BIOTRONIK Lumax VR ICD Series User manual

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

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

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

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

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

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

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

vi Lumax Technical Manual

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

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

Lumax Technical Manual 3
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 ICS 3000 Programming and Tachyarrhythmia
Monitoring System and the Implant Module System Analyzer or
Pacing System Analyzer for acute lead testing. The ICS 3000
programmer is used to interrogate and program the ICD/CRT-Ds.
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
•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.

4 Lumax Technical Manual
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)
The following LV leads were evaluated in the OPTION CRT/ATx
study with BIOTRONIK’s CRT-Ds:
•Guidant-Easytrak IS-1
•Guidant-Easytrak LV-1

Lumax Technical Manual 5
•Guidant-Easytrak 2
•Guidant-Easytrak 3
•Medtronic-Attain
•St. Jude-Aescula
•St. Jude-Quicksite
•Biomec-Myopore Epicardial
•Medtronic-Epicardial 5071
•Medtronic-CapSure EPI
•Biotronik-ELC 54-UP
The following LV leads were bench tested for compatibility with
BIOTRONIK’s CRT-Ds:
•Guidant EasyTrak 4512 (unipolar)
•Guidant EasyTrak 4513 (bipolar)
•Guidant EasyTrak 3 4525 (bipolar)
•Medtronic Attain OTW 4193 (unipolar)
•Medtronic Attain OTW 4194 (bipolar)
•Medtronic Attain LV 2187 (unipolar)
•St. Jude Medical QuickSite 1056K (unipolar)
•ELA Situs OTW (unipolar)
•Biotronik Corox OTW 75-UP Steroid #346542 (unipolar)
•Biotronik Corox+ LV-H 75-BP #341885 (bipolar)
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
•Insertion and withdrawal forces as specified by
ISO 5841-3 (IS-1) and ISO 11318:1993 (E) DF-1

6 Lumax Technical Manual
The following leads were evaluated in a retrospective study with
BIOTRONIK’s ICDs/CRT-Ds:
•Medtronic Sprint 6932
•Medtronic Sprint 6943
•Medtronic Sprint Quattro 6944
•Medtronic Transvene RV 6936
•St. Jude (Ventritex) TVL- ADX 1559
•St. Jude SPL SP02
•Guidant Endotak DSP
•Guidant Endotak Endurance EZ, Endotak Reliance
•Guidant (Intermedics) 497-24.
The following leads were bench tested for compatibility with
BIOTRONIK’s ICDs/CRT-Ds:
•Guidant Endotak Endurance “CPI 0125”
•Guidant Endotak Reliance 0148
•Medtronic Sprint 6932
•Medtronic Sprint 6942
•Medtronic Sprint 6943
•Medtronic Sprint 6945
•Medtronic Sprint Quattro 6944
•St. Jude Riata 1571/65
•St. Jude SPL SPO1
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.

Lumax Technical Manual 7
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 85 days. For
further information, please refer to Section 2.11.4, 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.

8 Lumax Technical Manual
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 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 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.
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.

Lumax Technical Manual 9
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, 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. 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.
Kinking Leads - Do not kink leads. This may cause additional
stress on the leads that can result in damage to the lead.

10 Lumax Technical Manual
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 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.

Lumax Technical Manual 11
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 implant
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.

12 Lumax Technical Manual
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:
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.