9.1.2
Accessible Parts of the Casing
COMPACT PIeZO leD is designed to operate in the electromagnetic environment specified
below.
The purchaser or user of COMPACT PIEZO LED 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 LED, 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 LED.
b) COMPACT PIEZO LED, 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 com-
munication devices should
not be used near any part of
the product, including cables,
except when they respect the
b)
recommended and calculated
c)
distances from the equation
applicable at the frequency of
the transmitter.
Power supply frequency mag-
netic fields should have levels
g)
characteristic 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 LED 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 leD and the magnetic field sources
with a supply frequency of at least 15 cm. If the RISK
ANAlYSIS indicates that COMPACT PIeZO leD 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
37