SONOPRO is a limited pre-production run of Automated Disinfector Devices. It is classified by the FDA as a Class II medical device, product code MEC. It is intended for use in the critical care areas of the hospital clinical setting, disinfecting Spaulding category low-risk hand-held re-useable medical devices. Devices must be first pre-cleaned or free of visible bioburden.
An electrically-powered unit designed for the disinfection of devices at the point-of-use using ultrasonically generated ultra-fine particle aerosolized disinfectant. It consists of a cabinet with internal shelves intended to accept pre-cleaned medical devices/equipment (including electrical devices), an ultrasonic disinfectant atomizer and a control panel. It is intended to be used as an alternative to wipe down disinfection, and is not intended for use in a reprocessing suite.