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
118 Lumax Technical Manual
If 90% of the maximum sensor rate is reached for 1 hour
within 24 hours, gain is reduced by one step.
2.9.12 Pulse Amplitude
The Pulse Amplitude parameters, are separately programmable
for atrial and both ventricular channels and they, define the
amplitude in volts of the pacing pulses. The pulse amplitude is
also independently programmable for normal bradycardia pacing
and fixed to 7.5V for post-shock pacing in RA and RV and as
permanent programmed in LV.
2.9.13 Pulse Width
The Pulse Width parameters are separately programmable for
atrial and both ventricular channels and they define the duration
of the pacing pulses. The pulse widths are also independently
programmable for normal bradycardia pacing and fixed to 1.5 ms
for post-shock pacing in RA and RV and as permanent
programmed in LV.
2.9.14 Post Ventricular Atrial Refractory Period
DR and HF versions only
Immediately following each paced ventricular event, an atrial
refractory period is started; this period is called Post Ventricular
Atrial Refractory Period or PVARP. Atrial signals are ignored
during this time for bradycardia timing purposes to prevent the
ICD/CRT-D from sensing inappropriate signals.
2.9.15 PVARP after VES
DR and HF versions only
This parameter extends the Post Ventricular Atrial Refractory
Period by the programmed interval, if the ventricular event is not
followed by an atrial sensed event (VES).