PASCAL
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Synthesis Ophthalmic Scanning Laser Systems Page 15 of 141
88292-EN, Rev D
Operator Manual Symbol Definitions
Please read this manual and follow its instructions carefully. These words WARNING &
CAUTION and NOTE carry special meanings and should be carefully reviewed.
Alert the user to use special care necessary for
the safe and effective use of the device. They
may include actions to be taken to avoid effects
on patients or users that may not be potentially
life threatening or result in serious injury, but
about which the user should be aware.
Cautions are also provided to alert the user to
adverse effects on this device of use or misuse
and the care necessary to avoid such
effects.
Alert the user to potential serious outcomes
(death, injury, or serious adverse events) to
the patient or the user.
Warning specifically related to hazard from a
laser beam
Warning specifically related to a hazard from
electricity
Provided when additional general information
is applicable.
General Safety and Regulatory Information
Iridex Corporation 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 pattern generator delivery system safety section should be read
thoroughly before operation.
Iridex Corporation 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.
Iridex Corporation does not recommend specific clinical practices. 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
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