Operation
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Explaining the i.Profiler
® plus
measurement procedure
to the patient
WARNING - GENERAL HAZARDS
Persons who are not authorized to use the device (see chapter Specified
purpose, page 7) may not be left unattended at or in the vicinity of the
device.
CAUTION - RISK OF MEASURING ERRORS
A misinterpretation of results may occur in the following patient categories
or measurement may not be possible.
• Unable to steadily fixate the fixation mark with the eye under
examination (e.g. in the case of nystagmus, extremely poor visus, lack of
concentration)
• Unable to follow the instructions of the user
• Unable to position him/herself upright in front of the medical device
• Lacking transparency of the optical media of the eye for wavefront/
refraction measurements (e.g. cataract with lens clouding stronger than
grade NO1 according to LOCS III (Lens Opacity Classification System III)
• Deficient specular reflection of the cornea for topography or wavefront
measurements (e.g. distortion of the tear film, scarring or caustic burn of
the cornea)
• Pupil opening too small (< 2 mm) for wavefront measurement
• Complete or partial coverage of the pupil caused by closed or
inadequate palpebral fissure
• Forehead or chin injuries that prevent the head from being supported on
the head/chin rest
• Morphological changes of the retinal anatomy in the region of the fovea
for wavefront/refraction measurements (e.g. retinal detachment, edema,
ulcer)
• Refractive errors or keratometry outside the measurement range