Technical description
29
Guide and manufacturer’s declaration – electromagnetic emission
The SISS BABYONTROL monitors are intended for use as described below. The client or
user of thr SISS BABYCONTROL monitors should make sure, that it is used in such an
environment.
Emission
Compliance
Electromagnetic environment -Guide
RF-Emission acc.
CISPR 11
Group 1
The BC SPO2 / ECG uses RF-
Energy
only for its internal function.
Therefore its RF-Emission is very
low and it is improbable that
electronic devices nearby will be
disturbed.
RF-Emission acc.
CISPR 11
Class B
The BC SPO2 is suitable for use
everywhere, inclusive home area
and such, which are connected
directly to a public supply network,
that also supplies buildings used for
habitation.
Emission of harmonics
acc.
IEC61000-3-2
Not applicable
Emission of voltage
deviation/
Flicker acc. IEC 61000-
3-3
Not applicable
Guide and manufacture’s declaration – electromagnetic immunity
The SISS BABYONTROL monitors are intended for use in electromagnetic environment as
described below. The client or user of The SISS BABYONTROL monitors should make sure
that it is used in such an environment.
Immunity test
IEC 60601-1-2
test level
compliance-level
Electromagnetic environment -
Guide
Electro static
discharge
(ESD ) acc.
IEC 61000-4-2
±6 kV contact
discharge
±8 kV air
discharge
±6 kV contact
discharge
±8 kV air
discharge
The floor should be made of
wood or concrete or should be
tiled with ceramic flag.
If the floor contains synthetic
material, the relative humidity
must be at least 30 %.
Fast transients /
Bursts acc.
IEC 61000-4-4
±1kV for input and
output lines
±1kV for input and
output lines
The quality of voltage supply
should be equivalent to typical
business- or clinical
environment.
Magnetic field at
frequency of supply
(50/60 Hz ) acc.
IEC 61000-4-8
3 A/m
3 A/m
Magnetic fields at mains
frequency should be in
accordance with the relevant
level of business- or clinical
environment.
