Chapter 4: Information about safety, support and quality
Classification and identification
In accordance with the Decree-Law Nº 273/95 of 23 October.
Device Class I with measuring function, Annex VII.
Internally powered equipment (IEC 60601-1). Class II device when
connected to external power supply (IEC 60601-1).
Device with applicable parts of the type BF (IEC 60601-1).
Non-ionizing electromagnetic radiation. The device includes radio
frequencies transmissions likely to cause interference in other equipment.
Serial number (affixed to the bioPLUXresearch device).
Contraindications
Do not use this device in patients with implanted electronic devices of any
kind, including pace-makers, electronic infusion pumps, stimulators,
defibrillators or similar.
Do not apply electrodes over damaged skin.
Do not use the system in patients with allergies to silver.
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