Descriptive Information; Indications For Use; Description Of The Device; English - Atos Medical Provox FreeHands Support Instrucciones De Uso

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The Instructions for Use, which accompany this product, may be revised from time to time and must therefore be

reviewed prior to each procedure in which the product is used.

1. Descriptive Information

Provox FreeHands Support provides support to the Provox Adhesive when using a Provox hands-free speaking valve

after total laryngectomy. The device is a single patient use device with a single use adhesive.

1.2 CONTRAINDICATIONS

• Do not use Provox FreeHands Support on breached skin.

• Provox FreeHands Support is NOT intended to be in place during MRI examination (Magnetic Resonance Imaging),

or during the period of Radiation Therapy treatment.

The Provox FreeHands Support system consists of two parts; Provox FreeHands Support and Provox FreeHands

Support Adhesive.

The reusable Provox FreeHands Support consists of a plastic part and a supporting metal ring. Provox FreeHands

Support is available in three different variants; 'Flat', 'Medium' and 'Deep'. On the reverse of the plastic part, just

under the ring, there are 1, 2 or 3 dots visible (fig. 1). The number of dots represents the depth of the ring.

1 dot = Provox FreeHands Support Flat (REF 8021)

2 dots = Provox FreeHands Support Medium (REF 8022)

3 dots = Provox FreeHands Support Deep (REF 8023)

The three variants, as well as the ability to adjust the metal ring and plastic parts, enable a personal fit.

Note, the metal ring contains nickel, however the amount of free nickel in the material is below the level which would

normally give a reaction in people with a nickel-allergy.

Provox FreeHands Support Adhesive consists of an adhesive tape with a peel-off liner and a plastic plate. Provox

FreeHands Support Adhesive is a single-use adhesive that is attached to the skin, beneath the Provox Adhesive.

Caution: Use only original components. Other accessories may cause product malfunction.

1.4 WARNINGS

• The adhesive may irritate the skin. If irritation occurs, stop using the adhesive and consult your clinician.

• Reuse of the Provox FreeHands Support Adhesive, by either yourself or someone else, or reuse of the Provox

FreeHands Support by another person may cause transfer of micro-organisms which can lead to infections.

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