MEDICAL DEVICE CLASS IIA, COMPLIANT WITH EUROPEAN STANDARDS.
WE, VISIOMED, HEREBY DECLARES UNDER OUR SOLE RESPONSIBILITY THAT THE
FOLLOWING PRODUCT BW-BT1 MYTENSIO IS IN COMPLIANCE WITH THE ESSENTIAL
REQUIREMENTS AND OTHER RELEVANT PROVISIONS OF THE R&TTE 1999/5/CE DIREC-
TIVE. THIS CONFORMITY DECLARATION CAN BE FOUND ON OUR WEBSITE AT:
https://bewell-connect.com/en/conformite-produits-bewellconnect/
TABLE OF CONTENTS
1. NOTES ON SAFETY ............................................................................................................... 23
1.1. WARNING ........................................................................................................................... 23
1.2. CAUTION ............................................................................................................................ 23
1.3. GENERAL PRECAUTION .................................................................................................... 23
2. INFORMATION ...................................................................................................................... 24
3. FEATURES ............................................................................................................................. 27
4. USE ......................................................................................................................................... 27
4.1. DESCRIPTION .................................................................................................................... 27
4.7. INSTRUCTIONS USE .......................................................................................................... 29
4.8. USER GUIDE ....................................................................................................................... 30
8. SPECIFICATIONS .................................................................................................................. 33
9. TROUBLESHOOTING ............................................................................................................ 34
Log onto our website to find out how to install and use the BewellConnect® application
https://bewell-connect.com/en/applications-support/
The manufacturer keeps the right to modify without any preliminary opinion
technical specifications of the product.
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BewellConnect - BW-BT1 - User Manual - 2018-03_V1
Dear Customer,
Thank you for purchasing MyTensio BW-BT1 from Visiomed®. In order to use it optimally and
efficiently, we recommend that you read the operating instructions carefully.
1. NOTES ON SAFETY
It is important to read all the warnings and precautions in this manual. They are for your safety,
to prevent injuries and avoid situations that could damage the device.
Consult your doctor, if you have a serious illness or if you want to know more about using this
medical device.
1.1. WARNING
- This product should not encourage you to self-medicate or adapt your treatment
- Too frequent measurements can cause injury to the patient due to blood flow interference.
- Do not curve the tube during measuring, the curved tube may block deflation and lead to
injury.
- Do not measure on an injured arm, thus could cause further injury.
- Stop measurement immediately, if an allergic reaction occurs.
1.2. CAUTION
- Do not inflate the upper arm cuff when it is not wrapped on the upper arm.
- Do not use force to bend or pull the cuff. Always use the specified accessories in the manual,
the use of other parts not approved by the manufacturer may cause hazard.
- Do not use accessories that are not specified on this user manual.
- Do not change the detachable components by yourself.
- Do not compress or restrict the connection tubing, in case of damage.
1.3. GENERAL PRECAUTION
- Use this device only for the use for which it is designed as described in this manual.
- This device may be used for personal use at home. Do not use the unit for other purposes.
- This device is designed for external use.
- Use and storage: Refer to the technical features (range of room temperature, relative humidity,
atmospheric pressure, altitude)
- This device must always be placed in a clean and dry place.
- Do not expose this device to sunlight or water.
- Do not expose this device to electric shocks.
- Do not use this device outdoors.
- Never drop the device.
- Follow the maintenance instructions specified in this manual.
- Do not attempt to open the device. In case of problems, contact customer service.
BewellConnect - BW-BT1 - User Manual - 2018-03_V1
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