BIOTRONIK Reocor D Manual Tecnico página 36

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33
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
Checking the resis-
tance to interference
Electrostatic
discharge (ESD)
according to
IEC 61000-4-2
Fast transient electric
interference/bursts
according to
IEC 61000-4-4
Surges voltages
(surges) according 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
Class B
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.
Test level
Compliance
according to
level
IEC 60601
±6 kV contact
±6 kV contact
discharge
discharge
±8 kV air
±15 kV air
discharge
discharge
Not applicable
Not applicable
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.
The device is suitable for use in all areas,
excluding residential areas and buildings that are
connected directly to the public power supply.
Guidelines for the electromagnetic
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%.
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