7
Synrad
Firestar OEM v30
reference guide
Agency compliance
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 requirements related to electromagnetic compatibility (EMC)
and product safety characteristics for industrial, scientific, and medical (ISM) equipment. The specific provisions to which
systems containing Firestar OEM v30 lasers must comply are identified and described in the following paragraphs.
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 Euro-
pean Union (EU) Directives and Standards.
In the matter of CE-compliant laser products, SYNRAD, Inc. 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 com-
pliance 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, Part 1040 or EN 60825-1. SYNRAD, Inc.
assumes no responsibility for the compliance of the system into which OEM laser products are integrated.
Center for Devices and Radiological Health
(CDRH) requirements
Firestar v30 OEM lasers are OEM products intended for incorporation as components in laser processing systems. As sup-
plied by SYNRAD, these lasers do not meet the requirements of 21 CFR, Subchapter 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 complies with all laser safety requirements before the actual sale of the system. Under CDRH regulations,
the Buyer must submit a report to the CDRH prior to shipping the system. In jurisdictions outside the U.S., it is the sole
responsibility of the Buyer of these OEM components to ensure that they meet all applicable local laser safety requirements.
In cases where the Buyer is also the end-user of the OEM laser product, the Buyer/end-user must integrate the laser so that it
complies with all applicable laser safety standards as set forth above.
To aid in the development of integrated v30 systems see Table 1,
Class 4
safety features
. The table indicates which features
are available on OEM v30 lasers, the type and description of the feature, and if the feature is required by CDRH regulations.
Federal Communications Commission
(FCC) requirements
The United States Communication Act of 1934 vested the Federal Communications Commission (FCC) with the author-
ity to regulate equipment that emits electromagnetic radiation in the radio frequency spectrum. The purpose of the Com-
munication Act was to prevent harmful electromagnetic interference (EMI) from affecting authorized radio communication
services. The FCC regulations that govern industrial, scientific, and medical (ISM) equipment are fully described in 47 CFR,
Part 18, Subpart C.
SYNRAD’s Firestar OEM v30E lasers have been tested and found to comply by demonstrating performance characteristics
that have met or exceeded the requirements of 47 CFR, Part 18, Radiated and Conducted Emissions.
FCC information to the user
NOTE: The following FCC information to the user is provided to comply with the requirements of 47 CFR, Part 18, Section
213.
Interference Potential
In our testing, SYNRAD, Inc. has not discovered any significant electrical interference traceable to Firestar
OEM v30 lasers.