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The Recom Model 100 battery-operated Ambulatory, Digital Wireless ECG Monitor System is a true 12 lead ambulatory ECG monitor system capable of recording up to 48 hours of ECG data for the purpose of cardiac monitoring and diagnosis by a medical professional where ambulatory (Holter) monitoring is prescribed by a physician. The system includes recording of ECG data from each of the 12 leads, RF transmission of the recorded data to a PDA and storage. The stored ECG data is then transferred from the PDA to another device, the Phillips Medical TraceMaster ECG Analysis System for ECG analysis. The Recom Model 100 battery-operated, Ambulatory, Digital, Wireless ECG Monitor System is not intended to sound any physiological alarms. The Recom Model 100 battery-operated, Ambulatory, Digital Wireless ECG Monitor System is only to be used by or on the order of a physician.

The device is a true 12 lead, battery-operated, ambulatory (Holter), digital, wireless, ECG monitor. The device acquires an ECG signal from 10 patient surface contact electrodes. Each electrode is connected to a cable that is connected to the Recom patient worn monitor/transmitter. The ECG signal is transmitted from the electrodes via the cable to a battery-operated ECG monitor unit worn by the patient where the signal is processed utilizing the company's signal processing technology and transmitted via radio frequency (Bluetooth) to a hand held Personal Digital Assistant (PDA) capable of recording up to 48 hours of ECG data. The PDA converts the signal stream into a specific data format where it is stored on a compact flash card for transmission to and analysis by another device, the Phillips Medical TraceMaster ECG Analysis System K032103. Monitoring data is not real time but is recorded and stored for further analysis by the Phillips System. The ECG data produced consists of Leads I, II, III, aVR, aVL, aVF and V1 through V6. The Recom Model 100 Ambulatory, Digital, Wireless monitor is not intended to alarm. The fundamental technology of the Recom battery-operated, Ambulatory. Digital ECG Monitor System is the same as that of the predicate devices. The Recom Ambulatory, Digital, Wireless ECG Monitor System relies on the company's signal processing technology to minimize noise in the ECG signal created by the ambulatory nature of the signal source.