Transcription of User's Manual - SJM
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Confirm Rx . Model DM3500. Insertable Cardiac Monitor User's Manual Unless otherwise noted, indicates that the name is a trademark of, or licensed to, St. Jude Medical or one of its subsidiaries. ST. JUDE MEDICAL and the nine-squares symbol are trademarks and service marks of St. Jude Medical, Inc. and its related companies. Pat. 2016 St. Jude Medical, Inc. All Rights Reserved. Description This Manual describes the following St. Jude Medical device: Table 1. Confirm Rx insertable cardiac monitor Name Model Number Description MRI Status Confirm Rx DM3500 Insertable cardiac MR Conditional monitor The St. Jude Medical Confirm Rx insertable cardiac monitor (ICM) is designed to detect arrhythmias and wirelessly transmit data to the Patient Care Network (PCN). The ICM constitutes the inserted portion of the system. The Merlin Patient Care System (PCS) with software version (or greater), magnet, myMerlin mobile application (app), and PCN.
with the requirements of ISO 14117:2012. This testing covered the operating frequencies (450 MHz - 3 GHz) and pulsed modulation techniques of all of the digital cellular phone technologies in worldwide use today. Based on the results of this testing, the device should not be
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