Winback Back4 Manuel Utilisateur page 50

Conducted RF induced by
RF fields IEC 61000-4-6
Comment:
a) Not applicable to CLASS II medical electrical equipment and medical electrical systems.
b) The ISM (industrial, scientific and medical) bands between 0.15 MHz 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. The amateur radio
bands between 0.15 MHz and 80 MHz are 1.8 MHz to 2.0 MHz, 3.5 MHz to 4.0 MHz, 5.3 MHz to 5.4 MHz, 7 MHz
to 7,3 MHz, 10.1 MHz to 10.15 MHz, 14 MHz to 14.2 MHz, 18.07 MHz to 18.17 MHz, 21.0 MHz to 21.4 MHz, 24.89 MHz
to 24.99 MHz, 28.0 MHz to 29.7 MHz and 50.0 MHz to 54.0 MHz.
Guidance and manufacturer's declaration - electromagnetic immunity
The BACK4 is suitable for use in the specified electromagnetic environment. The customer and/or the user
of the BACK4 should assure that it is used in an electromagnetic environment as described below.
Immunity test
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
a. Field strengths from fixed transmitters, such as base stations for radio telephones (cellular/cordless)
and land mobile radios, amateur radio, AM and FM radio broadcast, and TV broadcast cannot be accurately
predicted theoretically. To assess the electromagnetic environment resulting from fixed transmitters, an
electromagnetic site survey should be considered. If the measured field strength in the location in which the
equipment and/or system is being used exceeds the applicable compliance level above, the BACK4 should
be checked to verify normal operation. If abnormal performance is observed, additional measures may be
necessary, such as reorienting or relocating the BACK4.
b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [V1] V/m.
NOTE : These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorp-
tion and reflection from structures, objects, and people.
50
3Vrms out-
3Vrms outside the
side the ISM
ISM band
band
6Vrms in the ISM
6Vrms in the
band
ISM band
IEC 60601-1-2 Compliance
Test Level Level
3Vrms out-
side the ISM 3Vrms outside the
band ISM band
6Vrms in the 6Vrms in the ISM
ISM band band
3V/m 3V/m (80MHz-
(80MHz- 2.7GHz)
2.7GHz)
Mains power quality should be that of a
professional healthcare facility environ-
ment.
Electromagnetic environment guidance
Portable and mobile RF equipment
should not be used at a distance less
than the recommended separation dis-
tance, calculated using the equation for
the transmitting frequency.
Recommended separation distance:
d = 1.2 √P
d = 1.2 √P 80 MHz to 800 MHz
d = 2.3 √P 800 MHz to 2,7 GHz
Where P is the maximum output power
rating of the transmitter in watts (W) ac-
cording to the transmitter manufacturer,
and d is the recommended separation
distance in meters (m).
Field strengths from fixed RF transmit-
ters, as determined by an electromag-
netic 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: