Atos PROVOX 2, Instructions For Use Manual

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1. Glossary
Clinician - Medical professional or properly licensed speech
and language therapist / pathologist or clinical specialist
nurse who is trained in voice rehabilitation procedures.
HME - Heat and Moisture Exchanger. Device that retains
the heat and moisture of exhaled air, which is returned to
the air when you breathe in.
PE-Segment - Pharyngo-esophageal segment. The part of
the food pipe where sound is created by vibration of tissue
when using a voice prosthesis.
TE-puncture – Tracheoesophageal puncture. Small artificial
opening created between the wind pipe and the food pipe
in which the voice prosthesis is placed.
Tracheostoma - Breathing opening in the front of the
neck, where the windpipe is connected to the skin (also
called ‘stoma’).
Voice prosthesis - A one-way valve that is inserted into the
TE puncture. The valve has a flange on either side that allows
the valve to stay in place. Air can be redirected through the
valve to the food pipe for speaking, while reducing the risk
of food and liquids entering the wind pipe.
2. Descriptive Information
2.1 Intended use
The Provox2 Voice Rehabilitation System is intended
for use in surgical, prosthetic voice restoration after total
laryngectomy. The prosthesis may be inserted by the
physician at the time of the total laryngectomy (primary
puncture), or at a later date (secondary puncture), or may
be used to replace the present prosthesis.
2.2 CONTRAINDICATIONS
There are no known contraindications for use or replacement
of the Provox2 prosthesis among patients already using
prosthetic voice rehabilitation.
2.3 Description of the device
The Provox2 Voice Prosthesis (Fig.1) is a sterile single
use one-way valve that keeps a TE-puncture open for
speech, while reducing the risk of fluids and food entering
the windpipe. It is made of medical grade silicone rubber
and radio-opaque fluoroplastic. The prosthesis is not a
permanent implant and needs periodic replacement. The
outer diameter is 7.5 mm (22.5Fr). The Provox2 is available
in lengths 4.5, 6, 8, 10, 12.5 and 15 mm.
The Provox2 Voice Prosthesis package also contains one
Provox Brush with a Provox Brush Instructions for Use.
2.4 WARNINGS
Accidental swallowing of the Provox2 voice prosthesis
may occur. If this occurs, contact your physician who will
advise you further.
Accidental aspiration (i.e. the device falls into the windpipe)
of the Provox2 voice prosthesis or other components of the
Provox2 voice rehabilitation system may occur. Immediate
symptoms may include coughing, choking or wheezing.
If this occurs seek immediate medical treatment. A foreign
body in your airways may cause severe complications and
has to be removed by a clinician.