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SOCT User Manual Version 10.0 rev. A
WARNING: The system is not intended to be used as the sole diagnostic aid in
disease identification, classification or management. The system
provides data to be used in conjunction with other information,
intended to assist an eye care clinician in determining a diagnosis. A
patient diagnosis is the sole domain of a licensed eye care clinician.
WARNING: Equipment is not suitable for use in the presence of a Flammable
Anesthetic Mixture with Air, Oxygen, or Nitrous Oxide.
WARNING: The system has no special protection against harmful ingress of water
or other liquids (classified IPX0). To avoid damage to the instrument and
cause a safety hazard, the cleaning solutions, including water, should
not be directly applied to the device. Using a dampened cloth (without
dripping) is a good method to clean the exterior surface of the
enclosure. The table can be cleaned in the same manner as the system.
Care should be taken to avoid excess fluid near any of the system
components.
WARNING: While being examined, the patient must not touch any part of his or her
body to an electrical device that is not powered by the system. In
addition, while examining the patient, the system operator must not
touch at the same time the patient and any electrical device that is not
powered by the system. Failure to observe these warnings could result
in electrical shock to the patient and/or operator.
WARNING: The Real Corneal Power value determined by the topography is not
interchangeable with the corneal power value determined by any other
device. The Real Corneal Power determined by the topography function
is not intended to be used in lieu of, or replace a value from another
device into your standard IOL calculation formula.
WARNING: Make sure, that patient does not put his head inside the frame when
“up” or “down” chinrest elevation button is pressed.
WARNING: Users must check measurement readings for plausibility. This includes
the checking of the detected position boundaries on B-scan and the
adjusted lines, which automatically adjust to the signal, whenever one
of the measurements displays an unusually high standard deviation. The
operator must also take into account the type (e.g., posterior
subcapsular cataract) and density of the cataract when evaluating
plausibility.
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