Indications for Use, Contraindications, Warnings, and Precautions
Part Number: 0160-6411, Rev A, 02/2019 Page 19 of 314
Software Release: cOS 5.00
Physician
• Education: Board-certified ophthalmologist
• Knowledge and experience:
─ Experienced in performing cataract surgery
─ Fully trained in the use of the device
• Permissible impairments:
─ Vision: Mildly impaired but corrected to 20/30
─ Hearing: Mildly impaired but corrected to 85% of normal hearing
─ Mobility: No impairment that can limit use of system controls and application of
suction ring; must be able to load and unload patient and move patient bed/chair
Nurse
• Education: Registered nurse (RN)
• Knowledge and experience:
─ Experienced in assisting in ophthalmologic procedures
─ Fully trained to support the physician during the treatment
• Permissible impairments:
─ Vision: Mildly impaired but corrected to 20/30
─ Hearing: Mildly impaired but corrected to 85% of normal hearing
─ Mobility: No impairment; must be able to assist with positioning the patient, loading/
unloading the patient, and moving the patient bed/chair
─ Hand-eye coordination: No impairment
Technician/operator
• Education: 2-year associate degree; high school education and certificate from hospital,
vocational, or military school; and/or on-the-job training
• Knowledge and experience:
─ Fully trained to operate the system and support the physician during the treatment
• Primary duties (operating and frequently used functions): Positioning patient on bed/
chair, entering patient information, entering incision parameters, generating reports,
preparing system for use, verifying laser alignment
• Permissible impairments:
─ Vision: Mildly impaired but corrected to 20/30
─ Hearing: Mildly impaired but corrected to 85% of normal hearing
─ Mobility: No impairment; must be able to assist with positioning the patient, loading/
unloading the patient, and moving the patient bed/chair
─ Hand-eye coordination: No impairment
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