52
Manufacturer‘s Declaration - Electromagnetic Interference Immunity III
The device is approved for use in a specifi c electromagnetic environment.
The customer or user of the device must ensure that it is used in an electromagnetic environment as described below
ATTENTION: The use of this device directly adjacent to or coupled to another unit should be avoided as it may lead to
unintentional behaviour. However, if this arrangement is unavoidable, both devices must be observed to verify that they are
functioning normally.
CAUTION: Portable RF-communication equipment (including antenna cables or external antennas) should not be
closer than 30 cm to the ME-equipment or ME-system, including those cables specifi ed by the manufacturer. Otherwise, a
power limitation of the device could be caused.
Manufacturer‘s Declaration - Recommended Protective Distances between Portable or Mobile RF-Communication
Equipment and the Device
The device is intended for use in an electromagnetic environment where the radiated RF-disturbance variables are checked.
The customer or user of the device can help to prevent electromagnetic interference by maintaining a minimum distance
between portable and mobile RF-communication equipment (transmitters) and the device in accordance with the following
recommendations, which are based on the maximum output power and frequency of the communication device.
Interference Immunity
Test
IEC 60601-
test level
Compliance level
Electromagnetic environment –
guidelines
Fluctuations in the mains
frequency and mains volta-
ge according to IEC
601-1, section 10.2.2. a
(only for V 300/600)
Nominal frequency: up
to 100 Hz:
variationsof ± 1 Hz of
the
nominal frequency;
variations
of ± 10%Hz of theno-
minal voltage
Nennfrequenz: bis
zu 100 Hz:
Schwankungen
von± 1 Hz der
Nennfrequenz;
Schwankungen
von± 10%Hz der
Nennspannung
The quality of the mains voltage supply should
meet the requirements of a normal commercial or
clinical environment.
Maximum nominal power of
the transmitter in watts
(W)
Protective distance as a function of the frequency of the transmitter in metres (m)
150 kHz to 80 MHz
d = 1,2√P
80 MHz to 800 MHz
d = 1,2√P
800 MHz to 2,5 GHz
d = 2,3√P
0,01
0,12
0,12
0,23
0,1
0,38
0,38
0,73
1
1,2
1,2
2,3
10
3,8
3,8
7,3
100
12
12
23
For transmitters with a maximum output power not specifi ed above, the recommended safety distance d in meters (m) can be calculated
with an equation from the transmitter frequency and the maximum nominal output power P of the transmitter in watts (W) based on the
transmitter manufacturer‘s specifi cations.
Note 1:
At 80 MHz and 800 MHz respectively, the larger frequency range applies.
Note 2:
These guidelines may not apply to all situations. The propagation of electromagnetic waves is aff ected by the absorption and
refl ection of structures, objects, people and animals.
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