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The MAC 800 is a portable ECG acquisition, analysis and recording system. The MAC 800 is intended to acquire, analyze, display and record information from adult and pediatric populations. Pediatric population is defined as patients between the ages of 0 and 15 years. The MAC 800 is intended to be used by trained operators in a hospital or medical professional's facility environment to record ECG signals from surface electrodes. The basic system shall provide 2 modes of operation: (1) Resting ECG mode and (2) Arrhythmia mode. The basic systems shall print 3, 6-leads of ECG. The device shall be upgradeable to provide software options such as 12-lead ECG measurement and interpretive analysis. Transmission and reception of ECG data to and from a central ECG cardiovascular information system shall be optional. The arrhythmia detection portion of the MAC 800 is provided to the customer for the convenience of automatic documentation. The MAC 800 is used under the direct supervision of a licensed healthcare practitioner. Contraindications: The MAC 800 is not designed to provide alarms for arrhythmia detection. The device is not suitable for intra cardiac application. It is not intended for use: - As a vital signs physiological monitor; or - For use during patient transport.

The MAC 800 ECG acquisition, analysis and recording system can print and display multiple leads of ECG data. The MAC 800 will provide, in resting ECG mode, ECG quality information using the hookup advisor. The hookup advisor advises users of poor lead quality based on noise measurement. It can be upgraded to provide options such as ECG measurement and interpretation with 12SL. Transmission and reception of ECG data to and from a central ECG cardiovascular information system is also optional. Multiple QT correction formulas including Bazett, Framingham and Fridericia will be available as a user selectable option. Clinical Trials Data Guard and audit trail options are also available. The MAC 800 delivers multiple leads of ECG on full-size reports and includes an SMS/text message telephone keypad for patient demographics and other data entry with T9 input method, an integrated 7" color display, and an integrated thermal writer. The thermal writer will print real time continuous waveform, alphanumeric data and non real time reports. The device can print the resting ECG report via the external laser printer. The device will have optional internal memory and removable storage to store resting ECG records. The device also can export the resting ECG record to PDF file on SD card as an optional function. An optional barcode reader and magnetic card scanner to enter patient information is available. The MAC 800 can be used as a portable unit.

The Heart Rate Turbulence Analysis Program is intended for use in a hospital, doctor's office, or clinic environment under the direct supervision of a licensed healthcare practitioner. The intended use of the Heart Rate Turbulence Analysis Program is to analyze ECG signals, provide measurements of Heart Rate Turbulence in patients undergoing cardiovascular disease testing for interpretation by qualified healthcare practitioner for the purposes of risk stratification and prediction of sudden cardiac death. The Heart Rate Turbulence Analysis Program only provides measurements, not interpretations. The Heart Rate Turbulence Analysis Program is to be used in conjunction with the patient's clinical history, symptoms, and other diagnostic tests for final clinical judgment.

The Heart Rate Turbulence Analysis Program is a software algorithm that runs in GE Medical Systems Information Technologies electrocardiographic equipment.