Myray RX DC, Manual

Page: 58 / 309

58
OPERATOR'S MANUAL EN
1.2.1. CLASSIFICATION
- MEDICAL DEVICE classification.
Classification of the equipment according to the rules indicated in Annex IX of EEC Directive 93/42 and
subsequent changes: CLASS IIB.
- ELECTRO-MEDICAL EQUIPMENT classification.
Equipment classification in accordance with standard I.E.C. 60601-1 for safety of medical equipment: CLASS I
TYPE B.
- RADIO EQUIPMENT AND TELECOMMUNICATIONS TERMINAL EQUIPMENT Classification.
Equipment classification according to Directive 99/05/EC Art.12: CLASS I.
- EMC classification.
Equipment classification in accordance with standard CEI EN 55011: GROUP I TYPE B.
1.2.2. ENVIRONMENTAL CONDITIONS
The equipment is to be installed in rooms that satisfy the following requirements:
- Temperature from +10 to +40°C.
- Relative humidity from 25 to 75% without condensate.
- Atmospheric pressure from 700 to 1060 hPa.
- The electrical wiring in the room in which the equipment is installed must conform to I.E.C. 60364-7-710;V2
specification (i.e. the regulations concerning the electrical wiring to be used in surgeries) or equivalent standards
in force in the country where the equipment is installed.
- ELECTRICAL CONNECTIONS: The electrical wiring must have an effective ground conductor as set forth by
I.E.C. -US National Electrical Codes and C.E.I. standards. In Italy, electrical wiring must comply to standards IEC
60364-7-710 which require that a ground fault circuit interrupter is installed upstream.The ground fault circuit
interrupter must be as specified below:
- contact capacity: 250V 10A in compliance with standards IEC 60898-1 and IEC 60947-2;
- differential sensitivity: 0.03A;
- power supply: 3x2.5 mm
2
.
The color of the 3 wires should be as specified in the standards (brown power, BLUE neutral, YELLOW/GREEN
ground).
- POWER SUPPLY CUT OFF (INCORPORATED x-ray unit version):
A two-pole switch has to be installed in a position that can be easily reached by the operator in order to shut off
electrical power separately from the dental unit. The contacts of the two-pole switch, that may be used as a sole
device with differential-magnetothermal functions, should be at least 3 mm apart (as set forth in standard IEC
60601-1). In addition, it should have a 250V 10 A contact capacity and comply to standards IEC 61058-1 and IEC
60447. The ON position must be clearly indicated.