Spectrum RX I Getting Started Guide . 13
Laser Safety Regulations
The Spectrum RX I complies with the following laser safety regulations:
1.
21 CFR Chapter 1, Subchapter J, ‘Radiological Health’, Part 1040.10 -
administered by the Center for Devices and Radiological Health, U.S.
Department of Health and Human Services.
2.
British Standard BS EN 60825 (1992) - “Radiation safety of laser products,
equipment classification, requirements and user’s guide”.
BS EN 60825 implements CENELEC European Normalization document EN
60825 (CENELEC is the European Committee for Electrotechnical
Standardization).
3.
IEC Publication 825 (1984) - “Radiation safety of laser products,
equipment classification, requirements and user’s guide” and “Amendment
1 to Publication 825” (August 1990).
Spectrum RX I Laser Product Classification
The Spectrum RX I contains a CDRH Class II (BS EN 60825 and IEC 825 Class 2)
Helium Neon (HeNe) laser, which emits visible, continuous wave radiation at a
wavelength of 633 nm and has a maximum output power of less than 1 mW. A
portion of the laser radiation with a maximum power level of less than 0.4 mW
may be accessed in the sample compartment, which classifies the instrument as a
CDRH Class II, BS EN 60825 Class 2, and IEC 825 Class 2 laser product. The laser is
switched on when the main cover is closed and the Spectrum RX I’s power switch
is switched on. The laser is automatically switched off when the main cover of
the Spectrum RX I is raised or the power switch is switched off.
WARNING
Do not attempt to override or modify the interlock system.
Explanation of the Laser Radiation Hazard and its
Classification
Indirect observation of the laser beam radiation in the optical path is not
hazardous. Directly viewing the laser beam along its axis (allowing the laser
beam radiation to pass into the eye) can be hazardous, depending upon the
power of the beam, the length of time that the eye is exposed to the beam and
the optical efficiency of the exposed eye. Direct viewing of a laser beam along
its axis is termed
intrabeam viewing.
