Medtronic Aptus Heli-FX Gebrauchsanweisung Seite 16

The Heli-FX Applier is intended for use in the electromagnetic environment specified below. The customer or the user of the Heli-FX Applier should assure that it is
Emissions test
RF emissions
CISPR 11
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations/ Flicker emissions
IEC 61000-3-3
The Heli-FX Applier is intended for use in the electromagnetic environment specified below. The customer or the user of the Heli-FX Applier should assure that it is
Immunity test
Electrostatic discharge (ESD)
IEC 61000-4-2
Electrical fast transient/burst
IEC 61000-4-4
Surge
IEC 61000-4-5
Voltage dips, short interruptions, and volt-
age variations on power supply input lines
IEC 61000-4-11
Power frequency (50/60 Hz) magnetic
field
IEC 61000-4-8
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
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) and land mobile radios, amateur radio, AM and FM radio broadcast, and TV broadcast cannot be predicted with
theoretical 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
Heli-FX Applier is used exceeds the applicable RF compliance level above, the Heli-FX Applier should be observed to verify normal operation. If abnormal performance is observed, additional measures may
be necessary, such as reorienting or relocating the Heli-FX Applier.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Table 8. Recommended separation distances between portable and mobile RF communications equipment and the Heli- FX Applier
The Heli-FX Applier is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Heli-FX
Applier can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters)
and the Heli-FX Applier as recommended below, according to the maximum output power of the communications equipment.
Rated maximum output power of
transmitter
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.
Note: If electromagnetic interference is suspected, reorient the equipment with respect to the source of radiated interference. If interference continues, contact Medtronic for further
guidance.
14 Instructions for Use English
used in such an environment.
Compliance
Class B The Heli-FX Applier is suitable for use in all establishments, including domestic establishments.
Not applicable
Not applicable
Table 7. Guidance and manufacturer's declaration – electromagnetic immunity
used in such an environment.
IEC 60601 test level
±6 kV contact
±8 kV air
±2 kV for power supply lines
±1 kV for input/output lines
±1 kV lines to lines
±2 kV lines to earth
<5% U (>95% dip in U ) for
T T
0.5 cycle
40% U (60% dip in U ) for 5 cycles
T T
70% (30% dip in U ) for 25 cycles
T
<5% (>95% dip in U ) for 5 sec
T
Note: - U is the a.c. mains voltage prior to application of the test level.
T
3 A/m
3 Vrms
150 kHz to 80 MHz
3 V/m
80 MHz to 2.5 GHz
Separation distance according to frequency of transmitter
meters (m)
150 kHz to 80 MHz
d = 1.2√P
0.12
0.38
1.2
3.8
12
Electromagnetic environment–guidance
Compliance level
±6 kV contact
±8 kV air
Not applicable
Not applicable
Not applicable
3 A/m
3 Vrms
3 V/m
80 MHz to 800 MHz
d = 1.2√P
0.12
0.38
1.2
3.8
12
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%.
Power frequency magnetic fields should be at levels char-
acteristic 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 Heli-FX Applier, includ-
ing cables, than the recommended separation distance cal-
culated from the equation applicable to the frequency of
the transmitter.
Recommended separation distance
d = 1.2√P
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 trans-
mitter in watts (W) according to the transmitter manufac-
turer and d is the recommended separation distance in
meters (m).
Field strength from fixed RF transmitters, as determined by
a
an electromagnetic site survey , should be less than the
compliance level in each frequency range
Interference may occur in the vicinity of equipment marked
with the following symbol:
800 MHz to 2.5 GHz
d = 2.3√P
0.23
0.73
2.3
7.3
23
b
.