Welch Allyn RetinaVue 100 Imager, Directions For Use Manual

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Introduction
Intended use
The Welch Allyn RetinaVue 100 Imager is a digital hand-held eye-fundus camera used to
record digital photographs of the fundus (including retina, macula and optic disc) of the
human eye and surrounding area.
Prescription only or "For Use by or on the order of a licensed medical professional".
About warnings and cautions
Warning and caution statements can appear on the RetinaVue 100 Imager device, the
packaging, the shipping container, or in this Directions for use .
The RetinaVue 100 Imager is safe for patients and clinicians when used in accordance
with the instructions and the warning and caution statements presented in this
Directions for use .
Before using the device, you must familiarize yourself with all warnings and cautions,
with the steps to power up the device, and with the sections of this Directions for use
that pertain to your use of the device. Specific warnings and cautions are also found
throughout this manual.
•
Failure to understand and observe any warning statement in this manual could lead
to patient injury or illness.
• Failure to understand and observe any caution statement in this manual could lead to
damage to the equipment or other property, or loss of patient data.
General warnings, cautions, and notes
WARNING Exposure to the RetinaVue 100 Imager flash, in rare cases,
may contribute to migraines or temporary visual disturbances, particularly in
patients with a history of light sensitivity or migraines. Multiple flashes per
eye in a single exam may increase the likelihood of occurrence.
WARNING
Clean and disinfect the eye cup after each patient to avoid the
risk of cross-contamination.
WARNING Operating the device in the presence of a flammable
anesthetic mixture with air, oxygen, or nitrous oxide; in oxygen-enriched
environments; or in any other potentially explosive environment may cause
a fire and explosion hazard.
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