1.2. INTENDED USE
• The dental units described in this manual are Medical Devices intended for dental treatment.
• The dentist's board may hold up to 6 instruments.
• The assistant’s board can hold 2 suction tubes and 3 instruments.
• This equipment must be used only by adequately trained personnel (dentists and paramedics).
• The device is intended for non-continuous operation with intermittent loads (see the operating times of the individual parts in the dedicated sections).
• The device is classified as pollution degree 2.
• Overvoltage class: II.
1.2.1. CLASSIFICATION AND REFERENCE STANDARDS
• MEDICAL DEVICES classification
Classification of the dental unit in accordance with the indications given in annex IX of directive 93/42/EC as amended:
Class IIa.
• ELECTRICAL MEDICAL EQUIPMENT classification
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 and manufactured in compliance with IEC60601-1 3rd Ed. - 2007, IEC
60601-1-6 3rd Ed. - 2010, IEC 62366 1st Ed. - 2007, IEC 80601-2-60 1st Ed. - 2012, IEC 60601-1-2 3rd Ed., ISO 6875 3rd Ed. - 2011, ISO 7494-1
2nd Ed. - 2011 and EN 1717 (type AA and AB) standards as far as water mains safety devices are concerned.
• Classification of RADIO DEVICES AND COMMUNICATION TERMINALS (only when the WIRELESS foot control is present)
Equipment classification according to Directive 99/05/EC Art.12: Class I.
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. TRANSPORT AND PACKAGING 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 electrical wiring in the room in which the equipment is installed must conform to IEC 60364-7-710 (standards for electrical wiring 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.
To Next Page
Loading...