Sterilization; Storage - Summit Medical Instrusafe Gebrauchsanweisung

STERILIZATION

See Table 2. for sterilization methods and cycles that have been validated for the sterilization of InstruSafe Systems. These are only valid with
sterilization equipment that is properly maintained and calibrated – AAMI TIR 12 p.37. Minimum dry times are required to prevent wet packs.
Summit Medical has validated the following sterilization methods:
• The 4 minute autoclave sterilization cycle in legally marketed wrap, Aesculap rigid container or Genesis rigid container cleared by the FDA.
• The Ethylene Oxide (EO) sterilization cycle in legally marketed wrap and a Genesis sterile container cleared by the FDA.
• The STERRAD 100S Standard sterilization cycle in legally marketed wrap and an Aesculap rigid container cleared by the FDA.
• The STERRAD 100NX Standard sterilization cycle in legally marketed wrap and an Aesculap rigid container cleared by the FDA.
• The STERRAD 100NX Express sterilization cycle in legally marketed wrap cleared by the FDA.
• The STERRAD 100NX Flex sterilization cycle in legally marketed wrap and an Aesculap rigid container cleared by the FDA.
• The STERRAD NX Standard sterilization cycle in legally marketed wrap and an Aesculap rigid container cleared by the FDA.
• The STERIS AMSCO V-PRO, V-PRO 1 PLUS and V-PRO maX sterilization cycles in legally marketed wrap and an Aesculap rigid container
clearedy by the FDA.
Do not exceed the load capacity of the sterile container as specified by the manufacturer.
Use an FDA cleared accessory to maintain sterility.
Please consult the sterilizer instruction manual to ensure intended loads are compatible with the intended sterilization cycle.
Please consult the container instructions to ensure that the intended load is compatible with the FDA cleared loads for the container.

STORAGE

Store terminally sterile cassettes that are wrapped or containerized on storage shelf in a horizontal position. Consult wrap or container
manufacturer for shelf life information.
Table 2.
STERILIZATION METHOD
Steam - PreVacuum
Ethylene Oxide (EO)
STERRAD 100S
STERRAD 100NX
STERRAD 100NX
STERRAD 100NX
STERRAD NX
STERIS AMSCO V-PRO 1
STERIS AMSCO V-PRO 1 PLUS
STERIS AMSCO V-PRO maX
CYCLE
(times)
Parameter :
Temperature 270° F (132° C)
Expose Time 4 minutes
Dry Time 30 minutes
Preconditioning :
Temperature 131°F (55°C)
Relative humidity 70±15%
Precondition time 1 hour
Sterilization :
Exposure time 120 minutes
Temperature 131°F (55°C)
Aeration time 12 hours
Standard
Standard
Express
Flex
Standard
Standard
Lumen, Non-Lumen
Lumen, Non-Lumen
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