IGEA OSTEOSPINE - Electromagnetic Emission and Immunity Levels

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ENGLISH
IGEA OSTEOSPINE – User Manual
IGEA OSTEOSPINE – User Manual EN
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Power battery
Ni-MH battery with nominal voltage 9 VDC, Nominal capacity150 mAh, Average battery life with 1/10
C charge > 500 cycles. The rechargeable battery which powers the device is classified as polluting
refuse and must be disposed of in accordance with local current legislation.
External battery charger
Model*
MENB1020A1840B01
ME20A1840B01
Brand
AULT/SL Power
SL Power
Input power
230VAC (100-240)
230VAC (100-240)
Mains voltage
50-60Hz
50-60Hz
Max. input current
0,100 A
0,100 A
Output voltage
18 VDC
18VDC
Max output voltage
1,0 A
1,0A
Short-circuit protection
Continua
Continua
Insulation category
II
II
* IGEA reserves the right to provide different models of power supply, tested and approved for the system according
to EN60601-1, EN 60601-1-2; use only the power supply provided directly by the manufacturer.
Environmental condition of use
Atmospheric temperature : 0 - 40°C
Relative humidity : 30% - 75%
Atmospheric pressure : 700-1060hPa
Environmental transportation and storage conditions
Atmospheric temperature : -20 - +70°C
Relative humidity : 10% - 90%
Atmospheric pressure : 500 - 1060hPa
Note: After removing the device from its packaging it is considered that the environmental conditions
for use are applicable for transport and storage.
Warning: This device is not to be used in areas in which an explosion risk exists.
End of life disposal
OSTEOSPINE 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
OSTEOSPINE taking into account the risk analysis associated with electromagnetic disturbances,
complies with all test levels & complies to EN60601-1-2.
OSTEOSPINE
, 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
OSTEOSPINE, 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
OSTEOSPINE is suitable for use in all
environments,
including domestic environments and those directly
Harmonic Emissions EN
61000-3-2
Class A