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English
Guidance and Manufacturer’s Declaration - Electromagnetic Immunity:
This device is intended for use in the electromagnetic environment specified below. The user of this device should make
sure it is used in such an environment.
Immunity Test
IEC60601 test level
Compliance Electromagnetic Environment-Guidance
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3Vrms150 kHz to 80
MHz outside ISM
bands
a
3 V/m 80 MHz to 2.5
GHz
3 Vrms
3 V/m
Portable and mobile RF communications equipment should be
used no closer to any part of this device, including cables, than
there commended separation distance calculated from the
equation applicable to the frequency of the transmitter.
Recommended separation distance
P
d
2
.
1
=
150kHz to 80MHz
P
d
2
.
1
=
150kHz to 80MHz
P
d
3
.
2
=
80 MHz to 2.5G MHz
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).
b
Field strengths from fixed RF transmitters, as determined by an
electromagnetic site survey
c
, should be less than the
compliance level in each frequency range
d
.
Interference may occur in the vicinity of equipment marked with
the following symbol:
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.
c) Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones 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 device is used exceeds the applicable RF compliance level above, the device
should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as
reorienting or relocating the device.
d) Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
