Guidance And Manufacturer's Declaration; Electromagnetic Emissions; Electromagnetic Immunity - Kinetec Performa Manuel D'utilisation

GUIDANCE AND MANUFACTURER'S DECLARATION

Electromagnetic emissions

The « KINETEC Performa » is intended for use in the electromagnetic environment specified below.
The customer or the user of the « KINETEC Performa » should ensure that it is used in such an environment.
Emissions test
Radio electric-Frequency emissions
CISPR 11
Radio electric-Frequency emissions
CISPR 11
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations / Flicker emissions
IEC 61000-3-3
Electromedical appliances require special precautions concerning EMC. They therefore need to be installed and commissioned following
the EMC information supplied.
Electromedical appliances may be affected by mobile and portable RF communication devices.
WARNING: using cables and accessories other than those specified, except for those sold by Kinetec as replacements for internal
components, may lead to an increase in emissions or a decrease in the "KINETEC PERFORMA" splint's immunity.
WARNING: the "KINETEC PERFORMA" splint should not be used next to other appliances. If the "KINETEC PERFORMA" splint must be used next
to other appliances, the splint should be under constant supervision to check that it is working normally in the given configuration.

Electromagnetic immunity

The « KINETEC Performa » is intended for use in the electromagnetic environment specified below.
The customer or the user of the « KINETEC Performa » should ensure that it is used in such an environment.
Immunity test
Electrostatic discharge
(ESD)
IEC 61000-4-2
Electrical fast transient /
burst
IEC 61000-4-4
Surge
IEC 61000-4-5
Voltage dips and voltage
variations on power
supply input lines
CEI 61000-4-11
Power frequency (50/60
Hz) magnetic field
IEC 61000-4-8
NOTE : U is the a.c. mains voltage prior to application of the test level.
T
Performa
Compliance
Group 1
Class B
Non
Applicable
Complies
IEC 60601
Test level
±2 kV, ±4 kV, ±6 kV
contact
±2 kV, ±4 kV, ±8 kV
air
±2 kV for power supply lines
±1 kV for input/output lines
±1 kV between lines
±2 kV between line and
earth
< 5% U
T
(>95% dip in U )
T
for 0,5 cycle
40% U
T
(60% dip in U )
T
for 5 cycles
70% U
T
(30% dip in U )
T
for 25 cycles
< 5% U
T
(>95% dip in U )
T
for 5 seconds
3A/m
Electromagnetic environment – guidance
The « KINETEC Performa » 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.
The « KINETEC Performa » 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.
Compliance level
±2 kV, ±4 kV, ±6 kV
contact Floors should be wood, concrete or ceramic tile. If floors
are covered with synthetic material, the relative
±2 kV, ±4 kV, ±8 kV humidity should be at least 30%.
air
±2 kV for power supply
lines Mains power quality should be that of a typical
commercial or hospital environment.
Non Applicable
±1 kV between lines
Mains power quality should be that of a typical
±2 kV between line and commercial or hospital environment.
earth
< 5% U
T
(>95% dip in U )
T
for 0,5 cycle
40% U
T
Mains power quality should be that of a typical
(60% dip in U )
T
commercial or hospital environment. If the user of the
for 5 cycles
« KINETEC Performa» requires continued operation
during power supply interruptions, it is recommended
70% U
T
that the « KINETEC Performa» be powered from an
(30% dip in U )
T
uninterruptible power supply or a battery.
for 25 cycles
< 5% U
T
(>95% dip in U )
T
for 5 seconds
Power frequency magnetic fields should be at levels
3A/m characteristic of a typical location in a typical
commercial or hospital environment.
EN
Electromagnetic environment – guidance
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