Delphi Amplifier

The Delphi Amplifier is a mobile EEG recording device that acquires electroencephalography signals and transmits them digitally to a computer via USB connection. It is intended for use by or under physician direction in clinical environments (hospitals, clinics, physician offices) for EEG signal acquisition and is not intended for life support systems.

The Delphi Amplifier supports up to 48 referential channels and 8-bit trigger input, operates at sampling rates of 125, 250, 500, 1000, or 2000 Hz, provides 24-bit true DC input with >100 dB CMRR, and connects via USB to external software through an SDK interface. It differs from the predicate eego amplifier by having fewer input channels (48 vs. 64), lower input impedance (>10^8 vs. >10^9 Ohm), and USB-only power (versus battery option), but operates at equivalent specifications for clinical EEG acquisition.

IEC 80601-2-26 and IEC 60601-2-26 (EEG-specific safety and essential performance), IEC 60601-1 (general medical electrical equipment safety), IEC 60601-1-6 (usability), IEC 60601-1-2 and IEC TR 60601-4-2 (electromagnetic disturbances), and supplemental IEC 80601-2-26 system performance testing.

The Delphi Amplifier shares identical indications for use and intended clinical application as the predicate eego amplifier—both electrically amplify EEG signals for digital transmission to a computer in clinical settings. Although technological differences exist (fewer channels, lower input impedance, USB-only power), bench testing demonstrated equivalent performance in noise, CMRR, sampling capability, and reliability, and these differences do not raise new safety or effectiveness concerns since various FDA-cleared devices operate across the range of specifications presented (16-128 channels).