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Nouvag LipoSurg Gebruiksaanwijzing pagina 25

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Guidance and manufacturer's declaration – electromagnetic immunity
The Product is intended for use in the electromagnetic environment specified below. The customer or the user of the Product should
assure that it is used in such an environment.
Immunity tests
GEBRUIKSAANWIJZING
Electrostatic discharge
+/- 8 kV contact
(ESD)
+/- 2 kV, +/- 4 kV, +/- 8 kV,
IEC 61000-4-2
+/- 15 kV air
BIJLAGE
Electrical fast
+/- 2 kV with 100kHz
transient/burst
for power supply lines
IEC 61000-4-4
+/- 1 kV with 100kHz
for input/output lines
Surge
+/- 0.5 kV, +/- 1 kV
differential mode
IEC 61000-4-5
+/- 0.5 kV, +/- 1 kV, +/- 2 kV
common mode
Voltage dips, short
0 % U
interruptions and voltage
with 0, 45, 90, 135, 180, 225,
variations on power
270, 315 degree
supply input lines
0 % U
IEC 61000-4-11
70 % U
0 % U
Power frequency
30 A/m
(50/60Hz) magnetic field
IEC 61000-4-8
Note: U
is the a.c. mains voltage prior to application of the test level.
T
Guidance and manufacturer's declaration – electromagnetic immunity for not life support equipment
The Product is intended for use in the electromagnetic environment specified below. The customer or the user of the Product should
assure that it is used in such an environment.
Immunity tests
Conducted RF
3 V rms
IEC 61000-4-6
0.15 MHz to 80 MHz
6 V rms
inside ISM bands between
150 kHz to 80 MHz
80% AM bei 1 kHz
Radiated RF
3 V/m
IEC 61000-4-3
80 MHz to 2.7 GHz
80% AM bei 1 kHz
Note 1:
At 80 MHz and 800 MHz, the higher frequency range applies.
Note 2:
These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from
structures, objects and people.
a
Fixed strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios,
amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To access the
electromagnetic environment due to fixed RF transmitters, and electromagnetic site survey should be considered. If the
measured field strength in the location in which the Product is used exceeds the applicable RF compliance level above, the
Product should b observed to verify normal operation. If abnormal performance is observed, additional measures may be
necessary, such as reorienting or relocating the Product.
b
over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
© NOUVAG AG • 31648 • V20240624 • All rights  reserved
IEC 60601
Compliance level
Test level
+/- 8 kV contact
+/- 2 kV, +/- 4 kV, +/- 8 kV,
+/- 15 kV air
+/- 2 kV with 100kHz
for power supply lines
+/- 1 kV with 100kHz
for input/output lines
+/- 0.5 kV, +/- 1 kV
differential mode
+/- 0.5 kV, +/- 1 kV, +/- 2 kV
common mode
for 0,5 cycle
0 % U
T;
T;
with 0, 45, 90, 135, 180, 225,
270, 315 degree
for 1 cycle
0 % U
T;
T;
; for 25/30 cycles
70 % U
T
for 5 sec
0 % U
T;
T;
30 A/m
IEC 60601
Compliance level
Test level
3 V rms
0.15 MHz to 80 MHz
6 V rms
inside ISM bands between
150 kHz to 80 MHz
80% AM bei 1 kHz
3 V/m
80 MHz to 2.7 GHz
80% AM bei 1 kHz
Electromagnetic environment - guidance
Floors should be wood, concrete or ceramic
tile. If floors are covered with synthetic
material, the relative humidity should be at
least 30 %.
Mains power quality should be that of a typical
commercial or hospital environment.
Mains power quality should be that of a typical
commercial or hospital environment.
for 0,5 cycle
Mains power quality should bet hat of a typical
commercial or hospital environment.
If the user of the Product requires continued
for 1 cycle
operation during power mains interruptions, it
is recommended that the Product be powered
; for 25/30 cycles
from an uninterruptible power supply or a
T
battery.
for 5 sec
Power frequency magnetic fields should be at
levels characteristic of a typical location in a
typical commercial or hospital environment.
Electromagnetic environment - guidance
Portable and mobile RF communications
equipment should be used no closer to any part
of the Product, including cables, than the
recommended separation distance calculated
from the equation applicable to the frequency of
the transmitter.
Recommended separation distance:
d = 0,35
d = 0,35
P
d = 0,7
Where P is the maximum output power rating in
the transmitter in watts (W) according to the
transmitter manufacturer and d is the
recommended separation distance in metres
(m).
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey
should be less than the compliance level in each
frequency range
Interference may occur in the vicinity of
equipment marked with the following symbol:
LIPOSURG
P
P
80 MHz to 800 MHz
800 MHz to 2,7 GHz
b
.
a
,
25

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