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The following Indications for Use are identified for the CardiacLinx device: 1. MCT Mode: For use on adult patients who experience transient or non-transient symptoms that may suggest cardiac arrhythmias. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible notification when Ventricular Fibrillation/Flutter, Atrial Fibrillation/Flutter, Pause (Asystole), Bradycardia, or Tachycardia occurs. 2. Holter Mode: For use on adult patients experiencing palpitations, syncope, dizziness, arrhythmia, bradycardia, tachycardia, angina, ischemia and paced ECG. 3. Multi-Lead (Resting EKG) Mode: For use on adult patients for acquiring, storing and viewing/printing of up to twelve (12) leads of patient ECG waveforms through surface electrodes adhered to the patient's body. 4. The intended use locations for CardiacLinx are in a physician's office, hospital or rehabilitation facilities, patient's home, or similar use areas. It is intended to be used by or on the order of a physician or similarly qualified health care professional. 5. For general hospital or clinical use by medical professionals whenever an assessment of a patient's ambulatory ECG data is required. Allows for a trained physician or health care professional to download and analyze the data for review and to produce printed reports. This will enable the evaluation of arrhythmias, ischemic attacks, reporting of PQRST intervals, clinical and epidemiological research studies, evaluation of a patient response after resuming occupational or recreational activities (e.g., after myocardial infarction or cardiac surgery), and/or evaluation of patients with pacemakers. CardiacLinx is only available for use upon the order of a physician or other related licensed medical professional. 6. For use under the supervision of a qualified physician trained in ECG interpretation to record the electrical activity of the heart for the purpose of correlating resultant waveforms with the health of the heart muscle tissue structures.

The CardiacLinx System is a continuous real-time ECG monitor and arrhythmia detector. It is a multipurpose device designed with the ability to collect ECG data from the patient in order to perform: 1. 2-lead Mobile Cardiac Outpatient Telemetry (MCT) for up to 30 days; 2. 24 hour or longer 3-lead Holter monitoring; or 3. Resting 12-lead ECG with interpretation. The ambulatory device may be used on an outpatient basis with remote clinician data analysis whenever it is required to assess a patient's ambulatory ECG data (MCT and Holter modes), as well as for use within the physician office setting by the medical professional (resting 12-lead mode). The product consists of monitoring equipment worn by the patient that transmits all asymptomatic and symptomatic events to a central computer monitoring center in the outpatient setting. The central computer monitoring center is equipped with personal computers running CardiacLinx System software intended for use only by qualified medical professionals and their staff. CardiacLinx is comprised of three (3) main software components developed by Ross Medical Technology, consisting of: 1. The Ross Medical Technology PMD Software that can be run on a Personal Mobile Device ("PMD") with Bluetooth capabilities and a built-in cellular modem. The Personal Mobile Device is configured to process and transmit signals from an FDA cleared patient-worn ECG Monitor (also with Bluetooth capabilities); 2. The Ross Medical Technology MCT Server Software that can be run on a central server that receives, interprets (using embedded algorithms), and stores the ECG data from the PMD Software; and 3. The Ross Medical Technology MCT Client Software that can be run at a central computer monitoring center attended by trained medical professionals who can view the ECG data and interpretations. In addition to the three main software components manufactured by Ross Medical Technology. CardiacLinx includes third party components that are necessary to complete the functionality of the device. These third party components are: 1. An FDA cleared patient-worn ECG Monitor; 2. A Personal Mobile Device with Bluetooth capabilities and built-in cellular modem; and 3. Two embedded ECG Interpretation Algorithms found in other FDA cleared ECG analysis devices. The CardiacLinx device integrates these third party components with RMT's proprietary software.