VISIOMED Bewell Connect MyECG Mode D'emploi page 13

THIS PRODUCT IS COMPLIANT WITH EN ISO 13485:2012, EN ISO14971:2012, EN
ISO10993-1:2009/AC:2010, EN ISO10993-5:2009, EN ISO10993-10:2010, EN 60601-
1:2006/AC:2013, EN 60601-1-2:2007/AC:2010, EN 60601-2-47:2012, EN1041:2008, EN
980:2008, EN 62304: 2006, EN 60601-1-6:2010, EN 60601-1-11:2010 STANDARDS.
WE, VISIOMED, HEREBY DECLARES UNDER OUR SOLE RESPONSIBILITY THAT THE
FOLLOWING PRODUCT BW-HR1 MYECG IS IN COMPLIANCE WITH THE ESSENTIAL
REQUIREMENTS AND OTHER RELEVANT PROVISIONS OF THE R&TTE 1999/5/CE DI-
RECTIVE. THIS CONFORMITY DECLARATION CAN BE FOUND ON OUR WEBSITE AT:
http://bewell-connect.com/products-conformity
CONTENTS
1. NOTES ON SAFETY ...................................................................................................26
1.1. WARNINGS ............................................................................................................26
1.2. CAUTION ................................................................................................................27
2. USE .............................................................................................................................28
2.1. DESCRIPTION ........................................................................................................28
2.2. ELECTROCARDIOGRAM INDICATIONS ...............................................................29
2.3. CONTRAINDICATIONS ..........................................................................................29
2.4. PRECAUTIONS BEFORE USE ................................................................................29
2.5. DOWNLOADING THE APPLICATION
2.6. INSTRUCTIONS TO MEASURE YOUR HEART RYTHM .........................................30
2.7. USER GUIDE ...........................................................................................................30
2.7.1. HEART RATE MEASUREMENT : HAND MEASUREMENT .................................30
2.7.2. HEART RATE MEASUREMENT : CHEST MEASUREMENT ................................31
2.7.3. HEART RATE MEASUREMENT : CABLE MEASUREMENT ................................31
2.8. WRONG OPERATION METHODS ..........................................................................32
2.9. MEASUREMENT RESULTS .....................................................................................32
2.10. SETTINGS .............................................................................................................34
3. STORAGE AND MAINTENANCE...............................................................................36
4. SPECIFICATIONS ......................................................................................................37
5. TROUBLESHOOTING ................................................................................................39
Learn how to install and use the BewellConnect® application by logging onto our website
www.bewell-connect.com/install
The manufacturer reserves the right to modify the product specifications without prior notice.
WARNING: DO NOT USE WITH A CARDIAC PACEMAKER OR DEFIBRILLATOR.
25 BewellConnect - BW-HR1 - User Manual - 042016
.......................................................................30
Dear Customer,
Thank you for buying the BewellConnect® Handheld ECG Monitor. Please read this guide
prior to device use. Failure to follow the guide may cause measurement abnormalities and
equipment damages. The manufacturer assumes no responsibility for personal injury or de-
vice damage sustained by or through the use of this product.
For further information about your heart rhythm, PLEASE CONTACT YOUR DOCTOR.
1. NOTES ON SAFETY
1.1. WARNINGS
- When using USB cable, do not touch the USB ports. Contacting the ports may create elec-
trostatic discharge which may cause the system to freeze and prevent the USB peripherals
from functioning properly. Before restarting the device MyECG BW-HR1, attempt to restore
functionality by unplugging the USB device and re-plugging it back into the port. Wait ap-
proximately 10 seconds to determine if functionality has been restored. If not, restart the
device.
- Do not use with a cardiac pacemaker or defibrillator.
- Do not take measurements with overly wet skin.
- Disperse static electricity from your body before handling the device.
- The Handheld ECG Monitor is not intended to substitute a hospital diagnostic ECG device.
- This device is a handheld, personal electrocardiograph unit, which can measure electri-
cal activities of the heart easily and conveniently. It is immediately available at any time
to manually record transient cardiac events, suitable for hospital or home health care use,
which can detect, display and store ECG signal, and if possible, provide average heart rate
message after ECG measurement. The users can use it themselves to check their heart con-
dition. It is suitable for adult users, who suffer from cardiovascular disease, or adults who
care about their heart's working condition during their daily life. This device is not intended
for use as a conventional diagnostic tool, but is a healthcare tool which can provide a doc-
tor the recorded data as a reference. The product is not a conventional diagnostic tool.
- This product should not encourage self-medication or adaptation of your treatment.
Always consult your doctor if you have any questions or if you believe you have abnormal
measurements.
- The values displayed by the device are the ones derived at the time of measurement. Medi-
cal conditions can change suddenly. If you notice any change in your condition, consult
your doctor, regardless of the measured results. No alterations to the Handheld ECG Moni-
tor may be made. The device is sold as a finished product and any disassembly or modifica-
tions will render the warranty null and void.
- Discontinue use of the device in case of anomalies or malfunction.
- This electrical medical equipment requires specific precautions regarding electroma-
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