Atos Medical Provox Vega XtraSeal, Руководство для клиницистов

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6. Cut the Safety Strap with scissors
When the prosthesis is confirmed to be in place, position the oval
end of the tracheal flange pointing downwards and use a pair of
scissors to cut off the Safety Strap on the outer edge of the flange
(Fig. 3.10). The voice prosthesis is now ready for use.
2.3 Reloading the Provox SmartInserter
(Fig. 4.1 – 4.6)
If the first attempt to insert the Provox Vega XtraSeal voice prosthesis
into the TE-puncture was unsuccessful, it is possible to reload the
Provox Vega XtraSeal into the SmartInserter.
CAUTION: Do not reload the SmartInserter more than 2 times.
If the Provox Vega XtraSeal voice prosthesis shows any signs of damage,
do not use the prosthesis.
1. Make sure the prosthesis is still safely attached to the Inserter
Pin. If not, secure the Safety Strap on the Inserter Pin by leading
the Safety Strap through the Attachment Hole in the Inserter Pin
(Fig. 4.1).
2. Put the Provox Vega XtraSeal voice prosthesis with the tracheal
side down on top of the Inserter Pin (Fig. 4.2). Use your thumb
to ensure that the voice prosthesis is properly positioned.
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 (Fig. 4.3). 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 (Fig.
4.4). The Esophageal Flange of the prosthesis is now in level with
the Folding Device.
5. The enlarged E-flange must be manually positioned below the
curved tips of the folding device (Fig. 4.5).
NOTE: If this step is omitted, preloading the voice prosthesis
will require excessive force and may damage the voice prosthesis.
6. Attach the Loading Tube to the top of the Folding Device / Guide
(Fig. 4.6) and let the two parts snap together.
The Provox Vega XtraSeal voice prosthesis is now ready for
activation and can be used as described in section
“Anterograde
Replacement Procedure using 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 the Provox Vega XtraSeal
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 a 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.
Accessories to facilitate insertion of the prosthesis (for
clinician’s use)
• Provox Dilator: Helps to convert from a prosthesis with a smaller
shaft diameter to a Provox voice prostheses of larger diameter.
• Provox GuideWire: for placement of a Provox, Provox2 or a
Provox Vega voice prosthesis in a freshly made TE puncture, or for
retrograde replacement of a Provox indwelling voice prosthesis.