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ENGLISH
Provox® Vega™ XtraSeal™
The Instructions for Use, which accompanies this product, may be
revised from time to time and must therefore be reviewed prior to
each procedure in which the product is used.
Contents
1. Descriptive information......................................................................10
1.1 Intended use ....................................................................................10
1.2 Description of the device ............................................................10
1.3 CONTRAINDICATIONS...................................................................10
1.4 WARNINGS ........................................................................................10
1.5 PRECAUTIONS..................................................................................10
2. Instructions for use...............................................................................11
2.1 Preparation.......................................................................................11
2.2 Anterograde replacement procedure using overshooting11
2.3 Reloading the Provox SmartInserter .......................................12
3. Important patient information ........................................................12
3.1 General information......................................................................12
3.2 Prosthesis maintenance...............................................................12
3.3 Accessories........................................................................................12
4. Adverse events/Trouble shooting information..........................13
5. Additional information.......................................................................14
5.1 Compatibility with MRI, X-ray and radiation therapy........14
5.2 Device lifetime.................................................................................15
5.3 User assistance information .......................................................15
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 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 uids 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 ange that is
intended to solve problems with leakage around the voice prosthesis.
The device is made of medical grade silicone rubber and uoroplastic.
Provox Vega XtraSeal package
The Provox Vega XtraSeal package contains the following items:
• 1 Provox Vega XtraSeal voice prosthesis, pre-loaded in a single-
use SmartInserter, 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 a Provox Vega 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 t may cause tissue
necrosis and extrusion.
• Instruct the patient to consult a physician immediately if there are
any signs of tissue edema and/or signs of inammation/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 ange 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.
