Please see accompanying Illustration manual for illustrations referenced in this Instructions
for Use.
Stomal airway management
Emergency situations
It is important that emergency personnel knows that you are a neck breather. This will help them
determining that oxygen and rescue breathing need to be administered to your stoma and not to
your mouth or nose.
We recommend that you and your clinician download the guidelines for rescue breathing from
www.atosmedical.com/rescuebreathing
Elective situations
If you need to undergo a procedure that requires intubation (putting a breathing tube in your windpipe),
it is very important that the anesthesiologist and the doctor who is performing the procedure are
aware that you are a neck breather and that you are using a voice prosthesis. It is important for them
to understand that the voice prosthesis should stay in place. If it is removed, fluids from your mouth,
food pipe, or stomach may get into your windpipe.
It is very important that the intubation tube is inserted and removed carefully so that the voice
prosthesis does not dislodge or come out.
1. Descriptive information
1.1 Indications for use
Provox Vega Puncture Set is a device for performing a primary or secondary tracheo-esophageal (TE)
puncture in laryngectomized patients, with integrated placement of a Provox Vega voice prosthesis.
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.
1.2 CONTRAINDICATIONS
Do not use the Provox Vega Puncture Set if the patient has anatomical abnormalities that may
hinder safe puncturing of the TE wall or safe voice prosthesis placement (e.g., significant stenosis
or significant fibrosis at the puncture site) as this may cause tissue damage.
Do not use the Provox Vega Puncture Set for secondary TE puncture if the patient suffers from severe
trismus that precludes proper protection of the pharyngeal wall. Failure to protect the pharynx during
puncture may lead to unintended trauma of the pharyngeal/ esophageal tissue.
1.3 Description of the device
The Provox Vega Puncture Set is a device for creating a primary or secondary TE puncture, with
subsequent dilatation of that puncture to a width that facilitates placement of the included Provox
Vega voice prosthesis. The Provox Vega voice prosthesis is preloaded on the Puncture Dilator, which
is part of the device.
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 fluoroplastic,
• 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 fluoroplastic.
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 flange (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 fluids 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 sufficient for creation
of a TE puncture.
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