(322 days)
The Novaerus NV 1050 is intended as a room recirculating air cleaner. The system is used for filtering out and inactivating airborne particles from the air for medical purposes.
The Novaerus NV1050 (NV1050) is a free-standing cabinet of a size that can be maneuvered into position by a single person. The NV1050 is powered from an AC wall outlet. The NV1050 circulates the room air through its cabinet. The air is drawn in through the front of the cabinet, passes through a pre-filter then a Dielectric Barrier Discharge Plasma generator ("plasma generator") stage, and a further two filters (HEPA, Carbon) The cleaned air is exhausted out of the top panel of the cabinet. The device has simple controls: On/Off and fan speed setting from 1 to 5. There is a button to initiate a filter blockage test to check and inform the user if the filters are getting close to requiring changing. The only routine maintenance is a calendar-based filter change schedule indicated in the User Manual; the indicator light on the front panel acts as a reminder that the filters will soon need attention. The airflow path through the NV1050 is: - A general pre- filter to remove particles from the input air flow. . - A bank of three (3) plasma generators, each Plasma Generator consists of ● two (2) plasma Coils. Micro-Organisms, including virus and bacteria, are inactivated by the plasma generator. This occurs through damage by plasma constituents (ions, electrons, reactive oxidizing species, ultraviolet radiation, high electric fields) - A HEPA (High-efficiency Particulate Air) filter to trap the resulting virus/bacteria particulates. - . An activated carbon filter to trap any ozone in the airstream before it is output to the environment.
The provided text describes the Novaerus NV1050 medical recirculating air cleaner and its substantial equivalence to a predicate device. It includes information on non-clinical testing to demonstrate performance against acceptance criteria.
Here's the breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test name/Methodology/Standard name | Purpose | Acceptance Criteria | Result |
|---|---|---|---|
| IEC60601-1:2005/A1;2012 | Device electrical safety | Pass the requirements of the consensus standard | Pass |
| IEC60601-1-2:2014 | Device Electromagnetic Compatibility | Pass the requirements of the consensus standard | Pass |
| Ozone emissions | Confirm ozone emissions are below the maximum permitted levels |
§ 880.5045 Medical recirculating air cleaner.
(a)
Identification. A medical recirculating air cleaner is a device used to remove particles from the air for medical purposes. The device may function by electrostatic precipitation or filtration.(b)
Classification. Class II (performance standards).