Codman DirectLink ICP Gebrauchsanleitung Seite 9

The equipment should not be used adjacent to or stacked with
other equipment. If adjacent or stacked use is necessary, the
equipment should be observed to verify normal operation in
the configuration in which it will be used.
Guidance and manufacturer's declaration – electromagnetic emissions
The DirectLink is intended for use in the electromagnetic environment specified
below. The customer or the user of the DirectLink should ensure that it is used in such
an environment.
Emissions test Compliance
RF emissions
Group 1
CISPR 11
RF emissions
Class A
CISPR 11
Harmonic emissions
Not Applicable
IEC 61000-3-2
Voltage
fluctuations/flicker
Not Applicable
emissions
IEC 61000-3-3
Guidance and manufacturer's declaration – electromagnetic immunity
The DirectLink is intended for use in the electromagnetic environment specified
below. The customer or the user of the DirectLink should ensure that it is used in such
an environment.
IEC 60601
IMMUNITY test
test level
+/- 8 kV contact
Electrostatic
+/- 2 kV, +/- 4 kV,
discharge (ESD)
+/- 8 kV,
IEC 61000-4-2
+/- 15 kV air
± 2 kV for power
Electrical fast
supply lines
transient/burst
± 1 kV for input/
IEC 61000-4-4
output lines
Power frequency
(50/60 Hz)
magnetic field 30 A/m
IEC 61000-4-8
NOTE U is the AC mains voltage prior to application of the test level.
T
Table 1
Electromagnetic environment – guidance
The DirectLink 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.
The DirectLink is suitable for use in all
establishments other than domestic and
those directly connected to the public low-
voltage power supply network that supplies
buildings used for domestic purposes.
Table 2
Electromagnetic
Compliance level
environment – guidance
+/- 8 kV contact Floors should be wood,
concrete or ceramic tile.
+/- 2 kV, +/- 4 kV, If floors are covered with
+/- 8 kV, synthetic material, the
+/- 15 kV air relative humidity should be
at least 30 %.
± 2 kV for power
Mains power quality
supply lines
should be that of a typical
commercial or hospital
± 1 kV for input/
environment.
output lines
Power frequency magnetic
fields should be at levels
characteristic of a typical
30 A/m
location in a typical
commercial or hospital
environment.
Guidance and manufacturer's declaration – electromagnetic immunity
The DirectLink is intended for use in the electromagnetic environment specified
below. The customer or the user of the DirectLink should ensure that it is used in such
an environment.
IMMUNITY IEC 60601
test test level
Conducted RF 3 Vrms
IEC 61000-4-6 150 kHz to
80 MHz
3 V/m
Radiated RF 80 MHz to
IEC 61000-4-3 2.7 GHz
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.
Field strengths from fixed transmitters, such as base stations for radio (cellular/
a
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 DirectLink is used exceeds the applicable RF compliance level above, the
DirectLink should be observed to verify normal operation. If abnormal performance
is observed, additional measures may be necessary, such as re-orienting or relocating
the DirectLink.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than
3 V/m.
Recommended separation distances between portable and mobile RF
communications equipment and the DirectLink
The DirectLink is intended for use in an electromagnetic environment in which radiated
RF disturbances are controlled. The customer or the user of the DirectLink can help
prevent electromagnetic interference by maintaining a minimum distance between
portable and mobile RF communications equipment (transmitters) and the DirectLink as
recommended below, according to the maximum output power of the communications
equipment.
Separation distance according to frequency of transmitter m
Rated maximum
output power of
150 kHz to 80 MHz
transmitter
d = 1.2 √ P
W
0.01 0.12
0.1 0.38
1 1.2
10 3.8
100 12
For transmitters rated at a maximum output power not listed above, the recommended
separation distance d in meters (m) can be estimated using the equation applicable to
the frequency of the transmitter, where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for 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.
9
EN – ENGLISH
Table 3
Compliance Electromagnetic environment –
level guidance
Portable and mobile RF
communications equipment should
be used no closer to any part of
the DirectLink, 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 80 MHz to 800 MHz
3 Vrms
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
3 V/m
recommended separation distance in
meters (m).
Field strengths from fixed RF
transmitters, as determined by an
electromagnetic site survey,
be less than the compliance level in
each frequency range. b
Interference may occur in the vicinity
of equipment marked with the
following symbol:
Table 4
80 MHz to 800 MHz
d = 1.2 √ P
0.12
0.38
1.2
3.8
12
a should
800 MHz to
2.5 GHz
d = 2.3 √ P
0.23
0.73
2.3
7.3
23