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1 Safety Information
1.4.2 Applicable Standards and Directives
The instrument complies with the standards IEC and EN 60825-1 (Safety of
Laser Products - Equipment Classification and Requirements).
CDRH Compliance Statement
Polytec GmbH confirms that its laser products comply with all applicable
standards and regulations that are set forth by the United States of America's
Health and Human Services (HHS), Food and Drug Administration (FDA),
Center for Devices and Radiological Health (CDRH) for laser products. The
laser products comply with US 21 CFR 1040.10 and 1040.11 except for
conformance with IEC 60825-1 Ed. 3., as described in Laser Notice No. 56,
dated May 8, 2019.
1.4.3 Equipment
Laser
The instrument is equipped with a laser with visible laser radiation.
1.4.4 Information on Laser Class 3R
The properties of laser radiation differ from those of conventional light
sources and are classified accordingly.
•
The emitted optical output power of the laser beam is less than 5 mW
provided the equipment is used in the manner for which it was intended.
This means that the instrument conforms to laser class 3R. It can be
hazardous for the eyes if the laser beam hits the unprotected eye directly.
The skin is not harmed even by the focused laser beam.
•
Instruments that fall into this laser class require additional safety
precautions in the vicinity of the measurement location. These
requirements vary from country to country. In general, at least the black
and yellow laser warning symbols are required at the entrance to the
room, or the area in which the laser system is operating. Inform yourself
about the applicable regulations and standards and, if necessary, contact
your Laser Safety Officer.
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