Indications for Use, Contraindications, Warnings, and Precautions
Page 12 of 314 Part Number: 0160-6411, Rev A, 02/2019
Software Release: cOS 5.00
• Installation, maintenance, and repair should be performed only by OPTIMEDICA-certified
personnel per the manufacturer’s recommendation and institutional standards.
• Routinely inspect the system components for obvious signs of damage. Do not operate
the laser if any of the components are damaged or if the cords are faulty or frayed.
• Do not use in the presence of flammables or explosives such as volatile anesthetics,
alcohol, certain surgical preparation solutions, or other such substances. An explosion
and/or fire could occur. Refer to Fire Hazards on page 224 for detailed warnings.
• Never place hands or other objects in the path of the laser beam. Severe burns could
occur.
• Do not use caustic cleaners or strong detergents when cleaning the CATALYS® System.
• If the system becomes unresponsive at any time, press the emergency laser stop button
and turn the key to the (off) position.
• Do not use the system if the touchscreen and/or the control panel is either unresponsive
or blank. If restarting the system does not resolve the problem, contact the OPTIMEDICA
Service Department at +1.800.511.0911.
• The (laser emission) indicator is displayed on the touchscreen control panel at all
times the laser is energized to warn the user that the system is capable of emitting laser
energy. Precautions, such as wearing appropriate laser safety eyewear, should be taken if
required.
• Prior to INTEGRAL GUIDANCE System imaging and laser treatment, the suction ring must
be completely filled with sterile buffered saline solution, such as Alcon BSS (Alcon P/N
351/55005-1) or equivalent. Use the video image to verify that no air bubbles are
entrapped within the sterile buffered saline solution after the suction ring is captured.
The video image should provide a sharp and clear image of the patient's eye.
• Continuously monitor the video image immediately before and throughout each laser
treatment. Continuously verify that the suction ring remains completely filled with sterile
buffered saline solution. If any air bubbles and/or a meniscus appear on the video image
before treatment, do not initiate laser treatment. If air bubbles and/or a meniscus appear
during treatment, terminate the laser treatment by immediately releasing the laser
footswitch.
• Continuously verify that the eye has not moved with respect to its initial presentation at
the time of fluid confirmation. If the eye moves during INTEGRAL GUIDANCE System
imaging, press the RESCAN EYE button. If the eye moves during laser treatment,
terminate the laser treatment by immediately releasing the laser footswitch.
• Before initiating laser treatment, inspect the images created from the OCT data, surface
fits, and overlaid pattern in both axial and sagittal views, and review the treatment
parameters on the Final Review Screen for accuracy.
• Safety margins for all incisions are preserved only if custom fit adjustments to ocular
surface(s) are applied in accordance with the instructions for use. Refer to Customizing
Surface Fits on page 133 for detailed instructions on applying custom fit adjustments.
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