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Verfügbare Sprachen
US
Instructions for use
Fibula Nail 2 System, Ulna Nail 2 System:
Storage Case Part
Numbers:
Condition
1
:
Exposure Temperature
and Time:
Exposure Temperature
and Time
2
:
Dry Time:
1
US customers must use FDA-cleared sterilization packaging/wrap and other accessories appropriate for the cycle
parameters recommended in these instructions. Refer to PKGI-76 at
rigid sterilization containers.
2
The devices are compatible with exposure for 18 minutes at 134°C.
* Sterilization was validated using a STERIS Amsco 3023 Vacamatic Prevacuum sterilizer and KimGuard
KC600 One-Step wrap.
POST-STERILIZATION INSPECTION
• Do not store or use sterile devices if they are not dry.
- Moisture supports the survival of microorganisms.
- Moisture remaining on wrapped or contained products after sterilization could compromise the
sterile barrier.
- Moisture can corrode metal and dull sharp edges.
• Inspect the sterile barrier for signs of damage. Do not use the product if the sterile barrier has been
compromised.
STORAGE CONDITIONS
STORAGE OF SETS AFTER STEAM STERILIZATION
• Items should be stored under controlled conditions in a manner that minimizes the potential for
contamination per ANSI/AAMI ST79:2017. Refer to sterilization wrap or rigid container manufacturer's
IFU for limits on sterile product storage time and storage requirements for temperature and humidity.
STORAGE OF PACKAGED NON-STERILE AND STERILE PRODUCT
• Final packaged product should be stored at room temperature (59-77
direct sunlight, pests, and high humidity.
Prevacuum Steam Sterilizer Parameters
Base: 80-2521, 80-3946, 80-3948, 80-4062, 80-4064
Case Lid: 80-2522, 80-3947, 80-3949, 80-4068
Wrapped
270°F (132°C)
4 minutes
273°F (134°C)
3 minutes
30 minutes
U.S. English – US / PAGE 9
www.acumed.net/ifu
for sterilization in Aesculap®
o
F or 15-25
o
C) and protected from
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