Important Patient Information; General Information; Prosthesis Maintenance; Accessories - Atos Medical PROVOX Vega Bedienungsanleitung

2. Put the Provox Vega voice prosthesis with the tracheal side down
on top of the Inserter Pin (Figure 5e-f). Use your thumb to ensure
that the voice prosthesis is properly positioned (Figure 5f).
3. Check that the Folding Device and Guide are still assembled in the
upper Guide position. If not, re-assemble the Folding Device into
Guide according to figure 5g. Do not push the Folding Device in
the bottom position of the Guide.
4. Gently pull the Inserter Pin with the attached prosthesis into the
Folding Device until you can clearly hear it click in place (figure
5h). The Esophageal Flange of the prosthesis is now in level with
the Folding Device.
5. Attach the Loading Tube to the top of the Folding Device / Guide
(Figure 5i) and let the two parts snap together.
The Provox Vega voice prosthesis is now ready for activation and
can be used as described in section "Anterograde Replacement
Procedure" or "Anterograde Replacement Procedure including
voluntary overshooting".

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.
• Occasionally, mild leakage through or around the prosthesis may
occur in the first weeks after insertion of a new prosthesis. This
often resolves spontaneously and does not require immediate
replacement of the prosthesis.
• If leakage spontaneously occurs through the prosthesis a temporary
blockage can be done with a Provox Vega Plug.
• 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 helps 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.

3.3 Accessories

CAUTION: Only use genuine Provox accessories that are intended
for use with Provox Vega. Other accessories may cause patient
harm or product malfunction.
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