BIOTRONIK SE and KG LUMAXT50 Implantable Cardioverter defibrillator User Manual UserMan

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LUMAXT50 User Manual

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Lumax

Family of Implantable Cardioverter

Defibrillators and Cardiac

Resynchronization Therapy

Defibrillators

 VR ICD

 VR-T ICD

 VR-T DX 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:

Belos Technical Manual iii

Model X-Ray Identification Year of Manufacture

Lumax 300 HR nn

Lumax 340 HR nn

Lumax 500 SH nn

Lumax 540 SH nn

Lumax 600 RH nn

Lumax 640 RH nn

Lumax 700 RH nn

Lumax 740 RH nn

CAUTION

Federal (U.S.A.) law restricts this device to sale by, or on the

order of, a physician.

Lumax Technical Manual i

Contents

1. General ..............................................................................1

1.1 System Description .......................................................1

1.2 Indications and Usage...................................................4

1.3 Contraindications...........................................................5

1.4 Warnings and Precautions ............................................5

1.4.1 Sterilization, Storage, and Handling ......................8

1.4.2 Device Implantation and Programming .................8

1.4.3 Lead Evaluation and Connection ........................10

1.4.4 Follow-up Testing ................................................12

1.4.5 Pulse Generator Explant and Disposal ...............12

1.4.6 Hospital and Medical Hazards.............................12

1.4.7 Home and Occupational Hazards .......................14

1.4.8 Cellular Phones ...................................................14

1.4.9 Electronic Article Surveillance (EAS) ..................15

1.4.10 Home Appliances ................................................15

1.4.11 Home Monitoring® ..............................................15

1.5 Potential/Observed Effects of the Device on Health ...17

1.5.1 Potential Adverse Events ....................................17

1.5.2 Observed Adverse Events...................................18

1.6 Clinical Studies ............................................................27

1.6.1 Kronos LV-T Study ..............................................28

1.6.2 Tupos LV/ATx Study............................................30

1.6.3 Lumax HF-T V-V Clinical Study...........................48

1.6.4 TRUST Clinical Study..........................................55

1.6.5 Deikos A+ ............................................................63

1.7 Patient Selection and Treatment .................................67

1.7.1 Individualization of Treatment .............................67

1.7.2 Specific Patient Populations................................68

1.8 Patient Counseling Information ...................................68

1.9 Evaluating Prospective CRT-D/ICD Patients ..............69

2. Device Features ..............................................................70

2.1 SafeSync Telemetry ....................................................70

2.2 Cardiac Resynchronization Therapy (CRT) ................73

2.3 Sensing (Automatic Sensitivity Control) ......................76

2.3.1 Right Ventricular Sensitivity Settings...................77

2.3.2 Minimum Right Ventricular Threshold .................79

ii Lumax Technical Manual

2.3.3 Atrial Sensitivity Settings .....................................79

2.3.4 Minimum Atrial Threshold....................................80

2.3.5 Left Ventricular Sensitivity Settings .....................80

2.3.6 Minimum Left Ventricular Threshold....................81

2.3.7 Far Field Protection .............................................81

2.3.8 Additional Sensing Parameters ...........................81

2.4 Automatic Threshold Measurement (ATM) .................83

2.4.1 Signal Quality Check ...........................................84

2.4.2 Threshold Measurement .....................................84

2.4.3 Loss of Capture Detection...................................84

2.4.4 ATM in Lumax HF-T Models ...............................84

2.4.5 RV & LV Capture Control ....................................85

2.5 Ventricular Tachyarrhythmia Detection........................85

2.5.1 VF Classifications ................................................86

2.5.2 VT Interval Counters............................................86

2.5.3 VT Classification..................................................86

2.5.4 SMART Detection™ ............................................87

2.5.5 Onset ...................................................................88

2.5.6 Stability ................................................................88

2.5.7 Sustained VT Timer.............................................88

2.5.8 VT Monitoring Zone .............................................89

2.5.9 Atrial Monitoring Zone .........................................89

2.6 Tachyarrhythmia Redetection......................................90

2.6.1 VT Redetection....................................................90

2.6.2 SMART Redetection............................................90

2.6.3 Forced Termination .............................................90

2.6.4 VF Redetection....................................................91

2.7 Tachyarrhythmia Termination ......................................91

2.8 Tachyarrhythmia Therapy............................................91

2.8.1 Therapy Options ..................................................91

2.8.2 Anti-Tachycardia Pacing (ATP) ...........................91

2.8.3 Shock Therapy ....................................................95

2.8.4 Progressive Course of Therapy.........................101

2.9 Bradycardia Therapy .................................................102

2.9.1 Bradycardia Pacing Modes ...............................102

2.9.2 Basic Rate .........................................................103

2.9.3 Night Rate..........................................................103

2.9.4 Rate Hysteresis .................................................104

2.9.5 Dynamic AV Delay.............................................107

2.9.6 IOPT ..................................................................110

Lumax Technical Manual iii

2.9.7 Upper Tracking Rate .........................................110

2.9.8 Mode Switching .................................................111

2.9.9 PMT Management .............................................113

2.9.10 VES Discrimination after Atrial Sensed Events.115

2.9.11 Rate-Adaptive Pacing........................................116

2.9.12 Pulse Amplitude.................................................118

2.9.13 Pulse Width .......................................................118

2.9.14 Post Ventricular Atrial Refractory Period...........118

2.9.15 PVARP after VES ..............................................118

2.9.16 Auto PVARP ......................................................119

2.9.17 Noise Response ................................................119

2.9.18 Post Shock Pacing ............................................119

2.10 EP Test Functions......................................................120

2.10.1 P and R-wave Amplitude Measurements..........120

2.10.2 Pacing Impedance Measurements....................121

2.10.3 Shock Impedance Measurements.....................121

2.10.4 Testing for Retrograde Conduction ...................122

2.10.5 Pacing Threshold...............................................122

2.10.6 Arrhythmia Induction Features ..........................123

2.10.7 Manual Shock....................................................124

2.10.8 Test Shock.........................................................124

2.10.9 Manual ATP.......................................................125

2.10.10 Emergency Shock .............................................125

2.11 Special Features........................................................125

2.11.1 ICD Therapy Status ...........................................125

2.11.2 Thoracic Impedance..........................................126

2.11.3 Home Monitoring®.............................................126

2.11.4 Real-time IEGM Transmission ..........................138

2.11.5 Capacitor Reforming .........................................139

2.11.6 Patient and Implant Data...................................140

2.11.7 System Status ...................................................140

2.11.8 HF Monitor Statistics .........................................141

2.11.9 Holter Memory ...................................................142

2.11.10 Timing Statistics ................................................144

2.11.11 Atrial Arrhythmias ..............................................145

2.11.12 Ventricular Arrhythmias .....................................145

2.11.13 Sensor ...............................................................146

2.11.14 Sensing..............................................................146

2.11.15 Impedances .......................................................146

2.11.16 Automatic Threshold..........................................146

2.11.17 Asynchronous Pacing Modes............................146

iv Lumax Technical Manual

2.11.18 Far-Field IEGM for Threshold Testing (Leadless

ECG)..................................................................147

2.11.19 Advanced AT/AF Diagnostics (Lumax 700/740 only)

...........................................................................147

2.11.20 Atrial NIPS (Lumax 700/740 & 600/640 only) ...148

3. Sterilization and Storage .............................................149

4. Implant Procedure ........................................................151

4.1 Implant Preparation ...................................................151

4.2 Lead System Evaluation............................................156

4.3 Opening the Sterile Container ...................................156

4.4 Pocket Preparation....................................................157

4.5 Lead to Device Connection .......................................158

4.6 Blind Plug Connection ...............................................161

4.7 Program the ICD/CRT-D ...........................................162

4.8 Implant the ICD/CRT-D .............................................163

5. Follow-up Procedures..................................................167

5.1 General Considerations ............................................167

5.2 Longevity ...................................................................168

5.2.1 Lumax 300/340 Devices....................................169

5.2.2 Lumax 500/540 Devices....................................171

5.2.3 Lumax 600/640 & 700/740 Devices ..................174

5.3 Explantation...............................................................176

6. Technical Specifications..............................................179

Appendix A ..........................................................................198

Appendix B – Known Anomalies.......................................200

Lumax Technical Manual v

Figure 1. Lumax 300/340 ICDs and CRT-D

VR(-T) DR(-T)/VR-T DX HF(-T)

Figure 2. Lumax 500/540, 600/640 & 700/740 ICDs and CRT-D

Table 1. Lumax Specifications

Battery Voltage 3.2 Volts

Maximum Shock Energy

300/500/600/700 Models 30 Joules programmed

340/540/640/740 Models 40 Joules programmed

Defibrillation Lead Ports Two DF1 (3.2 mm)

Pacing Lead Ports

vi Lumax Technical Manual

VR(-T) Models One IS-1 (3.2 mm)

DR(-T)/VR-T DX Models Two IS-1 (3.2 mm)

HF(-T) Models Three IS-1 (3.2 mm)

Materials

Housing Titanium

Header Epoxy Resin

Sealing Plug Silicone

Detailed technical specifications are provided in Section 6.

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 Detection™

algorithm.

 Lumax HF-T - In addition, to the functionality found with

HF model, Lumax HF-T also has 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 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.

2 Lumax Technical Manual

 Lumax DR-T - In addition, to the functionality found with

the DR model, it also has 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 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-T DX – provides ventricular rate adaptive

bradycardia pacing support that can include atrial

tracking with a single pass ICD lead and also has

BIOTRONIK’s Home Monitoring system.

The 300/500/600/700 and 340/540/640/740 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, 600/640 and 700/740 models 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. The Lumax 600/640 and

700/740 models also feature an additional left ventricular (LV)

pacing polarity for HF-T devices from LV-tip to housing (unipolar).

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 2.4 provides further details.

Lumax Technical Manual 3

The Lumax 700/740 and 600/640 models feature ATM with

automatic adjustment of pacing amplitudes (RV & LV Capture

Control). This feature functions the same as ATM for threshold

search and is also separately programmable for the right (RV)

and left (LV) ventricle. In addition, it automatically adjusts the

permanent pacing amplitude with a programmed safety margin.

Section 2.4.5 provides a detailed description of this feature.

The Lumax 600/640 and 700/740 also provides wandless

telemetry to ease implantation and follow-up procedures. In

addition, these devices include Thoracic Impedance monitoring

and Atrial NIPS that can be used for an EP study to induce an

arrhythmia or to burst pace a patient out of a stable

tachyarrhythmia.

Lumax 700/740 and 600/640 will present with automatic Far-Field

IEGM to provide a means to generate the surface ECG-like signal

without the need for attaching the surface electrodes to the

patients.

The Lumax HF (-T) models have three IS-1 pacing/sensing

header ports and two DF-1 defibrillation/cardioversion ports. The

Lumax DR (-T) models have two IS-1 pacing/sensing header

ports. The Lumax VR (-T) models have 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/CRT-D System. These external

devices include the Programming and Tachyarrhythmia

Monitoring System and the Implant Module System Analyzer or

Pacing System Analyzer for acute lead testing. The ICS 3000 or

Renamic programmer are used to interrogate and program the

ICD/CRT-Ds.

The Lumax 600/640 and 700/740 models also feature SafeSync

Telemetry (RF-Telemetry) via the Renamic programmer or the

ICS 3000 programmer in combination with the SafeSync Module

(an external communication module).

4 Lumax Technical Manual

BIOTRONIK conducted the TRUST study to evaluate the safety

and effectiveness of Home Monitoring, which is available in most

models of this device. Refer to Section 1.6.4 for details regarding

the study design and results. With the TRUST study,

BIOTRONIK was able to show the following with regards to Home

Monitoring:

 BIOTRONIK Home Monitoring information may be used as a

replacement for device interrogation during in-office follow-up

visits.

 A strategy of care using BIOTRONIK Home Monitoring with

office visits when needed has been shown to extend the time

between routine, scheduled in-office follow-ups of

BIOTRONIK implantable devices in many patients. Home

Monitoring data is helpful in determining the need for

additional in-office follow-up.

 BIOTRONIK Home Monitoring-patients—who are followed

remotely with office visits when needed—have been shown to

have similar numbers of strokes, invasive procedures and

deaths as patients followed with conventional in-office

follow-ups.

 BIOTRONIK Home Monitoring provides early detection of

arrhythmias.

 BIOTRONIK Home Monitoring provides early detection of

silent, asymptomatic arrhythmias.

 Automatic early detection of arrhythmias and device system

anomalies by BIOTRONIK Home Monitoring allows for earlier

intervention than conventional in-office follow-ups.

 BIOTRONIK Home Monitoring allows for improved access to

patient device data compared to conventional in-office

follow-ups since device interrogation is automatically

scheduled at regular intervals.

1.2 Indications and Usage

The Lumax CRT-Ds are indicated for use in patients with all of the

following conditions:

 Indicated for ICD therapy

 Receiving optimized and stable Congestive Heart Failure

(CHF) drug therapy

 Symptomatic CHF (NYHA Class III/IV and LVEF  35%);

and

Lumax Technical Manual 5

 Intraventricular conduction delay (QRS duration 130 ms)

The Lumax Implantable Cardioverter Defibrillators (ICDs) and

Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) are

intended to provide ventricular anti-tachycardia pacing and

ventricular defibrillation, for automated treatment of life-

threatening ventricular arrhythmias.

1.3 Contraindications

The Lumax devices are contraindicated for use in patients with

the following conditions:

 Patients whose ventricular tachyarrhythmias may have

transient or reversible causes such as:

 Acute myocardial infarction

 Digitalis intoxication

 Drowning

 Electrocution

 Electrolyte imbalance

 Hypoxia

 Sepsis

 Patients with incessant ventricular fibrillation (VF) and

ventricular tachycardia (VT)

 Patients whose only disorder is brady arrhythmias or

atrial arrhythmias

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.

Left Ventricular Lead Systems – BIOTRONIK CRT-Ds may be

implanted with any legally marketed, compatible LV lead.

Compatibility is defined as:

 IS-1 pacing connector

 Active or passive fixation technology

 Insertion and withdrawal forces as specified by

ISO 5841-3 (IS-1)

6 Lumax Technical Manual

The following LV leads were evaluated in the OPTION CRT/ATx

study with BIOTRONIK’s CRT-Ds:

 Guidant-EASYTRAK® IS-1 Lead

 Guidant-EASYTRAK LV-1 Lead

 Guidant-EASYTRAK 2 Lead

 Guidant-EASYTRAK 3 Lead

 Medtronic-Attain® OTW Lead

 St. Jude-AesculaTM Lead

 St. Jude-QuickSite® Lead

 Biomec-MyoporeTM Epicardial Lead

 Medtronic-Epicardial 5071 Lead

 Medtronic-CapSure® EPI Lead

 BIOTRONIK-ELC 54-UP Lead

The following LV leads were bench tested for compatibility with

BIOTRONIK’s CRT-Ds:

 Guidant EASYTRAK 4512 (unipolar) Lead

 Guidant EASYTRAK 4513 (bipolar) Lead

 Guidant EASYTRAK 3 4525 (bipolar) Lead

 Medtronic Attain OTW 4193 (unipolar) Lead

 Medtronic Attain OTW 4194 (bipolar) Lead

 Medtronic Attain LV 2187 (unipolar) Lead

 St. Jude Medical QuickSite 1056K (unipolar) Lead

 ELA SITUS® OTW (unipolar) Lead

 BIOTRONIK Corox OTW 75-UP Steroid #346542

(unipolar) Lead

 BIOTRONIK Corox+ LV-H 75-BP #341885 (bipolar) Lead

ICD Lead Systems – BIOTRONIK ICDs/CRT-Ds maybe

implanted with any legally marketed, compatible ICD lead.

Compatibility is defined as:

 IS-1 pacing and sensing connector(s)

 DF-1 shock coil connector(s)

 Integrated or dedicated bipolar pacing and sensing

configuration

 Active or passive fixation technology

 Single or dual defibrillation shock coil (s)

 High energy shock accommodation of at least 30 joules

Lumax Technical Manual 7

 Insertion and withdrawal forces as specified by

ISO 5841-3 (IS-1) and ISO 11318:1993 (E) DF-1

The following leads were evaluated in a retrospective study with

BIOTRONIK’s ICDs/CRT-Ds:

 Medtronic SprintTM Lead 6932

 Medtronic Sprint Lead 6943

 Medtronic Sprint QuattroTM Lead 6944

 Medtronic TransveneTM RV Lead 6936

 St. Jude (Ventritex) TVLTM- ADX Lead 1559

 St. Jude SPL® SP02 Lead

 Guidant ENDOTAK® DSP Lead

 Guidant ENDOTAK Endurance EZ Lead, ENDOTAK

Reliance Lead

 Guidant (Intermedics) Lead 497-24.

The following leads were bench tested for compatibility with

BIOTRONIK’s ICDs/CRT-Ds:

 Guidant ENDOTAK Endurance Lead “CPI 0125”

 Guidant ENDOTAK Reliance Lead 0148

 Medtronic Sprint Lead 6932

 Medtronic Sprint Lead 6942

 Medtronic Sprint Lead 6943

 Medtronic Sprint Lead6945

 Medtronic Sprint Quattro Lead 6944

 St. Jude Riata® Lead 1571/65

 St. Jude SPL SPO1 Lead.

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/CRT-D system, it is necessary to induce and convert the

patient’s ventricular tachyarrhythmias.

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 implant

procedure.

Rate-Adaptive Pacing – Use rate-adaptive pacing with care in

patients unable to tolerate increased pacing rates.

8 Lumax Technical Manual

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 45°C

(41° - 113° 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.

Capacitor Reformation - Infrequent charging of the high voltage

capacitors may extend the charge times of the ICD/CRT-D. The

capacitors are reformed automatically at least every 90 days. For

further information, please refer to Section 2.11.5, Capacitor

Reforming.

Connector Compatibility – ICD/CRT-D and lead system

compatibility should be confirmed prior to the implant procedure.

Consult your BIOTRONIK representative regarding lead/pulse

generator compatibility prior to the implantation of an ICD/CRT-D

system. For further information, please refer to Appendix A.

Lumax Technical Manual 9

ERI (Elective Replacement Indicator) - Upon reaching ERI, the

battery has sufficient energy remaining to continue monitoring for

at least three months and to deliver a minimum of six maximum

energy shocks. After this period (EOS), all tachyarrhythmia

detection and therapy is disabled. Bradycardia functions are still

active at programmed values until the battery voltage drops below

1.75 volts.

Magnets - Positioning of a magnet or the programming wand

over the ICD/CRT-D will suspend tachycardia detection and

treatment. The minimum magnet strength required to suspend

tachycardia treatment is 1.8 mT. When the magnet strength

decreases to less than 1 mT, the reed contact is reopened.

Programmed Parameters – Program the device parameters to

appropriate values based on the patient’s specific arrhythmias

and condition.

Programmers - Use only BIOTRONIK ICS 3000 or Renamic

programmers to communicate with the device.

Sealing System - Failure to properly insert the torque wrench

into the perforation at an angle perpendicular to the connector

receptacle may result in damage to the sealing system and its

self-sealing properties.

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.

Manual Shocks – User-commanded shocks may be withheld if

the ICD/CRT-D is already busy processing a manual command or

the Battery Status is low.

Charge Time - When preparing a high energy shock the charge

circuit stops charging the capacitors after 20 seconds, and

delivers the stored energy as shock therapy. After the device

reaches ERI the stored energy may be less than the maximum

programmable energy for each shock.

10 Lumax Technical Manual

Programming Wand Separation Distance – The wand (with

magnet) must not be placed closer than 2 cm to the device

(implanted or out of the box). Programming wand (with magnet)

distance closer than 2 cm may damage the device.

Shipment Mode – The shipment mode is a factory set mode that

controls the charge current of automatic capacitor reformations.

This mode controls the charge current to avoid temporary low

battery readings. The shipment mode is automatically deactivated

as soon as electrophysiological tests (e.g., Impedance

measurement) have been performed. To ensure delivery of

programmed shock energy, make sure shipment mode is

disabled prior to completion of implant procedure.

Shock Therapy Confirmation – Programming CONFIRMATION

to OFF may increase the incidence of the ICD/CRT-D delivering

inappropriate shocks.

Shock Impedance - If the shock impedance is less than twenty-

five ohms (25 Ω), reposition the lead system to allow a greater

distance between the electrodes. Never implant the device with a

lead system that has measured shock impedance of less than

twenty-five ohms (25 Ω). Damage to the device may result.

Negative AV Hysteresis – This feature insures ventricular

pacing, a technique which has been used in patients with

hypertrophic obstructive cardiomyopathy (HOCM) with normal AV

conduction in order to replace intrinsic ventricular activation. No

clinical study was conducted to evaluate this feature, and there is

conflicting evidence regarding the potential benefit of ventricular

pacing therapy for HOCM patients. In addition, there is evidence

with other patient groups to suggest that inhibiting the intrinsic

ventricular activation sequence by right ventricular pacing may

impair hemodynamic function and/or survival.

1.4.3 Lead Evaluation and Connection

Capping Leads - If a lead is abandoned rather than removed, it

must be capped to ensure that it is not a pathway for currents to

or from the heart.

Gripping Leads - Do not grip the lead with surgical instruments

or use excessive force or surgical instruments to insert a stylet

into a lead.

Lumax Technical Manual 11

Kinking Leads - Do not kink leads. This may cause additional

stress on the leads that can result in damage to the lead.

Liquid Immersion - Do not immerse leads in mineral oil, silicone

oil, or any other liquid.

Short Circuit - Ensure that none of the lead electrodes are in

contact (a short circuit) during delivery of shock therapy as this

may cause current to bypass the heart or cause damage to the

ICD/CRT-D system.

Far-Field Sensing of signals from the atrium in the ventricular

channel or ventricular signals in the atrial channel should be

avoided by appropriate lead placement, programming of

pacing/sensing parameters, and maximum sensitivity settings. If it

is necessary to modify the Far Field Blanking parameter, the

parameter should be lengthened only long enough to eliminate

far-field sensing as evidenced on the IEGMs. Extending the

parameter unnecessarily may cause under sensing of actual atrial

or ventricular events.

Suturing Leads - Do not suture directly over the lead body as

this may cause structural damage. Use the appropriate suture

sleeve to immobilize the lead and protect it against damage from

ligatures.

Tricuspid Valve Bioprosthesis - Use ventricular transvenous

leads with caution in patients with a tricuspid valvular

bioprosthesis.

Setscrew Adjustment – Back-off the setscrew(s) prior to

insertion of lead connector(s) as failure to do so may result in

damage to the lead(s), and/or difficulty connecting lead(s).

Cross Threading Setscrew(s) – To prevent cross threading the

setscrew(s), do not back the setscrew(s) completely out of the

threaded hole. Leave the torque wrench in the slot of the

setscrew(s) while the lead is inserted.

Tightening Setscrew(s) – Do not over tighten the setscrew(s).

Use only the BIOTRONIK supplied torque wrench.

Sealing System – Be sure to properly insert the torque wrench

into the perforation perpendicular to the connector receptacle.

Failure to do so may result in damage to the plug and its self-

sealing properties.

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:

Lumax Technical Manual 13

Diathermy - Diathermy therapy is not recommended for

ICD/CRT-D patients due to possible heating effects of the pulse

generator and at the implant site. If diathermy therapy must be

used, it should not be applied in the immediate vicinity of the

pulse generator or lead system.

Electrocautery - Electrosurgical cautery could induce ventricular

arrhythmias and/or fibrillation, or may cause device malfunction or

damage. If use of electrocautery is necessary, the current path

and ground plate should be kept as far away from the pulse

generator and leads as possible (at least 6 inches (15 cm)).

External Defibrillation - The device is protected against energy

normally encountered from external defibrillation. However, any

implanted device may be damaged by external defibrillation

procedures. In addition, external defibrillation may also result in

permanent myocardial damage at the electrode-tissue interface as

well as temporary or permanent elevated pacing thresholds. When

possible, observe the following precautions:

 Position the adhesive electrodes or defibrillation paddles

of the external defibrillator anterior-posterior or along a

line perpendicular to the axis formed by the implanted

device and the heart.

 Set the energy to a level not higher than is required to

achieve defibrillation.

 Place the paddles as far as possible away from the

implanted device and lead system.

 After delivery of an external defibrillation shock,

interrogate the ICD/CRT-D to confirm device status and

proper function.

Lithotripsy - Lithotripsy may damage the ICD/CRT-D. If

lithotripsy must be used, avoid focusing near the ICD/CRT-D

implant site.

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.

Radiation - High radiation sources such as cobalt 60 or gamma

radiation should not be directed at the pulse generator. If a patient

requires radiation therapy in the vicinity of the pulse generator,

place lead shielding over the device to prevent radiation damage

and confirm its function after treatment.

14 Lumax Technical Manual

Radio Frequency Ablation - Prior to performing an ablation

procedure, deactivate the ICD/CRT-D during the procedure.

Avoid applying ablation energy near the implanted lead system

whenever possible.

1.4.7 Home and Occupational Hazards

Patients should be directed to avoid devices that generate strong

electromagnetic interference (EMI) or magnetic fields. EMI could

cause device malfunction or damage resulting in non-detection or

delivery of unneeded therapy. Moving away from the source or

turning it off will usually allow the ICD/CRT-D to return to its

normal mode of operation.

The following equipment (and similar devices) may affect normal

ICD/CRT-D operation: electric arc or resistance welders, electric

melting furnaces, radio/television and radar transmitters,

power-generating facilities, high-voltage transmission lines, and

electrical ignition systems (of gasoline-powered devices) if

protective hoods, shrouds, etc., are removed.

1.4.8 Cellular Phones

Testing has indicated there may be a potential interaction

between cellular phones and BIOTRONIK ICD/CRT-D systems.

Potential effects may be due to either the cellular phone signal or

the magnet within the telephone and may include inhibition of

therapy when the telephone is within 6 inches (15 centimeters) of

the ICD/CRT-D, when the ICD/CRT-D is programmed to standard

sensitivity.

Patients having an implanted BIOTRONIK ICD/CRT-D who

operate a cellular telephone should:

 Maintain a minimum separation of 6 inches

(15 centimeters) between a hand-held personal cellular

telephone and the implanted device.

 Set the telephone to the lowest available power setting, if

possible.

Lumax Technical Manual 15

 Patients should hold the phone to the ear opposite the

side of the implanted device. Patients should not carry

the telephone in a breast pocket or on a belt over or

within 6 inches (15 centimeters) of the implanted device

as some telephones emit signals when they are turned

ON, but not in use (i.e., in the listen or stand-by mode).

Store the telephone in a location opposite the side of

implant.

Based on results to date, adverse effects resulting from

interactions between cellular telephones and implanted

ICDs/CRT-Ds have been transitory. The potential adverse effects

could include inhibition or delivery of additional therapies. If

electromagnetic interference (EMI) emitting from a telephone

does adversely affect an implanted ICD/CRT-D, moving the

telephone away from the immediate vicinity of the ICD/CRT-D

should restore normal operation. A recommendation to address

every specific interaction of EMI with implanted ICDs/CRT-Ds is

not possible due to the disparate nature of EMI.

1.4.9 Electronic Article Surveillance (EAS)

Equipment such as retail theft prevention systems may interact

with pulse generators. Patients should be advised to walk directly

through and not to remain near an EAS system longer than

necessary.

1.4.10 Home Appliances

Home appliances normally do not affect ICD/CRT-D operation if

the appliances are in proper working condition and correctly

grounded and shielded. There have been reports of the

interaction of electric tools or other external devices (e.g. electric

drills, older models of microwave ovens, electric razors, etc.) with

ICDs/CRT-Ds when they are placed in close proximity to the

device.

1.4.11 Home Monitoring®

BIOTRONIK’s Home Monitoring system is designed to notify

clinicians in less than 24 hours of changes to the patient’s

condition or status of the implanted device. Updated data may not

be available if:

16 Lumax Technical Manual

 The patient’s CardioMessenger is off or damaged and is

not able to connect to the Home Monitoring system

through an active telephone link

 The CardioMessenger cannot establish a connection to

the implanted device

 The telephone and/or Internet connection do not operate

properly

 The Home Monitoring Service Center is off-line (upgrades

are typically completed in less than 24 hours)

Patient’s Ability - Use of the Home Monitoring system requires

the patient and/or caregiver to follow the system instructions and

cooperate fully when transmitting data.

If the patient cannot understand or follow the instructions because

of physical or mental challenges, another adult who can follow the

instructions will be necessary for proper transmission.

Use in Cellular Phone Restricted Areas - The mobile patient

device (transmitter/receiver) should not be utilized in areas where

cellular phones are restricted or prohibited (i.e., commercial

aircraft).

Lumax Technical Manual 17

1.5 Potential/Observed Effects of the

Device on Health

1.5.1 Potential Adverse Events

The following are possible adverse events that may occur relative

to the implant procedure and chronic implant of the CRT-D:

 Air embolism

 Allergic reactions to

contrast media

 Arrhythmias

 Bleeding

 Body rejection

phenomena

 Cardiac tamponade

 Chronic nerve damage

 Damage to heart valves

 Device migration

 Elevated pacing

thresholds

 Extrusion

 Fluid accumulation

 Hematoma

 Infection

 Keloid formation

 Lead dislodgment

 Lead fracture/insulation

damage

 Lead-related thrombosis

 Local tissue

reaction/fibrotic tissue

formation

 Muscle or nerve

stimulation

 Myocardial damage

 Myopotential sensing

 Pacemaker mediated

tachycardia

 Pneumothorax

 Pocket erosion

 Thromboembolism

 Under sensing of intrinsic

signals

 Venous occlusion

 Venous or cardiac

perforation

18 Lumax Technical Manual

In addition, patients implanted with the ICD/CRT-D system may

have the following risks. These are the same risks related with

implantation of any ICD/CRT-D system:

 Acceleration of

arrhythmias (speeding

up heart rhythm caused

by the CRT-D)

 Dependency

 Depression

 Fear of premature

battery depletion (fear

that battery will stop

working before predicted

time)

 Fear of shocking while

awake

 Fear that shocking

ability may be lost

 Anxiety about the CRT-D

resulting from frequent

shocks

 Imagined shock (phantom

shock)

 Inappropriate detection of

ventricular arrhythmias

 Inappropriate shocks

 Potential death due to

inability to defibrillate or

pace

 Shunting current or

insulating myocardium

during defibrillation with

external or internal paddles

There may be other risks associated with this device that are

currently unforeseeable.

1.5.2 Observed Adverse Events

Reported Adverse Events are classified as either observations or

complications. Complications are defined as clinical events that

require additional invasive intervention to resolve. Observations

are defined as clinical events that do not require additional

invasive intervention to resolve.

1.5.2.1 Kronos LV-T Study

NOTE:

The Kronos LV-T CRT-D is an earlier generation of

BIOTRONIK devices. The Lumax CRT-Ds are based upon

the Kronos LV-T and other BIOTRONIK CRT-Ds and ICDs

(i.e., Tupos LV/ATx CRT-D, Lexos and Lumos families of

ICDs).

Lumax Technical Manual 19

The HOME-CARE Observational study, conducted outside the

US on the Kronos LV-T cardiac resynchronization defibrillator

(CRT-D) in patients with congestive heart failure (CHF) involved

45 devices implanted with a cumulative implant duration of

202 months (mean implant duration of 4.5 months).

Of the 31 adverse events reported, there have been

26 observations in 23 patients and 5 complications in 3 patients

with a cumulative implant duration of 202 months (16.8 patient-

years). 6.7% of the enrolled patients have experienced a

complication with two patients experiencing 2 separate

complications. The rate of complications per patient-year was

0.30. 51% of the enrolled study patients had a reported

observation with 3 patients having more than 1 observation. The

rate of observations per patient-year is 1.54. Complications and

observations for the patient group are summarized in Table 2 and

Table 3, respectively.

Table 2: Summary of Complications – Kronos LV-T

Category

Number

Patients

% of

Patient

Number

Per

patient-

year

Left Ventricular Lead Related

Dislodgement 1 2.2% 1

0.06

No Capture 1 2.2% 1 0.06

Total 2 4.4% 2 0.12

ICD Lead Related

Dislodgement 1 2.2% 1

0.06

Elevated Pacing

Threshold 1 2.2% 1 0.06

Total 2 4.4% 2

0.12

Unrelated to CRT-D or Leads

Hemathorax 1 2.2% 1

0.06

Total 1 2.2% 1 0.06

Overall

Complication Totals 3 6.7% 5 0.30

Number of Patients = 45, Number of Patient-Years = 16.8

20 Lumax Technical Manual

Table 3: Summary of Observations – Kronos LV-T

Category

Number

Patients

%of

Patients Number

per

patient-

year

Unsuccessful LV

lead implant 8 17.8% 8 0.48

Elevated LV pacing

threshold 5 11.1% 5 0.30

Phrenic nerve

stimulation 3 6.7% 3 0.18

Elevated DFT

measurement 2 4.4% 2 0.12

T-wave oversensing 2 4.4% 2 0.12

Worsening CHF 2 4.4% 2 0.12

Elevated RV pacing

threshold 1 2.2% 1 0.06

Hepatitis 1 2.2% 1 0.06

Arrhythmias 1 2.2% 1 0.06

Cardiac

Decompensation 1 2.2% 1 0.06

All Observations 23 51.1% 26 1.54

Number of Patients = 45, Number of Patient-Years = 16

Two patient deaths were reported during the HOME-CARE

Observational Study. One death resulted from worsening heart

failure and the second death resulted from cardiogenic shock due

to ischemic cardiomyopathy. None of the deaths were related to

the implanted CRT-D system. There were no device explants

during the HOME-CARE Observational Study.

Lumax Technical Manual 21

1.5.2.2 Tupos LV/ATx Study

NOTE:

The clinical study information included in this section and in

Section 1.6.2 was performed with the Tupos LV/ATx CRT-D,

which is an earlier version of the Lumax CRT-D/ICD families.

The clinical study data presented here is applicable because

the Lumax family are downsized versions of the

Tupos LV/ATx CRT-D and Tachos ICD families. The Lumax

family is slightly different as compared to the Tupos LV/ATx

(and Tachos family) in the following areas:

 Reduced size from 50/48 cc to 40/35 cc

 Addition of Home Monitoring® functionality

 Addition of triggered pacing for biventricular pacing

modes

 True three chamber pacing and sensing capabilities

(CRT-Ds)

The OPTION CRT/ATx study was a prospective, randomized,

multi-center study to demonstrate the safety and effectiveness of

the investigational Tupos LV/ATx Cardiac Resynchronization

Therapy Defibrillator (CRT-D) in patients with congestive heart

failure (CHF) and atrial tachyarrhythmias. All patients enrolled into

the clinical study were randomly assigned to either the study

group or the control group at a 2 to 1 ratio. Patients in the study

group were implanted with the Tupos LV/ATx. Patients in the

control group were implanted with a legally marketed ICD that

provides CRT.

Of the 278 adverse events reported in the Tupos LV/ATx study

group, there have been 210 observations in 104 patients and 68

complications in 50 patients with a cumulative implant duration of

1240.4 months (101.9 patient-years). 37.6% of the enrolled study

patients have experienced a complication. The rate of

complications per patient-year is 0.67. 78.2% of the enrolled

study patients have a reported observation. The rate of

observations per patient-year is 2.06.

22 Lumax Technical Manual

Complications and observations for the Tupos LV/ATx study

group are summarized in Table 4 and Table 5. The total number

of patients may not equal the sum of the number of patients listed

in each category, as an individual patient may have experienced

more than one complication or observation.

Table 4: Summary of Complications – Tupos LV/ATx

Category

Number

Patients

% of

Patients

Number of

Complications

per patient-year

Procedure Related

Hematoma 4 3.01% 4 0.04

Pneumothorax 2 1.50% 2 0.02

Total 6 4.51% 6 0.06

Atrial Lead Related

Dislodgement 3 2.26% 3 0.03

Total 3 2.26% 3 0.03

ICD Lead Related

High threshold/No

capture 2 1.50% 2 0.02

Diaphragmatic/Interc

ostal stimulation

(RV)

1 0.75% 1 0.01

Total 3 2.26% 3 0.03

LV Lead Related

High

threshold/Intermitten

t biventricular

capture/No capture

11 8.27% 12 0.12

Unable to implant

lead via coronary

sinus

11 8.27% 11 0.11

Dislodgement 4 3.01% 4 0.04

Diaphragmatic/Interc

ostal stimulation 1 0.75% 2 0.02

Total 27 20.3% 29 0.28

Lumax Technical Manual 23

Table 4: Summary of Complications – Tupos LV/ATx

Category

Number

Patients

% of

Patients

Number of

Complications

per patient-year

Device Related

Infection 3 2.26% 7 0.07

Device migration 4 3.01% 4 0.04

Elective replacement

indicator reached 4 3.01% 4 0.04

Inductions and

conversions 1 0.75% 1 0.01

Unable to interrogate

device 1 0.75% 1 0.01

Total 12 9.02% 17 0.17

Total Procedure

and Device Related 43 32.33% 58 0.57

Other Medical Related

Non-CHF Cardiac

Symptoms 4 3.01% 4 0.04

Ventricular

arrhythmias 2 1.50% 3 0.03

Other medical 2 1.50% 2 0.02

Atrial arrhythmia 1 0.75% 1 0.01

Total 9 6.77% 10 0.10

Total – All Patients

and Categories 50 37.59% 68 0.67

Number of Patients = 133, Number of Patient-Years = 101.9

* 1 Unanticipated Adverse Device Effect (UADE) occurred with a

Tupos LV/ATx CRT-D during the OPTION clinical study. The device was

explanted after it was unable to be interrogated with the programmer

software and no pacing output was evident. The analysis showed an

inappropriately depleted battery and no anomalies with the IC module.

The battery depletion strongly suggests that the high voltage circuit was

activated over a prolonged period due to a single-bit execution path

failure. The current programmer software with Automatic Battery

Management (ABM) would have prevented the battery from becoming

completely depleted. There were no other instances of this failure

mechanism in Tupos LV/ATx devices.

24 Lumax Technical Manual

For the Tupos LV/ATx study group, there were 210 observations

in 104 patients with cumulative implant duration of 1240.4 months

(101.9 patient years). 78.2% of the enrolled study patients have a

reported observation. The rate of observations per patient-year

was 2.06. Table 5 summarizes by category each type of

observation for the study group.

Table 5: Summary of Observations – Tupos LV/ATx

Category

Number

Patients

% of

Patients Number per patient-

year

Procedure Related

Hematoma 10 7.52% 10 0.10

Cardiac arrest 2 1.50% 2 0.02

Unable to implant

system 1 0.75% 1 0.01

Total 13 9.77% 13 0.13

Atrial Lead Related

Dislodgement 1 0.75% 1 0.01

High threshold 1 0.75% 1 0.01

Total 2 1.50% 2 0.02

ICD Lead Related

High threshold/No

capture 1 0.75% 1 0.01

Total 1 0.75% 1 0.01

LV Lead Related

High threshold/

Intermittent

biventricular capture/

No capture

24 18.05% 24 0.24

Diaphragmatic/

Intercostal stimulation 8 6.02% 8 0.08

Total 30 22.56% 32 0.31

Lumax Technical Manual 25

Table 5: Summary of Observations – Tupos LV/ATx

Category

Number

Patients

% of

Patients Number per patient-

year

Device Related

Infection 1 0.75% 1 0.01

Inductions and

conversions 6 4.51% 6 0.06

Inappropriate sensing 20 15.04% 20 0.20

Symptomatic with

biventricular pacing 2 1.50% 2 0.02

Total 25 18.80% 29 0.28

Total Procedure,

Lead and Device

61 45.86% 77 0.76

Other Medical Related

Non-CHF Cardiac

Symptoms 21 15.79% 21 0.21

Ventricular

arrhythmias 11 8.27% 11 0.11

Other medical 26 19.55% 32 0.31

Atrial arrhythmia 14 10.53% 14 0.14

Dizziness 4 3.01% 4 0.04

Medication 5 3.76% 5 0.05

Worsening CHF 46 34.59% 46 0.45

Total 82 61.65% 133 1.31

Total – All Patients

and Categories 104 78.20% 210 2.06

Number of Patients = 133 Number of Patient-Years = 101.9

26 Lumax Technical Manual

There have been 4 patient deaths reported for the control group

(out of 67 total control patients) and 10 patient deaths have been

reported for the study group (out of 133 total study patients).

None of the deaths were related to the implanted CRT-D system.

One patient in the control group died prior to receiving a

biventricular device implant. There is no significant difference

between the number of deaths in the study group versus the

control group (p = 0.777, Fisher's Exact Test, 2 sided). Table 6

provides a summary of reported patient deaths and Table 7

provides survival percentages by follow-up interval during the first

12 months of study participation.

Table 6: Summary of Patient Deaths

Study

(N = 133)

Control

(N = 67)

Category of

Death

Number of Patients Number of Patients

Sudden Cardiac 1 1

Non-Sudden

Cardiac

5 2

Non-Cardiac 4 1

All Causes 10 4

Figure 3 shows the associated Kaplan-Meier survival curves for

the study and control group. The significance level for the

difference between the two study groups based on a Log Rank

test was p = 0.795.

Lumax Technical Manual 27

211815129630

Survival Time (months)

1.0

0.9

0.8

0.7

0.6

0.5

0.4

0.3

0.2

0.1

0.0

Cumulative Survival

Log Rank = 0.795

Control

Study

Figure 3: Kaplan-Meier Survival Curves

Table 7 Survival Table

Study Group

(n = 133)

Control Group

(n = 66)

Number % Number %

Enrollment 133 100.00% 67 100.00%

3-month 131 98.50% 63 94.03%

6-month 127 95.49% 63 94.03%

12-month 123 92.48% 63 94.03%

1.6 Clinical Studies

The Kronos LV-T Clinical study (HOME-CARE, Section 1.6.1)

supports the safety of the Lumax CRT-D/ICD device family.

Additionally, because the Tupos LV/ATx and the Lumax CRT-D

devices have identical CRT and ventricular ICD therapy, the

effectiveness results from the OPTION CRT/ATx IDE Clinical

study (Tupos LV/ATx, Section 1.6.2) support the effectiveness of

the Lumax family.

28 Lumax Technical Manual

1.6.1 Kronos LV-T Study

The purpose of the HOME-CARE Observational Study is to

demonstrate the safety of the CE-marked Kronos LV-T cardiac

resynchronization defibrillator (CRT-D) in patients with congestive

heart failure (CHF).

1.6.1.1 Methods

The multi-center, non-randomized observational study was

designed to evaluate the safety of the Kronos LV-T through an

analysis of the complication-free rate through three months.

The HOME-CARE Observational Study Primary Endpoint was to

evaluate complications (adverse events that require additional

invasive intervention to resolve) related to the implanted CRT

system which includes the Kronos LV-T, the right atrial lead, the

right ventricular ICD lead, and the left ventricular lead

Inclusion Criteria

To support the objectives of this investigation, patients were

required to meet the following inclusion criteria prior to

enrollment:

 Indication for Cardiac Resynchronization Therapy

 Sufficient GSM-network coverage in the patient’s area

 Age greater than or equal to 18 years

Exclusion Criteria

To support the objectives of this investigation, the exclusion

criteria at the time of patient enrollment included the following:

 Permanent atrial fibrillation

 Myocardial infarction or unstable angina pectoris within

the last 3 prior to enrollment

 Planned cardio-surgical intervention within 3 months after

enrollment (e.g. PTCA, CABG, HTX)

 Acute myocarditis

 Life expectancy less than 6 months

 Pregnant or breast-feeding woman

 Drug or Alcohol abuse

 The patient is mentally or physically unable to take part in

the observational study

 No signed declaration of consent for the patient

Lumax Technical Manual 29

At the enrollment screening, the physician evaluated the patient

to verify that all inclusion/exclusion criteria were met in

accordance to the protocol and the patient signed the informed

consent. After successful enrollment, all patients were implanted

with the Kronos LV-T CRT-D. Evaluations at the One- and Three-

month follow-ups included resting ECG, NYHA classification,

medications, and activation of Home Monitoring.

1.6.1.2 Summary of Clinical Results

The study involved 45 patients (37 males, 82.2%, and 8 females,

17.8%), with a mean age of 64 years (range: 36-79), a left

ventricular ejection fraction of 26 % (range: 15-43), NYHA Class

III (NHYA Class 1 (2.3%), Class II (11.4%), Class III (79.5%),

Class IV (6.8%)) and QRS duration of 154 ms (range: 84-208).

The mean implant duration was 4.5 months with a cumulative

implant duration of 202 months. The patient follow-up compliance

rate was 95.9% out of 221 required follow-ups.

Primary Endpoint

The safety of the Kronos LV-T was evaluated based on

complications (adverse events that require additional invasive

intervention to resolve) related to the implanted CRT system

which includes the Kronos LV-T, the right atrial lead, the right

ventricular ICD lead, and the left ventricular lead. 5 complications

were seen in 3 patients with cumulative implant duration of 202

months (16.8 patient-years). 6.7% of the patients had a reported

complication. The rate of complications per patient-year is 0.30.

The freedom from Kronos LV-T system-related complications is

93.3% with a two sided lower 95% confidence bound of 83.8%.

The null hypothesis is rejected, and it is concluded that the

complication-free rate is equivalent to 85% within 10%.

30 Lumax Technical Manual

1.6.2 Tupos LV/ATx Study

NOTE:

The clinical study information included in this section was

performed with the Tupos LV/ATx CRT-D, which is an earlier

version of the Lumax CRT-D/ICD families. The clinical study

data presented here is applicable because the Lumax family

are downsized versions of the Tupos LV/ATx CRT-D and

Tachos ICD families. The Lumax family is slightly different as

compared to the Tupos LV/ATx (and Tachos family) in the

following areas:

 Reduced size from 50/48 cc to 40/35 cc

 Addition of Home Monitoring functionality

 Addition of triggered pacing for biventricular pacing

modes

 True three chamber pacing and sensing capabilities

(CRT-Ds)

1.6.2.1 Study Overview

The purpose of the prospective, randomized, multi-center

OPTION CRT/ATx study was to demonstrate the safety and

effectiveness of the investigational Tupos LV/ATx Cardiac

Resynchronization Therapy Defibrillator (CRT-D) in patients with

congestive heart failure (CHF) and atrial tachyarrhythmias.

Patients in the study group were implanted with a BIOTRONIK

Tupos LV/ATx. Patients in the control group were implanted with

any legally marketed CRT-D. Patients in both the study and

control groups were implanted with a legally marketed left

ventricular lead.

Lumax Technical Manual 31

1.6.2.2 Methods

Primarily, the study evaluates and compares the functional

benefits of CRT between the two randomized groups using a

composite endpoint consisting of a six-minute walk test (meters

walked) and quality of life measurement (assessed using the

Minnesota Living with Heart Failure Questionnaire). Relevant

measurements were completed twice for each patient: once at

the Baseline evaluation (two-week post implant follow-up) and

again at a six-month follow-up evaluation. The data collected

during this clinical study was used to demonstrate equivalent

treatment of CHF in both the study and control groups. This study

also evaluated other outcomes including: the effectiveness of

atrial therapy to automatically convert atrial tachyarrhythmias, the

percentage of time CRT is delivered, and other measures of CHF

status including NYHA classification, peak oxygen consumption

during metabolic exercise testing, and the rate of hospitalization

for CHF.

Inclusion Criteria

To support the objectives of this investigation, patients were

required to meet the following inclusion criteria prior to

enrollment:

 Stable, symptomatic CHF status

 NYHA Class III or IV congestive heart failure

 Left ventricular ejection fraction  35% (measured within

Six-Months prior to enrollment)

 Intraventricular conduction delay (QRS duration greater

than or equal to 130 ms)

 For patients with an existing ICD/CRT-D, optimal and

stable CHF drug regimen including ACE-inhibitors and

beta-blockers unless contraindicated (stable is defined as

changes in dosages less than 50% during the last 30

days)

 Indicated for ICD therapy

 History or significant risk of atrial tachyarrhythmias

 Willing to receive possibly uncomfortable atrial shock

therapy for the treatment of atrial tachyarrhythmias

 Able to understand the nature of the study and give

informed consent

 Ability to tolerate the surgical procedure required for

implantation

32 Lumax Technical Manual

 Ability to complete all required testing including the six-

minute walk test and cardiopulmonary exercise testing

 Available for follow-up visits on a regular basis at the

investigational site

 Age greater than or equal to 18 years

Exclusion Criteria

To support the objectives of this investigation, the exclusion

criteria at the time of patient enrollment included the following:

 Previously implanted CRT device

 ACC/AHA/NASPE indication for bradycardia pacing

(sinus node dysfunction)

 Six-minute walk test distance greater than 450 meters

 Chronic atrial tachyarrhythmias refractory to

cardioversion shock therapy

 Receiving intermittent, unstable intravenous inotropic

drug therapy (patients on stable doses of positive

inotropic outpatient therapy for at least One-Month are

permitted)

 Enrolled in another cardiovascular or pharmacological

clinical investigation

 Expected to receive a heart transplant within 6 months

 Life expectancy less than 6 months

 Presence of another life-threatening, underlying illness

separate from their cardiac disorder

 Acute myocardial infarction, unstable angina or cardiac

revascularization within the last 30 days prior to

enrollment

 Conditions that prohibit placement of any of the lead

systems

1.6.2.3 Summary of Clinical Results

A total of 200 patients were enrolled in the OPTION CRT/ATx

clinical study at 25 sites:

There were 133 study patients and 67 active control patients in

this prospective, multi-center, randomized clinical study. For the

study group, there were 129 successful implants (91.4%) of the

Tupos LV/ATx CRT-D system. For the active control group, there

were 64 successful implants (92.2%) of the legally marketed

CRT-D systems.

Lumax Technical Manual 33

Patient Accountability

After randomization and enrollment, 7 patients (4 in the study

group and 3 in the control group) did not receive an implant. The

reasons for patients not receiving an implant are outlined in

Figure 4.

Enrolled and Randomized

Patients

Study 133

Control 67

No implant Attempted

Withdrawal of Consent

Study 2

Control 1

Not Meeting Inclusion Criteria

Study 1

Control 1

Implant Attempted

Study 130

Control 65

Unsuccessful implant

Withdrawal of IC before 2nd Attempt

Study 1

Control 0

Expired before Second Attempt

Study 0

Control 1

Successful implant

Study 129

Control 64

6-Month Follow-up Data

Patient Death before 6-Month

Study 7

Control 3

Withdrawal before 6-Month

Study 1

Control 2

Not Reached 6-Month FU

or Data Pending

Study 21

Control 10

Patients completed 6-Month

Follow-up

Study 100

Control 49

Figure 4: Patient Accountability

Overall Results

 There were 192 endocardial and 19 epicardial leads

implanted in 193 patients. Investigators were allowed to

choose among any legally marketed LV lead according to

familiarity with the lead and patient anatomy. The

Tupos LV/ATx CRT-D was implanted with 7 endocardial

and 4 epicardial lead models from 6 different

manufacturers. There were no adverse events reported

attributable to lead-generator incompatibility.

34 Lumax Technical Manual

 The cumulative implant duration was 1240.4 months with

a mean duration of 9.6 months for the study group. The

cumulative implant duration is 596.5 months with a mean

duration of 9.3 months for the control group.

 For the study group, there have been 278 adverse events

(210 observations in 104 patients and 68 complications in

50 patients). There has been one unanticipated adverse

device effect reported.

 For the control group, there have been 105 adverse

events (81 observations in 44 patients and 24

complications in 19 patients). There have been no

unanticipated adverse device effects reported.

 There have been 10 patient deaths reported in the study

group and 4 patient deaths reported in the control group.

The clinical investigators have determined that no deaths

were related to the study device.

1.6.2.4 Primary Endpoint 1: Six Minute Walk Test & QOL

(Effectiveness)

The purpose of Primary Endpoint 1 is to evaluate the

effectiveness of the Tupos LV/ATx system in providing CRT as

measured by the average composite rate of improvement in six

minute walk test and QOL.

Table 8 presents the average composite rate of improvement in

six minute walk test distance and QOL score, the average 6-

minute walk test distance and the average QOL score at Baseline

and at the Six-Month follow-up, as well as the average difference

in 6-minute walk test distance and QOL score between Baseline

and the Six-Month follow-up for the Study and Control Groups for

those patients with six minute walk test data and complete QOL

data at both Baseline and the Six-Month follow-up.

Lumax Technical Manual 35

Table 8: Composite of Six Minute Walk Test and QOL

(Effectiveness)

Category

Study

Group

(N = 74)

Mean  SE

Control

Group

(N = 38)

Mean  SE

P-value*

Distance Walked at

Baseline

310.51 ±

10.89

288.76 ±

15.37 0.249

Distance Walked at

Six-Months

340.77 ±

12.32

301.84 ±

17.02 0.067

∆ Distance Walked

30.26 ±

10.40

17.27% ±

5.59%

13.08 ±

13.05

8.71% ±

5.26%

0.322

0.326

QOL Score at

Baseline 44.39 ± 2.78 45.53 ± 4.13 0.817

QOL Score at Six-

Months 28.68 ± 2.66 33.95 ± 4.35 0.279

∆ in QOL Score**

15.72± 2.83

19.08% ±

12.21%

11.58 ± 3.45

-13.42% ±

34.54%

0.376

0.281

Composite Rate*** 18.18% ±

7.07%

-2.36% ±

17.73% 0.030

*The calculated p-values are associated with a Student's t-test (2-sided)

of the equality of means in the two groups, except for the p-value of the

composite rate, which is associated with a test of equivalence (non-

inferiority).

**∆ in QOL Score is calculated as the average of the individual

differences between Baseline and Six-Months for each patient. Negative

values for mean ∆ QOL in percent are possible when positive mean

values for absolute changes in QOL are recorded. In some cases, small,

negative changes in absolute QOL scores resulted in relatively large

percentage changes.

***The Composite Rate (=(∆ Distance Walked (%) + ∆ QOL Score (%))/2)

is calculated for each patient and then averaged to obtain the Composite

Rates. For all calculations, a positive number represents improvement

from Baseline to Six-Months.

36 Lumax Technical Manual

1.6.2.5 Effectiveness Endpoint Analysis and Conclusions

A composite rate of six minute walk test and QOL improvement

from Baseline to the Six-Month follow-up is evaluated as a

measure of CRT effectiveness. For this analysis both six minute

walk test and QOL are equally weighted at 50%.

The mean difference in the composite rate between study and

control group was 20.53% with an associated one-sided, 95%

confidence bound is (-6.10%). The p-value for non-inferiority

within 10% is 0.030. The analysis of the composite rate in six

minute walk test distance and QOL score demonstrates that the

study group is non-inferior to the control group and that the

primary effectiveness endpoint was met (p=0.030).

1.6.2.6 Primary Endpoint 2: Complication-Free Rate

(Safety)

The purpose of Primary Endpoint 2 was to evaluate complications

(adverse events that require additional invasive intervention to

resolve) related to the implanted CRT system which includes the

Tupos LV/ATx, the right atrial lead, the right ventricular ICD lead,

the left ventricular lead, and the implant procedure. The target

complication-free rate at Six-Months is 85%.

Table 9 provides the categorized complication rates at 6-months

for the study and the control group as well as a comparison

between the study and the control group.

Lumax Technical Manual 37

Table 9: Complications at 6-Month – Study and Control

Study versus Control

Comparison

Category Study

N = 133

Control

N = 67 Delta 95% CI P-value

Procedure

6 (4.51%) 1

(1.49%)

3.02

[-3.64%,

8.45%] 0.428

Atrial Lead

3 (2.26%) 1

(1.49%)

0.76

[-5.74%,

5.37%] 1.000

ICD Lead

3 (2.26%) 0 (0%) 2.26

[-3.03%,

6.53%] 0.552

LV Lead

(19.55%)

(13.43%)

6.12

[-5.50%,

16.45%] 0.329

Device

7 (5.26%) 5

(7.46%)

2.20

[-11.42%,

4.77%] 0.541

Other

Medical

9 (6.77%) 2

(2.99%)

3.78

% [-3.82%,

10.13%] 0.341

Total

Procedure,

Lead and

Device

(29.32%)

(22.39%)

6.94

[-6.46%,

19.17%] 0.317

Total 46

(34.59%)

(25.37%)

9.21

[-4.96%,

21.99%] 0.201

1.6.2.7 Primary Safety Enpoint Analysis and Conclusions

The observed procedure, lead and device related complication-

free rate at 6 months was 70.68%. The 95% confidence interval

for the complication-free rate was [62.16%, 78.25%]. The lower,

one-sided 95% confidence bound for the complication-free rate

was 63.50%. Therefore the procedure, lead and device related

complication-free rate at 6 months did not meet the pre-specified

acceptance criterion for this endpoint.

38 Lumax Technical Manual

1.6.2.8 Post-hoc Safety Analysis

BIOTRONIK did not meet the pre-specified objective performance

criteria of 85% within 10% for the safety endpoint. Therefore, a

post-hoc safety analysis was conducted. It was noted that

79.80% (39 out of 49 events) of the complications were right atrial

lead, right ventricular ICD lead, left ventricular lead and procedure

related. The atrial, ICD and LV leads used during this study are

legally marketed devices.

This post-hoc analysis evaluated the LV lead complications that

were “related” or “possibly related” to the Tupos LV/ATx CRT-D,

but excludes the complications that were “not related” to the

Tupos LV/ATx device (see Table 9). There were 11 patients who

had an attempt to implant the LV lead, but the physician was

unsuccessful in either obtaining coronary sinus (CS) access or

unable to find a stable position for the LV lead. Additionally, there

were 4 patients with a documented LV lead dislodgement that

has no direct relationship to the implanted Tupos LV/ATx.

Table 10: Complications at 6-Months (Excluding LV Lead

Related) - Study versus Control

Category Study

N=133

Control

N=67

Difference

Study vs.

Control

Procedure Related 6 (4.51%) 2 (2.99%) 1.53%

Atrial Lead Related 3 (2.26%) 1 (1.49%) 0.76%

ICD Lead Related 3 (2.26%) 0 (0%) 2.26%

LV Lead Related 11 (8.27%) 1 (1.49%) 6.78%

Device Related 7 (5.26%) 5 (7.46%) -2.20%

Other Medical Related 9 (6.77%) 2 (2.99%) 3.78%

Total Procedure,

Lead and Device

(20.30%)

(11.94%) 8.36%

Total 35

(26.32%)

(14.93%)

11.39%

Lumax Technical Manual 39

The pulse generator related complication rate is higher in the

control group as compared to the study group. The complication

rates for procedure related, atrial lead related, ICD lead related,

LV lead related and other medical related are higher in the study

group as compared to the control group.

1.6.2.9 Post hoc Safety Analysis Conclusion

There are no clinically substantial differences in the total

complication rate or in the rates for the different complication rate

categories between the study and the control group.

Table 11 compares this post-hoc Safety Endpoint analysis to

previous CRT-D clinical studies:

Table 11 Safety Endpoint Comparisons

CRT-D Study

Estimated

freedom from

Complications

@ 6mos.

Lower 95%

95%

lower

bound

criteria

BIOTRONIK OPTION

(Original Analysis) 70.68% 63.5% 75%

BIOTRONIK OPTION

(Post-hoc Analysis) 78.95% 72.29% 75%

Medtronic Insync ICD 81.1% 77.6% 67%

Guidant Contak CD N/A N/A 70%

St. Jude Medical Epic

HF 93.4% 90.6% 70%

This analysis confirms that the safety profile of the Tupos LV/ATx

is within a similar range determined during trials of other legally

marketed CRT-D devices.

40 Lumax Technical Manual

1.6.2.10 Secondary Endpoint Results

1. The purpose of Secondary Endpoint 1 is to evaluate the

overall ability of the Tupos LV/ATx to appropriately convert

spontaneous AT (atrial tachycardia) and AF (atrial fibrillation).

The results from the OPTION study were compared to the

results from BIOTRONIK’s TACT study (P000009/S4, dated

09-09-2002) that demonstrated the effectiveness of these

atrial therapy features in the Tachos DR - Atrial Tx ICD.

Table 12 summarizes success rates for each individual atrial

tachyarrhythmia therapy type and overall success rate from

the OPTION study compared to the TACT study. The number

of episodes and patients receiving any therapy is less than

the total episodes of each therapy type, as episodes may

have included more than one type of therapy.

Table 12 Overall Atrial Conversion Rate

OPTION Study

Patients Success Episodes Conversion

rate

ATP 3 3 5 60.0%

HF Burst 17 45 111 40.5%

Shock 12 30 34 88.2%

All

Therapies 25 78 129 60.5%

TACT Study

ATP 29 62 142 43.6 %

HF Burst 49 156 408 38.2 %

Shock 42 84 108 77.8 %

All

Therapies 66 302 542 55.7 %

The overall conversion rate and the conversion rates for each

therapy are comparable to the conversion rates observed in

the TACT study, demonstrating that the Tupos LV/ATx device

has similar atrial conversion capabilities as the legally

marketed Tachos DR – Atrial Tx ICD.

Lumax Technical Manual 41

2. The purpose of Secondary Endpoint 2 is to evaluate VT

(ventricular tachycardia) and VF (ventricular fibrillation)

detection times of the Tupos LV/ATx. This is a measure of the

ability of the ventricular detection algorithm to detect VT and

VF in an appropriate timeframe. This endpoint was evaluated

based on the review of electrograms following induced VT/VF

episodes. A comparison of data from the TACT study that

utilized the legally marketed Tachos DR – Atrial Tx ICD

(P000009/S4, dated 09-09-2002) to data collected during the

OPTION study for the Tupos LV/ATx was performed.

Table 13 summarizes and compares the results from these

two clinical studies.

Table 13: Summary of Detection Times

Detection

Time

Tachos DR -

Atrial Tx ICD

Mean (SE)/N

Tupos

LV/ATx Mean

(SE)/N

Difference

Individual

Readings 2.27 (0.06)/52 2.26 (0.06)/71 0.01

By Patient 2.27 (0.07)/26 2.24 (0.06)/35 0.03

The analysis demonstrates that the average detection times

of the Tupos LV/ATx are comparable to the detection times

observed with the legally marketed Tachos DR - Atrial Tx

ICD. Both devices utilize identical ventricular detection

algorithms and only sense with the right ventricular lead. This

clinical data demonstrates that the ventricular detection times

are similar in both devices.

3. The purpose of Secondary Endpoint 3 is to evaluate the

percentage of ventricular pacing (thus, CRT) as

demonstrated by the device diagnostics at required follow-

ups. This data was based on diagnostic data stored by the

Tupos LV/ATx.

Table 14 summarizes the percentage of ventricular pacing

between follow-ups as shown by device diagnostics for

patients in the study group.

42 Lumax Technical Manual

Table 14: Percentage of Ventricular Pacing –

3-Month and 6-Month Follow-ups

Percentage of

Ventricular

Pacing

3-Months

Patients

(percentage)

6-Months Patients

(percentage)

<80% 9 (7.4%) 4 (4.0%)

81 – 85 % 4 (3.3%) 2 (2.0%)

86 – 90 % 13 (10.7%) 9 (9.1%)

91 – 95 % 19 (15.7%) 20 (20.2%)

96 – 100 % 76 (62.8%) 64 (64.7%)

Totals 121 (100%) 99 (100%)

The majority of the follow-ups (84.9%) show a percentage of

ventricular pacing of 91% or more at Six-Months.

4. The purpose of secondary endpoint 4 is to evaluate

improvement in functional capacity as measured by the six

minute walk test. The six minute walk test is a well-accepted

measure of functional capacity and exercise tolerance. Also,

this test more closely mimics the patient’s day-to-day

activities than maximal exercise testing.

Table 15 summarizes the six minute walk test distance at

Baseline and the Six-Month follow-up for patients in the study

group and the control group.

Lumax Technical Manual 43

Table 15: Six Minute Walk Distance

Distance

(meters) Study Control

Baseline

Mean  SE

Range

Median

127

283.14  9.27

23 to 511

302.00

269.43  13.77

29 to 507

244.00

Six-Month

Mean  SE

Range

Median

329.73  10.82

78 to 596

335.00

310.70  15.49

91 to 489

313.00

* Student's t-test, 2-sided

There are no clinically relevant differences in the six minute

walk test results between the study and the control group.

5. The purpose of Secondary Endpoint 5 is to evaluate the

improvement in the patient’s NYHA classification. Table 16

summarizes the average improvement in NYHA from

Baseline to Six-Months for 140 patients that were able to

complete both NYHA classification evaluations.

Table 16: Improvement in NYHA Classification at Six-

Months from Baseline

NYHA Change During OPTION Study

Change in NYHA

Class

Study Patients

(N=97)

(percentage)

Control Patients

(N=43)

(percentage)

Improved 2 classes 10 (10.3%) 2 (4.7%)

Improved 1 class 47 (48.5%) 20 (46.5%)

Total improved 57 (58.8%) 23 (51.2%)

No change 39 (40.2%) 20 (46.5%)

Worsened 1 class 1 (1.0%) 1 (2.3%)

44 Lumax Technical Manual

The study and the control group have similar NYHA classes

and similar rates of improvement in NYHA class from

Baseline to the Six-Month follow-up.

6. The purpose of Secondary Endpoint 6 is to evaluate the rate

of hospitalization, for CHF and for all other causes. The

occurrence rate and reasons for hospitalization of the study

group were compared to the control group. To be consistent

with other large-scale clinical trials, clinical sites were

instructed to report hospitalizations for CHF using the

following definitions: 1) hospitalization for heart failure

management, 2) outpatient visit in which IV inotropes or

vasoactive infusion are administered continuously for at least

4 hours, or 3) emergency room (ER) visit of at least 12 hours

duration in which intravenous heart failure medications

including diuretics are administered.

Table 17 summarizes hospitalization, ER visits and outpatient

visits for enrolled patients.

Lumax Technical Manual 45

Table 17: Hospitalization, ER Visits and Outpatient Visits

Medical Visits Study

(N=128)

Control

(N=65)

Hospital

Admissions

Patients

Hospitalizations

Patients

Hospitalizations

CHF Related:

20 (15.6%)

All causes:

68 (53.1%)

CHF Related:

5 (7.7%)

All causes:

29 (44.6%)

Emergency

Room Visits

Patients

Visits

Patients

Visits

CHF Related:

1 (0.8%)

All causes:

13 (10.1%)

CHF Related:

0 (0.0%)

All causes:

2 (3.1%)

Outpatient Visits

Patients

Visits

Patients

Visits

CHF Related:

1 (0.8%)

All causes:

5 (3.9%)

CHF Related:

0 (0.0%)

All causes:

2 (3.1%)

A large percentage of All Cause hospitalizations can be

attributed to pacing lead revisions, device infections, or other

device-related interventions (e.g., pocket revision or device

replacements for ERI or device recall). The CHF

hospitalization rate for both the study and control groups is

clinically acceptable considering the enrollment CHF status of

the patients.

46 Lumax Technical Manual

7. The purpose of Secondary Endpoint 7 is to evaluate the

observation rate. Observations are defined as clinical events

that do not require additional invasive intervention to resolve.

For the study group, there were 210 observations in 104

patients with cumulative implant duration of 1240.4 months

(101.9 patient years). 78.2% of the enrolled study patients

have a reported observation. The rate of observations per

patient-year is 2.06. For the control group, there were 81

observations in 44 patients with cumulative implant duration

of 596.5 months (49.0 patient years). 65.7% of the enrolled

control patients had a reported observation. The rate of

observations per patient-year was 1.65.

8. The purpose of Secondary Endpoint 8 is to evaluate peak

VO2 as a measure of effectiveness of the Tupos LV/ATx

system in providing CRT. The core lab was blinded to study

randomization assignments during evaluation of the results of

the cardiopulmonary exercise (CPX) testing in order to

minimize the potential for bias. According to the protocol, to

be included in the analysis, patients were required to attain a

respiratory exchange ratio (RER) of  1.

Table 18 provides a summary of peak VO2 results for 42

patients with CPX testing completed at Baseline and the Six-

Month follow-up and with an RER of  1.

Lumax Technical Manual 47

Table 18: Peak VO2 Testing Results – Patients with RER

 1

Results Study Control

Peak VO2

(ml/kg/min)

N=32

Baseline:

Mean:

13.46 ± 0.57

Range:

6.9 to 21.1

Six-Month:

Mean:

13.39 ± 0.53

Range:

7.6 to 20.70

Difference:

Mean:

-0.06 ± 0.42

Range:

-7.9 to 4.9

N=10

Baseline:

Mean:

12.58 ± 0.75

Range:

8.0 to 14.8

Six-Month:

Mean:

12.89 ± 0.94

Range:

7.0 to 17.2

Difference:

Mean:

0.31 ± 0.67

Range:

-2.7 to 4.6

1.6.2.11 Multi-site Poolability and Gender Analysis

The OPTION CRT/ATx clinical report includes data from multiple

centers with centralized coordination, data processing, and

reporting at BIOTRONIK. All of the clinical centers followed the

requirements of an identical clinical protocol, and all of the clinical

centers used the same methods to collect and report the clinical

data. In order to justify pooling of the data from multiple centers,

several analyses were completed. All of the centers were divided

into two groups based on implant volume. Comparisons were

then made between the patient populations based on the results

of each of the endpoints. Additionally, analyses were performed

on the data collected in the OPTION CRT/ATx clinical

investigation in order to compare results between males and

females. The first type of analysis compared enrollment by patient

gender in each of the study and control groups. The second type

of analysis compared effectiveness outcomes in each gender.

The results of these analyses demonstrate poolability of the data

between sites. There were no significant differences in the

second primary endpoint or any of the secondary endpoints

between high and low volume implant centers.

48 Lumax Technical Manual

The gender distribution in this clinical investigation is consistent

within the study groups and includes a representative proportion

of female participants. There were no significant differences in

any of the primary or secondary endpoints between the male and

female population.

1.6.2.12 Conclusions

The IDE Clinical study (OPTION LV/ATx) demonstrated that the

safety and effectiveness of the Tupos LV/ATx CRT-D device is

equivalent to that of similar legally marketed CRT-D devices.

Although the study missed its primary safety endpoint, additional

post hoc analyses were conducted to reassure that the safety

profile of the device is comparable to other legally marketed

CRT-D devices.

1.6.3 Lumax HF-T V-V Clinical Study

1.6.3.1 Study Overview

The Lumax HF-T V-V clinical study is a randomized, double-

blinded, crossover, multi-center, prospective trial. The purpose of

the study is to assess the safety and efficacy of adding

programmable V-V delay biventricular pacing when used as part

of echo optimization of V-V timing (OPT). The assessment

consisted of comparing one-month periods of CRT with (OPT)

and without (SIM) V-V programmability and optimization in the

same patients to assess whether a statistically significant

increase of worsened HF status occurred during V-V adjustment.

The V-V delay feature is programmed to provide CRT through the

selection of the first chamber paced and adjustment of the V-V

delay. When V-V delay programmability is not available, CRT

provides simultaneous biventricular pacing (V-V delay is 0 ms).

Lumax Technical Manual 49

1.6.3.2 Methods

The study primarily evaluates and compares the functional

benefits of the Lumax HF-T with OPT versus the Lumax HF-T

with SIM using an endpoint that includes both a 6-minute walk

(6MW) test and quality of life (QOL) measurement assessed

using the Minnesota Living with Heart Failure questionnaire

(MLWHFQ). As such, relevant measurements are completed 3

times for each patient: once at the baseline evaluation (up to 14

days after enrollment), once at the 1-month follow-up (30 days

after baseline) and once at the 2-month follow-up (30 days after

the 1-month follow-up). Baseline data is collected with the

Lumax HF-T programmed to SIM.

6MW testing was chosen as a meaningful measure of CRT

therapy effect on HF status because 6MW has been shown to

improve during chronic CRT therapy (Olsson LG, Swedberg K,

Clark AL et al. Six minute corridor walk test as an outcome

measure for the assessment of treatment in randomized, blinded

intervention trials of chronic heart failure: a systematic review. Eur

Heart J 2005; 26:778–793.) Example improvements of 6MW

include increase in the range of 20 meters.

In this trial, the intent was to detect any loss of CRT benefit by

assessing the incidence of HF “worsening”, defined as reduction

of 35 meters distance on 6MW during CRT with V-V

programmability and optimization compared to during CRT

without V-V programmability and optimization.

QOL testing was chosen as a meaningful measure of CRT

therapy effect on HF status because QOL has been shown to

improve during chronic CRT therapy (Albouaini K, Egred M, Rao

A, et al. Cardiac resynchronisation therapy: evidence based

benefits and patient selection. Eur J Intern Med. 2008

May;19(3):165-72) Example magnitude improvements of QOL

include change in the range of 10 points.

In this trial, the intent was to detect any loss of CRT benefit by

assessing the incidence of HF “worsening”, defined as increase

of 10 points in QOL score by MLWHFQ during CRT with V-V

programmability and optimization compared to during CRT

without V-V programmability and optimization.

Worsening in the trial was defined as either a worsening (as

defined) in 6MW or in QOL score during CRT with V-V

programmability and optimization.

50 Lumax Technical Manual

The primary endpoint hypothesis required that a high proportion

of subjects remain “not worsened” when CRT with V-V

programmability and optimization was delivered compared to

when CRT without V-V programmability and optimization. A high

proportion was defined according to an Objective Performance

Criteria (OPC), derived from observations of how often stable

subjects in the BIOTRONIK Tupos LV/ATX CRT-D trial (OPTION)

experienced spontaneous worsening due to the underlying

disease among other factors.

During the Lumax V-V clinical study, the V-V optimization was

completed utilizing echocardiography specifically determining an

optimal V-V delay using the velocity time integral (VTI) to non-

invasively measure stroke volume. The assessment was

performed by determining the V-V delay setting associated with

the largest VTI value. The VTI of the aortic flow is measured in

the apical 5 chamber view.

Prior to the V-V delay optimization procedure, each patient

underwent an optimization of AV timing. Following the AV timing

adjustment, this standardized procedure was followed for the

optimization of V-V delay:

1. Program the Lumax HF-T “Initially Paced Chamber”

parameter to either RV or LV based on preference.

2. Assess the VTI measurement at the following V-V delays

(additional V-V settings may be utilized at the investigator’s

discretion):

 100 ms

 80 ms

 60 ms

 40 ms

 20 ms

 0 ms

Note: Use the average VTI parameter over a 3 beat cycle and

wait 10 to 15 seconds between changing V-V delay settings.

Also, attempt to measure the VTI parameter within the same

patient respiratory cycle.

3. Record the VTI measurement associated with each V-V

delay setting

Repeat steps 1-3 for the remaining “Initially Paced Chamber”

parameters

Lumax Technical Manual 51

Select permanent “Initially Paced Chamber” and “V-V delay after

Vp” to reflect the maximum VTI measurement for final

programming.

Inclusion Criteria

To support the objectives of this investigation, the inclusion

criteria at the time of patient enrollment for this investigational

study included the following requirements:

 Meet the indications for therapy.

 Successfully implanted with a BIOTRONIK Lumax HF-T

CRT-D system and have received SIM for a minimum of

30 days prior to enrollment.

 Treated with stable and optimal CHF medications.

 Age ≥ 18 years.

 Able to understand the nature of the study and give

informed consent.

 Able to complete all testing required by the clinical

protocol, including the 6-minute walk test and QOL

questionnaire.

 Available for follow-up visits on a regular basis at the

investigational site.

Exclusion Criteria

To support the objectives of this investigation, the exclusion

criteria at the time of patient enrollment included the following

requirements:

 Meet one or more of the contraindications.

 Have a life expectancy of less than 6 months.

 Expected to receive heart transplantation within 6

months.

 Have had more than 1 CHF-related hospitalization within

past 30 days.

 Currently receiving IV inotropic medications.

 Chronic atrial fibrillation.

 Enrolled in another cardiovascular or pharmacological

clinical investigation, except for FDA required post-market

registries.

 Any condition preventing the patient from being able to

perform required testing.

52 Lumax Technical Manual

 Presence of another life-threatening, underlying illness

separate from their cardiac disorder.

1.6.3.3 Summary of Clinical Results

The study involved 122 patients (96 males, 78.7%, and 26

females, 21.3%), with a mean age of 67.1 years (range: 35-87).

The cumulative enrollment duration is 621.3 months with mean

enrollment duration of 5.1 months. The patient follow-up

compliance rate for all enrolled patients is 98.5% (394 of 400

required follow-ups).

1.6.3.3.1 Primary Endpoint 1: Effectiveness of the V-V Delay

Feature

The primary endpoint was intended to detect whether V-V

programmability and optimization contributed to significantly more

patients with “worsened” HF. Worsened was defined as:

 For 6MW, reduction of 35 meters distance on 6MW

during CRT with V-V programmability and optimization

compared to during CRT without V-V programmability

and optimization

 For QOL score, increase of 10 points in QOL score by

MLWHFQ during CRT with V-V programmability and

optimization compared to during CRT without V-V

programmability and optimization

 For each patient, i.e. as a responder’s analysis, the

occurrence of either worsened 6MW or QOL score during

CRT with V-V programmability and optimization.

Table 19 presents the mean 6-minute walk test distances and

QOL scores for Group 1 and Group 2 patients at the baseline, 1-

month and 2-month follow-ups. Table 19 reports unpaired patient

data for information purposes, with the primary endpoint analysis

utilizing paired data from the 1-month and 2-month follow-ups.

Lumax Technical Manual 53

The analysis of the primary effectiveness endpoint is an intention-

to-treat analysis based on the responder classification of changes

in the MLWHFQ and 6-minute walk distance between periods of

SIM and OPT, obtained at the 1-month and 2-month follow-ups.

Table 20 presents the percentage of all patients worsened and

not worsened to evaluate the effectiveness of OPT vs. SIM

utilizing the QOL and 6-minute walk responder classification. A

total of 106 out of the 110 patients that completed the primary

endpoint follow-up met the primary endpoint analysis based on

paired QOL and 6-minute walk data at the 1-month and 2-month

follow-up visits.

Table 19. QOL and 6-Minute Walk Test Results (Effectiveness)

Category Group 1 Group 2

QOL score at baseline N = 60

35.4 ± 23.0

N = 53

30.0 ± 21.6

QOL score at 1-month

follow-up

N = 57

31.2 ± 24.0

OPT

N = 54

30.1 ± 22.5

SIM

QOL score at 2-month

follow-up

N = 58

32.6 ± 25.5

SIM

N = 52

25.9 ± 19.8

OPT

Distance walked at

baseline (m)

N = 61

328.9 ± 152.8

N = 54

309.1 ± 139.7

Distance walked at 1-

month follow-up (m)

N = 58

343.9 ± 161.8

OPT

N = 54

337.6 ± 160.7

SIM

Distance walked at 2-

month follow-up (m)

N = 57

341.1 ± 152.6

SIM

N = 51

334.7 ± 148.9

OPT

54 Lumax Technical Manual

Table 20. QOL and 6-Minute Walk Responder Classification

(Effectiveness)

QOL Group 1

(N = 56)

Group 2

(N = 52)

Total

(N = 108)

Worsened 9 (16.1%) 6 (11.5%) 15 (13.9%)

Not worsened 47 (83.9%) 46 (88.5%) 93 (86.1%)

6-Minute Walk (N = 56) (N = 51) (N = 107)

Worsened 14 (25.0%) 15 (29.4%) 29 (27.1%)

Not worsened 42 (75.0%) 36 (70.6%) 78 (72.9%)

Composite (N = 55) (N = 51) (N = 106)

Worsened 21 (38.2%) 18 (35.3%) 39 (36.8%)

Not worsened 34 (61.8%) 33 (64.7%) 67 (63.2%)

The estimate of the proportion of subjects who were classified as

“Not Worsened” was 63.2% (67/106). The lower, exact, one-sided

95% confidence bound for this observed proportion is 54.8%. The

difference between the performance goal of 63% and 54.8% is

8.2%. This is lower than the pre-specified clinically significant

difference () of 12%.

1.6.3.3.2 Primary Endpoint 2: Safety of the V-V Delay

Feature

The purpose of Primary Endpoint 2 is to evaluate adverse events

that require additional invasive intervention to resolve, specifically

related to the V-V delay feature of the Lumax HF-T. These

adverse events include any software issues related to V-V delay

programming or any adverse event that occurs after V-V delay

optimization and that can be directly attributed to the use of the

V-V delay feature.

There have been 0 reported complications related to the V-V

delay feature for the 122 patients enrolled into the study.

Lumax Technical Manual 55

The observed complication-free rate was 100.0%. The lower,

exact, one-sided 95% confidence bound for this observed rate is

97.6%. This exceeds the pre-specified rate (90% - δ) required for

demonstrating non-inferiority.

1.6.3.4 Conclusions

The cumulative enrollment duration is 621.3 months with a mean

duration of 5.1 months. Sixty-one (50.0%) of the patients have

been enrolled for 91-180 days.

The proportion of subjects who are “Not Worsened” while their

device was programmed to OPT was found to be not inferior to

the performance goal of 63% within 12%. In addition, there have

been 0 complications reported regarding the Lumax HF-T V-V

delay feature.

The data received and analyzed demonstrates the general safety

of the Lumax HF-T V-V timing feature, with 0 complications

reported as caused by the feature. Also, the data received and

analyzed demonstrates the effectiveness of the Lumax HF-T V-V

timing feature, by providing evidence of non-inferiority to

simultaneous biventricular pacing in a responder classification.

1.6.4 TRUST Clinical Study

1.6.4.1 Study Overview

The TRUST study is a multi-center, prospective and randomized

trial. The purpose of the study was to demonstrate that the use of

the BIOTRONIK Home Monitoring system (HM) can safely reduce

the number of regularly scheduled office follow up visits,

compared to the conventional method of ICD follow-up. The

assessment consists of comparing the number of in-office follow-

ups for patients with HM (HM group) versus patients without HM

(Control group). With the use of HM, the number of in-office follow

up visits per year could be reduced from an expected five

scheduled office follow up visits (3, 6, 9, 12 and 15 months) to two

visits (3 and 15 months). Additionally, the time from onset to

evaluation of arrhythmias in both groups was compared. It was

expected that evaluation of cardiac events in the HM arm would

occur earlier than those in the Control group.

56 Lumax Technical Manual

1.6.4.2 Methods

All enrolled patients received a BIOTRONIK ICD with Home

Monitoring/IEGM-Online technology and were randomized to

either Group 1 (Home Monitoring (HM)) or Group 2 (No Home

Monitoring (Control)) using a randomization ratio of 2:1.

Group 1 (HM)

Device evaluations for scheduled follow-ups, patient-initiated

inquiries and event triggered notifications were performed with

HM/IEGM Online. Patients were scheduled for office device

interrogations only at the 3 month and 15 month follow-up points

(following the HM online check). At 6, 9 and 12 months, a HM

check was performed first. Investigators may then elect to

perform an office device interrogation if they determine that it is

necessary after reviewing the HM data.

Group 2 (Control)

Patients were evaluated using conventional, calendar-based

office visits at 3, 6, 9, 12 and 15 months post-implant. Interim

visits were made according to physician discretion (e.g. following

any ICD discharges or symptoms). Home Monitoring was

programmed OFF for the duration of the study.

HM Event Triggered Device Evaluations

Investigators with patients in Group 1 (HM) may receive HM

notifications in response to pre-programmed events such as VT1

detected and SVT detected. Upon the receipt of a HM Event

Notification, investigators reviewed the notification and the

associated information on the HM/IEGM-Online website and

recorded the type of event and what type of action, if any, was

taken as a result of this notification.

Patient-Initiated Device Evaluations

Investigators may be contacted by the patient for

device/arrhythmia-related care (e.g. perceived device discharge,

symptoms). For patients in Group 1 (HM), investigators triaged

the complaint using the Home Monitoring website. Investigators

recorded if the information from Home Monitoring was sufficient.

For patients in Group 2 (Control), the complaint was assessed

per standard of care or normal clinic procedures.

Lumax Technical Manual 57

Primary Endpoints

The purpose of primary endpoint 1 (HM efficacy) was to compare

the number of in-office ICD follow-ups for patients in Group 1

(HM) to the conventional, calendar-based method of ICD follow-

up as in Group 2 (Control).

The purpose of the primary endpoint 2 (safety) was to compare

the Safety Event Rate (SER), which includes death, incidence of

strokes and events requiring surgical interventions (e.g. device

explants or lead revision) between the two groups.

Secondary Endpoints

The purpose of secondary endpoint 1 was to compare AF, VT

and VF events between Group 1 and Group 2 in terms of the

number, categories, and detection time relative to onset.

Inclusion Criteria

To support the objectives of this investigation, the inclusion

criteria at the time of patient enrollment for this investigational

study included the following requirements:

 Implanted within the last 45 days or being considered for

implant with a BIOTRONIK ICD with Home

Monitoring/IEGM-Online technology

 Able to utilize the HM system throughout the study

 Ability to give informed consent

 Geographically stable and able to return for regular

follow-ups for fifteen (15) months

 At least 18 years old

Exclusion Criteria

To support the objectives of this investigation, the exclusion

criteria at the time of patient enrollment included the following

requirements:

 Patients who do not fulfill all inclusion criteria

 Patients who are pacemaker dependent

 Currently enrolled in any other cardiac clinical

investigation.

58 Lumax Technical Manual

Clinical Events Committee

The Clinical Events Committee (CEC) is an advisory review board

comprised of three physicians that are not participating in the

TRUST Study who reviewed and adjudicated all deaths, strokes,

surgical interventions, and cardiac adverse events that occur

during the study. The CEC also reviewed all divergent

classifications of actionable vs. non-actionable office follow up

visits between the physician and BIOTRONIK, and reviewed a

random sampling of 1% of office follow up visits in which there is

no disputed classification.

1.6.4.3 Summary of Clinical Results

The study involved 1443 patients (1038 males, 71.9%), with a

mean age of 63.5 years (range: 20-95). The cumulative

enrollment duration is 18,367 months with mean enrollment

duration of 12.7 months. The patient follow-up compliance rate for

all enrolled patients is 87.5% in Group 1 and 78.8% in Group 2.

1.6.4.3.1 Primary Endpoint 1: Home Monitoring

Effectiveness

The purpose of primary endpoint 1 (HM efficacy) was to compare

the number of in-office ICD follow-ups for patients in Group 1

(HM) to the conventional, calendar-based method of ICD

follow-up as in Group 2 (Control).

Detailed primary endpoint 1 results are presented in Table 21.

Table 21: Primary Endpoint Group 1 vs. Group 2

Office Follow-up Visits

No. of

Pts** Scheduled Unscheduled Total

Group 1

(HM) 898

n = 991

1.3 ± 1.0 per pt yr

13.1% actionable

n = 401

0.6 ± 1.7 per pt yr

29.7% actionable

1.9 ± 1.9

per pt yr

Group 2

(Control) 414

n = 1110

3.0 ± 1.1 per pt yr

10.7% actionable

n = 117

0.4 ± 1.4 per pt yr

29.1% actionable

3.4 ± 1.7

per pt yr

p value < 0.001 0.032

< 0.001

* Up to and including 12 month follow-up data

** Number of patients that have contributed at least 1 follow-up

Lumax Technical Manual 59

Analysis

The comparison of the number of 3, 6, 9, and 12 month and

unscheduled office follow-up visits in Group 1 versus Group 2

showed that there was an average number of 1.9 office follow-up

visits on a per year basis in Group 1 (HM) and an average

number of 3.4 office follow-up visits on a per year basis in Group

2 (Control). Therefore, the null hypothesis (HØ) can be rejected,

indicating that the average number of office visits per year is

statistical significantly less in the HM group than in the Control

group (p < 0.001). The primary effectiveness endpoint was met.

1.6.4.3.2 Primary Endpoint 2: Safety Event Rate

The purpose of the primary endpoint 2 was to compare the Safety

Event Rate (SER), which includes death, incidence of strokes and

events requiring surgical interventions (e.g. device explants or

lead revision) between the two groups.

Table 22 summarizes the Safety Event Rate for the study

patients for 12 months post-enrollment. Figure 5 shows these

data in a Kaplan-Meier analysis.

Table 22: Safety Event Rate Comparison

Safety Event Rate* Group 1 Group 2 p value**

Type of Event

Death

Stroke

Surgical

intervention

36/608 (5.9%)

2/574 (0.3%)

57/605 (9.4%)

18/245 (7.3%)

3/227(1.3%)

22/239 (9.2%)

0.440

0.141

1.000

Any Event 95/643 (14.8%) 42/256 (16.4%) 0.539

* Only includes events occurring within 12 months of enrollment

** 2-sided Fisher Exact test

60 Lumax Technical Manual

Figure 5: Safety Event Rate Kaplan Meier

Analysis

The safety event rate for a 12-month duration was 14.8% for

Group 1 (HM) and 16.4% for Group 2 (Control), with a non-

inferiority p-value of 0.005. Therefore, the safety event rate for

HM Group was non-inferior to the safety event rate for the Control

Group within 5%. The upper, one-sided 95% confidence bound

for the difference was 2.7%.

A rejection of the null hypothesis indicates that the safety event

rate for Group 1 (HM) is equivalent (non-inferior) to that of Group

2 (Control).

1.6.4.3.3 Secondary Endpoint 1: Early Detection of Cardiac

Events (AF, VT & VF)

The purpose of secondary endpoint 1 was to compare AF, VT

and VF events between Group 1 and Group 2 in terms of the

number, categories, and detection time relative to onset.

Lumax Technical Manual 61

Table 23 compares the time from onset to evaluation of the first

AF, VT and VF events for each patient that have occurred in each

group, as well as the first of any type of event for each patient in

each group. Figure 6 illustrates the time from onset to evaluation

of arrhythmic events in a box plot graph.

Table 23: Time from First Event Onset to Evaluation

Time from Event Onset

to Evaluation of First

Event/Patient

Group 1

N=972

Group 2

N=471 p value

Median

Mean ± SD (days)

Min

Max

# of patients with events

5.0

25.2 +/- 34.2

171

73 (7.5%)

39.5

46.8 +/- 33.7

114

28 (5.9%)

p < 0.001

p = 0.005

VT1 & VT2

Median

Mean ± SD (days)

Min

Max

# of patients with events

2.0

12.9 +/- 33.8

256

149 (15.3%)

32.0

46.6 +/- 46.9

245

53 (11.2%)

p < 0.001

Median

Mean ± SD (days)

Min

Max

# of patients with events

1.0

10.5 +/- 22.2

145

236 (24.3%)

35.5

45.0 +/- 47.0

287

92 (19.5%)

p < 0.001

SVT

Median

Mean ± SD (days)

Min

Max

# of patients with events

2.0

16.6 ± 27.4

108

94 (9.7%)

39.0

42.1 ± 35.6

157

35 (7.4%)

p < 0.001

62 Lumax Technical Manual

Figure 6: Median Time from Onset to Evaluation of

Arrhythmic Events

Analysis

The mean time from onset to evaluation of first AF, VT, and VF

events in Group 2 is greater than the mean time from onset to

evaluation of first AF, VT, or VF events in Group 1. A rejection of

the null hypothesis for AF, VT and VF event types indicates that

the mean time from onset to evaluation of the first AF, VT and VF

events in Group 1 is significantly less than the mean time from

onset to evaluation of the first AF, VT and VF events in Group 2.

P-values are =0.005, <0.001 and <0.001 respectively.

1.6.4.4 Conclusions

 Use of HM in Group 1 resulted in an average of 1.9 office

visits per patient year in the 12 months post-implant, versus

an average of 3.4 office visits per patient year in Group 2, a

44% reduction in office visits. The average number of office

visits is significantly less in the HM group than in the Control

group (p < 0.001).

Lumax Technical Manual 63

 The safety event rate for a 12 month duration for Group 1

(HM) was non-inferior to the safety event rate for Group 2

(Control) within 5% (p = 0.005). The upper, one-sided 95%

confidence bound for the difference was 2.7%.

 The mean time from onset to evaluation of AF, VT and VF

events indicates that those events for Group 1 patients are

evaluated in significantly less time when compared to Group

2 patients (AF p = 0.005, VT p < 0.001, VF p < 0.001).

1.6.5 Deikos A+

NOTE:

The clinical study information included in this section was

performed with the Deikos A+ ICD and the Kainox VDD ICD

lead. Due to the similarities in detection and therapy a clinical

study of the Lumax 540 VR-T DX with the Kainox A+ was not

performed.

The Deikos A+ was formed on the Tachos DR platform,

whereas the Lumax 540 VR-T DX was formed on the

Lumax DR-T platform. Both ICDs are designed to be used

with a VDD lead. In this study, the Kainox VDD lead (single

shock RV shock coil and dual atrial floating dipoles) was

implanted. In order to enhance the intrinsic signal from the

floating dipoles, both ICDs contain an atrial sensing amplifier.

The signal is amplified 4 times in the Deikos A+ and 5 times

in the Lumax 540 VR-T DX.

Both the Kainox VDD and the Kainox A+ ICD leads have

identical floating electrodes in the atrium and identical pacing

electrode tip, ring and shock electrodes designed for

placement in the right ventricle. The minor differences are in

the ventricular shock coil (Kainox A+ coil has a slightly larger

surface area, and the surface is not coated with fractal

iridium).

64 Lumax Technical Manual

1.6.5.1 U.S. Clinical Study

1.6.5.1.1 Patients Studied

The Single-Lead ICD system clinical study involved 9 patients (7

males and 2 female) with a mean age of 58.8 years (range: 25 to

83 years). 66.7% presented with ventricular

fibrillation/polymorphic ventricular tachycardia as their primary

tachycardia. The Single-Lead ICD system was selected for the

diagnostic value of the atrial EGMs in 88.9% of the patients.

1.6.5.1.2 Methods

The feasibility clinical investigation was designed to evaluate the

quality of atrial signals obtained using the Single-Lead ICD. The

study was also designed to evaluate the safety and effectiveness

of the Single-Lead ICD system to detect and treat monomorphic

ventricular tachycardia (MVT), polymorphic ventricular

tachycardia (PVT), ventricular fibrillation (VF), and bradycardia.

The specific predefined objectives of the investigation included

UADE-free survival rate, appropriate bradycardia sensing and

pacing, detection and treatment of ventricular tachyarrhythmias

and appropriate atrial sensing during activities of daily living.

1.6.5.1.3 Results

The mean implant duration was 6.1 ± 9.4 months with a

cumulative implant duration of 54.5 months. There were 5

patients followed for over six months and 2 patients followed for

over three months. The patient follow-up compliance rate was

100%, 43 out of 43 required follow-ups.

Table 24 provides a summary of the results of the study group.

Table 24: Clinical Study Results

Description Results

UADE-free Survival Rate 100% (9/9)

Lumax Technical Manual 65

Description Results

Complication Rate 11.1% (1/9)

Appropriate Atrial Sensing Rate1 97.6% (41/42)

Appropriate Atrial Sensing during 24-hour

Holter Test 100% (9/9)

Appropriate Atrial Sensing during

Exercise Treadmill Test 100% (6/6)

Detection and Conversion of Ventricular

Tachyarrhythmias2 100% (68/68)

1.6.5.2 European Clinical Study

1.6.5.2.1 Patients Studied

The European Deikos A+/Kainox VDD lead clinical study involved

82 patients (66 males and 16 female) with a mean age of 61.8

years (range: 29 to 84 years). 42.7% presented with

monomorphic ventricular tachycardia as their primary

tachycardia.

1 The investigator determined the appropriateness of atrial sensing. The rate is

determined by the number of appropriate atrial sensing evaluations divided by

the total number of evaluations.

2 Conversion data were collected in the clinical study for both induced and

spontaneous ventricular tachyarrhythmia episodes. Therefore, both types of

tachyarrhythmia episodes were included in the analysis.

66 Lumax Technical Manual

1.6.5.2.2 Study Objectives

This clinical investigation was designed to collect information on

the performance and function of the Deikos A+/Kainox VDD ICD

system. The specific predefined objectives of the investigation

included the rate of inappropriate, i.e. unnecessary deliveries of

antitachycardia therapy due to supraventricular tachycardia

(SVT), the tachyarrhythmia conversion efficacy of the system with

activated SMART Detection™ algorithm, the rate of appropriate

atrial sensing and the morbidity rate.

1.6.5.2.3 Results

The mean implant duration was 8.9 ± 4.4 months with a

cumulative implant duration of 732 months. No unanticipated

adverse events were reported during the study. There were two

deaths reported, which were unrelated to the implanted device. A

summary of the results obtained during the evaluation is provided

in Table 25 .

Table 25: OUS Clinical Study Results

Description Results

UADE-free Survival Rate 100% (82/82)

Complication Rate 19.5% (16/82)

Inappropriate Therapies with SMART

Detection™ algorithm ON Rate 94.8% (234/250)

Inappropriate Therapies with SMART

Detection™ algorithm OFF Rate 84.7% (133/157)

Appropriate Atrial Sensing Rate1 92.7% (165/211)

Detection and Conversion of Ventricular

Tachyarrhythmias2 100% (211/211)

1 The investigator determined the appropriateness of atrial sensing. The rate is

determined by the number of appropriate atrial sensing evaluations divided by the

total number of evaluations.

2 Conversion data were collected in the clinical study for both induced and

spontaneous ventricular tachyarrhythmia episodes. Therefore, both types of

tachyarrhythmia episodes were included in the analysis.

Lumax Technical Manual 67

1.7 Patient Selection and Treatment

1.7.1 Individualization of Treatment

 Determine whether the expected device benefits

outweigh the possibility of early device replacement for

patients whose ventricular tachyarrhythmias require

frequent shocks.

 Determine if the device and programmable options are

appropriate for patients with drug-resistant

supraventricular tachyarrhythmias (SVTs), because drug-

resistant SVTs can initiate unwanted device therapy.

 Direct any questions regarding individualization of patient

therapy to your BIOTRONIK representative or

BIOTRONIK technical services at 1-800-547-0394.

The prospective patient’s size and activity level should be

evaluated to determine whether a pectoral or abdominal implant

is suitable. It is strongly recommended that candidates for an

ICD/CRT-D have a complete cardiac evaluation including EP

testing prior to device implant to gather electrophysiologic

information, including the rates and classifications of all the

patient’s cardiac rhythms. When gathering this information,

delineate all clinically significant ventricular and atrial arrhythmias,

whether they occur spontaneously or during EP testing.

If the patient’s condition permits, use exercise stress testing to do

the following:

 Determine the maximum rate of the patient’s normal

rhythm.

 Identify any supraventricular tachyarrhythmias.

 Identify exercise-induced tachyarrhythmias.

The maximum exercise rate or the presence of supraventricular

tachyarrhythmias may influence selection of programmable

parameters. Holter monitoring or other extended ECG monitoring

also may be helpful.

68 Lumax Technical Manual

If the patient is being treated with antiarrhythmic or cardiac drugs,

the patient should be on a maintenance drug dose rather than a

loading dose at the time of pulse generator implantation. If

changes to drug therapy are made, repeated arrhythmia

inductions are recommended to verify pulse generator detection

and conversion. The pulse generator also may need to be

reprogrammed.

Changes in a patient’s antiarrhythmic drug or any other

medication that affect the patient’s normal cardiac rate or

conduction can affect the rate of tachyarrhythmias and/or efficacy

of therapy.

If another cardiac surgical procedure is performed prior to

implanting the pulse generator, it may be preferable to implant the

lead system at that time. This may prevent the need for an

additional thoracic operation.

1.7.2 Specific Patient Populations

Pregnancy - If there is a need to image the device, care should

be taken to minimize radiation exposure to the fetus and the

mother.

Nursing Mothers - Although appropriate biocompatibility testing

has been conducted for this implant device, there has been no

quantitative assessment of the presence of leachables in breast

milk.

Geriatric Patients - Most (about 71%) of the patients receiving a

CRT-D or ICD in the clinical studies detailed in this manual were

over the age of 60 years (see Clinical Studies).

Handicapped and Disabled Patients - Special care is needed in

using this device for patients using an electrical wheel chair or

other electrical (external or implanted) devices.

1.8 Patient Counseling Information

The implanted devices are subject to random component failure.

Such failure could cause inappropriate shocks, induction of

arrhythmias or inability to sense arrhythmias, and could lead to

the patient’s death.

Persons administering CPR may experience the presence of

voltage on the patient’s body surface (tingling) when the patient’s

CRT-D/ICD system delivers a shock.

Lumax Technical Manual 69

A patient manual is available for the patient, patient’s relatives,

and other interested people. Discuss the information in the

manual with concerned individuals both before and after pulse

generator implantation so they are fully familiar with operation of

the device. (For additional copies of the patient manual, contact

BIOTRONIK at the address listed in this manual.)

1.9 Evaluating Prospective CRT-D/ICD

Patients

The prospective ICD/CRT-D implant candidate should undergo a

cardiac evaluation to classify any and all tachyarrhythmias. In

addition, other patient specific cardiac information will help in

selecting the optimal device settings. This evaluation may include,

but is not limited to:

 an evaluation of the specific tachycardia rate(s)

 the confirmation and/or evaluation of any supraventricular

arrhythmias or bradyarrhythmias

 the evaluation of various ATP and cardioversion

therapies

 the presence of any post-shock arrhythmias, and

 an evaluation of the maximum sinus rate during exercise.

If a patient’s drug regimen is changed or adjusted while the

CRT-D/ICD is implanted, additional EP testing may be required to

determine if detection or therapy parameter settings are relevant

and appropriate.

Empirical changes to the detection or therapy parameters should

be assessed based on patient safety. Some changes may

necessitate a re-assessment of sensing, pacing, or arrhythmia

conversion treatment. Thorough technical knowledge of

BIOTRONIK CRT-D/ICDs, additional CRT-D/ICD experience, and

individual medical judgment will aid in determining the need for

additional testing and follow-up.

70 Lumax Technical Manual

2. Device Features

The Lumax family feature set is presented under the following

sub-headings: Tachyarrhythmia Detection, Tachyarrhythmia

Redetection/Acceleration, Tachyarrhythmia Therapy,

Tachyarrhythmia Termination, Bradycardia Therapy, EP Test

Functions and Special Features. The features apply to all

members of the Lumax family except where specifically

referenced differently.

CAUTION

Programmed Parameters – Program the device

parameters to appropriate values based on the patient’s

specific arrhythmias and condition.

2.1 SafeSync Telemetry

The Lumax 700/740 and 600/640 models offer ”wandless”

communication between the device and the programmer by using

radio frequency (RF) telemetry, in addition to the currently

available telemetry used by applying the programming head

(PGH) over the implanted device. This function is called SafeSync

Telemetry.

SafeSync Telemetry can be used with the Renamic programmer

or with the ICS 3000 programmer (using the SafeSync Module,

an external communication module).

To Establish SafeSync Telemetry contact:

The programmer (or the SafeSync module) must be no more than

9 feet (3 m) from the device; ideally there should be no obstacles

between the patient and the programmer.

 Switch on RF telemetry on the programmer. Select:

Preferences→Connectivity→RF telemetry→

Interrogation→ON. Or, select: More→Lumax→

Telemetry→RF, during the follow-up.

 Apply the programming head for about 2 seconds until

successful initialization is displayed on the programmer:

Lumax Technical Manual 71

The SafeSync symbol is displayed in the navigator and

the signal strength is displayed in green bars on the

information line. The SafeSync telemetry status is shown

in five increments: 1 bar = 20% up to 5 bars = 100%. A

weak contact shows only one bar in green, whereas all

five bars are shown in green when there is optimal

contact. The bars are shown in gray if RF telemetry is

lost. The display should have at least three green bars.

Otherwise, it is recommended to reposition the

programmer until an adequate signal strength is

achieved.

 Remove the programming head.

 To restore the SafeSync Telemetry after an interruption

during follow-up or after a programmer restart: select

Special→Continue RF session on the start screen to

restore the most recent active session. This SafeSync

Telemetry session must not have been inactive for longer

than five minutes, since the device's SafeSync Telemetry

activity is automatically switched off after five minutes of

inactivity.

Note: If the SafeSync Telemetry session has been

inactive for more than 5 minutes, the programming

head must be reapplied to reinitialize the SafeSync

Telemetry.

To End SafeSync Telemetry contact:

To end the SafeSync Telemetry session:

 End Follow-up session

To switch to telemetry via the programming head (PGH):

72 Lumax Technical Manual

 Apply the programming head on the patient over the

device.

 Select: More→Lumax→ Telemetry→PGH.

Power Consumption Consideration:

SafeSync telemetry requires somewhat more power than

telemetry via the programming head. Power consumption during

implantation corresponds to approximately 10 days of service

time and consumption during 20-minute follow-up corresponds to

approximately 3 days. As a result:

 Do not establish SafeSync Telemetry sessions

unnecessarily.

 After 5 minutes without input, SafeSync Telemetry

switches to the economy mode. In order to re-establish

telemetry from the economy mode, select “Close” in the

pop-up window with the patient’s name:

 Check the battery capacity of the device at regular

intervals.

Lumax Technical Manual 73

2.2 Cardiac Resynchronization Therapy

(CRT)

HF versions only

For Cardiac Resynchronization Therapy (CRT), a sensing/pacing

lead is placed in the right atrium, while an ICD lead is placed in

the right ventricle. The third lead is positioned to pace the left

ventricle. When connected together, this system provides

coordinated, simultaneous stimulation of the right and left

ventricles. This resynchronization therapy is designed to

coordinate the contraction of both ventricles, which allows the

heart to contract more efficiently. As a result, patients with CHF

and intraventricular conduction delay may have a greater ability to

complete physical activities thus improving their quality of life.

As a result of the device design and header configuration,

ventricular pacing pulses can be delivered between the right/left

ventricular lead tip electrodes simultaneously (cathode) and at

programmed intervals. In some configurations the ring of the right

ventricular lead works as LV anode. Ventricular sensing primarily

uses the poles of the right ventricular lead tip and ring. This

design avoids sensing of ventricular activity twice during a single

cardiac cycle (double counting) in patients with a wide QRS

complex. However, for diagnostic purposes and LV pacing

protection the Lumax HF devices can be programmed to sense in

the left ventricle.

Atrial Channel

The Lumax ICDs/CRT-Ds pace and sense in bipolar

configuration, between the atrial lead’s tip and ring electrodes. A

bipolar atrial lead must be used to ensure reliable sensing of atrial

activity.

Ventricular Channel

The Lumax HF devices can be programmed to pace in both the

right and left ventricle (as well as RV only). The Lumax HF

primarily senses in a bipolar configuration in the right ventricle.

However, for diagnostic purposes and LV pacing protection the

Lumax HF devices can be programmed to sense in the left

ventricle.

Potential Ventricular lead configurations are provided in Table 26.

74 Lumax Technical Manual

Table 26. Lead Configurations

Configuration Explanation

RV Only Sensing takes place between

the tip and ring electrodes of

the right ventricular lead.

Sensing

LV Only Sensing takes place between

the tip and ring electrodes

(bipolar) or the tip electrode of

the left ventricular lead and the

CRT-D housing (unipolar).

Pacing RV & LV

Together (BiV)

Pacing configuration is

programmable between the tip

and ring electrodes of the right

and left ventricular leads.

See Figure 7

Pacing RV Only Pacing takes place between

the tip and ring electrodes of

the right ventricular lead.

See Figure 7

Figure 7 Programmable Pacing Configurations

Lumax Technical Manual 75

For CRT to be effective, ventricular pacing must occur. Therefore,

AV delays must be programmed short enough to override intrinsic

ventricular contractions. Additional information to further optimize

AV delays can be obtained with echocardiography.

CRT can be programmed ON or OFF via the programmer using

the [Ventricular Pacing] parameter. Ventricular Pacing

Configuration allows standard right ventricular [RV] (CRT = OFF)

pacing or Cardiac Resynchronization Therapy [BiV] (CRT = ON).

The Lumax HF CRT-D can provide triggered biventricular pacing.

This is a functional expansion of the basic ventricular modes

(DDD(R); DDI(R); VDI(R); VDD(R); VVI(R)) used for biventricular

pacing. The “RVs triggering” was designed to ensure CRT is

delivered even when rapid intrinsic activation interferes with

pacing, such as in the case of conducted atrial fibrillation. This

function triggers LV pacing (Vp) after intrinsic sensing (RVs) in

the right ventricle. Triggered pacing can be programmed to react

to only normal RV sensed events or to right ventricular

extrasystoles as well as normal RV sensed events. The maximum

trigger rate is normally limited by the programmed UTR

(+20bpm), but can also be programmed to function up to a

separate and higher maximum trigger rate.

V-V Delay Programming

V-V delays should be programmed based on optimization of the

echocardiographic parameter Aortic Valve Velocity Time Integral,

evaluating the full range of available delays, as was performed in

the clinical study demonstrating the safety and effectiveness of

this feature. RV pre-excitation may cause a decline of LV

function.

The V-V delay features for the Lumax HF-T devices include the

ability to program the following parameters “first chamber paced,”

which allows either the right or the left ventricle to be paced first,

and “VV delay” for setting a delay between the left and right

ventricular pacing pulses (programmable range: 0 ms … (5ms) …

100 ms).

Suggested optimization procedure:

During the V-V clinical study assessment was performed by

determining the V-V delay setting associated with the largest VTI

value. The VTI of the aortic flow is measured in the apical 5

chamber view.

76 Lumax Technical Manual

Prior to the V-V delay optimization procedure, each patient

underwent an optimization of AV timing. Following the AV timing

adjustment, this standardized procedure was followed for the

optimization of V-V delay:

1. Program the Lumax HF-T “Initially Paced Chamber”

parameter to either RV or LV based on preference

2. Assess the VTI measurement at the following V-V delays

(additional V-V settings may be utilized at the physician’s

discretion):

 •100 ms

 • 80 ms

 • 60 ms

 • 40 ms

 • 20 ms

 • 0 ms

Note: Use the average VTI parameter over a 3 beat cycle and

wait 10 to 15 seconds between changing V-V delay settings.

Also, attempt to measure the VTI parameter within the same

patient respiratory cycle.

3. Record the VTI measurement associated with each V-V

delay setting

Repeat steps 1-3 for the remaining “Initially Paced Chamber”

parameters

Select permanent “Initially Paced Chamber” and “V-V delay after

Vp” to reflect the maximum VTI measurement for final

programming.

2.3 Sensing (Automatic Sensitivity Control)

The Lumax ICDs/CRT-Ds use Automatic Sensitivity Control

(ASC) to adjust the input stage sensitivity threshold for each

channel to appropriately detect the various cardiac signals. The

characteristics of the sensing circuitry have been optimized to

ensure appropriate sensing during all potential cardiac rhythms.

Lumax Technical Manual 77

Cardiac signals vary in amplitude; therefore detection thresholds

cannot be static. With the Automatic Sensitivity Control (ASC)

every paced/sensed event is measured, and the upper and lower

thresholds are re-set accordingly (also known as beat-by-beat

adaptation). The ASC begins by tracking the cardiac signals (R

and P-waves) during the sensed refractory periods. The peak

values measured during this time are used to set the sensing

thresholds during the active detection periods.

2.3.1 Right Ventricular Sensitivity Settings

There are three programmable preset options for setting the

sensitivity of the right ventricular input stage. The sensitivity

selections are designed to adapt the parameters of the input

stage to various signal conditions. The predefined parameter sets

are described in Table 27.

Table 27: Sensitivity Settings

Setting Definition for Use

Standard This setting is recommended for most

patients, especially for those with

measured R-wave amplitude of 3 mV.

Enhanced

T Wave

Suppression

This setting offers suppression of T-wave

oversensing. This mode should not be

used on patients with the following

conditions:

 Sinus rhythms with small signal

amplitudes, R-waves 4 mV

 VF with highly fluctuating signal

amplitudes.

Enhanced

VF Sensitivity

This setting enhances VF detection, in

cases of highly fluctuating signal

amplitudes. It is not to be used for patients

that have sinus rhythms containing large

amplitude T-waves.

Typically, the upper threshold is reset with each sensed R-wave,

but in order to ensure that pacing does not occur during an

episode of VF, the ASC behaves differently with paced events.

Each paced event is followed by a paced refractory period after

which the ventricular threshold is set to the minimum

programmed value.

78 Lumax Technical Manual

For example, the upper threshold is set at 50% of the measured

R-wave for the Standard sensitivity setting following the 100 ms

sensed refractory period. The upper threshold decays 0.125 mV

every 250 ms through the T-wave discrimination period (hold of

upper threshold: 360 ms). After the T-wave discrimination period,

the threshold is decreased to the lower threshold. The lower

threshold is set to 25% of the measured peak R-wave. The lower

threshold then decreases 0.125 mV every 500 ms until the

Minimum Threshold is reached or until the next sensed (or paced)

event.

For Lumax 600/640 and 700/740 devices, the decrease is

controlled on a percentage basis. Every 156 ms 87.5% of the

threshold reference. Initially this is the maximum amplitude. Hold

of upper threshold: 400 ms.

Figure 8 Automatic Sensitivity Control with Standard Setting

Figure 8 provides an illustration of Automatic Sensitivity Control

with the sensitivity programmed to Standard. The tracked R –

wave is measured to be 6.0 mV, following the sensed refractory

period the upper threshold is set to 3.0 mV. After the T-wave

discrimination period, the threshold is further reduced to 1.5 mV.

Both the Upper and Lower Thresholds decay over time, but the

Minimum Threshold is never violated. Nominally, the minimum

threshold is set to 0.8 mV, but it can be adjusted by the user.

Lumax Technical Manual 79

The Enhanced VF Sensitivity setting is specifically designed to

improve VF detection when the VF signal is very small. Two

adjustments are made to ASC with this setting:

 The T-wave discrimination period (hold of upper

threshold) is decreased to 100 ms [110 ms for Lumax

600/640 and 700/740 models], thus eliminating the Upper

Threshold.

 The decay rate of the Lower Threshold is increased to

0.125 mV every 250 ms. This is not applicable for the

Lumax 600/640 and 700/740 models.

These adjustments ensure that the threshold reaches the lower

values more quickly in order to assure that all VF signals are

sensed appropriately.

The Enhanced T-Wave Suppression setting is specifically

designed to avoid double counting of each QRS-T complexes

during normal sinus rhythms. With sensitivity programmed to

Enhanced T-Wave Suppression:

 High pass filtering is increased to reduce low frequency

signal components such as T-waves and respiratory

artifacts.

 The Upper Threshold is increased to 75% of the

measured R-wave.

 The Upper Threshold may not retrigger with each sensed

event, it is only triggered when the new sensed R-wave

crosses the 50% point of the previous measured R-wave.

2.3.2 Minimum Right Ventricular Threshold

This parameter limits the minimum sensitivity of the ICD/CRT-D to

a programmable value. Nominally, the minimum threshold is set

to 0.8 mV, but it can be adjusted from 0.5 to 2.5 mV.

2.3.3 Atrial Sensitivity Settings

DR and HF versions only

The primary option for setting the sensitivity of the atrial input

stage is “Standard”. When atrial sensing is active, the sensitivity

is set to “Standard” for most patients, which is designed to adapt

the parameters of the input stage to various signal conditions.

The available settings are described in Table 28.

80 Lumax Technical Manual

Table 28: Atrial Sensitivity Settings

Setting Definition for Use

Standard This setting is recommended for all

patients with a functioning atrial lead.

Inactive This setting deactivates the atrial channel

for sensing, EGM telemetry and Holter

recording and is typically used when no

atrial lead is implanted.

Typically, the upper threshold is reset with each sensed P-wave,

but in order to ensure that pacing does not occur during an

episode of AF/VF, the ASC behaves differently with paced

events. Each paced event is followed by a paced refractory

period after which the atrial threshold is set to the minimum

programmed value.

2.3.4 Minimum Atrial Threshold

This parameter limits the minimum sensitivity of the ICD/CRT-D to

a programmable value. Nominally, the minimum threshold is set

to 0.4 mV, but it can be adjusted from 0.2 to 2.0 mV.

2.3.5 Left Ventricular Sensitivity Settings

HF versions only

The primary option for setting the sensitivity of the left ventricular

input stage is “Standard”. When LV sensing is active, the

sensitivity is set to “Standard” for most patients, which is designed

to adapt the parameters of the input stage to various signal

conditions. The available settings are described in Table 29.

Lumax Technical Manual 81

Table 29: Left Ventricular Sensitivity Settings

Setting Definition for Use

Standard This setting is recommended for all

patients with a functioning left ventricular

lead.

Inactive This setting deactivates the left ventricular

channel for sensing, EGM telemetry and

Holter recording and is typically used when

no LV lead is implanted.

2.3.6 Minimum Left Ventricular Threshold

This parameter limits the minimum sensitivity of the CRT-D to a

programmable value. Nominally, the minimum threshold is set to

0.8 mV, but it can be adjusted from 0.5 to 5.0 mV.

2.3.7 Far Field Protection

DR and HF versions only

This parameter blanks the atrial channel of the ICD/CRT-D to the

period before and after each ventricular event. This blanking

period is programmable separately based on whether the

ventricular event is a paced or sensed event and is designed to

prevent sensing of ventricular signals with the atrial leads.

CAUTION

Far-field sensing of signals from the atrium in the

ventricular channel or ventricular signals in the atrial channel

should be avoided by appropriate lead placement,

programming of pacing/sensing parameters, and maximum

sensitivity settings. If it is necessary to modify the Far Field

Blanking parameter, the parameter should be lengthened

only long enough to eliminate far-field sensing as evidenced

on the IEGMs. Extending the parameter unnecessarily may

cause undersensing of actual atrial or ventricular events.

2.3.8 Additional Sensing Parameters

The parameters of the Additional Sensing Parameters menu are

to provide additional flexibility for physicians to non-invasively

correct over/undersensing situations. The ranges and nominal

values are located in the Technical Specifications in Section 6.

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.

Lumax Technical Manual 83

2.4 Automatic Threshold Measurement

(ATM)

Lumax 500/540 Models only

The Lumax 500/540 models have an automatic threshold

measurement (ATM) feature for determining ventricular pacing

thresholds. This feature is separately programmable for the right

(RV) and left (LV) ventricles.

ATM is initiated once each day, typically during the nighttime

while the patient is normally sleeping. It can measure the right

and the left ventricular pacing thresholds and stores this

information for use in trends of daily threshold values. This

information is available on the programmer during in-office follow-

ups and via BIOTRONIK’s Home Monitoring system. The

permanent pacing amplitude is not adjusted by the ATM feature.

The ATM features of Lumax 500/540 are based on the evaluation

of the morphology of the ventricular evoked response (VER) to

determine if the pacing pulse has captured the myocardium. In

order to measure the pacing threshold, a sequence of two

algorithmic steps is carried out:

 Signal Quality Check (SQC)

 Threshold Measurement

The signal quality check determines if the morphology of the

evoked response of a captured beat is sufficiently different from

the morphology of the evoked response of a non-captured pace.

If the SQC is sufficient (i.e., if the algorithm can clearly distinguish

between capture and non-capture), then the automatic threshold

measurement is activated by initiating a series of pacing pulses.

The amplitude of these pulses is continuously decreased until a

loss of capture is detected. When loss of capture is detected a

back-up pulse is delivered (right ventricle only) to avoid

ventricular pauses caused by the threshold measurement.

84 Lumax Technical Manual

2.4.1 Signal Quality Check

During the Signal Quality Check, five single effective pacing

pulses are delivered. These pulses are followed by five double

pulses. The second pulse of each double pulse is delivered into

the refractory phase of the ventricle (as a non-capturing pulse).

The VER morphology of the single pulses and the second pulse

of the double pulses are assessed. The signal quality check is

successful if the single pulses are recognized as capturing pulses

and the second pulses of the double pulses are classified as non-

capturing pulses. The AV delay of the 2 x 5 pulses is shortened to

50 ms after pace and by 15 ms after sense, in order to avoid

ventricular fusion beats which would otherwise disturb the SQC. If

the SQC is successful, then the threshold measurement is

started, if not, the SQC is repeated once again after 30 minutes.

2.4.2 Threshold Measurement

The threshold measurement begins by delivering pulses at the

programmed pacing amplitude. The pulse amplitude is decreased

in steps of 0.6 Volts (V) each until loss of capture is detected.

During the loss of RV-capture sequence, a backup pulse is

issued. The back-up is set to a value of the programmed pacing

amplitude plus 0.6 V with a pulse width of 1.0 ms. There are no

backup paces for left ventricular ATM (LV-ATM).

The pulse amplitude is then set to the last effective value (0.6

Volts above the initial non-capture level) and then subsequent

pacing pulses are reduced in 0.1 V steps until loss of capture

reoccurs. The last effective pacing amplitude is then recorded as

the pacing threshold.

2.4.3 Loss of Capture Detection

In order to ensure against ATM loss of capture detection due to

an isolated non-capture event (i.e. as a result of VES), loss of

capture is only declared if two out of three consecutive cycles

show loss of capture.

2.4.4 ATM in Lumax HF-T Models

If the device is programmed to biventricular pacing (BiV), the RV

ATM functions in the RV mode as described above. The LV ATM,

if active, is initiated after the RV ATM is complete. For the LV

ATM, the left ventricle is stimulated first with a VV delay of 50 ms

and then completed in a similar manner.

Lumax Technical Manual 85

Lumax 600/640 & 700/740 Models only

2.4.5 RV & LV Capture Control

RV & LV Capture Control uses the determined pacing threshold

to adjust the permanent pulse amplitude. The new permanent

pulse amplitude is composed of the determined pacing threshold

plus a safety margin (1.0 or 1.2 V) and is automatically

programmed in the ICD.

2.5 Ventricular Tachyarrhythmia Detection

The Lumax ICDs/CRT-Ds detect and measure the rate of sensed

cardiac signals to discriminate ventricular tachyarrhythmias from

supraventricular tachycardias, sinus rhythm or sinus bradycardia.

This is accomplished through programmable rate detection

parameters in the device. When a tachyarrhythmia is present, the

ICD/CRT-D classifies the arrhythmia and delivers the appropriate

therapy. If a tachyarrhythmia continues following the first therapy

attempt, then the ICD/CRT-D will redetect the tachyarrhythmia

and deliver subsequent therapies as necessary.

WARNING

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 implant procedure.

Classification of cardiac signals is accomplished primarily by

measuring the cardiac cycle length (R-R, P-R and P-P). In

addition, the ICD/CRT-D can also utilize abrupt changes in rate or

irregularity of the cardiac signal to further differentiate ventricular

tachyarrhythmias. Each detected ventricular tachyarrhythmia is

classified into one of the following zones:

 VT-1 Lower rate ventricular tachycardia

 VT-2 Higher rate ventricular tachycardia

 VF Ventricular fibrillation

Each rhythm class is programmable to a separate rate with the

zone limit defining the lowest rate in each class. The upper rate

limit of each class is equal to the zone limit of the next higher

class, creating a continuous range of rate classes.

86 Lumax Technical Manual

2.5.1 VF Classifications

Detection of ventricular fibrillation (VF) utilizes programmable X

out of Y criterion. For the Lumax 300/340 & 500/540 models, both

X and Y are programmable. For the Lumax 600/640 and 700/740

models there are fixed combinations of X out of Y criterion. If X

number of intervals within the sliding window (defined by Y) are

shorter than the programmed VF rate interval (>bpm), VF is

detected. After fibrillation is detected, the programmed therapy

sequence for VF is initiated.

Nominal settings for classification of ventricular fibrillation (VF)

are 8 of 12 intervals; meaning that within a sample window of

12 intervals, 8 intervals must meet or exceed the VF zone rate

criteria.

2.5.2 VT Interval Counters

The VT Interval Counters are separately programmable for VT-1

and VT-2 rate classifications. The Counter: Detection is the

number of intervals required to declare a tachyarrhythmia as VT.

A tachyarrhythmia must meet the rate/interval criteria and the

programmed Counter/Detection criteria, in addition to any other

detection enhancements to be declared a tachycardia.

2.5.3 VT Classification

Both VT-1 and VT-2 classification zones utilize separately

programmable detection parameters. Classification of VT-1 or

VT-2 is based on the last interval average preceding declaration

of tachyarrhythmia detection. If this average falls within the VT-1

zone, the programmed VT-1 therapy is delivered. If the average

falls within the VT-2 limits, the programmed VT-2 therapy is

delivered. If additional detection parameters are activated, each

of these supplemental criteria must also be satisfied before a VT

rhythm can be classified and treated.

Lumax Technical Manual 87

The ICDs/CRT-Ds may be programmed to use ventricular-only

information, or both atrial and ventricular information for the

discrimination of ventricular tachyarrhythmias. With SMART

Detection™ turned ON, the Lumax ICDs/CRT-Ds use atrial and

ventricular signals for discrimination of fast heart rhythms. With

SMART Detection™ turned OFF, only the ventricular rate is used

to discriminate between ventricular rhythm classes. If SMART

Detection is enabled, this algorithm evaluates all cardiac signals

within the VT range and increments the VT Sample Count for all

intervals that are deemed VT. A full description of SMART

Detection™ is provided in Section 2.5.4.

In addition, when the Lumax senses the programmed number of

consecutive intervals (termination count) within the sinus rate

zone, all tachyarrhythmia detection criteria, including the VT

sample counters are reset.

2.5.4 SMART Detection™

DR and HF versions only

This discrimination algorithm enhances VT-1 and VT-2 detection

by applying a series of tests to the sensed cardiac signal. SMART

Detection™ is intended to discriminate VT from a variety of

supraventricular arrhythmias that are conducted to the ventricle

and that would otherwise satisfy VT-1 or VT-2 rate detection

criteria.

First, the average ventricular rate is compared to the average

atrial rate. In the event that the measured ventricular rate is faster

than the atrial rate, the device immediately declares the rhythm a

VT and delivers programmed ventricular therapy for the detected

VT zone.

In the event that an atrial rate is faster compared to the ventricular

rate one of three tests are performed:

Ventricular rhythm stability, (see Stability in Section 2.5.6 if the

ventricular signal is unstable, then the rhythm is declared a

supraventricular tachyarrhythmia, (SVT) and ventricular therapy is

typically withheld.

If the ventricular signal is stable, and the atrial rate is a multiple of

the ventricle rate, then the rhythm is declared a supraventricular

tachyarrhythmia (SVT) and ventricular therapy is typically

withheld.

88 Lumax Technical Manual

If the ventricular rhythm is stable and the atrial rate is not a

multiple of the ventricular rate, then the rhythm is declared a VT

and ventricular tachycardia therapy is delivered.

In the event that both the atrial and ventricular signals are

detected at the same rate, a series of additional discrimination

tests are applied.

2.5.5 Onset

Another detection enhancement that may be used independently

(VT-1 or VT-2, when SMART Detection is active) or as an adjunct

to the SMART Detection™ algorithm is the Onset parameter.

This parameter measures abrupt changes in ventricular cycle

length to discriminate between sinus tachycardias and ventricular

and atrial tachyarrhythmias, which characteristically begin with an

abrupt change in cardiac rate.

This feature allows therapy to be withheld if a sinus tachycardia

rate crosses into one of the VT zones.

2.5.6 Stability

In VT-1 and VT-2 zones, the purpose of STABILITY is to assist in

discriminating between stable ventricular tachyarrhythmias and

supraventricular tachyarrhythmias that conduct irregularly to the

ventricles. STABILITY evaluates sudden changes in the

regularity of cardiac events (R-R and P-P intervals) on a beat by

beat basis. The STABILITY criterion compares the current

measured interval with the three preceding cardiac intervals. If a

difference between the current interval and each of the three

preceding intervals is less than the stability range, then the

current intervals are stable.

The SMART Detection™ algorithm utilizes both atrial and

ventricular STABILITY as integral parts of the discrimination

algorithm. Therefore, when SMART Detection™ is enabled, the

STABILITY parameter must also remain enabled and set to 12%.

2.5.7 Sustained VT Timer

The Sustained VT Timer can be programmed between

30 seconds and 30 minutes (or to OFF) for the Lumax 300/340 &

500/540 models and 1 min to 30 minutes (or to OFF) in the

Lumax 600/640 and 700/740 models. When the timer expires,

therapy is initiated regardless of the detection enhancements.

Lumax Technical Manual 89

The Sustained VT parameter is intended to force tachycardia

therapy in cases where a cardiac rhythm meets the VT rate

criteria but does not satisfy one or more detection enhancement

criterion (Onset, SMART Detection, or Stability) for an extended

duration. This “safety” timer is initiated within one of the VT

zones. If the programmed Sustained VT time period expires

without tachycardia detection, redetection is initiated without

utilizing the detection enhancements.

A simple up/down counter is used to initiate the safety timer. The

counter is incremented by one when an interval falls into a VT

zone and decrements by one when an interval falls into the sinus

zone. When the counter reaches a number equal to the

programmed VT detection counter, the safety timer is started.

The timer runs until the programmed time expires and therapy is

delivered or until the timer is reset. The timer is reset with initial

detection or VT termination.

The safety timer is not used in redetection. If initial detection was

due to the safety timeout and SMART Redetection is

programmed “ON”, then SMART Detection will not be used for

redetection.

2.5.8 VT Monitoring Zone

The VT1 zone can be programmed to monitor for non-sustained

arrhythmias not requiring therapy. The monitoring zone can be

programmed with all the standard detection enhancements

including SMART DetectionTM to monitor for non-sustained

ventricular tachycardia or atrial tachyarrhythmias. Any

tachyarrhythmia meeting the Monitor Zone criteria will store an

IEGM.

2.5.9 Atrial Monitoring Zone

This feature allows the device to store an IEGM for atrial

tachyarrhythmias such as Atrial Fibrillation or Atrial Flutter. The

zone is programmed by rate with a range of 100 bpm to 250 bpm.

Any atrial tachyarrhythmia meeting the Atrial Arrhythmia Monitor

Zone criteria will store an IEGM.

90 Lumax Technical Manual

2.6 Tachyarrhythmia Redetection

The Lumax ICDs/CRT-Ds offer independently programmable

settings for determining if tachyarrhythmias remain after therapy

has been delivered. The redetection routine allows the

ICDs/CRT-Ds to determine whether further therapy is required

when the initial therapy was unsuccessful in terminating the

arrhythmia.

Tachyarrhythmia redetection criteria are based on cardiac cycle

length and number of intervals. The number of intervals is distinct

and independent of the initial detection criteria.

2.6.1 VT Redetection

The Counter: Redetection parameter may be programmed

separately for each arrhythmia class, independent of the initial

detection parameters:

Redetection of an ongoing tachyarrhythmia is declared when the

Counter: Redetection is satisfied (based on individual cycles). If a

sensed cardiac signal meets any VT rate criteria, following

therapy, that signal is counted and compared to the programmed

Counter: Redetection setting.

Redetection functions are based exclusively on the VT criterion.

2.6.2 SMART Redetection

DR and HF versions only

With SMART Redetection programmed ON, both atrial and

ventricular signals are used for redetection after initial detection

and therapy for a VT. SMART Detection™ will function identically

as in initial VT detection. SMART Redetection is autotmatically

programmed ON in the Lumax 600/640 and 700/740 models.

2.6.3 Forced Termination

DR and HF versions only

With SMART Redetection programmed ON, this programmed

parameter sets a time after which the SMART Redetection will be

terminated even if the SVT is still ongoing. This forces the device

to terminate the episode and allow detection of a new VT or VF

episode.

Lumax Technical Manual 91

2.6.4 VF Redetection

VF redetection uses the same X in Y algorithm as initial detection.

The X and Y values for initial detection are also used for

redetection to ensure consistent classification of VF.

2.7 Tachyarrhythmia Termination

Termination of a ventricular tachyarrhythmia episode is declared

when 12 out of 16 consecutive sensed intervals are longer than

the VT-interval parameter of the lowest VT class (sinus or

bradycardia rhythm).

2.8 Tachyarrhythmia Therapy

The Lumax ICDs/CRT-Ds offer a variety of therapy options that

can be tailored to meet a patient’s specific anti-tachycardia or

defibrillation therapy requirements. Anti-tachycardia pacing (ATP)

therapies can be combined with defibrillation therapies to provide

a broad spectrum of tachyarrhythmia treatment options.

2.8.1 Therapy Options

The Lumax ICDs/CRT-Ds offer multiple therapy options for each

tachyarrhythmia class (VT1, VT2, VF). Therapy options (up to 20

ATP sequences and 8 shocks) are available for the VT1 and VT2

zones, whereas ATP One Shot and up to 8 shock therapies are

available for the VF class. The specific characteristics of an ATP

and shock therapy are independently programmed for each

VT/VF zone.

The ATP and shock therapy options are discussed in detail in the

following sections.

2.8.2 Anti-Tachycardia Pacing (ATP)

Anti-tachycardia pacing therapy (ATP) is available in both VT

detection zones. Available modes of ATP include Burst, Ramp,

and Burst + PES (Programmed Extra Stimuli). However, in the

Lumax 600/640 and 700/740 models, Burst + PES is only

available at DFT test for EP examinations. In addition, the Burst

and Ramp modes allow interval scanning of the R-S1 Interval,

the S1 Decrement, or both. The Attempts parameter determines

the number of burst schemes to be delivered before the scan

parameter is incremented.

92 Lumax Technical Manual

Burst – This mode will deliver a series of pacing stimuli with user

defined duration of the burst (Number S1), coupling cycle length

(R-S1) and burst rate (S1-S1). The coupling interval and the start

interval are calculated from the intrinsic R-R average.

Ramp - This mode will deliver a series of pacing stimuli with the

above options including a parameter which decrements each

successive stimuli interval in the burst.

Burst + PES – In the Lumax 300/340 & 500/540 models, this

mode provides a pulse train followed by one additional timed

stimuli. The coupling cycle length of the burst and each extra

stimulus (S1-S2 Interval) is individually programmed either as an

adaptive value (as a percentage) or as an absolute value

(expressed in milliseconds). In the Lumax 600/640 & 700/740

models, Burst + PES is only available at DFT test for EP

examinations.

Ventricular Pacing - This parameter defines the type of

ventricular pacing performed during delivery of ATP sequences in

CRT-Ds and is programmable to biventricular (VV delay = 0 ms)

or right ventricular only.

Number S1 - This parameter defines the number of stimuli for an

ATP. For Burst + PES, a single extra stimulus with a separate

parameter setting is coupled. In the Lumax 600/640 & 700/740

models, Burst + PES is only available at DFT test for EP

examinations.

Add S1 - This feature can be programmed with any Burst, Ramp,

or Burst + PES (Lumax 300/340 & 500/540 models only) scheme.

When “Add S1” is “ON,” the number of S1 intervals is

incremented by one on each successive ATP therapy. The next

S1-S1 interval is dependent on the initial start interval (S1

decrement) and the programmed Scan Decrement (if activated).

R-S1 Interval - The R-S1 programmable coupling interval occurs

at the beginning of each ATP. It defines the interval between the

last R-wave signal and the first stimulus (S1). The second

stimulus always follows the first one with the same interval.

S1 Decrement - The S1 decrement continuously reduces the

pulse intervals of the ATP from the second pulse onward.

Lumax Technical Manual 93

S1-S2 Interval - The S1-S2 programmable coupling interval

occurs between the Burst sequence and the extra stimuli (PES). It

defines the interval between the first stimulus (S1) and the extra

stimuli (S2).

Scan Decrement - The Scan decrement continuously reduces

the starting pulse intervals of each Burst or Scan.

Minimum ATP Interval – For the Lumax 300/340 & 500/540

models, the programmed minimum interval prevents ATPs from

being given with stimulation values less than the minimum

interval. When the ATP interval reaches the value of the minimum

interval with the S1 decrement or scan decrement, it then

assumes this value and remains constant. For the Lumax

600/640 & 700/740 models, the minimum ATP interval is 200 ms

fixed.

2.8.2.1 ATP Help

ATP help is a useful tool to assist the physician in choosing and

confirming appropriate ATP programming. The “ATP Help” button

is displayed in each ATP therapy option. When the ATP help

button is pressed, a histogram of the chosen therapy scheme is

shown. The histogram displays the intervals for the programmed

ATP scheme. When rate adaptive intervals are programmed, the

displayed intervals are based on the programmed R-R average.

2.8.2.2 ATP Optimization

In order to optimize future therapies, the ICD will store the

parameter configuration of the last successful ATP attempt in

each the VT1 and VT2 classes. The last successful stored ATP

attempt is then used as the starting point for the next detected

episode of the same arrhythmia class. If the stored parameter

configuration is not successful, it is deleted from the ATP

optimization memory of the respective arrhythmia class and

subsequent therapy sequences will begin with ATP1 for the next

detected episode.

ATP Optimization is programmable ON or OFF for all ATP

therapies and VT zones with one parameter.

94 Lumax Technical Manual

NOTE:

In VT zones, the ICD/CRT-D stores successful ATP therapies

only. The stored information includes not only the number of

the ATP therapy (e.g., ATP2), but also the successful

configuration in detail (for example: Burst; R-S1 Interval:

320 ms, S1-S1 Interval: 320 ms; etc.).

2.8.2.3 ATP Timeout

ATP Timeout is a timer that decrements after the initial ventricular

ATP is delivered (VT-1 zone) and limits the additional ATP

therapies that may be delivered. Once the timer expires, all

further ATP therapies in the sequence are blocked. If further

therapy is required after the timer has expired, the system

advances to the first programmed shock therapy for the

applicable VT zone. Therapy continues until arrhythmia

termination or all programmed therapy (in the applicable zone)

has been delivered. The ATP Timeout is reset each time an

arrhythmia is terminated.

Note: ATP Timeout is not applicable in the Lumax 600/640 &

700/740 models since the Progressive Course of Therapy is

automatically programmed in these devices.

2.8.2.4 ATP One Shot

ATP One Shot offers the opportunity to treat fast VTs that are

detected in the VF zone with a single ATP sequence delivered

immediately before charging of the high energy capacitors. The

device performs a stability check (same as VT zones, criterion

12% fixed) to determine if the arrhythmia might be a fast VT and if

the rhythm is stable, the programmed ATP sequence is delivered

prior to charging. Charging starts without redetection and the

successful treatment of the arrhythmia will be confirmed prior to

shock delivery during shock charging. If the arrhythmia is

converted by the ATP, the shock is aborted. All ATP therapy

parameters are available for programming ATP One Shot and it

can only be used with Shock Therapy programmed ON.

Lumax Technical Manual 95

2.8.3 Shock Therapy

Shock Therapy is developed by internal circuitry that stores

energy across high energy capacitors. The voltage level for the

charging cycle is based on the programmed energy level. The

energy is then delivered over the connected ICD lead and

through the ICD/CRT-D housing utilizing a biphasic waveform.

The first and second shock energies in each shock module have

independently programmable Shock Energy.

A synchronization window is started at the end of the charging

period. During this window, the device will attempt to synchronize

the shock therapy to an R-wave. If no R-wave is detected and

Confirmation is programmed to OFF, the shock will be delivered

asynchronously at the end of the synchronization period (DF). If

no R-wave is detected and Confirmation is programmed to ON,

the shock will be aborted at the end of the synchronization period

(DFc = Cardio Version).

2.8.3.1 Confirmation

The Confirmation parameter is used to verify the presence of a

tachyarrhythmia during charging of the shock capacitors. This

function is designed to avoid delivery of shock therapy if a

tachyarrhythmia has spontaneously terminated. The programmed

shock will be delivered unless bradycardia or a normal sinus

rhythm is detected during the Confirmation period. Confirmation

may be programmed ON or OFF for each zone (VT-1, VT-2 or

VF). Although if a shock is aborted and redetection occurs (even

in a zone with confirmation programmed ON) the subsequent

shock will be delivered without confirmation (see confirmation

OFF).

Confirmation OFF

When Confirmation is programmed OFF, shock therapy will be

delivered to the patient during the synchronization period

regardless of the detected cardiac signal.

Confirmation ON

If the tachyarrhythmia spontaneously converts to bradycardia or a

normal sinus rhythm during the confirmation period, shock

therapy is aborted. If the device confirms the presence of the

tachyarrhythmia, the device will deliver the programmed shock

therapy synchronized to the R-wave.

96 Lumax Technical Manual

2.8.3.2 Number of Shocks

The number of shocks defines the total number of shock attempts

per therapy zone (VT-1, VT-2 or VF). Up to 8 shocks are

available in each therapy zone. The first and second shock

energies are independently programmable, while the remaining

shocks are fixed at maximum energy (30 joules for

300/500/600/700 series devices and 40 joules for

340/540/640/740 series devices).

2.8.3.3 Shock Waveform

Two waveforms of shock therapy are available with the Lumax

ICDs/CRT-Ds, Biphasic and Biphasic 2 (ms). The following

diagram describes each of the shock waveforms.

Figure 9. Biphasic Waveforms

Both waveforms start at the calculated voltage, based on the

programmed energy level. After an exponential discharge through

the lead system to 40% of the initial charge voltage, both shock

waveforms switch polarity. At the second phase the:

 Biphasic waveform discharges to 20% of the initial charge

voltage before the waveform is truncated

 Biphasic 2ms waveform discharges the remaining energy

for two milliseconds before the waveform is truncated

Figure 9 provides a pictorial representation of both biphasic

waveforms.

BIOTRONIK recommends use of the standard Biphasic shock

waveform for initial defibrillation threshold testing. If testing

demonstrates high defibrillation thresholds, testing with the

Biphasic 2ms waveform is offered as a therapeutic alternative to

the standard Biphasic shock.

Lumax Technical Manual 97

2.8.3.4 Shock Energy

The Lumax ICDs/CRT-Ds are designed to charge to the energy

selected on the programmer screen, but similar to all other

commercially available ICDs/CRT-Ds, the actual therapy

delivered is somewhat less depending on several factors

including the shock lead impedance. The first two shock energies

in each therapy class are programmable between 1 joules for

Lumax 300/340 & 500/540 models and 2 joules for Lumax

600/640 & 700/740 models and the maximum energy for the

device type. The energy of the second shock is always greater

than the first shock. The remaining shock energies will be

delivered at maximum programmable energy.

Actual energy delivered for each programmable shock energy is

approximately equal to the “Energy Delivered” for the high energy

Lumax 340/540/640/740 variants in Table 30, and for the Lumax

300/500/600/700 in Table 31

98 Lumax Technical Manual

Table 30 Delivered Shock Energy (340/540/640/740

Variants)

Programmed Energy

(joules)

Approximate Delivered

Energy (joules)

1 0.8

2 1.7

3 2.6

4 3.5

5 4.3

6 5.2

7 6.1

8 6.9

9 7.8

10 8.7

11 9.6

12 10.5

13 11.3

14 12.2

15 13.1

16 13.9

18 15.7

20 17.3

22 19.1

24 21.1

26 22.8

28 24.4

30 26.3

32 27.9

34 29.7

36 31.5

38 33.3

40 35.0

Lumax Technical Manual 99

Table 31 Delivered Shock Energy (300/500/600/700

Variants)

Programmed Energy

(joules)

Approximate Delivered

Energy (joules)

1 0.8

2 1.7

3 2.5

4 3.3

5 4.3

6 5.1

7 6.0

8 7.0

9 7.8

10 8.6

11 9.6

12 10.6

13 11.4

14 12.3

15 13.1

16 14.2

18 16.0

20 17.7

22 19.5

24 21.4

26 23.2

28 24.9

30 27.0

100 Lumax Technical Manual

CAUTION

Shock Impedance - If the shock impedance is less than

twenty-five ohms (25 Ω), reposition the lead system to allow

a greater distance between the electrodes. Never implant the

device with a lead system that has measured shock

impedance as less than twenty-five ohms (25 Ω). Damage to

the device may result.

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.

Shock Therapy Confirmation – Programming

CONFIRMATION to OFF may increase the incidence of the

ICD/CRT-D delivering inappropriate shocks.

2.8.3.5 Shock Polarity

The polarity of the shock therapy may be programmed and

changed non-invasively. The Normal polarity configures the HV 1

or RV connector port as the negative electrode and the HV 2 or

SVC connector port and the outer housing of the ICD/CRT-D as

the positive electrode for the first phase of the shock. Reversed

polarity will switch the electrical polarity of the connector ports

and housing. The shock polarity is separately programmable for

each arrhythmia zone.

Alternating polarity is automatically employed when a maximum

energy shock with normal polarity fails to cardiovert. The next

shock will have reversed polarity and alternates the polarity for all

subsequent shocks.

Lumax Technical Manual 101

2.8.3.6 Third Programmable Shock Pathway

Lumax 500/540, 600/640 & 700/740 Models only

The Lumax 500/540, 600/640 and 700/740 models offer three

programmable shock delivery configurations. The defibrillation

shock pathways include a “non-active housing” shock path and a

shock paths between the ICD/CRT-D housing and either or both

shock coils when connected to a dual coil shock lead.

The Shock Configuration parameter operates independently of

Shock Polarity. So each of the pathways described below can be

reversed for delivered defibrillation/cardioversion shocks.

Table 32 outlines the current shock pathways that are available

with Lumax 500/540, 600/640 and 700/740 models.

Table 32 Lumax 500/540, 600/640 & 700/740

Programmable Shock Pathways

# Electrical Pathway

1) RV SVC and Housing (can)*

2) RV  SVC

3) RV  Housing (can)

* 300/340 Models are limited to this configuration.

2.8.4 Progressive Course of Therapy

By design, the Lumax ICDs/CRT-Ds will deliver more aggressive

therapy for each successive attempt within a single detected

episode. Therefore, the device will not deliver ATP1 therapy

following ATP2 therapy, and will not deliver ATP therapy following

a high voltage defibrillation shock.

When Progressive Course of Therapy is turned ON (this is

automatically programmed ON in the Lumax 600/640 & 700/740

models), the ICD/CRT-D will always deliver a maximum energy

shock after re-detecting in an arrhythmia class with programmed

shock energy less than or equal to the previously delivered

therapy. In addition, the ICD/CRT-D blocks all ATP therapy during

the current episode if a shock has already been delivered during

the episode.

102 Lumax Technical Manual

Furthermore, the ICD/CRT-D prevents therapies of different

arrhythmia classes from permanently retarding or accelerating a

VT in such a way that the cardiac rhythm fluctuates between the

different arrhythmia classes without achieving termination of the

arrhythmia, regardless of the Progressive Course of Therapy

setting.

For example, a 10-joule defibrillation shock is delivered for an

arrhythmia detected in the VT-2 zone and results in a

deceleration of the VT so that it is subsequently redetected in the

VT-1 zone. At that point, the Lumax ICDs/CRT-Ds would continue

with shock therapy, but all shocks programmed at less than 10

joules would be delivered at 10 joules.

If a defibrillation shock is delivered but does not terminate the

arrhythmia, the next shock will always have the same or higher

energy than the last delivered shock. Beginning with the third

shock, all shocks are delivered at maximum energy.

2.9 Bradycardia Therapy

The Lumax ICDs/CRT-Ds have independently programmable

single, dual and triple chamber and post-shock pacing functions.

The post-shock bradycardia parameters may be programmed to

higher rates or output values for the period following a delivered

shock, without significantly compromising the longevity of the

ICD/CRT-D for patients who require chronic bradycardia pacing.

The post-shock programmable values are presented in a

separate subsection from the normal bradycardia pacing support

values.

2.9.1 Bradycardia Pacing Modes

The available bradycardia pacing modes for each member of the

Lumax ICD/CRT-D family are listed in Table 33.

Table 33 Lumax Pacing Modes

Mode Lumax

HF(-T)

Lumax

DR(-T)

Lumax

VR(-T)

Lumax

VR-T DX

DDDR X X N/A N/A

DDIR X X N/A N/A

VDDR X X N/A X

VDIR X X N/A X

AAIR X X N/A N/A

Lumax Technical Manual 103

Table 33 Lumax Pacing Modes

Mode Lumax

HF(-T)

Lumax

DR(-T)

Lumax

VR(-T)

Lumax

VR-T DX

VVIR X X X X

DDD X X N/A N/A

DDI X X N/A N/A

VDD X X N/A X

VDI X X N/A X

AAI X X N/A N/A

VVI X X X X

V00 X X X X

D00 X X N/A N/A

OFF X X X X

The basic rate timer is started by a sensed or paced event. A

sensed event outside of the refractory period inhibits pacing and

resets the lower rate time; in the absence of a sensed event, a

pacing pulse will be delivered at the end of the lower rate interval.

The pacing modes with an “R” indicate rate adaptive pacing

controlled by a motion based capacitive sensor. These modes are

functionally the same as the corresponding non-rate-adaptive

modes, except that the pacing rate is increased based on

physical activity.

2.9.2 Basic Rate

The basic rate is the pacing rate in the absence of a patient’s

intrinsic rhythm. This rate may be independently programmed for

normal and post-shock bradycardia pacing.

2.9.3 Night Rate

The night rate is the effective basic rate during the programmed

“sleep” period for the patient. This parameter provides a different

pacing rate during the patient’s normal sleep time in an attempt to

match, for example, the decreased metabolic needs during sleep.

When Night Mode is active, the basic rate automatically changes

to the programmed NIGHT RATE during the nighttime hours.

104 Lumax Technical Manual

At the programmed start time (Begin of Night), the rate gradually

adapts to the night rate. When the internal clock reaches the

programmed end time (End of Night), the pacing rate gradually

changes to the programmed basic rate. The rate changes at the

same rate as the Sensor Gain decrease and increase

parameters.

NOTE:

The Night Mode time is based on the programmer clock.

Therefore, the programmer time should be checked prior to

device programming. If a patient travels across different time

zones, the Night Mode time may require adjustment.

2.9.4 Rate Hysteresis

The ability to decrease the effective lower rate through

Hysteresis is intended to preserve a spontaneous rhythm. The

pulse generator operates by waiting for a sensed event throughout

the effective lower rate interval (Hysteresis interval). If no sensed

event occurs, a pacing pulse is emitted following the Hysteresis

interval.

Hysteresis can be programmed OFF or to values as low as

-90 bpm in Lumax 300/340 & 500/540 models (-65 bpm in the

Lumax 600/640 & 700/740 models) of the basic rate. Hysteresis

is initiated by a sensed event. The resulting Hysteresis rate is

always less than the lower rate. The Hysteresis rate can only be

programmed to provide a basic rate that is 30 bpm or greater.

NOTES:

If rate adaptation is active, the Hysteresis rate is based on the

current sensor-indicated rate and the value of the

programmable parameter.

If Hysteresis is used in the DDI mode, the AV delay must be

programmed shorter than the spontaneous AV conduction

time. Otherwise, stimulation in the absence of spontaneous

activity occurs at the hysteresis rate instead of the lower rate.

Lumax Technical Manual 105

Night Rate is the limit for the Hysteresis when Night Mode is

active. Programming conflicts arise when the total decrease

in rate is below 30 ppm. Care should be exercised to avoid

programming a Night Mode rate and hysteresis that are

below what is appropriate and may be tolerated by the

individual patient.

2.9.4.1 Repetitive Hysteresis

Repetitive hysteresis is expanded programmability of the

Hysteresis feature. Repetitive hysteresis searches for an intrinsic

cardiac rhythm, which may exist below the programmed lower

rate (or sensor-indicated rate) of the patient (see Figure 10).

Following 180 consecutive sensed events, this feature allows the

intrinsic rhythm to drop to or below the hysteresis rate. During the

time when the intrinsic rate is at or below the hysteresis rate,

pacing occurs at the hysteresis rate for the programmed number

of beats (up to 10) in the Lumax 300/340 & 500/540 models and

at 10 beats with scan hysteresis in the Lumax 600/640 & 700/740

models. Should the number of programmed beats be exceeded,

the stimulation rate returns to the lower rate (or sensor-indicated

rate).

If an intrinsic cardiac rhythm is detected within the programmed

number of beats between the hysteresis rate and the lower rate,

the intrinsic rhythm is allowed and inhibits the pulse generator.

Figure 10. Repetitive Hysteresis

106 Lumax Technical Manual

Repetitive hysteresis has been incorporated to promote

spontaneous cardiac rhythm and may reduce pulse generator

energy consumption.

NOTE:

Repetitive and Scan Hysteresis are only available when

Hysteresis is selected ON.

There is one Standard Hysteresis interval which occurs

before the programmable number of Repetitive Hysteresis.

2.9.4.2 Scan Hysteresis

Scan hysteresis is expanded programmability of the Hysteresis

feature. Scan hysteresis searches for an intrinsic cardiac rhythm,

which may exist just below the programmed lower rate (or

sensor-indicated rate). Following 180 consecutive paced events,

the stimulation rate is temporarily decreased to the hysteresis

rate for a programmed number of beats (see Figure 11) in the

Lumax 300/340 & 500/540 models and at 10 beats with scan

hysteresis in the Lumax 600/640 & 700/740 models. If a cardiac

rhythm is not detected within the programmed number of beats at

the hysteresis rate, the stimulation rate returns back to the

original lower rate (or sensor-indicated rate). Several

programmable beat intervals are available to allow a greater

probability of detecting a spontaneous rhythm.

If an intrinsic cardiac rhythm is detected within the programmed

number of beats between the hysteresis rate and the lower rate,

the intrinsic rhythm is allowed and the pulse generator inhibits.

Lumax Technical Manual 107

Figure 11. Scan Hysteresis

Scan hysteresis has been incorporated to promote intrinsic

cardiac rhythm and may reduce pulse generator energy

consumption.

2.9.5 Dynamic AV Delay

DR and HF versions only

The AV Delay defines the interval between an atrial paced or

sensed event and the ventricular pacing pulse. If the pulse

generator is programmed to a dual chamber sensing mode, an

intrinsic ventricular event falling within the AV Delay will inhibit the

ventricular pacing pulse. If not contraindicated, a longer AV Delay

can be selected to preserve intrinsic AV conduction.

Dynamic AV Delay is where the AV Delay is varied depending on

the spontaneous atrial rate. Dynamic AV Delay provides a linear

change of AV Delays depending on current rate at preset lower

and upper AV Delay values.

In addition to selecting the preset values (Low, Medium, and

High) with the Dynamic AV Delay window, the Dynamic

AV Delays may be programmed individually (Individual) for each

rate zone or to a fixed AV Delay (Fixed).

108 Lumax Technical Manual

The AV Delay feature includes an AV Delay shortening option

(Sense Compensation) for dual chamber pacing modes. When

enabled, the AV Delay is shortened by the programmed value

(-5 to -60 ms in Lumax 300/340 & 500/540 models and up to

-120 ms in Lumax 600/640 & 700/740 models) from the

programmed AV Delay after an intrinsic atrial sensed event.

The Dynamic AV Delay is intended to mimic physiologic-

shortening of the AV Delay with increasing heart rate. It also

serves for automatic prevention and termination of “circus

movement” pacemaker mediated tachycardia and for prevention

of reentrant supraventricular tachycardias. Dynamic AV Delay is

available with the Lumax DR-T and HF-T ICDs/CRT-Ds.

2.9.5.1 Positive AV Hysteresis

Positive AV Hysteresis allows a user-programmable change in

AV delay that is designed to encourage normal conduction of

intrinsic signals from the atrium into the ventricles. With Positive

AV hysteresis enabled, the AV delay is extended by a defined

time value after sensing a ventricular event (10 … (10) …150 ms)

in the Lumax 300/340 & 500/540 models and (70, 110, 150, 200

ms) in the Lumax 600/640 & 700/740 models. The long AV

interval is used as long as intrinsic ventricular activity is detected.

The programmed short AV delay interval resumes after a

ventricular paced event.

2.9.5.2 AV Repetitive Hysteresis

With AV Repetitive Hysteresis, the AV delay is extended by a

defined hysteresis value after sensing an intrinsic ventricular

event. When a ventricular paced event occurs, a long AV delay is

used for the programmed number of cycles. (OFF, 1 … 10) in

Lumax 300/340 & 500/540 models and 5 fixed cycles with scan

AV hysteresis in the Lumax 600/640 & 700/740 models. If an

intrinsic rhythm occurs during one of the repetitive cycles, the

long duration AV delay interval remains in effect. If an intrinsic

rhythm does not occur during the repetitive cycles, the original AV

delay interval resumes.

Lumax Technical Manual 109

2.9.5.3 AV Scan Hysteresis

With AV Scan Hysteresis enabled, after 180 consecutive pacing

cycles, the AV delay is extended for the programmed number of

pacing cycles. (OFF, 1 … 10) in Lumax 300/340 & 500/540

models and 5 fixed cycles with scan AV hysteresis in the Lumax

600/640 & 700/740 models. If an intrinsic rhythm is detected

within the extended AV delay, the longer AV delay remains in

effect. If an intrinsic rhythm is not detected within the number of

scan cycles, the original AV delay value resumes.

2.9.5.4 Negative AV Hysteresis

With Negative AV Hysteresis, the AV delay is decreased by a

programmable value (10 … (10) …150 ms) after a ventricular

event is sensed, thereby promoting ventricular pacing. The

shortened AV interval is used for one time.

2.9.5.5 Negative AV Repetitive Hysteresis

With AV Repetitive Hysteresis and negative AV Hysteresis, the

AV delay is shortened by a defined hysteresis value after sensing

an intrinsic ventricular event as described above. The short AV

Delay will remain until the programmed number of cycles has

elapsed. (OFF,1 … 180) in Lumax 300/340 & 500/540 models

and 180 fixed cycles in the Lumax 600/640 & 700/740 models.

The normal AV delay resumes after the programmed number of

consecutive ventricular paced events (Repetitive Negative AV

Hysteresis) elapses.

CAUTION

Negative AV Hysteresis – This feature insures ventricular

pacing, a technique which has been used in patients with

hypertrophic obstructive cardiomyopathy (HOCM) with normal

AV conduction, in order to replace intrinsic ventricular

activation. No clinical study was conducted to evaluate this

feature, and there is conflicting evidence regarding the

potential benefit of ventricular pacing therapy for HOCM

patients. In addition, there is evidence with other patient

groups to suggest that inhibiting the intrinsic ventricular

activation sequence by right ventricular pacing may impair

hemodynamic function and/or survival.

110 Lumax Technical Manual

2.9.6 IOPT

DR versions only

The IOPT function serves to support the patient’s intrinsic rhythm

and avoid excessive ventricular pacing. This feature simply

activates all of the AV hysteresis parameters with a single

selection. Table 34 details the settings that are preset when

IOPT is turned ON:

Table 34 IOPT Parameters

Parameter IOPT

AV Hysteresis (max AV Delay) 400 ms

AV Scan Hysteresis 5

Repetitive AV Hysteresis 5

2.9.7 Upper Tracking Rate

DR and HF versions only

In the atrial tracking modes (DDDR, VDDR, DDD, and VDD)

ventricular pacing tracks atrial pace/sense events. The maximum

tracking rate (ventricular pacing rate) is limited by the Upper Rate

parameter.

The UTR response will automatically toggle between 2:1 and

WKB (Wenckebach) depending on the relative programmed

values for upper rate and atrial refractory period (AV Delay +

PVARP).

If the UTR is less than the maximum sensed atrial rate, defined

by the atrial refractory period (60,000/ARP), the WKB response is

utilized. Atrial rates exceeding the selected upper rate will result

in a Wenckebach-type pacing pattern. This is accomplished by

progressively lengthening the AV delay to keep the ventricular

pacing rate at the upper rate. Lengthening of the AV interval is

interrupted as soon as: 1) a P-wave falls within the atrial blanking

period and is not detected; or 2) a succeeding P-wave is detected

before the end of the AV delay previously started. In the second

case, the corresponding ventricular pacing pulse is suppressed. If

the atrial rate is just above the upper rate, a low degree (i.e. 6:5)

block results. Higher atrial rates result in higher degrees of AV

block until the intrinsic atrial cycle length violates the programmed

atrial refractory period causing a 2:1 or greater block.

Lumax Technical Manual 111

The 2:1 response is utilized when the rate defined by the atrial

refractory period is less than the upper rate. In such a case, the

maximum pacing rate is regulated by the inability to respond to

P-waves falling within the atrial refractory period.

If the resulting length of the spontaneous atrial cycle is shorter

than the atrial refractory period in a rate-adaptive mode, the

resulting pacing rate will depend on whether the 2:1 rate has

been exceeded. If this is the case, the pulse generator will use

the sensor rate as the pacing rate. If the 2:1 rate is not exceeded,

the pulse generator will use a rate that lies between the sensor

rate and the rate determined by the atrial refractory period.

Atrial Upper Rate is designed to prevent pacing in the vulnerable

period after an atrial sensed event during PVARP. It ensures that

the next atrial pace is emitted outside of the patient’s normal

sinus atrial refractory period. Atrial Upper Rate is limited to

240 ppm or OFF in Lumax 300/340 & 500/540 models and OFF,

175, 200 or 240 ppm in the Lumax 600/640 & 700/740 models.

NOTE:

Lumax DR ICDs and Lumax HF CRT-Ds allow the UTR to be

programmed within the VT-1 zone. This feature is for patients

that are active and have exercise and VT rates that overlap.

This may be desirable in young active patients. Also, with

RVsense Triggering programming the UTR in the VT-1 zone

is blocked.

2.9.8 Mode Switching

DR and HF versions only

Mode switching is designed to avoid tracking of atrial arrhythmias.

In the presence of a high atrial rate, the bradycardia pacing mode

is automatically reprogrammed to a non-atrial tracking mode. The

modes available during mode switching are as shown in

Table 35. Mode switching is not available during the post-shock

pacing period. Mode Switching is only available with the Lumax

DR and Lumax HF ICDs/CRT-Ds.

112 Lumax Technical Manual

Table 35: Mode Switching Modes

Programmed Mode Converted Mode

DDDR DDIR

DDI

DDD DDIR

DDI

VDDR VDIR

VDI

VDD VDIR

VDI

Mode switching is initiated in atrial tracking modes when the atrial

rate, defined by the programmable mode switch Intervention

Rate is achieved. However, mode switching will not occur until

the Mode Switch Onset Criterion is also met. The activation

criterion is a programmable X out of 8 high rate intervals as

programmed. RVsense Triggering can be programmed

separately during mode switching.

After switching to a non-atrial tracking mode, the ICD/CRT-D

activates a Y out of 8 counter that deactivates mode switching

when Y number of cardiac cycles out of the last 8 are below the

Intervention Rate. When this Resolution Criterion parameter is

fulfilled, the ICD/CRT-D returns to the normal programmed pacing

mode.

In addition, the ventricular pacing configuration (RV or BiV) and

biventricular pacing parameters (LV T-wave protection and

Triggering) are programmable separately for mode switching

events.

2.9.8.1 Mode Switch Basic Rate

Whenever Mode Switching occurs, the device switches to a non-

tracking mode and will provide bradycardia pacing support at the

Mode Switch Basic Rate, which is displayed as the Change of

Basic Rate parameter. Once Mode Switching is terminated, the

permanently programmed pacing mode and programmed pacing

rate are restored.

Lumax Technical Manual 113

2.9.8.2 Post Mode Switch Response

Whenever Mode Switching event terminates, deactivating the

mode switch pacing, the device can be programmed to react with

a different basic rate for a specified amount of time. Two

parameters are used to set the Post Mode Switch Response.

Post ModeSw Rate sets the rate difference (from permanent

program) in pacing rate during the programmed Post ModeSw

Duration time period. After the Post ModeSw Duration expires,

the pacing rate is ramped down to the programmed basic rate.

2.9.9 PMT Management

A PMT is defined as a tachycardia caused by inadvertently

tracking retrograde P-waves. The PMT management feature

includes PMT Protection/Termination and a programmable PMT

detection and termination algorithm.

2.9.9.1 Protection

PMT protection is accomplished by the following mechanisms

(see Figure 12):

 Upon detection of a ventricular extrasystole (VES), the

lower rate interval and the atrial refractory period (ARP)

are reset. Additionally, in VDD mode, the atrial refractory

period is initiated with a ventricular pacing pulse that has

not been triggered by atrial detection. This prevents a

retrograde P-wave with a VA conduction time shorter

than the ARP from being sensed and thus from triggering

a ventricular pacing pulse. This provides an automatic

PMT protection.

 A programmable atrial refractory period extension

(ARPE) is available in the DDD and VDD modes. To

prevent the initiation of a pacemaker mediated

tachycardia (PMT) by a ventricular depolarization not

preceded by an atrial depolarization, the ARP will be

extended by the ARPE if the ARP was:

o started by a ventricular sense event outside of the AV

delay (e.g., PVC) in DDD and VDD or

o reset by a ventricular pulse not triggered by an atrial

sense event in VDD.

114 Lumax Technical Manual

In these instances, the ARP will usually be long enough to

prevent sensing of retrograde P-waves. Programming to an

ARPE other than 0 ms may rarely be required but could provide

additional protection if the ARP is limited or the retrograde

conduction time extended.

Figure 12. Prevention of PMT by VES starting ARP (DDD).

2.9.9.2 Termination

PMT termination can be accomplished by the following

mechanism:

The programmable dynamic AV delay in combination with a fixed

TARP (i.e. modulated PVARP) can act as a ‘passive’ termination

of a PMT. Because a PMT is generally at higher rates, the

AV delay will be relatively short. This causes the PVARP to be

prolonged, which then increases the chance that a retrograde

conducted atrial depolarization falls in the PVARP and thus will be

inhibited, terminating the PMT (see Figure 13).

Figure 13. Dynamic AV delay for PMT termination

Lumax Technical Manual 115

2.9.9.3 PMT Detection and Termination

In addition to PMT prevention, Lumax contains a programmable

PMT detection and termination algorithm. The termination feature

will take action in case the prevention was not effective and a

PMT is detected. The PMT detection constantly monitors for the

presence of a PMT.

The Lumax PMT detection/termination algorithm consists of

suspicion, confirmation and termination components and is

described as follows.

Suspicion

A PMT is suspected when two criteria are met:

 8 successive V pace-A sense (Vp-As) sequences have

occurred with a length shorter than the VA criterion. This

VA criterion is programmable between 250 and 500 ms.

 The mean deviation of these 8 Vp-As intervals is less

than the Stability criterion parameter, defined as less than

25 ms.

Confirmation

When the suspicion criterion has been met, the Lumax slightly

modifies the AV delay interval (+ or - 50 ms) or the upper tracking

rate (+50ms) for one cardiac cycle. If the Vp-As interval remains

stable, a PMT is confirmed. Otherwise, a PMT is not confirmed

and the algorithm restarts. Once the PMT algorithm has

confirmed a PMT, the cycle is broken as follows:

Termination

Lumax extends TARP (Total Atrial Refractory Period) for one

cycle to equal the V-V interval + 50 ms. The Lumax 600/640 &

700/740 models extend the AV delay and the PVARP+ Ext.

2.9.10 VES Discrimination after Atrial Sensed

Events

Lumax ICD/CRT-D has a special timing interval (VES/As) – VES

discrimination after atrial sense events to identify ventricular

extrasystoles.

116 Lumax Technical Manual

With each As and As (PVARP), a VES discrimination interval is

started in the ventricle. If a ventricular sensed event occurs within

the discrimination interval, this event is interpreted as a Vs

(ventricular sensed event), and no PVARP after VES protection

interval is started.

In the factory setting, the VES discrimination after As is set to

350 ms (programmable: 250…(50)…450 ms in Lumax 300/340 &

500/540 models and up to 500 ms in the Lumax 600/640 &

700/740 models). The VES/As terminates with each ventricular

event.

If a ventricular event does not fall within the AV delay or the VES

discrimination interval, it is classified as a VES. A ventricular

event that is sensed within the VES discrimination interval, but

outside the AV delay, starts a VA delay after which an atrial pace

is delivered.

2.9.11 Rate-Adaptive Pacing

WARNING

Rate-Adaptive Pacing – Use rate-adaptive pacing with care

in patients unable to tolerate increased pacing rates.

Lumax ICD/CRT-D allows the selection of rate-responsive pacing

modes. These modes allow the ICD/CRT-D’s bradycardia therapy

function to adapt the pacing rate to increasing or decreasing

patient physical activity, based on data collected from a motion

based sensor within the ICD/CRT-D. Separately programmable

criteria allow the clinician to control the rate of increase and

decrease of pacing, as well as the sensitivity of the sensors in

response to motion.

Lumax Technical Manual 117

2.9.11.1 Sensor Gain and Threshold

The Sensor Gain defines how much the sensor signal is amplified

before it is transformed to a rate change. When the Sensor Gain

is low (e.g., 2), a great deal of exertion is needed to cause a

significant change in sensor output (and an equal change in the

pacing rate). When the Sensor Gain is high (e.g., 18), little

exertion is needed to increase the sensor output. Ideally, the gain

is programmed so the maximum desired pacing rate during

exercise occurs at a maximum exertion level. The Lumax 600/640

& 700/740 models use AUTO, VERY LOW, LOW, MEDIUM,

HIGH, and VERY HIGH values to program the Sensor Gain.

The device ignores all activity that occurs below the Sensor

Threshold because the Sensor Threshold defines the lowest

sensor output that initiates a change in the pacing rate. Five

different threshold settings are available including; VERY LOW,

LOW, MEAN, HIGH, and VERY HIGH. When the threshold is

programmed optimally, the basic rate is the effective rate while

the patient is not moving (at rest).

2.9.11.2 Rate Increase/Decrease

The Rate Increase and Decrease parameters work with the

Sensor Gain to determine how quickly the pacing rate will

increase or decrease during changes in the sensor output.

2.9.11.3 Maximum Sensor Rate

Regardless of the sensor output, the sensor-driven pacing rate

never exceeds the programmable Max. Sensor Rate. The

maximum sensor rate only limits the pacing rate during sensor-

driven pacing.

2.9.11.4 Auto Sensor Gain

The Lumax ICDs/CRT-Ds offer Automatic Sensor Gain Auto

Gain settings, which allows the Auto Gain parameter to be

adjusted automatically.

When the Automatic Sensor Gain is activated, the pulse

generator samples the sensor-indicated rate.

 If 90% of the maximum sensor rate is not reached for the

duration of 1 hour within a week (7 days), gain is

incremented by one step.

118 Lumax Technical Manual

 If 90% of the maximum sensor rate is reached for 1 hour

within 24 hours, gain is reduced by one step.

2.9.12 Pulse Amplitude

The Pulse Amplitude parameters, are separately programmable

for atrial and both ventricular channels and they, define the

amplitude in volts of the pacing pulses. The pulse amplitude is

also independently programmable for normal bradycardia pacing

and fixed to 7.5V for post-shock pacing in RA and RV and as

permanent programmed in LV.

2.9.13 Pulse Width

The Pulse Width parameters are separately programmable for

atrial and both ventricular channels and they define the duration

of the pacing pulses. The pulse widths are also independently

programmable for normal bradycardia pacing and fixed to 1.5 ms

for post-shock pacing in RA and RV and as permanent

programmed in LV.

2.9.14 Post Ventricular Atrial Refractory Period

DR and HF versions only

Immediately following each paced ventricular event, an atrial

refractory period is started; this period is called Post Ventricular

Atrial Refractory Period or PVARP. Atrial signals are ignored

during this time for bradycardia timing purposes to prevent the

ICD/CRT-D from sensing inappropriate signals.

2.9.15 PVARP after VES

DR and HF versions only

This parameter extends the Post Ventricular Atrial Refractory

Period by the programmed interval, if the ventricular event is not

followed by an atrial sensed event (VES).

Lumax Technical Manual 119

2.9.16 Auto PVARP

DR and HF versions only

This parameter automatically adjusts the Post Ventricular Atrial

Refractory Period (PVARP) and PVARP after VES, if a

pacemaker mediated tachycardia (PMT) has been detected and

terminated to avoid additional PMT events. After seven days,

PVARP and PVARP after VES are reduced as short as possible

until a new PMT occurs or the shortest value of these parameters

is reached. This helps to keep the PVARP and PVARP after VES

as short as possible to protect the patient from PMT.

2.9.17 Noise Response

The Lumax ICD/CRT-D’s response to detected noise is to deliver

asynchronous pacing in the affected channel.

2.9.18 Post Shock Pacing

Separately programmable bradycardia pacing support is available

with the ICD/CRT-D following shock therapy delivery. Because a

delay in bradycardia pacing may avoid re-initiation of a

tachyarrhythmia, after a short blanking period (1 second), the

ICD/CRT-D will begin in standard program (DDI in DR & HF type

devices and VVI in VR & DX type devices) bradycardia therapy at

the post shock pacing rate, amplitude (fixed to 7.5 V for RV and

as permanent programmed for LV), and pulse width (fixed to 1.5

ms) for the programmed Post-Shock Duration.

Separate post shock programming of the following parameters is

available:

 Ventricular Pacing Configuration (RV, BiV)

 Basic Rate

 Rate Hysteresis

 Fixed AV Delay

 Post Shock Duration

If bradycardia pacing is still required after the post shock duration

expires, standard bradycardia pacing parameters are active.

120 Lumax Technical Manual

2.10 EP Test Functions

Several EP test functions are available with the Lumax family of

ICD/CRT-Ds including; P and R-wave amplitude, pacing and

shock impedances, retrograde conduction and pacing threshold

measurements. Extensive testing of defibrillation thresholds as

well as the ability to verify the effectiveness of anti-tachycardia

pacing and defibrillation shocks are also available.

2.10.1 P and R-wave Amplitude Measurements

The Lumax ICDs/CRT-Ds provide a P-/R-wave test for measuring

the amplitude of intrinsic events during follow-up examination.

The test determines the amplitudes with a predetermined

temporary pacing mode.

To permit evaluation of the sensing function, the pacing rate must

be lower than the patient's intrinsic rate. In demand pacing, the

proper sensing function can be recognized if the interval between

intrinsic events and the following pacing pulse equals the basic

interval (if no Hysteresis is programmed). The following

parameters are programmable when performing the

measurements:

 Pacing Mode

 Ventricular Pacing (HF(-T) only)

 Pacing Rate

 Upper Rate (Dual Chamber modes only, not in Lumax

600/640 & 700/740 models)

 Pulse Amplitude (Not applicable to Lumax 600/640 &

700/740 models)

 Pulse Width (Not applicable to Lumax 600/640 & 700/740

models)

For evaluation of the sensing function, the pulse generator

features an intracardiac electrogram (IEGM) with marker signals

to indicate sensed and paced events.

Lumax Technical Manual 121

2.10.2 Pacing Impedance Measurements

The Lumax ICDs/CRT-Ds have the ability to perform automatic

and manual pacing impedance measurements. The devices can

measure the pace impedance in all leads; RA, RV and LV. In

Lumax 300/340 and 500/540 models, the measurement can be

performed in any the of the pacing configurations; RA, RV, LV or

BiV. In Lumax 600/640 and 700/740 models, it uses a sub-

threshold measurement in all channels connected to leads

automatically. In all Lumax devices, the LV pacing polarity is also

programmable for impedance measurements additionally. (See

Section 2.1).

The impedance in Lumax 300/340 and 500/540 models is

measured using a triggered mode with paces of 2.4 Volts and

0.5 ms, or programmed value (whichever is higher). During

automatic measurements both atrial (only with an atrial pacing

mode) and ventricular (RV, LV or BiV) impedances are

measured. However, they will not be measured if the normal

pacing output is programmed to a value greater than the

impedance test output (2.8 V).

2.10.3 Shock Impedance Measurements

The Lumax ICDs/CRT-Ds have the ability to perform automatic

and manual painless shock impedance measurements. The

devices can measure the shock impedance by delivering an

undetectable 3 nJ shock by applying 1 mA of current. The device

then measures the resulting voltage drop and calculates the

resulting shock impedance. This impedance measurement is tied

to the pacing impedance measurement, meaning that the pacing

impedance measurement is done daily, and shock impedance is

done (concurrently with pacing impedance measurement) every

fourth day. The results of these impedance measurements are

available through the device’s statistics function.

122 Lumax Technical Manual

2.10.4 Testing for Retrograde Conduction

Retrograde conduction from the ventricles to the atrium can be

assumed when a 1:1 relationship between the ventricular

stimulation and atrial depolarization has been obtained with a

constant coupling interval during ventricular stimulation. The

ICD/CRT-D features a test for measuring retrograde conduction

time. During operation of this test, the patient is paced (in VDI

mode) at an increased ventricular rate over several cycles while

the retrograde conduction time is measured. Therefore, the

pacing Rate must be programmed at a rate higher than the

patient’s intrinsic rhythm.

This measurement can be made for both the right and left

ventricles, but only one at a time. The ventricle being tested,

pacing rate, voltage and pulse width are all programmable. In

addition, the pacing polarity of the left ventricle is also

programmable as described in Section 2.1. Both the programmer

display and printout provide measured retrograde conduction

times. The duration of time that the test is conducted is based on

how long the Measure button is depressed. The paper speed for

the test printout is also programmable for this test.

To prevent retrograde P-waves from triggering ventricular pulses,

thereby mediating a “re-entry” tachycardia (pacemaker mediated

tachycardia, PMT), it is recommended that the programmed post-

ventricular atrial refractory period be programmed longer than the

retrograde conduction time.

2.10.5 Pacing Threshold

The test is activated as a temporary program with specific

operation. Removal of the programmer head immediately stops

the test and reactivates the permanent program.

The following parameters are programmable during the pacing

threshold test: Appropriate chamber and pacing mode, pacing

rate, AV Delay (if appropriate), upper rate, pulse amplitude and

pulse width, and number of pulses for each test voltage. In

addition, the preferred automatic printing capabilities are

adjustable. The pacing modes available for the threshold test are

AAI (atrial only), VVI (LV and RV only), DDI, and DDD. The pulse

amplitude is easily adjustable during the threshold testing by

selecting the desired value from the table.

Lumax Technical Manual 123

2.10.6 Arrhythmia Induction Features

The ICD/CRT-D offers three arrhythmia induction methods for

non-invasive EP testing. These include the following:

WARNING

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/CRT-D system, it is necessary to induce and convert

the patient’s ventricular tachyarrhythmias.

CAUTION

Manual Shocks – User-commanded shocks may be withheld

if the ICD/CRT-D is already busy processing a manual

command or the Battery Status is low.

HF Burst Induction consists of a large number of pulses

delivered in rapid succession over a period of several seconds.

The frequency of the pulses and the duration of the burst are

defined by the user.

Burst + PES (Lumax 300/340 & 500/540 models only) Induction

delivers a programmed number of pacing stimuli followed by a

programmable number (Number S1) of timed extra stimuli. The

burst rate (intervals) is independently programmable, as is the

chamber being stimulated (RV, LV or BiV). The interval between

S1s and the remaining programmed extra stimuli (PES: S1

through S4 possible) are also programmable.

Shock on T induction mode allows tachyarrhythmia induction by

means of a timed T wave shock delivered after a series of paced

stimuli. Energy of the T wave shock, number of pulses

(Number S1) in the pulse train, synchronization interval (R-S1)

and the shock Coupling interval are all programmable.

124 Lumax Technical Manual

2.10.7 Manual Shock

The ICD/CRT-D can deliver a manual shock on demand through

a programmer command in the EP test menu. For manual

shocks, the energy, polarity and waveform are programmable

by the user. To deliver a shock, place the wand over the device

and select the Start Shock button. A confirmation menu will

appear and the shock command will be delivered upon selecting

the OK button in this screen. After each manual shock, the EP

test screen will display the shock energy, lead impedance and

charge time.

2.10.8 Test Shock

The ICD/CRT-D can deliver a 1 Joule (R-wave synchronous) test

shock on demand through a programmer command in the EP test

menu. This shock is designed to measure the shock impedance

and test the integrity of the shock electrodes of an implanted ICD

lead.

NOTE:

When the test shock is administered, VF detection is

automatically enabled.

WARNING

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/CRT-D system, it is necessary to induce and convert

the patient’s ventricular tachyarrhythmias.

CAUTION

Defibrillation Threshold - Be aware that the 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.

Lumax Technical Manual 125

2.10.9 Manual ATP

The ICD/CRT-D can deliver a manual ATP on demand through a

programmer command in the EP test menu. To deliver an ATP

sequence, place the wand over the device and select the Start

ATP button. A confirmation menu will appear and the

programmed pacing sequence command will be delivered upon

selecting the OK button in this screen. Programming of the

manual ATP is similar to the programming available for automatic

ATP therapy as described in Section 2.8.2.

2.10.10 Emergency Shock

The ICD/CRT-D can deliver an emergency maximum energy

shock on demand through a programmer command in the EP test

menu. For emergency shocks, the energy (maximum 30 or 40 J),

polarity (Standard) and waveform (Biphasic) are pre-defined. To

deliver a shock, place the wand over the device and select the

Emergency Shock button. A confirmation menu will appear and

the shock will be delivered.

2.11 Special Features

The Lumax includes several special features to improve ease of

use and provide additional information to the user.

2.11.1 ICD Therapy Status

Interrogate the device to observe the ICD Therapy window (upper

right hand corner) of the main programming screen which

indicates the ICD Therapy status (either ON or OFF). The overall

ICD therapy can be controlled by selecting ON (enabled) or OFF

(disabled). If the device has not been interrogated, the

programmer displays “Unknown” highlighted in red in the ICD

therapy window.

126 Lumax Technical Manual

WARNING

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 implant procedure.

2.11.2 Thoracic Impedance

The thoracic impedance is measured between the distal shock-

coil of the RV lead and the ICD housing. Up to 1,024

measurements are done every hour and these measurements are

then averaged. The 24 measurements per day are stored in the

device and transmitted via Home Monitoring. The Home

Monitoring website then displays a trend of the daily average. The

same trend of daily TI averages is displayed on the programmer

upon interrogation of the ICD. The TI trend does not replace

assessments that are part of standard of care for the clinical

practice. The clinical value of this feature has not been

established for the management of patients.

Note: Pocket and or lead revisions may affect the TI trend data.

Therefore, the TI trend data should be interpreted cautiously within 6-

10 weeks of a revision.

2.11.3 Home Monitoring®

Home Monitoring enables the exchange of information about a

patient’s cardiac status from the implant to the physician. Home

Monitoring can be used to provide the physician with advance

reports from the implant and process them into a graphical and

tabular format called a Cardio Report. This information helps the

physician optimize the therapy process, as it allows the patient to

be scheduled for additional clinical appointments between regular

follow-up visits if necessary.

BIOTRONIK conducted the TRUST study to evaluate the safety

and effectiveness of Home Monitoring. Refer to Section 1.6.4 for

details regarding the study design and results. With the TRUST

study, BIOTRONIK was able to show the following with regards to

Home Monitoring:

 BIOTRONIK Home Monitoring information may be used as a

replacement for device interrogation during in-office follow-up

visits.

Lumax Technical Manual 127

 A strategy of care using BIOTRONIK Home Monitoring with

office visits when needed has been shown to extend the time

between routine, scheduled in-office follow-ups of

BIOTRONIK implantable devices in many patients. Home

Monitoring data is helpful in determining the need for

additional in-office follow-up.

 BIOTRONIK Home Monitoring-patients—who are followed

remotely with office visits when needed—have been shown to

have similar numbers of strokes, invasive procedures and

deaths as patients followed with conventional in-office

follow-ups.

 BIOTRONIK Home Monitoring provides early detection of

arrhythmias.

 BIOTRONIK Home Monitoring provides early detection of

silent, asymptomatic arrhythmias.

 Automatic early detection of arrhythmias and device system

anomalies by BIOTRONIK Home Monitoring allows for earlier

intervention than conventional in-office follow-ups.

 BIOTRONIK Home Monitoring allows for improved access to

patient device data compared to conventional in-office

follow-ups since device interrogation is automatically

scheduled at regular intervals.

The implant’s Home Monitoring function can be used for the

entire operational life of the implant (prior to EOS) or for shorter

periods, such as several weeks or months. Home Monitoring is

programmable, ON or OFF.

NOTE:

When ERI mode is reached, this status is transmitted. All

measurements and transmissions are unaffected. When End

of Service (EOS) is reached and transmitted, further

measurements and transmissions of Home Monitoring data

are no longer possible.

128 Lumax Technical Manual

2.11.3.1 Transmission of Information

The implant transmits information with a small transmitter, which

has a range of about 2 meters. The patient’s implant data are

sent to the corresponding patient device in configurable periodic

intervals. The transmissions may also be activated by the

detection of a cardiac event, as programmed. The types of

transmissions are discussed in Section 2.11.3.3.

The minimal distance between the implant and the patient device

must be maintained at 15 cm.

2.11.3.2 CardioMessenger II

The CardioMessenger II patient device (Figure 14) is designed

for use in the home and is comprised of the mobile device and the

associated charging station. The patient can carry the mobile

device with them during his or her occupational and leisure

activities. The patient device is rechargeable, allowing for an

approximate operational time of approximately 24 hours. It

receives information from the implant and forwards it via

telephone networks (cellular or traditional) to the BIOTRONIK

Service Center.

For additional information about the CardioMessenger II, please

refer to its manual.

Lumax Technical Manual 129

Figure 14: Example of CardioMessenger II with Charging

Stand

2.10.2.3 Transmitting Data

The implant’s information is digitally formatted by the BIOTRONIK

Service Center and processed into a concise report called a

Cardio Report. The Cardio Report is available in two formats; via

fax or via BIOTRONIK’s secure Internet connection. Reports are

available depending on the type of report transmission—periodic

or event triggered. This Cardio Report, which is adjusted to the

individual needs of the patient, contains current and previous

implant data. An Intracardiac Electrogram (IEGM) is included for

each tachycardia episode (VT⁄VF). The Internet site allows the

physician to “program” the Service Center on how the Cardio

Report information is supplied; either by fax, SMS message or on

the Internet. All reports use a similar report format.

For more information on registering for Home Monitoring, contact

your BIOTRONIK sales representative.

130 Lumax Technical Manual

The password protected BIOTRONIK Home Monitoring website

can be accessed at the following URL:

www.biotronik-homemonitoring.com

An online help menu is available in order to assist with the use of

the Home Monitoring website.

Use of the Internet for reviewing Home Monitoring data must be in

conjunction with the system requirements listed in Table 36

Additionally, Table 36 provides system specifications that are

recommended for optimizing usage of the Internet.

Table 36: System Requirements/Recommendations

System

Requirements

System

Recommendation

s (for Optimal

Usage)

Screen Resolution

1024 x 768

≥ 1280 x 1024

Internet Bandwidth

56 kB/sec

≥ 128 kB/sec

(DSL, cable

modem)

800 MHz Pentium

processor, 128 MB

RAM

N/A

Internet Browser

MS Internet

Explorer 5.5

≥ MS Internet

Explorer 5.5

- or -

≥ Mozilla 1.8

(Firefox ≥ 2.0)

Acrobat Reader

Version 6.1

Version 6.1 or

higher

Lumax Technical Manual 131

Table 36: System Requirements/Recommendations

System

Requirements

System

Recommendation

s (for Optimal

Usage)

Communication

Channel

Fax (G3) or e-mail

Fax (G3), e-mail or

mobile phone

2.11.3.3 Types of Report Transmissions

When the Home Monitoring function is activated, the transmission

of information from the implant can be triggered as follows:

 Daily report – the time period (daily) initiates the

transmission (IEGM included if not yet sent)

 Event report – the ICD/CRT-D detects certain events,

which initiate a transmission (IEGM included if not yet

sent)

 Periodic IEGM report – certain event reports can be

programmed to have an IEGM included each time that

they are transmitted. The IEGM includes comprehensive

event details with up to 10 seconds of IEGM (8 seconds

pre-detection and 2 seconds pre-termination).

 Programmer triggered report – a test message

transmitted upon request of the physician in the clinic.

Daily Report

The time of daily Home Monitoring Report transmission is

programmable. For periodic messages, the time can be set

anywhere between 0:00 and 23:59 hours. It is recommended to

select a time between 0:00 and 4:00.

132 Lumax Technical Manual

Periodic Report with IEGM

The Lumax ICDs and CRT-Ds can be programmed to transmit

IEGMs with the daily Home Monitoring report on a periodic basis

with the interval selected; OFF, 2, 3, 4, or 6 months.

Event Report

When certain cardiac and technical events occur, a report is

automatically generated. This information is described as an

“event report.”

The implant supports the following automatic event triggers:

 Termination of VT/VF Episode (not Termination of a

Monitoring episode, SVT episode or Detection while

Magnet applied (DTM) episode)

 Ongoing Atrial Monitoring Episode lasting longer than the

programmed time (0.5, 6, 12 or 18 hours)

 Impedance out-of-range for A, RV, LV, shock lead

(painless)

 Special Device Status

 First ineffective 30 J shock detected

 Initial detection SVT

 Percent of ventricular sensing below set limit

 Device status – ERI/EOS/ROM-Mode

Programmer Triggered Report

With the device status screen, it is possible to test the

ICD/CRT-D’s Home Monitoring capabilities during device

implantation or follow-up.

NOTE:

Battery voltage and pace/sense lead impedance are

measured before the first transmission of the day. Therefore,

the first transmission may occur 2 minutes after the

programmed transmission time.

2.11.3.4 Description of Transmitted Data

The following data are transmitted for the Cardio Report by the

Home Monitoring system, when activated. In addition to the

medical data, the serial number of the implant is also transmitted.

Lumax Technical Manual 133

Device Status & Home Monitoring Settings

Containing device and message identifying values that pertain to

the implant and Home Monitoring:

 Implantation Date

 Battery voltage & Date of Measurement

 Device Status

 Master-switch (e.g., ICD Therapy ON or OFF)

 Standard error flags

 Current Consumption for ERI calculation (done by the

Service Center)

 Date and time of Last Follow-up and Program Counter

 Message Creation Date/Time

 Device Serial Number

 Current ROM/RAM Version Information

Leads

 Automatic Threshold Monitoring

 Measured RV pacing threshold

 Measured LV pacing threshold

 RV enabled/disabled

 LV enabled/disabled

 Date/time of ATM measurement

 Pacing Impedance (RA, RV, LV/BiV)

 Mean of 4 daily measurements

 Sensing Amplitude (RA, RV, LV(BiV)

 Mean of 4 daily measurements

 Minimum of 4 daily measurements

 Painless Shock Impedance

 Mean of 4 daily measurements

 Thoracic Impedance

 Hourly mean of up to 1024 measurements/hour

 Data of last Shock

 Impedance & Date of last Shock delivered

 Complete Shock Holter Entry

134 Lumax Technical Manual

Pacing Counters (Brady)

 AV-Sequences

 Intrinsic Rhythm (AsVs)

 Conducted Rhythm (AsVp)

 Atrial Paced Rhythm (ApVs)

 Complete Paced Rhythm (ApVp)

The above parameters are transmitted as 3 byte counter.

Pacing Counters (CRT)

 LV-RV-Sequences

 BiVp (RVp-LVp or LVp-RVp

 RVs-LVp

 RVp-noLVp, RVs-noLVp (LV T-wave protection ON)

 LVp, noLVp (LV pacing only)

 VES-Triggered Resynchronization

 VES-LVp (Triggering: RVs+RVES)

 VES-noLVp (LV T-wave protection ON)

 VES per hour

The above parameters are transmitted as 3 byte counter.

Atrial Arrhythmia

 Atrial Tachy Episodes (36 out of 48 criteria)

 Life-Time Counter on AT/AF detections

 Atrial Burden per Day°

 Ongoing Atrial Episode Time (programmable for

30min, 6, 12 or 18 hrs)

 Mode Switching

 Number of Mode Switches per Day°

 SVT (Discrimination within VT zones)

 Lifetime Counter of Detections in SVT

 Number of SVT by SMART

 Number of SVT without SMART

 Ongoing SVT episode (current episode open)

Ventricular Arrhythmia

 Lifetime Counters

 Detections in VT1, VT2, VF,

Lumax Technical Manual 135

 Initial Detections during Detection while Magnet

applied (DTM) (induction)

 Started + successful ATP in VT

 Started + successful ATP-One-Shot in VF

 Started + cancelled + successful Shocks

 Shock Path

 Ineffective maximum energy shocks

 Date, Time and Number of last Episode (number as in

episode listing in Holter)

 Other Ventricular Arrhythmia

 Number of Mean PVC/h per day ("per Day" is

referenced to the Monitor Interval Duration)

Heart Failure Monitoring (all data based on Monitoring

Interval)

 Heart Rate

 Mean ventricular heart rate

 Minimal ventricular heart rate at rest

 Max/mean ventricular heart rate during atrial

episodes

 Heart Rate Variability

 Atrial SDANN per day (5 min periods of As-As)

 Patient Activity

 Duration per day (from Sensor)

Transmitted Device Settings

The primary programmed parameters for the following are sent in

the data package:

 Leads – (e.g., Pacing Output, Configuration)

 Brady - (e.g., Basic Rate, UTR, AV-Delays, RV

Sensitivity)

 CRT - (e.g., Configuration, VES Triggering, VV delay)

 IOPT - (ON/OFF)

 AV Delay Adjust setting - (ON/OFF)

 Ventricular Tachycardia Detection - (e.g., Zone limits,

SMART Detection, Sustained VT)

136 Lumax Technical Manual

 Ventricular Tachycardia Therapy - (e.g., ATP Schemes,

Shock energies)

 HM Settings - (e.g., ON/OFF, transmission time (daily),

IEGM transmissions ON/OFF, periodic IEGM, ongoing

atrial episode, statistics, holter)

System Information

Information is also added by the CardioMessenger II to the

message from the implant. This information contains the following

data:

 Timing delay between reception in the

CardioMessenger II and Delivery to a provider

 Cardio Messenger II Serial Number

 Technical Parameters for Troubleshooting

2.11.3.5 IEGM Online HDs

The Lumax ICDs/CRT-Ds provide the ability to transmit IEGM

Online HD (IEGM and marker data) from the most recent

SVT/VT/VF/AF episodes as an additional to the current

messages.

An IEGM with up to 3 channels (RV, LV, RA or Far-Field) are sent

in one message, depending on the number of IEGM channels

programmed in the Holter configuration.

If an episode is terminated each IEGM Frame contains up to 8s of

pre-detection IEGM and up to 2s of pre-termination IEGM

If the episode is not terminated each IEGM Frame shall contain

up to 10s of pre-detection IEGM

The IEGMs delivered for specific events are as follows

 For VT/VF therapy episodes both pre-detection and pre-

termination parts are sent (8s + 2s), because HM is

triggered after termination detection.

 If AF, SVT, or VT monitoring episodes are terminated,

both pre-detection and post-detection parts are sent (8s +

2s), if this episode is the most actual episode at the time

of the next periodic message, because termination of the

monitoring episodes does not trigger a message. If it is

not terminated only pre-detection is sent.

Lumax Technical Manual 137

 If an ongoing atrial episode fulfills a programmed time

duration criteria, a message is triggered to provide the

physician with the information early on.

 For the periodic IEGM only a pre-detection-part is

available, recording of this episode is performed right

before a periodic message, as often as configured.

The Lumax ICD/CRT-D transmits the following data from the

Episode List with the IEGM message:

 Episode Number,

 Date and time of initial detection,

 Date and time of termination,

 Indication of magnet application (induced episode and

forced termination)

 Zone of Initial Detection,

 Number of delivered ATP and shocks during this episode,

 Number of redetections per zone

 SMART Detection setting (VT zones activated)

 SMART path (for SVT)

 Duration of episode

The following markers are also transmitted: AS (including Ars), AP,

VS (including Vrs), VP, VT1, VT2, VF, SVT (atrial and refractory

sensed events included with sensed events), and AF.

The IEGM Online HD from the most recent episode is stored in

the device in an IEGM data buffer. The firmware updates the

IEGM transmission buffer before the first IEGM transmission

episode. IEGM data from a VT/VF episode is available after

Termination detection of an episode. If the Holter configuration

records an SVT IEGM episode, the IEGM data from an SVT

episode is available after Termination detection of an episode. An

IEGM message is transmitted with daily, periodic IEGM, and

episode messages (unless already sent). An IEGM is not sent

with programmer triggered and ROM/EOS messages.

The Lumax ICD/CRT-D includes a programmable parameter to

disable or enable the IEGM transmission. The default value is

“enabled.”

138 Lumax Technical Manual

2.11.3.6 Scheduling Remote Follow-up

The Lumax 700/740 and 600/640 ICDs/CRT-Ds provide the

ability to automatically schedule remote follow-ups using the

programmer. This feature has the following two options:

1. Fixed Follow-up Intervals (using 30-180 day cycles) from

the date of the first scheduled transmission:

2. Selection of 5 sequential dates* with a minimum time lag

of 20 days between any two selected dates.

*If the 5 dates have been expired the standard period for periodic

IEGM (30 days) will be enabled.

2.11.4 Real-time IEGM Transmission

The pulse generators provide real time transmission of the

unfiltered intracardiac electrogram (IEGM) to the programmer.

IEGMs from the atrium and ventricles can be simultaneously

recorded with a bandwidth of 0.5 to 200 Hz. Depending on the

device, the following channels are simultaneously recorded:

 During single chamber (VR/VR-T) operation, far field, and

RV electrograms are available.

 During dual chamber (DR/DR-T) operation, far field, RA,

and RV electrograms are available.

 During triple chamber (HF/HF-T) operation, RA, RV, and

LV electrograms are available.

Lumax Technical Manual 139

The IEGMs may be transmitted to the programmer via the

programming wand positioned over the implanted pulse

generator. The surface ECG is continuously displayed in the

Overview screen, the Sensing screen and the EP test functions

module. Real-time IEGMs are available in the EP tests and

sensing/impedance screens. They are then displayed together

with surface ECG and markers on the programmer screen and

printed on the ECG recorder. Likewise, intracardiac signals and

markers identifying atrial/ventricular paced and sensed events are

received via the programming wand, and may be displayed on the

programmer screen and printed on the ECG recorder.

To determine the amplitudes of intracardiac signals (P-/R-waves)

the automatic P/R-wave measurement function may be used.

Please refer to the appropriate software technical manual for a

description of marker signal operation.

2.11.5 Capacitor Reforming

Shock charge times may be prolonged if the high voltage

capacitors remain uncharged for an extended period of time.

Conditioning (or reforming) the capacitors by periodically charging

them will help assure shorter charge times for those patients that

do not regularly receive shock therapy. The Lumax devices

automatically re-form the capacitors after every 3 months. The

capacitor reformation clock is reset following an automatic or

manual capacitor reform. Any device initiated maximum charging

of the high voltage capacitors also resets the automatic

reformation clock (i.e., shock therapies).

An automatic or manually initiated capacitor reform fully charges

the capacitors and then allows the capacitors to discharge into an

internal resistor. No shock will be delivered to the patient.

Throughout the re-formation process the ICD/CRT-D will provide

bradycardia pacing support and tachyarrhythmia sensing and

detection as programmed. If a tachyarrhythmia is detected during

capacitor reformation, the process is aborted and therapy is

available if required.

140 Lumax Technical Manual

CAUTION

Capacitor Reformation - Infrequent charging of the high

voltage capacitors may extend the charge times of the

ICD/CRT-D. The capacitors are automatically reformed.

2.11.6 Patient and Implant Data

The Patient and Implant data screens allow input of data

regarding the patient name, demographics, implanting physician,

date, devices implanted, location of the implant, and various

conditions related to the patient. This information is transmitted to

the ICD/CRT-D and resides in the device memory for later recall if

needed.

2.11.7 System Status

Various device parameters can be monitored through the Status

section of the programmer screen. Displayed data includes

ICD/CRT-D information, charge circuit parameters, capacitor

reform information, battery status and voltage, and lead

information. The system status screen presents a large variety of

information about the Lumax ICDs/CRT-Ds including:

 Serial number (always displayed after interrogation)

 Software Release

 ICD status

 PID Number

 Battery status

 Battery voltage

 Last charge event and Last event with a maximum

energy charge:

 Energy

 Charge time

 Date

 Time

 Total number of charges

 Last Home Monitoring message

 Type of message

 Time and date

Lumax Technical Manual 141

2.11.8 HF Monitor Statistics

The ICD/CRT-D stores a variety of useful diagnostic data related

to heart failure status as described in the following sections.

2.11.8.1 Patient Activity

The patient’s activity is monitored based on the sensor indicated

pacing rate in both, rate adaptive and non-rate adaptive pacing

modes. The Lumax devices store information about the patient’s

activity level based on the sensor indicated pacing rate on a daily

basis. The device stores the time that the patient is active for

each 24-hour period. The time active is defined as the time where

the sensor indicated pacing rate is reached.

The sensor indicated pacing rate is the sensor rate above the

sensor’s threshold. The cumulative daily time when the sensor is

active is stored in the device for a period of 240 days. After 240

days, new daily values replace the oldest daily values.

2.11.8.2 Mean Heart Rate

The mean heart rate is calculated based on both ventricular

sensed and paced events. All types of events, including VES

(PVC) shall be included in the calculation of the mean value. On a

daily basis, the device measures and stores the patient’s mean

heart rate over a 24 hour period and has a value range of 0 to

180 bpm. The daily value is stored for a period of 240 days. After

240 days, new daily values shall replace the oldest daily values.

The programmer presents the daily bpm-value in a trend graph

for the last 240 days.

2.11.8.3 Mean Heart Rate at Rest

On a daily basis, the Lumax CRT-D measures and stores the

patient’s resting heart rate (MHRR). Average values are

calculated over a defined period. The daily value is based on the

smallest mean value in any evaluation window over the resting

period. The mean heart rate is calculated based on both

ventricular sensed and paced events. All types of events,

including VES (PVC) shall be included in the calculation of the

mean value.

142 Lumax Technical Manual

The MHRR value is measured during a programmed period,

defined by a Rest Period Start Time and a Rest Period Duration.

The resting period shall be adjustable via the programmer. The

MHRR has a value range of 0 to 180 bpm. The daily value

(MHRR) is stored for a period of 240 days. After 240 days, new

daily values replace the oldest daily values. The programmer

presents the daily bpm-value in a trend graph for the last 240

days.

2.11.8.4 Heart Rate Variability

Heart Rate Variability, which is the standard deviation of the 5-

minute mean normal to normal interval over the recorded time is

available in the statistics of the Lumax devices. This is based on

the atrial rate (P-P).

2.11.9 Holter Memory

Various device information is available within the Holter memory.

The Holter memory can be configured a number of different ways

depending on the physician’s preference.

2.11.9.1 Episode List

The ICD/CRT-D stores a variety of useful diagnostic data about

tachyarrhythmia episodes, which may be used to optimize

tachyarrhythmia detection and therapy parameters. This

diagnostic data includes detection counters; therapy counters,

last delivered ATP and shock therapy, shock data memory,

therapy history, and stored intracardiac electrograms.

Episode Details

Detailed information about each individual episode presented as

a table of events ordered from most recently delivered to the first

delivered. Each IEGM segment can be viewed from the episode

detail sub-menu by selecting the IEGM button (icon). From this

screen, an IEGM can be expanded and scrolled to assist in a

more accurate IEGM interpretation by enabling a closer

examination of specific segments.

Lumax Technical Manual 143

Stored IEGM

The ICD/CRT-D can store up to 32 minutes of triple chamber

intracardiac electrograms (IEGMs) including the history and

prehistory of the following events regarding AT/AF, VT/VF and

SVTs:

 Time

 Zone

 Descriptions

 PP and RR intervals

(before detection and

termination, displayed

only in the episode list)

 IEGMs

2.11.9.2 Shocks

The device history regarding high energy shocks is presented in a

table format with the following information:

 Shock Number

 Date

 Time

 Energy

 Charge time

 Impedance

 Type of shock/Remark

 Shock Pathway

2.11.9.3 Counters

The device history regarding several therapy and detection

parameters is presented in the “Counters” screen. For detection

and SVT details, this screen contains both the number of events

since the last ICD/CRT-D follow-up and totals since the device

was implanted. The available parameters include:

Detection Episodes (since last follow-up and since

implantation)

 Atr.

 SVT

 VT1

 VT2

 VF

144 Lumax Technical Manual

SVT Details

 AFlut

 AFib

 Sinus T

 1:1

Therapy Episodes (since last follow-up and since

implantation)

 Successful ATP Therapies in VT and ATP-One Shot

 Unsuccessful ATP Therapies in VT and ATP-One Shot

 Successful Shock Therapies

 Unsuccessful Shock Therapies

 Delivered ATP Therapies in VT and ATP-One Shot

 Delivered Shock Therapies

2.11.10 Timing Statistics

The ICD/CRT-D stores a variety of useful diagnostic data of the

bradycardia history as described in the following sections.

2.11.10.1 Event Counters

The total percentages of atrial sensed (PVARP and atrial

refractory period), atrial paced, right ventricular sense (VES and

refractory period) and ventricular paced events since the statistics

package was initiated are available. The total percentage of time

for each of the above listed events is also available. The total

numbers of atrial and ventricular events are also recorded.

2.11.10.2 Event Episodes

The total percentages of several timing events are displayed

under the Event Episode heading. These include:

Pacing Counters (Brady)

 AV-Sequences

 Intrinsic Rhythm (AsVs)

 Conducted Rhythm (AsVp)

 Atrial Paced Rhythm (ApVs)

 Complete Paced Rhythm (ApVp)

Pacing Counters (CRT)

 LV-RV-Sequences

Lumax Technical Manual 145

 BiVp (RVp-LVp or LVp-RVp

 RVs-LVp

 RVp-noLVp, RVs-noLVp (LV T-wave protection ON)

 LVp, noLVp (LV pacing only)

 VES-Triggered Resynchronization

 VES-LVp (Triggering: RVs+RVES)

 VES-noLVp (LV T-wave protection ON)

 VES per hour

2.11.10.3 Rate Trends

The device counts the number of paced and sensed events and

displays them in two different graphs (rate and paced). These

trends are available for 24 hour periods and as long-term

durations.

2.11.10.4 Rate Histogram

The rate histogram shows the percentage of time the rate lies

within given heart rate bins regardless if the sensor is used or not.

The heart rate range is divided into sixteen segments ranging

from less than 40 to greater than 380 ppm.

2.11.10.5 Counters

The following counters are available within the Timing Statistics:

 PMTs

 Safety Window Pacings

 Mode Switching Episodes

2.11.11 Atrial Arrhythmias

The activity report provides information that can assist the

physician in determining the patient’s susceptibility to atrial

arrhythmias including Atrial Burden (length of episodes), Number

of Episodes and Stress Duration (minutes/day). This screen also

includes graphing of the ventricular reaction to atrial arrhythmias

including the rates of paced and sensed ventricular events.

2.11.12 Ventricular Arrhythmias

The activity report provides information in graphic form that

details number of PVCs/hour.

146 Lumax Technical Manual

2.11.13 Sensor

This report contains individual rate bins for the sensor indicated

rate percentages. The activity report provides information that can

assist the physician in optimizing pacing and/or sensor

parameters.

2.11.14 Sensing

The activity report provides trend information on atrial and right

ventricular sensing measurements.

2.11.15 Impedances

The activity report provides trend information on atrial and right

ventricular pacing impedance as well as shock impedance

measurements.

2.11.16 Automatic Threshold

The activity report provides trend information on right and left

ventricular pacing thresholds, if active.

2.11.17 Asynchronous Pacing Modes

The Lumax 700/740 and 600/640 models offer the following

asynchronous pacing modes for use during medical procedures:

 V00 – asynchronous pacing in the ventricle

 D00 – asynchronous pacing in the atrium and ventricle

with a fixed AV delay for conduction between chambers

Tachyarrhythmia detection is deactivated when using these

asynchronous modes in the Lumax 700/740 and 600/640

devices.

The asynchronous modes are intended for use during medical

procedures, such as cautery. In patients with inadequate intrinsic

rhythm, the pacemaker should be reprogrammed to an

asynchronous mode during the procedure in order to prevent

inhibition by electromagnetic interference. Thus, the

asynchronous modes V00 and D00 are intended to prevent

possible inhibition by electromagnetic interference during invasive

intervention (such as during electrocauterization).

Lumax Technical Manual 147

The patient must be monitored when asynchronous pacing

modes are used. The asynchronous modes V00 and D00 can

only be set if tachyarrhythmia sensing is deactivated. However,

this would leave the patient without sensing and therefore without

ICD therapy. Thus, during the use of asynchronous modes:

- Continually monitor the patient.

- Keep an external defibrillator ready.

2.11.18 Far-Field IEGM for Threshold Testing

(Leadless ECG)

The Lumax 700/740 and 600/640 models offer a new feature,

leadless ECG, which allows for an alternative to ECG and IEGM

for the threshold testing without the external/surface ECG leads.

The Far-Field IEGM can be used to replace surface ECG leads

during threshold testing. There is now an option to select between

(near-field) IEGM, conventional surface ECG signals (I, II, or III)

or leadless ECG (FF IEGM) as display options automatically. The

figure below shows FF option:

2.11.19 Advanced AT/AF Diagnostics (Lumax

700/740 only)

The Lumax 700/740 models offer the ability to record longer pre-

history of atrial episodes (AT/AF events). This feature has been

doubled from 30 seconds to > 1 minute. This feature is important

in terms of genesis evaluation of atrial tachyarrhythmias.

148 Lumax Technical Manual

2.11.20 Atrial NIPS (Lumax 700/740 & 600/640

only)

The Lumax 700/740 models offer Atrial Non-Invasive

Programmable Stimulation (NIPS), which allows manual

stimulation in the atrium via the programmer. With Atrial NIPS

manual stimulation in the atrium can be programmed to the

following (shown in the figure below):

 Programmed stimulation from 80 to 2000 ms

 Burst Stimulation from 30 to 800 bpm

 Backup stimulation in VVI mode

Lumax Technical Manual 149

3. Sterilization and Storage

The ICD/CRT-D is shipped in a storage box, equipped with a

quality control seal and product information label. The label

contains the model specifications, technical data, serial number,

use before date, as well as sterilization and storage information.

The ICD/CRT-D and its accessories have been sealed in a

container and gas sterilized with ethylene oxide. To assure

sterility, the container should be checked for integrity prior to

opening.

CAUTION

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

45°C (41° - 113° 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.

150 Lumax Technical Manual

Lumax Technical Manual 151

4. Implant Procedure

4.1 Implant Preparation

Prior to beginning the ICD/CRT-D implant procedure; ensure that

all necessary equipment is available. The implant procedure

requires the selected lead system (including sterile back-ups), the

programmer with appropriate software, and the necessary cabling

and accessories.

For ICS 3000 and Implant Module based DFT testing, the

following cabling and accessories are available:

PK44 - used to connect the Implant Module to implanted lead

systems for complete testing of the lead systems during the

implant procedure. The following adapters may be necessary:

 Adapters PA-2/PA-3 - The PA-2 adapter is used to

connect IS-1 compatible leads to the PK-44 cable. The

PA-3 adapter is used to connect DF-1 compatible leads

to the PK-44 cable.

 Adapter PA-4 - used to connect the PK-44 cable to

sensing and pacing leads while the stylet is still inserted.

The ICD/CRT-D System also has the following accessory

available (at the discretion of the physician) for the implant

procedure:

 Test housing that allows acute testing of the lead system

prior to opening the sterile package.

Perform an interrogation of the ICD/CRT-D. Ensure programmer

operation, nominal device parameters and battery status is

appropriate for a new Lumax ICD/CRT-D. Note that the battery

status may appear lower than its true value when the ICD/CRT-D

is not at body temperature. Program detection and therapy to

“Disabled” prior to handling the Lumax ICD/CRT-D.

Sufficient training on the device and its associated components is

required prior to implanting the ICD/CRT-D. For additional

information, training and training materials contact your

BIOTRONIK representative.

152 Lumax Technical Manual

WARNING

ICD Lead Systems - BIOTRONIK ICDs/CRT-Ds may be

implanted with any legally marketed, compatible ICD lead.

Compatibility is defined as:

 IS-1 pacing and sensing connector(s)

 DF-1 shock coil connector(s)

 Integrated or dedicated bipolar pacing and sensing

configuration

 Active or passive fixation technology

 Single or dual defibrillation shock coil (s)

 High energy shock accommodation of at least 30

joules

 Insertion and withdrawal forces as specified by

ISO 5841-3 (IS-1) and ISO 11318:1993 (E) DF-1

The following leads were evaluated in a retrospective study

with BIOTRONIK’s ICDs/CRT-Ds:

 Medtronic SprintTM Lead 6932

 Medtronic Sprint Lead 6943

 Medtronic Sprint QuattroTM Lead 6944

 Medtronic TransveneTM RV Lead 6936

 St. Jude (Ventritex) TVLTM- ADX Lead 1559

 St. Jude SPL® SP02 Lead

 Guidant ENDOTAK® DSP Lead

 Guidant ENDOTAK Endurance EZ Lead, ENDOTAK

Reliance Lead

 Guidant (Intermedics) Lead 497-24.

The following leads were bench tested for compatibility with

BIOTRONIK’s ICDs/CRT-Ds:

 Guidant ENDOTAK Endurance Lead “CPI 0125”

 Guidant ENDOTAK Reliance Lead 0148

 Medtronic Sprint Lead 6932

 Medtronic Sprint Lead 6942

 Medtronic Sprint Lead 6943

 Medtronic Sprint Lead6945

 Medtronic Sprint Quattro Lead 6944

 St. Jude Riata® Lead 1571/65

Lumax Technical Manual 153

 St. Jude SPL SPO1 Lead

154 Lumax Technical Manual

WARNING

Left Ventricular Lead Systems – BIOTRONIK CRT-Ds

maybe implanted with any legally marketed, compatible LV

lead. Compatibility is defined as:

 IS-1 pacing connector

 Active or passive fixation technology

 Insertion and withdrawal forces as specified by

ISO 5841-3 (IS-1)

The following LV leads were evaluated in the

OPTION CRT/ATx study with BIOTRONIK’s CRT-Ds:

 Guidant-EASYTRAK® IS-1 Lead

 Guidant-EASYTRAK LV-1 Lead

 Guidant-EASYTRAK 2 Lead

 Guidant-EASYTRAK 3 Lead

 Medtronic-Attain® OTW Lead

 St. Jude-AesculaTM Lead

 St. Jude-QuickSite® Lead

 Biomec-MyoporeTM Epicardial Lead

 Medtronic-Epicardial 5071 Lead

 Medtronic-CapSure® EPI Lead

 BIOTRONIK-ELC 54-UP Lead

The following LV leads were bench tested for compatibility

with BIOTRONIK’s CRT-Ds:

 Guidant EASYTRAK 4512 (unipolar) Lead

 Guidant EASYTRAK 4513 (bipolar) Lead

 Guidant EASYTRAK 3 4525 (bipolar) Lead

 Medtronic Attain OTW 4193 (unipolar) Lead

 Medtronic Attain OTW 4194 (bipolar) Lead

 Medtronic Attain LV 2187 (unipolar) Lead

 St. Jude Medical QuickSite 1056K (unipolar) Lead

 ELA SITUS® OTW (unipolar) Lead

 BIOTRONIK Corox+ LV-H 75-BP #346542

 BIOTRONIK Corox OTW 75-UP Steroid #346542

(unipolar)

Lumax Technical Manual 155

CAUTION

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.

Connector Compatibility - ICD/CRT-D and lead system

compatibility should be confirmed prior to the implant

procedure. Consult your BIOTRONIK representative

regarding lead/pulse generator compatibility prior to the

implantation of an ICD/CRT-D system. For further

information, please refer to Appendix A.

Programmed Parameters – Program the device

parameters to appropriate values based on the patient’s

specific arrhythmias and condition.

Programming Wand Separation Distance – The wand

(with magnet) must not be placed closer than 2 cm to the

device (implanted, in the box, or out of the box).

Programming wand (with magnet) distance closer than 2 cm

may damage the device.

CAUTION

Shock Impedance - If the shock impedance is less than

twenty-five ohms (25 Ω), reposition the lead system to allow

a greater distance between the electrodes. Never implant the

device with a lead system that has a measured shock

impedance of less than twenty-five ohms (25 Ω). Damage to

the device may result.

Far-field sensing of signals from the atrium in the ventricular

channel or ventricular signals in the atrial channel should be

avoided by appropriate lead placement, programming of

pacing/sensing parameters, and maximum sensitivity

settings. If it is necessary to modify the Far Field Blanking

parameter, the parameter should be lengthened only long

enough to eliminate far-field sensing as evidenced on the

IEGMs. Extending the parameter unnecessarily may cause

undersensing of actual atrial or ventricular events.

156 Lumax Technical Manual

4.2 Lead System Evaluation

The ICD/CRT-D is mechanically compatible with DF-1

defibrillation lead connectors and IS-1 sensing and pacing lead

connectors. IS-1, wherever stated in this manual, refers to the

international standard, whereby leads and pulse generators from

different manufacturers are assured a basic fit [Reference ISO

5841-3:1992]. DF-1, wherever stated in this manual, refers to the

international standard [Reference ISO 11318:1993].

Refer to the appropriate lead system technical manual.

4.3 Opening the Sterile Container

The Lumax ICD/CRT-Ds are packaged in two plastic containers,

one within the other. Each is individually sealed and then

sterilized with ethylene oxide.

Due to the double packing, the outside of the inner container is

sterile and can be removed using standard aseptic technique and

placed on the sterile field.

Peel off the sealing paper of the

outer container as indicated by

the arrow. Do not contaminate the

inner tray.

Take out the inner sterile tray by

gripping the tab. Open the inner

tray by peeling the sealing paper

as indicated by the arrow.

Lumax Technical Manual 157

CAUTION

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.

4.4 Pocket Preparation

Using standard surgical technique, create a pocket for the device

either in the patient’s pectoral or abdominal region dependent on

patient anatomy. The device may be implanted either below the

subcutaneous tissue or in the muscle tissue. The ICD/CRT-D

should be implanted with the etched side facing up. The leads

should be tunneled or surgically brought into the device pocket. If

lead tunneling is performed, re-evaluation of the baseline lead

signals, after tunneling is recommended.

CAUTION

The ICD/CRT-D system should have detection and therapy

disabled prior to performing medical procedures. In addition,

the ICD/CRT-D should be checked after the procedures to

assure proper programming:

Electrocautery - Electrosurgical cautery could induce

ventricular arrhythmias and/or fibrillation, or may cause

device malfunction or damage. If use of electrocautery is

necessary, the current path and ground plate should be kept

as far away from the pulse generator and leads as possible

(at least 6 inches (15 cm)).

158 Lumax Technical Manual

4.5 Lead to Device Connection

The Lumax ICD/CRT-Ds have been designed and are

recommended for use with a defibrillation lead systems having

one IS-1 connector for ventricular sensing and pacing and up to

two DF-1 connectors for delivery of shock therapy. A separate

bipolar atrial lead with IS-1 connector is required for atrial sensing

and pacing functions and the CS lead for biventricular pacing

(LV). Figure 15 depicts the configuration of the header ports on

the Lumax 300/340 ICD/CRT-Ds, where HV1/RV and HV2/SVC

are for DF-1 connectors, and A P/S and V P/S are for IS-1

connectors. Figure 16 depicts the configuration of the header

ports on the Lumax 500/540, 600/640 and 700/740 ICD/CRT-D

devices.

VR(-T) DR(-T)/VR-T DX HF(-T)

Figure 15. Lumax 300/340 ICD and CRT-D Header Ports

Lumax Technical Manual 159

Figure 16. Lumax 500/540, 600/640 & 700/740 ICDs and CRT-D

Header Ports

160 Lumax Technical Manual

CAUTION

Connector Compatibility - ICD/CRT-D and lead system

compatibility should be confirmed prior to the implant

procedure. Consult your BIOTRONIK representative

regarding lead/pulse generator compatibility prior to the

implantation of an ICD/CRT-D system. For further

information, please refer to Appendix A.

Setscrew Adjustment – Back-off the setscrew(s) prior to

insertion of lead connector(s) as failure to do so may result in

damage to the lead(s), and/or difficulty connecting lead(s).

Cross Threading Setscrew(s) – To prevent cross threading

the setscrew(s), do not back the setscrew(s) completely out

of the threaded hole. Leave the torque wrench in the slot of

the setscrew(s) while the lead is inserted.

Tightening Setscrew(s) – Do not overtighten the

setscrew(s). Use only the BIOTRONIK supplied torque

wrench.

Sealing System – Be sure to properly insert the torque

wrench into the perforation at an angle perpendicular to the

connector receptacle. Failure to do so may result in damage

to the plug and its self-sealing properties.

Far-Field Sensing of signals from the atrium in the

ventricular channel or ventricular signals in the atrial channel

should be avoided by appropriate lead placement,

programming of pacing/sensing parameters, and maximum

sensitivity settings. If it is necessary to modify the Far Field

Blanking parameter, the parameter should be lengthened

only long enough to eliminate far-field sensing as evidenced

on the IEGMs. Extending the parameter unnecessarily may

cause undersensing of actual atrial or ventricular events.

Refer to the following steps when connecting the leads to the

device.

Lumax Technical Manual 161

1. Confirm that the setscrews are not protruding into the

connector receptacles. To retract a setscrew, insert the

enclosed torque wrench through the perforation in the

self-sealing plug at an angle perpendicular to the lead

connector until it is firmly placed in the setscrew. Rotate

the wrench counterclockwise until the receptacle is clear

of obstruction.

2. Insert the lead connector into the connector port of the

ICD/CRT-D without bending the lead until the connector

pin becomes visible behind the setscrew. Hold the

connector in this position. If necessary, apply silicone oil

only to the o-rings on the connector (not the connector

pin).

3. Insert the enclosed torque wrench through the perforation

in the self-sealing plug at an angle perpendicular to the

lead connector until it is firmly placed in the setscrew.

4. Securely tighten the setscrew of the connector clockwise

with the torque wrench until torque transmission is limited

by the wrench.

5. Carefully retract the torque wrench. The perforation will

self-seal.

4.6 Blind Plug Connection

The Lumax DR ICD and HF CRT-D are shipped with a blind plug

(pre inserted) in an unused header port. Refer to the following

steps when connecting blind plugs to the device.

1. Confirm that the setscrews are not protruding into the

connector receptacles. To retract a setscrew, insert the

enclosed torque wrench through the perforation in the

self-sealing plug at an angle perpendicular to the lead

connector until it is firmly placed in the setscrew. Rotate

the wrench counterclockwise until the receptacle is clear

of obstruction.

2. Insert the blind plug into the connector port of the

ICD/CRT-D until the connector pin becomes visible

behind the setscrew.

3. Insert the enclosed torque wrench through the perforation

in the self-sealing plug at an angle perpendicular to the

connector until it is firmly placed in the setscrew.

4. Securely tighten the setscrew of the connector clockwise

with the torque wrench until torque transmission is limited

by the wrench.

162 Lumax Technical Manual

5. Carefully retract the torque wrench. The perforation will

self-seal.

CAUTION

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.

4.7 Program the ICD/CRT-D

Program the ICD/CRT-D to appropriately treat the patient’s

arrhythmias and other therapy needs. The information obtained

during the lead system evaluation should be helpful in tailoring

the various parameters of the ICD/CRT-D to treat each individual

patient. The detection and therapy status of the ICD/CRT-D may

be activated for testing purposes once all of the lead connectors

have been securely fastened in the device header ports. The

physician shall be made aware of the program that is in effect

after the patient leaves the office, by viewing the parameters

displayed on the programmer screen after the device has been

programmed and interrogated.

CAUTION

Programmed Parameters – Program the device parameters

to appropriate values based on the patient’s specific

arrhythmias and condition.

Programmers - Use only BIOTRONIK’s ICS 3000 or

Renamic programmers to communicate with the device.

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.

Lumax Technical Manual 163

WARNING

Unwanted Shocks – Always program ICD therapy to OFF

prior to handling the device to prevent the delivery of shocks

to the patient or the person handling the device during the

implant procedure.

4.8 Implant the ICD/CRT-D

The ICD/CRT-D may be placed in the pocket at this time. Place

the device into the pocket with either side facing up (it can be

interrogated and programmed from either side). Carefully coil any

excess lead length behind the ICD/CRT-D.

The pacing and sensing functions of the device should be

evaluated. It is also recommended that at least one induction and

device conversion be done prior to closing the pocket. This will

ensure that the lead system has been securely connected to the

device and has not changed position.

CAUTION

Connector Compatibility - ICD/CRT-D and lead system

compatibility should be confirmed prior to the implant

procedure. Consult your BIOTRONIK representative

regarding lead/pulse generator compatibility prior to the

implantation of an ICD/CRT-D system. For further

information, please refer to Appendix A.

Shock Impedance – If the shock impedance is less than

twenty-five ohms (25 Ω), reposition the lead system to allow

a greater distance between the electrodes. Never implant the

device with a lead system that has a measured shock

impedance of less than twenty-five ohms (25Ω). Damage to

the device may result.

164 Lumax Technical Manual

WARNING

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/CRT-D system, it is necessary to induce and convert

the patient’s ventricular tachyarrhythmias.

CAUTION

Pacing Threshold - Testing of the pacing threshold by the

ICD/CRT-D system should be performed with the pacing rate

programmed to a value higher than the patient's intrinsic rate.

Defibrillation Threshold - Be aware that the 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.

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 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:

Electrocautery - Electrosurgical cautery could induce

ventricular arrhythmias and/or fibrillation, or may cause

device malfunction or damage. If use of electrocautery is

necessary, the current path and ground plate should be kept

as far away from the pulse generator and leads as possible

(at least 6 inches (15 cm)).

Lumax Technical Manual 165

Prior to surgically closing the pocket, the telemetry contact should

be evaluated to help ensure chronic programmer communication.

Close the device pocket using standard surgical technique. As

the final step at device implant and each patient follow-up, the

permanent program should be retransmitted to the ICD/CRT-D.

Typically, each device that you receive is in the “Shipment Mode”.

This mode includes factory settings that control the charge

current of automatic capacitor reformations to avoid the possibility

of temporary low battery readings. Shipment mode is

automatically deactivated when electrophysiological tests (e.g.,

Impedance Measurement) are initiated by the programmer. The

following can be used to verify status of the shipment mode:

 The shipment mode is ON if the device displays

"Shipment Mode Active" in the event list

 The Shipment Mode is OFF if the device does not display

"Shipment Mode Active" in the event list

Complete the Medical Device Registration Form provided with the

ICD/CRT-D and return it to BIOTRONIK.

166 Lumax Technical Manual

Lumax Technical Manual 167

5. Follow-up Procedures

5.1 General Considerations

An ICD/CRT-D follow-up serves to verify appropriate function of

the ICD/CRT-D system, and to optimize the programmable

parameter settings.

In addition to evaluating the patient’s stored therapy history and

electrograms, acute testing of sensing and pacing is

recommended. The physician shall be made aware of the

program that is in effect after the patient leaves the office after

each follow-up, by viewing the parameters displayed on the

programmer screen after the device has been programmed and

interrogated. As the final step at device implant and each patient

follow-up, the permanent program should be retransmitted to the

ICD/CRT-D. Due to longevity concerns, it is recommended the

physician schedule a patient follow-up visit every 3 months.

WARNING

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/CRT-D system, it is necessary to induce

and convert the patient’s ventricular tachyarrhythmias.

CAUTION

Programming Wand Separation Distance – The wand

(with magnet) must not be placed closer than 2 cm to the

device (implanted or out of the box). Programming wand

(with magnet) distance closer than 2 cm may damage the

device.

168 Lumax Technical Manual

5.2 Longevity

The service time of an ICD/CRT-D can vary based on several

factors, including the number of charge sequences, programmed

parameters, number of tachyarrhythmias detected, relative

amount of bradycardia pacing required, pacing lead impedance,

storage time, battery properties, and circuit operating

characteristics. Service time is the time from beginning of service

(BOS) to the elective replacement indication (ERI). To assist the

physician in determining the optimum time for ICD/CRT-D

replacement, a replacement indicator is provided that notifies the

user that replacement within a certain period of time is required.

Upon reaching ERI, the battery has at least enough energy left to

continue monitoring for three months along with the ability to

deliver six high-energy shocks. After this period, all

tachyarrhythmia detection and tachyarrhythmia therapy is

disabled.

CAUTION

Charge Time - When preparing a high energy shock the

charge circuit stops charging the capacitors after 20 seconds,

and delivers the stored energy as shock therapy. After the

device reaches ERI the stored energy may be less than the

maximum programmable energy for each shock.

The projected service times from beginning of service (BOS) to

elective replacement indication (ERI) are listed in the following

tables. All estimates were calculated assuming a pacing rate of

60 ppm with a pulse width of 0.4 ms and pulse amplitude of 2.8

volts and 500 ohm pacing impedance with all shocks at maximum

programmable energy at 37C. It is assumed that the shocks are

equally spaced throughout the life of the ICD/CRT-D. The

estimates associated with 0% pacing support assume the

ICD/CRT-D is sensing an intrinsic sinus rhythm at a rate of

70 bpm. The tables represent the mean longevity estimates for

the specified devices. If there are multiple available batteries for a

particular device, the worst case longevity option is presented.

Lumax Technical Manual 169

5.2.1 Lumax 300/340 Devices

The single chamber Lumax (Lumax 300 VR, Lumax 340 VR,

Lumax 300 VR-T, and Lumax 340 VR-T) ICDs are intended to

operate for more than 4 years under normal use. Table 37

provides longevity estimates for the Lumax 340 VR-T ICD, which

has the worst case longevity estimates of the devices listed

above. The table provides several different support scenarios. It

is assumed that the shocks are equally spaced throughout the life

of the ICD.

Table 37 Lumax 340 VR-T Longevity Estimates

Pacing Support

Shocks per year

(max energy)

0% 15% 50% 100%

4 6.0 5.8 5.4 4.9

5 5.7 5.5 5.2 4.7

6 5.4 5.3 4.9 4.5

7 5.2 5.0 4.7 4.4

8 5.0 4.8 4.5 4.2

9 4.8 4.6 4.4 4.0

10 4.6 4.4 4.2 3.9

11 4.4 4.3 4.1 3.8

12 4.2 4.1 3.9 3.7

The dual chamber Lumax (Lumax 300 DR, Lumax 340 DR,

Lumax 300 DR-T, and Lumax 340 DR-T) ICDs are intended to

operate for more than 5 years under normal use. Table 38

provides longevity estimates for the Lumax 340 DR-T ICD (order

number 355267), which has the worst case longevity estimates of

the devices listed above. The table provides several different

support scenarios. It is assumed that the shocks are equally

spaced throughout the life of the ICD.

170 Lumax Technical Manual

Table 38 Lumax 340 DR-T Longevity Estimates

Pacing Support

Shocks per year

(max energy)

0% 15% 50% 100%

4 5.7 5.4 4.8 4.1

5 5.4 5.1 4.6 3.9

6 5.2 4.9 4.4 3.8

7 5.0 4.7 4.2 3.7

8 4.8 4.5 4.1 3.6

9 4.6 4.4 3.9 3.4

10 4.4 4.2 3.8 3.3

11 4.2 4.0 3.7 3.2

12 4.1 3.9 3.6 3.2

Table 39 and Table 40 provide longevity estimates for the

Lumax 300 & 340 HF-T CRT-D with Greatbatch batteries. The

tables are limited to 100% ventricular pacing because that is the

goal for each CRT-D device. It is assumed that the shocks are

equally spaced throughout the life of the ICD.

Table 39 Lumax 300 HF-T Longevity Estimates

Shocks per year 100% Pacing Support

(in years)

4 5.4

5 5.3

6 5.2

7 5.1

8 4.9

9 4.8

10 4.7

11 4.6

12 4.5

Lumax Technical Manual 171

Table 40 Lumax 340 HF-T Longevity Estimates

Shocks per year 100% Pacing Support

(in years)

4 5.2

5 5.0

6 4.8

7 4.7

8 4.6

9 4.4

10 4.3

11 4.2

12 4.1

The Lumax 300/340 HF CRT-Ds (Lumax 300 HF-T, and

Lumax 340 HF-T) are intended to operate for more than 5 years

under normal use.

5.2.2 Lumax 500/540 Devices

The single chamber Lumax 500/540 ICD variants

(Lumax 500 VR-T and Lumax 540 VR-T) of are intended to

operate for more than 6 years under normal use. Table 41

provides longevity estimates for these devices. The table provides

several different support scenarios. It is assumed that the shocks

are equally spaced throughout the life of the ICD.

Table 41 Lumax VR-T Longevity Estimates

Pacing Support

Device Shocks per

year

0% 15% 50% 100%

4 8.3 8.1 7.6 7.0

8 7.0 6.9 6.5 6.1

500 VR-T

12 6.1 6.0 5.7 5.4

4 8.7 8.5 8.0 7.4

8 7.1 6.9 6.6 6.2

540 VR-T

12 6.0 5.9 5.6 5.3

172 Lumax Technical Manual

The dual-chamber Lumax 500/540 variants (Lumax 500 DR-T,

and Lumax 540 DR-T) of ICDs are intended to operate for more

than 6 years under normal use. Table 42 provides longevity

estimates for these devices. The table provides several different

support scenarios. It is assumed that the shocks are equally

spaced throughout the life of the ICD.

Table 42 Lumax DR-T Longevity Estimates

Pacing Support

Device Shocks per

year

0% 15% 50% 100%

4 7.9 7.5 6.7 5.8

8 6.7 6.4 5.8 5.2

500 DR-T

12 5.9 5.6 5.2 4.6

4 8.3 7.9 7.1 6.2

8 6.8 6.5 6.0 5.4

540 DR-T

12 5.8 5.6 5.2 4.7

The Lumax 540 VR-T DX ICDs are intended to operate for more

than 6 years under normal use. Table 43 provides longevity

estimates for these devices. The table provides several different

support scenarios. It is assumed that the shocks are equally

spaced throughout the life of the ICD.

Table 43 Lumax VR-T DX Longevity Estimates

Pacing Support

Device Shocks per

year

0% 15% 50% 100%

4 8.3 8.1 7.6 7.1

8 6.8 6.6 6.4 6.0

540 VR-T

DX 12 5.8 5.7 5.4 5.2

The Lumax 500/540 HF-T variants of ICDs are intended to

operate for more than 6 years under normal use. Table 44

provides longevity estimates for these devices with Greatbatch

batteries. The table provides several different support scenarios.

It is assumed that the shocks are equally spaced throughout the

life of the ICD.

Lumax Technical Manual 173

Table 44 Lumax 500/540 HF-T Longevity

Estimates

Pacing Support

Device Shocks per year 100%

4 5.6

5 5.5

6 5.4

7 5.2

8 5.1

9 5.0

10 4.9

11 4.7

500 HF-T

12 4.6

4 5.3

5 5.1

6 5.0

7 4.8

8 4.6

9 4.5

10 4.4

11 4.3

540 HF-T

12 4.1

Upon reaching ERI, the battery has enough energy left to

continue monitoring for three months and to deliver six high

energy shocks. The estimates associated with duration of ERI

assume the ICD/CRT-D is sensing an intrinsic sinus rhythm at a

rate of 70 bpm. After this period the device is at EOS (End of

Service) and requires explantation. Once at EOS, all

tachyarrhythmia detection and therapy is disabled. The ERI and

EOS voltages are listed in the Table 45.

Table 45 ERI and EOS Voltages

Operating Mode Voltage

Elective Replacement Indicator (ERI) 2.50 Volts

End of Service (EOS) 1.75 Volts

174 Lumax Technical Manual

5.2.3 Lumax 600/640 & 700/740 Devices

Table 41 provides longevity estimates for the single chamber

Lumax 600/640 & 700/740 ICD variants (Lumax 600/700 VR-T

and Lumax 640/740 VR-T). The table provides several different

support scenarios. It is assumed that the shocks are equally

spaced throughout the life of the ICD.

Table 46 Lumax VR-T Longevity Estimates

Pacing Support

Device Shocks per

year

0% 15% 50% 100%

4 9.91 9.60 8.95 8.17

8 8.32 8.10 7.64 7.06

600 VR-T

700 VR-T 12 7.17 7.01 6.66 6.21

4 10.21 9.92 9.31 8.55

8 8.20 8.01 7.60 7.09

640 VR-T

740 VR-T 12 6.84 6.71 6.42 6.05

Table 42 provides longevity estimates for the dual-chamber

Lumax 600/640 and 700/740 ICD variants (Lumax 600/700 DR-T,

and Lumax 640/740 DR-T). The table provides several different

support scenarios. It is assumed that the shocks are equally

spaced throughout the life of the ICD.

Table 47 Lumax DR-T Longevity Estimates

Pacing Support

Device Shocks per

year

0% 15% 50% 100%

4 8.95 8.42 7.40 6.31

8 7.62 7.24 6.47 5.61

600 DR-T

700 DR-T 12 6.64 6.34 5.74 5.06

4 9.31 8.80 7.80 6.71

8 7.59 7.25 6.55 5.77

640 DR-T

740 DR-T 12 6.40 6.16 5.65 5.05

Table 43 provides longevity estimates for the

Lumax 640/740 VR-T DX ICDs. The table provides several

different support scenarios. It is assumed that the shocks are

equally spaced throughout the life of the ICD.

Lumax Technical Manual 175

Table 48 Lumax VR-T DX Longevity Estimates

Pacing Support

Device Shocks per

year

0% 15% 50% 100%

4 9.31 9.07 8.54 7.89

8 7.59 7.43 7.07 6.62

640 VR-T

740 VR-T

DX 12 6.40 6.29 6.03 5.70

Table 44 provides longevity estimates for the Lumax 600/640 and

700/740 HF-T variants of CRT-Ds. The table provides several

different support scenarios. It is assumed that the shocks are

equally spaced throughout the life of the CRT-D.

Table 49 Lumax 600/640 & 700/740 HF-T

Longevity Estimates

Pacing Support

Device Shocks per year 100%

4 6.09

5 5.93

6 5.77

7 5.63

8 5.49

9 5.36

10 5.23

11 5.11

600 HF-T

700 HF-T

12 5.00

4 5.72

5 5.53

6 5.34

7 5.17

8 5.01

9 4.86

10 4.72

11 4.59

640 HF-T

740 HF-T

12 4.46

176 Lumax Technical Manual

Upon reaching ERI, the battery has enough energy left to

continue monitoring for three months and to deliver six high

energy shocks. The estimates associated with duration of ERI

assume the ICD/CRT-D is sensing an intrinsic sinus rhythm at a

rate of 70 bpm. After this period the device is at EOS (End of

Service) and requires explantation. Once at EOS, all

tachyarrhythmia detection and therapy is disabled. The ERI

voltages are listed in the Table 45.

Table 50 ERI and EOS Voltages

Operating Mode Voltage

Elective Replacement Indicator (ERI) 2.50 & 2.85 Volts

5.3 Explantation

Explanted ICDs/CRT-Ds, lead systems, and accessories may not

be reused. Please complete the appropriate out of service (OOS)

form and return it to BIOTRONIK with the explanted devices. All

explanted devices should be sent either to the local BIOTRONIK

representative or the BIOTRONIK home office for expert disposal.

Contact BIOTRONIK if you need assistance with returning

explanted devices. If possible, the explanted devices should be

cleaned with a sodium-hyperchlorine solution of at least 1%

chlorine and then washed with water prior to shipping.

The pulse generator should be explanted before the cremation of

a deceased patient.

WARNING

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 implant procedure.

Lumax Technical Manual 177

CAUTION

Device Incineration – Never incinerate the ICDs/CRT-Ds

due to the potential for explosion. The ICD/CRT-D must be

explanted prior to cremation.

Explanted Devices – Return all explanted devices to

BIOTRONIK.

178 Lumax Technical Manual

Lumax Technical Manual 179

6. Technical Specifications

The following are the technical specifications for the

Lumax ICDs/CRT-Ds. The ranges are presented in the format:

x…(y)…z

where x = the lowest value, y = the increment, and z = the largest

value.

Mechanical Properties

Lumax

300/500

600/700

Lumax

340/540

640/740

Lumax

500

600/700

HF-T

Lumax

340/540

640/740

HF-T

Dimensions 66 mm x

55 mm x

12 mm

66 mm x

55 mm x

13 mm

66 mm x

59 mm x

12 mm

66 mm x

59 mm x

13 mm

Volume 34.6 cm3 37.2 cm3 37.1 cm3 39.8 cm3

Mass 81 g 92 g 83 g 94 g

Housing Titanium

Header Epoxy resin

Seal Plug Silicone

VR-T

Lead Ports

1 x 3.2 mm IS-1 Bipolar

2 x 3.2 mm DF-1

DR-T

Lead Ports

2 x 3.2 mm IS-1 Bipolar

2 x 3.2 mm DF-1

3 x 3.2 mm IS-1 Bipolar

2 x 3.2 mm DF-1

Parameter Range Standard

Bradycardia

Atrial Sensing Parameters

Sensing STD - standard,

OFF - inactive

STD

Minimum threshold 0.2...(0.1)...2.0 mV 0.4 mV

Far-field protection

after Vp

50...(25)...225 ms 75 ms

Far-field protection

after Vs

Off, 25...(25)...225 ms 75 ms

Upper threshold 50; 75; 87.5 % 50 %

180 Lumax Technical Manual

Parameter Range Standard

Upper threshold

(Lumax 700/740 &

600/640 only)

25, 50; 75 % 50 %

Lower threshold 12.5; 25; 50 % 25 %

Lower threshold

(Lumax 700/740 &

600/640 only)

25 25 %

Hold of upper

threshold after As

(Lumax 700/740 &

600/640 only)

350 ms 350 ms

Hold of upper

threshold after Ap

(Lumax 700/740 &

600/640 only)

350 ms 350 ms

Initial Noise Interval

(Lumax 700/740 &

600/640 only)

110 ms 110 ms

High pass

(Lumax 700/740 &

600/640 only)

18 Hz 18 Hz

Right-ventricular Sensing Parameters

Sensing RV STD - standard,

TWS - extended T-wave

suppression,

VFS - extended VF

sensitivity

STD

Minimum threshold 0.5...(0.1)...2.5 mV 0.8 mV

Blanking after atrial

pacing 50...(10)...100 ms 50 ms

(N/A

VR-T DX)

Upper threshold 50; 75; 87.5 % 50 %

Upper threshold

(Lumax 700/740 &

600/640 only)

50; 75 % 50 %

Lower threshold 12.5; 25; 50% 25 %

Lower threshold

(Lumax 700/740 &

600/640 only)

25; 50% 25 %

Lumax Technical Manual 181

Parameter Range Standard

Hold of upper

threshold

100...(20)...600 ms 360 ms

Hold of upper

threshold after Vs

(Lumax 700/740 &

600/640 only)

110, 150...(50)...500 ms

110 ms (VFS)

350 ms

Hold of upper

threshold after Vp

(Lumax 700/740 &

600/640 only)

110, 150...(50)...500 ms

110 ms (VFS)

400 ms

Initial Noise Interval

(Lumax 700/740 &

600/640 only)

110 …(10) … 200 ms 110 ms

High pass

(Lumax 700/740 &

600/640 only)

24, 32 Hz

32 Hz (TWS, VFS)

24 Hz

Low pass

(Lumax 700/740 &

600/640 only)

100 Hz 100 Hz

Left-ventricular Sensing Parameters

Sensing LV STD - standard,

OFF - inactive

STD

Min. threshold 0.5...(0.1)...2.5 mV 1.6 mV

Min. threshold

(Lumax 700/740 &

600/640 only)

0.5…(0.1)…2.5….(0.5)….

5.0 mV

1.6 mV

Blanking after atrial

pacing

= Safety window 100 ms

(N/A

VR-T DX)

Upper threshold 50; 75; 87.5% 50 %

Upper threshold

(Lumax 700/740 &

600/640 only)

50; 75 % 50 %

Hold of upper

threshold

100...(20)...600 ms 360 ms

Hold of upper

threshold after Vs

(Lumax 700/740 &

600/640 only)

110, 150...(50)...500 ms 350 ms

182 Lumax Technical Manual

Parameter Range Standard

Hold of upper

threshold after Vp

(Lumax 700/740 &

600/640 only)

110, 150...(50)...500 ms 400 ms

Lower threshold 12.5; 25; 50 % 50 %

Lower threshold

(Lumax 700/740 &

600/640 only)

50 % 50 %

In channel/Cross channel Blanking

In-channel blank

after RV pace

Auto, 100...(10)...350 ms Auto

RV Blanking after

RV pacing

(Lumax 700/740 &

600/640 only)

100...(10)...350 ms 120 ms

In-channel blank

after LV pace

Auto, 100...(10)...350ms Auto

LV Blanking after LV

pacing

(Lumax 700/740 &

600/640 only)

100...(10)...350 ms 120 ms

LV cross-blank after

RV pace

50...(10)...100 ms 80 ms

RV cross-blank after

LV pace

50...(10)...100 ms 80 ms

Polarity Pace/Sense

LV polarity pace LV-tip -> LV-ring

(bipolar (1)),

LV-tip -> RV-ring

(common ring bipolar (2)),

LV-ring -> LV-tip

(inverse bipolar (3)),

LV-ring -> RV-ring

(ring ring bipolar (4))

LV-tip -> RV-

ring

LV polarity pace

(Lumax 700/740 &

600/640 models

only)

LV-tip -> housing

(unipolar (5)),

LV polarity sense UNIP (LV-tip/housing),

BIPL (LV-tip/LV-ring)

UNIP

Lumax Technical Manual 183

Parameter Range Standard

Shock Path (Valid

for all shocks

including the pain-

free shock

impedance)

RV -> SVC + ICD

(Housing)

RV -> ICD (500/540 only)

RV -> SVC (500/540

only)

RV -> SVC +

ICD

Pulse Amplitudes and Pulse Widths

Pulse amplitude 0.2...(0.1)...6.2, 7.5 V 2.8 V

Pulse amplitude

(Lumax 700/740 &

600/640 models

only)

0.5…(0.25)…4.0…(0.5)…

..6.0, 7.5 V

2.5 V

Pulse width 0.4, 0.5, 0.7, 1.0, 1.2, 1.5

0.4 ms

Pulse width

(Lumax 700/740 &

600/640 models

only)

0.4, 0.5…(0.25)…1.5 ms 0.4 ms

Automatic Threshold Measurement (ATM)

For Lumax 500/540 Models Only

RV ON; OFF ON1

LV (HF-T Only) ON; OFF ON

Active Threshold Tracking (ATT)

For Lumax 700/740 & 600/640 Models Only

RV ON; OFF ON2

LV (HF-T Only) ON; OFF ON

Thoracic Impedance Measurement (TI)

For Lumax 700/740 & 600/640 Models Only

TI ON; OFF ON

Mode

Modes DDD, DDDR, DDI, DDIR,

VDD, VDDR, VDI, VDIR,

VVI, VVIR, AAI, AAIR,

OFF

DDD

1 The Standard Program for the ATM feature is ON only for the

Lumax 500/540 VR-T

2 The Standard Program for the ATT feature is ON only for the

Lumax 700/740 & 600/640 VR-T

184 Lumax Technical Manual

Parameter Range Standard

Modes (Lumax

700/740 & 600/640

models only)

DDD, DDDR, DDI, DDIR,

D00, VDD, VDDR, VDI,

VDIR, VVI, VVIR, V00,

AAI, AAIR, OFF

Modes (VR-T DX

Only)

VDD, VDDR, VDI, VDIR,

VVI, VVIR, OFF

Modes (Lumax

740/640 VR-T DX

Only)

VDD, VDDR, VDI, VDIR,

VVI, VVIR, V00, OFF

VVI

Basic Rate Day/Night

Basic rate 30..(5)..100..(10)..160

bpm

60 bpm

Night rate OFF, 30..(5)..100 bpm OFF

Night beginning 00:00..(1 min)..23:59 h:m [22:00 h:m]

Night ending 00:00..(1 min)..23:59 h:m [06:00 h:m]

Rate Hysteresis

Rate hysteresis OFF, -5..(-5)..-90 ppm OFF

Rate hysteresis

(Lumax 740/640

VR-T DX Only)

OFF, -5…(-5)… -25…

(-20)…-65 bpm

OFF

Repetitive OFF; 1..(1)..15 [OFF]

Scan OFF; 1..(1)..15 [OFF]

Scan / Repetitive

(Lumax 740/640

VR-T DX Only)

OFF; ON (10) [ON(10)]

AV Delay

AV delay Low, medium, high, fixed,

individ.

Low

AV delay 1 40..(5)..350 ms 150 ms

AV delay 1 after

pace

(Lumax 740/640

VR-T DX Only)

15, 40..(5)..350 ms -

AV delay 1 after

sense

(Lumax 740/640

VR-T DX Only)

=AV delay 1 after pace +

Sense compensation

AV rate 1 30..(10)..120 bpm 60 bpm

Lumax Technical Manual 185

Parameter Range Standard

AV rate 1

(Lumax 740/640

VR-T DX Only)

50..(10)..130 bpm 60 bpm

AV delay 2 40..(5)..350 ms 120 ms

AV delay 2

(Lumax 740/640

VR-T DX Only)

15, 40..(5)..350 ms -

AV rate 2 70..(10)..160 bpm 130 bpm

AV rate 2

(Lumax 740/640

VR-T DX Only)

60..(10)..140 bpm 130 bpm

Sense

compensation

OFF; -5..(-5)..-60 ms -30 ms

(N/A

VR-T DX)

Sense

compensation

(Lumax 740/640

VR-T DX Only)

OFF; -5..(-5)..-120 ms -40 ms

(N/A

VR-T DX)

AV-hysteresis mode OFF,

positive,

negative

OFF

AV hysteresis 10..(10)..150 ms [50 ms]

AV hysteresis

(positive)

(Lumax 740/640

VR-T DX Only)

70, 110, 150, 200 ms [70 ms]

AV hysteresis

(negative)

(Lumax 740/640

VR-T DX Only)

10..(10)..150 ms [50 ms]

AV repetitive

(positive)

OFF; 1..(1)..10 [5]

AV repetitive

(negative)

OFF;

1..(1)..15..(5)..100..(10)..1

[180]

AV scan / repetitive

(positive)

(Lumax 740/640

VR-T DX Only)

OFF; ON (5) [ON (5)]

186 Lumax Technical Manual

Parameter Range Standard

AV repetitive

(negative)

(Lumax 740/640

VR-T DX Only)

ON (180) ON (180)

AV scan OFF, 1..(1)..10 [5]

I-Opt

I-Opt OFF, ON OFF

AV hysteresis at I-

Opt

400 ms 400 ms

AV repetitive at I-

Opt

OFF; 1..(1)..10 [5]

AV scan at I-Opt OFF, 1..(1)..10 [5]

AV scan / repetitive

at I-Opt

(Lumax 740/640

VR-T DX Only)

ON (5) [ON(5)]

AV max at I-Opt 400 ms 400ms

Post-ventricular Atrial Refractory Period (PVARP)

PVARP 175..(25)..600 ms, Auto 250 ms

PVARP

(Lumax 740/640

VR-T DX Only)

175..(25)..600 ms, Auto 225 ms

Auto PVARP OFF, ON OFF

VES Classification (VES Lock-in Protection)

VES discrimination

after As

250..(50)..450 ms 350 ms

VES discrimination

after As

(Lumax 740/640

VR-T DX Only)

250..(50)..500 ms 350 ms

Rate Adaptation (Acceleration Sensor)

Maximum sensor

rate

90..(5)..160 bpm 120 bpm

Maximum sensor

rate (Lumax 740/640

VR-T DX Only)

80..(10)..160 bpm 120 bpm

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;

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

188 Lumax Technical Manual

Parameter Range Standard

Deactivation

criterion Z

3..(1)..8 5

Mode DDI, DDIR at permanent

DDD(R)

VDI, VDIR at permanent

VDD(R)

DDI

[VDI]

Modes (VR-T DX

Only)

VDI, VDIR at permanent

VDD(R)

VDI

Change in basic rate OFF, +5 ... (5) ...+30 bpm +10 bpm

Post-Mode Switch Response (PMSR)

Post-ModeSw rate OFF, +5 ... (5) ...+50 bpm +10 bpm

Post-ModeSw

duration

1..(1)..30 min 1 min

PMT Protection

PMT

detection/terminatio

OFF, ON ON

VA criterion 250..(10)..500 ms 350 ms

Detection

Detection/Therapy ON, OFF ON

Interval

Interval AT/AF 100….(10)…250 bpm

(240…..600 ms)

200 bpm

Interval VT1 OFF, 270...(10)...600 ms OFF

Interval VT2 OFF, 270...(10)...500 ms OFF

Interval VF OFF, 200...(10)...400 ms 300 ms

Interval VF

(Lumax 700/740 &

600/640 only)

OFF, 240...(10)...400 ms 300 ms

Detection Counter

Detection counter

VT1

10...(2)...60 [16]

Detection counter

VT2

10...(2)...40 [14]

Detection counter

VF – X

6...(1)...30 8

Detection counter

VF – Y

8...(1)...31 12

Lumax Technical Manual 189

Parameter Range Standard

Detection counter

VF – X out of Y

(Lumax 700/740 &

600/640 only)

6 out of 8

8 out of 12

10 out of 14

12 out of 16

16 out of 20

18 out of 24

20 out of 26

22 out of 30

24 out of 30

8 out of 12

Onset

Onset in VT1/2 with

SMART

20% [20%]

Onset VT1 without

SMART

OFF; 4…(4)…32% 20%

Onset VT2 without

SMART

OFF; 4…(4)…32% 20%

Stability

Stability in VT1/2

with SMART

12% [12%]

Stability VT1 without

SMART

OFF; 8…(4)…48 ms 24 ms

Stability VT2 without

SMART

OFF; 8…(4)…48 ms 24 ms

SMART Detection

SMART detection

VT1

OFF, ON [ON]

SMART detection

VT2

OFF, ON [ON]

Sustained VT (without SMART Detection and without

SMART Redetection)

Sustained VT OFF, 00:30, 01:00, 02:00,

03:00, 05:00, 10:00,

15:00, 20:00, 25:00,

30:00 [mm:ss]

[OFF]

Sustained VT

(Lumax 700/740 &

600/640 only)

OFF, 01:00, 02:00, 03:00,

05:00, 10:00, 20:00,

30:00 [mm:ss]

[OFF]

Forced Termination (with SMART Detection Including

SMART Redetection)

Forced termination OFF; 1…(1)…15 min [1 min]

190 Lumax Technical Manual

Parameter Range Standard

Forced termination

(Lumax 700/740 &

600/640 only)

OFF; 1…(1)…10 min [1 min]

Redetection Counter

Redetection counter

VT1

10...(2)...30 [12]

Redetection counter

VT2

10...(2)...30 [10]

SMART Redetection

SMART redetection

(VT1 & VT2)

OFF, ON [ON]

Ventricular Therapy Parameters

Energy 1st shock

and 2nd shock

VT1, VT2 (model

300/500)1

OFF; 1..(1)..16..(2)..30 J 30 J

Energy 1st shock of

VT1, VT2

(Lumax 700/600

only)

OFF; 2..(2)..20..(5)..30 J 30 J

Energy 2nd shock of

VT1, VT2

(Lumax 700/600

only)

OFF; 4..(2)..20..(5)..30 J 30 J

Energy 1st shock

and 2nd shock

VF (model 300/500)

1..(1)..16..(2)..30 J 30 J

Energy 1st shock of

VF (Lumax 700/600

only)

2..(2)..20..(5)..30 J 30 J

Energy 2nd shock of

VF (Lumax 700/600

only)

4..(2)..20..(5)..30 J 30 J

1 Programmed values are stored energies.

Lumax Technical Manual 191

Parameter Range Standard

Energy 1st shock

and 2nd shock

VT1, VT2 (model

340/540) 1

OFF; 1..(1)..16..(2)..40 J 40 J

Energy 1st shock of

VT1, VT2

(Lumax 740/640

only)

OFF; 2..(2)..20..(5)..40 J 40 J

Energy 2nd shock of

VT1, VT2

(Lumax 740/640

only)

OFF; 4..(2)..20..(5)..40 J 40 J

Energy 1st shock

and 2nd shock

VF (model 340/540)

1..(1)..16..(2)..40 J 40 J

Energy 1st shock of

VF (Lumax 740/640

only)

2..(2)..20..(5)..40 J 40 J

Energy 2nd shock of

VF (Lumax 740/640

only)

4..(2)..20..(5)..40 J 40 J

Number of shocks

(VT1/VT2)

0..(1)..8 [8]

Number of shocks

(VT1/VT2)

(Lumax 700/740 &

600/640 only)

0, 1, 2, 6, 8 [8]

Number of shocks

(VF)

2; 6..(1)..8 8

Number of shocks

(VF)

(Lumax 700/740 &

600/640 only)

6, 8 8

Confirmation (per

zone)

OFF, ON ON

Shock form (per

zone)

Biphasic, Biphasic2 Biphasic

192 Lumax Technical Manual

Parameter Range Standard

Polarity (per zone) Normal,

Reverse,

Alternating

Normal

ATP Parameters

ATP type Burst, Ramp, Burst +

PES

[Burst]

ATP type

(Lumax 700/740 &

600/640 only)

Burst, Ramp [Burst]

ATP attempts OFF, 1…(1)...10 3

ATP attempts

(Lumax 700/740 &

600/640 only)

OFF, 1…(1)...10 [OFF]

S1 number 1...(1)...10 [5]

Add. S1 OFF, ON [ON]

R1-S1 interval 200...(10)...500 ms

(absolute);

70...(5)...95 % (adaptive)

[80 %]

R1-S1 interval

(Lumax 700/740 &

600/640 only)

70...(5)...95 % (adaptive) [80 %]

S1 (RAMP)

decrement

5...(5)...40 ms [10 ms]

Scan decrement OFF, 5...(5)...40 ms [OFF]

S1-S2 interval 200...(10)...500 ms

(absolute);

70...(5)...95 % (adaptive)

[70 %]

Minimal ATP interval 200...(5)...300 ms [200 ms]

Minimal ATP interval

(Lumax 700/740 &

600/640 only)

200 ms -

ATP timeout (not

applicable in Lumax

700/740 & 600/640)

OFF,

00:15...(00:15)...05:00

mm:ss

OFF

ATP optimization OFF, ON OFF

ATP pulse amplitude 7.5 V 7.5 V

ATP pulse width 1.5 ms 1.5 ms

ATP One-Shot Parameter (ATP in VF)

ATP type OFF, Burst, Ramp, Burst

+ PES

OFF

Lumax Technical Manual 193

Parameter Range Standard

ATP type

(Lumax 700/740 &

600/640 only)

OFF, Burst, Ramp Burst

S1 number 1...(1)...10 [5]

S1 number

(Lumax 700/740 &

600/640 only)

1...(1)...10 [8]

R-S1 interval 200...(10)...350 ms

(absolute);

70...(5)...95 % (adaptive)

[80%]

R-S1 interval

(Lumax 700/740 &

600/640 only)

70...(5)...95 % (adaptive) [85%]

S1 decrement 5...(5)...40 ms [10 ms]

S1-S2 interval 200...(10)...350 ms

(absolute);

70...(5)...95 % (adaptive)

[70%]

Stability 12% 12%

ATP attempts 1 [1]

ATP pulse amplitude 7.5 V 7.5 V

ATP pulse width 1.5 ms 1.5 ms

Ventricular NIPS

Lumax 700/740 & 600/640 Only

ATP type Burst, Ramp, Burst +

PES

Ramp

Attempts 1 1

Ventricular Pacing BiV, LV, RV RV

S1 number 1...(1)...25 [5]

R-S1 interval 200...(10)...600 ms

(absolute);

70...(5)...95 % (adaptive)

[80%]

S1 decrement 5...(5)...40 ms [10 ms]

S1-S2 interval 200...(10)...600 ms

simply alterable via [+ / -]

buttons

290

S2-S3 interval OFF, 200...(10)...600 ms

simply alterable via [+ / -]

buttons

OFF

194 Lumax Technical Manual

Parameter Range Standard

S3-S4 interval OFF, 200...(10)...600 ms

simply alterable via [+ / -]

buttons

OFF

Minimum ATP

interval

200 ms

Atrial NIPS

Lumax 700/740 & 600/640 Only

Backup Stimulation

(VVI-Rate)

OFF, 30 .. (10) .. 120

bpm

OFF

Report OFF, 5, 10, 25, 50 mm/s Preference

S1-S1 interval 80…(10)…2000 ms 600 ms

S1 cycles 0...(1)...10 7

S1-S2 interval None, 80...(10)...1000 ms

simply alterable via [+ / -]

buttons

None

S2-S3 interval None, 80...(10)...1000 ms

simply alterable via [+ / -]

buttons

None

S3-S4 interval None, 80...(10)...1000 ms

simply alterable via [+ / -]

buttons

None

Burst rate Min. 30…(10)…250 bpm 150 bpm

Burst rate Start 30…(10)…800 bpm 250 bpm

Burst rate Max. 30…(10)…800 bpm 350 bpm

Post-Shock Pacing

Mode DDI at permanent

DDD(R), DDI (R), AAI(R)

VDI at permanent

VDD(R), VDI(R),

VVI at permanent VVI(R),

OFF

Modes (VR-T DX

Only)

AAI

VDI at permanent

VDD(R), VDI(R),

VVI at permanent VVI(R),

OFF

Basic rate 30 .. (5)..100..(10) .. 160

bpm

60 bpm

Rate hysteresis OFF, -5 .. (-5) .. –65 bpm OFF

Lumax Technical Manual 195

Parameter Range Standard

Rate hysteresis

(Lumax 700/740 &

600/640 only)

OFF -

AV delay 50..(10)..350 ms (fixed

AV delay)

140 ms

Post-shock duration OFF, 00:10 .. (00:10) ..

00:50, 01:00 .. (01:00) ..

10:00 mm:ss

00:10 mm:ss

Post-shock duration

(Lumax 700/740 &

600/640 only)

OFF, 00:10, 00:30, 01:00,

02:00, 05:00, 10:00

mm:ss

00:10 mm:ss

CRT Therapy Parameters

Initially paced

chamber

LV, RV LV

VV delay after Vp 0… (5)… 100 ms 0 ms

Home Monitoring

Home Monitoring OFF, ON OFF

Transmission time Time (hh:mm) [01:00

hh:mm]

Transmission time

(Lumax 700/740 &

600/640 only)

Std., 00:00 ..(01:00) ..

23:00 (hh:mm)

[Std.]

IEGM for therapy

episode

OFF, ON [OFF]

IEGM for therapy

episode

(Lumax 700/740 &

600/640 only)

OFF, ON [ON]

IEGM for monitoring

episode

OFF, ON [OFF]

IEGM for monitoring

episode

(Lumax 700/740 &

600/640 only)

OFF, ON [ON]

Periodic IEGM OFF, 2, 3, 4, 6 months [OFF]

Periodic IEGM

(Lumax 700/740 &

600/640 only)

OFF, Date, 30, 60, 90,

120, 180 days

[90]

Sustained atrial

episode

OFF, 0,5, 6, 12, 18 h [12 h]

196 Lumax Technical Manual

Parameter Range Standard

Sustained atrial

episode

(Lumax 700/740 &

600/640 only)

OFF, 6, 12, 18 h

(5 min, 30 min)

[12 h]

Diagnostics

if Home Monitoring ON: =

Cycle duration

[90] Periodic Recordings

(Lumax 700/740 &

600/640 only) If Home Monitoring OFF:

OFF, 30 .. (30) .. 180

[90]

FCC Statement: (FCC ID: QRILUMAXT, QIRLUMAXT50): This

implant is equipped with an RF transmitter for wireless

communications. This device may not interfere with stations

operating in the 400.150–406.000 MHz band in the

Meteorological Aids, Meteorological Satellite, and Earth

Exploration Satellite Services and must accept any interference

received, including interference that may cause undesired

operation.

Lumax Technical Manual 197

198 Lumax Technical Manual

Appendix A

Connector Compatibility

Lumax ICDs/CRT-Ds are indicated for use only with commercially

available BIOTRONIK bipolar ICD lead systems or other lead

systems with which it has been tested. The separate atrial

pacing/sensing lead may be any commercially available pacing

lead. The Lumax family of ICDs/CRT-Ds are mechanically

compatible with:

 IS-1 sensing/pacing lead connectors

 DF-1 defibrillation lead connectors.

The Lumax DR ICD has two IS-1 header ports and two DF-1

header ports while the Lumax VR ICD has a single IS-1 header

port and two DF-1 header ports. The Lumax HF CRT-Ds have

three IS-1 header ports and two DF-1 header ports

Lumax Technical Manual 199

200 Lumax Technical Manual

Appendix B – Known

Anomalies

Anomaly Possible Effect on

Patient or Implant

Procedure

Lumax Application (Programmer

Software)

Impact on

Lumax 700/740 &

600/640

communication

session may be

unexpectedly

interrupted

when a long

episode is

printed with

high paper

feed.

ID# 424185

Limited effect on patient.

Functional/Usability

Issue (missing,

insufficient user

guidance, unexpected

behavior): may cause

follow-up prolongation.

Acceptable residual risk

resulting from low

severity and low

probability of

occurrence.

Product safety and

performance are

only marginally

affected.

Caption

annotation

missing in

printout for

Lumax 740 VR-

T DX and

several

statistics (Rate

Histogram, AV

Histogran,

Paced Trend),

ID# 422748

Limited effect on patient.

Layout Issue (Screen

Display, Printout): User

confusion unlikely.

Acceptable residual risk

resulting from low

severity and low

probability of

occurrence.

Lumax 740 VR-T DX

only: Product safety

and performance are

only marginally

affected.

Lumax Technical Manual 201

Anomaly Possible Effect on

Patient or Implant

Procedure

Lumax Application (Programmer

Software)

Impact on

Lumax 700/740 &

600/640

The Far Field

channel display

may disappear

when the ECG

window is

minimized after

having been

maximized

immediately

before.

ID# 421905

Limited effect on patient.

Diagnostic Data Issue

(Interrogation, Display,

Printout):

Display/printout of

missing diagnostic

information may cause

user confusion.

Acceptable residual risk

resulting from low

severity and low

probability of

occurrence.

Product safety and

performance are

only marginally

affected.

Missing

parameter "AF

Intervall/Rate"

in printout.

ID# 421245

Limited effect on patient.

Program Parameter

Issue (Interrogation,

Display, Selection,

Transmission):

Display/Printout of

missing program data

without risk of incorrect

diagnosis. Acceptable

residual risk resulting

from low severity and

low probability of

occurrence.

Product safety and

performance are

only marginally

affected.

202 Lumax Technical Manual

Anomaly Possible Effect on

Patient or Implant

Procedure

Lumax Application (Programmer

Software)

Impact on

Lumax 700/740 &

600/640

The

transmission

date for

Periodic IEGM

messages for

Remote

Follow-Up

(Home

Monitoring)

may be off by

one day.

ID# 412325

No effect on patient.

Functional/Usability

Issue (missing,

insufficient user

guidance, unexpected

behavior):

Unexpected/Unspecified

behavior without clinical

relevance or negative

therapeutical/diagnostic

implication. No message

is lost, no data is

altered. Accepted due to

low probability of

occurrence and very low

severity

N/A

Event Counter

Statistics may

be slightly off

by single

counts of Vx

events

dependent on

internal

statistics state

transitions.

This is a rare

event.

ID# 410925

Limited effect on patient.

Diagnostic Data Issue

(Interrogation, Display,

Printout):

Display/printout of

incorrect diagnostic

information without risk

of incorrect diagnosis.

Acceptable residual risk

resulting from low

severity and low

probability of

occurrence.

Product safety and

performance are

only marginally

affected.

Lumax Technical Manual 203

Anomaly Possible Effect on

Patient or Implant

Procedure

Lumax Application (Programmer

Software)

Impact on

Lumax 700/740 &

600/640

Inconsistent

behavior for

"Alert"

navigation.

Clicking the

alert icon on

the TrendView

time axis and

on the

Information

Details the

expectedly the

navigation

leads to the

corresponfing

trend. This is

omitted if the

alert icons are

clicked from

the Diagnostics

Details.

ID# 406945

No effect on patient.

Functional/Usability

Issue (missing,

insufficient user

guidance, unexpected

behavior): without

clinical relevance or

negative

therapeutical/diagnostic

implication. Acceptable

residual risk resulting

from low severity and

low probability of

occurrence.

N/A

204 Lumax Technical Manual

Anomaly Possible Effect on

Patient or Implant

Procedure

Lumax Application (Programmer

Software)

Impact on

Lumax 700/740 &

600/640

For long patient

names

involving

umlauts the

transmission of

patient data

may suppress

the patient

name (empty

field).

ID# 393925

No effect on patient.

Functional/Usability

Issue (missing,

insufficient user

guidance, unexpected

behavior):

Unexpected/Unspecified

behavior without clinical

relevance or negative

therapeutical/diagnostic

implication. Acceptable

residual risk resulting

from low severity and

low probability of

occurrence.

N/A

Dual Chamber

devices only:

When

programmed to

DDDR mode

and with

sensor activity

it is possible for

a sudden rate

drop at start of

a capacitor

reformation

procedure.

After the

reformation the

pacing rate

again sensor

indicated rate.

ID# 19607

Limited effect on patient,

temporary rate drop to

programmed post-shock

pacing rate ensures

sufficient support.

N/A

Lumax Technical Manual 205

Anomaly Possible Effect on

Patient or Implant

Procedure

Lumax Application (Programmer

Software)

Impact on

Lumax 700/740 &

600/640

An ineffective

pacing program

may continue

during the

threshold test

programming

distances close

to the loss of

communication

. Lifting the

wand corrects

the problem.

ID# 17903

Limited potential effect

on patient, non-capture

is quickly recognized

and removal of

programming wand is

typical response. This

anomaly can only occur

during manual threshold

testing (in physician’s

office).

N/A

Distributed by:

BIOTRONIK, Inc.

6024 Jean Road

Lake Oswego, OR 97035-5369

(800) 547-0394 (24-hour)

(503) 635-9936 (FAX)

Manufactured by:

BIOTRONIK SE & Co. KG

Woermannkehre 1

12359 Berlin

M4117-H 10/11 Germany

BIOTRONIK SE and KG LUMAXT50 Implantable Cardioverter defibrillator User Manual UserMan

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