3B Medical Lumin LM3000 Petunjuk Manual - Halaman 2

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LUMIN LM3000 BIOBURDEN REDUCTION UV SYSTEM

The U.S. Food and Drug Administration has issued an Emergency Use Authorization (EUA) for the emergency

use of the Lumin LM3000 Bioburden Reduction UV System (hereafter referred to as the "Lumin LM3000") for

use in bioburden reduction of 3M model 1860 N95 respirators (also referred to as "compatible N95

respirators") for single-user reuse by healthcare personnel (HCP) to supplement the Centers for Disease Control

and Prevention (CDC) reuse recommendations. Healthcare personnel should follow these instructions, as well

as procedures at their healthcare facility, to prepare compatible N95 respirators for bioburden reduction using

the Lumin LM3000.

The Lumin LM3000 has been authorized by FDA under an EUA for bioburden reduction of 3M model 1860 N95

respirators only for single-user reuse by HCP to supplement CDC reuse recommendations to prevent exposure

to SARS-CoV-2 and other pathogenic biological airborne particulates. The Lumin LM3000 has not been FDA

cleared or approved for this use. The Lumin LM3000 is authorized only for the duration of the declaration that

circumstances exist justifying the authorization of the emergency use of medical devices, during the COVID-19

outbreak, under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1),

unless the authorization is terminated or revoked sooner.

Respirators that are NIOSH-approved before bioburden reduction (https://wwwn.cdc.gov/niosh-cel/) only

retain their NIOSH approval status post-bioburden reduction if the respirator manufacturer permits the use of

the bioburden reduction method with the specific system and cycle parameters. To determine the NIOSH

approval status of a specific bioburden-reduced NIOSH-approved respirator, please check with the respirator

manufacturer and/or the respirator labeling. If a respirator is no longer NIOSH-approved after use of the

particular bioburden reduction method, its performance (i.e., fit, filtration, and breathability) might not

consistently meet NIOSH-approved N95 standards.

Equipment protected throughout by double insulation or reinforced insulation.

Refer to instruction manual.

Important information concerning your safety or the operation of your device.

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

authorized for use with any other respirator model or other types of personal protective equipment.

The Lumin LM3000 Bioburden Reduction System is intended for bioburden reduction of compatible N95

respirators for single-user reuse by healthcare personnel serving in healthcare settings, including

nursing homes, assisted living facilities, primary care offices, and clinics, to supplement CDC reuse

recommendations.

EXPLANATION OF SYMBOLS USED

COMPATIBLE N95 RESPIRATORS

INTENDED ENVIRONMENTS FOR USE