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The Stealth System S300 is indicated for use on adult patients who may be asymptomatic or who may suffer from transient symptoms such as palpitations, dizziness, anxiety, fatigue, syncope, light-headedness, shortness of breath or who are at risk of developing atrial fibrillation and where a software-assisted analysis of an ambulatory ECG could identify potential cardiac causes of these symptoms. It includes a prescription only, single use, continuous ECG recorder that can be worn up to 7 days during activities of daily living.

The Stealth System S300 consists of three components: (1) Sensor, (2) Smart Cable, and (3) StealthView personal computer software (PC Software). No component of the system is provided sterile. The Sensor is a 7-day, wearable, single use, disposable recorder that detects and records ECG signals and records patient event markers. Recorded data is retrieved by connecting the Sensor to StealthView software using the Smart Cable after the Sensor has been removed from the patient. StealthView software analyzes the recorded ECG signal and provides a report of heart rhythms for clinician review.

The Stealth™ Monitor is a prescription only single use, continuous recording ECG monitor that can be worn up to 168 hours (7 days) during activities of daily living. It is indicated for use on adult patients who may be asymptomatic or who may suffer from transient symptoms such as palpitations, dizziness, anxiety, fatigue, syncope, presyncope, light-headedness, shortness of breath and where a software-assisted analysis of the potential causes of these symptoms is desirable.

The Stealth™ Monitor is a small, lightweight, patch-style, single-use cardiac monitor designed for ambulatory collection of electrocardiographic (ECG) data continuously for up to 168 hours (7 days) and ECG signal characterization. It is worn on the patient's chest similar to an adhesive bandage. The housing is constructed of a foam material making the device very lightweight (less than 9 grams). A software application is installed at a physician's office to receive the data from the monitor using a direct connection. Data retrieved from the monitor may be printed or saved and stored for later viewing. The DSD software has the ability to generate reports as well as the ability to save a full disclosure ECG file for viewing.

The Stealth™ Monitor is a prescription only single use, continuous recording ECG monitor that can be worn up to least 24 hours. It is indicated for use with patients where it would be desirable to record ECG signals for this period of time.

Stealth™ Monitor, Docking Cable and Display and Storage Device