Manufacturer's Declaration - vivocare Handy Mode D'emploi

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Manufacturer's Declaration

The HANDY is intended for use in the electromagnetic environment specified
below. The customer or the user of the HANDY should assure that it is used in
such an environment.
Electromagnetic Emissions: (IEC60601-1-2)
Emission Test
RF emission CISPR 11
RF emissions CISPR 11
Harmonic emissions IEC
61000-3-2
Voltage fluctuations/flicker IEC
61000-3-3
Electromagnetic Immunity: (IEC60601-1-2)
Immunity test
Electrostatic
discharge (ESD)
IEC 61000-4-2
Electric fast
transient/ burst
IEC 61000-4-4
Surge IEC
61000-4-5
Compliance
Group 1
Class B
Not applicable
Not applicable
IEC60601-1-2 test level
±6 kV contact
±8 kV air
±2 kV for power supply
lines
±1 kV for input/output
lines
±1 kV differential mode
±2 kV common mode
Electromagnetic Environment
The HANDY uses RF energy only
for internal functions. Therefore,
this RF emission is extremely
weak and there is little chance of
it creating any kind of interference
whatsoever with nearby electronic
equipment.
The HANDY is suitable for use in
all establishments, including do-
mestic establishments and those
directly connected to the public low
voltage power supply network that
supplies buildings used for domes-
tic purposes.
Compliance
Electromagnetic environ-
level
ment -guidance
Floors should be wood,
concrete or ceramic tile.
±6 kV
If floors are covered with
contact
synthetic material, the
±8 kV air
relative humidity should be
at least 30 %.
Mains power quality
Not
should be that of a typical
applicable
commercial or hospital
environment.
Mains power quality
Not
should be that of a typical
applicable
commercial or hospital
environment.
116

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