Ceribell Monitor
Ceribell, Inc.The Ceribell Monitor is a portable, full-montage EEG system designed to acquire, transmit, display, and store brain electrical activity signals (EEG), with optional ECG and video recordings. It helps healthcare professionals capture high-quality EEG data for neurological evaluation and monitoring in professional clinical settings.
Intended Use
The Ceribell Monitor is intended to acquire, transmit, display and store electroencephalogram (EEG) and optionally electrocardiogram (ECG) and video. The Ceribell Monitor is intended for prescription use in professional healthcare facilities.
Technology
The device is a portable, full-montage EEG system which includes a monitor device, power adapter, USB cable for data transfer, and optional extension cables for EEG and ECG electrodes. It supports up to 19 EEG electrodes and 1 ECG channel, captures signals at 500 Hz with 24-bit ADC resolution, and displays data on an integrated touchscreen. Wireless communication is through Wi-Fi and it can operate on internal battery or external power supply.
Performance
The device underwent extensive performance testing including compliance to IEC 80601-2-26 safety, electromagnetic compatibility and electrical safety testing (IEC 60601-1 and IEC 60601-1-2), wireless coexistence testing (C63.27), battery safety testing (IEC 62133), bench testing for system performance, shipping/distribution vibration testing (ASTM D7386), and software verification and validation per FDA guidance and IEC 62304.
Predicate Devices
No predicate devices specified
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