Protection Of Patient Health Information; Safety - Zeiss CIRRUS HD-OCT 500 User Manual

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Protection of Patient Health Information

Safety

2660021169012 Rev. A 2017-12
Protection of Patient Health Information
CAUTION: Do not reconfigure system components on the table, nor add non–system
devices or components to the table, nor replace original system components with
substitutes not approved by Zeiss. Such actions could result in failure of the table height
adjustment mechanism, instability of the table, tipping and damage to the instrument, and
injury to operator and patient.
CAUTION: Do not use the printer, the instrument, or the optional power table with an
extension cord or a power strip (multiple portable socket outlet).
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 ophthalmologist, 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: The appliance coupler is the main disconnect device of the instrument.
Position the instrument in such a way to have easy access to disconnect the appliance
coupler in case of an emergency. For the CIRRUS HD-OCT, the most accessible power cord
is the one that plugs into the bottom of the table.
CAUTION: In case of an emergency, disconnect the appliance coupler. For the CIRRUS
HD-OCT, the most accessible power cord is the one that plugs into the bottom of the table.
NOTE: Health care providers have responsibility for the protection of patient health
information (PHI), both hardcopy and electronic. To protect patient confidentiality of your
exported electronic data, the use of encryption is recommended and is the responsibility of
the user.
NOTE: If a serious incident has occurred in relation to this medical device, to the user, or to
another person, then the user (or responsible person) must report the serious incident to
the medical device manufacturer or the distributor. In the European Union, the user (or
responsible person) must also report the serious incident to the Competent Authority in the
state where the user is established.
CIRRUS HD-OCT User Manual