Ceribell® Indications, Safety & Warnings

Indications for Use

• Headband
  • The Ceribell EEG Headband is an electroencephalogram (EEG) electrode array intended for single patient use in the recording of EEGs. The EEG Headband is intended for prescription use in the home, healthcare facility, or clinical research environment.
• 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
  • The Ceribell EEG Recorder 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 to make neurological diagnoses. The Ceribell EEG Recorder is intended to be used in a professional healthcare facility environment. Additionally, the EEG Recording Viewer Software component of the Ceribell EEG Recorder 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 Ceribell EEG Recorder and the optional sending of an e-mail message. 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 EEG Recorder 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.
  • (Electrographic Status Epilepticus Monitor): 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.
  • (Expanded Seizure Detection Population): 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.
  • (Expanded Infant Seizure Detection Population): 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.
  • (Delirium Monitor System): 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 System 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.
  • (Artifact Reduction Software): Ceribell Artifact Reduction Software is intended for the review, monitoring and analysis of EEG recordings made by electroencephalogram (EEG) devices using scalp electrodes and to aid neurologists in the assessment of EEG. This device is intended to be used by qualified clinical practitioners who will exercise professional judgment in using the information. The Artifact Reduction component is intended to reduce artifact in EEG recordings. The Artifact Reduction component does not remove the entire artifact signal and may modify portions of waveforms representing cerebral activity. Waveforms must still be read by a qualified clinical practitioner trained in recognizing artifact, and any interpretation or diagnosis must be made with reference to the original waveforms.

Warnings

• Headband & Headcap
  • MR Unsafe. Remove headband (or headcap) from patient prior to performing Magnetic Resonance Imaging (MRI).
  • Do not use for electrical stimulation.
  • Do not use on patients with a known history of skin allergies to parabens.
  • Do not place headband (or headcap) electrodes on a wound or inflamed skin.
  • If skin irritation is noted, stop use and remove device.
  • Only connect the headband (or headcap) to a Ceribell EEG Device.
  • The electrical performance characteristics of the headband (or headcap) electrodes may affect the safety and effectiveness of the recording.
  • Only use the headband (or headcap) with electroconductive gel (or paste) that is FDA cleared or approved for use in electromedical applications.
  • The headband (or headcap) is non-sterile and single use only.
• System & Software
  • The Ceribell EEG Recorder is not defibrillation-proof. Remove the Ceribell EEG Recorder and all accessories from the patient prior to using a defibrillator.
  • The Ceribell EEG Recorder is MR Unsafe. Remove the Ceribell Recorder and all accessories from the patient prior to entering an MRI (magnetic resonance imaging) scanning room.
  • Only use the included power adapter and micro-USB cable to charge the Ceribell EEG Recorder. Use of other charging devices is not authorized.
  • All EEG acquisition functions are automatically disabled when the Ceribell Recorder is plugged into an external power supply or computer. EEG measurements and recordings cannot be taken while the Ceribell EEG Recorder is charging or connected to a computer.
  • The Ceribell EEG Recorder does not contain any user-serviceable parts. Contact Ceribell if your device requires service. Do not attempt to open or disassemble the Ceribell EEG Recorder.
  • The Ceribell EEG Recorder provides notifications for Seizure Detection that can be used when processing a record during acquisition. These include an on screen display and the optional sending of an email message. Delays of up to several minutes can occur between the beginning of a seizure and when the Ceribell EEG Recorder notifications will be shown to a user.
  • The Ceribell EEG Recorder Seizure Detection (or Ceribell Artifact Reduction Software) output cannot be used as a substitute for review of the underlying EEG by a trained expert.
  • Do not rely solely on the Seizure Detection (or Artifact Reduction Software) output for review of the study. The Seizure Detection (or Artifact Reduction) output is a tool used to assist the qualified practitioner with the analysis and diagnosis of the patient.
  • The Seizure Detection Software only analyzes signals recorded by Fp1, Fp2, F7, F8, T3, T4, T5, T6, O1 and O2 electrodes.
  • The Infant Seizure Detection Software only analyzes signals recorded by Fp1, Fp2, T3, T4, C3, Cz, C4, O1 and O2 electrodes.
  • The Delirium Monitor is not intended to be used as a stand-alone diagnostic.
  • The use of accessories, transducers, and cables other than those specified by Ceribell may result in increased EMISSIONS or decreased IMMUNITY of the Ceribell EEG Recorder.
  • Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the Ceribell EEG Recorder, including its cables. Otherwise, degradation of the performance of this equipment could result. See operator manual for recommended separation between portable and mobile RF communications equipment and the Ceribell EEG Recorder.
  • The Ceribell EEG Recorder should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the Ceribell EEG Recorder should be observed to verify normal operation in the configuration in which it will be used.
  • This equipment/system is intended for use by healthcare professionals only. This equipment/system may cause radio interference or may disrupt the operation of nearby equipment. It may be necessary to take mitigation measures, such as reorienting or relocating the Ceribell EEG Device or shielding the location.

Precautions

• Headband & Headcap
  • Caretakers should assess patients for adverse reactions on the skin where the device has contact, such as redness (erythema), swelling (edema), irritation, sensitization (delayed Type IV hypersensitivity), allergy, immune response, or other reactions.
  • Use caution if headband (or headcap) electrodes are applied over areas of skin that lack normal sensation.
  • Use outside of the prescribed head circumference range will significantly negatively impact device effectiveness and the reliability of the resulting data, which may lead to misdiagnosis.
  • The long-term effects of cutaneous electrodes for recording are unknown.
  • Use caution when using the headband (or headcap) in conjunction with other medical equipment, as such equipment may affect the safety and performance of the headband (or headcap).
  • Keep the headband (or headcap) out of the reach of children. When used on a pediatric patient, ensure that the patient cannot become entangled in the headband (or headcap) cable.
  • Not made of natural rubber latex.
  • Dispose of contents/container in accordance with federal, state, regional, local and/or hospital rules and regulations.
• System & Software
  • The Status Epilepticus Monitor is only compatible with the Ceribell EEG Recorder and the Ceribell EEG Headband. Users of the Status Epilepticus Monitor must be familiar with the operation of the Ceribell EEG Recorder and the Ceribell EEG Headband; consult the instructions for use of each for further information.
  • The Status Epilepticus Monitor is intended only to analyze EEG waveforms against criteria for ESE. The absence of a detection of ESE by the device does not preclude the possibility that seizures, other epileptiform patterns, or other pathologies are present in the EEG recording.
  • 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 Status Epilepticus Monitor output has not been tested with patients under 18 years old.
  • The Infant Seizure Detection Software is only compatible with the Ceribell EEG Recorder and the Ceribell Instant EEG Headcap. Users of the Infant Seizure Detection Software must be familiar with the operation of the Ceribell EEG Recorder and Ceribell Instant EEG Headcap; consult the instructions for use of each for further information.
  • The absence of a detection of seizure by the Infant Seizure Detection Software does not preclude the possibility that seizures, other epileptiform patterns, or other pathologies are present in the EEG recording.
  • The Artifact Reduction Software is only compatible with the Ceribell EEG Recorder. Users of the Artifact Reduction Software must be familiar with the operation of the Ceribell EEG Recorder. Consult the instructions for use for the Ceribell EEG Recorder for further information.
  • The Ceribell Delirium Monitor System analyzes discrete 30-minute segments of EEG to notify clinicians when EEG patterns associated with delirium are detected. The performance of the Ceribell Delirium Monitor has been validated by comparing its output to a bedside clinical assessment of delirium conducted during the same time period. This validation measured the accuracy of the device output for each point at which a bedside clinical assessment was performed. Bedside clinical assessments of delirium are made using the delirium diagnostic criteria of the DSM-5. These diagnostic criteria result in a determination that the patient is either delirium-positive or delirium-negative and a bedside clinical assessment is only able to determine the condition of the patient at the time the assessment is performed. Therefore, the output of the device can only be compared to a clinical ground truth during time periods that are classified by a bedside clinical assessment. Changes in patient condition that are detected by the device should be verified before commencing any interventions, and the output of the device should not be used as the sole determinant of the time that the patient’s condition changed.
  • The Delirium Monitor is only compatible with the Ceribell EEG Recorder and the Ceribell EEG Headband. Users of the Delirium Monitor must have familiarized themselves with all the manuals and labeling of the Ceribell EEG Recorder and the Ceribell EEG Headband; consult the instructions for use of each for further information.
  • The Delirium Monitor is only intended for use with adult patients (18 years and older). The Delirium Monitor output has not been tested on pediatric patients.

Ordering and Use

• Caution: Federal (US) law restricts this device to sale by or on the order of a physician.
• Refer to operator manual and labeling for indications, contraindications, warnings, precautions and instructions for use.
• 24/7 Tech and Other Support: 1-800-763-0183

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.