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Chronos® is indicated for use in a healthcare environment to achieve a high-level disinfection of surfaces of external, transvaginal, and transrectal ultrasound probes that do not contain lumens and that do not contain indentations or channels that are deeper than their widths.

The Germitec Chronos® device is intended to provide Ultraviolet C (UV-C) chemical-free highlevel disinfection (HLD) of ultrasound probes within an enclosed disinfection chamber. As defined in FDA Guidance - Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, found at https://www.fda.gov/media/80265/download, HLD is a lethal process utilizing a sterilant under less than sterilizing conditions. The process kills all forms of microbial life except for large numbers of bacterial spores. The subject device is intended for use in health care facilities by trained personnel. The Chronos® is an automated medical device consisting of a sealed disinfection chamber, incorporating multiple UV-C lamps and reflective walls. UV-C dose is identified as the only critical determinant of the effectiveness of the disinfection cycle. The software is used to determine achievement of the disinfection total dose and acceptance of the automated HLD cycle. The total dose delivered to the surface of each ultrasound probe undergoing. the disinfection process is continuously monitored by two optical sensors, UV-C sensitive photodiodes. The control system continuously takes readings from the sensors, tracks progress of the ongoing disinfection cycle, and terminates the disinfection cycle when the cycle-controlling photodiodes indicate that the pre-defined UV-C dose has been achieved. Additionally, the device utilizes an independent cycle monitoring step through the use of a third UV-C photodiode. This independent probe is used to verify that the pre-defined UV-C HLD dose has been delivered. Onto each ultrasound probe for which compatibility has been validated, a ring is placed onto the ultrasound cable. This ring is used to set the probe into the proper position within the chamber, as well as to include an identifier barcode. This barcode is read by the Chronos® software, and provides identification of both the appropriate disinfection dose as well as traceability for the ultrasound probe undergoing disinfection. The encoding of the barcode to each specific probe model and installation of the ring on each probe can only be performed by an authorized service representative from Germitec.