disinfectants on cotton pads, with isopropyl alcohol, in order to prevent the risk of contaminants impairing the optical path, as well as
to minimize patient cross-contamination. Excessive use of cleaning or disinfectants will in time damage the coating and color on the
product.
Do not place the device under running water, splash solvents, or use soaked towels or cotton pads when cleaning the
device. Liquid entering the device may damage electrical circuits or cause damage to the batteries, resulting in short-circuit,
laser emission failure, battery fluid leakage, heat generation etc.
Dirty lenses or lenses containing a crack may absorb laser radiation, thereby creating a tiny heated spot on the lens. This may, when
the aperture is placed in contact with the skin, cause discomfort to the patient. Patients may experience a sensation similar to that of a
slight needle prick.
9.2 Visual inspections
The operator should perform a visual inspection of the device before use and contact the distributor or manufacturer for support or
service in any case where real or perceived changes in the performance of the device occur. To ensure a safe inspection, follow the
instructions described below:
Inspection of the housing
(overview of the device)
Damaged mechanical parts or a deformed shape, such as
dents, may indicate that the device is no longer functioning
normally. A deformed enclosure may be uncomfortable for
the patient and could, in worst cases, cause skin breakage
or small cut wounds
Do not use the device. The battery may be damaged.
Contact the distributor or manufacturer for technical
service and replacement of part
Laser aperture protective lenses
Damaged lenses may cause cut wounds. Cleaning or
using the device in this condition may cause electrical
component failure
Do not use or clean the device.
Contact the distributor or manufacturer for technical
service and replacement of part
Loose or lost screws may cause the housing of the device
to come apart
Reattach the screws. Contact the distributor or
manufacturer for technical service and replacement of
lost screws
Legible labels and markings
If symbols, text markings or labels have deteriorated, their
meaning could be misunderstood. This might increase any
potential usage risks
Contact the distributor or manufacturer for technical
service and replacement of signs, labels and markings
Green LED is lit when the push
button is pressed ON (ready
state)
If not lit; failure of switch or LED. Batteries may be
replaced in wrong direction
Check the positioning of batteries. Contact the
distributor or manufacturer for technical service and
replacement of part
Laser aperture LEDs are lit when
the laser is activated
If not lit; the laser diode may not emit laser radiation, or
the aperture LED is broken and does not indicate when
the laser is emitting radiation
Control the output power with a power meter. Contact
the distributor or manufacturer for technical service
and replacement of part
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