Guidance And Manufacturer's Declaration - Kinetec Prima XL User Manual

Knee continuous passive motion machine
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Guidance and manufacturer's declaration

Guidance and manufacturer's declaration - Electromagnetic emissions
The device Kinetec Prima XL™ is intended for use in the electromagnetic environment specified below. The customer or the user of the
device Kinetec Prima XL™ should ensure that it is used in such an environment.
Emissions test
Radio frequency emissions (RF)
CISPR 11
Radio 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 device Kinetec Prima XL™ machine's immunity.
WARNING: the device Kinetec Prima XL™ should not be used next to other appliances. If the device Kinetec Prima XL™ must be used next
to other appliances, it should be under constant supervision to check that it is working normally in the given configuration.
Guidance and manufacturer's declaration - Electromagnetic immunity
The device Kinetec Prima XL™ is intended for use in the electromagnetic environment specified below. The customer or the user of the
device Kinetec Prima XL™ 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, short
interruptions and voltage
variations on power
supply input lines
IEC 61000-4-11
Power frequency (50/60
Hz) magnetic field - EC
61000-4-8
NOTE: U
is the AC mains voltage prior to application of the test level.
T
Kinetec Prima XL™
Compliance Electromagnetic environment – guidance
Group 1
Class B
Class A
Complies
IEC 60601
Test level
±6 kV - contact
±8 kV - air
±2 kV for electrical power
lines
±1 kV for input/output
lines
1 kV phase-to-phase
±2 kV phase-to-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
The device Kinetec Prima XL™ 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 device Kinetec Prima XL™ 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
±6 kV - contact
±8 kV - air
±2 kV for electrical power
lines
±1 kV for input/output lines
1 kV phase-to-phase
±2 kV phase-to-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
EN
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%.
If the movement stops, push the start button, the
movement starts again.
If the yellow LED is blinking, switch the machine OFF
then ON again and push the START button: the
movement will start again.
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.
Mains power quality should be that of a typical
commercial or hospital environment. If the user of the
device Kinetec Prima XL™ requires continued
operation during power supply interruptions, we
recommend powering the device Kinetec Prima XL™
using an uninterruptible power supply or a battery.
Power frequency magnetic fields should be at levels
characteristic of a typical location in a typical
commercial or hospital environment.
10/11

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