St.Jude Medical PressureWire Aeris Mode D'emploi page 11

RF emissions
CISPR 11
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations
/flicker emissions
IEC 61000-3-3
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 used in such an
environment.
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 to power
supply input lines
IEC 61000-4-11
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
N/A
Conducted RF
IEC 61000-4-6
2) No mains power input
3) No signal or interconnecting cables
Class B
N/A
No mains connection
N/A
No mains connection
IEC 60601 Compliance level
Test level
±6 kV contact ±6 kV contact
±8 kV air ±8 kV air
±2 kV for power N/A
supply lines
2)
±1 kV for input/
3)
output lines
±1 kV line(s) to line N/A
(s)
2)
±2 kV line(s) to earth
<5% U (>95% dip in N/A
T
U ) for 0,5 cycle
2)
T
40% U (60% dip in
T
U ) for 5 cycles
T
70% U (30% dip in
T
U ) for 25 cycles
T
<5% U (>95% dip in
T
U ) for 5 sec
T
3 A/m 3 A/m
N/A N/A
3 Vrms N/A
150 kHz to 80 MHz 2)
The PressureWire system is
suitable for use in all establishments
including domestic establishments
and those directly connected to the
public low-voltage power supply
network that supplies building for
domestic purposes.
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.
Portable and mobile RF communication
equipment should be used no closer to
any part of the PressureWire system,
including cables, than the recommended
separation distance calculated from the
equation applicable to the frequency of
the transmitter.
Recommended separation distance
N/A
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