Product Manual

SE-2003&SE-2012 Holter System Recorder User Manual
- 44 -
Guidance and manufacture’s declaration - electromagnetic immunity -
for all EQUIPMENT and SYSTEMS
Guidance and manufacture’s declaration – electromagnetic immunity
Holter System Recorder is intended for use in the electromagnetic environment specified
below. The customer or the user of Holter System Recorder should assure that it is used in
such an environment.
Immunity test
IEC/EN 60601
test level
Complianc
e level
Electromagnetic environment –
guidance
Electrostatic
discharge (ESD)
IEC/EN 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/EN 61000-4-4
±2 kV for power
supply lines
Not
applicable
Mains power quality should be that
of a typical commercial or hospital
environment.
Surge
IEC/EN 61000-4-5
±1 kV line to line
±2 kV line to
ground
Not
applicable
Mains power quality should be that
of a typical commercial or hospital
environment.
Power frequency
(50/60 Hz)
magnetic field
IEC/EN 61000-4-8
3 A/m 3 A/m
Power frequency magnetic fields
should be at levels characteristic of a
typical location in a typical
commercial or hospital environment.
Voltage dips, short
interruptions and
voltage variations
on power supply
input lines IEC/EN
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 sec
Not
applicable
Mains power quality should be that
of a typical commercial or hospital
environment. If the user of the
Holter System Recorder requires
continued operation during power
mains interruptions, it is
recommended that the Holter
System Recorder be powered from
an uninterruptible power supply or a
battery.
NOTE: U
T
is the a.c. mains voltage prior to application of the test level.