Application-Related Safety Instructions - schwa-medico TENStem eco basic Instructions For Use Manual

it is to be used in. Wait for at least 30 minutes. Otherwise, condensation that forms inside
the device may result in electrical shock, fire, damage to the device and/or personal injury.
For commercial use in Germany, the operator is required, as per Section 11 of the Ordi-
nance on Operators of Medical Devices (MPBetreibV), to conduct technical safety controls
for the product in regular and appropriate intervals. The manufacturer recommends run-
ning technical safety checks on the product every 24 months. Please observe the legal re-
quirements that apply in your country.
1.3.2

Application-related safety instructions

Affixing the electrodes:
1. The device may only be connected to one patient at a time.
2. Clean the skin surface where the electrodes will be affixed before attaching the elec-
trodes. Otherwise, faulty operation cannot be ruled out.
3. Caution: Make sure that no metallic objects such as jewellery or piercings come into
contact with the electrodes during stimulation, as this may result in localised burns.
4. Caution: Tattoo inks can contain metallic pigments which, under the influence of cur-
rent, could in rare cases cause high current densities and skin damage. Wherever possi-
ble, stimulation in areas of the body with tattoos should be avoided. If it is not possible,
stimulation in these areas of the body should be observed with closer attention and
ended immediately in the event of an emergency.
5. Caution: Place the electrodes on the skin so that the electrode surface makes full and
even contact with the skin. Make sure additionally that the distance between the elec-
trodes is at least 2 cm. Otherwise, too high current densities can occur and painful skin
lesions might appear on the skin.
6. Caution: In patients with metal implants who have sensory disorders in the area of the
metal, special caution should be taken when stimulating and placing electrodes in this
area. The sensory disorder might tempt users to increase the stimulation intensity set-
ting and lead to skin irritation with reddening of the skin or pain in the area around the
metal. In this case, it will be necessary to stop the stimulation.
7. Caution: Please also observe the instructions for use of the electrodes you use, espe-
cially the safety instructions they include.
8. Caution: Electrical stimulation therapy should only be applied over or through the head,
directly to the eyes, with the mouth covered, at the front of the neck (particularly the
carotid sinus) or using electrodes placed on the chest and upper back or crossing the
heart after prior consultation with a physician.
Warning: Attaching the electrodes next to the thorax might increase the risk of cardiac
arrhythmia. In the case of electrode systems being used in the chest area, intensive high-fre-
quency stimulation (from approx. 15 Hz) can lead to disturbed breathing activity during
stimulation.
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