promed 10ER Butterfly Elektrode Instruction Manual

promed 10ER Butterfly Elektrode Instruction Manual

Explanation of Symbols

| Medical Device
| Unique Device Identifier
| Consult instructions
for use
| Manufacturer
| Catalogue number

| Batch code

| Use by
| Single multiple  use
| Temperature
limitation
| Humidity limitation
| Keep away from sunlight

| Quantity of pieces
| Do not contain natural rubber latex
| Distributor

INSTRUCTION FOR USE

FULLY GELLED ELECTRODES, WITH CABLE, FOR ELECTRO-STIMULATION

INTENDED USE

Adhesive skin electrodes with conductive gel, suitable for electro-stimulation equipment.

CONTRA INDICATIONS

The product must not be used:

• With pregnant women.
• With epileptic patients.
• With wearers of pacemakers.
• In subjects with progressive episodes of skin irritation or contact allergies.

DIRECTIONS FOR USE

• Check the integrity of the electrode and gel packaging; do not use the product in the presence of visible damage and defects (eg. altered, dry or non-homogeneous gel; damage to the electrode or the connection cable).

• Choose an area free from hair, skin lesions or scars, folds in the skin, or bony protuberances, which is not in the vicinity of metallic prostheses.

• Clean and dry the application surface. The electrodes may not adhere sufficiently if there are residues of lotion, oil, make-up, dirt, etc. on the skin.

• Connect the electrode to the cable of the electro stimulator.

• N.B. Only use equipment specifically designed for electrostimulation with a low current intensity. Not to exceed intensity of 0.1 WattJcm2.

• Remove the liner and apply the electrode to the skin surface.

• Before switching on the electro-stimulator, check the perfect adherence of the electrode to tie skin surface, over its entire area. It may be useful to moisten the skin before applying the electrodes to improve adhesiveness. Do not use the product if tie contact between the electrode and the skin is incomplete or unstable.

• If the stimulation capacity is lower than normal, do not increase the output, without having previously checked that the entire surface of the electrode is in contact with the patient’s skin

• Interrupt the treatment if the patient complains discomfort or a burning sensation.

• After the session, turn off the electro stimulator, disconnect the cable from the electrode and gently remove the electrode by lifting it up by one corner.
  N.B. Rapid removal of the electrode could cause skin traumas. Do not remove by pulling the connection part of the cable.

• After the use, reposition electrodes on the plastic liner and insert it in the pouch.

Examples of Electrode Positioning

Abdominal Muscles

Lower Back

Upper Back

Back of the Thighs

Buttocks

Shoulder

WARNING

• Electrode may be reused: reuse only on the same patient.
• Always check the perfect adhesion of the electrodes before use. The duration of the electrodes depends on the type of skin, the methods of storage, the frequency of use, as well as the type and area of stimulation. If the adhesive capacity decreases, one or -wo drops of water on the gel layer could extend the usability of the electrode. If not, replace the electrodes.
• The devices must be connected and put into operation by qualified users
• Do not apply electrodes on skin affected by abrasions, erythema or wounds.
• Do not use the electrodes after the “use before” date indicated on the label.
• Keep the package closed in order to prevent the unused electrodes from becoming dehydrated.
• WARNING: Reduced contact be-ween the skin and the electrode can concentrate the current in one point and cause burns.

STORAGE

• The product must be stored in the original package at the environmental conditions (temperature and relative humidity) specified on the pouch s label. Putting external heavy weights on the package may damage the product.

WASTE DISPOSAL

• – Refuses deriving from health structures must be disposed in according to the regulation in torte.

GENERAL NOTES

If, during the use of this device or as a result of its use, a serious incident has occurred, please report it to the manufacturer and to your national authority. For any malfunction or defect of the device, inform the Manufacturer’s Quality Service.

Promed GmbH Kosmetische Erzeugnisse
Lindenweg 11, D-82490 Farchant
Tel: +49 (0)8821/9621-0
Fax: +49 (0)8821/9621-21
[email protected]
www.promed.de

FIAB SpA
via Costoli, 4 50039
Vicchio
(Florence, Italy) www.fiab.it

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