Gendex AcuCam Concept IV FWT User Manual page 55

Chapter
7
The AcuCam® Concept® IV FWT intraoral camera system, 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 affect Medical
Electrical Equipment. The Concept IV FWT camera system 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 Dental Systems and specified as replacement parts
for internal components, may result in increased emissions or decreased immunity of the
Concept IV FWT camera system. The Concept IV FWT camera system should not be used
adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the
Concept IV FWT camera system should be observed to verify normal operation in the
configuration in which it will be used.
Guidance and Manufacturer's Declaration - electromagnetic emissions - for all equipment and
systems (see 6.8.3.201 a) (3).
The AcuCam® Concept® IV FWT intraoral camera system is intended for use in the
electromagnetic environment specified below. The customer or the user of the Concept IV FWT
camera system should ensure that it is used in such an environment.
Guidance and Manufacturer's Declaration - Electromagnetic Emissions
Emissions Test
RF emissions CISPR 11
RF emissions CISPR 11
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations/flicker emissions
IEC 61000-3-3
032-0161-EN Rev 5
Compliance with Applicable
Standards
Compliance
Group 1
Class A
Class A
Complies
Electromagnetic Environment -
Guidance
The Concept IV FWT camera system
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 Concept IV FWT camera system 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.
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