Introduction; Indications For Use - Clarity RetCam3 User Manual

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Introduction

The RetCam 3 and RetCam Shuttle Ophthalmic Imaging Systems are designed to
allow the quick and easy capture of wide field, high resolution, fully digital images and
videos of the eye.
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Indications for Use

• General ophthalmic imaging including retinal, corneal, and external imaging
• Photodocumentation of pediatric ocular diseases including retinopathy of prematurity
• Screening for Type 2 pre-threshold retinopathy of prematurity (ROP) (zone 1, stage 1
1. Cryotherapy for Retinopathy of Prematurity Cooperative Group. Multicenter trial of cryotherapy for retinopathy of
2. Early Treatment for Retinopathy of Prematurity Cooperative Group. Revised indications for the treatment of retinopa-
RetCam 3 and RetCam Shuttle User Manual
NOTE
Throughout this user manual, "RetCam System" refers to both the RetCam 3
and RetCam Shuttle systems. Where information applies to only one system,
that specific system is identified.
Indications for Use on page 15
Contraindications on page 16
Warnings and Cautions on page 16
RetCam 3 System Hardware on page 18
Main Hardware Components on page 21
Electrical Safety Information on page 25
System Hardware (RetCam Shuttle) on page 29
Important User Safety Notices for All RetCam Systems on page 39
Labels and Symbols on page 40
(ROP)
or 2, without plus disease, or zone 2, stage 3, without plus disease) or treatment
requiring ROP, defined as Type 1 ROP (zone 1, any stage, with plus disease; zone 1,
stage 3 without plus disease; or zone 2, stage 2 or 3, with plus disease) or threshold
ROP (at least 5 contiguous or 8 non-contiguous clock hours of stage 3 in zone 1 or 2,
1, 2
with plus disease) in 35-37 week postmenstrual infants.
prematurity: preliminary results. Archives of Ophthalmology 1988; 106(4):471-479.
thy of prematurity: results of the Early Treatment for Retinopathy of Prematurity Randomized Trial. Archives of Oph-
thalmology 2003; 121(12):1684-1694.
Introduction 15
PN 18-000393 Rev. A