Limitations - Summit Medical Instrusafe Gebrauchsanweisung

Sterilization Methods and Configurations
» STERRAD® 100NX Standard Cycle:
Summit Cassette Model
IN-8823-AE
IN-6105
* Validated by Summit Medical for use in STERRAD 100NX Standard Cycle
ONLY. Consult container instructions to ensure that contents do not exceed
the sterilization containers intended load claims.
Note : The worst case validated load based on vent-to-volume calculation
is the IN-2681 tray. The worst case validated load based on the number of
instruments and estimated weight is the IN-8823-XX tray.
» STERRAD® 100NX Express Cycle:
This cycle is not validated for use in rigid containers.
» STERRAD® 100NX Flex Cycle:
Summit Cassette Model
IN-0000
IN-6105
* Validated by Summit Medical for use in STERRAD 100NX Flex Cycle ONLY.
Consult container instructions to ensure that contents do not exceed the
sterilization containers intended load claims.
Note : The worst case validated load based on vent-to-volume calculation is
the IN-0000 tray.
Limitation on Processing
1) The end of useful life on the InstruSafe Instrument Protection System is a minimum of 25 sterilization cycles. Inspect
the tray before use for wear and damage caused by use and discontinue use if visible signs of wear are present
including corrosion, mechanical failures, cracking, peeling, flaking, broken welds, damaged feet, damaged latches,
damaged Hold-It / Hold-Down, discoloration, etc.
See Table 2. for sterilization methods and configurations.
2)
3) DO NOT OVERLOAD InstruSafe Systems or components, see the maximum weight chart in Appendix A.
` 4) DO NOT OVERLOAD individual Hold-It slots. Load only one instrument per Hold-It slot. For Hold-it table visit
www.instrusafe.com Resources page.
5) For rigid container users, DO NOT WRAP InstruSafe Systems or components and place inside of container for sterilization.
6) Inside of sterilizers, DO NOT STACK individually wrapped or containerized InstruSafe Systems or components. Separate
wrapped or containerized InstruSafe Systems or components from each other or any other items on separate shelves of
the sterilizer to allow for maximum sterilant flow.
7) The use of non absorbent tray liners (i.e. silicone fingered organizing mat) can cause condensate to pool. If visible
moisture is present, re-sterilize with a longer dry time.
(continued)
Aesculap Container Model
®
*JM444
*JM440
Aesculap Container Model
®
*JM444
*JM440
» STERRAD® NX Standard Cycle:
Summit Cassette Model
IN-2681
IN-8987-S
IN-8615
IN-6105
Note : The worst case validated load based on vent-to-volume calculation is
the IN-2681 tray.
» STERIS® AMSCO V-PRO
Sterilizer Standard
V-PRO 1
V-PRO 1 PLUS
V-PRO maX
Summit Cassette Model
IN-8823
IN-6105
* Validated by Summit Medical for use in STERIS AMSCO V-PRO Low
Temperature Sterilization Systems ONLY. When using the Aesculap container
as a sterile barrier, the load (Summit Tray and contents), should not exceed
the load claims for the container in weight or load type.
Note : The worst case validated load based on vent-to-volume calculation is
the IN-2861 tray.
2
Aesculap Container Model
®
*JM441
*JM441
*JM441
*JM441
Low Temperature Sterilization Systems:
Lumen Non Lumen
Cycle Cycle
X N/A
N/A X
N/A X
Aesculap Container Model
®
*JM444
*JM742
Cycle
N/A
X
X