BEWELL CONNECT BW BT1 User Manual

BW-BT1

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1. Armband

2. Socket

3. Cuff tubing connector

4. Connection tube

5. CPU

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SYMBOLS DEFINITIONS

Refer to instruction manual. Note on the equipment “Follow instructions for
use”

Caution

Type BF applied part

The device, accessories, and the packaging have to be disposed of correctly
at the end of usage. Please follow local ordinances and regulations for
disposal.

Authorized representative in the European community

Manufacturer

Storage temperature

Relative humidity
Serial number

Batch code

Easy broken

Keep dry

This way up.

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THIS PRODUCT COMPLIES WITH IEC 60601-1:2005+A1:2012; IEC 60601-1-11:2015; IEC
80601-2-30: 2009/AMD1:2013; IEC 60601-1-2:2014.

WE, VISIOMED, HEREBY DECLARES UNDER OUR SOLE RESPONSIBILITY THAT THE
FOLLOWING PRODUCT BW-BT1 MYTENSIO IS IN COMPLIANCE WITH THE ESSENTIAL
REQUIREMENTS AND OTHER RELEAVANT PROVISIONS OF THE RED 2014/53/EU DIRECTIVE.
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 ....................................................................................................................................5

1.1 WARNING ..............................................................................................................................................5

1.2 CAUTION ...............................................................................................................................................5

1.3 GENERAL PRECAUTION ....................................................................................................................5

1.4 CYBERSECURITY INFORMATIONS AND RECOMMENDATIONS .........................................6

2. INFORMATION ............................................................................................................................................6

3. FEATURES ......................................................................................................................................................8

4. USE ..................................................................................................................................................................8

4.1 DESCRIPTION .......................................................................................................................................8

4.2 DOWNLOAD APPLICATION ............................................................................................................8

4.3 INDICATIONS FOR SELF-MEASUREMENT ..................................................................................9

4.4 CONTRADICATIONS FOR SELF-MEASUREMENT ....................................................................9

4.5 PRECAUTIONS BEFORE USE ............................................................................................................9

4.6 SUGGESTIONS BEFORE MEASUREMENT ................................................................................. 10

4.7 INSTRUCTIONS ................................................................................................................................. 10

4.8 USER GUIDE ....................................................................................................................................... 10

5. INSERT OR REPLACE BATTERIES ........................................................................................................ 12

6. HOW TO MAINTAIN AND STORE THE UNIT ................................................................................. 12

7. HOW TO PREVENT A MALFUNCTION ............................................................................................. 12

8. SPECIFICATIONS ...................................................................................................................................... 13

9. TROUBLESHOOTING .............................................................................................................................. 13

10. EMC DECLARATION .......................................................................................................................... 14

11. FCC COMPLIANCE ............................................................................................................................. 17

12. CALIBRATION AND SERVICE .......................................................................................................... 17

13. WARRANTY INFORMATION ........................................................................................................... 17

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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.

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.

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- 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.

- Do not leave this device within the reach of children.

- This appliance is not designed for use by people (including children) with reduced physical,
emotional or mental abilities or those lacking experience or knowledge unless used in the
presence of someone responsible for their security, under supervision or following
instructions about how to use the appliance.

- Discontinue use of the device in case of anomalies or malfunction.

- Stop using the unit in the event of a failure or malfunction.

- This electrical medical equipment requires specific precautions regarding electromagnetic
compatibility. It must be installed and used according to the electromagnetic information.

- The equipment is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the equipment can help prevent
electromagnetic interference by maintaining a minimum distance between portable and
mobile RF communications equipment (transmitters) and the equipment as recommended at
the end of the manual, according to the maximum output power of the communications
equipment.

- Readings may be distorted if the unit is used near a television, microwave oven, mobile
phone or any other device with an electrical field.

1.4 CYBERSECURITY INFORMATIONS AND RECOMMENDATIONS

 To get the mobile application to work properly, be sure to get a reliable and secure

network connection.

 For the correct functioning of the app, a Bluetooth connection is necessary.
 Personal data are stored in a Healthcare data host (with network connection) located in

France. For the security of your data, do not share your smartphone/tablet with your app
logged in. Data are transferred from your device to the Healthcare data host under a
secured protocol.

 The MyTensio app is compatible with the following operating systems:

Android 4.3 or higher
iOS 8.0 or higher

 Check regularly if the APP has been updated on the stores. Proceed to any product

update when applicable. Theses updates may concern security improvement.

2. INFORMATION

Blood pressure varies considerably throughout the day, and these variations are even more
significant in hypertensive subjects. It is lower in the morning and increases in the afternoon
and the evening. When sleeping, it decreases. Blood pressure is lower in summer than in
winter, and it rises noticeably with age. Blood pressure also increases during exercise, sex,
pregnancy, stress, etc.