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multipiezo
11.4.2 Points of Contact with the Patient
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
discharges
IEC 61000-4-2
(ESD)
c)
Conducted
disturbances
IEC 61000-4-6
induced by RF
fields
a)
a) The following apply:
• All connection cables with the patient must be tested,
either individually or grouped together.
• The connection cables with the patient must be
tested using a current clamp unless the current clamp
is not suitable. If a current clamp is not suitable, an
EM clamp must be used.
• In any case, no intentional decoupling device should
be used between the injection site and POINT OF
CONNECTION TO THE PATIENT.
• The tests can be performed with other modulation
frequencies identified by the RISK MANAGEMENT
PROCESS.
• The tubes that are intentionally filled with conductive
liquids and intended to be placed in contact with the
PATIENT must be considered connection cables with
the patient.
62
Immunity test values
method
±8 kv on contact
±2 kv, ±4 kv, ±8 kv,
±15 kv in air
3 V
b)
0.15 MHz - 80 MHz
6 V
in ISM bands
b)
between 0.15 MHz and
80 MHz
80% AM at 1 KHz
Electromagnetic
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
respect the recommended
distances, calculated from the
equation applicable at the
frequency of the transmitter.
• If an ISM or amateur radio band is not present
among the frequency samples, as appropriate, an
additional test frequency has to be used in the ISM
band or in the amateur radio band. This applies
to each ISM and amateur radio band within the
specified frequency range.
• The ISM bands (industrial, scientific and medical)
between 0.15 MHz and 80 MHz are 6.765 MHz to
6.795 MHz; 13.553 MHz to 13.567 MHz; 26.957 MHz
to 27.283 MHz; and 40.66 MHz to 40.70 MHz. The
amateur radio bands between 0.15 MHz and 80
MHz are 1.8 MHz to 2.0 MHz, 3.5 MHz to 4.0 MHz,
5.3 MHz to 5.4 MHz, 7 MHz to 7.3 MHz, 10.1 MHz
to 10.15 MHz, 14 MHz to 14.2 MHz, 18.07 MHz to
18.17 MHz, 21.0 MHz to 21.4 MHz, 24.89 MHz to
24.99 MHz, 28.0 MHz to 29.7 MHz and 50.0 MHz to
54.0 MHz.
b) R.M.S., applied before modulation.
c) The discharges must be applied without connection
to an artificial hand and without connection to the
PATIENT simulation. The PATIENT simulation can be
connected after the test, if necessary, to verify BASIC
SAFETY and ESSENTIAL PERFORMANCE.
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