Regulatory and Safety Information
RET
eval
Device User Manual 85
Regulatory and Safety Information
Applicability
Regulatory and Safety requirements are occasionally revised. Please refer to the user manual that
originally accompanied your RET
eval
device for regulatory and safety information relevant to
that specific device.
Intended use
The RET
eval
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 is indicated for use in the measurement of visual electrophysiological potentials,
including electroretinogram (ERG) and visual evoked potential (VEP). RETeval is also indicated for
use in the measurement of pupil diameter.
RETeval is intended as an aid in diagnosis and disease management in visual pathway
dysfunctions or ophthalmic disorders (e.g., diabetic retinopathy, glaucoma).
Latex statement
The components of the RETeval device that could contact the user or patient were not made with
natural rubber latex. This includes all items that could be contacted during normal operation, and
all other functions, such as user maintenance and cleaning, as are defined in the User Manual.
No internal components are known to be made with natural rubber latex.
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