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Performance of this device may be affected in proximity of another device and/or equipment
capable of producing high levels of RF emissions. The device should be used no closer than
12 inches (30 cm) to any part of RF equipment including cables. In the event performance of
this device is affected due to high levels of RF emissions, relocation of the suspected device
and/or equipment producing high levels of RF emissions, or the headlight system may reduce
or eliminate the problem.
2.2 Cautions
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Before each procedure, carefully check the illuminator for damage. DO NOT use a damaged
illuminator.
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The user should verify the light guide end tip and the active illumination port are of the same
type before insertion. DO NOT attempt to force an end tip into an incorrect port.
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All servicing and repair must be performed by the manufacturer or qualified service
technicians.
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Ensure that the air vents located on the illuminator are not obstructed to allow the device to
receive the necessary cooling to prevent an overheating.
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The illuminator is designed to only be used with ST Technologies® fused light guides. Other
light guides may damage the unit due to the high levels of light intensity produced by the unit.
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Any serious incident that has occurred in relation to the device should be reported to the
manufacturer and the competent authority of the Member State in which the user and/or
patient is established.
2.3 Notes
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If there is a power interruption during use, the illuminator will shut down and automatically
restart if the power switch remains in the ON position. There may be a short delay as the unit
reboots.
®
LIT-216 CUDA
Surgical
Rev. E
Page 5 of 104
(English)
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