12(17)
Immunity test
IEC 60601
Test level
Compliance
level
Electromagnetic
environment - guidance
Electrostatic
discharge (ESD)
IEC 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
IEC 61000-4-4
±2 kV for power
supply lines
±1 kV for input/
output lines
N/A
1)
2)
N/A
Surge IEC 61000-4-5
±1 kV differential mode
±2 kV common mode
N/A
2)
N/A
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 cycle
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 sec
N/A
1)
N/A
Power frequency
(50/60 Hz)
magnetic filed
IEC 61000-4-8
3 A/m
3 A/m
Power frequency magnetic fields
should be at levels characteristic of a
typical location in a typical commercial
or hospital environment.
NOTE: U
T
is the a.c. mains voltage prior to application of the test level.
1)
No mains power input
2) Patient
connection
Guidance and manufacturer's declaration - electromagnetic immunity
The PressureWire® system is intended for use in the electromagnetic environment specified below.
The customer or the user of the PressureWire® system should assure that it is in such an
environment.
Immunity test
IEC 60601
Test level
Compliance
level
Electromagnetic environment
- guidance
Portable and mobile RF
communication equipment should
be used no closer to any part of the
PressureWir® system, including
cables, than the recommended
separation distance calculated from
the equation applicable to the
frequency of the transmitter.
Conducted RF
3 Vrms
N/A
d = 1,2
√
P
