Biocare iE 101 User manual

Digital Electrocardiograph
Model: iE 101 & iE 300 for vet
User Manual
Shenzhen Biocare Bio-Medical Equipment Co., Ltd.
P/N: 02111785-01
Version: V1.1
Date: 2019-08

About The User Manual
Thank you for purchasing our product!
In order to enable you to skillfully operate our product as soon as possible, a detailed user manual is attached.
Please make sure to read all the content when installing and using the product for the first time.
To improve the performance and reliability of its parts, the product (including hardware and software) may be
changed from time to time, during which, we will try to modify or add contents. Please forgive us as there may
still be inconsistency with some descriptions.
We look forward to your corrections in case of any errors and omissions in this manual.
All rights reserved © Shenzhen Biocare Bio-Medical Equipment Co., Ltd.
Information contained in this document is proprietary to Shenzhen Biocare Bio-Medical Equipment Co., Ltd. No
part of this publication may be reproduced, stored in a retrieval system, or transmitted in any form, in whole or in
part, by any means electronic, mechanical or other, including photocopying and recording, for any purpose
without written permission of Biocare.
is registered trademark owned by our company.
®

Explanation of key words
WARNING
Indicate a potentially hazardous situation which, if not avoided, could result in death or serious injury.
CAUTION
Indicate a potentially hazardous situation which, if not avoided, may result in slight personal injury or equipment
failure.
EXPLANATION
Other important information besides warning or caution.
Explanation of part symbols
Symbol
Explanation
Symbol
Explanation
Alternating Current
Type CFApplied Part
Direct Current
Type CF applied part including
defibrillation-Proof
Battery Charging
LAN Port
Equipotential Terminal
USB Port
Please refer to user manual!

Conventions
Format
Explanation
”***”
Used to quote the texts in the screen of the machine.
[****]
Used to quote the shortcut buttons or keys in the screen of the machine.
TEXT
Used to quote the referenced chapters or sections in this manual.

Contents
User Manual for Electrocardiograph --I--
Contents
Foreword .................................................................................................................................................................. 1
Chapter 1 Introduction ........................................................................................................................................... 9
1.1 Equipment Overview................................................................................................................................. 10
1.1.1 Front View ...................................................................................................................................... 10
1.1.2 Left View .........................................................................................................................................11
1.1.3 Right View.......................................................................................................................................11
1.1.4 Operating Buttons........................................................................................................................... 12
1.2 Handle Installation..................................................................................................................................... 13
1.3 Waveform Display..................................................................................................................................... 14
1.3.1 Same Screen Display...................................................................................................................... 14
1.3.2 Split-screen Display........................................................................................................................ 15
Chapter 2 Preparation........................................................................................................................................... 17
2.1 Locate the ECG Machine........................................................................................................................... 17
2.2 Install Recording Paper.............................................................................................................................. 17
2.3 Connect to Power Supply .......................................................................................................................... 18
2.4 Connect to Animal Cable........................................................................................................................... 19
2.5 Power On/Off............................................................................................................................................. 20
2.6 Connect to Network................................................................................................................................... 20
2.7 Apply Electrodes........................................................................................................................................ 21
2.7.1 Electrodes Attachment.................................................................................................................... 22
Chapter 3 EnteringAnimal Information............................................................................................................. 23
3.1 Enter Animal Information.......................................................................................................................... 23
3.2 Introduction of Input Method .................................................................................................................... 25
3.2.1 Standard Character Keyboard......................................................................................................... 25
3.2.2 Digital Keyboard ............................................................................................................................ 26
Chapter 4 ECG Recording.................................................................................................................................... 27
4.1 Introduction of Sensitivities, Filters, Print Speed...................................................................................... 28
4.2 Record ECGs............................................................................................................................................. 29

Contents
--II--User Manual for Electrocardiograph
4.2.1 Main Steps to Record ECG............................................................................................................. 30
4.3 Introduction of Record Mode .................................................................................................................... 31
4.3.1 Auto Mode...................................................................................................................................... 32
4.3.2 Manual Mode.................................................................................................................................. 33
4.3.3 Upload Mode.................................................................................................................................. 33
4.4 Advanced Mode......................................................................................................................................... 34
4.4.1 Rhythm Mode................................................................................................................................. 34
4.4.2 Analysis Report Mode .................................................................................................................... 35
4.4.3 Freeze Mode ................................................................................................................................... 36
Chapter 5 Setting System Parameters................................................................................................................. 37
5.1 ECG Setting............................................................................................................................................... 37
5.2 Print Setting............................................................................................................................................... 39
5.3 Display Setting........................................................................................................................................... 40
5.4 Animal Information Setting ....................................................................................................................... 40
5.5 System Setting........................................................................................................................................... 41
5.6 Factory Maintain........................................................................................................................................ 43
Chapter 6 Data Management................................................................................................................................ 45
6.1 Open an ECG File...................................................................................................................................... 46
6.2 Edit an ECG File........................................................................................................................................ 46
6.3 Delete ECG Files....................................................................................................................................... 46
6.4 Copy and Move ECG files......................................................................................................................... 47
Chapter 7 Maintenance......................................................................................................................................... 49
7.1 Main Unit................................................................................................................................................... 49
7.2 Animal Cable............................................................................................................................................. 49
7.3 Cleaning and Disinfection ......................................................................................................................... 49
7.4 Recording Paper......................................................................................................................................... 50
7.5 Battery ....................................................................................................................................................... 50
7.6 Silicon Rubber Shaft for Printing .............................................................................................................. 52
7.7 Thermal Print Head.................................................................................................................................... 52
Chapter 8 Troubleshooting................................................................................................................................ 53

Contents
User Manual for Electrocardiograph --III--
8.1 Lead Fault.................................................................................................................................................. 53
8.2 Printer Failure............................................................................................................................................ 54
8.3 Indicator of Lead Off................................................................................................................................. 54
8.4 AC Interference.......................................................................................................................................... 55
8.5 EMG Interference...................................................................................................................................... 55
8.6 Baseline Wander........................................................................................................................................ 56
8.7 The ECG Machine cannot be turned on..................................................................................................... 57
8.8 Paper Feeding Failure................................................................................................................................ 57
8.9 Battery is quickly Charged and Discharged............................................................................................... 58
8.10 File Uploading Failure............................................................................................................................. 58
AppendixA Package and Accessories.................................................................................................................. 59
A.1 Packing List .............................................................................................................................................. 59
A.2 Dimensions and Weight............................................................................................................................ 59
Appendix B Technical Specification..................................................................................................................... 61
B.1 Specifications............................................................................................................................................ 61
B.1.1 Main Unit....................................................................................................................................... 61
B.1.2 Recorder Specification................................................................................................................... 62
B.1.3 Other Specification......................................................................................................................... 62
B.2 Environment Requirements....................................................................................................................... 63
Appendix C EMC-Guidance and manufacture’s declaration............................................................................ 65
C.1 Guidance and manufacturer’s declaration – electromagnetic emission .................................................... 65
C.2 Guidance and manufacture’s declaration-electromagnetic immunity for all EQUIPMENT and SYSTEMS.
......................................................................................................................................................................... 66
C.3 Guidance and manufacture’s declaration-electromagnetic immunity for EQUIPMENT and SYSTEMS
those are not LIFE-SUPPORTING.................................................................................................................. 67
C.4 Recommended separation distance between portable and mobile RF communications equipment and the
EQUIPMENT or SYSTEM for EQUIPMENT or SYSTEM that are not LIFE-SUPPORTING..................... 69

Contents
--IV--User Manual for Electrocardiograph
-- Blank Page –

Foreword
User Manual for Electrocardiograph -- 1 --
Foreword
CAUTION
This ECG machine shall be used by qualified health professionals in the medical units.
In sequence to use this ECG machine correctly, safely and effectively, please read through the user manual
carefully.
★Safety Information
WARNING
Avoid using and storing in the places with sulfur, salt, alkaline gas or with risk of gas leakage.
Avoid using in the places with anesthetic gases, flammable gases such as oxygen, hydrogen or other
flammable chemicals, or it may cause explosion or fire.
Select a room with intact infrastructure (good power supply system and grounding facilities).
Be cautious when the animal is connected with more than one instrument, because the total leak current may
be harmful to the animal. Devices in compliance with the standard of IEC60601-1 are allowed to be
connected to this ECG machine, and the equipotential points of all the connected devices should be
connected reliability. (The equipotential point and the protection ground of this ECG machine have been
connected). Total leak current should be measured by the users to determine that it meets the requirement and
can be used after connection.
All the analog and digital equipment that is connected to this ECG machine in the using environment has to
be in compliance with the standard IEC60601-1; All the analog and digital equipment that is connected to
this ECG machine out of using environment has to be in compliance with other national safety standards
(IEC or ISO safety standards); the composition system should be in compliance with the standards of IEC
60601-1-1.
When the equipment is used simultaneously with cardiac defibrillators, avoid contacting with animals or
hospital beds. All the electrodes connected and unconnected to animals as well as animals themselves do not
have to be grounded. Do not use other electrical stimulators at the same time. If needed, it should be a
professional technician to carry out the operation.
Chest and limb electrodes along with the device in the packing box could not meet the requirements of

Foreword
-- 2 -- User Manual for Electrocardiograph
defibrillation polarization recovery time (however, they are essential accessories of ECG), should not be used
immediately for reliable measurements and diagnostics after defibrillation. To ensure proper defibrillator
protection, use only the recommended disposable electrodes (Name: Skintact; Type, RT-34), lead wire and
electrode adapters by our company. To ensure the protection of defibrillator discharge, use the lead wire with
defibrillation-proof by our company.
When the ECG machine is used together with a defibrillator or other electrical stimulators (like
high-frequency surgical devices), we recommend using disposable chest electrodes. Otherwise the animal
may get serious injury by using mental electrodes.
During defibrillation, the device can detect the discharge of defibrillator, and process automatically, and then
quickly recover the waveform.
Keep the ECG machine electrodes away from the electrodes of high-frequency electrosurgical units. Ensure
the resistance between the electrosurgical unit and animal body is as low as possible. If necessary, the
disposable electrodes can be used because of its larger contact area on the animal body, which can keep the
high-frequency current density in an acceptable range.
When the relevant packaging material including, depleted batteries and scrapping products are disposed,
please follow the local laws; the user should properly follow requirements of local laws, and recycling laws.
CAUTION
Avoid contacting with water or other liquids, and avoid using and storing in spaces with too large barometric
pressure, humidity and temperature beyond the prescribed standards, poor ventilation, or with excessive dust.
The ECG machine should be place on the flat horizontal table and avoid strong vibration and mechanical
shock while moving.
The frequency of AC power supply and system voltage should be complied with the requirements. More
importantly, the current capacity should be sufficient.
The instrument should not be surrounded by high-voltage cables, ultrasound equipment, electrotherapy
machines and other high-power equipment.
To more accurately record the ECG, the equipment shall be placed in a quiet and comfortable environment.
The circuit of application parts works based on floating ground and meets the safety standards in IEC60601-1
CF Type. It can be used in acquiring the body surface ECG signals, but cannot applied to the heart directly.
Turn off the ECG machine if an accident happens.

Foreword
User Manual for Electrocardiograph -- 3 --
Please clean and disinfect reusable electrodes with medical alcohol before using.
The conductive parts of electrodes and connectors (including neutral electrodes) on the ECG machine should
not in touch with other conductive parts.
Do not press the buttons with sharp or hard articles or it may cause permanent damage to the buttons.
Do not make any modifications to this ECG machine.
Perform regular maintenance and inspection for this ECG machine and all its accessories (at least once every
six months).
The maintenance and repair of this ECG machine should be performed by experienced technicians. When
there is any functional abnormality, it should be clearly identified to prevent the ECG machine from running
with fault.
The electrical schematic diagrams and parts listed are only provided to a qualified repair station or
technicians recognized by the company.
★General Operation Precautions
Before operation:
CAUTION
Make sure the ECG machine is in good condition and the recording paper is sufficient.
Make sure the temperature and humidity of operating environment comply with the requirements.
Do not operate ECG machine in a place with X-ray equipment, ultrasound scanner, or other similar
equipment. Those equipments may interfere with the ECG machine. If necessary, power off the mentioned
equipments or move the ECG machine to an environment without interference.
Make sure all lead wires are connected correctly and are kept away from the AC power cable.
Make sure the equipotential cable of the ECG machine is reliable and properly connected.
Make sure the power cable is properly connected with the ECG machine and is not twisted with other cables
or wires.
Put the lead wires in good order before connecting them to the electrodes.
Make sure the electrodes are in good contact with skin. Please refer to Apply Electrodes for details.
Please install the ECG machine near an AC power outlet. Cut off the power supply immediately when there
is an emergency.
Please keep the animal quiet and motionless.

Foreword
-- 4 -- User Manual for Electrocardiograph
Use wide hospital beds and keep the animal from touching the metal parts of the hospital bed, which may
cause interference in ECG waveform recording.
Keep the Examination room quiet and comfortable.
WARNING
All circuits that come in contacting the animal directly should be examined closely.
When using the battery as the power supply, please check the voltage and condition of the battery first and
make sure the battery is fully charged. For new batteries, please discharge and charge it fully before using.
Use only 3-core power cable when using AC power, otherwise hazard of electric shock to the animal and
operator cannot be completely eliminated. If the power cable is not working, only the built-in battery can
safely power the ECG machine.
Make sure equipotential connection is complete and reliable, or else only use the built-in battery.
If the ECG machine is used for the first time or stored for more than three months without use, please verify
that the system time is correct before use, otherwise set the system time first.
In operation:
WARNING
The physician should observe the animal closely without leaving during the operation. If necessary, turn off
the ECG machine and remove the electrodes to ensure the animal’s safety.
Prevent the animals from contacting the other parts of the ECG machine or other conductors except for the
electrodes.
After operation:
CAUTION
Please return to the main interface before turning off the ECG machine.
Remove the electrodes gently and do not pull the lead wires emphatically.
Clear up the ECG machine and all the accessories for trouble-free operation of next use.

Foreword
User Manual for Electrocardiograph -- 5 --
About LCD screen
CAUTION
Do not place any heavy objects onto the LCD screen or strike it, otherwise it could damage the LCD screen.
When not using it, please put it away or have a cover on it. Keep it away from water.
About lithium battery
WARNING
Only the authorized installation or service engineer can open the battery cover and replace the battery; do use
the same type of rechargeable lithium battery provided by our company.
The positive and negative terminals of the batteries cannot be reversed, or it could cause an explosion.
Do not connect the two polarities of the battery with metal wires. Otherwise, there will be the hazard of fire.
Do not use the battery near a heat source or in and the environment with temperature up to 60 ℃; do not heat
the battery or throw it into the fire.
Keep the battery away from water; do not drop the battery into the water.
Do not press any metal into the battery; Do not hammer or beat the battery or use other ways to damage the
battery, otherwise it will cause heat, smoke, deform or burn, which is very dangerous.
When you find battery leakage or its emitting unpleasant odors, please get away from it immediately. If the
fluid leaks onto the skin or clothes, wash with clean water at once. If the electrolyte enters the eyes, do not
rub the eyes, wash with clean water immediately, and then go to see a doctor.
The users need to check the battery status regularly. When the battery reaches the end of its lifetime, when it
smells, deforms, discolor, contorts, the users should stop using and dispose of it according to local
regulations.
★EMC Considerations
This ECG machine conforms to the IEC60601-1-2, a safety standard for medical electronic devices or systems.
However, the electromagnetic environment exceeding the limit or level defined by the standard IEC60601-1-2
will introduce the unwanted interference to the ECG machine, disable its intended functions or it will compromise
its intended performance. Thus, if there is any discrepancy with this ECG machine compared to its intended

Foreword
-- 6 -- User Manual for Electrocardiograph
functions during operation, please do not use it for longer until the adverse affect is identified and eliminated. The
appropriate preventing measures are given below by this manual for such cases:
Influence of radiated electromagnetic wave:
The use of a mobile phone may affect this ECG machine. Instruct all the people around to turn off their
mobile phone or mini-radio devices when any medical electronic device is in use.
Influence of impact and conductive electromagnetic waves:
The high frequency noise produced by other devices can be introduced into this ECG machine through the
alternating current socket. Please identify the noise source first, and if possible, stop the working of related
devices. If they are not allowed to be stopped, measures such as application of noise abatement device should
be taken to minimize the influence.
Influence of static electricity:
The static electricity in a dry environment (indoor) may affect this ECG machine, especially in winter. Please
humidify the indoor air or pre-discharge the static electricity on the cable and the electrocardiogram
recording personnel prior to using this ECG machine.
Influence of thunder and lightning:
A thunder and lightning strike nearby may cause voltage surge in this ECG machine. You can unplug the
power supply and run the ECG machine using its internal battery in case of any danger.
Instrument classification
Methods
Class
By Type of Protection Against Electric Shock
Class I, internal power supply
By Degree of ProtectionAgainst Electric Shock
Type CF applied part
By Degree of Liquid Proof
Ordinary equipment (enclosed device without liquid proof)
By Level of Protection Against Explosion
This equipment is unsuitable for use in an environment with
air, oxygen or nitrous oxide mixed with flammable anesthetic
gas.
By Mode of Operation
Continuous operation equipment

Foreword
User Manual for Electrocardiograph -- 7 --
Maintenance Warranty
Our company guarantees the new instrument on the material and technological qualification for this product
within 18 months and the accessories within 6 months since purchasing day, while consumables are not covered
by the guarantee in principle. This guarantee is also inapplicable to the products undergoing any modification,
disassembly, refitting or self-repairing without permission of our company, as well as the products damaged by
accidents, fire disaster, thunder and lightning, flood and other disaster, intentional damage, improper installation
and improper usage.
CAUTION
For all dated reference documents in this manual, its subsequent amendments (excluding corrections) or
revisions do not apply to this manual; for undated reference documents, the latest version applies in this
manual.
Due to product improvement, the content of this User Manual may differ from the product you purchased,
which will not affect the usage, please operate according to the actual functions of the product.
This manual is subject to change without prior notice. We apologize for any inconvenience caused.

Foreword
-- 8 -- User Manual for Electrocardiograph
-- Blank Page --

Chapter 1 Introduction
User Manual for Electrocardiograph -- 9 --
Chapter 1 Introduction
[Main structure, performance]
The ECG machine is mainly composed of the main unit, animal cable andAnimal ECG Electrode Holders.
[Scope of application]
This ECG machine is used to extract the electrocardio complex from the animal body for clinical diagnosis and
research.
[Intended Use]
Only suitable for: animals;
Used in: animal hospitals, animal clinics;

Chapter 1 Introduction
-- 10 -- User Manual for Electrocardiograph
1.1 Equipment Overview
1.1.1 Front View
Figure 1-1 Front View
Number
Name
Description
1
Switch Button
Push down to open the Paper Drawer.
2
Paper Drawer
Place the recording paper.
3
Display Screen
Display the waveforms, animals’ information and the device status.
4
Operating Buttons
For button operations and inputting methods. Refer to Operating
Buttons for more details.