Introduction; Intended Use; Indications For Use; Usage - Zeiss CIRRUS HD-OCT 500 User Manual

2 Introduction

Intended Use

Indications for Use

Usage

CIRRUS HD-OCT User Manual
The CIRRUS™ HD-OCT with Retinal Nerve Fiber Layer (RNFL), Macular, Optic Nerve Head,
Ganglion Cell and Asian Normative Databases is indicated for in-vivo viewing, axial
cross-sectional, and three-dimensional imaging and measurement of anterior and posterior
ocular structures.
The CIRRUS™ HD-OCT is a non-contact, high resolution tomographic and biomicroscopic
imaging device. It is indicated for in-vivo viewing, axial cross-sectional, and
three-dimensional imaging and measurement of anterior and posterior ocular structures,
including cornea, retina, retinal nerve fiber layer, ganglion cell plus inner plexiform layer,
macula, and optic nerve head. In addition, the system physically interacts with the
patient's forehead and chin.
The CIRRUS normative databases are quantitative tools for the comparison of retinal nerve
fiber layer thickness, macular thickness, ganglion cell plus inner plexiform layer thickness,
and optic nerve head measurements to a database of normal subjects. The CIRRUS Asian
Normative Database is a quantitative tool for the comparison of these measurements to a
database of normal subjects of Asian descent. The CIRRUS HD-OCT is intended for use as a
diagnostic device to aid in the detection and management of ocular diseases including, but
not limited to, macular holes, cystoid macular edema, diabetic retinopathy, age-related
macular degeneration, and glaucoma.
NOTE: The CIRRUS HD-OCT is not intended to be used as the sole diagnostic method for
disease.
The CIRRUS instrument is designed for continuous use, although it is expected that most
sites operate the instrument for 10 hours or less per day, indoors, within a medical office or
hospital setting. This setting shall have clean air free of soot, vapors from adhesives, grease
or volatile organic chemicals. Other Operating Environment specifications are given in
Chapter 13 "Specifications". Application–related warnings are given in this chapter
and elsewhere.
CIRRUS HD-OCT is not a portable device. It is intended for placement in one location.
However, there is no permanently installed infrastructure associated with the instrument,
and it can be moved between locations following the applicable guidelines and warnings
in this chapter.
Intended Use
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