modality intended to be operated by the patient for HOME CARE.The treatment modality of medical laser devices is commonly
called Low Level Laser Therapy (LLLT), photobiomodulation, or cold (non-thermal) laser therapy, when used for reducing pain and
inflammation, as well as to promote tissue repair and recovery.
5.1 Operation description of laser treatment (general)
Treatment is performed by applying a generally optimal dose of laser energy in contact mode onto and around a condition, using a
point-by-point application procedure by holding the device in position, and switching application point at each signal. An audible and
visible signal informs the operator when to switch application point. At each signal, the laser aperture is moved approximately 1.5 cm
until the whole condition area has been covered. Treatment shall only be performed onto and in contact with intact normal skin and
skin conditions.
WARNING! Do NOT use the device in contact with sensitive and broken skin or open wounds. Do NOT use the device in
contact with eyelids. Do NOT view the divergent beam with magnifiers.
5.2 General risks and hazards with class 3R lasers (IEC60825-1:2014)
Laser products that emit radiation that exceed the MPE under direct intra-beam viewing, the risk of injury in most cases is relative low.
Class 3R laser products are not considered intrinsically unsafe, the risk is limited because unintentional exposures would rarely reflect
worst-case conditions (beam alignment, large pupil with entire beam energy entering the eye, as well as the safety margin in the MPE,
and the natural aversion behavior for exposure to bright light of visible radiation and by response to heating of the cornea for far
infrared radiation). The risk of injury increases with exposure duration, and exposure may be hazardous for ocular exposure under
worst-case conditions or for intentional direct intra-beam viewing.
Dazzle, flash-blindness and afterimages may be caused by a beam from a Class 3R laser product in the visible wavelength range,
particularly under low ambient light conditions. This may have indirect general safety implications resulting from temporary
disturbance of vision or from startle reactions. Such visual disturbances could be of particular concern if experienced while performing
safety-critical operations such as working with machines or at height, with high voltages or driving. Class 3R lasers should only be
used where direct intra-beam viewing is unlikely.
Blue light lasers can cause photochemical injuries to the eye if one looks at the light for a prolonged period of time. Lasers with
wavelengths close to the UV-spectrum (400 nm) should be used with caution on patients that are light sensitive or who are using
herbs or drugs causing sensitivity to light. Pulsed visible laser light with a pulse frequency up to 60Hz may trigger photosensitive
epilepsy.
