Mindray EPA001 User manual

I

Wearable ECG Monitor
Operator’s Manual

II
© Copyright 2014-2016 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. All rights
reserved.
For this Operator’s Manual, the issue date is 2016-4.

III
Intellectual Property Statement
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. (hereinafter called Mindray)
owns the intellectual property rights to this Mindray product and this manual. This manual may refer
to information protected by copyrights or patents and does not convey any license under the patent
rights of Mindray, nor the rights of others.
Mindray intends to maintain the contents of this manual as confidential information. Disclosure of
the information in this manual in any manner whatsoever without the written permission of Mindray
is strictly forbidden.
Release, amendment, reproduction, distribution, rental, adaption and translation of this manual in
any manner whatsoever without the written permission of Mindray is strictly forbidden.
, , and are the registered trademarks or trademarks owned by
Mindray in China and other countries. All other trademarks that appear in this manual are used only
for editorial purposes without the intention of improperly using them. They are the property of their
respective owners.
Responsibility on the Manufacturer
Party
Contents of this manual are subject to changes without prior notice.
All information contained in this manual is believed to be correct. Mindray shall not be liable for
errors contained herein nor for incidental or consequential damages in connection with the
furnishing, performance, or use of this manual.
Mindray is responsible for the effects on safety, reliability and performance of this product, only if:
all installation operations, expansions, changes, modifications and repairs of this product are
conducted by Mindray authorized personnel;
the electrical installation of the relevant room complies with the applicable national and local
requirements;
the product is used in accordance with the instructions for use.

IV
Warranty
THIS WARRANTY IS EXCLUSIVE AND IS IN LIEU OF ALL OTHER WARRANTIES, EXPRESSED
OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY OR FITNESS FOR ANY
PARTICULAR PURPOSE.
Exemptions
Mindray's obligation or liability under this warranty does not include any transportation or other
charges or liability for direct, indirect or consequential damages or delay resulting from the
improper use or application of the product or the use of parts or accessories not approved by
Mindray or repairs by people other than Mindray authorized personnel.
This warranty shall not extend to
Malfunction or damage caused by improper use or man-made failure.
Malfunction or damage caused by unstable or out-of-range power input.
Malfunction or damage caused by force majeure such as fire and earthquake.
Malfunction or damage caused by improper operation or repair by unqualified or unauthorized
service people.
Malfunction of the instrument or part whose serial number is not legible enough.
Others not caused by instrument or part itself.
Company Contact
Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Address: Mindray Building, Keji 12th Road South, Hi-tech industrial park,
Nanshan,Shenzhen 518057,P.R.China
Website: www.mindray.com
E-mail
Address: [e-mail]
Tel: [phone]
Fax: [phone]
EC-Representative: Shanghai International Holding Corp. GmbH(Europe)
Address: Eiffestraβe 80, 20537 Hamburg, Germany
Tel: [phone]
Fax: [phone]

V
Preface
Manual Purpose
This manual contains the instructions necessary to operate the product safely and in accordance
with its function and intended use. Observance of this manual is a prerequisite for proper product
performance and correct operation and ensures patient and operator safety.
This manual is based on the maximum configuration and therefore some contents may not apply to
your product. If you have any question, please contact us.
This manual is an integral part of the product. It should always be kept close to the equipment so
that it can be obtained conveniently when needed.
Intended Audience
This manual is geared for clinical professionals and common people.
Illustrations
All illustrations in this manual serve as examples only. They may not necessarily reflect the setup or
data displayed on your product.
Conventions
Italic text is used in this manual to quote the referenced chapters or sections.


1
Contents
1.1.1 Warnings...............................................................................................................2
1.1.2 Cautions................................................................................................................3
1.1.3 Notes.....................................................................................................................3
1.2 Equipment Symbols.........................................................................................................4
2.1 Product introduction.........................................................................................................1
2.1.1 Apply scope..........................................................................................................1
1.2.1AppliedParts..........................................................................................................1
2.2 Product appearance.........................................................................................................2
3.1 Installation.........................................................................................................................1
3.1.1 Unpacking and Checking...................................................................................1
1.2.2 Environmental Requirements............................................................................2
3.1.2 Power requirements............................................................................................2
3.1.3 Installation method..............................................................................................2
3.2 Cleaning and Disinfection...............................................................................................2
3.2.1 Cleaning................................................................................................................2
3.2.2 Disinfection...........................................................................................................3
4.1 Preparation before use....................................................................................................1
4.2 Wear the ECG recorder...................................................................................................1
4.3 View ECG data.................................................................................................................3
4.4 Take off the ECG recorder..............................................................................................3
4.5 Charge the ECG recorder...............................................................................................4
4.6 Offline data transimission................................................................................................5
5.1 Frequence Questions Management..............................................................................6
7.1 ECG Sensor......................................................................................................................2
7.2 Charger..............................................................................................................................3
AProduct Specifications.................................................................................................A‐1
A.1 Safety Specifications...................................................................................................A‐1
A.2 Environmental Specifications.....................................................................................A‐1
A.3 Power Supply Specifications......................................................................................A‐1
A.4 Physical Specifications...............................................................................................A‐2
A.5 Display, Recorder and Storage Specification..........................................................A‐2
A.6 ECG Specification.......................................................................................................A‐2
A.7 Charger Specification..................................................................................................A‐2
BEMC and Radio Regulatory Compliance....................................................................B‐1
B.1 EMC...............................................................................................................................B‐1
B.2 Radio Regulatory Compliance...................................................................................B‐6
CSymbols and Abbreviations.........................................................................................C‐1
C.1 Symbols.........................................................................................................................C‐1
C.2 Abbreviations................................................................................................................C‐2

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1
1.Safety
1.1 Safety Information
WARNING
Indicates a potential hazard or unsafe practice that, if not avoided, could result in death or
serious injury.
CAUTION
Indicates a potential hazard or unsafe practice that, if not avoided, could result in minor
personal injury or product/property damage.
NOTE
Provides application tips or other useful information to ensure that you get the most from
your product.

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1.1.1 Warnings
WARNING
This equipment can not be used for infant whose weight is less than 10 Kg.
Before putting the system into operation, the operator must verify that the equipment,
connecting cables and accessories are in correct working order and operating
condition.
This equipment can not be used for the person whose skin is hypersusceptible to the
the accessories.
To avoid explosion hazard, do not use the equipment in the presence of oxygen-rich
atmospheres, flammable anesthetics, or other flammable agents (such as gasoline).
There is a battery inside. Do not open the equipment housings. All servicing and
future upgrades must be carried out by the personnel trained and authorized by our
company only.
Please don’t bend or reverse the ECG recorder. Otherwise the equipment may be
damaged.
Remove the equipment from patients during defibrillation. Otherwise the equipment
may be damaged.
Remove the equipment from patients during using the electro-surgery unit. Otherwise
the equipment may be damaged.
When disposing of the package material, be sure to observe the applicable waste
control regulations and keep it out of children’s reach.
Keep the equipment and accessories out of children’s reach. Otherwise children may
inadvertently damage the equipment and accessories or swallow the same small
parts casuing apnea or other hazards.
The equipment is suit for violent sports such as football, basketball and volleyball.
The balls hit the equiepment that may hurt the user.
The equipment transmit wireless signal via sape. The signal may be interrupted by
serval possible sources of interference. The transmission failure may happen
sometime, although the equipment has some anti- interference capacity.

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1.1.2 Cautions
CAUTION
Make sure that the operating environment of the equipment meets the specific
requirements.
To prolong the service life of the wquipment, please don’t put it under the sunshine for
a long time.
To ensure patient safety, use only parts and accessories specified in this manual.
Single-use accessories are not designed to be reused. Reuse may cause a risk of
contamination and affect the measurement accuracy.
At the end of its service life, the equipment, as well as its accessories, must be
disposed of in compliance with the guidelines regulating the disposal of such
products. If you have any questions concerning disposal of the equipment, please
contact us.
Magnetic and electrical fields are capable of interfering with the proper performance
of the equipment. For this reason make sure that all external devices operated in the
vicinity of the equipment comply with the relevant EMC requirements. Mobile phone,
X-ray equipment or MRI devices are a possible source of interference as they may
emit higher levels of electromagnetic radiation.
1.1.3 Notes
NOTES
Keep this manual in the vicinity of the equipment so that it can be obtained
conveniently when needed.

4
1.2 Equipment Symbols
General warning sign
DATE OF MANUAFACTURE
Serial number
AUTHORISED REPRESENTATIVE IN THE EUROPEAN COMMUNITY
The product bears CE mark indicating its conformity with the provisions of the
Council Directive 93/42/EEC concerning medical devices and fulfils the
essential requirements of Annex I of this directive.
Note: The product complies with the Council Directive 2011/65/EU.
Waterproof level 7
Refer to instruction manual/booklet
Type CF APPLIED PART
Non-ionization radiation symbol

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2.Safety
2.1 Product introduction
Wearable ECG monitor contain adhesive ECG recorder，ECG sensor. The adhesive ECG recorder
collect ECG signal via ECG sensor. The data collected is stored in ECG recorder. It can be transmitted
to protocol compatible device or APP.
2.1.1 Apply scope
Can be used for measuring, recording and storing human ECG data, for applications that require long
continuous records of patients ECG data. Can be used in medical departments or in home environment.
WARNING
This equipment is used for single user at a time.
The PATIENT is an intended OPERATOR.
The ECG recorder is suitable for use within the patient environment.
The waterproof level of the ECG recorder is IPX7. It can be used in the shower or in
water for a short time.
Prohibit using the equioment in the hyperbaric oxygen chamber.
1.2.1 Applied Parts
TheappliedpartsofthewearableECGmonitorare:
Shell of ECG recorder,
ECG electrodes
ECG sensor

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2.2 Product appearance
Picture 错误！文档中没有指定样式的文字。-1 Adhesive ECG recorder front
Picture 错误！文档中没有指定样式的文字。-2 Adhesive ECG recorder back

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1
3.Installation and Maintenance
3.1 Installation
WARNING
The software copyright of the equipment is solely owned by us. No organization or
individual shall resort to juggling, copying, or exchanging it or to any other
infringement on it in any form or by any means without due permission.
3.1.1 Unpacking and Checking
Before unpacking, examine the packing case carefully for signs of damage. If any damage is detected,
contact the carrier or us.
If the packing case is intact, open the package and remove the equipment and accessories carefully.
Check all materials against the packing list and check for any mechanical damage. Contact us in case
of any problem.
NOTE
Save the packing case and packaging material as they can be used if the equipment must
be reshipped.
WARNING
When disposing of the packaging material, be sure to observe the applicable waste
control regulations and keep it out of children’s reach.
The equipment might be contaminated during storage and transport. Before use, please
verify whether the packages are intact, especially the packages of single use
accessories. In case of any damage, do not apply it to patients / users.

2
1.2.2 Environmental Requirements
The operating environment of the equipment must meet the Environmental Specification in
Appendix B.
3.1.2 Power requirements
The power used for this equipment must meet the Power Specification in Appendix B.
WARNING
Make sure that the operating environment and power of the equipment meets the
specific requirements. Otherwise unexpected consequences, e.g. damage to the
equipment, could result.
3.1.3 Installation method
Installation methods of adhesive ECG recorder, please refer chapter 4.
3.2 Cleaning and Disinfection
Only adhesive ECG recorder and changer need cleaning and disinfection. The accessories are single
use products. So they need not cleaning and disinfection.
3.2.1 Cleaning
The ECG recorder should be cleaned beroe and after use. The charger should be cleaned beroe use.
Please use clean and soft cloth, sponge or tampon adsorb non-erosive cleaning agent and dry
appropriately to clean the surface of the equipment. Recommended cleaning agents are:
Water
Ethanol (70%)
Isopropyl alcohol (70%)
To clean your equipment, follow these rules:
1. Clean the exterior surface of the equipment using a soft cloth dampened with the cleaner,
making sure that no cleanser is dripping from the cloth.
2. Wipe off all the cleaning solution with a dry cloth after cleaning if necessary.
3. Dry your equipment in a ventilated, cool place.

3
WARNING
Please clean the surface under the rules abbove. Otherwise, it may damage the shell
or the print of the equipement
3.2.2 Disinfection
Disinfect the equipment as required in your hospital’s servicing schedule. Cleaning equipment before
disinfecting is recommended.

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1
4.Operations
4.1 Preparation before use
Please shake the ECG recorder and observe the LED light before use.
The green light flicker means the ECG recorder is normal.
The red light flicker every 3 seconds means the ECG recorder is malfunction.
The red light flicker every 9 seconds means the ECG recorder is low power.
No light flicker means the ECG recorder is mal function or its battery uses out.
NOTES
The ECG recorder need be waked up by charger before first use.
The battery will use out when the ECG recorder doesn’t use for a long time. It can not
be waked up by shaking. It needs be charged before use.
It is ready to use when it is waked up and flicker greens light. The time is less than 15
seconds.
The time required for me equipment to warm from the minimum storage temperature
between uses until it is ready for intended use is less than 30 minutes.
The time required for me equipment to cool from the maximum storage temperature
between uses until it is ready for intended use is less than 30 minutes.
4.2 Wear the ECG recorder
Picture 4-1 shows how to install accessory and wear the equipment on human body.

2
Picture 错误！文档中没有指定样式的文字。‐3ECG recorder installatiosketch map with one
channel ECG sensor
Installation process shows as below:
1.Tear off the tape marked①.
2.Stick the ECG recorder to the accessory.
3.Tear off the tape marked②.
4.Stick the ECG recorder with accessory nearby to heart such as A, B, C area in the picture.
5.Tear off the tape marked③.
When use two channels ECG sensor, the operation is similar with one channel ECG sensor. The
position shows as picture 4-2.


3
Picture错误！文档中没有指定样式的文字。‐4ECG recorder installatiosketch map with two
channel ECG sensor
NOTES
The ECG recorder can work with one channel ECG sensor or two channel ECG
sensor. Please use of accessories approved by Mindray.
Check the accessories and their packages for any sign of damage. Do not use them if
any damage is detected.
4.3 View ECG data
The ECG recorder can transmit data by Bluetooth. It can work with mobile equipment that is
android 4.3 upwards, iOS 7.1 upwards, and Bluetooth 4.0 upwards. The ECG data can be read by
protocol compatible APP’s.
4.4 Take off the ECG recorder
1.Take off the ECG recorder with ECG sensor from human body.
2.Tear off the ECG recorder from the ECG sensor
3.Put the ECG recorder to the original box.
Picture 错误！文档中没有指定样式的文字。‐5Take off the ECG recorder

4
NOTES
The ECG recorder will enter sleep mode. There is no need to power off it.
4.5 Charge the ECG recorder
Please charge the ECG recorder under following conditions:
First use
There is no light indicator when shake the ECG recorder.
Reuse the ECG recorder over one month between last use.
Please charge it once every month to protect its battery, if it will not be used for a long
time. Store it in a cool and dry place. You can check the battery volume on the APP and
decide to charge or not basing on the intended using time. Recommend charging the
ECG recorder when the battery volume is less than 10%.
Show as picture 4-4, put the ECG recorder on the charger and connect the cable to DC
5V 500mA out put power. The blue light of ECG recorder will be on and the red light will
flicker, when it is charging. The red light will go out when the battery is full.

Picture错误！文档中没有指定样式的文字。‐6theindicatorsofcharger
The charger indicator lights
Battery volume indicator: Every light represents 25% volume.
Charge indicator: This light turning on means the ECG recorder is charing.
Data transimission indicator: This light flicker means the ECG recorder is sending data
to the charger.

5
NOTES
The charger that model is EPC001 has no Battery volume indicator. Only can check
the battery is full or not by ECG recorder’s indicator.
4.6 Offline data transimission
The data stored in ECG recorder can be exported by Bluetooth of charger. A
computer and export software are needed as well. You can get the download link by
scanning the picture below.

Connect the charger to the computer with thw USB cable. Then open the software.
Put the ECG recorder to the charger. Operate the software following the instruction
on the software. The data can be exported to computer by Bluetooth of charger and
upload to cloud by internet.
NOTES
The charger that model is EPC001 can not export data.