Indications For Use - Covidien TipVision Instrucciones De Uso

INDICATIONS FOR USE

4 Minute Steam, 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 pre-vacuum steam 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.
Autoclave Sterilization Parameter
Cycle
Temperature
Exposure Time
Minimum Dry Time
Summit Cassette Model
IN-8823-AE
IN-2880
IN-6105
* Validated by Summit Medical for use in Pre-Vacuum Steam 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 container's intended load claims.
4 Minute Steam, 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 Instrument Protection System cassettes are intended to allow sterilization of the enclosed medical
devices during a pre-vacuum steam sterilization cycle. The InstruSafe Instrument Protection System cassettes are intended to be used
in conjunction with a legally marketed Genesis rigid containers. 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.
Lumen Claims for 4 Minute Pre-Vacuum Steam Sterilization Cylcle
Minimum Inside
Summit Cassette Model
Diameter
IN-2681 1mm
IN-2681 3mm
IN-6105 5mm
1mm
IN-0000 3mm
5mm
Rigid Container
®
Pre-Vacuum
270°F (132°C)
4 minutes
30 minutes
Aesculap Container Model
*JN444
*JK444
*JN742
Maximum Number of
Length Lumens
65mm 1
200mm 1
241mm 1
400mm 5
400mm 1
400mm 1
Lumen Claims for 4 Minute Pre-Vacuum Steam Sterilization Cylcle
Summit Cassette Model
IN-8823-CF
IN-8823-CF
IN-2880
IN-2880
IN-6105
IN-2681
IN-2681
IN-7823
8
Minimum Inside Maximum
Diameter Length
3mm 400mm
3mm 200mm
1mm 76mm
3mm 177mm
5mm 241mm
1mm 65mm
3mm 200mm
1mm 400mm
Number of
Lumens
4
2
2
1
1
1
1
17