GENDEX Oralix AC Manual Del Usuario página 26

IEC 60601-2-28 : 1993
Particular requirements for the basic safety and essential performance of X-ray tube
assemblies for medical diagnosis.
IEC 60601-2-32 : 1994
Particular requirements for the safety of associated equipment of X-ray equipment
Council Directive 93/42/CEE, European Medical Device Directive
ISO 13485 : 2003/Cor 1 : 2009
Medical devices – Quality management systems – Requirements for regulatory purposes
Oralix AC is a Class I, Type B equipment (IEC 60601-1 : 1988).
The Gendex Oralix AC, classified as Medical Electrical Equipment, requires special precautions
regarding EMC and must be installed and put into service according to the EMC information provided
in the accompanying product documentation. Portable and mobile RF communications equipment can
effect Medical Electrical Equipment. The Gendex Oralix AC complies with EMC requirements when
used with the cables and accessories supplied with the product. The use of accessories and cables
other than those sold by Gendex Imaging and specified as replacement parts for internal components,
may result in increased emissions or decreased immunity of the Gendex Oralix AC. The Gendex
Oralix AC should not be used adjacent to or stacked with other equipment. If adjacent or stacked use
is necessary, the Gendex Oralix AC should be observed to verify normal operation in the configuration
in which it will be used.
Table 201 - Guidance and manufacturer's declaration - electromagnetic emissions
Guidance and manufacturer's declaration –electromagnetic emissions
The Gendex Oralix AC is intended for use in the electromagnetic environment specified below. The
customer or the user of the Gendex Oralix AC should assure that it is used in such an environment.
Emissions test
RF emissions
CISPR 11
RF emissions
CISPR 11
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
Compliance
Group 1
Class B
Class B
Complies
Printed on: 22 Mär 2012, 09:22:12 am; Printed by: TOBIAS BAUER
GENDEX
Electromagnetic environment - guidance
The Gendex Oralix AC uses RF energy only for its
internal function. Therefore, its RF emissions are very
low and are not likely to cause any interference in
nearby electronic equipment.
The Gendex Oralix AC is suitable for use in all
establishments, including domestic establishments
and those directly connected to the public low-voltage
power supply network that supplies buildings used for
domestic purposes.
22 Oralix AC