Country-specific information and labels
000000-2121-813-GA-GB-050416
7
Intended use
The CIRRUS photo is a non-contact, high-resolution tomographic and
biomicroscopic imaging device that incorporates a digital camera which is
suitable for photographing, displaying and storing the data of the retina and
surrounding parts of the eye to be examined under mydriatic and non-
mydriatic conditions.
These photographs support the diagnosis and subsequent observation of eye
diseases which can be visually monitored and photographically documented.
The CIRRUS photo 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, macula,
and optic disc.
It also includes a Retinal Nerve Fiber Layer (RNFL), Optic Nerve Head (ONH),
and Macular Normative Database which is a quantitative tool for the
comparison of retinal nerve fiber layer, optic nerve head, and the macula in
the human retina to a database of known normal subjects. The CIRRUS
photo 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.
CAUTION - HAZARDS DUE TO SIDE EFFECTS
When using mydriatics observe the respective information of the
manufacturer on contraindications and side effects!
CAUTION – GENERAL HAZARDS
This device works with visual stimuli, including lights and patterns flashing
and flickering between 5 and 65 Hz. It is the responsibility of the physician
to decide whether this device is suitable for use with patients who may be
light-sensitive. This group includes epileptics.
Summary of Contents for CIRRUS photo 600
Page 1: ...CIRRUS photo CIRRUS photo 600 and CIRRUS photo 800 Documentation set...
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Page 7: ...CIRRUS photo CIRRUS photo 600 and CIRRUS photo 800 User manual...
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Page 77: ...Remote maintenance tool Addendum to the documentation set...
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