Device Lifetime; Prosthesis Maintenance - Atos Provox ActiValve Manual Del Usuario

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8. Cut off the safety strap using scissors on the outer edge of the tracheal flange (Fig. 14). The Provox ActiValve voice
prosthesis is now ready for use.
Note: If the insertion is not successful, it can be repeated with the same tools and devices as long as the safety strap has not been
cut off. If the procedure has to be repeated more than twice, add additional water-soluble lubrication inside the loading tube.
Replacement by overshooting
Overshooting means that during the insertion of the voice prosthesis it is initially pushed entirely into the esophagus. This
approach can be useful when inserting a short prosthesis (4.5 mm) or when there is a concern whether the esophageal flange
can be entirely delivered into the esophageal lumen using the normal insertion procedure.
Procedure: Prepare and insert the valve as described in steps 1-3 above but insert the complete prosthesis into the esophagus,
by pushing the Inserter Pin past mark line 2. Release the prosthesis as described in step 5. Leave the safety strap attached
to the inserter.
Use a non-toothed hemostat to pull the prosthesis into position. CAUTION: Do not pull by the safety strap. Slight rotation
might be helpful to fully position the prosthesis. The end of the tracheal flange should point downwards into the trachea and
the identification knobs must always face the stoma. Cut the safety strap only after the correct fit is obtained.
Retrograde replacement
Provox GuideWire (REF 7215) may be used for retrograde insertion of the voice prosthesis in cases where the Provox
ActiValve cannot be inserted in an anterograde manner. See Instructions for Use accompanying the Provox GuideWire.
Retrograde insertion must be performed by a clinician.

2.2 Device lifetime

Biofilm (bacteria and candida) overgrowth will occur in almost all patients. This will eventually cause material degradation,
leakage through the prosthesis or other incompetence of the valve. Radiotherapy, salivary content, gastroesophageal reflux,
and dietary habits may influence how rapidly biofilm forms. It is therefore not possible to predict the device lifetime.
Laboratory testing shows that in the absence of bacteria and yeasts the device will maintain its structural integrity for 12
months of simulated use. Usage beyond this limit is under the sole discretion of the prescriber.
Indications for replacement include leakage through or (partial) blockage of the valve, degradation of the materials, or medical
indications such as problems with the puncture tract (See also Section 3).

2.3 Prosthesis maintenance

Instruct the patient to clean the prosthesis at least twice a day and after each meal.
Use the Provox Brush and if possible also the Provox Flush to clean the prosthesis from food remnants and mucus. This
helps to increase the device life.
If excessive candida overgrowth occurs treatment with antifungal medications may be considered as a preventive measure.
Laboratory testing shows no negative influence on the function of the voice prosthesis when using the following antifungal
medications: Nystatin, Fluconazole and Mikonazol. Other drugs directly to or within close proximity of the voice prosthesis
should be carefully assessed, since an unknown variety of chemical substances may influence the material.
Lubrication
Lubricating the inner lumen of the prosthesis helps prevent occasional stickiness of the valve that might otherwise occur,
typically after sleep or a prolonged time of not speaking. Therefore instruct the patient that after cleaning the voice prosthesis
in the morning the patient should lubricate the inner lumen of the Provox ActiValve.
Apply a single drop of Provox ActiValve Lubricant on the second Provox Brush; avoid touching the Provox ActiValve Lubricant
bottle with the bristles to avoid contamination of the bottle. Brush the inner lumen of the Provox ActiValve without touching
the stomal mucosa. After use, wipe the brush thoroughly with a gauze to remove any excess oil.
Note that the liquid is thick and that the lubricant bottle releases the lubricant very slowly, one drop at a time. It is important to use
only one drop of oil each time and to make sure that any superfluous oil is removed before using the brush (no dripping brush).
The Provox ActiValve Lubricant can be used until the expiration date or 8 months after opening the bottle, whichever occurs
first. Inform the patient to register the date of opening on the bottle using a water resistant permanent marking pen.
After each use the Provox Brush and any other Provox accessory used should be cleaned, and then disinfected at least once
a day according to their Instructions for Use.
Note: Incidental ingestion or aspiration of small amounts of Provox ActiValve Lubricant is harmless, but may cause coughing.
No health problems have been reported regarding repeated aspiration of small amounts of silicone oil, but it is still better
to be cautious and avoid it.
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