Electromagnetic Compatibility; Biological Safety; Manufacturer's Liability; Device Returns - IGEA I-ONE User Manual

IGEA
il • In the case of an established or presumed pregnancy, although no adverse effects attributable to the treatment
have been described, treatment in the pelvic area should be avoided as a precautionary measure. In any case,
always inform the doctor who prescribed the treatment, who will assess the need for continuation/interruption
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on a case-by-case basis.
g
• Pacemaker recipients may receive treatment with the I-ONE, but they must notify the prescribing doctor, who
will assess whether to start/continue the treatment.
n
• Fewer than 2 in every 1000 patients report heat/burning during treatment. In this case, it is recommended that
in the first week of treatment the daily sessions be divided up into several lasting one hour each; the treatment
g
should then be gradually increased until the standard regimen is reached. The burning sensation disappears when
the treatment is interrupted.
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• While not presenting the use of the device, usually, any contraindications in conjunction with the use of
medication, notify the doctor prescribing the therapy of any medications you take.
• There are no restrictions on the use of the device with simultaneous implantable medical devices (e.g. joint
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prostheses), but these must be CE-marked and are not supplied by the manufacturer. Clinical studies with similar
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devices indicate that stimulation relieves pain in subjects with mobilised and painful prostheses and no
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contraindications have emerged.
7.4

Electromagnetic Compatibility

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The I-ONE has been tested and certified as compliant with medical device electromagnetic compatibility standards
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and declared suitable for use at home.
The I-ONE can be used in conjunction with other electrical or electronic devices if they too conform to current
standards without causing interference or receiving interference. However, the following general requirements must
be observed:
d
• The I-ONE must not be used adjacent to or on top of other devices. If the I-ONE must be used in this way, the
medical device must be observed to ensure it works correctly in the configuration in which it is used;
• The I-ONE must be positioned and used in accordance with the EMC information provided later in this manual.
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• The I-ONE must not be used at the same time as other treatments or applications of electromedical device that
involve the release of energy to the patient's body, particularly if they use high-frequency signals, as these
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signals could interfere with the operation of the I-ONE and cause undesirable alterations in the treatment signal.
• The use of accessories and cables other than those specified and supplied directly by the I-ONE manufacturer
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may result in increased emissions or lower immunity for the I-ONE and cause it not to work properly.
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Portable and mobile RF communication devices, including peripherals such as antenna cables and external
•
antennas, should be kept more than 30 cm away from all I-ONE components including cables. Failure to do so
n.
could lead to a deterioration in the performance of the medical device.
at
d.
Blocked device: Electromagnetic interference, in particular electrostatic discharges of a power greater than
8kV, could alter the normal operation of the I-ONE and cause the device to become blocked.
In the event of a blocked device, or in any case in which the device does not switch off or does not react when
o
the On/Off button is pressed, reset the device to restore normal operation following the instructions in section
6.2.
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7.5 Biological safety

a
The safety of treatment with the I-ONE has been extensively verified; all tests showed the absence of adverse
4
treatment effects.
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8. MANUFACTURER'S LIABILITY

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r,
The manufacturer is only responsible for the safety, reliability and performance of the I-ONE if:
The device is used in accordance with the operating instructions described in this manual.
•
• The device is not opened or tampered with in any way by the user or other unauthorised persons.
• Only the power supply unit supplied directly by the manufacturer as a spare should be used.
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• The external power supply is used exclusively for the I-ONE device as described in this manual.
• Regular inspections, modifications and/or repairs are carried out by personnel authorised by IGEA.
I-ONE - User Manual
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