12
Indications for Use
Intended use
The AUVS Germicidal Enclosure disinfection unit is intended to allow authorized trained personnel the
ability to disinfect a non-critical medical device (NCD) or mobile devices such as Tablets, and Phones on
demand. Only devices that make topical contact with intact skin are intended for AUVS disinfection.
Devices suitable for AUVS Germicidal Enclosure application are non-critical devices used in a
healthcare environment. The AUVS Germicidal Enclosure is not intended to be used to pre-clean or
decontaminate critical or semi-critical medical devices prior to terminal sterilization or high level
disinfection.
WARNING: Do not place vessels containing liquid of any kind, or bottles containing
medications of any kind, into the AUVS Germicidal Enclosure.
Device Indications for Use Statement
The AUVS Germicidal Enclosure’s disinfection function is achieved through the application of high
intensity germicidal UVC light applied at a known intensity and for a known duration. The intention is
to allow the user to position their non-critical medical devices and small mobile devices inside the AUVS
Germicidal Enclosure for disinfection process. Operation of the system is to take place outside of sterile
fields and by personnel performing their duties outside of sterile fields. Typical operating personnel are
trained professionals, including but not limited to physicians, nurses, technicans and environmental
services staff.