iM3 REVOLUTION 4DC - Intended Use of the X-ray Unit

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OPERATOR'S MANUAL
EN
It is necessary to refer to the user manual.
Pushing prohibited.
Stepping prohibited.
UA.TR.101
Ukrainian national symbol of conformity.
1.2. STANDARDS AND REGULATIONS
The system has been designed to meet the following standards:
- Directive 93/42/EEC and s.c. (dir. 2007/47/EC) - Medical Device Directive;
Technical Standards:
IEC 60601-1:2005
IEC 60601-1-2:2007
IEC 60601-1-3:2008
IEC 60601-2-65:2012
IEC 60601-1-6:2010
IEC 62366:2008
The CE marking certifies compliance of the product as described by Medical Device Directive 93/42/EEC and
subsequent amendments.
1.3. INTENDED USE
This x-ray unit is designed for use in the dental 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.
1.4. CLASSIFICATION
- MEDICAL DEVICE classification.
Classification of the equipment according to the rules indicated in Annex IX of Directive 93/42/EEC 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, not continuous use.
- 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.