- 27 -
GB
Guidance and manufacturer’s declaration – Electromagnetic immunity
Enclosure port
The Translux 2Wave device is designed to work in the electromagnetic environment specifi ed below.
The client or user of the Translux 2Wave device should always make sure that it is used only in such environment.
Phenomenon
Basic EMC standard
or test method
Immunity test levels
Electromagnetic environment – Guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
±8 kV contact
±2 kV, ±4 kV, ±8 kV,
±15 kV air
Floors must be wood, concrete or ceramic. If the fl oor
is lined with synthetic materials, the relative humidity
should be at least 30 %
Radiated RF EM
fi elds
a)
IEC 61000-4-3
3 V/m
f)
80 MHz – 2,7 GHz
b)
80 % AM at 1 kHz
c)
Portable or mobile RF communication device must
not be used in close proximity of the product,
including its cables, except when these respect the
distances of separation recommended and calculat-
ed from the equation applicable to the frequency of
the transmitter.
Rated power
frequency magnetic
fi elds
d) e)
IEC 61000-4-8
30 A/m
g)
50 Hz or 60 Hz
Grid frequency magnetic fi elds should have levels
characteristic of a typical commercial or hospital
environment.
a) The interface between the PATIENT physiological signal simulation, if used, and the Translux 2Wave shall be located within 0,1 m of the vertical plane of the
uniform fi eld area in one orientation of the Translux 2Wave.
b) Translux 2Wave that intentionally receive RF electromagnetic energy for the purpose of their operation shall be tested at the frequency of reception. Testing
may be performed at other modulation frequencies identifi ed by the RISK MANAGEMENT PROCESS. This test assesses the BASIC SAFETY and ESSENTIAL
PERFORMANCE of an intentional receiver when an ambient signal is in the passband. It is understood that the receiver might not achieve normal reception
during the test.
c) Testing may be performed at other modulation frequencies identifi ed by the RISK MANAGEMENT PROCESS.
d) Applies only to Translux 2Wave with magnetically sensitive components or circuitry.
e) During the test, the Translux 2Wave may be powered at any NOMINAL input voltage, but with the same frequency as the test signal.
f) Before modulation is applied.
g) This test level assumes a minimum distance between the Translux 2Wave and sources of power frequency magnetic fi eld of at least 15 cm. If the RISK
ANALYSIS shows that the Translux 2Wave will be used close than 15 cm to sources of power frequency magnetic fi eld, the IMMUNITY TEST LEVEL shall be
adjusted as appropriate for the minimum expected distance.
1707_11667_GBA_Translux_2Wave_EU_NENA.indb GB27
1707_11667_GBA_Translux_2Wave_EU_NENA.indb GB27
07.09.17 16:22
07.09.17 16:22
