(183 days)
Pūrgo is a combination UV and air filtration device, equipped with UV-C LEDs and a True HEPA filter intended for the reduction of bacteria, virus, fungal spores, and particles in air for use in medical facilities and other indoor spaces. Pūrgo is non-sterile.
Pūrgo has been demonstrated to remove the following organisms under the following exposure conditions:
| Organism | Name | Avg. max log reduction / exposure time (min) |
|---|---|---|
| Gram + Bacteria | Methicillin resistant Staphylococcus | |
| epidermidis | 4.6 (45) at normal speed | |
| Gram + Bacteria | Bacillus globigii endospore | 4.1 (60) at normal speed |
| Gram - Bacteria | Escherichia coli | 5.4 (45) at normal speed |
| RNA Virus | MS2 bacteriophage | 5.4 (60) at normal speed |
| DNA Virus | Phi-X174 bacteriophage | 4.4 (45) at normal speed |
| Fungal Spore | Aspergillus brasiliensis spore | 4.3 (90) at normal speed |
Pūrgo is a free-standing air disinfection system employing two technologies for purifying air: HEPA filtration and UV-C light irradiation, removing or destroying bacteria and viruses in air. Pūrgo may be used in medical facilities and commercial home healthcare environments. Pūrgo's main components consist of
- . LED UV-C lamps that generate irradiation to destroy microorganisms that are not filtered:
- . a proprietary SteriDuct chamber that intensifies the UV-C light to destroy microbiological material:
- . a filtration system with pre-filter, activated carbon filter, and HEPA filter;
- . a motor/impeller to move air through the filtration system:
- . sensors to monitor UV irradiance and airflow;
- . an electronic control system to power and control the device; and
- . a touch panel interface equipped with LEDs to indicate the working status of the device.
Pūrgo has several built-in safety features that will prevent operation of the filter cartridge is not in place or if the filter door is not closed. The unit also incorporates UV and airflow sensors that provide warnings to the user if the device is not performing as designed to purify air.
Pūrgo pulls air through a filter cartridge and then passes the filtered air through a chamber containing UV-C light to neutralize remaining airborne microorganisms (such as bacteria, viruses, and fungi). The filter cartridge contains a series of three filters, the first of which is a pre-filter that removes physically large particulate matter (such as dust) and protects the finer particle filters downstream. This is followed by an Activated Carbon filter. Finally, a HEPA (highefficiency particulate air) filter that removes 99.995% of the remaining airborne particles above a particle size of 0.1 µm.
Any microbes that still manage to make it through the filters, pass through the SteriDuct chamber where they are subjected to Ultraviolet Radiation at 265 nm (UV-C). UV radiation at this wavelength is particularly effective at destroying microbes. UV-C irradiation has been shown to damage the microbe's RNA and DNA genetic materials sufficiently to prevent the microbe's ability to reproduce.
After passing through the filtration and SteriDuct UV-C chamber, the purified air then exits back into the room. The exit air does not destroy laminar air flow in a typical operating room environment.
The document describes the acceptance criteria and the studies conducted for the Pūrgo device, a combination UV and air filtration system.
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Name | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Microorganism Performance | 4 log reduction (99.99%) | Average net log reduction / time: |
| - Methicillin resistant Staphylococcus epidermidis: 4.6 / 45 mins at normal | ||
| - Bacillus globigii endospore: 4.1 / 60 mins at normal, 4.4 / 60 mins at sleep, 4.2 / 45 mins at boost | ||
| - Escherichia coli: 5.4 / 45 mins at normal | ||
| - MS2 bacteriophage: 5.4 / 60 mins at normal, 4.3 / 60 mins at sleep, 4.5 / 45 mins at boost | ||
| - Phi-X174 bacteriophage: 4.4 / 45 mins at normal | ||
| - Aspergillus brasiliensis spore: 4.3 / 90 mins at normal | ||
| Fractional Efficiency | Per Standard (IEST-RP-CC001.6) | - Filter: 99.995% at 0.1-0.2 µm |
| - Pūrgo Unit with Filter: 99.990% at 0.1-0.2 µm | ||
| UV Intensity | ≥ 0.240 mW/cm² | Pass |
| UV Irradiance Exposure | Per Standard (ACGIH 2019 TLVs, ANSI/IENSA RP-27.3-07) | - Meets daily exposure limits ( |
§ 880.6500 Medical ultraviolet air purifier.
(a)
Identification. A medical ultraviolet air purifier is a device intended for medical purposes that is used to destroy bacteria in the air by exposure to ultraviolet radiation.(b)
Classification. Class II (performance standards).