3B Medical Lumin LM3000 Manuel d'instructions - Page 5
Parcourez en ligne ou téléchargez le pdf Manuel d'instructions pour {nom_de_la_catégorie} 3B Medical Lumin LM3000. 3B Medical Lumin LM3000 14 pages. Instructions for healthcare facilities: bioburden reduction uv system user's manual
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Lumin LM3000 is small, lightweight, portable, and economical, allowing for bioburden reduction of
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compatible N95 respirators at mobile or smaller healthcare facilities
Potential risks include:
Inadequate bioburden reduction of SARS-CoV-2 or other pathogens due to insufficient UV delivery to
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the item placed in the device
Failure of filtration efficiency
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Reduced breathability
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Strap failure and ineffective face-fit
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UV exposure
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Electrical and Electromagnetic Compatibility (EMC) hazards
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What is bioburden reduction?
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Caution: Bioburden reduction is not decontamination or sterilization. Specifically, bioburden
reduction is a term used to indicate that a product or process provides a lower level of pathogen
reduction than a product or process that provide decontamination, disinfection, or sterilization.
However, information on bioburden reduction shows this method may be effective against
SARS-CoV-2 when used as a supplement to CDC reuse recommendations. Please refer to the
CDC recommendations for Decontamination and Reuse of Filtering Facepiece Respirators,
available at
https://www.cdc.gov/coronavirus/2019-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
strategy.html. Consistent with CDC reuse recommendations, it is critical that the respirator must
be allowed to rest for 5 days to reduce the risk of inhaling pathogens that may remain in the
filter material.
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Bioburden reduction requires all surfaces and components of the respirator, including the
straps, be exposed to adequate doses of UV light. Any shadowing or obstruction resulting from
device features, load organization, or chamber design could prevent successful bioburden
reduction. Therefore, place a single, compatible N95 respirator in the device.
How much virus will remain on my N95 respirator after use of the Lumin LM3000?
The Lumin LM3000 will reduce the amount of virus on the N95 respirator by up to 99.9%. This means
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that if the N95 respirator had 1 million virus particles, 1000 may remain. Therefore, do not treat the
N95 respirator as sterile. Touch it only with gloves, and do not share it.
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Testing has not been conducted to show that the Lumin LM3000 reduces all bacteria, molds,
fungi, or viruses from the N95 respirator. Therefore, if the N95 respirator was used near a
patient with another infectious disease, discard the respirator.
What N95 respirators can be put into the Lumin LM3000?
Caution: The Lumin LM3000 Bioburden Reduction UV System is only authorized for use with
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the 3M model 1860 N95 respirator. The Lumin LM3000 is not authorized for use with any
other respirator model.
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Do not put face masks, surgical masks, goggles, or other medical devices in the Lumin LM3000. The
https://www.cdc.gov/coronavirus/2019-ncov/hcp/checklist-n95-
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