Prosthesis Hood; Prosthesis Shaft; Tracheal Flange; Radio-Opaque Fluoroplastic Valve Seat - Atos PROVOX Vega Mode D'emploi

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. Glossary
Clinician
HME
PE-Segment
Silicone
TE-puncture
Tracheostoma
Voice prosthesis
2. Descriptive information
2.1 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.
2.2 Description of the device
Provox Vega is a single-use medical device with a one-way valve
that keeps a TE-puncture open for speech, and reduces the risk of
liquid and food entering the trachea. It is made of medical grade
silicone and fluoroplastic.
For illustration see Fig. 1.
a) Prosthesis Hood
b) Prosthesis Shaft
c) Tracheal Flange
d) Radio-opaque fluoroplastic Valve Seat
e) Esophageal Flange
f) Valve Flap
Provox Vega package
The Provox Vega package contains the following user accessories:
• 1 Provox Brush of a size corresponding to the voice prosthesis,
non-sterile
• 1 Provox Brush Instructions for Use
• 1 Provox Vega Patient's manual
2.3 CONTRAINDICATIONS
There are no known contraindications for use or replacement of the
Provox Vega voice prosthesis among patients already using prosthetic
voice rehabilitation.
2.4 WARNINGS
Accidental aspiration (entering the windpipe) of the Provox Vega
voice prosthesis or other components of the Provox voice rehabilitation
system may occur. Immediate symptoms may include gagging,
coughing, choking or wheezing. If this occurs seek immediate
medical treatment. A foreign body in your airway may cause severe
complications such as acute respiratory distress and/or respiratory
arrest, and has to be removed by a clinician.
Accidental swallowing of the Provox Vega voice prosthesis may occur.
If this occurs, contact your physician who will advise you further.
Re-use and re-processing may cause cross-contamination and damage
to the device, which could cause patient harm.
6

ENGLISH

Medical professional or properly licensed
speech and language therapist / pathologist
or clinical specialist nurse who is trained in
voice rehabilitation procedures.
Heat and Moisture Exchanger (Artificial
Nose). Device that retains the heat and
moisture in the exhaled air, which otherwise is
lost when breathing through a tracheostoma.
Pharyngo-esophageal segment. The part of
the esophagus (food pipe) where sound is
created by vibration of tissue when using a
voice prosthesis.
A material often used in medical devices.
Small artificial opening created between the
trachea (wind pipe) and the esophagus (food
pipe).
Breathing opening in the front of the neck,
where the windpipe is connected to the skin
(also called 'stoma').
A one-way valve with retaining flanges
inserted into a TE-puncture to allow speech
by redirecting air to the esophagus (food pipe)
while reducing the risk of food and liquids
entering the trachea (wind pipe).