Atos Medical PROVOX Vega, Инструкция по эксплуатации

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ENGLISH
Provox® Vega™
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 .............................................9
1.1 Indications for use .....................................................9
1.2 Description of the device .......................................9
1.3 CONTRAINDICATIONS .............................................9
1.4 WARNINGS ................................................................ 10
1.5 PRECAUTIONS .......................................................... 10
2. Instructions for use ................................................... 10
2.1 Preparation .............................................................. 10
2.2 Anterograde replacement procedure ............. 10
2.3 Anterograde replacement procedure
using voluntary overshooting .................................. 11
2.4 Reloading the rovox SmartInserter .................. 11
3. Important patient information ............................ 12
3.1 General information .............................................. 12
3.2 Prosthesis maintenance ....................................... 12
4. Adverse events/Trouble shooting information 12
5. Additional information ........................................... 12
5.1 Compatibility with MRI, X-ray and radiation
therapy .............................................................................. 12
5.2 Device lifetime ......................................................... 12
5.3 Compatibility with antifungal medicine ........ 13
5.4 User assistance information ............................... 13
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.
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