Maintenance; Contraindications And Side Effects; E Blectromagnetic Iological Safety C; Ompatibility - IGEA I-ONE User Manual

IGEA
• When using the coil under heavy blankets, the coil surface may become overheated: if the temperature of the coil
causes discomfort, it is advisable to carry out the therapy without covering the coil.
• In environments where the temperature is above 30°C you may experience warming of the coil surface; if the
temperature of the coil causes discomfort, it is advisable to split the daily therapy time into several sessions lasting
no less than two hours each.
• Keep the generator away from the body when charging the battery.
During use, the display may exceed a temperature of 41°C, but this is in any case below the regulatory limit given
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the limited patient contact time.
Clean the coil regularly, using only neutral detergents; do not use solvents or aggressive cleaning agents. Cleaning
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must be carried out when the coil is disconnected from the generator. The coil is for individual patient use only.
The generator can be cleaned using a cloth that has been slightly dampened with water or a neutral detergent; the
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generator must be cleaned when the unit is switched off.
• Avoid any mechanical shocks to the device during transportation or movement.
• In the event of a collision or fall that causes the device to break and/or open, the device and all its parts must be
collected and placed in the transport container and not used for any purpose. If the device is connected to the
mains socket, first remove the power supply unit from the mains socket. The user should then contact the
manufacturer to return the device and to possibly repair it.
• Before each treatment session, check the integrity of the connection cable between the generator and the coil; if
it is damaged, replace the coil with a new, undamaged one supplied by the manufacturer.
• Before using the external power supply, check that the casing and cable are not damaged; if they are, replace the
power supply with one supplied by the manufacturer.
Do not expose the device to heat sources and do not throw it into fire as there is a danger of explosion!
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• The battery is a polluting waste that must be disposed of according to current disposal regulations.
If the device is left unused for long periods of time, the battery may go completely flat and must be fully charged
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before starting treatment again.
Caution: only use the power supply unit supplied to charge the battery. The use of other devices could cause
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damage to the generator, battery or user for which the manufacturer waives any liability.
• The device is equipped with self-monitoring mechanisms to ensure it is working correctly; any anomalies are
signalled by the device and are described in the instruction manual.
• Any serious accident occurring during the use of the medical device and related to it must be reported by the user
to the manufacturer, who will notify the competent authority of the member state where the user and/or patient
is established.
• The device can be used with implantable medical devices (e.g. joint prostheses) with the CE conformity certification.
There are no restrictions on the use of this combination since clinical studies with similar devices indicate that
stimulation relieves pain in subjects with mobilised and painful prostheses and no contraindications have emerged.
7.2

Maintenance

The device is assembled by the manufacturer and requires a specific mechanical tool to open it. This is so as to
prevent tampering and/or unauthorised repair attempts by the user or third parties.
Any work on the device that requires the generator to be opened must be carried out by the manufacturer or
authorised technical support; otherwise the safety of the device is no longer guaranteed.
• In order to ensure a reliable performance, the manufacturer recommends that the device undergoes a
routine maintenance procedure and checks on the operating parameters at intervals no greater than 24
months. This maintenance should be requested from the IGEA Customer Support.
The power supply battery contained in the device cannot be removed/replaced by the user. If necessary, the
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battery may only be replaced by the manufacturer or by the manufacturer's authorised technical support.
The manufacturer recommends repeating the safe tests on the device to check that safety standards are
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being continuously maintained, at intervals no greater than 24 months. By agreement with the customer,
IGEA can provide the recommended electrical safety inspection service.
7.3

Contraindications and side effects

There are no known contraindications to the use of I-ONE and no side effects attributable to the treatment have
been observed. However, the following precautions must be taken:
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I-ONE - User Manual
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