Tabla De Contenido; Descriptive Information - Atos Medical Provox Vega XtraSeal Manual Del Usuario

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 overshooting .........................................11
2.3 Reloading the Provox SmartInserter ...................................................................................11
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 ......................................................................12
5. Additional information ...................................................................................................................13
5.1 Compatibility with MRI, X-ray and radiation therapy ....................................................13
5.2 Device lifetime .............................................................................................................................13
5.3 User assistance information ...................................................................................................13
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 fl 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 fl ange that is intended to solve problems
with leakage around the voice prosthesis. The device is made of medical grade silicone
rubber and fl 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 fi 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 infl ammation/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 fl 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.
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 damaged or opened, do not use the product.
• Always use aseptic technique when handling the prosthesis to reduce infection risk.
• Make sure that any external or internal stoma attachment devices used do not exert
pressure or hook the fl ange 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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