Complaint Handling/ Reporting - Stryker SPY-PHI Manual Del Usuario

3. Bring the upper edge of the wrap down completely over
the contents and fold it back on itself to form another
cuff,
overlapping the original.
4. Fold the left edge of the wrapper snuggly over the pack
and back on itself to form a cuff.
5. Fold the right side of the wrapper over the pack, overlapping
the previous fold and folded back to form a cuff, or tuck
under and secure with indicator tape.
Gravity
Sterilize at 121°C (250°F) for 30 minutes with a 30-minute dry
time.
Prevacuum United States Standards
Sterilize at 132°C (270°F) for 4 minutes with a 30-minute dry time.
Prevacuum EU Standards
Sterilize at 134°C (273°F) for 3 minutes with a 30-minute dry time.
Autoclave temperatures should not surpass 280°F (137°C), as
the handle, insulation or other non-metallic parts may be
affected. (Note: The steam autoclave manufacturer may be
contacted to confirm appropriate temperatures and sterilization
times.)

11. Complaint Handling/ Reporting

Any adverse event involving the SPY-PHI Articulating Arm
should be reported to Stryker and the country specific
regulatory authorities immediately. To report an event to
Stryker, call:
(800) 624 - 4422 Toll Free (USA only) or Email:
EndoCustomerSupport@stryker.com
©2020 IFU-0100 / rev3 13