Table Of Electromagnetic Emission And Immunity Levels - IGEA BIOSTIM SPT User Manual

IGEA
IGEA
End of life disposal
BIOSTIM SPT and all its parts are subject to separate collection in the manner established by local
authorities.

Table of Electromagnetic Emission and Immunity Levels

7.1
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
RF emissions - CISPR 11
RF emissions - CISPR 11
Harmonic Emissions EN 61000-3-2
Voltage fluctuations / flicker emissions EN
61000-3-3
Immunity Test
Electrostatic discharge
(ESD)
EN 61000-4-2
Radiated RF
EN 61000-4-3
Electrical fast
transient/burst
EN 61000-4-4
Surges
EN 61000-4-5
Conducted disturbances
induced by RF fields
EN 61000-4-6
Voltage dips, short
interruptions and voltage
variations on power supply
input lines
EN 61000-4-11
Power frequency (50/60 Hz)
magnetic fields
EN 61000-4-8
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
BIOSTIM SPT – User Manual
Compliance
Group 1
Class B
Class A
Compliant
EN 60601-1-2 Test Level Compliance Level
± 8 kV contact
± 15 kV air
10 V/m
from 80 MHz to 2,7 GHz
± 2 kV for power supply lines
± 1 kV for input/output
± 1 kV between phases
± 2 kV form phase to ground
3 Vrms
6 V - ISM Frequencies and
from 150 kHz to 80 MHz
Radio amateur band
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%
3 A/m
BIOSTIM SPT User Manual-EN
Electromagnetic Environment
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.
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.
Electromagnetic Environment
IEC 60601-1-2 All environments,
Test level environment(
Any environment,
environment with portable and mobile RF
IEC 60601-1-2
equipment kept as far as possible from
Test level
BIOSTIM SPT, including connection cables.
Minimum distance 30 cm(
IEC 60601-1-2 All environments,
Test level environment.
IEC 60601-1-2 All environments,
Test level environment.
Any environment,
environment with portable and mobile RF
IEC 60601-1-2
equipment kept as far as possible from
Test level
BIOSTIM SPT, including connection cables.
Minimum distance 30 cm
IEC 60601-1-2 All environments,
Test level environment.
IEC 60601-1-2 All environments,
Test level environment.
including domestic
1
).
including domestic
2
)
including domestic
including domestic
including domestic
including domestic
including domestic
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