BIOTRONIK Lumax DR ICD Series, Technical Manual, Page: 3 / 176

Lumax Technical Manual i
Contents
1.1 System Description .......................................................1
1.2 Indications and Usage...................................................3
1.3 Contraindications...........................................................4
1.4 Warnings and Precautions ............................................4
1.4.1 Sterilization, Storage, and Handling ......................7
1.4.2 Device Implantation and Programming .................7
1.4.3 Lead Evaluation and Connection ..........................9
1.4.4 Follow-up Testing ................................................11
1.4.5 Pulse Generator Explant and Disposal ...............11
1.4.6 Hospital and Medical Hazards.............................11
1.4.7 Home and Occupational Hazards .......................13
1.4.8 Cellular Phones ...................................................13
1.4.9 Electronic Article Surveillance (EAS) ..................14
1.4.10 Home Appliances ................................................14
1.4.11 Home Monitoring .................................................15
1.5 Potential/Observed Effects of the Device on Health ...16
1.5.1 Potential Adverse Events ....................................16
1.5.2 Observed Adverse Events...................................17
1.6 Clinical Studies ............................................................27
1.6.1 Kronos LV-T Study ..............................................27
1.6.2 Tupos LV/ATx Study............................................29
1.7 Patient Selection and Treatment .................................48
1.7.1 Individualization of Treatment .............................48
1.7.2 Specific Patient Populations................................49
1.8 Patient Counseling Information ...................................50
1.9 Evaluating Prospective CRT-D/ICD Patients ..............50
2.1 Cardiac Resynchronization Therapy (CRT) ................53
2.2 Sensing (Automatic Sensitivity Control) ......................56
2.2.1 Right Ventricular Sensitivity Settings...................57
2.2.2 Minimum Right Ventricular Threshold .................59
2.2.3 Atrial Sensitivity Settings .....................................59
2.2.4 Minimum Atrial Threshold....................................60
2.2.5 Left Ventricular Sensitivity Settings .....................60