Smartscope M5 is a medical digital camera that is used with dedicated optics modules intended to take images of the eye fundus and surface of the eye.
Supported optics modules and their intended uses are:
Model: Description:
Smartscope EY4
Optomed Smartscope M5 digital camera with EY4 optics module is intended to capture digital images and video of the fundus of the human eye.
Smartscope FA
Optomed Smartscope M5 digital camera with FA optics module is intended to capture fluorescein angiograms of the human eye.
Smartscope ES2
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.
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.
Intended users
The device may only be operated by persons who have been properly trained, who are familiar with fundus cameras, ophthalmoscopes, etc., or who have the required knowledge to operate the device or a similar device.
This device may only be used in accordance with its intended use.
Intended patient population
All patients may be imaged with Smartscope M5 digital camera with optics module.
Clinical benefits
The images captured with Smartscope M5 support health care professionals with detecting, monitoring, and screening of conditions visible in the human fundus. The applicable specialties include but are not limited to ophthalmology, optometry, diabetology, neurology, pediatry, and primary care.
Good image quality together with the wide field of view (40 degrees) and ability to capture images from different parts of the retina enable accurate and comprehensive retinal examination.
The small size and low weight of the device allow easy transportation and use in different locations. These features help to reach wider populations and capturing of images of people who may not be able to sit still during the imaging procedure.
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Device’s usability and possibility of non-mydriatic imaging improve the operators’ and target population’s experience of the process. These features lead to broader acceptability among the target population and faster workflow and patient management.
Connectivity and transfer of digital images improve accessibility of eye health services. They enable the use of tele-medicine and automated image analysis, which both can streamline the workflow. This has direct positive impact on public health.
Contraindications for use of the optics modules EY4, FA and ES2
Because prolonged intense light exposure can damage the retina, the use of the device for ocular examination should not be unnecessarily prolonged, and the brightness setting should not exceed what is needed to provide clear visualization of the target structures.
The retinal exposure dose for a photochemical hazard is a product of the radiance and the exposure time. If the value of radiance were reduced in half, twice the time would be needed to reach the maximum exposure limit.
While no acute optical radiation hazards have been identified for direct or indirect ophthalmoscopes, it is recommended that the intensity of light directed into the patient's eye be limited to the minimum level which is necessary for diagnosis. Infants and persons with aphakia or diseased eyes will be at greater risk.
The risk may also be increased if the person being examined has had any exposure with the same instrument or any other ophthalmic instrument using a visible light source during the previous 24 hours. This will apply particularly if the eye has been exposed to retinal photography.
Smartscope EY4, FA and ES2 are classified as Group 2 based on standard ISO 15004-2:2007. Smartscope FA module has also been classified as Group 1 based on ANSI Z80.36-2016. The daily usage time and maximum allowed number of pulses is calculated based on optical classification results according to standard ISO 15004-2:2007 and ANSI Z80.36-2016.
