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SOCT User Manual Version 10.0 rev. A
Warnings
Warnings indicate hazards that, if not avoided, may result in property damage, injury or death.
WARNING: Do not scan patients who have been injected with photo-dynamic
therapy (PDT) treatment drugs in the previous 48 hours. Failure to
observe this warning could result in unintended exposure and
uncontrolled treatment of neovascular vessels.
WARNING: Medical professionals need to determine whether this device should be
used for patients who may be photosensitive, including those with
epilepsy.
WARNING: To avoid risk of electric shock, this equipment must only be connected
to a mains supply with protective earth. Ignoring safety rules can lead
to accidents.
WARNING: Multiple portable socket-outlets shall not be placed on the floor.
WARNING: Any Additional Multiple Socket-Outlet or extension cord shall not be
connected to the ME System.
WARNING: All activities that demand removing main body housing may be
performed by Manufacturer or Authorized Personnel trained by
Manufacturer only.
WARNING: Ignoring or disregarding the statements above may lead to danger of
death or serious injury.
WARNING: No modification of this equipment is allowed.
WARNING: OPTOPOL recommends that no accessories other than those specifically
called out in this user manual may be connected to the system. Any
customer accessory equipment connected to the interface ports must
be certified according to the respective IEC standards (for example, IEC
60950 for data processing equipment and IEC 60601-1 for medical
equipment) Also, all configurations shall comply with the system
standard IEC 60601-1. Any person who connects or installs accessories
to the system has the responsibility to verify the compliance. If in doubt,
consult an OPTOPOL Technology representative.
WARNING: The system cannot replace clinical judgment and is intended to be used
only in conjunction with other clinical tools considered to be the
standard of care for diagnosis of eye health and disease.