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2022/09/27
MEG010XN102-A11 (ENG)
CAUTION
: Under certain conditions, the effective value of the stimulation pulses
may exceed 10 mA and 10 V. Please follow the information in this manual carefully.
CAUTION
: The user must pay particular attention and adapt the size of the
electrodes to the area to be treated.
ATTENTION
:
It is important to check the size of the electrodes used.
The current density must be less than 2mA rms/cm².
CAUTION
: The output signals of the device are biphasic symmetrical with zero
average and do not include a DC component. Any unpleasant sensation (irritation,
overheating) at low intensities could mean a defect in the equipment.
Do not use the device without the advice of the MANUFACTURER.
CAUTION
: The device must not be accessible to the patient.
It should not be placed in contact with the patient.
CAUTION
:
If the computer used is not approved as a medical device, the computer
must not be located in a space accessible to the patient
2.5
Risks residual
To avoid the risk of burns or tetanization, be sure to disconnect the cables in the event of a
power failure or malfunction of the control PC.
Old or poor quality application parts can impair the quality of contact with the patient and cause
discomfort. Make sure you change them regularly.
Microbes or viruses can be transmitted from one patient to another via the applied parts. Make
sure that the hygiene conditions recommended by the manufacturer of the applied part are
observed.
If water enters the unit, it may not function properly. In this case, unplug the unit and
disconnect the cables. In any case, avoid the presence of water in the vicinity of the device.
2.6
Confidentiality of patient data
The device collects data from the computer to which it is connected. No data is stored in the
device.
It is the responsibility of the practitioner to apply and comply with the European Parliament's
General Data Protection Regulation 2016/679.
When returning to the Service Department, if the computer is returned with the device, the
practitioner must delete the patient data so that it is not disclosed. The practitioner has the
option of making a backup copy of this data by saving it to an external media before deleting it.
