Zimmer enPuls, Руководство по эксплуатации

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Manufacturer’s declaration of
Electromagnetic Compatibility
15
45
Guidance and manufacturer’s declaration – Electromagnetic immunity
The en
Puls
Version 2.0 device is intended for use in the electromagnetic environment specified below. The customer or the
user of the en
Puls
Version 2.0 device should assure that it is used in such an environment.
Immunity test IEC 60601 test level Compliance level Electromagnetic environment -
Guidance
Electrostatic discharge
(ESD) to IEC 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 to IEC 61000-4-4 ± 2 kV for power
supply lines
± 1 kV for input /
output lines ± 2 kV for power supply
lines
not applicable Mains power quality should be that of a
typical commercial or hospital
environment.
Surge IEC 6100-4-5 ± 1 kV differential
mode
± 2 kV common mode ± 1 kV differential mode
± 2 kV common mode Mains power quality should be that of a
typical commercial or hospital
environment.
Voltage dips, short
interruptions and voltage
variations on power supply
input lines IEC 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
seconds)
<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
seconds)
Mains power quality should be that of a
typical commercial or hospital
environment. The user of the en
Puls
Version 2.0 requires continued operation
during power mains interruptions. It is
recommended that the en
Puls
Version
2.0 be powered from an uninterruptable
power supply or a battery.
Power frequency
(50/60 Hz) magnetic field
to IEC 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 commerical or
hospital environment.
Note: U
T
is the AC mains voltage prior to application of the test level.