Indications for Use, Contraindications, Warnings, and Precautions
Page 14 of 314
Part Number: 0160-6411, Rev A, 02/2019
Software Release: cOS 5.00
and may require service by
OPTIMEDICA
personnel. If the control panel remains blank for
an extended period of time during system start-up, press the Power button on the front
of the control panel to turn on the control panel. If the control panel remains blank, turn
off the system with the key, wait at least one minute, and then restart the system. If the
screen is still blank, turn off the system and contact
OPTIMEDICA
Service.
• When not in use, laser equipment should be protected against unqualified use by
removing the key from the key switch.
• Never perform maintenance on any part of the
CATALYS®
System when it is in use with a
patient.
• When the
CATALYS®
System is interconnected with other medical electrical equipment,
leakage currents may be additive. Ensure that all systems are installed according to the
requirements of IEC 60601-1.
• Treatment can be discontinued at any time by pressing the patient vacuum, capture, or
patient lock
O
(off) button on the docking keypad or by pressing the emergency laser
stop button on the system front panel. During laser emission, the treatment can also be
discontinued by releasing the laser footswitch or by pressing the PAUSE TREATMENT
button on the control panel.
• If the system displays a “Clearable Error” message, press the OK button to clear the error
and continue the treatment. Alternatively, when in doubt, always choose the safest
approach and shut down the system and abort the treatment.
• The
CATALYS®
System has not been adequately evaluated in patients with a cataract
greater than Grade 4 (via LOCS III); therefore, no conclusions regarding either safety or
effectiveness are presently available.
• Cataract surgery may be more difficult in patients with an axial length less than 22 mm or
greater than 26 mm, and/or an anterior chamber depth less than 2.5 mm, due to
anatomical restrictions.
• Use caution when treating patients who may be taking medications such as alpha
blockers (e.g., Flomax®, tamsulosin HCL [Boehringer Ingelheim GmbH, Ingelheim am
Rhein, Germany]), as these medications may be related to Intraoperative Floppy Iris
Syndrome (IFIS). This condition may include poor preoperative pupil dilation, iris
billowing and prolapse, and progressive intraoperative miosis. These conditions may
require modification of surgical technique, such as the utilization of iris hooks, iris dilator
rings, or viscoelastic substances.
• Adequate iris dilation medication protocol should be used to ensure iris dilation of at
least 1.0 mm larger than the intended capsulotomy diameter.
• Surgical removal of the cataract more than 30 minutes after laser anterior capsulotomy
and laser lens fragmentation has not been clinically evaluated. The clinical effects of
delaying surgical removal more than 30 minutes after laser anterior capsulotomy and
laser lens fragmentation are unknown.
