User Manual
Table Of Contents
- 1. General
- 1.1 System Description
- 1.2 Indications and Usage
- 1.3 Contraindications
- 1.4 Warnings and Precautions
- 1.4.1 Sterilization, Storage, and Handling
- 1.4.2 Device Implantation and Programming
- 1.4.3 Lead Evaluation and Connection
- 1.4.4 Follow-up Testing
- 1.4.5 Pulse Generator Explant and Disposal
- 1.4.6 Hospital and Medical Hazards
- 1.4.7 Home and Occupational Hazards
- 1.4.8 Cellular Phones
- 1.4.9 Electronic Article Surveillance (EAS)
- 1.4.10 Home Appliances
- 1.4.11 Home Monitoring®
- 1.5 Potential/Observed Effects of the Device on Health
- 1.6 Clinical Studies
- 1.6.1 Kronos LVT Study
- 1.6.2 Tupos LV/ATx Study
- 1.6.2.1 Study Overview
- 1.6.2.2 Methods
- 1.6.2.3 Summary of Clinical Results
- 1.6.2.4 Primary Endpoint 1: Six Minute Walk Test & QOL (Effectiveness)
- 1.6.2.5 Effectiveness Endpoint Analysis and Conclusions
- 1.6.2.6 Primary Endpoint 2: Complication-Free Rate (Safety)
- 1.6.2.7 Primary Safety Enpoint Analysis and Conclusions
- 1.6.2.8 Post-hoc Safety Analysis
- 1.6.2.9 Post hoc Safety Analysis Conclusion
- 1.6.2.10 Secondary Endpoint Results
- 1.6.2.11 Multi-site Poolability and Gender Analysis
- 1.6.2.12 Conclusions
- 1.6.3 Lumax HFT VV Clinical Study
- 1.6.4 TRUST Clinical Study
- 1.6.5 Deikos A+
- 1.7 Patient Selection and Treatment
- 1.8 Patient Counseling Information
- 1.9 Evaluating Prospective CRTD/ICD Patients
- 2. Device Features
- 2.1 SafeSync Telemetry
- 2.2 Cardiac Resynchronization Therapy (CRT)
- 2.3 Sensing (Automatic Sensitivity Control)
- 2.4 Automatic Threshold Measurement (ATM)
- 2.5 Ventricular Tachyarrhythmia Detection
- 2.6 Tachyarrhythmia Redetection
- 2.7 Tachyarrhythmia Termination
- 2.8 Tachyarrhythmia Therapy
- 2.9 Bradycardia Therapy
- 2.9.1 Bradycardia Pacing Modes
- 2.9.2 Basic Rate
- 2.9.3 Night Rate
- 2.9.4 Rate Hysteresis
- 2.9.5 Dynamic AV Delay
- 2.9.6 IOPT
- 2.9.7 Upper Tracking Rate
- 2.9.8 Mode Switching
- 2.9.9 PMT Management
- 2.9.10 VES Discrimination after Atrial Sensed Events
- 2.9.11 Rate-Adaptive Pacing
- 2.9.12 Pulse Amplitude
- 2.9.13 Pulse Width
- 2.9.14 Post Ventricular Atrial Refractory Period
- 2.9.15 PVARP after VES
- 2.9.16 Auto PVARP
- 2.9.17 Noise Response
- 2.9.18 Post Shock Pacing
- 2.10 EP Test Functions
- 2.11 Special Features
- 2.10.2.3 Transmitting Data
- 2.11.3.3 Types of Report Transmissions
- 2.11.3.4 Description of Transmitted Data
- 2.11.3.5 IEGM Online HDs
- 2.11.3.6 Scheduling Remote Follow-up
- 2.11.4 Real-time IEGM Transmission
- 2.11.5 Capacitor Reforming
- 2.11.6 Patient and Implant Data
- 2.11.7 System Status
- 2.11.8 HF Monitor Statistics
- 2.11.9 Holter Memory
- 2.11.10 Timing Statistics
- 2.11.11 Atrial Arrhythmias
- 2.11.12 Ventricular Arrhythmias
- 2.11.13 Sensor
- 2.11.14 Sensing
- 2.11.15 Impedances
- 2.11.16 Automatic Threshold
- 2.11.17 Asynchronous Pacing Modes
- 2.11.18 Far-Field IEGM for Threshold Testing (Leadless ECG)
- 2.11.19 Advanced AT/AF Diagnostics (Lumax 700/740 only)
- 2.11.20 Atrial NIPS (Lumax 700/740 & 600/640 only)
- 3. Sterilization and Storage
- 4. Implant Procedure
- 5. Follow-up Procedures
- 6. Technical Specifications
ii Lumax Technical Manual
2.3.3 Atrial Sensitivity Settings .....................................79
2.3.4 Minimum Atrial Threshold....................................80
2.3.5 Left Ventricular Sensitivity Settings .....................80
2.3.6 Minimum Left Ventricular Threshold....................81
2.3.7 Far Field Protection .............................................81
2.3.8 Additional Sensing Parameters ...........................81
2.4 Automatic Threshold Measurement (ATM) .................83
2.4.1 Signal Quality Check ...........................................84
2.4.2 Threshold Measurement .....................................84
2.4.3 Loss of Capture Detection...................................84
2.4.4 ATM in Lumax HF-T Models ...............................84
2.4.5 RV & LV Capture Control ....................................85
2.5 Ventricular Tachyarrhythmia Detection........................85
2.5.1 VF Classifications ................................................86
2.5.2 VT Interval Counters............................................86
2.5.3 VT Classification..................................................86
2.5.4 SMART Detection™ ............................................87
2.5.5 Onset ...................................................................88
2.5.6 Stability ................................................................88
2.5.7 Sustained VT Timer.............................................88
2.5.8 VT Monitoring Zone .............................................89
2.5.9 Atrial Monitoring Zone .........................................89
2.6 Tachyarrhythmia Redetection......................................90
2.6.1 VT Redetection....................................................90
2.6.2 SMART Redetection............................................90
2.6.3 Forced Termination .............................................90
2.6.4 VF Redetection....................................................91
2.7 Tachyarrhythmia Termination ......................................91
2.8 Tachyarrhythmia Therapy............................................91
2.8.1 Therapy Options ..................................................91
2.8.2 Anti-Tachycardia Pacing (ATP) ...........................91
2.8.3 Shock Therapy ....................................................95
2.8.4 Progressive Course of Therapy.........................101
2.9 Bradycardia Therapy .................................................102
2.9.1 Bradycardia Pacing Modes ...............................102
2.9.2 Basic Rate .........................................................103
2.9.3 Night Rate..........................................................103
2.9.4 Rate Hysteresis .................................................104
2.9.5 Dynamic AV Delay.............................................107
2.9.6 IOPT ..................................................................110