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2. TRANSCUTANEOUS NEUROSTIMULATION INFORMATION
The device works on the principle of transcutaneous electrical neurostimulation (TENS),
which enables you to relieve pain and soothe muscle tension. This device also helps to promote
venous return and to strengthen the muscle mass. The device has been specially designed to be
used at home. Transcutaneous electrical neurostimulation (TENS) is a non-analgesic drug therapy
the nerves. This stimulation brings the body to produce and disseminate endogenous analgesic-
painkilling substances (endorphins, enkephaline) whose function is to anesthetize the pain.
In case of pain or muscle tension, mini-electrical impulses in the nervous tissue may block the
transmission of pain signals to the nervous system and trigger the release of endorphins. You
can choose your programme among 11 preset TENS protocols on theapplication.
For the strengthening of your muscle mass, you can select a programme among 8 protocols
of electrical muscle stimulation (EMS). The electrical stimulator sends, via the electrodes placed
on the area to stimulate, electrical pulses causing a muscle contraction which strengthens the
muscle. It is controlled from the application. A diagram of the human body with treatment
zones helps you to position the electrodes correctly (see paragraph 10).
The application (Mytens) is available on the App Store or Google play. The app operates on IOS,
Android platforms (IOS 8.0, Android 5.0).
Intended use
The device designed to be used for temporary relief of pain associated with sore and aching
muscles in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg)
due to strain from exercise or normal household work activities. It should be applied to normal,
healthy, dry and clean skin of adult patients. And is to be used for stimulate healthy muscles in
order to improve and facilitate muscle performance.
Contraindication
Do not use this device with the following medical devices:
-Implanted electronic medical devices, such as pacemakers. This may cause electric shock, burns,
or death.
-Electronic life support equipment, such as respirators.
-Electronic medical devices worn on the body, such as electrocardiographs.
If you use this device together with other electronic medical devices, these devices may not work
correctly.
Counter indications
Do not use the device :
- In case of heart disease
- If you have epilepsy
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example a drug administration system). In these conditions, use could cause an electric shock,
interference, burns or even death.
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tus are not yet known. During pregnancy, do not use the appliance on the uterus or abdomen
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to avoid triggering of contractions. Always consult your doctor or midwife if you are pregnant
and intend to use the device.
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cal muscle stimulation (EMS) device could in this case cause a blood clot.
- In case of cognitive impairment
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If your pains have not been diagnosed, with the exception of the positive opinion of your doc-
tor to use this device
.
-if stimulation is applied over the menstruating or pregnant uterus;
-if stimulation is applied over areas of skin that lack normal sensation
FCC
Caution: The user is cautioned that changes or modifications not expressly approved by the party
responsible for compliance could void the user's authority to operate the equipment.
This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions:
(1) this device may not cause harmful interference, and (2) this device must accept any interference
received, including interference that may cause undesired operation.
NOTE: This equipment has been tested and found to comply with the limits for a Class B digital device,
pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection
against harmful interference in a residential installation. This equipment generates, uses and can
radiate radio frequency energy and, if not installed and used in accordance with the instructions, may
cause harmful interference to radio communications. However, there is no guarantee that interference
will not occur in a particular installation.
If this equipment does cause harmful interference to radio or television reception, which can be
determined by turning the equipment off and on, the user is encouraged to try to correct the
interference by one or more of the following measures:
-- Reorient or relocate the receiving antenna.
-- Increase the separation between the equipment and receiver.
-- Connect the equipment into an outlet on a circuit different from that to which the receiver is
connected.
-- Consult the dealer or an experienced radio/TV technician for help.
FCC Radiation Exposure Statement:
This equipment complies with FCC radiation exposure limits set forth for an uncontrolled environment.
This transmitter must not be co-located or operating in conjunction with any other antenna or
transmitter.
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