Intended Use/Indications For Use Summary; Device Description; Intended User; Limitation On Processing - Summit Medical IUUS Instrucciones De Uso

EN
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 IUUS Probe Reprocessing Tray OM-1000-GS (Instrument Protection System) is intended to contain and protect the Sonata®
Intrauterine Ultrasound (IUUS) Probe model IUSP-002 during transport, sterilization, and storage. The IUUS Probe Reprocessing Tray is
used to organize and protect IUUS Probes that are sterilized by a healthcare provider. The IUUS Probe Reprocessing Tray is intended to
allow sterilization of the enclosed IUUS Probe model IUSP-002 during these sterilization cycles:
STERRAD® 100NX® Standard
STERIS® AMSCO® V-PRO 1®, V-PRO 1 Plus, V-PRO maX and V-PRO maX 2
The IUUS Probe Reprocessing Tray is intended to be used in conjunction with a legally marketed wrap. The IUUS Probe Reprocessing
Tray is not intended on its own to maintain sterility. A full list of device models is provided in Appendix A.

DEVICE DESCRIPTION

IUUS Probe Reprocessing Trays manufactured by Summit Medical are used to enclose and hold the Sonata® IUUS Probe model IUSP-
002 in an organized manner during the sterilization process and subsequent storage and transportation. The tray does not have
direct patient contact. The tray by itself does not maintain sterility. The tray has a rectangular base with latchable cover. The tray has
perforations to allow sterilant penetration. The tray contains silicone inserts in the base and/or cover to hold, organize, and protect the
IUUS Probe within the tray during the sterilization process and subsequent storage and transportation.

INTENDED USER

The IUUS Probe Reprocessing Tray is intended to be used by healthcare professionals in the operating room and sterile processing
department for transportation, sterilization, and storage of the Sonata® IUUS Probe model IUSP-002.

LIMITATION ON PROCESSING

1. The end of useful life on the IUUS Probe Reprocessing Tray 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 Systems or components.
4. DO NOT OVERLOAD individual Hold-Its® slots. Load only one instrument per Hold-Its® slot.
5. Inside of sterilizers, DO NOT STACK individually wrapped Systems or components. Separate wrapped Systems or components
from each other or any other items on separate shelves of the sterilizer to allow for maximum sterilant flow.
6. The total weight of the system (e.g. tray, and instrument load) must not exceed 25 pounds (11.34 kg).
7. The Sonata® IUUS Probe should be prepared and sterilized according to the IUUS Probe manufacturer's instructions.
8. It is the responsibility of the processor to maintain specific validations for the terminal sterilization process being applied to the
configurations of instruments being presented to the sterilization process.
1