Equipment And The Directlink - Depuy Synthes CODMAN NEURO DirectLink ICP Module Betriebsanleitung

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
Voltage dips, short
interruptions and
voltage variations
on power supply Not Applicable
input lines
IEC 61000-4-11
Power frequency
(50/60 Hz)
magnetic field 3 A/m
IEC 61000-4-8
NOTE U is the AC mains voltage prior to application of the test level.
T
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 Compliance
IMMUNITY test test level level
Conducted RF 3 Vrms 3 Vrms
IEC 61000-4-6 150 kHz to
80 MHz
3 V/m
Radiated RF 80 MHz to
IEC 61000-4-3 2.5 GHz 3 V/m
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/cordless) telephones
a
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.
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
b
Table 2
Electromagnetic environment
Compliance level
– guidance
Not Applicable Not Applicable
Power frequency magnetic fields
should be at levels characteristic
3 A/m
of a typical location in a typical
commercial or hospital environment.
Table 3
Electromagnetic environment – 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
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,
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:
Recommended separation distances between portable and mobile RF communications
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.
Rated maximum
output power of
150 kHz to 80 MHz
transmitter
d = 1.2 √ P
W
0.01
0.1
1
10
100
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.
Figure 1a
A
a
B
A. DirectLink ICP Module
B. ICP Extension Cable
8
Table 4

equipment and the DirectLink

Separation distance according to frequency of transmitter m
80 MHz to 800 MHz
d = 1.2 √ P
0.12 0.12
0.38 0.38
1.2 1.2
3.8 3.8
12 12
Figure 1b
Label on back panel of module
800 MHz to 2.5 GHz
d = 2.3 √ P
0.23
0.73
2.3
7.3
23