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8.3 EMC Data
Independent laboratory testing for electromagnetic compatibility for conformity to the
Sub-clause 5.10 requirements of ISO/IEC 17025 “General Criteria for the Competence of
Testing and Calibration Laboratories” was conducted by:
Nemko CCL, Inc.
1940 West Alexander St.
Salt Lake City, Utah 84119-2039
USA
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.
Test Specifications – Radio Frequency Emissions and Electromagnetic Immunity tests in
accordance with requirements of EN 60601-1-2, A1: 2006 as follows:
Test Type
In Accordance with
Document Document Title
Conducted and Radiated
Emissions
EN 55011:2007, Class “B”
Industrial, Scientific and Medical (ISM)
Radiofrequency Equipment – Radio
Disturbance Characteristics – Limits and
Methods of Measurement
Electrostatic Discharge
Immunity
IEC 61000-4-2:1995,
A1:1998, A2:2000
Electromagnetic Compatibility, Basic
Immunity Standard, Electrostatic
Discharge Immunity Test
Radio Frequency Immunity IEC 61000-4-3:2006
Electromagnetic Compatibility, Basic
Immunity Standard, Radiated Radio
Frequency Electromagnetic Field,
Immunity Test
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