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
82 Lumax Technical Manual
Upper Threshold (A, RV & LV) - This feature allows the user to
change the upper sensing threshold level (UT in Figure 8
) from
the nominal value of 50% of the sensed R-wave/P-wave
amplitude to either 75% or 87.5% of the R-wave/P-wave value.
This feature is used in the ventricle for example to eliminate
oversensing of large T-waves. This is not applicable to the Lumax
600/640 and 700/740 models.
Hold of Upper Threshold (RV & LV) - This parameter
determines when the sensing decrement begins after an event
(small step-down on the 50% threshold before LT in the figure
above). This parameter “holds” the threshold at a constant value
(UT in Figure 8
) for the programmed time. Maximum Hold Time is
programmable from 100 to 600 ms in Lumax 300/340 & 500/540
and 110 to 500 ms in the Lumax 600/640 & 700/740 models (T-
Wave discrimination period). Additionally, the Lumax 600/640 &
700/740 models are separately programmable between the
paced and sensed signals.
Lower Threshold (A, RV & LV)- This feature allows the user to
change the lower sensing threshold (labeled LT in Figure 8
) from
the default value of 25% of the sensed R-wave/P-wave amplitude
to either 12.5 or 50% of the measured R-wave/P-wave value. This
is not applicable to the Lumax 600/640 and 700/740 models. This
feature is also used in the ventricles to alleviate T-wave
oversensing and/or undersensing of small amplitude events (e.g.,
fine VF).
Blank after atrial pacing (RV) - This feature is used to eliminate
sensing of artifacts after atrial paced events. Blank Post atrial
Pace in the RV is programmable from 50 to 100 ms. For the left
ventricle, this parameter is equal to the safety window time
(100 ms).
VES Discrimination after As - This feature is used to correctly
identify and classify ventricular extrasystoles (VES). With each
atrial sensed event (also with Ars falling into PVARP) a special
timing interval is started for the ventricle, if the subsequent
ventricular event does not fall within the AV delay or the
programmed VES discrimination interval, it is classified as a VES.
LV T-wave Protection - Used to eliminate unintended pacing in
the vulnerable period of the left ventricle. This feature is only used
when left ventricular sensing is active. HF versions only.