Introduction; Intended Use; About Warnings And Cautions - Welch Allyn RetinaVue 100 Imager Pro 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.
Prescription only or "For Use by or on the order of a licensed medical professional".
Note
For information on configuring the RetinaVue 100 Imager Pro device to connect to the
RetinaVue Network system, contact Welch Allyn support to discuss setting up a
RetinaVue Network account.

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.
It is the responsibility of the health care provider to protect patient health
information and to meet regulatory and HIPAA compliance. The images on
the RetinaVue 100 Imager Pro may contain identifiable patient information
and it is the responsibility of the health care provider to ensure that data
safeguards are implemented to protect patient health information.
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