Storage; Disposal; Serious Incident Reporting - Covidien TipVision Instrucciones De Uso

INDICATIONS FOR USE (continued)
AMSCO V-PRO Low Temperature Sterilization Cycles, Wrap & Aesculap
® ®
InstruSafe® Instrument Protection System cassettes are used to organize and protect other medical devices that are sterilized by a
healthcare provider. lnstruSafe Instrument Protection System cassettes are intended to allow sterilization of the enclosed medical
devices during Amsco V-PRO Low Temperature Sterilization Cycles. The lnstruSafe 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.
AMSCO V-PRO Low Temperature Sterilization Systems
Sterilizer Standard Cycle
V-PRO 1 X
V-PRO 1 PLUS N/A
V-PRO maX N/A
V-PRO maX 2 N/A
Summit Cassette Model
IN-8823
IN-6105
* Validated by Summit Medical for use in AMSCO V-PRO Low
Temperature Sterilization Systems ONLY. When using Aesculap
container as sterile barrier, the load (Summit tray and contents), should
not exceed the load claims for the container is weight or load type.

STORAGE

Store terminally sterile cassettes that are wrapped or containerized on storage shelf in a horizontal position. Consult wrap or container
manufacturer for shelf life information.

DISPOSAL

In the event the InstruSafe® Instrument Protection Systems do not pass inspection prior to use or have otherwise been deemed no longer
fit for purpose, the devices shall be disposed of in line with local protocol. The method of disposal shall depend on the potential risks of
cross-contamination and infection when the need for disposal is identified.

SERIOUS INCIDENT REPORTING

Any serious incident that has occurred in relation to the device should be reported to the manufacturer and the FDA/competent authority
of the Member State in which the user and/or patient is established.
Lumen Cycle Non Lumen Cycle
N/A N/A
X X
X X
X X
Aesculap Container Model
*JM444
*JM742
Rigid Container
®
Lumen size of instrumentation validated includes:
Summit Cassette Model
IN-8823
IN-6105
IN-2681
Note: The worst case validated load based on vent-to-volume calculation
is the IN-2681 tray.
11
Minimum Inside Maximum
Diameter Length
3mm 400mm
3mm 200mm
1mm 64mm
Number of
Lumens
2
1
1