A) Prosthesis Hood; B) Prosthesis Shaft; C) Tracheal Flange; D) Radio-Opaque Fluoroplastic Valve Seat - Atos Medical PROVOX VEGA Manual Del Usuario

For illustration see Fig. 1.
a) Prosthesis Hood
b) Prosthesis Shaft
c) Tracheal Flange
d) Radio-opaque fluoroplastic Valve Seat
e) Esophageal Flange
f) Valve Flap
Provox Vega package
The Provox Vega package contains the following user accessories:
• 1 Provox Brush of a size corresponding to the voice prosthesis, non-sterile
• 1 Provox Brush Instructions for Use
• 1 Provox Vega Patient's manual
2.3 CONTRAINDICATIONS
There are no known contraindications for use or replacement of the Provox Vega voice
prosthesis among patients already using prosthetic voice rehabilitation.
2.4 WARNINGS
Accidental aspiration (entering the windpipe) of the Provox Vega voice prosthesis or other
components of the Provox voice rehabilitation system may occur. Immediate symptoms
may include gagging, coughing, choking or wheezing. If this occurs seek immediate
medical treatment. A foreign body in your airway may cause severe complications such
as acute respiratory distress and/or respiratory arrest, and has to be removed by a clinician.
Accidental swallowing of the Provox Vega voice prosthesis may occur. If this occurs,
contact your physician who will advise you further.
Re-use and re-processing may cause cross-contamination and damage to the device,
which could cause patient harm.
2.5 PRECAUTIONS
Consult your 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 region (pain,
heat, swelling, traces of blood on the brush after brushing).
To reduce infection risk:
Make sure that your hands are thoroughly clean and dry before using your hands in the
area of your tracheostoma, and before cleaning your voice prosthesis and/or accessories.
Keep all devices clean that may enter or make any contact with your tracheostoma
and voice prosthesis.
To reduce risk of product damage:
Only use genuine Provox accessories that are intended for use with Provox Vega for the
handling and cleaning of your prosthesis.
3. Instructions for use
3.1 Using the Provox Vega to speak
When you close off your tracheostoma, you can direct the air from your lungs through
the prosthesis into your esophagus (Fig. 2).
That air stream causes vibration of the tissues in your esophagus, which produces
the sound of your voice. You can speak by using a Heat and Moisture Exchanger like the
Provox HME, using a handsfree speaking device like Provox Freehands HME or simply
by closing your stoma directly with a finger.
An HME may improve pulmonary function and also facilitates stoma occlusion and
speaking. A handsfree device enables speech without the need to close the tracheostoma
by a finger.
3.2 Cleaning the Provox Vega
In order for you to speak with your voice prosthesis, the prosthesis needs to be clean so that
air can pass through it. Regular cleaning of the prosthesis also helps to prolong device life.
• Brushing the prostheses with the Provox Brush twice a day removes 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 have been assessed by
the clinician to be able to 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.
CAUTION: Only use genuine Provox accessories that are intended for use with
Provox Vega when cleaning your prosthesis. Other devices may cause personal
injury or damage to the voice prosthesis.
3.3 Accessories
The Provox Brush / Provox Brush XL is used by the patient to clean the inside of the
prosthesis (Fig. 3).
The Provox Flush is an additional cleaning device that allows flushing of the prosthesis (Fig. 4).
The Provox Vega Plug is a First Aid tool for patient's use that temporarily blocks leakage
through the prosthesis (Fig. 5).
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