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The instructions provided within have been validated by the device manufacturer as being capable of reprocessing
reusable medical devices.
Individual sterilizers, instrument cleanliness, specific loading of instrument trays, types and geometry of
instruments, sterilization containers, filters, and wrappings vary at each location.
READ THIS SECTION BEFORE PLACING PRODUCT INTO SERVICE
INTENDED USE/INDICATIONS FOR USE SUMMARY
The InstruSafe® Instrument Protection Systems cassettes/trays are intended to contain and protect reusable medical devices during
transport, sterilization, and storage. InstruSafe® Instrument Protection System cassettes/trays are used to organize and protect other
medical devices that are sterilized by a healthcare provider. InstruSafe Instrument Protection System cassettes/trays are intended to
allow sterilization of the enclosed medical devices during these sterilization cycles:
Pre-Vacuum Steam (EN 285)
Ethylene Oxide (ISO 11135)
Validated Gas Plasma Sterilization i.e.
STERRAD® 100S Standard
STERRAD® 100NX® Express
STERRAD® NX® Standard
The InstruSafe Instrument Protection System cassettes/trays are intended to be used in conjunction with a legally marketed wrap,
Aesculap® rigid containers, or 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.
DEVICE DESCRIPTION
Summit Medical InstruSafe Instrument Protection Systems are cassettes/trays used to enclose and hold surgical instruments and
instrument accessories in an organized manner during the sterilization process and subsequent storage and transportation.
The cassettes/trays do not have direct patient contact. The cassettes/trays by themselves do not maintain sterility. The cassettes/
trays are different sizes of the same basic configuration: a rectangular base with latchable cover. The cassettes/trays have perforations
to allow sterilant penetration. The cassettes/trays contain silicone inserts in the base and/or cover to hold, organize, and protect the
surgical instruments within the cassette/tray during the sterilization process and subsequent storage and transportation.
INTENDED USER
The InstruSafe® Instrument Protection Systems are intended to be used by healthcare professionals in the operating room and sterile
processing department for transportation, sterilization, and storage of medical devices.
LIMITATION ON PROCESSING
1. The end of useful life on the InstruSafe Instrument Protection System is a minimum of 25 sterilization cycles. Inspect the
tray before use for wear and damage caused by use. Discontinue use if visible signs of wear are present, including corrosion,
mechanical failures, cracking, peeling, flaking, broken welds, damaged feet, damaged latches, damaged Hold-Its®/Hold-Downs®,
discoloration, etc.
2. See Table 2 for sterilization methods and configurations.
3. DO NOT OVERLOAD InstruSafe Systems or components.
4. DO NOT OVERLOAD individual Hold-Its® slots. Load only one instrument per Hold-Its® slot.
5. For rigid container users, DO NOT WRAP InstruSafe Systems or components and place inside of container for sterilization.
6. Inside of sterilizers, DO NOT STACK individually wrapped or containerized InstruSafe Systems or components. Separate wrapped
or containerized InstruSafe Systems or components from each other or any other items on separate shelves of the sterilizer to
allow for maximum sterilant flow.
7. The use of non absorbent tray liners (e.g. silicone fingered organizing mat) can cause condensate to pool. If visible moisture is
present, re-sterilize with a longer dry time.
8. The total weight of the container system (e.g. container, tray, and instrument load) must not exceed 25 pounds (11.34 kg).
9. Instruments (e.g. endoscopes and instruments with lumens or channels) should be prepared and sterilized according to the
instrument manufacturer's instructions.
10. It is the responsibility of the processor to maintain specific validations for the terminal sterilization process being applied to the
configurations of instruments and containers being presented to the sterilization process.
STERRAD® 100NX® Standard
STERRAD® 100NX® Flex
STERIS® AMSCO® V-PRO 1®, V-PRO 1 Plus, V-PRO maX and V-PRO maX 2
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