acumed Acu-Loc Instrucciones De Uso página 8

US Instructions for use
• 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 -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.
Acu-Loc System:
Storage Case Part
Numbers:
Condition 1 :
Exposure Temperature:
Exposure Time:
Dry Time:
Acu-Loc 2 System , Acu-Loc 2 Core System:
Acu-Loc 2 System Storage
Case Part Numbers:
Acu-Loc 2 Core 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
sterilization containers.
Prevacuum Steam Sterilizer Parameters
Base: DR-017
Case Lid: DR-015
Wrapped
A towel should be used inside the wrap if a non-wicking
wrap material is employed (e.g. polypropylene).
270°F (132°C)
15 minutes
45 minutes
Prevacuum Steam Sterilizer Parameters
Base: 80-0674
Case Lid: 80-0673
Base: N/A
Case Lid: 80-1996
Wrapped
270°F (132°C)
4 minutes
273°F (134°C)
3 minutes
30 minutes
U.S. English – US / PAGE 8
www.acumed.net/ifu for sterilization in Aesculap® rigid