PKGI-79-F Effective 03-2019
English – EN / PAGE 25
EN
STERILITY:
System components may be provided sterile or nonsterile.
Sterile Product:
Sterile product was exposed to a minimum
dose of 25.0-kGy gamma irradiation. Acumed does not
recommend resterilization of sterile-packaged product. If sterile
packaging is damaged, the incident must be reported to Acumed.
The product must not be used and must be returned to Acumed.
Non-Sterile Product:
Unless clearly labeled as sterile and
provided in an unopened sterile package provided by Acumed, all
implants and instruments must be considered nonsterile and
sterilized by the hospital prior to use.
Follow current AORN “Recommended Practices for
Sterilization in Perioperative Practice Settings” and ANSI/AAMI
ST79:2010 – Comprehensive guide to steam sterilization and
sterility assurance in health care facilities.
Consult your equipment manufacturer’s written instructions for
specific sterilizer and load configuration instructions.
Gravity-displacement steam sterilization is not recommended.
Flash sterilization is not recommended.
Prevacuum Steam Sterilizer Parameters
1
1
Values in this table reflect the minimum parameters validated to
achieve the required Sterility Assurance Level (SAL), for a fully
loaded tray with all parts placed appropriately.
2
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 ST79:2010
Section 8.8.1.
Tray Case Part Numbers:
80-2340 and 80-2341
Condition:
Wrapped
Preconditioning Vacuum Pulses: 3
Exposure Temperature:
270
o
F (132
o
C)
Exposure Time:
4 minutes
Dry Time:
30 minutes
Cooling Time
2
:
30 minutes
Summary of Contents for Ankle Plating System 3
Page 36: ...PKGI 79 F Effective 03 2019 3 3 3 ASTM F67 ASTM F136 EL 36 EL...
Page 37: ...PKGI 79 F Effective 03 2019 Acumed acumed net EL 37 EL...
Page 39: ...PKGI 79 F Effective 03 2019 Acumed SUD SUD pH 8 5 1 2 3 4 pH 8 5 EL 39 EL...
Page 41: ...PKGI 79 F Effective 03 2019 Acumed pH pH 11 1 2 20 3 3 4 EL 41 EL...
