Kinetec CEM - Guidance and Manufacturers Declaration

KINETEC CEM™ 21/22 EN
PRODUCT INFORMATION
8. Guidance and manufacturer’s declaration
Guidance and manufacturer’s declaration - Electromagnetic emissions
The device KINETEC CEM™ is intended for use in the electromagnetic environment specified below. The customer or the user of the device KINETEC
CEM™
should ensure that it is used in such an environment.
Emissions test Compliance Electromagnetic environment – guidance
Radio frequency emissions (RF)
CISPR 11
Group 1
The device KINETEC CEM™ 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.
Radio frequency emissions
CISPR 11
Class B
The device KINETEC CEM™ 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
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 CEM™ immunity.
WARNING: the device KINETEC CEM™ should not be used next to other appliances. If the device KINETEC CEM™ 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 CEM™ is intended for use in the electromagnetic environment specified below.
The customer or the user of the device KINETEC CEM™ should ensure that it is used in such an environment.
Immunity test
IEC 60601
Test level
Compliance level
Electromagnetic environment –
Guidance
Electrostatic discharge
(ESD)
IEC 61000-4-2
±6 kV - contact
±8 kV - air
±6 kV - contact
±8 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 for electrical power lines
±1 kV for input/output lines
±2 kV for electrical power
lines
±1 kV for input/output lines
Mains power quality should be that of a typical commercial or
hospital environment.
Surge
IEC 61000-4-5
±1 kV phase-to-phase
±2 kV phase-to-earth
±1 kV phase-to-phase
±2 kV phase-to-earth
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
IEC 61000-4-11
< 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
< 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
Mains power quality should be that of a typical commercial or
hospital environment. If the user of the device KINETEC
CEM™ requires continued operation during power supply
interruptions, we recommend powering the device KINETEC
CEM™ using an uninterruptible power supply or a battery.
Power frequency (50/60
Hz) magnetic field
IEC 61000-4-8
3A/m 3A/m
Power frequency magnetic fields should be at levels
characteristic of a typical location in a typical commercial or
hospital environment.
NOTE: U
T
is the AC mains voltage prior to application of the test level.