Introduction Intended use The Oxymap Retinal Oximeter system is intended for non-invasive measurement of the retinal vessel oxygen saturation and the vessel width. The Oxymap Retinal Oximeter device captures images of the retina which are taken with a fundus camera. The Oxymap Retinal Oximeter software (Oxymap Analyzer) grabs, stores, displays and analyzes those images. Clinical investigations
The Oxymap Retinal Oximeter is an investigational device intended for use in hospitals, eye clinics, research institutions or other research facilities for clinical investigations only. It is not intended to aid in diagnosing or monitoring diseases of the eye in individual patients. The Oxymap Retinal Oximeter can be used by researchers to study retinal oxygenation in health and eye diseases. Such studies will add to earlier and more indirect evidence for the role of retinal oxygenation in eye diseases. The Oxymap Retinal Oximeter can also be used to compare oxygenation in groups of individuals or to compare oxygenation before and after treatment, such as medicinal or laser treatments. Retinal vessel width can be used in combination with oxygen saturation measurements in these studies.
Instruction manual Oxymap Retinal Oximeter Oxymap Analyzer version 2.2.1 revision 3844
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