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