The STERIZONE VP4 Sterilizer has been authorized by the FDA under an Emergency Use Authorization (EUA) for use in decontaminating compatible N95 respirators for single-user reuse by healthcare personnel during the COVID-19 outbreak.
This manual provides instructions for healthcare facilities on how to prepare compatible N95 respirators for decontamination using the STERIZONE VP4 N95 Respirator Decontamination Cycle in the STERIZONE VP4 Sterilizer.
Important Safety Information
Respirators that are NIOSH-approved before decontamination may not retain their NIOSH approval status post-decontamination.
The STERIZONE VP4 Sterilizer is not authorized for use with respirators containing cellulose-based materials, antimicrobial agents, duck-billed designs, or exhalation valves.
Decontamination Cycle
The STERIZONE VP4 N95 Respirator Decontamination Cycle consists of a maximum of 20 pouched, compatible N95 respirators, which must be placed in a Tyvek pouch with a STERIZONE CI+ Chemical Indicator.
The decontaminated respirators are ready for use after a 24-hour aeration period.
Compatible N95 respirators may be decontaminated a maximum of two times.
Manual:
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