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8.3 Manufacturer’s Declaration
The KaVo NOMAD PRO 2 Dental X-ray System has been tested and found to comply with
the limits of electromagnetic compatibility standards for medical devices, which provide
reasonable protection against harmful interference in a typical medical/dental setting.
The KaVo NOMAD PRO 2 may generate and radiate radio frequency energy that causes
interference to other devices in the vicinity, if not used in accordance with the instructions
(though there is no guarantee that interference will not occur in a particular instance).
If interference occurs, the user is encouraged to try the following corrective measures:
reorient or relocate the receiving device; increase the separation between the equipment;
consult the device manufacturer or field service technician for help.
The KaVo NOMAD PRO 2 is intended for use in the electromagnetic environment as
specified. The following tables describe the tests performed and the status of the testing.
The KaVo NOMAD PRO 2 uses RF energy only for its internal function. Its RF emissions are
very low and are not likely to cause any interference in nearby electronic equipment.
The test results show that the KaVo NOMAD PRO 2 is suitable for use in all establishments,
including domestic establishments and those directly connected to public low-voltage
power supply networks that supply buildings used for domestic purposes.
The KaVo NOMAD PRO 2, classified as Medical Electrical Equipment, needs 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.
Electromagnetic disturbances may affect the equipment’s ability to generate X-rays at
controlled technical factors. Accuracy of loading factors and reproducibility of radiation
output may be affected.
The KaVo NOMAD PRO 2 is suitable for use in hospitals except for near active HF surgical
equipment and the RF shielded room of an ME system for magnetic resonance imaging,
where the intensity of EM disturbance is high.
The KaVo NOMAD PRO 2 device should not be used adjacent to or stacked with
other equipment. If adjacent or stacked use is necessary, the device should be
observed to verify normal operation in the configuration in which it will be used.
Portable RF communications equipment (including peripheral such as antenna cables
and external antennas) should be used no closer than 30 cm (12 inches) to any
part of the KaVo NOMAD PRO 2, including cables specified by the manufacturer.
Otherwise, degradation of the performance of this equipment could result.
