Warnings - Atos Medical Provox Vega Instrucciones De Uso

The Provox Vega Puncture Set is intended for single use only and the package contains
the following sterile items in a blister package (Fig. 1):
• 1 Pharynx Protector (Fig. 1.1) made of transparent thermoplastic,
• 1 Puncture Needle (Fig. 1.2) made of surgical stainless steel,
• 1 Guidewire (Fig. 1.3) made of pre-colored fl uoroplastic,
• 1 Puncture Dilator with 1 preloaded Provox Vega voice prosthesis (Fig. 1.4). The
Puncture Dilator is made of thermoplastic elastomer and polypropylene; and the Vega
voice prosthesis is made of medical grade silicone rubber and fl uoroplastic.
The preloaded Puncture Dilator contains the following functional characteristics and
components:
• a dilator (Fig. 1.4.1),
• a dilator strap (Fig. 1.4.2) connecting the dilator and the voice prosthesis interface,
• a dilator loop (Fig. 1.4.3) constituting the voice prosthesis interface,
• a Wirelock (Fig. 1.4.4) containing interfaces to the voice prosthesis safety strap (Fig. 1.4.6)
and to the Guidewire,
• a Provox Vega voice prosthesis (Fig. 1.4.5) with its safety strap (Fig. 1.4.6) connected
to the Wirelock and oriented so that the tracheal fl ange (Fig. 1.4.7) of the voice
prosthesis is facing towards the Wirelock.
The Provox Vega voice prosthesis contains a one-way valve that keeps the 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 is available in different diameters and several sizes.
The set also includes the following non-sterile items:
• 1 Instructions for use - Provox Vega Puncture Set
(including 1 Illustration manual)
• 1 Provox Vega Patient's Manual
• 1 Provox Brush of a size corresponding to the voice prosthesis
• 1 Provox Brush Instructions for Use

1.4 WARNINGS

Pre-surgery
• DO NOT use the product if the package is damaged or opened. Unsterile product may
cause infection.
• DO NOT REUSE and DO NOT RESTERILIZE by any method. This device is
intended for single use only. Reuse may cause cross contamination. Cleaning and
resterilization may cause structural damage to the device.
• DO proceed with great care if the patient has received radiotherapy with or without
concurrent chemotherapy. These circumstances increase the risk of puncture-related
complications (e.g., widening, granulation, atrophy). Therefore, ensure that the tissue
integrity is suffi cient for creation of a TE puncture.
During surgery
General
• DO ensure that the Pharynx Protector is inserted deep enough into the esophagus
before performing primary TE puncture, by palpating the TE wall. Puncture without
proper positioning of the Pharynx Protector may cause tissue damage.
• DO ensure that the Guidewire is inserted through the needle and through the lumen of
the Pharynx Protector so that it does not damage the TE wall.
• DO ensure that the Puncture Needle is removed before removing the pharynx protector.
The Puncture Needle may cause tissue damage without proper pharynx protection.
• DO ensure that the Puncture Dilator is mounted on the esophageal end of the Guidewire
and not the tracheal. The dilatation should be performed in the posteroanterior
direction. Dilatation in the wrong direction causes reversed placement of the voice
prosthesis, which causes aspiration and inability to speak.
• DO NOT withdraw the Guidewire back through the Puncture Needle. Damage,
shearing and/or scraping of the Guidewire may occur. If the Guidewire must be
withdrawn, remove the Guidewire and the Puncture Needle simultaneously, as one
unit, to prevent the Puncture Needle from damaging the Guidewire.
• DO NOT use toothed hemostats or other instruments that may damage the product.
Secondary puncture
• DO NOT use the included Pharynx Protector during Secondary punctures. It is only
intended to be used during Primary punctures.
• DO ensure that the pharyngeal/esophageal tissue is adequately protected, e.g., by use
of a rigid endoscope before performing secondary TE puncture.
Post surgery
Use of the voice prosthesis
Dislodgement or extrusion of the Provox Vega voice prosthesis from the TE puncture and
subsequent ingestion, aspiration or tissue damage may occur. For further information
about these events and how to prevent them, see section Adverse Events and Trouble
Shooting Information below.
To reduce the risk of dislodgment or extrusion and its potential consequences:
• DO select the proper prosthesis size (i.e. length). A tight fi t due to a too short voice
prosthesis may cause tissue necrosis and extrusion.
• DO instruct the patient to only use genuine Provox accessories of corresponding size
and diameter (e.g., Brush, Flush, Plug) for maintenance and to avoid all other kinds of
manipulation.
• DO instruct the patient to consult a physician immediately if there are any signs of
tissue edema and/or infl ammation/infection.
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