Mada Sigma Series, Руководство по эксплуатации

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SIGMA LASER STENT AND TUBE CUTTER
990-401 B-3
Class IV laser product means any laser that permits human access during operation to levels of laser
radiation in excess of the accessible emission limits contained in Table III-B of 21 CFR Subchapter J
Part 1040.10. Class IV levels of laser radiation are considered to be an acute hazard to the skin and eyes
from direct and scattered radiation. Class IV laser products may have removable panels that, when
displaced, permit access to levels of laser radiation ranging from Class II to Class IV.
(2)
Note that the FDA/CDRH LPP Standard is under revision and is [proposing the adoption of the IEC
Standard’s Classification Scheme described below.
OSHA
Within the Department of Labor is the Occupational Safety and Health Administration (OSHA), which
is responsible for assuring a safe work place. At the present time, OSHA does not have a comprehensive
laser safety standard. Instead, the OSHA policy has been to rely on ANSI Z136.1, the generally accepted
industry laser standard, and FDA/CDRH laser manufacturer requirements.
IEC
The International Electrotechnical Commission (IEC) is a global organization that prepares and
publishes international standards for all electrical, electronic and related technologies. The IEC
document 60825-1 is the primary standard that outlines the safety of laser products. Classification is
based on calculations and determined by the AEL as with the ANSI standard, but the IEC standard also
incorporates viewing conditions:
Class 1 lasers are very low risk and "safe under reasonably foreseeable use", including the use of optical
instruments for intrabeam viewing.
Class 1M lasers have wavelengths between 302.5 nm and 4000 nm, and are safe except when used with
optical aids (e.g. binoculars).
Class 2 lasers do not permit human access to exposure levels beyond the Class 2 AEL for wavelengths
between 400 nm and 700 nm. Any emissions outside this wavelength region must be below the Class 1
AEL.
Class 2M lasers have wavelengths between 400 nm and 700 nm, and are potentially hazardous when
viewed with an optical instrument. Any emissions outside this wavelength region must be below the
Class 1M AEL.
Class 3R lasers range from 302.5 nm and 106 nm, and is potentially hazardous but the risk is lower than
that of Class 3B lasers. The accessible emission limit is within 5 times the Class 2 AEL for wavelengths
between 400 nm and 700 nm, and within 5 times the Class 1 AEL for wavelengths outside this region.
Class 3B lasers are normally hazardous under direct beam viewing conditions, but are normally safe
when viewing diffuse reflections.
Class 4 lasers are hazardous under both intrabeam and diffuse reflection viewing conditions. They may
cause also skin injuries and are potential fire hazards.