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1 introduction, Features, Indications for use – Canon CR-2 User Manual

Page 4: Features indications for use, Introduction

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Features

The Canon Digital Retinal Camera CR-2 takes digital photographic retinal images of patient’s eyes
across an angle of view of 45 degrees, in a naturally dilated state without using mydriatics. The CR-2
has the following features.

Reduced flash intensity

The CR-2 can take images at ISO 1600 at the standard flash intensity, and ISO 6400 in low flash
intensity mode. This reduces patient discomfort caused by light glare.

Compact, user-friendly design

The CR-2 is designed to be even smaller, more lightweight and compact. This makes it easier to
assist patients and provides significantly improved ease-of-operation.
An integrated operation lever has been adopted for vertical movement of the main unit, switching
between anterior eye and retina, and focus operations, which significantly improves alignment
operability.

Special digital camera

The CR-2 is equipped with a special digital camera using EOS digital technology. This enables the
CR-2 to fully maximize Canon technology for shooting high-quality, high-resolution diagnostic images.

Small pupil photography function

The CR-2 take retinal images through pupils of the normal diameters from 4.0 mm. When using the
small pupil photography function, it can take through pupils of the diameters from 3.3 mm.

System optimized for digital photography

With the Retinal imaging control software, the photographed images can be browsed, processed,
stored, output to the DICOM storage server, exported in DICOM or JPEG format and output to a
printer.

Indications for Use

For U.S.A.

The device is intended to be used for taking digital images of the retina of the human eye without a
mydriatic.

For European Union

This medical device is intended to observe image and record retinal fundus through the pupil
without contact with subject’s eye for the purpose of diagnosis by way of producing fundus image
information.

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Introduction