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IMPORTANT NOTICE–PLEASE READ CAREFULLY AND COMPLETELY
The RH™-‐N95 employs High-‐Velocity Hot Air (HVHA) to decontaminate N95 masks,
using fluidized hot, dry air to transfer dry heat energy to N95 masks by a
combination of convection and conductive processes. Conventional practices
necessary for steam sterilization do not apply to HVHA technology and in many
instances are contrary to HVHA protocols provided in this user manual.
The RH-‐N95 edition of RH-‐Pro series of this technology has been designed to address
the critical shortage of N95 masks in healthcare during the Covid-‐19 pandemic. This
unit has one dedicated “N95 Mask” cycle that incorporates the time and temperature
parameters that provide the conditions necessary (1) to destroy coronavirus and
Mycobacterium and (2) to maintain the performance of the mask for breathability and
microbial filtration. FDA has not cleared this cycle for marketing, but is allowing the
RH-‐N95 to be used during this pandemic to decontaminate N95 masks for safe re-‐use
as described in
FDA’s document entitled “Enforcement Policy for Sterilizers,
Disinfectant Devices, and Air Purifiers During the Coronavirus Disease 2019 (COVID-‐
19) Public Health Emergency” issued March 2020.
Applicable FDA-‐recognized standards for dry heat sterilizers [AAMI ST50:2004
(R2018); ANSI/AAMI ST40:2004m (R2018)] underlie the design, evaluation, and
validation of the RH-‐N95. Although microbial efficacy testing has not yet been
completed to date, peer-‐reviewed data on microbial efficacy against coronavirus and
Mycobacterium indicates that a > 6Log
10
reduction in both microbial species can be
achieved under the time-‐temperature parameters established for the “N95 Mask”
cycle. Bacterial spores cannot be inactivated under these parameters, however
Mycobacterium represents the most thermal resistant of microbial species (other
than spores) and is used as the demonstrative surrogate for inactivation of other
vegetative bacteria, fungi, parasites, and viruses. See Appendix I for a more extensive
review of our research.
There are many manufacturers and variations of N95 masks. Initial testing on
material compatibility has been performed on only a limited number of N95 masks to
date (See Appendix I). All masks use polyester and polypropylene nonwoven fabrics
as filtration material which are compatible with our dry heat process. Other materials
may not be compatible and should be checked before and after mask reprocessing.
Such incompatibilities may be found in the elastic bands, foam nose fittings, and
adhesives. Although internal testing by CPAC Equipment has indicated a mask can be
re-‐processed at least 20 times, the number or recycles can also be limited to use and
wear conditions. Before using a reprocessed mask, check elasticity, adhesive
connections, form fit to nose and face to ensure proper and secure fit.
Please read this manual carefully, paying particular attention to the requirements for
loading capacities, load configurations, and other restrictions of the RH-‐N95. Failure
to follow the operating instructions in this manual may result in damage to the unit,
user injury, or reduction in microbial killing efficacy. Following these instructions will
result in a worry-‐free decontamination process.
