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Instructions for use
• Lubrication ("instrument milk") may increase the useful life of surgical instruments. Do not use silicone-
based lubricants, oil, or grease, as these will interfere with steam sterilization. Only use a water-based
lubricant intended for use on surgical instruments and with steam sterilization. Use the lubricant as
directed by the manufacturer. Use critical water if dilution is required.
• Fully replenish the system trays and caddies.
STERILIZATION
• Perform sterilization using a dynamic-air-removal (prevacuum) autoclave.
- Gravity displacement sterilization is not recommended.
- Immediate use (flash) sterilization is not recommended.
• Ensure the sterilizer's maximum load limit is not exceeded when sterilizing multiple sets or devices.
• Do not stack containers as this might prevent the penetration of steam and inhibit drying.
• Refer to the sterilizer manufacturer's instructions and ensure proper installation, calibration, use, and
ongoing maintenance.
• The sterilized items should be allowed to cool to room temperature before handling. This allows for safe
handling and preventing condensation.
• Follow current industry best practice guidelines such as ANSI/AAMI ST79:2017*.
* Association for the Advancement of Medical Instrumentation (AAMI). Comprehensive guide to steam
sterilization and sterility assurance in health care facilities. AAMI ST79:2017. Arlington, VA.
• The following table shows the minimum parameters validated* to achieve a required Sterility Assurance
Level (SAL) of 10
for the system.
-6
Important:
- Sterilization parameters are only valid for devices that have been cleaned per these instructions
and are thoroughly dry.
- Sterilization parameters are only valid when the devices are properly housed in the Acumed
storage case part numbers identified in the table.
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
Use sterilization packaging/wrap and other accessories appropriate for the cycle parameters recommended in these
instructions and in accordance with national regulations. Refer to PKGI-76 at
Aesculap® 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.
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
English (non-U.S.) – EN / PAGE 47
www.acumed.net/ifu
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