Cleaning And Sterilization; How Supplied - Atos Medical Provox Dilator 7211 Mode D'emploi

Operating instruction
Remove the voice prosthesis from the TE puncture.
Probe the puncture with the tapered tip of the
dilator, its curvatures directed downwards, and
gently insert the device until a certain puncture
resistance can be felt.
Hold the dilator in this position for the desired
amount of time, and then continue gently inserting
it in the same way, section by section, until the
desired puncture diameter has been reached. The
waiting time needed for each section can vary
from case to case. You shall carefully tape the
medallion to the skin during the waiting time.
Once the dilator has been in the final position
for the desired amount of time, gently pull the
rod - not the medallion - for removal and insert
the Provox voice prosthesis using its standard
procedure.

Cleaning and sterilization

Cleaning, disinfection and sterilization are
described in "Instructions for cleaning and
sterilization". If this information is missing,
please contact your supplier or visit our website
on www.atosmedical.com.
The material in the Provox Dilator withstands
50 cleaning and steam sterilization procedures
at 137°C/278°F for 3 minutes or at 134°C/273°F
for 18 minutes.

How supplied

The device is manufactured in a cleanroom and
supplied non-sterile.
Device lifetime
Caution: The dilator shall be replaced every
2 years, or after 50 sterilization cycles, whichever
comes first. Check mechanical integrity of the
device prior to each use according to the Checkout
procedures.
Disposal
After use, the product may be a potential biohazard.
Handling and disposing should be carried out in
agreement with medical practice and applicable
national laws and legislations.
Ordering information
See last page of this manual.
7