Zeiss Humphrey II-i series, User Manual

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Introduction & Instrument Setup
Humphrey Field Analyzer II-
i
series User Manual 2660021145640 A
1-2
Essential Performance
The Essential Performance of the instrument is to provide accurate visual field measurements.
Patient Population
The Humphrey Field Analyzer II-
i
may be used on all adults and children over the age of six in need
of diagnostic evaluation 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
• Postural problems
• Fixation problems
• Deafness
• Large body, but not those above 99th percentile based on anthropomorphic data
There is a general requirement that the patient be able to sit upright and be able to place their face
in the chin and forehead rest of the instrument (with or without supplemental human or mechanical
support).
Part of the Body
The Humphrey Field Analyzer II-
i
physically interacts with the patient’s forehead and chin. The
patient's hand and fingers (or similar ability) are also required to press the Patient Response button.
Application
The Humphrey Field Analyzer II-
i
is designed for continuous use, although it is expected that most
sites operate the instrument for 10 hours or less per day, indoors, within a medical office or hospital
setting. This setting shall have clean air free of soot, vapors from adhesives, grease, or volatile
organic chemicals. Other Operating Environment specifications are given in
Appendix (A), "Product
Specifications," . Application related warnings are given in Chapter (1), "Introduction & Instrument
Setup," and elsewhere.
User Profile
We assume that users are clinicians with professional training or experience in the use of
ophthalmic equipment, and in diagnostic interpretation of the test results. Specific assumptions
regarding the profiles of individuals performing instrument operation or data interpretation are
given below. This manual contains information that will aid in the proper instrument operation and
interpretation of the resultant data.
Instrument Operation
Demographic
The user should be adult, and at least one of the following:
• Ophthalmologist
• Optometrist
• Nurse