Boston Scientific CRMN11906 Implantable Defibrillator User Manual Cognis Part 1 Manual

Boston Scientific Corporation Implantable Defibrillator Cognis Part 1 Manual

CRMN11906 User Manual >

SYSTEM GUIDECOGNIS™100-DCARDIAC RESYNCHRONIZATION THERAPYHIGH ENERGY DEFIBRILLATORREF N118, N119CAUTION: 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.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: AtrialABM: Autonomic Balance MonitorAF: Atrial FibrillationAFib: Atrial FibrillationAFR: Atrial Flutter ResponseAGC: Automatic Gain ControlAIVR: Accelerated Idioventricular RhythmThe following are trademarks of Boston Scientiﬁcoritsafﬁliates: AUTONOMIC BALANCEMONITOR, COGNIS, CONTAK, CONTAK CD, CONTAK RENEWAL, EASYTRAK, ENDOTAK,RENEWAL, RHYTHM ID, SmartDelay, VITALITY, ZIP.- DRAFT -

$AT: Atrial TachycardiaATP: Antitachycardia PacingATR: Atrial Tachy ResponseAV: AtrioventricularBiV: BiventricularBCL: Burst Cycle LengthBOL: Beginning of LifeCPR: Cardiopulmonary ResuscitationCRT: Cardiac Resynchronization TherapyCRT-D: Cardiac Resynchronization Therapy DeﬁbrillatorECG: ElectrocardiogramDFT: Deﬁbrillation ThresholdEAS: Electronic Article SurveillanceEF: Ejection FractionEGM: ElectrogramEMI: Electromagnetic InterferenceEP: Electrophysiology; ElectrophysiologicFCC: Federal Communications CommissionHE: High EnergyHRV: Heart Rate VariabilityIBP: Indications-Based ProgrammingIC: Industry CanadaICD: Implantable Cardioverter DeﬁbrillatorLRL: Lower Rate LimitLV: Left VentricularLVPP: Left Ventricular Protection PeriodLVRP: Left Ventricular Refractory PeriodMI: Myocardial InfarctionMPR: Maximum Pacing RateMRI: Magnetic Resonance ImagingMSR: Maximum Sensor RateMTR: Maximum Tracking RateNSR: Normal Sinus RhythmPAC: Premature Atrial ContractionPAT: Paroxysmal Atrial TachycardiaPES: Programmed Electrical StimulationPMT: Pacemaker-Mediated TachycardiaPRM: Programmer/Recorder/MonitorPSA: Pacing System AnalyzerPVARP: Post-Ventricular Atrial Refractory PeriodPVC: Premature Ventricular ContractionRADAR: Radio Detection and RangingRF: Radio Frequency- DRAFT -$

$RV: Right VentricularRVRP: Right Ventricular Refractory PeriodSCD: Sudden Cardiac DeathSRD: Sustained Rate DurationSVT: Supraventricular TachycardiaTARP: Total Atrial Refractory PeriodTENS: Transcutaneous Electrical Nerve StimulationV: VentricularVFib: Ventricular FibrillationVF: Ventricular FibrillationVRP: Ventricular Refractory PeriodVRR: Ventricular Rate RegulationVT: Ventricular TachycardiaVTR: Ventricular Tachycardia Response- DRAFT -$

CONTENTSINFORMATION FOR USE ................................................................................................. 1-1CHAPTER 1New or Enhanced Features................................................................................................ 1-3Device Description.............................................................................................................. 1-4Related Information ............................................................................................................ 1-5Indications and Usage ........................................................................................................ 1-6Contraindications................................................................................................................ 1-6Warnings ............................................................................................................................ 1-6Precautions......................................................................................................................... 1-8Potential Adverse Events ................................................................................................. 1-19Mechanical Speciﬁcations ................................................................................................ 1-21Lead Connections............................................................................................................. 1-21Items Included in Package ............................................................................................... 1-22Symbols on Packaging ..................................................................................................... 1-22Characteristics as Shipped............................................................................................... 1-23X-Ray Identiﬁer................................................................................................................. 1-24Federal Communications Commission (FCC) .................................................................. 1-25Industry Canada (IC) ........................................................................................................ 1-25Pulse Generator Longevity ............................................................................................... 1-26Warranty Information ........................................................................................................ 1-27Product Reliability............................................................................................................. 1-27- DRAFT -

Patient Counseling Information ........................................................................................ 1-28Patient Handbook ...................................................................................................... 1-29USING THE PROGRAMMER/RECORDER/MONITOR..................................................... 2-1CHAPTER 2ZOOM LATITUDE Programming System ........................................................................... 2-2Indications-Based Programming (IBP) ............................................................................... 2-2Manual Programming ......................................................................................................... 2-5Software Terminology and Navigation ................................................................................ 2-5Main Screen................................................................................................................. 2-5PRM Mode Indicator .................................................................................................... 2-6ECG/EGM Display ....................................................................................................... 2-7Toolbar .........................................................................................................................2-7Tabs ............................................................................................................................. 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............................................................................................................. 2-12Starting a Wanded Telemetry Session ....................................................................... 2-13Starting a ZIP Telemetry Session............................................................................... 2-13Ending a Telemetry Session ...................................................................................... 2-14ZIP Telemetry Security............................................................................................... 2-14DIVERT THERAPY .......................................................................................................... 2-16STAT SHOCK ................................................................................................................... 2-17STAT PACE ...................................................................................................................... 2-18Safety Mode ..................................................................................................................... 2-18Backup 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....................................................................... 3-4CRT Delivery Zone and Tachyarrhythmia Zones ........................................................ 3-5Use of Atrial Information .............................................................................................. 3-5Ventricular Detection .......................................................................................................... 3-6Ventricular Detection Enhancement Suites.................................................................. 3-7Ventricular Redetection.............................................................................................. 3-11Ventricular Post-shock Detection Enhancements ...................................................... 3-12Ventricular Detection Details...................................................................................... 3-13TACHYARRHYTHMIA 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 ........................................................................................... 4-18- DRAFT -$

QUICK CONVERT ATP ............................................................................................. 4-20Ventricular 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 5Device Programming Recommendations ........................................................................... 5-2Maintaining CRT................................................................................................................. 5-4Pacing Therapies................................................................................................................ 5-6Basic Parameters ............................................................................................................... 5-7Brady Mode.................................................................................................................. 5-7Lower Rate Limit (LRL) .............................................................................................. 5-10Maximum Tracking Rate (MTR) ................................................................................. 5-11Maximum Sensor Rate (MSR) ................................................................................... 5-13Ventricular Pacing Chamber ...................................................................................... 5-14Pulse Width................................................................................................................ 5-15Amplitude ................................................................................................................... 5-16Sensitivity................................................................................................................... 5-16Post-Therapy Pacing ........................................................................................................ 5-17Post-Shock Pacing Delay .......................................................................................... 5-17Post-Therapy Period .................................................................................................. 5-18Temporary Pacing............................................................................................................. 5-18Sensors and Trending ...................................................................................................... 5-19Sensor Trending......................................................................................................... 5-19Adaptive-rate Pacing.................................................................................................. 5-20Accelerometer............................................................................................................ 5-21Atrial Tachy Response...................................................................................................... 5-27ATR Mode Switch ...................................................................................................... 5-27Ventricular Rate Regulation (VRR) ............................................................................ 5-32Biventricular Trigger ................................................................................................... 5-33- DRAFT -

$Atrial Flutter Response (AFR) .................................................................................... 5-34PMT Termination........................................................................................................ 5-35Rate Enhancements ......................................................................................................... 5-35Tracking Preference................................................................................................... 5-36Rate Hysteresis.......................................................................................................... 5-36Rate Smoothing ......................................................................................................... 5-38Lead Conﬁguration ........................................................................................................... 5-42Left Ventricular Electrode Conﬁguration .................................................................... 5-42AV Delay........................................................................................................................... 5-46Paced AV Delay ......................................................................................................... 5-46Sensed AV Delay ....................................................................................................... 5-48SmartDelay Optimization ........................................................................................... 5-50Refractory ......................................................................................................................... 5-52A-Refractory (PVARP) ............................................................................................... 5-52RV-Refractory (RVRP) ............................................................................................... 5-54LV-Refractory (LVRP)................................................................................................. 5-55Left Ventricular Protection Period (LVPP) .................................................................. 5-55Blanking and Noise Rejection .................................................................................... 5-56Noise Response ............................................................................................................... 5-60Ventricular Tachy Sensing Interactions............................................................................. 5-62SYSTEM 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 .................................................................................................... 6-8- DRAFT -$

PATIENT DIAGNOSTICS................................................................................................... 7-1CHAPTER 7Therapy History ..................................................................................................................7-2Trends ................................................................................................................................ 7-3Arrhythmia Logbook ........................................................................................................... 7-5Histograms ................................................................................................................. 7-11Heart Rate Variability (HRV) ...................................................................................... 7-12Counters .................................................................................................................... 7-15Patient Triggered Monitor ................................................................................................. 7-17ELECTROPHYSIOLOGIC 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 ................................................................................. 9-9- DRAFT -

Step H: Program the Pulse Generator .................................................................... 9-10Step I: Implant the Pulse Generator ........................................................................ 9-11Step J: Complete and Return the Implantation Form .............................................. 9-12POST 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 .......................................................................................................... 10-4Magnet Feature.......................................................................................................... 10-5Explantation...................................................................................................................... 10-8PROGRAMMABLE OPTIONS........................................................................................... A-1APPENDIX ACLINICAL STUDY - COMPANION .................................................................................... B-1APPENDIX BClinical Study Populations .................................................................................................. B-1Summary ............................................................................................................................ B-1Observed Adverse Events.................................................................................................. B-2Prior History ................................................................................................................. B-2Study Background........................................................................................................ B-2Adverse Event Deﬁnitions............................................................................................ B-3Deaths..........................................................................................................................B-8Study Design ...................................................................................................................... B-9Inclusion/Exclusion Criteria .............................................................................................. B-10Endpoints.......................................................................................................................... B-12Follow-up Schedule .......................................................................................................... B-15Demographic Data............................................................................................................ B-15- DRAFT -

Patient Accountability and Follow-up Duration ................................................................. B-16Data Analysis and Results for Primary Endpoint and Secondary All-Cause MortalityEndpoint ........................................................................................................................... B-20Additional Study Data ....................................................................................................... B-25Additional Outcome Measures ......................................................................................... B-25Data Analysis and Results - CRT-D System Safety ......................................................... B-29Data Analysis and Results - COMPANION Sub-study ..................................................... B-30CLINICAL STUDY - DECREASE HF................................................................................. C-1APPENDIX CSummary ............................................................................................................................ C-1Study Design ...................................................................................................................... C-1Follow-up Schedule ............................................................................................................ C-2Inclusion/Exclusion Criteria ................................................................................................ C-2Demographic Data.............................................................................................................. C-4Study Results ..................................................................................................................... C-6CLINICAL STUDY - CONTAK CD ..................................................................................... D-1APPENDIX DClinical Study Populations .................................................................................................. D-1Summary ............................................................................................................................ D-1Observed Adverse Events.................................................................................................. D-1Deaths..........................................................................................................................D-5Study Design ...................................................................................................................... D-5Inclusion/Exclusion Criteria ................................................................................................ D-6Follow-up Schedule ............................................................................................................ D-7- DRAFT -

Demographic Data.............................................................................................................. D-8Endpoints............................................................................................................................ D-8Study Results ..................................................................................................................... D-9Focused Conﬁrmatory Study ............................................................................................ D-30Study Design.............................................................................................................. D-30Demographic Data ..................................................................................................... D-30Inclusion Criteria ........................................................................................................ D-31Major Differences Between CONTAK CD and Focused Conﬁrmatory StudyPatients ...................................................................................................................... D-32Endpoints ................................................................................................................... D-33Study Results............................................................................................................. D-33CLINICAL STUDY - CONTAK RENEWAL ........................................................................ E-1APPENDIX EClinical Study Populations .................................................................................................. E-1Summary ............................................................................................................................ E-1Study Design ...................................................................................................................... E-1Inclusion/Exclusion Criteria ................................................................................................ E-1Demographic Data.............................................................................................................. E-2Ventricular Tachyarrhythmia Detection Time ...................................................................... E-3Holter Study - CONTAK RENEWAL ................................................................................... E-3Study Design................................................................................................................ E-3Inclusion/Exclusion Criteria.......................................................................................... E-4Demographic Data ....................................................................................................... E-4Programming Parameters............................................................................................ E-5Endpoints ..................................................................................................................... E-5Study Results............................................................................................................... E-6CLINICAL STUDY - SUMMARY OF CRT OPTIMIZATION ALGORITHM VALIDATIONSTUDY ............................................................................................................................... F-1APPENDIX FClinical Study Design.......................................................................................................... F-1- DRAFT -

Study Results ..................................................................................................................... F-2Conclusions ...................................................................................................................... F-10CLINICAL STUDY - VITALITY.......................................................................................... G-1APPENDIX GClinical Study Populations ................................................................................................. G-1Chronic Implant Study - VITALITY..................................................................................... G-1Acute Study - VITALITY..................................................................................................... G-3CLINICAL STUDY - SUMMARY OF GDT1000 SENSING ACUTE STUDY...................... H-1APPENDIX HClinical Study Populations .................................................................................................. H-1Study Methods....................................................................................................................H-1Study Results ..................................................................................................................... H-3Conclusions ........................................................................................................................ H-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 1-5• "Indications and Usage" on page 1-6• "Contraindications" on page 1-6• "Warnings" on page 1-6• "Precautions" on page 1-8• "Potential Adverse Events" on page 1-19• "Mechanical Speciﬁcations" on page 1-21• "Lead Connections" on page 1-21• "Items Included in Package" on page 1-22• "Symbols on Packaging" on page 1-22• "Characteristics as Shipped" on page 1-23• "X-Ray Identiﬁer" on page 1-24• "Federal Communications Commission (FCC)" on page 1-25• "Industry Canada (IC)" on page 1-25• "Pulse Generator Longevity" on page 1-26• "Warranty Information" on page 1-27• "Product Reliability" on page 1-27- DRAFT -

1-2 INFORMATION FOR USE• "Patient Counseling Information" on page 1-28- 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 DESCRIPTIONSensing• 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 COGNIS 100 family of cardiacresynchronization therapy deﬁbrillators (CRT-Ds) (speciﬁc models are listed in"Mechanical Speciﬁcations" on page 1-21).TherapiesThis 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• Cardiac Resynchronization Therapy (CRT), which treats heart failure byresynchronizing ventricular contractions through biventricular electricalstimulation• 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• 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)- DRAFT -

INFORMATION FOR USERELATED INFORMATION 1-5LeadsThe pulse generator has independently programmable outputs and acceptsthe following leads:•OneIS-11atrial lead• One IS-1 coronary venous pace/sense lead• One LV-1 coronary venous pace/sense 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 dataRELATED 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.1. 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 USEINDICATIONS AND USAGEThe 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 cardiac resynchronization therapy deﬁbrillators (CRT-Ds) areindicated for patients with moderate to severe heart failure (NYHA III/IV) whoremain symptomatic despite stable, optimal heart failure drug therapy and haveleft ventricular (LV) dysfunction (EF 35%) and QRS duration 120 ms.CONTRAINDICATIONSThere are no contraindications for this device.WARNINGSGeneral• 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.- DRAFT -

$INFORMATION FOR USEWARNINGS 1-7• Magnetic Resonance Imaging (MRI) exposure. Do not expose a patientto MR device scanning. Strong magnetic ﬁelds may damage the deviceand cause injury to the patient.•Diathermy.Do not subject a patient with an implanted pulse generatorto diathermy since diathermy may cause ﬁbrillation, burning of themyocardium, and irreversible damage to the pulse generator because ofinduced currents.Programming and Device Operations• Atrial tracking modes. Do not use atrial tracking modes in patients withchronic refractory atrial tachyarrhythmias. Tracking of atrial arrhythmiascould result in VT or VF.• Atrial-only modes. Do not use atrial-only modes in patients with heartfailure because such modes do not provide CRT.• Ventricular sensing. Left ventricular lead dislodgement to a position nearthe atria can result in atrial oversensing and left ventricular pacing inhibition.•SlowVT.Physicians should use medical discretion when implanting thisdevice in patients who present with slow VT. Programming therapy for slowmonomorphic VT may preclude CRT delivery at faster rates if these ratesare in the tachyarrhythmia zones.Implant Related• Do not kink leads. Kinking leads may cause additional stress on theleads, possibly resulting in lead fracture.• Patch leads. Do not use deﬁbrillation patch leads with the pulse generatorsystem, or injury to the patient may occur.• Separate pulse generator. Do not use this pulse generator with anotherpulse generator. This combination could cause pulse generator interaction,resulting in patient injury or a lack of therapy delivery.- DRAFT -$

1-8 INFORMATION FOR USEPRECAUTIONSPRECAUTIONSClinical 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.Implantation 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.- DRAFT -

INFORMATION FOR USEPRECAUTIONS 1-9•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.• Biventricular pacing therapy. This device is intended to providebiventricular pacing therapy. Programming the device to provide RV-onlypacing, or programming the RV pace amplitude below the pacing threshold(resulting in LV-only pacing), is not intended for the treatment of heartfailure. The clinical effects of LV-only or RV-only pacing for the treatment ofheart failure have not been established.• 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 lead conﬁguration. If the Lead Conﬁgurationis programmed to Bipolar when a unipolar lead is implanted, pacing willnot occur.• 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 -

$1-10 INFORMATION FOR USEPRECAUTIONS•Deﬁbrillation power surge. Deﬁbrillation that causes a power surgeexceeding 360 watt-seconds can damage the pulse generator system.• Programming for supraventricular tachyarrhythmias (SVTs).Determine if the device and programmable options are appropriate forpatients with SVTs because SVTs can initiate unwanted device therapy.• AV Delay. To ensure a high percentage of biventricular pacing, theprogrammed AV Delay setting must be less than the patient’s intrinsic PRinterval.• Adaptive-rate pacing. Adaptive-rate pacing should be used with care inpatients who are unable to tolerate increased pacing rates.• Ventricular refractory periods (VRPs) in adaptive-rate pacing.Adaptive-rate pacing is not limited by refractory periods. A long refractoryperiod programmed in combination with a high MSR can result inasynchronous pacing during refractory periods since the combination cancause a very small sensing window or none at all. Use dynamic AV Delayor dynamic PVARP to optimize sensing windows. If you are entering aﬁxed AV delay, consider the sensing outcomes.• Atrial Tachy Response (ATR). ATRshouldbeprogrammedtoOnifthepatient has a history of atrial tachyarrhythmias. The delivery of CRT iscompromised because AV synchrony is disrupted if the ATR mode switchoccurs.• Threshold test. During the LV threshold test, RV backup pacing isunavailable.• Left ventricular pacing only. The clinical effect of LV pacing alone forheart failure patients has not been studied.• Do not bend the lead near the lead-header interface. Improper insertioncan cause insulation damage near the terminal end that could result inlead failure.• Shock waveform polarity. For IS-1/DF-1 leads, never change the shockwaveform polarity by physically switching the lead anodes and cathodesin the pulse generator header—use the programmable Polarity feature.Device damage or nonconversion of the arrhythmia post-operatively mayresult if the polarity is switched physically.- DRAFT -$

INFORMATION FOR USEPRECAUTIONS 1-11• 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.• Atrial oversensing. Take care to ensure that artifacts from the ventriclesare not present on the atrial channel, or atrial oversensing may result. Ifventricular artifacts are present in the atrial channel, the atrial lead mayneed to be repositioned to minimize its interaction.•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.• Left ventricular lead conﬁguration. Proper programming of the LVcoronary venous lead conﬁguration is essential for proper LV leadfunction. Program the lead conﬁguration in accordance with the number ofelectrodes on the LV lead; otherwise, erratic LV sensing, loss of LV pacing,or ineffective LV pacing might occur.- DRAFT -

1-12 INFORMATION FOR USEPRECAUTIONS• Left Ventricular Protection Period (LVPP). Use of a long LVPP reducesthe maximum LV pacing rate and may inhibit CRT at higher pacing rates.• 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.Environmental 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.- DRAFT -

INFORMATION FOR USEPRECAUTIONS 1-13Hospital 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.• 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.- DRAFT -

1-14 INFORMATION FOR USEPRECAUTIONS• 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.• 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.- DRAFT -

INFORMATION FOR USEPRECAUTIONS 1-15• 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 -

1-16 INFORMATION FOR USEPRECAUTIONS• 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 -

INFORMATION FOR USEPRECAUTIONS 1-17• 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 -

1-18 INFORMATION FOR USEPRECAUTIONS• 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 -

$INFORMATION FOR USEPOTENTIAL ADVERSE EVENTS 1-19POTENTIAL ADVERSE EVENTSBased on the literature and on pulse generator implant experience, thefollowing alphabetical list includes the possible adverse events associated withimplantation of a pulse generator system:• Air embolism• Allergic reaction• Bleeding• Cardiac tamponade• Chronic nerve damage• Component failure• Conductor coil fracture•Death• Electrolyte imbalance/dehydration• Elevated thresholds•Erosion• Excessive ﬁbrotic tissue growth• Extracardiac stimulation (muscle/nerve stimulation)• Failure to convert an induced arrhythmia• Foreign body rejection phenomena• Formation of hematomas or seromas• Inability to deﬁbrillate or pace• Inappropriate therapy (e.g., shocks where applicable, ATP, pacing)• Incisional pain• Incomplete lead connection with pulse generator• Infection• Insulating myocardium during deﬁbrillation with internal or external paddles• Lead dislodgment• Lead fracture• Lead insulation breakage or abrasion• Lead tip deformation and/or breakage• Myocardial infarction (MI)• Myocardial necrosis- DRAFT -$

1-20 INFORMATION FOR USEPOTENTIAL ADVERSE EVENTS• Myocardial trauma (e.g., cardiac perforation, irritability, injury)• Myopotential sensing• Oversensing/undersensing• Pacemaker-mediated tachycardia (PMT)• 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 shockingIn addition to the implantation of a pulse generator system, potential adverseevents associated with the implantation of a coronary venous lead systeminclude:• Allergic reaction to contrast media (i.e., renal failure, etc.)• Breakage/failure of implant instruments• Prolonged exposure to ﬂuoroscopic radiation- DRAFT -

INFORMATION FOR USEMECHANICAL SPECIFICATIONS 1-21MECHANICAL SPECIFICATIONSDevice mechanical speciﬁcations for speciﬁc models are listed in the tablebelow.Table 1-1. Mechanical SpeciﬁcationsModel DimensionsWxHxDVolume(cm3)Mass (g) Connector Type(RV : LV)CaseElectrodeSurface Area(mm²)N118 6.17 x 7.95 x 0.99 32.5 72.0 IS-1/DF-1 : LV-1 6670N119 6.17 x 7.95 x 0.99 32.5 72.0 IS-1/DF-1 : IS-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 RA DF-1 IS-1 BI DF-1 LV LV-1 UNI/BI IS-1 BI – + RV RA DF-1 IS-1 BI DF-1 IS-1 BI LV IS-1 UNI/BIFigure 1-1. Lead connections- DRAFT -

1-22 INFORMATION FOR USEITEMS INCLUDED IN PACKAGENOTE: 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 1-22):Table 1-2. Symbols on packagingSymbol DescriptionReference numberPackage contentsPulse generatorTorque wrenchDisk for data storageLiterature enclosedSerial numberUse by- DRAFT -

INFORMATION FOR USECHARACTERISTICS AS SHIPPED 1-23Table 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 page1-23).Table 1-3. Characteristics as shippedParameter SettingTachy Mode StorageTachy Therapy available ATP, ShockPacing Mode Storage- DRAFT -

1-24 INFORMATION FOR USEX-RAY IDENTIFIERTable 1-3. Characteristics as shipped (continued)Parameter SettingPacing Therapy available DDDRSensor Accelerometer (MV for respiratory rate trend)Pace/Sense Conﬁguration RA: BI/BIPace/Sense Conﬁguration RV: BI/BIPace/Sense Conﬁguration LV: OffThe 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 -

INFORMATION FOR USEFEDERAL COMMUNICATIONS COMMISSION (FCC) 1-25The x-ray identiﬁer is embedded in the header of the device at the approximatelocation (Figure 1-2 on page 1-25).HeaderPulse Generator CaseX-Ray IdentifierFigure 1-2. 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 -

1-26 INFORMATION FOR USEPULSE GENERATOR LONGEVITYPULSE 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 70 ppmLRL; DDDR mode; 100% biventricular pacing; 15%atrium pacing and 0.4 ms pacing pulse width (RA, RV, LV); RA impedance500 .• 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 ModelsaPacing Amplitude Longevity (years) at 500 Ωand 700 ΩPacing Impedance (RV and LV)RA/RV LV 500 Ω700 Ω2.5V 3.0V 6.6 6.92.5V 3.5V 6.2 6.63.5V 3.5V 5.5 5.93.5V 5.0V 4.6 5.0a. For RF-enabled models, assumes ZIP wandless telemetry use for 3 hours at implant time and for 20 minutesduring each 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 -

INFORMATION FOR USEWARRANTY INFORMATION 1-27• 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 4 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 -

1-28 INFORMATION FOR USEPATIENT COUNSELING INFORMATIONRefer 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 -

INFORMATION FOR USEPATIENT COUNSELING INFORMATION 1-29• 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 -

1-30 INFORMATION FOR USEPATIENT COUNSELING INFORMATION- 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 2-5• "Data Management" on page 2-11• "Communicating with the Pulse Generator" on page 2-12• "DIVERT THERAPY" on page 2-16• "STAT SHOCK" on page 2-17• "STAT PACE" on page 2-18• "Safety Mode" on page 2-18- 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 promote intrinsic atrial eventsand provide CRT pacing.– If Chronotropically Incompetent is selected, the intent is to providerate-adaptive CRT pacing.– If Sick Sinus Syndrome is selected, the intent is to provide atrial pacingsupport and CRT pacing.• AV Node:– The intent is for nominal Paced AV delay and Sensed AV delaysettings. The SmartDelay optimization feature may be used to adjustthe AV delay.NOTE: The selected settings for AF and Sinus Node may affect the suggestedvalue for the setting of AV Node.• 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.- DRAFT -

2-4 USING THE PROGRAMMER/RECORDER/MONITORINDICATIONS-BASED PROGRAMMING (IBP)• 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– Onset/Stability 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).NOTE: 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.- DRAFT -

USING THE PROGRAMMER/RECORDER/MONITORMANUAL PROGRAMMING 2-5Primary 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 manualfor 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).- DRAFT -

2-6 USING THE PROGRAMMER/RECORDER/MONITORSOFTWARE TERMINOLOGY AND NAVIGATIONPatient 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.Patient 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.- DRAFT -

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

2-8 USING THE PROGRAMMER/RECORDER/MONITORSOFTWARE TERMINOLOGY AND NAVIGATION• 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.Patient—opens a window with patient information details.Leads—opens a window with details on leads.- DRAFT -

USING THE PROGRAMMER/RECORDER/MONITORSOFTWARE TERMINOLOGY AND NAVIGATION 2-9Battery—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)Increment and Decrement IconsIncrement—indicates that an associated value can beincremented.Decrement—indicates that an associated value can bedecremented.- DRAFT -

2-10 USING THE PROGRAMMER/RECORDER/MONITORSOFTWARE TERMINOLOGY AND NAVIGATIONScroll 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• 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 addressed- DRAFT -

USING THE PROGRAMMER/RECORDER/MONITORDATA MANAGEMENT 2-11When 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• Save All to Disk—allows you to save information to a disk, including thefollowing:– Therapy history– Programmed parameter values– Trending values–HRV– Histogram paced/sensed counters- DRAFT -

2-12 USING THE PROGRAMMER/RECORDER/MONITORCOMMUNICATING WITH THE PULSE GENERATORPrintYou 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• 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 a- DRAFT -

USING THE PROGRAMMER/RECORDER/MONITORCOMMUNICATING WITH THE PULSE GENERATOR 2-13wanded 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).3. 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.- DRAFT -

2-14 USING THE PROGRAMMER/RECORDER/MONITORCOMMUNICATING WITH THE PULSE GENERATOR2. 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 depletedIn 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.- DRAFT -

USING THE PROGRAMMER/RECORDER/MONITORCOMMUNICATING WITH THE PULSE GENERATOR 2-15RF 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• 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.- DRAFT -

2-16 USING THE PROGRAMMER/RECORDER/MONITORDIVERT THERAPYThe 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.DIVERT 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.- DRAFT -

USING THE PROGRAMMER/RECORDER/MONITORSTAT SHOCK 2-17Also, 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.2. 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.- DRAFT -

2-18 USING THE PROGRAMMER/RECORDER/MONITORSTAT PACE4. 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.SAFETY 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.- DRAFT -

USING THE PROGRAMMER/RECORDER/MONITORSAFETY MODE 2-19Limited 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 BiV output characteristics:•0msoffset• 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,the therapy is diverted and detection is inhibited. The magnet must then beremoved for 2 seconds in order to allow detection to continue.- DRAFT -

2-20 USING THE PROGRAMMER/RECORDER/MONITORSAFETY MODEProgramming 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/CRT ModeExcept for STAT SHOCK and STAT PACE, no commanded therapies,inductions, or diagnostic tests will be allowed while Electrocautery Protection isenabled.Biventricular pacing with LV Offset programmed to zero will be deliveredwhile Electrocautery Protection Mode is enabled if the programmed modeis a ventricular pacing mode.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.- DRAFT -

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