Important Patient Information; General Information; Additional Information - PROVOX Vega XtraSeal Mode D'emploi

3. Ensure the Voice Prosthesis is properly positioned on the Insertion Pin, firmly
attached and with the tip of the pin positioned all the way into the blue ring of the
voice prosthesis (Fig. 3). Connect the Folding Tool.
4. Guide the Insertion Pin through the opening in the Folding Tool until it clicks in
place. Pull the pin until the pin is snapped into the Folding Tool. (Fig. 11). The
Provox Insertion System is now ready for preparation. Continue the preparation
as described above in section 2.2.
CAUTION: Do not reload more than twice. If the Provox Vega voice prosthesis shows
any signs of damage, do not use the voice prosthesis.
2.5 Finalize the procedure
After insertion:
Ensure proper fit
1. Ensure the proper position of the voice prosthesis by rotating and gently pulling
the Insertion Pin (Fig. 12). The prosthesis is in an ideal position when the Safety
Strap is pointing downwards.
CAUTION: Confirm that both esophageal flanges have deployed entirely in the
lumen of the esophagus. No part of the enlarged esophageal flange should be visible
alongside the shaft of the voice prosthesis and when rotated the voice prosthesis
should move freely. Rotating the voice prosthesis while at the same time slightly
pushing it towards the esophagus can help to unfold the enlarged flange completely.
In case of uncertainty, use flexible endoscopy to confirm proper placement inside
the esophagus.
Test proper function
2. Brush the Provox Vega with the Provox Brush. Test proper function of the prosthesis
by asking the patient to speak and by observing that the prosthesis does not leak
while the patient drinks water (Fig. 18).
Cut the Safety Strap
3. After ensuring the voice prosthesis is placed correctly, cut off the Safety Strap
so that it is flush with the Tracheal Flange (Fig. 14). The voice prosthesis is now
ready for use.
2.6 Disposal
Always follow medical practice and national requirements regarding biohazard
when disposing of a used medical device.

3. Important patient information

3.1 General information

Ensure that the patient understands to contact their clinician if:
• There is leakage through or around the prosthesis (coughing and/or change of mucus
color).
• Speaking becomes difficult (higher effort and/or voice sounds more strained).
• There are any signs of inflammation or tissue changes at the puncture site or the
stoma region (pain, redness, heat, swelling, traces of blood on the brush after
brushing).
Also inform the patient that:
• After a prosthesis replacement traces of blood may be found in the sputum. This may
come from granulation tissue on the edges of the TE puncture.
• The Provox Vega Plug can be used to temporarily stop leakage through the voice
prosthesis.
• Speech Training Sessions with a trained clinician are advised in order to acquire
optimal voice sound, fluent speech, and optimal intelligibility.
3.2 Prosthesis maintenance
Instruct the patient when and how to clean the Provox Vega XtraSeal voice prosthesis.
Cleaning the prosthesis at least twice a day can help prolong the device life.
CAUTION: Only use genuine Provox accessories that are intended for use with
Provox Vega when cleaning the prosthesis.
• Brushing the prosthesis with the Provox Brush twice a day will help to remove
mucus and food remnants from the prosthesis.
• Flushing the prosthesis with the Provox Flush also helps to clean debris and mucus
from the prosthesis, can help increase the life of the device.
Note: The Provox Flush is intended for use only by patients who, as assessed by the
clinician who prescribes the device, have demonstrated ability to understand and
consistently follow the instructions for use without clinician supervision.
• Some dietary measures, like the daily intake of yogurt or butter milk containing
lactobacilli, are considered to be helpful against excessive Candida growth.
For detailed information on how to clean a Provox Vega, please see Instructions for
each accessory.

4. Additional information

4.1 Compatibility with MRI, X-ray and radiation therapy
Provox Vega XtraSeal voice prostheses have been tested and found to be compatible with
Magnetic Resonance Imaging (tested up to 3 Tesla), x-ray and radiation therapy (tested
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