Glossary; Descriptive Information; Indications For Use; Contraindications - Atos Medical Provox ActiValve Patient Manual

1. Glossary

Candida
Type of yeast-like organism, which is normally present
in the throat and intestines. May multiply and overgrow
voice prostheses.
Clinician
Medical professional or properly licensed speech and
language therapist/ pathologist who are trained in voice
rehabilitation procedures.
Esophagus
Food pipe. Passage from the throat to the stomach.
HME
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.
Pharynx
Throat
PE-Segment
Pharyngo-esophageal segment. The part of the esophagus
(food pipe) where sound is created by vibration of tissue
when using a voice prosthesis.
Silicone
A latex-free material often used in medical devices.
Tracheostoma
Breathing opening in the front of the neck, where the
windpipe is connected to the skin (also called 'stoma').
TE-puncture
Small opening between the trachea and the esophagus
in which the voice prosthesis is inserted.
Trachea
Windpipe
Voice prosthesis
A one-way valve with retaining flanges inserted into a
TE-puncture to allow speech.

2. Descriptive Information

2.1 Indications for use

The Provox ActiValve is an unsterile indwelling voice
prosthesis intended for anterograde insertion in a healed
puncture for voice rehabilitation after total laryngectomy.
The device is intended for patients who are experiencing
early leakage with previous voice prostheses (device life
less than 4-8 weeks). The device reduces the need for
frequent replacements in a majority of users, but not in all.

2.2 Contraindications

The Provox ActiValve is NOT intended:
• for insertion in a freshly made puncture,
• to be in place during MRI-examination, (Magnetic
Resonance Imaging),
• to be in place during Radiation Therapy.

2.3 Description of the device

The Provox ActiValve voice prosthesis [Fig. 1a-1b] has a
one-way valve and two retention flanges [A]. The retention
flanges and the body of the prosthesis are made of medical
grade silicone rubber. A rigid blue ring [B] sits inside
the prosthesis, adding stability and providing an even
sealing surface for the valve flap [C]. The ring and valve
flap are made of medical grade fluoroplastic. The blue
ring and valve flap can be seen on X-ray.
Magnets [D] in the ring and valve flap determine the force
needed to open the valve (the magnets are not adjustable).
Provox ActiValve comes in different opening forces
It is the responsibility of your clinician to select the
appropriate version of Provox ActiValve for you.
Some people suffer from negative pressure in the pharynx/
esophagus during swallowing, or inhalation. The magnetic
force in the valve mechanism increases the pressure
needed to open the valve. As a consequence, you may
feel that you need more force to begin speaking. During
speech, however, the magnetic resistance of the valve
is overcome, so that speech should be easily achievied.
The package contains the following patient
items:
2 Provox Brushes,
1 Provox Plug,
1 ActiValve Lubricant,
2 Provox ActiValve User Cards,
1 Emergency Card,
which should all be handed to the patient.
User Cards
Because Provox ActiValve has different opening forces
that are not apparent upon simple visual inspection,
it comes with Provox ActiValve User Cards that also
provides important information about the Provox
ActiValve prosthesis.
Carry a Provox ActiVale User Card with you at all times
in case of emergency, consultation with healthcare
providers (e.g. radiology), or during travel. If you have
lost the user cards contact your clinician who can arrange
for a replacement.
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