Page 157
Technical Data
12
User guide
Electromagnetic interferences
12.7
A
rt.
no.
: 0-48-
0227
Rev.:
g
DEFIGARD/PHYSIOGARD Touch 7
Conducted HF
IEC 61000-4-6
3 Veff between 150 kHz and
80 MHz outside of the ISM
frequency bands
a
10 Veff between 150 kHz and
80 MHz within the ISM frequency
bands
a
3 V
10 V
Radiated HF
IEC 61000-4-3
10 V/m 80 MHz to 2.5 GHz
10 V/m
20 V/m
SpO2 monitor:
between 80 MHz and 800 MHz
between 800 MHz and 2.5 GHz
ECG, Temp, NIBP monitoring and defibrillator:
between 80 MHz and 800 MHz
between 800 MHz and 2.5 GHz
where P is the maximum transmitting power of the transmitter
in Watt (W) according to manufacturer data, and d the
recommended minimum distance in metres (m)
b
.
The field strength of stationary HF transmitters (according to
an on-location measurement
c
) must not exceed the
conformity level for each frequency range
d
.
When operating the device near devices bearing the
symbol “ionising radiation”, interferences can occur.
Note 1
For 80 MHz to 800 MHz, the higher frequency range applies.
Note 2
These guidelines might not always be applicable. Electromagnetic radiation is influenced by absorption and reflection on
structures, objects and people.
a.
The ISM frequency bands (ISM = industrial, scientific, medical) 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 conformity levels within the ISM frequency bands between 150 kHz and 80 MHz and between 80 MHz and 2.5 GHz
serve to minimise the probability of interferences caused by mobile/portable communication equipment that accidentally happens to be in the
patient environment. The formula for the calculation of the recommended distance has been adapted by the factor 10/3 for transmitters in this
frequency range.
c.
The field strength of stationary transmitters, e.g. base stations for radio telephones (mobile or cordless) and portable radio
equipment, amateur radios, AM and FM radios and TV signals cannot be predicted accurately in a theoretical way. In order to analyse
electromagnetic environments caused by stationary HF transmitters, an electromagnetic analysis on site should be considered. If the measured
field strength exceeds the HF conformity level, it needs to be checked whether the
DEFIGARD/PHYSIOGARD Touch 7
can be used in this
environment. If an abnormal behaviour is detected, additional measures need to be taken, e.g. reorientation or change of location of the
DEFIGARD/PHYSIOGARD Touch 7
.
d.
For the frequency range between 150 kHz and 80 MHz, the field strength must be lower than 3 V/m.
Interference testing
IEC 60601 test level
Conformity lev-
el
Electromagnetic environment - explanations
d
3 5
,
3
-------
P
=
d
12
10
------
P
=
d
12
10
------
P
=
d
23
10
------
P
=
d
12
20
------
P
=
d
23
20
------
P
=
