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: +86-20-8307-0896
Fax: +86-20-8307-0817
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.
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