetic gas mixed with oxygen or nitrous oxide
(1) temperature: 5-40℃
Operating (2) humidity: 20-90%, non-condensable
(3) atmospheric pressure: 86-106kPa
(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

IEC60601-2-24:2012
Medical electrical equipment – Part 2-24: Particular requirements for the safety o
f infusion pumps and controllers

Main Safety IEC60601-1-8：2006+A1：2012

Standards Medical electrical equipment –Part 1-8: General requirements for basic safety an
d essential performance –Collateral Standard: General requirements, tests and gui
dance for alarm systems in medical electrical equipment and medical electrical sy
stems

EN60601-1-2:2007+AC:2010
Medical Electrical Equipment - Part1-2: General requirements for basic safety an
d essential performance-Collateral standard:Electromagnetic compatibility-Requi
rements and tests
16
 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

17
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【Home】

Enter system home page.

⑦【Bolus/Purge】

⑧【Power】

Pump power switch, press and hold for 3 seconds, pump power off. Stand-by selection button.

⑨ AC indicator

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

18
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 workstation
icon
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 the
indication icon
following states:

19
 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

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
2. Before infusion starting, it is『Purge』function, click it to exhaust air
Button
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 to the
Left
left page

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

Single selection
Mean that this parameter is selected
box-1
ON Mean this function is ON

OFF Mean this function is OFF.

20
 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』.

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

21
3.4 Rear View

① Line clamp

Keep the IV line neat② 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 and RS232

⑥ USB Port for drop sensor

Only supporting external drop sensor made by our company

⑦ Battery Compartment

Built-in lithium-ion battery

⑧ Loudspeaker

22
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

Connectto the equipment drop sensor port

23
 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 packaging 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:
IEC60950 information technology equipment safety and IEC60601-1 medical electric device safety)
certification, and all devices must be connected according to the valid version of IEC60601-1-1
system. The technician who takes charge of connecting to additional devices with the equipment
interface is responsible for meeting the IEC60601-1-1 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.

24
 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.

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 green line.

(3) Liquid level should be below the red line.

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.

25
 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.

26
 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

27
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 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.
9) If installed with success, infusion pump will recognize IV set brand and size automatically, if
failed, please repeat the above mentioned steps.
28
 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.

29
 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
30
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.
(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.
31
- 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.

32
 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 works to complete the
fluid/drug in the infusion container.

7.2 Infusion Parameters Setting Range

Infusion Mode Infusion Parameter Parameter Range
VTBI 0.01-9999ml
Rate 20-drop specification infusion apparatus:
0.01-1200ml/h
ml /h mode
60-drop specification infusion apparatus:
0.01-400ml/h
Time 1min-99hrs59min
Weight(Body weight) 0.1-300kg
Acti agentia(Drug mass) 0.01-99999
ng/ml, ug/ml, mg/ml, g/ml, U/ml, kU/ml,
Conc.unit(Concentration unit) IU/ml, EU/ml, mmol/ml, mol/ml, kcal/ml

Volume(Fluid amount) 0.01-9999ml

Dose rate 0.01-9999
Dose unit ng/min, ug/min, mg/min, g/min, U/min,
Body weight mode KU/min, 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, 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
33
 VTBI The same as ml/h mode
Drip mode
Drop rate 1-400 drops/min
VTBI
Loading dose Maintain rate The same as ml/h mode
mode Loading rate
Loading time
VTBI The same as ml/h mode
Ramp up/down Rate
mode Rise time
Fall time
Rate The same as ml/h mode
Sequence mode
Time
Weight
Concentration
Drug library mode The same as body weight 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.

34
 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).

35
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.

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
36
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.

37
 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.

38
 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

(1) EN-V7 Smart 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.

(2) EN-V7 supports 30 drug names, and allows to edit the drug name, save the names after
turning off the machine, but the upper and lower limit function is unavailable.

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『OK』.
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『OK』.
Please refer to Chapter 2.5 for the adjustable Bolus rate range.

39
 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
immediately take measure if there’s any abnormality.

● Under the equipment fault state, the max pressure generated by the infusion line is 300kPa.
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: EN-V7 Occlusion Pressure Level: 4 levels

Level Pressure Intensity Pressure Intensity Pressure Intensity Pressure Intensity
(mmHg) (Kpa) (bar) (psi)
1 225 30 0.3 4.35
2 450 60 0.6 8.7
3 675 90 0.9 13.05
4 900 120 1.2 17.4

40
Applicable Model: EN-V7Smart Occlusion Pressure Level: 12 levels
Level Pressure Intensity Pressure Intensity Pressure Intensity Pressure Intensity
(mmHg) (Kpa) (bar) (psi)
1 75 10 0.1 1.45
2 150 20 0.2 2.9
3 225 30 0.3 4.35
4 300 40 0.4 5.8
5 375 50 0.5 7.25
6 450 60 0.6 8.7
7 525 70 0.7 10.15
8 600 80 0.8 11.6
9 675 90 0.9 13.05
10 750 100 1 14.5
11 825 110 1.1 15.95
12 900 120 1.2 17.4

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 or the total air bubbles
within 15min in the line reach the preset air bubble testing alarm threshold value, it will activate
air bubble alarm. The air bubble testing sensitivity is 20ul. It is suggested to select suitable level
according to the actual requirement.

41
 Air Bubble detector level Alarm Threshold Value
Level 1 50ul
Level 2 100ul
Level 3 200ul
Level 4 300ul
Level 5 450ul
Level 6 600ul
Level 7 800ul

8.1.7 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.

8.1.8 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.

8.1.9 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.

8.1.10 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.

42
Unit Mark Unit Conversion
kPa 1 kPa=7.5mmHg=0.145psi=0.01bar
psi 1psi=51.724mmHg=6.897kpa=0.069bar
bar 1bar=750mmHg=14.5psi=100kPa

8.1.11 Micro Mode

Click『Micro mode』to enter into micro mode setting interface. ON/OFF is optional in this function
Optional. Under the ON mode, set the rate limit, then the infusion rate under any infusion mode is
not allowed to exceed this limit.

8.1.12 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.

8.1.13 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.

8.1.14 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.
The system built-in infusion apparatus brand: B.Braun.

● 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.

8.1.15 Reset Total Volume

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

43
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.

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.

44
 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 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.

45
 8.2.5 Brightness
Click 『Brightness』to enter into display brightness setting interface. The brightness has 10 levels.
The equipment has the function of automatic brightness adjustment if external power supply is
unavailable. When there is no external power supply, and the power is supplied by battery, if it is
not operated within 3min, the system will automatically adjust the brightness to the lowest level,
when it is touched or button is clicked by user or when there’s alarm, it will automatically recover
the brightness.

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.
46
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 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.

8.4.4 Clear all records

Click 『Clear all records』to clear all history records and therapy records.

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 Factory Default

Click『Factory data reset』to clear the User defined option, and this function is open to the user.

47
 8.5.3 SN(Serial Number)
Check the serial number of the equipment, and user can’t modify the serial number.

8.5.4 Version
Check the software version in this interface.

8.5.5 Maintenance
Input password: 2341.
More details please refer to Chapter 11

8.6 Electronic Memory Function

After turning off the equipment, the electronic memory function can be saved for 5 years at least.
When the power failure time is ≤30s, the alarm setting before power failure will be automatically
recovered.

48
 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:

49
 Table9.2-1

Multilevel Alarm Rules

Several alarms of different Display the alarms of highest level with sound, light and text,
levels generate report middle alarm after eliminating all alarms of highest level
simultaneously
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’smalfunction, 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.

50
 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

51
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.

● 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.

52
Maintenance Items Cycle
Once every 2 years, please check after
Safety check according to IEC60601-1 replacing the printed circuit board assembly or
the equipment is dropped or knocked.
Once every 2 years, when the occlusion alarm,
Preventive system maintenance items (pressure
air bubble alarm, or infusion accuracy is doubt
calibrate, sensor calibrate, pump)
to be abnormal
Using the equipment for the first time, infusion
Brand of user-defined infusion apparatus, apparatus brand using for the first time, reusing
infusion accuracy calibration the 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.

(1) Add new brand

Note: ● If the actual using infusion apparatus brand is not listed in the system built-in brand,

53
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.

54
5) Click『 』to start Calibrate

6) After 5mins, the equipment will automatically stop, then record the net weight of fluid by ml;

7) Click 『 』, Input the net weight(ml).

8) Calibration completed.
(2) Delete
Enter into『Delete』interface, click it to delete user-defined infusion apparatus brand.

55
(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『 』to start Calibrate

5) After 5mins, the equipment will automatically stop, then record the net weight of fluid by ml;

56
6) Click 『 』Input the net weight(ml).

7) Calibration completed.

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.
57
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
Locking mechanism
Equipment Components Battery
Pole clamp
Power wire
Handle

10.6 Production Date

Please refer to the label of the product.

10.7 Recycling

The normal service life of this equipment is 5 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.

58
 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 isrecommended 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.

59
 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.

Manufacturer: Shenzhen Enmind Technology Co., Ltd.

Room 201,Block A,No.1,Qianhai Road 1,Qianhaishen Port Cooperative District,
Shenzhen, 518000,Guangong,China
Site included: 5th Floor, Block A, Defengsheng Building, No.41 Dabao Road, Bao'an District 23,
Shenzhen, 518101, P.R.China
TEL: +86 755 2331 6007
Fax: +86 755 2227 6344

Authorized representative in the European Community: Wellkang Ltd

Address: Suite B, 29 Harley Street,LONDON W1G 9QR, England, United Kingdom

60
 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

61
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

62
Appendix B Occlusion Response Property

EN-V7 Smart Delay and Possible Dose

Flow Rate Occlusion Pressure Max bolus

Time to occlusion alarm(min)
(ml/h) (mmHg) (ml)
Low 75 0h 6min 10sec 0.008
1
High 900 0h 47min 27sec 0.143
Low 75 0h 0min 25sec 0.007
25
High 900 0h 1min 32sec 0.131

EN-V7 Delay and Possible Dose

Flow Rate Occlusion Pressure Max bolus

Time to occlusion Alarm(min)
(ml/h) (mmHg) (ml)
Low 225 0h 7min 19sec 0.012
1
High 900 0h 46min 45sec 0.133
Low 225 0h 0min 36sec 0.008
25
High 900 0h 1min 29sec 0.126

Notes: The alarm pressure intensity error for EN-V7 Smart is ±15% or ±100mmHg, the higher
value shall be taken;
The alarm pressure intensity error for EN-V7 is ±20% or ±150mmHg, 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

63
 Appendix C Alarm and Solution
Alarm Type Alarm Reason Solution
Level
The preset value infusion Press 【 Stop 】 button to stop
VTBI infused High
Completion. alarm.
Manually solve the problem of
1. Line occlusion during
occlusion, Press【Start】 button
infusion.
to continue infusion.
2. Fluid/drug in the actual
Rise the alarm Level, Press
Pressure high High infusion line of high viscosity,
【 Start 】 button to restart
while the system occlusion
infusion.
level is set too low.
3. The pressure sensor is Please contact the dealer or
damaged. manufacturer for repair
The upper part of the line is Check if the rate regulating
obstructed during infusion, and adjuster or fluid stopping device
Check upstream High in turn drops the line pressure is open at the upper part of the
intensity. line, Press【Stop】button to stop
alarm.
When power is supplied by the
built-in battery only, under low Immediately connect with
battery, the alarm duration external power supply.
Battery empty High is >30min.
2. Battery aging or the
Please contact the dealer or
equipment charging circuit is
manufacturer for repair.
fault.
KVO working time reached
KVO finished High 30min, infusion pump stops Press【Stop】button to stop alarm
working.
The angle of inclination of the Check the installation of drop
drip cup is too big or drop sensor or drip cup fluid level,
sensor is installed lower than Press 【 Stop 】 button to stop
the drip cup fluid level. alarm.
Check if the infusion apparatus
Drop error High The specification of infusion
specification is accordant with
apparatus is not accordant with
displayed parameters, if it is not
the specification displayed in
accordant, , it shall be modified
the interface, which causes
by professional maintenance
drop rate error.
technician.
During infusion, the infusion Close the infusion pump door to
Door Open High
pump door is opened. stop this alarm.

64
Alarm Type Alarm Reason Solution
Level
Press 【 Stop 】 button to stop
alarm, disconnect the line from
the patient, eliminate the air
Air bubble High Air bubble in the infusion line.
with purge function, or open the
infusion pump door to manually
remove the air bubbles.
While using drugs in drug
library to infuse, alarm will be
Drug dose limits Press 【 Stop 】 button to stop
High triggered if max dose in
exceeded alarm.
certain time have exceeded the
preset limits.
If system self check failed or Restart device to check whether
internal fault, system error alarm is eliminated, if still
System error High
alarm will give with code exists, contact maintenance
number. personnel.
During infusion, the remaining
This alarm can’t be eliminated,
VTBI near end Middle time reached or is less than the
and wait till infusion completes.
set nearing completion time.
Line pressure close to preset Check if there is occlusion in
Occlusion pre alarm Middle occlusion pressure level. line and click OK to eliminate
alarm.
pressure in line is dropped in Check extension line or patient
Drop in pressure Middle sudden. connection. Click OK to
eliminate alarm.
1. When power is supplied
The alarm automatically
only with the built-in battery,
eliminates after connecting the
under low battery, the alarm
external power supply.
Battery nearly empty Middle duration is >30min
2. Battery aging or the
Please contact the dealer or
equipment charging circuit is
manufacturer for repair.
fault.
Keep connecting with external
No battery inserted Middle Battery is removed. power supply, reinstall the
battery.
After installing infusion tube ,
under non-working or alarm
Reminder alarm Middle Click any button to stop.
state, it is not operated within
the set time of the system.

During standby, after reaching Press 【 Stop 】 button to stop

Standby time expired Middle
the standby time. alarm.

65
Alarm Type Alarm Reason Solution
Level
When turning on the drop
Drop sensor sensor, the equipment is not Connect the drop sensor, or turn
Low
connection connected with the drop off the drop sensor in the menu.
sensor.
Under ON state, AC power
The alarm automatically
supply is adopted, but the AC
No power supply Low eliminates after connecting the
power wire is dropped during
external power supply.
the process.

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

66
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 The Infusion pump is suitable for use
CISPR 11
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/ flicker
that supplies buildings used for
emissions Not applicable domestic purposes.
IEC 61000-3-3

67
 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 ±2kV for power Mains power quality should be
transient/burst supply 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 ± 1 kV line(s) to Mains power quality should be

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

Voltage dips, <5% UT <5% UT Mains power quality should be

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

70% UT 70% UT

p in UT) (30% dip in UT)

for 25 cycles for 25 cycles

<5% UT <5% UT

(>95% dip in UT) (>95% dip in UT)

for 5 sec for 5 sec

68
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.

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 test Electromagnetic

Immunity test Compliance level
level environment - guidance

Portable and mobile RF

communications equipment
Conducted RF 3 Vrms should be used no closer to
10 Vrms any part of the Infusion
IEC 61000-4-6 150 kHz to 80 MHz
pump, including cables, than
the recommended separation
distance calculated from the
equation applicable to the
frequency of the transmitter.

Recommended separation
distance

d = 1.167 P

d = 1.167 P 80 MHz to

800 MHz
Radiated RF 3 V/m

IEC 61000-4-3 80 MHz to 2.5 GHz 10 V/m d = 2.333 P 800 MHz

to 2.5 GHz

Where P is the maximum

output power rating of the
transmitter in watts (W)
according to the transmitter
manufacturer and d is the
recommended separation
distance in metres (m).

Field strengths from fixed RF

69
 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.

70
 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 metres (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.

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Appendix E Wireless Module Information

Parameter Name Parameter Value

Frequency Range 2.412GHz-2.482GHz

Modulating Type OFDM, CCK, DSSS

Effective Radiating <20dBm

Power

72
Appendix F Factory Default Data Set

Parameters Default Setting Parameters Default Setting

Commonly used
KVO rate 1ml/h B.Braun
tube brand
Occlusion pressure 450mmHg Sound 40%
Bubble size 1 levels (50ul) Screen lock ON
Finish pre-alarm 2min Brightness 90%
Reminder alarm 2min Night mode OFF
Pressure unit mmHg Nurse call OFF
Micro mode OFF Drug library OFF
Drop sensor OFF Relay mode OFF

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P/N: 34‐000006‐00 (2.2)