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10. Informations sur la compatibilité électromagnétique (CEM)
Les appareils électromédicaux sont soumis à des précautions spéciales en matière de compatibilité électromagnétique
et doivent être installés et mis en service conformément aux instructions de compatibilité électromagnétique figurant
dans les documents d'accompagnement. Les dispositifs de communication RF portables et mobiles (par exemple les
téléphones portables) peuvent affecter les appareils électriques médicaux.
Pour que le Porti 7 soit utilisé conformément aux instructions, seuls les accessoires spécifiés doivent être utilisés dans
le mode d'emploi. L'utilisation d'accessoires externes peut entraîner une augmentation des émissions et une immunité
réduite.
Guidelines and Manufacturer's Declaration – Electromagnetic Emissions
The Porti 7 is intended for use in an electromagnetic environment as specified below. The customer or user of the Porti
7 should ensure that it is used in such an environment.
Emission Test
RF – Emission according to CISPR 11
RF – Emission according to CISPR 11
Harmonic Emissions according to
IEC 61000-3-2
Voltage Fluctuations / Flicker Emissions
according to IEC 61000-3-3
Guidelines and Manufacturer's Declaration – Electromagnetic Immunity
The Porti 7 is intended for the electromagnetic environment as specified below. The customer and user of the Porti 7
should ensure that it is used in such an environment.
Immunity Test
Electrostatic Discharge
(ESD)
IEC 61000-4-2
Electrical fast Transient /
Burst
IEC 61000-4-4
Surges
IEC 610004-5
Voltage dips, short
interruptions and voltage
variations on power supply
input lines
IEC 61000-4-11
Power Frequency
(50/60 Hz) Magnetic Field
IEC 61000-4-8
Note
Compliance
Group 1
Class B
Not applicable
Not applicable
Table 1: Table 201 EN 60601-1-2, Electromagnetic Emissions
IEC 60601- Test Levell
± 6 kV contact
± 8 kV air
± 2 kV for AC power line
± 1kV for input and output line
± 1 kV differential mode
± 2kV common mode
< 5 % U
T
(> 95 % dip in U
) for ½ cycle
T
40 % U
T
(60 % dip in U
) for 5 cycle
T
70 % U
T
(30 % dip in U
) for 25 cycle
T
< 5 % U
T
(> 95 % dip in U
)
T
for 5 s
3 A/m
U
is the a.c. mains voltage prior to application of the test level.
T
Table 2: Table 202 EN 60601-1-2, Electromagnetic Immunity
Electromagnetic Environment - Guidelines
The Porti 7 uses RF energy only for it's internal function.
So it's RF emission is very low and it's implausible that
it cause any interferences to surrounding electronical
devices.
The Porti 7 is suitable for the use in all establishments,
including domestic establishments and those, which are
connected to the public power supply, which powers
buildings for residential purposes.
Compliance Level
Floors
concrete or should be covered with
±4 kV contact
ceramic titles. If the floor is covered
±8 kV air
with synthetic material, the relative
humidity must be at least 30 %.
Not applicable
Not applicable
Not applicable
Not applicable
- 12 -
Electromagnetic Environment -
Guidance
should
consists
of
wood,
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