ALTRUA™ 40 Pacing System
Contents
1. Nominal by Device Type Parameter Programmable Range Increments DR SR PMT Termination ON OFF ON Magnet Response OFF ASYNC EGM ASYNC ASYNC A or V Lead Safety Switch ON OFF RESET OFF OFF Runaway Protection Not Programmable ppm 203 203 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 2Longevity projection as described in user manual Settings 60 ppm A 2 5 V V 2 5 V 500 ohms 100 paced MV Blended Sensor ON Onset EGMS ON Pacing Systems from Boston Scientific CRM Indications Pacemaker 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 phys2. to provide therapy pacing sensing infection procedure related and component failure In rare cases severe complications or device failures can occur Refer to the product labeling for specific indications contraindications warnings precautions and adverse events Rx only Rev K Bostons cient Delivering what s next Cardiac Rhythm Management Boston Scientific Corporation 4100 Hamline Avenue North St Paul MN 55112 5798 USA Tel 651 582 4000 Fax 651 582 4166 Medical Professionals 1 800 CARDIAC 227 3422 Patients and Families 1 866 484 3268 www bostonscientific com Copyright 2009 by Boston Scientific Corporation or its affiliates All rights reserved C2 189 0409
3. ALTRUA 40 Pacing System Specifications ALTRUA 40 Models S401 S403 and S404 The ALTRUA 40 pacing system from Boston Scientific offers Minute Ventilation MV Blended Sensor technology enabling the physician to customize adaptive rate therapy to individual needs restoring chronotropic competence All models offer atrial arrhythmia management features and leading edge diagnostics including stored EGMs with onset and event markers Ease of use tools such as Auto Sense and Quick Check help to streamline patient follow up visits Lead configurations are IS 1 compatible and devices are programmable for either unipolar or bipolar pacing and sensing All ALTRUA 40 pacemakers are programmed using the ZOOM Programming System with the CONSULT Model 2892 software application MECHANICAL SPECIFICATIONS Size mm Mass Volume Projected Model Type H x W x D g ce Longevity yrs Connector 401 SR 42 x 42 x8 23 4 10 0 Well IS 1 403 DR 44x 42x8 25 4 10 8 5 9 IS 1 404 DR 49 x 43 x8 29 6 12 1 8 1 IS 1 ALL MODELS OF ALTRUA 40 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 BRADY
4. 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 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 80 185 ppm 5 ppm 130 130 Maximum Sensor Rate 80 185 ppm 5 ppm 130 130 Boston A and V Pulse Width 0 05 ms 0 1 1 0 ms 0 1 ms 0 4 0 4 A and V Pulse Amplitude 0 1 3 5 V 0 1 V 4 0 5 0 V 0 5 6 5 V 35 35 Scientific A Delay Paced 10 300ms 1Oms 8 Delivering what s next 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 0ON A 4 gt 0N V OFF _ Response Factor Passive 1 16 1 3 3 Auto Response Factor ON OFF Reset ON ON High Rate Response OFF 55 70 85 70 70 High Rate Break Point 80 185 ppm 5 ppm 110 110 Sensor Rate Target 70 175 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 Au
5. 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 recalibrated 4ON when the patient and pacing system have stabilized post implant Continued monitoring of the MV sensor performance should be performed at all follow up visits until implant stabilization has occurred Precautions For information on precautions refer to the following sections of the product labeling clinical considerations sterilization storage and handling lead evaluation 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 reverts to asynchronous operation at the programmed pacing rate or at the magnet rate while in the presence of the EMI moving away from the source or turning it off will usually allow the pulse generator to return to its normal mode of operation Potential Adverse Events Potential adverse events from implantation of the pacing system include but are not limited to the following allergic physical physiologic reaction death erosion migration fibrillation or other arrhythmias lead or accessory breakage fracture insulation lead tip hematoma seroma inappropriate or inability
6. ble Range Increments DR SR Atrial Tachy Response ATR ON OFF ON E Trigger Rate 100 200 ppm 5 ppm 170 E Fallback Mode VDI R DDI R VDI R E Duration 0 8 2048 cycles powers of 2 8 E 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 Maximum Pacing Rate 80 185 ppm 5 ppm 130 130 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 25 9 0 10 0 mV 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 E 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
7. ical 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 tracking modes for patients with chronic refractory atrial tachyarrhythmias 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 Warnings Read the product labeling thoroughly before implanting the pulse generator to avoid damage to the system Such damage can result in patient injury or death Inappropriate sustained high rate pacing occurred in the PULSAR MAX clinical study in 5 out of 130 patients with MV
8. to Response Factor ON OFF Reset ON ON Recovery Time 2 16 minutes 1 minute 2 2 Time Dependent Blended Sensor ON OFF OFF OFF 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 20 300 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 a PVARP fixed 150 500 ms 10 ms 250 a Dynamic PVARP ON OFF ON E Maximum PVARP 160 500 ms 10 ms 250 E Minimum PVARP 150 490 ms 10 ms 240 a PVARP after PVC PAC OFF 150 500 ms 50 ms 400 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 ARRHYTHMIA MANAGEMENT continued Nominal by Device Type Parameter Programma
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