IGEA OSTEOSPINE User Manual page 30

IGEA
IGEA
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*
Brand
Input power
Mains voltage
Max. input current
Output voltage
Max output voltage
Short-circuit protection
Insulation category
* 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
Relative humidity
Atmospheric pressure
Environmental transportation and storage conditions
Atmospheric temperature
Relative humidity
Atmospheric pressure
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
RF emissions - CISPR 11
RF emissions - CISPR 11
Harmonic Emissions EN
61000-3-2
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OSTEOSPINE – User Manual
MENB1020A1840B01
AULT/SL Power
230VAC (100-240)
50-60Hz
0,100 A
18 VDC
1,0 A
Continua
II
: 0 - 40°C
: 30% - 75%
: 700-1060hPa
: -20 - +70°C
: 10% - 90%
: 500 - 1060hPa
Compliance
OSTEOSPINE, generates RF signals exclusively as a
result of the operation of internal electronic circuits. Its RF
Group 1
emissions are very low and hardly cause radio
interference in nearby equipment.
Class B
OSTEOSPINE is suitable for use in all environments,
including domestic environments and those directly
Class A
OSTEOSPINE – User Manual EN
ME20A1840B01
230VAC (100-240)
Electromagnetic Environment
SL Power
50-60Hz
0,100 A
18VDC
1,0A
Continua
II
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