COMPACT PIEZO P2K
9.1.2
Accessible Parts of the Casing
COMPACT PIeZO P2K is designed to operate in the electromagnetic environment specified
below.
The purchaser or user of COMPACT PIEZO P2K 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
COMPACT PIEZO P2K, must be positioned within a 0.1
m radius of the vertical plane of the uniform field area
in the same direction as COMPACT PIEZO P2K.
b) COMPACT PIEZO P2K, 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.
34
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
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, COMPACT PIEZO P2K 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
COMPACT PIeZO P2K and the magnetic field sources
with a supply frequency of at least 15 cm. If the RISK
ANAlYSIS indicates that COMPACT PIeZO P2K 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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