Maa: Australia
Kieli: englanti
Lähde: Department of Health (Therapeutic Goods Administration)
Medtronic Australasia Pty Ltd
Medical Device Included AIMD
Protecta™ XT VR D354VRM Digital single chamber implantable cardioverter defibrillator (VVE-VVIR) SmartShock ® Technology (RV Lead Noise Discrimination, RV Lead Integrity Alert, TWave Discrimination, Confirmation+, Wavelet), OptiVol ® 2.0 Fluid Status Monitoring, Complete Capture Management ® Diagnostic (RVCM) and ATP During Charging™ Feature Clinician Manual Protecta™ XT VR D354VRM Clinician Manual A guide to the operation and programming of the Model D354VRM Protecta XT VR digital single chamber implantable cardioverter defibrillator (VVE-VVIR) The following list includes trademarks or registered trademarks of Medtronic in the United States and possibly in other countries. All other trademarks are the property of their respective owners. Active Can, ATP During Charging, Capture Management, Cardiac Compass, CareAlert, CareLink, ChargeSaver, Conexus, Flashback, Intrinsic, Marker Channel, Marquis, Medtronic, Medtronic CareAlert, Medtronic CareLink, OptiVol, Protecta, Quick Look, SmartShock, Switchback, T-Shock, TherapyGuide CONTENTS 1 SYSTEM OVERVIEW . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 1.1 CE mark of conformity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 1.2 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 1.3 System description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 1.4 Indications and usage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 1.5 Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 2 WARNINGS, PRECAUTIONS, AND POTENTIAL ADVERSE EVENTS . . . . . . . . . . . . . . . . . . 14 2.1 General warnings and precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 2.2 Explant and disposal . . Lue koko asiakirja