Device Lifetime Of The Provox Vega Voice Prosthesis; Disposal; Accessories; Additional Information - Atos Medical Provox Vega Instrucciones De Uso

the Provox Brush, the patient may also clean the Provox Vega voice prosthesis with the
Provox Flush. The Provox Flush can be used with drinking water or air. For details and
how to clean the Provox Flush see Instructions for Use that come with the Provox Flush.
Compatibility with antifungal substances
In most cases treatment with antifungal agents should not be indicated but may be considered
as a preventive measure if excessive candida overgrowth occurs on the prosthesis.
An unknown variety of chemical substances may infl uence the material properties
of the device. Therefore, the introduction of antifungal medicines or drugs directly to or
within close proximity of the voice prosthesis should be carefully assessed.
Laboratory testing shows no negative infl uence on the function of the Vega voice
prosthesis and components when using the following antifungal medications: Nystatin,
Fluconazole and Mikonazol.
Cleaning and disinfection of the accessories
The accessories should be cleaned after each use and disinfected at least once a day
according to their Instructions for Use. During hospitalization there is an increased risk
of device contamination and patient infection. Therefore, during hospitalization, it is
important to clean and disinfect the accessories immediately after use and again just
before use, and rinse using sterile water, rather than tap water.
For details and how to clean the Provox Accessories see Instructions for Use that accompanies
the Provox Accessories.

2.5 Device lifetime of the Provox Vega voice prosthesis

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.
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 and cause leakage through the prosthesis or other incompetence of the
valve. Also see; Prosthesis maintenance under section 2.4 Important patient information.
The prosthesis is not a permanent implant, and requires periodic replacement.
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 prosthesis
and especially the silicone material of the device will be affected by e.g., bacteria and
Candida, and the structural integrity of the device will eventually deteriorate.
Indications for replacement of the Provox Vega 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 earlier replacement could include medical indications such as problems with
the puncture tract. Also see section 1.6 Adverse events and troubleshooting information
/ 1.6.2 During use of the voice prosthesis.

2.6 Disposal

After use, the product may be a potential biohazard. Handling and disposal should be
carried out in agreement with medical practice and applicable national laws and legislations.

2.7 Accessories

Provox accessories are designed to be safe and effective for use with the Provox Vega
voice prostheses. Do not use other devices since they may cause patient harm or product
malfunction.
Accessories to maintain the device function (for patient use)
Provox Brush/Provox Brush XL: is used by the patient to clean the inside of the prosthesis.
Provox Flush: An additional cleaning device for patient use that allows fl ushing of the
prosthesis.
Provox Plug: A tool for patient use that temporarily blocks the voice prosthesis.
Please see www.atosmedical.com or contact your local distributor for more info.

3. Additional information

3.1 Ordering information

See end of the Instructions for Use.

3.2 User assistance information

For additional help or information please see back cover of the Instructions for Use for
contact information.
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