4. Safety
Safety considerations
It is well established that exposure of the eye to intense light
sources for extended periods of time poses a risk of retinal photic
injury. Many ophthalmic instruments illuminate the eye with
intense light. The decision about the intensity of the light level to
use in any procedure must be made on a case to case basis. In
each case, the clinician must take a risk benefit judgement about
the intensity of light to be used. Use of insufficient intensity may
result in inadequate visualization and in adverse effects more
serious than retinal photic damage. Further, despite all efforts
taken to minimise the risk of retinal damage, damage may still
occur. Retinal photic injury is a possible complication of the need
to use bright light clearly visualize ocular structure during delicate
ophthalmic surgical procedure.
While no visible retinal lesions have been identified for
ophthalmic instruments, it is recommended that illumination
levels be set to the minimum level necessary to perform the
diagnostic function. Young children and persons with diseased
eyes may be at a higher 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 an intense
visible light source during the previous 24 hours. This will apply
particularly if the eye has been exposed to retinal photography.
The light emitted from this instrument is potentially hazardous.
The longer the duration of exposure, the greater the risk of
ocular damage. Exposure to light from this instrument when
operated at maximum intensity will exceed the safety guideline
after 27 minutes.
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