Hitachi LM-C300 Series, Руководство пользователя

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1.4. COMPLIANCE WITH REGULATION AND LAW
The Laser Marker is subject to several United States and European Union (EU) directives. These
directives impose product performance requirements related to electromagnetic compatibility (EMC) and
product safety features for laser products. The associated directives and specific provisions to which the
Laser Marker must comply are identified and described in the following paragraphs.
1.4.1. CDRH REQUIREMENTS
HITACHI Laser Marker is designed to 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, Part 1040.10) was developed to protect public health and
safety by imposing requirements upon manufacturers of laser products to provide an indication 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.
Federal regulation require that all laser products manufactured on or after August 2, 1976 must be
certified as complying with the per
formance standard. The manufacturer must demonstrate the product’s
compliance with the standard prior to certification or introduction of the product in the market by filing
reports pertaining to the radiation safety of the product and the associated quality control program to the
Centre for Devices and Radiological Health (CDRH). Failure to provide the required reports or product
certification is a violation of Section 360B of the Radiation Control and Health and Safety Service Act of
1968.
Product features included in the design of the laser marking system to comply with CDRH requirements
are built into the system as control panels or indicators, internal circuit elements, or input/output signal
interfaces. Specifically, these features include a key switch, Laser and Ready indicators, emergency stop
button, remote interlock and five-second delay between POWER-ON (Ready indicator) and operation of
laser. Table 1 summarizes the laser marking system product features, indicating type and description,
and which features are required by CDRH regulations.
Common safe operating practices should be exercised at all times when
the laser is in use. To prevent exposure to direct or diffused laser
radiation, follow all safety precautions specified in this Instruction
Manual. The use of controls or adjustments or performance of
procedures other than those specified herein may result in exposure to
hazardous invisible laser radiation, damage to, or malfunction of the
laser. Severe burns may result from direct exposure to the laser beam.
Always wear safety goggles with side shields to reduce the risk of
damage to the eyes when operating the laser.
Safe operation of the laser requires the use of external beam block to
safely block the beam from travelling beyond the desired work area. Use
a firebrick or similar non-dispersive, non-combustible material as the
block. NEVER use organic material or metals as the beam blocker.
Organic material, in general, are combustible and metals act as
reflectors that may create an area of immediate danger.