Hedy HealFusion User manual

HEDY Medical Device Co. Ltd.
HealFusion
Infusion Pump User Manual
(i7, ip-3)

Product Information
Congratulations on your purchase of HealFusion Infusion Pump. Before using
this product, please read this manual carefully for proper use of the product.
Please keep this manual after reading so that you can access at any time when
needed.
Manufacturer: HEDY Medical Device Co., Ltd.
Address: No.286, Science Avenue, Guangzhou High and New Tech
Development Zone, 510663, P. R. China
Tel: [phone]
Fax: [phone]
Mail: [email protected]
REVISION HISTORY:
VER
DATE
v1.0
May, 2015
v2.0
Dec.,2015
v3.0
Jun.,2016

I
Contents
Chapter 1 Safety Precaution ..........................................................1-1
1.1 Safety Signs................................................................................ 1-1
1.2 Safety Information...................................................................... 1-2
1.3 Electric Safety Preventive Measurements................................... 1-4
1.4 Contraindications........................................................................ 1-5
1.5 EMC ........................................................................................... 1-5
1.6 Environment Safety Preventive Measurements .......................... 1-5
Chapter 2 Brief Introduction ..........................................................2-1
2.1 Brief Introduction of the User Manual........................................ 2-1
2.2 Brief Introduction of the Pump................................................... 2-2
2.3 Device Features and Intended Use.............................................. 2-3
2.4 Overview .................................................................................... 2-3
2.5 Daily Use Procedures ............................................................... 2-13
Chapter 3 Operation ......................................................................3-1
3.1 Before the Operation................................................................... 3-1
3.2 Operation Procedure................................................................... 3-1
3.2.1 Turn On ......................................................................................3-1
3.2.2 Basic Settings .............................................................................3-1
3.3 Modes......................................................................................... 3-6
3.3.1 Rate Mode ..................................................................................3-7
3.3.2 Dosage Mode..............................................................................3-8
3.3.3 V-T Mode.................................................................................3-10
3.3.4 R-T Mode .................................................................................3-12

II
3.3.5 Trapezia Mode..........................................................................3-12
3.3.6 Intermittent Mode.....................................................................3-14
3.3.7 Loading Dose Mode .................................................................3-15
3.3.8 Sequence Mode......................................................................... 3-17
3.4 Relay Mode............................................................................... 3-18
3.5 Settings..................................................................................... 3-18
3.5.1 VTBI Finish Setting..................................................................3-20
3.5.2 Manual Bolus setting................................................................3-21
3.5.3 Push Vol. Setting......................................................................3-21
3.5.4 Power On Settings ....................................................................3-22
3.5.5 Vol. & Brightness Setting......................................................... 3-24
3.5.6 Auto-Lock Setting .................................................................... 3-25
3.5.7 Cap Rate Setting.......................................................................3-25
3.5.8 Drip Rate Display Setting.........................................................3-26
3.5.9 Bubble Size Setting................................................................... 3-27
3.5.10 IV Set Type Setting ..................................................................3-28
3.5.11 Day & Night Setting................................................................. 3-28
3.5.12 System Time setting ................................................................. 3-29
3.5.13 Extended IV Set Calibration.....................................................3-30
3.5.14 System Version......................................................................... 3-32
3.6 Logs.......................................................................................... 3-32
3.6.1 Operation Logs.........................................................................3-33
3.6.2 Alarm Logs...............................................................................3-34
3.6.3 Infusion Logs............................................................................3-34
3.7 Drugs ........................................................................................ 3-35

III
3.8 Service...................................................................................... 3-36
Chapter 4 Technical Data ...............................................................4-1
4.1 Infusion Accuracy........................................................................ 4-1
4.2 KVO Mode................................................................................... 4-2
4.3 Blocking Threshold...................................................................... 4-3
Chapter 5 Alarm and Tips...............................................................5-1
5.1 Alarm Function........................................................................... 5-1
5.2 Alarm Priority............................................................................. 5-1
5.2.1 High-level Alarm........................................................................5-2
5.2.2 Intermediate-level Alarm............................................................5-4
5.2.3 Low-level Alarm.........................................................................5-4
5.2.4 Alarm acknowledgement reference table....................................5-6
5.3 Tips............................................................................................. 5-6
Chapter 6 Maintenance .................................................................6-1
6.1 Cleaning/Disinfection................................................................. 6-1
6.2 Maintenance................................................................................ 6-2
6.3 Safe Use and Maintenance of the Rechargeable Batteries.......... 6-2
Appendix A Start-up Curves and Trumpet Curves....................A-1
Appendix B EMC Information.....................................................B-1
Appendix C Abbreviations............................................................C-1

IV
Preface
Statement
HEDY Medical Device Co., Ltd. (hereinafter referred to as the manufacturer)
has the copyright of this non-publication manual. This manual is for reference
only while operating, maintaining and repairing the manufacturer’s products.
Other persons have no right to disclose the content of this manual to any other
persons.
This manual contains the proprietary data and information which are protected
by the copyright law. All rights reserved. No part of this Manual is
photographically reproduced, copied or translated to other languages without
prior written permission from the manufacturer.
All contents of this manual are considered correct. The manufacturer has no
legal liability and responsibility for the accidental or inevitable damage caused
by improper installation and operation. The manufacturer doesn’t give the
concessions granted by the copyright law to any other parties. For the legal
consequences caused by the infringement of copyright law and any third
party’s rights, the manufacturer has no legal liability and responsibility.
Contents contained in this manual are subject to change without prior notice.
Manufacturer’s Responsibility
The manufacturer should be responsible for the safety, reliability and
performance of this machine only under the following conditions, i.e.:
The assembling operation, extension, readjustment, improvement and
maintenance are done by the qualified personnel approved by the
manufacturer.
The related electrical devices conform to national standards.

V
The machine is used according to the conditions and requirements
described in this manual.
User Notice
To ensure operation safety and long-term stable performance of the
system, it’s strongly recommended reading this manual to get a full
knowledge on the function, operation and maintenance before operating the
system.
Pay special attention to contents of ―Warning‖, ―Caution‖ and ―Note‖ in
this manual.
The manufacturer takes no responsibility for any damage or harm
caused by incorrect operation or maintenance inconsistent with instructions of
the manufacturer or its agent thereof.
The Dosage Mode, Drugs, WiFi and some other functions are optional,
the user can choose to have these functions or not.
Warranty
The manufacturer guarantees 12 months of warranty for the main unit
and its material and technology. During warranty period, the manufacturer
provides free repairing and damaged part replacement.
The warranty only applies to faults occurred in operation under
conditions specified by this manual. So, please make sure the system is used
within the application scope recommended by this manual.
The warranty doesn’t apply to damage caused by accidents, misuse,
abuse, falls, modification or alteration to any part or component of the system.
Surface damage is not included in the free repair or replacement range.
Battery replacement, training material supply, etc. are not free, either.

VI
The manufacturer takes no responsibility for any damage caused by
other system or unauthorized connection to other systems.
The manufacturer takes no responsibility for any loss, damage or harm
caused by delayed service request.
Please report to the manufacturer after-sale service department if the
system has any malfunction. Model number, series number and a brief
description of the malfunction are supposed to be provided in the report.

1-1
Chapter 1 Safety Precaution
1.1 Safety Signs
The following messages can be read throughout this manual, they are
supposed to be paid special attention to.
WARNING!
A WARNING label applies to information that may
cause severe personal injury, death or actual property loss
if neglected.
CAUTION！
A CAUTION label applies to information that may cause
mild personal injury or property loss if neglected.
NOTE！
A NOTE label applies to information on installation,
operation or maintenance, which is very important but
poses no risk potential.
Table 1-1 Equipment Symbols
Num.
Symbol
Description
1
Defibrillation-proof type CF applied part
2
Refer to the instruction manual/booklet
3
Labeling of electric and electronic devices
according to directive 2002/96/EC(WEEE)

1-2
4
Serial number
5
Manufacture date
6
Manufacture information
7
European community representative
8
General warning sign
9
Flow direction arrow
10
Non-ionizing radiation
11
IPX3
Waterproofing grade
1.2 Safety Information
Safety of the operator or the examinee, and reliability of the system are
generally considered during designing and manufacturing. However the
following safety preventive instructions should be followed.
1. The system should be operated by qualified personnel or under the
guidance of qualified personnel.
2. The system belongs to type CF, class I system，defibrillation recovery
time for 5s.
3. When there is any equipment failure, please turn off the pump and
contact the manufacturer or its authorized agent immediately.

1-3
4. Avoid operation or storage in the following environments:
Sharp temperature variance.
Rather high humidity, poor ventilation.
Water vapor exposure, do not operate the system with wet hands.
Near heat-emitting systems.
Direct solar irradiation.
Violent shakes or vibration.
Near chemical materials or explosive gas.
Do not let dust or metal articles fall into the system.
Do not disassemble or open the system. the company won't shoulder any
responsibility for any result caused thereby.
Take the plug rather than the wire for pulling out the power line.
5. Environmental specifications
Transport & Storage Temperature: -30℃～70℃.
Transport & Storage Relative Humidity: 10％～90％.
Transport & Storage Atmospheric Pressure: 22kPa～106kPa.
Operating Temperature: 5℃～40℃.
Operating Relative Humidity: 10％～90％.
Operating Atmospheric Pressure: 70kPa～106kPa.
Maximum elevation of 3000 meters.
6. Power supply
AC: 100-240VAC 50/60Hz 35VA.
DC: 10-15VDC 2.5A.
7. Pump mobile condition
When handling equipment (especially the stairs), care must be taken.

1-4
If the pump fall or bump, it must be inspected and tested by service
personnel.
After selecting the location to place the equipment, before installing this
system, please make sure the power supply is normal.
8. The emergency measure and corrective action during use
If there are any errors or equipment failure during use, the user should
immediately stop operation and take care of the wounded. Contact the
manufacturer or its authorized agent immediately.
Users are not permitted to repair any components of the equipment
without authorization. Please put all the maintenance tasks to qualified
maintenance personnel.
WARNING!
The Infusion pump is not a raw material, and the device is
not supposed to be used as a portable device.
WARNING!
The hospital & agent which have the right to use the pump,
are responsible for the proper use of the system, otherwise
it may cause abnormal fault and damage the patients’ life.
1.3 Electric Safety Preventive Measurements
The pump meets the requirement of IEC 60601-1:2005，IEC 60601-2-24:2012，
IEC 60601-1-8:2007. In addition, the following points should be paid
attention to.
The power cable should conform to the power cable of the system. The
system should be well grounded (otherwise, noise may be produced).

1-5
WARNING!
To avoid the risk of electric shock, this equipment must
only be connected to supply mains with protective earth.
Do not open the enclosure without permission. Do not change any other
parts of the pump without permission.
In case of any equipment failure, cut off the power supply immediately
and contact the manufacturer or its authorized agent.
The fuse is manufactured by Littelfuse, Inc. The specification is 392 T1
AL 250 V.
1.4 Contraindications
/
1.5 EMC
The EMC-limits (electro-magnetic compatibility) according to IEC/EN
60601-1-2 and IEC/EN 60601-2-24 are maintained. If the equipment is
operated in the vicinity of other equipment which may cause high levels of
interference (e.g. HF surgical equipment, nuclear spin tomography units,
mobile telephones etc.) maintain the recommended protective distances from
these devices.
Refer to Appendix B for more information.
1.6 Environment Safety Preventive Measurements
The waste must be treated follow the local laws timely (especially the
disposable infusion device).

1-6
Equipment and accessories probably cannot be normal used at the end of
life, ensure to replace the equipment or accessories timely to decrease the risk
to the minimum. The battery inside the device is not replaceable.
Harmful substances and the content in the product:
Table 1-2 Harmful Material and Its Content
Component
Hazardous Substance
Pb
Hg
Cd
Cr6+
PBB
PBDE
Host
○
○
○
○
○
○
Cable
○
○
○
○
○
○
○indicates that the concentration of the hazardous substance in all
homogeneous materials in the parts is below the relevant threshold of the
RoHS Directive (2011/65/EU Directive), the system is fully in compliance
with RoHS requirements in terms of component selection and application,
production process control, overall testing, appearance and labeling.
╳indicates that the concentration of the hazardous substance in all
homogeneous materials in the parts is beyond the relevant threshold of the
RoHS Directive (2011/65/EU Directive), the system is fully in compliance
with RoHS requirements in terms of component selection and application,
production process control, overall testing, appearance and labeling.

2-1
Chapter 2 Brief Introduction
2.1 Brief Introduction of the User Manual
This User manual introduced the HealFusion Infusion Pump. It applies
enough information for the user to operate and storage the pump. Please read
it carefully before using.
This User manual applies enough information for the user to operate the
pump safety. It contains the system’s basic function, security features, operate
mode, how to care and maintenance the pump. Please read it carefully before
using.
In daily operations, we can refer to fast operation card to make quick
access.
This manual consists of several independent chapters. Partial contents in
some chapters are identical. All chapters are compiled to provide the user with
reading convenience and content consistency.
Any query on operation of this system, please turn to the manufacturer’s
service engineer or its authorized distributor for support.
NOTE！
The User manual describes the operation of the pump,
before using, the user must be familiar with the
operation and precautions, in order to avoid
unnecessary losses.
Also, medical equipment used in the room must
conform to the relevant regulations (such as IEC,
VDE0100 or VDE0107).

2-2
2.2 Brief Introduction of the Pump
Product name: Infusion Pump
Product type: i7/ip-3, The differences between two types are as follows:
i7 has gray panel, and can support up to 2000 logs.
ip-3 has purple panel, and can support up to 1500 logs.
This system consists of the following parts: Infusion pump enclosure,
drive system, input system, storage system, control system, display system,
sensor monitoring system, alarm system, internal rechargeable battery.
Congratulations on your purchase of HealFusion Infusion Pump. This
system is a high quality system which is stable and convenient to operate. It is
suitable for all qualified doctors, this pump consists of the following modes:
Rate Mode
Time Mode(include V-T Mode and R-T Mode)
Dosage Mode(optional)
Trapezia Mode(optional)
Intermittent Mode(optional)
Loading Dose Mode(optional)
Sequence Mode(optional)
Note: Mean Time to power down from fully charged @ 5ml/h under normal conditions is
more than 6 hours, @ 2000ml/h more than 1.5h, and need less than 4 hours to be charged full.
Classification
Class I / Internally powered equipment;
Type CF applied part;
IPX3–Protected against vertically falling drops of water;
No sterilization requirement;
Not Category AP / APG equipment;

2-3
Mode of operation: Continuous;
2.3 Device Features and Intended Use
Intended use: working with the infusion set. The pump is suitable for the
hospital operating room, ICU, outpatient and general wards and other places,
which is used to control the flow of liquid infused into the patient. The
injection site support for intravenous.
The pump is an advanced device for treatment, which is used for
infusion. It can accurately control the infusion velocity, and input the liquid to
the patient timely and accurately. It can guarantee the accuracy of the dose
rate and work safely into the patient, making it especially suitable for the
situation that requires liquid flow rate and dosage controlled strictly.
NOTE！
Since the infusion pump is a kind of life support
equipment, ensure to enter the correct infusion rate
and volume, otherwise it may damage the patients’ life.
2.4 Overview
1. Features of the Pump

2-4
Figure 2-1 Pump Closed
Figure 2-2 Pump Open

2-5
Figure 2-3 Rear View
Table 2-1 Equipment Parts Description Table
Num.
Symbol
Description
1
Connect button
Fixed stacked Infusion pump and syringe pump
2
3.5 inch color
display
Display menus and submenus, can be operated
by touching
3
Indicator
ALARM indicator indicates the alarm status,
POWER indicator indicates the power status
4
Operation panel
ON/OFF button, RUN/STOP button,
MUTE/BACK button, PUSH/ BOLUS button,
Arrow keys, ENTER/OK button, indicators
5
Door handle
Open/close the door
6
Safety clamp
Prevent the infusion liquid from flowing when
the door open
7
Air sensor
Detect air bubbles in the infusion tube(note: the
infusion tube between pump and patient cannot be
detected, it must be artificial ruled out)
8
Pressure sensor
Detect the pressure in the infusion tube

2-6
9
Door fixed shaft
Fixed the door
10
Door sensor
Detect the door’s state
11
Infusion tube slot
Fixed the infusion tube
12
Back interface
AC power connector(12(a)), RS232
Connector(12(b))
SIP/SOP function
12(b) is RS232 Connector, it provides:
External DC voltage input function.
RS232 Connector: RS232 interface can be used with a two-way
communication, please ask our Customer Service Department to obtain an
interface protocol if necessary, RS232 communication cable need to use
shielded cable. The device which is connected to the RS232 interface should
conform to the standard of IEC60950.
Staff call: RS232 Connector generated high.
WARNING!
The plug is used as disconnect to the mains supply, do
not to position the pump to make it difficult to operate
the disconnection device when an appliance coupler or
mains plug or other separable plug is used as
isolation.
2. Operation Panel