Cleaning And Maintenance; Device Lifetime; Accessories; Additional Devices - Atos Medical Provox ActiValve Patient Manual

when starting to speak.
After the prosthesis has been placed, mild leakage
may occur initially, which may resolve spontaneously.
For a short time after replacement of the prosthesis,
traces of blood may also be found in the mucus. This
may result from micro-bleedings around the puncture.
If this persists contact your clinician.

3.2 Cleaning and Maintenance

Caution: Only use genuine Provox accessories that
are intended for use with Provox ActiValve for the
handling and cleaning of your prosthesis.
Avoid all other kinds of manipulation of the prosthesis
than the cleaning and maintenance described below.
Clean the prosthesis at least twice a day and after each
meal with the Provox Brush. Insert the brush into the
prosthesis and move it gently back and forth with a twisting
movement. Remove the brush, wipe it with a gauze, and
repeat the procedure until the prosthesis is clean. For
details and how to clean the brush see Instructions for
Use that accompanies the Provox Brush. In addition to
using the Provox Brush, you may also clean your Provox
ActiValve 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 accompanies the Provox Flush.
Once a day, after cleaning in the morning, lubricate the
inner lumen of the Provox ActiValve prosthesis with
one drop of Provox ActiValve Lubricant using a Provox
Brush. [Fig. 2]. Before use read the Instructions for Use
that accompanies the Provox ActiValve Lubricant.
Caution:
Overuse of the lubricant in quantity or frequency can
result in severe coughing, pneumonia or serious breathing
problems.
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.

3.3 Device lifetime

The prosthesis is not a permanent implant, and requires
periodic replacement. Depending on individual biological
circumstances the device life varies, and it is not possible
to predict the function of the device over a longer period
of time. The prosthesis and especially the silicone parts
of the device will be affected by bacteria and Candida.
Adding certain food items such as buttermilk, probiotics
and caffeinated soft drinks may reduce the occurrence
of bacteria and yeasts on the voice prosthesis. A well-
balanced diet is important, please discuss with your
clinician if changes in your diet are recommended.
Flushing the voice prosthesis with the Provox Flush,
blowing air through the voice prosthesis and imitated
coughing may also reduce the formation of yeasts and
bacteria. Please discuss with your clinician if the use of
the Provox Flush and any of these techniques may be
beneficial for you.
Indications for replacement of the Provox ActiValve voice
prosthesis include leakage through the valve, blockage
of the prosthesis, bacterial and candidal overgrowth
leading to degradation of the materials and /or excessive
pressure needed to obtain speech. Other reasons for
replacement include medical indications such as problems
with the puncture tract.

3.4 Accessories

CAUTION: Only use genuine Provox accessories that are
intended for use with Provox ActiValve. Other accessories
may cause patient harm or product malfunction.
Provox Brush / Provox Brush XL is used by the patient
to clean the inside of the prosthesis.
Provox Flush is an additional cleaning device that allows
flushing of the prosthesis.
Provox Plug is a tool for patient's use that temporarily
blocks leakage through the prosthesis while eating and
drinking.
Provox ActiValve Lubricant serves as lubricant for the
valve surface inside the Provox ActiValve.

3.5 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 Adhesives: Different types of adhesives to
attach HME´s.
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