acumed Anatomic Radial Head System Gebrauchsanweisung Seite 50

EN Instructions for use
Anatomic Radial Head Solutions, Anatomic Radial Head Solutions 2:
ARH Solutions Storage Case Part Numbers:
ARH Solutions 2 Storage Case Part Numbers:
Condition 1 :
Exposure Temperature and Time:
Exposure Temperature and Time
Dry Time:
Cooling 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
rigid sterilization containers.
2
The devices are compatible with exposure for 18 minutes at 134°C.
3 Cooling time describes the validated interval following dry time and prior to handling. This interval is included for safe handling
and the prevention of contamination. See ANSI/AAMI ST79:2017 Section 10.3.1.
* 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.
Prevacuum Steam Sterilizer Parameters
2 :
:
3
English (non-U.S.) – EN / PAGE 50
Base: 80-2000
Case Lid: 80-2001
Base: 80-3640, 80-3692, or 80-3693
Case Lid: 80-3641
Wrapped
270°F (132°C)
4 minutes
273°F (134°C)
3 minutes
30 minutes
30 minutes
www.acumed.net/ifu for sterilization in Aesculap®