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
12 Lumax Technical Manual
1.4.4 Follow-up Testing
Defibrillation Threshold - Be aware that changes in the patient’s
condition, drug regimen, and other factors may change the
defibrillation threshold (DFT), which may result in non-conversion
of the arrhythmia post-operatively. Successful conversion of
ventricular fibrillation or ventricular tachycardia during arrhythmia
conversion testing is no assurance that conversion will occur
post-operatively.
Resuscitation Availability - Ensure that an external defibrillator
and medical personnel skilled in cardiopulmonary resuscitation
(CPR) are present during post-implant device testing should the
patient require external rescue.
Safe Program – Within the EP Test screen, pressing the “Safe
Program” key on the programmer head immediately sends the
safe program to the ICD/CRT-D.
1.4.5 Pulse Generator Explant and Disposal
Device Incineration – Never incinerate the ICD/CRT-D due to
the potential for explosion. The ICD/CRT-D must be explanted
prior to cremation.
Explanted Devices – Return all explanted devices to
BIOTRONIK.
Unwanted Shocks – Always program ICD Therapy to OFF prior
to handling the device to prevent the delivery of serious shocks to
the patient or the person handling the device during the
procedure.
1.4.6 Hospital and Medical Hazards
Electromagnetic interference (EMI) signals present in hospital
and medical environments may affect the function of any
ICD/CRT-D or pacemaker. The ICD/CRT-D is designed to
selectively filter out EMI noise. However, due to the variety of EMI
signals, absolute protection from EMI is not possible with this or
any other ICD/CRT-D.
The ICD/CRT-D system should have detection and therapy
disabled (OFF) prior to performing any of the following medical
procedures. In addition, the ICD/CRT-D should be checked after
the procedures to assure proper programming: