Electromagnetic Compatibility; Electromagnetic Emission - Dentsply Sirona X-Smart Pro Instructions For Use Manual

Dentsply Sirona
Instructions for Use X-Smart
Emission measurement
RF emissions according to CISPR 11
RF emissions according to CISPR 11
Harmonics according to IEC 61000-3-2
Voltage fluctuations / flicker according
to IEC 61000-3-3
67 98 487 D3778
D3778.201.01.02.02 2023-05
3.4

Electromagnetic compatibility

CAUTION
Under or over instrumentation due to electromagnetic interference!
The apex locator can be affected by electromagnetic fields. This may
lead to measurement errors. Strong influence is indicated by red
flashing of the distance display.
➢ Ensure that there are no sources of electromagnetic interference
close to the device.
The following information must be observed to ensure safe operation
regarding EMC aspects.
X-Smart Pro/Pro+ complies with the requirements for electromagnetic
compatibility (EMC) according to IEC 60601-1-2:2014/AMD1:2020
X-Smart Pro/Pro+ is designed for use in environments in professional
health care facilities.
X-Smart Pro/Pro+ is hereinafter referred to as UNIT.
Essential performance: The product has no clinical functions that are
not related to basic safety and whose loss or impairment would lead to
an unacceptable risk. (IEC 60601-1-2 sub-section 5.2.1.1b)
Environment: Professional healthcare environment (IEC 60601-1-2 sub-
section 5.2.1.1a )
3.4.1

Electromagnetic emission

The UNIT is intended for operation in the electromagnetic environment
specified below.
The customer or user of the UNIT should make sure that it is used in
such an environment.
Conformity
Group 1
Class B
Class A
Conform
3.4 Electromagnetic compatibility
Electromagnetic environment - guidelines
The UNIT uses RF energy only for its internal
function. Therefore, its RF emissions are very
low and are not likely to cause any interfer-
ence in nearby electronic equipment.
The UNIT is intended for use in all facilities,
including residential areas and in any facilities
connected directly to a public power supply
also providing electricity to buildings used for
residential purposes.
3 System description
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