PROVOX Vega Manual De Instrucciones página 12

For better control, firmly grasp the Guidewire close to the Puncture Dilator (Fig. 3.10).
CAUTION: Dilatation and integral placement of the voice prosthesis should be carried out in
the anterior/caudal direction with limited lateral movement in order to limit the force applied to
the TE wall.
11. In the same continuous, smooth motion, carefully pull the Guidewire, Puncture Dilator and the
Puncture Dilator loop through the puncture. The Puncture Dilator loop folds the tracheal flange
of the voice prosthesis as the loop is pulled over the flange and through the puncture. The tracheal
flange unfolds in the trachea when the loop releases it (Fig. 3.11).
Stop pulling immediately when the tracheal flange is released by the Puncture Dilator loop.
If the tracheal flange does not unfold completely, it can be rotated in place using two non-toothed
hemostats.
12. Grasp the tracheal flange with a non-toothed hemostat, turn the prosthesis in the correct position
and cut the safety strap (Fig. 3.12).
2.2.3 Reload of the Puncture Set
www.atosmedical.com/reload-of-the-puncture-set
CAUTION: Reload of the Provox Vega Puncture Set must not be performed if the voice prosthesis
safety strap has been cut or damaged during the first placement attempt.
If the procedure needs to be restarted the Provox Vega Puncture Set can be reloaded.
In order to reload the system:
1. Push the Guidewire from the narrow end of the Puncture Dilator until the Guidewire loosens
from the Wirelock (Fig. 4.1-4.2).
2. Pull the Guidewire through the Puncture Dilator (Fig. 4.3).
3. Reload the Vega voice prosthesis in the Puncture Dilator ring (Fig. 4.4).
WARNING: The safety strap and tracheal flange of the voice prosthesis must be oriented towards
the Puncture Dilator strap and the Wirelock when it is inserted into the Puncture Dilator loop
(Fig. 4.4).
4. If needed, the Guidewire can be straightened to facilitate reinsertion.
5. Proceed according to "2.2 Operating Instructions".
2.3 Cleaning and sterilization
The surgical components in the puncture set, as well as the voice prosthesis, are provided sterile (EO)
and are intended for single use only and can NOT be cleaned or resterilized.
After placement, the voice prosthesis requires regular cleaning by the patient while the prosthesis
remains in situ (see prosthesis maintenance below).
2.4 Important patient information
Inform the patient that:
• After a prosthesis placement traces of blood may be found in the sputum.
• Occasionally, mild leakage through or around the prosthesis may occur in the first weeks after
insertion of a prosthesis. This often resolves spontaneously and does not require immediate
replacement of the prosthesis.
• Speech training sessions with a speech language pathologist are advised in order to acquire optimal
voice sound, fluent speech, and optimal intelligibility.
Ensure that the patient understands to contact their clinician if:
• Any changes in the appearance of the material of the prosthesis or in the way it fits in the puncture
occur.
• Leakage occurs during eating and/or drinking, and cleaning the prosthesis does not help. Provox
Vega Plug can be used for temporary preventing leakage during eating and drinking until the device
can be replaced.
• Speaking becomes difficult (requires higher effort) and cleaning does not help.
• There are any signs of inflammation or tissue change at or near the puncture tract.
• Bleeding or overgrowth of tissue around the device.
• Persistent pain or discomfort in the region of the Vega voice prosthesis.
• Chronic cough, trouble breathing, or blood in the mucus. These can be signs of a serious health
conditions that requires medical attention.
Prosthesis maintenance:
CAUTION: Only use genuine Provox accessories that are intended for use with Provox Vega when
cleaning the prosthesis.
The patient should clean the prosthesis at least twice a day and after each meal with the Provox
Brush by inserting the brush into the prosthesis and moving it gently back and forth with a twisting
movement. After the brush is removed it should be wiped with a gauze. The procedure can be repeated
as often as necessary. For details and how to clean the brush see Instructions for Use that come with
the Provox Brush. In addition to using the Provox Brush, the patient may also clean the Provox Vega
voice prosthesis with the Provox Flush. The Provox Flush can be used with drinking water or air. For
details and how to clean the Provox Flush see Instructions for Use that come with the Provox Flush.
Compatibility with antifungal substances
In most cases treatment with antifungal agents should not be indicated but may be considered as a
preventive measure if excessive candida overgrowth occurs on the prosthesis.
An unknown variety of chemical substances may influence the material properties of the device.
Therefore, the introduction of antifungal medicines or drugs directly to or within close proximity
of the voice prosthesis should be carefully assessed.
Laboratory testing shows no negative influence on the function of the Vega voice prosthesis and
components when using the following antifungal medications: Nystatin, Fluconazole and Mikonazol.
Cleaning and disinfection of the accessories
The accessories should be cleaned after each use and disinfected at least once a day according to their
Instructions for Use. During hospitalization there is an increased risk of device contamination and
patient infection. Therefore, during hospitalization, it is important to clean and disinfect the accessories
immediately after use and again just before use, and rinse using sterile water, rather than tap water.
For details and how to clean the Provox Accessories see Instructions for Use that accompanies the
Provox Accessories.
2.5 Device lifetime of the Provox Vega voice prosthesis
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.
Candida overgrowth of the prosthesis occurs in almost all patients. Radiotherapy, salivary content
and dietary habits may influence how rapidly Candida can affect the silicone material and cause
leakage through the prosthesis or other incompetence of the valve. Also see; Prosthesis maintenance
under section 2.4 Important patient information.
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