acumed Polarus Bedienungsanleitung Seite 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. Sterilization of nonsterile
devices has been validated using the sterilization parameters
listed below, where devices are provided in fully-loaded trays with
all parts placed appropriately.
Sterilization Methods
• Consult your equipment manufacturer's written instructions for
specific sterilizer and load configuration instructions.
• 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.
• Flash sterilization is not recommended, but if used, should only
be performed according to requirements of ANSI/AAMI ST79:
2010 – Comprehensive guide to steam sterilization and sterility
assurance in health care facilities.
PKGI-22-P Effective 05-2020
Gravity Displacement Autoclave:
Exposure Temperature: 270 °F (132 °C)
Exposure Time: 30 minutes
Dry Time: 65 minutes
Pre-Vacuum Autoclave:
Exposure Temperature: 270 °F (132 °C)
Exposure Time: 14 minutes
Dry Time: 65 minutes
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