Sustain™ XL SC - Sante International SA
Contents
1. Pace Sustain XL SC Single Chamber Pacemaker 18 1 comparve ST JUDE MEDICAL Syma CA USA Product Highlights Device features small physiologic shape and offers superior longevity 12 8 years without compromising size cee SUSTAIN XL AoA S SAN 1 Instant follow up with automatic P or R wave lead impedance measurements and ventricular threshold tests 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 1 A V 2 5V 0 4 ms A V 500 ohms 100 VVI pacing 60 bpm SEGMs ON data on file Ordering Information Contents Cardiac pulse generator Connector IS 1 Volume cc 10 4 Model Number PM1134 Dimensions H x W x T mm Weight g 42x 52x6 23 Indications and Usage Implantation of Sustain pulse generators is indicated in the following permanent conditions when associated with symptoms including but not limited to syncope presyncope fatigue disorientation due to arrhythmia bradycardia or any combination of those symptoms Symptomatic bilateral bundle branch block when tachy arrhythmia and other causes have been ruled out Atrial Pacing is indicated for patients with sinus node dysfunction and norm2. Time Rate Responsive VREF Rest Rate bpm Shortest VREF Output Sensing 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 Off Low Medium High Off 30 130 in steps of 5 140 150 20 350 in steps of 10 A or V Pulse Amplitude V Aor V Pulse Width ms Aor V Sensitivity mV A or V Pulse Configuration Aor V Sense Configuration Ventricular AutoCapture Pacing System Primary Pulse Configuration Backup Pulse Configuration Backup Pulse Amplitude V Search Interval hours Customer Support 46 8 474 4756 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 5 5 0 in steps of 0 5 6 10 in steps of 1 0 12 54 nipolar tip case Bipolar tip ring Unipolar Tip tip case Bipolar tip ring Unipolar Ring ring case On Off nipolar Bipolar nipolar Bipolar 5 05 8 24 GMCRM 8 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 JU
3. DE 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 Item GMCRM877EN Stored Electrograms Pace ers Options Sampling Options No of Stored EGMs Channel Triggers Magnet Placement High Atrial Rate No of Consecutive Cycles High Ventricular Rate No of Consecutive Cycles Freeze Continuous 1 2 4 8 12 Atrial or Ventricular On Off Off 125 150 175 200 225 250 275 300 2 3 4 5 10 15 20 Off 125 150 175 200 225 250 275 300 2 3 4 5 10 15 20 Advanced Hysteresis On Off Other Lead Monitoring Off Monitor Auto Polarity Switch Aor V Low Impedance Limit Q Aor V High Impedance Limit Q Aor V Signal Amplitude Monitoring Magnet Response Lead Type NIPS Options Stimulation Chamber Coupling Interval ms S1 Count S16 2 S3 and S4 Cycle ms Sinus Node Recovery Delay sec 1 0 5cc 2 The actual pacing rate for the 30 ppm is 31 ppm 2005 750 1000 1250 1500 1750 2000 Off On Off Battery Test Uncoded Unipolar Bipolar Only Unipolar Bipolar Atrial or Ventricular 100 800 in steps of 10 1 25 in steps of 1 100 800 in steps of 10 1 5 in steps of 1 3 The highest available setting for Hysteresis Rate will be 5 ppm below the programmed Base Rate 4 Sensitivity is with respect to a 20 ms haversin
4. al AV and intraventricular conduction systems Ventricular Pacing is indicated for patients with significant bradycardia and Normal sinus rhythm with only rare episodes of A V block or sinus arrest chronic atrial fibrillation severe physical disability Contraindications mplanted Cardioverter Defibrillator ICD Because Sustain pulse generators will be 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 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 Potential Adverse Events Arrhythmia heart block thrombosis threshold elevation valve damage pneumothorax myopotential sensing vessel damage air embolism body rejection phenomena cardiac tamponade or perforation formation of fibrotic tissue local tissue reaction inability to interrogate or program a pulse generator because of programmer malfunction infection interruption of desired pulse generator function due to electrical interference loss of desired pacing and or sensing due to lead displacement body reaction at electrode interface or lead malfunction fracture or damage to insulation loss of normal pacemaker function due to battery
5. e test signal 5 This parameter is not programmable 6 S1 Burst Cycle is applied at the preprogrammed S1 cycle length tT mam ST JUDE MEDICAL MORE CONTROL LESS RISK
6. failure or component malfunction pacemaker migration pocket erosion or hematoma pectoral muscle stimulation phrenic nerve or diaphragmatic stimulation Refer to the User s Manual for detailed indications contraindications warnings precautions and potential adverse events 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 LLL usu ST JUDE MEDICAL MORE CONTROL LESS RISK Sustain XL SC Single Chamber Pacemaker Product Specifications E 7 7 PHYSICAL SPECIFICATIONS Model PM1134 Dimensions mm 42x52x6 Weight g 23 Volume cc 10 4 Connector IS 1 PARAMETER SETTINGS Rate Timing Aor V Refractory ms 125 500 in steps of 25 325 Base Rate bpm 30 40 130 in steps of 5 140 170 in steps of 10 Mode A00 AAI AAT 0A0 VOO VVI VVT OVO Hysteresis Rate bpm Off 30 130 in steps of 5 140 150 Search Interval bpm Off 5 10 15 30 Cycle Count 16 in steps of 1 Intervention Rate bpm Intervention Duration min Recovery
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