IGEA BIOSTIM SPT, User Manual, Page: 22 / 56

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IGEA BIOSTIM SPT – User Manual
IGEA BIOSTIM SPT User Manual-EN
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cause discomfort, it is recommended to split the daily time therapy in multiple sessions lasting no
less than two hours each.
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The device must be used in compliance with the normal rules of hygiene, and should be cleaned
regularly. The presence in the environment of use of hair, hair, dust, as well as exposure to direct
sunlight, while not causing malfunction of the device, should be avoided.
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Before proceeding with cleaning the coil or the generator ensure that the appliance is switched off
and disconnected from the power supply. All BIOSTIM SPT components can be cleaned using
neutral detergents; never use any aggressive solvents or detergents for cleaning.
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The coil is single patient
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The Velcro strap can be washed like any garment.
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Avoid knocking the appliance during transportation and movement.
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The device is equipped with mechanisms of self-control of the correct functioning of any anomaly
that may occur is indicated by the system and is described in the instruction manual. Any
malfunctions therefore do not affect therapeutic efficacy.
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IGEA recommends to repeat safe test at regular intervals not exceeding 24 months of use, to
ensure that safety standards are consistently maintained. IGEA, in agreement with the client, is
able to perform the recommended safe test.
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IGEA recommended a routine maintenance procedure for the operating parameters check at
regular intervals not exceeding 24 months of use to ensure reliable performance; ccontact IGEA or
an authorized assistance centre.
5.2 Contraindications and adverse effects
In the many international studies carried out, no negative side effects have been detected due to the
therapy, nevertheless it is necessary to follow the below mentioned precautions:
• In case of pregnancy, certain or supposed, even if no negative effects are described relating to the
therapy, as a caution it is suggested to avoid to treat the pelvis bones directly. In any case, always
contact the doctor who has prescribed the therapy, he will evaluate case by case the need of
prosecuting/interrupting it.
•
The pacemakers currently in use today are not affected by electromagnetic fields, however those
who are fitted with a pacemaker are advised to verify the features of their own pacemaker with their
cardiologist, and to avoid any treatments that involve direct coil application to the chest.
•
Fewer than 0,2% of patients complained of burning sensations during treatment. In the event that
this occurs it is necessary to reduce the treatment time to 3 hours in the first 7 days of treatment,
to be divided into 3 sessions of one hour each; then gradually increase the treatment time by one
hour a day until the standard application time is reached. The burning sensation ceases on
suspension of treatment.
•
The use of the device at the same time the use of drugs not normally presents no contraindication.
The doctor who prescribes the therapy should be informed by the patient for any medication.
5.3 Electromagnetic compatibility
BIOSTIM SPT has been tested and certified according to the electromagnetic compatibility standards
for medical devices and it is declared suitable for the home environment.
BIOSTIM SPT can be used together with other electrical or electronic devices, providing they also
conform to current standards, without causing interference or receiving disturbances. However, the
following general requirements must be observed:
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BIOSTIM SPT must not be used adjacent or overlapped with other devices. If adjacent or
overlapping use is required, the medical device must be observed to verify normal operation in the
configuration in which it is used;
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BIOSTIM SPT requires special precautions regarding electromagnetic compatibility and must be
installed and used in compliance with the electromagnetic compatibility information provided below
in this manual;
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BIOSTIM SPT must not be used at the same time as other therapies or applications of electro-
medical devices that release energy to the patient's body, particularly if they use high-frequency