2 Introduction Instructions for Use
2660021169042 Rev. A 2018-032.2 Subject/Patient Profile
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2.1.4 Essential Performance
The PLEX® Elite 9000 is a retinal imaging device intended to be
used as a non-contact, diagnostic imaging instrument for in vivo
viewing, axial cross-sectional imaging, and three-dimensional
imaging of ocular structures. No cases have been identified in
which the product's failure to perform its intended clinical
functions would result in unacceptable risk.
2.2 Subject/Patient Profile
NOTE
Patients must be able to sit upright and place their face in
the chin and forehead rest of the instrument (with or
without supplemental human or mechanical support).
The device may be used on all adults in need of diagnostic evalu-
ation of the eye. This includes (but is not limited to) patients with
the following disabilities or challenges:
• Wheelchair user
• Very low or not measurable visual acuity
• Fixation problems
• Postural problems
• Deafness
• Large body, but not those above 99th percentile based on
anthropomorphic data
2.3 Operator Profile
2.3.1 Intended Demographic (Operators)
Operators are adults with professional training or experience in the
use of ophthalmic imaging equipment. Specific assumptions
regarding the qualifications of individuals operating the instrument
are given below:
• Ophthalmologist or other Medical Doctor
• Optometrist or equivalent
• Nurse
• Certified Medical Technician
• Ophthalmic Photographer
• Non-certified Assistant
2.3.2 Required Occupational Skills (Operators)
Must possess all of the following skills:
• Computer literate
• Basic knowledge of the eye
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