Covidien TipVision Instrucciones De Uso página 9

INDICATIONS FOR USE (continued)
8 Minute Steam & Ethylene Oxide (EO), Wrap & Genesis™ Rigid Container
InstruSafe® Instrument Protection System cassettes are used to organize and protect other medical devices that are sterilized by a
healthcare provider. InstruSafe System cassettes are intended to allow sterilization of the enclosed medical devices during Pre-Vacuum
steam or ethylene oxide sterilization cycles. The InstruSafe System cassettes are intended to be used in conjunction with central legally
marketed wrap or with a Genesis rigid container. The InstruSafe System cassettes are not intended on the own to maintain sterility.
Sterilization methods and configurations
Steam 8 Minute Preconditioning at 132°C
140 count woven wrap
Non-woven wrap (Kimberly Clark)
Genesis Container (reference
Table 1 for filter paper to use)
Table 1
Genesis Container
CD2-4B
CD2-5B
CD3-4B
CD3-5B
CD3-6B
CD3-7B
CD4-5B
CD5-61B
CD6-6B
See V. Mueller Genesis Sterilizer Container system User's Operating
Instructions when using any Genesis Rigid Container.
STERRAD 100S & STERRAD
®
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 a Sterrad 100S Standard and Sterrad 100NX Standard sterilization cycles. The InstruSafe Instrument Protection System cassettes
are intended to be used in conjunction with legally marketed wrap or Aesculap 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.
The following sterilization trays were validated with the corresponding rigid containers:
STERRAD 100S Standard Cycle
Summit Cassette Model
IN-8823-AE
IN-6105
STERRAD 100NX Standard Cycle
Summit Cassette Model
IN-8823-AE
IN-6105
* Validated by Summit Medical for use in STERRAD 100S Standard Cycle
and STERRAD 100NX Standard Cycle ONLY. Consult container instructions
to ensure that contents do not exceed the sterilization container's
intended load claims.
10 minute dry time
50 minute dry time
30 minute dry time
Genesis Container Filter Paper
FX3-1: 9x9"
FX3-1: 9x9"
FX3-1: 9x9"
FX3-1: 9x9"
FX3-1: 9x9"
FX3-1: 9x9"
FO3-2: 9x6"
FO3-2: 9x6"
FX3-1: 9x9"
100NX Standard Cycles, Wrap & Aesculap
® ®
Aesculap Container Model
*JM444
*JM440
Aesculap Container Model
*JM444
*JM440
Ethylene Oxide (EO)
1 hour preconditioning at 131°F (55°C) with relative Humidity of 70 ± 15%
2 hours exposure at 131°F (55°C)
12 hours aeration
Rigid Container
®
Lumen Claims for STERRAD 100S Standard and STERRAD 100NX
4 Stainless steel lumens with 3mm inner
diameter x 400mm length
2 Stainless steel lumens with 3mm inner
diameter x 200mm length
1 Stainless steel lumens with 3mm inner
diameter x 200mm length
1 Stainless steel lumens with 1mm inner
diameter x 65mm length
9
Standard Cycles
All appropriately sized
models are listed in
Appendix A with the
exception of IN-2681.
IN-2681