ALTRUA™ 60 Pacing System
Contents
1. 25 4 10 8 6 5 IS 1 S606 DR 49 x 43 x 8 29 6 12 1 8 8 IS 1 ALL MODELS OF ALTRUA 60 Shape Modified elliptical Envelope Hermetically sealed titanium Sensors Minute ventilation sensor integrated circuit accelerometer Power Supply 2 8 V solid state lithium iodine battery Setscrew Style Preinserted captive setscrews and seal plugs Lead Barrel Various lead connectors accept IS 1 and 3 2 mm leads IS 1 refers to the international standard ISO 5841 3 1992 gBoston Select Auto to enable Automatic Capture under V Pulse Amplitude parameter options Delivering what next BRADY ARRHYTHMIA PACING Nominal by Device Type Parameter Programmable Range Increments DR SR Mode DDD R DDI R DOO R VDD VVT DDD SSI VVI R VOO R AAT AAI R AOO R ODO OOO SSI R SOO R SST OSO Modes beginning with O are available in temporary mode only Lower Rate Limit LRL 30 50 ppm 5 ppm 50 90 ppm 1 ppm 60 60 90 150 ppm 5 ppm 155 180 ppm 5 ppm 180 300 ppm 10 ppm 300 380 ppm 20 ppm in temporary mode only and only in SSI SOO VVI VOO AAI AOO modes Maximum Tracking Rate MTR 80 185 ppm 5 ppm 130 130 Maximum Sensor Rate MSR 80 185 ppm 5 ppm 130 130 Aor V Pulse Width 0 05 ms 0 1 1 0 ms 0 1 ms 0 4 0 4 A Pulse Amplitude 0 1 3 5 V 0 1 V 4 0 5 0 V 0 5 V 6 5 V 3 5 3 5 V Pulse Amplitude Manual 0 1 3 5 V 0 1 V 4 0 5 0 V 0 5 V 6 5 V 3 5 3 5 Autom2. ALTRUA 60 Pacing System Specifications ALTRUA 60 Models S601 S602 S603 and S606 The ALTRUA 60 pacing system from Boston Scientific offers multiple features that can be specifically programmed to tailor therapy for patient needs e Multiple AV Delay programming options fixed dynamic and AV Search Hysteresis now extendable to 400 ms provide increased flexibility in minimizing unnecessary RV pacing e Minute Ventilation MV Blended Sensor is designed to provide a physiologic response for various levels of work in patients of all ages and restores chronotropic competence e Stored Onset EGMs provide a snapshot of the patient s rhythm before during and after a triggered event without sacrificing battery longevity e AutoLifestyle automatically adjusts the blended sensor to ensure appropriate rate response for each individual patient e Automatic Capture enhances patient safety and projected device longevity over the same model e Ventricular Rate Regulation VRR for atrial arrhythmia management All models offer atrial arrhythmia management features and leading edge diagnostics Ease of use tools such as Auto Sense and Quick Check help to streamline patient follow up visits MECHANICAL SPECIFICATIONS Size mm Mass Volume Projected Model Type H x W x D g cc Longevity yrs Connector S601 SR 42x42 x8 23 4 10 0 8 6 IS 1 IS 1 compatible S602 DR 49 x 43 x 8 29 6 12 6 8 8 132 mim S603 DR 44x 42x8
3. LEAD CONFIGURATION Nominal by Device Type Parameter Programmable Range Increments DR SR A or V Lead Configuration Unipolar Bipolar Split BI BI REFRACTORY Nominal by Device Type Parameter Programmable Range Increments DR SR A Refractory Period 150 500 ms 10 ms 300 _ V Refractory Period 200 500 ms 10 ms 250 250 A Blanking after V Pace 30 200 ms 10 ms 120 E V Blanking after A Pace 30 200 ms 10 ms 40 E OTHER FEATURES Nominal by Device Type Parameter Programmable Range Increments DR SR PMT Termination ON OFF ON E Magnet Response OFF ASYNC EGM ASYNC ASYNC A or V Lead Safety Switch ON OFF RESET OFF OFF Runaway Protection Not Programmable ppm 210 210 1 Chronotropic competence is defined by Wilkoff BL Corey J Blackburn G A mathematical model of cardiac chronotropic response to exercise J Electrophysio 1989 3 3 176 180 Refer to Physician s System Guide for more information on adaptive rate therapy Additional clinical performance was assessed using INSIGNIA Ultra clinical data with the AutoLifestyle feature programmed On Data on file 2 Back up pulses are 1 5 V above the last threshold with a minimum of 3 5 V and maximum of 4 5 V 3 Longevity projections as described in device user manual Settings 60 ppm A 2 5 V V 1 0 V 500 ohms 100 paced MV Blended Sensor ON Onset EGMs ON Automatic Capture ON Pacing Systems from Boston Scientific CRM Indications Pac
4. a ATRIAL ARRHYTHMIA MANAGEMENT Nominal by Device Type Parameter Programmable Range Increments DR SR Ventricular Rate Regulation VRR ON OFF ON OFF VRR Maximum Pacing Rate 60 150 ppm 5 ppm 110 110 Sudden Bradycardia Response SBR ON OFF OFF E SBR Detect Time 1 15 minutes 1 minute 5 E SBR Number of Beats 1 8 cycles 1 4 E SBR Therapy Duration 1 15 minutes 1 minute 10 E SBR Therapy Rate Offset 5 40 ppm 5 ppm 5 E SBR MV Offset OFF 10 50 10 increments OFF E Atrial Tachy Response ATR ON OFF ON E Trigger Rate 100 200 ppm 5 ppm 170 E Fallback Mode VDI R DDI R VDI E Duration 0 8 2048 cycles powers of 2 8 B Fallback Time 0 120 sec 5 sec 30 E ATR Entry Count 1 8 cycles 1 8 E ATR Exit Count 1 8 cycles 1 8 E ATR Lower Rate Limit 30 50 ppm 5 ppm 50 90 1 ppm 70 ppm E 90 150 5 ppm ATR Lower Rate Limit must be equal to or greater than the permanent Lower Rate Limit Atrial Flutter Response OFF 130 230 ppm 10 ppm DDI R OFF E mode only 230 ppm Rate Smoothing OFF 3 24 3 increments Separately OFF OFF programmable for increase and decrease SENSITIVITY ADJUSTMENT Nominal by Device Type Parameter Programmable Range Increments DR SR Atrial Sensitivity Auto 0 15 0 25 0 5 0 75 1 0 8 0 mV 0 75 E 0 5 mV 9 0 10 0 mV Ventricular Sensitivity Auto 0 25 0 5 0 75 1 0 8 0 mV 0 5 mV 2 5 2 5 9 0 10 0 mV
5. atic Capture Auto AV Delay Paced 0 400 ms 10 ms DYN a SENSORS Nominal by Device Type Parameter Programmable Range Increments DR SR Minute Ventilation Single chamber OFF ON 430N E OFF Dual chamber OFF ON 4 gt 0N A 4 gt 0N V OFF E Response Factor Passive 1 16 1 3 3 High Rate Response OFF 55 70 85 70 70 High Rate Break Point 80 185 ppm 5 ppm 110 110 Accelerometer ON OFF ATR only OFF OFF Activity Threshold V low Low Med low Medium Med high Med Med High V high Reaction Time 10 50 sec 10 sec 30 30 Response Factor Passive 1 16 1 8 8 Recovery Time 2 16 minutes 1 minute 2 2 Time Dependent Blended Sensor ON OFF OFF OFF AutoLifestyle ON OFF RESET ON ON 4 Minute Fast Walk Within 30 Minutes YES NO YES YES RATE ENHANCEMENTS Nominal by Device Type Parameter Programmable Range Increments DR SR Hysteresis Offset OFF 5 to 80 ppm 5 ppm OFF OFF Search Hysteresis OFF 256 4096 cycles powers of 2 OFF OFF Dynamic AV Delay ON OFF ON E Maximum AV Delay 20 400 ms 10 ms 150 E Minimum AV Delay 10 290 ms 10 ms 80 E Sensed AV Offset OFF 100 to 10 ms 10 ms 30 E AV Search Interval OFF 32 1024 cycles powers of 2 OFF E AV Delay Increase 10 100 10 increments 30 E PVARP fixed 150 500 ms 10 ms 250 E Dynamic PVARP ON OFF ON Maximum PVARP 160 500 ms 10 ms 250 E Minimum PVARP 150 490 ms 10 ms 240 PVARP after PVC PAC OFF 150 500 ms 50 ms 400
6. emaker indications include symptomatic paroxysmal or permanent second or third degree AV block symptomatic bilateral bundle branch block symptomatic paroxysmal or transient sinus node dysfunction with or without associated AV conduction disorders bradycardia tachycardia syndrome to prevent symptomatic bradycardia or some forms of symptomatic tachyarrhythmias neurovascular vaso vagal syndromes or hypersensitive carotid sinus syndromes Adaptive rate pacing is indicated for patients who may benefit from increased pacing rates concurrent with increases in minute ventilation and or level of physical activity Pacemakers dual chamber and atrial tracking modes are also indicated for patients who may benefit from maintenance of AV synchrony Dual chamber modes are specifically indicated for conduction disorders that require restoration of AV synchrony including varying degrees of AV block VVI intolerance eg pacemaker syndrome in the presence of persistent sinus rhythm Contraindications Pacemakers are contraindicated for the following patients under the circumstances listed patients with unipolar pacing leads or in MV mode with an implanted ICD because it may cause unwanted delivery or inhibition of ICD therapy use of the MV sensor in patients with only unipolar leads because a bipolar lead is required in either the atrium or the ventricle for MV detection single chamber atrial pacing in patients with impaired AV nodal conduction atrial trac
7. king modes for patients with chronic refractory atrial tachyarrhythmias Boston which might trigger ventricular pacing dual chamber and single chamber atrial pacing in patients with chronic refractory atrial tachyarrhythmias asynchronous pacing in the presence or likelihood of competition between paced and intrinsic rhythms Scienti C Warnings a i i Read the product labeling thoroughly before implanting the pulse generator to avoid damage to the system Such damage can result in Delivering what next patient injury or death Inappropriate sustained high rate pacing occurred in the PULSAR MAX clinical study in 5 out of 130 patients with MV ON 4 to 14 days after implant If sustained high rate pacing could be of concern consider programming a reduced Max Sensor Rate or MV to Passive These programming recommendations are intended to assure that MV calibration is evaluated and if necessary Cardiac Rhythm Management recalibrated 4ON when the patient and pacing system have stabilized post implant Continued monitoring of the MV sensor Sears performance should be performed at all follow up visits until implant stabilization has occurred Boston Scientific Corporation 4100 Hamline Avenue North Precautions i l TEN eer N St Paul MN 55112 5798 USA For information on precautions refer to the following sections of the product labeling clinical considerations sterilization storage Tel 651 582 4000 Fax 651 582 4166 and handling lead eva
8. luation and connection implantation programming and pacemaker operation MV initialization environmental and medical therapy hazards Advise patients to avoid sources of electric or magnetic interference EMI If the pacemaker inhibits or Medical Professionals reverts to asynchronous operation at the programmed pacing rate or at the magnet rate while in the presence of the EMI moving away 1 800 CARDIAC 227 3422 from the source or turning it off will usually allow the pulse generator to return to its normal mode of operation Patients and Families Potential Adverse Events 1 866 484 3268 Potential adverse events from implantation of the pacing system include but are not limited to the following allergic physical www bostonscientific com physiologic reaction death erosion migration fibrillation or other arrhythmias lead or accessory breakage fracture insulation lead tip hematoma seroma inappropriate or inability to provide therapy pacing sensing infection procedure related and component failure Copyright 2009 by In rare cases severe complications or device failures can occur Boston Scientific Corporation Refer to the product labeling for specific indications contraindications warnings precautions and adverse events Rx only or its affiliates Alll rights reserved Rev K C2 180 0409
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