General Standards And Main Warnings - Faro ALYA Mode D'emploi

1.4
• The device can be applied to the dental unit, but also be installed on specific applications.
The device can be powered both by the dental unit and by a power supply unit connected
directly to the mains. See the specific installation paragraph.
• The device does not have Essential Performances for which inadequacy of the device
performance does not prejudice patient safety.
• The device does not provide life support.
• The device must be clean before use (see Device Cleaning paragraph).
• The packaging of the light is suitable to adequately protect it from penetration of external
agents.
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GENERAL STANDARDS AND MAIN WARNINGS

Warnings against electrical danger and fire
Do not use the light in the event parts are damaged.
Installation of the device must only be carried out by qualified staff.
The dental light must be installed on a specific control and power supply device,
such as dental units, or with an electrical system that meets standard IEC 60364-1
and "national installation regulations for electrical systems in premises for medical
use". The appliance must be installed with an omnipolar separation device from
the mains and compliant with Standard IEC 61058-1. Installation and maintenance
of device conformity with the standard IEC 60601-1 is the responsibility of the
installation technician or the manufacturer of the combined units. Check the power
supply voltage, indicated on the data plate, corresponds to the mains voltage. Do
not carry out any maintenance on the light when the power supply is inserted: then
disconnect the power supply from the mains before intervening.
Warning against danger of wear of the mechanical parts and falling suspended
weights
Do not use detergents containing the following to clean plastic parts: AMMONIUM
HYDROXIDE - SODIUM HYDROXIDE - METHYLENE CLORIDE – METHYL
ALCOHOL. Non-compliance with this specification could cause: RISK OF WEAR
ON PLASTIC PARTS RESULTING IN BREAKAGE. Do not spray any kind of
chemical agent directly on the light. In particular, use is forbidden of abrasive sub-
stances, acids, containing chlorine.
Warnings for danger of suspended loads falling
Strictly comply with compliance for maximum loads planned.
Do not knock against or overload the limit switches on the arms and heads.
Warnings for biological danger and glare
Do not fasten or focus the light strip directly in the patient's eyes, especially patients
at greater risk of eye injury (e.g. children with eye diseases). In this case, always
use appropriate guards and precautions. The light is classified as exempt from pho-
to-biological risk in compliance with EN 62471. However, it cannot be excluded
that particularly photo-sensitive patients or those who have taken photo-sensitising
medicine can develop a rash or allergic reactions to light. In this case, suspend the
treatment and use very low lighting levels.The articulated arm and the joints of the
light allow correct positioning of the light strip.
Warning for danger of damaging the electrical parts
Do not overcharge the arms and the joints with end of stroke knocks. Rotation of the
head and arms as well as the limit switches can damage the conductor insulations.
Warning for danger of explosion
The device is not suitable for installation in environments with the presence of in-
flammable gas or risks of oxygen.
Warning for danger of patient-patient cross contamination
The dentist must use disposable protection on the handles of the light and sterilise
them after each patient. To disinfect the surfaces use water-alcohol mixed disinfec-
tant (see maintenance/cleaning paragraph).
Warning for danger of wrong maintenance
Do not carry out maintenance operations or replacements of parts other than those
outlined in the manual. Any intervention not indicated in the manual could compro-
mise the safe appearance of the device.
Only carry out the maintenance operations in the manual; in any other case, contact
technical support.