BIOTRONIK Lumax VR ICD Series User manual

Lumax
Family of Implantable Cardioverter
Defibrillators and Cardiac
Resynchronization Therapy
Defibrillators
•VR ICD
•VR-T ICD
•DR ICD
•DR-T ICD
•HF CRT-D
•HF-T CRT-D
Technical Manual

X-ray Identification
Lumax Family
Implantable Cardioverter Defibrillator and Cardiac
Resynchronization Therapy Defibrillators
Inside the housing:
X-Ray identification Year of manufacture
HR nn
CAUTION
Federal (U.S.A.) law restricts this device to sale by, or on the
order of, a physician.
2008 BIOTRONIK, Inc., all rights reserved.

Lumax Technical Manual i
Contents
1.1 System Description .......................................................1
1.2 Indications and Usage...................................................3
1.3 Contraindications...........................................................4
1.4 Warnings and Precautions ............................................4
1.4.1 Sterilization, Storage, and Handling ......................7
1.4.2 Device Implantation and Programming .................7
1.4.3 Lead Evaluation and Connection ..........................9
1.4.4 Follow-up Testing ................................................11
1.4.5 Pulse Generator Explant and Disposal ...............11
1.4.6 Hospital and Medical Hazards.............................11
1.4.7 Home and Occupational Hazards .......................13
1.4.8 Cellular Phones ...................................................13
1.4.9 Electronic Article Surveillance (EAS) ..................14
1.4.10 Home Appliances ................................................14
1.4.11 Home Monitoring .................................................15
1.5 Potential/Observed Effects of the Device on Health ...16
1.5.1 Potential Adverse Events ....................................16
1.5.2 Observed Adverse Events...................................17
1.6 Clinical Studies ............................................................27
1.6.1 Kronos LV-T Study ..............................................27
1.6.2 Tupos LV/ATx Study............................................29
1.7 Patient Selection and Treatment .................................48
1.7.1 Individualization of Treatment .............................48
1.7.2 Specific Patient Populations................................49
1.8 Patient Counseling Information ...................................50
1.9 Evaluating Prospective CRT-D/ICD Patients ..............50
2.1 Cardiac Resynchronization Therapy (CRT) ................53
2.2 Sensing (Automatic Sensitivity Control) ......................56
2.2.1 Right Ventricular Sensitivity Settings...................57
2.2.2 Minimum Right Ventricular Threshold .................59
2.2.3 Atrial Sensitivity Settings .....................................59
2.2.4 Minimum Atrial Threshold....................................60
2.2.5 Left Ventricular Sensitivity Settings .....................60

ii Lumax Technical Manual
2.2.6 Minimum Left Ventricular Threshold....................61
2.2.7 Far Field Protection .............................................61
2.2.8 Additional Sensing Parameters ...........................62
2.3 Automatic Threshold Measurement (ATM) .................63
2.3.1 Functional Description.........................................63
2.4 Intra-Thoracic Impedance Measurement ....................65
2.4.1 Functional Description.........................................65
2.5 Ventricular Tachyarrhythmia Detection .......................66
2.5.1 VF Classifications ................................................67
2.5.2 VT Interval Counters............................................67
2.5.3 VT Classification..................................................67
2.5.4 SMART Detection™ ............................................68
2.5.5 Onset ...................................................................69
2.5.6 Stability ................................................................69
2.5.7 Sustained VT Timer.............................................70
2.5.8 VT Monitoring Zone .............................................70
2.5.9 Atrial Monitoring Zone .........................................71
2.6 Tachyarrhythmia Redetection......................................71
2.6.1 VT Redetection....................................................71
2.6.2 SMART Redetection............................................72
2.6.3 Forced Termination .............................................72
2.6.4 VF Redetection....................................................72
2.7 Tachyarrhythmia Termination ......................................72
2.8 Tachyarrhythmia Therapy............................................72
2.8.1 Therapy Options ..................................................73
2.8.2 Anti-Tachycardia Pacing (ATP) ...........................73
2.8.3 Shock Therapy ....................................................76
2.8.4 Progressive Course of Therapy...........................82
2.9 Bradycardia Therapy ...................................................83
2.9.1 Bradycardia Pacing Modes .................................83
2.9.2 Basic Rate ...........................................................84
2.9.3 Night Rate............................................................85
2.9.4 Rate Hysteresis ...................................................85
2.9.5 Dynamic AV Delay...............................................88
2.9.6 IOPT ....................................................................91

Lumax Technical Manual iii
2.9.7 Upper Tracking Rate ...........................................91
2.9.8 Mode Switching ...................................................93
2.9.9 PMT Management ...............................................94
2.9.10 VES Discrimination after Atrial Sensed Events...97
2.9.11 Rate Adaptive Pacing..........................................98
2.9.12 Pulse Amplitude...................................................99
2.9.13 Pulse Width .........................................................99
2.9.14 Post Ventricular Atrial Refractory Period...........100
2.9.15 PVARP after VES ..............................................100
2.9.16 Auto PVARP ......................................................100
2.9.17 Noise Response ................................................100
2.9.18 Post Shock Pacing ............................................101
2.10 EP Test Functions .....................................................101
2.10.1 P and R-wave Amplitude Measurements..........101
2.10.2 Pacing Impedance Measurements....................102
2.10.3 Shock Impedance Measurements.....................103
2.10.4 Testing for Retrograde Conduction ...................103
2.10.5 Pacing Threshold...............................................104
2.10.6 Arrhythmia Induction Features ..........................104
2.10.7 Manual Shock....................................................105
2.10.8 Test Shock.........................................................105
2.10.9 Manual ATP.......................................................106
2.10.10 Emergency Shock .............................................106
2.11 Special Features........................................................107
2.11.1 ICD Therapy Status ...........................................107
2.11.2 Home Monitoring ...............................................107
2.11.3 Real-time IEGM Transmission ..........................117
2.11.4 Capacitor Reforming .........................................118
2.11.5 Patient and Implant Data...................................118
2.11.6 System Status ...................................................119
2.11.7 HF Monitor Statistics .........................................119
2.11.8 Holter Memory ...................................................121
2.11.9 Timing Statistics ....................................................2
2.11.10 Atrial Arrhythmias ..................................................3
2.11.11 Ventricular Arrhythmias .........................................3

iv Lumax Technical Manual
2.11.12 Sensor ...................................................................3
2.11.13 Sensing..................................................................3
2.11.14 Impedances ...........................................................4
2.11.15 Automatic Threshold..............................................4
4.1 Implant Preparation .......................................................7
4.2 Lead System Evaluation..............................................12
4.3 Opening the Sterile Container .....................................12
4.4 Pocket Preparation......................................................13
4.5 Lead to Device Connection .........................................13
4.6 Blind Plug Connection .................................................16
4.7 Program the ICD/CRT-D .............................................17
4.8 Implant the ICD/CRT-D ...............................................18
5.1 General Considerations ..............................................23
5.2 Longevity .....................................................................24
5.2.1 Lumax 300/340 Devices......................................25
5.2.2 Lumax 500/540 Devices......................................26
5.3 Explantation.................................................................29
*Lumax VR (-T) and DR (-T) ICDs do not have coronary sinus
pace/sense ports
** Lumax VR (-T) ICDs do not have atrial pace/sense ports

Lumax Technical Manual v
Lumax Specifications and Description
Battery Voltage: 3.2 Volts
300/500 models:
Maximum Shock Energy:
30 Joules programmed
340/540 models:
Maximum Shock Energy:
40 Joules programmed
Defibrillation Lead Ports Two DF-1 (3.2 mm)
Pacing Lead Ports Three IS-1 (3.2 mm)
(one for Lumax VR (-T)
and two for
Lumax DR (-T)s)
Dimensions:
Volume:
Mass:
See Technical Details in
Section 6
Housing Material: Titanium
Header Material: Epoxy Resin
Sealing Plug Material: Silicone

vi Lumax Technical Manual

Lumax Technical Manual 1
1. General
1.1 System Description
The Lumax family of Implantable Cardioverter Defibrillators
(ICDs) and Cardiac Resynchronization Therapy Defibrillators
(CRT-Ds) detect and treat ventricular tachyarrhythmias and
provide rate adaptive bradycardia pacing support. The HF and
HF-T versions of Lumax provide Cardiac Resynchronization
Therapy (CRT) through biventricular pacing. Both CRT-Ds and
ICDs detect and treat ventricular tachyarrhythmias and provide
rate adaptive bradycardia pacing support. They are designed to
collect diagnostic data to aid the physician’s assessment of a
patient’s condition and the performance of the implanted device.
The Lumax family of devices provides therapy for ventricular
tachyarrhythmias with a sophisticated range of programmable
anti-tachycardia pacing (ATP), and/or defibrillation therapy
features. The shock polarity and energy may be programmed to
tailor the therapy to appropriately treat each patient's
tachyarrhythmias. The ICDs/CRT-Ds provide shock therapies
with programmable energies from 5 to 40 joules.
The Lumax family of ICDs/CRT-Ds includes the following
members:
•Lumax HF - provides three chamber rate adaptive
bradycardia pacing support including biventricular pacing
via a left ventricular pacing lead. The CRT-D uses right
atrial and ventricular sensing/pacing leads to provide
enhanced atrial and ventricular tachyarrhythmia
discrimination through BIOTRONIK’s SMART
DetectionTM algorithm.
•Lumax HF-T - In addition to the functionality found with
HF model Lumax HF-T also has the added functionality of
BIOTRONIK’s Home Monitoring system. The Home
Monitoring System enables automatic exchange of
information about a patient’s cardiac status from the
implant to the physician remotely.

2 Lumax Technical Manual
•Lumax DR - provides dual chamber rate adaptive
bradycardia pacing support. The ICD uses atrial and
ventricular sensing/pacing leads to provide enhanced
atrial and ventricular tachyarrhythmia discrimination
through BIOTRONIK’s SMART DetectionTM algorithm.
•Lumax DR-T - In addition to the functionality found with
the DR model it also has the added functionality of
BIOTRONIK’s Home Monitoring system. The Home
Monitoring System enables automatic exchange of
information about a patient’s cardiac status from the
implant to the physician remotely.
•Lumax VR - provides single chamber rate adaptive
bradycardia pacing support as well as tachyarrhythmia
detection and therapy.
•Lumax VR-T - In addition to the functionality found with
standard VR model it also has the added functionality of
BIOTRONIK’s Home Monitoring system. The Home
Monitoring System enables automatic exchange of
information about a patient’s cardiac status from the
implant to the physician remotely.
The 300/500 and 340/540 designation for each of the above-
described models denote the maximum programmable shock
energy of 30 joules and 40 joules, respectively.
The Lumax 500/540 models also feature a third programmable
shock path for delivery of defibrillation/cardioversion shocks. The
shock path is programmable between the different shock coils
(SVC/RV) and/or the device housing. Section 2.8.3.6 provides
further details on the available shock configurations.
Additionally, the Lumax 500/540 models feature Automatic
Threshold Measurement (ATM) of ventricular pacing thresholds.
This feature is separately programmable for the right (RV) and left
(LV) ventricle. Section 2.3 provides further details.