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The CK100 CardioKey Holter Recorder is intended for patients requiring ambulatory (Holter) Monitoring. The following is a listing of the most frequent indications for use: 1. Evaluation of symptoms suggesting arrhythmia or myocardial ischemia. 2. Evaluation of ECG documenting therapeutic interventions in individual patients or groups of patients. 3. Evaluation of patients for ST segment changes. 4. Evaluation of a patient's response after resuming occupational or recreational activities (e.g., after M.I. or cardiac surgery.) 5. Clinical and epidemiological research studies. 6. Reporting of time and frequency domain heart rate variability. 7. Reporting of QT Interval.

The CardioKey Hotter Recorder, Model CK100, is an ambulatory ECG recorder which is comprised of three (3) main components: 1) a patient-worn Sensor, 2) a Lead wire and 3) a host application. The Sensor is a USB dongle that acquires ECG data and stores the data in nonvolatile memory. The Sensor is worn for up to 14 days and operates on one coin cell battery for the duration of the recording period. This Sensor can plug directly into a host computer's USB port for data transfer. The female end of the lead wire cable assembly plugs onto the Sensor. The lead wire cabling on the other end of the assembly is connected to the User via two electrodes The host application extracts user data from the Sensor and translates it to processing by a 510(k) cleared third party analysis software.