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 187
Parameter Range Standard
Sensor gain 1.0; 1.1; 1.3; 1.4; 1.6; 1.8;
2.0; 2.2; 2.6; 3.0; 3.3; 3.7;
4.0; 4.5; 5.0; 6.0; 7.0; 8.0;
9.0; 10; 11; 12; 14; 16;
18; 20; 22; 24; 28; 32; 35;
40
6.0
Sensor gain
(Lumax 700/740 &
600/640 only)
AUTO, Very low (1.3),
Low (3), Medium (6),
High (12), Very high (26)
Medium (6)
Auto Sensor gain OFF, ON OFF
Sensor threshold
(numbers are not
displayed on screen)
Very low = 0
Low = 3
Medium = 7
High = 11
Very high = 15
Medium
Rate increase 0.5; 1..(1)..6 ppm/cycle 2 bpm/cycle
Rate increase
(Lumax 700/740 &
600/640 only)
1, 2, 4, 8 bpm/cycle 2 bpm/cycle
Rate drop 0.25..(0.25)..1.25
ppm/cycle
0.5
ppm/cycle
Rate decrease
(Lumax 700/740 &
600/640 only)
0.1, 0.2, 0.5, 1.0
bpm/cycle
0.5
ppm/cycle
Upper Tracking Rate (UTR)
Upper tracking rate 90..(10)..160 bpm 130 bpm
Upper tracking rate
atrium
OFF, 240 bpm 240 bpm
(N/A
VR-T DX)
Upper tracking rate
atrium
(Lumax 700/740 &
600/640 only)
OFF, 175, 200. 240 bpm 200 ppm
(N/A
VR-T DX)
Mode Switching
Intervention rate OFF, 100..(10)..250 bpm 160 bpm
Intervention rate
(Lumax 700/740 &
600/640 only)
OFF, 120..(10)..200 bpm 160 bpm
Activation criterion X 3..(1)..8 5