Patient Manual ERC 4P
Model: ERC 4P
LC0265-D 04/2022 Page
51
of
54
Guidance and manufacturer’s declaration – electromagnetic emissions
The ERC is intended for use in the electromagnetic environment specified below. The customer or the user of
the ERC should assure that it is used in such an environment.
Emission test
Compliance
Electromagnetic environment - guidance
RF emissions CISPR 11
Class B
The model ERC 4P for Precice may emit unintentional
electromagnetic energy during normal operation up to
permissible limits suitable for use in domestic establishments
and in establishments directly connected to a low-voltage
power supply network.
RF emissions CISPR 11
Class B
The ERC is suitable for use in all establishments, including
domestic establishments and those directly connected to the
public low-voltage power supply network that supplies
buildings used for domestic purposes.
Harmonic emissions IEC
61000-3-2
Complies
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
Complies
Guidance and manufacturer’s declaration – electromagnetic immunity
The ERC is intended for use in the electromagnetic environment specified below. The customer or the user of the
ERC should assure that it is used in such an environment.
Immunity test
IEC 60601
test level
Compliance
level
Electromagnetic environment
–
guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
± 2, 4, 8 kV (contact)
± 2, 4, 8, 15 kV (air)
± 2, 4, 8 kV (indirect, HCP
and VCP)
Complies
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 61000-4-4
± 2 kV for power supply
lines
Complies
Mains power quality should be that of a
typical commercial or hospital
environment.
Surge
IEC 61000-4-5
± 1 kV line(s) to line(s)
± 2 kV line(s) to earth
Complies
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
Short Interrupts:
0% at ½ cycle
0% at 1 cycle
70% at 25 cycles for 50Hz
70% at 30 cycles for 60Hz
Complies
Mains power quality should be that of a
typical commercial or hospital
environment. If the user of the model
ERC 4P for Precice requires continued
operation during power mains
interruptions, it is recommended that the
model ERC 4P for Precice be powered
from an uninterruptible power supply.
Power frequency
(50 Hz) magnetic
field IEC 61000-4-8
30 A/m at 230V
Complies
Power frequency magnetic fields should
be at levels characteristic of a typical
location in a typical commercial or
hospital environment.