Covidien TipVision Instrucciones De Uso página 10

INDICATIONS FOR USE (continued)
STERRAD NX Standard Cycle, Wrap & Aesculap
® ®
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 NX Standard Sterilization Cycle. The InstruSafe Instrument Protection System cassettes are intended to be
used in conjunction with a 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.
Sterilization Methods and configurations
- Sterrad NX Standard Sterilization Cycle
Lumen Claims for STERRAD NX Standard Sterilization Cycle
Minimum Inside
Summit Cassette Model
Diameter
IN-2681 1mm
IN-2681 3mm
IN-8987-S 1mm
IN-8615 2.3mm
IN-6105 4mm
Note: The worst case validated load based on vent-to-volume calculation
is the IN-2681 tray.
STERRAD 100NX Express Cycle, Wrap
® ®
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® 100NX Express Cycle. The InstruSafe Instrument Protection System cassettes are intended to be used in
conjunction with a legally marketed wrap. The InstruSafe Instrument Protection System cassettes are not intended on their own to
maintain sterility. The InstruSafe Instrument Protection System has no lumen claims for the Sterrad 100NX Express Cycle.
STERRAD 100NX Flex Sterilization Cycle, Wrap & Aesculap
® ®
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 100NX Flex Sterilization Cycle. The InstruSafe Instrument Protection System cassettes are intended to be used
in conjunction with a 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.
STERRAD 100NX Flex Sterilization Cycle
Summit Cassette Model
IN-0000
IN-6105
* Validated by Summit Medical for use in STERRAD 100NX Flex
Sterilization Cycle ONLY. Consult container instructions to ensure that
contents do not exceed the sterilization container's intended load
claims.
Lumen Claims for STERRAD 100NX Flex Sterilization Cycle
Summit Minimum
Cassette Inside
Model Diameter
IN-0000 1mm
IN-8823 1mm
IN-7344 1mm
IN-6105 4mm
®
Maximum Number of
Length Lumens
65mm 1
200mm 1
500mm 5
210mm 5
235mm 1
Aesculap Container Model
*JM440
*JM440
Maximum Number of Wrap/Rigid
Length Lumens Container
Wrap + Rigid
850mm 1
Container
Wrap + Rigid
850mm 1
Container
850mm 1 Wrap
Wrap + Rigid
235mm 1
Container
Rigid Container
Rigid Container
®
The worst case validated load based on vent-to-volume calculation is
the IN-0000 tray.
Note: The IN-0000 tray is for testing purposes only.
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