Indications for Use, Contraindications, Warnings, and Precautions
Part Number: 0160-6411, Rev A, 02/2019 Page 17 of 314
Software Release: cOS 5.00
1.6 User Training and Certification
All users are required to participate in training provided by OPTIMEDICA personnel prior to
treating patients with the CATALYS® Precision Laser System. Training will be tailored for the
surgeon(s) and support staff and will consist of lectures and hands-on experience with the
equipment. Users may be trained and certified for two different roles: surgeon and system
operator. In addition, OPTIMEDICA technical and clinical support personnel will observe and
assist each user according to designated role during treatment of 10 patients, or as required for
each user to achieve competence.
The training presentation will include a general review of this manual, with emphasis on those
topics of particular individual relevance for the different user roles. The curriculum will cover:
• Plan (template driven treatment planning);
•Engage the LIQUID OPTICS™ Interface (docking and vacuum controls);
• Visualize/Customize (INTEGRAL GUIDANCE System 3-D OCT imaging, automated surface
detection and laser exclusion zones); and
• Treat (parameter choices and patterns for all treatments).
The curriculum and hands-on training are divided according to user roles. Overall, the
curriculum addresses the following:
1. System Overview
a. Laser safety
b. Specifications and operation
c. Emergency system shutdown
d. System error codes and their mitigation
e. Daily system alignment verification and warm-up requirements
f. System maintenance
2. Workflow Considerations
3. Use of the Graphical User Interface
a. Treatment planning
b. Treatment
4. Use of the LIQUID OPTICS™ Interface
a. Packaging and handling of the LIQUID OPTICS™ Interface
b. Docking with the LIQUID OPTICS™ Interface: Vacuum, Capture, and Lock
5. Use of INTEGRAL GUIDANCE System imaging
a. Acquisition of the INTEGRAL GUIDANCE System data
b. Surface detection and adjustments
c. Laser treatment exclusion zones
6. Use of the Mobile Patient Bed (if applicable)
a. Safety information
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