RH-N95 Decontamination System Respirator Masks | UK

RH-N95 Decontamination System

Peer review literature research has documented that the RH-N95 can meet or exceed a 6Log reduction of Coronavirus (or its surrogate) and that of Mycobacterium while assuring respirator performance for multiple use.
The RH-N95 Decontamination System meets the criteria for market clearance contained in FDA’s March 2020 guidance document.

Mask Loading On Trays

Comparison with VHP & UV

RH-N95 Tech Sheet

HELPING OUR MEDICAL PROFESSIONALS FIGHT COVID-19

Decontaminates N95 Respirator Masks for multiple use. (tested to 20 cycles)

The RH-N95 provides a fast, effective method of decontaminating N95 masks without compromising mask performance – Up to 100 masks per hour.

Through the convenience of on-site reprocessing of used N95 masks using the tabletop RH-N95, healthcare facilities can achieve required level of viral kill, while maintaining mask performance and function.

On-site decontamination will assure that personnel can receive their previously used mask. Units can be installed in departments, floor, units or wings of healthcare facilities.

Features and Benefits

High Velocity Hot Air Sterilisers from Metafix (UK) Ltd

Low temperature @ 72°C
30 minute cycle
50 mask capacity
No chemicals or water required
No drying or aeration
Energy efficient
Easy touch screen operation

Included with the RH-N95 Decontamination System

RH-N95 Specifications

4 Instrument trays
Tray removal safety gloves
3 Year inclusive parts and labour warranty
Nationwide engineer support and service

SUMMARY OF CPAC EQUIPMENT’S HVHA RAPIDHEAT™ RH-N95 MASK/RESPIRATOR REPROCESSOR

Reconfigured from CPAC Equipment’s RH-Pro series of FDA-cleared sterilizers, the RapidHeat RH-N95 Mask/Respirator Re-processor has been designed to decontaminate N95 respirators, to counteract the severe shortage of N95 masks during this pandemic. RH-N95 offers the following features/advantages over other thermal, chemical, and radiological alternatives as listed below.

RH-N95 Features

Preferred decontamination process (Stanford Report, March, 2020) that provides documented evidence of maintaining filtration and breathability performance (no electrostatic charge reduction in melt-blown fibers used as viral filtration fabric)
Meets or exceeds published (peer-reviewed) > 6 Log10 reduction requirements for coronavirus and Mycobacterium to assure coronavirus kill and that of other non-spore pathogens as well
Meets FDA criteria to market device for coronavirus decontamination under FDA’s emergency authorization
Dedicated unit for the re-processing of N95 respirators/masks
Requires no water in its operation
Requires only 110-115V or 220-240V electric service
No ancillary chemical or other treatment or supply products required
No drying time required after treatment; masks are cool to the touch in seconds after their removal from the unit and ready for immediate re-use
No residues to evacuate from treated masks after treatment; no worry about lingering toxic, chemical residues to sensitive nasal passages, facial skin, and other respiratory passages
Ability to monitor decontamination parameters (time-temperature). Other non-thermal processes have no method to measure chemical concentrations at site of required kill
No deformation in mask structure or change in filtration/breathability performance for atleast twenty (20) re-use cycles
Low cost for RH-95 Mask Re-Processor (~ $7000)
Multi-purpose unit that functions as N95 mask re-processor, but can be simply re-programed via USB port to be used as a medical/dental sterilizer (FDA-cleared) post-pandemic
Countertop unit with small footprint at 11” (279mm)W x 17.75” (433mm)D x 11.75” (299mm)H which can be placed almost anywhere electrical service is available
Large rectangular decontamination chamber volume: 2294 cubic inches (10 gal/38 liters)
Stainless steel construction
TUV, UL, CE – approved
Four-tray configuration allowing approximately 100 masks to be processed per hour
Direct time-temperature documentation at mask location to ensure decontamination conditions are met (72°C, 162°F; 30 minutes) via an autonomous time-temperature sensor; replaces the need for chemical indicators
Offers point-of-use mask decontamination to serve need on ships, on med-evac aircraft, for field operations, and within hospital wings/floors/departments

DECONTAMINATING N95 MASKS USING RAPIDHEAT TECHNOLOGY

CPAC Equipment, Inc. (CPAC) is an FDA registered New York manufacturing company (www.cpac.com) that has recently responded to the COVID-19 Public Health Emergency and the emerging reuse of N95 Respirator Masks by repurposing their FDA-Cleared tabletop sterilizers to decontaminate certain identified used N95 Respirator Masks. Under the Emergency Use Authorization (EAU) granted to manufacturers by the FDA, CPAC has modified the functionality of its RapidHeat RH-Pro11 sterilizer to decontaminate used N95 masks. Research of peer reviewed studies from the last SARS -coronavirus (2002-2003) confirmed that CPAC ‘s RapidHeat High-Velocity Hot Air (HVHA) technology would be the ideal vehicle for decontaminating identified used N95 Respirator Masks through a modification of its software and time/temperature profile.

CPAC’s FDA-Cleared RH-Pro11 Sterilizer has been repurposed to decontaminate N95 Masks.
FDA’s “Emergency Authorized Use” allows FDA-Cleared Devices to Modify Functionality.
The RH-N95 System was engineered to Decontaminate (kill) Viruses and Bacteria (not spores).
CPAC has successfully researched and tested a number of popular quality N95 Respiratory Masks.
Research has proven that repeated thermal cycles do not damage “N95 Fit and Filtration”.
N95 Masks made of Polypropylene Thermoplastic Fabric are proven to withstand over 300° F.
CPAC’s RH-N95 System temperature uses heating technology that is stable and uniform.
RH-N95 System uses State-of-the-art Software to Control time and temperature.
RH-N95 Cycles are calibrated to maintain a time/temperature profile of 72° C. for 30 minutes.
Peer-reviewed studies have provided the criteria for achieving mask decontamination.
RH-N95 RapidHeat Technology protocol allows Masks to be returned to the original user.
The RH-N95 DOES NOT Sterilize – It “inactivates” vegetative microorganisms to a level of ≥6Logs.

CPAC’s decontamination chamber is a closed system; air going in with door open is air from ambient environment. Ambient environmental air in hospitals is required to be 40-60% relative humidity. Therefore, air in the chamber is an average 50% humidity which is favorable for viral kill under the RH-N95 time and temperature parameters of 68 degrees C for 30 minutes. The mass of air and moisture content entering the chamber before the door is closed remains the same mass during the decontamination process.

IMPORTANT: Healthcare Practitioners should contact CPAC/Metafix to determine if their N95 Masks have been tested for maintaining their integrity and functionality using the RH-N95 Decontamination System. There are low quality masks manufactured by some companies using inexpensive non-durable construction that may not survive under the reprocessing temperatures of the RH-N95.