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BIOTRONIK ICS 3000 - Page 47

BIOTRONIK ICS 3000
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44 Electromagnetic Compatibility
Resistance to Electromagnetic Interference
(Tables 202 and 204)
When the measured field strength exceeds the
specified compliance level at the operating location of
the ICS 3000, observe the device in order to determine
whether it is functioning properly.
If abnormal performance is observed, additional
measures may be necessary, such as re-orienting or
relocating the device. In the frequency range of
150 kHz to 80 MHz, ensure that field strengths are
lower than 3 V/m.
Note: U
T
is the mains alternating voltage before applying the
test levels.
Test of Interference
Resistance
Test Level
According to
IEC 60601-1-2
Compliance Guidelines for the
Electromagnetic
Environment
Electrostatic discharge
(ESD)
According to
IEC 61000-4-2
±6 kV contact
discharge
±8 kV air
discharge
Same as test
level
Operate the devices on
floors made of wood,
concrete, or ceramic tile.
If the floor is covered with
synthetic material, the
relative humidity must be
at least 30%.
Fast transient electric
interference (bursts)
According to
IEC 61000-4-4
±2 kV for power
lines
±1 kV for input
and output lines
Same as test
level
Ensure that the power
supply quality is that of a
typical commercial and/
or hospital environment.
Surges
According to
IEC 61000-4-5
±1 kV push-pull
voltage
±2 kV push-
push voltage
Voltage drops, brief
interruptions, and
supply voltage
fluctuations
According to
IEC 61000-4-11
<5% U
T
for
1/2 period
>95% drop
40% U
T
for
5periods
60% drop
70% U
T
for
25 periods
30% drop
<5% U
T
for 5 s
>95% drop
Same as test
level
Ensure that the power
supply quality is that of a
typical commercial and/
or hospital environment.
If you require continued
operation during power
supply interruptions,
connect the device to an
uninterruptible power
supply or use a battery
for operation.

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