English; Descriptive Information; Intended Use; Description Of The Device - Atos Medical PROVOX Vega XtraSeal Instrucciones De Uso

Provox® Vega™ XtraSeal™

1. Descriptive information

1.1 Intended 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 Insertion System 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 Insertion System 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 (Fig. 1) is available in different diameters and several lengths.
Provox Vega XtraSeal has an additional enlarged esophageal flange that is intended to
solve problems with leakage around the voice prosthesis.
The device is made of medical grade silicone rubber and fluoroplastic.
Provox Vega XtraSeal package
The Provox Vega XtraSeal package contains the following items:
• 1 Provox Vega XtraSeal voice prosthesis, pre-assembled in a single use Insertion
System, sterile (Fig. 2)
• 1 Provox Brush of a size corresponding to the voice prosthesis, non-sterile
• 1 Provox Vega XtraSeal 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 a Provox Vega voice
prosthesis among patients already using prosthetic voice rehabilitation.
1.4 WARNINGS
• Dislodgement or extrusion of the Provox Vega voice prosthesis from the TE
puncture and subsequent ingestion, aspiration or tissue damage may occur. A foreign
body in the airway may cause severe complications such as acute respiratory distress
and/or respiratory arrest.
• 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.
• Instruct the patient to consult a physician if leakage through or around the voice
prosthesis occurs. Leakage may cause aspiration pneumonia.
• 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. This may
lead to severe tissue damage and/or accidental ingestion of the prosthesis.
• 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.
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ENGLISH