BORSAM WeCardio UN User Manual

Ecg event recorder

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ECG EVENT RECORDER

User's Manual for recorder

TO USE THE ECG EVENT RECORDER

<Note: the smart phone shall support Bluetooth 4.0, Android 4.3+ or IOS>

BORSAM Biomedical Instruments Co.,Ltd

You will need:

> A Smartphone or an iPad(with Bluetooth & Wifi/Data on)

> The ECG Event recorder

> The AIRCardio APP

Call: +86 0755 86325336

Fax: +86 0755 86325336

Emial: aircardio@bioxtime.com

www.bioxtime.com

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Summary of Contents for BORSAM WeCardio UN

Page 1 > A Smartphone or an iPad(with Bluetooth & Wifi/Data on) > The ECG Event recorder > The AIRCardio APP <Note: the smart phone shall support Bluetooth 4.0, Android 4.3+ or IOS> Contact us: BORSAM Biomedical Instruments Co.,Ltd Call: +86 0755 86325336 Fax: +86 0755 86325336 Emial: aircardio@bioxtime.com www.bioxtime.com...
Page 2: Copyright Declaration
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.
Page 3: Danger
(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.
Page 4: Table Of Contents
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 ..........
Page 5: Overview
  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...
Page 6: Downlisd App
Use the download link: http://www.bioxtime.com/download/wecardio.apk 2.For Apple IOS system: Go to “App Store” and search “WECARDIO” 3.Scan the following QR Code [User Log in] 1．Register Register free with your email. 2. Sign In If registered already, input the user name and password directly to access. Click the >...
Page 7: Arrhythmia Check
↓ 2.With two fingers touching the two metal pads,wait the light turning red. App will pop up and ask enter the paring code. Still keep fingers on the metal pads and use another hand to input Bluetooth Pin "000000" [Arrhythmia Check] 1.Start the Arrhythmia checking...
Page 8: St Check
2.Forefinger and middle finger of both hands gently grip the metal sheet, leaning hands on the desktop or the thigh, maintain a relaxed state, do not push too hard. 3.Waiting to finish the progress bar. Please don’t talk or move, keep relaxing 4.Select the Symptoms during checking 5.Display the wave forms, return to the recording list and wait for update.
Page 9 ↓ 2. Forefinger and middle finger of both hands gently grip the metal sheet, leaning hands on the desktop or the thigh, maintain a relaxed state, do not push too hard. 3. Keep clamping the device with right Forefinger, and put side electrode at the 6 position (I II V1 V2 V4 V6) one by one in the picture, if the light don't show red, please slightly wet the skin.
Page 10: Hrv/Ans Check
[HRV/ANS Check] Note: HRV/ANS check is to evaluate the Self-regulation capability of heart. For the users with high working pressure, too much social engagement, mental stress or poor sleep, please check HRV once every two weeks. 1. Start HRV/ANS checking ↓...
Page 11: Setting
a.Moving the cursor to the left or right to view waveform b.Zooming to view the waveform c.Clicking “PDF”to download the report.Users can also mail to the report to the doctor. b).Cloud Recordings Cloud Recordings is the data been successfully uploaded to our server. The cloud recordings will be emptied when clearing the phone cache, but can be re-downloaded when pull down the page.
Page 12: Regulatory Compliance
& IEC 60601-2-25 for Medical electrical equipment. This device complies with the FCC Rules and with EMC & R&TTE. Also, it passes the Biological Evaluation Test and has CE mark. BORSAM Biomedical Instruments Co., Ltd.’s Quality System conforms to ISO13485 issued by TUV SUD. MAINTENANCE: [BATTERY] Caution: Use only rechargeable Lithium batteries.
Page 13: Precautions
cause a malfunction. Keep accessories that might be swallowed away from children. [PRECAUTIONS] Warning: Dispose of all used batteries in a proper waste disposal in accordance with local regulation. Used batteries must not be discarded in the normal trash. [PREVENTIVE MAINTENANCE] The following simple preventive maintenance tasks should be performed monthly to ensure continued performance of the device at maximum capacity, and to reduce the possibility of a failure.
Page 14: Equipment Symbols
[Situation when patients operate the device by himself/herself] 1. Patients is the operator 2. During usage, patients only need simply clean the device with clean soft cloth 3. Patients can only set the patients information 4. Repairing device need to be done by manufacturer, patients cannot repair it by himself/herself 5.
Page 15 Please make sure the side electrode touch the skin directly if with too much chest hair. Please change a new battery or recharge the device if power off. Please check whether Bluetooth on Always show waiting and cannot enter to Log out and re-enter ECG check page Please restart the Bluetooth of the phone...
Page 16 Table 1 – Guidance and MANUFACTURER’S declaration – ELECTROMAGNETIC EMISSIONS for all ME EQUIPMENT and ME SYSTEMS Guidance and manufacturer’s declaration - electromagnetic emissions The [FG9131] is intended for use in the electromagnetic environment specified below. The customer or the user of the [FG9131] should assure that it is used in such an environment Emissions test Compliance...
Page 17 Table 3 – Guidance and MANUFACTURER’S declaration – electromagnetic IMMUNITY – for ME EQUIPMENT and ME SYSTEMS that are not LIFE‐SUPPORTING Guidance and manufacturer’s declaration - electromagnetic immunity The [FG9131] is intended for use in the electromagnetic environment specified below. The customer or the user of the [FG9131] should assure that it is used in such an environment Immunity Compliance 60601...
Page 18 Table 4 – Recommended separation distances between portable and mobile RF communications equipment and the ME EQUIPMENT or ME SYSTEM – for ME EQUIPMENT and ME SYSTEMS that are not LIFE‐SUPPORTING Recommended separation distances between portable and mobile RF communications equipment and the [FG9131] The [FG9131] is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the [FG9131] can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the [FG9131] as recommended below, according to the maximum output power of the communications equipment.
Page 19 FCC Caution § 15.19 Labeling requirements. 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. §...

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