InMode Without Vasculaze Operator Manual
Section 2: Safety
4 of 96
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 Diolaze
and DiolazeXL lasers or the Lumecca IPL.
1.1
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.
1.1
Ocular Hazards
The light emitted by the Diolaze and DiolazeXL Handpieces are capable of causing
serious eye damage or blindness. The light emitted by the Lumecca IPL Handpiece 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 Diolaze and DiolazeXL lasers wavelength of 730 - 1085nm (OD 5); 755nm (OD
7); 1064nm(OD >6); at the Lumecca IPL wavelength of 515-1200 nm. For users
outside the U.S., the protection values are for 730-1085, DIR LB5; for 755, DIR LB6 +
IR LB7; and for 1064, DIR LB6 + IR LB7. All 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. For the laser,
a remote Interlock is provided, which can be connected to the treatment room
doors, disabling laser output if the door is opened during a procedure. In addition,
compliance with ANSI Z1 36.3 and EN 60825-l requires that laser safety signs be
posted at all entrances whenever the laser is in use. Compliance with IEC 60601-2-57
requires that warning label from IR exposure be posted at all entrances whenever the
IPL is in use. Approved sign is provided with each system along with protective
eyewear. Additional eyewear or safety signs may be obtained from the
manufacturer.
