Purpose And Use Of The Equipment; Classification; Environmental Conditions; Guarantee - iM3 Revolution 4DC Bedienungsanleitung

1.2. Purpose and use of the equipment

This x-ray unit is designed for use in the dental veterinary surgery to make endo-oral x-rays for diagnostic purposes.
This equipment can be used to produce traditional x-rays developed using chemicals or, alternatively, it can be used with digital x-ray sensors.
ATTENTION!
This x-ray unit is FOR VETERINARY USE ONLY.
This x-ray unit is NOT FOR HUMAN USE.

1.2.1. Classification

RADIO EQUIPMENT AND TELECOMMUNICATIONS TERMINAL EQUIPMENT Classification
Equipment classification in accordance with directive 99/05/EEC art.12: Class I.
EMC classification
Classification of the equipment according to standard CEI EN 55011: Group 1 - Type B.
1.2.2.

Environmental conditions

The equipment should be installed in an area where the following conditions are present:
• 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 where the equipment is installed must conform to the 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: 250 V 10A in compliance with standards IEC 60898-1 and IEC 60947-2.
- differential sensitivity: 0.03A.
- power supply: 3 x 2.5 sq.mm
The color of the 3 wires should be as specified in the standards (brown power, BLUE neutral, YELLOW/GREEN ground).

1.2.3. Guarantee

CEFLA SC - CEFLA DENTAL GROUP guarantees the safety of the operator as well as the reliability and high performance of the equipment. The
guarantee shall be voided if the following precautions are not taken:
• Observe the conditions specified in the guarantee certificate itself.
• The equipment must only be used by following the instructions contained herein.
• Equipment installation, expansion and technical support must be performed exclusively by personnel authorized by the manufacturer to carry out
these operations.
• Never open the equipment casing. Installation, repairs and, in general, any other operations requiring the casing to be opened are to be performed
exclusively by personnel authorized by the manufacturer to carry out these operations.
• The equipment must be installed in areas which comply with that stated above at point 1.2.2 "Ambient Conditions".
• The area where the x-ray unit is installed must comply with official regulations regarding protection against radiation in the country where the
equipment is used.
SAFETY PRECAUTIONS
• If any person who is not an authorized technician changes the product in any way by replacing parts or components with other ones not used by
the manufacturer they shall assume responsibility for the product.
• Do not forget to turn off the main switch on the equipment before leaving the surgery.
• This equipment is not water-proof (risk of electrocution).
• This equipment is not suitable for use in the presence of a mix of inflammable anaesthetic gas with oxygen or nitrous oxide.
• This equipment must be stored properly so that it is kept in top working order at all times.
• Use of electric scapels or other electric apparatus that do not comply to standard I.E.C. 60601-1-2, in the doctor's office or in the immediate vicinity
of it may cause electromagnetic interferences or interferences of other types, resulting in equipment malfunctions. In these cases shut off the
power supply to the equipment before hand.
• The manufacturer shall not be held responsible for misuse, carelessness or improper use of the equipment.
• This equipment is to be used exclusively by qualified personnel with the proper medical training.
• The user must be present at all times when the equipment is turned on or ready for start-up. In particular, never leave the equipment unattended
in the presence of children/the mentally disabled or other unauthorised personnel in general.
• If the x-ray equipment is damaged or oil leaks, do not use the equipment and contact customer service immediately.
Protection against radiation
X-rays are hazardous and adequate precautions must be taken when using them. Areas where it is possible to be exposed to the x-rays
shall be clearly indicated by using this symbol which should remind personnel to observe the safety rules laid down by the laws in force
in the country where the equipment is used.
• Control the emission of x-rays from the greatest distance possible (several metres) from the focal spot and the X-ray irradiation beam in the
opposite direction to where the rays are emitted.
• Only the authorized personnel and the patient can remain in the area when x-rays are being emitted.
• Always protect the patient's thyroid and gonads under all circumstances.
EN
OPERATING INSTRUCTIONS 5 5