Synrad Firestar TI Series, Руководство оператора

Страница: 18 / 112

laser safety
6 Synrad Firestar ti-Series 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 Euro-
pean Union (EU) regulations. These regulations impose product performance requirements related to elec-
tromagnetic compatibility (EMC) and product safety characteristics for industrial, scientific, and medical
(ISM) equipment. The specific provisions to which systems containing Firestar ti-Series 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
Note: Firestar ti-Series lasers are available in either Keyswitch or OEM versions.
Keyswitch models
Firestar ti-Series Keyswitch model lasers comply with requirements for Class IV laser products imposed
by the Radiation Control for Health and Safety Act of 1968. Under this Act, the U.S. Food and Drug
Administration (FDA) issued a performance standard in the
Code of Federal Regulations (CFR) for laser
products. This performance standard, (21 CFR, Subchapter J, Part 1040.10) was developed to protect pub-
lic health and safety by imposing requirements upon manufacturers of laser products to provide an indica-
tion of the presence of laser radiation, to provide the user with certain means to control radiation, and to
assure that all personnel are adequately warned of potential hazards through the use of product labels and
instructions.
Product features incorporated into the design of Firestar ti-Series 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 IV safety features , indicates which features are available on ti-Series lasers, the type and
description of the feature, and if the feature is required by CDRH regulations.