Important Patient Information; General Information; Prosthesis Maintenance; Adverse Events/ Troubleshooting Information - Atos PROVOX Vega Instrucciones De Uso

2.5 Finalize the procedure
After insertion:
Ensure proper fit
1. Ensure the proper position of the voice prosthesis by rotating and gently pulling
the Insertion Pin (Fig. 17). The prosthesis is in an ideal position when the Safety
Strap is pointing downwards.
Test proper function
2. Brush the Provox Vega with the Provox Brush. Test proper function of the prosthesis
by asking the patient to speak and by observing that the prosthesis does not leak
while the patient drinks water (Fig. 18).
Cut the Safety Strap
3. After ensuring the voice prosthesis is placed correctly, cut off the Safety Strap so
that it is flush with the Tracheal Flange (Fig. 19). The Provox Vega voice prosthesis
is now ready for use.

3. Important patient information

3.1 General information

Ensure that the patient understands to contact their clinician if:
• There is leakage through or around the prosthesis (coughing and/or change of mucus
color).
• Speaking becomes difficult (higher effort and/or voice sounds more strained).
• There are any signs of inflammation or tissue changes at the puncture site or the
stoma region (pain, redness, heat, swelling, traces of blood on the brush after
brushing).
Also inform the patient that:
• After a prosthesis replacement traces of blood may be found in the sputum. This may
come from granulation tissue on the edges of the TE puncture.
• The Provox Vega Plug can be used to temporarily stop leakage through the voice
prosthesis.
• Speech Training Sessions with a trained clinician are advised in order to acquire
optimal voice sound, fluent speech, and optimal intelligibility.

3.2 Prosthesis maintenance

Instruct the patient when and how to clean his or her Provox Vega voice prosthesis.
Cleaning the prosthesis at least twice a day can help prolong the device life.
CAUTION: Only use genuine Provox accessories that are intended for use with
Provox Vega when cleaning the prosthesis.
• Brushing the prosthesis with the Provox Brush twice a day will help to remove
mucus and food remnants from the prosthesis.
• Flushing the prosthesis with the Provox Flush also helps to clean debris and mucus
from the prosthesis, which can help increase the life of the device.
Note: The Provox Flush is intended for use only by patients who, as assessed by the
clinician who prescribes the device, have demonstrated ability to understand and
consistently follow the instructions for use without clinician supervision.
• Some dietary measures, like the daily intake of yogurt or butter milk containing
lactobacilli, are considered to be helpful against excessive Candida growth.
For detailed information on how to clean the Provox Vega, please see Instructions
for each accessory.

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 (except Provox ActiValve) have been tested and found to be
compatible, with Magnetic Resonance Imaging (tested up to 3 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.
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