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
Lumax Technical Manual 119
2.9.16 Auto PVARP
DR and HF versions only
This parameter automatically adjusts the Post Ventricular Atrial
Refractory Period (PVARP) and PVARP after VES, if a
pacemaker mediated tachycardia (PMT) has been detected and
terminated to avoid additional PMT events. After seven days,
PVARP and PVARP after VES are reduced as short as possible
until a new PMT occurs or the shortest value of these parameters
is reached. This helps to keep the PVARP and PVARP after VES
as short as possible to protect the patient from PMT.
2.9.17 Noise Response
The Lumax ICD/CRT-D’s response to detected noise is to deliver
asynchronous pacing in the affected channel.
2.9.18 Post Shock Pacing
Separately programmable bradycardia pacing support is available
with the ICD/CRT-D following shock therapy delivery. Because a
delay in bradycardia pacing may avoid re-initiation of a
tachyarrhythmia, after a short blanking period (1 second), the
ICD/CRT-D will begin in standard program (DDI in DR & HF type
devices and VVI in VR & DX type devices) bradycardia therapy at
the post shock pacing rate, amplitude (fixed to 7.5 V for RV and
as permanent programmed for LV), and pulse width (fixed to 1.5
ms) for the programmed Post-Shock Duration.
Separate post shock programming of the following parameters is
available:
Ventricular Pacing Configuration (RV, BiV)
Basic Rate
Rate Hysteresis
Fixed AV Delay
Post Shock Duration
If bradycardia pacing is still required after the post shock duration
expires, standard bradycardia pacing parameters are active.