BIOTRONIK Lexos DR-T User manual

Lexos
Family of Implantable Cardioverter
Defibrillators
Technical Manual

X-ray Identification
Lexos DR, DR-T, VR and VR-T
Implantable Cardioverter Defibrillator
Inside the housing, right-hand side:
X-Ray identification
KV
Year of manufacture
nn
CAUTION
Federal (U.S.A.) law restricts this device to sale by, or on the
order of, a physician.
2003 BIOTRONIK, Inc., all rights reserved.

Lexos Technical Manual i
Contents
1. General...........................................................................1
1.1 System Description....................................................1
1.2 Indications and Usage ...............................................2
1.3 Contraindications .......................................................3
1.4 Warnings and Precautions.........................................3
1.4.1 Sterilization, Storage, and Handling ..................4
1.4.2 Device Implantation and Programming..............4
1.4.3 Lead Evaluation and Connection.......................6
1.4.4 Follow-up Testing...............................................8
1.4.5 Pulse Generator Explant and Disposal..............8
1.4.6 Hospital and Medical Hazards ...........................9
1.4.7 Home and Occupational Hazards......................10
1.4.8 Cellular Phones..................................................11
1.4.9 Electronic Article Surveillance (EAS).................12
1.4.10 Home Appliances...............................................12
1.5 Adverse Events..........................................................13
1.5.1 Potential Adverse Events...................................13
1.5.2 Observed Adverse Events .................................14
1.6 Clinical Studies ..........................................................17
1.6.1 Tachos DR .........................................................17
1.6.2 Phylax AV...........................................................19
1.7 Patient Selection and Treatment ...............................21
1.7.1 Individualization of Treatment............................21
1.7.2 Specific Patient Populations ..............................22
1.8 Patient Counseling Information .................................23
1.9 Evaluating Prospective ICD Patients.........................23
2. Device Features ............................................................25
2.1 Sensing (Automatic Sensitivity Control) ....................25
2.1.1 Ventricular Sensitivity Settings ..........................25
2.1.2 Minimum Ventricular Threshold .........................28
2.1.3 Atrial Sensitivity Settings....................................28
2.1.4 Minimum Atrial Threshold ..................................29
2.1.5 Far Field Blanking ..............................................29

ii Lexos Technical Manual
2.2 Ventricular Tachyarrhythmia Detection ......................30
2.2.1 VF Classifications ..............................................31
2.2.2 VT Interval Counters ..........................................31
2.2.3 VT Classification ................................................31
2.2.4 SMART Detection™...........................................32
2.2.5 Onset..................................................................33
2.2.6 Stability...............................................................33
2.2.7 Sustained VT Timer ...........................................34
2.3 Tachyarrhythmia Redetection ....................................34
2.3.1 VT Redetection ..................................................35
2.3.2 SMART Redetection ..........................................35
2.3.3 VF Redetection ..................................................35
2.4 Tachyarrhythmia Termination.....................................35
2.5 Tachyarrhythmia Therapy ..........................................36
2.5.1 Therapy Options ................................................36
2.5.2 Anti-Tachycardia Pacing (ATP) .........................36
2.5.3 Shock Therapy...................................................39
2.5.4 Progressive Course of Therapy .........................42
2.6 Bradycardia Therapy .................................................43
2.6.1 Bradycardia Pacing Modes................................43
2.6.2 Basic Rate..........................................................44
2.6.3 Night Rate ..........................................................44
2.6.4 Rate Hysteresis..................................................44
2.6.5 Dynamic AV Delay .............................................48
2.6.6 Upper Tracking Rate..........................................49
2.6.7 Mode Switching..................................................50
2.6.8 PMT Management .............................................51
2.6.9 Rate Adaptive Pacing ........................................51
2.6.10 Pulse Amplitude .................................................53
2.6.11 Pulse Width........................................................53
2.6.12 Post Ventricular Atrial Refractory Period ...........53
2.6.13 PVARP Extension ..............................................53
2.6.14 Noise Response.................................................54
2.6.15 Post Shock Pacing.............................................54
2.7 EP Test Functions......................................................54

Lexos Technical Manual iii
2.7.1 P and R-wave Amplitude Measurments ............54
2.7.2 Testing for Retrograde Conduction....................55
2.7.3 Pacing Threshold ...............................................56
2.7.4 Arrhythmia Induction Features...........................56
2.7.5 Manual Shock ....................................................57
2.7.6 Manual ATP .......................................................57
2.7.7 Test Shock .........................................................57
2.8 Special Features........................................................58
2.8.1 Detection and Therapy Status ...........................58
2.8.2 Home Monitoring (Lexos DR-T and VR-T Only) 59
2.8.3 Real-time IEGM Transmission...........................64
2.8.4 Capacitor Reformation .......................................64
2.8.5 Patient and Implant Data ...................................65
2.8.6 System Status....................................................66
2.8.7 Holter Memory ...................................................66
2.8.8 Real-time IEGM .................................................69
2.8.9 Brady Diagnostics ..............................................70
3. Sterilization and Storage..............................................72
4. Implant Procedure ........................................................74
4.1 Implant Preparation ...................................................74
4.2 Lead System Evaluation ............................................76
4.3 Opening the Sterile Container ...................................76
4.4 Pocket Preparation ....................................................77
4.5 Lead to Device Connection .......................................78
4.6 Blind Plug Connection ...............................................81
4.7 Pacemaker Interaction Testing ..................................83
4.8 Program the ICD........................................................86
4.9 Implant the ICD..........................................................87
5. Follow-up Procedures ..................................................91
5.1 General Considerations.............................................91
5.2 Longevity....................................................................92
5.3 Explantation ...............................................................94
6. Technical Specifications ..............................................95
Appendix A...........................................................................103