Sustain™ XL DR
Contents
1. Sustain XL DR Dual Chamber Rate Responsive Pacemaker Product Highlights Device features small physiologic shape and offers superior longevity 9 8 years without compromising size Instant follow up with automatic P or R wave lead impedance measurements and ventricular threshold tests a Ventricular Intrinsic Preference VIP algorithm automatically searches for intrinsic conduction The AutoCapture Pacing System feature offers the maximum in threshold adaptability and patient safety with ventricular Beat by Beat capture confirmation Stored electrograms EGMs record a real time EGM waveform as well as the associated event markers that precede and follow a specific triggering event The system also includes the clinically proven Omnisense accelerometer sensor featuring auto rest rate based on activity rather than on preset clock settings and auto rate response 1 A V 2 5V 0 4 ms A V 500 ohms 100 DDD pacing 60 bpm SEGMs ON data on file Ordering Information Contents Cardiac pulse generator Model Number Dimensions H x W x T mm Weight g Volume cc Connector PM2136 44x 52 x6 23 5 11 IS 1 Indications and Usage Implantation of Sustain pulse generators is indicated in the following permanent Dual Chamber Pacing Models PM2134 and PM2136 only though not contraindicated for patients with conditions when associated with symptoms including but not limited to syncope pre2. Very Slow On Off Passive 120 350 in steps of 10 170 Auto 1 Auto 0 Auto 1 Auto 2 Auto 3 1 16 in steps of 1 Auto 0 5 Auto 0 0 Auto 0 5 Auto 1 0 Auto 1 5 Auto 2 0 1 7 in steps of 0 5 Brief Summary Prior to using these devices please review the Instructions for Use for a complete listing of indications contraindications warnings precautions potential adverse events and directions for use Devices depicted may not be available in all countries Check with your St Jude Medical representative for product availability in your country Unless otherwise noted indicates that the name is a trademark of or licensed to St Jude Medical or one of its subsidiaries ST JUDE MEDICAL the nine squares symbol and MORE CONTROL LESS RISK are registered and unregistered trademarks and service marks of St Jude Medical Inc and its related companies 2011 St Jude Medical Inc All rights reserved AF Management AF Suppression Algorithm Lower Rate Overdrive min Upper Rate Overdrive min No of Overdrive Pacing Cycles Rate Recovery ms Maximum AF Suppression Rate min Atrial Tachycardia Detection Rate min Auto Mode Switch AMS Base Rate min Stored Electrograms Off On 10 52 15 40 in steps of 5 8 12 80 150 in steps of 5 160 180 in steps of 10 110 150 in steps of 5 160 200 in steps of 10 225 300 in steps of 25 180 Off DDDR to DDIR DDD to DDI V
3. DDR to VVIR VDD to VVI DDDR to DDI DDD to DDIR VDDR to VVI VDD to VVIR DDIR Base Rate 0 to Base Rate 35 in steps of 5 Base Rate 20 Options Sampling Options No of Stored EGMs Channel Triggers Advanced Hysteresis AMS Entry AMS Exit AT AF Detection Magnet Placement High Atrial Rate No of Consecutive Cycles Freeze Continuous 1 2 4 8 12 Atrial Ventricular Dual Cross Channel On Off On Off On Off On Off Off 125 150 175 200 225 250 275 300 2 3 4 5 10 15 20 High Ventricular Rate Off 125 150 175 200 225 250 275 300 No of Consecutive Cycles 2 3 4 5 10 15 20 PMT Termination On Off PVC Detection On Off No of Consecutive PVCs 2 3 4 5 Other A and V Lead Monitoring Off Monitor Auto Polarity Switch Aand V Low Impedance Limit Q Aand V High Impedance Limit Q Lead Type Magnet Response Negative AV PV Hysteresis Search ms NIPS Options Stimulation Chamber Coupling Interval S1 Count S1 2 S3 and S4 Cycle ms Ventricular Support Rate min Sinus Node Recovery Delay sec PMT Options PMT Detection Rate min PVC Options Signal Amplitude Monitoring P Wave Monitoring R Wave Monitoring Ventricular Intrinsic Preference VIP ms VIP Search Interval VIP Search Cycles Ventricular Safety Standby 1 0 5cc 2 This parameter is not programmable 2007 750 1000 1250 1500 1750 2000 Uncoded Unipolar Bipolar Only Unipolar Bipolar Off Battery Test O
4. OO R DVI R DDI R DDD R ODO 60 70 80 85 95 100 110 115 125 130 140 150 55 165 170 180 185 195 200 25 30 200 in steps of 10 225 325 in steps of 25 150 Off 30 130 in steps of 5 140 150 30 50 in steps of 5 60 120 in steps of 10 100 2 52 in steps of 4 12 25 500 in steps of 25 250 Aor V Pulse Amplitude V Aor V Pulse Width ms Aor V Pulse Configuration Aor V Sense Configuration Atrial Sensitivity mV Ventricular AutoCapture Pacing System Primary Pulse Configuration Backup Pulse Configuration Backup Pulse Amplitude V Threshold Search Interval hours Ventricular Sensitivity mV Rate Modulated Parameters 0 4 0 in steps of 0 25 4 5 7 5 in steps of 0 5 2 5 05 0 1 1 5 in steps of 0 1 0 4 Unipolar tip case Bipolar tip ring Unipolar Tip tip case Bipolar tip ring Unipolar Ring ring case 1 0 4 in steps of 0 18 0 5 0 75 2 0 in steps of 0 25 2 0 4 0 in steps of 0 5 5 0 0 5 On Off Unipolar Unipolar Bipolar 5 02 8 24 0 5 5 0 in steps of 0 5 6 10 in steps of 1 0 12 5 2 07 Maximum Sensor Rate min Rate Responsive AV PV Delay Rate Responsive PVARP VREF Reaction Time Recovery Time Sensor Shortest PVARP VREF Slope Threshold Customer Support 46 8 474 4756 Item GMCRM874EN 80 150 in steps of 5 160 180 in steps of 10 130 Off Low Medium High Off Low Medium High Very Fast Fast Medium Slow Fast Medium Slow
5. ered trademarks and service marks of St Jude Medical Inc and its related companies 2011 St Jude Medical Inc All rights reserved ST JUDE MEDICAL MORE CONTROL LESS RISK Pace S Sustain XL DR Dual Chamber Rate Responsive Pacemaker Product Specifications Model Dimensions mm Weight g Volume cc Connector PM2136 44x52x66 23 5 iv IS 1 PARAMETER Rate Timing SETTINGS Atrial Absolute Refractory Period Atrial Protection Interval ms Atrial Refractory PVARP ms AV Delay ms Base Rate bpm Far Field Protection Interval ms Hysteresis Rate min Search Interval min Cycle Count ntervention Rate min intervention Duration min Recovery Time Maximum Tracking Rate min Mode Post Vent Atrial Blanking PVAB ms PV Delay ms Rest Rate min Shortest AV PV Delay ms Ventricular Blanking ms Ventricular Refractory ms Output Sensing 60 80 100 350 in steps of 25 25 25 500 in steps of 25 275 25 30 200 in steps of 10 225 300 in steps of 25 350 200 303 40 130 in steps of 5 140 170 in steps of 10 60 62 Off 30 130 in steps of 5 140 150 Off 5 10 15 30 16 in steps of 1 Off 60 80 120 in steps of 10 Intrinsic 0 Intrinsic 10 Intrinsic 20 Intrinsic 30 10 in 1 minute intervals Fast Medium Slow Very Slow 90 130 in steps of 5 140 180 in steps of 10 130 AOO R AAI R AAT R OAO VOO R VVI R VVT R VDD R OVO D
6. ff 10 to 110 in steps of 10 Atrial Ventricular 100 800 in steps of 108 1 25 in steps of 1 100 800 in steps of 10 Off 30 40 45 50 55 60 65 70 75 80 85 90 95 1 5 in steps of 1 Off 10 Beats gt PMT Auto Detect 90 150 in steps of 5 160 180 in steps of 10 Off 110 Off A Pace on PVC PVARP on PVC VDD mode only Off On Off On Off 50 150 in steps of 25 160 200 in steps of 10 30 sec 1 3 5 10 30 min 1 2 3 Off On 3 The actual pacing rate for the 30 bpm is 31 bpm 4 The highest available setting for Hysteresis Rate will be 5 bpm below the programmed Base Rate 5 In dual chamber modes the maximum Ventricular Refractory Period is 325 ms 6 Values 0 1 0 4 not available in a Unipolar Sense Configuration 7 Sensitivity is with respect to a 20 ms haversine test signal 8 During atrial NIPS in dual chamber modes the shortest Coupling Interval will be limited by the programmed AV PV delay 9 S1 Burst Cycle is applied at the preprogrammed S1 cycle length ST JUDE MEDICAL Hae MORE CONTROL LESS RISK
7. radycardia and Normal sinus rhythm with only rare episodes of A V block or sinus pneumothorax myopotential sensing vessel damage air embolism body rejection phenomena cardiac arrest chronic atrial fibrillation severe physical disability AF Suppression Models PM2134 and PM2136 tamponade or perforation formation of fibrotic tissue local tissue reaction inability to interrogate or program only is indicated for suppression of paroxysmal or persistent atrial fibrillation episodes in patients with one a pulse generator because of programmer malfunction infection interruption of desired pulse generator or more of the above pacing indications For specific indications associated with individual modes refer to the function due to electrical interference loss of desired pacing and or sensing due to lead displacement programmer s on screen help body reaction at electrode interface or lead malfunction fracture or damage to insulation loss of normal Contraindications Implanted Cardioverter Defibrillator ICD Because Sustain pulse generators will be pacemaker function due to battery failure or component malfunction pacemaker migration pocket erosion or hematoma pectoral muscle stimulation phrenic nerve or diaphragmatic stimulation The following in addition to the above are potential complications associated with the use of rate modulated pacing systems may be inappropriate for patients who experience angina or other symptoms of myocardial dy
8. sfunction at lage ropriate rapid tee di rates due po sensor f nure oro ie areenan of signals other than patient activity higher sensor driven rates An appropriate Maximum Sensor Rate should be selected based on assessment OSS Ol activity response QUE tO SENSOr TAllUre paiprtations WIth MEN rate pacing of the highest stimulation rate tolerated by the patient AF Suppression Models PM2134 and PM2136 only Refer to the User s Manual for detailed indications contraindications warnings precautions and potential stimulation is not recommended in patients who cannot tolerate high atrial rate stimulation adverse events automatically programmed to a unipolar pulse configuration if the device initiates Backup VVI pacing Sustain devices are contraindicated in patients with an implanted cardioverter defibrillator Rate Adaptive Pacing Customer Support 46 8 474 4756 Brief Summary Prior to using these devices please review the Instructions for Use for a complete listing of indications contraindications warnings precautions potential adverse events and directions for use Devices depicted may not be available in all countries Check with your St Jude Medical representative for product availability in your country Unless otherwise noted indicates that the name is a trademark of or licensed to St Jude Medical or one of its subsidiaries ST JUDE MEDICAL the nine squares symbol and MORE CONTROL LESS RISK are registered and unregist
9. syncope fatigue chronic atrial flutter chronic atrial fibrillation or silent atria may provide no benefit beyond that of single disorientation due to arrhythmia bradycardia or any combination of those symptoms Rate Modulated Pacing chamber pacing in such patients Single Chamber Ventricular Demand Pacing is relatively contraindicated is indicated for patients with chronotropic incompetence and for those who would benefit from increased in patients who have demonstrated pacemaker syndrome have retrograde VA conduction or suffer a drop stimulation rates concurrent with physical activity Dual Chamber Pacing Models PM2134 and PM2136 in arterial blood pressure with the onset of ventricular pacing Single Chamber Atrial Pacing is relatively only is indicated for those patients exhibiting sick sinus syndrome chronic symptomatic second and contraindicated in patients who have demonstrated compromise of AV conduction hird degree AV block recurrent Adams Stokes syndrome symptomatic bilateral bundle branch block when achyarrhythmia and other causes have been ruled out Atrial Pacing is indicated for patients with sinus For specific contraindications associated with individual modes see the programmer s on screen help node dysfunction and normal AV and intraventricular conduction systems Ventricular Pacing is indicated for Potential Adverse Events Arrhythmia heart block thrombosis threshold elevation valve damage patients with significant b
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