Welch Allyn RETeval-DR, Directions For Use Manual

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Introduction
RETeval-DR
TM
Electroretinograph is designed as an aid in diagnosis and disease
management of visual pathway dysfunctions or ophthalmic disorders such as diabetic
retinopathy (DR). The DR Assessment Protocol has been clinically validated to match the
diagnosis from seven-field stereoscopic fundus images.
Test results are visible immediately on the device screen. The device automatically
creates PDF reports that include test results, patient information and your practice or
institution information. These PDF reports can be transferred to any PC via a USB cable.
Before using the device, read the sections of the manual that pertain to your use of the
RETeval-DR.
For information about any Welch Allyn product, contact Welch Allyn at
www.welchallyn.com/about/company/locations .
Intended use
The RETeval-DR device is intended to generate photic signals and measure and display
evoked responses generated by the retina and the visual nervous system.
The operators of the device are intended to be physicians, optometrists, medical
technicians, clinical medical assistants, nurses, and other health-care professionals.
Indications for use
RETeval-DR is indicated for use in the measurement of visual electrophysiological
potentials, including electroretinogram (ERG). RETeval is also indicated for use in the
measurement of pupil diameter.
RETeval-DR is intended as an aid in diagnosis and disease management in visual
pathway dysfunctions or ophthalmic disorders (e.g., diabetic retinopathy).
Contraindications
Use of the RETeval-DR device is contraindicated under these conditions:
•
Do not use with patients diagnosed with photosensitive epilepsy.
• Do not use with patients who are allergic to the sensor strip gel.
• Avoid use when the orbit structure is damaged or surrounding soft tissue has an
open lesion.
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