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IGEA I-ONE - User Manual
Page 16
Coil drive signal characteristics and magnetic field strength:
Signal type : Rectangular signal
Frequency : 75 Hz ± 5%
Pulse width : 1.0 ± 0.1 milliseconds
Magnetic field intensity produced : 10-18 Gauss (peak value)
Method of use: Device with internal rechargeable electrical source with specified power supply unit. Device for
continuous operation not to be used in the presence of flammable anaesthetic mixtures with air, oxygen or nitrous
oxide.
Device with IP22 protection class. The IP22 class offers protection against the entrance of solids with a diameter
> 12 mm and protection against the entrance of water or rain drops falling at an angle ≤ 15° from the vertical of the
device.
Conditions of use of the device:
Room temperature : 5 - 34 °C
Relative humidity : 15% - 90% (free from condensation)
Atmospheric pressure : 700-1060hPa
Transportation and storage conditions:
Room temperature : -25 - +70°C
Relative humidity : 0 % at -25°C to 90% (non-condensing) at 70°C
Atmospheric pressure : 500 - 1060hPa
Storage conditions between uses:
Between one session and the next, the device must be stored in its packaging or in another clean and dry place under
the same environmental conditions as when it was intended for use.
Warning! The device must not be used in places where there is a danger of explosion.
Restoration of environmental conditions of use
If the device comes from a place with a different temperature (e.g. due to transportation or storage), wait about
10 minutes for it to adjust to the room temperature before using it.
End-of-life disposal
The I-ONE device and each of its parts cannot be disposed of as municipal waste but are subject to a separate
collection according to the procedures established by the local authorities.
10.1 Table 1 - Electromagnetic Emissions
MANUFACTURER'S GUIDANCE AND DECLARATION - ELECTROMAGNETIC EMISSIONS
The I-ONE - CBA04 model is usable in the specified electromagnetic environment. The user must ensure that it is
used in an electromagnetic environment with the characteristics described below.
Emission Test
Compliance
Electromagnetic Environment
RF emissions - CISPR 11
Group 1
The I-ONE - CBA04 model generates radio frequency signals solely
as a consequence of the internal electronic circuits. Its radio
emissions are very low and are unlikely to cause radio interference
with nearby devices.
RF emissions - CISPR 11
Class B
The I-ONE - CBA04 model is suitable for use in any environment,
including households and those directly connected to a low-voltage
public mains supply that supplies buildings used for domestic
purposes.
Harmonic Emissions
EN 61000-3-2
Class A
Voltage fluctuation / flicker emissions
EN 61000-3-3
Compliant
10.2 Table 2 - Electromagnetic Immunity
Manufacturer's guidance and declaration - electromagnetic immunity
Proof of Immunity
Test Level
EN 60601-1-2
Compliance
Level
Electromagnetic Environment
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