Indications For Use; Device Description; Sterilization Methods And Configurations - Summit Medical INSTRUSAFE Gebrauchsanweisung

The instructions provided within have been validated by the device manufacturer as being capable of
Individual sterilizers, instrument cleanliness, specific loading of instrument trays, types and geometry of
instruments, sterilization containers, filters and wrappings vary at each location.
READ THIS SECTION BEFORE PLACING PRODUCT INTO SERVICE

Indications for Use:

InstruSafe® Instrument Protection System cassettes are used to organize and protect other medical devices that are sterilized by a
healthcare provider. InstruSafe Instrument Protection System cassettes are intended to allow sterilization of the enclosed medical
devices during these sterilization cycles :
• pre-vacuum steam
• ethylene oxide
• STERRAD® 100S Standard
• STERRAD® 100NX Standard
The InstruSafe Instrument Protection System cassettes are intended to be used in conjunction with a legally marketed wrap, Aesculap®
rigid container or Genesis™ rigid container. The InstruSafe Instrument Protection System cassettes are not intended on their own to
maintain sterility. A full list of device models is provided in Appendix A.

Device Description:

Summit Medical Inc. InstruSafe Instrument Protection Systems are cassettes / trays used to enclose and hold surgical instruments
and instrument accessories in an organized manner during the sterilization process and subsequent storage and transportation. The
cassettes / trays do not have direct patient contact. The cassettes / trays by themselves do not maintain sterility. The cassettes / trays
are different sizes of the same basic configuration: a rectangular base with latchable cover. The cassettes / trays have perforations
to allow sterilant penetration. The cassettes / trays contain silicone inserts in the base and/or cover to hold, organize and protect the
surgical instruments within the cassette / tray during the sterilization process and subsequent storage and transportation.

Sterilization Methods and Configurations

The following sterilization trays were validated with the corresponding rigid containers :
» Autoclave Sterilization Parameter:
Cycle : Pre-vacuum
Temperature : 270° F (132° C)
Exposure Time : 4 minutes
Minimum Dry Time : 30 minutes
Summit Cassette Model
IN-8823-AE
IN-2880
IN-6105
Summit Cassette Model
IN-2681
IN-0000
IN-8613
IN-6105
* Validated by Summit Medical for use in steam prevacuum sterilizers ONLY
operating at 270° F (132° C) for 4 minutes exposure time. Consult container
instructions to ensure that contents do not exceed the sterilization containers
intended load claims.
reprocessing reusable medical devices.
Aesculap Container Model
®
*JN444
*JK444
*JN742
Genesis™ Container Model
*CD2-10-CDL
*CD2-10-CDL
*CD2-10-CDL
*CD2-10-CDL
• STERRAD® 100NX Express
• STERRAD® 100NX Flex
• STERRAD® NX Standard
• STERIS®AMSCO® V-PRO™, V-PRO 1 and V-PRO maX
» Ethylene Oxide (EO):
Preconditioning Parameters:
Temperature: 131°F (55°C)
Relative Humidity: 70± 15%
Time: 1 hour
Sterilization Parameter:
Temperature: 131°F (55°C)
Minimum Exposure Time: 120 minutes
Minimum Aeration Time: 12 hours
Summit Cassette Model
IN-8823
IN-2880
IN-6105
* Validated by Summit Medical for use in ethylene oxide sterilizers ONLY
operating at 131° F (55° C). Consult container instructions to ensure that
contents do not exceed the sterilization containers intended load claims.
» STERRAD® 100S Standard Cycle:
Summit Cassette Model
IN-8823-AE
IN-6105
* Validated by Summit Medical for use in STERRAD 100S Standard Cycle
ONLY. Consult container instructions to ensure that contents do not exceed
the sterilization containers intended load claims.
1
Genesis™ Container Model
*CD3-9CDL
*CD6-6C
*CD5-61C
Aesculap Container Model
®
*JM444
*JM440