17
tEChNiCal sPECiFiCatiONs
8.1.2
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.
Phenomenon
Basic EMC
standard or test
method
Immunity test levels
Electromagnetic
Environment Guidance
Electrostatic
discharge
(EsD)
IEC 61000-4-2
±8 kV on contact
±2 kv, ±4 kv, ±8 kv,
±15 kv in air
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 %.
radiated rF
IEC 61000-4-3
3 V/m
80 MHz - 2,7 GHz
80 % aM a 1 khz
Portable and mobile rF
communication devices
should not be used near any
part of the product, including
cables, except when they
respect the recommended
distances, calculated from the
equation applicable at the
frequency of the transmitter.
ratED power
frequency
magnetic
IEC 61000-4-8
30 a/m
50 Hz o 60 Hz
The magnetic fields at the
mains frequency should
have levels characteristic
of a typical location in a
commercial or hospital
environment.
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.
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