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
108 Lumax Technical Manual
The AV Delay feature includes an AV Delay shortening option
(Sense Compensation) for dual chamber pacing modes. When
enabled, the AV Delay is shortened by the programmed value
(-5 to -60 ms in Lumax 300/340 & 500/540 models and up to
-120 ms in Lumax 600/640 & 700/740 models) from the
programmed AV Delay after an intrinsic atrial sensed event.
The Dynamic AV Delay is intended to mimic physiologic-
shortening of the AV Delay with increasing heart rate. It also
serves for automatic prevention and termination of “circus
movement” pacemaker mediated tachycardia and for prevention
of reentrant supraventricular tachycardias. Dynamic AV Delay is
available with the Lumax DR-T and HF-T ICDs/CRT-Ds.
2.9.5.1 Positive AV Hysteresis
Positive AV Hysteresis allows a user-programmable change in
AV
delay that is designed to encourage normal conduction of
intrinsic signals from the atrium into the ventricles. With Positive
AV hysteresis enabled, the AV delay is extended by a defined
time value after sensing a ventricular event (10 … (10) …150 ms)
in the Lumax 300/340 & 500/540 models and (70, 110, 150, 200
ms) in the Lumax 600/640 & 700/740 models. The long AV
interval is used as long as intrinsic ventricular activity is detected.
The programmed short AV delay interval resumes after a
ventricular paced event.
2.9.5.2 AV Repetitive Hysteresis
With AV Repetitive Hysteresis, the AV delay is
extended by a
defined hysteresis value after sensing an intrinsic ventricular
event. When a ventricular paced event occurs, a long AV delay is
used for the programmed number of cycles. (OFF, 1 … 10) in
Lumax 300/340 & 500/540 models and 5 fixed cycles with scan
AV hysteresis in the Lumax 600/640 & 700/740 models. If an
intrinsic rhythm occurs during one of the repetitive cycles, the
long duration AV delay interval remains in effect. If an intrinsic
rhythm does not occur during the repetitive cycles, the original AV
delay interval resumes.