IGEA I-ONE - User Manual
Page 15
• The device is subjected to a function parameter check and safe-test at least every 24 months.
Please contact the manufacturer for further information or updates.
Manufacturer:
IGEA S.p.A. Via Parmenide 10/A, 41012 Carpi (MO) ITALY
Tel. 059 699600 Fax. 059 695778 e-mail: info@igeamedical.com
9. DEVICE RETURNS
If the device is to be returned to IGEA, the user is requested to use the original packaging complete with all its parts.
The adjacent image shows the correct positioning of the various components to ensure that they are adequately
protected.
Place the external power supply in the rectangular
hole on the right with the plug pointing to the left,
passing the cable through the space below the hole.
Insert the elastic band supporting the coil into the
housing next to the external power supply.
Then insert the I-ONE CBA04 generator into the hole
on the left, pressing slightly to fit it into the housing.
Insert the coil into the dedicated central space.
10. TECHNICAL DATA
The I-ONE complies with EU Medical Device Regulation
2017/745 and is marked
under the control of IMQ.
The I-ONE has an expected lifetime of 5 years after being placed on the market.
The applied parts (coils) have an expected lifetime of 12 months after being placed on the market.
I-ONE Generator - CBA04
Power supply voltage : 11.1 VDC
Maximum current consumption : 0.250 A
Maximum input power : 3 W
Classification according to EN 60601-1 : Class II device - Type BF
Classification according to MDR 2017/745 EU : Class IIa device
Li-ion 11.1 VDC/1100 mAh
or Li-ion 11.1 VDC/1350 mAh rechargeable battery
Do not expose the battery to heat sources and do not throw it into fire as there is a danger of explosion!
Do not immerse the battery pack in liquids or pour liquids onto it.
The battery is a polluting waste that must be disposed of according to current disposal regulations.
External power supply
The power supply model supplied by the manufacturer is approved according to EN60601-1 and EN60601-1-2.
Exclusively use the power supply unit supplied by the manufacturer.
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.
Electromagnetic Environment
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.
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
Voltage fluctuation / flicker emissions
EN 61000-3-3
10.2 Table 2 - Electromagnetic Immunity
Manufacturer's guidance and declaration - electromagnetic immunity
Electromagnetic Environment
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