Important Patient Information; General Information; Prosthesis Maintenance; Accessories - Atos Medical Provox Vega XtraSeal Manual Del Usuario

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 diffi cult (higher effort and/or voice sounds more strained).
• There are any signs of infl ammation 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.
• Occasionally, mild leakage through or around the prosthesis may occur in the fi rst
weeks after insertion of a new prosthesis. This often resolves spontaneously and does
not require immediate replacement of the prosthesis.
• If leakage spontaneously occurs through the prosthesis a temporary blockage can be
done with a Provox Vega Plug.
• Speech Training Sessions with a trained clinician are advised in order to acquire
optimal voice sound, fl uent 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, which helps 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.

3.3 Accessories

CAUTION: Only use genuine Provox accessories that are intended for use with
Provox Vega. Other accessories may cause patient harm or product malfunction.
Accessories to facilitate insertion of the prosthesis (for clinician's use)
• Provox Dilator: Helps to convert from a prosthesis with a smaller shaft diameter to a
Provox voice prostheses of larger diameter.
• Provox GuideWire: for placement of a Provox, Provox2 or a Provox Vega voice
prosthesis in a freshly made TE puncture, or for retrograde replacement of a Provox
indwelling voice prosthesis.
Accessories to maintain the device function (for patient's use)
• Provox Brush / Provox Brush XL is used by the patient to clean the inside of the
prosthesis.
• Provox Flush is an additional cleaning device that allows fl ushing of the prosthesis.
• Provox Vega Plug is a First Aid tool for patient's use that temporarily blocks leakage
through the prosthesis.
Other supplementary products that can be used with Provox voice prostheses
• 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 information

The following are possible risks associated with prosthetic voice rehabilitation:
Prosthesis related
Leakage through the valve – Leakage through the prosthesis may occur in association
with Candida overgrowth of the valve fl ap or dislodgement of the radio opaque ring (valve
seat). It may also occur if the esophageal fl ange of the prosthesis is not fully developed
in the lumen of the esophagus or if the prosthesis is too short. Endoscopic examination
should be performed to determine whether any of these phenomena has occurred. If the
prosthesis is in the correct position and of the right length, and if cleaning of the prosthesis
does not resolve leakage through the prosthesis, replacement of the prosthesis is indicated.
Candida overgrowth – Candida overgrowth of the prosthesis occurs in almost all patients.
Radiotherapy, salivary content and dietary habits may infl uence how rapidly Candida
can affect the silicone material. Treatment with antifungal agents may be considered as a
preventive measure if Candida overgrowth causes leakage through the prosthesis or other
incompetence of the valve.
Compatibility with antifungal medicine – An unknown variety of chemical substances
may immediately infl uence the material properties of the device or may be absorbed by
the material and subsequently released at a later time. Therefore, the introduction of
antifungal medicines or drugs directly to or within close proximity of the voice prosthesis
should be carefully assessed.
Laboratory tests show only minor negative infl uence on the function of the Provox
Vega voice prosthesis and components when using the following antifungal medications:
• Nystatin
• Fluconazole
• Mikonazol
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