IGEA BIOSTIM SPT, User Manual, Page: 25 / 56

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IGEA BIOSTIM SPT – User Manual
IGEA BIOSTIM SPT User Manual-EN
pag. 23
End of life disposal
BIOSTIM SPT and all its parts are subject to separate collection in the manner established by local
authorities.
7.1 Table of Electromagnetic Emission and Immunity Levels
BIOSTIM SPT taking into account the risk analysis associated with electromagnetic disturbances,
complies with all test levels & complies to EN60601-1-2.
BIOSTIM SPT, can be used in the specified electromagnetic environment. The user must
ensure that it is used in an electromagnetic environment with the features described below
Emissions tests Compliance Electromagnetic Environment
RF emissions - CISPR 11 Group 1
BIOSTIM SPT, generates RF signals exclusively as a result of
the operation of internal electronic circuits. Its RF emissions are very
low and hardly cause radio interference in nearby equipment.
RF emissions - CISPR 11 Class B BIOSTIM SPT, is suitable for use in all environments, including
domestic environments and those directly connected to the public low-
voltage power supply network that supplies buildings used for domestic
purposes.
Harmonic Emissions EN 61000-3-2 Class A
Voltage fluctuations / flicker emissions EN
61000-3-3
Compliant
Immunity Test EN 60601-1-2 Test Level Compliance Level Electromagnetic Environment
Electrostatic discharge
(ESD)
EN 61000-4-2
± 8 kV contact
± 15 kV air
IEC 60601-1-2
Test level
All environments, including domestic
environment( 1 ).
Radiated RF
EN 61000-4-3
10 V/m
from 80 MHz to 2,7 GHz
IEC 60601-1-2
Test level
Any environment, including domestic
environment with portable and mobile RF
equipment kept as far as possible from
BIOSTIM SPT, including connection cables.
Minimum distance 30 cm( 2 )
Electrical fast
transient/burst
EN 61000-4-4
± 2 kV for power supply lines
± 1 kV for input/output
IEC 60601-1-2
Test level
All environments, including domestic
environment.
Surges
EN 61000-4-5
± 1 kV between phases
± 2 kV form phase to ground
IEC 60601-1-2
Test level
All environments, including domestic
environment.
Conducted disturbances
induced by RF fields
EN 61000-4-6
3 Vrms
from 150 kHz to 80 MHz
6 V - ISM Frequencies and
Radio amateur band
IEC 60601-1-2
Test level
Any environment, including domestic
environment with portable and mobile RF
equipment kept as far as possible from
BIOSTIM SPT, including connection cables.
Minimum distance 30 cm
Voltage dips, short
interruptions and voltage
variations on power supply
input lines
EN 61000-4-11
10 ms – 0% a 0°,
45°, 90°, 135°, 180°,
225°, 270°, 315°
20 ms – 0% a 0°
500 ms – 70% a 0°
5 s – 0%
IEC 60601-1-2
Test level
All environments, including domestic
environment.
Power frequency (50/60 Hz)
magnetic fields
EN 61000-4-8
3 A/m
IEC 60601-1-2
Test level
All environments, including domestic
environment.
1 Electrostatic discharges of potential> 6kV (in contact) and> 8kV (in air) may cause a blockage of the device or an
interruption in the delivery of therapy. Potential 15kV discharges could cause a permanent failure as described in the
paragraph
2 The presence of electromagnetic disturbances at high levels, limited to some intervals of frequency, could cause an
interruption in the delivery of the signal, signaled by the device. BIOSTIM SPT, considering the risk analysis EMC
meets all test levels and complies with the EN 60601-1-2 Standard