IGEA OSTEOSPINE User Manual page 31

IGEA
IGEA
Voltage fluctuations
flicker emissions EN
61000-3-3
Guide and declaration of the manufacturer – Electromagnetic Immunity
Immunity Test
Electrostatic discharge
1
(ESD)
EN 61000-4-2
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
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.
OSTEOSPINE – User Manual
/ connected to the public low-voltage power supply network
Compliant that supplies buildings used for domestic purposes.
EN 60601-1-2 Test
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
from 150 kHz to 80
6 V - ISM Frequencies
MHz
and
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
OSTEOSPINE – User Manual EN
Compliance
Level
IEC 60601-1-2 All environments, including
Test level domestic environment.
Any environment, including
domestic environment with
portable
IEC 60601-1-2
equipment kept as far as
Test level
possible from OSTEOSPINE,
including connection cables.
Minimum distance 30 cm.
IEC 60601-1-2 All environments, including
Test level domestic environment.
IEC 60601-1-2 All environments, including
Test level domestic environment.
Any environment, including
domestic environment with
portable
IEC 60601-1-2
equipment kept as far as
Test level
possible from OSTEOSPINE,
including connection cables.
Minimum distance 30 cm.
IEC 60601-1-2 All environments, including
Test level domestic environment.
IEC 60601-1-2 All environments, including
Test level domestic environment.
Electromagnetic
Environment
and mobile RF
and mobile RF
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