User Manual

Lumax Technical Manual i
Contents
1. General ..............................................................................1
1.1 System Description .......................................................1
1.2 Indications and Usage...................................................4
1.3 Contraindications...........................................................5
1.4 Warnings and Precautions ............................................5
1.4.1 Sterilization, Storage, and Handling ......................8
1.4.2 Device Implantation and Programming .................8
1.4.3 Lead Evaluation and Connection ........................10
1.4.4 Follow-up Testing ................................................12
1.4.5 Pulse Generator Explant and Disposal ...............12
1.4.6 Hospital and Medical Hazards.............................12
1.4.7 Home and Occupational Hazards .......................14
1.4.8 Cellular Phones ...................................................14
1.4.9 Electronic Article Surveillance (EAS) ..................15
1.4.10 Home Appliances ................................................15
1.4.11 Home Monitoring® ..............................................15
1.5 Potential/Observed Effects of the Device on Health ...17
1.5.1 Potential Adverse Events ....................................17
1.5.2 Observed Adverse Events...................................18
1.6 Clinical Studies ............................................................27
1.6.1 Kronos LV-T Study ..............................................28
1.6.2 Tupos LV/ATx Study............................................30
1.6.3 Lumax HF-T V-V Clinical Study...........................48
1.6.4 TRUST Clinical Study..........................................55
1.6.5 Deikos A+ ............................................................63
1.7 Patient Selection and Treatment.................................67
1.7.1 Individualization of Treatment .............................67
1.7.2 Specific Patient Populations................................68
1.8 Patient Counseling Information ...................................68
1.9 Evaluating Prospective CRT-D/ICD Patients ..............69
2. Device Features ..............................................................70
2.1 SafeSync Telemetry ....................................................70
2.2 Cardiac Resynchronization Therapy (CRT) ................73
2.3 Sensing (Automatic Sensitivity Control) ......................76
2.3.1 Right Ventricular Sensitivity Settings...................77
2.3.2 Minimum Right Ventricular Threshold .................79