Atos PROVOX Vega Mode D'emploi page 7

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).
3.4 Additional devices
Provox HME: Heat- and Moisture Exchanger partially restores lost nasal
functions (heating, humidifying, breathing resistance).
Provox FreeHands HME: A Heat and Moisture Exchanger combined with
an automatic tracheostoma valve, designed to allow hands-free speech.
Provox LaryTube: A silicone tracheal cannula intended to support
shrinking stomas while retaining other rehabilitation devices of the
Provox System.
Provox LaryButton: A soft, self-retaining silicone tracheal
cannula intended to support shrinking stomas while retaining other
rehabilitation devices of the Provox System.
4. Adverse events/ Trouble shooting by
symptom
It is the responsibility of your clinician to inform you about risks and
benefits of prosthetic voice rehabilitation and to instruct you what to
do in case you may encounter adverse events. If you are not sure that
you have completely understood all instructions, ask your clinician
for further explanation.
Symptom: Coughing (triggered by drinking or eating) while the
prosthesis is in place.
Most common reasons: Leakage through or around the prosthesis.
Measures:
1. Clean the prosthesis with the Provox Brush and/or Flush. There
may be food remnants preventing the valve from proper closure.
If leakage continues:
2. Observe the prosthesis while drinking. Try to identify if it leaks
through the center or around the prosthesis.
a.) If you think it leaks through the center you can use the Provox
Vega Plug while you are eating and drinking to prevent leakage.
Notify your clinician that you need a new prosthesis.
b.) If you think it leaks around, or if the Plug does not stop the
leakage. Notify your clinician that you may have leakage around
your prosthesis.
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