Medtronic lifepak 12 Gebrauchsanweisung Seite 302

Konformitätserklärung/Richtlinien zur elektromagnetischen Verträglichkeit
Guidance and Manufacturer's Declaration - Electromagnetic Immunity
Table H-3
The LIFEPAK 12 defibrillator/monitor system is intended for use in the electromagnetic environment
specified below. The customer or the user of the LIFEPAK 12 defibrillator/monitor system should ensure
that the device is used in such an electromagnetic environment.
Immunity Test IEC 60601 Test Level
Conducted RF 3 Vrms
IEC 61000-4-6 150 kHz to 80 MHz
outside ISM bands
10 Vrms
150 kHz to 80 MHz
in ISM bands
Radiated RF 10 V/m
IEC 61000-4-3 80 MHz to 2.5 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.
a.The ISM (industrial, scientific and medical) bands between 150 kHz and 80 MHz are 6,765 MHz to 6,795 MHz;
13,553 MHz to 13,567 MHz; 26,957 MHz to 27,283 MHz; and 40,66 MHz to 40,70 MHz.
b.The compliance levels in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz
to 2.5 GHz are intended to decrease the likelihood that mobile/portable communications equipment could cause
interference if it is inadvertently brought into patient areas. For this reason, an additional factor of 10/3 is used in
calculating the recommended separation distance for transmitters in these frequency ranges.
H-4
Compliance Electromagnetic Environment - Guidance
Level
Portable and mobile RF communications
equipment should be used no closer to any part
of the LIFEPAK 12 defibrillator/monitor system,
including cables, than the recommended
separation distance calculated from the equation
applicable to the frequency of the transmitter.
Recommended separation distance
3 Vrms d = 1.2
a
10 Vrms d = 1.2
a
10 V/m d = 1.2
d = 2.3
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.
Interference may occur in the vicinity of
equipment marked with the following symbol:
√ P
√ P
√ P 80 MHz to 800 MHz
P 800 MHz to 2.5 GHz
√
b
d
LIFEPAK 12 Defibrillatoren/Monitore Gebrauchsanweisung
c