Interference Immunity - MEDICA THERA-vital Gebrauchsanweisung

Interference immunity

Guidance and manufacturer's declaration on electromagnetic interference immunity
The THERA-vital is intended for operation in the electromagnetic environment specified below. The THERA-vital owner or user should ensure
that the apparatus is used in such an environment.
Interference immunity test
Electrostatic discharge (ESD)
as per IEC 61000-4-2
Rapid transient electrical
interference bursts as per
IEC 61000-4-4
Voltage surges to
IEC 61000-4-5
Voltage dips, temporary inter-
ruptions and fluctuations of the
power supply voltage as per
IEC 61000-4-11
Magnetic field at power supply
frequency (50/60 Hz) as per
IEC 61000-4-8
NOTE: U is the mains alternating voltage before application of the testing level.
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IEC 60601 testing level Compliance level
± 6 kV contact discharge ± 6 kV contact discharge
(indirect)
± 8 kV air discharge ± 8 kV air discharge
± 2 kV ± 2 kV
for power leads for power leads
± 1 kV ± 1 kV
for input and output leads for input and output leads
± 1 kV ± 1 kV
out-of-phase voltage out-of-phase voltage
(symmetrical) (symmetrical)
± 2 kV in-phase voltage ± 2 kV in-phase voltage
(asymmetrical) (asymmetrical)
< 5 % U for 0.5 periods < 5 % U
T
(> 95 % dip) (> 95 % dip)
40 % U for 5 periods 40 % U
T
(60 % dip) (60 % dip)
70 % U for 25 periods 70 % U
T
(30 % dip) (30 % dip)
< 5 % U for 5 s < 5 % U
T
(> 95 % dip) (> 95 % dip)
3 A/m 3 A/m
Guidance on electromagnetic environment
Floors should be wooden or concrete or surfaced
with ceramic tiles. If the floor has a covering made
of synthetic material, the relative humidity must be
at least 30%.
The quality of the power supply voltage should
match that of a typical business or hospital environ-
ment.
The quality of the power supply voltage should
match that of a typical business or hospital environ-
ment.
for 0.5 periods The quality of the power supply voltage should
T
match that of a typical business or hospital environ-
ment.
for 5 periods
T
If the THERA-vital user requires continued function-
ing even during power supply interruptions we rec-
for 25 periods
T
ommend that the THERA-vital is supplied by an un-
interruptible power supply or battery.
for 5 s
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Magnetic fields at the power supply frequency
should match the typical levels encountered in busi-
ness and hospital environments.
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