Adverse Events/ Troubleshooting Information; Additional Information - Atos Medical PROVOX Vega XtraSeal Instrucciones De Uso

4. Adverse events/ Troubleshooting information

For information regarding adverse events and troubleshooting, please visit
www.provoxweb.info.

5. Additional information

5.1 Compatibility with MRI, X-ray and radiation therapy
Provox voice prostheses have been tested and found to be compatible, except Provox
ActiValve, with Magnetic Resonance Imaging (tested up to 1.5 Tesla), x-ray and radiation
therapy (tested up to 70 Gy). The prosthesis can be left in the TE-puncture during the
examination/ therapy session. Note that the radio-opaque valve seat is visible on x-ray.
5.2 Device lifetime
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.
5.3 Compatibility with antifungal medicine
Laboratory tests show only minor negative influence on the function of the Provox Vega
voice prosthesis and components when using the following antifungal medications:
Nystatin, Fluconazole, Mikonazol.
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