Novanta SYNRAD Pulstar p100, User Manual

Page: 25 / 89

AGENCY COMPLIANCE PAGE | 20
Agency Compliance
•
Center for Devices and Radiological Health (CDRH) requirements.
•
Federal Communications Commission (FCC) requirements.
•
European Union (EU) requirements.
NOVANTA® lasers are designed, tested, and certified to comply with certain United States (U.S.) and
European Union (EU) regulations. These regulations impose product performance requirements related
to electromagnetic compatibility (EMC) and product safety characteristics for industrial, scientific, and
medical (ISM) equipment. The specific provisions to which systems containing p100/150 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 radiated emission
standards fall under the jurisdiction of the U.S. Federal Communications Commission (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, NOVANTA, 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 processing system,
they NOVANTA® lasers are designed, tested, and certified to comply with certain United States (U.S.)
and European Union (EU) regulations. These regulations impose product performance requirements
related to electromagnetic compatibility (EMC) and product safety characteristics for industrial,
scientific, and medical (ISM) equipment. The specific provisions to which systems containing p100/150
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 radiated emission
standards fall under the jurisdiction of the U.S. Federal Communications Commission (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, NOVANTA, 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 processing system,
they do not meet all of the Standards for complete laser processing systems as specified by 21 CFR, §1040
or EN 30825-1. NOVANTA, assumes no responsibility for the compliance 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 p100/150 lasers to comply with CDRH requirements 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). Table 2-1, Class 4 safety features,
indicates which features are available on p100/150 lasers, the type and description of the feature, and if
the feature is required by CDRH regulations.