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 and Headband, 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 intended to facilitate rapid and consistent electrode placement for EEG signal acquisition in conjunction with the Ceribell Rapid Response EEG System in patients aged 1 year or older.
    • The Headband is intended for single-patient, short-term use in clinical settings by trained healthcare professionals.
  • System & Software
    • The Ceribell® Rapid Response EEG System, including the Seizure Detection Software, is intended to mark sections of EEG recordings that may correspond to electrographic seizures in patients 1 year of age or older, 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 Section notifications will be shown to a user.
    • The system is intended for use by healthcare professionals trained in EEG interpretation. The 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.

Contraindications

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

Warnings

  • Headband
    • To enable reliable signal acquisition, the Headband must be applied by trained personnel in accordance with the Instructions for Use.
    • Improper placement of the Headband may result in poor signal quality or missed seizure activity.
    • Do not use a damaged or contaminated Headband.
    • The Headband is designed for single-patient use. Do not reuse single-use Headbands; 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 on the Seizure Detection Software for standalone clinical decision-making.
    • 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.
  • Improper application or use outside of the labeled indications may result in inaccurate recordings or missed seizure events.

Precautions

  • Headband
    • Confirm that all electrodes make consistent contact with the scalp.
    • Do not use the Headband on patients with open wounds, severe dermatological conditions, or cranial implants in the placement region.
    • Use caution with pediatric patients near the minimum age and head circumference thresholds; fit and contact may vary.
    • Store and handle the Headband in a clean, dry environment before use.
    • Clean and dry skin before applying Headband, to enhance electrode adhesion and signal quality.
    • Dispose of Headband 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.
    • This device is not indicated for infants under 12 months of age

Potential Adverse Events

  • Headband
    • Skin abrasion or pressure marks from prolonged Headband 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.