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IX. Environmental Specifications
Guidance and Manufacturer’s Declaration - Electromagnetic Emissions
Medical electronic devices are designed to ensure electromagnetic compatibility (EMC).
Portable and mobile RF communications devices may affect medical electronic devices.
Do not place the
Monarch
next to or on top of another device when using it. If it has to be placed
next to or on top of another device, check that this instrument and the device function properly
before use. If accessories other than those supplied as spare parts by NeuroSigma are used, the
emission of the
Monarch
may increase and immunity may be reduced.
The
Monarch
eTNS System is intended for use in the electromagnetic environment specified
in the following tables. The customer or the user of the
Monarch
®
should assure that it is used
in such an environment.
Emissions test
Compliance
Electromagnetic Environment— guidance
RF emissions
CISPR 11
Group 1
The
Monarch
uses RF energy for its internal function. Therefore, its RF
emissions are very low and are not likely to cause any interference in nearby
electronic equipment.
RF emissions
CISPR 11
Class B
The
Monarch
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.
Harmonic emissions
IEC 61000-3-2
Class A
Voltage fluctuations/flicker
emissions
IEC 61000-3-3
Complies
