Descriptive Information; Indications For Use; Description Of The Device; Contraindications - Atos Medical PROVOX Vega Bedienungsanleitung

1. Descriptive information

1.1 Indications for use

The Provox Vega Voice Prosthesis is a sterile single use indwelling voice
prosthesis intended for voice rehabilitation after surgical removal of the
larynx (laryngectomy). Cleaning of the voice prosthesis is performed
by the Patient while it remains in situ.
The Provox SmartInserter is a sterile single use device intended for
anterograde replacement of the Provox Vega Voice Prosthesis. This
replacement procedure is carried out by a medical doctor or a trained
medical professional in accordance with local or national guidelines.
The Provox SmartInserter is not intended to be used for insertion of
a voice prosthesis in a freshly made puncture.

1.2 Description of the device

General
The Provox Vega is a one-way valve (prosthesis) that keeps a TE-puncture
open for speech, while reducing the risk of fluids and food entering the
trachea. The Provox Vega voice prosthesis is not a permanent implant,
and needs periodic replacement. The prosthesis (figure 1) is available in
different diameters and several lengths. The device is made of medical
grade silicone rubber and fluoroplastic.
Provox Vega package
The Provox Vega package contains the following items:
• 1 Provox Vega voice prosthesis pre-loaded in a single-use
SmartInserter, sterile (figure 2)
• 1 Provox Brush of a size corresponding to the voice prosthesis,
non-sterile
• 1 Provox Vega Clinician's manual
• 1 Provox Vega Patient's manual
• 1 Provox Brush Instructions for Use

1.3 Contraindications

There are no known contraindications for use or replacement of the
Provox Vega voice prosthesis among patients already using prosthetic
voice rehabilitation.

1.4 WARNINGS

Dislodgement or extrusion of the ProvoxVega voice prosthesis from
the TE puncture and subsequent ingestion, aspiration or tissue damage
may occur. For further information about these events, see section
Adverse Events/Trouble Shooting Information below.
To reduce the risk of dislodgment/extrusion and its potential sequelae:
• Select the proper prosthesis size. A tight fit may cause tissue
necrosis and extrusion.
• Instruct the patient to consult a physician immediately if there
are any signs of tissue edema and/or inflammation/infection.
• If used, choose laryngectomy tubes or stoma buttons with
a suitable shape that do not exert pressure on the prosthesis or
catch onto the tracheal flange of the prosthesis during insertion and
removal of the laryngectomy tube or stoma button.
• Instruct the patient to use only genuine Provox accessories of
corresponding size (Brush, Flush, Plug) for maintenance and to
avoid all other kinds of manipulation.
• Re-use and re-processing may cause cross-contamination and
damage to the device, which could cause patient harm.

1.5 PRECAUTIONS

• Carefully assess any patient with bleeding disorders or who is
undergoing anticoagulant treatment for the risk of bleeding or
hemorrhage prior to placement or replacement of the prosthesis.
• Inspect the package before use. If the package is damaged or
opened, do not use the product.
• Always use aseptic technique when handling the prosthesis in order
to reduce infection risk.
• Make sure that any external or internal stoma attachment devices
used do not exert pressure or hook the flange of the prosthesis (e.g.,
HME base plates, laryngectomy tubes, or stoma buttons). This may
lead to severe tissue damage and/or accidental ingestion of the
prosthesis.
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