Zeiss Humphrey FDT 710, Руководство пользователя

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Humphrey FDT User Manual 2660021149532 Rev. B 2015-11
Introduction 2-1
(2) Introduction
Intended Use
Humphrey FDT is an AC-powered device intended to determine the extent of the peripheral
visual field of a patient. The device is intended to determine the amount of visual field loss
in a patient, which can then be used to diagnose/track the progression of glaucoma and
other eye diseases.
Indications for Use
Humphrey FDT is an AC-powered device intended to determine the extent of the peripheral
visual field of a patient. The device is intended to determine the amount of visual field loss
in a patient, which can then be used to diagnose/track the progression of glaucoma and
other eye diseases.
Note: These perimetry results are an aid to interpretation, not a diagnosis. The doctor’s
judgment is still the most important element in determining the clinical significance of
the results, including considering the limitations of the statistical package.
Essential Performance
The main essential performance of the instrument is to provide accurate visual field
mapping.
Patient Population
The Humphrey FDT may be used on all adults 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
• 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 forehead rest of the instrument (with or without supplemental human or
mechanical support).
Part of the Body
The Humphrey FDT 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 FDT 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,