Additional Devices; Adverse Events/ Trouble Shooting By Symptom; Additional Information; Air Travel - Atos Provox ActiValve Manual Del Paciente

3.5 Additional devices

Provox XtraFlow and Provox XtraMoist: Heat- and Moisture Exchangers that partially restore lost nasal functions
(conditioning of the air, breathing resistance).
Provox FreeHands FlexiVoice: 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

Indications for replacement of the Provox ActiValve voice prosthesis include leakage through the valve, blockage of the
prosthesis, bacterial and candidal overgrowth leading to degradation of the materials and /or excessive pressure needed to
obtain speech. Other reasons for replacement include medical indications such as problems with the puncture tract.
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 if possible also with the Provox 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 is sometimes not possible (valve does not open).
Probable cause: The valve lid sticks to the valve seat, preventing the valve from opening. This becomes more likely the
longer the valve has not been in use (e.g. overnight).
Measures: Clean the voice prosthesis and lubricate it (see section Cleaning and Maintenance). If cleaning and lubricating
does not help: Contact your clinician.
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 Air travel

This device contains 2 magnets; size 1-1.5 mm, weight 0.15 – 0.2 gram. The magnets are unlikely to set off metal detectors
such as those used in airports but in order to avoid incidents it could be advisable to inform the security personnel in advance
of your voice prosthesis and show them your Provox ActiValve User Card.

5.2 Date of printing and user assistance information

The version number of this Instruction for use and manufacturer contact information is located on the back cover.
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