acumed Anatomic Radial Head System Gebrauchsanweisung Seite 8

US Instructions for use
• Verify the legibility of all markings and reference scales. Replace any device that is unreadable.
• Repair, replace, and/or repeat the cleaning of instruments as needed to ensure proper operation before
proceeding with sterilization.
• 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.
• 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 -6 for the system.
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.
Anatomic Radial Head System:
Prevacuum Steam Sterilizer Parameters
Storage Case Part Numbers:
Condition 1 :
Exposure Temperature:
Exposure Time:
Dry Time:
U.S. English – US / PAGE 8
Base: TR-0003
Case Lid: TR-0002
Wrapped
270°F (132°C)
25 minutes
50 minutes