2 9
EP59-50399
Issue D
English
Spectral Radiance
It is well established that exposure of the eye to intense light for extended
periods poses a risk of retinal photic injury. Many ophthalmic instruments
illuminate the eye with intense light. The clinician must make a risk benefit
judgement about the light intensity to be used in any procedure. The use
of insufficient illumination to examine patients may result in adverse effects
more serious than a retinal photic injury. Further, despite all efforts taken
to minimise the risk of retinal damage, damage may still occur. While no
visible retinal photic lesions have been identified for ophthalmic
instruments, illumination levels have been set to the minimum necessary to
perform the diagnostic function in the Pulsair EasyEye. Young children and
persons with diseased eyes may be at 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 time to reach a potential optical radiation hazard for this device is 120
minutes. This time is for cumulative exposure in a day. It should be noted
that there is a safety factor of about 10 built into the safety guidelines.
Hence for a source with continuous light output, if the exposure time is
120 min, photoretinitis might be expected for an exposure time of
10 x 120 min = 1200 mins (about 20 hours).
-0.005
0
0.005
0.01
0.015
0.02
0.025
30
0
40
0
50
0
60
0
70
0
80
0
90
0
10
00
11
00
Wavelength (nm)
Pulsair EasyEye
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O
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tp
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(M
W
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Ophthalmic Instruments - Fundamental Requirements and Test Methods
Содержание Pulsair EasyEye
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