General Information
Stratus OCT Model 3000 Service Manual
4
2660021155438 A
WARNING: Do not scan the same location on the retina with the same
scan pattern for more than 10 minutes per day. Failure to follow this
guideline could result in overexposure of the patient’s eye to optical
radiation.
WARNING: Do not scan patients who have been injected with photo-
dynamic therapy (PDT) treatment drugs, such as Visudyne®, in the
previous 48 hours. Failure to observe this warning could result in
unintended exposure and uncontrolled treatment of neovascular
vessels.
WARNING: This device contains visual stimuli, including flickering light
and flashing patterns, between 5 and 65 Hz. Medical professionals
need to determine whether this device should be used for patients who
may be photosensitive, including those with epilepsy.
Disclaimer:
Carl Zeiss Meditec does not offer advice or instruction in the
diagnostic interpretation of OCT images. It is the clinician’s responsibility to
make diagnostic interpretations of OCT scans.
Applicable Phototoxicity Statements (FDA CDRH Ophthalmoscope
Guidance#71): Because prolonged intense light exposure can damage
the retina, the use of the device for ocular examination should not be
unnecessarily prolonged. 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. 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.
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.
CAUTION:
The appliance coupler of the power table is the main disconnect
device of the complete STRATUS system. Position the system in such a way to
have easy access to disconnect the appliance coupler in case of an
emergency.
Summary of Contents for Stratus OCT 3000
Page 1: ......
Page 80: ...Parts Diagrams Stratus OCT Model 3000 Service Manual 76 2660021155438 A...
Page 86: ......
Page 87: ......
