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ENGLISH
IGEA I-ONE - User Manual
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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.
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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
the limited patient contact time.
• Clean the coil regularly, using only neutral detergents; do not use solvents or aggressive cleaning agents. Cleaning
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
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!
• The battery is a polluting waste that must be disposed of according to current disposal regulations.
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If the device is left unused for long periods of time, the battery may go completely flat and must be fully charged
before starting treatment again.
• Caution: only use the power supply unit supplied to charge the battery. The use of other devices could cause
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.
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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.
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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
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
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:
IGEA I-ONE - User Manual
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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
on a case-by-case basis.
• 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.
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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
should then be gradually increased until the standard regimen is reached. The burning sensation disappears when
the treatment is interrupted.
• 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
prostheses), but these must be CE-marked and are not supplied by the manufacturer. Clinical studies with similar
devices indicate that stimulation relieves pain in subjects with mobilised and painful prostheses and no
contraindications have emerged.
7.4 Electromagnetic Compatibility
The I-ONE has been tested and certified as compliant with medical device electromagnetic compatibility standards
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:
• 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.
• 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
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
may result in increased emissions or lower immunity for the I-ONE and cause it not to work properly.
• 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
could lead to a deterioration in the performance of the medical device.
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
the On/Off button is pressed, reset the device to restore normal operation following the instructions in section
6.2.
7.5 Biological safety
The safety of treatment with the I-ONE has been extensively verified; all tests showed the absence of adverse
treatment effects.
8. MANUFACTURER’S LIABILITY
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.
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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.
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