Electromagnetic Immunity - AtriCure System Cart Manual Del Usuario

The ARC-EPMS can radiate radio frequency energy and, if not installed and used in
accordance with the instructions, may cause harmful interference to other devices
in the vicinity. However, there is no guarantee that interference will not occur in a
particular installation.
Guidance and manufacturer's declaration – electromagnetic emissions
The AtriCure RF, Cryo, and EP Mapping System (ARC-EPMS) is intended for use in the electromagnetic
environment specified below. The customer or the user of the ARC-EPMS unit should ensure that it is used
in such an environment.
Emissions test
RF emissions CISPR 11
RF emissions
CISPR 11
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations/
flicker emissions
IEC 61000-3-3

5.1.1. Electromagnetic Immunity

Guidance and manufacturer's declaration – electromagnetic immunity
The AtriCure RF, Cryo, and EP Mapping System (ARC-EPMS) is intended for use in the electromagnetic
environment specified below. The customer or the user of the ARC-EPMS unit should ensure that it is used
in such an environment.
Immunity test
Electrostatic
discharge (ESD) IEC
61000-4-2
Compliance
Group 1
Class A
Class A
Complies
IEC 60601 test
level
± 8 kV contact
± 2 kV, ± 4 kV, ± 8 kV,
± 15 kV air
Electromagnetic environment –
guidance
The ARC-EPMS unit, with the exception of the
ASU2 / ASU3 RF Generator only during RF ener-
gy delivery, uses RF energy only for its internal
function. Therefore, its RF emissions are very
low and are not likely to cause any interference
in nearby electronic equipment.
The ARC-EPMS unit is suitable for use in all
establishments other than domestic and those
directly connected to the public low-voltage
power supply network that supplies buildings
used for domestic purposes.
Compliance level
± 8 kV contact
± 2 kV, ± 4 kV, ± 8 kV,
± 15 kV air
7
Electromagnetic
environment –
guidance
Floors should be wood,
concrete, or ceramic tile.
If floors are covered with
synthetic material, the
relative humidity should
be at least 30 %.
2021/09 | P000880.L