Safety Manual

Electromagnetic Compatibility (EMC)
Table 9: EMC Immunity Test
Immunity Test EN60601 Test Level Compliance Level Electromagnetic
Environment–
Guidance
Electrostatic discharge
(ESD)
IEC 61000-4-2
± 8 kV contact
± 15 kV air
± 8 kV contact
± 15 kV air
Floors should be wood,
concrete, or ceramic
tile. If the floors are
covered with synthetic
material, the relative
humidity should be at
least 30%.
Electrical Fast
Transient/burst (EFT)
IEC 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 hospital
environment.
Surge
IEC 61000-4-5
± 1 kV line(s) to line(s)
± 2 kV line(s) to earth
± 1 kV line(s) to line(s)
± 2 kV line(s) to earth
Mains power should
be that of a typical
commercial or hospital
environment.
Voltage dips, short
interruptions, and
voltage variations on
power supply input
lines
IEC 61000-4-11
< 5% U
t
(> 95% dip in
U
t
) for 0.5 cycles
< 40% U
t
(> 60% dip in
U
t
) for 5 cycles
< 70% U
t
(> 30% dip in
U
t
) for 25 cycles
< 5% U
t
(> 95% dip in
U
t
) for 5 s
< 5% U
t
(> 95% dip in
U
t
) for 0.5 cycles
< 40% U
t
(> 60% dip in
U
t
) for 5 cycles
< 70% U
t
(> 30% dip in
U
t
) for 25 cycles
< 5% U
t
(> 95% dip in
U
t
) for 5 s
Mains power should
be that of a typical
commercial or hospital
environment.
U
t
is the AC mains
voltage prior to
application of the test
level.
If the user requires
continued system
operation during
power mains
interruptions, it is
recommended that
the system is powered
from an applicably
rated uninterruptible
power supply or a
battery.
Power frequency
(50/60 Hz) magnetic
field
IEC 61000-4-8
30 A/m 30 A/m Power frequency
magnetic fields
should be at levels
characteristic of a
typical location in a
typical commercial or
hospital environment.
2109599-003 A MAC
™
7 Resting ECG Analysis System 25