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Prosthesis maintenance:
CAUTION:
Only use genuine Provox accessories that are intended for use with Provox Vega when
cleaning the prosthesis.
The patient should clean the prosthesis at least twice a day and after each meal with the Provox
Brush by inserting the brush into the prosthesis and moving it gently back and forth with a twisting
movement. After the brush is removed it should be wiped with a gauze. The procedure can be repeated
as often as necessary. For details and how to clean the brush see Instructions for Use that come with
the Provox Brush. In addition to using 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 influence 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 influence 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 influence 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 flushing 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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