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11.1.2 Accessible Parts of the Casing
multipiezo is designed to operate in the electromagnetic environment specified below.
The purchaser or user of multipiezo should ensure that it is used in such an environment.
Essential EMC
Phenomenon
standard or test
Electrostatic
discharge
IEC 61000-4-2
(ESD)
Radiated RF
IEC 61000-4-3
EM fields
a)
Magnetic field
at the mains
IEC 61000-4-8
frequency
d) e)
a) If used, the interface between the PATIENT'S
physiological signal simulation and multipiezo, must
be positioned within a 0.1 m radius of the vertical
plane of the uniform field area in the same direction
as multipiezo.
b) multipiezo, which intentionally receives RF
electromagnetic energy for its operation, must
be tested at the receiving frequency. The test can
be performed with other modulation frequencies
identified by the RISK MANAGEMENT PROCESS. This
test evaluates the BASIC SAFETY and ESSENTIAL
PERFORMANCE of an intentional receiver when
an environmental signal is in the passband. It is
understood that the receiver may not receive normally
during the test.
c) The test can be performed at other modulation
frequencies identified by the RISK MANAGEMENT
PROCESS.
Immunity test values
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 at 1 kHz
30 A/m
50 Hz or 60 Hz
TECHNICAL DATA
Environment Guidance
The floor must be made of
wood, concrete or ceramic
tiles. If floors are covered with
synthetic material, the relative
humidity should be at least
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)
and calculated distances from
the equation applicable at the
frequency of the transmitter.
Power supply frequency
magnetic fields should
have levels characteristic
g)
of a typical location in a
commercial or hospital
environment.
d) Only applicable to equipment and systems with
magnetically sensitive components or circuits.
e) During the tests, multipiezo can be supplied with any
NOMINAL input voltage, but with the same frequency
as the test signal.
f) Before applying the modulation.
g) This test value assumes a minimum distance between
multipiezo and the magnetic field sources with
a supply frequency of at least 15 cm. If the RISK
ANALYSIS indicates that multipiezo will be used less
than 15 cm from the sources of the magnetic field
with power frequency, the immunity test value should
be adjusted according to the minimum expected
distance.
Electromagnetic
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