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Introduction
About this document
This Directions for use manual is a comprehensive guide designed to help you
understand the capabilities and operation of your Spot Vision Screener VS100. The
information in this manual includes all options available with the Spot Vision Screener.
The applicability of some sections of this manual depends on the configuration of your
particular device. Read this manual thoroughly before attempting to use the device.
The vision screener is a hand-held instrument with a video display on the rear of the unit
that provides subject visualization and alignment. Video display also provides user
interface functionality for data input and display. The vision screener provides visual and
audible cues to attract subject's attention and gaze. The device provides a fast data
collect for easy evaluation of the most difficult pediatric subjects of limited compliance.
Each screening provides simultaneous binocular assessment of the subject's refraction,
pupil size and gaze.
Intended use
The Spot Vision Screener is intended to produce optical images that can help identify
refractive errors and ocular misalignments by detecting special light reflexes from each
eye during screening. The Spot Vision Screener evaluates these light reflexes from the
retina to estimate refractive error. It also estimates pupil size, pupil distance and eye
gaze deviation. It is intended for use on subjects six months of age through adults.
Indications for use
The Spot Vision Screener is indicated for use by healthcare professionals or under the
direction of a healthcare professional to screen or evaluate individuals for potential
refractive errors associated with poor vision. This type of photoretinoscopy device is
intended to help the healthcare professional assess whether the subject should be
referred to an eye care specialist for further evaluation or simply be monitored at future
screenings. This screening is not intended to replace a full eye examination.
Contraindications
The Spot Vision Screener has no known contraindications.
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