Ceribell® Indications, Safety & Warnings

Important Safety Information: This device is intended for prescription use only and must be used by or under the direction of qualified clinical practitioners. The device cannot be used as a substitute for real-time monitoring of an EEG by a trained expert. It is intended to support clinical decision-making and does not replace professional medical judgment, diagnosis, or standard of care. Always refer to the full Instructions for Use for complete safety information.

Intended Use

  • The Ceribell® Rapid Response EEG System, including the Seizure Detection Software, Headband, and Headcap is intended for use by healthcare professionals to facilitate rapid assessment and monitoring of patients suspected of experiencing seizure activity.
  • The system is designed for short-term clinical use in inpatient or emergency care settings.
  • It is not intended to replace standard clinical EEG or comprehensive neurological evaluation.

Indications for Use

  • Headband
    • The Ceribell® Headband is an electroencephalogram (EEG) electrode array intended for single patient use in the recording of EEGs.
    • The Headband is intended for prescription use in clinical settings by trained healthcare professionals.
  • Headcap
    • The Ceribell® Instant EEG Headcap is intended for use in routine clinical settings where rapid placement of a number of EEG electrodes is desired.
    • The headcap shall be placed on the head of infants, including newborns and preterm babies.
  • System & Software
    • K191301
      • The Ceribell Pocket EEG Device is intended to record and store EEG signals, and to present the EEG signals in visual and audible formats in real time. The visual and audible signals assist trained medical staff in making neurological diagnoses. The Pocket EEG Device is intended to be used in a professional healthcare facility environment.
      • Additionally, the EEG Recording Viewer Software component of the Pocket EEG Device incorporates a Seizure Detection component that is intended to mark previously acquired sections of EEG recordings in patients greater than or equal to 18 years of age that may correspond to electrographic seizures in order to assist qualified clinical practitioners in the assessment of EEG traces. The Seizure Detection component provides notifications to the user when detected seizure prevalence is “Frequent,” “Abundant,” or “Continuous,” per the definitions of the American Clinical Neurophysiology Society Guideline 14. Notifications include an on-screen display on the Pocket EEG Device and the optional sending of an e-mail message to a clinician. Delays of up to several minutes can occur between the beginning of a seizure and when the Seizure Detection notifications will be shown to a user.
      • The Pocket EEG Device does not provide any diagnostic conclusion about the subject’s condition, and Seizure Detection notifications cannot be used as a substitute for real time monitoring of the underlying EEG by a trained expert.
    • K223504
      • The Ceribell Status Epilepticus Monitor software is indicated for the diagnosis of Electrographic Status Epilepticus in patients greater than or equal to 18 years of age who are at risk for seizure. The Ceribell Status Epilepticus Monitor software analyzes EEG waveforms and identifies patterns that may be consistent with electrographic status epilepticus as defined in the American Clinical Neurophysiology Society’s Guideline 14.
      • The diagnostic output of the Ceribell Status Epilepticus Monitor is intended to be used as an aid for determining patient treatment in acute-care environments. The device’s diagnosis of Electrographic Status Epilepticus provides one input to the clinician that is intended to be used in conjunction with other elements of clinical practice to determine the appropriate treatment course for the patient.
      • The Ceribell Status Epilepticus Monitor is intended for diagnosis of Electrographic Status Epilepticus only. The device does not substitute for the review of the underlying EEG by a qualified clinician with respect to any other types of pathological EEG patterns. The device is not intended for use in Epilepsy Monitoring Units.
    • K241589
      • The Ceribell Seizure Detection Software is intended to mark previously acquired sections of EEG recordings in patients greater or equal to 1 year of age that may correspond to electrographic seizures in order to assist qualified clinical practitioners in the assessment of EEG traces. The Seizure Detection Software also provides notifications to the user when detected seizure prevalence is “Frequent,” “Abundant,” or “Continuous,” per the definitions of the American Clinical Neurophysiology Society Guideline 14. Delays of up to several minutes can occur between the beginning of a seizure and when the Seizure Detection notifications will be shown to a user.
      • The Ceribell Seizure Detection Software does not provide any diagnostic conclusion about the subject’s condition, and Seizure Detection notifications cannot be used as a substitute for real time monitoring of the underlying EEG by a trained expert.
    • K252072
      • The Ceribell Infant Seizure Detection Software is intended to mark previously acquired sections of EEG recordings in newborns (defined as preterm or term neonates of 25-44 weeks postmenstrual age) and infants less than 1 year of age that may correspond to electrographic seizures in order to assist qualified clinical practitioners in the assessment of EEG traces. The Seizure Detection Software also provides notifications to the user when detected seizure prevalence is “Frequent,” “Abundant,” or “Continuous,” per the definitions of the American Clinical Neurophysiology Society Guideline 14. Delays of up to several minutes can occur between the beginning of a seizure and when the Seizure Detection notifications will be shown to a user.
      • The Ceribell Infant Seizure Detection Software does not provide any diagnostic conclusion about the subject’s condition, and Seizure Detection notifications cannot be used as a substitute for real time monitoring of the underlying EEG by a trained expert.
    • K251936
      • The Ceribell Delirium Monitor System is intended to analyze features associated with diffuse slowing electroencephalogram (EEG) patterns that may be indicative of delirium. The Ceribell Delirium Monitor software is intended to aid in the screening and monitoring of delirium with clinical assessments in adult patients in critical care settings within hospitals.
      • The Ceribell Delirium Monitor System analyzes discrete segments of EEG to notify clinicians when EEG patterns associated with delirium are detected while monitoring the patient. Changes in patient condition that are detected by the device should be verified before commencing any interventions.

Contraindications

There are no known contraindications for use of the Ceribell® EEG System, Headband, or Headcap.

Warnings

  • Headband and Headcap
    • To enable reliable signal acquisition, the Headband or Headcap must be applied by trained personnel in accordance with the Instructions for Use.
    • Improper placement of the Headband or Headcap may result in poor signal quality or missed seizure activity.
    • Do not use a damaged or contaminated Headband or Headcap.
    • The Headband and Headcap are designed for single-patient use. Do not reuse single-use Headbands and Headcaps; reuse may compromise hygiene or signal integrity.
  • System & Software
    • The Ceribell® EEG System does not replace review of EEG data by a trained clinician.
    • Do not rely solely on the Seizure Detection output for review of the study. The Seizure Detection output is a tool used to assist the qualified practitioner with the analysis and diagnosis of the patient. The absence of a detection of seizure by the Seizure Detection Software does not preclude the possibility that seizures, other epileptiform patterns, or other pathologies are present in the EEG recording.
    • The system should only be used by or under the supervision of qualified medical personnel.
    • Interpretation of EEG data may be affected by artifacts or signal noise. Always review raw EEG data when making clinical decisions.
    • The Seizure Detection Software is only compatible with the Ceribell Pocket EEG Device and the Ceribell Instant EEG Headcap. Users of the Seizure Detection Software must be familiar with the operation of the Ceribell Pocket EEG Device and the Ceribell Instant EEG Headcap. Consult the instructions for use for the Ceribell Pocket EEG Device and the Ceribell Instant EEG Headcap for further information.
  • Improper application or use outside of the labeled indications may result in inaccurate recordings or missed seizure events.

Precautions

  • Headband and Headcap
    • Confirm that all electrodes make consistent contact with the scalp.
    • Do not use the Headband or Headcap on patients with open wounds, severe dermatological conditions, or cranial implants in the placement region.
    • Use caution with patients near the head circumference thresholds; fit and contact may vary.
    • Store and handle the Headband or Headcap in a clean, dry environment before use.
    • Clean and dry skin before applying Headband or Headcap, to enhance electrode adhesion and signal quality.
    • Dispose of Headband or Headcap per institutional protocol for medical waste after single use.
    • Monitor for signs of skin irritation, breakdown, or pressure injury, especially in sensitive populations or after prolonged use.
  • System & Software
    • Review the full Instructions for Use before deploying the device in a clinical setting.
    • Ensure proper electrode placement and verify signal quality during setup.
    • Use only components and accessories approved by Ceribell.®
    • Use in environments with strong electromagnetic interference may affect signal quality.
    • Residual risks may remain despite proper use; users should adhere strictly to all warnings and precautions.

Potential Adverse Events

  • Headband and Headcap
    • Skin abrasion or pressure marks from prolonged Headband or Headcap contact.
    • Allergic reactions to adhesives or materials in contact with skin.
    • Discomfort in pediatric or sensitive patients due to tightness or electrode pressure.
  • System & Software
    • Although rare, use of EEG monitoring may be associated with:
      • Minor skin irritation at electrode sites
      • Risk of misinterpretation if EEG data is not reviewed by qualified personnel
      • False positives leading to unnecessary intervention or over-medication, or false negatives leading to missed diagnoses or treatment

Ordering and Use

Regulatory Notice

Using the Ceribell® system or any of its components outside of the FDA-cleared indications described above may be considered off-label use and is not supported by Ceribell, Inc. ® Users should adhere to all applicable institutional policies and regulatory requirements when determining appropriate use of the device.