Faro ALYA - Page 5

ALYA INSTALLATION AND USER’S MANUAL - EN
Edition 2.0 Sept 2018 Pag. 5 di 32
Warnings against electrical danger and fire
Do not use the light if any part of it is damaged.
Installation of the device must only be carried out by qualified personnel.
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”.
When installed with ceiling, floor or wall applications the device must be installed with an
omnipolar separation device from the mains and compliant with Standard IEC 61058-1. This
separation device must be approved to withstand 4 kV of transient voltage.
Installation and maintenance of device conformity with the standard IEC 60601-1 is the
responsibility of the installation technician or the manufacturer of the medical system /dental
unit).
Check that the power supply voltage, indicated on the main plate, corresponds to the mains
voltage.
Do not carry out any maintenance on the light when the power supply is inserted: disconnect
the power supply from the mains before any operation.
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 OR
METALLIC PARTS RESULTING IN BREAKAGE.
Do not spray any kind of chemical agent directly on the light.
It is also forbidden the of abrasive substances, acids, chemicals containing chlorine or
phosphor.
Warnings for danger of suspended loads
Strictly comply with compliance for maximum loads allowed.
Do not knock or overload the mechanical limit switches on arms and heads.
Do not position the light head directly upon the head of the patient.
Warnings for biological danger and glare
Do not direct or focus the light beam directly in the patient’s eyes, especially patients with
greater risk of eye injury (e.g. children with eye diseases, diabetic patients, older men). In this
case, always use appropriate guards and precautions.
The light is classified as Class 1 from photobiological risk in compliance with IEC/EN 62471, in
labelling exempt, at the distance of 200 mm.
However, it cannot be excluded that particularly photo-sensitive patients or those who have
taken photo-sensitizing 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 spot.
Warning for danger of damaging the electrical parts
Do not overload the arms and the joints with impact to mechanical end run switches.
Overtravel the mechanical 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 flammable gas
or rich of oxygen.
Warning for danger of patient-patient cross contamination
The user must use disposable protection on the handles of the light and sterilize them after
each patient.
To disinfect the surfaces use water-alcohol mixed disinfectant (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 compromise the safe
appearance of the device. Only carry out the maintenance operations in the manual; in any
other case, contact technical support.
The product is covered by WEEE Directive 2012/19/EU.
To scrap and dispose of the materials, comply with the standard in force in your country, if necessary
contacting recognized and authorized specialist companies.
At the end of the life cycle, divide the materials based on their type (ferrous, rubber, plastic).
Do not leave small parts of the equipment unguarded or within reach of exposed people (children) because
they are a potential sources of danger.
Other warnings are outlined in the titles of this manual.