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Guidance and Manufacturer’s Declaration - Electromagnetic Immunity:
The Concentrator is intended for use in the electromagnetic environment specified below. The user of the
Concentrator should make sure it is used in such an environment.
Immunity Test
IEC 60601
Test Level
Compliance
Level
Electromagnetic
Environment - Guidance
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 Vrms
150 kHz
to 80 MHz
6Vrms at various
bands per standard
10V/m
80 MHz
to 6.0 GHz
3 Vrms
6Vrms at various
bands per standard
10V/m
Portable and mobile RF communications
equipment should be used no closer to any
part of the device, including cables, than the
recommended separation distance calculated
from the equation applicable to the frequency of
the transmitter.
Recommended separation distance:
d=1.2√P 150 kHz to 80 MHz
d=1.2√P 80 MHz to 800 MHz
d=2.3√P 800 MHz to 2.5 GHz
Where P is the maximum output power rating
of the transmitter in watts (W) according to
the transmitter manufacturer and d is the
recommended separation distance in meters (m).
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey a,
should be less than the compliance level in each
frequency rangeb.
As a condition observed to ensure compliance
with current FCC RF exposure guidelines,
maintain at least 6 cm separation distance
between the antenna and the user’s body at all
times.
Interference may occur in the vicinity of
equipment marked with the following symbol:
Electrostatic
discharge (ESD)
IEC 61000-4-2
± 8 kV contact
± 15 kV air
± 8 kV contact
± 15 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
EC 61000-4-4
± 2 kV for power
supply lines
± 1 kV for input/
output lines
± 2 kV for power
supply lines
± 1 kV for input/
output lines
Mains power quality should be that of a typical
commercial or hospital environment.
Surge
IEC 61000-4-5
± 1 kV line(s) to line(s)
± 2 kV line(s) to earth
± 1 kV line(s) to line(s)
± 2 kV line(s) to earth
Mains power quality should be that of a typical
commercial or hospital environment. Inbed 6cm
distance info somewhere
Voltage
dips, short
interruptions
and voltage
variations on
power supply
input lines
IEC 61000-4-11
0% U
T
for 0.5 cycle at
0 °, 45 °, 90 °, 135 °,
180 °, 225 °, 270 °, and
315 °.
0% U
T
for 1 cycle
70% U
T
for 25/30 cycle
0% U
T
for 200/300
cycle
0% U
T
for 0.5 cycle at
0 °, 45 °, 90 °, 135 °,
180 °, 225 °, 270 °, and
315 °.
0% U
T
for 1 cycle
70% U
T
for 25/30 cycle
0% U
T
for 200/300
cycle
Mains power quality should be that of a typical
commercial or hospital environment. If the user
of the [ME EQUIPMENT or ME SYSTEM] requires
continued operation during power mains
interruptions, it is recommended that the
[ME EQUIPMENT or ME SYSTEM] be powered
from an uninterrupted power supply or a battery.
Power
frequency
(50/60 Hz)
magnetic
field
IEC 61000-4-8
30 A/m
30 A/m
Power frequency magnetic fields should be at
levels characteristic of a typical location in a
typical hospital or home environment.
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