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The InvisionECG System is intended to acquire, display and record electrocardiographic information from adult and pediatric patients. The InvisionECG System is intended to be used in a clinical or home environment by trained healthcare professionals.

The InvisionECG System is a hand-held, battery powered, 12 lead electrocardiograph (ECG) system. The InvisionECG System acquires ECG information via a patient-attached lead set, and processes and transmits the ECG information to a mobile device where the ECG waveform may be viewed in near real-time. A 12 second snapshot of the waveform can be acquired, and then uploaded to an medical device data system (MDDS) from where these records can be retrieved and analyzed by trained medical professionals. Patient data is also transmitted with the ECG waveform. The primary functions of the InvisionECG System are to: • Acquire ECG signals from the patient's body and display the near real-time ECG waveform. The displayed waveform is intended to provide the bedside care provider with a preliminary view of the ECG and additional opportunity to control the quality of captured ECGs. - Capture a 12-second ECG waveform. . - Associate the captured ECG waveform to the patient. . - . Forward captured ECG waveform to an MDDS for later retrieval. analysis and diagnosis by a trained professional.