- ページ 5

アクセサリー 3B Medical Lumin LM3000のPDF 取扱説明書をオンラインで閲覧またはダウンロードできます。3B Medical Lumin LM3000 14 ページ。 Instructions for healthcare facilities: bioburden reduction uv system user's manual
3B Medical Lumin LM3000 にも：ユーザーマニュアル (7 ページ)

ページを印刷する

Lumin LM3000 is small, lightweight, portable, and economical, allowing for bioburden reduction of

•

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

•

the item placed in the device

Failure of filtration efficiency

•

Reduced breathability

•

Strap failure and ineffective face-fit

•

UV exposure

•

Electrical and Electromagnetic Compatibility (EMC) hazards

•

What is bioburden reduction?

•

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.

•

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

•

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.

•

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

•

the 3M model 1860 N95 respirator. The Lumin LM3000 is not authorized for use with any

other respirator model.

•

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-