Accessories; Adverse Event/Trouble Shooting Information - Atos Provox ActiValve Manual Del Usuario

2.4 Accessories

CAUTION: Only use genuine Provox accessories that are intended for use with Provox ActiValve. Other accessories may
cause patient harm or product malfunction.
Accessories to facilitate insertion of the prosthesis (for clinician's use)
• Provox Measure: Indicates the length (prosthesis size) of the TE puncture.
• Provox Dilator: Is used to upsize smaller TE punctures to allow fitting of Provox voice prostheses. The dilator may also be
used to temporarily block or stent the TE puncture.
• Provox GuideWire: For placement of a Provox ActiValve, Provox2 or Provox Vega voice prosthesis in a freshly made TE
puncture, or for retrograde replacement of a Provox indwelling voice prosthesis.
Accessories to maintain the device function (for patient's use)
• Provox Brush / Provox Brush XL are used to clean the lumen and valve of the prosthesis.
• Provox Flush allows for flushing the lumen of prosthesis with air or water.
• Provox Plug is a First Aid tool to temporarily block leakage through the prosthesis.
3. Adverse events/Trouble shooting information
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.
Instruct your patient to consult a clinician if any of the following occurs:
• Any changes in the appearance of the material of the prosthesis or the way it fits in the puncture,
• there is leakage during drinking and cleaning the prosthesis does not help,
• speaking becomes difficult (requires higher effort) and cleaning does not help,
• there are signs of inflammation or tissue change at or near the puncture tract,
• there is bleeding or overgrowth of tissue around the device,
• the patient experiences persistent pain or discomfort in the region of the Provox ActiValve,
• the patient has chronic cough, trouble breathing, or blood in the mucus. These can be signs of a serious health condition, for
example rare lipoid pneumonia, or cancer that requires medical attention.
Prosthesis related
Problem: Leakage through the voice prosthesis. This is a normal development and may be an indication of the end of the
device life.
Solution: Use a Provox Brush and/or Provox Flush to clean the voice prosthesis. If cleaning of the device does not resolve
the leakage, replace the voice prosthesis.
Studies suggest that adding certain food items to the laryngectomized patients' diet may reduce the occurrence of yeasts and
bacteria in voice prosthesis biofilms. Food items that have been suggested to have such an effect are buttermilk
milk-drink containing Lactobacillus Casei Shirota (Yakult
thermophilus
B and Lactobacillus fermentum B54, Lactobacillus rhamnosus744, Lactobacillus lactis cremoris SK11, and Lactobacillus
3,4
casei Shirota , and regular caffeinated soft drinks ("Cola")
4
Problem: Speaking is sometimes not possible (valve does not open).
Probable cause: The valve lid sticks to the valve seat, preventing the valve from opening. This becomes more likely the
longer the valve has not been in use (e.g. overnight).
Solution: Clean the voice prosthesis and lubricate it (see section Cleaning and maintenance). If cleaning and lubricating
does not help: Replace the prosthesis.
Problem: Leakage through the voice prosthesis immediately after insertion.
Probable cause: Immediate leakage after voice prosthesis replacement can occur if the esophageal flange of the prosthesis
has not fully deployed into the lumen of the esophagus or if the prosthesis is too short. If the tip of the voice prosthesis inserter
has not been placed far enough into the puncture during the insertion, the esophageal flange can unfold in the puncture tract
instead of in the esophagus. Immediate leakage after voice prosthesis replacement can also occur if the voice prosthesis has
been damaged during the insertion.
Solution: Rotate the voice prosthesis to check the fit. Perform an endoscopic examination to determine if the voice prosthesis
is in the correct position and of the right length. Correct the position of the device. If the voice prosthesis is too short, replace
with a longer device. If the leakage remains after repositioning, pull out the voice prosthesis with the inserter, or a non-toothed
hemostat. Inspect the voice prosthesis. If the voice prosthesis has been damaged (e.g. the blue ring has been dislodged or the
valve has been torn off), discard the prosthesis, otherwise reload and repeat the insertion procedure as described in section 2.1.
) , probiotic bacteria Lactibacillus lactis 53 and Streptococcus
®
2
.
5
, a probiotic
1,2
11