Table 2
Manufacturer's guide and declaration - electromagnetic emissions
The TIBODA device is intended to be used in the following electromagnetic
conditions. The client or user must ensure that it is used in these conditions.
Immunity tests
Electrostatic
discharge (ESD)
IEC 61000-4-2
Electrical fast
transient/burst
IEC 61000-4-4
Surge
IEC 61000-4-5
Immunity tests
Voltage drop outs,
brief interruptions and
variations of voltage on
the power supply lines.
IEC 61000-4-11
Mains frequency
magnetic field
(50/60 Hz)
IEC 61000-4-8
Note: UT is the AC mains voltage prior to application of the test level.
Test level IEC 60601
± 6 kV contact
± 8 kV air
±2KV for power lines
±1 kV for I/O lines
1 kV differential mode
±2 KV common mode
Test level IEC 60601
<5% UT
(>95% UT drop out)
for 0.5 cycles
40% UT
(60% UT drop out)
for 5 cycles
70% UT
(30% UT drop out)
for 25 cycles
<5% UT
(>95% UT drop
out) for 5 s.
3 A/m
Conformity level
± 6 kV contact
± 8 kV air
2KV for power lines
±1 kV for I/O lines
1 kV differential mode
±2 KV common mode
Conformity level
<5% UT
(>95% UT drop out)
for 0.5 cycles
40% UT
(60% UT drop out)
for 5 cycles
70% UT
(30% UT drop out)
for 25 cycles
<5% UT
(>95% UT drop
out) for 5 s.
3 A/m
33
Electromagnetic
environment – guide
Information for using
the device and charging
the battery. The floor
must be wood, concrete
or ceramic. If the
floor is covered with
a synthetic material,
the relative humidity
must be at least 30%.
The quality of the
mains supply must
be that of a typical
commercial hospital
when charging
the battery
The quality of the mains
supply must be that of
a typical commercial
or hospital when
charging the battery.
Electromagnetic
environment – guide
The quality of the
mains supply must
be that of a typical
commercial hospital
when charging
the battery.
Power frequency
magnetic fields
should be at levels
characteristic of a
typical location in a
typical commercial or
hospital environment.
(Applies both to
using the device and
charging the battery).