BIOTRONIK SE & Co. KG ICSPGH Manual De Usuario

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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 
5 periods
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.