Device Returns; Technical Data; Ablelablectromagnabletic Lablectromagnabletic Able Immunity Missions; T Immunity To Proximity Fields From Able 2 - Electromagnetic Immunity Rf - IGEA I-ONE User Manual

IGEA
• 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:

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
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
Maximum current consumption
Maximum input power
Classification according to EN 60601-1
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
Model
Brand
Input voltage
Network frequency
Max. current input
Output voltage
Max. output current
Short-circuit protection
Insulation class
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.
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info@igeamedical.com
under the control of IMQ.
0051
: 11.1 VDC
: 0.250 A
: 3 W
: Class II device - Type BF
ME30A1541B01
SL Power
230 VAC (100-240)
50-60 Hz
0.150 A
15 VDC
2.0 A
Continued
II
I-ONE - User Manual