34 / 374
SOCT User Manual Version 10.0 rev. A
Cautions
Cautions indicate hazards that, if not avoided, may result in property damage or injury.
CAUTION: This manual does not provide guidance on interpretation of clinical
results. The clinician must ensure that he or she has received
appropriate medical training in such interpretation. OPTOPOL
Technology Sp. z o. o. cannot be held responsible for misdiagnosis of
results.
CAUTION: Do not use this instrument for purposes other than intended and
specified.
CAUTION: Federal law restricts this device to sale by or on the order of a physician
or practitioner (CFR 801.109(b) (1)).
CAUTION: Before the first use, the device operator should be trained how to use
the system efficiently and safely.
CAUTION: Applicable Phototoxicity Statements (FDA CDRH Ophthalmologist
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 image acquisition. 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. 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: Be extremely cautious when examining high risk group of optical
radiation, patient without crystalline lens, infants and patient who is
insensitive to light for having ocular fundus disease with optical
coherence topographer (OCT).
CAUTION: The SOCT weighs approximately 23 kg or 30 kg. It should be lifted by at
least two persons. Use only the indicated positions for lifting.
To Next Page
Loading...
