Cardioline ECG200+ - Guidance and Manufacturers Declaration - Electromagnetic Emissions

ECG100+ - ECG200+ - ECG100S - ECG200S
3. ELECTROMAGNETIC COMPABILITY (EMC)
Fixed, portable and mobile equipment for RF communication may affect the protection of the medical
equipment. See par. 3.4 for the recommended separation distance between the radio equipment and the
device.
The purpose of the device is the acquisition of ECG signals and the presentation of ECG reports for diagnostic
purposes, as defined in IEC 60601-2-25.
Electromagnetic disturbances can cause disturb or degradation of the acquired ECG signal, resulting in
misdiagnosis or delayed treatment.
3.1. Guidance and Manufacturer's declaration - Electromagnetic
emissions
The ECG100+/ECG100S is intended to operate in the electromagnetic environment specified below. The
customer or the user of the ECG100+/ECG100S must guarantee that it is used in this environment.
Emission test
Compliance
Electromagnetic environment – guidance
Radio frequency (RF) emissions
CISPR 11
Group 1
The ECG100+/ECG100S uses RF energy only for its internal function.
Therefore, its RF emissions are very low and are not likely to cause any
interference in nearby electronic equipment.
Radio frequency (RF) emissions
CISPR 11
Class A
The ECG100+/ECG100S 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, because the emission level is low enough to not
affect nearby equipment.
Harmonics emissions
IEC 61000-3-2
Class A
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
Complies
The ECG200+/ECG200S is intended to operate in the electromagnetic environment specified below. The
customer or the user of the ECG200+/ECG200S must guarantee that it is used in this environment.
Emission test
Compliance
Electromagnetic environment – guidance
Radio frequency (RF) emissions
CISPR 11
Group 1
The ECG200+/ECG200S uses RF energy only for its internal function.
Therefore, its RF emissions are very low and are not likely to cause any
interference in nearby electronic equipment.
Radio frequency (RF) emissions
CISPR 11
Class A
The ECG200+/ECG200S 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, because the emission level is low enough to not
affect nearby equipment.
Harmonics emissions
IEC 61000-3-2
Class A
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
Complies