AMO Catalys OptiMedica, Руководство оператора

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Chapter 2 System Overview
Page 28 of 314 Part Number: 0160-6411, Rev A, 02/2019
Software Release: cOS 5.00
Door Interlock Connector
The external door interlock is a safety feature that disables laser and OCT emission if the
treatment room doors are opened or the interlock connector is removed.
Use of an external door interlock is optional; however, the door interlock connector must be
inserted into the door interlock receptacle on the rear of the system whether or not the external
door interlock feature is used. The laser remains inoperative until the interlock connector is
inserted into the interlock receptacle.
NOTE
The services of a qualified electrical professional must be used to install the external door
interlock switch. The total length of the cable must not exceed 5 m (16 ft).
Treatment Laser
The CATALYS® System is classified as a CDRH Class 4 stand-alone laser device, because of
intentional laser exposure to the patient's eye.
1
The treatment laser is a diode-pumped solid-
state configuration with a 1030 (±5) nm center wavelength incorporating femtosecond (FS) laser
technology. The benefit of the FS laser is that the laser spot can be focused very tightly to deliver
a pulse of light that is approximately 10
-13
seconds in duration, which delivers microjoule levels
of energy to disrupt tissue (thereby using substantially lower energy levels than those required if
ultrasound energy were used for lens fragmentation). With the addition of precision scanners
under computer control, patterns may be pre-planned and exactly positioned for precise
capsulotomy, lens fragmentation, and corneal cuts/incisions.
Optical Coherence Tomography
The CATALYS® System uses an Optical Coherence Tomography (OCT) subsystem to create a
three-dimensional model of the anterior portion of the eye to guide the laser treatment. The
OCT system employs an 820–930 nm spectral domain OCT to create three-dimensional images
of anterior ocular structures. The system provides for identification of the anterior/posterior
surfaces of both the cornea and the lens (
INTEGRAL GUIDANCE System imaging). The system’s
INTEGRAL GUIDANCE System also detects the lens capsule, iris border, and limbus border,
providing targeted centration for the capsulotomy. Similarly, the detection of the iris and limbus
border also provides for targeted centration of corneal cuts/incisions. Centration of the
capsulotomy and corneal cuts/incisions may also be adjusted at the discretion of the surgeon
through the Graphical User Interface (GUI).
For lens fragmentation, the INTEGRAL GUIDANCE System software algorithm analyzes the
backscattered light from the OCT system to identify the posterior lens surface and presents that
information graphically for the operating physician’s consideration. Streaming X- and Y-axis
cross-sectional OCT images are displayed with computer modeling of potential laser cut patterns
overlaid for verification by the operating physician. In the event that the
INTEGRAL GUIDANCE
1. Classification according to U.S. Code of Federal Regulations, Title 21, Part 1040.10 (Performance Stan‐
dards for Laser Products).