UM-1151140EN, Rev. C, May 2016
Laser
Safety
and
Regulatory
● Caution: Federal law restricts this device to sale by or on
the order of a physician
.
● Do not use the device in environment with known sources
of Electromagnetic Interference (EMI) such as; Magnetic
Resonance Imaging (MRI), Computerized-axial
Tomography (CT), Diathermy, Radio Frequency
Identification (RFID) and electromagnetic security systems
(e.g., metal detectors)
.
● Lumenis medical lasers and laser delivery systems are
intended solely for physicians trained in the use of these
instruments
.
2.5. Fire Hazards
Personnel in operating rooms, private and out-patient clinics should be
aware of the following safety considerations and potential fire hazards
when using laser equipment:
● Laser energy can ignite most non-metallic materials.
● Use fire-retardant drapes and gowns.
● A UL or CE approved or equivalent fire extinguisher and water should
be readily available.
• Do not use this device in an oxygen-rich environment and in
the presence of flammables or explosives, such as volatile
anesthetics, alcohol, volatile surgical preparation solutions,
and similar substances. An explosion or fire could occur.
• The area around the target site can be protected with wet
towels or gauze sponges. If allowed to dry, these protective
towels and sponges can increase the potential fire hazard.
In the US: Caution
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