Device
operation
39
EN 20_070_0009I v1.5
Explaining measurements with the i.Profiler
plus
to
customers
WARNING - GENERAL HAZARD
Persons not authorized to use the device (see chapter
Proper use
,
page 7) may not be left unattended on or near the device.
CAUTION - HAZARD DUE TO MEASURING ERRORS
With the following categories of customers, there is a danger that
measured values may be interpreted incorrectly or that measurement
may not be possible:
●
No ability to achieve stable fixation on the fixation mark with the eye
to be examined (for instance in case of nystagmus, very poor vision,
lack of concentration)
●
No ability to follow the instructions of the user
●
No ability to position self in a sitting position in front of the medical
device
●
Refractive medium of the eye not sufficiently transparent for
wavefront/refraction measurements (e.g. cataract with lens opacity
higher than degree NO1 according to LOCS III (Lens Opacities
Classification System III)
●
Disrupted specular reflection of the cornea for topography or
wavefront measurements (such as disruptions to the tear film, corneal
scarring or scratches)
●
Pupil opening too small (< 2 mm) for wavefront measurement
●
Lid gap closed or too small, resulting in partial or complete coverage
of the pupil
●
Injuries to the chin or forehead preventing the head from being
placed in head supports
●
Morphological changes to the retinal anatomy in the fovea area for
wavefront/refraction measurements (such as retinal detachment,
edema, ulcer)
●
Refractive errors or keratometry outside of the measurement range
