BIOTRONIK Lexos DR-T User manual

Lexos
Family of Implantable Cardioverter
Defibrillators
Technical Manual

X-ray Identification
Lexos DR, DR-T, VR and VR-T
Implantable Cardioverter Defibrillator
Inside the housing, right-hand side:
X-Ray identification
KV
Year of manufacture
nn
CAUTION
Federal (U.S.A.) law restricts this device to sale by, or on the
order of, a physician.
2003 BIOTRONIK, Inc., all rights reserved.

Lexos Technical Manual i
Contents
1. General...........................................................................1
1.1 System Description....................................................1
1.2 Indications and Usage ...............................................2
1.3 Contraindications .......................................................3
1.4 Warnings and Precautions.........................................3
1.4.1 Sterilization, Storage, and Handling ..................4
1.4.2 Device Implantation and Programming..............4
1.4.3 Lead Evaluation and Connection.......................6
1.4.4 Follow-up Testing...............................................8
1.4.5 Pulse Generator Explant and Disposal..............8
1.4.6 Hospital and Medical Hazards ...........................9
1.4.7 Home and Occupational Hazards......................10
1.4.8 Cellular Phones..................................................11
1.4.9 Electronic Article Surveillance (EAS).................12
1.4.10 Home Appliances...............................................12
1.5 Adverse Events..........................................................13
1.5.1 Potential Adverse Events...................................13
1.5.2 Observed Adverse Events .................................14
1.6 Clinical Studies ..........................................................17
1.6.1 Tachos DR .........................................................17
1.6.2 Phylax AV...........................................................19
1.7 Patient Selection and Treatment ...............................21
1.7.1 Individualization of Treatment............................21
1.7.2 Specific Patient Populations ..............................22
1.8 Patient Counseling Information .................................23
1.9 Evaluating Prospective ICD Patients.........................23
2. Device Features ............................................................25
2.1 Sensing (Automatic Sensitivity Control) ....................25
2.1.1 Ventricular Sensitivity Settings ..........................25
2.1.2 Minimum Ventricular Threshold .........................28
2.1.3 Atrial Sensitivity Settings....................................28
2.1.4 Minimum Atrial Threshold ..................................29
2.1.5 Far Field Blanking ..............................................29

ii Lexos Technical Manual
2.2 Ventricular Tachyarrhythmia Detection ......................30
2.2.1 VF Classifications ..............................................31
2.2.2 VT Interval Counters ..........................................31
2.2.3 VT Classification ................................................31
2.2.4 SMART Detection™...........................................32
2.2.5 Onset..................................................................33
2.2.6 Stability...............................................................33
2.2.7 Sustained VT Timer ...........................................34
2.3 Tachyarrhythmia Redetection ....................................34
2.3.1 VT Redetection ..................................................35
2.3.2 SMART Redetection ..........................................35
2.3.3 VF Redetection ..................................................35
2.4 Tachyarrhythmia Termination.....................................35
2.5 Tachyarrhythmia Therapy ..........................................36
2.5.1 Therapy Options ................................................36
2.5.2 Anti-Tachycardia Pacing (ATP) .........................36
2.5.3 Shock Therapy...................................................39
2.5.4 Progressive Course of Therapy .........................42
2.6 Bradycardia Therapy .................................................43
2.6.1 Bradycardia Pacing Modes................................43
2.6.2 Basic Rate..........................................................44
2.6.3 Night Rate ..........................................................44
2.6.4 Rate Hysteresis..................................................44
2.6.5 Dynamic AV Delay .............................................48
2.6.6 Upper Tracking Rate..........................................49
2.6.7 Mode Switching..................................................50
2.6.8 PMT Management .............................................51
2.6.9 Rate Adaptive Pacing ........................................51
2.6.10 Pulse Amplitude .................................................53
2.6.11 Pulse Width........................................................53
2.6.12 Post Ventricular Atrial Refractory Period ...........53
2.6.13 PVARP Extension ..............................................53
2.6.14 Noise Response.................................................54
2.6.15 Post Shock Pacing.............................................54
2.7 EP Test Functions......................................................54

Lexos Technical Manual iii
2.7.1 P and R-wave Amplitude Measurments ............54
2.7.2 Testing for Retrograde Conduction....................55
2.7.3 Pacing Threshold ...............................................56
2.7.4 Arrhythmia Induction Features...........................56
2.7.5 Manual Shock ....................................................57
2.7.6 Manual ATP .......................................................57
2.7.7 Test Shock .........................................................57
2.8 Special Features........................................................58
2.8.1 Detection and Therapy Status ...........................58
2.8.2 Home Monitoring (Lexos DR-T and VR-T Only) 59
2.8.3 Real-time IEGM Transmission...........................64
2.8.4 Capacitor Reformation .......................................64
2.8.5 Patient and Implant Data ...................................65
2.8.6 System Status....................................................66
2.8.7 Holter Memory ...................................................66
2.8.8 Real-time IEGM .................................................69
2.8.9 Brady Diagnostics ..............................................70
3. Sterilization and Storage..............................................72
4. Implant Procedure ........................................................74
4.1 Implant Preparation ...................................................74
4.2 Lead System Evaluation ............................................76
4.3 Opening the Sterile Container ...................................76
4.4 Pocket Preparation ....................................................77
4.5 Lead to Device Connection .......................................78
4.6 Blind Plug Connection ...............................................81
4.7 Pacemaker Interaction Testing ..................................83
4.8 Program the ICD........................................................86
4.9 Implant the ICD..........................................................87
5. Follow-up Procedures ..................................................91
5.1 General Considerations.............................................91
5.2 Longevity....................................................................92
5.3 Explantation ...............................................................94
6. Technical Specifications ..............................................95
Appendix A...........................................................................103

iv Lexos Technical Manual
*Lexos VR and VR-T ICDs do not have an atrial pace/sense port
Lexos Specifications and Description
Battery Voltage: 6.3 Volts
Maximum Shock Energy: 30 joules
Defibrillation Lead Ports Two DF-1 (3.2 mm)
Pacing Lead Ports Two IS-1 (3.2 mm) (one
for Lexos VR and VR-T)
Dimension: 67 x 55 x 12 mm
Volume: 32 cc
Mass: 80 g
Housing Material: Titanium
Header Material: Epoxy Resin
Sealing Plug Material: Silicone
Battery Composition Li / MnO2

Lexos Technical Manual 1
1. General
1.1 System Description
The Lexos family of Implantable Cardioverter Defibrillators
(ICDs) detect and treat ventricular tachyarrhythmias and provide
rate adaptive bradycardia pacing support. The ICDs 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 Lexos ICDs provide therapy for ventricular tachyarrhythmias
with a sophisticated range of programmable anti-tachycardia
pacing (ATP), and/or defibrillation therapy. The shock polarity
and energy may be programmed to tailor the therapy to
appropriately treat each patient's tachyarrhythmias. The ICDs
provide shock therapies with programmable energies from 5 to
30 joules.

2Lexos Technical Manual
The Lexos family of ICDs includes the following members:
• Lexos 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.
• Lexos DR-T is identical to the Lexos DR with 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.
• Lexos VR provides single chamber rate adaptive
bradycardia pacing support.
• Lexos VR-T is identical to the Lexos VR with 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 Lexos DR and DR-T have two DF-1 defibrillation/
cardioversion and two IS-1 pacing/sensing header ports. The
Lexos VR and VR-T have two DF-1 defibrillation/ cardioversion
and one IS-1 pacing/sensing header ports. IS-1 refers to the
international standard whereby leads and generators from
different manufacturers are assured a basic fit [Reference ISO
5841-3:1992]. DF-1 refers to the international standard for
defibrillation lead connectors [Reference ISO 11318:1993].
External devices that interact with and test the implantable
devices are also part of the ICD System. These external devices
include the TMS 1000
PLUS Tachyarrhythmia Monitoring System
and the EPR 1000
PLUS Programming and Monitoring System.
These programmers are used to interrogate and program the
ICD.
1.2 Indications and Usage
The Lexos Implantable Cardioverter Defibrillators (ICDs) are
intended to provide ventricular anti-tachycardia pacing and
ventricular defibrillation, for automated treatment of life-
threatening ventricular arrhythmias.

Lexos Technical Manual 3
1.3 Contraindications
Do not use the Lexos Implantable Cardioverter Defibrillators
(ICDs) in patients:
• Whose ventricular tachyarrhythmias may have transient
or reversible causes including:
− acute myocardial infarction
− digitalis intoxication
− drowning
− electrocution
− electrolyte imbalance
− sepsis
− hypoxia
• Patients with incessant VT of VF
• Patients with unipolar pacemaker
• Patients whose only disorder is bradyarrhythmia or atrial
arrhythmia
1.4 Warnings and Precautions
MRI (Magnetic Resonance Imaging) - Do not expose a patient
to MRI device scanning. Strong magnetic fields may damage
the device and cause injury to the patient.
Electrical Isolation - To prevent inadvertent arrhythmia
induction, electrically isolate the patient during the implant
procedure from potentially hazardous leakage currents.
Lead Systems - The use of another manufacturer’s ICD lead
system may cause potential adverse consequences such as
under sensing of cardiac activity and failure to deliver necessary
therapy.
Resuscitation Availability - Do not perform induction testing
unless an alternate source of patient defibrillation such as an
external defibrillator is readily available. In order to implant the
ICD system, it is necessary to induce and convert the patient’s
ventricular tachyarrhythmias.

4Lexos Technical Manual
Unwanted Shocks – Always program the VT/VF Detection and
Therapy status to DISABLED prior to handling the device to
prevent the delivery of serious shocks to the patient or the
person handling the device during the implant procedure.
Rate-Adaptive Pacing – Use rate-adaptive pacing with care in
patients unable to tolerate increased pacing rates.
1.4.1 Sterilization, Storage, and Handling
Device Packaging - Do not use the device if the device’s
packaging is wet, punctured, opened or damaged because the
integrity of the sterile packaging may be compromised. Return
the device to BIOTRONIK.
Re-sterilization - Do not re-sterilize and re-implant explanted
devices.
Storage (temperature) - Store the device between 5° to 55°C
(41° - 131° F) because temperatures outside this range could
damage the device.
Storage (magnets) - To avoid damage to the device, store the
device in a clean area, away from magnets, kits containing
magnets, and sources of electromagnetic interference (EMI).
Temperature Stabilization - Allow the device to reach room
temperature before programming or implanting the device
because temperature extremes may affect initial device function.
Use Before Date - Do not implant the device after the USE
BEFORE DATE because the device may have reduced
longevity.
1.4.2 Device Implantation and Programming
Blind Plug - A blind plug must be inserted and firmly connected
into any unused header port to prevent chronic fluid influx and
possible shunting of high energy therapy.