Biological Safety; Manufacturer's Responsibility - IGEA BIOSTIM SPT User Manual

IGEA
IGEA
signals, as these signals may interact with the operation of BIOSTIM SPT and cause unwanted
changes in the therapeutic signal;
The use of accessories and cables other than those specified and provided directly by the BIOSTIM
§
SPT manufacturer, may result in increased emissions or decreased immunity of BIOSTIM SPT
and cause improper operation;
BIOSTIM SPT may be sensitive to electrostatic discharge with a potential > 8kV; the user must
§
take every precaution to avoid discharges to the device that could cause a operational block or a
malfunction.
Electrostatic discharge with a potential of more than 15kV may damage the signal generator until
§
it causes a permanent failure; in this case the generator still maintains the basic safety required
and does not constitute any danger for the user or for third parties. In this case the generator will
have to be replaced with an efficient one.
Portable and mobile RF communications devices, including peripheral devices such as antenna
§
cables and external antennas, should be kept more than 30 cm away from all BIOSTIM SPT
components, including cables. Otherwise the performance of the medical device may deteriorate.
Device lock: Electromagnetic interference, such as those due to active cell phones or disturbances
to the power system, can interfere with the normal operation of BIOSTIM SPT and cause the device to
lock. In the event of a operational block, indicated by BIOSTIM SPT as a situation of failure or
interruption in the delivery of therapy, the device must be turned off and then on again after a few
seconds, using the switch on the side of the device to restore normal operation.
Be sure to remove the source of the disturbance before continuing treatment, if this is not possible,
increase the distance to the source of disturbance to at least 1 meter.
Caution: Using the device in the immediate vicinity of a shortwave or microwave (in operation)
therapy device may cause disturbances in the output signal which, although it does not pose a risk to
the patient, could nullify the therapeutic effect; therefore it shall be avoided.
5.4

Biological safety

The safety of the treatment with BIOSTIM SPT has been extensively verified; all tests showed the
absence of negative effects of treatment.
6.

MANUFACTURER'S RESPONSIBILITY

IGEA considers itself responsible for the safety, reliability and performance of the BIOSTIM SPT system
providing that:
1. Any modifications or repairs are undertaken only by personnel authorized by the same.
2. The appliance is not opened or tampered with in any way by the user or other non-authorized
persons.
3. The appliance is used in accordance with the operating instructions of the present manual;
4. The power is supplied using only power supply provided by the manufacturer.
5. The power supply is exclusively used for operating the BIOSTIM SPT system according to the
instructions of the present manual.
6. The user regularly perform the safe test and the operating parameters check recommended by
IGEA.
IGEA company reserves the right to implement updates that improve the system performances without
modifying pictures or instructions of the present manual.
For any further information or revisions that user can contact the local dealer or the manufacturer itself:
Manufacturer & Maintenance Service Centre:
IGEA S.p.A. Via Parmenide 10/A - 41012 Carpi (MO) – ITALY
Tel. +39 059 699 600
BIOSTIM SPT – User Manual
Fax. +39 059 695 778 - info@igeamedical.com
BIOSTIM SPT User Manual-EN
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