How Supplied; Device Lifetime - Atos Medical Provox Dilator 17 Manual

How supplied

The device is manufactured in a cleanroom and
supplied non-sterile.

Device lifetime

Caution: The dilator(s) 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
Always follow medical practice and national
requirements regarding biohazard
when disposing of a used medical device.
Date of printing
See version number on the back cover of this
manual.
User assistance information
For additional help or information please
see back cover of this manual for contact
information.
Reporting
Please note that any serious incident that has
occurred in relation to the device shall be
reported to the manufacturer nd the national
authority of the country in which the user
and/or patient resides.
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