Intended Use; Cleaning And Disinfection; En - English - PROVOX Brush Manual Del Usuario

ENGLISH

Intended Use

Provox Brush is a single patient use device intended for cleaning
Provox Voice Prosthesis, for insertion of Provox Plug and Provox
Vega Plug, for applying lubricant and anti-candida agents and
for cleaning of fenestration holes on Provox LaryTubes. The
product is intended for use by the patient.
Before use
Always inspect the Provox Brush (fig. 1) to make sure that it is
not broken or worn out.
Before each use, make sure that
• the protective tip is not cracked or loose.
• the bristles do not appear worn or are loose.
• the wires are not bent or broken.
• the entire handle is not cracked or broken and that the safety
wings have not been removed.
If any defects are found, the brush must be discarded.

Cleaning and disinfection

Clean the Provox Brush after each use according to fig. 4-7
using drinking water.
Disinfect the Provox Brush (fig. 8) with one of the following
methods:
• Ethanol 70% for 10 minutes
• Isopropylalcohol 70% for 10 minutes
• Hydrogenperoxide 3% for 60 minutes
Do not use the device until it is completely dry
Note: Always clean and disinfect before use.
Precaution
• The device is intended for single patient use only. Reuse in
another patient may cause cross contamination.
• Do not clean or disinfect by any other method as this might
cause product damage and injury.
Disposal
Always follow medical practice and national requirements
regarding biohazard when disposing of a used medical device.
Reporting
Please note that any serious incident that has occurred in relation
to the device shall be reported to the manufacturer and the national
authority of the country in which the user and/or patient resides.
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