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LUMENIS SELECTA - Additional Safety Considerations; Electrical Hazards; Fire Hazard; Protecting Nontarget Tissues

LUMENIS SELECTA
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Selecta
PBL200051, Rev J
14 Safety and Regulatory
Additional Safety Considerations
Electrical hazards
WARNING - Never remove the laser protective covers. Removing the
covers will expose the user to high voltage components, the laser resonator,
and possible laser radiation. Only Lumenis-certified service technicians shall
work inside the laser console.
WARNING - The area around the laser and footswitch should be kept dry.
Do not operate the laser if any of the cords are faulty or frayed. The laser
should undergo routine inspection and maintenance per Lumenis
manufacturer’s recommendations and institutional standards.
Fire hazard
WARNING - Do not use this device in the presence of flammables or
explosives, such as volatile anesthetics, alcohol, certain surgical preparation
solutions, and similar substances. An explosion and/or fire could occur.
Protecting nontarget tissues
WARNING - Except during actual treatment, the system must always be in
the standby mode. Maintaining the system in the standby mode prevents
accidental laser exposure if the footswitch or joystick laser activation
pushbutton is inadvertently depressed.
WARNING - Never place hands or other objects in the path of the laser
beam. Severe burns could occur.
WARNING - Only the person directing the laser beam should have access to
the laser footswitch or joystick pushbutton. Use caution depressing the laser
footswitch when it is in proximity to footswitches for other equipment. Make
sure the footswitch depressed is the correct one to avoid accidental laser
exposure.
WARNING - To avoid accidental exposure to laser radiation, always move
the patient out of the beam path before restarting the system.
WARNING - Use of controls or adjustments or performance of procedures
other than those specified herein may result in hazardous laser radiation
exposure.
CAUTION - U.S. fedederal law restricts this device to sale by or on the order
of a physician.
CAUTION - Lumenis medical lasers and laser delivery systems are intended
solely for physicians trained in the use of these instruments.

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