C-4 MAC™ 3500 Resting ECG Analysis System Revision L
2021337-036
Electromagnetic Compatibility: Electromagnetic Compatibility (EMC)
Guidance and Manufacturer’s Declaration - Electromagnetic
Immunity
The MAC 3500 system is intended for use in the electromagnetic environment
specified below. It is the responsibility of the customer or user to ensure that the
MAC 3500 system is used in such an environment.
NOTE
Ut is the AC m
ains voltage prior to application of the test level.
Immunity Test EN 60601 Test Level Compliance Level Electromagnetic Environment - Guidance
Electrostatic discharge
(ES
D)
EN 61000-4-2
± 6 kV contact
± 8 kV air
± 6 kV contact
± 8 kV air
Floors should be wood, concrete or ceramic
tile. If floors are covered with synthetic
material, the relative humidity should be at
least 30%.
Electrical fast
transient/burst
EN 61000-4-4
± 2 kV for power supply lines
±1 kV for input/output lines
± 2 kV for power supply lines
±1 kV for input/output lines
Mains power should be that of a typical
commercial or h
ospital environment.
Surge
EN 61000-4-5
± 1 kV differential mode
± 2 kV common mode
± 1 kV differential mode
± 2 kV common mode
Mains power should be that of a typical
commercial or h
ospital environment.
Voltage dips, short
interruptions and
voltage va
riations on
power supply input
lines
EN 61000-4-11
<5% Ut (>95% dip in U
t
)
for 0.5 cycles
40% Ut (60% dip in U
t
)
for 5 cycles
70% Ut (30% dip in U
t
)
for 25 cycles
<5% Ut (>95% dip in U
t
)
for 5 sec
<5% Ut (>95% dip in U
t
)
for 0.5 cycles
40% Ut (60% dip in U
t
)
for 5 cycles
70% Ut (30% dip in U
t
)
for 25 cycles
<5% Ut (>95% dip in U
t
)
for 5 sec
Mains power should be that of a typical
commercial or h
ospital environment. If the
user of the MAC 3500 requires continued
operation during power mains interruptions,
it is recommended that the MAC 3500 be
powered from an uninterruptible power
supply or a battery.
Power frequency
(50/60 Hz) magnetic
field
EN 61000-4-8
3 A/m 3 A/m
Power frequency magnetic fields should be
at levels characteristics of a typical location
in a typical commercial or hospital
environment.