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Guidance and manufacturer’s declaration – electromagnetic emissions
The 20 MHz FlowCOUPLER Monitor system is intended for use in the
electromagnetic environment specified below. The user of the 20 MHz
FlowCOUPLER Monitor should assure that it is used in such an environment.
Emissions Test Compliance Electromagnetic Environment -- guidance
RF Emissions,
CISPR 11 Group 1 The 20 MHz FlowCOUPLER Monitor system
uses RF energy only for its internal function.
Therefore, its RF emissions are very low and
are not likely to cause any interference in nearby
electronic equipment.
RF Emissions
CISPR 11
Class A The 20 MHz FlowCOUPLER Monitor meets
the conducted and radiated performance
requirements for non-life supporting equipment
and also meet the harmonic emissions, voltage
dips and variations and voltage fluctuation
(flicker) requirements for non-life supporting
equipment pursuant to IEC 60601-1-2:2007 and
CISPR 11, A1 & A2, and IEC 61000-3-3.
The 20 MHz FlowCOUPLER Monitor is
suitable for use in all establishments other
than domestic, and may be used in domestic
establishments and those directly connected to the
public low-voltage power supply network that
supplies buildings used for domestic purposes,
provided the following warning is heeded:
Caution The FlowCOUPLER Monitor is
intended for use by healthcare professionals
only. The FlowCOUPLER Monitor and
system may cause radio interference or may
disrupt the operation of nearby equipment. It
may be necessary to take mitigation measures,
such as re-orienting or relocating the 20 MHz
FlowCOUPLER Monitor system or shielding
the location.
Power
Harmonic
emissions
Not Applicable
(see Note)
Voltage
fluctuations/
flicker
emissions
Not Applicable
(see Note)
NOTE: Outside the scope of the standard.
Guidance and manufacturer’s declaration – electromagnetic immunityy
The 20 MHz FlowCOUPLER Monitor is intended for use in the electromagnetic
environment specified below. The customer or the user of the 20 MHz
FlowCOUPLER Monitor should assure that it is used in such an environment.
Immunity test IEC 60601
test level Compliance
level Electromagnetic
environment -- guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
±6 kV contact
±8 kV air
±2, ±4 and
±6kV Contact
Discharge.
±2, ±4, and
±8 kV Air
Discharge
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 AC Mains
±1 kV I/O Ports
±2 kV AC
Mains
±2 kV I/O Ports
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 to
line (DM)
±2 kV line(s) to
earth (CM)
Mains power quality
should be that of a typical
commercial or hospital
environment.
Voltage
dips, short
interruptions
and voltage
variations on
power supply
input lines.
IEC 61000-4-11
<5% UT(>95% dip
in UT) for 0,5 cycle.)
40% UT(60% dip in
UT) for 5 cycles
70% UT(30% dip in
UT) for 25 cycles
<5% UT(>95% dip
in UT) for 5s
10 ms >95% dip
(0.5 period)
100 ms 60% dip
(5 periods)
500 ms 30% dip
(25 periods)
5 seconds > 95%
dip/interruptions
(300 periods)
Mains power quality
should be that of a
typical commercial or
hospital environment. If
the user of the 20 MHz
FlowCOUPLER Monitor
requires continued
operation during power
mains interruptions, it is
recommended that the
FlowCOUPLER Monitor
system be powered from
an uninterruptible power
supply or the built-in
battery.
Power
frequency (50/60
Hz) magnetic
field
IEC 61000-4-8
3 A/m 3 A/m 50 Hz
& 60 Hz three
orthogonal
orientations
Power frequency magnetic
fields should be at levels
characteristic of a typical
location in a typical
commercial or hospital
environment.
Portable and mobile
RF communications
equipment should be
used no closer to any part
of the Doppler system,
including cables, than the
recommended separation
distance calculated from
the equation applicable
to the frequency of the
transmitter.
Recommended separation
distance:
Conducted RF
IEC 61000-4-6 3 V rms
150 kHz to 80 MHz
[V1}V=3 Vrms d=[3.5/V1]√P=1.2√P
Radiated RF
IEC 61000-4-3 3 V/m
80 MHz to 2,5 GHz
E1=3V/m d=[3.5/E1]√P=1.2√P
80 MHz to 800 MHz
d=[7/E1]√P=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
metres (m)
Field strengths from
fixed RF transmitters,
as determined by an
electromagnetic site survey,
ashould be less than the
compliance level in each
frequency range.b
Interference may occur in
the vicinity of equipment
marked with the following
symbol:
NOTE: UTis the a.c. mains voltage prior to application of the test level.
NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic
propagation is affected by absorption and reflection from structures, objects and
people.
aField strengths from fixed transmitters, such as base stations for radio (cellular/
cordless telephones and land mobile radios, amateur radio, AM and FM radio
broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess
the electromagnetic environment due to fixed RF transmitters, an electromagnetic
site survey should be considered. If the measured field strength in the location in
which the Doppler system is used exceeds the applicable RF compliance level above,
the Doppler system should be observed to verify normal operation. If abnormal
performance is observed, additional measures may be necessary, such as re-orienting
or relocating the Doppler system.
bOver the frequency range 150 kHz to 80 MHz, field strengths should be less than
3 V/m.
