▪ Personnel should not operate the System until they have been fully educated in
its use. Make sure that all treatment personnel are familiar with the System
controls and know how to shut down the System instantly.
▪ There are no user-serviceable parts in the System, and all service and repair must
be performed only by the factory or authorized field service technicians.
▪ Protective goggles must be used by all treatment attendants when using the
DiolazeXL laser, Vasculaze laser or the Lumecca IPL Handpieces
2.3 Cautions
The following cautions should be heeded for safe System use:
▪ Do not touch the System’s inner parts.
▪ Service is supplied by company authorized personal only.
▪ To avoid damage, do not allow the Handpiece to come in contact with hard
materials.
2.4 Ocular Hazards
▪ The light emitted by the DiolazeXL laser Handpieces and Vasculaze laser
Handpiece is capable of causing serious eye damage or blindness. The light
emitted by the Lumecca handpieces is capable of causing eye irritation or
damage.
▪ All persons potentially subject to exposure must wear protective goggles or
eyewear whenever the main power is on, in accordance with national and
international standards. The protective eyewear must have an optical density
(OD) of 5 or greater at the DiolazeXL wavelength of 810nm, and at the Lumecca
wavelength of 515-1200nm.
▪ For users outside the U.S., the appropriate standard may be EN 207, in which
case the safety eyewear must have a protection class of L5. The protective
eyewear must have an optical density (OD) of 5 or greater at the DiolazeXL laser
wavelength of 730 - 1085nm (OD 5); 755nm (OD 7); 1064nm (OD >6); at the
Vasculaze laser wavelength 1064nm (OD >6)) and at the Lumecca IPL wavelength
of 515-1200 nm. For users outside the U.S., the protection values are for
1064nm, DIR LB6 + IR LB7, approved by PSP S CE.
▪ The laser and the IPL are to be operated only in an enclosed room with
protective eyewear for all persons; direct eye exposure is not safe at any distance
within the room. All windows in the laser room must be covered with opaque
material, and measures should be taken to prevent unauthorized access to the
room.
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