VISIOMED bewell connect MyPeriTens Mode D'emploi page 10

Medical device class IIa, compliant with European Standards and with part 15 of the FCC
rules.
TABLE OF CONTENTS
1. NOTES ON SAFETY ....................................................................................................... 19
1.1. WARNING ................................................................................................................... 19
1.2. CAUTION .................................................................................................................... 20
1.3. GENERAL PRECAUTIONS ......................................................................................... 21
1.4. INSTALLATION AND USAGE PRECAUTIONS .......................................................... 22
2. INTENTED USE .............................................................................................................. 22
3. FEATURES ..................................................................................................................... 22
4. USE ................................................................................................................................. 23
4.1. SUGGESTIONS BEFORE USE .................................................................................... 23
4.1.1. INDICATOR DESCRIPTION .................................................................................... 23
4.1.2. CHARGING .............................................................................................................. 23
4.1.3. POWER ON/OFF ...................................................................................................... 24
4.2. DOWNLOAD APPLICATION ..................................................................................... 24
5. HOW TO MAINTAIN AND STORE THE UNIT ............................................................... 24
5.1. CLEANING .................................................................................................................. 24
5.2. MAINTENANCE .......................................................................................................... 25
5.3. DISPOSAL .................................................................................................................. 25
6. SPECIFICATIONS .......................................................................................................... 25
7. TROUBLESHOOTING .................................................................................................... 27
Find out how to install and use the BewellConnect® app by visiting our website at
www.bewell-connect.fr/application-bewellconnect
Hereby, Visiomed declares that the radio equipment type MyPeriTens is in compliance with
Directive 2014/53/EU. The full text of the EU declaration of conformity is available at the
following internet address: https://bewell-connect.com/en-gb/products-conformity/
The manufacturer keeps the right to modify the specification and technical
characteristics of the product without prior notice.
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Dear Customer,
You have just purchased MyPeriTens from BewellConnect®. In order to use it optimally and
efficiently, we recommend that you read these operating instructions carefully.
1. NOTES ON SAFETY
It is important that you read all the warnings and precautions included in this manual. They are
intended to keep you safe, prevent injury and avoid a situation that could result in damage to
the device.
1.1. WARNING
DO NOT USE THIS DEVICE WITH THE FOLLOWING MEDICAL DEVICES:
- Using this stimulator with other electronic medical devices may cause erroneous operation of
those devices.
- Internally transplanted electronic medical devices, such as a pacemaker.
- Electronic life support equipment, such as respirators.
- Electronic medical devices attached to the body, such as electrocardiographs.
DO NOT USE THIS DEVICE UNDER THESE CONDITIONS:
- The device may cause lethal rythm disturbances in certain susceptible individuals, consult your
physician before using this device.
- For hygiene reasons, do not share this device with others. This device is a single user device:
meaning only one person should use this device. There is a risk of infection, even if you clean
the device.
- You are pregnant. The safety of electrical stimulation during pregnancy has not been
established.
«British Journal of Anaesthesia»: Transcutaneous electrical nerve stimulation. Iain Jones MB ChB FRCA Mark I Johnson PhD.
doi:10.1093/bjaceaccp/mkp021. 26 June, 2008
- You must be 6 weeks postpelvic surgery or vaginal childbirth to use this device.
- People must not be treated with this device.
- If you are less than 6 weeks postpelvic surgery or vaginal childbirth.
- If you have active pelvic cancer.
- If you have complete peripheral denervation of the pelvic floor, nerve damage or other
diseases that reduce pain sensation in your genital area.
- If pain killers that reduce the feeling of pain in the vaginal area have been administered.
- During menstruation, abnormal vaginal discharge, vaginal or urinary tract inflammation or
infection.
- While using a sanitary tampon or diaphragm.
- While the user is connected to high-frequency surgical equipment; it may cause burn injuries
on the skin under the electrodes, as well as problems with the stimulator.
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