This user's manual provides comprehensive information regarding the St. Jude Medical Confirm Rx™ Insertable Cardiac Monitor (ICM), model DM3500. The device is designed for monitoring and diagnosing cardiac arrhythmias and unexplained symptoms in patients.
Key Features and Information
The Confirm Rx™ ICM system includes the implantable monitor and external components like the Merlin™ Patient Care System (PCS) and the myMerlin™ mobile application for data transmission and review. The manual details the device's description, indications for use, intended use for physicians, and contraindications.
It also covers essential warnings and precautions, including sterilization, package inspection, storage, handling, insertion procedures, device replacement, and explant/disposal guidelines. Information on environmental and medical therapy hazards, such as electromagnetic interference (EMI) and interactions with various medical equipment, is also provided to ensure safe operation.
The document outlines potential adverse events, clinician use information, package contents, pre-insertion setup, sterile package opening, insertion site selection, and detailed insertion steps. It also includes patient education materials, radiopaque identification, physical and battery specifications, and regulatory compliance statements.
Resources
For further details and support, users can refer to the Monitoring Devices Help manual or the Merlin™ PCS on-screen help. Additional information is available at manuals.sjm.com.
