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The ZOLL E Series External Defibrillator is indicated for the defibrillation, Noninvasive Transcutaneous Pacing, and multi-parameter monitoring of patient vital signs, including: ECG Monitoring, Pulse Oximetry, End Tidal CO2, 12-Lead ECG Monitoring, Non-Invasive Blood Pressure measurement and data printing and recording for resting patients in critical care and transport. The ZOLL E Series intended for use by qualified medical personnel who are trained and authorized to respond to medical emergencies, to facilitate the ability to monitor and assess the physiological characteristics of the indicated patients in a critical care environment.

Defibrillation: Use of the E Series products in the manual mode for defibrillation is indicated for converting/terminating ventricular fibrillation and rapid ventricular tachycardia to sinus rhythm or other cardiac rhythms capable of producing hemodynamically significant heart beats. Use of the device in the Semiautomatic mode for defibrillation is indicated on victims of cardiac arrest where there is apparent lack of circulation as indicated by: Unconsciousness, Absence of breathing, Absence of pulse.

External Pacemaker (Pacer Version Only): This product may be used for temporary external, demand or non-demand pacing, as an alternative to endocardial stimulation. External cardiac pacing is indicated for use on conscious or unconscious patients in asystole, profound bradycardia or any other conditions determined by a clinician to require external pacing.

ECG Monitoring: The device is indicated for monitoring a patient's electrocardiogram (ECG), via the 3 or 5 lead patient cable, MFE Pads, or through the paddles, for the purposes of identifying and diagnosing cardiac rhythms and dysrhythmias and calculating heart rate.

SpO2 Option (if equipped): The SpO2 Option with Masimo Set Technology is indicated for the continuous noninvasive monitoring of arterial oxygen saturation (SpO2) and pulse rate for adult, pediatric and neonatal patients, during both no motion and patient motion conditions, and for patients who are well or poorly perfusing in the hospital or pre-hospital environments.

EtCO2 Option (if equipped): The EtCO2 Option with Respironics Novametrix Technology and Capnostat® is indicated for the continuous noninvasive monitoring of end tidal carbon dioxide (EtCO2) and respiration rate in adult, pediatric and neonatal patient's requiring ventilatory support, transport and anesthesia.

12SL Analysis Option (if equipped): The 12SL™ Analysis Option using the GE/Marquette 12SL™ Algorithm is useful in the diagnosis of patients with acute myocardial infarction (AMI) and is useful in the diagnosis of patients with other transient cardiac arrhythmias. The interpretation and 12-Lead ECG Analysis is indicated for the recording and analysis of ECG signals acquired from adult and pediatric patients in the supine, resting position.

NIBP Option (if equipped): The NIBP Option with SunTech Medical Systems, Inc. Technology is indicated for the noninvasive measurement of arterial blood pressure for resting patients in critical care and transport. The NIBP Option on M Series units is designed to measure blood pressure for adult, pediatric, and neonatal patients.

The ZOLL E Series External Defibrillator is indicated for the defibrillation, Noninvasive Transcutaneous Pacing, and multi-parameter monitoring of patient vital signs, including: ECG Monitoring, Pulse Oximetry, End Tidal CO2, 12-Lead ECG Monitoring, Non-Invasive Blood Pressure measurement and data printing and recording for resting patients in critical care and transport. The ZOLL E Series intended for use by qualified medical personnel who are trained and authorized to respond to medical emergencies, to facilitate the ability to monitor and assess the physiological characteristics of the indicated patients in a critical care environment.

The E Series products contain a DC defibrillator capable of delivering up to 200 joules of energy. It may be used in synchronized mode to perform synchronized cardioversion by using the R-wave of the patient's ECG. The E Series uses either standard paddles or disposable, pre-gelled, MFE Pads for defibrillation.

The provided document is a 510(k) summary for the ZOLL E Series defibrillator and does not contain information regarding objective performance acceptance criteria or a study designed to prove the device meets such criteria for AI/ML-driven features.

The document discusses the substantial equivalence of the ZOLL E Series to predicate devices based on:

• Technological Characteristics: The design characteristics are the same as indicated predicate devices, and the technology is very similar to the ZOLL M Series. ECG analysis algorithms are identical to those in the ZOLL AED Plus defibrillator.
• Performance Testing: "Extensive performance testing ensures that the ZOLL E Series Defibrillator meets all of its functional requirements and performance specifications."
• Safety Testing: "Safety testing assures the device complies with applicable sections of recognized industry and safety standards."

However, it does not detail specific acceptance criteria for the mentioned "ECG Analysis Algorithms" or "12SL Analysis Option," nor does it describe a study with a test set, ground truth, or statistical endpoints typically associated with AI/ML device performance evaluation as per your request. The document describes a traditional medical device clearance process focused on equivalence to existing devices, functional requirements, and safety standards.

Therefore, I cannot provide the requested information in the format specified.

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