Leaf User Manual
P/N: 97-4000, Revision 08, Release date: 2020-11-10 Page 55 of 85
General Safety and Regulatory Information
Norlase laser systems are precision medical instruments. The systems have
undergone extensive testing. With proper handling, they are useful and reliable clinical
instruments. To protect operating personnel and patients, this safety section and the
appropriate slit lamp and delivery system safety section should be read thoroughly
before operation.
Norlase lasers are classified as Class IV lasers by the National Center for Devices and
Radiological Health. Class IV represents the highest power lasers; for this reason, the
user must take precautions to prevent exposure of laser energy to the eye and skin
from either direct or diffusely reflected laser beams, except as a therapeutic
application. In addition, precautions must be taken in the surgical environment to
prevent the hazards of fire and electrical injury.
Norlase does not recommend specific clinical practices as the device is intended for
use by or on the order of a licensed physician. The following precautions are
extensive but may not be complete. Laser users are advised to supplement this
information with technological advances in surgical products and techniques as they
become available to the medical laser user community through medical literature.
See also the American National Standard (ANSI) publications ANSI Z136.3-
2005―American National Standard for the Safe Use of Lasers in Health Care
Facilities, ANSI Z136.1-2000―American National Standard for the Safe Use of
Lasers, CAN/CSA-S386-2008―Laser Safety in Health Care Facilities and other
national standards as may be applicable for the country in which the laser system is
used.
Ocular Protection
Never look directly into the laser aperture or scattered laser light from reflective
surfaces when the treatment beam is activated. Severe eye damage could occur.
Never look into the path of a laser beam. Laser safety eyewear only offers protection
against stray or diffuse laser beam energy for a maximum exposure of 10 seconds.
Never substitute glass prescription eyewear for the appropriate laser safety eyewear,
as severe eye damage could occur. The glass in prescription eyewear can
concentrate the laser light onto the retina. A laser beam with high energy density can
also shatter glass prescription eyewear, resulting in possible severe eye damage.
Do not use eyewear that is broken or damaged.
The
(laser emission) indicator is displayed on the Treatment screen to warn the
user that the system is capable of emitting laser energy. Appropriate precautions,
such as wearing appropriate eyewear in the room, should be taken.
As a precaution against accidental exposure to the output beam or its reflection,
anyone checking or adjusting calibration should wear appropriate laser safety
eyewear.
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