10/52
MED 113539 2017-12-15
Light exposure hazard
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 the funduscope, 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, aphakes and persons with 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.
Disposal
The product must be recycled as separated electrical and electronic devices. Please observe the
relevant state-specific disposal regulations.
The appendix contains following tables
- Electromagnetic disturbances – Requirements and tests
- Technical specification
- Explanation of the used symbols
