Electromagnetic compatibility (EMC)
Remark:
The
Product
subsequently referred to herein always denotes the LipoSurg.
Changes or modifications to this product not expressly approved by the manufacturer may result in increased emissions or decreased immunity
performance of the product and could cause EMC issues with this or other equipment. This product is designed and tested to comply with
applicable regulations regarding EMC and shall be installed and put into service according to the EMC information stated as follows.
WARNING
Use of portable phones or other radio frequency (RF) emitting equipment, including accessories (antennas e.g.) in distances below
30 cm (12 inches) to the product, may cause unexpected or adverse operation.
WARNING
The product is suitable for use in hospitals other than in the vicinity of active devices of the HF surgical devices or except in HF
screening rooms used for magnetic resonance imaging.
WARNING
The product shall not be used adjacent to, or stacked with, other equipment. If adjacent or stacked use is necessary, the product
shall be tested to verify normal operation in the configuration in which it is being used.
Essential Performance
The essential performance is that the infiltration of tumescent solution in the fat tissue and peel off the fat cells with CHP handpiece taking into
account the infiltration flow rate, pressure and handpiece speed is maintained. The maximum speed deviation is ± 15%, the infiltration flowrate is
between 100 and 480ml/min and the maximum pressure is 2.5bar.
Compliant Cables and Accessories
WARNING
The use of accessories, transducers and cables other than those specified may result in increased emissions or decreased immunity
performance of the product.
The table below lists cables, transducers, and other applicable accessories for which the manufacturer claims EMC compliance.
NOTE:
Any supplied accessories that do not affect EMC compliance are not listed.
Description
Length max.
Power supply cord REF 22261 / 22262 / 22264 / 22266
3.0m
Electronic motor REF 2101nou
4.0m
Foot pedal IPX8 REF 1511nou
2.9m
Guidance and manufacturer’s declaration – electromagnetic emissions
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.
Emissions test
Compliance
Electromagnetic environment - guidance
RF emissions
CISPR 11
Group 1
The Product uses RF energy only for its internal function.
Therefore, its RF emissions are very low and are not likely to
cause any interference in nearby electronic equipment.
RF emissions
CISPR 11
Class B
The Product is suitable for use in all establishments, including
domestic establishments and those directly connected to the
public low-voltage power supply network that supplies buildings
used for domestic purposes.
Harmonic emissions
IEC 61000-3-2
Class A
Voltage fluctuations/flicker emissions
IEC 61000-3-3
complies
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
IEC 60601
Test level
Compliance level
Electromagnetic environment - guidance
Electrostatic discharge
(ESD)
IEC 61000-4-2
+/- 8 kV contact
+/- 2 kV, +/- 4 kV, +/- 8 kV,
+/- 15 kV air
+/- 8 kV contact
+/- 2 kV, +/- 4 kV, +/- 8 kV,
+/- 15 kV air
Floors should be wood, concrete or ceramic
tile. If floors are covered with synthetic
material, the relative humidity should be at
least 30 %.
Electrical fast
transient/burst
IEC 61000-4-4
+/- 2 kV with 100kHz
for power supply lines
+/- 1 kV with 100kHz
for input/output lines
+/- 2 kV with 100kHz
for power supply lines
+/- 1 kV with 100kHz
for input/output lines
Mains power quality should be that of a typical
commercial or hospital environment.
Surge
IEC 61000-4-5
+/- 0.5 kV, +/- 1 kV
differential mode
+/- 0.5 kV, +/- 1 kV, +/- 2 kV
common mode
+/- 0.5 kV, +/- 1 kV
differential mode
+/- 0.5 kV, +/- 1 kV, +/- 2 kV
common mode
Mains power quality should be that of a typical
commercial or hospital environment.
Voltage dips, short
interruptions and voltage
variations on power
supply input lines
0 % U
T;
for 0,5 cycle
with 0, 45, 90, 135, 180, 225,
270, 315 degree
0 % U
T;
for 1 cycle
0 % U
T;
for 0,5 cycle
with 0, 45, 90, 135, 180, 225,
270, 315 degree
0 % U
T;
for 1 cycle
Mains power quality should bet hat of a typical
commercial or hospital environment.
If the user of the Product requires continued
operation during power mains interruptions, it
