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510(k) Data Aggregation
(274 days)
The UV Smart D60 is indicated for use in a healthcare environment to achieve a high level disinfection (HLD) of external surfaces of Transesophageal Echocardiogram (TEE) probes that do not contain lumens and that do not contain indentations or channels that are deeper than their widths.
The UV Smart D60 provides chemical-free high level disinfection using Ultraviolet-C (UV-C) light within a fully enclosed disinfection chamber. The system features eight UV-C lamps, UV-C-reflective chamber walls, and UV-C-transmitting instrument holders designed to suspend the intended load in an optimal position. The fixed disinfection cycle time of 120 seconds is the only critical determinant of disinfection efficacy. The disinfection efficacy is verified during each cycle by two independent threshold sensors—one for UV-C dose and one for power consumption.
The UV Smart D60 is intended to be used in healthcare facilities by trained personnel. Prior to disinfection, each soiled instrument must be cleaned at the bedside and manually cleaned in accordance with the original equipment manufacturer (OEM) instructions for use. Under normal operating conditions, the UV Smart D60 has an expected service life of ten years, with preventive maintenance and lamp replacement required annually, as specified in the UV Smart D60's Instructions for Use.
To ensure that the intended load is both physically compatible with the disinfection chamber and capable of receiving the required HLD UV-C dose (Minimum Effective Dose or MED) on its surfaces, the intended load is approved for use with the UV Smart D60. Once approved, the intended load is released for use in the UV Smart D60's traceability system. The UV Smart D60 will not initiate a disinfection cycle unless a registered instrument is recognized, ensuring that only approved instruments can be processed.
Each disinfection cycle accommodates a single instrument, which is suspended entirely within the D60's disinfection chamber—ensuring that all surfaces, including handles and attached cables, receive the MED for validated high level disinfection.
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