Introduction; Intended Use; About Warnings And Cautions; General Warnings And Cautions - Welch Allyn RetinaVue 100 Imager Directions For Use Manual

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.

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 and cautions

WARNING Clean 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.
WARNING Do not use batteries from other sources. This may result in
excessive temperatures, fire, or explosion.
WARNING To prevent fire or electrical shock, do not expose the device to
rain or moisture.
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