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Immunity test
Electrostatic
discharge (ESD)
IEC 61000-4-2
Electrical fast
transient/burst
IEC 61000-4-4
Surge IEC 61000-4-5
Voltage dips, short
interruptions and
voltage variations on
power supply input
lines IEC 61000-4-11
Power frequency
(50/60 Hz)
magnetic filed
IEC 61000-4-8
NOTE: U
is the a.c. mains voltage prior to application of the test level.
T
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
Conducted RF
IEC 60601
Compliance
Test level
level
±6 kV contact
±6 kV contact
±8 kV air
±8 kV air
±2 kV for power
N/A
supply lines
1)
±1 kV for input/
2)
output lines
±1 kV differential mode
N/A
±2 kV common mode
2)
N/A
<5% U
T
1)
(>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
3 A/m
3 A/m
IEC 60601
Compliance
Test level
level
3 Vrms
N/A
Electromagnetic
environment - guidance
Floors should be wood, concrete
or ceramic tile. If floors are covered
with synthetic material, the relative
humidity should be at least 30%.
N/A
N/A
N/A
Power frequency magnetic fields
should be at levels characteristic of a
typical location in a typical commercial
or hospital environment.
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.
d = 1,2√ P
12(17)
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