Descriptive Information - Atos Medical PROVOX VEGA Manual Del Usuario

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. glossary ..................................................................................................................................................6

2. descriptive information .....................................................................................................................6

2.1 indications for use .........................................................................................................................6
2.2 description of the device ...........................................................................................................6
2.3 conTRaindicaTionS ..................................................................................................................7
2.4 WaRningS .......................................................................................................................................7
2.5 PREcauTionS .................................................................................................................................7
3. instructions for use ..............................................................................................................................7
3.1 using the Provox Vega to speak ...............................................................................................7
3.2 cleaning the Provox Vega ..........................................................................................................7
3.3 accessories.......................................................................................................................................7
3.4 additional devices .........................................................................................................................8
4. adverse events/ Trouble shooting by symptom ......................................................................8
5. additional information ......................................................................................................................8
5.1 compatibility with MRi, X-ray and radiation therapy .......................................................8
5.2 device lifetime ................................................................................................................................8
5.3 user assistance information .....................................................................................................8
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.
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).