Room Disinfection System Salient Characteristics.docx

ROOM DISINFECTION SYSTEM SALIENT CHARACTERISTICS

1. A continuous 254nm wavelength UV-C Disinfection system.

2. The disinfection system must be able to combine multiple emitters into one single system, operating together or as a single emitter operating independently. The disinfection system must be able to maximize the effectiveness of each emitter to significantly reduce shadows in a single operation.

3. The system must deliver the effective dose of energy per the systems labeling for total delivered energy during a single cycle without the need for repositioning. No staff interaction must be required to move or adjust emitters designed for use with the multiple UV-C emitters for room coverage in a single operation. The system must be capable of overcoming shadows and maximizing proximity to all surfaces.

4. The system of multiple UV-C emitters must incorporate a UV-C concentrator for increased energy dosage and intensity. This process must be controlled by the system and not require any staff interaction.

5. The system must be able to pause a cycle during normal operation and resume the cycle without needing to start over from the beginning.

6. The UV-C system must have a feature to apply “targeted and limited” range disinfection with safe continuous disinfection delivered unilaterally in a single direction from multiple emitters while safely ensuring that no UV-C energy is delivered outside of the chosen disinfection area.

7. The system must incorporate a process for control of emitter’s from outside the room when starting the system for employee safety. This control must include starting and stopping the system and reporting the status and operations information. The operator must not have to enter the room for any reason while the system is operating. All functions must be controllable from the control device.

8. The system must perform unattended room disinfection to all surfaces within direct line of site and within the effective distance as stated in the manufacture’s labeling in a single, uninterrupted cycle without a need for repositioning or movement of the emitters.

9. The entire system must be certified to the appropriate safety standards (e.g., IEC 61010-1) by an independent, third-party safety accreditation organization such at Underwriters Laboratory (UL mark) or Intertek Testing Services (ETL mark).

10. The system shall incorporate multiple motion sensors within a single room with multiple entry/exit points for added safety. The system shall incorporate multiple motion sensors with Passive Infrared motion detection and movement detection by an accelerometer/gravimeter to ensure staff safety and avoiding false starts or stops. Additionally, motion sensors shall be activated prior to turning on the UV-C lights to ensure that the UV-C lights cannot be turned on if motion is detected.

11. The system must have Bluetooth technology to connect to the tablet to operate the emitters wirelessly.

12. The system must have Wi-Fi connectivity allowing “Cloud” connectivity for maintaining and monitoring performance, archive capability and remote accessibility.

13. The system must include all applicable technical specifications, studies, and white papers as evidence of meeting these requirements.

14. The product must be made in the United States of America.

15. The technology must be manufactured by an ISO 13485 registered facility.

16. A clear description of the available data on the device’s new indications or functions related to SARS-CoV-2 or co-existing conditions, such as:

a. Device performance; and

b. Potential risks (e.g., risk of UV exposure)

17. A clear distinction delineating FDA-cleared or FDA-approved indications from those that are not FDA-cleared or FDA-approved.

18. A clear statement of the level of disinfection.

19. The system must adhere to the FDA Labeling Requirements, including the follow items:

a. A caution that the UV disinfection will reduce the number of pathogens on the device, but it will not eliminate them completely.

b. A statement that the device is an adjunct to currently existing reprocessing practices and not a replacement or modification to such practices.

c. A statement regarding the time, distance, and maximum area over which the device has been evaluated for effectiveness.

d. An appropriate UV hazard warning label.

e. Identification of the expected UV lamp operational life and instructions for procedures on replacement of the UV lamp when needed.

f. Procedures to follow if the UV lamp malfunctions or fails.

g. Description of the preparation of equipment or the room for disinfection.

h. A statement that the equipment intended to be disinfected is UV compatible.

i. Identification of the UV dose.

20. Objective evidence of meeting # 14 – 19 must be provided.