8.1.3.3
Parts Accessible to the Input / Output Signals
PIEZOSURGERY® white is designed to operate in the electromagnetic environment specified
below.
The customer or the user of PIEZOSURGERY® white should ensure that it is used in such an
environment.
Basic EMC
Phenomenon
standard or test
Electrostatic
discharges
IEC 61000-4-2
(ESD)
e)
Electrical fast
transients /
IEC 61000-4-4
bursts
b) f)
Surges Line-
IEC 61000-4-5
to-ground
a)
Conducted
disturbances
IEC 61000-4-6
induced by RF
fields
b) d) g)
a) This test applies only to output lines intended to
connect directly to outdoor cables.
b) SIP/SOPS whose maximum cable length is less than 3
m in length are excluded.
c) Testing may be performed at other modulation
frequencies identified by the RISK MANAGEMENT
PROCESS.
d) Calibration for current injection clamps shall be
performed in a 150 Ω system.
e) Connectors shall be tested per 8.3.2 and Table 4 of
IEC 61000-4-2:2008. For insulated connector shells,
perform air discharge testing to the connector shell
and the pins using the rounded tip finger of the ESD
generator, with the exception that the only connector
pins that are tested are those that can be contacted or
touched, under conditions of INTENDED USE, by the
standard test finger shown in Figure 6 of the general
standard, applied in a bent or straight position.
f) Capacitive coupling shall be used.
34
Immunity test levels
method
±8 kV on contact
±2 kV, ±4 kV, ±8 kV,
±15 kV in air
±1 kV on contact
100 KHz repetition
frequency
± 2kV
3 V
h)
0.15 MHz - 80 MHz
6 V
in the ISM bands
h)
between 0.15 MHz and
80 MHz
80 % AM a 1 KHz
Environment Guidance
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%.
The quality of the network
voltage should be that of a
typical commercial or hospital
environment.
The quality of the network
voltage should be that of a
typical commercial or hospital
environment.
Portable and mobile RF
communication devices
should not be used near any
part of the product, including
cables, except when they
respect the recommended
i)
distances, calculated from the
c)
equation applicable at the
frequency of the transmitter.
g) If the frequency stepping skips over an ISM or
amateur radio band, as applicable, an additional test
frequency shall be used in the ISM or amateur radio
band. This applies to each ISM and amateur radio
band within the specified frequency range.
h) R.M.S., before modulation os applied.
i) The ISM (industrial, scientific and medical) bands
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.
Electromagnetic