Exsurco Medical Amalgatome SD, Руководство пользователя

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A
MALGATOME
®
SD U
SER
G
UIDE
PN#: X101456, Rev. C Page 32 of 56
Sterilization
The Amalgatome SD System has only been validated for steam sterilization using the sterilization tray and FDA-
cleared wrap. Should any other method or sterilization tray be used, it is the sole responsibility of the facility to
validate any sterilization parameters that are not provided directly by the manufacturer. The Amalgatome SD
System is provided non-sterile and must be sterilized prior to use.
The wrapped sterilization tray shall be placed inside an autoclave validated in compliance with current version of
AAMI ST8, Hospital Steam Sterilizers .
Utilize one of the two validated steam sterilization methods listed below to provide a sterility assurance level of
10
-6
. Upon completing sterilization, store the Amalgatome SD System in the sterilization packaging in a dry and
dust-free place. The shelf life is dependent on the sterile barrier employed, manner in which product is stored,
environment and handling conditions. A maximum shelf life for sterilized medical devices before use should be
defined by each healthcare facility.
NOTE: See References & Internal Validation details in Appendix E.
Cycle Type Pre-vacuum
Pulses 4
Set-Point Temperature 135°C/ 275°F
Exposure Time
1
3 minutes
Drying Time
2
16 minute in chamber
Cycle Type Gravity
Set-Point Temperature 135°C/ 275°F
Exposure Time
1
10 minutes
Drying Time
2
30 minute in chamber
1
Exposure time: Period for which the load and entire chamber is maintained at the sterilization temperature.
2
Drying time: Period during which steam is removed from the chamber pressure is reduced to permit the evaporation of condensate from the load either by prolonged
evacuation or by the injection and extraction of hot air or other gases. The drying time varies due to load configuration, wrapping method and material. It is the
hospital’s responsibility to validate the appropriate drying time with the sterilization equipment used.