Synovis GEM FlowCoupler GEM1020M Handbuch Seite 7

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, Group 1 The 20 MHz FlowCOUPLER Monitor system
CISPR 11 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 Class A The 20 MHz FlowCOUPLER Monitor meets
the conducted and radiated performance
CISPR 11
requirements for non-life supporting equipment
Power Not Applicable
and also meet the harmonic emissions, voltage
Harmonic (see Note)
dips and variations and voltage fluctuation
emissions
(flicker) requirements for non-life supporting
equipment pursuant to IEC 60601-1-2:2007 and
Voltage Not Applicable
CISPR 11, A1 & A2, and IEC 61000-3-3.
fluctuations/ (see Note)
flicker The 20 MHz FlowCOUPLER Monitor is
emissions 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.
NOTE: Outside the scope of the standard.
Guidance and manufacturer's declaration – electromagnetic
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 Compliance
test level level
Electrostatic ±6 kV contact ±2, ±4 and
discharge (ESD) ±6kV Contact
±8 kV air
Discharge.
IEC 61000-4-2
±2, ±4, and
±8 kV Air
Discharge
Electrical fast ±2 kV AC Mains ±2 kV AC
transient/burst Mains
±1 kV I/O Ports
IEC 61000-4-4 ±2 kV I/O Ports
Surge ±1 kV line(s) to
line(s)
IEC 61000-4-5
±2 kV line(s) to
earth
Voltage <5% U
dips, short in U
interruptions
40% U
and voltage
U ) for 5 cycles
T
variations on
70% U
power supply
U ) for 25 cycles
input lines.
T
<5% U
IEC 61000-4-11
in U
Power 3 A/m
frequency (50/60
Hz) magnetic
field
IEC 61000-4-8
immunityy
Conducted RF 3 V rms
IEC 61000-4-6
150 kHz to 80 MHz
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%.
Mains power quality
should be that of a typical
commercial or hospital
environment.
±1 kV line to Mains power quality
line (DM) should be that of a typical
commercial or hospital
±2 kV line(s) to
environment.
earth (CM)
(>95% dip 10 ms >95% dip Mains power quality
T
) for 0,5 cycle.) (0.5 period) should be that of a
T
typical commercial or
(60% dip in 100 ms 60% dip
T
hospital environment. If
(5 periods)
the user of the 20 MHz
(30% dip in 500 ms 30% dip
FlowCOUPLER Monitor
T
(25 periods)
requires continued
(>95% dip 5 seconds > 95%
operation during power
T
) for 5s dip/interruptions
mains interruptions, it is
T
recommended that the
(300 periods)
FlowCOUPLER Monitor
system be powered from
an uninterruptible power
supply or the built-in
battery.
3 A/m 50 Hz Power frequency magnetic
& 60 Hz three fields should be at levels
orthogonal characteristic of a typical
orientations 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:
[V }V=3 Vrms d=[3.5/V ]√P=1.2√P
1 1
7 7
Radiated RF 3 V/m E =3V/m
1
IEC 61000-4-3
80 MHz to 2,5 GHz
NOTE: U is the a.c. mains voltage prior to application of the test level.
T
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.
a Field 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.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than
3 V/m.
d=[3.5/E ]√P=1.2√P
1
80 MHz to 800 MHz
d=[7/E ]√P=2.3√P
1
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,
a should be less than the
compliance level in each
frequency range.
b
Interference may occur in
the vicinity of equipment
marked with the following
symbol: