BORSAM WeCardio UN User manual

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ECG EVENT RECORDER
User’s Manual for recorder
TO USE THE ECG EVENT RECORDER
You will need:
> A Smartphone or an iPad(with Bluetooth & Wifi/Data on)
>TheECGEventrecorder
>TheAIRCardioAPP
<Note: the smart phone shall support Bluetooth 4.0, Android 4.3+ or IOS>
Contact us:
BORSAM Biomedical Instruments Co.,Ltd
Call: [phone]
Fax: [phone]
Emial: [email protected]
www.bioxtime.com

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CopyrightDeclaration:
Copyright©BORSAM Biomedical Instruments Co., Ltd.
All rights reserved.
iPhone, iPad, iPod, iOS and the Apple logo are either registered trademarks or
trademarks of Apple Corporation in the United States and/or other countries.
BORSAM Biomedical Instruments Co., Ltd., BORSAM logo, and WECARDIO logo and
ECG Web Center are trademarks orregistered trademarks of BORSAM Biomedical
Instruments Co., Ltd.
All other brand names and product names used in this document are trade names, service
marks, trademarks or registered trademarks of their respective owners.
The information and screens provided in this manual are subject to change without notice.
BORSAM Biomedical Instruments Co., Ltd. SHALL NOT BE LIABLE FOR TECHNICAL
OR EDITORIAL ERRORS OR OMISSIONS CONTAINED HEREIN; NOR FOR
INCIDENTAL OR CONSEQUENTIAL DAMAGES RESULTING FROM THE
FURNISHING,PERFORMANCE, OR USE OF THIS MATERIAL.
Authorized Representatives:
CHINA
BORSAM Biomedical Instruments Co., Ltd.
Rm. 502, University Innovation PARK
Lishan road
Xili Town
518055 Shenzhen
86-755-8632 5336
DeclarationofConformity:
Conformance to Standards – non-clinical testing demonstrated conformance to voluntary
safety IEC60601-1 and to IEC60601-1-2-2014 Class IIa.
Warning: Changes or modifications to this unit not expressly approved by the party
responsible for compliance could void the user’s authority to operate the equipment.
NOTE: This equipment has been tested and found to comply with the limits for a Class B
digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide
reasonable protection against harmful interference in a residential installation. This
equipment generates, uses and can radiate radio frequency energy and, if not installed and
used in accordance with the instructions, may cause harmful interference to radio
communications.
However, there is no guarantee that interference will not occur in a particular installation.
If this equipment does cause harmful interference to radio or television reception, which
can be determined by turning the equipment off and on, the user is encouraged to try to
correct the interference by one or more of the following measures:

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Reorient or relocate the receiving antenna.
Increase the separation between the equipment and receiver.
Connect the equipment into an outlet on a circuit different from that to which
the receiver is connected.
Consult the dealer or an experienced radio/TV technician for help.
This device complies with Part 15 of the FCC Rules. Operation is subject to the following
two conditions:
(1) this device may not cause harmful interference, and
(2) this device must accept any interference received, including interference that
may cause undesired operation.
BORSAM Biomedical Instruments Co., Ltd.’s Quality System conforms to21 CFR 820 and
ISO13485:2012
Danger:
Equipment not suitable for use in the presence of flammable anesthetic mixture with air or
with Oxygen or Nitrous Oxide.
Contraindications:
There are no potential adverse effects of the ECG-Event Recorder on health.
Description:
This guide describes the ECG Event Recorder to use, and related cleaning
and maintenance operations.
The metal sheets on the side and front is the position of application part.
Patients can safely use the ECG signal collection function of the device; The device
does not have unsafe functions.
Classification:
Class II / Internally powered equipment;
Type BF applied part;
IP22;
Continuous operation mode

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TABLE OF CONTENTS
COPYRIGHT DECLARATION ........................................2
DECLARATION OF CONFORMITY................................ 2
DANGER .........................................................................3
CONTRAINDICATIONS ..................................................3
DESCRIPTION ................................................................3
CLASSIFICATION........................................................... 3
OVERVIEW ........................................... ...5
INTENDED USE .............................................................. 5
ACCESSORIES............................................................... 5
SPECIFICATIONS...........................................................5
OPERATING CONDITIONS............................................5
STORAGE AND SHIPPING ............................................5
TO GET STARTED .................................. 6
DOWNLISD APP............................................................. 6
USER LOG IN .................................................................6
BULETOOTH PARTING YOUR DEVICE........................ 6
ARRHYTHMIA CHECK................................................... 7
ST CHECK ......................................................................8
HRV/ANS Check........................................................... 10
Recording List.............................................................. 10
SETTING .......................................................................11
NOTICE .........................................................................11
WHO SHOULD USE THE DEVICE ............................... 11
WARNING .....................................................................11
REGULATORY COMPLIANCE..................................... 12
MAINTENANCE ..................................... 12
BATTERY......................................................................12
CARING FOR YOUR ECG EVENT RECORDER..........12
ENVIRONMENT ............................................................12
PRECAUTIONS............................................................. 13
PREVENTIVE MAINTENANCE..................................... 13
CLEANING.................................................................... 13
EXPLAIN .......................................................................13
EQUIPMENT SYMBOLS............................................... 14
FAQ ............................................................................... 14
OVERVIEW:

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[Intended use]
The produce is intended to use at temperature of + 5 ℃~ + 40 ℃，relative humidity
of 25% to 93% (without condensation).ECG event recorder is suitable for real-time
ECG signal acquisition 、Storage and wireless transmission of patients with
arrhythmia。
Note：The above indications for use of the ECG Event Recorder monitoring stations is to
provide a reference for medical diagnosis, not a replacement for diagnostic clinicians。
[Accessories]
1x ECG Event Recorder
1x Strap
1xUSB Charger cable
1xUser manual
1xWarranty Card
1xBox
[Specifications]
Model：WeCardio UN ；WeCardio WF
Size：87mm×49mm×7mm ；90mm×50mm×10mm
Weight（with battery）：33g；38g
Carton：PC plastic
Battery：lithium ion battery/d.c.3.7V
Working hours：8 hours (approximately 480 recordings)
Bandwidth：0.5Hz – 40Hz
Input Impedance：≥3.0 Mohm
Input range：0.05～6 mV
Sample Rate：200 Hz
Sampling precision：12 bits
Transmission mode：Bluetooth 4.0
Recording：30 seconds, single-lead ECG
[Operating conditions]
Temperature: +5℃to +40℃
Humidity: 25% to 93% RH (without condensation)
Pressure altitude: 700 hPa to 1060 hPa
[Storage and shipping conditions]
Temperature: -25℃to 55℃
Humidity: 15% to 93% RH (without condensation)
Pressure altitude: 700 hPa to 1060 hPa
TOGETSTARTED:
[Download APP]
1.For Android system:
Go to “Google Play” and search the “WECARDIO” .