Bionet Cardio7, Operation Manual

Page: 164 / 171

V 1.31
2021. 05 164 / 171 Doc. # : BN-OP-C7
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
Complies
supply network that supplies buildings used for
domestic purposes, provided the following
warning is heeded:
Warning : This equipment/system is intended for
use by healthcare professionals only.
This equipment/system may cause radio
interference or may disrupt the operation of
nearby equipment. It may be necessary to take
mitigation measures, such as re-orienting or
relocating the Cardio7e/Cardio7 or shielding the
location.
Guidance and manufacturer’s declaration – electromagnetic immunity
The Cardio7e/Cardio7 is intended for use in the electromagnetic environment specified below.
The customer or the user of the Cardio7e/Cardio7 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
± 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 61000-4-4
± 2 kV for power
supply lines
±
1 kV for
input/output lines
± 2 kV for power supply
lines
±
1 kV for input/output
lines
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
± 1 kV line(s) to line(s)
± 2 kV line(s) to earth
Mains power quality should
be that of a typical
commercial or hospital
environment.