Indications For Use; Storage; Disposal; Serious Incident Reporting - Summit Medical IUUS Instrucciones De Uso

INDICATIONS FOR USE

STERILIZATION OF IUUS PROBE IS ONLY VALIDATED FOR WRAP, STERRAD 100NX AND V-PRO CYCLES
STERRAD 100S & STERRAD
®
InstruSafe® Instrument Protection System trays are used to organize and protect other medical devices that are sterilized by a healthcare
provider. InstruSafe Instrument Protection System trays 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 trays are intended to be used
in conjunction with legally marketed wrap. The InstruSafe Instrument Protection System trays are not intended on their own to maintain
sterility. A full list of device models is provided in Appendix A.
* Validated by Summit Medical for use in STERRAD 100S Standard Cycle and STERRAD 100NX Standard Cycle ONLY.
AMSCO V-PRO Low Temperature Sterilization Cycles, Wrap
® ®
InstruSafe® Instrument Protection System trays are used to organize and protect other medical devices that are sterilized by a
healthcare provider. lnstruSafe Instrument Protection System trays are intended to allow sterilization of the enclosed medical devices
during Amsco V-PRO Low Temperature Sterilization Cycles. The lnstruSafe Instrument Protection System trays are intended to be
used in conjunction with a legally marketed wrap. The InstruSafe Instrument Protection System trays 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
* Validated by Summit Medical for use in AMSCO V-PRO Low
Temperature Sterilization Systems ONLY.

STORAGE

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

DISPOSAL

In the event the 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.
100NX Standard Cycles, Wrap
® ®
Lumen Cycle Non Lumen Cycle
N/A N/A
X X
X X
X X
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