Electromagnetic Immunity - AtriCure P000880 Manual Del Usuario

AtriCure, Inc.
5.1.1
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
Electrical fast
transient/burst
IEC 61000-4-4
Surge
IEC 61000-4-5
Conducted RF
IEC 61000-4-6
Voltage dips,
short
interruptions
and voltage
variations on
power supply
input lines
IEC 61000-4-11
Power
frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
NOTE: U is the a.c. mains voltage prior to application of the test level.
T

Electromagnetic Immunity

IEC 60601 test level
± 8 kV contact
± 2 kV, ± 4 kV, ± 8 kV,
± 15 kV air
± 2 kV @ 100 kHz
repetition frequency for
power supply lines
± 2 kV @ 100 kHz
repetition frequency for
input/output lines
Power inputs
± 0,5 kV, ± 1 kV Line-
to-Line
± 0,5 kV, ± 1 kV, ± 2
kV Line-to-Ground
Signal input/outputs:
± 2 kV Line-to-Ground
0,15 MHz – 80 MHz
3V, 80 % AM at 1 kHz
ISM bands between
0,15 MHz and 80 MHz
6V, 80 % AM at 1 kHz
Voltage Dips:
0 % UT; 0,5 cycle
At 0°, 45°, 90°, 135°,
180°, 225°, 270° and
315° phase angles
0 % UT; 1 cycle and
70 % UT; 25/30 cycles
Single phase: at 0°
Voltage interruptions:
0 % UT; 250/300 cycle
30 A/m
50 Hz or 60 Hz
Compliance level
± 8 kV contact
± 2 kV, ± 4 kV, ± 8 kV,
± 15 kV air
± 2 kV @ 100 kHz
repetition frequency for
power supply lines
± 2 kV @ 100 kHz
repetition frequency for
input/output lines
Power inputs
± 0,5 kV, ± 1 kV Line-to-
Line
± 0,5 kV, ± 1 kV, ± 2 kV
Line-to-Ground
Signal input/outputs:
± 2 kV Line-to-Ground
0,15 MHz – 80 MHz
3V, 80 % AM at 1 kHz
ISM bands between
0,15 MHz and 80 MHz
6V, 80 % AM at 1 kHz
Voltage Dips:
0 % UT; 0,5 cycle
At 0°, 45°, 90°, 135°,
180°, 225°, 270° and
315° phase angles
0 % UT; 1 cycle
Single phase: at 0°
70 % UT; 25/30 cycles
Single phase: at 0°
Voltage interruptions:
0 % UT; 250/300 cycle
30 A/m
50 Hz or 60 Hz
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P000880.J
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 %.
Mains power quality should be
that of a typical commercial or
hospital environment.
Mains power quality should be
that of a typical commercial or
hospital environment.
Mains power quality should be
that of a typical commercial or
hospital environment.
Mains power quality should be
that of a typical commercial or
hospital environment. If the user of
the ARC-EPMS unit requires
continued operation during power
mains interruptions, it is
recommended that the
ARC-EPMS unit be powered from
an uninterruptible power supply or
a battery.
Power frequency magnetic fields
should be at levels characteristic
of a typical location in a typical
commercial or hospital
environment.