Zimmer enPuls, User Manual

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Manufacturer's EMC Declaration
17
Page 35
Guidelines 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 ensure that it is used in such an environment.
Interferance
immunity tests
IEC 60601 - Test Level Compliance level Electromagnetic environment -
Guidelines
Electrostatic
discharge (ESD) in
accordance with
IEC 61000-4-2
± 6 kV contact discharge
± 8 kV air discharge
± 6 kV contact discharge
± 8 kV air discharge
Floors should be made from wood,
concrete or ceramic tiles. If floors are
covered with synthetic material, the
relative humidity must be at least
30%.
Electrical fast
transient / burst in
accordance with
IEC 61000-4-4
± 2 kV for power supply lines
± 1 kV for input and output
lines
± 2 kV for power supply lines
Not applicable for input and
output lines
The supply voltage quality must
correspond to that of a typical
commercial or hospital environment.
Surges in
accordance with
IEC 6100-4-5
± 1 kV differential mode
voltage
± 2 kV common mode voltage
± 1 kV differential mode
voltage
± 2 kV common mode
voltage
The supply voltage quality must
correspond to that of a typical
commercial or hospital environment.
Voltage dips,
short-term
interruptions and
voltage variations
in accordance with
IEC 61000-4-11
<5% U
T
(>95% dip in U
T
for ½ a
period)
40% U
T
(60% dip in U
T
for 5 periods)
70% U
T
(30% dip in U
T
for 25 periods)
<5% U
T
(> 95% dip in U
T
for 5
seconds)
<5% U
T
(> 95% dip in U
T
for ½ a
period)
40% U
T
(60% dip in U
T
for 5 periods)
70% U
T
(30% dip in U
T
for 25 periods)
<5% U
T
(> 95% dip in U
T
for 5
seconds)
The supply voltage quality must
correspond to that of a typical
commercial or hospital environment.
If the user of en Puls Version 2.0
requires continued operation, even in
the event of interruptions to the power
supply, it is recommended that the
en Puls Version 2.0 be be powered
from an uninterruptible power supply
or a battery.
Magnetic field at
supply frequency
(50/60 Hz) in
accordance with
IEC 61000-4-8
3 A/m 3 A/m Magnetic fields at mains frequency
should have the typical values found
in a business or hospital environment.
Note: U
T
is the AC mains voltage prior to application of the test level.