Introduction; Indications For Use; Warnings And Cautions - Clarity RetCam 3 User Manual

Introduction 7

1 Introduction
The RetCam3 Ophthalmic Imaging System (system) is designed to allow the
quick and easy capture of wide field, high resolution, fully digital images and videos
of the eye.

Indications for Use

For general ophthalmic imaging, including retinal, corneal, and external.

Warnings and Cautions

CAUTION: Federal law (US) restricts this device to sale by or on the order of a
physician or licensed medical practitioner.
WARNING: Prior to using the system, read all user safety information.
WARNING: Before using this equipment to acquire images from patient eyes, users
must be trained in proper clinical technique by personnel authorized by Clarity.
WARNING: The RetCam system is designed and tested as a system. Omission or
substitution of RetCam components may adversely affect system performance and
is strongly not recommended.
WARNING: Unauthorized modifications or additions to the RetCam system
(including hardware and software, etc.) could adversely affect system function and
will void the warranty.
WARNING: Carefully inspect and clean the lens piece before each use. DO NOT
USE if the lens piece has nicks, breaks, scratches, or rough surfaces that may
damage the eye.
WARNING: To mitigate the potential for excess light exposure, always start at the
lowest light intensity level and increase if necessary. Use only the shortest amount
of exposure time necessary; no greater than 5 minutes.
WARNING: Use care when contacting the eye; i.e., use the least amount of
pressure and/or movement necessary.
WARNING: A risk/benefit ratio must be assessed before confirming a patient for
RetCam imaging if they are: photosensitive, concomitantly exposed to
photosensitizing agents, or aphakic.
WARNING: To avoid the risk of electric shock, the equipment must be connected to
a supply mains with protective earth.
WARNING: To mitigate the potential for excess light exposure, the user should
avoid looking directly at the illuminated light source.
RetCam3 User Manual PN 21-100375 Rev. A