Guidance And Manufacturer's Declaration - Kinetec Spectra User Manual

Passive mobilisation device of the knee
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  • ENGLISH, page 25

Guidance and manufacturer's declaration

Electromagnetic emissions
The device Kinetec Spectra™ is intended for use in the electromagnetic environment specified below. The customer or user of the device
Kinetec Spectra™ should ensure that it is used in such an environment.
Emissions test
Radio frequency emissions CISPR 11
Radio frequency emissions - CISPR 11
Harmonic emissions - IEC 61000-3-2
Voltage fluctuations / Flicker emissions - IEC
61000-3-3
Electromagnetic immunity
The device Kinetec Spectra™ is intended for use in the electromagnetic environment specified below. The customer or user of the device
Kinetec Spectra™ 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 interruptions
IEC 61000-4-11
Voltage dips 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 Spectra™
Compliance
Group 1
Class B
Class A
Complies
IEC 60601
Compliance level
Test level
±2 kV, ±4 kV, ±6 kV
contact
±2 kV, ±4 kV, ±8 kV
air
±2 kV
for power supply lines
±0.5 kV, ±1 kV
between lines
< 5% U
T
(>95% dip in U
)
T
for 5 seconds
< 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
3A/m
Electromagnetic environment – guidance
The device Kinetec Spectra™ 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 Spectra™ 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.
Electromagnetic environment – guidance
±2 kV, ±4 kV, ±6 kV
contact
Floors should be wood, concrete or ceramic tile. If floors
are covered with synthetic material, the relative humidity
±2 kV, ±4 kV, ±8 kV
should be at least 30%.
air
±2 kV
Mains power quality should be that of a typical
for power supply lines
commercial or hospital environment.
±0.5 kV, ±1 kV
Mains power quality should be that of a typical
between lines
commercial or hospital environment.
< 5% U
When the interruption occurs, the device Kinetec
T
(>95% dip in U
)
Spectra™ is reset. After turning on, push START to begin
T
for 5 seconds
the session.
< 5% U
T
(>95% dip in U
)
T
for 0.5 cycle
Mains power quality should be that of a typical
commercial or hospital environment. If the user of the
40% U
T
device Kinetec Spectra™ requires continued operation
(60% dip in U
)
T
during power supply interruptions, we recommend
for 5 cycles
powering the device Kinetec Spectra™ using an
uninterruptible power supply or a battery.
70% U
T
(30% dip in U
)
T
for 25 cycles
Power frequency magnetic fields should be at levels
3A/m
characteristic of a typical location in a typical
commercial or hospital environment.
EN
18/20

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