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En S7+User+Manual

Q: Why is it recommended to use syringes of the same brand as the equipment, and what are the possible consequences of using a different brand?

It is recommended to use syringes of the same brand as the equipment because compatibility is crucial for ensuring infusion accuracy and the functionality of the device's automatic recognition system . Using a different brand might result in inaccurate flow rates and doses, as the system is optimized for specific syringe specifications. Deviations caused by non-compatible syringes could lead to under or over-infusion, risking patient safety . Ensuring compatibility also prevents mechanical issues like syringe slot fitting problems, which could cause device malfunction.

Q: What environmental conditions should be maintained to optimize the syringe pump's performance?

To optimize the syringe pump's performance, it should be used away from direct sunlight, high temperatures, high humidity, and chemical gases, as these conditions can degrade performance and harm internal components . It is also crucial to avoid environments that exceed the designated temperature range, as this could lead to inaccurate infusion rates or equipment malfunction . Proper environmental control not only ensures device longevity but also maintains infusion accuracy and patient safety.

Q: What are the safety precautions one must take before using the syringe pump, especially after it has been unused for a long period?

Before using the syringe pump after a period of disuse, it is essential to first charge the equipment fully with an AC power supply to ensure that it can function properly without reliance on the built-in battery, which may not hold a charge if left unused . Additionally, a thorough inspection should be conducted to ensure there are no cracks, leaks, or damage, and all moving components should function smoothly . The equipment's system time should be checked to ensure accurate historical recording . Adhering to these precautions prevents electrical failures and ensures the device operates safely and correctly.

Q: What is the significance of setting the correct occlusion pressure level, and how should it be adjusted according to actual requirements?

Setting the correct occlusion pressure level is crucial to prevent unnecessary alarms and ensure patient safety. A properly set occlusion level helps avoid false positives and negatives in detecting actual occlusion events . It should be adjusted based on the viscosity and specific gravity of the infusion fluid; higher viscosity fluids may require a higher occlusion pressure setting to accurately detect real obstructions without premature alarms . By aligning the occlusion pressure settings with the specific characteristics of the infusion fluid, the device’s performance is optimized and patient risks minimized.

Q: Explain the sequence and relay modes within the syringe pump, highlighting their purpose and functionality.

The sequence mode allows the syringe pump to administer infusions using a set sequence after users establish the rate and time of up to 26 different sequences. This functionality is particularly useful for complex, multi-step infusion protocols that require precise timing and dosage intervals . Relay mode, on the other hand, utilizes the device's infrared communication to integrate with an EN-D7 Smart infusion workstation. This mode enables seamless transfer of control and infusion continuity across multiple linked devices, ensuring consistent patient care without manual intervention . Both modes enhance the pump's flexibility and efficiency in various medical settings.

Q: What are the necessary steps to ensure the syringe pump's successful startup and self-test?

To ensure the syringe pump starts up successfully and passes the self-test, the device should be mounted on an infusion stand and connected to an AC power supply. Then, press the power button to turn it on. The system will automatically check the motor, sensor, battery, CPU communication, and alarm indicator . If any component fails during this process, the device cannot be used for patient infusion, and a company service should be contacted . This process ensures that critical components are functioning before infusion begins.

Q: Discuss the considerations for using the built-in battery of the syringe pump effectively, especially in case of power failure or movements.

Effective use of the syringe pump's built-in battery involves fully charging it before prolonged use, especially when AC power is unavailable due to power failure or when moving the infusion setup . Regular use of AC power is recommended to prolong battery life, with the battery serving as an auxiliary power source . It is critical to ensure the battery remains in effective working condition to avoid interruption in medication delivery, maintaining patient safety even during transitions or contingencies.

Q: How does the occlusion detection function of the syringe pump work, and what are its limitations?

The occlusion detection function on the syringe pump works by alarming when the pressure in the syringe tube reaches a certain value, indicating a potential obstruction such as a twisted tube or blocked needle . However, it has limitations as it only alarms when the pressure surpasses a set threshold, meaning it may not detect occlusions below this level, which can still cause harm, like redness or swelling at the puncture site. Therefore, periodic manual checks are recommended to complement the automatic alarm system .

Q: How should the syringe pump be handled to avoid causing damage during use or transport?

To handle the syringe pump without causing damage during use or transport, it must be securely fixed to a stable infusion stand, ensuring that the syringe pump does not fall or cause the stand to tip over . Careful movement is essential to prevent dropping or knocking against surrounding objects . Additionally, the equipment should not be used in high humidity or near chemical gases, as these conditions can damage internal components . Regular inspections post-transport can help ensure that any unseen damage is addressed before use.

Q: What procedures should be followed if the syringe pump experiences physical impact, such as dropping or collision?

If the syringe pump experiences a physical impact, such as being dropped or colliding with another object, its use should be immediately discontinued, and the company's after-sales service should be contacted . This is important because internal components might be damaged, even if the outer appearance seems normal and no immediate functional issues appear. Proper inspection and professional servicing are necessary to ensure the device's reliability and safety for patient use after such incidents.

This user manual provides comprehensive information on the EN-S7 and EN-S7 Smart syringe pumps, including application scope, safety instructions, and operational guidelines. It is intended for trained medical professionals and covers installation, usage, maintenance, and troubleshooting. The manual also details the product specifications, features, and various infusion modes available in the syringe pumps.

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En S7+User+Manual

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USER MANUAL

SYRINGE PUMP
(EN-S7 Smart, EN-S7)
0
Manufacturer: Shenzhen Enmind Technology Co., Ltd.

Room 201,Block A,No.1,Qianhai Road 1,Qianhaishen Port Cooperative District, Shenzhen,

518000,Guangdong,China

Site included: 5th Floor, Block A, Defengsheng Building, No.41 Dabao Road, Bao'an District 23, Shenzhen,
518101, [Link]

TEL: +86 755 2331 6007

Authorized representative in the European Community: Shanghai International Holding Corp.

GmbH (Europe)

Address: Eiffestrasse 80, 20537 Hamburg，Germany

1
Preface
1 Application Scope of the User Manual
Applicable to EN-S7/EN-S7 Smart syringe pumps of our company.
This User Manual describes the product’s most complete configuration, accessories and functions which
may not exist in the product of the user, for more detailed information, please contact manufacturer.

2 Applicable Object of the User Manual

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.
Our company is responsible for the reliability and performance of the equipment only all following
conditions are met:
 Use the equipment according to this User Manual.
 The equipment can only be disassembled, assembled, replaced, tested, improved and repaired by the
professional technicians of our company.
 All components and accessories as well as consumables for repairing are provided by manufacturer.
● Relevant electric devices meet the international standard IEC/EN 60601-1 and this User Manual.

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

2
Content
Preface ............................................................................................................................................................ 2
1 Application Scope of the User Manual ..................................................................................................... 2
2 Applicable Object of the User Manual ..................................................................................................... 2
3 Use Instructions .......................................................................................................................................... 2
4 Paraphrase .................................................................................................................................................. 2
Chapter1 Safety Instructions................................................................................................................. 5
1.1 Warnings ........................................................................................................................................ 5
1.2 Cautions ......................................................................................................................................... 6
1.3 Dialogue window ........................................................................................................................... 7
1.4 Symbols .......................................................................................................................................... 7
Chapter2 Overview ................................................................................................................................ 8
2.1 Application Scope .......................................................................................................................... 8
2.2 Contraindications .......................................................................................................................... 8
2.3 Working Principle ......................................................................................................................... 8
2.4 Structure and Performance .......................................................................................................... 8
2.5 Product Specification .................................................................................................................... 9
Chapter3 Appearance .......................................................................................................................... 12
3.1 Left Front View ............................................................................................................................ 12
3.2 Right Front View ......................................................................................................................... 13
3.3 Operation Panel ........................................................................................................................... 14
3.4 Display Screen.............................................................................................................................. 15
3.5 Rear View ..................................................................................................................................... 17
Chapter4 Installation ........................................................................................................................... 18
4.1 Unpacking and Checking ............................................................................................................ 18
4.2 Installation ................................................................................................................................... 18
Chapter5 Use Preparation and Cautions............................................................................................ 19
5.1 Use Preparation ........................................................................................................................... 19
5.2 Operation Cautions ..................................................................................................................... 19
Chapter6 Basic Operation ................................................................................................................... 20
6.1 Operation Flow ............................................................................................................................ 20
6.2 Infusion Operation ...................................................................................................................... 20
Chapter7 Set Infusion Parameters ...................................................................................................... 23
7.1 Introduction to Infusion Parameters Setting ............................................................................ 23
7.2 Infusion Parameters Setting Range ........................................................................................... 23
7.3 Infusion Mode Setting ................................................................................................................. 24
Chapter8 System Setting ...................................................................................................................... 27
8.1 Settings ......................................................................................................................................... 27
8.2 General ......................................................................................................................................... 30
3
8.3 Patient........................................................................................................................................... 32
8.4 Records ......................................................................................................................................... 33
8.5 System........................................................................................................................................... 36
8.6 Electronic Memory Function...................................................................................................... 36
Chapter9 Alarm Prompt and Troubleshooting .................................................................................. 37
9.1 Introduction to Alarm Level ....................................................................................................... 37
9.2 Multi-level Alarm Rules .............................................................................................................. 37
9.3 Alarm Handle .............................................................................................................................. 37
9.4 Malfunction Analysis and Solution ............................................................................................ 37
Chapter10 Maintenance ......................................................................................................................... 38
10.1 Cleaning, disinfecting and sterilizing ......................................................................................... 38
10.2 Periodical maintenance ............................................................................................................... 38
10.3 Add new brand and Calibration ................................................................................................ 39
10.4 Repair ........................................................................................................................................... 41
10.5 Equipment Components/Accessories ......................................................................................... 41
10.6 Production Date ........................................................................................................................... 41
10.7 Recycling ...................................................................................................................................... 41
Chapter11 Battery .................................................................................................................................. 42
11.1 Check the Battery Performance ................................................................................................. 42
11.2 Replaced the Battery ................................................................................................................... 42
Chapter12 After Sale Service ................................................................................................................ 43
Chapter13 Appendix .............................................................................................................................. 44
Appendix A Start Up Graphs and Trumpet Curves ................................................................................. 44
Appendix B Occlusion Response Property................................................................................................ 46
Appendix C Alarm and Solution ................................................................................................................ 47
Appendix D Electro Magnetic Compatibility declaration ....................................................................... 49
Appendix E Wireless Module Information ............................................................................................... 53
Appendix F Factory Default Data Set........................................................................................................ 54

4
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
syringe 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 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 syringe extension tube is twisted, or the filter or needle is obstructed, or blood in the needle
which may obstruct the syringe, the pressure in the 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 extension tube near the puncturing position, then loosen the 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 syringe tube may keep rising, and
may break or cut off the tube, or hurt the patient.
 This equipment has the occlusion detection function for detecting and alarming when the syringe
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 sterile hypodermic syringes for single use 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 syringe with same brand as this equipment. It can’t ensure the infusion
accuracy if the unsuitable syringe is adopted. Please use the syringe and the extension tube with a
screw, or may be because of the pipeline pull to cause damage to the patient.
 It is not allowed to disassemble or refit this equipment or use it for other purposes except normal
infusion.
5
 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
earth.

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 connect 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.
 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.

6
1.3 Dialogue window
Dialogue window mainly content include operation select, operation confirm etc. tips information. For
instance:
(Figure1.3-1: Operation select window) (Figure1.3-2: Operation confirm window)

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

Marks Description Marks Description

Batch code Protective earth (ground)

Drip Proof(Degree of protection

Serial number IP24
against ingress of fluids)

Caution Alternating current

Defibrillation-proof type CF
Handle with harmless method
applied Part

Date of Manufacture Manufacturer

environment-friendly use Non-ionizing electromagnetic

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

Unlock Lock

Input / output Input

This side up Fragile items

Keep dry Stacking level limit

CE-mark/Notified Body

7
Chapter2 Overview

2.1 Application Scope

2.1.1Expected Purpose
The syringe pump is used together with syringe to control the dose of liquid infused into patient’s body, for
example intravenous infusion.

2.1.2Expected Working Environment

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

2.1.3Suitable object
Adult, child or neonate.

2.2 Contraindications
No

2.3 Working Principle

It is controlled to move into a linear motion from a microcontroller based system which drives a step motor,
allowing a wide range of pumping rates configured to the inside diameter of the loaded syringe. The
syringe plunger is driven from a lead screw and drive-nut mechanism, infusing the drugs into the patient.

2.4 Structure and Performance

2.4.1Structure and Performance

The syringe pump mainly composes of the main unit and built-in battery. 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, TIVA 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, alarm and so on.

2.4.2Accessories
Power wire、Pole clamp、Handle

2.4.3Description on Model
This equipment has two models: EN-S7, EN-S7 Smart, the main function differences are shown in table
below.

Function /Model EN-S7 EN-S7Smart

ml/h mode √ √
infusion mode Body weight mode √ √
TIVA mode - √
Loading- dose mode - √
8
Sequence mode - √
Ramp up/down 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
History Record ≥5000 ≥5000
Brand Library ≥200 ≥200

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

2.5 Product Specification

Safety Classification
Electric protection
Class I
Type
Electric protection
Defibrillation proof type CF applied Part
Level
Protection against
IP24
fluid ingress
Working mode Continuous operation

Classification Portable equipment, non-portable syringe pump

Specification Parameters

Compatible Syringes 2/3ml、5ml, 10ml, 20ml, 30ml , 50/60ml

≥1ml/h, ±2%
System Accuracy
<1ml/h，accuracy ±5% or ±0.005ml/h choosing the higher value
Syringe size 2/3ml: (0.01-50) ml/h
Syringe size 5ml: (0.01-100) ml/h
Syringe size 10ml: (0.01-300) ml/h
Infusion Rate
Syringe size 20ml: (0.01-600) ml/h
Syringe size 30ml: (0.01-900) ml/h
Syringe size 50/60ml: (0.01-2000)ml/h
Syringe size 2/3ml: (0.1-50) ml/h
Bolus Rate Syringe size 5ml: (0.1-100) ml/h
Syringe size 10ml: (0.1-300) ml/h

9
Syringe size 20ml: (0.1-600) ml/h
Syringe size 30ml: (0.1-900) ml/h
Syringe size 50/60ml: (0.1-2000)ml/h
Syringe size 2/3ml: 50 ml/h
Syringe size 5ml: 100 ml/h
Syringe size 10ml: 300 ml/h
Purge rate
Syringe size 20ml: 600ml/h
Syringe size 30ml: 900ml/h
Syringe size 50/60ml: 2000ml/h
KVO Rate 0.01-5.00ml/h

KVO Accuracy ≤±5%

Syringe size 2/3ml: (0.1-50) ml/h
Syringe size 5ml: (0.1-100) ml/h
Micro mode Syringe size 10ml: (0.1-200) ml/h
setting range Syringe size 20ml: (0.1-200) ml/h
Syringe size 30ml: (0.1-200) ml/h
Syringe size 50/60ml: (0.1-200)ml/h
Minimum flow rate
0.01ml/h
increment
Pill dose after
≤0.5ml
inversion
Single failure pill
≤3.5ml
dose
Syringe size 2/3ml: Minimum 0.1ml, max 2ml
Syringe size 5ml: Minimum 0.1ml, max 5ml
Syringe size 10ml: Minimum 0.1ml, max 10ml
Bolus Volume
Syringe size 20ml: Minimum 0.1ml, max 20ml
Syringe size 30ml: Minimum 0.1ml, max 30ml
Syringe size 50/60ml: Minimum 0.1ml, max 50ml
VTBI 0-9999ml, minimum step is 0.01ml

Total Volume Infused 0.01-9999.99ml, minimum step is 0.01ml

Time Range 1min-99hrs59min

Fuse Type T2AL 250V

Dimensions 394(W)*90(D)*123(H) mm

Weight Approx. 2kg

Power Supply

AC power supply 100-240V 50/60Hz

Input power 50VA

DC power supply DC 15V

Battery Model: DC 203

10
Specifications Specification: 11.1V 2600mAh
Charging time: 5h under OFF status
Working time: ≥12h (after completely charging the new battery, when the
environment temperature is 25℃ and flow rate is 5ml/h, the constantly working
time)
Alarm
Alarm signal sound When the sound is set at lowest level, alarm signal sound pressure level ≥50dB(A)
pressure level When the sound is set at highest level, alarm signal sound pressure level ≤80dB(A)
VTBI near end, Syringe near empty, VTBI infused, Syringe empty,Pressure high,
Occlusion pre alarm, Battery nearly empty, Battery empty, No battery inserted,
Alarm information
No power supply, Check syringe installation, Reminder alarm, Standby time
expired, KVO finished, Drop in pressure, Drug dose limits exceeded, system error.
Environment
Non AP/APG type Do not use it in the environment with inflammable anesthetic gas mixed with air,
equipment and inflammable anesthetic gas mixed with oxygen or nitrous oxide
(1) temperature: 5-40℃
Operating (2) humidity: 15-95%, non-condensable
(3) atmospheric pressure: 57-106kPa
(1) temperature: -20-60℃
Transport & Storage (2) humidity: 10-95%, non-condensable
(3) atmospheric pressure: 50-106kPa
Safety Standard
IEC 60601-1:2005+A1:2012
Medical electrical equipment-Part 1: General requirements for basic safety and
essential performance
IEC 60601-1-2 :2014
Medical electrical equipment - Part 1-2: General requirements for basic safety and
essential performance - Collateral standard: Electromagnetic disturbances-
Requirements And Tests
IEC 60601-1-6 :2010 （BS EN 60601-1-6:2010+A1:2015）
Main Safety
Medical electrical equipment - Part 1-6: General requirements for basic safety and
Standards
essential performance - Collateral standard: Usability
IEC 60601-1-8 ： 2006+A1:2012 Medical electrical equipment –Part 1-8:
General requirements for basic safety and essential performance –Collateral
Standard: General requirements, tests and guidance for alarm systems in medical
electrical equipment and medical electrical systems
IEC 60601-2-24: 2012
Medical electrical equipment –Part 2-24: Particular requirements for the basic
safety and essential performance of infusion pumps and controllers

11
Chapter3 Appearance

3.1 Left Front View

① Handle

Control syringe pump push-pull sliding box and clip.

② Slider box

③ Syringe clip

Clamp the syringe plunger.

④ Lead-screw

⑤ Syringe fixture lever

Pull forward then turn right, install the syringe into the slot.

⑥ Extension tube hook

⑦ Tube line Clamp

Keep the IV tube in line and neat

⑧ Syringe protect cover（Optional）

Protect syringe from large dose infusion caused by fallen.

12
3.2 Right Front View

① Syringe fixture lever

② Flange plate

Pull the fixture lever, put the syringe flange into the slot.

13
3.3 Operation Panel

① 【Fn】For future option

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 9.1

⑤ 4.3 inches TFT(LCD) touch screen

⑥ 【Menu】

Enter system home page.

⑦ 【Bolus/Purge】

⑧ 【Power】

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

⑨ AC indicator

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

14
3.4 Display Screen
The display screen interface layout composes of title bar and typical interface.

3.4.1Title Bar
Title bar displays real-time state information and is not touchable, the left upper corner displays the name
of current editing parameter.
Table3.4.1-1: Title Bar Icon

Icon Paraphrase Description

Syringe apparatus
/
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:

3.4.2Typical 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.

[Link] Typical Interface Icon Paraphrase

15
Table:[Link]-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
from the syringe
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.

[Link] 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

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3.5 Rear View

① IV tube clamp

Keep the syringe extension tube in line and neat

② A/C Adapter Port

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

③ Pole Clamp

Using for mounting the equipment on the infusion stand

④ IrDA

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

⑤ USB Port

Port for software upgrade

⑥ Syringe Protection Cover (Optional )

Protect syringe from large dose infusion caused by fallen

⑦ USB Port for future using

⑧ Loudspeaker

⑨ Battery Compartment

Built-in lithium-ion battery

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Chapter4 Installation

4.1 Unpacking and Checking

1) Please check the appearance before unpacking, if broken, please contact the transportation company or
our after-sale service department quickly.
2) Please carefully open the package to avoid damaging the equipment and relevant accessories.
3) After unpacking, please check the objects according to the packing list, if there’re insufficient or
damaged accessories, please contact our company as soon as possible.
4) Please keep relevant accessories, User Manual.
5) Please keep the packing case and packing materials for future transportation or storage.
Warning: Please put the packing materials out of reach of children. Please obey local laws and
regulations or the hospital waste treatment system to handle the packing materials.

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

4.2.1Install the syringe 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 syringe pump, tighten the pole
clamp to fix the syringe pump on the infusion stand (shown in drawing below). Hold the syringe 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.

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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; the pump piston 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 0.65m 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.

19
Chapter6 Basic Operation

6.1 Operation Flow

¤ Mount the syringe pump on the IV stand

¤ Power on

¤Install syringe

¤ Select syringe brand or add new brand

¤ Select infusion mode

¤ Set infusion Parameters

¤ Remove air bubble in the line

¤ Connect infusion line with patient

¤ Start infusion

¤ Infusion finish

¤ Remove syringe

¤ Power off or Standby

6.2 Infusion Operation

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

6.2.2Starting 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.

6.2.3Install Syringe
(1) Hold the clutch and pull the slider to the right side.
(2) Pull the syringe fixture lever, turn to the right.
(3) Insert the syringe flange into the slot, clip the plunger firmly.

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(4) Hang the extension tube of the syringe on the extension hook and put the syringe inside the
tube clamp.
(5) If installed with success, syringe pump will recognize syringe brand and size automatically, if
failed, please repeat the above mentioned steps.
Warning:
 The flange of the syringe should be firmly inserted into the slot, and not jutting on the outside
of the flange plate.
 Before using the syringe pump, pls. ensure the syringe brand specifications of the syringe
used must be confirmed. The brand of syringe pump should be calibrated on the equipment.
If there are no settings for the syringe used, the rate and the alarms may not be accurate.

6.2.4Set Infusion Parameters

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

6.2.5Remove Air bubble

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（Syringe size 2/3ml is
2ml）, purge will automatically stop.

6.2.6Start Infusion
Connect extension linewith patient, confirm infusion parameters, Press【Start】button or touch
screen 『Start』 , icon ,start infusion.

6.2.7Change 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 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.

6.2.8Bolus Application
In operation, Bolus functions have two operation modes: Manual bolus and Automatic bolus.

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(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.

Note: The “VTBI near end ” alarms are not triggered during Bolus.

6.2.9Infusion Completion
When infusion near completion, pump will alarm. If ignore it, the system will keep alarming until
finishing infusion.
After VTBI completed, it activates VTBI infused alarm, if KVO function is ON, the equipment
automatically starts KVO function, click 『OK』 in the alarm interface to stop KVO and eliminate
alarm.
The default working time of the KVO system is 30min, after reaching the time, it will activate
KVO completion alarm and stop infusion.
Please refer to Chapter 8.1.2 for setting 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 syringe

Disconnect the extension linewith the patient, then remove the syringe sets.
Replace syringe, please follow the steps of Chapter 6.2.3.

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.
⑴ Turn off the equipment: click 『Power off』icon, the equipment is turned OFF.
⑵ 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.
⑶ Cancel: click『Cancel』, return to the interface before OFF setting.
⑷ If no operation, the device will enter standby interface automatically.

Note: ● The equipment has standby function only under the non-working state.

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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 sub-menu, 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 syringe specification.
(3) If didn’t set VTBI (Volume to be infused), the syringe pump will work to complete the
fluid/drug in the syringe.

7.2 Infusion Parameters Setting Range

Infusion Mode Infusion Parameter Parameter Range
VTBI 0.01-9999ml
Rate (0.01-50)ml/h for 2/3ml syringes
(0.01-100)ml/h for 5ml syringes
(0.01-300)ml/h for 10ml syringes
ml /h mode
(0.01-600)ml/h for 20ml syringes
(0.01-900)ml/h for 30ml syringes
(0.01-2000)ml/h for 50/60ml syringes
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,

[Link](Concentration
IU/ml, IE/ml, mmol/ml, mol/ml, kcal/ml
unit)
Volume(Fluid amount) 0.01-9999ml
Dose rate 0.01-9999
Dose rate 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, ug/h, mg/h, g/h, U/h,
KU/h, IU/h, IE/h, mmol/h, mol/h, kcal/h,
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,
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

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Acti agentia(Drug mass),
Concentration unit
Volume(Fluid amount)
Weight, Loading rate,
TIVA mode Loading rate Unit. The same as Body Weight mode
Loading time,
Maintaining dose,
Maintain dose unit,
Dose Unit,
VTBI
Loading dose Maintain rate
The same as ml/h mode
mode Loading rate
Loading time
VTBI
Ramp up/down Rate
The same as ml/h mode
mode Rise time
Fall time
Rate
Sequence mode The same as ml/h 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.

7.3.1ml/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), [Link](concentration unit), Acti agentia(drug
mass),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).

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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)

7.3.3TIVA Mode
Under this mode, firstly, set the basic parameters of the [Link](concentration unit),Acti agentia(drug
mass), Volume(fluid volume), Weight, and then set the Loading stage: set Loading dose rate, Loading
time. Set maintenance stage: set Maintaining dose and units, the system will automatically calculate the
fluid rate, start running, first run the Loading dose rate after the end of the Loading time change to
works at the Maintaining dose which automatically calculate by system until manually stop or stop
with alarm.

7.3.4Loading -dose Mode

The Loading- dose mode means to infusion with the Loading flow rate according to the Loading
time, after reaching the Loading time, it works at the Maintain rate till complete the VTBI(Volume
to be infused).
Loading dose VTBI =Loading rate ×Loading time
Maintain time = (VTBI -Loading VTBI) /Maintain rate
Under this mode, set the VTBI, Maintain rate, Loading rate, Loading time, system automatically
calculate Loading dose VTBI and Maintain time.

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

7.3.5Ramp 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 dropping
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.

7.3.6Sequence Mode
Sequence mode means to infuseaccording to the set sequence after setting the rate and time of

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different sequence groups. At most 5 sequence can be set in this mode.

7.3.7Relay 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.

7.3.8Drug 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.

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Chapter8 System Setting

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

8.1.1Drug 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.

[Link] Introduction to Drug library

(1) EN-S7 Smart supports over 2000 medicines, which can be imported with external tool, and
has the functions such as upper and lower limit, concentration and so on.
Select medicine and then import the medicine parameters, the user may change the parameters
including the concentration and dosage rate, but the parameters won’t be saved.
(2) EN-S7 supports 30 drugs, and allows to edit the medicine name, save the names after turning
off the machine, but the upper and lower limit function is unavailable.

[Link] Setting Drug library

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

8.1.2KVO Rate
Click『KVO rate』, input the numerical value, after confirming, click .
Please refer to Chapter 2.5 for the adjustable KVO range.

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

8.1.3Bolus Rate
Click『Bolus rate』, input the numerical value, after confirming, click .
Please refer to Chapter 2.5 for the adjustable Bolus rate range.

8.1.4Occlusion Pressure
Click『Occlusion pressure』to enter into occlusion 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

27
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 blocking pressure is set to high grade, the larger pressure inside the pipeline is
likely to be washed away from the extension tube connected to the syringe. Please confirm
that the extension tube is securely attached to the syringe.
 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 160kPa.
Under single fault state, the max infusion volume is 3.5ml.
 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-S7 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
Applicable Model: EN-S7 Smart Occlusion Pressure Level: 12 levels
Level Pressure Intensity Pressure Intensity Pressure Intensity Pressure Intensity
(mmHg) (Kpa) (bar) (psi)
1 150 20 0.2 2.90
2 225 30 0.3 4.35
3 300 40 0.4 5.8
4 375 50 0.5 7.25
5 450 60 0.6 8.7
6 525 70 0.7 10.15
7 600 80 0.8 11.6
8 675 90 0.9 13.05
9 750 100 1 14.5
10 825 110 1.1 15.95
11 900 120 1.2 17.4
12 975 130 1.3 18.85
When the line occlusion activates occlusion alarm, the system will automatically trigger anti-bolus
function to drop the line pressure and avoid additional impact bolus to the patient after contacting
the occlusion. Liquid leakage will be less than 0.2ml, line pressure will be less than 300mmHg.

8.1.5DPS(Dynamic Pressure System)

With DPS switch on, line pressure is graphically and dynamically visible during infusing status.

28
“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

8.1.6Finish 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.

8.1.7Reminder 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 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
when the syringe is loaded within the preset time for “Reminder alarm” when the equipment is
under no infusion no alarm state.

8.1.8Weight 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.

8.1.9Pressure Unit
Click 『Pressure unit』to enter into pressure unit select setting interface, four units are available:
mmHg, kPa, bar, psi, click the preset unit option.

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

Unit Mark Unit Conversion

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

8.1.10 Micro Mode

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

Warning: Speed setting requires department head nurse authority

29
Syringe Size Max Rate Range
2/3ml 0.1-50ml/h
5ml 0.1-100ml/h
10ml 0.1-200 ml/h
20ml 0.1-200 ml/h
30ml 0.1-200 ml/h
50/60ml 0.1-200 ml/h

8.1.11 Commonly used syringe brand

For the built-in syringe brand of the system, after installing the syringe, click『Commonly used
syringe brand』to enter into the syringe brand selecting interface, and click the preset brand option.
The system built-in syringe brand: Double-Dove, [Link], BD,TERUMO.

Syringe brand 2/3ml 5ml 10ml 20ml 30ml 50/60ml

Double-Dove √ √ √ √ √ √
[Link] Perfusor √ √
BD √ √ √ √ √
TERUMO √ √ √ √ √

● The syringe 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 syringe
brand.

8.1.12 Reset Total Volume

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

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

8.2.1NetWork
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.

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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.

[Link] Connection Mode

The interconnection channel supports WLAN and serial port modes, please select according to the
actual requirement.

[Link] Relay
Set the Relay mode switch and Relay sequence number.

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

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

8.2.2Sound
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 value,
after confirming, click『OK』.

8.2.3Date & 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.

8.2.4Screen 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

31
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.

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

8.2.6Night 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.

8.2.7Nurse 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 on the nurse call function as the main alarm notice mode, and
shall identify according to the equipment alarm and the patient state.

8.2.8Nurse Call Alarm Level

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

8.2.9Battery 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.

8.3.1Patient Information
Click『Patient』to enter into the patient information setting interface and set bed number, MRN,
name, gender, age, body weight, height.

8.3.2Prescription
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.

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8.4 Records

8.4.1History 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.

8.4.2Last 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, it starts 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.

8.4.3Export 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.

[Link] The tool ‘Enmind Tool’ running environment

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

[Link] Enmind Tool installation instructions.

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

33
Finally, click ‘Finish’. Here, ‘enmind tool’ is installed successfully.

[Link] Export historical data

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

34
（4）Export data, click software UI 『query』button，read the pump’s historical data, the syringe
pump UI will display “Send Completed”.

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

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

35
8.5 System
Click『System』under the menu interface, enter the system information setting interface

8.5.1Language
This equipment supports simplified Chinese, English,Spanish [Link]『Language』to change
device language.

8.5.2SN (Serial Number)

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

8.5.3Version
Check the software version in this interface.

8.6 Electronic Memory Function

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

36
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, 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:
Multilevel Alarm Rules
Several alarms of different Display the alarms of highest level with sound, light and text,
levels generate simultaneously report middle alarm after eliminating all alarms of highest level
Several alarms of same level Alarm circularly by turns, the time interval is 3s
generate simultaneously

9.3 Alarm Handle

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

9.4 Malfunction Analysis and Solution

When there’s malfunction, the syringe 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.

37
Chapter10 Maintenance

10.1 Cleaning, disinfecting and sterilizing

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

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

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

10.2 Periodical maintenance

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

38
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 slider of the syringe pump is flexible in movement, and the clamp is ok.
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

1) Self-test and normal infusion function.
2) Alarm function normal
3) Battery performance.

10.2.3 Maintenance Plan

The following check/maintenance items must be performed by the professional technician
recognized by our company. If the following maintenances are necessary, please contact our
company. Please clean and disinfect the equipment before testing or maintaining.

Maintenance Items Cycle

Safety check according to IEC Once every 2 years, please check after replacing the printed circuit
60601-1 board assembly or the equipment is dropped or knocked.
Preventive system maintenance Once every 2 years, when the occlusion alarm, or infusion accuracy
items (pressure calibrate, sensor is doubt to be abnormal
calibrate, pump)
Brand of user-defined Using the equipment for the first time, syringe brand using for the
syringe,infusion accuracy first time, reusing the equipment after stopping for a very long
calibration 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.

39
(1) Add new brand

Note: ●If the actual using syringe brand is not listed in the system built-in brand, please add the
syringe brand in this interface.

Please follow the below steps to add a new brand:

1) Click『Brand』, Edit syringe brand name.
2) Click『Size』, Select syringe size.
3) Install syringe, pull the syringe piston beyond size scale line a little, press and hold on
【bolus】, push the piston to the corresponding size line.
4) Press 【start】, begin calibration, wait the calibration done.
5) Repeat above step 2~step 4, complete the new brand other size parameters
6) Press ，page down, find those different size syringe technical parameters, “Out diameter”,
“Full range length”, “Empty Space”, manually input the parameters to other same syringe
pumps after edit name
(2) Delete brand
Enter into『Delete』interface, click it to delete user-defined syringe brand.
(3) Calibration

Note

 When first time use pump need calibration

 When added new brand need calibration
 When accuracy is not good need calibration.
Calibrating Steps:
Automatic:
1) Select syringe brand.
2) Select syringe size.
3) Install syringe, pull the syringe piston beyond size scale line a little, press and hold on 【bolus】,
push the piston to the corresponding size line.
4) Press 【start】, begin calibration
5) Calibration completed.
Manual:
1) Select syringe brand.
2) Select syringe size.
3)Turn down to the second page.
4)Click to Input “ ”, “ ”, “ ” parameters.
5)Calibration completed.

40
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 syringe 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 occlusion alarm test.
3. Test the battery discharging and charging duration to confirm that the battery is also usable.

10.5 Equipment Components/Accessories

Warning: ● Only the components and accessories designated by our company shall be adopted,
otherwise, it may possibly damage the equipment or drop the equipment performance.

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

41
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 infusion.
(2) Supply public power to the equipment to charge the battery for 5h at least.
(3) Supply power to the syringe pump only with battery, infuse at the rate of 5ml/h, test the time
till the battery runs down and the equipment is turned off.
- If the infusion time exceeds 10h, the battery keeps at good status.
- If the infusion time exceeds 7h but less than 10h, the battery starts deterioration, but it can be
used temporarily.
- If the infusion time is less than 7h, the battery is reaching the service life, please replace the
battery.

11.2 Replaced the Battery

It is recommended to replace the battery every 2 years, it is suggested to replace the battery by the
dealer or manufacturer.
The steps of replacing battery are shown as below:
⑴ Cut off the power supply of the equipment, disconnect the power cable. Open the cover of
battery chamber and take out the battery.
⑵ Push the new battery into the battery chamber, and insert in the battery fastener.
⑶ After replacing the battery, install the battery cover, and check the battery.
Warning: ● When replace the battery, please do not touch the 12V DC plug inside of the
batter Chamber.

42
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.

43
Chapter13 Appendix

Appendix A Start Up Graphs and Trumpet Curves

Appendix A. 1 Start-up Graphs
Brand: Double-Dove Size:50/60ml
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: Double-Dove Size:50/60ml

Flow Rate: 5ml/h
Measurement Interval: ∆ t = 0.5min
Measurement duration: T = 2h

Graph 2 Start-up graph: Flow rate 5 (ml/h)against time (min) plotted from data gathered
during the first 2 h of the test period

44
Appendix A.2 Trumpet Curves
Brand: Double-Dove Size:50/60ml
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: Double-Dove Size:50/60ml

Flow Rate:5ml/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

45
Appendix B Occlusion Response Property

EN-S7 Smart Delay and Possible Dose

Flow Rate Occlusion Pressure Max bolus

Time to occlusion alarm(min)
(ml/h) (mmHg) (ml)
Low 150 0h38min40sec 0.046
1
High 975 2h29min0sec 0.109
Low 150 0h13min55sec 0.053
5
High 975 0h31min43sec 0.086

EN-S7 Delay and Possible Dose

Flow Rate Occlusion Pressure Max bolus

Time to occlusion alarm (min)
(ml/h) (mmHg) (ml)
Low 225 0h49min18sec 0.039
1
High 900 2h11min0sec 0.085
Low 225 0h14min20sec 0.040
5
High 900 0h29min46sec 0.077

Notes: The alarm pressure intensity error for EN-S7Smart is ±15% or ±100mmHg, the higher
value shall be taken;
The alarm pressure intensity error for EN-S7 is ±20% or ±150mmHg, the higher value shall be
taken.

Notes: ● Conditions for above testing data: Syringe Brand: Double-Dove Size:50/60ml
● 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.

46
Appendix C Alarm and Solution

Alarm Type Alarm Level Reason Solution

The preset value infusion Press【Stop】button to stop

VTBI infused High
Completion. alarm.
Syringe The liquid medicine in the Press 【Stop】 button to
High
empty syringe is empty. stop the alarm.
Click『Mute』to silence,
1. Line occlusion during Manually solve the problem
infusion. of occlusion, Press 【Start】
button to restart infusion.
2. Fluid/drug in the
Pressure high High infusion line of high Rise the alarm Level, Press
viscosity, while the system 【Start】button to restart
occlusion level is set too infusion.
low.
3. The pressure sensor is Please contact the dealer or
damaged. manufacturer for repair.
[Link] power is supplied
by the built-in battery only, Immediately connect to
under low battery, the external power supply.
Battery empty High alarm duration is >3min.
2. Battery aging or the
Please contact the dealer or
equipment charging circuit
manufacturer for repair.
is fault.
Check Syringe drop off during
High Reinstall the syringe.
syringe infusion.
KVO working time
Press 【Stop】button to stop
KVO finished High reached 30min, syringe
alarm
pump stops working.

While using drugs in drug

Drug dose library to infuse, alarm will
Press 【Stop】button to stop
limits High be triggered if max dose
alarm.
exceeded limit in certain time is
exceeded the preset limits.

If system self-check fail or Restart device to check

internal fault, system error whether alarm eliminated, if
System error High
alarm will give with code still exist, contact
number. maintenance personnel.

47
Alarm Type Alarm Level Reason Solution
During infusion, the
remaining time of preset This alarm can’t be
VTBI near
Middle value reaches or is less than eliminated, and waits till
end
the set nearing completion infusion completes.
time.

The syringe is near empty

status which is calculated by This alarm can not be
Syringe near
Middle checking the liquid medicine eliminated, waiting until
empty
remaining in the syringe by syringe is empty.
current flow rate.

Check if there is occlusion in

Occlusion pre Line pressure close to preset
Middle line and click OK to
alarm occlusion pressure level.
eliminate alarm.
Check extension line or
Drop in Pressure in line is dropped in
Middle patient connection. Click OK
pressure sudden.
to eliminate alarm.

1. When power is supplied

The alarm automatically
only with the built-in battery,
eliminates after connecting
under low battery, the alarm
Battery nearly the external power supply.
Middle duration is >30min.
empty
2. Battery aging or the
Please contact the dealer or
equipment charging circuit is
manufacturer for repair.
fault.
Keep connecting with
No battery
Middle Battery is removed. external power supply,
inserted
reinstall the battery.
After installing syringe tube ,
under non-working or alarm
Reminder
Middle state, it is not operated Click any button to stop.
alarm
within the set time of the
system.
Standby time During standby, after Press 【Stop】button to stop
Middle
expired reaching the standby time. alarm.
Under ON state, AC power
The alarm automatically
No power supply is adopted, but the
Low eliminates after connecting
supply AC power wire is dropped
the external power supply.
during the process.

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

48
Appendix D 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.

Caution:
 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.

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

Guidance and manufacture’s declaration – electromagnetic emission

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

Emission s test Compliance Electromagnetic environment –

guidance

The Syringe pump uses RF energy

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

RF emissions
Class A
CISPR 11 The Syringe pump is suitable for use
in all establishments, including
Harmonic emissions
Not applicable domestic establishments and those
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

49
Guidance and manufacture’s declaration – electromagnetic immunity

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

Immunity test IEC 60601 test level Compliance level Electromagnetic

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

±2 kV for power supply Mains power quality should

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

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

Surge ± 1 kV line(s) to line(s) line(s) be that of a typical
IEC 61000-4-5 +2 KV line(s)to earth +2 KV line(s)to commercial or hospital
earth environment.
<5% UT <5% UT
(>95% dip in UT) (>95% dip in UT)
for 0.5 cycle for 0.5 cycle Mains power quality should
be that of a typical
Voltage dips,
40% UT 40% UT commercial or hospital
short
(60% dip in UT) (60% dip in UT) environment. If the user of
interruptions
for 5 cycles for 5 cycles the Syringe pump requires
and voltage
continued operation during
variations on
70% UT 70% UT power mains interruptions, it
power supply
(30% dip in UT) (30% dip in UT) is recommended that the
input lines
for 25 cycles for 25 cycles Syringe pump be powered
IEC 61000-4-11
from an uninterruptible
<5% UT <5% UT power supply or a battery.
(>95% dip in UT) (>95% dip in UT)
for 5 sec for 5 sec
Power frequency magnetic
Power
fields should be at levels
frequency
characteristic of a typical
(50Hz/60Hz) 3 A/m 400A/m
location in a typical
magnetic field
commercial or hospital
IEC 61000-4-8
environment.

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

50
Guidance and manufacture’s declaration – electromagnetic immunity

The Syringe pump is intended for use in the electromagnetic environment specified below. The
customer or the user of Syringe pump should assure that it is used in such an environment.
IEC 60601 Compliance
Immunity test Electromagnetic environment - guidance
test level level

Portable and mobile RF communications

equipment should be used no closer to any
3 Vrms part of the Syringe pump, including cables,
Conducted RF
150 kHz to 80 10 Vrms than the recommended separation distance
IEC 61000-4-6
MHz calculated from the equation applicable to
the frequency of the transmitter.
Recommended separation distance
d = 1.167
d = 1.167 P 80 MHz to 800 MHz
d = 2.333 P 800 MHz to 2.5 GHz
Where P is the maximum output power
rating of the transmitter in watts (W)
according to the transmitter manufacturer
3 V/m and d is the recommended separation
Radiated RF
10 V/m distance in meters (m).
80 MHz to
IEC 61000-4-3
2.5 GHz Field strengths from fixed RF transmitters,
as determined by an electromagnetic site
survey, a should be less than the compliance
level in each frequency range.b
Interference may occur in the vicinity of
equipment marked with the following
symbol:

NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.

a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV
broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic
environment due to fixed RF transmitters, an electromagnetic site survey should be
considered. If the measured field strength in the location in which the Syringe pump is used
exceeds the applicable RE compliance level above the Syringe pump should be observed
to verify normal operation. If abnormal performance is observed, additional measures may
be necessary, such as reorienting or relocating the Syringe pump.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

51
Recommended separation distances between

portable and mobile RF communications equipment and the Syringe pump .

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

Separation distance according to frequency of transmitter

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

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

0.01 0.117 0.117 0.233

0.1 0.369 0.369 0.738

1 1.167 1.167 2.333

10 3.689 3.689 7.379

100 11.667 11.667 23.333

For transmitters rated at a maximum output power not listed above, the recommended separation
distance d in meters (m) can be estimated using the equation applicable to the frequency of the
transmitter, where P is the maximum output power rating of the transmitter in watts (W)
according to the transmitter manufacturer.

NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range
applies.

NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.

52
Appendix E Wireless Module Information

Parameter Name Parameter Value

Frequency Range 2.412GHz-2.482GHz

Modulating Type OFDM, CCK, DSSS

Effective Radiating Power < 20dBm

53
Appendix F Factory Default Data Set
Parameters Default Setting Parameters Default Setting
KVO rate 1ml/h Sound 10%
Occlusion pressure 450mmHg Screen lock ON
Finish pre-alarm 2min Brightness 100%
Reminder alarm 2min Night mode OFF
Pressure unit mmHg Nurse call OFF
Micro mode OFF Drug Library None
Commonly used
Double-Dove Relay mode OFF
syringe brand

54
Version:V5.0

Revising Date:2020.3.12

Common questions