Conformity According To Iec 60601-1-2 - BIOTRONIK Reocor S Manual Tecnico

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Emissions test
HF emission
according to CISPR 11
HF emission
according to CISPR 11
Emission of harmonic
oscillations according to
IEC 61000-3-2
Voltage fluctuations
according to
IEC 61000-3-3
Test of resistance Test level according to
to interference IEC 60601
Electrostatic ±6 kV contact
discharge (ESD) discharge
according to ±8 kV air discharge
IEC 61000-4-2
Fast transient Not applicable
electric inter-
ference/bursts
according to
IEC 61000-4-4
Surges voltages Not applicable
(surges) accord-
ing to IEC 61000-
4-5

Conformity According to IEC 60601-1-2

Manufacturer guidelines and declaration -
electromagnetic radiation (IEC 60601-1-2: Table 1)
The device is intended for use in an electromagnetic environ-
ment as described below. The user should make sure that the
device is used in such an environment.
Compliance level Guidelines for the electromagnetic environment
Group 1 The device uses HF energy exclusively for its own
function. Therefore, the high-frequency inter-
ference is very low and not likely to cause any
interference in nearby electronic equipment.
Class B The device is suitable for use in all areas, exclud-
ing residential areas and buildings that are con-
nected directly to the public power supply.
Not applicable
Not applicable
Manufacturer guidelines and declaration –
resistance to electromagnetic interference
(IEC 60601-1-2: Table 2)
The device is intended for use in an electromagnetic environ-
ment as described below. The user of the device should make
sure that it is used in such an environment.
Compliance
level
±6 kV contact
discharge
±15 kV air
discharge
Guidelines for the electro-
magnetic environment
Floors should be made of wood,
cement or ceramic tiles. When the
floor consists of a synthetic mate-
rial, the relative humidity must be at
least 30%.