When using the handles with 35 mm and 37 mm sizer rings, hold the
sterilized sizer ring so that you can see the size printed on the ring.
Screw the sterilized handle into the ring until the pins on the handle
are flat against the ring.
See the instructions for use packaged with the applicable implantable
device for detailed sizing, handling, and implantation instructions.
The handles have been designed and tested for repeated use. However,
if visual signs of deterioration become apparent, please contact your
customer service representative.
Reprocessing Requirements
St. Jude Medical has validated these reprocessing instructions. If
alternate methods are used, it is the user's responsibility to ensure that
their methods provide effective cleaning and disinfection. The cleaning
method must remove all visible blood soil and contamination.
Testing indicates that products described herein may undergo
100 cleaning/disinfection cycles when cleaned using the specified
reprocessing methods. Deviations from the specified methods
may result in reduced instrument life or inadequate cleaning and
disinfection.
Reprocess instruments as soon as reasonably possible following use.
After each reprocessing cycle inspect instruments for signs of cracking,
crazing, or degradation that may affect function.
5