Contraindications; Warnings And Cautions - Clarity RetCam3 User Manual

16 Chapter 1
See
screening for ROP.

Contraindications

Any patient with a perforating injury to the globe must not be imaged using contact
technique with the RetCam until the wound is repaired. In the case of an eye infection, and
if at all possible, use of the RetCam must be delayed until treatment for the infection has
been rendered. The RetCam must not be used to image an infant determined to be
unstable by a neonatologist.

Warnings and Cautions

RetCam 3 and RetCam Shuttle User Manual
RetCam Physician Information on page 141
Federal law (US) restricts this device to sale by or on the order of a physician
or licensed medical practitioner.
RetCam devices are intended for use by individuals knowledgeable and
skilled in the use of ophthalmology devices including physicians, nurses,
ophthalmic photographers, and ophthalmic technicians. Special instructions
addressing the use of the device with infants are found in this user manual in
Chapter 11, Screening for Retinopathy of Prematurity (ROP) on page
Prior to using the system, read all user safety information.
Before using this equipment to acquire images of patient eyes, users must be
trained in proper clinical technique by personnel authorized by Clarity.
The RetCam system is designed and tested as a system. Do not remove or
substitute RetCam components because doing so might adversely affect
system performance.
Unauthorized modifications or additions to the RetCam system (including
hardware and software, etc.) void the warranty and can adversely affect
system function.
for detailed information on RetCam and
PN 18-000393 Rev. A
Introduction
141.