Guidance and Manufacturer's Declaration - Electromagnetic Immunity
The TheraKair Visio MRS is intended for use in the electromagnetic environment specified below. The
customer or the end user of the TheraKair Visio MRS should ensure that it is used in such an environment.
Immunity Test
Electromagnetic
Discharge (ESD)
EN / IEC 61000-4-2
Electrical Fast Transient
/ Burst
EN / IEC 61000-4-4
Surge
EN / IEC 61000-4-5
Voltage dips, short
interruptions and
voltage variations on
power supply input
lines
EN / IEC 61000-4-11
Power frequency
(50 / 60 Hz) magnetic
field
EN / IEC 61000-4-8
Note UT is the a.c. mains voltage prior to application of the test level.
EN / IEC 60601
Test Level
± 6kV Contact
± 6kV Contact
± 8kV Air
± 8kV Air
± 2kV for power
± 2kV for power
supply lines
supply lines
± 1kV for input /
± 1kV for input /
output lines
output lines
± 1kV line(s) to
± 1kV differential
line(s)
mode
± 2kV line(s) to
± 2kV common
earth
mode
<5% UT (>95% dip
<5% UT (>95% dip
in UT) for 0,5 cycle
in UT) for 0,5 cycle
40% UT (60% dip in
40% UT (60% dip in
UT) for 5 cycles
UT) for 5 cycles
70% UT (30% dip in
70% UT (30% dip in
UT) for 25 cycles
UT) for 25 cycles
<5% UT (>95% dip
<5% UT (>95% dip
in UT) for 5 seconds
in UT) for 5 seconds
3A/m
3A/m
Compliance
Level
Floors should be wood, concrete
or ceramic tile. If floors are
covered with synthetic material,
the relative humidity should be at
least 30%.
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 TheraKair Visio MRS requires
continued operation during
power mains interruptions, it is
recommended that the TheraKair
Visio MRS be powered from an
uninterruptible power supply or
a battery.
Power frequency magnetic fields
should be at levels characteristic
of a typical commercial or hospital
environment.
41
Intended Electromagnetic
Environment