Additional Devices; Additional Information - Atos Medical PROVOX VEGA Manual Del Usuario

3.4 Additional devices

Provox HME: Heat- and Moisture Exchanger partially restores lost nasal functions (heating,
humidifying, breathing resistance).
Provox FreeHands HME: A Heat and Moisture Exchanger combined with an automatic
tracheostoma valve, designed to allow hands-free speech.
Provox LaryTube: A silicone tracheal cannula intended to support shrinking stomas
while retaining other rehabilitation devices of the Provox System.
Provox LaryButton: A soft, self-retaining silicone tracheal cannula intended to support
shrinking stomas while retaining other rehabilitation devices of the Provox System.
4. Adverse events/ Trouble shooting by symptom
It is the responsibility of your clinician to inform you about risks and benefits of prosthetic
voice rehabilitation and to instruct you what to do in case you may encounter adverse
events. If you are not sure that you have completely understood all instructions, ask your
clinician for further explanation.
Symptom: Coughing (triggered by drinking or eating) while the prosthesis is in place.
Most common reasons: Leakage through or around the prosthesis.
Measures:
1. Clean the prosthesis with the Provox Brush and/or Flush. There may be food remnants
preventing the valve from proper closure.
If leakage continues:
2. Observe the prosthesis while drinking. Try to identify if it leaks through the center
or around the prosthesis.
a.) If you think it leaks through the center you can use the Provox Vega Plug while
you are eating and drinking to prevent leakage. Notify your clinician that you need
a new prosthesis.
b.) If you think it leaks around, or if the Plug does not stop the leakage. Notify your
clinician that you may have leakage around your prosthesis.
Symptom: Speaking becomes more and more difficult.
Most common reasons: Valve obstruction, tissue swelling in the throat (e.g. during
radiotherapy).
Measures:
1. Clean the prosthesis with the Provox Brush and/or Flush. There may be food remnants
increasing the airflow resistance.
2. If that does not help: Contact your clinician immediately.
Symptoms: Pain, heat, swelling, and rash (together or alone) in the area of the prosthesis
or stoma.
Most common reasons: Tissue inflammation and infections.
Measures: Contact your clinician immediately.
Symptoms: Traces of blood are seen on the Brush after brushing.
Most common reasons: Tissue inflammation and infections at the esophageal side.
Measures: Contact your clinician immediately.

5. Additional information

5.1 Compatibility with MRI, X-ray and radiation therapy
The Provox Vega voice prosthesis can be left in the TE-puncture during the MRI, X-ray
and radiation examination/therapy session. The Provox Vega voice prosthesis is compatible
with Magnetic Resonance Imaging up to 3.0 Tesla, X-ray and radiation therapy up to 70
Gy. Note that the radio-opaque valve seat is visible on x-ray.
5.2 Device lifetime
Depending on individual biological circumstances the device life varies, and it is not
possible to predict the integrity of the device over a longer period of time. The material
of the device will be affected by e.g. bacteria and yeast, and the structural integrity of
the device will eventually deteriorate.
5.3 User assistance information
For additional help or information please see back cover of the Instructions for Use for
contact information.
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