Boston Scientific CRMN11906 Implantable Defibrillator User Manual Teligen Part 1 Manual

Boston Scientific Corporation Implantable Defibrillator Teligen Part 1 Manual

CRMN11906 User Manual >

SYSTEM GUIDETELIGEN™100IMPLANTABLE CARDIOVERTER HIGH ENERGYDEFIBRILLATORREF E102, E110CAUTION: Federal lawrestricts this device to sale byor on the order of a physiciantrained or experienced indevice implant and follow-upprocedures. Part 1 of 2- DRAFT -

ABOUT THIS MANUALBoston Scientiﬁc Corporation acquired Guidant Corporation in April 2006.During our transition period, you may see both the Boston ScientiﬁcandGuidant names on product and patient material. As we work through thetransition, we will continue to offer doctors and their patients technologicallyadvanced and high quality medical devices and therapies.The text conventions discussed below are used throughout this manual.PRM KEYS The names of Programmer/Recorder/Monitor (PRM)keys appear in capital letters (e.g., PROGRAM,INTERROGATE).1., 2., 3. Numbered lists are used for instructions that should befollowed in the order given.•Bulleted lists are used when the information is notsequential.This product family includes single- and dual-chamber models, with featurevariations. This manual is written for full description of a full-featured model(e.g., a dual-chamber model with ZIP telemetry). Some models will containfewer features; for those devices, disregard descriptions of the unavailablefeatures.The screen illustrations used in this manual are intended to familiarize you withthe general screen layout. The actual screens you see when interrogatingor programming the pulse generator will vary based on the model andprogrammed parameters.A complete list of programmable options is provided in the appendix("Programmable Options" on page A-1). The actual values you see wheninterrogating or programming the pulse generator will vary based on the modeland programmed parameters.ThefollowingacronymsmaybeusedinthisSystemGuide:A: AtrialAF: Atrial FibrillationThe following are trademarks of Boston Scientiﬁcoritsafﬁliates: ENDOTAK, RHYTHM ID,TELIGEN, VENTAK, VITALITY, ZIP.- DRAFT -

$AFib: Atrial FibrillationAFR: Atrial Flutter ResponseAGC: Automatic Gain ControlAIVR: Accelerated Idioventricular RhythmAT: Atrial TachycardiaATP: Antitachycardia PacingATR: Atrial Tachy ResponseAV: AtrioventricularBCL: Burst Cycle LengthBOL: Beginning of LifeCPR: Cardiopulmonary ResuscitationECG: ElectrocardiogramDFT: Deﬁbrillation ThresholdEAS: Electronic Article SurveillanceEF: Ejection FractionEGM: ElectrogramEMI: Electromagnetic InterferenceEP: Electrophysiology; ElectrophysiologicFCC: Federal Communications CommissionHE: High EnergyIBP: Indications-Based ProgrammingIC: Industry CanadaICD: Implantable Cardioverter DeﬁbrillatorLRL: Lower Rate LimitMI: Myocardial InfarctionMPR: Maximum Pacing RateMRI: Magnetic Resonance ImagingMSR: Maximum Sensor RateMTR: Maximum Tracking RateNSR: Normal Sinus RhythmPAC: Premature Atrial ContractionPAT: Paroxysmal Atrial TachycardiaPES: Programmed Electrical StimulationPMT: Pacemaker-Mediated TachycardiaPRM: Programmer/Recorder/MonitorPSA: Pacing System AnalyzerPVARP: Post-Ventricular Atrial Refractory PeriodPVC: Premature Ventricular ContractionRADAR: Radio Detection and RangingRF: Radio FrequencyRV: Right VentricularRVRP: Right Ventricular Refractory PeriodSCD: Sudden Cardiac Death- DRAFT -$

$SRD: Sustained Rate DurationSVT: Supraventricular TachycardiaTARP: Total Atrial Refractory PeriodTENS: Transcutaneous Electrical Nerve StimulationV: VentricularVFib: Ventricular FibrillationVF: Ventricular FibrillationVRP: Ventricular Refractory PeriodVRR: Ventricular Rate RegulationVT: Ventricular TachycardiaVTR: Ventricular Tachycardia Response- DRAFT -$

CONTENTSINFORMATION FOR USE ................................................................................................. 1-1CHAPTER 1New or Enhanced Features................................................................................................ 1-3Device Description.............................................................................................................. 1-4Related Information ............................................................................................................ 1-6Indications and Usage ........................................................................................................ 1-6Contraindications................................................................................................................ 1-6Warnings ............................................................................................................................ 1-7Precautions......................................................................................................................... 1-8Potential Adverse Events ................................................................................................. 1-18Mechanical Speciﬁcations ................................................................................................ 1-19Lead Connections............................................................................................................. 1-20Items Included in Package ............................................................................................... 1-21Symbols on Packaging ..................................................................................................... 1-21Characteristics as Shipped............................................................................................... 1-22X-Ray Identiﬁer................................................................................................................. 1-23Federal Communications Commission (FCC) .................................................................. 1-24Industry Canada (IC) ........................................................................................................ 1-24Pulse Generator Longevity ............................................................................................... 1-25Warranty Information ........................................................................................................ 1-26Product Reliability............................................................................................................. 1-26- DRAFT -

Patient Counseling Information ........................................................................................ 1-27Patient Handbook ...................................................................................................... 1-28USING THE PROGRAMMER/RECORDER/MONITOR..................................................... 2-1CHAPTER 2ZOOM LATITUDE Programming System ........................................................................... 2-2Indications-Based Programming (IBP) ............................................................................... 2-2Manual Programming ......................................................................................................... 2-5Software Terminology and Navigation ................................................................................ 2-6Main Screen................................................................................................................. 2-6PRM Mode Indicator .................................................................................................... 2-6ECG/EGM Display ....................................................................................................... 2-7Toolbar .........................................................................................................................2-8Tabs ............................................................................................................................. 2-8Buttons.........................................................................................................................2-8Icons ............................................................................................................................ 2-8Common Objects ....................................................................................................... 2-10Use of Color ............................................................................................................... 2-10Data Management ............................................................................................................ 2-11Patient Information..................................................................................................... 2-11Disk Operations ......................................................................................................... 2-11Print............................................................................................................................ 2-12Communicating with the Pulse Generator ........................................................................ 2-12ZIP Telemetry............................................................................................................. 2-13Starting a Wanded Telemetry Session ....................................................................... 2-13Starting a ZIP Telemetry Session............................................................................... 2-14Ending a Telemetry Session ...................................................................................... 2-14ZIP Telemetry Security............................................................................................... 2-14DIVERT THERAPY .......................................................................................................... 2-17STAT SHOCK ................................................................................................................... 2-17STAT PACE ...................................................................................................................... 2-18Safety Mode ..................................................................................................................... 2-19Backup Pacemaker.................................................................................................... 2-19- DRAFT -

$Backup Deﬁbrillator.................................................................................................... 2-19Programming the Device Safety Tachy Mode ............................................................ 2-20TACHYARRHYTHMIA DETECTION.................................................................................. 3-1CHAPTER 3Device Mode....................................................................................................................... 3-2Ventricular Tachy Mode................................................................................................ 3-2Electrocautery Protection Mode................................................................................... 3-3Rate Sensing...................................................................................................................... 3-3Calculating Rates and Refractory Periods ................................................................... 3-4Ventricular Rate Thresholds and Zones....................................................................... 3-4Use of Atrial Information .............................................................................................. 3-5Ventricular Detection .......................................................................................................... 3-6Ventricular Detection Enhancement Suites.................................................................. 3-7Ventricular Redetection.............................................................................................. 3-11Ventricular Post-shock Detection Enhancements ...................................................... 3-11Ventricular Detection Details...................................................................................... 3-12TACHYARRHYTHMIA THERAPY ..................................................................................... 4-1CHAPTER 4Ventricular Therapy ............................................................................................................ 4-2Ventricular Therapy Prescription.................................................................................. 4-2Ventricular Therapy Selection ...................................................................................... 4-3Ventricular Redetection after Ventricular Therapy Delivery ......................................... 4-8Ventricular Redetection after Ventricular ATP Therapy................................................ 4-8Ventricular Redetection after Ventricular Shock Therapy ............................................ 4-9Antitachycardia Pacing Therapies and Parameters ......................................................... 4-10Burst Parameters ....................................................................................................... 4-11Coupling Interval and Coupling Interval Decrement .................................................. 4-12Burst Cycle Length (BCL) .......................................................................................... 4-14Minimum Interval........................................................................................................ 4-14Burst Scheme ............................................................................................................ 4-15Ramp Scheme ........................................................................................................... 4-15Scan Scheme............................................................................................................. 4-16Ramp/Scan Scheme .................................................................................................. 4-17ATP Pulse Width and ATP Amplitude ........................................................................ 4-18Ventricular ATP Time-out ........................................................................................... 4-19QUICK CONVERT ATP ............................................................................................. 4-20- DRAFT -$

Ventricular Shock Therapy and Parameters..................................................................... 4-21Ventricular Shock Vector............................................................................................ 4-21Ventricular Shock Energy........................................................................................... 4-21Charge Time .............................................................................................................. 4-22Waveform Polarity...................................................................................................... 4-22Committed Shock/Reconﬁrmation of the Ventricular Arrhythmia ............................... 4-23PACING THERAPIES ........................................................................................................ 5-1CHAPTER 5Pacing Therapies................................................................................................................ 5-2Basic Parameters ............................................................................................................... 5-2Brady Mode.................................................................................................................. 5-3Lower Rate Limit (LRL) ................................................................................................ 5-4Maximum Tracking Rate (MTR) ................................................................................... 5-5Maximum Sensor Rate (MSR) ..................................................................................... 5-6Pulse Width.................................................................................................................. 5-7Amplitude ..................................................................................................................... 5-8Sensitivity.....................................................................................................................5-8Post-Therapy Pacing .......................................................................................................... 5-9Post-Shock Pacing Delay ............................................................................................ 5-9Post-Therapy Period .................................................................................................. 5-10Temporary Pacing............................................................................................................. 5-10Sensors and Trending ...................................................................................................... 5-11Sensor Trending......................................................................................................... 5-11Adaptive-rate Pacing.................................................................................................. 5-12Accelerometer............................................................................................................ 5-13Atrial Tachy Response...................................................................................................... 5-19ATR Mode Switch ...................................................................................................... 5-19Ventricular Rate Regulation (VRR) ............................................................................ 5-24Atrial Flutter Response (AFR) .................................................................................... 5-25PMT Termination........................................................................................................ 5-25Rate Enhancements ......................................................................................................... 5-26Rate Hysteresis.......................................................................................................... 5-26Rate Smoothing ......................................................................................................... 5-28Lead Conﬁguration ........................................................................................................... 5-31- DRAFT -

$AV Delay........................................................................................................................... 5-32Paced AV Delay ......................................................................................................... 5-32Sensed AV Delay ....................................................................................................... 5-33AV Search+ ................................................................................................................ 5-35Refractory ......................................................................................................................... 5-36A-Refractory (PVARP) ............................................................................................... 5-36RV-Refractory (RVRP) ............................................................................................... 5-37Blanking and Noise Rejection .................................................................................... 5-38Noise Response ............................................................................................................... 5-41Ventricular Tachy Sensing Interactions............................................................................. 5-43SYSTEM DIAGNOSTICS................................................................................................... 6-1CHAPTER 6Battery Status ..................................................................................................................... 6-2Capacitor Re-formation................................................................................................ 6-5Charge Time Measurement ......................................................................................... 6-5Last Delivered Ventricular Shock ................................................................................. 6-6Lead Tests .......................................................................................................................... 6-6Intrinsic Amplitude Test ................................................................................................ 6-7Lead Impedance Test................................................................................................... 6-8Pace Threshold Test .................................................................................................... 6-8PATIENT DIAGNOSTICS................................................................................................... 7-1CHAPTER 7Therapy History ..................................................................................................................7-2Trends ................................................................................................................................ 7-3Arrhythmia Logbook ........................................................................................................... 7-5Histograms................................................................................................................. 7-11Counters .................................................................................................................... 7-11Patient Triggered Monitor ................................................................................................. 7-13- DRAFT -$

ELECTROPHYSIOLOGIC TESTING................................................................................. 8-1CHAPTER 8EP Test Features ................................................................................................................ 8-2Temporary EP Mode .................................................................................................... 8-2Backup Ventricular Pacing During Atrial EP Testing .................................................... 8-2EP Test Screen ............................................................................................................ 8-2Induction Methods .............................................................................................................. 8-4VFib Induction .............................................................................................................. 8-5Shock on T Induction ................................................................................................... 8-6Programmed Electrical Stimulation (PES) ................................................................... 8-750 Hz/Manual Burst Pacing ......................................................................................... 8-9Commanded Therapy Methods ........................................................................................ 8-10Commanded Shock ................................................................................................... 8-10Commanded ATP....................................................................................................... 8-11IMPLANT INFORMATION ................................................................................................. 9-1CHAPTER 9Implanting the Pulse Generator.......................................................................................... 9-2Step A: Check Equipment ......................................................................................... 9-2Step B: Interrogate and Check the Pulse Generator................................................. 9-3Step C: Implant the Lead System.............................................................................. 9-3Step D: Take Baseline Measurements ...................................................................... 9-4Step E: Form the Implantation Pocket....................................................................... 9-5Step F: Connect the Leads to the Pulse Generator .................................................. 9-6Step G: Evaluate Lead Signals ................................................................................. 9-9Step H: Program the Pulse Generator .................................................................... 9-10Step I: Implant the Pulse Generator ........................................................................ 9-10Step J: Complete and Return the Implantation Form .............................................. 9-11POST IMPLANT INFORMATION..................................................................................... 10-1CHAPTER 10Follow Up Testing ............................................................................................................. 10-2Predischarge Follow Up ............................................................................................. 10-2Routine Follow Up...................................................................................................... 10-2Post Implant features........................................................................................................ 10-3Sensitivity Adjustment................................................................................................ 10-3Beeper Feature .......................................................................................................... 10-4- DRAFT -

Magnet Feature.......................................................................................................... 10-5Explantation...................................................................................................................... 10-8PROGRAMMABLE OPTIONS........................................................................................... A-1APPENDIX APACEMAKER INTERACTION ........................................................................................... B-1APPENDIX BCLINICAL STUDY - MADIT II ............................................................................................ C-1APPENDIX CSummary ............................................................................................................................ C-1Indications for Use.............................................................................................................. C-1Observed Adverse Events.................................................................................................. C-1Mortality .............................................................................................................................. C-6Summary of Clinical Study ................................................................................................. C-6Study Design ...................................................................................................................... C-7Inclusion/Exclusion Criteria ................................................................................................ C-8Patient Status ...................................................................................................................C-10Primary Endpoint .............................................................................................................. C-10Follow-up Schedule .......................................................................................................... C-11Study Results ................................................................................................................... C-12CLINICAL STUDY - VENTAK AV II DR ............................................................................. D-1APPENDIX DClinical Study Populations .................................................................................................. D-1Chronic Implant Study - VENTAK AV II DR ........................................................................ D-1- DRAFT -

CLINICAL STUDY - VITALITY........................................................................................... E-1APPENDIX EClinical Study Populations .................................................................................................. E-1Chronic Implant Study - VITALITY...................................................................................... E-1Acute Study - VITALITY...................................................................................................... E-3CLINICAL STUDY - SUMMARY OF GDT1000 SENSING ACUTE STUDY...................... F-1APPENDIX FClinical Study Populations .................................................................................................. F-1Study Methods....................................................................................................................F-1Study Results ..................................................................................................................... F-3Conclusions........................................................................................................................ F-7- DRAFT -

1-1INFORMATION FOR USECHAPTER 1This chapter contains the following topics:• "New or Enhanced Features" on page 1-3• "Device Description" on page 1-4• "Related Information" on page 1-6• "Indications and Usage" on page 1-6• "Contraindications" on page 1-6• "Warnings" on page 1-7• "Precautions" on page 1-8• "Potential Adverse Events" on page 1-18• "Mechanical Speciﬁcations" on page 1-19• "Lead Connections" on page 1-20• "Items Included in Package" on page 1-21• "Symbols on Packaging" on page 1-21• "Characteristics as Shipped" on page 1-22• "X-Ray Identiﬁer" on page 1-23• "Federal Communications Commission (FCC)" on page 1-24• "Industry Canada (IC)" on page 1-24• "Pulse Generator Longevity" on page 1-25• "Warranty Information" on page 1-26• "Product Reliability" on page 1-26- DRAFT -

1-2 INFORMATION FOR USE• "Patient Counseling Information" on page 1-27- DRAFT -

1-3NEW OR ENHANCED FEATURESThese pulse generator systems include additional features as compared toprevious products.Ease of Use• ZOOMVIEW Programmer Software: the new user interface offers thefollowing beneﬁts:– Clinical focus—features such as patient diagnostic trends andindications-based programming emphasize the patient’s clinicalcondition over device status and parameters.– Consistency—ZOOMVIEW software will be available on future pulsegenerators, providing the same screens whether you are following abrady, tachy, or heart failure device.– Simplicity—screen complexity is reduced through the use ofprogressive disclosure (displaying the information you use frequentlyand minimizing the information you only rarely access) andexception-based reporting.• Indications-Based Programming (IBP): the new ZOOMVIEW feature allowsyou to quickly set up programming parameters based on the patient’sclinical needs and indications.Tachy Therapy• Rhythm ID and Onset/Stability detection: the selection between detectionenhancements provides you the opportunity and ﬂexibility to adjust forindividual patient conditions.• QUICK CONVERT ATP: in an attempt to avoid an otherwise scheduledcharge and painful shock for a pace-terminable fast ventricular tachycardia(VT), the pulse generator delivers one rapid burst of antitachycardia pacing(ATP) for an episode detected in the ventricular ﬁbrillation (VF) zone.• Programmable Shock Vectors: this capability allows you to electronicallychange the shocking vectors for added ﬂexibility in treating highdeﬁbrillation thresholds (DFTs).- DRAFT -

1-4 INFORMATION FOR USEDEVICE DESCRIPTIONBrady Therapy• AV Search +: this feature is designed to reduce unnecessary RV pacing forpatients with intact or intermittent AV conduction by allowing intrinsic AVconduction beyond the programmed AV delay during episodes of normalAV nodal function—an enhanced version of AV Search Hysteresis.Sensing• Sensing is designed to combine the strengths of both implantablecardioverter deﬁbrillator (ICD) and pacemaker sensing capabilities toimprove detection and therapy by reducing inappropriate mode switching,pacing inhibition, and shocks.DEVICE DESCRIPTIONThis manual contains information about the TELIGEN 100 family of implantablecardioverter deﬁbrillators (ICDs). The TELIGEN 100 family contains thefollowing types of pulse generators (speciﬁc models are listed in "MechanicalSpeciﬁcations" on page 1-19):• VR—single-chamber ICD combining ventricular tachyarrhythmia therapywith ventricular pacing and sensing• DR—dual-chamber ICD combining ventricular tachyarrhythmia therapywith ventricular and atrial pacing and sensingTherapiesThis family of pulse generators has a small, thin, physiologic shape thatminimizes pocket size and may minimize device migration. Pulse generatorswithin this family provide a variety of therapies, including:• Ventricular tachyarrhythmia therapy, which is used to treat rhythmsassociated with sudden cardiac death (SCD) such as VT and VF• Bradycardia pacing, including adaptive rate pacing, to detect and treatbradyarrhythmias and to provide cardiac rate support after deﬁbrillationtherapyCardioversion/deﬁbrillation therapies include:• A range of low- and high-energy shocks using a biphasic waveform- DRAFT -

INFORMATION FOR USEDEVICE DESCRIPTION 1-5• The choice of multiple shock vectors:– Distal shock electrode to proximal shock electrode and pulse generatorcase (TRIAD electrode system)– Distal shock electrode to proximal shock electrode (RV Coil to RA Coil)– Distal shock electrode to pulse generator case (RV Coil to Can)LeadsThe pulse generator has independently programmable outputs and acceptsthe following leads:•OneIS-11atrial lead•OneDF-1/IS-12cardioversion/deﬁbrillation leadThe pulse generator and the leads constitute the implantable portion of thepulse generator system.PRM SystemThese pulse generators can be used only with the ZOOM LATITUDEProgramming System, which is the external portion of the pulse generatorsystem and includes:• Model 3120 Programmer/Recorder/Monitor (PRM)• Model 2868 ZOOMVIEW Software Application• Model 6577 Accessory Telemetry WandYoucanusethePRMsystemtodothefollowing:• Interrogate the pulse generator• Program the pulse generator to provide a variety of therapy options• Access the pulse generator’s diagnostic features• Perform noninvasive diagnostic testing• Access therapy history data1. IS-1 refers to the international standard ISO 5841.3:2000.2. DF-1 refers to the international standard ISO 11318:2002.- DRAFT -

1-6 INFORMATION FOR USERELATED INFORMATIONRELATED INFORMATIONRefer to the lead’s instruction manual for implant information, general warningsand precautions, indications, contraindications, and technical speciﬁcations.Read this material carefully for implant procedure instructions speciﬁctothechosen lead conﬁgurations.The Physician’s Technical Manual is packaged with the pulse generator. Itprovides the technical information needed at implant.Refer to the PRM system Operator’s Manual for speciﬁc information about thePRM such as setup, maintenance, and handling.INDICATIONS AND USAGEBoston Scientiﬁc implantable cardioverter deﬁbrillators (ICDs) are intended toprovide ventricular antitachycardia pacing (ATP) and ventricular deﬁbrillationfor automated treatment of life-threatening ventricular arrhythmias.CONTRAINDICATIONSThese Boston Scientiﬁc pulse generators are contraindicated for the followingpatients:• Patients whose ventricular tachyarrhythmias may have reversible cause,such as:– Digitalis intoxication– Electrolyte imbalance– Hypoxia–Sepsis• Patients whose ventricular tachyarrhythmias have a transient cause, suchas:– Acute myocardial infarction (MI)– Electrocution–Drowning• Patients who have a unipolar pacemaker- DRAFT -

$INFORMATION FOR USEWARNINGS 1-7WARNINGSGeneral• Labeling knowledge. Read this manual thoroughly before implanting thepulse generator to avoid damage to the system. Such damage can result inpatient injury or death.• Avoid shock during handling. Program the pulse generator TachyMode(s) to Off during implant, explant, or postmortem procedures to avoidinadvertent high voltage shocks.• Backup deﬁbrillation protection. Always have sterile external andinternal deﬁbrillation protection available during implant. If not terminated ina timely fashion, an induced ventricular tachyarrhythmia can result in thepatient’s death.• Resuscitation availability. Ensure that an external deﬁbrillator andmedical personnel skilled in CPR are present during post-implant devicetesting should the patient require external rescue.• Protected environments. Advise patients to seek medical guidancebefore entering environments that could adversely affect the operationof the active implantable medical device, including areas protected by awarning notice that prevents entry by patients who have a pulse generator.• Magnetic Resonance Imaging (MRI) exposure. Do not expose a patientto MR device scanning. Strong magnetic ﬁelds may damage the deviceand cause injury to the patient.•Diathermy.Do not subject a patient with an implanted pulse generatorto diathermy since diathermy may cause ﬁbrillation, burning of themyocardium, and irreversible damage to the pulse generator because ofinduced currents.Programming and Device Operations• Atrial tracking modes. Do not use atrial tracking modes in patients withchronic refractory atrial tachyarrhythmias. Tracking of atrial arrhythmiascould result in VT or VF.- DRAFT -$

$1-8 INFORMATION FOR USEPRECAUTIONSImplant Related• Do not kink leads. Kinking leads may cause additional stress on theleads, possibly resulting in lead fracture.• Separate pulse generator. Do not use this pulse generator with anotherpulse generator. This combination could cause pulse generator interaction,resulting in patient injury or a lack of therapy delivery.PRECAUTIONSClinical Considerations• Pacemaker-mediated tachycardia (PMT). Retrograde conductioncombined with a short PVARP might induce PMT.Sterilization, Storage, and Handling• For single use only; do not resterilize devices. Do not resterilize thedevice or the accessories packaged with it because the effectiveness ofresterilization cannot be ensured.• If package is damaged. The pulse generator blister trays and contentsare sterilized with ethylene oxide gas before ﬁnal packaging. When thepulse generator is received, it is sterile provided the container is intact. Ifthe packaging is wet, punctured, opened, or otherwise damaged, return thedevice to Boston Scientiﬁc.• Storage temperature and equilibration. Recommended storagetemperatures are 0°C–50°C (32°F–122°F). Allow the device to reach aproper temperature before using telemetry communication capabilities,programming or implanting the device because temperature extremes mayaffect initial device function.•Devicestorage.Store the pulse generator in a clean area away frommagnets, kits containing magnets, and sources of EMI to avoid devicedamage.•Usebydate.Implant the device system before or on the USE BY date onthe package label because this date reﬂects a validated shelf life. Forexample, if the date is January 1, do not implant on or after January 2.- DRAFT -$

INFORMATION FOR USEPRECAUTIONS 1-9Implantation and Device Programming• Lead system. Do not use any lead with this device without ﬁrst verifyingconnector compatibility. Using incompatible leads can damage theconnector and/or result in potential adverse consequences, such asundersensing of cardiac activity or failure to deliver necessary therapy.• Telemetry wand. Make sure the telemetry wand is connected to theprogrammer and that it is available throughout the session. Verify that thewand cord is within reach of the pulse generator.•STATPACEsettings.When a pulse generator is programmed to STATPACE settings, it will continue to pace at the high-energy STAT PACEvalues if it is not reprogrammed. The use of STAT PACE parameters willdecrease device longevity.• Pacing and sensing margins. Consider lead maturation in your choice ofpacing amplitude, pacing pulse width, and sensitivity settings.• An acute pacing threshold greater than 1.5 V or a chronic pacingthreshold greater than 3 V can result in loss of capture becausethresholds may increase over time.• An R-wave amplitude less than 5 mV or a P-wave amplitude less than2 mV can result in undersensing because the sensed amplitude maydecrease after implantation.• Pacing lead impedance should be within the range of 200 and2000 .• Line-powered equipment. Exercise extreme caution if testing leads usingline-powered equipment because leakage current exceeding 10 µA caninduce ventricular ﬁbrillation. Ensure that any line-powered equipment iswithin speciﬁcations.• Proper programming of the shock vector. If the shock vector isprogrammed to RVcoil>>RAcoil and the lead does not have an RA coil,shocking will not occur.• Replacement device. Implanting a replacement device in a subcutaneouspocket that previously housed a larger device may result in pocket airentrapment, migration, erosion, or insufﬁcient grounding between thedevice and tissue. Irrigating the pocket with sterile saline solution decreasesthe possibility of pocket air entrapment and insufﬁcient grounding. Suturingthe device in place reduces the possibility of migration and erosion.- DRAFT -

$1-10 INFORMATION FOR USEPRECAUTIONS•Deﬁbrillation power surge. Deﬁbrillation that causes a power surgeexceeding 360 watt-seconds can damage the pulse generator system.• Programming for supraventricular tachyarrhythmias (SVTs).Determine if the device and programmable options are appropriate forpatients with SVTs because SVTs can initiate unwanted device therapy.• Ventricular refractory periods (VRPs) in adaptive-rate pacing.Adaptive-rate pacing is not limited by refractory periods. A long refractoryperiod programmed in combination with a high MSR can result inasynchronous pacing during refractory periods since the combination cancause a very small sensing window or none at all. Use dynamic AV Delayor dynamic PVARP to optimize sensing windows. If you are entering aﬁxed AV delay, consider the sensing outcomes.• Do not bend the lead near the lead-header interface. Improper insertioncan cause insulation damage near the terminal end that could result inlead failure.• Shock waveform polarity. For IS-1/DF-1 leads, never change the shockwaveform polarity by physically switching the lead anodes and cathodesin the pulse generator header—use the programmable Polarity feature.Device damage or nonconversion of the arrhythmia post-operatively mayresult if the polarity is switched physically.• Absence of a lead. The absence of a lead or plug in a lead port mayaffect device performance. If a lead is not used, be sure to properly inserta plug in the unused port.• Electrode connections. Do not insert a lead into the pulse generatorconnector without ﬁrst visually verifying that the setscrew is sufﬁcientlyretracted to allow insertion. Fully insert each lead into its lead port and thentighten the setscrew onto the electrodes.• Tachy Mode to Off. To prevent inappropriate shocks, ensure that thepulse generator’s Tachy Mode is programmed to Off when not in useand before handling the device. For tachyarrhythmia therapy, verify thatthe Tachy Mode is activated.- DRAFT -$

INFORMATION FOR USEPRECAUTIONS 1-11• Atrial oversensing. For dual-chamber models, take care to ensure thatartifacts from the ventricles are not present on the atrial channel, oratrial oversensing may result. If ventricular artifacts are present in theatrial channel, the atrial lead may need to be repositioned to minimize itsinteraction.•Deﬁbrillation lead impedance. Neverimplantthedevicewithaleadsystem that has less than 15 total shock lead impedance. Devicedamage may result. If a shocking lead impedance is less than 20 ,reposition the shocking electrodes to allow a greater distance between theshocking electrodes.• ATR entry count. Exercise care when programming the Entry Count tolow values in conjunction with a short ATR Duration. This combinationallows mode switching with very few fast atrial beats. For example, if theEntry Count was programmed to 2 and the ATR Duration to 0, ATR modeswitching could occur on 2 fast atrial intervals. In these instances, a shortseries of premature atrial events could cause the device to mode switch.• ATR exit count. Exercise care when programming the Exit Count to lowvalues. For example, if the Exit Count was programmed to 2, a few cyclesof atrial undersensing could cause termination of mode switching.• Shunting energy. Do not allow any object that is electrically conductiveto come into contact with the lead or device during induction because itmay shunt energy, resulting in less energy getting to the patient, and maydamage the implanted system.• Expected beneﬁts. Determinewhethertheexpecteddevicebeneﬁtsoutweigh the possibility of early device replacement for patients whosetachyarrhythmias require frequent shocks.• Device communication. Use only the designated PRM and softwareapplication to communicate with this pulse generator.- DRAFT -

1-12 INFORMATION FOR USEPRECAUTIONSEnvironmental and Medical Therapy Hazards• Avoid electromagnetic interference (EMI). Advise patients to avoidsources of EMI because EMI may cause the pulse generator to deliverinappropriate therapy or inhibit appropriate therapy. Examples of EMIsources are:• Electrical power sources, arc welding equipment, and robotic jacks• Electrical smelting furnaces• Large RF transmitters such as radar• Radio transmitters, including those used to control toys• Electronic surveillance (antitheft) devices• An alternator on a car that is running• Elevated Pressures. Elevated pressures due to hyperbaric chamberexposure of SCUBA diving may damage the pulse generator. The pulsegenerator has been tested to function normally at 1.5 AtmospheresAbsolute (ATA) pressure or 15 ft (4.6 m) depth in sea water. For speciﬁcguidelines prior to hyperbaric chamber exposure, or if the patient isplanning scuba diving activity, contact Technical Services at the numbershown on the back cover of this manual.Hospital and Medical Environments• Mechanical ventilators. During mechanical ventilation, respiration ratetrending may be misleading; therefore, the Respiratory Sensor should beprogrammed to Off.• Internal deﬁbrillation. Do not use internal deﬁbrillation paddles orcatheters unless the pulse generator is disconnected from the leadsbecause the leads may shunt energy. This could result in injury to thepatient and damage to the implanted system.•Externaldeﬁbrillation. Use of external deﬁbrillation can damage thepulse generator.- DRAFT -

INFORMATION FOR USEPRECAUTIONS 1-13• Transcutaneous electrical nerve stimulation (TENS). TENS mayinterfere with pulse generator function. If necessary, the following measuresmay reduce interference:1. Place the TENS electrodes as close to each other as possible and asfar from the pulse generator and lead system as possible.2. Monitor cardiac activity during TENS use.For additional information, contact Technical Services at the number shownon the back cover of this manual.• Electrocautery. The use of electrocautery could induce ventriculararrhythmias and/or ﬁbrillation, cause asynchronous or inhibited pulsegenerator operation, or cause the pulse generator to deliver aninappropriate shock. If electrocautery cannot be avoided, observe thefollowing precautions to minimize complications:• Select Electrocautery Protection Mode. Avoid direct contact with thepulse generator or leads.• Monitor the patient and have temporary pacing equipment, externaldeﬁbrillation equipment, and knowledgeable medical personnelavailable.• Position the ground plate so that the current pathway does not passthrough or near the pulse generator system.• Use short, intermittent, and irregular bursts at the lowest feasibleenergy levels.• Use a bipolar electrocautery system where possible.Remember to reactivate the Tachy Mode after turning off the electrocauteryequipment.- DRAFT -

1-14 INFORMATION FOR USEPRECAUTIONS• Ionizing radiation therapy. Ionizing radiation therapy may adversely affectdevice operation. During ionizing radiation therapy (e.g., radioactive cobalt,linear accelerators, and betatrons), the pulse generator must be shieldedwith a radiation-resistive material, regardless of the distance of the deviceto the radiation beam. Do not project the radiation port directly at thedevice. After waiting a minimum of one hour following radiation treatment(to allow for a device memory check to occur), always evaluate deviceoperation, including interrogation and sensing and pacing threshold testing.At the completion of the entire course of treatments, perform deviceinterrogation and follow-up, including sensing and pacing threshold testingand capacitor re-formation.• Lithotripsy. Lithotripsy may permanently damage the pulse generator ifthe device is at the focal point of the lithotripsy beam. If lithotripsy must beused, avoid focusing near the pulse generator site.The lithotriptor is designed to trigger off the R-wave on the ECG, resultingin shock waves being delivered during the VRP.• If the patient does not require pacing, program the pulse generatorBrady Mode to Off.• If the patient requires pacing, program the pulse generator to the VVImode because atrial pacing pulses can trigger the lithotriptor.• Ultrasound energy. Therapeutic ultrasound (e.g., lithotripsy) energy maydamage the pulse generator. If therapeutic ultrasound energy must beused, avoid focusing near the pulse generator site. Diagnostic ultrasound(e.g., echocardiography) is not known to be harmful to the pulse generator.- DRAFT -

INFORMATION FOR USEPRECAUTIONS 1-15• Radio frequency ablation. Exercise caution when performing radiofrequency ablation procedures in device patients. If the pulse generatorTachy Mode is programmed to Monitor + Therapy during the procedure,the device may inappropriately declare a tachycardia episode and delivertherapy. Pacing therapy may also be inhibited unless the device isprogrammed to Electrocautery mode. RF ablation may cause changes inpacing thresholds; evaluate the patient’s thresholds appropriately.Minimize risks by following these steps:• Program the Tachy Mode(s) to Electrocautery Protection to avoidinadvertent tachycardia detection (sensing) or therapy.• Monitor the patient and have external deﬁbrillation equipment andknowledgeable medical personnel available.• Avoid direct contact between the ablation catheter and the implantedlead and pulse generator.• Keep the current path (electrode tip to ground) as far away from thepulse generator and leads as possible.• Consider the use of external pacing support for pacemaker-dependentpatients (i.e., using internal or external pacing methods).• Monitor pre- and post-measurements for sensing and pacing thresholdsand impedances to determine the integrity of the lead-patient function.Remember to reactivate the pulse generator after turning off the radiofrequency ablation equipment.• Electrical interference. Electrical interference or “noise” from devicessuch as electrocautery and monitoring equipment may interfere withestablishing or maintaining telemetry for interrogating or programming thedevice. In the presence of such interference, move the programmer awayfrom electrical devices, and ensure that the wand cord and cables are notcrossing one another. If telemetry is cancelled as a result of interference,the device should be re-interrogated prior to evaluating information frompulse generator memory.- DRAFT -

1-16 INFORMATION FOR USEPRECAUTIONS• Radio frequency (RF) interference. RF signals from devices thatoperate at frequencies near that of the pulse generator may interrupt ZIPtelemetry while interrogating or programming the pulse generator. ThisRF interference can be reduced by increasing the distance between theinterfering device and the PRM and pulse generator. Examples of devicesthat may cause interference include:• Cordless phone handsets or base stations• Certain patient monitoring systems• Remote control toysHome and Occupational Environments• Home appliances. Home appliances that are in good working order andproperly grounded do not usually produce enough EMI to interfere withpulse generator operation. There have been reports of pulse generatordisturbances caused by electric hand tools or electric razors used directlyover the pulse generator implant site.• Magnetic ﬁelds. Advise patients that extended exposure to strong (greaterthan 10 gauss or 1 mTesla) magnetic ﬁelds may trigger the magnet feature.Examples of magnetic sources include:• Industrial transformers and motors•MRIdevices• Large stereo speakers• Telephone receivers if held within 1.27 cm (0.5 inches) of the pulsegenerator• Magnetic wands such as those used for airport security and in theBingo game• Electronic Article Surveillance (EAS). Advise patients to avoid lingeringnear antitheft devices such as those found in the entrances and exits ofdepartment stores and public libraries. Patients should walk through themat a normal pace because such devices may cause inappropriate pulsegenerator operation.- DRAFT -

INFORMATION FOR USEPRECAUTIONS 1-17• Cellular phones. Advise patients to hold cellular phones to the earopposite the side of the implanted device. Patients should not carry acellular phone that is turned on in a breast pocket or on a belt within 15 cm(6 inches) of the implanted device since some cellular phones may causethe pulse generator to deliver inappropriate therapy or inhibit appropriatetherapy.Follow-up Testing• Conversion testing. Successful VF or VT conversion duringarrhythmia conversion testing is no assurance that conversion will occurpost-operatively. Be aware that changes in the patient’s condition, drugregimen, and other factors may change the DFT, which may result innonconversion of the arrhythmia post-operatively.• Pacing threshold testing. If the patient’s condition or drug regimenhas changed or device parameters have been reprogrammed, considerperforming a pacing threshold test to conﬁrm adequate margins for pacecapture.Explant and Disposal• Incineration. Be sure that the pulse generator is removed beforecremation. Cremation and incineration temperatures might cause the pulsegenerator to explode.• Device handling. Before explanting, cleaning, or shipping the device,complete the following actions to prevent unwanted shocks, overwriting ofimportant therapy history data, and audible tones:• Program the pulse generator Tachy and Brady Modes to Off.• Program the Magnet Response feature to Off.• Program the Beep When Explant is Indicated feature to Off.• Explanted devices. Return all explanted pulse generators and leads toBoston Scientiﬁc. Examination of explanted pulse generators can provideinformation for continued improvement in device reliability and will permitcalculation of any warranty replacement credit due.Do not implant an explanted pulse generator in another patient as sterility,functionality, and reliability cannot be ensured.- DRAFT -

$1-18 INFORMATION FOR USEPOTENTIAL ADVERSE EVENTSPOTENTIAL ADVERSE EVENTSBased on the literature and on pulse generator implant experience, thefollowing alphabetical list includes the possible adverse events associated withimplantation of a pulse generator system:• Air embolism• Allergic reaction• Bleeding• Cardiac tamponade• Chronic nerve damage• Component failure• Conductor coil fracture•Death• Elevated thresholds•Erosion• Excessive ﬁbrotic tissue growth• Extracardiac stimulation (muscle/nerve stimulation)• Failure to convert an induced arrhythmia• Foreign body rejection phenomena• Formation of hematomas or seromas• Heart failure following chronic RV apical pacing• Inability to deﬁbrillate or pace• Inappropriate therapy (e.g., shocks where applicable, ATP, pacing)• Incisional pain• Incomplete lead connection with pulse generator• Infection• Insulating myocardium during deﬁbrillation with internal or external paddles• Lead dislodgment• Lead fracture• Lead insulation breakage or abrasion• Lead tip deformation and/or breakage• Myocardial infarction (MI)• Myocardial necrosis- DRAFT -$

INFORMATION FOR USEMECHANICAL SPECIFICATIONS 1-19• Myocardial trauma (e.g., cardiac perforation, irritability, injury)• Myopotential sensing• Oversensing/undersensing• Pacemaker-mediated tachycardia (PMT) (Applies to dual-chamber devicesonly.)• Pericardial rub, effusion• Pneumothorax• Pulse generator migration• Shunting current during deﬁbrillation with internal or external paddles• Tachyarrhythmias, which include acceleration of arrhythmias and early,recurrent atrial ﬁbrillation• Thrombosis/thromboemboli• Valve damage• Venous occlusion• Venous trauma (e.g., perforation, dissection, erosion)• Worsening heart failurePatients may develop psychological intolerance to a pulse generator systemand may experience the following:• Dependency•Depression• Fear of premature battery depletion• Fear of shocking while conscious• Fear that shocking capability may be lost• Imagined shockingMECHANICAL SPECIFICATIONSDevice mechanical speciﬁcations for speciﬁc models are listed in the tablebelow.- DRAFT -

1-20 INFORMATION FOR USELEAD CONNECTIONSTable 1-1. Mechanical SpeciﬁcationsModel DimensionsWxHxD(cm)Volume(cm3)Mass (g) Connector Type(RV)Case ElectrodeSurface Area(mm²)E102 (VR) 6.17 x 7.45 x 0.99 31.5 72.0 IS-1/DF-1 6670E110 (DR) 6.17 x 7.45 x 0.99 31.5 72.0 IS-1/DF-1 6670Models include ZIP telemetry with a nominal RF frequency of 916.5 MHz.Material speciﬁcations are shown below:•Case: hermetically sealed titanium•Header: implantation-grade polymer•Power Supply: lithium-manganese dioxide cell; Boston Scientiﬁc; 401988LEAD CONNECTIONSLead connections are illustrated below.CAUTION: Do not use any lead with this device without ﬁrst verifyingconnector compatibility. Using incompatible leads can damage the connectorand/or result in potential adverse consequences, such as undersensing ofcardiac activity or failure to deliver necessary therapy.– + RV DF-1 IS-1 BI DF-1 Figure 1-1. Lead connections, single chamber– + RV RA DF-1 IS-1 BI DF-1 IS-1 BI Figure 1-2. Lead connections, dual chamber- DRAFT -

INFORMATION FOR USEITEMS INCLUDED IN PACKAGE 1-21NOTE: The pulse generator case is used as a deﬁbrillating electrode unlessthe pulse generator has been programmed to the Distal Coil to Proximal Coil(or “Cold Can”) Shock Vector.ITEMS INCLUDED IN PACKAGEThe following items are included with the pulse generator:• One torque wrench• Product literature• One patient data diskNOTE: Accessories (e.g., wrenches) are intended for one-time use only.They should not be resterilized or reused.SYMBOLS ON PACKAGINGThe following symbols may be used on pulse generator packaging and labeling(Table 1-2 on page 1-21):Table 1-2. Symbols on packagingSymbol DescriptionReference numberPackage contentsPulse generatorTorque wrenchDisk for data storageLiterature enclosedSerial numberUse by- DRAFT -

1-22 INFORMATION FOR USECHARACTERISTICS AS SHIPPEDTable 1-2. Symbols on packaging (continued)Symbol DescriptionLot numberDate of manufactureNon-ionizing electromagnetic radiationSterilized using ethylene oxideDo not reuseDangerous voltageConsult instructions for useTemperature limitationWand placement indicator for interrogationOpening instructionCHARACTERISTICS AS SHIPPEDRefer to the table for pulse generator settings at shipment (Table 1-3 on page1-22).Table 1-3. Characteristics as shippedParameter SettingTachy Mode StorageTachy Therapy available ATP, ShockPacing Mode Storage- DRAFT -

INFORMATION FOR USEX-RAY IDENTIFIER 1-23Table 1-3. Characteristics as shipped (continued)Parameter SettingPacing Therapy available DDDR (DR models) VVIR (VR models)Sensor Accelerometer (MV for respiratory rate trend)Pace/Sense Conﬁguration RA: BI/BI (DR models)Pace/Sense Conﬁguration RV: BI/BIThe pulse generator is shipped in a power-saving Storage mode to extend itsshelf life. In Storage mode, all features are inactive except:• Telemetry support, which allows interrogation and programming• Real-time clock• Commanded capacitor re-formation• STAT SHOCK and STAT PACE commandsThe device leaves Storage mode when one of the following actions occurs;however, programming other parameters will not affect the Storage mode:• STAT SHOCK or STAT PACE is commanded• Tachy Mode is programmed to:–Off– Monitor Only– Monitor + TherapyOnce you have programmed the pulse generator out of Storage mode, thedevice cannot be reprogrammed to that mode.X-RAY IDENTIFIERThe pulse generator has an identiﬁer that is visible on x-ray ﬁlm or underﬂuoroscopy. This identiﬁer provides noninvasive conﬁrmation of themanufacturer and consists of the following:• The letters, BOS, to identify Boston Scientiﬁcasthemanufacturer• The number, 112, to identify the Model 2868 PRM software applicationneeded to communicate with the pulse generator- DRAFT -

1-24 INFORMATION FOR USEFEDERAL COMMUNICATIONS COMMISSION (FCC)The x-ray identiﬁer is embedded in the header of the device at the approximatelocation (Figure 1-3 on page 1-24).HeaderPulse Generator CaseX-Ray IdentifierFigure 1-3. X-ray identiﬁerFor information on identifying the device via the PRM, refer to the PRMoperator’s manual.The pulse generator model number is stored in device memory and is shownon the PRM summary screen once the pulse generator is interrogated.FEDERAL COMMUNICATIONS COMMISSION (FCC)This device complies with Title 47, Part 15 of the FCC rules. Operation issubject to the following two conditions:• This device may not cause harmful interference, and• This device must accept any interference received, including interferencethat may cause undesired operation.CAUTION: Changes or modiﬁcations not expressly approved by BostonScientiﬁc could void the user’s authority to operate the equipment.INDUSTRY CANADA (IC)This device complies with Radio Standards Speciﬁcation RSS-210. Operationis subject to the following two conditions:• This device may not cause harmful interference, and• This device must accept any interference received, including interferencethat may cause undesired operation.CAUTION: Changes or modiﬁcations not expressly approved by BostonScientiﬁc could void the user’s authority to operate the equipment.- DRAFT -

INFORMATION FOR USEPULSE GENERATOR LONGEVITY 1-25PULSE GENERATOR LONGEVITYBased on simulated studies, it is anticipated that these pulse generators haveaverage longevity to explant as shown below.The longevity expectations, which account for the energy used duringmanufacture and storage, apply at the conditions shown in the table alongwith the following:• Assumes 60 ppm LRL, ventricular and atrial settings of 2.5 V pacing pulseamplitude and 0.4 ms pacing pulse width; RA Impedance 500 .• Projected longevity is calculated at 6 to 14 maximum energy charging cyclesper year (depending on battery status) with automatic capacitor/batterymanagement and maximum energy charges, and 3-channel EGM Onsetset to On.Table 1-4. Pulse generator life expectancy estimation (implant to explant) for HE modelsHE ModelsaLongevity (years) at 500 Ω,700Ω,and 900 ΩPacing Impedance (RV)500 Ohms 700 Ohms 900 OhmsPacing VR DR VR DR VR DR0% 8.7 8.3 8.7 8.3 8.7 8.315% 8.4 7.8 8.5 7.9 8.6 8.050% 8.1 7.3 8.2 7.5 8.3 7.6100% 7.8 6.7 8.0 6.9 8.1 7.0a. For RF-enabled models, assumes ZIP telemetry use for 1 hour at implant time and for 20 minutes duringeach quarterly follow-up.NOTE: The energy consumption in the longevity table is based upontheoretical electrical principles and veriﬁed via bench testing only.The pulse generator longevity may increase with a decrease in any of thefollowing:• Pacing rate• Pacing pulse amplitude(s)• Pacing pulse width(s)• Percentage of paced to sensed events- DRAFT -

1-26 INFORMATION FOR USEWARRANTY INFORMATION• Charging frequencyLongevity is also reduced in the following circumstances:• With a decrease in pacing impedance• When Patient Triggered Monitor is programmed to On• For models with ZIP wandless telemetry, one hour of additional telemetryreduces longevity by approximately 7 days.Device longevity may also be affected by:• Tolerances of electronic components• Variations in programmed parameters• Variations in usage as a result of patient conditionAn additional maximum-energy shock reduces longevity by approximately19 days.Refer to the PRM Summary screen for an estimate of pulse generator longevityspeciﬁc to the implanted device.WARRANTY INFORMATIONA limited warranty certiﬁcate for the pulse generator is packaged with thedevice. For additional copies, please contact Boston Scientiﬁc at the addressand phone number shown on the back cover of this manual.PRODUCT RELIABILITYIt is Boston Scientiﬁc’s intent to provide implantable devices of high quality andreliability. However, these devices may exhibit malfunctions that may result inlost or compromised ability to deliver therapy. These malfunctions may includethe following:• Premature battery depletion• Sensing or pacing issues• Inability to shock• Error codes• Loss of telemetry- DRAFT -

INFORMATION FOR USEPATIENT COUNSELING INFORMATION 1-27Refer to Boston Scientiﬁc’s CRM Product Performance Report onwww.bostonscientiﬁc.com for more information about device performance,including the types and rates of malfunctions that these devices haveexperienced historically. While historical data may not be predictive of futuredevice performance, such data can provide important context for understandingthe overall reliability of these types of products.Sometimes device malfunctions result in the issuance of safety advisories.Boston Scientiﬁc determines the need to issue safety advisories based ontheestimatedmalfunctionrateandtheclinical implication of the malfunction.When Boston Scientiﬁc communicates safety advisory information, thedecision whether to replace a device should take into account the risks of themalfunction, the risks of the replacement procedure, and the performance todate of the replacement device.PATIENT COUNSELING INFORMATIONThe following topics should be discussed with the patient prior to discharge.• The patient should:– Contact their physician immediately if they hear tones coming fromtheir pulse generator– Contact their physician to have their pulse generator system evaluatedif they receive external deﬁbrillation– Understand the signs and symptoms of infection– Understand the symptoms that should be reported (e.g., sustainedhigh-rate pacing requiring reprogramming)– Seek medical guidance before entering protected environments suchas areas protected by a warning notice that prevents entry by patientswhohaveapulsegenerator– Understand and avoid potential sources of EMI and magnetic ﬁeldsin home, work, and medical environments (See Warnings andPrecautions for more detailed information about speciﬁc sources)• Persons administering CPR may experience the presence of voltage(tingling) on the patient’s body surface when the pulse generator deliversashock.- DRAFT -

1-28 INFORMATION FOR USEPATIENT COUNSELING INFORMATION• It is Boston Scientiﬁc’s intent to provide implantable devices of high qualityand reliability. However, these devices may exhibit malfunctions that mayresult in lost or compromised ability to deliver therapy. When BostonScientiﬁc communicates safety advisory information, the decision whetherto replace a device should take into account the risks of the malfunction,the risks of the replacement procedure, and the performance to date of thereplacement device.Patient HandbookThe Patient Handbook is provided for each device.It is recommended that you discuss the information in the Patient Handbookwith concerned individuals both before and after implantation so they are fullyfamiliar with pulse generator operation.For additional copies, contact your sales representative, or contact BostonScientiﬁc at the phone number shown on the back cover of this manual.- DRAFT -

2-1USING THE PROGRAMMER/RECORDER/MONITORCHAPTER 2This chapter contains the following topics:• "ZOOM LATITUDE Programming System" on page 2-2• "Indications-Based Programming (IBP)" on page 2-2• "Manual Programming" on page 2-5• "Software Terminology and Navigation" on page 2-6• "Data Management" on page 2-11• "Communicating with the Pulse Generator" on page 2-12• "DIVERT THERAPY" on page 2-17• "STAT SHOCK" on page 2-17• "STAT PACE" on page 2-18• "Safety Mode" on page 2-19- DRAFT -

2-2 USING THE PROGRAMMER/RECORDER/MONITORZOOM LATITUDE PROGRAMMING SYSTEMZOOM LATITUDE PROGRAMMING SYSTEMThe ZOOM LATITUDE Programming System is the external portion of thepulse generator system and includes:• Model 3120 Programmer/Recorder/Monitor (PRM)• Model 2868 ZOOMVIEW Software Application• Model 6577 Accessory Telemetry WandThe ZOOMVIEW software provides advanced device programming and patientmonitoring technology. It was designed with the intent to:• Enhance device programming capability• Improve patient and device monitoring performance• Simplify and expedite programming and monitoring tasksYoucanusethePRMsystemtodothefollowing:• Interrogate the pulse generator• Program the pulse generator to provide a variety of therapy options• Access the pulse generator’s diagnostic features• Perform noninvasive diagnostic testing• Access therapy history dataYou can program the pulse generator using two methods: automatically usingIBP or manually.INDICATIONS-BASED PROGRAMMING (IBP)IBP is a tool that provides speciﬁc programming recommendations based onthe patient’s clinical needs and primary indications.IBP is a clinical approach to programming that was developed based onphysician consultation and case studies. The intent of IBP is to enhance patientoutcomes and save time by providing base programming recommendationsthat you can customize as needed. IBP systematically presents the speciﬁcfeatures intended for use with the clinical conditions you identify in the IBP userinterface, and allows you to take maximum advantage of the pulse generator’scapabilities.IBP can be accessed from the Settings tab on the main application screen(Figure 2-1 on page 2-3).- DRAFT -

USING THE PROGRAMMER/RECORDER/MONITORINDICATIONS-BASED PROGRAMMING (IBP) 2-3Figure 2-1. Indications-based Programming screenIndications are clustered in general categories as illustrated above. The intentfor each category of indications is described below:• Sinus Node:– If Normal is selected, the intent is to provide RV pacing when necessary.– If Chronotropically Incompetent is selected, the intent is to providerate-adaptive pacing.– If Sick Sinus Syndrome is selected, the intent is to provide atrial pacingsupport.• AV Node:– If Normal or 1st Degree Block is selected, the intent is to provide RVpacing when necessary.– If 2nd Degree Block is selected, the intent is to promote intrinsic AVconduction and provide AV sequential pacing when conduction is notpresent.– If Complete Heart Block is selected, the intent is to provide AVsequential pacing.NOTE: The selected settings for AF and Sinus Node may affect the suggestedvalue for the Normal/1st Degree Block setting of AV Node.- DRAFT -

2-4 USING THE PROGRAMMER/RECORDER/MONITORINDICATIONS-BASED PROGRAMMING (IBP)• Atrial Arrhythmias– If Paroxysmal/Persistent is selected, the intent is to avoid trackingatrial arrhythmias by using dual-chamber pacing mode with ATR ModeSwitch.– If Permanent/Chronic AF is selected, the intent is to provide rateadaptive RV pacing.• Ventricular Arrhythmias– When History of VF/SCD or Prophylaxis for VT/VF is selected, a2-zone conﬁguration with the following rate thresholds and therapiesis provided:– 180 bpm for the VF zone with QUICK CONVERT ATP andMaximum Energy Shocks enabled– 160 bpm for the VT zone with therapy disabled (Monitor Only)– When History of VT/VF is selected, a 2-zone conﬁguration with thefollowing rate thresholds and therapies is provided:– 200 bpm for the VF zone with QUICK CONVERT ATP andMaximum Energy Shocks enabled– 160 bpm for the VT zone with ATP and Maximum Energy Shocksenabled– Rhythm ID enabled– When VF Only is selected, the intent is for a single VF zone of 220 bpmis provided with only Maximum Energy Shocks enabled.When you have chosen the patient indications, select the View RecommendedSettings button to view a summary of the programming recommendations(Figure 2-2 on page 2-5).- DRAFT -

USING THE PROGRAMMER/RECORDER/MONITORMANUAL PROGRAMMING 2-5NOTE: You must view the settings before you can program them. Selectingthe View Recommended Settings button allows you to view the settingsthat are recommended based on the indications that you selected. Viewingthe recommended settings does not overwrite any pending (i.e., not yetprogrammed) parameter changes. You must choose to program or rejectthe recommended settings after viewing them. If you choose to reject therecommended settings, all of your pending settings will be restored. If youchoose to program the recommended settings, any pending parameterchanges will be overwritten, with the exception of sensitivity, shock outputs,and pacing outputs, which are independent of IBP.Primary Settings SummaryFigure 2-2. Proposed Settings Summary screenThe Proposed Settings Summary screen displays the primary programmingrecommendations. Additional details about all changed parameters areavailable by selecting the View Changes button from the toolbar. You have theoption to program the proposed settings or reject them, as long as telemetryis still engaged:• Program—select the Program this Proﬁle button to accept the proposedsettings.• Reject—select the Reject this Proﬁle button to reject the proposed settings;this action will return you to the main IBP screen with no changes made.MANUAL PROGRAMMINGManual programming controls such as sliders and menus are available to allowyou to individually adjust pulse generator program settings.Manual programming controls are located on the Settings Summary tab, whichcan be accessed from the Settings tab or by selecting the Settings Summarybutton on the Summary tab. Refer to other feature descriptions in this manual- DRAFT -

2-6 USING THE PROGRAMMER/RECORDER/MONITORSOFTWARE TERMINOLOGY AND NAVIGATIONfor speciﬁc manual programming information and instructions. Refer to"Programmable Options" on page A-1 for detailed listings of available settings.SOFTWARE TERMINOLOGY AND NAVIGATIONThis section provides an overview of the PRM system.Main ScreenThe main PRM screen is shown below, followed by a description of thecomponents (Figure 2-3 on page 2-6).Patient name Device nameDetailsbuttonTab sECG/EGM displayToolbarDevice modelPRM Mode IndicatorFigure 2-3. Main ScreenPRM Mode IndicatorThe PRM Mode Indicator displays at the top of the screen to identify the currentPRM operational mode.Patient—indicates that the PRM is displaying data obtained bycommunicating with a device.- DRAFT -

$USING THE PROGRAMMER/RECORDER/MONITORSOFTWARE TERMINOLOGY AND NAVIGATION 2-7Patient Data Disk—indicates that the PRM is displaying storeddata from a patient data disk.Demo Mode—indicates that the PRM is displaying sample dataand operating in demonstration mode.ECG/EGM DisplayThe ECG area of the screen shows real-time status information about thepatient and the pulse generator. This information is useful in evaluating systemperformance:• Real-time EGMs can be transmitted from the pace/sense or shockingelectrodes to evaluate lead system integrity and help identify faults such aslead fractures, insulation breaks, or dislodgments.• Annotated event markers identify certain intrinsic cardiac and device-relatedevents, and provide information such as sensed/paced events, decision ofdetection criteria, and therapy delivery.You can select the Details button to enlarge the ECG/EGM screen. Thefollowing options are available:• Show Device Markers—displays annotated markers• Enable Surface Filter—minimizes noise on the surface ECG• Display Pacing Spikes—shows detected pacing spikes, annotated by amarker on the surface ECG waveformYou can print a real-time EGM report, which includes annotated event markers,by performing the following steps:1. Press one of the print speed keys on the PRM (for example, speed key 25).2. Press the Paper Form Feed key. The EGM report will begin printing.You can print a report containing the deﬁnitions of all of the annotated markersby performing the following steps:1. From the toolbar, click the Reports button. The Reports window displays.2. Select the Marker Legend checkbox.3. Click the Print button. The Marker Legend Report is sent to the printer.- DRAFT -$

2-8 USING THE PROGRAMMER/RECORDER/MONITORSOFTWARE TERMINOLOGY AND NAVIGATIONToolbarThetoolbarallowsyoutoperformthefollowingtasks:• Select system utilities• Generate reports• Interrogate and program the pulse generator• View pending or programmed changes• View attentions and warnings• End your PRM sessionTabsTabs allow you to select PRM tasks, such as viewing summary data orprogramming device settings. Selecting a tab displays the associated screen.Many screens contain additional tabs, which allow you to access more detailedsettings and information.ButtonsButtons are located on screens and dialogs throughout the application. Buttonsallow you to perform various tasks, including:• Obtain detailed information• View setting details• Set programmable valuesWhen a button selection opens a window in front of the Main Screen, a Closebutton displays in the upper-right corner of the window to allow you to close thewindow and return to the Main Screen.IconsIcons are graphic elements that, when selected, may initiate an activity, displaylists or options, or change the information displayed.Details—opens a window containing detailed information.- DRAFT -

USING THE PROGRAMMER/RECORDER/MONITORSOFTWARE TERMINOLOGY AND NAVIGATION 2-9Patient—opens a window with patient information details.Leads—opens a window with details on leads.Battery—opens a window with details on the pulse generatorbattery.Run—causes the programmer to perform an action.Check—indicates that an option is selected.Event—indicates that an event has occurred. When you view theTrends timeline on the Events tab, event icons display whereverevents have occurred. Selecting an events icon displays detailsabout the event.Slider IconsHorizontal Slider—indicates that a slider object can be clickedand dragged left or right.Vertical Slider—indicates that a slider object can be clicked anddragged up or down.Sort IconsSort Ascending—indicates that Ascending sort is currentlyselected on a table column sort button. (e.g., 1, 2, 3, 4, 5)Sort Descending—indicates that Descending sort is currentlyselected on a table column sort button. (e.g., 5, 4, 3, 2, 1)- DRAFT -

2-10 USING THE PROGRAMMER/RECORDER/MONITORSOFTWARE TERMINOLOGY AND NAVIGATIONIncrement and Decrement IconsIncrement—indicates that an associated value can beincremented.Decrement—indicates that an associated value can bedecremented.Scroll IconsScroll Left—indicates that an associated item can be scrolled left.Scroll Right—indicates that an associated item can be scrolledright.Scroll Up—indicates that an associated item can be scrolled up.Scroll Down—indicates that an associated item can be scrolleddown.Common ObjectsCommon objects such as status bars, scroll bars, menus, and dialogs are usedthroughout the application. These operate similarly to the objects found in webbrowsers and other computer applications.Use of ColorColors are used to highlight buttons, icons, and other objects. The use ofspeciﬁc color conventions is intended to provide a more consistent userexperience and simplify programming.Red and yellow are used to provide Warning and Attention indications, asdescribed below:• Red—indicates Warning conditions such as the following:– The selected device parameter value is not allowed– Device and patient diagnostic information that requires seriousconsideration- DRAFT -

USING THE PROGRAMMER/RECORDER/MONITORDATA MANAGEMENT 2-11• Yellow—indicates Attention conditions such as the following:– The selected device parameter value is not recommended, but isallowed– Device and patient diagnostic information that should be addressedWhen a red Warning or yellow Attention button displays in the toolbar, click thebutton. The Parameter Interactions screen will display, with information aboutcorrective action.DATA MANAGEMENTThe PRM system allows you to manage patient and pulse generator data byviewing, printing, storing, or retrieving it. This section describes the PRM datamanagement capabilities.Patient InformationInformation about the patient can be stored in pulse generator memory. Theinformation is accessible from the Summary screen by selecting the Patienticon. This information includes, but is not limited to, the following:• Patient and physician names• Pulse generator serial number• Implant date• Lead conﬁgurations• Implant test measurementsThe information can be retrieved at any time by interrogating the pulsegenerator and viewing it on the PRM screen or printing it as a report.Disk OperationsThe PRM system allows you to store patient data on a removable data disk.Toaccessthedatastoredonadisk,ﬁrst select the Utilities button, then selectthe Disk tab. Insert a disk into the disk drive, and select one of the followingdisk options:• Read Disk—allows you to retrieve saved data from a patient data disk- DRAFT -

2-12 USING THE PROGRAMMER/RECORDER/MONITORCOMMUNICATING WITH THE PULSE GENERATOR• Save All to Disk—allows you to save information to a disk, including thefollowing:– Therapy history– Programmed parameter values– Trending values– Histogram paced/sensed countersPrintYou can print PRM reports by using the internal printer, or by connecting to anexternal printer. To print a report, select the Reports button. Then select thereport you wish to print from the following categories:• Follow-up reports• Episode reports• Other reports (includes device settings, patient data, and other information)COMMUNICATING WITH THE PULSE GENERATORThe PRM communicates with the pulse generator using a telemetry wand.After initiating communication with the wand, some pulse generator models canuse wandless ZIP telemetry (two-way RF communication) to interface with thePRM. Wanded or ZIP telemetry is required to:• Direct commands from the PRM system, such as:– INTERROGATE–PROGRAM– STAT SHOCK–STATPACE– DIVERT THERAPY• Modify device parameter settings• Conduct EP testing- DRAFT -

USING THE PROGRAMMER/RECORDER/MONITORCOMMUNICATING WITH THE PULSE GENERATOR 2-13• Conduct diagnostic tests including the following:– Pacing impedance tests– Pacing threshold tests– Intrinsic amplitude tests• Perform manual capacitor re-formZIP TelemetryZIP telemetry is a wandless, two-way RF communication option that allows thePRM system to communicate with some pulse generator models. When awanded telemetry session is initiated, the PRM checks the pulse generator’stelemetry capability. If the PRM detects a pulse generator with ZIP telemetrycapability, a message will display indicating that ZIP telemetry is available andthe wand can be removed. Otherwise, the session will continue with wandedtelemetry.ZIP telemetry offers the following advantages over traditional wanded telemetry:• The faster data transmission speed means less time is required for deviceinterrogation• Data transmission over a longer distance (within 3 meters) minimizes theneed to keep the wand in the sterile ﬁeld during implant, which may reducethe risk of infection• Continuous telemetry is possible during the entire implant procedure,allowing monitoring of pulse generator performance and lead integrityduring implantRegardless of whether ZIP telemetry is being used, wanded communicationis still available.Starting a Wanded Telemetry SessionFollow this procedure to begin a wanded telemetry communication session:1. Make sure the telemetry wand is connected to the PRM system and isavailable throughout the session.2. Position the wand over the pulse generator at a distance not greater than 6cm (2.4 inches).- DRAFT -

2-14 USING THE PROGRAMMER/RECORDER/MONITORCOMMUNICATING WITH THE PULSE GENERATOR3. Use the PRM to Interrogate the pulse generator.4. Retain the wand position whenever communication is required.Starting a ZIP Telemetry SessionFollow this procedure to begin a ZIP telemetry communication session:1. Start a wanded telemetry session. Verify that the wand cord is within reachof the pulse generator to enable the use of wanded telemetry should itbecome necessary.2. Keep the telemetry wand in position until either a message appears,indicating that the telemetry wand may be removed from proximity of thepulse generator, or the ZIP telemetry light illuminates on the PRM system.Ending a Telemetry SessionSelect the End Session button to quit a telemetry session and return to thestartup screen. You can choose to end the session or return to the currentsession. Upon ending a session, the PRM system terminates all communicationwith the pulse generator.ZIP Telemetry SecurityThe pulse generator is a compliant low-power transceiver. The pulse generatorcan only be interrogated or programmed by RF signals that employ theproprietary ZIP telemetry protocol. The pulse generator veriﬁes that it iscommunicating with a ZOOMVIEW system before responding to any RFsignals. The pulse generator stores, transmits, and receives individuallyidentiﬁable health information in an encrypted format.ZIP telemetry is possible when all of the following conditions are met:• ZIP telemetry setting for the PRM is programmed On• The pulse generator has RF communication capabilities• The ZIP telemetry channel is available for use• The pulse generator is within range of the PRM system• The pulse generator has not reached Explant; note that a total of 1.5 hoursof ZIP telemetry will be available after the pulse generator reaches Explant• The pulse generator battery capacity is not depleted- DRAFT -

USING THE PROGRAMMER/RECORDER/MONITORCOMMUNICATING WITH THE PULSE GENERATOR 2-15In order to meet local communications rules and regulations, ZIP telemetryshould not be used when the pulse generator is outside its normal operatingtemperature of 20°C–43°C (68°F–109°F).The PRM supports communication between two PRMs and two pulsegenerators at a time, as two independent sessions. If there are two PRMsalready communicating in the vicinity, a third session will not be allowed to start;wanded communication will be necessary in this case.The PRM notiﬁes you if ZIP telemetry is unavailable because of other sessionsalready in progress.RF signals in the same frequency band used by the system may interfere withZIP telemetry communication. These interfering signals include:• Signals from other pulse generator/PRM system RF communicationsessions after the maximum number of independent sessions has beenreached. Other nearby pulse generators and PRMs using ZIP telemetrymay prevent ZIP telemetry communication.• Interference from other RF sources.CAUTION: RF signals from devices that operate at frequencies near thatof the pulse generator may interrupt ZIP telemetry while interrogating orprogramming the pulse generator. This RF interference can be reduced byincreasing the distance between the interfering device and the PRM and pulsegenerator. Examples of devices that may cause interference include:• Cordless phone handsets or base stations• Certain patient monitoring systems• Remote control toysRadio frequency interference may temporarily disrupt ZIP telemetrycommunication. The PRM will normally reestablish ZIP communication whenthe RF interference ends or subsides. Because continued RF interference mayprevent ZIP telemetry communication, the system is designed to use wandedtelemetry when ZIP telemetry is not available.If ZIP telemetry is not available, wanded telemetry communication with thePRM can be established. The system provides the following feedback toindicate that ZIP telemetry is not available:• The ZIP telemetry indicator light on the PRM turns off- DRAFT -

2-16 USING THE PROGRAMMER/RECORDER/MONITORCOMMUNICATING WITH THE PULSE GENERATOR• If event markers and/or EGMs are activated, transmission of the eventmarkers and/or EGMs is interrupted• If a command or other action has been requested, the PRM displays anotiﬁcation indicating the wand should be placed in range of the pulsegeneratorZIP telemetry operates consistently with wanded telemetry—no programmingstep can be completed unless the entire programming command has beenreceived and conﬁrmed by the pulse generator.The pulse generator cannot be misprogrammed as a result of interrupted ZIPtelemetry. Interruptions of ZIP telemetry may be caused by RF signals thatoperate at frequencies near that of the pulse generator and are strong enoughto compete with the ZIP telemetry link between the pulse generator and thePRM. Signiﬁcant interference may result in a break or drop-outs of real-timeEGMs. If commands are interrupted, the PRM displays a message to placethe wand on the pulse generator. These situations can be resolved by usingstandard wanded telemetry. There will be no interruption of device functionalityor therapy during this period.NOTE: The PRM operates on a speciﬁc frequency range depending ongeography. The PRM determines the ZIP frequency range that the pulsegenerator uses based on the speciﬁc device model. If the PRM and pulsegenerator ZIP frequency ranges do not match, it indicates that the patient hastraveled outside their geography. The PRM will display a message indicatingthat ZIP telemetry cannot be used; however, the patient’s pulse generator canbe interrogated by using the wand.Considerations for Reducing InterferenceIncreasing the distance from the source of interfering signals may enable theuse of the ZIP telemetry channel.Repositioning the PRM antenna or repositioning the PRM may improve ZIPtelemetry performance. If ZIP telemetry performance is not satisfactory, theoption of using wanded telemetry is available.Depending on the environment and PRM orientation relative to the pulsegenerator, the system is capable of maintaining ZIP telemetry communicationat distances up to 12 m (40 ft). For optimum ZIP telemetry communication,position the PRM antenna within 3 m (10 ft) of the pulse generator and removeany obstruction between the PRM and the pulse generator.- DRAFT -

USING THE PROGRAMMER/RECORDER/MONITORDIVERT THERAPY 2-17DIVERT THERAPYWhen the pulse generator is charging to deliver a shock, the shock deliverymay be diverted from the patient. If diverted, the shock does not count asone of the total number of shocks that may be delivered during an episode. Ifredetection occurs and more shock therapy is required, and if more shocks areavailable in the therapy prescription, the pulse generator will charge again todeliver subsequent shocks.Also, the DIVERT THERAPY key can be pressed to divert ATP therapy inmidburst. If redetection occurs, the ATP scheme will not be used again and thenext programmed therapy in the sequence will be initiated.1. If you are not already in a session, position the telemetry wand within rangeof the pulse generator.2. Press the DIVERT THERAPY key. A message window will appearindicating that a divert attempt is being made.3. If using wanded telemetry, maintain the wand position until the messagewindow disappears, indicating the shock has been diverted. Prematurelyremoving the wand (breaking the telemetry link) may allow the pulsegenerator to continue charging and to deliver the shock.NOTE: There is a 500 ms delay between the end of charging and shockdelivery designed to provide a minimum period for the DIVERT THERAPYcommand. After this time, pressing DIVERT THERAPY may not divert theshock.STAT SHOCKA nonprogrammable, maximum-output STAT SHOCK can be delivered to thepatient at any time during a communication session. The STAT SHOCK can bedelivered when the pulse generator’s Tachy Mode is programmed to any mode.This function does not affect the programmed shock sequences (lower-energyshocks can be delivered following a STAT SHOCK) and does not count asone of the total number of shocks in a therapy sequence for a given episode.The output of the STAT SHOCK is at the maximum-output energy and atthe programmed polarity and waveform; STAT SHOCK is always committedregardless of programmed parameters.1. If you are not already in a session, position the telemetry wand within rangeof the pulse generator.- DRAFT -

2-18 USING THE PROGRAMMER/RECORDER/MONITORSTAT PACE2. Press the STAT SHOCK key. A message window appears with informationabout the shock and instructions to initiate the shock.3. To initiate the shock, press the STAT SHOCK key again. A differentmessage window appears indicating that STAT SHOCK is in process.When the shock has been delivered, the message window disappears.4. Subsequent high-energy STAT SHOCKS may be delivered by repeatingthe previous steps.NOTE: TheSTATSHOCKmaybedivertedusingtheDIVERTTHERAPYkey.NOTE: Following STAT SHOCK delivery, if the Tachy Mode is programmedto Monitor Only or Monitor + Therapy, post-shock redetection is initiated(initial detection criteria and enhancements are not used). If the Tachy Modeis programmed to Monitor + Therapy and redetection determines that furthertherapy is required, the programmed sequence of therapy will be resumed orinitiated, including ATP and/or low-energy shocks.STAT PACEEmergency bradycardia pacing using the STAT PACE command sets thebradycardia operation to parameters intended to ensure capture and keepthe patient stable.1. If you are not already in a session, position the telemetry wand within rangeof the pulse generator.2. Press the STAT PACE key. A message window displays the STAT PACEvalues.3. Press the STAT PACE key a second time. A message indicates that STATPACE is being performed, followed by the STAT PACE values.4. Select the Close button on the message window.5. To stop STAT PACE, reprogram the pulse generator.CAUTION: When a pulse generator is programmed to STAT PACE settings,it will continue to pace at the high-energy STAT PACE values if it is notreprogrammed. The use of STAT PACE parameters will decrease devicelongevity.- DRAFT -

USING THE PROGRAMMER/RECORDER/MONITORSAFETY MODE 2-19SAFETY MODEThe pulse generator hardware includes a safety core feature. The safety coreis intended to provide life-sustaining therapy in the event of speciﬁc failureswithin the pulse generator. If the pulse generator is interrogated while safetycore is active, the PRM will indicate that the pulse generator is in Safety Mode.Limited inductive telemetry and some device programming are available duringSafety Mode. If you interrogate a pulse generator that is in Safety Mode, thePRM will display a warning screen directing you to call Technical Services.Backup PacemakerThe Safety Mode feature provides a simple VVI pacemaker programmed to72.5 ppm, with the following output characteristics.• 5 V amplitude• 1.0 ms pulse widthBackup DeﬁbrillatorThe Safety Mode feature provides a single-zone backup deﬁbrillator, which canbe enabled or disabled using the PRM.Tachycardia Detection in Safety ModeIn Safety Mode, the tachycardia detection monitors RV senses using atraditional tachycardia detection window with a rate threshold of 165 bpm.Tachycardia Therapy in Safety ModeIn Safety Mode, tachycardia therapy consists of maximum energy, committedshocks, with the following settings:• Shock polarity—initial• Shock waveform—biphasic• Shock vector—V-TRIADWithin the period of a declared episode, therapy is limited to 5 shocks.When a magnet is detected, therapy delivery is immediately inhibited althoughcharging may continue. After the magnet has been applied for 1 second,- DRAFT -

2-20 USING THE PROGRAMMER/RECORDER/MONITORSAFETY MODEthe therapy is diverted and detection is inhibited. The magnet must then beremoved for 2 seconds in order to allow detection to continue.Programming the Device Safety Tachy ModeIn Safety Mode, you can perform the following steps to program the SafetyTachy Mode:1. Select the Tachy Mode button. The Change Device Mode dialog displays.2. Click to select the required Safety Tachy Mode setting, either Off or Monitor+ Therapy. Click Apply Changes to apply the new setting, or CancelChanges to cancel the new setting.3. Click Close to dismiss the Change Device Mode dialog.NOTE: The safety tachy mode automatically will be set to Off if additionalfaults are detected while in Safety Mode.- DRAFT -

3-1TACHYARRHYTHMIA DETECTIONCHAPTER 3This chapter contains the following topics:• "Device Mode" on page 3-2• "Rate Sensing" on page 3-3• "Ventricular Detection" on page 3-6- DRAFT -

3-2 TACHYARRHYTHMIA DETECTIONDEVICE MODEDEVICE MODETheDeviceModeallowsyoutoprogramthedevicetoprovidethetypeoftherapy and detection desired.Ventricular Tachy ModeThe Ventricular Tachy Mode controls the availability of the detection andtherapy functions in the ventricle (Table 3-1 on page 3-2).You can program the Ventricular Tachy Mode to the following modes:• Off––disables ventricular tachyarrhythmia detection and automaticventricular therapy delivery. This mode is useful during implant or explant,when connecting the leads to or disconnecting them from the pulsegenerator.• Monitor Only––enables ventricular tachyarrhythmia detection and episodestorage, but does not automatically deliver therapy to the patient. Thismode is useful in controlled environments, such as during EP testing,exercise testing, and immediately postoperative, where alternate therapy(e.g., external deﬁbrillation) is available.• Monitor + Therapy––enables the full range of ventricular detection andventricular therapy options.Table 3-1. Device feature availability in the Ventricular Tachy Mode settingsDevice features Ventricular Tachy ModeOff Monitor Only Monitor +TherapyRate sensing XaXXBradycardia pacing X X XVentricular detection/therapy history XbXXSTAT SHOCK XXXSTAT PACE XXXReal-time annotated EGMs XXXVentricular tachyarrhythmia detection X XCommanded ventricular ATP XXcCommanded ventricular shock XX- DRAFT -

TACHYARRHYTHMIA DETECTIONRATE SENSING 3-3Table 3-1. Device feature availability in the Ventricular Tachy Mode settings (continued)Device features Ventricular Tachy ModeOff Monitor Only Monitor +TherapyVentricular EP test XdXdAutomatic ventricular tachyarrhythmia therapy Xa. In order to enable ventricular sensing when the Ventricular Tachy Mode is programmed to Off, you must program the Brady Modeto a mode with ventricular sensing.b. While programmed to Off Mode, the pulse generator will store only STAT SHOCK in history.c. When the ventricular tachy mode is Monitor + Therapy, the EP Temp V Mode must be programmed to Monitor Only in order touse the commanded ventricular ATP.d. Not all forms of EP Tests are available in this mode.Electrocautery Protection ModeElectrocautery Protection Mode deactivates the tachyarrhythmia detection andtherapy features of the pulse generator during use of electrocautery equipment.When Electrocautery Protection is enabled, bradycardia pacing is stillfunctional; however, the pacing mode switches to an XOO mode (where Xis determined by the programmed pacing mode). Other pacing parametersremain at the programmed settings.After cancelling Electrocautery Protection, the following modes will revert tothe previously programmed settings:• Ventricular Tachy Mode• Brady ModeExcept for STAT SHOCK and STAT PACE, no commanded therapies,inductions, or diagnostic tests will be allowed while Electrocautery Protection isenabled.RATE SENSINGRate sensing is critical to all detection decisions. The pulse generator relieson the following to determine cardiac cycle length:• Bipolar electrodes in the atrium and right ventricle.• Automatic gain-controlled sensing circuit for rate sensing. This circuitensures proper rate sensing by compensating for changing or diminishedsignal amplitudes.- DRAFT -

$3-4 TACHYARRHYTHMIA DETECTIONRATE SENSINGCalculating Rates and Refractory PeriodsThe pulse generator evaluates rate on an interval-by-interval basis. Followinga sensed depolarization, a cycle length is measured and compared to theprogrammed detection parameters.The pulse generator uses refractory periods following paced and sensedintrinsic events; intrinsic events that fall within these periods are ignored fordetection purposes. The refractory periods, together with noise windows, mayprevent the sensing of nonphysiologic signals and the potential delivery ofunwanted therapy. The nonprogrammable refractory periods are as follows:• 85 ms atrial refractory following an atrial sensed event• 150 ms atrial refractory following an atrial pace in DDD(R) and DDI(R)modes• 135 ms RV refractory following an RV sensed event or a capacitor charge• 500 ms refractory following shock delivery (sensing is ignored in allchambers)Ventricular Rate Thresholds and ZonesThe pulse generator compares each sensed RV cardiac cycle interval againstthe programmed Ventricular Tachyarrhythmia Rate Threshold.A Ventricular Tachyarrhythmia Zone is a range of heart rates deﬁned by atleast one programmed Ventricular Tachyarrhythmia Rate Threshold. You canprogram from 1 to 3 Ventricular Tachyarrhythmia Zones, each of which can betreated by a separate therapy prescription (Table 3-2 on page 3-4, Figure 3-1on page 3-5).Table 3-2. Nominal values for Ventricular Rate Threshold conﬁgurationsVentricular Zone Conﬁguration VT-1 Zone VT Zone VF Zone1 Zone –– –– 200 bpm- DRAFT -$

TACHYARRHYTHMIA DETECTIONRATE SENSING 3-5Table 3-2. Nominal values for Ventricular Rate Threshold conﬁgurations (continued)Ventricular Zone Conﬁguration VT-1 Zone VT Zone VF Zone2 Zones –– 160 bpm 200 bpm3 Zones 140 bpm 160 bpm 200 bpmFigure 3-1. Ventricular Tachy Detection settings• Rate thresholds in adjacent zones must differ by at least 20 bpm• The lowest Ventricular Tachyarrhythmia Rate Threshold must be at least5 bpm higher than the MTR, MSR, and the MPR• The lowest Ventricular Tachyarrhythmia Rate Threshold must be at least15 bpm higher than the LRLUse of Atrial InformationThe atrial rate may be used to:• Inhibit ventricular therapy in the presence of atrial ﬁbrillation or atrial ﬂutter• Bypass ventricular therapy inhibitors if the ventricular rate is faster thanthe atrial rateThe pulse generator will respond to atrial sensing regardless of whether anatrial lead is implanted. If an atrial lead is not implanted or it has a fault,program the atrial lead from Bipolar to Off (when programmed to Off, atrialsensing is not performed; atrial pacing will occur). When programming theatrial lead to Off, change the Brady Mode to prevent atrial sensing or pacing.Next, on the applicable VT/VT-1 Detection Enhancement screens, program thefollowing features accordingly to avoid the use of erroneous atrial data:• V Rate > A Rate––program to Off (for Onset/Stability detectionenhancement suite)- DRAFT -

3-6 TACHYARRHYTHMIA DETECTIONVENTRICULAR DETECTION• AFib Rate Threshold––program to Off (for Onset/Stability detectionenhancement suite)• Atrial Tachyarrhythmia Discrimination––program to Off (for Rhythm IDdetection enhancement suite)• Brady Mode––program to Off, VVI, or VVI(R)• Atrial Rate EGM––do not select the atrial traceNOTE: An atrial EP test should not be performed if the atrial lead isprogrammed to Off.VENTRICULAR DETECTIONVentricular detection consists of the following components:• Initial ventricular detection• Reconﬁrmation/committed shock• Redetection and post-shock detectionInitial ventricular detection criteria consist of the programmable parametersRate and Duration. The detection criteria may also include one of the followingtwo detection enhancement suites, which may be used during initial andpost-shock ventricular detection to add speciﬁcity beyond Rate and Duration.• Onset/Stability•RhythmIDThe pulse generator initiates ventricular therapy when it determines thatdetection is met. Ventricular detection is met when all of the following occur:• A ventricular zone’s detection window becomes and remains satisﬁedthroughout Duration• The ventricular zone’s Duration expires• A higher ventricular zone’s detection window is not satisﬁed• Detection enhancements (if programmed to On) indicate therapy• The last detected interval is in the ventricular zoneIf the above criteria are not met, therapy is not initiated and the pulse generatorcontinues to evaluate intervals.- DRAFT -

TACHYARRHYTHMIA DETECTIONVENTRICULAR DETECTION 3-7Ventricular Detection Enhancement SuitesOne of the following ventricular detection enhancement suites may beprogrammed to provide speciﬁcity beyond Rate and Duration (Table 3-3 onpage 3-7):•RhythmID• Onset/StabilityDetection enhancement suites are not available in the VF zone.Table 3-3. Detection enhancement suites available per zoneVT-1 Zone VT Zone VF ZoneRhythm ID Rhythm ID3-zone conﬁgurationaOnset/Stability Onset/StabilitycNoneRhythm ID3-zone conﬁguration (with Monitor Onlyzone)bNoneOnset/StabilityNoneRhythm ID2-zone conﬁgurationOnset/StabilityNone2-zone conﬁguration (with Monitor Only zone)bNone None1-zone conﬁguration Nonea. If the detection enhancement suite is enabled in a 3-zone conﬁguration, it applies to both the VT-1 and VT zones. Detectionenhancement suites cannot be independently enabled for each zone.b. Detection enhancement suites are not available in the lowest zone of a multi-zone conﬁguration when the zone is used as aMonitor Only zone (no therapy programmed for that zone).c. Shock if unstable is the only Onset/Stability detection enhancement available in the VT zone of a 3-zone conﬁguration (appliesonly to 3-zone conﬁguration without a Monitor Only zone).NOTE: There is no clinical data to suggest that one detection enhancementsuite is superior to the other for any given patient indication. Therefore,individual programming and evaluation of detection enhancement speciﬁcityis recommended.Rhythm IDRhythm ID uses Vector Timing and Correlation analysis in addition to atrial andventricular interval analysis to determine if a patient’s rhythm should be treated(VT) or if therapy should be inhibited (SVT).With Rhythm ID, the pulse generator performs a vector timing and correlationanalysis using the shock EGM and rate EGM. Based on this data, it saves areference template of the patient’s normal sinus rhythm.- DRAFT -

3-8 TACHYARRHYTHMIA DETECTIONVENTRICULAR DETECTIONDuring Rhythm ID analysis, the pulse generator ﬁrst determines if theventricular rate is greater than the atrial rate. If so, therapy will be initiated. Ifthe ventricular rate is not greater than the atrial rate, Rhythm ID evaluates thefollowing criteria to determine if therapy should be inhibited or initiated:• Vector Timing and Correlation analysis during initial detection determinesif the rhythm is SVT by comparing it to the previously stored referencetemplate. If the rhythm is declared SVT, therapy is inhibited.• If Vector Timing and Correlation does not declare the rhythm SVT, Stabilityand AFib Rate Threshold determine if the ventricular rhythm is unstableand the atrial rate is fast. If the ventricular rhythm is unstable and the atrialrate is fast, the rhythm is declared SVT and therapy is inhibited.Rhythm ID does not consider atrial detection criteria (V Rate > A Rate or Agreater than AFib Rate Threshold) for the following conﬁgurations:• Single-chamber devices• Dual-chamber devices if Atrial Tachyarrhythmia Discrimination isprogrammed to OffWhen conﬁgured this way, Stability is not evaluated for initial detection. Thismay be useful in instances where atrial lead problems have occurred. Forthese conﬁgurations,therapy is inhibited at initial detection if the rhythm isdeclared SVT (correlated based on Vector Timing and Correlation). Otherwise,therapy is initiated.Two methods are available for the device to automatically acquire a RhythmID reference template: passive and active. The active method may be usefulfor patients who are frequently ventricular paced.If the passive method is enabled, the pulse generator will attempt to collect theRhythm ID reference template every two hours using the programmed bradysettings.Iftheactivemethodisenabledandsevendayshavepassedsincethelastsuccessful collection of a reference template, then every 28 hours the deviceautomatically analyzes the patient’s intrinsic rhythm by adjusting the bradyparameters. During a Rhythm ID active reference template update, thefollowing will occur:1. The device veriﬁes that the patient is at rest (as measured by theaccelerometer input).- DRAFT -

TACHYARRHYTHMIA DETECTIONVENTRICULAR DETECTION 3-92. The device enables a controlled pacing rate decrease to the programmedRhythm ID Fallback LRL. During this fallback period, the following occurs:• The device temporarily switches the pacing mode to DDI, VDI, VVI,AAI, or Off (according to the programmed brady mode) and extendsthe AV delay up to 400 ms.• Rate Smoothing, ATR, hysteresis, and dynamic programming(excluding Dynamic VRP) are suspended.3. After the Fallback period, pacing parameters are restored to normalprogrammed parameters. Fallback periods occur no more than once perday and will typically last less than one minute.A method for manually commanding the device to acquire a Rhythm IDreferencetemplateisalsoavailable.NOTE: If Rhythm ID is not enabled, a manual reference template update canstill be performed. However, the acquired template will not be used in analysisto determine if the patient’s rhythm is VT or SVT.During a manual Rhythm ID reference template update, the pulse generator willperform the following tasks:1. Enable a controlled rate decrease to the programmed Rhythm ID FallbackLRL. During the fallback period, the following occurs:• The device temporarily switches to the programmed Manual RhythmID Brady Mode and extends the AV delay up to 400 ms.• Rate Smoothing, ATR, hysteresis, and dynamic programming(excluding Dynamic VRP) are suspended.2. After the Fallback interval, pacing parameters are restored to normalprogrammed parameters. This process will typically last one minute.NOTE: Rhythm ID Fallback LRL settings should be selected such that normalsinus rhythms are promoted (e.g., normal AV node conduction). Care must beused when selecting LRL less than 50 ppm (rates that approach the patient’sventricular escape rates). Ventricular escape rhythms during Rhythm IDupdates may result in inappropriate therapy decisions.- DRAFT -

3-10 TACHYARRHYTHMIA DETECTIONVENTRICULAR DETECTIONNOTE: A manual Rhythm ID reference template update should not becommanded immediately after shock therapy. It may take several minutes forirregularities in EGM morphology caused by the shock to subside.Onset/StabilityThe Onset/Stability detection enhancement suite analyzes the cardiac cycleintervals to determine if a patient’s rhythm should be treated (VT) or if therapyshould be inhibited (SVT).Onset/Stability allows you to program detection enhancements by identifyingthe desired type of rhythm discrimination: atrial tachyarrhythmia, sinustachycardia, or polymorphic VT (Table 3-4 on page 3-10).Table 3-4. Onset/Stability rhythm discrimination available per zoneVT-1 Zone VT Zone VF ZoneAtrial Tachyarrhythmia Polymorphic VTa3-zone ConﬁgurationSinus TachycardiaNoneAtrial TachyarrhythmiaSinus Tachycardia3-zone Conﬁguration(with Monitor Only zone)bNonePolymorphic VTaNoneAtrial TachyarrhythmiaSinus Tachycardia2-zone ConﬁgurationPolymorphic VTaNone2-zone Conﬁguration (with Monitor Only zone)bNone None1-zone Conﬁguration Nonea. Polymorphic VT Discrimination is only available in the VT zone.b. Rhythm discrimination is not available in the lowest zone of a multi-zone conﬁguration if the zone is used as a Monitor Onlyzone (no therapy programmed for that zone).Reconﬁrmation/Committed ShockReconﬁrmation refers to the monitoring performed by the device during andimmediately following capacitor charging for a shock. When the CommittedShock parameter is programmed to Off, the device is allowed to reconﬁrm thata shock should be delivered.- DRAFT -

TACHYARRHYTHMIA DETECTIONVENTRICULAR DETECTION 3-11Ventricular RedetectionVentricular Redetection occurs following any:• Ventricular therapy delivery• Diverted therapy due to reconﬁrmation analysis (diverted-reconﬁrm)• Manually diverted therapy• Therapy not available at Detection MetRedetection uses the same ventricular detection window process andprogrammed tachycardia rate thresholds as initial detection to identify atachyarrhythmia.The primary differences between initial detection and redetection are theduration parameters used and the detection enhancements that are available:• If ventricular shock therapy is delivered, the following will occur:– The redetection duration time is determined by the value of thePost-shock Duration parameter– Detection enhancements (except for Vector Timing and Correlation)are available during redetection• If ventricular ATP is delivered or if therapy is diverted or unavailable, thefollowing will occur:– The redetection duration time is determined by the RedetectionDuration parameter– Detection enhancements (except for Shock if Unstable) are notavailable during redetectionWhichever duration is determined to be appropriate, that type of duration(Redetection or Post-shock) will be in effect in all zones at each zone’sprogrammed duration value.Ventricular Post-shock Detection EnhancementsWhen programmed to On, the following ventricular post-shock detectionenhancements will be in effect following the Post-shock Duration:• Post-shock V Rate > A Rate• Post-shock AFib Rate Threshold- DRAFT -

3-12 TACHYARRHYTHMIA DETECTIONVENTRICULAR DETECTION• Post-shock Stability• Post-shock SRD• Post-shock Rhythm ID (uses AFib Rate Threshold, Stability, V Rate > ARate, and SRD)With the exception of Rhythm ID, all post-shock detection enhancementsperform the same as the corresponding Initial Detection enhancements (withRhythm ID, Vector Timing and Correlation is not available post-shock).Post-shock Stability may be used to prevent shock-induced AF from causingthe pulse generator to deliver undesired additional shocks (Figure 3-2 onpage 3-12.)TheAFibRateThresholdcanbeprogrammedinconjunctionwithPost-shockStability to further discriminate AF and prevent the pulse generator fromdelivering undesired ventricular shock therapy.0 s 5 s 20 s0 s 15 sLowest zone detection window satisfied.Post-shock Duration = 5 sPost-shock SRD = 15 sPost-shock Duration starts in lowest zone.Post-shock Duration expires.Evaluate Stability. If stable, charge and shock. If unstable, inhibit therapy. Post-shock SRD timer starts.Continue Post-shock Stability analysis throughout SRD time as long as the detection window remains satisfied.If Stability indicates therapy, charge and shock.Post-shock SRD times out. Charge and deliver shock if therapy had been inhibited during SRD.ShockFigure 3-2. Post-shock Duration and Post-shock Stability analysisVentricular Detection DetailsThe pulse generator uses the following information to determine appropriatetherapy delivery:• Ventricular detection windows• Duration parameter• Redetection duration and post-shock duration• Ventricular episodes• Ventricular detection enhancements- DRAFT -

TACHYARRHYTHMIA DETECTIONVENTRICULAR DETECTION 3-13Ventricular Detection WindowsAppropriate therapy delivery is dependent upon accurately classifying apatient’s rhythm. To ensure that appropriate therapy is delivered, the pulsegenerator employs detection windows to differentiate tachycardias.Each ventricular zone has a detection window that consists of the 10 mostrecent RV R–R intervals measured by the pulse generator. As each newinterval is measured, it is compared to each zone’s programmed rate thresholdand classiﬁed as either fast or slow (i.e., above or below the rate threshold) ineach detection window.The pulse generator prepares for a potential episode when it counts 3consecutive fast intervals. The detection window is satisﬁed and an episode isdeclared when 8 out of 10 fast intervals are counted. The detection windowwill remain satisﬁed as long as 6 of 10 intervals remain classiﬁed as fast. If thenumber of fast intervals falls below 6, the zone’s detection window is no longersatisﬁed. The zone’s detection window will only become resatisﬁedwhen8of10 intervals are again classiﬁed as fast (Figure 3-3 on page 3-13).630 600 600 380 370 390 380 370 600 370 350 370 490 500 500 500 500 370 S S S S F F F F F F F F S S S S S F F 6 of 10 intervals are fast, VF window not satisfied. 8 of 10 intervals are fast, VF window is satisfied. 7 of 10 intervals are fast, VF window remains satisfied. 7 of 10 intervals are fast, VF window not satisfied. 6 of 10 intervals are fast, VF window remains satisfied. 5 of 10 intervals are fast, VF window is no longer satisfied. 6 of 10 intervals are fast, VF window is not yet resatisfied 7 of 10 intervals are fast, VF window is not yet resatisfied 8 of 10 intervals are fast, VF window is resatisfied VF window Intervals in ms VF Zone Rate = 150 min-1 (bpm) = 400 ms S = Slow F = Fast One-zone configuration Right Ventricle Figure 3-3. Ventricular detection window satisﬁedBecause Rate Threshold in the higher zones must be programmed at a valuegreater than Rate Threshold in lower zones, an interval classiﬁed as fast- DRAFT -

3-14 TACHYARRHYTHMIA DETECTIONVENTRICULAR DETECTIONin a higher window would also be classiﬁed as fast in any lower windows(Figure 3-4 on page 3-14).630 600 600 370 390 380 275 275 600 275 250 250 S S S S F F F F F F F F 240 240 F F S S S S S S S F F F F F F F 240 F F VF Zone Rate = 200 min-1 (bpm) = 300 ms VT Zone Rate = 150 min-1 (bpm) = 400 ms S = Slow F = Fast Intervals in ms 8 of 10 intervals are fast, VF window is satisfied. 7 of 10 intervals are fast, VF window not satisfied. 6 of 10 intervals are fast, VF window not satisfied. 8 of 10 intervals are fast, VT window is satisfied. 7 of 10 intervals are fast, VT window not satisfied. 6 of 10 intervals are fast, VT window not satisfied. VF window VT window Figure 3-4. Interaction of ventricular detection windows, 2-zone conﬁgurationDuration ParameterThe Duration parameter is a timer that measures the length of time in eachzone that a rhythm must be sustained before therapy is delivered.A Duration timer begins when its respective zone’s detection window issatisﬁed. The programmed Duration time is checked following every cardiaccycle to determine if it has expired.NOTE: Since the Duration timer is examined synchronously with a cardiaccycle, the programmed Duration may be exceeded by up to one full cardiaccycle.• As long as the zone’s detection window remains satisﬁed, the Durationtimer continues to elapse. If the last detected interval is in the zone whenits Duration time expires, detection is considered met and therapy isinitiated (assuming no programmed detection enhancements inhibit therapydelivery) (Figure 3-5 on page 3-15).• If the last detected interval is not in the zone, therapy is not initiated. Eachsubsequent interval will be checked until an interval is in the original zone,or the window is no longer satisﬁed (Figure 3-6 on page 3-15).- DRAFT -

TACHYARRHYTHMIA DETECTIONVENTRICULAR DETECTION 3-15• If at any point during Duration a zone’s detection window detects fewerthan 6 of 10 fast intervals, that zone’s Duration is reset to 0 (Figure 3-7 onpage 3-16). Duration will start again only if the detection window becomesresatisﬁed.VT detection window remains satisfied during VT Duration. VT Duration expires and the next detected interval is in the VT zone, detection is met. ATP therapy is initiated.VT window satisfied. VT Duration starts. VT Duration 1-30 s VT detected Right Ventricle Duration starts when a window becomes satisﬁed and continues to elapse as long as the ventricular detection windowremains satisﬁed. Detection is met when Duration expires and the next detected interval is in the same ventricularzone.Figure 3-5. Ventricular Duration timerVT detection window remains satisfied during VT Duration.VT Duration expires and the last detected interval is not in the same zone, detection in that zone is not met. Therapy in that zone is not initiated.VT window satisfied. VT Duration starts.VT detected VT Duration 1-30 sRight ventricleFigure 3-6. Last detected interval- DRAFT -

3-16 TACHYARRHYTHMIA DETECTIONVENTRICULAR DETECTIONVT detection window is no longer satisfied; fewer than 6 of 10 intervals are classified as fast. VT window satisfied. VT Duration starts. VT Duration resets to zero. VT Duration will start again when the window becomes resatisfied. Need 8 of 10 intervals classified as fast to restart VT Duration. VT Duration 1-30 seconds VT detected Right ventricle Duration resets when during the Duration period the window is no longer satisﬁed.Figure 3-7. Ventricular Duration resetA Duration is programmed for each ventricular zone. Different values areavailable depending on the conﬁguration programmed (Table 3-5 on page 3-16).The Duration programmed in lower ventricular rate zones must be greater thanor equal to higher ventricular zones. Longer Durations may be used to preventthe device from initiating treatment of non-sustained arrhythmias.Table 3-5. Duration programmable ranges by ventricular zone and conﬁgurationConﬁguration VT-1 ZoneaVT ZoneaVF Zoneb1 Zone –– –– 1–15 seconds2 Zones –– 1–30 seconds 1–15 seconds3 Zones 1–60 seconds 1–30 seconds 1–15 secondsa. The maximum redetect duration for the VT-1 and VT Zones is 15 seconds.b. In the VF Zone, the redetect and post-shock duration is ﬁxed at 1 second.Duration in a Multi-zone ConﬁgurationDuration timers run independently of each other within their respectiveventricular zones.• If the arrhythmia is detected in the highest zone, that zone’s Duration timertakes precedence over the lower zones’ timers; the lower zones’ Durationtimers continue to elapse but are ignored while the higher zone’s Durationtimer runs.• If the higher zone’s Duration expires and detection is met, therapy for thatzone will be initiated regardless of whether the lower zones’ Durationtimers have expired.- DRAFT -

TACHYARRHYTHMIA DETECTIONVENTRICULAR DETECTION 3-17• If the higher zone’s detection window does not remain satisﬁed, then theDuration timers for the lower ventricular zones are no longer ignored.Programmed therapy for lower ventricular zones will be initiated when a lowerventricular zone’s duration is met and no higher ventricular zone’s window issatisﬁed (Figure 3-8 on page 3-17, Figure 3-9 on page 3-17).VF window satisfied. VF Duration starts. VF Duration 1 s VF window remains satisfied. VF Duration expires and detection is met. Charging begins. VT Duration expires during charging, but is ignored. Charging VT window satisfied. VT Duration starts. VT detected VT Duration 5 s VF detected Figure 3-8. Interaction of ventricular Duration, 2-zone conﬁguration, chargingVF window satisfied. VF Duration starts. VF window does not remain satisfied. VF Duration is not satisfied. VT Detection is met. VT window satisfied. VT Duration starts. VT Duration expires. Detection is not met because VF window is satisfied. VT detected VF detected VF Duration 1 s VT Duration 5 s Charging Figure 3-9. Interaction of ventricular Duration, 2-zone conﬁguration, charging delayedVentricular Redetection Duration and Post-shock DurationDuration parameters are used to identify tachyarrhythmias during the ventricularredetection process.• Redetection Duration is applied following delivery of ATP therapy (exceptQUICK CONVERT ATP), a diverted-reconﬁrm, manually diverted therapy,or if therapy is unavailable at Detection Met (Figure 3-10 on page 3-18).• Post-shock Duration is applied following shock therapy delivery (Figure 3-11on page 3-18).- DRAFT -

3-18 TACHYARRHYTHMIA DETECTIONVENTRICULAR DETECTIONRedetection Duration is programmable in the lower ventricular zones of amulti-zone conﬁguration. It is nonprogrammable in the VF Zone. Post-shockDuration can be programmed in the same manner; the values programmed inthe lower ventricular rate zones must be greater than or equal to the valuesprogrammed in the higher zones.To help minimize time to potential therapy, it is recommended that RedetectionDuration in the VT-1 and VT zones of multi-zone conﬁgurations be programmedat less than or equal to 5 seconds.It is recommended that Post-shock Duration in the VT-1 and VT zones ofmulti-zone conﬁgurationsalsobeprogrammedatlessthanorequalto5seconds. However, you may program for longer durations if shock-induced,non-sustained, high-rate rhythms, such as accelerated idioventricular rhythm(AIVR) or AF are evident. The longer durations may allow the rhythm to returnto a lower rate before redetection is met.3 s8 of 10 intervals are fast, window satisfiedStart Redetection DurationStart RedetectionATP therapy programmed. Redetection Duration programmed at 3 s.Initial Detection metATP therapy ATP therapyRedetection Duration expires. Detection met.Start RedetectionLook for 8 of 10 fast intervalsIgnored IgnoredFigure 3-10. Redetection following ventricular ATP delivery3 sShock therapy programmed. Post-shock Duration programmed at 3 s.Initial Detection met Start Redetection Start Post-shock DurationPost-shock Duration expires. Detection met.Start RedetectionCharging 8 intervals are fast Charging Look for 8 of 10 fast intervalsShockShockIgnored IgnoredFigure 3-11. Redetection following ventricular shock delivery- DRAFT -

TACHYARRHYTHMIA DETECTIONVENTRICULAR DETECTION 3-19Ventricular EpisodesIf three consecutive fast ventricular beats are detected, then the pulsegenerator performs the following:• Increments the episode number• Allocates memory for history data and electrogram storage• Starts monitoring for a detection window to be satisﬁedWhen any zone’s detection window becomes satisﬁed, the start of a ventricularepisode is declared and duration timers begin in those zones where detectionwindows are satisﬁed. The ventricular episode is declared complete when alldetection windows are no longer satisﬁed and remain unsatisﬁed for a speciﬁedtime.Each ventricular tachy episodes is classiﬁed as treated or non-treated(Figure 3-12 on page 3-20 through Figure 3-16 on page 3-22).• A treated episode is one in which therapy is delivered• A nontreated episode is one in which no therapy is deliveredFor a treated episode, an End-of-Episode timer starts after therapy is delivered.For a non-treated episode, an End-of-Episode timer starts at the point thatthe pulse generator recognizes that all detection windows are no longersatisﬁed. The End-of-Episode time interval is intended to allow the patientto stabilize before initial detection and initial therapy are used again. Theepisode is declared complete if no detection window becomes satisﬁed for aspeciﬁed time following the last therapy attempt (Table 3-6 on page 3-19). Ifany window becomes satisﬁed while the End-of-Episode timer is elapsing, theEnd-of-Episode timer is reset to zero. It will start again when either therapy isattempted or all windows are not satisﬁed (Figure 3-16 on page 3-22).Once an episode has been declared complete, the pulse generator will applyinitial detection and therapy to subsequent tachyarrhythmias.Table 3-6. End-of-Episode TimerEpisode Classiﬁcation Ventricular End-of-Episode Timer(elapsed time required to declare episode over)Nontreated (no therapy delivered) 10 seconds- DRAFT -

3-20 TACHYARRHYTHMIA DETECTIONVENTRICULAR DETECTIONTable 3-6. End-of-Episode Timer (continued)Episode Classiﬁcation Ventricular End-of-Episode Timer(elapsed time required to declare episode over)Treated (only ATP therapy delivered) 10 secondsTreated (any shock therapy delivered) 30 secondsNOTE: The episode is terminated immediately if the Tachy Mode isreprogrammed, an induction method or lead test is attempted before theEnd-of-Episode time out, or any ventricular detection or ventricular therapyparameters are reprogrammed.Coupling Interval Detection window does not become satisfied. End-of-Episode times out. Episode is over. Detection met. Deliver ATP. Start Duration. Start episode. Start End-of-Episode timer.Detection window remains satisfied. ATP Burst 10 s Detection window satisfied. Figure 3-12. Treated episode, ventricular mode is Monitor + Therapy and ATP is deliveredDetection window remains satisfied. Detection met. Start Charging. Start Duration. Start episode. Detection window satisfied. Charging Shock End-of-Episode times out. Episode is over. Start End-of-Episode timer. 30 s Detection window does not become satisfied. Figure 3-13. Treated episode, ventricular mode is Monitor + Therapy and shock is delivered- DRAFT -

TACHYARRHYTHMIA DETECTIONVENTRICULAR DETECTION 3-21Start Duration. Start episode.Duration did not expire. Duration resets to zero. Start End-of-Episode timer.End-of-Episode times out. Episode is over.Detection window is no longer satisfied; fewer than 6 of 10 intervals are classified as fast.Detection window satisfied.10 sDetection window does not become satisfied.Figure 3-14. Nontreated episode, ventricular mode is Monitor + Therapy or Monitor Only, duration is notexpired10 sTa chyarrhythmia spontan eously converts.Reconfirmation monitors rhythm for five of ten slow intervals during charging.End-of-Episode times out. Episode is over.Reconfirmation indicates tachyarrhythmia not present; shock not delivered. Start End-of-Episode timer.Start Duration. Start episode.Detection met. Start Charging.Detection window satisfied.F = FastS = SlowDetection window remains satisfied.FSSSSSChargingRight VentricleThis example assumes Committed Shock is programmed to Off.Figure 3-15. Nontreated episode, ventricular mode is Monitor + Therapy and charging is stopped priorto shock delivery- DRAFT -

3-22 TACHYARRHYTHMIA DETECTIONVENTRICULAR DETECTIONDetection window satisfied. Start End-of-Episode timer.Start Post-shock Duration End-of-Episode timer resets to zero. Detection met. Start Charging. Restart End-of-Episode timer. End-of-Episode times out. Episode is over. Charging 30 s Shock Shock Ventricular rate remains fast. Detection window does not become satisfied. Right Ventricle This example illustrates a Treated Episode when Ventricular mode is Monitor + Therapy. The End-of-Episode timer isreset to 0 when a ventricular detection window becomes satisﬁed after ventricular therapy delivery, but prior to theepisode time-out being reached. In this example, 2 shocks were delivered in the episode.Figure 3-16. Treated episode, ventricular mode is Monitor + Therapy and End-of-Episode timer is reset to 0Ventricular Detection EnhancementsVentricular detection enhancements add speciﬁcity to the Rate and Durationdetection criteria. You may program ventricular detection enhancements toperform the following:• Delay or inhibit therapy delivery• Override therapy inhibition• Bypass a sequence of ATP therapy in favor of shock therapyVentricular detection enhancements may be programmed to one of thefollowing:•RhythmID• Onset/Stability• Off (i.e., rate only)If Off is selected, only the ventricular rate and duration are used for therapydecisions.- DRAFT -

TACHYARRHYTHMIA DETECTIONVENTRICULAR DETECTION 3-23If either Rhythm ID or Onset/Stability is selected, enhancement parameters areused in addition to ventricular rate and duration for therapy decisions (Table 3-7on page 3-23) as follows:• Vector Timing and Correlation inhibits therapy when the conduction vector(EGM morphology and timing) during tachyarrhythmia matches a referenceconduction vector of the patient’s normal sinus rhythm.• VRate>ARatecanbeusedtooverridetheinhibitdecisionofOnset,Stability, Vector Timing and Correlation, and/or AFib Rate Threshold. VRate > A Rate can be used to deliver ventricular therapy anytime theventricular rate is greater than the atrial rate.• AFib Rate Threshold can be programmed (together with stability) to inhibitventricular therapy if the atrial rhythm is fast.• Stability can be programmed to inhibit ventricular therapy delivery if theventricular rhythm is unstable.• Shock if Unstable can be programmed to bypass the ventricular ATPtherapy and deliver shock therapy if the ventricular rhythm is declaredunstable.• Onset can be programmed to inhibit ventricular therapy if the patient’sheart rate increases gradually.• SRD enables the pulse generator to override the Stability, Onset, VectorTiming and Correlation, and/or AFib Rate Threshold parameters’ decisionto inhibit ventricular therapy if the high rate continues throughout theprogrammed time period.Table 3-7. Enhancement parameters available with detection enhancementsRhythm ID Onset/StabilityEnhancement ParameterInitial Post-Shock Initial Post-ShockVector Timing and CorrelationaX–– –– ––V Rate > A Rate (dual-chamber devices only) Xbc Xbc XXAFib Rate Threshold (dual-chamber devices only) Xbd Xbd XeXeStability (to inhibit) XfXfXXShock if Unstable –– –– X––- DRAFT -

3-24 TACHYARRHYTHMIA DETECTIONVENTRICULAR DETECTIONTable 3-7. Enhancement parameters available with detection enhancements (continued)Rhythm ID Onset/StabilityEnhancement ParameterInitial Post-Shock Initial Post-ShockOnset –– –– X––SRDgXXXXa. This enhancement is not individually programmable.b. When Rhythm ID is selected, this enhancement is automatically enabled when Atrial Tachyarrhythmia Discrimination isprogrammed to On. However, it is not available in single chamber devices or when the Atrial Tachyarrhythmia Discrimination isprogrammed to Off in dual chamber devices.c. This enhancement is not individually programmable when Rhythm ID is enabled.d. When Rhythm ID is selected, this parameter uses the same value for both initial and post-shock detection. It cannot beindependently enabled or disabled for post-shock detection.e. When Onset/Stability is selected, this parameter can be enabled and disabled independently for post-shock detection. If enabled,it uses the same value as the initial detection.f. When Rhythm ID is enabled and Atrial Tachyarrhythmia Discrimination is programmed to On in dual chamber devices, thisenhancement uses the same value for both initial and post-shock detection. In single chamber devices, or when AtrialTachyarrhythmia Discrimination is programmed to Off, this enhancement is automatically disabled for Initial Detection, but is stillenabled for post-shock detection.g. SRD is available when detection enhancements, which inhibit therapy, are programmed.Some of these detection enhancement parameters are also independentlyprogrammable as post-shock parameters (Table 3-7 on page 3-23).The individual detection enhancement parameters that are available dependon the number of tachy zones that are programmed: 3, 2, or 1 (Table 3-8 onpage 3-24).Table 3-8. Individual Ventricular Detection Enhancements available in multizone conﬁgurationsVT-1 Zone VT Zone VF ZoneVector Timing andCorrelationVector Timing andCorrelationaV Rate > A Rate V Rate > A RateaAFib Rate Threshold AFib Rate ThresholdaStability to Inhibit Stability (to Inhibit)aOnset Shock if Unstable3-zone conﬁgurationSRD SRDa––- DRAFT -

TACHYARRHYTHMIA DETECTIONVENTRICULAR DETECTION 3-25Table 3-8. Individual Ventricular Detection Enhancements available in multizone conﬁgurations (continued)VT-1 Zone VT Zone VF ZoneVector Timing and CorrelationV Rate > A RateAFib Rate ThresholdStability (to Inhibit)Shock if UnstablecOnset3-zone conﬁguration(with Monitor Only zone)b––SRD––Vector Timing and CorrelationV Rate > A RateAFib Rate ThresholdStability (to Inhibit)Shock if UnstablecOnset2-zone conﬁgurationSRD––2-zone conﬁguration (with Monitor Only zone)b–– ––1-zone conﬁguration ––a. Enhancement is available in the middle zone of a 3-zone conﬁguration only when Rhythm ID is enabled.b. Detection enhancements are not available in the lowest zone of a multi-zone conﬁguration when it is used as a Monitor Onlyzone (no therapy programmed for that zone).c. Shock if Unstable cannot be programmed on in the same zone as other detection enhancements that are programmed toinhibit therapy (Onset, Stability, and AFib Rate Threshold).When a speciﬁc rhythm discrimination is selected, preselected values aredisplayed for the detection enhancements that are suitable for discriminatingthat rhythm. However, you can modify those values at your discretion (Table 3-9on page 3-26).- DRAFT -

3-26 TACHYARRHYTHMIA DETECTIONVENTRICULAR DETECTIONTable 3-9. Preselected values for initial detection and redetection enhancementsOnset/Stability Rhythm IDParameter AtrialTachyarrhythmiaDiscriminationSinusTachycardiaDiscriminationPolymorphicVTDiscriminationAtrialTachyarrhythmiaDiscriminationOnAtrialTachyarrhythmiaDiscriminationOffVectorTiming andCorrelation–– –– –– OnaOnaVRate>ARate(dual-chambermodelsonly)On On –– Onb––AFib RateThreshold(dual-chambermodelsonly)170 bpm –– –– 170 bpm ––Stability(Inhibit)20 ms(DR devices)30 ms(VR devices)–– –– 20 ms(DR devices)30 ms(VR devices)30 msOnset(initialdetectiononly)–– 9% –– –– ––SRD Initial 3:00minutes:seconds3:00minutes:seconds–– 3:00minutes:seconds3:00minutes:secondsSRDRedetection0:15minutes:seconds–– –– 0:15minutes:seconds0:15minutes:secondsShock ifUnstable–– –– 30 ms –– ––a. Parameter is not individually programmable.b. Parameter is not individually programmable when Rhythm ID is enabled.Vector Timing and CorrelationVector Timing and Correlation compares EGM signals for an unknown rhythmwith a stored reference template of the EGM signals of a normal sinus rhythm(NSR). Rhythms that are not similar to the reference template (are notcorrelated) are classiﬁed as VT. Rhythms that are correlated with the referencetemplate are classiﬁed as SVT.When an unknown fast rhythm is sensed in the VT or VT-1 zones, each beatof the fast rhythm is compared to the stored reference template. The pulse- DRAFT -

TACHYARRHYTHMIA DETECTIONVENTRICULAR DETECTION 3-27generator calculates a Feature Correlation Coefﬁcient and makes the followingtherapy decisions based on the calculation:• If at least 3 out of 10 beats are correlated, the rhythm is classiﬁed as SVT• If fewer than 3 out of 10 beats are correlated, the rhythm is classiﬁed as VTRhythm ID makes its decision to treat or inhibit therapy at the end of Duration. Ifthe decision is made to inhibit therapy, Rhythm ID (including Vector Timing andCorrelation, V Rate > A Rate, AFib Rate Threshold, and Stability) continuesto be recalculated beat-by-beat throughout SRD.V Rate > A RateThe V Rate > A Rate (ventricular rate greater than atrial rate) enhancementcompares the atrial and ventricular rates to classify the type of fast ventricularrhythm. When the ventricular rate is greater than the atrial rate, therapy willbe initiated regardless of the analysis of the other programmed detectionenhancements.Analysis is made by comparing the average rate of the last 10 ventricularintervals prior to the end of Duration to the average rate of the last 10 atrialintervals prior to the end of Duration (Figure 3-17 on page 3-28). If fewer than10 atrial intervals are available, those intervals will be used to calculate theaverage atrial rate. This analysis is performed using the following criteria:• If the average ventricular rate is greater than the average atrial rate by atleast 10 bpm, the ventricular rate is declared to be faster than the atrialrate (indicated as True on the Episode Detail Report), and therapy willbe initiated.• If the average ventricular rate is not greater than the average atrial rate byat least 10 bpm (indicated as False on the Episode Detail Report), therapymay continue to be inhibited. The Episode Detail report will indicate themeasured value even though the parameter may be programmed to Off.If therapy is inhibited, the V Rate > A Rate analysis continues until either theventricular rate is greater than the atrial rate or other enhancements indicatetherapy treatment, at which time therapy will be initiated.NOTE: V Rate > A Rate is not evaluated during redetection following ATPtherapy.- DRAFT -

3-28 TACHYARRHYTHMIA DETECTIONVENTRICULAR DETECTION400 380 420 390 410 400 360 440 410 390 580 620 600 640 560 600 580 600 620 1 2 3 4 5 6 7 8 9 1 2 3 4 5 6 7 8 Number of Intervals Intervals in ms Third fast interval (of the 8 out of 10 that satisfy the detection window) Start Duration. Evaluate Onset. Compute the sum of 10 most recent ventricular intervals. Average = 400 ms = 150 min-1 (bpm).Duration expired. Onset is gradual. Analyze V Rate > A Rate. Deliver therapy because V > A. Average ventricular rate (150 min-1 [bpm]) is greater than average atrial rate (100 min-1 [bpm]) by at least 10 bpm, so delivery therapy.Compute the sum of the atrial intervals. Average = 600 ms = 100 min-1 (bpm).Number of Intervals Intervals in ms Atrium Ventricle VT detected ATP therapy Figure 3-17. V Rate > A Rate analysisV Rate > A Rate can be programmed to bypass inhibitors (Vector Timing andCorrelation, AFib Rate Threshold, Stability, and/or Onset) and initiate therapy inthe event that the ventricular rate is faster than the atrial rate.NOTE: Refer to "Use of Atrial Information" on page 3-5 for additionalinformation about device performance when the atrial lead is programmed toOff.NOTE: In a Rhythm ID conﬁguration, the evaluation of V Rate > A Rate islinked to the AFib Rate Threshold. If Atrial Tachyarrhythmia Discrimination isprogrammed to Off, the AFib Rate Threshold and V Rate > A Rate detectionenhancements are not evaluated.AFib Rate ThresholdAFib Rate Threshold analysis identiﬁes AF by comparing the atrial rate to theprogrammed AFib Rate Threshold.AFib Rate Threshold cannot be enabled without also enabling the Stabilitydetection enhancement. The device analyzes both parameters to determinewhether to withhold or deliver therapy.If the intrinsic atrial rate is greater than the AFib Rate Threshold and theventricular rhythm is classiﬁed as unstable, the ventricular rhythm is declaredto be due to AF.- DRAFT -

TACHYARRHYTHMIA DETECTIONVENTRICULAR DETECTION 3-29The intrinsic atrial rate is declared to be above the AFib Rate Threshold in thefollowing manner (Figure 3-18 on page 3-29):• Atrial analysis begins at initiation of ventricular tachyarrhythmia detection.Each atrial interval is classiﬁed as faster or slower than the AFib RateThreshold Interval.• When 6 of the last 10 intervals are classiﬁed as faster than the AFib RateThreshold, the device declares AF to be present.• Ventricular stability is then checked. If unstable, therapy is inhibited.In the event that ventricular therapy is not delivered, the atrial rate continuesto be examined. As long as 4 of 10 intervals remain classiﬁed as fast, AFis considered present. Therapy is inhibited by AFib Rate Threshold/Stabilityuntil any of the following occur:• The atrial rate drops below the AFib Rate Threshold• The ventricular rhythm becomes stable• IfprogrammedtoOn,VRate>ARateistrue•SRDtimesout12345678Only 3 of 10 intervals are above the AFib Rate Threshold4 of 10 > AFib Rate Threshold4 of 10 intervals must remain > AFib Rate Threshold6 of 10 atrial intervals are greater than AFib Rate ThresholdThird fast interval (of the 8 out of 10 that satisfy the detection window)Detection satisfied.Start duration.Start episode.Start Stability analysis.Atrial rate > AFib Rate Threshold.Duration expires.Atrial rate > AFib Rate Threshold.Rhythm declared unstable.Therapy is inhibited.Rhythm remains unstable.Atrial rate is less than AFib Rate Threshold.Initiate therapy.ATP therapyVT detectedVentricleAtriumFigure 3-18. Interaction of AFib Rate Threshold and Stability- DRAFT -

3-30 TACHYARRHYTHMIA DETECTIONVENTRICULAR DETECTIONWhen AFib Rate Threshold and Stability are used alone, ventricular therapyis initiated when a stable rhythm is declared. Ventricular therapy is initiatedfor an unstable rhythm when it is determined that the atrial rate is lessthan the AFib Rate Threshold (Table 3-10 on page 3-30). When AFibRate Threshold and Stability are used with other inhibitor enhancements,ventricular therapy is not always initiated when no longer inhibited by AFib RateThreshold/Stability. Therapy may continue to be inhibited by other programmeddetection enhancements, such as Onset (when the Onset/Stability detectionenhancement suite is enabled) or Vector Timing and Correlation (when theRhythm ID detection enhancement suite is enabled).Consider the following information during these interactions:• The AFib Rate Threshold and V Rate > A Rate detection enhancementsare not evaluated if Atrial Tachyarrhythmia Discrimination is programmed toOff in a Rhythm ID conﬁguration.• Because the AFib Rate Threshold is not evaluated during redetection(following ventricular ATP therapy delivery, any aborted ventricular therapy,or therapy not available), the Episode Detail report will not display datafor the enhancement during redetection, even though the parameter isprogrammed On.• The AFib Rate Threshold enhancement is not evaluated for arrhythmiadetection in the following cases; however, the Episode Detail report will stilldisplay the data for the AFib Rate Threshold enhancement based on athreshold of 170 bpm:– The AFib Rate Threshold is programmed to Off– Ventricular Zones is programmed to 1– No detection enhancement suite is enabled• An atrial sense event will only be classiﬁedasAFwhiletheAFibRateThreshold is being evaluated for arrhythmia detection.Table 3-10. AFib Rate Threshold and Stability combinations and resulting therapyDetected Ventricular RhythmaTherapy DecisionbUnstable, A > AFib Rate Threshold InhibitStable, A > AFib Rate Threshold Treat- DRAFT -

TACHYARRHYTHMIA DETECTIONVENTRICULAR DETECTION 3-31Table 3-10. AFib Rate Threshold and Stability combinations and resulting therapy (continued)Detected Ventricular RhythmaTherapy DecisionbUnstable, A < AFib Rate Threshold TreatStable, A < AFib Rate Threshold Treata. If the detected ventricular rhythm changes, then the appropriate, corresponding row in the table is evaluated.b. Decisions to inhibit can be overridden by V > A or expiration of SRD.NOTE: Refer to "Use of Atrial Information" on page 3-5 for additionalinformation about device performance when the atrial lead is programmed toOff.Stability AnalysisStability analysis distinguishes unstable (irregular) ventricular rhythms fromstable (regular) ventricular rhythms. This is accomplished by measuring thedegree of variability of the tachycardia R–R intervals.This degree of variability, when used alone, may allow the device to distinguishconducted AF (which may produce greater R–R variability) from monomorphicVT (which is typically stable). It also may be used to differentiate MVTs (whichare pace terminable) from polymorphic VTs and VF (which are typically notpace terminable).Based on the patient’s needs, you may choose to program Stability as aninhibitor to prevent therapy for AF, or use stability analysis to direct the type oftherapy to be delivered (Shock if Unstable).The stability algorithm calculates RV R–R interval differences. Thesedifferences are calculated throughout Duration; an average difference is alsocalculated. When Duration expires, rhythm stability is evaluated by comparingthe current average difference to the programmed Stability threshold and/orShock If Unstable thresholds. If the average difference is greater than theprogrammed thresholds, the rhythm is declared unstable. Independentthresholds are available for the Stability (to inhibit) or Shock If Unstablefunctions; you cannot program both in the same ventricular zone.The pulse generator performs stability calculations for all episodes (even whenStability is programmed to Off) and stores the results in therapy history. Thisstored data may be used to select an appropriate stability threshold.- DRAFT -

3-32 TACHYARRHYTHMIA DETECTIONVENTRICULAR DETECTIONStability to InhibitThe Stability parameter may help you identify rapid rhythms originating in theatrium, such as AF. These rhythms may result in unstable ventricular rhythmswhose rate exceeds the lowest rate threshold and should not be treated. If arhythm is declared stable when Duration expires, programmed therapy willbe delivered. If the rhythm is declared unstable, ventricular therapy will beinhibited.At the end of initial Duration, if a tachycardia is declared unstable andventricular therapy is inhibited, the pulse generator continues to evaluate forstability on each new detected interval (Figure 3-19 on page 3-32). Therapy willnot be inhibited by Stability if:• V Rate > A Rate declares the ventricular rate greater than the atrial rate• The SRD has expired (if programmed to On)Ventricular therapy is not always initiated when no longer inhibited byStability. Therapy may continue to be inhibited by other programmeddetection enhancements, such as Onset (when the Onset/Stability detectionenhancement suite is enabled) or Vector Timing and Correlation (when theRhythm ID detection enhancement suite is enabled).NOTE: Ventricular Therapy can also be inhibited through analysis of theStability algorithm as it is used with the AFib Rate Threshold enhancement.Unstable intervals Detection window satisfied. Start Duration. Stability analysis begins. Duration expires. Rhythm declared unstable. Start SRD. Therapy inhibited until rhythm stabilizes, V is greater than A, or SRD times out. Stability analysis continues Figure 3-19. Stability evaluation when Duration expires- DRAFT -

TACHYARRHYTHMIA DETECTIONVENTRICULAR DETECTION 3-33Shock if UnstableWhen programmed to Shock if Unstable, the stability analysis helps determineif ventricular ATP therapy should be bypassed in preference for the ﬁrstprogrammed ventricular shock therapy (which may be low- or high-energy) forthe ventricular zone (Figure 3-20 on page 3-33).Dynamic ventricular arrhythmias such as polymorphic VT or VF may be sensedat a rate lower than the highest ventricular rate threshold and can be classiﬁedas unstable. Since the sensed rhythm may be detected in a lower ventricularzone in which ATP may be programmed, the stability analysis may be usedto skip over the programmed ventricular ATP therapies and instead provideshocks to the patient. Stability is evaluated on each detection/redetection cycle,including evaluation between bursts of an ATP scheme. Once a ventricularshock has been delivered in an episode, the Shock If Unstable function nolonger affects therapy selection.Shock If Unstable may be used only in the VT zone of a 2- or 3-zoneconﬁguration. You cannot program it in a 2-zone conﬁguration if Stability orOnset is already programmed to On, or if Post V-Shock Stability or AFib RateThresholdisprogrammedtoOn.Detection window satisfied. Start Duration. Stability analysis begins. Duration expires. Rhythm declared stable. Deliver programmed ATP therapy. Start Redetection. Detection window satisfied. Start Redetection Duration. Reanalyze Stability. Redetection Duration expires. Rhythm declared unstable. Skip remaining ATP and proceed to the first programmed shock therapy. Charging Shock ATP Burst Figure 3-20. Shock if UnstableOnsetOnset differentiates physiologic sinus tachycardias, which typically beginslowly, from pathologic tachycardias, which typically begin abruptly. It measuresthe rate of transition in the ventricular rhythm from slow rates to tachycardia. Ifthe rate increase is gradual, it enables the device to inhibit ventricular therapyin the lowest tachycardia rate zone.- DRAFT -

3-34 TACHYARRHYTHMIA DETECTIONVENTRICULAR DETECTIONWhen a detection window becomes satisﬁed, the pulse generator beginscalculating for sudden Onset in a two-stage sequence.• Stage 1 measures the ventricular intervals prior to the start of the episodeand locates the pair of adjacent intervals (pivot point) where the cyclelength decreased the most. If the decrease in cycle length is equal to orgreater than the programmed Onset value, stage 1 declares sudden Onset.• Stage 2 then compares additional intervals. If the difference between theaverage interval before the pivot point and 3 out of the ﬁrst 4 intervalsfollowing the pivot point is equal to or greater than the programmed OnsetThreshold, stage 2 declares sudden Onset.If both stages declare the rhythm sudden, therapy will be initiated. If eitherstage indicates a gradual onset, initial ventricular therapy will be inhibited in thelowest zone. Therapy will not be inhibited by Onset if:• The rate accelerates to a higher ventricular zone• Information from the atrial lead determines that the RV rate is faster thantheatrialrate(VRate>ARateprogrammedtoOn)• The SRD timer expiresOnset is measured using RV intervals only. It can be programmed as apercentage of cycle length or as an interval length (in ms). It is limited to thelowest therapy zone of a multi-zone conﬁguration. The selected Onset valuerepresents the minimum difference that must exist between intervals that areabove and below the lowest programmed rate threshold. The pulse generatorperforms Onset calculations (even when the feature is programmed to Off) forall episodes except induced or commanded episodes. The measured Onsetresults from a two-stage calculation are stored in therapy history. This storeddata may be used to program an appropriate Onset value.Sustained Rate Duration (SRD)Sustained Rate Duration allows delivery of the programmed ventricular therapywhen a tachycardia is sustained for a programmed period beyond Duration, butthe programmed therapy inhibitors (Vector Timing and Correlation, AFib RateThreshold, Onset, and/or Stability) indicate to withhold therapy (Figure 3-21 onpage 3-35).- DRAFT -

TACHYARRHYTHMIA DETECTIONVENTRICULAR DETECTION 3-350 s 5 s 35 s0 s 30 sDuration = 5 secondsSRD = 30 secondsEvaluate programmed detection enhancements. If enhancements indicate to inhibit therapy, start SRD timer; otherwise, deliver therapy.Continue detection enhancement analysis throughout SRD time.If detection enhancements indicate therapy, deliver therapy.SRD times out. Deliver therapy.Detection window satisfiedDuration starts. Start detection enhancement analysis.Duration expires.Figure 3-21. Combination of Onset OR Stability, SRD programmed onSRD is available in a zone only when an inhibitor enhancement is programmedon in that zone. When the Rhythm ID detection enhancement suite is enabled,SRD may be programmed separately for the VT and VT-1 zones.• If an inhibitor is withholding ventricular therapy delivery and the Ratecriterion in the lowest zone is maintained, the programmed SRD timerbegins at the end of the ﬁrst zone’s completed Duration.• If the detection window in the lowest zone is maintained for the programmedSRD period, the programmed ventricular therapy will be delivered at theend of the VT-1 SRD period if VT-1 SRD is programmed and the rhythmis in the VT-1 zone. Therapy will be delivered at the end of the VT SRDperiod if VT SRD is programmed and the rhythm is in the VT zone.• If the rate accelerates to a higher ventricular zone, detection enhancementsare not programmed to On in the higher zone, and the Duration for thehigher zone expires, therapy is initiated in that zone without waiting forSRD time-out in a lower ventricular zone. If SRD is programmed to Off,an SRD timer will not start when Duration expires, thus allowing detectionenhancements to potentially inhibit therapy indeﬁnitely.An independent Post-Shock SRD value may be programmed.Combinations of AFib Rate Threshold, Stability, and Vector Timing andCorrelationThe combination of AFib Rate Threshold, Stability, and Vector Timing andCorrelation add speciﬁcity to ventricular detection beyond rate and duration.In addition to using AFib Rate Threshold and Stability to identify AF, thiscombination of enhancements uses Vector Timing and Correlation analysisto differentiate SVT rhythms from VT rhythms based on conduction patternswithin the heart.- DRAFT -

3-36 TACHYARRHYTHMIA DETECTIONVENTRICULAR DETECTIONThe AFib Rate Threshold, Stability, and Vector Timing and Correlation detectionenhancement combination also includes V Rate > A Rate; both AFib RateThreshold and V Rate > A Rate are enabled when Atrial TachyarrhythmiaDiscrimination is programmed to On. This combination is only available whenthe Rhythm ID detection enhancement suite is enabled, and only for InitialDetection(Table3-11onpage3-36).If V Rate > A Rate is programmed to On (by programming AtrialTachyarrhythmia Discrimination to On) and is True, it will take precedence overall inhibitor enhancements.Table 3-11. AFib Rate Threshold, Stability, and Vector Timing and Correlation combinations and resultingtherapy decision if Atrial Tachyarrhythmia Discrimination is programmed to OnDetected Ventricular Rhythmabc Therapy DecisiondCorrelated, Unstable, A > AFib Rate Threshold InhibitCorrelated, Unstable, A < AFib Rate Threshold InhibitUncorrelated, Unstable, A > AFib Rate Threshold InhibitUncorrelated, Unstable, A < AFib Rate Threshold TreatCorrelated, Stable, A > AFib Rate Threshold InhibitCorrelated, Stable, A < AFib Rate Threshold InhibitUncorrelated, Stable, A > AFib Rate Threshold TreatUncorrelated, Stable, A < AFib Rate Threshold Treata. If the detected ventricular rhythm changes, then the appropriate, corresponding row in the table is evaluated.b. If a Rhythm ID reference template is not available, the detected ventricular rhythm is considered to be Uncorrelated.c. For post shock detection (if enabled), Vector Timing and Correlation is considered to be Uncorrelated.d. Decisions to inhibit can be overridden by V > A or expiration of SRD.When Atrial Tachyarrhythmia Discrimination is programmed to Off, then VectorTiming and Correlation is used for Initial Detection and Stability is used forPost-shock detection. V Rate > A Rate and AFib Rate Threshold are no longerused (Table 3-12 on page 3-36).Table 3-12. Vector Timing and Correlation and Stability combinations with resulting therapy decision if AtrialTachyarrythmia Discrimination is programmed to OffDetectionab Dectected VentricularRhythmacTherapy DecisionInitial Correlated InhibitdInitial Uncorrelated Treat- DRAFT -

TACHYARRHYTHMIA DETECTIONVENTRICULAR DETECTION 3-37Table 3-12. Vector Timing and Correlation and Stability combinations with resulting therapy decision if AtrialTachyarrythmia Discrimination is programmed to Off (continued)Detectionab Dectected VentricularRhythmacTherapy DecisionPost-shock Unstable InhibitdPost-shock Stable Treata. If the detected ventricular rhythm changes, then the appropriate, corresponding row in the table is evaluated.b. If Atrial Tachyarrhythmia Discrimination is programmed to Off, then Vector Timing and Correlation is used for Initial Detection,and Stability is used for Postshock Detection.c. If a Rhythm ID reference template is not available, the detected ventricular rhythm is considered to be Uncorrelated.d. Decision to inhibit can be overridden by expiration of SRD.Combinations of AFib Rate Threshold, Stability, and OnsetThe combination of AFib Rate Threshold, Stability, and Onset add speciﬁcityto ventricular detection beyond rate and duration. This combination ofdetection enhancements is available only when the Onset/Stability detectionenhancement suite is enabled and is available only for Initial Detection. Whendetection enhancements are enabled, they will act to recommend or inhibittherapy for a speciﬁc zone.If AFib Rate Threshold, Stability, and Onset parameters are all programmedto On, ventricular therapy will be initiated if the rhythm has a sudden onsetprovided that either the ventricular rate is stable or the atrial rate is less thanthe AFib Rate Threshold (Table 3-13 on page 3-37).Table 3-13. AFib Rate Threshold, Stability, and Onset combinations and resulting ventricular therapyDetected Ventricular RhythmaTherapy DecisionbGradual, Unstable, A > AFib RateThresholdInhibitGradual, Unstable, A < AFib RateThresholdInhibitSudden, Unstable, A > AFib RateThresholdInhibitSudden, Unstable, A < AFib RateThresholdTreatcGradual, Stable, A > AFib Rate Threshold TreatGradual, Stable, A < AFib Rate Threshold InhibitSudden, Stable, A > A Fib Rate Threshold TreatSudden, Stable, A < AFib Rate Threshold Treata. If the detected ventricular rhythm changes, then the appropriate, corresponding row in the table is evaluated.b. Decisions to inhibit can be overridden by V > A or expiration of SRD.c. If V Rate > A Rate is programmed to On and is False, ventricular therapy will be inhibited because the rhythm is unstable.- DRAFT -

3-38 TACHYARRHYTHMIA DETECTIONVENTRICULAR DETECTIONIf V Rate > A Rate is programmed to On and is True, it will take precedenceover all inhibitor enhancements.Combinations of Onset and StabilityWhen Stability is programmed to inhibit, it may be combined with Onset toprovide even greater speciﬁcity in classifying arrhythmias.This combination of detection enhancements is available only when theOnset/Stability detection enhancement suite is enabled and is available only forInitial Detection. The enhancements can be programmed to initiate ventriculartherapy if the following options are selected (Table 3-14 on page 3-38):• Both Onset And Stability indicate to treat• Either Onset Or Stability indicates to treatBased on these programming decisions, ventricular therapy is inhibited whenany of the following criteria is met:• If the combination programmed is Onset And Stability, ventricular therapyis inhibited if either parameter indicates that therapy should be withheld;that is, the rhythm is gradual Or unstable (the And condition to treat isnot satisﬁed).• If the combination programmed is Onset Or Stability, ventricular therapy isinhibited immediately at the end of Duration only if both parameters indicatethat therapy should be withheld; that is, the rhythm is gradual and unstable(the Or condition to treat is not satisﬁed).In either case, ventricular therapy will be initiated only if the And/Or conditionsto treat are satisﬁed. When these two combinations (And/Or) are used inconjunction with SRD, and the And/Or conditions are not satisﬁed, ventriculartherapy will be inhibited until V Rate > A Rate is True or SRD times out(Table 3-14 on page 3-38).Table 3-14. Combinations of Onset And Stability and resulting therapyDetectionRhythmOnset And Stability Combinationab Onset Or Stability CombinationcGradual, unstable Inhibit InhibitGradual, stable Inhibit Treat- DRAFT -

TACHYARRHYTHMIA DETECTIONVENTRICULAR DETECTION 3-39Table 3-14. Combinations of Onset And Stability and resulting therapy (continued)DetectionRhythmOnset And Stability Combinationab Onset Or Stability CombinationcSudden, unstable Inhibit TreatSudden, stable Treat Treata. If the detected ventricular rhythm changes, then the appropriate, corresponding row in the table is evaluated.b. The And combination is the nominal setting when both are enabled.c. Decisions to inhibit can be overridden by V > A or expiration of SRD.- DRAFT -

3-40 TACHYARRHYTHMIA DETECTIONVENTRICULAR DETECTION- DRAFT -

4-1TACHYARRHYTHMIA THERAPYCHAPTER 4This chapter contains the following topics:• "Ventricular Therapy" on page 4-2• "Antitachycardia Pacing Therapies and Parameters" on page 4-10• "Ventricular Shock Therapy and Parameters" on page 4-21- DRAFT -

4-2 TACHYARRHYTHMIA THERAPYVENTRICULAR THERAPYVENTRICULAR THERAPYThe pulse generator can deliver the following types of therapy to terminateVT or VF:• Antitachycardia pacing (ATP)• Cardioversion/deﬁbrillation shocksATP pacing schemes are bursts of pacing pulses delivered between theventricular pace/sense electrodes. Shocks are high-voltage biphasic pulsesdelivered through the shocking electrodes synchronously with detected heartactivity.Ventricular Therapy PrescriptionA ventricular therapy prescription determines the type of therapy to bedelivered in a particular ventricular rate zone. It consists of ventricular ATPand/or shocks. Each ventricular zone may be programmed with independentventricular therapy prescriptions (Figure 4-1 on page 4-2).Lowest strength Highest strength Within each zone, therapy strength must be in ascending order. Zone ATP12 ATP22 QUICK CONVERT ATP Shock 11 Shock 21 Remaining (Maximum) Shocks1 VF VT VT-1 Not available All ATP types available On/Off N/A N/A 0.1-max J 0.1-max J 0.1-max J 0.1-max J 0.1-max J 0.1-max J max J max J max JAll ATP types available All ATP types available All ATP types available Between zones, therapy strengths are not restricted. 1 In the lowest zone of a multi-zone configuration, some or all of the shocks may be programmed to Off, starting with the maximum shocks first. If the maximum shocks are programmed to Off, then Shock 2 can be programmed to Off. If Shock 2 is programmed to Off, then Shock 1 can be programmed to Off. If the arrhythmia persists in the lowest zone when some or all of the shocks are programmed to Off, no further therapy will be delivered unless the arrhythmia accelerates to a higher zone. A Disable Therapy button is available in the VT or VT-1 zones’ therapy window to quickly disable all ATP and Shock therapy in that zone.2 Ventricular ATP therapy can be programmed as Off, Burst, Ramp, Scan, or Ramp/Scan in VT-1 and VT zones.Figure 4-1. Ventricular therapy prescription, 3-zone conﬁgurationThe therapies within a ventricular zone must be ordered in ascending therapystrengths. All ventricular ATP therapies are considered to be of equal strength,but are of lower strength than any shock therapy. The strength of theshock therapies is determined by the programmed energy. In a multi-zoneconﬁguration, therapies in a higher ventricular zone may be of lesser, greater,or equal strength to those in a lower ventricular zone; however, within eachzone the therapies must be programmed in equal or increasing energy output.- DRAFT -

TACHYARRHYTHMIA THERAPYVENTRICULAR THERAPY 4-3Ventricular Therapy SelectionThe pulse generator determines which ventricular therapy to deliver basedon the following rules:• Each successive therapy delivery must be greater than or equal to thestrength of the previous therapy in a ventricular episode. Whenever aventricular shock therapy has been delivered, no further ventricular ATPtherapy is allowed in that episode since ATP therapy is of lower strengththan shock therapy. Each subsequent ventricular shock delivery must be ofequal or greater strength regardless of ventricular zone changes during aventricular episode.• Each ventricular ATP scheme (which may consist of multiple bursts) canonly be delivered once during a ventricular episode.• Up to 8 shocks may be delivered in a ventricular episode. The ﬁrst 2 shocksare programmable. The following maximum-energy, non-programmableshocks are available in each zone:– VT-1 zone: 3 maximum-energy shocks– VT zone: 4 maximum-energy shocks– VF zone: 6 maximum-energy shocksNOTE: In the event a shock is diverted with the DIVERT THERAPYprogrammer command, by magnet application or due to a Diverted-Reconﬁrm,the diverted shock is not counted as one of the available shocks for thattachyarrhythmia episode. Also, commanded therapies and STAT SHOCK arenot counted as one of the available shocks for an episode and do not affectsubsequent therapy selection.Based on initial ventricular detection criteria, the pulse generator selects theﬁrst prescribed therapy in the ventricular zone in which the tachyarrhythmiais detected (i.e., detection is met; see "Ventricular Detection" on page 3-6).After delivering the selected therapy, the pulse generator begins redetection todetermine whether the arrhythmia has been converted.• If the arrhythmia is converted to a rate below the lowest programmedthreshold, the pulse generator continues monitoring until the end of theepisode is declared. When the episode ends, the pulse generator will againuse initial ventricular detection criteria for a new episode. When a newepisode is declared, the ﬁrst prescribed therapy will be delivered again.- DRAFT -

4-4 TACHYARRHYTHMIA THERAPYVENTRICULAR THERAPY• If the arrhythmia is not converted and an arrhythmia is redetected inthe same ventricular zone, the next programmed therapy in that zoneis selected and delivered (Figure 4-2 on page 4-4), followed again byredetection. If the arrhythmia persists in the same zone, the therapy willprogress in that zone.• If an arrhythmia crosses ventricular zones (accelerates or decelerates)following therapy delivery and is redetected in a higher or lower ventricularzone, a therapy of equal or greater strength than the previously deliveredtherapy is selected from the detected zone and delivered (Figure 4-3 onpage 4-5 through Figure 4-10 on page 4-8). For shock therapy, the pulsegenerator determines which shock to deliver prior to capacitor chargingbased on the detected rate threshold. If during capacitor charging, thetachyarrhythmia accelerates or decelerates from the initial detected rate,the predetermined energy will still be delivered.Redetection is performed after each therapy delivery to determine if furthertherapy is required.1 3 2 4 5 6 7 Zone ATP1 ATP2 QUICK CONVERT ATP Shock 1 Shock 2 Remaining Shocks VF VT VT-1 On/Off N/A N/A 5 J 3 J 0.1 J 11 J 9 J 2 J Burst Scan Ramp Burst max max max max max max max max max max max max max Figure 4-2. Therapy delivery progression, arrhythmia remains in same zone as initially detectedAfter each redetection cycle, therapy delivery progresses in the directionindicated by the circled numbers (Figure 4-3 on page 4-5 through Figure 4-10on page 4-8).• Upward sloping lines indicate acceleration of the arrhythmia to a higherventricular zone• Downward sloping lines indicate deceleration into a lower ventricular zoneThe lowest strength therapy is in the ATP columns; the therapy strengthsincrease as you move to the right in the table.- DRAFT -

TACHYARRHYTHMIA THERAPYVENTRICULAR THERAPY 4-5NOTE: In the VT-1 zone of a 3-zone conﬁguration or the VT zone of a2-zone conﬁguration, one or two ATP schemes may be programmed as theonly therapy, with all shocks in the lowest zone programmed to Off. If thosepacing schemes do not terminate an arrhythmia detected in the VT-1 zone, nofurther therapy will be delivered in the episode unless the rate is redetectedin a higher zone.1 3 6 7 8 9 4 5 2 Zone ATP1 ATP2 QUICK CONVERT ATP Shock 1 Shock 2 Remaining Shocks VF VT VT-1 On/Off N/A N/A 2 J 3 J 0.1 J 11 J 9 J 2 J Burst Off Ramp Burst max max max max max max max max max max max max max When the rhythm accelerates to the VF zone, Shock 2 in the VF zone is delivered since Shock 1 is a lower energy level than Shock 1 in the VT zone. ATP1 in the VT zone is delivered because it is considered of equal strength to VT-1 ATP2 therapy. Figure 4-3. Therapy delivery progression, ATP1 in the VT zone and shock 2 in the VF zone3 1 8 9 5 4 2 6 7 Zone ATP1 ATP2 QUICK CONVERT ATP Shock 1 Shock 2 Remaining Shocks VF VT VT-1 On/Off N/A N/A 11 J 5 J 3 J 17 J 9 J 5 J Burst Scan Ramp Burst max max max max max max max max max max max max max When the rhythm accelerates back to the VT zone, ATP2 therapy is delivered because ATP1 has already been used during the episode. Figure 4-4. Therapy delivery progression, ATP2 therapy- DRAFT -

4-6 TACHYARRHYTHMIA THERAPYVENTRICULAR THERAPY3 5 2 1 4 6 8 9 7 Zone ATP1 ATP2 QUICK CONVERT ATP Shock 1 Shock 2 Remaining Shocks VF VT VT-1 On/Off N/A N/A 5 J 1.1 J 3 J 11 J 9 J 5 J Burst Scan Ramp Burst max max max max max max max max max max max max max This is the third shock, since two programmable shocks have been delivered. When the rhythm decelerates to the VT-1 zone, ATP2 of the VT-1 zone is not delivered since a shock had already been delivered in the VT zone. So the next higher strength therapy (Shock 1 of the VT-1 zone) is delivered. Figure 4-5. Therapy delivery progression, shock 1 in the VT-1 zone3 2 1 4 Zone ATP1 ATP2 QUICK CONVERT ATP Shock 1 Shock 2 Remaining Shocks VF VT VT-1 On/Off N/A N/A 2 J 3 J 0.1 J 11 J 9 J 2 J Burst Scan Ramp Burst max max max max max max max max max max Off Off Off If the arrhythmia persists in the VT-1 zone after the second shock delivery, no further shock therapy will be delivered unless the arrhythmia accelerates to a higher zone since Shocks 3-5 are programmed Off in the VT-1 zone. Figure 4-6. Therapy delivery progression, shocks 3 to 5 programmed to Off in the VT-1 zone- DRAFT -

TACHYARRHYTHMIA THERAPYVENTRICULAR THERAPY 4-75 6 7 3 2 1 4 10 8 9 The arrhythmia accelerated back to the VF zone, the seventh shock is delivered. The arrhythmia persists in the VF zone so the eighth (and final) shock is delivered. A sixth shock is delivered since the arrhythmia is in the VF zone. The arrhythmia decelerated to a lower zone, an additional shock would not be delivered until the arrhythmia accelerated back to the VF zone. Zone ATP1 ATP2 QUICK CONVERT ATP Shock 1 Shock 2 Remaining Shocks VF VT VT-1 On/Off N/A N/A 2 J 3 J 0.1 J 11 J 9 J 2 J Burst Off Ramp Burst max max max max max max max max max max max max max Figure 4-7. Therapy delivery progression, sixth shock delivered1 3 2 Zone ATP1 ATP2 If reconfirmation indicates the arrhythmia persists after delivery of QUICK CONVERT ATP, the device immediately begins charging for Shock 1. QUICK CONVERT ATP Shock 1 Shock 2 Remaining Shocks VF VT VT-1 On N/A N/A 11 J 3 J 0.1 J 21 J 9 J 2 J Burst Scan Ramp Burst max max max max max max max max max max max max max Figure 4-8. Therapy delivery progression, QUICK CONVERT ATP and shock in the VF zone- DRAFT -

4-8 TACHYARRHYTHMIA THERAPYVENTRICULAR THERAPY2 1 4 5 3 Zone ATP1 ATP2 QUICK CONVERT ATP Shock 1 Shock 2 Remaining Shocks VF VT VT-1 On N/A N/A 2 J 3 J 0.1 J 11 J 9 J 2 J Burst Scan Ramp Burst max max max max max max max max max max max max max ATP1 in the VT zone is delivered because it is considered of equal strength to QUICK CONVERT ATP therapy. Figure 4-9. Therapy delivery progression, QUICK CONVERT ATP decelerates the rhythm, ATP1 and shockdelivered in the VT zone1 2 3 Zone ATP1 ATP2 QUICK CONVERT ATP Shock 1 Shock 2 Remaining Shocks VF VT VT-1 On N/A N/A 11 J 3 J 0.1 J 21 J 9 J 2 J Burst Scan Ramp Burst max max max max max max max max max max max max max When the rhythm accelerates to the VF zone, Shock 1 is delivered because QUICK CONVERT ATP is only available as the first therapy in an episode. Figure 4-10. Therapy delivery progression, ATP1 in VT zone accelerates the rhythm, QUICK CONVERT ATPisskippedinVFzoneVentricular Redetection after Ventricular Therapy DeliveryAfter ventricular therapy delivery, the pulse generator uses redetection criteriato evaluate the rhythm and determine whether more therapy is appropriate.When redetection criteria are satisﬁed, the rules for therapy selection thendetermine the type of therapy to deliver.Ventricular Redetection after Ventricular ATP TherapyVentricular Redetection after ventricular ATP therapy determines if anarrhythmia has been terminated.As a ventricular ATP scheme is delivered, the pulse generator monitors thecardiac rate after each burst and uses ventricular detection windows (looking- DRAFT -

TACHYARRHYTHMIA THERAPYVENTRICULAR THERAPY 4-9for 8 of 10 fast intervals) and the Ventricular Redetection Duration to determineifthearrhythmiahasterminated.The ATP scheme will continue with the next bursts in the sequence until anyone of the following conditions is satisﬁed:• Redetection declares that the therapy has been successful (end-of-episode)•Thespeciﬁed number of ATP bursts in the scheme has been delivered• The ATP Time-out for the ventricular zone has expired• The detected ventricular arrhythmia rate changes to a different ventricularrate zone, whereby a different therapy is selected• Shock If Unstable forces the device to skip the remaining ATP therapyand initiate shock therapy• A DIVERT THERAPY command is received from the PRM during deliveryof a burst of a scheme• A magnet abort occurs during delivery of a scheme• The temporary Tachy Mode has changed• A commanded therapy is requested• The episode ends due to reprogrammed Tachy Mode, reprogrammedventricular tachy parameters, or attempted induction method or lead testNOTE: Aborting an ATP burst terminates the affected ATP scheme. If furthertherapy is required, the next programmed therapy (either ATP or shocks) inthe prescription is initiated.Ventricular Redetection after Ventricular Shock TherapyVentricular redetection after ventricular shock therapy determines if anarrhythmia has been terminated.As shock therapy is delivered, the pulse generator monitors the cardiac rateafter each shock and uses ventricular detection windows (looking for 8 of10 fast intervals) and post-shock detection enhancements, if applicable, to- DRAFT -

4-10 TACHYARRHYTHMIA THERAPYANTITACHYCARDIA PACING THERAPIES AND PARAMETERSdetermine if the arrhythmia has been terminated. Shock therapy will continueuntil one of the following conditions is satisﬁed:• Redetection declares the therapy has been successful (end-of-episode)• All available ventricular shocks have been delivered for an episode• The rhythm is redetected in either the VT or VT-1 zone, the availablenumber of programmed shock(s) in those zones has been delivered andthe arrhythmia stays in one of these lower zonesIf all available shocks have been delivered for an episode, no further therapyis available until the pulse generator monitors a rate below the lowest ratethreshold for 30 seconds and end-of-episode is declared.ANTITACHYCARDIA PACING THERAPIES AND PARAMETERSAntitachycardia Pacing (ATP) therapy and parameters enable the pulsegenerator to interrupt the following fast rhythms by delivering a series ofcritically timed pacing pulses:• Monomorphic ventricular tachycardia• Supraventricular tachycardiasATP Therapy is delivered when the last sensed event fulﬁlls the programmeddetection criteria (Figure 4-11 on page 4-11).An ATP scheme may be customized with the following parameters:• Number of bursts delivered• Number of pulses within each burst• Coupling Interval• Burst Cycle Length• Minimum pacing intervalThese parameters can be programmed to produce the following ATP therapyschemes:•Burst•Ramp•Scan- DRAFT -

TACHYARRHYTHMIA THERAPYANTITACHYCARDIA PACING THERAPIES AND PARAMETERS 4-11• Ramp/ScanThe ATP amplitude and pulse width are common to all schemes. They areindependently programmable from the normal pacing settings. The ATPamplitude and pulse width share the same programmable value as thepost-therapy pacing settings.Coupling IntervalCoupling IntervalBurst Cycle LengthBurst 1 Burst 2ATP SchemeRedetectionATP Pace PulseBurst Cycle LengthFigure 4-11. ATP therapy basic parameters are Coupling Interval, Burst Cycle Length, Number of Bursts,and Number of Pulses within each burst.Burst ParametersA burst is a series of critically timed pacing pulses delivered by the pulsegenerator during ATP therapy. By programming burst parameters, you canoptimize ATP therapy for the patient.All ATP schemes have several parameters in common. In addition toprogramming the type of scheme (Off, Burst, Ramp, Scan, Ramp/Scan), thefollowing burst parameters are programmable (Figure 4-12 on page 4-12):• The Number of Bursts parameter determines the number of bursts usedin an ATP scheme and may be programmed independently for each ATPscheme. Programming the parameter to Off will deactivate the ATPscheme.• The Initial Pulse Count parameter determines the number of pulsesdelivered in the ﬁrst burst of a scheme.• The Pulse Increment parameter determines the number of pulses per burstto be increased for each successive burst in the scheme.- DRAFT -

4-12 TACHYARRHYTHMIA THERAPYANTITACHYCARDIA PACING THERAPIES AND PARAMETERS• The Maximum Number of Pulses parameter determines the greatestnumber of pulses used in an ATP burst and may be programmedindependently for each ATP scheme. After the maximum number of pulsesis reached in a burst, each additional burst remaining in the schemecontains the programmed Maximum Number of Pulses. The parameter isavailable only if the Pulse Increment is greater than zero.Coupling IntervalRedetect Redetect RedetectDetection SatisfiedBurst 1; Initial pulse count at 3Burst 2; Pulse count incremented by 1Burst 3; Pulse count incremented by 1; Maximum Number of Pulses reachedBurst 4; (programmed number); Pulse count remaining at Maximum Number of Pulses (5)Number of Bursts = 4Initial Pulse Count = 3Pulse Increment = 1Maximum Number of Pulses = 5Figure 4-12. Interaction of Maximum Number of Pulses and Number of BurstsCoupling Interval and Coupling Interval DecrementThe Coupling Interval controls the timing of the ﬁrstpulseinaburst.Itdeﬁnesthetimebetweenthelastsensedeventthatfulﬁlls the detection criteria anddelivery of the ﬁrst pulse in a burst.The Coupling Interval is programmed independent from the Burst Cycle Length.This allows aggressive ramps and scans to be used without compromisingcapture of the ﬁrst pacing pulse in a burst. The Coupling Interval can beprogrammed as any of the following:• Adaptive, with timing speciﬁed as percentages of the computed averageheart rate•Aﬁxed interval, with timing speciﬁed in absolute time (ms) independent ofthe measured average rateWhen programmed as adaptive, the Coupling Interval adjusts to the patient’srhythmbasedonafour-cycleaverage(Figure4-13onpage4-13). TheCoupling Interval Decrement may be programmed such that the Coupling- DRAFT -

TACHYARRHYTHMIA THERAPYANTITACHYCARDIA PACING THERAPIES AND PARAMETERS 4-13Interval decreases from one burst to the next within a multiple-burst scheme(Figure4-14onpage4-13).NOTE: You cannot program an ATP burst that lasts longer than 15 seconds.The length of an adaptive burst is calculated based on the interval of theventricular zone in which the ATP is programmed, which means it is basedon worst-case timing.Coupling Interval = 382 ms4-Cycle Average = 420 ms400 ms410 ms420 ms450 msCoupling Interval (C.I.) = 91%First C.I. is 420 x 91% = 382 msSecond C.I. is 400 x 91% = 364 msThe 4-cycle average is calculated on the four cycles prior to each tachycardia therapy delivery only when no Decrement (Coupling Interval or Scan) is programmed.Coupling Interval = 364 ms4-Cycle Average = 400 msFigure 4-13. Adaptive Coupling Interval, Coupling Interval Decrement and Scan Decrement programmed to 0Coupling Interval = 91%C.I. Decrement = 10 ms4-Cycle Average = 420 msCoupling Interval = 382 ms Coupling Interval Decrement(4-cycle average is not recalculated)Coupling Interval = 372 msPaced PulsesLast sensed R-wave that fulfills redetectionRedetection satisfiedPaced PulsesLast sensed R-wave that fulfills detectionDetection satisfied400 ms410 ms420 ms450 msFigure 4-14. Coupling Interval DecrementThe following information should be taken into consideration when programmingthe Coupling Interval and Coupling Interval Decrement:• When the Coupling Interval Decrement is programmed to On, theprogrammedATPschemeiscalledaScan- DRAFT -

4-14 TACHYARRHYTHMIA THERAPYANTITACHYCARDIA PACING THERAPIES AND PARAMETERS• When the Coupling Interval is programmed as adaptive, the CouplingInterval will not re-adapt following redetection when the following areprogrammed to On (greater than zero):– Coupling Interval Decrement––the decrement value determines thetiming of the ﬁrst pulse in subsequent bursts– Scan Decrement––the decrement value determines the timing of thesecond pulse in subsequent burstsBurst Cycle Length (BCL)The Burst Cycle Length controls the interval between pacing pulses after theCoupling Interval.This timing is controlled in the same fashion as the Coupling Interval: rateadaptive to the sensed tachycardia or ﬁxedtimespeciﬁed in ms.NOTE: An adaptive BCL is affected in the same manner as an adaptiveCoupling Interval; the average cycle length is not continually recalculated forsubsequent bursts if the Scan Decrement or Coupling Interval Decrement areprogrammed to On.The following parameters may be programmed to decrement the burst cyclelength during an ATP scheme:• Ramp Decrement controls the pulse timing within a given burst• Scan Decrement controls the pulse timing between burstsMinimum IntervalThe Minimum Interval limits the Coupling Interval and the BCL in Burst, Ramp,and Scan.If the Coupling Interval reaches the limit, subsequent Coupling Intervalswill remain at the minimum value. Likewise, if the BCL reaches the limit,subsequent BCLs will remain at the minimum value. The Coupling Interval andBCL may reach the limit independently.- DRAFT -

TACHYARRHYTHMIA THERAPYANTITACHYCARDIA PACING THERAPIES AND PARAMETERS 4-15Burst SchemeA Burst scheme is a sequence of critically timed pacing pulses intended tointerrupt a reentrant loop, usually delivered at a rate faster than the patient’stachycardia.An ATP scheme is deﬁned as a Burst (as indicated on the PRM screen) whenthe timing of all pacing intervals within a burst is the same. The ﬁrst BCL ofeach Burst is determined by the programmed BCL. When the number of pulsesprogrammed in a Burst is greater than one, you can use the BCL to control thetiming between these paced pulses (Figure 4-15 on page 4-15).Coupling Interval400 ms410 ms420 ms450 ms315ms BCL315ms BCL315ms BCL315ms BCLCoupling Interval300ms BCL300ms BCL300ms BCL300ms BCLBurst4-Cycle Average = 400 msBurst4-Cycle Average = 420 msBCL = 75%420 ms x .75 = 315 ms400 ms x .75 = 300 msThe first BCL of each burst is calculated by multiplying the 4-cycle average prior to delivery of the first pacing pulse of the burst by the BCL percentage.Figure 4-15. Adaptive-rate Burst schemeRamp SchemeA Ramp scheme is a burst in which each paced-to-paced interval within theburst is shortened (decremented).To program a Ramp scheme, program (in ms) the Ramp Decrement to specifyhow much the paced-to-paced interval should be shortened, and the ScanDecrement and Coupling Interval Decrement each to 0 ms. As each additionalpaced pulse in a burst is delivered, its interval is shortened by the programmedRamp Decrement until either of the following occur:• The last paced pulse of the burst is delivered• The Minimum Interval is reached- DRAFT -

4-16 TACHYARRHYTHMIA THERAPYANTITACHYCARDIA PACING THERAPIES AND PARAMETERSIf subsequent bursts are required, the programmed Ramp Decrement will beapplied based on the calculated BCL of that subsequent burst (Figure 4-16 onpage 4-16).Burst Cycle Length = 75%Ramp Decrement (R-R Within Burst) = 10 msScan Decrement (R-R Between Bursts) = 0 msC.I. Decrement = 0 msMinimum Interval = 265 ms300 ms290 ms280 ms270 ms4-Cycle Average = 400 msRamp Ramp4-Cycle Average = 380 msReadapt 75%285 ms275 ms265 ms265msMinimum interval reached; subsequent interval is not decremented.RedetectFigure 4-16. Adaptive Ramp Scheme, Coupling Interval Decrement and Scan Decrement programmed to 0Scan SchemeA Scan scheme is a burst in which the BCL of each burst in a scheme issystematically shortened (decremented) between successive bursts.YoucanprogramaScanschemebyprogrammingtheScanDecrementtospecify the BCL decrement to a value greater than 0 ms, while the RampDecrement is programmed to 0 ms. The BCL of subsequent bursts isdetermined by subtracting the Scan Decrement from the BCL of the previousburst (Figure 4-17 on page 4-17).- DRAFT -

TACHYARRHYTHMIA THERAPYANTITACHYCARDIA PACING THERAPIES AND PARAMETERS 4-17Initial BCL is determined and then Scan Decrement is applied on the next burst BCL of previous Burst is determined and then Scan Decrement is applied again on the next burst 300 ms 300 ms 300 ms 300 ms 290 ms 290 ms 290 ms 290 ms 280 ms 280 ms 280 ms 280 ms Burst Cycle Length = 300 ms Scan Decrement = 10 ms Ramp Decrement = 0 ms Coupling Interval Decrement = 0 ms Scan Scan Redetect Redetect Scan Figure 4-17. Scan scheme, nonadaptive BCL and Scan Decrement programmed onRamp/Scan SchemeA Ramp/Scan scheme is a sequence of bursts. Each scheme contains a RampDecrement and a Scan Decrement (Figure 4-18 on page 4-18).- DRAFT -

4-18 TACHYARRHYTHMIA THERAPYANTITACHYCARDIA PACING THERAPIES AND PARAMETERS290 ms270 ms280 ms270 ms*240 ms250 ms260 ms240 ms250 ms220 ms220 ms230 msMinimum interval reached4-Cycle Average = 370 msPARAMETERNumber of BurstsPulses per Burst: Initial Increment MaximumCoupling Interval DecrementBurst Cycle Length Ramp Decrement Scan DecrementMinimum IntervalVALUE341681%0 ms78%10 ms20 ms220 ms* When a Scan Decrement is programmed to On, the Coupling Interval and BCL, if programmed as a percentage, will not re-adapt following redetection.Maximum Number of Pulses reached (6) and Maximum Number of Bursts reached (3)Number of Pulses incremented by 1Ramp Burst Ramp/Scan Burst Ramp/Scan BurstRedetect RedetectC.I. 300 msScan ScanC.I. 300 ms* C.I. 300 ms*Figure 4-18. Ramp/Scan scheme, interaction of ATP parametersTo program a Ramp/Scan scheme, both the Scan Decrement and RampDecrement are programmed to values greater than 0 ms.ATP Pulse Width and ATP AmplitudeThe ATP Pulse Width is the duration of a pacing pulse. The ATP Amplitude isthe leading edge voltage of a pacing pulse.The ATP Pulse Width and ATP Amplitude parameters share the same valueas the post therapy pacing Pulse Width and Amplitude. If the programmablevalue is changed for one parameter, that value will be reﬂected in the otherparameters.TheprogrammedATPPulseWidthandATPAmplitudearesharedforallATPschemes regardless of zone and position in a prescription. The ATP amplitudeand pulse width share the same programmable value as the post-therapypacing settings.- DRAFT -

TACHYARRHYTHMIA THERAPYANTITACHYCARDIA PACING THERAPIES AND PARAMETERS 4-19Ventricular ATP Time-outThe Ventricular ATP Time-out forces the pulse generator to skip over anyremaining ATP therapy in a ventricular zone to begin delivering ventricularshock therapy programmed in the same zone. This parameter is effectiveonly for ventricular therapy delivery.The ATP Time-out may be used in the VT or VT-1 zone as long as ATP therapyis programmed to On. Timer values are independent, although VT-1 ATPTime-out must be equal to or greater than the VT ATP Time-out.The timer starts when the ﬁrst burst is delivered and continues until any of thefollowing occur:• The timer expires (Figure 4-19 on page 4-19)• A ventricular shock is delivered• The ventricular episode endsThe time-out is examined after each redetection sequence to determine iffurther ATP bursts can be delivered. If the time-out has been reached orexceeded, further ATP therapy will not be initiated during that ventricularepisode. The time-out will not terminate a burst in process.Detection window met.Start episode.Start Duration.Start stability analysis.Duration expires.Initiate ATP therapy.Start ATP Time-out.Redetection Duration expires.Initiate shock therapy.ChargeRedetect RedetectATP Time-out expires30 sFigure 4-19. ATP Time-out expirationNOTE: Once a ventricular shock has been delivered during a ventricularepisode, ATP will no longer be invoked, irrespective of the time remainingon the ATP Time-out timer.- DRAFT -

4-20 TACHYARRHYTHMIA THERAPYANTITACHYCARDIA PACING THERAPIES AND PARAMETERSThe timer alone does not invoke therapy; the rate and duration criteria anddetection enhancements must still be satisﬁed in order for a shock therapyto be delivered.If three zones are programmed, you may program ATP Time-out settings ineach of the lower two ventricular zones (Figure 4-20 on page 4-20).0 s 10 s 20 s 30 s 40 sVF ZoneVT ZoneVT-1 ZoneVT Detection window satisfied.Duration starts.Start episode. VT Detection met.Therapy intitiated.Start ATP Time-out.AT Time-out expires in VT zone.VT-1 Time-out expires.VT-1 Detection met.Initiate shock therapy.Programmed therapy for lower zones:VT-1 ATP Time-out = 40 sVT ATP Time-out = 30 sATP is programmed in VT-1 and VT zones.Redetection and ATP burstsATP Time-outATP 1 ATP 1Burst 1 Burst 5RedetectChargingRhythm changes to VT-1 zoneFigure 4-20. ATP Time-outs, 3-zone conﬁgurationQUICK CONVERT ATPQUICK CONVERT ATP provides you with an additional option to treat fast,monomorphic VT that is detected in the VF zone.When QUICK CONVERT ATP is programmed to On, the pulse generatordelivers one burst of ATP for an episode detected in the VF zone in anattempt to avoid an otherwise scheduled charge and painful shock for apace-terminable fast VT.When delivering QUICK CONVERT ATP therapy, the pulse generator deliversone burst of ATP for an episode detected in the VF zone. This therapy consistsof 8 pacing pulses at 88% Coupling Interval and 88% BCL. It is delivered onlyas the ﬁrst therapy attempted in an episode and is followed by reconﬁrmation(2 out of 3 intervals faster than the lowest rate threshold) prior to the shocksequence.- DRAFT -

TACHYARRHYTHMIA THERAPYVENTRICULAR SHOCK THERAPY AND PARAMETERS 4-21In the event that QUICK CONVERT ATP was unsuccessful in converting therhythm and shock therapy is required, the feature’s algorithm minimizes thedelay to begin charging. QUICK CONVERT ATP is not applied to any rhythmabove a maximum rate of 250 bpm.VENTRICULAR SHOCK THERAPY AND PARAMETERSThe pulse generator delivers shocks synchronous to a sensed event. Theshock vector, energy level, and polarity of the shocks are programmable.Ventricular Shock VectorThe programmed Ventricular Shock Vector indicates the vector of energydelivery for ventricular shock therapy.The following programmable conﬁgurations are available:• RV Coil to RA Coil and Can––this vector is also known as the V-TRIADvector. It uses the metallic housing of the pulse generator as an activeelectrode (“hot can”) combined with the ENDOTAK two-electrodedeﬁbrillation lead. Energy is sent via a dual-current pathway from the distalshocking electrode to the proximal electrode and to the pulse generatorcase.• RV Coil to Can––this vector uses the metallic housing of the pulsegenerator as an active electrode (“hot can”). Energy is sent from the distalshocking electrode to the pulse generator case. This conﬁguration shouldbe selected when using a single-coil lead.• RV Coil to RA Coil––this vector removes the pulse generator case asan active electrode and is also known as a “cold can” vector. Energy issent from the distal shocking electrode to the proximal electrode. Thisvector should never be used with a single-coil lead, as a shock will notbe delivered.Ventricular Shock EnergyVentricular shock energy determines the strength of shock therapy deliveredby the pulse generator.Shock output remains constant over the lifetime of the pulse generator,regardless of changes in lead impedance or battery voltage. The constant- DRAFT -

4-22 TACHYARRHYTHMIA THERAPYVENTRICULAR SHOCK THERAPY AND PARAMETERSoutput is accomplished by varying pulse width to adjust to changes in leadimpedance.The ﬁrst two shocks in each ventricular zone can be programmed to optimizecharge time, longevity, and safety margins. The remaining shock energies ineach zone are nonprogrammable at the maximum-energy value.Charge TimeCharge time is the time the pulse generator requires to charge for delivery ofthe programmed shock energy.Charge time is dependent on the following:• Programmed output energy level• Battery condition• Condition of the energy storage capacitorsCharge times increase as the pulse generator is programmed to higher energyoutput levels and as the battery depletes (Table 4-1 on page 4-22).Capacitor deformation can occur during inactive periods and may result in aslightly longer charge time. To reduce the impact of capacitor deformation oncharge time, the capacitors are automatically reformed.Table 4-1. Typical charge time required at 37 degrees C at BOLEnergy Stored (J)aEnergy Delivered(J)bCharge Time(seconds)c11.0 10.0 1.917.0 15.0 2.926.0 22.0 4.741.0d35.0 8.4a. Values indicate the energy level stored on the capacitors and correspond to the value programmed for shock energy parameters.b. The energy delivered indicates the shock energy level delivered through the shocking electrodes.c. Charge times shown are at BOL after capacitor re-formation.d. HE.Waveform PolarityWaveform polarity reﬂects the relationship between the leading edge voltageson the deﬁbrillating output electrodes. All shocks will be delivered using abiphasic waveform (Figure 4-21 on page 4-23).- DRAFT -

TACHYARRHYTHMIA THERAPYVENTRICULAR SHOCK THERAPY AND PARAMETERS 4-23The selection of the shock polarity applies to all shocks delivered by the device.If the preceding shocks in a zone are unsuccessful, the last shock of that zonewill be automatically delivered at an inverted polarity to the previous shock(initial or reversed) (Figure 4-22 on page 4-23).CAUTION: For IS-1/DF-1 leads, never change the shock waveformpolarity by physically switching the lead anodes and cathodes in the pulsegenerator header—use the programmable Polarity feature. Device damageor nonconversion of the arrhythmia post-operatively may result if the polarityis switched physically.BiphasicV1V2PW1 PW2V3V4PW = Pulse WidthPW2 = PW1 x 0.66V2 = V3Figure 4-21. Biphasic waveform+–+–+–Initial polarity Reverse polarityFigure 4-22. Polarity of shock deliveryCommitted Shock/Reconﬁrmation of the Ventricular ArrhythmiaCommitted Shock/Reconﬁrmation refers to the monitoring performed by thepulse generator before delivery of a ventricular shock.- DRAFT -

$4-24 TACHYARRHYTHMIA THERAPYVENTRICULAR SHOCK THERAPY AND PARAMETERSIf the patient is subject to non-sustained arrhythmias, reconﬁrmation may bedesirable in order to prevent delivery of unnecessary shocks to the patient.The device monitors tachyarrhythmias during and immediately followingcapacitor charging. During this time, it checks for the spontaneous conversionof the tachyarrhythmia and determines whether ventricular shock therapyshould be delivered; it does not affect therapy selection.Ventricular shock therapy can be programmed as committed or non-committed.If the Committed Shock feature is programmed to On, the shock is deliveredsynchronously with the ﬁrst sensed R-wave following a 500-ms delay after thecapacitors are charged, whether the arrhythmia is sustained or not (Figure 4-23on page 4-24). The 500-ms delay allows a minimum time for a divert commandto be issued from the PRM, if desired. If there is no sensed R-wave detectedwithin 2 seconds following the end of charging, the ventricular shock isdelivered asynchronously at the end of the 2-second interval.Shock2 3 4 5 6 7 8 9 10 11 121FF FF F F FFF FShock is committed.Synchronize with R-wave and deliver shock.Duration complete. Start charging.Refractory periodDivert windowCharging 500 ms135 msRedetection starts. Detection window satisfied.Post-Shock Duration starts.Number of intervals(F = Fast)Figure 4-23. Committed Shock is programmed to On, Reconﬁrmation is OffNOTE: There is a forced 135-ms refractory period following the end ofcharging; events that occur during the ﬁrst 135 ms of the 500-ms delay areignored.If the Committed Shock feature is programmed to Off, Reconﬁrmation consistsof the following steps:1. During capacitor charging, the pulse generator continues to sense thearrhythmia. Sensed and paced beats are evaluated. If 5 slow beats (sensedor paced) are counted in a 10-beat detection window (or 4 consecutiveslow beats after an unsuccessful QUICK CONVERT ATP attempt), thepulse generator stops charging and considers this a Diverted-Reconﬁrm.- DRAFT -$

$TACHYARRHYTHMIA THERAPYVENTRICULAR SHOCK THERAPY AND PARAMETERS 4-252. If 5 of 10 beats are not detected as slow (or less than 4 consecutive slowbeats after an unsuccessful QUICK CONVERT ATP attempt) and chargingcompletes, post-charge reconﬁrmation is performed after charging ends.After the post-charge refractory and the ﬁrst sensed event, the pulsegenerator measures up to 3 intervals following charging and comparesthem to the lowest rate threshold.• If 2 of the 3 intervals following charging are faster than the lowest ratethreshold, the shock will be delivered synchronously with the secondfast event.• If 2 of the 3 intervals following charging are slower than the lowestrate threshold, the shock will not be delivered. If no beats are sensed,pacing will begin at the programmed LRL following the 2-secondno-sense period. If a shock is not delivered, or if pacing pulses aredelivered, this is also considered a Diverted-Reconﬁrm.If a shock is required after redetection, the charge time for the shock maybe short.The reconﬁrmation algorithm will not allow two consecutive Diverted-Reconﬁrmcycles. If the arrhythmia is detected after a Diverted-Reconﬁrm, the next shockin the episode is delivered as if Committed Shock were programmed to On.Once a shock has been delivered, the reconﬁrmation algorithm can be appliedagain (Figure 4-24 on page 4-25).23 4 56 7 8123 4 51231Intervals are measured and compared to the lowest Rate threshold. If 2 of 3 are slow, the shock will not be delivered. If 2 of 3 are fast, the shock will be delivered.Reconfirmation determines arrhythmia is no longer present. Shock is not delivered. If no beats are sensed, pacing will start.Duration complete. Start charging.Refractory periodDivert windowIntervals are measured during charging.Charging 500 ms135 msFigure 4-24. Committed Shock is programmed to Off, reconﬁrmation is On- DRAFT -$

4-26 TACHYARRHYTHMIA THERAPYVENTRICULAR SHOCK THERAPY AND PARAMETERS- DRAFT -

Boston Scientiﬁc4100 Hamline Avenue NorthSt. Paul, MN 55112–5798 USAwww.bostonscientiﬁc.com1.800.CARDIAC (227.3422)+1.651.582.4000© 2007 Boston ScientiﬁcoritsafﬁliatesAll rights reserved.357389-001 EN US 12/07FCC ID: ESCCRMN11906IC: 4794A-CRMN1196Part 1 of 2*357389-001*- DRAFT -

$5-1PACING THERAPIESCHAPTER 5This chapter contains the following topics:• "Pacing Therapies" on page 5-2• "Basic Parameters" on page 5-2• "Post-Therapy Pacing" on page 5-9• "Temporary Pacing" on page 5-10• "Sensors and Trending" on page 5-11• "Atrial Tachy Response" on page 5-19• "Rate Enhancements" on page 5-26• "Lead Conﬁguration" on page 5-31• "AV Delay" on page 5-32• "Refractory" on page 5-36• "Noise Response" on page 5-41• "Ventricular Tachy Sensing Interactions" on page 5-43- DRAFT -$

5-2 PACING THERAPIESPACING THERAPIESPACING THERAPIESSingle chamber ICDs provide ventricular bipolar (pace/sense) normal andpost-therapy bradycardia pacing, including adaptive-rate modes. Dual chamberICDs provide both atrial and ventricular bipolar (pace/sense) normal andpost-therapy bradycardia pacing, including adaptive-rate modes.The bradycardia pacing function is independent of the tachycardia detectionand therapy functions of the device, with the exception of interval-to-intervalsensing.The pulse generator provides the following types of therapies:Normal Bradycardia Pacing• If the intrinsic heart rate falls below the programmed pacing rate (i.e., LRL),the device delivers pacing pulses at the programmed settings• Sensor-based rate modulation allows the pulse generator to adapt thepacing rate to the patient’s changing activity levelsPost-Therapy Pacing—alternative bradycardia pacing therapy may bedelivered for a programmed period to ensure capture after delivery of a shock.Additional Options•Temporary Bradycardia Pacing––allows the clinician to examinealternate therapies while maintaining the previously programmed Normalpacing settings in the pulse generator memory.•STAT PACE––initiates emergency ventricular pacing at high output settingswhen commanded via the PRM using telemetry communication.BASIC PARAMETERSNormal Settings include the following:• Pacing parameters, which are independently programmable frompost-therapy and temporary pacing parameters• Pacing and Sensing• Leads• Sensors and Trending- DRAFT -

$PACING THERAPIESBASIC PARAMETERS 5-3Post-Therapy Settings include the following:• Pacing parameters, which are independently programmable from normaland temporary pacing parameters• Post-ventricular shockBrady ModeBrady modes provide you with programmable options to help individualizepatient therapy.This pulse generator includes the pacing modes identiﬁed in the ProgrammableOptions appendix.Dual-Chamber ModesDo not use DDD(R) and VDD(R) modes in the following situations:• In patients with chronic refractory atrial tachyarrhythmias (atrial ﬁbrillationor ﬂutter), which may trigger ventricular pacing• In the presence of slow retrograde conduction that induces PMT, whichcannot be controlled by reprogramming selective parameter valuesAtrial Pacing ModesIn DDD(R), DDI(R), and AAI(R) modes, atrial pacing may be ineffective inthe presence of chronic atrial ﬁbrillation or ﬂutter or in an atrium that doesnot respond to electrical stimulation. In addition, the presence of clinicallysigniﬁcant conduction disturbances may contraindicate the use of atrial pacing.WARNING: Do not use atrial tracking modes in patients with chronic refractoryatrial tachyarrhythmias. Tracking of atrial arrhythmias could result in VT or VF.NOTE: If a separate pacemaker is desired, a dedicated bipolar pacemakeris recommended.NOTE: Refer to "Use of Atrial Information" on page 3-5 for additionalinformation about device performance when the atrial lead is programmed toOff.- DRAFT -$

5-4 PACING THERAPIESBASIC PARAMETERSIf you have any questions regarding the individualization of patient therapy,contact your sales representative or call Technical Services at the numbershown on the back cover of this manual.Lower Rate Limit (LRL)LRL is the number of pulses per minute at which the pulse generator paces inthe absence of sensed intrinsic activity.The following interactive limits are effective when programming the LRL.Exercise caution when programming permanent pacing rates below 50 ppm orabove 100 ppm.•LRLmustbelessthan:–MPR–MSR– MTR (dual-chamber)• LRL must be at least 15 ppm less than the lowest tachy zone threshold• The greater of the following values must be at least 10 ppm less than thelowest tachy zone threshold:–MPR–MSR– MTR (dual-chamber)Runaway ProtectionRunaway protection is designed to prevent pacing rate accelerations for mostsingle-component failures. This feature is not programmable and operatesindependently from the pulse generator’s main pacing circuitry.The basic pulse period is equal to the pacing rate and the pulse interval (withouthysteresis). Runaway protection prevents the pacing rate from increasingabove 205 ppm.NOTE: Magnet application does not affect the pacing rate (pulse interval).NOTE: Runaway protection is not an absolute assurance that runaways willnot occur.- DRAFT -

$PACING THERAPIESBASIC PARAMETERS 5-5During PES, Manual Burst pacing, and ATP, runaway protection is temporarilysuspended to allow for high-rate pacing.Maximum Tracking Rate (MTR)TheMTRisthemaximumrateatwhichthepacedventricularratetracks1:1with nonrefractory sensed atrial events. MTR applies to atrial synchronouspacing modes, namely DDD(R) and VDD(R).The following are considerations for programming the MTR:• Interactive limits ("Lower Rate Limit (LRL)" on page 5-4).• When the sensed atrial rate is between the programmed LRL and MTR, 1:1ventricular pacing will occur in the absence of a sensed ventricular eventwithin the programmed AV Delay. If the sensed atrial rate exceeds the MTR,the pulse generator might begin a Wenckebach-like behavior to preventthe paced ventricular rate from exceeding the MTR. This Wenckebach-likebehavior is characterized by a progressive lengthening of the AV delayuntil an occasional P-wave is not tracked because it falls into the PVARP.This results in an occasional loss of 1:1 tracking as the pulse generatorsynchronizes its paced ventricular rate to the next sensed P-wave. Shouldthe sensed atrial rate continue to increase further above the MTR, the ratioof sensed atrial events to sequentially paced ventricular events becomeslower until, eventually, 2:1 block results (e.g., 5:4, 4:3, 3:2, and ﬁnally 2:1).• The PRM will not allow you to program an MTR interval shorter than TARP(AV Delay + PVARP = TARP). If TARP is less than the interval of theprogrammed MTR, then the pulse generator’s Wenckebach-like behaviorlimits the ventricular pacing rate to the MTR. With TARP, the PRM does notconsider the AV Search AV Delay. If AV Search is on, Wenckebach-likebehavior may occur at rates lower than the MTR.• Rapid changes in the paced ventricular rate (e.g., Wenckebach-like, 2:1block) caused by sensed atrial rates above the MTR may be dampened oreliminated by the implementation of any of the following:–AFR–ATR– Rate Smoothing parameters and sensor input–VRR- DRAFT -$