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8.1.3 Guidance and Manufacturer’s Declaration - Electromagnetic
Immunity
8.1.3.1 Power Connection A.C. Input
PIEZOSURGERY® GP is designed to operate in the electromagnetic environment specified
below.
The customer or the user of PIEZOSURGERY® GP should ensure that it is used in such an
environment.
Phenomenon
Basic EMC
standard or test
method
Immunity test levels
Electromagnetic
Environment Guidance
Electrical fast
transients /
bursts
a) l) o)
IEC 61000-4-4
±2 kV on contact
100 KHz repetition
frequency
The quality of the network
voltage should be that of a
typical commercial or hospital
environment.
Surges
a) b) j) o)
Line-to-line
IEC 61000-4-5 ± 0.5 kV, ± 1 kV
The quality of the network
voltage should be that of a
typical commercial or hospital
environment.
Surges
a) b) j) k) o)
Line-to-
ground
IEC 61000-4-5 ± 0.5 kV, ± 1 kV, ± 2kV
The quality of the network
voltage should be that of a
typical commercial or hospital
environment.
Conducted
disturbances
induced by RF
fields
c) d) o)
IEC 61000-4-6
3 V
m)
0.15 MHz - 80 MHz
6 V
m)
in the ISM bands
between 0.15 MHz and
80 MHz
n)
80 % AM at 1 KHz
e)
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.
Voltage dips
f) p) r)
IEC 61000-4-11
0% UT; 0,5 cycle
g)
At 0°, 45°, 90°, 135°,
180°, 225°, 270° and
315°
The quality of the network
voltage should be that of a
typical commercial or hospital
environment.
0 % UT; 1 cycle and
70 % UT; 25/30 cycle
h)
Single phase: at 0°
Voltage
interruptions
f) i) o) r)
IEC 61000-4-11 0% UT; 250/300 cycle
h)
The quality of the network
voltage should be that of a
typical commercial or hospital
environment.
a) The test may be performed at any one power input
voltage within the PIEZOSURGERY® GP RATED voltage
range. If the PIEZOSURGERY® GP is tested at one
power input voltage, it is not necessary to re-test at
additional voltages.
b) All PIEZOSURGERY® GP cables are attached during
the test.
c) Calibration for current injection clamps shall be
performed in a 150 Ω system.