IGEA OSTEOSPINE - Electromagnetic Immunity Declaration

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ENGLISH
IGEA OSTEOSPINE – User Manual
IGEA OSTEOSPINE – User Manual EN
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Voltage fluctuations /
flicker emissions EN
61000-3-3
Compliant
connected to the public low-voltage power supply network
that supplies buildings used for domestic purposes.
Guide and declaration of the manufacturer – Electromagnetic Immunity
Immunity Test
EN 60601-1-2 Test
Level
Compliance
Level
Electromagnetic
Environment
Electrostatic discharge
(ESD)
1
EN 61000-4-2
± 8 kV contact
± 15 kV air
IEC 60601-1-2
Test level
All environments, including
domestic environment.
Radiated RF (
2
)
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 OSTEOSPINE,
including connection cables.
Minimum distance 30 cm.
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 OSTEOSPINE,
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
OSTEOSPINE is sensitive to electrostatic discharge; potential discharges > 8kV may cause a lock in normal
operation or a device failure. In the event of a lock, unlock the device using the Reset button or by disconnecting and
reconnecting the supply battery.
2
OSTEOSPINE in the presence of radiofrequencies between 150 and 250Mhz, could present problems during
charging; in thiscase OSTEOSPINE must be removed from the source of disturbance to eliminate such interference.