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1. Indications for use
Smartscope M5 is a medical digital camera that is used with dedicated optics lens intended to take images
of the eye fundus and surface of the eye.
Supported optics lenses and their intended uses are:
Model:
Smartscope EY4
Smartscope FA
Smartscope ES2
The device may only be operated by persons who have been properly trained or who have the required
knowledge and experience to do so.
Smartscope M5 with optics modules is a prescription device: Federal law restricts this device to sale by or
on the order of a physician or licensed practitioner.
Description:
Optomed Smartscope M5 digital camera with EY4 optics module is
intended to capture digital images and video of the fundus of the
human eye.
Optomed Smartscope M5 digital camera with FA optics module is
intended to capture digital images of the fundus angiograms of the
human eye.
Optomed Smartscope M5 digital camera with ES2 optics module is
intended to capture images and video of the surface of the human eye
and surrounding areas.
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