VISIOMED MyTensio VMT-BPT1B User Manual

1. Armband

2. Socket

3. Cuff tubing connector

4. Connection tube

5. CPU

TABLE OF CONTENTS

1. NOTES ON SAFETY

1.1. WARNING

1.2. CAUTION

1.3. GENERAL PRECAUTION

1.4. CYBERSECURITY INFORMATIONS AND RECOMMENDATIONS

2. INFORMATION

3. FEATURES

4. USE

4.1. DESCRIPTION

4.2. DOWNLOAD APPLICATION

4.3. INDICATIONS FOR SELF-MEASUREMENT

4.4. CONTRAINDICATIONS FOR SELF-MEASUREMENT

4.5. PRECAUTIONS BEFORE USE

4.6. SUGGESTIONS BEFORE MEASUREMENT

4.7. INSTRUCTIONS

4.8. USER GUIDE

5. INSERT OR REPLACE BATTERIES

6. HOW TO MAINTAIN AND STORE THE UNIT

7. HOW TO PREVENT A MALFUNCTION

8. SPECIFICATIONS

9. TROUBLESHOOTING

10. EMC DECLARATION

11. FCC COMPLIANCE

12. CALIBRATION AND SERVICE

13. WARRANTY INFORMATION

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 VMT-BPT1B 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/

Dear Customer,

Thank you for purchasing MyTensio VMT-BPT1B 濹瀅瀂瀀澳濩濼瀆濼瀂瀀濸濷瀻濁澳濜瀁澳瀂瀅濷濸瀅澳

to use it optimally and efficiently, we recommend that you read the

operating instructions carefully.

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application

https://bewell-connect.com/en/applications-support/

The manufacturer keeps the right to modify without any preliminary opinion

technical specifications of the product.

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.

- 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.

Note: One or two blood pressure readings will not provide a true indication

of your blood pressure, it is important to measure it daily and regularly to

obtain accurate data. Sharing your results with your

physician, may help him/her diagnose you and prevent potential health

problems.

BLOOD PRESSURE CATEGORIES IN UNITED STATES. (2017 ACC/AHA

GUIDELINES)

When systolic and diastolic pressure fall into different categories, the higher

pressure determines color code.

Self-measurement of blood pressure

- MAM (Measurement average mode): MAM technology makes it possible

to automatically perform three repeated measurements in moments.

Repetition is essential when measuring blood pressure oneself, because

isolated readings are often wrong for many reasons, including the high

variability of blood pressure, and high susceptibility to outside factors such

as recent activity or stress. Taking 3 consecutive readings and averaging

them can improve the reliability of blood pressure measurement at home

by a non-professional. This mode of use is especially recommended by the

SFHTA in case of self-measurement.

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