Manuel D’UtilisationTable des matièresDescription7Related Information7Intended Audience7Indications for Use7Contraindications7Warnings7General7Handling8Implantation8Post-Implant9Precautions9Clinical Considerations9Sterilization and Storage10Implantation10Device Programming11Environmental and Medical Therapy Hazards12Hospital and Medical Environments12Home and Occupational Environments16Follow-up Testing18Explant and Disposal18Supplemental Precautionary Information18Potential Adverse Events19Clinical Summary21S-ICD System Clinical Investigation21Methods21Primary Objectives21Additional Objectives22Accountability of PMA Cohort23Study Population Demographics and Baseline Parameters24Safety and Effectiveness Results30Effectiveness Results38Subgroup Analyses41Conclusion42Patient Screening43Collecting the Surface ECG43Evaluating the Surface ECG44Determining an Acceptable Sense Vector46Operation47General47Modes of Operation47Shelf Mode47Therapy On Mode47Therapy Off Mode47Sensing Configuration and Gain Selection48Sensing and Tachyarrhythmia Detection48Detection Phase48Certification Phase49Decision Phase49Therapy Zones49Analysis in the Conditional Shock Zone50Charge Confirmation51Therapy Delivery51Smart Charge51Redetection52Shock Waveform and Polarity52Post-Shock Bradycardia Pacing Therapy52Manual and Rescue Shock Delivery52Additional Features of the S-ICD System52Auto Capacitor Reformation53Internal Warning System – Beeper Control53Arrhythmia Induction53System Diagnostics53Subcutaneous Electrode Impedance54Device Integrity Check54Battery Performance Monitoring System54Storing and Analyzing Data55Treated Episodes55Untreated Episodes55Captured S-ECG55S-ECG Rhythm Strip Markers56Patient Data57S-ICD System Magnet Use58Magnet use for patients with deep implant placement59Magnet Response and Pulse Generator Mode60Bidirectional Torque Wrench61Using the EMBLEM S-ICD Pulse Generator61Items Included in Package61Implanting the S-ICD System62Check Equipment62Interrogate and Check the Pulse Generator63Creating the Device Pocket63Implanting the EMBLEM S-ICD Subcutaneous Electrode64Connecting the Subcutaneous Electrode to the Device67Setting up the EMBLEM S-ICD Pulse Generator using the Model 3200 S-ICD Programmer71Defibrillation Testing72Complete and Return the Implantation Form73Patient Counseling Information74Patient Guide74Post Implant Follow-Up Procedures75Explantation76Loosening Stuck Setscrews77Communication Compliance78Federal Communications Commission (FCC) Compliance78Additional Information78Product Reliability78Pulse Generator Longevity79Specifications80X-ray Identifier80Definitions of Package Label Symbols87S-ICD System and Pacemaker Interaction89Warranty Information90Taille: 1,9 MoPages: 92Language: EnglishOuvrir le manuel
