PASCAL
®
Synthesis TwinStar Ophthalmic Scanning Laser Systems
Page 16 of 142
88293-EN, Rev C
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.
CAUTION
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.
WARNING
Alert the user to potential serious outcomes
(death, injury, or serious adverse events) to the
patient or the user.
LASER
WARNING
Warning specifically related to hazard from a
laser beam
DANGEROUS
WARNING
Warning specifically related to a hazard from
electricity
NOTE
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
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,
