11
1. Guidance and manufacturer’s declaration - electromagnetic emission
The medical monitor is intended for use in the electromagnetic environment specifi ed below. The user of
the device should make sure that the medical monitor is operated in such an environment.
Interference emission measurements
Conformity level
Electromagnetic environment -guidance
RF emissions acc. to CISPR 11
Complies with Group 1
The characteristics of this device determined
by broadcasting permit its industrial and
hospital use (CISPR 11, Class A). When used in a
living area (for which CISPR 11 usually requires
Class B), this device may not provide adequate
protection of radio services. The user must, if
necessary, take remedial action such as imple-
mentation or reorientation of the device.
RF emissions acc. to CISPR 11
Complies with Class B
Emission of harmonic oscilla-
tions acc. to IEC 61000-3-2
Complies with Class A
Voltage fl uctuations/fl icker
emissions acc. to IEC 61000-3-3
Complies
2. For the use of ME devices in professional healthcare facilities.
Guidance and manufacturer’s declaration - electromagnetic immunity
The medical monitor is intended for use in the electromagnetic environment specifi ed below.
The user of the medical monitor should make sure that it is used in such an environment.
Interference
immunity test
IEC 60601-1-2:2014 con-
formity level
Electromagnetic environment-guidance
Electrostatic
discharge (ESD)
acc. to
IEC 61000-4-2
Complies ±2 kV, ±4 kV, ±6
kV, ± 8 kV contact discharge
±2 kV, ±4 kV, ±8 kV,
± 15 kV air discharge
Floors should be made of wood, concrete or ceramic tile.
If fl oors are covered with synthetic material, the relative
humidity must be at least 30%
Rapid transient elec-
tric interferences/
bursts acc. to
IEC 61000-4-4
Complies
± 2 kV for mains lines
± 1 kV for input/output lines
The quality of the supply voltage should correspond to
that of a typical business or hospital environment.
Surge acc. to
IEC 61000-4-5
Complies
± 1 kV push-pull voltage
± 2 kV common-mode
voltage
The quality of the supply voltage should correspond to
that of a typical business or hospital environment.
Voltage dips, short
interruptions and
fl uctuations of the
supply acc. to
IEC 61000-4-11
0 % U
T
*; 0.5 cycle
At 0°, 45°, 90°, 135°, 180°,
225°, 270°, 315°
0% U
T;
1 cycle and
70% U
T;
25/30 cycles
Single phase: at 0°
0% U
T;
250/300 cycle
Mains power quality should be that of a typical commer-
cial or hospital environment.
If the user of the device requests continued functioning
even when interruptions of the power supply occur, it is
recommended that the device be supplied from a power
supply that is free of interruptions.
*Note: U
T
is the mains alternating voltage before applying the test levels.
