Synrad Pulstar P100 Series, Руководство оператора, Страница: 17 / 110

laser safety
5 Synrad Pulstar p100 operator’s manual
Agency compliance
The Agency compliance section includes subsections:
■ 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 Eu-
ropean Union (EU) regulations. These regulations impose product performance requirements related to
electromagnetic compatibility (EMC) and product safety characteristics for industrial, scientific, and medi-
cal (ISM) equipment. The specific provisions to which systems containing Pulstar OEM p100 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, 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 compo-
nents 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, 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
Product features incorporated into the design of Pulstar OEM p100 lasers to comply with CDRH require-
ments are integrated as panel controls or indicators, internal circuit elements, or input/output signal inter-
faces. Specifically, these features include a
Keyswitch
(Keyswitch versions), 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 1,
Class 4
safety features , indicates which features are available on OEM p100 lasers, the type and
description of the feature, and if the feature is required by CDRH regulations.
OEM models
Pulstar OEM p100 lasers are OEM products intended for incorporation as components in laser processing
systems. As supplied 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 require-
ments 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.