Anthos A5 CONTINENTAL, Operator'S Manual

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A5 - A6 PLUS - L6
6
EN
1.2.1. CLASSIFICATION AND REFERENCE STANDARDS
• Classification of MEDICAL DEVICES:
Classification of the dental unit in accordance with the indications given in annex IX of directive 93/42/EC as amended and supplemented: Class IIa .
• Classification of ELECTRICAL MEDICAL EQUIPMENT:
Classification of the dental unit in accordance with standard EN 60601-1 on safety of medical equipment: Class I - Type B.
• Reference standards:
the dental units described in this manual are designed in compliance with IEC 60601-1:2005 + CORR.1 (2006) + CORR.2 (2007) (Ed.3), IEC 60601-1-
6:2010 (Ed.3), IEC 62366:2007 (Ed.1), IEC 80601-2-60:2012 (Ed.1), IEC 60601-1-2:2014 (Ed.4), IEC 62304:2006 (Ed.1), ISO 6875:2011 (Ed.3), ISO
7494-1:2011 (Ed.2) and EN 1717:2000 (Ed.1) standards on devices for the safety of the water system (protection unit type AA and AB).
1.2.2. ENVIRONMENTAL CONDITIONS
The equipment is to be installed in rooms that satisfy the following requirements:
• temperature between 10 and 40 °C;
• relative humidity between 30 and 75%;
• atmospheric pressure ranging from 700 to 1060 hPa;
• altitude ≤ 3000 m;
• air pressure entering equipment ranging from 6 to 8 bar;
• water hardness at the equipment inlet must not be above 25 °f (French degrees) or 14 °d (German degrees) for untreated drinking water. For water with
a higher hardness degree, it is recommended to soften water until it reaches a hardness degree between 15 and 25 °f (French degrees) or between 8.4
and 14 °d (German degrees);
• water pressure entering equipment ranging from 3 to 5 bar;
• water temperature entering equipment not higher than 25 °C.
1.2.2.1. STORAGE CONDITIONS
• Temperature between -10 and 70°C;
• Relative humidity between 10 and 90%;
• Atmospheric pressure: from 500 to 1060hPa.
1.2.3. WARRANTY
CEFLA s.c. stands behind its products warranting safety, reliability and performance.
The warranty is valid only under the following terms:
• Conditions given on the warranty certificate are observed.
• Yearly scheduled maintenance is performed.
• The equipment is used only as instructed in this manual.
• The electric system in the room in which the equipment is installed must conform to IEC 60364-7-710 (standards for electric systems in medical and
dental offices).
• A 3x1.5 mm
2
line protected by a bi-polar cut-out that conforms to applicable standards (10 A, 250 V, distance between contacts at least 3 mm) must be
used to feed the equipment.
The colour of the three wires (POWER, NEUTRAL and EARTH) should satisfy the requirements of current standards.
• Installation, repairs, equipment enlargement, settings and, in general, any other operation requiring the casing to be opened are to be performed
exclusively by personnel authorised by CEFLA s.c..
1.2.4. DISPOSING THE EQUIPMENT WHEN NO LONGER USED
In compliance with Directives 2011/65/EU and 2012/19/EU regarding restriction of the use of certain hazardous substances in electrical and electronic
equipment along with waste electrical and electronic equipment, it is forbidden to dispose of this equipment in the municipal waste stream as unsorted
municipal waste.
When purchasing a new device of an equivalent type, one for one, the device that has come to the end of its lifetime should be returned to the dealer for
disposal. As regards reuse, recycling and other forms of recovery of waste electrical and electronic equipment, the Manufacturer carries out the functions
defined by current local laws. Appropriate differentiated waste collection for subsequent recycling treatment and environmentally friendly disposal
contributes to preventing possible negative effects on the environment and health and encourages recycling of the materials of which the device is made
up. The symbol indicating separate collection for electrical and electronic equipment consists of the crossed out bin marked on the equipment.
Under local legislation, fines can be imposed if the equipment is disposed in an illegal manner.