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PLUSOPTIX Vision Screener - Intended Use

PLUSOPTIX Vision Screener
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1. Intended use
The used symbols have the following meaning:
Warnings are identified by this Attention symbol.
Tips & tricks are identified by this light bulb icon.
Only the included medical power adapter GSM36B12-P1J may be
connected to the device for power supply.
The Plusoptix Vision Screener is used for the early detection of vision disorders (preventive
eye care). These vision disorders can cause permanent loss of vision (amblyopia) if they are
not detected and treated in the early years of a child’s life.
To detect vision disorders, the Plusoptix Vision Screener measures the sphere, cylinder,
axis, line of vision and pupil size of both eyes at the same time. Using these measurement
values, the spherical equivalent, gaze symmetry and interpupillary distance are calculated.
All measurement values are compared with age-based referral criteria. “Refer” is
automatically displayed as a precautionary result for every patient requiring an
ophthalmologist appointment.
Note:
False-positive and false-negative results can occur in any type of preventive
examination.
Note:
Preventive eye care with the Plusoptix Vision Screener does not replace the eye
examination carried out by an eye care professional. An eye care professional
remains the only person qualified to interpret the measurement values and
establish a diagnosis. The measurement values must not be used directly to
prescribe glasses or contact lenses.
All patients who are not already being treated by an eye care professional should undergo a
preventive eye care examination. The first preventive eye care examination should be
performed before the child's first birthday. In the event of a family history of visual disorders,
an earlier preventive eye care examination at ages between 5 and 8 months is
recommended. The examination should then be repeated regularly, as the eyes can change
during growth and new visual disorders can manifest at any time.

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