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11.1.2 Accessible Parts of the Casing
the device is designed to operate in the electromagnetic environment specified below.
The customer or the user of the device should ensure that it is used in such environment.
Basic EMC
Phenomenon
standard or test
Electrostatic
discharge
IEC 61000-4-2
(ESD)
Radiated RF
IEC 61000-4-3
EM fields
a)
RATED power
frequency
IEC 61000-4-8
magnetic
fields
d) e)
a) The interface between the PATIENT physiological signal simulation, if used, and the device shall be located within 0,1 m
of the vertical plane of the uniform field area in one orientation of the device.
b) the device that intentionally receives RF electromagnetic energy for the purpose of its operation shall be tested
at the frequency of reception. testing may be performed at other modulation frequencies identified 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 identified by the RISK MANAGEMENt PROCESS.
d) Applies only to ME EQUIPMENt and ME SYStEMS with magnetically sensitive components or circuitry.
e) During the test, the device 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 device and sources of power frequency magnetic field of at
least 15 cm. If the RISK ANALYSIS shows that the device will be used closer than 15 cm to sources of power frequency
magnetic field, the IMMUNItY tESt LEVEL shall be adjusted as appropriate for the minimum expected distance.
Immunity test levels
method
±8 kV on contact
±2 kV, ±4 kV, ±8 kV,
±15 kV in air
3 V/m
f)
80 MHz - 2,7 GHz
80 % AM a 1 kHz
30 A/m
50 Hz o 60 Hz
tECHNICAL SPECIFICAtIONS
Environment Guidance
the floor must be made of
wood, concrete or ceramic
tiles. If the floor is covered
with synthetic material, the
relative humidity should be at
least equal to 30 %.
Portable and mobile RF
communication devices
should not be used near any
part of the product, including
cables, except when they
b)
respect the recommended
c)
distances, calculated from the
equation applicable at the
frequency of the transmitter.
the magnetic fields at the
mains frequency should
have levels characteristic
g)
of a typical location in a
commercial or hospital
environment.
Electromagnetic
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