Cirrus Hd-Oct User Manual 2660021169012 Rev. A - Zeiss CIRRUS HD-OCT 500 User Manual

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Safety
Product Safety
WARNING: To prevent electric shock, the instrument must be plugged into an earth
grounded outlet. Do not remove or disable the ground pin. Only an authorized Zeiss service
representative may install the instrument.
WARNING: Do not open the instrument covers. Opening the instrument covers could
expose you to electrical and optical hazards.
WARNING: To maintain patient safety, if the instrument is externally connected to non–
medical peripheral devices (i.e., printer, storage devices, etc.), the complete system must
comply with the system requirements in standard IEC 60601–1. This standard requires the
usage of an Isolation Transformer to power the non–medical peripheral device(s) if located
within 1.5 m from the patient. If the peripheral device is located outside the patient
environment (beyond 1.5 m) and is connected to the instrument, a separation device must
be used if there shall be electrical connection between the non–medical peripheral device
and the instrument.
WARNING: The person or the responsible organization connecting additional devices or
reconfiguring the system must evaluate the complete system to ensure compliance to the
applicable IEC 60601–1 requirements.
CAUTION: The instrument operator must not attempt to touch the patient and the
peripheral device simultaneously.
WARNING: This instrument may cause ignition of flammable gases or vapors. Do NOT use
in the presence of flammable anesthetics such as nitrous oxide, or in the presence of pure
oxygen.
WARNING: The instrument itself is transportable and may be moved from one location to
another. However, if the instrument is placed on a power table provided by CZMI, do not
move the table to another location while the instrument and any other peripherals are
placed on it. Doing so may cause the system components to tip over and cause harm to the
patient, the operator, or others in the vicinity.
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.
CAUTION: Avoid tipping. Do not use the instrument on an uneven or sloped surface.
Also, do not roll the table in deep pile carpet or over objects on the floor such as power
cords. Failure to observe these precautions could result in tipping of the instrument and/or
table and resulting injury to operator or patient and damage to the instrument.
CIRRUS HD-OCT User Manual 2660021169012 Rev. A 2017-12