Indications for Use, Contraindications, Warnings, and Precautions
Page 18 of 314 Part Number: 0160-6411, Rev A, 02/2019
Software Release: cOS 5.00
b. Specifications and operation
c. Emergency shutdown
d. Maintenance
7. Review of the clinical trial results – text and iPad presentation
8. Indications for use, contraindications, warnings, and precautions
The hands-on training includes but is not limited to:
a. Treatment planning
b. Mobile Patient Bed or patient chair controls
c. Installing the LIQUID OPTICS™ Interface
d. Patient, head, and eye positioning
e. Use of CATALYS® System controls including the Graphical User Interface
f. Docking with the LIQUID OPTICS™ Interface with an artificial eye and head
g. The INTEGRAL GUIDANCE System process and custom adjustments
h. Treatment application
Upon the recommendation of the OPTIMEDICA-certified Clinical Application Specialist, each
user will be certified as competent, according to the defined user roles, in the operation and use
of the CATALYS® System and ancillary equipment, as well as being well-informed about
indications for use, contraindications, warnings, precautions, and laser safety. Users who
successfully complete the certification will receive a signed certificate from OPTIMEDICA
personnel.
1.7 Target Patient Profile
• Male or female; age > 22 years; anthropometric characteristics fall within 2
nd
and 98
th
percentile in all target markets
• Weight: Patient weight is limited to a maximum of 181 kg (399 lb)
• Height: Patient height is limited to a maximum of 1.93 m (76 in)
•Health:
─ ASA category 1: approx. 5% of patient population
─ ASA category 2: approx. 54% of patient population
─ ASA category 3: approx. 40% of patient population
─ ASA category 4: approx. 1% of patient population
• Nationality: Multiple
• Mobility: Ambulatory, ability to successfully transfer to patient bed/chair, with help if
necessary
1.8 Target Operator Profile
• Male or female; age > 18 years; anthropometric characteristics fall within 5
th
and 95
th
percentile in all target markets
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