SYNRAD OEM v40 Operator’s Manual Version 4
36
Laser Safety
Agency compliance
Center for Devices and Radiological Health (CDRH) requirements.
Federal Communications Commission (FCC) requirements.
European Union (EU) requirements.
SYNRAD
®
lasers are designed, tested, and certified to comply with certain United States (U.S.)
and European Union (EU) regulations. These regulations impose product performance re-
quirements related to electromagnetic compatibility (EMC) and product safety characteris-
tics for industrial, scientific, and medical (ISM) equipment. The specific provisions to which
systems containing laser lasers must comply are identified and described in the following
paragraphs. Note that compliance to CDRH, FCC, and EU requirements depends in part on the
laser version selected—Keyswitch or OEM.
In the U.S., laser safety requirements are governed by the Center for Devices and Radiological
Health (CDRH) under the auspices of the U.S. Food and Drug Administration (FDA) while radi-
ated emission standards fall under the jurisdiction of the U.S. Federal Communications Com-
mission (FCC). Outside the U.S., laser safety and emissions are governed by European Union
(EU) Directives and Standards.
In the matter of CE-compliant laser products, SYNRAD assumes no responsibility for the
compliance of the system into which the product is integrated, other than to supply and/or
recommend laser components that are CE marked for compliance with applicable European
Union Directives.
Because OEM laser products are intended for incorporation as components in a laser process-
ing system, they do not meet all of the Standards for complete laser processing systems as
specified by 21 CFR, §1040 or EN 60825-1. SYNRAD assumes no responsibility for the compli-
ance of the system into which OEM laser products are integrated.
Center for Devices and Radiological Health (CDRH)
requirements
Product features incorporated into the design of laser lasers to comply with CDRH require-
ments are integrated as panel controls or indicators, internal circuit elements, or input/output
signal interfaces. Specifically, these features include a lase and laser ready indicators, remote
interlock for power on/off, a laser aperture shutter switch, and a five-second delay between
power on and lasing. Incorporation of certain features is dependent on the laser version
(Keyswitch or OEM). See the following table for Class 4 safety features, indicating which fea-
tures are available on laser lasers, the type and description of the feature, and if the feature is
required by CDRH regulations.
OEM models
Laser OEM lasers are OEM products intended for incorporation as components in laser pro-
cessing systems. As supplied by SYNRAD, these lasers do not meet the requirements of 21
CFR, §§J without additional safeguards. In the U.S., the Buyer of these OEM laser components
is solely responsible for the assurance that the laser processing system sold to an end user
Содержание Firestar V Series
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