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© OmniGuide, Inc.
8.0 SAfETY
Laser Safety Requirements
This laser conforms to the United States requirements for laser safety. These
laser safety requirements are contained in 21 CfR, 1040.10 and 1040.11 and are
administered by the fDA Center for Devices and Radiological Health.
A laser Report, detailing how the laser product complies with the federal laws is required to be
submitted to fDA on an annual basis. The form of this report is covered in a pamphlet entitled:
Guide for Preparing Product Reports for Lasers and Products Containing Lasers, Sept. 1995:
U.S. Department of Health and Human Services Public Health Service food and
Drug Administration Center for Devices and Radiological Health Division of Small
Manufactures Assistance Rockville, MD 20857 Web Site: http://www.fda.gov/CDRH
for jurisdictions, outside of the United States, it is the responsibility of the buyer of
this laser device to ensure that it meets the local Laser safety regulations.
Optical Safety
The BEACON Advanced Energy Laser System has undergone extensive testing
to ensure that, with proper usage, it is a safe and reliable device.
Laser light, because of its special properties, poses safety hazards not associated with light from other sources.
The light from the BEACON Advanced Energy Laser System is invisible to the naked eye. The safe use of Laser
requires that all operators be properly trained and the proper use of PPE be used in the operation of this device.
Laser energy exposure near the aperture may cause burns
Direct eye contact with the output beam from the Laser will cause serious damage and
may cause blindness. CO
2
Laser Radiation is invisible. All personnel in the Laser Treatment
Control Area, LTCA or anyone who may enter the LTCA should be informed that a Laser
is in operation. All personnel within the Nominal Hazard Zone (NHZ) must wear Laser
safety glasses (OD > 4), which protect against the wavelength (10.6 microns) in use.
The NHZ (Nominal Hazard Zone) is 2.4m from the exit of the fiber. The NHZ (Nominal
Hazard Zone) and Nominal Ocular Hazard Zone (NOHZ) are 93m from the exit of the
articulating arm. for laparoscopic cases, the NHZ is isolated within the patient. The
proper use of appropriate optical filters on endoscopes are recommended.
Exercise caution to protect against reflections off shiny and mirror-like surfaces. Reflections
of the BEACON Advanced Energy Laser System light are invisible to the naked eye. Eye,
skin and fire safety is a great concern when using a high-power, FDA class IV Laser such
as The BEACON Advanced Energy Laser System. There is potential for secondary beams
present at various angles near the incident radiation site. While weaker than the main beam,
such beams may still be sufficiently intense to cause eye damage and skin burns.
Laser beams are also powerful enough to burn skin, clothing or paint and can damage
the light-sensitive elements in video cameras, photo multipliers and photo diodes.
