IGEA OSTEOSPINE User Manual page 28

IGEA
IGEA
use high frequency signals as they may interact with the device and cause harm to the patient or
to the device.
- The use of the device at the same time of the use of drugs do not normally presents
contraindication. The doctor who prescribes the therapy should be informed by the patient for
any medication.
5.3 Electromagnetic compatibility
OSTEOSPINE has been tested and certified according to the electromagnetic compatibility standards
for medical devices and it is declared suitable for the home environment.
OSTEOSPINE 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:
OSTEOSPINE must not be used adjacent or overlapped with other devices. If adjacent or
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overlapping use is required, the medical device must be observed to verify normal operation in
the configuration in which it is used;
OSTEOSPINE requires special precautions regarding electromagnetic compatibility and must be
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installed and used in compliance with the electromagnetic compatibility information provided
below in this manual;
OSTEOSPINE must not be used at the same time as other therapies or applications of electro-
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medical devices that release energy to the patient's body, particularly if they use high-frequency
signals, as these signals may interact with the operation of OSTEOSPINE and cause unwanted
changes in the therapeutic signal;
The use of accessories and cables and electrodes other than those specified and provided directly
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by the OSTEOSPINE manufacturer, may result in increased emissions or decreased immunity of
OSTEOSPINE and cause improper operation;.
Portable and mobile RF communications devices, including peripheral devices such as antenna
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cables and external antennas, should be kept more than 30 cm away from all OSTEOSPINE
components, including cables. Otherwise the performance of the medical device may deteriorate
and the device may report a fault situation. If this situation should occur, the user must interrupt
the treatment in progress, place the device and all of its parts at least 1 meter from any possible
source of electrical/electronic noise and resume treatment;
OSTEOSPINE may be sensitive to electrostatic discharge with a potential > 15kV; It is advisable
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to use particular care not to subject the device to discharges of this magnitude, which could in the
worst case, cause a blockage during the charging phase of the device;
Device block: Electromagnetic interference, such as those due to active cell phones or
disturbances to the power supply system, or high potential electrostatic discharge > 8kV, can interfere
with the normal functioning of OSTEOSPINE and cause the device to stop. Should this occur, follow
the instructions given in paragraph 4.1. Be sure to remove the source of the disturbance before
continuing treatment.
Caution: Using the device in the immediate vicinity of a shortwave or microwave therapy device
(in operation) may cause disturbances in the output signal which, although it does not pose a risk to
the patient, could nullify the therapeutic effect; it may therefore be avoided.
5.4 Biological safety
The electrodes used for the application of the therapeutic signal, which are supplied together with the
system, are made of non-allergic materials, which are totally biocompatible; such features being
attested by the CE making certificates released by the manufacturer.
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OSTEOSPINE – User Manual
OSTEOSPINE – User Manual EN
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