Additional Information; Compatibility With Mri, X-Ray And Radiation Therapy; Device Lifetime; Date Of Printing - Atos Medical Provox Vega Clinician Manual

or esophageal tissues may occur. In patients undergoing radiotherapy
this may happen more easily. Inspect the conditions regularly to avoid
severe damage.

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 within 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.
Laboratory testings of simulated usage for a test period of 12 months
show that, in the absence of bacteria and yeasts, the device will maintain
its structural integrity for this time period. The device has not been
tested for usage beyond 12 months. Usage beyond this limit is under
the sole discretion of the prescriber.

5.3 Date of printing

See version number on the back cover of this manual.

5.4 User assistance information

For additional help or information please see back cover for contact
information.
16