Intended Use And Patient Target Group; Contraindications; Residual Risks And Undesirable Side Effects - SUBLIMED actiTENS Gebrauchsanleitung

1. INTENDED USE AND PATIENT TARGET GROUP

The is a connected medical device for transcutaneous electrical neurostimulation designed
actiTENS
to treat pain in adults. The intended patient population for
(persons over 18 years of age with unimpaired intellectual abilities) suffering from pain, and being
mentally and physically capable of placing the electrodes and adjusting the intensity, or capable of
expressing pain or wishes regarding treatment modifications or treatment termination.

2. CONTRAINDICATIONS

The should not be used on the following patients without medical advice:
actiTENS
ƒ Patients with pacemakers, implantable cardioverter defibrillators, or other similar electronic
implantable devices.
ƒ Patients at risk of heart problems.
ƒ Patients with epilepsy.
ƒ Patients with decreased or impaired sensation or sensibility on the area to be treated, for example
patients suffering from allodynia (pain triggered by a normally painless stimulus).
ƒ should not be used on pregnant women without medical advice. The electrodes must
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not be placed on the abdomen of a pregnant woman.
Failure to respect these contraindications may have serious consequences and be harmful to the
patient.

3. RESIDUAL RISKS AND UNDESIRABLE SIDE EFFECTS

ƒ Use of the
actiTENS
by a painful stimulus). It is recommended to stop using the device and to consult a healthcare
professional.
ƒ Use of the
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allergy or burns in the area where the electrodes are placed or the area where textile accessories are
fixed. In case of skin irritation after a stimulation session, you should stop the treatment temporarily
and consult a healthcare professional.
ƒ If the electrodes start to peel off, this may cause a slight electric shock. Make sure you change your
electrodes regularly to limit peeling off (see section 20).
ƒ Using the
actiTENS
recommended to consult a healthcare professional before using the device.
ƒ Certain accessories (cables, AC charger and textile accessories) may present a risk of strangulation.
All serious incidents related to the use of the device must be declared to the
manufacturer at the address contact@subli-med.com and the competent authority of
the member state where the user lives (cf list on the back of the instructions).
4. WARNINGS
ƒ Always keep the
impaired intellectual ability.
ƒ Do not position the electrode and the neurostimulator on the front of the neck (especially the carotid
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may in certain cases cause hyperalgesia (abnormally amplified pain caused
may in certain cases cause erythema (redness), skin irritation, inflammation,
may cause temporary muscular pain or involuntary muscular contractions. It is
and its accessories out of reach of children, animals and persons of
actiTENS
medical device is adult patients
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