Search Results

The Signalife Fidelity 200 Cardiac Event Recorder is a battery operated, user-activated recorder and transmitter intended to record an ECG and transmit their ECG data to medical professionals via a communication device to a cardiac monitoring service. This allows users to record and transmit their ECG data to medical professionals who are concerned about their heart rhythm and have experienced the following symptoms that are suggestive of abnormal cardiac rhythms: Pounding heart (Palpitations), Heart racing or irregular pulse, Lightheadedness or Faintness, History of Arrhythmia.

The device acquires an ECG signal and produces a single lead ECG. Upon user activation, an ECG signal is acquired and digitized producing a 45-second ECG recording utilizing the company's signal processing technology. The Signalife Fidelity 200 Cardiac Event Recorder converts the signal stream into a specific data format where it is stored on a memory chip for transtelephonic transmission to and analysis by another device such as the PaceArt System K024278 manufactured by Medtronic, Inc. Recorded data is not real time but stored for further analysis. The Signalife Fidelity 200 Cardiac Event Recorder is not intended to evaluate the signal or alarm. The fundamental technology of the Signalife Fidelity 200 Cardiac Event Recorder is the same as that of the predicate devices. The Signalife Fidelity 200 Cardiac Event Recorder employs the company's signal processing technology to minimize noise in the ECG signal created by the ambulatory nature of the signal source.