Compliance with the European CE rules and with the USA FDA Regulation 882.5050
MindLab Set is an integrated system for Applied Psychophysiology and Biofeedback, CE-marked.
The device is powered from the computer through the USB connection and, therefore, for the purposes of protecting, to the maximum, and beyond any possible risk, the safety of the patient, Psychotech applied, in the design phase and realizes, in the course of production, the stringent standards that must be met for any instrumentation which must be connected with the human body. For this reason, both data and voltage transfers, from the computer to the Psychodata Acquistion Unit, and vice versa, are implemented through some high insulation systems which satisfy the severe European directives in the field of biomedical instrumentation.
The passage of current and the transfer of information between the computer and the Psychodata Acquisition Unit, is realized, in fact, by means of some galvanic decoupling systems and some photo-optical devices that operate in accordance with the standard EN60601-1-2. The electromagnetic safety has been managed according to the EN55011 rules.
The device is powered from the computer through the USB connection and, therefore, for the purposes of protecting, to the maximum, and beyond any possible risk, the safety of the patient, Psychotech applied, in the design phase and realizes, in the course of production, the stringent standards that must be met for any instrumentation which must be connected with the human body. For this reason, both data and voltage transfers, from the computer to the Psychodata Acquistion Unit, and vice versa, are implemented through some high insulation systems which satisfy the severe European directives in the field of biomedical instrumentation.
The passage of current and the transfer of information between the computer and the Psychodata Acquisition Unit, is realized, in fact, by means of some galvanic decoupling systems and some photo-optical devices that operate in accordance with the standard EN60601-1-2. The electromagnetic safety has been managed according to the EN55011 rules.
MindLAB Set is not designed for use within hospitals (the real reason for an eventual Class IIa Medical Certification) and therefore it is NOT a medical devices.
The users should be Psychologists, Psychiatrists, Psychotherapists, Nurses, Social Workers Coach and Sport Trainers.
When purchased and used in USA, MindLAB Set belongs with the FDA Regulation 882.5050. The Food and Drug administration status, concerning premarket notification, is: not filed.
Licensed professionals may use MindLAB Set for any purpose defined by the scope and practice of their license.
Any user must protect the patient's safety by careffully reading the MindLAB Set manuals before starting to use it and then must respect every rule for safety established and prescribed by Psychotech.
