1 Safety and Certifications
Instructions for Use
2660021169042 Rev. A 2018-03
1.3 Safety
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2660021169042 Rev. A 2018-03
WARNING!
Patient injection with photo–dynamic therapy (PDT)
treatment drugs, such as Visudyne®
could lead to unintended exposure and uncontrolled treatment of
neovascular vessels.
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Do not scan patients who have been injected with photo–
dynamic therapy (PDT) treatment drugs, such as Visudyne®, in
the previous 48 hours.
CAUTION!
Applicable Phototoxicity Statements (FDA CDRH Ophthalmo-
scope Guidance #71):
Because prolonged intense light exposure can damage the retina,
the use of the device for ocular examination should not be unnec-
essarily prolonged.
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While no acute optical radiation hazards have been identified
for direct or indirect ophthalmoscopes, it is recommended that
the exposure time for the patient’s eye be limited to the
minimum time that is necessary for diagnosis.
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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.
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This will apply particularly if the eye has been exposed to retinal
photography.
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Note:
This medical device has no user adjustable intensity
settings for light incident on the retina, nor does it produce UV
radiation or short–wavelength blue light.
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