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The ePatch® is indicated for use on patients who may be asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath, dizziness, light headedness, pre-syncope, fatigue, chest pain and/or anxiety. The ePatch® is intended for use by adolescents 18-21 and adults.

The ePatch® ECG Recorder is intended for continuous recording of heart action potentials (ECG). While in use, the sensor is connected to a compatible ECG electrode and placed on the patient. The ePatch® ECG Recorder is a small digital Holter recorder intended for use by professionals to acquire continuous ambulatory recording of heart action potentials (ECG) from a patient through a compatible ECG patch electrode. The ePatch® is intended for use in a clinical, point of care or at a patient setting. The recording time of the ECG recorder is dependent on the set configuration of the recorder (sample rate and channel selection). The patient's ECG is recorded to the ePatch® ECG Recorder and then transferred via the ePatch® USB cable to a Holter analysis system for review by physician or other qualified personnel. The ePatch® ambulatory electrocardiograph (ECG) recorder is a small, lightweight monitor that records ECG continuously. The unit records 1, 2 or 3 channels of ECG up to 9 days. The device is composed of a large ECG electrode and an ECG recorder. The ECG recorder snaps onto the electrode and records until the recorder is removed from the electrode. At the end of the recording, the recorder can be plugged into a PC via a USB cable. The ECG recording can be transferred in an available file format at can be processed through recording processing software provided by recording processing software manufacturers and analyzed by qualified healthcare providers. The ePatch® can be worn continuously up to 5 days in homes, healthcare facilities, hospitals, and wherever the patient may go. The components that are part of the ePatch® recorder are a lead wire, USB cable and the ePatch® electrode. During the recording the patient wears the ePatch® connected to an electrode on the upper sternum or an alternative placement on the upper torso. The ePatch® consists of a microprocessor, measuring circuit, memory, data storage, lightemitting diode (trans-illuminates the plastic casing), and contract to the electrode. In addition to that, ePatch® contains firmware to control the collection of the ECG data and software to transfer to the processing software.

The device is designated as Rx only. Its indications for use are as follows: 1. Patients who have a demonstrated need for cardiac Monitoring. These may include but are not limited to patients who require Monitoring for: a) non-life threatening arrhythmias such as supraventricular tachycardias (e.g. atrial fibrillation, atrial flutter, PACs, PSVT) and ventricular ectopy; b) evaluation of bradyarhythmias and intermittent bundle branch block, including after cardiovascular surgery and myocardial infarction; and c) arrhythmas associated with co-morbid conditions such as hyperthyroidism or chronic lung disease. 2. Patients with symptoms that may be due to cardiac arrhythmias. These may include but are not limited to symptoms such as: a) dizziness or lightheadedness; b) syncope of unknown etiology in which arrhythmias are suspected or need to be excluded; c) dyspnea (shortness of breath). 3. Patients with palpitations with or without known arrhythmias to obtain correlation of rhythm with symptoms. 4. Patients who require outpatient monitoring of antiarrhythmic therapy: a) Monitoring of therapeutic and potential proarrhythmic effects of membrane active drugs, b) Monitoring of effect of drugs to control ventricular rate in various atrial arrhythmias (e.g. atrial fibrillation). 5. Patients recovering from cardiac surgery who are indicated for outpatient arrhythmia Monitoring 6. Patients with diagnosed sleep disordered breathing including sleep apnea (obstructive, central) to evaluate possible nocturnal arrhythmias 7. Patients requiring arthythmia evaluation of etiology of stroke or transient cerebral ischemia, possibly secondary to atrial fibrillation or atrial flutter. 8. Patients requiring measurement, analysis and reporting of QT interval, excluding patients with a documented history of sustained atrial fibrillation or atrial flutter 9. Patients who require monitoring for potential arrhythmias based on risk factors (e.g. atrial fibrillation). 10. Patients requiring measurement of ST segment changes. The device is not intended to sound any alarms for ST segment changes.

The Braemar Telemetry Patch System BTPS-1000 is an ambulatory ECG monitor with capability to detect cardiac arrhythmias and transmit ECG data to a customerstaffed monitoring center (referred to as "Remote Site"). The subject device is comprised of two (2) main components: 1) a patient-worn Sensor and 2) a Monitor. The Sensor functions as the data acquisition element in the Braemar BTPS-1000 system. It collects ECG data and transmits it with appropriate Sensor status updates to the Monitor. The Sensor software also manages Leads Off detection and Pacemaker Pulse detection, monitors battery voltage, motion information, and controls a sounder (beeper) for notifications or warnings. The Sensor software manages battery charging and data retrieval from the Monitor via Bluetooth®. The user interacts with the Sensor software only by connecting the Sensor to the Patch / Electrodes providing a usable battery at which time the Sensor automatically starts. There are four integrated Electrodes built into the Patch, and these adhere to the user. The Electrodes are hardwired to the Sensor within the Patch. There are no Sensor software functions that are controlled or modified by the user. The Monitor will perform data/arrhythmia detection analysis and transmit the data to the customer Remote Site via cell modem for further post-processing and reporting. The Monitor software is responsible for managing patient ECG data for the purpose of storage, analysis, and transmission. The Monitor software also performs system integrity checks on itself. The Monitor software provides all visual indications for itself and its associated Sensor. The Monitor also contains software that enables transmission of ECG data via cellular. The user interacts with the software via an On/Off physical button and by touching buttons drawn on the Monitor LCD touch screen. All other physical buttons are disabled and on lock-down by the Monitor, which prevents use of camera and other functions. The user can start/stop the Monitor, declare a symptomatic event, change the screen and speaker intensity levels, and enable/disable the built-in cellular communications. The user can also acknowledge alerts and warnings such as Leads Off or Low Battery, and request help for notices or system messages. The user is not otherwise provided with any means to control or modify software functions The data is received by trained technicians at the Remote Site who make use of Medical Device Data System (MDDS) software to review the ECG waveforms and determine if they concur with the analysis made by the algorithm in the Monitor. The Sensor-Monitor network is designed to be operational in a home environment, able to co-exist with other Bluetooth. WiFi, and other protocols operating in the 2.4GHz ISM band. Robustness of Bluetooth networks to interferences from other documented players in this band is in literature (www.bluetooth.com/Pages/Basics.aspx ). In addition, attached summary test reports (Attachments T and U) regarding testing specified in IEC60601-1-2 confirm that the device is fully capable of the standard's required safe and effective communication across the cellular (WWAN) and Bluetooth protocols. The subject device provides continuous ECG recording and automated analysis through operation in MCOT mode (Mobile Cardiac Outpatient Telemetry). Some documentation (including the System Risk Analysis in Attachment G), refers to the subject device as BTPS-1000 MCOT or version 1. The subject device continuously collects ECG data from the patient. The Sensor acquires the ECG data and transmits the data to the Monitor wirelessly. In MCOT mode, the Monitor continuously and automatically analyzes the ECG data using the same proprietary algorithm found in predicate K093288. The data is algorithmically processed and transmitted to customer Remote Site using cellphone.