3B Medical Lumin LM3000 Manual de instruções - Página 4
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Use of Lumin LM3000 Bioburden Reduction UV System
WARNING: The Lumin LM3000 does not sterilize or decontaminate. Prior to use of the Lumin
LM3000 to reduce bioburden on the compatible N95 respirator, the respirator must be placed
in a breathable paper bag and held for a minimum of 5 days, in accordance with the CDC
recommendations for reuse of N95 respirators.
The Lumin LM 3000 Reduction UV System is intended for use in bioburden reduction of compatible N95
respirators in healthcare facilities for single-user reuse by healthcare personnel to supplement CDC reuse
recommendations.
The Lumin LM3000 Bioburden Reduction UV System supplements single-user reuse (i.e., the
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same respirator is returned for reuse to the same healthcare personnel following bioburden reduction) of
compatible N95 respirators that are placed in a paper bag and held for a minimum of 5 days in accordance with
CDC reuse recommendations. If used as directed, the Lumin LM3000 offers a reliable method for achieving a 3-log
mean reduction in non-enveloped virus, which provides additional safety when used to supplement the CDC
reuse recommendations of a 5-day wait time. A compatible N95 respirator can be worn up to 5 times, or after
four bioburden reduction cycles using the Lumin LM3000, whichever comes first.
The Lumin LM3000 is authorized only for use as a supplement to CDC reuse recommendations for single-user
reuse of N95 respirators. Place the compatible N95 respirator in a paper bag for a minimum of five days prior
to placing the compatible N95 respirator in the Lumin LM3000.
The Lumin LM3000 Bioburden Reduction UV System works by delivering ultraviolet germicidal irradiation (UVGI).
Each bioburden reduction cycle results in an estimated irradiance of 1 J/cm
LM3000 Bioburden Reduction UV System can bioburden reduce one (1) compatible N95 respirator at a time by
performing two 5-minute cycles, one with the outer surface of the respirator facing up and one with the inner
surface of the respirator facing up. Two 5 minute cycles of 1 J/cm
compatible N95 respirator) is considered one bioburden reduction cycle.
What are the known and potential benefits and risks of using bioburden reduced N95
respirators?
Potential benefits include:
May help prevent exposure to airborne pathogens, and therefore reduce the risk of infection or
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illness
Extends the usability and reuse of compatible N95 respirators by additionally performing a 3-log
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mean bioburden reduction beyond the natural decay of SARS-CoV-2 when CDC recommendations
are followed alone
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The CDC has issued specific recommendations on the reuse of N95 respirators. Refer to the CDC recommendations for
Decontamination and Reuse of Filtering Facepiece Respirators, available at
ncov/hcp/ppe-strategy/decontamination-reuse-respirators.html, Recommended Guidance for Extended Use and Limited
Reuse of N95 Filtering Facepiece Respirators in Healthcare Settings, available at
https://www.cdc.gov/niosh/topics/hcwcontrols/recommendedguidanceextuse.html, and Summary for Healthcare Facilities:
Strategies for Optimizing the Supply of N95 Respirators during Shortages, available at
https://www.cdc.gov/coronavirus/2019-ncov/hcp/checklist-n95-strategy.html.
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per 5 minute cycle. The Lumin
(i.e., one 5 minute cycle on each side of the
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https://www.cdc.gov/coronavirus/2019-
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