50
Directives and manufacturer’s declaration – Electromagnetic immunity
The
IMPLANTEO®
is intended to be used in the electromagnetic environment specified below.
The customer or user of the
IMPLANTEO®
must ensure that it is used in such an environment.
Immunity test
Test level CEI 60601
Compliance level
Electromagnetic environment - directives
Electrostatic
discharges
CEI 61000-4-2
± 6 kV on contact
± 8 kV in the air
± 6kV on contact
± 8kV in the air
Floors must be wooden, concrete or ceramic
tiles. If floors are covered with synthetic
materials, the relative humidity must be
at least 30 %.
Rapid transition
into salvos
CEI 61000-4-4
± 2 kV for electricity
supply cables
± 1 kV for input/
output cables
± 2 kV for electricity
supply cables
± 1 kV for input/output
cables
The quality of the electricity supply network
must be that of a typical commercial or hospital
environment.
Transitory excess
voltage
CEI 61000-4-5
± 1 kV between phases
± 2 kV between phases
and earth
± 1 kV between phases
± 2 kV between phases
and earth
The quality of the electricity supply network
must be that of a typical commercial or hospital
environment.
Brief cut in voltage
and variations
in voltage in input
electricity supply
cables
CEI 61000-4-11
<5 % UT
(>95 % cavity of UT)
for 0,5 cycle
40 % UT
(60 % cavity of UT)
for 5 cycles
70 % UT
(30 % cavity of UT)
for 25 cycles
<5 % UT
(>95 % cavity of UT)
for 5 s
<5 % UT
(>95 % cavity of UT)
for 0,5 cycle
40 % UT
(60 % cavity of UT)
for 5 cycles
70 % UT
(30 % cavity of UT)
for 25 cycles
<5 % UT
(>95 % cavity of UT)
for 5 s
The quality of the electricity supply network
must be that of a typical commercial or hospital
environment.
If the user of the
IMPLANTEO®
needs
continuous operation during cuts in supply,
it isrecommended supplying the
IMPLANTEO®
from energy supply with no cut-out or with
a battery.
Magnetic field
for the frequency
of the electricity
network (50/60Hz)
CEI 61000-4-8
3 A/m
3A/m
The magnetic fields at the frequency of the
electricity network must have the levels
characteristic of a representative place located
in a typical commercial or hospital environment.
NOTE :
U
T
is the alternative voltage before applying the test level
Emissions test
Compliance
Electromagnetic environment - directives
RF CISPR 11 emissions
Class B
The
IMPLANTEO®
is suitable for use in all facilities,
including domestic facilities and those directly connected
to the low voltage public electricity network supplying
buildings for domestic use.
Harmonic emissions
CEI61000-3-2
Class A
Voltage fluctuation /
Flicker twinkling
CEI61000-3-3
Compliance
