AMO Catalys OptiMedica, Руководство оператора

Страница: 21 / 314

Part Number: 0160-6411, Rev A, 02/2019 Page 21 of 314
Software Release: cOS 5.00
2 System Overview
This chapter contains the following major sections:
• 2.1 Introduction , page 21
• 2.2 CATALYS® System Components , page 22
• 2.3 Bench Testing , page 30
• 2.4 Animal and Cadaver Testing , page 30
• 2.5 Clinical Summary , page 31
• 2.6 System Specifications , page 33
• 2.7 System Installation and Setup , page 34
• 2.8 System Basics , page 39
2.1 Introduction
The OPTIMEDICA CATALYS® Precision Laser System is an integrated scanning laser system that is
used by cataract surgeons to create a precise anterior capsulotomy and/or subsequent
fragmentation (phacofragmentation) of the crystalline lens, with or without single plane and
multi-plane arc cuts/incisions in the cornea. Treatment is accomplished through the use of
ultrafast (τ ~10
-13
s, or hundreds of femtoseconds [FS]) infrared laser pulses. The on-board
Optical Coherence Tomography (OCT) subsystem provides a three-dimensional image of the
anterior segment of the eye and guides laser treatment. A common optical scanning system is
used for both the OCT and the FS laser to provide inherent co-registration of the two optical
subsystems.
Each FS laser pulse creates a highly localized plasma and subsequent cavitation event that
disrupts only microns of tissue per pulse. The treatment consists of applying user-defined laser
patterns to the crystalline lens, lens capsule, and cornea of the eye to create incisions by
applying FS laser pulses, guided by the OCT data.
Intended treatment patterns are overlaid on streaming cross-sectional OCT images of the
anterior segment for review before the physician allows treatment to begin.
The system has been designed to be used by a single operator, who will sit beside the patient
during the preoperative. The Graphical User Interface (GUI) allows for pretreatment planning
without interfering with the Mobile Patient Bed or patient chair. The
CATALYS® System may be
used for in-patient or out-patient treatments performed in a hospital or in an Ambulatory
Surgery Center (ASC) setting.
Prior to surgery, the operator or surgical assistant will seat the patient in the procedure bed and
then prepare the patient for the operation, including anesthetizing and dilating the patient's
eyes.
Once the preparations are made, the operator will position the patient under laser aperture,
and connect the
LIQUID OPTICS™ Interface to the laser. The physician will then sit where they