5150
8.3 Manufacturer’s Declaration
The 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
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 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
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 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 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 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 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 NOMAD Pro 2, including cables specified by the manufacturer. Otherwise,
degradation of the performance of this equipment could result.
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