3B Medical Lumin LM3000 Petunjuk Manual - Halaman 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

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

•

illness

Extends the usability and reuse of compatible N95 respirators by additionally performing a 3-log

•

mean bioburden reduction beyond the natural decay of SARS-CoV-2 when CDC recommendations

are followed alone

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.

per 5 minute cycle. The Lumin

(i.e., one 5 minute cycle on each side of the

https://www.cdc.gov/coronavirus/2019-