Cardiac Rhythm Maagemet Iteratioal Product Catalog Jauary 2012
A Comprehesive Portfolio of Cardiac Rhythm Maagemet Products St. Jude Medical offers comprehesive solutios for the diagosis ad treatmet of cardiac arrhythmias. Our product portfolio rages from prove pacemakers, implatable cardioverter defibrillators (ICDs) ad cardiac resychroisatio therapy systems to iovative ad reliable lead techologies. Additioally, we offer highperformace products for atrial fibrillatio (AF), icludig mappig ad surgical ad catheter ablatio systems. Other St. Jude Medical products iclude remote care solutios, heart valves ad vascular closure devices. High-performace devices with log-lastig batteries, expasive data storage ad fast processors pave the way for disease maagemet. These systems ot oly moitor device status but also take the patiet ad disease progressio ito accout. I combiatio with telemedicie capabilities, patiet moitorig ca start i the patiet s bedroom ad exted beyod the parameters of rhythm maagemet aloe. Advaced disease maagemet features iclude: ST segmet moitorig CorVue cogestio moitorig AT/AF alerts Our corporate missio is to develop medical techology ad services that make it possible for physicias worldwide to treat cardiac ad eurological diseases ad chroic pai with more cotrol. Reducig risk for every patiet stads at the ceter of our efforts to advace medicie ad improve therapeutic results. To meet our objectives of more cotrol ad less risk, we parter with physicias to develop tools ad techiques that simplify patiet care ad facilitate reproducible outcomes. Our efforts exted to physicia traiig ad educatio. We sposor more tha 170 programs with various themes geared toward physicias specialisig i may areas of cardiology. Descriptios ad specificatios for the St. Jude Medical comprehesive portfolio of cardiac rhythm maagemet products ca be foud throughout this catalogue.
Table of Cotets Cardiac Resychroisatio Therapy (CRT) Devices Left-Heart ad Epicardial Leads Implatable Cardioverter Defibrillator (ICD) Devices Defibrillatio Leads Pacemakers Pacig Leads Accessories Implatable Cardiac Moitors Coectivity ad Remote Care Brief Summary: Prior to usig these devices, please review the Istructios for Use for a complete listig of idicatios, cotraidicatios, warigs, precautios, potetial adverse evets ad directios for use. Devices depicted may ot be available i all coutries. Check with your St. Jude Medical represetative for product availability i your coutry. Uless otherwise oted, idicates that the ame is a trademark of, or licesed to, St. Jude Medical or oe of its subsidiaries. ST. JUDE MEDICAL, the ie-squares symbol ad MORE CONTROL. LESS RISK. are registered ad uregistered trademarks ad service marks of St. Jude Medical, Ic. ad its related compaies. 2011 St. Jude Medical, Ic. All rights reserved.
Cardiac Resychroisatio Therapy (CRT) Devices
Exclusive St. Jude Medical Iovatios Eable Delivery of Optimal Cardiac Resychroisatio Therapy From desig ad developmet to market release, exclusive techical iovatios reduce life-threateig risk ad eable delivery of idividually-tailored cardiac resychroisatio therapies (CRT-D ad CRT-P). Simplified implatatio ad remote moitorig beefit physicias ad patiets alike. More Cotrol. Comprehesive oivasive programmig techiques ad algorithms such as QuickOpt ad DeFT Respose eable physicias to better meet the eeds of their patiets. These features provide the flexibility ad cotrol eeded for idividual therapy success. Improvemets such as wireless telemetry help save time ad improve efficiecies i the cliic. Less Risk. The latest fuctios of St. Jude Medical CRT devices provide the possibility to deliver optimal therapy to patiets with less risk.
Cardiac Resychroisatio Therapy (CRT) Devices Uify Quadra Cardiac Resychroisatio Therapy Defibrillator (CRT-D) Product Highlights The Uify Quadra CRT-D ad Quartet quadripolar LV pacig lead feature four pacig electrodes ad 10 pacig vectors to provide more optios ad greater cotrol to miimise implat complicatios such as diaphragmatic stimulatio ad high pacig thresholds Dowsized device for a smaller footprit The CorVue Cogestio Moitorig feature moitors the itrathoracic impedace i multiple vectors for improved accuracy, ad it provides the optio for both patiet ad physicia alerts ShockGuard techology with DecisioTx programmig, desiged to reduce iappropriate therapy ad miimise the eed for programmig adjustmets at implat 40 J delivered eergy provides usurpassed eergy for defibrillatio Merli@home Trasmitter Compatible Streamlied header coectors (IS4-LLLL/DF4-LLHH) reduce pocket bulk QHR * chemistry battery provides greater capacity for ehaced logevity ad improved charge time performace Orderig Iformatio Cotets: Cardiac pulse geerator Model Number Dimesios (H x W x T, mm) Weight (g) Volume (cc) Coector CD3251-40 83 x 41 x 14 83 40 DF1, IS4, IS-1 CD3251-40Q 76 x 41 x 14 81 38 DF4, IS4, IS-1 Idicatios: The devices are iteded to provide vetricular atitachycardia pacig ad vetricular defibrillatio for automated treatmet of life-threateig vetricular arrhythmias. Cardiac Resychroisatio Therapy Defibrillators (CRT-Ds) are also iteded to resychroise the right ad left vetricles i patiets with cogestive heart failure. Cotraidicatios: Cotraidicatios for use of the pulse geerator system iclude vetricular tachyarrhythmias resultig from trasiet or correctable factors such as drug toxicity, electrolyte imbalace, or acute myocardial ifarctio. Adverse Evets: Implatatio of the pulse geerator system, like that of ay other device, ivolves risks, some possibly life-threateig. These iclude but are ot limited to the followig: acute hemorrhage/bleedig, air emboli, arrhythmia acceleratio, cardiac or veous perforatio, cardiogeic shock, cyst formatio, erosio, exacerbatio of heart failure, extrusio, fibrotic tissue growth, fluid accumulatio, hematoma formatio, histotoxic reactios, ifectio, keloid formatio, myocardial irritability, erve damage, peumothorax, thromboemboli, veous occlusio. Other possible adverse effects iclude mortality due to: compoet failure, device-programmer commuicatio failure, lead abrasio, lead dislodgmet or poor lead placemet, lead fracture, iability to defibrillate, ihibited therapy for a vetricular tachycardia, iterruptio of fuctio due to electrical or magetic iterferece, shutig of eergy from defibrillatio paddles, system failure due to ioisig radiatio. Other possible adverse effects iclude mortality due to iappropriate delivery of therapy caused by: multiple coutig of cardiac evets icludig T waves, P waves, or supplemetal pacemaker stimuli. Amog the psychological effects of device implatatio are imagied pulsig, depedecy, fear of iappropriate pulsig, ad fear of losig pulse capability. Refer to the User s Maual for detailed idicatios, cotraidicatios, warigs, precautios ad potetial adverse evets. Brief Summary: Prior to usig these devices, please review the Istructios for Use for a complete listig of idicatios, cotraidicatios, warigs, precautios, potetial adverse evets ad directios for use. Devices depicted may ot be available i all coutries. Check with your St. Jude Medical represetative for product availability i your coutry. Uless otherwise oted, idicates that the ame is a trademark of, or licesed to, St. Jude Medical or oe of its subsidiaries. ST. JUDE MEDICAL, the ie-squares symbol ad MORE CONTROL. LESS RISK. are registered ad uregistered trademarks ad service marks of St. Jude Medical, Ic. ad its related compaies. 2011 St. Jude Medical, Ic. All rights reserved.
Cardiac Resychroisatio Therapy (CRT) Devices Uify Quadra Cardiac Resychroisatio Therapy Defibrillator (CRT-D) Product Specificatios PHYSICAL SPECIFICATIONS Models CD3251-40 CD3251-40Q Telemetry RF RF Delivered Eergy (J) 40 40 Volume (cc) 40 38 Weight (g) 83 81 Size (mm) 83 x 41 x 14 76 x 41 x 14 Defibrillatio Lead Coectios DF1 DF4-LLHH LV Lead Coectios IS4-LLLL IS4-LLLL Sese/Pace Lead Coectios IS-1 IS-1 High-Voltage Ca Electrically active titaium ca Electrically active titaium ca PARAMETER Bivetricular Pacig SETTINGS VectSelect Quartet LV Distal Tip 1 - Mid 2, Distal Tip 1 - Proximal 4, Distal Tip 1 - RV Coil; Pulse Cofiguratio Mid 2 - Proximal 4; Mid 2 - RV Coil; Mid 3 - Mid 2; Mid 3 - Proximal 4; Mid 3 - RV Coil; Proximal 4 - Mid 2; Proximal 4 - RV Coil V. Triggerig (BiV Trigger Mode) O; Off QuickOpt Timig Cycle Optimisatio Sesed/paced AV delay, itervetricular pace delay V-V Timig Simultaeous*; RV First; LV First Itervetricular Pace Delay (ms) RV First 10-80 / LV First 15-80 i icremets of 5 Vetricular Sesig RV oly (ot programmable) Vetricular Pacig Chamber RV oly; bivetricular Negative AV Hysteresis/Search (ms) Off; -10 to -120 Shortest AV Delay (ms) 25-120 AF Maagemet AF Suppressio Pacig O; Off No. of Overdrive Pacig Cycles 15-40 i steps of 5 Maximum AF Suppressio Rate 80-150 mi -1 Sesig/Detectio SeseAbility Techology Automatic Sesitivity Cotrol adjustmet for atrial ad vetricular evets Low Frequecy Atteuatio O; Off Sese Filter (Post-Sesed; Atrial) 50; 62,5; 75; 100%; (Post-Paced; Atrial) 0,2-3,0 mv; Threshold Start (Post-Sesed; Vetricular) 50; 62,5; 75; 100%; (Post-Paced; Vetricular) Auto; 0,2-3,0 mv Decay Delay (Post-Sesed/Post-Paced; Atrial/Vetricular) 0-220 Vetricular Sese Refractory (ms) 125; 157 Detectio Zoes VT-1; VT-2; VF SVT Discrimiators AV Rate Brach; Sudde Oset; Iterval Stability; Morphology Discrimiatio (MD) with Maual or Automatic Template Update Recofirmatio Cotiuous sesig durig chargig Atitachycardia Pacig Therapy ATP Cofiguratios Ramp; Burst; Sca; 1 or 2 schemes per zoe ATP i VF Zoe ATP While Chargig; ATP Prior to Chargig; Off ATP Upper Rate Cutoff 150-300 bpm Burst Cycle Legth Adaptive; Readaptive or Fixed Mi. Burst Cycle Legth (ms) 150-400 i icremets of 5 Number of Bursts/Stimuli 1-15 with 2-20 Stimuli Add Stimuli per Burst O; Off High-Voltage Therapy High-Voltage Output Mode Fixed Pulse Width; Fixed Tilt Waveform Biphasic; Moophasic RV Polarity Cathode (-); Aode (+) Electrode Cofiguratio RV to Ca; RV to SVC/Ca Bradycardia Pacig Permaet Modes Off; DDD(R); DDT(R); DDI(R); VVT(R); VVI(R); AAI(R) Temporary Modes Off; DDD(R); DDT(R); DDI(R); VVT(R); VVI(R); AAI(R); AAT; DOO; VOO; AOO Rate-Adaptive Sesor O; Off; Passive Programmable Rate ad Off; Base Rate (mi -1 ); Rest Rate (mi -1 ); Maximum Trackig Rate (mi -1 ); Delay Parameters Maximum Sesor Rate (mi -1 ); Paced AV Delay (ms); Sesed AV Delay (ms); Rate Resposive AV Delay; Hysteresis Rate (mi -1 ); Rate Hysteresis with Search Auto Mode Switch (AMS) Off; DDI(R); DDT(R); VVI(R); VVT(R) Atrial Tachycardia Detectio Rate (mi -1 ) 110-300 AMS Base Rate (mi -1 ) 40; 45;... 135 Auto PMT Detectio/Termiatio Atrial Pace; Off; Passive Rate Resposive PVARP/VREF Off; Low; Medium; High Vetricular Itrisic Preferece (VIP ) Off; 50-200 (50-150 i icremets of 25; 160-200 i icremets of 10) BiVCap Cofirm; LVCap Cofirm; Setup; O; Moitor; Off RVCap Cofirm Setup; O; Moitor; Off ACap Cofirm O; Moitor; Off Post-Therapy Pacig (idepedetly programmable from Bradycardia ad ATP) Post-Shock Pacig Mode Off; AAI; VVI; DDI; or DDD Post-Shock Base Rate (mi -1 ) 30-100 i icremets of 5 Post-Shock Pacig Duratio (mi) Off; 0,5; 1; 2,5; 5; 7,5; or 10 Device Testig/Iductio Methods DC Fibber Pulse Duratio (sec) 0,5-5,0 Burst Fibber Cycle Legth (ms) 20-100 Noivasive Programmed 2-25 stimuli with up to 3 extrastimuli Stimulatio (NIPS) Patiet Notifiers Programmable Notifiers (O; Off) Device at ERI; Charge Time Limit Reached; Possible HV Circuit Damage; Atrial Lead Impedace Out of Rage; RV Lead Impedace Out of Rage; LV Lead Impedace Out of Rage; High-Voltage Lead Impedace Out of Rage; AT/AF Burde; V Rate Durig AT/AF; % V Pacig; CorVue Cogestio Trigger Device Parameter Reset O Etry ito Backup VVI Mode O Vibratio Duratio (sec) 2; 4; 6; 8; 10; 12; 14; 16 Number of Vibratios per Notificatio 2 Number of Notificatios 1-16 Time Betwee Notificatios (hours) 10; 22 Electrograms ad Diagostics Stored Electrograms Up to 45 miutes; icludig up to 1 miute programmable pre-trigger data per VT/VF diagosis/detectio electrograms; triggers iclude diagosis; therapy; atrial episode; PMT termiatio; PC shock delivery; oise reversio; maget reversio; ad morphology template verificatio Therapy Summary Diagram of therapies delivered Episodes Summary Directory listig of up to 60 episodes with access to more details icludig stored electrograms Lifetime Diagostics History of bradycardia evets ad device-iitiated chargig AT/AF Burde Tred Tred data ad couts Vetricular HV Lead Impedace Tred Multi-Vector Tred Data Histograms Evet Histogram; AV Iterval Histogram; Mode Switch Duratio Histogram; Peak Filtered Rate Histogram; Atrial Heart Rate Histogram; Vetricular Heart Rate Histogram; AT/AF Burde; Exercise ad Activity Tredig; V Rates Durig AMS PMT Data Iformatio regardig PMT detectios Real-Time Measuremets (RTM) Pacig lead impedaces; high-voltage lead impedaces; sigal amplitudes CorVue Cogestio Moitorig O; Off CorVue Cogestio Trigger 8-18 days * QHR is a trademark of Greatbatch, LTD. ** LV first with 10ms itervetricular delay (GMCRM798EN) Brief Summary: Prior to usig these devices, please review the Istructios for Use for a complete listig of idicatios, cotraidicatios, warigs, precautios, potetial adverse evets ad directios for use. Devices depicted may ot be available i all coutries. Check with your St. Jude Medical represetative for product availability i your coutry. Uless otherwise oted, idicates that the ame is a trademark of, or licesed to, St. Jude Medical or oe of its subsidiaries. ST. JUDE MEDICAL, the ie-squares symbol ad MORE CONTROL. LESS RISK. are registered ad uregistered trademarks ad service marks of St. Jude Medical, Ic. ad its related compaies. 2011 St. Jude Medical, Ic. All rights reserved. Item GMCRM798EN
Cardiac Resychroisatio Therapy (CRT) Devices Promote Quadra Cardiac Resychroisatio Therapy Defibrillator (CRT-D) Product Highlights The Promote Quadra CRT-D ad Quartet quadripolar LV pacig lead feature four pacig electrodes ad 10 pacig vectors to provide more optios ad greater cotrol to miimise implat complicatios such as diaphragmatic stimulatio ad high pacig thresholds VectSelect Quartet programmable LV pulse cofiguratio (Distal Tip 1 - Mid 2, Distal Tip 1 - Proximal 4, Distal Tip 1 - RV Coil, Mid 2 - Proximal 4, Mid 2 - RV Coil, Mid 3 - Mid 2, Mid 3 - Proximal 4, Mid 3 - RV Coil, Proximal 4 - Mid 2, Proximal 4 - RV Coil) may be adjusted oivasively via the programmer The CorVue cogestio moitorig feature moitors the itrathoracic impedace i multiple vectors for improved accuracy, ad it provides the optio for both patiet ad physicia alerts 40 J delivered eergy provides usurpassed eergy for defibrillatio Merli@home Trasmitter Compatible Dual DF4 header optio for defibrillatio lead (DF4-LLHH) ad LV pacig lead (IS4-LLLL) reduce pocket bulk QHR * chemistry battery provides greater capacity for ehaced logevity ad charge times Triggered pacig with BiV Trigger Mode helps maitai a high percetage of BiV pacig by triggerig pacig i both the left ad right vetricles i respose to a sesed vetricular evet Negative AV hysteresis with search promotes vetricular pacig by automatically reducig the AV delay whe itrisic activity is preset, thereby promotig a high degree of vetricular pacig Orderig Iformatio Cotets: Cardiac pulse geerator Dimesios Coector Coector Model Number (H x W x T, mm) Weight (g) Volume (cc) Defibrillatio Sese/Pace CD3239-40 81 x 51 x 14 88 46 DF1 IS-1 CD3239-40Q 74 x 51 x 14 87 44 DF4 IS-1; DF4 Idicatios: The devices are iteded to provide vetricular atitachycardia pacig ad vetricular defibrillatio for automated treatmet of life-threateig vetricular arrhythmias. Cardiac Resychroisatio Therapy devices (CRT-Ds) are also iteded to resychroise the right ad left vetricles i patiets with cogestive heart failure. Cotraidicatios: Cotraidicatios for use of the pulse geerator system iclude vetricular tachyarrhythmias resultig from trasiet or correctable factors such as drug toxicity, electrolyte imbalace or acute myocardial ifarctio. Adverse Evets: Implatatio of the pulse geerator system, like that of ay other device, ivolves risks, some possibly life-threateig. These iclude but are ot limited to the followig: acute hemorrhage/bleedig, air emboli, arrhythmia acceleratio, cardiac or veous perforatio, cardiogeic shock, cyst formatio, erosio, exacerbatio of heart failure, extrusio, fibrotic tissue growth, fluid accumulatio, hematoma formatio, histotoxic reactios, ifectio, keloid formatio, myocardial irritability, erve damage, peumothorax, thromboemboli, veous occlusio. Other possible adverse effects iclude mortality due to: compoet failure, device-programmer commuicatio failure, lead abrasio, lead dislodgmet or poor lead placemet, lead fracture, iability to defibrillate, ihibited therapy for a vetricular tachycardia, iterruptio of fuctio due to electrical or magetic iterferece, shutig of eergy from defibrillatio paddles, system failure due to ioisig radiatio. Other possible adverse effects iclude mortality due to iappropriate delivery of therapy caused by: multiple coutig of cardiac evets icludig T-waves, P-waves or supplemetal pacemaker stimuli. Amog the psychological effects of device implatatio are imagied pulsig, depedecy, fear of iappropriate pulsig ad fear of losig pulse capability. Refer to the User s Maual for detailed idicatios, cotraidicatios, warigs, precautios ad potetial adverse evets. Brief Summary: Prior to usig these devices, please review the Istructios for Use for a complete listig of idicatios, cotraidicatios, warigs, precautios, potetial adverse evets ad directios for use. Devices depicted may ot be available i all coutries. Check with your St. Jude Medical represetative for product availability i your coutry. Uless otherwise oted, idicates that the ame is a trademark of, or licesed to, St. Jude Medical or oe of its subsidiaries. ST. JUDE MEDICAL, the ie-squares symbol ad MORE CONTROL. LESS RISK. are registered ad uregistered trademarks ad service marks of St. Jude Medical, Ic. ad its related compaies. 2011 St. Jude Medical, Ic. All rights reserved.
Cardiac Resychroisatio Therapy (CRT) Devices Promote Quadra Cardiac Resychroisatio Therapy Defibrillator (CRT-D) Product Specificatios PHYSICAL SPECIFICATIONS Models CD3239-40 CD3239-40Q Telemetry RF RF Delivered Eergy (J) 40 40 Volume (cc) 46 44 Weight (g) 88 87 Size (mm) 81x51x14 74x51x14 Defibrillatio Lead Coectios DF1 DF4-LLHH LV Lead Coectios IS4-LLLL IS4-LLLL Sese/Pace Lead Coectios IS-1 IS-1 High-Voltage Ca Electrically active titaium ca Electrically active titaium ca PARAMETER Bivetricular Pacig SETTINGS VectSelect Quartet LV Distal Tip 1 - Mid 2; Distal Tip 1 - Proximal 4; Distal Tip 1 - RV Coil; Pulse Cofiguratio Mid 2 - Proximal 4; Mid 2 - RV Coil; Mid 3 - Mid 2; Mid 3 - Proximal 4; Mid 3 - RV Coil; Proximal 4 - Mid 2; Proximal 4 - RV Coil V. Triggerig (BiV Trigger Mode) O; Off QuickOpt Timig Cycle Optimisatio Sesed/paced AV delay, itervetricular pace V-V Timig Simultaeous**; RV First; LV First Itervetricular Pace Delay (ms) RV First 10-80 / LV First 15-80 i icremets of 5 Vetricular Sesig RV oly (ot programmable) Vetricular Pacig Chamber RV oly; bivetricular Negative AV Hysteresis/Search (ms) Off; -10 to -120 Shortest AV Delay (ms) 25-120 AF Maagemet AF Suppressio Pacig O; Off No. of Overdrive Pacig Cycles 15-40 i steps of 5 Maximum AF Suppressio Rate 80-150 mi -1 Sesig/Detectio SeseAbility Techology Automatic Sesitivity Cotrol adjustmet for atrial ad vetricular evets Low Frequecy Atteuatio O; Off Threshold Start (Post-Sesed; Atrial) 50; 62,5; 75; 100%; (Post-Paced; Atrial) 0,2-3,0 mv; (Post-Sesed; Vetricular) 50; 62,5; 75; 100%; (Post-Paced; Vetricular) Auto; 0,2-3,0 mv Decay Delay (Post-Sese/Post-Pace; Atrial/Vetricular) 0-220 Vetricular Sese Refractory (ms) 125; 157 Detectio Zoes VT-1; VT-2; VF SVT Discrimiators AV Rate Brach; Sudde Oset; Iterval Stability; Morphology Discrimiatio (MD) with Maual or Automatic Template Update Recofirmatio Cotiuous sesig durig chargig Atitachycardia Pacig Therapy ATP Cofiguratios Ramp; Burst; Sca; 1 or 2 schemes per zoe ATP i VF Zoe ATP While Chargig; ATP Prior to Chargig; Off ATP Upper Rate Cutoff 150-300 bpm Burst Cycle Legth Adaptive; Readaptive or Fixed Mi. Burst Cycle Legth (ms) 150-400 i icremets of 5 Number of Bursts/Stimuli 1-15 with 2-20 Stimuli Add Stimuli per Burst O; Off High-Voltage Therapy High-Voltage Output Mode Fixed Pulse Width; Fixed Tilt Waveform Biphasic; Moophasic RV Polarity Cathode (-); Aode (+) Electrode Cofiguratio RV to Ca; RV to SVC/Ca Post-Therapy Pacig (Idepedetly programmable from Bradycardia ad ATP) Post-Shock Pacig Mode Off; AAI; VVI; DDI; or DDD Post-Shock Base Rate (mi -1 ) 30-100 i icremets of 5 Post-Shock Pacig Duratio (mi) Off; 0,5; 1; 2,5; 5; 7,5; or 10 Device Testig/Iductio Methods DC Fibber Pulse Duratio (sec) 0,5-5,0 Burst Fibber Cycle Legth (ms) 20-100 Noivasive Programmed Stimulatio (NIPS) 2-25 stimuli with up to three extrastimuli Patiet Notifiers Programmable Notifiers (O; Off) Device at ERI; Charge Time Limit Reached; Possible HV Circuit Damage; Atrial Lead Impedace Out of Rage; RV Lead Impedace Out of Rage; LV Lead Impedace Out of Rage; High-Voltage Lead Impedace Out of Rage; AT/AF Burde; V Rate Durig AT/AF; % V pacig; CorVue Cogestio Trigger Device Reset O Etry ito Backup VVI Mode O Vibratio Duratio (sec) 2; 4; 6; 8; 10; 12; 14; 16 Number of Vibratios per Notificatio 2 Number of Notificatios 1-16 Time Betwee Notificatios (hours) 10; 22 Electrograms ad Diagostics Stored Electrograms Up to 45 miutes; icludig up to oe miute programmable pre-trigger data per VT/VF diagosis/detectio electrograms; triggers iclude diagosis; therapy; atrial episode; PMT termiatio; PC shock delivery; oise reversio; maget reversio; ad morphology template verificatio Therapy Summary Diagram of therapies delivered Episodes Summary Directory listig of up to 60 episodes with access to more details icludig stored electrograms Lifetime Diagostics History of bradycardia evets ad device-iitiated chargig AT/AF Burde Tred Tred data ad couts Vetricular HV Lead Impedace Tred Multi-Vector Tred Data Histograms Evet Histogram; AV Iterval Histogram; Mode Switch Duratio Histogram; Peak Filtered Rate Histogram; Atrial Heart Rate Histogram; Vetricular Heart Rate Histogram; AT/AF Burde; Exercise ad Activity Tredig; V Rates Durig AMS PMT Data Iformatio regardig PMT detectios Real-Time Measuremets (RTM) Pacig lead impedaces; high-voltage lead impedaces; sigal amplitudes CorVue Cogestio Moitorig O; Off CorVue Cogestio Trigger 8-18 days *QHR is a trademark of Greatbatch, LTD. **LV first with 10 ms itervetricular delay. Bradycardia Pacig (GMCRM766EN) Permaet Modes Off; DDD(R); DDT(R); DDI(R); VVT(R); VVI(R); AAI(R) Temporary Modes Off; DDD(R); DDT(R); DDI(R); VVT(R); VVI(R); AAI(R); AAT; DOO; VOO; AOO Rate-Adaptive Sesor O; Off; Passive Programmable Rate ad Off; Base Rate (mi -1 ); Rest Rate (mi -1 ); Maximum Trackig Rate (mi -1 ) Delay Parameters Maximum Sesor Rate (mi -1 ); Paced AV Delay (ms); Sesed AV Delay (ms); Rate Resposive AV Delay; Pulse Amplitude (Atrial; RV ad LV) (V); Pulse Width (Atrial; RV ad LV) (ms); Hysteresis Rate (mi -1 ); Rate Hysteresis with Search Auto Mode Switch (AMS) Off; DDI(R); DDT(R); VVI(R); VVT(R) AMS Detectio Rate (mi -1 ) 110-300 AMS Base Rate 40; 45;...135 Auto PMT Detectio/Termiatio A Pace o PMT; Off; Passive Rate Resposive PVARP/VREF Off; Low; Medium; High Vetricular Itrisic Preferece (VIP ) Off; 50-200 (50-150 i icremets of 25; 160-200 i icremets of 10) BiVCap Cofirm; LVCap Cofirm; RVCap Cofirm Setup; O; Moitor; Off ACap Cofirm O; Moitor; Off Brief Summary: Prior to usig these devices, please review the Istructios for Use for a complete listig of idicatios, cotraidicatios, warigs, precautios, potetial adverse evets ad directios for use. Devices depicted may ot be available i all coutries. Check with your St. Jude Medical represetative for product availability i your coutry. Uless otherwise oted, idicates that the ame is a trademark of, or licesed to, St. Jude Medical or oe of its subsidiaries. ST. JUDE MEDICAL, the ie-squares symbol ad MORE CONTROL. LESS RISK. are registered ad uregistered trademarks ad service marks of St. Jude Medical, Ic. ad its related compaies. 2011 St. Jude Medical, Ic. All rights reserved. Item GMCRM766EN
Cardiac Resychroisatio Therapy (CRT) Devices Uify Cardiac Resychroisatio Therapy Defibrillator (CRT-D) Product Highlights Smallest footprit of ay HV device available The CorVue cogestio moitorig feature moitors the itrathoracic impedace i multiple vectors for improved accuracy, ad it provides the optio for both patiet ad physicia alerts 40 J delivered eergy provides usurpassed eergy for defibrillatio ShockGuard techology with DecisioTx programmig, desiged to reduce iappropriate therapy ad miimise the eed for programmig adjustmets at implat DF coector is desiged simplifies the implat by decreasig the defibrillatio coectios ito a sigle termial pi ad reducig the umber of set screws. QHR * chemistry battery provides greater capacity for ehaced logevity ad charge times Triggered pacig with BiV Trigger Mode helps maitai a high percetage of BiV pacig by triggerig pacig i both the left ad right vetricles i respose to a sesed vetricular evet Negative AV hysteresis with search promotes vetricular pacig by automatically reducig the AV delay whe itrisic activity is preset, thereby promotig a high degree of vetricular pacig Merli@home Trasmitter Compatible Orderig Iformatio Cotets: Cardiac pulse geerator Model Dimesios Coector Coector Number (H x W x T, mm) Weight (g) Volume (cc) Defibrillatio Sese/Pace CD3235-40 79 x 40 x 14 78 36 DF1 IS-1 CD3235-40Q 73 x 40 x 14 77 36 DF4 DF4; IS-1 Idicatios: The devices are iteded to provide vetricular atitachycardia pacig ad vetricular defibrillatio for automated treatmet of life-threateig vetricular arrhythmias. Cardiac Resychroisatio Therapy Defibrillators (CRT-Ds) are also iteded to resychroise the right ad left vetricles i patiets with cogestive heart failure. Cotraidicatios: Cotraidicatios for use of the pulse geerator system iclude vetricular tachyarrhythmias resultig from trasiet or correctable factors such as drug toxicity, electrolyte imbalace or acute myocardial ifarctio. Adverse Evets: Implatatio of the pulse geerator system, like that of ay other device, ivolves risks, some possibly life-threateig. These iclude but are ot limited to the followig: acute hemorrhage/bleedig, air emboli, arrhythmia acceleratio, cardiac or veous perforatio, cardiogeic shock, cyst formatio, erosio, exacerbatio of heart failure, extrusio, fibrotic tissue growth, fluid accumulatio, hematoma formatio, histotoxic reactios, ifectio, keloid formatio, myocardial irritability, erve damage, peumothorax, thromboemboli, veous occlusio. Other possible adverse effects iclude mortality due to: compoet failure, device-programmer commuicatio failure, lead abrasio, lead dislodgmet or poor lead placemet, lead fracture, iability to defibrillate, ihibited therapy for a vetricular tachycardia, iterruptio of fuctio due to electrical or magetic iterferece, shutig of eergy from defibrillatio paddles, system failure due to ioisig radiatio. Other possible adverse effects iclude mortality due to iappropriate delivery of therapy caused by: multiple coutig of cardiac evets icludig T waves, P waves or supplemetal pacemaker stimuli. Amog the psychological effects of device implatatio are imagied pulsig, depedecy, fear of iappropriate pulsig ad fear of losig pulse capability. Refer to the User s Maual for detailed idicatios, cotraidicatios, warigs, precautios ad potetial adverse evets. Brief Summary: Prior to usig these devices, please review the Istructios for Use for a complete listig of idicatios, cotraidicatios, warigs, precautios, potetial adverse evets ad directios for use. Devices depicted may ot be available i all coutries. Check with your St. Jude Medical represetative for product availability i your coutry. Uless otherwise oted, idicates that the ame is a trademark of, or licesed to, St. Jude Medical or oe of its subsidiaries. ST. JUDE MEDICAL, the ie-squares symbol ad MORE CONTROL. LESS RISK. are registered ad uregistered trademarks ad service marks of St. Jude Medical, Ic. ad its related compaies. 2011 St. Jude Medical, Ic. All rights reserved.
Cardiac Resychroisatio Therapy (CRT) Devices Uify Cardiac Resychroisatio Therapy Defibrillator (CRT-D) Product Specificatios PHYSICAL SPECIFICATIONS Models CD3235-40 CD3235-40Q Telemetry RF RF Delivered/Stored Eergy (J) 40/45 40/45 Volume (cc) 36 36 Weight (g) 78 77 Size (mm) 79 x 40 x 14 73 x 40 x 14 Defibrillatio Lead Coectios DF1 DF4 Sese/Pace Lead Coectios IS-1 IS-1; DF4 High Voltage Ca Electrically active titaium ca Electrically active titaium ca PARAMETER Bivetricular Pacig SETTINGS V. Triggerig (BiV Trigger Mode) O; Off QuickOpt Timig Cycle Optimisatio Sesed/paced AV delay; Itervetricular Pace delay V-V Timig Simultaeous**; RV First; LV First Itervetricular Pace Delay (ms) RV First 10-80 / LV First 15-80 i icremets of 5 Vetricular Sesig RV oly (ot programmable) Vetricular Pacig Chamber RV oly; bivetricular Negative AV Hysteresis/Search (ms) Off; -10 to -120 Shortest AV Delay (ms) 25-120 VectSelect LV Pulse Cofiguratio LV tip to RV coil; LV bipolar; LV rig to RV coil AF Maagemet AF Suppressio Pacig O; Off No. of Overdrive Pacig Cycles 15-40 i steps of 5 Maximum AF Suppressio Rate 80-150 mi -1 Sesig/Detectio SeseAbility Techology Automatic Sesitivity Cotrol adjustmet for atrial ad vetricular evets Low Frequecy Atteuatio O; Off Sese Filter (Post-Sesed; Atrial) 50; 62,5; 75; 100%; (Post-Paced; Atrial) 0,2-3,0 mv; Threshold Start (Post-Sesed; Vetricular) 50; 62,5; 75; 100%; (Post-Paced; Vetricular) Auto; 0,2-3,0 mv Decay Delay (Post-Sese/Post-Pace; Atrial/Vetricular) 0-220 Vetricular Sese Refractory (ms) 125; 157 Detectio Zoes VT-1; VT-2; VF SVT Discrimiators AV Rate Brach; Sudde Oset; Iterval Stability; Morphology Discrimiatio (MD) with Maual or Automatic Template Update Recofirmatio Cotiuous sesig durig chargig Atitachycardia Pacig Therapy ATP Cofiguratios Ramp; Burst; Sca; 1 or 2 schemes per zoe ATP i VF Zoe ATP While Chargig; ATP Prior to Chargig; Off ATP Upper Rate Cutoff 150-300 bpm Burst Cycle Legth Adaptive; Readaptive or Fixed Mi. Burst Cycle Legth (ms) 150-400 i icremets of 5 Number of Bursts/Stimuli 1-15 with 2-20 Stimuli Add Stimuli per Burst O; Off High-Voltage Therapy High-Voltage Output Mode Fixed Pulse Width; Fixed Tilt Waveform Biphasic; Moophasic RV Polarity Cathode (-); Aode (+) Electrode Cofiguratio RV to Ca; RV to SVC/Ca Bradycardia Pacig Permaet Modes Off; DDD(R); DDT(R); DDI(R); VVT(R); VVI(R); AAI(R) Temporary Modes Off; DDD(R); DDT(R); DDI(R); VVT(R); VVI(R); AAI(R); AAT; DOO; VOO; AOO Rate-Adaptive Sesor O; Off; Passive Programmable Rate ad Off; Base Rate (mi -1 ); Rest Rate (mi -1 ); Maximum Trackig Rate (mi -1 ) Delay Parameters Maximum Sesor Rate (mi -1 ); Paced AV Delay (ms); Sesed AV Delay (ms); Rate Resposive AV Delay; Pulse Amplitude (Atrial; RV ad LV) (V); Pulse Width (Atrial; RV ad LV) (ms); Hysteresis Rate (mi -1 ); Rate Hysteresis with Search Auto Mode Switch (AMS) Off; DDI(R); DDT(R); VVI(R); VVT(R) AMS Detectio Rate (mi -1 ) 110-300 Atrial Tachycardia Base Rate 40; 45;... 135 Auto PMT Detectio/Termiatio A Pace o PMT; Off; Passive Rate Resposive PVARP/VREF Off; Low; Medium; High Vetricular Itrisic Preferece (VIP ) Off; 50-200 (50-150 i icremets of 25; 160-200 i icremets of 10) LV Cap Cofirm; RV Cap Cofirm Setup; O; Moitor; Off ACap Cofirm O; Moitor; Off Post-Therapy Pacig (Idepedetly programmable from Bradycardia ad ATP) Post-Shock Pacig Mode Off; AAI; VVI; DDI; or DDD Post-Shock Base Rate (mi -1 ) 30-100 i icremets of 5 Post-Shock Pacig Duratio (mi) Off; 0,5; 1; 2,5; 5; 7,5; or 10 Device Testig/Iductio Methods DC Fibber Pulse Duratio (sec) 0,5-5,0 Burst Fibber Cycle Legth (ms) 20-100 Noivasive Programmed 2-25 stimuli with up to three extrastimuli Stimulatio (NIPS) Patiet Notifiers Programmable Notifiers (O; Off) Device at ERI; Charge Time Limit Reached; Possible HV Circuit Damage; Atrial Lead Impedace Out of Rage; RV Lead Impedace Out of Rage; LV Lead Impedace Out of Rage; High-Voltage Lead Impedace Out of Rage; AT/AF Burde; V Rate Durig AT/AF; % V pacig; CorVue Cogestio Trigger Device Parameter Reset O Etry ito Backup VVI Mode O Vibratio Duratio (sec) 2; 4; 6; 8; 10; 12; 14; 16 Number of Vibratios per Notificatio 2 Number of Notificatios 1-16 Time Betwee Notificatios (hours) 10; 22 Electrograms ad Diagostics Stored Electrograms Up to 45 miutes icludig up to oe miute programmable pre-trigger data per VT/VF diagosis/detectio electrograms; triggers iclude: diagosis; therapy; atrial episode; PMT termiatio; PC shock delivery; oise reversio; maget reversio; ad morphology template verificatio Therapy Summary Diagram of therapies delivered Episodes Summary Directory listig of up to 60 episodes with access to more details icludig stored electrograms Lifetime Diagostics History of bradycardia evets ad device-iitiated chargig AT/AF Burde Tred Tred data ad couts Vetricular HV Lead Impedace Tred Multi-Vector Tred Data Histograms Evet Histogram; AV Iterval Histogram; Mode Switch Duratio Histogram; Peak Filtered Rate Histogram; Atrial Heart Rate Histogram; Vetricular Heart Rate Histogram; AT/AF Burde; Exercise ad Activity Tredig; V Rates Durig AMS PMT Data Iformatio regardig PMT detectios Real-Time Measuremets (RTM) Pacig lead impedaces; high voltage lead impedaces; uloaded battery voltage; ad sigal amplitudes CorVue Cogestio Moitorig O; Off CorVue Cogestio Trigger 8-18 days *QHR is a trademark of Greatbatch, LTD. **LV first with 10 ms itervetricular delay. (GMCRM767EN) Brief Summary: Prior to usig these devices, please review the Istructios for Use for a complete listig of idicatios, cotraidicatios, warigs, precautios, potetial adverse evets ad directios for use. Devices depicted may ot be available i all coutries. Check with your St. Jude Medical represetative for product availability i your coutry. Uless otherwise oted, idicates that the ame is a trademark of, or licesed to, St. Jude Medical or oe of its subsidiaries. ST. JUDE MEDICAL, the ie-squares symbol ad MORE CONTROL. LESS RISK. are registered ad uregistered trademarks ad service marks of St. Jude Medical, Ic. ad its related compaies. 2011 St. Jude Medical, Ic. All rights reserved. Item GMCRM767EN
Cardiac Resychroisatio Therapy (CRT) Devices Promote Accel Cardiac Resychroisatio Therapy Defibrillator (CRT-D) Product Highlights The DF4 coector is desiged to simplify implats by streamliig defibrillatio coectios ito a sigle termial pi ad reducig the umber of set screws LV, RV ad Atrial Capture Cofirmatio features esure capture of the myocardium i respose to pacig stimuli i the left vetricle, right vetricle ad right atrium. LVCap, RVCap ad ACap Cofirm help esure patiet safety ad therapy delivery by automatically moitorig ad adjustig capture thresholds accordig to chagig patiet eeds Advaced Bivetricular Pacig optios Merli@home Trasmitter Compatible Triggered Pacig with BiV Trigger Mode helps maitai a high percetage of BiV pacig by triggerig pacig i both the left ad right vetricles i respose to a sesed vetricular evet VectSelect programmable LV pulse cofiguratio (LV rig-rv coil, LV tip- RV coil or LV bipolar) may be adjusted oivasively via the programmer Negative AV hysteresis with search promotes vetricular acig by automatically reducig the AV delay whe itrisic activity is preset, thereby promotig a high degree of vetricular pacig DeFT Respose techology offers the most oivasive optios for maagig high DFTs The SeseAbility feature provides the flexibility to fie-tue programmig aroud T-wave oversesig without decreasig sesitivity Vibratory patiet otifier eables patiets with hearig problems to be alerted to a low battery, lead-related complicatios ad more Automatic daily high-voltage lead itegrity test is desiged to esure optimal patiet safety Orderig Iformatio Cotets: Cardiac pulse geerator Model Dimesios Coector Coector Number (H x W x T, mm) Weight (g) Volume (cc) Defibrillatio Sese/Pace CD3215-36 81 x 50 x 14 82 43 DF1 IS-1 CD3215-36Q 75 x 50 x 14 82 42 DF4 IS-1; DF4 Idicatios: The devices are iteded to provide vetricular atitachycardia pacig ad vetricular defibrillatio for automated treatmet of life-threateig vetricular arrhythmias. Cardiac Resychroisatio Therapy Defibrillators (CRT-Ds) are also iteded to resychroise the right ad left vetricles i patiets with cogestive heart failure. Cotraidicatios: Cotraidicatios for use of the pulse geerator system iclude vetricular tachyarrhythmias resultig from trasiet or correctable factors such as drug toxicity, electrolyte imbalace or acute myocardial ifarctio. Adverse Evets: Implatatio of the pulse geerator system, like that of ay other device, ivolves risks, some possibly life-threateig. These iclude but are ot limited to the followig: acute hemorrhage/bleedig, air emboli, arrhythmia acceleratio, cardiac or veous perforatio, cardiogeic shock, cyst formatio, erosio, exacerbatio of heart failure, extrusio, fibrotic tissue growth, fluid accumulatio, hematoma formatio, histotoxic reactios, ifectio, keloid formatio, myocardial irritability, erve damage, peumothorax, thromboemboli, veous occlusio. Other possible adverse effects iclude mortality due to: compoet failure, device-programmer commuicatio failure, lead abrasio, lead dislodgmet or poor lead placemet, lead fracture, iability to defibrillate, ihibited therapy for a vetricular tachycardia, iterruptio of fuctio due to electrical or magetic iterferece, shutig of eergy from defibrillatio paddles, system failure due to ioisig radiatio. Other possible adverse effects iclude mortality due to iappropriate delivery of therapy caused by: multiple coutig of cardiac evets icludig T waves, P waves or supplemetal pacemaker stimuli. Amog the psychological effects of device implatatio are imagied pulsig, depedecy, fear of iappropriate pulsig ad fear of losig pulse capability. Refer to the User s Maual for detailed idicatios, cotraidicatios, warigs, precautios ad potetial adverse evets. Brief Summary: Prior to usig these devices, please review the Istructios for Use for a complete listig of idicatios, cotraidicatios, warigs, precautios, potetial adverse evets ad directios for use. Devices depicted may ot be available i all coutries. Check with your St. Jude Medical represetative for product availability i your coutry. Uless otherwise oted, idicates that the ame is a trademark of, or licesed to, St. Jude Medical or oe of its subsidiaries. ST. JUDE MEDICAL, the ie-squares symbol ad MORE CONTROL. LESS RISK. are registered ad uregistered trademarks ad service marks of St. Jude Medical, Ic. ad its related compaies. 2011 St. Jude Medical, Ic. All rights reserved.
Promote Accel Cardiac Resychroisatio Therapy Defibrillator (CRT-D) Product Specificatios Cardiac Resychroisatio Therapy (CRT) Devices (GMCRM917EN) PHYSICAL SPECIFICATIONS Models CD3215-36 CD3215-36Q Telemetry RF RF Delivered Eergy (J) 36 36 Volume (cc) 43 42 Weight (g) 82 82 Size (mm) 81 x 50 x 14 75 x 50 x 14 Defibrillatio Lead Coectios DF1 DF4 Sese/Pace Lead Coectios IS-1 IS-1; DF4 High Voltage Ca Electrically active Electrically active titaium ca titaium ca PARAMETER Settigs V. Triggerig (BiV Trigger Mode) O; Off QuickOpt Timig Cycle Optimisatio Sesed/paced AV delay; Itervetricular Pace delay V-V Timig Simultaeous*; RV First; LV First Itervetricular Pace Delay (ms) RV First 10-80 / LV First 15-80 i icremets of 5 Vetricular Sesig RV oly (ot programmable) Vetricular Pacig Chamber RV oly; bivetricular Negative AV Hysteresis/Search (ms) Off; -10 to -120 Shortest AV Delay (ms) 25-120 VectSelect LV Pulse Cofiguratio LV tip to RV coil; LV bipolar; LV rig to RV coil AF Maagemet AF Suppressio Pacig O; Off No. of Overdrive Pacig Cycles 15-40 i steps of 5 Maximum AF Suppressio Rate 80-150 mi -1 Sesig/Detectio SeseAbility Techology Automatic Sesitivity Cotrol adjustmet for atrial ad vetricular evets Threshold Start (Post-Sesed; Atrial) 50; 62,5; 75; 100%; (Post-Paced, Atrial) 0,2-3,0 mv; (Post-Sesed; Vetricular) 50; 62,5; 75; 100%; (Post-Paced; Vetricular) Auto; 0,2-3,0 mv Decay Delay (Post-Sese/Post-Pace; Atrial/Vetricular) 0-220 Vetricular Sese Refractory (ms) 125; 157 Detectio Zoes VT-1; VT-2; VF SVT Discrimiators AV Rate Brach; Sudde Oset; Iterval Stability; Morphology Discrimiatio (MD) with Maual or Automatic Template Update Recofirmatio Cotiuous sesig durig chargig Atitachycardia Pacig Therapy ATP Cofiguratios Ramp; Burst; Sca; 1 or 2 schemes per zoe Burst Cycle Legth Adaptive; Readaptive or Fixed Mi. Burst Cycle Legth (ms) 150-400 i icremets of 5 Number of Bursts/Stimuli 1-15 with 2-20 Stimuli Add Stimuli per Burst O; Off High-Voltage Therapy High-Voltage Output Mode Fixed Pulse Width; Fixed Tilt Waveform Biphasic; Moophasic RV Polarity Cathode (-); Aode (+) Electrode Cofiguratio RV to Ca; RV to SVC/Ca Bradycardia Pacig Permaet Modes Off; DDD(R); DDT(R); DDI(R); VVT(R); VVI(R); AAI(R) Temporary Modes Off; DDD(R); DDT(R); DDI(R); VVT(R); VVI(R); AAI(R); AAT; DOO; VOO; AOO Rate-Adaptive Sesor O; Off; Passive Programmable Rate ad Off; Base Rate (mi -1 ); Rest Rate (mi -1 ); Maximum Trackig Rate (mi -1 ) Delay Parameters Maximum Sesor Rate (mi -1 ); Paced AV Delay (ms); Sesed AV Delay (ms); Rate Resposive AV Delay; Pulse Amplitude (Atrial; RV ad LV) (V); Pulse Width (Atrial; RV ad LV) (ms); Hysteresis Rate (mi -1 ); Rate Hysteresis with Search Auto Mode Switch (AMS) Off; DDI(R); DDT(R); VVI(R); VVT(R) AMS Detectio Rate (mi -1 ) 110-300 Atrial Tachycardia Base Rate 40; 45;...135 Auto PMT Detectio/Termiatio A Pace o PMT; Off; Passive Rate Resposive PVARP/VREF Off; Low; Medium; High Vetricular Itrisic Preferece (VIP ) Off; 50-200 (50-150 i icremets of 25; 160-200 i icremets of 10) LV Cap Cofirm, RV Cap Cofirm Setup; O; Moitor; Off ACap Cofirm O; Moitor; Off Brief Summary: Prior to usig these devices, please review the Istructios for Use for a complete listig of idicatios, cotraidicatios, warigs, precautios, potetial adverse evets ad directios for use. Devices depicted may ot be available i all coutries. Check with your St. Jude Medical represetative for product availability i your coutry. Uless otherwise oted, idicates that the ame is a trademark of, or licesed to, St. Jude Medical or oe of its subsidiaries. ST. JUDE MEDICAL, the ie-squares symbol ad MORE CONTROL. LESS RISK. are registered ad uregistered trademarks ad service marks of St. Jude Medical, Ic. ad its related compaies. 2011 St. Jude Medical, Ic. All rights reserved. Item GMCRM917EN Post-Therapy Pacig (Idepedetly programmable from Bradycardia ad ATP ) Post-Shock Pacig Mode Off; AAI; VVI; DDI; or DDD Post-Shock Base Rate (mi -1 ) 30-100 i icremets of 5 Post-Shock Pacig Duratio (mi) Off; 0,5; 1; 2,5; 5; 7,5; or 10 Device Testig/Iductio Methods DC Fibber Pulse Duratio (sec) 0,5-5,0 Burst Fibber Cycle Legth (ms) 20-100 Noivasive Programmed Stimulatio (NIPS) 2-25 stimuli with up to three extrastimuli Patiet Notifiers Programmable Notifiers (O, Off) Device at ERI; Charge Time Limit Reached; Possible HV Circuit Damage; Atrial Lead Impedace Out of Rage; RV Lead Impedace Out of Rage; LV Lead Impedace Out of Rage; High-Voltage Lead Impedace Out of Rage; AT/AF Burde Device Parameter Reset O Etry ito Backup VVI Mode O Vibratio Duratio (sec) 2; 4; 6; 8; 10; 12; 14; 16 Number of Vibratios per Notificatio 2 Number of Notificatios 1-16 Time Betwee Notificatios (hours) 10; 22 Electrograms ad Diagostics Stored Electrograms Up to 45 miutes icludig up to oe miute programmable pre-trigger data per VT/VF diagosis/detectio electrograms; triggers iclude diagosis; therapy; atrial episode; PMT termiatio; PC shock delivery; oise reversio; maget reversio; ad morphology template verificatio Therapy Summary Diagram of therapies delivered Episodes Summary Directory listig of up to 60 episodes with access to more details icludig stored electrograms Lifetime Diagostics History of bradycardia evets ad device-iitiated chargig AT/AF Burde Tred Tred data ad couts Vetricular HV Lead Impedace Tred Multi-Vector Tred Data Histograms Evet Histogram; AV Iterval Histogram; Mode Switch Duratio Histogram; Peak Filtered Rate Histogram; Atrial Heart Rate Histogram; Vetricular Heart Rate Histogram; AT/AF Burde; Exercise ad Activity Tredig; V Rates Durig AMS PMT Data Iformatio regardig PMT detectios Real-Time Measuremets (RTM) Pacig lead impedaces; high voltage lead impedaces; uloaded battery voltage; ad sigal amplitudes *LV first with 10 ms itervetricular delay. 1 Mouchawar G, Kroll M, Val-Mejias JE et al. ICD waveform optimizatio: a radomized prospective, pair-sampled multiceter study. PACE 2000; 23 (Part II):1992-1995. 2 Sweeey MO, Natale A, Volosi KJ et al. Prospective radomized compariso of 50%/50% versus 65%/65% tilt biphasic waveform o defibrillatio i humas. PACE 2001; 24:60-65. 3 Baker et al. Acute evaluatio of programmer-guided AV/PV ad VV delay optimizatio comparig a IEGM method ad echocardiogram for cardiac resychroizatio therapy i heart failure patiets ad dual-chamber ICD implats. Joural of Cardiovascular Electrophysiology, Vol. 18 No. 2, Feb. 2007. 4 Cha et al. Tissue Doppler guided optimizatio of A-V ad V-V delay of bivetricular pacemaker improves respose to cardiac resychroizatio therapy i heart failure patiets. J Cardiac Failure 2004; 10:4 (supplemet): 572 (abstract 199). 5 Sperzel J, Meie M et al. A ew automatic update fuctio of the morphology template used for SVT/VT discrimiatio i a ICD. Europace Supplemets; Vol. 3, July 2002; A 131, #1515. 6 Carlso MD et al. A ew pacemaker algorithm for the treatmet of atrial fibrillatio: results of the Atrial Dyamic Overdrive Pacig Trial (ADOPT). JACC 2003; 42:627-633. 7 Sharma AD, O Neill PG, Fai E et al. Shock o T versus DC for iductio of vetricular fibrillatio: a radomized prospective compariso. 21st Aual Scietific Sessio North America Society of Pacig ad Electrophysiology (NASPE). Poster presetatio published i meetig proceedigs. Washigto D.C., U.S.A. May 2000.
Cardiac Resychroisatio Therapy (CRT) Devices Promote + Cardiac Resychroisatio Therapy Defibrillator (CRT-D) Product Highlights The DF4 coector is desiged to simplify implats by streamliig defibrillatio coectios ito a sigle termial pi ad reducig the umber of set screws Triple redudacy safety platform is desiged to miimise risk ad icrease security ad patiet comfort through multiple hardware ad software system safeguards Triggered pacig with BiV Trigger Mode helps maitai a high percetage of BiV pacig by triggerig pacig i both the left ad right vetricles i respose to a sesed vetricular evet Negative AV hysteresis with search promotes vetricular pacig by automatically reducig the AV delay whe itrisic activity is preset, thereby promotig a high degree of vetricular pacig AT/AF Alerts ca be programmed to otify patiets ad their cliics whe a programmed AT/AF threshold or cotiuous episode duratio has bee exceeded, or whe a high vetricular rate accompaies the AT/AF episode Vibratory patiet otifier eables patiets with hearig problems to be alerted to a low battery, lead-related complicatios ad more QuickOpt timig cycle optimisatio provides quick ad effective optimisatio for more patiets at the push of a butto VectSelect programmable LV pulse cofiguratio (LV rig-rv coil, LV tip- RV coil or LV bipolar) may be adjusted oivasively via the programmer DeFT Respose techology tools provide more cliically prove, oivasive optios for maagig high DFTs Merli@home Trasmitter Compatible Orderig Iformatio Cotets: Cardiac pulse geerator Model Dimesios Coector Coector Number (H x W x T, mm) Weight (g) Volume (cc) Defibrillatio Sese/Pace CD3211-36 81 x 50 x 14 82 43 DF1 IS-1 CD3211-36Q 75 x 50 x 14 82 42 DF4 IS-1; DF4 Idicatios: The devices are iteded to provide vetricular atitachycardia pacig ad vetricular defibrillatio for automated treatmet of life-threateig vetricular arrhythmias. Cardiac Resychroisatio Therapy Defibrillators (CRT-Ds) are also iteded to resychroise the right ad left vetricles i patiets with cogestive heart failure. Cotraidicatios: Cotraidicatios for use of the pulse geerator system iclude vetricular tachyarrhythmias resultig from trasiet or correctable factors such as drug toxicity, electrolyte imbalace or acute myocardial ifarctio. Adverse Evets: Implatatio of the pulse geerator system, like that of ay other device, ivolves risks, some possibly life-threateig. These iclude but are ot limited to the followig: acute hemorrhage/bleedig, air emboli, arrhythmia acceleratio, cardiac or veous perforatio, cardiogeic shock, cyst formatio, erosio, exacerbatio of heart failure, extrusio, fibrotic tissue growth, fluid accumulatio, hematoma formatio, histotoxic reactios, ifectio, keloid formatio, myocardial irritability, erve damage, peumothorax, thromboemboli, veous occlusio. Other possible adverse effects iclude mortality due to: compoet failure, device-programmer commuicatio failure, lead abrasio, lead dislodgmet or poor lead placemet, lead fracture, iability to defibrillate, ihibited therapy for a vetricular tachycardia, iterruptio of fuctio due to electrical or magetic iterferece, shutig of eergy from defibrillatio paddles, system failure due to ioisig radiatio. Other possible adverse effects iclude mortality due to iappropriate delivery of therapy caused by: multiple coutig of cardiac evets icludig T waves, P waves or supplemetal pacemaker stimuli. Amog the psychological effects of device implatatio are imagied pulsig, depedecy, fear of iappropriate pulsig ad fear of losig pulse capability. Refer to the User s Maual for detailed idicatios, cotraidicatios, warigs, precautios ad potetial adverse evets. Brief Summary: Prior to usig these devices, please review the Istructios for Use for a complete listig of idicatios, cotraidicatios, warigs, precautios, potetial adverse evets ad directios for use. Devices depicted may ot be available i all coutries. Check with your St. Jude Medical represetative for product availability i your coutry. Uless otherwise oted, idicates that the ame is a trademark of, or licesed to, St. Jude Medical or oe of its subsidiaries. ST. JUDE MEDICAL, the ie-squares symbol ad MORE CONTROL. LESS RISK. are registered ad uregistered trademarks ad service marks of St. Jude Medical, Ic. ad its related compaies. 2011 St. Jude Medical, Ic. All rights reserved.
Cardiac Resychroisatio Therapy (CRT) Devices Promote + Cardiac Resychroisatio Therapy Defibrillator (CRT-D) Product Specificatios PHYSICAL SPECIFICATIONS Models CD3211-36 CD3211-36Q Telemetry RF RF Delivered/Stored Eergy (J) 36/42 36/42 Volume (cc) 43 42 Weight (g) 82 82 Size (mm) 81 x 50 x 14 75 x 50 x 14 Defibrillatio Lead Coectios DF1 DF4 Sese/Pace Lead Coectios IS-1 IS-1; DF4 High-Voltage Ca Electrically active titaium ca Electrically active titaium ca PARAMETER Bivetricular Pacig SETTINGS V. Triggerig (BiV Trigger Mode) O; Off QuickOpt Timig Cycle Optimisatio Sesed/paced AV delay; Itervetricular Pace delay V-V Timig Simultaeous*; RV First; LV First Itervetricular Pace Delay (ms) RV First 10-80 / LV First 15-80 i icremets of 5 Vetricular Sesig RV oly (ot programmable) Vetricular Pacig Chamber RV oly; bivetricular Negative AV Hysteresis/Search (ms) Off; -10 to -120 Shortest AV Delay (ms) 25-120 VectSelect LV Pulse Cofiguratio LV tip to RV coil; LV bipolar; LV rig to RV coil AF Maagemet AF Suppressio Pacig O; Off No. of Overdrive Pacig Cycles 15-40 i steps of 5 Maximum AF Suppressio Rate 80-150 mi -1 Sesig/Detectio SeseAbility Techology Threshold Start Automatic Sesitivity Cotrol adjustmet for atrial ad vetricular evets (Post-Sesed; Atrial) 50; 62,5; 75; 100%; (Post-Paced; Atrial) 0,2-3,0 mv; (Post-Sesed; Vetricular) 50; 62,5; 75; 100%; (Post-Paced; Vetricular) Auto; 0,2-3,0 mv Decay Delay (Post-Sesed/Post-Paced; Atrial/Vetricular) 0-220; (Post-Paced Vetricular), Auto Vetricular Sese Refractory (ms) 125; 157 Detectio Zoes VT-1; VT-2; VF SVT Discrimiators AV Rate Brach; Sudde Oset; Iterval Stability; Morphology Discrimiatio (MD) with Maual or Automatic Template Update Recofirmatio Cotiuous sesig durig chargig Atitachycardia Pacig Therapy ATP Cofiguratios Ramp; Burst; Sca; 1 or 2 schemes per zoe Burst Cycle Legth Readaptive or Fixed Mi. Burst Cycle Legth (ms) 150-400 i icremets of 5 Number of Bursts/Stimuli 1-15 with 2-20 Stimuli Add Stimuli per Burst O; Off High-Voltage Therapy High-Voltage Output Mode Fixed Pulse Width; Fixed Tilt Waveform Biphasic; Moophasic RV Polarity Cathode (-); Aode (+) Electrode Cofiguratio RV to Ca; RV to SVC/Ca Bradycardia Pacig Permaet Modes Off; DDD(R); DDT(R); DDI(R); VVT(R); VVI(R); AAI(R); DOO(R); VOO(R); AOO(R) Temporary Modes Off; DDD(R); DDT(R); DDI(R); VVT(R); VVI(R); AAI(R); AAT(R); DOO; VOO; AOO Rate-Adaptive Sesor O; Off; Passive Programmable Rate ad Off; Base Rate (mi -1 ); Rest Rate (mi -1 ); Maximum Trackig Rate (mi -1 ); Delay Parameters Maximum Sesor Rate (mi -1 ); Paced AV Delay (ms); Sesed AV Delay (ms); Rate Resposive AV Delay; Pulse Amplitude (Atrial; RV ad LV) (V); Pulse Width (Atrial; RV ad LV) (ms); Hysteresis Rate (mi -1 ); Rate Hysteresis with Search Auto Mode Switch (AMS) Off; DDI(R); DDT(R); VVI(R); VVT(R) Atrial Tachycardia Detectio Rate (mi -1 ) 110-300 AMS Base Rate (mi -1 ) 40; 45;... 135 Auto PMT Detectio/Termiatio Atrial Pace; Off; Passive Rate Resposive PVARP/VREF Off; Low; Medium; High Vetricular Itrisic Preferece (VIP ) Off; 50-200 (50-150 i icremets of 25; 160-200 i icremets of 10) Post-Therapy Pacig (idepedetly programmable from Bradycardia ad ATP) Post-Shock Pacig Mode Off; AAI; VVI; DDI; or DDD Post-Shock Base Rate (mi -1 ) 30-100 i icremets of 5 Post-Shock Pacig Duratio (mi) Off; 0,5; 1; 2,5; 5; 7,5; or 10 Device Testig/Iductio Methods DC Fibber Pulse Duratio (sec) 0,5-5,0 Burst Fibber Cycle Legth (ms) 20-100 Noivasive Programmed 2-25 stimuli with up to 3 extrastimuli Stimulatio (NIPS) Patiet Notifiers Programmable Notifiers (O; Off) Device at ERI; Charge Time Limit Reached; Possible HV Circuit Damage; Atrial Lead Impedace Out of Rage; RV Lead Impedace Out of Rage; LV Lead Impedace Out of Rage; High-Voltage Lead Impedace Out of Rage; AT/AF Burde; V Rate Durig AT/AF; Backup VVI; Log AT/AF Episode Device Parameter Reset O Etry ito Backup VVI Mode O Vibratio Duratio (sec) 2; 4; 6; 8; 10; 12; 14; 16 Number of Vibratios per Notificatio 2 Number of Notificatios 1-16 Time Betwee Notificatios (hours) 10; 22 Electrograms ad Diagostics Stored Electrograms Up to 45 miutes icludig up to 1 miute programmable pre-trigger data per VT/VF diagosis/detectio electrograms; triggers iclude: diagosis; therapy; atrial episode; PMT termiatio; PC shock delivery; oise reversio; maget reversio; ad morphology template verificatio Therapy Summary Diagram of therapies delivered Episodes Summary Directory listig of up to 60 episodes with access to more details icludig stored electrograms Lifetime Diagostics History of bradycardia evets ad device-iitiated chargig AT/AF Burde Tred Tred data ad couts Vetricular HV Lead Impedace Tred Multi-Vector Tred Data Histograms Evet Histogram; AV Iterval Histogram; Mode Switch Duratio Histogram; Peak Filtered Rate Histogram; Atrial Heart Rate Histogram; Vetricular Heart Rate Histogram; AT/AF Burde; Exercise ad Activity Tredig; V Rates Durig AMS PMT Data Iformatio regardig PMT detectios Real-Time Measuremets (RTM) Pacig lead impedaces; high-voltage lead impedaces; uloaded battery voltage; ad sigal amplitudes *LV first with 10 ms itervetricular delay. (GMCRM768EN) Brief Summary: Prior to usig these devices, please review the Istructios for Use for a complete listig of idicatios, cotraidicatios, warigs, precautios, potetial adverse evets ad directios for use. Devices depicted may ot be available i all coutries. Check with your St. Jude Medical represetative for product availability i your coutry. Uless otherwise oted, idicates that the ame is a trademark of, or licesed to, St. Jude Medical or oe of its subsidiaries. ST. JUDE MEDICAL, the ie-squares symbol ad MORE CONTROL. LESS RISK. are registered ad uregistered trademarks ad service marks of St. Jude Medical, Ic. ad its related compaies. 2011 St. Jude Medical, Ic. All rights reserved. Item GMCRM768EN
Cardiac Resychroisatio Therapy (CRT) Devices Athem RF Cardiac Resychroisatio Therapy Pacemaker Product Highlights IvisiLik wireless telemetry, i cojuctio with the Merli@home wireless trasmitter ad Merli.et Patiet Care Network (PCN), allows for daily remote moitorig ad follow-up AT/AF Alerts ca be programmed to otify patiets ad their cliics whe a programmed AT/AF threshold or cotiuous episode duratio has bee exceeded, or whe a high vetricular rate accompaies the AT/AF episode Exclusive AF Suppressio algorithm is cliically prove to suppress episodes of paroxysmal ad persistet AF AT/AF burde tred provides a graphical represetatio of the percetage of time i AT/AF ad the umber of AT/AF episodes i the previous 52 weeks Up to 14 miutes of stored electrograms help idetify key itrisic ad pacemaker-related evets ad simplify the diagosis of complex ECG rhythms associated with heart failure Merli@home Trasmitter Compatible Orderig Iformatio Cotets: Cardiac pulse geerator Model Number Dimesios (H x W x T, mm) Weight (g) Volume (cc) Coector PM3212 58 x 52 x 6 25 13,7 1 IS-1 Idicatios: Implatatio of Athem ad Athem RF devices is idicated for: maitaiig sychroy of the left ad right vetricles i patiets who have udergoe a AV odal ablatio for chroic atrial fibrillatio ad have NYHA Class II or III heart failure, the reductio of the symptoms of moderate to severe heart failure (NYHA Class III or IV) i those patiets who remai symptomatic despite stable, optimal medical therapy, ad have a left vetricular ejectio fractio 35% ad a prologed QRS duratio, implatatio of Accet, Accet RF, Athem, ad Athem RF devices is idicated i oe or more of the followig permaet coditios: sycope, presycope, fatigue, disorietatio, or ay combiatio of those symptoms. Rate-Modulated Pacig is idicated for patiets with chrootropic icompetece, ad for those who would beefit from icreased stimulatio rates cocurret with physical activity. Dual-Chamber Pacig is idicated for those patiets exhibitig: sick sius sydrome, chroic, symptomatic secod- ad third-degree AV block, recurret Adams-Stokes sydrome, symptomatic bilateral budle brach block whe tachyarrhythmia ad other causes have bee ruled out. Atrial Pacig is idicated for patiets with sius ode dysfuctio ad ormal AV ad itravetricular coductio systems. Vetricular Pacig is idicated for patiets with sigificat bradycardia ad ormal sius rhythm with oly rare episodes of A-V block or sius arrest, chroic atrial fibrillatio, severe physical disability. AF Suppressio is idicated for suppressio of paroxysmal or persistet atrial fibrillatio episodes i patiets with oe or more of the above pacig idicatios. Cotraidicatios: Implated Cardioverter-Defibrillator (ICD). Devices are cotraidicated i patiets with a implated cardioverter-defibrillator. Rate-Adaptive Pacig may be iappropriate for patiets who experiece agia or other symptoms of myocardial dysfuctio at higher sesor-drive rates. A appropriate Maximum Sesor Rate should be selected based o assessmet of the highest stimulatio rate tolerated by the patiet. AF Suppressio stimulatio is ot recommeded i patiets who caot tolerate high atrial-rate stimulatio. Dual-Chamber Pacig, though ot cotraidicated for patiets with chroic atrial flutter, chroic atrial fibrillatio, or silet atria, may provide o beefit beyod that of sigle-chamber pacig i such patiets. Sigle-Chamber Vetricular Demad Pacig is relatively cotraidicated i patiets who have demostrated pacemaker sydrome, have retrograde VA coductio, or suffer a drop i arterial blood pressure with the oset of vetricular pacig. Sigle-Chamber Atrial Pacig is relatively cotraidicated i patiets who have demostrated compromise of AV coductio. Atrial Fibrillatio. Athem devices are cotraidicated i patiets havig chroic atrial fibrillatio or itermittet atrial fibrillatio that does ot termiate. For specific cotraidicatios associated with idividual modes, refer to the programmer s o-scree help. Potetial Adverse Evets: The followig are potetial complicatios associated with the use of ay pacig system: air embolism, body rejectio pheomea, cardiac tampoade or perforatio, hematoma, bleedig hematoma, seroma, formatio of fibrotic tissue, local tissue reactio, iability to iterrogate or program due to programmer or device malfuctio, ifectio/erosio, iterruptio of desired pulse geerator fuctio due to electrical iterferece, either electromyogeic or electromagetic, lead malfuctio due to coductor fracture or isulatio degradatio, loss of capture or sesig due to lead dislodgemet or reactio at the electrode/ tissue iterface, loss of desired pacig ad/or sesig due to lead displacemet, body reactio at electrode iterface, or lead malfuctio (fracture or damage to isulatio), loss of ormal device fuctio due to battery failure or compoet malfuctio, pacemaker migratio or pocket erosio, pectoral muscle or diaphragmatic stimulatio, phreic erve stimulatio, peumothorax/hemothorax, edocarditis, excessive bleedig, iduced atrial or vetricular arrhythmias, myocardial irritability, pericardial effusio, pericardial rub, pulmoary edema, rise i threshold ad exit block, valve damage, cardiac/coroary sius dissectio, cardiac/coroary sius perforatio, coroary sius or cardiac vei thrombosis. Refer to the User s Maual for detailed idicatios, cotraidicatios, warigs, precautios ad potetial adverse evets. Brief Summary: Prior to usig these devices, please review the Istructios for Use for a complete listig of idicatios, cotraidicatios, warigs, precautios, potetial adverse evets ad directios for use. Devices depicted may ot be available i all coutries. Check with your St. Jude Medical represetative for product availability i your coutry. Uless otherwise oted, idicates that the ame is a trademark of, or licesed to, St. Jude Medical or oe of its subsidiaries. ST. JUDE MEDICAL, the ie-squares symbol ad MORE CONTROL. LESS RISK. are registered ad uregistered trademarks ad service marks of St. Jude Medical, Ic. ad its related compaies. 2011 St. Jude Medical, Ic. All rights reserved.
Cardiac Resychroisatio Therapy (CRT) Devices Athem RF Cardiac Resychroisatio Therapy Pacemaker Product Specificatios (GMCRM769EN) PHYSICAL SPECIFICATIONS Model PM3212 Telemetry RF Dimesios (mm) 58 x 52 x 6 Weight (g) 25 Volume (cc) 1 13,7 1 Coector IS-1 PARAMETER SETTINGS Resychroisatio Therapy QuickOpt Timig Cycle Optimisatio Sesed/Paced AV Delay; Itervetricular Paced Delay RV ad LV Pulse Width (ms) 0,05; 0,1 1,5 i steps of 0,1 RV ad LV Pulse Amplitude (V) 0,25 4,0 i steps of 0,25; 4,5 7,5 i steps of 0,5 RV Pulse Cofiguratio Uipolar; Bipolar LV Pulse Cofiguratio Uipolar; Bipolar; LV Tip-RV Rig; LV Rig-RV Rig Vetricular Sese Cofiguratio BV Uipolar Tip; BV Bipolar; RV Uipolar Tip; RV Bipolar; LV Uipolar Tip; LV Bipolar; RV Uipolar Rig; LV Tip-RV Tip Vetricular Pacig Chamber BV; RV oly; LV oly (temporary mode) First Chamber Paced Simultaeous 2 ; RV; LV Itervetricular Pace Delay (ms) 10 80 i steps of 5 Output/Sesig Negative AV Hysteresis Search (ms) Off; -10 to -120 i steps of 10 Shortest AV/PV Delay (ms) 25 50 i steps of 5; 60 120 i steps of 10 Atrial ACap Cofirm O; Off; Moitor Primary Pulse Cofirmatio Bipolar Backup Pulse Cofirmatio Bipolar Backup Pulse Amplitude (V) 5,0 Searchable Itervals (hrs) 8; 24 Atrial Pulse Cofiguratio Uipolar (tip case); Bipolar (tip rig) Atrial Sese Cofiguratio Uipolar Tip (tip case); Bipolar (tip rig); Uipolar Rig (rig case) Atrial Sesitivity 3,4 (Fixed) (mv) 0,1 0,5 i steps of 0,1; 0,75 2,0 i steps of 0,25; 2,5 5,0 i steps of 0,5 Atrial Pulse Amplitude (V) 0,25 4,0 i steps of 0,25; 4,5 7,5 i steps of 0,5 Atrial Pulse Width (ms) 0,05; 0,1 1,5 i steps of 0,1 RVCap Cofirm O; Off; Moitor Searchable Iterval (hrs) 8; 24 LVCap Cofirm O; Off; Moitor Searchable Iterval (hrs) 8; 24 SeseAbility Techology Off; O (Automatic Sesitivity Cotrol adjustmet for atrial ad vetricular evets) A Max Sesitivity (mv) 0,2-1,0 i steps of 0,1 V Max Sesitivity (mv) 0,2-2,0 i steps of 0,1 Threshold Start (Atrial ad Vetricular Post-Sese) 50; 62,5; 75; 100% (Atrial Post-Pace) 0,2-3,0 i steps of 0,1 mv (Vetricular Post-Pace) Auto; 0,2-3,0 i steps of 0,1 mv Decay Delay (ms) (Atrial ad Vetricular Post-Sese) 0; 30; 60; 95; 125; 160; 190; 220 (Atrial Post-Pace) 0; 30; 60; 95; 125; 160; 190; 220 (Vetricular Post-Pace) Auto; 0; 30; 60; 95; 125; 160; 190; 220 Vetricular Sesitivity (fixed) (mv) 0,5-12,5 i steps of 0,5 3,4 Rate/Timig Mode A00(R); AAI(R); AAT(R); VOO(R); VVI(R); VVT(R); DOO(R); DVI(R); DDI(R); DDT(R); DDD(R); VDD(R); Pacig Off DDT Trigger 5 R wave DDT Timig 5 DDI Base Rate (mi -1 ) 30 130 i steps of 5; 140 170 i steps of 10 Hysteresis Rate (mi -1 ) Off; 30-150 i steps of 5 6 Search Iterval (mi) Off; 1; 5; 10; 15; 30 Cycle Cout 1 16 Itervetio Rate (mi -1 ) Off; Same Base Rate; 80-120 i steps of 10 (Itrisic +0; Itrisic +10; Itrisic +20; Itrisic +30) Itervetio Duratio (mi -1 ) 1 10 Recovery Time Fast; Medium; Slow; Very Slow Rest Rate (mi -1 ) Off; 30-150 i steps of 5 Maximum Trackig Rate (mi -1 ) 90 130 i steps of 5; 140 180 i steps of 10 Sesed AV Delay (ms) 25; 30 200 i steps of 10; 225 325 i steps of 25 Paced AV Delay (ms) 25; 30 200 i steps of 10; 225 300 i steps of 25; 350 Vetricular Pace/Sese Refractory 7 (Fixed) (ms) 125; 160-400 i steps of 30; 440; 470 8 Atrial Pace Refractory 190-400 i steps of 30; 440; 470 8 Atrial Sese Refractory 93; 125; 157; 190-400 i steps of 30; 440; 470 8 PVARP (ms) 125 500 i steps of 25 Atrial Protectio Iterval (ms) 5 125 Far-Field Protectio Iterval (ms) 5 16 1 ± 0,5 cc 2 LV first with 10 ms itervetricular delay. 3 Sesitivity is with respect to a 20 ms haversie test sigal. 4 Values 0,1-0,4 ot available i a Uipolar Sese Cofiguratio. 5 This parameter is ot programmable. 6 The highest available settig for hysteresis rate is 5 mi -1 below the programmed base rate. 7 I dual-chamber modes, the maximum Vetricular Refractory Period is 325 ms. 8 Programmig optios depedet o pacig mode. 9 Durig atrial NIPS i dual-chamber modes, the shortest Couplig Iterval will be limited by the programmed AV/PV Delay. 10 S1 Burst Cycle is applied at the preprogrammed S1 cycle legth. Brief Summary: Prior to usig these devices, please review the Istructios for Use for a complete listig of idicatios, cotraidicatios, warigs, precautios, potetial adverse evets ad directios for use. Devices depicted may ot be available i all coutries. Check with your St. Jude Medical represetative for product availability i your coutry. Uless otherwise oted, idicates that the ame is a trademark of, or licesed to, St. Jude Medical or oe of its subsidiaries. ST. JUDE MEDICAL, the ie-squares symbol ad MORE CONTROL. LESS RISK. are registered ad uregistered trademarks ad service marks of St. Jude Medical, Ic. ad its related compaies. 2011 St. Jude Medical, Ic. All rights reserved. Item GMCRM769EN Rate-Modulated Rate Resposive AV/PV Delay Off; Low; Medium; High Rate Resposive PVARP/VREF Off; Low; Medium; High Shortest PVARP/VREF 125 475 i steps of 25 Sesor O; Off; Passive Max Sesor Rate (mi -1 ) 80 150 i steps of 5; 160-180 i steps of 10 Threshold Auto (-0,5); Auto (+0,0); Auto (+0,5); Auto (+1,0); Auto (+1,5); Auto +(2,0); 1-7 i steps of 0,5 Slope Auto (-1); Auto (+0); Auto (+1); Auto (+2); Auto (+3); 1-16 Reactio Time Very Fast; Fast; Medium; Slow Recovery Time Fast; Medium; Slow; Very Slow AF Maagemet AF Suppressio Algorithm Off; O Lower Rate Overdrive (mi -1 ) 5 10 Upper Rate Overdrive (mi -1 ) 5 5 No. of Overdrive Pacig Cycles 15 40 i steps of 5 Rate Recovery (ms) 8; 12 Auto Mode Switch Off; DDD(R) to DDI(R); DDD(R) to DDT(R); DDD(R) to VVI(R); DDD(R) to VVT(R); VDD(R) to VVI(R); VDD(R) to VVT(R) AMS Base Rate (mi -1 ) 40-170 i steps of 5 Stored Electrograms Optios Priority Optios Chael 1; 2; 3 Triggers Advaced Hysteresis AMS Etry/AMS Exit/ AMS Etry ad Exit AT/AF Detectio Maget Respose High Atrial Rate Rate (mi -1 ) 125-300 i steps of 25 No. of Cosecutive Cycles 2; 3; 4; 5; 10; 15; 20 High Vetricular Rate Rate (mi -1 ) 125-300 i steps of 25 No. of Cosecutive Cycles 2; 3; 4; 5; 10; 15; 20 PMT Termiatio Cosecutive PVCs No. of Cosecutive PVCs 2; 3; 4; 5 Noise Reversio Other Maget Respose Off; Battery Test Vetricular Itrisic Preferece, VIP (ms) Off; 50 150 i steps of 25; 160-200 i steps of 10 VIP Search Iterval 30 sec.; 1; 3; 5; 10; 30 mi. VIP Search Cycles 1; 2; 3 of the Atrial Tachycardia Detectio Rate (mi -1 ) 110 200 i steps of 10; 225 300 i steps of 25 Post Vet. Atrial Blakig (PVAB) (ms) 60-200 i steps of 10; 225; 250 Vetricular Safety Stadby Off; O PVC Respose Off; Atrial Pace 8 PMT Optios Off; Passive; Atrial Pace 8 PMT Detectio Rate (mi -1 ) 90 180 i steps of 5 Lead Type Ucoded; Uipolar; Bipolar NIPS Optios Stimulatio Chamber Atrial; Right Vetricular Couplig Iterval 9 (ms) 200-800 i steps of 10 S1 Cout 2-25 i steps of 1 S1 10 ; S2; S3 ad S4 Cycle (ms) Off; 100 800 i steps of 10 (Fixed or Adaptive) Right Vetricular Support Rate (mi -1 ) Off; 30-95 i steps of 5 Sius Node Recovery Delay (s) 1-5 i steps of 1 Diagostic Treds AT/AF Activity; Exercise; Lead Impedace; P ad R Wave; A ad V threshold Patiet Notifiers Programmable Notifiers (O; Off) Device at ERI; Atrial Lead Impedace Out of Rage; Vetricular Lead Impedace Out of Rage; LV Lead Impedace Out of Rage; AT/AF Burde; AT/AF Episode Duratio; High V Rate Durig AT/AF Device Reset O Etry ito Backup VVI Mode O Audible Duratio (sec) 2; 4; 6; 8; 10; 12; 14; 16 Number of Audible Alerts per Notificatio 2 Number of Notificatios 1 16 Time Betwee Notificatios (hours) 10; 22
Cardiac Resychroisatio Therapy (CRT) Devices Athem Cardiac Resychroisatio Therapy Pacemaker Product Highlights AT/AF Alerts ca be programmed to otify patiets ad their cliics whe a programmed AT/AF threshold or cotiuous episode duratio has bee exceeded, or whe a high vetricular rate accompaies the AT/AF episode Exclusive AF Suppressio algorithm is cliically prove to suppress episodes of paroxysmal ad persistet AF AT/AF burde tred provides a graphical represetatio of the percetage of time i AT/AF ad the umber of AT/AF episodes i the previous 52 weeks Exclusive SeseAbility feature, with Decay Delay ad Threshold Start, provides the flexibility to fie-tue sesig to idividual patiet eeds ad help elimiate oversesig of T waves, fractioated QRS complexes ad other extraeous sigals Up to 14 miutes of stored electrograms help idetify key itrisic ad pacemaker-related evets ad simplify the diagosis of complex ECG rhythms associated with heart failure Orderig Iformatio Cotets: Cardiac pulse geerator Model Number Dimesios (H x W x T, mm) Weight (g) Volume (cc) Coector PM3112 52 x 52 x 6 21 11,5 1 IS-1 Idicatios: Implatatio of Athem ad Athem RF devices is idicated for: maitaiig sychroy of the left ad right vetricles i patiets who have udergoe a AV odal ablatio for chroic atrial fibrillatio ad have NYHA Class II or III heart failure, the reductio of the symptoms of moderate to severe heart failure (NYHA Class III or IV) i those patiets who remai symptomatic despite stable, optimal medical therapy, ad have a left vetricular ejectio fractio 35% ad a prologed QRS duratio, implatatio of Accet, Accet RF, Athem, ad Athem RF devices is idicated i oe or more of the followig permaet coditios: sycope, presycope, fatigue, disorietatio, or ay combiatio of those symptoms. Rate-Modulated Pacig is idicated for patiets with chrootropic icompetece, ad for those who would beefit from icreased stimulatio rates cocurret with physical activity. Dual-Chamber Pacig is idicated for those patiets exhibitig: sick sius sydrome, chroic, symptomatic secod- ad third-degree AV block, recurret Adams-Stokes sydrome, symptomatic bilateral budle brach block whe tachyarrhythmia ad other causes have bee ruled out. Atrial Pacig is idicated for patiets with sius ode dysfuctio ad ormal AV ad itravetricular coductio systems. Vetricular Pacig is idicated for patiets with sigificat bradycardia ad ormal sius rhythm with oly rare episodes of A-V block or sius arrest, chroic atrial fibrillatio, severe physical disability. AF Suppressio is idicated for suppressio of paroxysmal or persistet atrial fibrillatio episodes i patiets with oe or more of the above pacig idicatios. Cotraidicatios: Implated Cardioverter-Defibrillator (ICD). Devices are cotraidicated i patiets with a implated cardioverter-defibrillator. Rate-Adaptive Pacig may be iappropriate for patiets who experiece agia or other symptoms of myocardial dysfuctio at higher sesor-drive rates. A appropriate Maximum Sesor Rate should be selected based o assessmet of the highest stimulatio rate tolerated by the patiet. AF Suppressio stimulatio is ot recommeded i patiets who caot tolerate high atrial-rate stimulatio. Dual-Chamber Pacig, though ot cotraidicated for patiets with chroic atrial flutter, chroic atrial fibrillatio, or silet atria, may provide o beefit beyod that of sigle-chamber pacig i such patiets. Sigle-Chamber Vetricular Demad Pacig is relatively cotraidicated i patiets who have demostrated pacemaker sydrome, have retrograde VA coductio, or suffer a drop i arterial blood pressure with the oset of vetricular pacig. Sigle-Chamber Atrial Pacig is relatively cotraidicated i patiets who have demostrated compromise of AV coductio. Atrial Fibrillatio. Athem devices are cotraidicated i patiets havig chroic atrial fibrillatio or itermittet atrial fibrillatio that does ot termiate. For specific cotraidicatios associated with idividual modes, refer to the programmer s o-scree help. Potetial Adverse Evets: The followig are potetial complicatios associated with the use of ay pacig system: air embolism, body rejectio pheomea, cardiac tampoade or perforatio, hematoma, bleedig hematoma, seroma, formatio of fibrotic tissue, local tissue reactio, iability to iterrogate or program due to programmer or device malfuctio, ifectio/erosio, iterruptio of desired pulse geerator fuctio due to electrical iterferece, either electromyogeic or electromagetic, lead malfuctio due to coductor fracture or isulatio degradatio, loss of capture or sesig due to lead dislodgemet or reactio at the electrode/ tissue iterface, loss of desired pacig ad/or sesig due to lead displacemet, body reactio at electrode iterface, or lead malfuctio (fracture or damage to isulatio), loss of ormal device fuctio due to battery failure or compoet malfuctio, pacemaker migratio or pocket erosio, pectoral muscle or diaphragmatic stimulatio, phreic erve stimulatio, peumothorax/hemothorax, edocarditis, excessive bleedig, iduced atrial or vetricular arrhythmias, myocardial irritability, pericardial effusio, pericardial rub, pulmoary edema, rise i threshold ad exit block, valve damage, cardiac/coroary sius dissectio, cardiac/coroary sius perforatio, coroary sius or cardiac vei thrombosis. Refer to the User s Maual for detailed idicatios, cotraidicatios, warigs, precautios ad potetial adverse evets. Brief Summary: Prior to usig these devices, please review the Istructios for Use for a complete listig of idicatios, cotraidicatios, warigs, precautios, potetial adverse evets ad directios for use. Devices depicted may ot be available i all coutries. Check with your St. Jude Medical represetative for product availability i your coutry. Uless otherwise oted, idicates that the ame is a trademark of, or licesed to, St. Jude Medical or oe of its subsidiaries. ST. JUDE MEDICAL, the ie-squares symbol ad MORE CONTROL. LESS RISK. are registered ad uregistered trademarks ad service marks of St. Jude Medical, Ic. ad its related compaies. 2011 St. Jude Medical, Ic. All rights reserved.
Cardiac Resychroisatio Therapy (CRT) Devices Athem Cardiac Resychroisatio Therapy Pacemaker Product Specificatios (GMCRM776EN) PHYSICAL SPECIFICATIONS Model PM3112 Telemetry Iductive Dimesios (mm) 52 x 52 x 6 Weight (g) 21 Volume (cc) 1 11,5 1 Coector IS-1 PARAMETER SETTINGS Resychroisatio Therapy QuickOpt Timig Cycle Optimisatio Sesed/Paced AV Delay; Itervetricular Paced Delay RV ad LV Pulse Width (ms) 0,05; 0,1 1,5 i steps of 0,1 RV ad LV Pulse Amplitude (V) 0,25 4,0 i steps of 0,25; 4,5 7,5 i steps of 0,5 RV Pulse Cofiguratio Uipolar; Bipolar LV Pulse Cofiguratio Uipolar; Bipolar; LV Tip-RV Rig; LV Rig-RV Rig Vetricular Sese Cofiguratio BV Uipolar Tip; BV Bipolar; RV Uipolar Tip; RV Bipolar; LV Uipolar Tip; LV Bipolar; RV Uipolar Rig; LV Tip-RV Tip Vetricular Pacig Chamber BV; RV oly; LV oly (temporary mode) First Chamber Paced Simultaeous 2 ; RV; LV Itervetricular Pace Delay (ms) 10 80 i steps of 5 Output/Sesig Negative AV Hysteresis Search (ms) Off; -10 to -120 i steps of 10 Shortest AV/PV Delay (ms) 25 50 i steps of 5; 60 120 i steps of 10 Atrial ACap Cofirm O; Off; Moitor Primary Pulse Cofirmatio Bipolar Backup Pulse Cofirmatio Bipolar Backup Pulse Amplitude (V) 5,0 Searchable Itervals (hrs) 8; 24 Atrial Pulse Cofiguratio Uipolar (tip case); Bipolar (tip rig) Atrial Sese Cofiguratio Uipolar Tip (tip case); Bipolar (tip rig); Uipolar Rig (rig case) Atrial Sesitivity 3,4 (Fixed) (mv) 0,1 0,5 i steps of 0,1; 0,75 2,0 i steps of 0,25; 2,5 5,0 i steps of 0,5 Atrial Pulse Amplitude (V) 0,25 4,0 i steps of 0,25; 4,5 7,5 i steps of 0,5 Atrial Pulse Width (ms) 0,05; 0,1 1,5 i steps of 0,1 RVCap Cofirm O; Off; Moitor Searchable Iterval (hrs) 8; 24 LVCap Cofirm O; Off; Moitor Searchable Iterval (hrs) 8; 24 SeseAbility Techology Off; O (Automatic Sesitivity Cotrol adjustmet for atrial ad vetricular evets) A Max Sesitivity (mv) 0,2-1,0 i steps of 0,1 V Max Sesitivity (mv) 0,2-2,0 i steps of 0,1 Threshold Start (Atrial ad Vetricular Post-Sese) 50; 62,5; 75; 100% (Atrial Post-Pace) 0,2-3,0 i steps of 0,1 mv (Vetricular Post-Pace) Auto; 0,2-3,0 i steps of 0,1 mv Decay Delay (ms) (Atrial ad Vetricular Post-Sese) 0; 30; 60; 95; 125; 160; 190; 220 (Atrial Post-Pace) 0; 30; 60; 95; 125; 160; 190; 220 (Vetricular Post-Pace) Auto; 0; 30; 60; 95; 125; 160; 190; 220 Vetricular Sesitivity (fixed) (mv) 0,5-12,5 i steps of 0,5 3,4 Rate/Timig Mode A00(R); AAI(R); AAT(R); VOO(R); VVI(R); VVT(R); DOO(R); DVI(R); DDI(R); DDT(R); DDD(R); VDD(R); Pacig Off DDT Trigger 5 R wave DDT Timig 5 DDI Base Rate (mi -1 ) 30 130 i steps of 5; 140 170 i steps of 10 Hysteresis Rate (mi -1 ) Off; 30-150 i steps of 5 6 Search Iterval (mi) Off; 1; 5; 10; 15; 30 Cycle Cout 1 16 Itervetio Rate (mi -1 ) Off; Same Base Rate; 80-120 i steps of 10 (Itrisic +0; Itrisic +10; Itrisic +20; Itrisic +30) Itervetio Duratio (mi -1 ) 1 10 Recovery Time Fast; Medium; Slow; Very Slow Rest Rate (mi -1 ) Off; 30-150 i steps of 5 Maximum Trackig Rate (mi -1 ) 90 130 i steps of 5; 140 180 i steps of 10 Sesed AV Delay (ms) 25; 30 200 i steps of 10; 225 325 i steps of 25 Paced AV Delay (ms) 25; 30 200 i steps of 10; 225 300 i steps of 25; 350 Vetricular Pace/Sese Refractory 7 (Fixed) (ms) 125; 160-400 i steps of 30; 440; 470 8 Atrial Pace Refractory 190-400 i steps of 30; 440; 470 8 Atrial Sese Refractory 93; 125; 157; 190-400 i steps of 30; 440; 470 8 PVARP (ms) 125 500 i steps of 25 Atrial Protectio Iterval (ms) 5 125 Far-Field Protectio Iterval (ms) 5 16 1 ± 0,5 cc 2 LV first with 10 ms itervetricular delay. 3 Sesitivity is with respect to a 20 ms haversie test sigal. 4 Values 0,1-0,4 ot available i a Uipolar Sese Cofiguratio. 5 This parameter is ot programmable. 6 The highest available settig for hysteresis rate is 5 mi -1 below the programmed base rate. 7 I dual-chamber modes, the maximum Vetricular Refractory Period is 325 ms. 8 Programmig optios depedet o pacig mode. 9 Durig atrial NIPS i dual-chamber modes, the shortest Couplig Iterval will be limited by the programmed AV/PV Delay. 10 S1 Burst Cycle is applied at the preprogrammed S1 cycle legth. Brief Summary: Prior to usig these devices, please review the Istructios for Use for a complete listig of idicatios, cotraidicatios, warigs, precautios, potetial adverse evets ad directios for use. Devices depicted may ot be available i all coutries. Check with your St. Jude Medical represetative for product availability i your coutry. Uless otherwise oted, idicates that the ame is a trademark of, or licesed to, St. Jude Medical or oe of its subsidiaries. ST. JUDE MEDICAL, the ie-squares symbol ad MORE CONTROL. LESS RISK. are registered ad uregistered trademarks ad service marks of St. Jude Medical, Ic. ad its related compaies. 2011 St. Jude Medical, Ic. All rights reserved. Item GMCRM776EN Rate-Modulated Rate Resposive AV/PV Delay Off; Low; Medium; High Rate Resposive PVARP/VREF Off; Low; Medium; High Shortest PVARP/VREF 125 475 i steps of 25 Sesor O; Off; Passive Max Sesor Rate (mi -1 ) 80 150 i steps of 5; 160-180 i steps of 10 Threshold Auto (-0,5); Auto (+0,0); Auto (+0,5); Auto (+1,0); Auto (+1,5); Auto +(2,0); 1-7 i steps of 0,5 Slope Auto (-1); Auto (+0); Auto (+1); Auto (+2); Auto (+3); 1-16 Reactio Time Very Fast; Fast; Medium; Slow Recovery Time Fast; Medium; Slow; Very Slow AF Maagemet AF Suppressio Algorithm Off; O Lower Rate Overdrive (mi -1 ) 5 10 Upper Rate Overdrive (mi -1 ) 5 5 No. of Overdrive Pacig Cycles 15 40 i steps of 5 Rate Recovery (ms) 8; 12 Auto Mode Switch Off; DDD(R) to DDI(R); DDD(R) to DDT(R); DDD(R) to VVI(R); DDD(R) to VVT(R); VDD(R) to VVI(R); VDD(R) to VVT(R) AMS Base Rate (mi -1 ) 40-170 i steps of 5 Stored Electrograms Optios Priority Optios Chael 1; 2; 3 Triggers Advaced Hysteresis AMS Etry/AMS Exit/ AMS Etry ad Exit AT/AF Detectio Maget Respose High Atrial Rate Rate (mi -1 ) 125-300 i steps of 25 No. of Cosecutive Cycles 2; 3; 4; 5; 10; 15; 20 High Vetricular Rate Rate (mi -1 ) 125-300 i steps of 25 No. of Cosecutive Cycles 2; 3; 4; 5; 10; 15; 20 PMT Termiatio Cosecutive PVCs No. of Cosecutive PVCs 2; 3; 4; 5 Noise Reversio Other Maget Respose Off; Battery Test Vetricular Itrisic Preferece, VIP (ms) Off; 50 150 i steps of 25; 160-200 i steps of 10 VIP Search Iterval 30 sec.; 1; 3; 5; 10; 30 mi. VIP Search Cycles 1; 2; 3 of the Atrial Tachycardia Detectio Rate (mi -1 ) 110 200 i steps of 10; 225 300 i steps of 25 Post Vet. Atrial Blakig (PVAB) (ms) 60-200 i steps of 10; 225; 250 Vetricular Safety Stadby Off; O PVC Respose Off; Atrial Pace 8 PMT Optios Off; Passive; Atrial Pace 8 PMT Detectio Rate (mi -1 ) 90 180 i steps of 5 Lead Type Ucoded; Uipolar; Bipolar NIPS Optios Stimulatio Chamber Atrial; Right Vetricular Couplig Iterval 9 (ms) 200-800 i steps of 10 S1 Cout 2-25 i steps of 1 S1 10 ; S2; S3 ad S4 Cycle (ms) Off; 100 800 i steps of 10 (Fixed or Adaptive) Right Vetricular Support Rate (mi -1 ) Off; 30-95 i steps of 5 Sius Node Recovery Delay (s) 1-5 i steps of 1 Diagostic Treds AT/AF Activity; Exercise; Lead Impedace; P ad R Wave; A ad V threshold Patiet Notifiers Programmable Notifiers (O; Off) Device at ERI; Atrial Lead Impedace Out of Rage; Vetricular Lead Impedace Out of Rage; LV Lead Impedace Out of Rage; AT/AF Burde; AT/AF Episode Duratio; High V Rate Durig AT/AF Device Reset O Etry ito Backup VVI Mode O Audible Duratio (sec) 2; 4; 6; 8; 10; 12; 14; 16 Number of Audible Alerts per Notificatio 2 Number of Notificatios 1 16 Time Betwee Notificatios (hours) 10; 22
Cardiac Resychroisatio Therapy (CRT) Devices Frotier II Cardiac Resychroisatio Therapy Pacemaker Product Highlights QuickOpt Timig Cycle Optimisatio provides quick ad effective AF optimizatio at the touch of a butto Cotiuous Bivetricular Pacig AF Suppressio algorithm helps cotrol atrial rhythm ad maitais AV sychroy Negative AV/PV Hysteresis is desiged to esure bivetricular pacig by temporarily shorteig the AV/PV delay upo sesig vetricular activity DDT Bivetricular Trigger Mode provides triggered pacig i the presece of itrisic R-waves or PVCs to help promote bivetricular pacig Mode Switch Base Rate helps maage vetricular activity durig AF episodes Exclusive AF Suppressio Algorithm is cliically prove to reduce AF burde 1 ad improve quality of life 2,3 AT/AF Burde Tred provides weekly cout of the percet of time i AF ad idetifies log-term treds for device or drug maagemet 1. Carlso M et al. A ew pacemaker algorithm for the treatmet of atrial fibrillatio, results of the Atrial Dyamic Overdrive Pacig Trial (ADOPT). JACC 2003; 42:627-33. 2. Attuel P et al ad the INOVA Study Group. Quality of life i permaetly paced AF patiets. The INOVA Study. Europace 2003; Abstract A42-6. 3. Davy et al ad the INOVA Study Group. Permaet atrial overdrive tolerace i patiets with symptomatic paroxysmal AF. The INOVA Study Europace 2003; Abstract A42-3. Orderig Iformatio Cotets: Cardiac pulse geerator Model Number Dimesios (H x W x T, mm) Weight (g) Volume (cc) Coector 5596 49 x 52 x 6 25 11,5(±0,5) IS-1 Idicatios: Implatatio of Frotier II device is idicated for: maitaiig sychroy of the left ad right vetricles i patiets who have udergoe a AV odal ablatio for chroic atrial fibrillatio ad have NYHA Class II or III heart failure, the reductio of the symptoms of moderate to severe heart failure (NYHA Class III or IV) i those patiets who remai symptomatic despite stable, optimal medical therapy, ad have a left vetricular ejectio fractio 35% ad a prologed QRS duratio, implatatio of Accet, Accet RF, Athem, ad Athem RF devices is idicated i oe or more of the followig permaet coditios: sycope, presycope, fatigue, disorietatio, or ay combiatio of those symptoms. Rate-Modulated Pacig is idicated for patiets with chrootropic icompetece, ad for those who would beefit from icreased stimulatio rates cocurret with physical activity. Dual-Chamber Pacig is idicated for those patiets exhibitig: sick sius sydrome, chroic, symptomatic secod- ad third-degree AV block, recurret Adams-Stokes sydrome, symptomatic bilateral budle brach block whe tachyarrhythmia ad other causes have bee ruled out. Atrial Pacig is idicated for patiets with sius ode dysfuctio ad ormal AV ad itravetricular coductio systems. Vetricular Pacig is idicated for patiets with sigificat bradycardia ad ormal sius rhythm with oly rare episodes of A-V block or sius arrest, chroic atrial fibrillatio, severe physical disability. AF Suppressio is idicated for suppressio of paroxysmal or persistet atrial fibrillatio episodes i patiets with oe or more of the above pacig idicatios. Cotraidicatios: Implated Cardioverter-Defibrillator (ICD). Devices are cotraidicated i patiets with a implated cardioverter-defibrillator. Rate-Adaptive Pacig may be iappropriate for patiets who experiece agia or other symptoms of myocardial dysfuctio at higher sesor-drive rates. A appropriate Maximum Sesor Rate should be selected based o assessmet of the highest stimulatio rate tolerated by the patiet. AF Suppressio stimulatio is ot recommeded i patiets who caot tolerate high atrial-rate stimulatio. Dual-Chamber Pacig, though ot cotraidicated for patiets with chroic atrial flutter, chroic atrial fibrillatio, or silet atria, may provide o beefit beyod that of sigle-chamber pacig i such patiets. Sigle-Chamber Vetricular Demad Pacig is relatively cotraidicated i patiets who have demostrated pacemaker sydrome, have retrograde VA coductio, or suffer a drop i arterial blood pressure with the oset of vetricular pacig. Sigle-Chamber Atrial Pacig is relatively cotraidicated i patiets who have demostrated compromise of AV coductio. Atrial Fibrillatio. Athem devices are cotraidicated i patiets havig chroic atrial fibrillatio or itermittet atrial fibrillatio that does ot termiate. For specific cotraidicatios associated with idividual modes, refer to the programmer s o-scree help. Potetial Adverse Evets: The followig are potetial complicatios associated with the use of ay pacig system: air embolism, body rejectio pheomea, cardiac tampoade or perforatio, hematoma, bleedig hematoma, seroma, formatio of fibrotic tissue, local tissue reactio, iability to iterrogate or program due to programmer or device malfuctio, ifectio/erosio, iterruptio of desired pulse geerator fuctio due to electrical iterferece, either electromyogeic or electromagetic, lead malfuctio due to coductor fracture or isulatio degradatio, loss of capture or sesig due to lead dislodgemet or reactio at the electrode/ tissue iterface, loss of desired pacig ad/or sesig due to lead displacemet, body reactio at electrode iterface, or lead malfuctio (fracture or damage to isulatio), loss of ormal device fuctio due to battery failure or compoet malfuctio, pacemaker migratio or pocket erosio, pectoral muscle or diaphragmatic stimulatio, phreic erve stimulatio, peumothorax/hemothorax, edocarditis, excessive bleedig, iduced atrial or vetricular arrhythmias, myocardial irritability, pericardial effusio, pericardial rub, pulmoary edema, rise i threshold ad exit block, valve damage, cardiac/coroary sius dissectio, cardiac/coroary sius perforatio, coroary sius or cardiac vei thrombosis. Refer to the User s Maual for detailed idicatios, cotraidicatios, warigs, precautios ad potetial adverse evets. Brief Summary: Prior to usig these devices, please review the Istructios for Use for a complete listig of idicatios, cotraidicatios, warigs, precautios, potetial adverse evets ad directios for use. Devices depicted may ot be available i all coutries. Check with your St. Jude Medical represetative for product availability i your coutry. Uless otherwise oted, idicates that the ame is a trademark of, or licesed to, St. Jude Medical or oe of its subsidiaries. ST. JUDE MEDICAL, the ie-squares symbol ad MORE CONTROL. LESS RISK. are registered ad uregistered trademarks ad service marks of St. Jude Medical, Ic. ad its related compaies. 2011 St. Jude Medical, Ic. All rights reserved.
Frotier II Cardiac Resychroisatio Therapy Pacemaker Cardiac Resychroisatio Therapy (CRT) Devices PHYSICAL SPECIFICATIONS Model Number 5596 Dimesios (mm) 49 x 52 x 6 Weight (g) 25 Volume (cm3) 11.5 Coector IS-1 PARAMETER SETTINGS Resychroizatio Therapy QuickOpt Timig Cycle Optimizatio Sesed/paced AV delay, Itervetricular Pace delay RV ad LV Pulse Width (ms) 0,05, 0,1-1,5 i steps of 0,1 RV ad LV Pulse Amplitude (V) 0,0-4,0 i steps of 0,25, 4,5-7,5 i steps of 0,5 RV Pulse Cofiguratio Uipolar, Bipolar LV Pulse Cofiguratio Uipolar, Bipolar, LV Tip-RV rig Vetricular Sese Cofiguratio BV Uipolar Tip, BV Bipolar, RV Uipolar Tip, RV Bipolar, LV Uipolar Tip, LV Bipolar, RV Uipolar Rig, LV tip-rv tip Vetricular Pacig Chamber BV, RV oly, LV oly First Chamber Paced Simultaeous***, RV, LV Itervetricular Pace Delay (ms) 20-80 i steps of 5 Vetricular Sesitivity (mv) 0,5-5,0 i steps of 0,5, 6-10 i steps of 1,0, 12,5 Negative AV/PV Hysteresis Search (ms) Off, 10 to 110 i steps of 10 Shortest AV/PV Delay (ms) 30 50 i steps of 5, 60 120 i steps of 10 Atrial Output/Sesig Atrial Pulse Cofiguratio Uipolar (tip case), Bipolar (tip rig) Atrial Sese Cofiguratio Uipolar Tip (tip case), Bipolar (tip rig), Uipolar Rig (rig case) Atrial Sesitivity v (mv) 0,1-0,5 i steps of 0,1, 0,75-2,0 i steps of 0,25, 2,5-5,0 i steps of 0,5 Atrial Amplitude 0,0-4,0 i steps of 0,25, 4,5-7,5 i steps of 0,5 Atrial Pulse Width 0,05, 0,1-1,5 i steps of 0,1 Rate/Timig Mode A00(R), AAI(R), AAT(R), OAO, VOO(R), VVI(R), VVT(R), OVO, DOO(R), DVI(R), DDI(R), DDT(R), DDD(R), ODO DDT Trigger Δ R-wave DDT Timig Δ DDD, DDI Base Rate (mi -1 ) 30*, 40 130 i steps of 5, 140 170 i steps of 10 Hysteresis Rate (mi -1 ) Off, 30 130 i steps of 5, 140, 150** Search Iterval (mi -1 ) Off, 5, 10, 15, 30 Cycle Cout 1 16 Itervetio Rate (mi -1 ) Off, 60, 80-120 i steps of 10 (Itrisic +0, Itrisic +10, Itrisic +20, Itrisic +30) Itervetio Duratio (mi -1 ) 1 10 Recovery Time Fast, Medium, Slow, Very Slow Rest Rate (mi -1 ) Off, 30 130 i steps of 5, 140, 150 Maximum Trackig Rate (mi -1 ) 90 130 i steps of 5, 140 180 i steps of 10 AV Delay (ms) 25, 30 200 i steps of 10, 225 300 i steps of 25, 350 PV Delay (ms) 25, 30-200 i steps of 10, 225 325 i steps of 25 Vetricular Refractory (ms) 125 500 i steps of 25 Atrial Refractory (PVARP) (ms) 125 500 i steps of 25 Vetricular Absolute Refractory Period (ms) 60-240 i steps of 10 Vetricular Blakig (ms) 12-52 i steps of 4 Atrial Absolute Refractory Period (ms) 60, 80, 100 350 i steps of 25 Atrial Protectio Iterval (ms) Δ 125 Far Field Protectio Iterval (ms) Δ 16 SETTINGS AF Maagemet AF Suppressio Off, O Lower Rate Overdrive (mi -1 ) Δ 10 Upper Rate Overdrive (mi -1 ) Δ 5 No. of Overdrive Pacig Cycles 15-40 i steps of 5 Rate Recovery Δ (ms) 8, 12 Auto Mode Switch Off, DDDR to DDIR, DDD to DDI, DDT (D) to DDT (I), DDT (D) to DDTR (I), DDTR (D) to DDTR (I), DDTR (D) to DDT (I), DDDR to DDI, DDD to DDIR AMS Base Rate (mi -1 ) Base Rate +0 to Base Rate +35 i steps of 5 Rate-Modulated Rate Resposive AV/PV Delay Off, Low, Medium, High Rate Resposive PVARP/VREF Off, Low, Medium, High Shortest PVARP/VREF 120 350 i steps of 10 Sesor O, Off, Passive Max Sesor Rate (mi -1 ) 80-150 i steps of 5, 160-180 i steps of 10 Threshold Auto (-0,5), Auto (+0,0), Auto (+0,5), Auto (+1,0), Auto (+1,5), Auto (+2,0), 1-7 i steps of 0,5 Slope Auto (-1), Auto (+0), Auto (+1), Auto (+2), Auto (+3), 1-16 Reactio Time Very Fast, Fast, Medium, Slow Recovery Time Fast, Medium, Slow, Very Slow Stored Electrograms Optios Samplig Optios Freeze, Cotiuous No. of Stored EGMs 1, 2, 4, 8, 12 Chael Sigle, Dual Triggers Maget Placemet O, Off High Atrial Rate (ms) Off, 125-300 i steps of 25 No. of Cosecutive Cycles 2, 3, 4, 5, 10, 15, 20 AMS Etry/Exit O, Off High Vetricular Rate (ms) Off, 125-300 i steps of 25 PVC O, Off No. of Cosecutive PVCs 2, 3, 4, 5 PMT Detectio O, Off AT/AF Detectio O, Off Advaced Hysteresis O, Off Other Maget Respose Off, Battery Test AutoItrisic Coductio Search (ms) Off, +10 to +120 i steps of 10 Atrial Tachycardia Detectio Rate (mi -1 ) 110 150 i steps of 5, 160 200 i steps of 10, 225 300 i steps of 25 Post Vet. Atrial Blakig (PVAB) (ms) 60, 70, 80, 85, 95, 100, 110, 115, 125, 130, 140, 150, 155, 165, 170, 180, 185, 195, 200 Vetricular Safety Stadby Off, O PVC Optios Off, +PVARP o PVC PMT Optios Off, 10 Beats > PMT, Auto Detect PMT Detectio Rate (mi -1 ) 90-150 i steps of 5, 160-180 i steps of 10 Lead Type Ucoded, Uipolar, Uipolar/Bipolar NIPS Optios Stimulatio Chamber Atrial, Right Vetricular Couplig Iterval (ms) 200-800 i steps of 10 S1 Cout 1-25 i steps of 1 S1, S2, S3, ad S4 Cycle (ms) 100-800 i steps of 10 Right Veticular Support Rate (mi -1 ) Off, 30, 40-95 i steps of 5 Sius Node Recovery Delay (s) 1-5 i steps of 1 ± 0,5 cm 3 * The actual pacig rate for the 30 mi -1 settig is 31 mi -1. ** The highest available settig for Hysteresis Rate is 5 mi -1 below the programmed Base Rate. *** LV first with 10 ms itervetricular delay. I dual-chamber modes, the maximum Vetricular Refractory Period is 325 ms. Sesitivity is with respect to a 20 ms haversie test sigal. v Values 0,1-0,4 ot available i a Uipolar Sese Cofiguratio. Durig atrial NIPS i dual-chamber modes, the shortest Couplig Iterval will be limited by the programmed AV/PV Delay. S1 Burst Cycle is applied at the preprogrammed S1 cycle legth. Δ This parameter is ot programmable. (GMCRM889EN) Brief Summary: Prior to usig these devices, please review the Istructios for Use for a complete listig of idicatios, cotraidicatios, warigs, precautios, potetial adverse evets ad directios for use. Devices depicted may ot be available i all coutries. Check with your St. Jude Medical represetative for product availability i your coutry. Uless otherwise oted, idicates that the ame is a trademark of, or licesed to, St. Jude Medical or oe of its subsidiaries. ST. JUDE MEDICAL, the ie-squares symbol ad MORE CONTROL. LESS RISK. are registered ad uregistered trademarks ad service marks of St. Jude Medical, Ic. ad its related compaies. 2011 St. Jude Medical, Ic. All rights reserved. Item GMCRM889EN
Left-Heart ad Epicardial Leads
St. Jude Medical Left-Heart Lead Techology We place great importace i left-heart leads, because they help esure that the capabilities of the St. Jude Medical high-performace CRT-D ad CRT devices are fully utilised. Through a systematic developmet effort, St. Jude Medical has combied the safety of prove leads with iovative techology. More Cotrol. Whe used with the Uify Quadra CRT-D device ad the Promote Quadra CRT-D device, the Quartet left vetricular pacig lead eables 10 pacig cofiguratio optios to provide better maagemet of pacig complicatios itra- ad post-operatively. Less Risk. Optim lead isulatio combies the biostability ad flexibility of high-performace silicoe ad the stregth, tear resistace ad abrasio resistace of polyurethae. The combiatio eables a abrasio-resistat, thi diameter lead.
Left-Heart Leads Quartet Left-Heart Lead Product Highlights Four pacig electrodes to provide more optios ad greater cotrol i pacig vector selectio Superb deliverability with exceptioal stability ad performace Low profile 4,7 F lead body; 4,0 F lead tip Optim lead isulatio a chemical co-polymer that bleds the best features of polyurethae ad silicoe for improved hadlig ad icreased durability Steerable tip distal tip agle ca be cotrolled to maeuver through veous aatomy Flexible lead body arrow rig electrodes provide lead tip flexibility Allows Direct-To-Target placemet through CPS Aim SL ier catheter to deliver leads to small, acute veous aatomies that may have bee ureachable i the past Compatible with over-the-wire or stylet approaches Orderig Iformatio Cotets: Left-heart lead Model Isulatio S-Curve Miimum Number Height (mm) Itroducer (F) Coector Legths (cm) 1458Q Optim 16 5 IS4-LLLL 75; 86; 92 Idicatios ad Usage: The Quartet lead has applicatio as part of a St. Jude Medical bivetricular system. Cotraidicatios: The use of the Quartet lead is cotraidicated i patiets who: Are expected to be hypersesitive to a sigle dose of 1,0 mg of dexamethasoe sodium phosphate. Are uable to udergo a emergecy thoracotomy procedure. Have coroary veous vasculature that is iadequate for lead placemet, as idicated by veogram. Brief Summary: Prior to usig these devices, please review the Istructios for Use for a complete listig of idicatios, cotraidicatios, warigs, precautios, potetial adverse evets ad directios for use. Devices depicted may ot be available i all coutries. Check with your St. Jude Medical represetative for product availability i your coutry. Uless otherwise oted, idicates that the ame is a trademark of, or licesed to, St. Jude Medical or oe of its subsidiaries. ST. JUDE MEDICAL, the ie-squares symbol ad MORE CONTROL. LESS RISK. are registered ad uregistered trademarks ad service marks of St. Jude Medical, Ic. ad its related compaies. 2011 St. Jude Medical, Ic. All rights reserved.
Left-Heart Leads Quartet Left-Heart Lead Product Specificatios PHYSICAL SPECIFICATIONS Model 1458Q Parameter Descriptio Coector IS4-LLLL Lead Legth 75; 86; 92 cm Maximum Lead Size 5,1 F (1,70 mm/0,067 ) at the rig electrode Lead Body Size 4,7 F (1,57 mm/0,062 ) Tip Electrode Size 4,0 F (1,3 mm/0,052 ) LV Lead Delivery System Itroducer Size Miimum 5 F ID Miimum S-curve Height 16 mm Tip Electrode Pt/Ir; TiN coated; rig-shaped; two grooves Steroid Dexamethasoe sodium phosphate Tip Electrode Surface Area 4,9 mm 2 Rig Electrode Surface Area 7,4 mm 2 Electrode Spacig Distal tip 1 - Mid 2 20 mm Distal tip 1 - Mid 3 30 mm Distal tip 1 - Proximal 4 47 mm Lead Body Isulatio Optim isulatio Lead Body Coatig Coductors Distal (coil) Proximal (cables) Suture Sleeve Fast-Pass coatig MP35N LT* ETFE; MP35N LT Attached *MP35N is a trademark of SPS Techologies, Ic. (GMCRM770EN) Brief Summary: Prior to usig these devices, please review the Istructios for Use for a complete listig of idicatios, cotraidicatios, warigs, precautios, potetial adverse evets ad directios for use. Devices depicted may ot be available i all coutries. Check with your St. Jude Medical represetative for product availability i your coutry. Uless otherwise oted, idicates that the ame is a trademark of, or licesed to, St. Jude Medical or oe of its subsidiaries. ST. JUDE MEDICAL, the ie-squares symbol ad MORE CONTROL. LESS RISK. are registered ad uregistered trademarks ad service marks of St. Jude Medical, Ic. ad its related compaies. 2011 St. Jude Medical, Ic. All rights reserved. Item GMCRM770EN
Left-Heart Leads QuickFlex Left-Heart Lead Product Highlights Superb deliverability combied with exceptioal stability ad performace Low profile - 5,6 F proximal lead body; 5,0 F distal lead body; 4,0 F lead tip Steerable tip - distal tip agle ca be cotrolled to maeuver through veous aatomy Flexible lead body Expaded tip-to-rig electrode spacig of 20 mm Shorter tip ad rig electrodes reduce the legth of rigid portios of the lead body Compatible with over-the-wire or stylet approaches Composite costructio - proximal polyurethae sectio ad cable/coil coductors are desiged to offer exceptioal push ad torque, while the flexible distal silicoe portio is desiged for improved trackig i tortuous aatomy Orderig Iformatio Cotets: Left-heart lead Model Isulatio Isulatio S-Curve Miimum Number Proximal Distal Height (mm) Itroducer (F) Coector Legths (cm) 1156T Polyurethae Silicoe 8 7 IS-1 bipolar 75; 86 1158T Polyurethae Silicoe 16 7 IS-1 bipolar 75; 86 Idicatios ad Usage: The QuickFlex lead has applicatio as part of a St. Jude Medical bivetricular system. Cotraidicatios: The use of QuickFlex leads is cotraidicated i patiets who: Are expected to be hypersesitive to a sigle dose of 1,0 mg of dexamethasoe sodium phosphate. Are uable to udergo a emergecy thoracotomy procedure. Have coroary veous vasculature that is iadequate for lead placemet, as idicated by veogram. Brief Summary: Prior to usig these devices, please review the Istructios for Use for a complete listig of idicatios, cotraidicatios, warigs, precautios, potetial adverse evets ad directios for use. Devices depicted may ot be available i all coutries. Check with your St. Jude Medical represetative for product availability i your coutry. Uless otherwise oted, idicates that the ame is a trademark of, or licesed to, St. Jude Medical or oe of its subsidiaries. ST. JUDE MEDICAL, the ie-squares symbol ad MORE CONTROL. LESS RISK. are registered ad uregistered trademarks ad service marks of St. Jude Medical, Ic. ad its related compaies. 2011 St. Jude Medical, Ic. All rights reserved.
Left-Heart Leads QuickFlex Left-Heart Lead Product Specificatios PHYSICAL SPECIFICATIONS MODELS 1156T 1158T Parameter Descriptio Descriptio Coector IS-1 Bipolar IS-1 Bipolar Lead Legth 75 cm; 86 cm 75 cm; 86 cm Maximum Lead Body Size 6,0 F (2 mm/0,079 ) 6,0 F (2 mm/0,079 ) Proximal Polyurethae Lead Body Size 5,6 F (1,85 mm/0,073 ) 5,6 F (1,85 mm/0,073 ) Distal Silicoe Rubber Lead Body Size 5,0 F (1,68 mm/0,066 ) 5,0 F (1,68 mm/0,066 ) Tip Electrode Size 4,0 F (1,33 mm/0,052 ) 4,0 F (1,33 mm/0,052 ) LV Lead Delivery System Itroducer Size Miimum 7 F ID Miimum 7 F ID Miimum S-Curve Height 8 mm 16 mm Tip Electrode Pt/Ir; TiN coated; rig-shaped; two grooves Pt/Ir; TiN coated; rig-shaped; two grooves Steroid Dexamethasoe sodium phosphate Dexamethasoe sodium phosphate Tip Electrode Surface Area 4,9 mm 2 4,9 mm 2 Rig Electrode Surface Area 7,4 mm 2 7,4 mm 2 Tip-to-Rig Electrode Spacig 20 mm 20 mm Lead Body Isulatio Proximal: polyurethae 55D Proximal: polyurethae 55D Distal 7 cm: silicoe rubber Distal 7 cm: silicoe rubber Lead Body Coatig Fast-Pass coatig Fast-Pass coatig Coductors* Distal (coil) MP35N MP35N Proximal (cables) MP35N MP35N Suture Sleeve Attached Attached *MP35N is a trademark of SPS Techologies, Ic. (GMCRM771EN) Brief Summary: Prior to usig these devices, please review the Istructios for Use for a complete listig of idicatios, cotraidicatios, warigs, precautios, potetial adverse evets ad directios for use. Devices depicted may ot be available i all coutries. Check with your St. Jude Medical represetative for product availability i your coutry. Uless otherwise oted, idicates that the ame is a trademark of, or licesed to, St. Jude Medical or oe of its subsidiaries. ST. JUDE MEDICAL, the ie-squares symbol ad MORE CONTROL. LESS RISK. are registered ad uregistered trademarks ad service marks of St. Jude Medical, Ic. ad its related compaies. 2011 St. Jude Medical, Ic. All rights reserved. Item GMCRM771EN
Left-Heart Leads QuickFlex µ Left-Heart Lead Product Highlights Superb deliverability combied with exceptioal stability ad performace Low profile - 4,3 F lead body; 4,0 F lead tip Optim lead isulatio a chemical co-polymer that bleds the best features of polyurethae ad silicoe for improved hadlig ad icreased durability Steerable tip - distal tip agle ca be cotrolled to maeuver through veous aatomy Flexible lead body Tip-to-rig electrode spacig of 20 mm Shorter tip ad rig electrodes reduce the legth of rigid portios of the lead body Allows Direct-To-Target placemet through CPS Aim SL ier catheter to deliver leads to small, acute veous aatomies that may have bee ureachable i the past Compatible with over-the-wire or stylet approaches Orderig Iformatio Cotets: Left-heart lead Model Isulatio S-Curve Miimum Number Height (mm) Itroducer (F) Coector Legths (cm) 1258T Optim 16 5 IS-1 bipolar 75; 86; 92 Idicatios ad Usage: The QuickFlex lead has applicatio as part of a St. Jude Medical bivetricular system. Cotraidicatios: The use of QuickFlex leads is cotraidicated i patiets who: Are expected to be hypersesitive to a sigle dose of 1,0 mg of dexamethasoe sodium phosphate. Are uable to udergo a emergecy thoracotomy procedure. Have coroary veous vasculature that is iadequate for lead placemet, as idicated by veogram. Brief Summary: Prior to usig these devices, please review the Istructios for Use for a complete listig of idicatios, cotraidicatios, warigs, precautios, potetial adverse evets ad directios for use. Devices depicted may ot be available i all coutries. Check with your St. Jude Medical represetative for product availability i your coutry. Uless otherwise oted, idicates that the ame is a trademark of, or licesed to, St. Jude Medical or oe of its subsidiaries. ST. JUDE MEDICAL, the ie-squares symbol ad MORE CONTROL. LESS RISK. are registered ad uregistered trademarks ad service marks of St. Jude Medical, Ic. ad its related compaies. 2011 St. Jude Medical, Ic. All rights reserved.
Left-Heart Leads QuickFlex µ Left-Heart Lead Product Specificatios PHYSICAL SPECIFICATIONS MODEL Parameter 1258T Descriptio Coector IS-1 Bipolar Lead Legth 75 cm; 86 cm; 92 cm Lead Body Size 4,3 F (1,42 mm/0,056 ) Tip Electrode Size 4,0 F (1,33 mm/0,052 ) LV Lead Delivery System Itroducer Size Miimum 5 F ID Miimum S-Curve Height 16 mm Tip Electrode Pt/Ir; TiN coated; rig-shaped; two grooves Steroid Dexamethasoe sodium phosphate Tip Electrode Surface Area 5,0 mm 2 Rig Electrode Surface Area 7,4 mm 2 Tip-to-Rig Electrode Spacig 20 mm Lead Body Isulatio Optim isulatio Lead Body Coatig Coductors* Distal (coil) Proximal (cables) Suture Sleeve Fast-Pass coatig MP35N MP35N Attached *MP35N is a trademark of SPS Techologies, Ic. (GMCRM772EN) Brief Summary: Prior to usig these devices, please review the Istructios for Use for a complete listig of idicatios, cotraidicatios, warigs, precautios, potetial adverse evets ad directios for use. Devices depicted may ot be available i all coutries. Check with your St. Jude Medical represetative for product availability i your coutry. Uless otherwise oted, idicates that the ame is a trademark of, or licesed to, St. Jude Medical or oe of its subsidiaries. ST. JUDE MEDICAL, the ie-squares symbol ad MORE CONTROL. LESS RISK. are registered ad uregistered trademarks ad service marks of St. Jude Medical, Ic. ad its related compaies. 2011 St. Jude Medical, Ic. All rights reserved. Item GMCRM772EN
Left-Heart Leads QuickSite Left-Heart Lead Product Highlights Superb deliverability combied with exceptioal stability ad performace Low profile 5,6 F proximal lead body; 5,0 F distal lead body Steerable tip the distal tip ca be cotrolled to maeuver through veous aatomy Compatible with over-the-wire or stylet approaches Composite costructio proximal polyurethae sectio ad cable/coil coductors are desiged to offer exceptioal push ad torque, while the flexible distal silicoe portio is desiged for improved trackig i tortuous aatomy Orderig Iformatio Cotets: Left-heart lead Model Isulatio Isulatio S-Curve Miimum Number Proximal Distal Height (mm) Itroducer (F) Coector Legths (cm) 1056T Polyurethae Silicoe 8 7 IS-1 bipolar 75; 86 1058T Polyurethae Silicoe 16 7 IS-1 bipolar 75; 86 Idicatios ad Usage: The QuickSite leads have applicatio as part of a St. Jude Medical bivetricular system. Cotraidicatios: The use of QuickSite leads is cotraidicated i patiets who: Are expected to be hypersesitive to a sigle dose of 1,0 mg of dexamethasoe sodium phosphate. Are uable to udergo a emergecy thoracotomy procedure. Have coroary veous vasculature that is iadequate for lead placemet, as idicated by veogram. Brief Summary: Prior to usig these devices, please review the Istructios for Use for a complete listig of idicatios, cotraidicatios, warigs, precautios, potetial adverse evets ad directios for use. Devices depicted may ot be available i all coutries. Check with your St. Jude Medical represetative for product availability i your coutry. Uless otherwise oted, idicates that the ame is a trademark of, or licesed to, St. Jude Medical or oe of its subsidiaries. ST. JUDE MEDICAL, the ie-squares symbol ad MORE CONTROL. LESS RISK. are registered ad uregistered trademarks ad service marks of St. Jude Medical, Ic. ad its related compaies. 2011 St. Jude Medical, Ic. All rights reserved.
Left-Heart Leads QuickSite Left-Heart Lead Product Specificatios PHYSICAL SPECIFICATIONS MODELS 1056T 1058T Parameter Descriptio Descriptio Coector IS-1 Bipolar IS-1 Bipolar Lead Legth 75 cm, 86 cm 75 cm, 86 cm Maximum Lead Body Size 6,0 F (2 mm/0.079 ) at PU SR trasitio 6,0 F (2 mm/0,079 ) at PU SR trasitio Proximal Polyurethae Lead Body Size 5,6 F (1,85 mm/0,073 ) 5,6 F (1,85 mm/0,073 ) Distal Silicoe Rubber Lead Body Size 5,0 F (1,68 mm/0,066 ) 5,0 F (1,68 mm/0,066 ) LV Lead Delivery System Itroducer Size Miimum 7 F ID Miimum 7 F ID Miimum S-curve height 8 mm 16 mm Tip Electrode Pt/Ir, TiN coated, two grooves, blut tip Pt/Ir, TiN coated, two grooves, blut tip Steroid Dexamethasoe sodium phosphate Dexamethasoe sodium phosphate Tip Electrode Surface Area 4,8 mm 2 4,8 mm 2 Rig Electrode Surface Area 14,7 mm 2 14,7 mm 2 Tip-to-Rig Electrode Spacig 15 mm 20 mm Lead Body Isulatio Proximal: polyurethae 55D Proximal: polyurethae 55D Distal 8 cm: silicoe rubber Distal 7 cm: silicoe rubber Coductors Two ETFE-isulated low resistace cables, Two ETFE-isulated low resistace cables, multifilar MP35N *coil multifilar MP35N * coil ACCESSORIES PACKAGED WITH THE QUICKSITE LEAD Stylets (6) Guidewire Lead Flushig Tools (2) Stylet Guide (fuel) Vei Pick 0,36 mm/0,014 (diameter) PTFE-coated stailess steel stylets, with 15 cm distal tapers: Soft 0,15 mm/0,006 (diameter) gree kob (3 stylets) Firm 0,20 mm/0,008 (diameter) yellow kob (2 stylets) Extra Firm 0,25 mm/0,010 (diameter) red kob (1 stylet) PTFE-coated, 180 cm log, 0,36 mm/0,014 (diameter) with 5 cm floppy tip; two torque tools icluded White ABS couplig with Luer Lock coector *MP35N is a trademark of SPS Techologies, Ic. (GMCRM773EN) Brief Summary: Prior to usig these devices, please review the Istructios for Use for a complete listig of idicatios, cotraidicatios, warigs, precautios, potetial adverse evets ad directios for use. Devices depicted may ot be available i all coutries. Check with your St. Jude Medical represetative for product availability i your coutry. Uless otherwise oted, idicates that the ame is a trademark of, or licesed to, St. Jude Medical or oe of its subsidiaries. ST. JUDE MEDICAL, the ie-squares symbol ad MORE CONTROL. LESS RISK. are registered ad uregistered trademarks ad service marks of St. Jude Medical, Ic. ad its related compaies. 2011 St. Jude Medical, Ic. All rights reserved. Item GMCRM773EN
Epicardial Pacig Leads Myodex Bipolar, Steroid-elutig Epicardial Pacig Lead Product Highlights Active-fixatio, sutureless desig Full 3.5 mm helix peetratio helps provide stable fixatio Superb deliverability combied with exceptioal stability ad performace Low pacig thresholds with steroid elutio Precise sesig ad low polarisatio Easy to implat with the FasTac Lead Implat Tool Orderig Iformatio Cotets: Epicardial lead Model Number Isulatio Coector Legths (cm) 1084T Silicoe IS-1 bipolar 25; 35; 54
Epicardial Pacig Leads Myodex Bipolar, Steroid-elutig Epicardial Lead Product Specificatios PHYSICAL SPECIFICATIONS MODELS 1084T (25 cm) 1084T (35 cm) 1084T (54 cm) Electrode surface area 10 mm 2 cathode 10 mm 2 10 mm 2 62 mm 2 aode 62 mm 2 62 mm 2 Helix peetratio depth 3,5 mm 3,5 mm 3,5 mm Number of helix turs to implat 2,5 2,5 2,5 Lead resistace 20 ohms cathode 27 ohms 41 ohms 38 ohms aode 46 ohms 75 ohms Itroducer legth 27 cm 27 cm 27 cm Tueler legth 27 cm 27 cm 27 cm Coector type IS-1 Bi IS-1 Bi IS-1 Bi Electrode material Titaium-itride coated helix Titaium-itride coated Titaium-itride coated Platium/Iridium Platium/Iridium Platium/Iridium Titaium-itride coated aode plate Titaium-itride coated Titaium-itride coated titaium titaium titaium Coductor material MP35N (multifilar coil) MP35N (multifilar coil) MP35N (multifilar coil) Isulatio material Silicoe rubber Silicoe rubber Silicoe rubber (medical grade) (medical grade) (medical grade) Coector pi material 316L stailess steel 316L stailess steel 316L stailess steel Steroid plug <1 mg dexamethasoe <1 mg dexamethasoe <1 mg dexamethasoe sodium phosphate sodium phosphate sodium phosphate Suture sleeve ad pi cap material Silicoe rubber Silicoe rubber Silicoe rubber ACCESSORIES PACKAGED WITH THE Myodex LEAD 1 FasTac itroducer 1 tueler 1 bidirectioal tueler tip 1 coector pi cap 1 slit suture sleeve (detached from lead) (GMCRM918EN) Brief Summary: Prior to usig these devices, please review the Istructios for Use for a complete listig of idicatios, cotraidicatios, warigs, precautios, potetial adverse evets ad directios for use. Devices depicted may ot be available i all coutries. Check with your St. Jude Medical represetative for product availability i your coutry. Uless otherwise oted, idicates that the ame is a trademark of, or licesed to, St. Jude Medical or oe of its subsidiaries. ST. JUDE MEDICAL, the ie-squares symbol ad MORE CONTROL. LESS RISK. are registered ad uregistered trademarks ad service marks of St. Jude Medical, Ic. ad its related compaies. 2011 St. Jude Medical, Ic. All rights reserved. Item GMCRM918EN
Implatable Cardioverter Defibrillator (ICD) Devices
St. Jude Medical Implatable Cardioverter Defibrillators Our ew geeratio of implatable cardioverter defibrillators (ICDs) feature a triple redudacy safety platform desiged to miimise risk ad icrease security ad patiet comfort through multiple hardware ad software system safeguards. More Cotrol. Idividually tailored therapy helps esure successful therapy. St. Jude Medical ICDs allow for comprehesive cotrol over therapy delivery ad make it possible to fie-tue programmig to meet idividual patiet eeds. Comfortable, simple cotrols alog with advaced automaticity eable efficiet patiet care ad help improve the patiet s quality of life. Less Risk. A progressive approach to safety based o the cocept of redudat prove desigs alog with iovative fuctios offers the best prospects for optimal patiet therapy.
Implatable Cardioverter Defibrillator (ICD) Devices Fortify ST DR Dual-Chamber Implatable Cardioverter Defibrillator (ICD) Product Highlights The ST moitorig diagostic provides iformatio o sigificat ST segmet chages for improved isight i decisio makig ShockGuard techology with DecisioTx programmig, desiged to reduce iappropriate therapy ad miimise the eed for programmig adjustmets at implat Uique 40 J delivered eergy safety shock optio ca provide a greater DFT safety margi The DF4 coector is desiged to simplify implats by streamliig defibrillatio coectios ito a sigle termial pi ad reducig the umber of set screws QHR * chemistry battery provides greater capacity for ehaced logevity ad stable charge times Atitachycardia pacig (ATP) while chargig ad prior to chargig i the VF zoe further exteds the programmig optios for termiatig tachyarrhythmias without a high-voltage shock The low frequecy atteuatio filter is desiged to ehace sesig performace ad may reduce the possibility of oversesig T waves DeFT Respose techology offers the most oivasive optios for maagig high DFTs Vibratory patiet otifier eables patiets with hearig problems to be alerted to a low battery, lead-related complicatios ad more The SeseAbility feature provides the flexibility to fie-tue programmig aroud T-wave oversesig without decreasig sesitivity Merli@home Trasmitter Compatible Orderig Iformatio Cotets: Cardiac pulse geerator Model Dimesios Coector Coector Number (H x W x T, mm) Weight (g) Volume (cc) Defibrillatio Sese/Pace CD2235-40 74 x 40 x 14 76 35 DF1 IS-1 CD2235-40Q 71 x 40 x 14 75 35 DF4 IS-1; DF4 Idicatios: The devices are iteded to provide vetricular atitachycardia pacig ad vetricular defibrillatio for automated treatmet of life-threateig vetricular arrhythmias. Cotraidicatios: Cotraidicatios for use of the pulse geerator system iclude vetricular tachyarrhythmias resultig from trasiet or correctable factors such as drug toxicity, electrolyte imbalace, or acute myocardial ifarctio. Adverse Evets: Implatatio of the pulse geerator system, like that of ay other device, ivolves risks, some possibly life-threateig. These iclude but are ot limited to the followig: acute hemorrhage/bleedig, air emboli, arrhythmia acceleratio, cardiac or veous perforatio, cardiogeic shock, cyst formatio, erosio, exacerbatio of heart failure, extrusio, fibrotic tissue growth, fluid accumulatio, hematoma formatio, histotoxic reactios, ifectio, keloid formatio, myocardial irritability, erve damage, peumothorax, thromboemboli, veous occlusio. Other possible adverse effects iclude mortality due to: compoet failure, device-programmer commuicatio failure, lead abrasio, lead dislodgmet or poor lead placemet, lead fracture, iability to defibrillate, ihibited therapy for a vetricular tachycardia, iterruptio of fuctio due to electrical or magetic iterferece, shutig of eergy from defibrillatio paddles, system failure due to ioisig radiatio. Other possible adverse effects iclude mortality due to iappropriate delivery of therapy caused by: multiple coutig of cardiac evets icludig T waves, P waves, or supplemetal pacemaker stimuli. Amog the psychological effects of device implatatio are imagied pulsig, depedecy, fear of iappropriate pulsig, ad fear of losig pulse capability. Refer to the User s Maual for detailed idicatios, cotraidicatios, warigs, precautios ad potetial adverse evets. Brief Summary: Prior to usig these devices, please review the Istructios for Use for a complete listig of idicatios, cotraidicatios, warigs, precautios, potetial adverse evets ad directios for use. Devices depicted may ot be available i all coutries. Check with your St. Jude Medical represetative for product availability i your coutry. Uless otherwise oted, idicates that the ame is a trademark of, or licesed to, St. Jude Medical or oe of its subsidiaries. ST. JUDE MEDICAL, the ie-squares symbol ad MORE CONTROL. LESS RISK. are registered ad uregistered trademarks ad service marks of St. Jude Medical, Ic. ad its related compaies. 2011 St. Jude Medical, Ic. All rights reserved.
Implatable Cardioverter Defibrillator (ICD) Devices Fortify ST DR Dual-Chamber Implatable Cardioverter Defibrillator (ICD) Product Specificatios PHYSICAL SPECIFICATIONS Models CD2235-40 CD2235-40Q Telemetry RF RF Delivered/Stored Eergy (J) 40/45 40/45 Volume (cc) 35 35 Weight (g) 76 75 Size (mm) 74 x 40 x 14 71 x 40 x 14 Defibrillatio Lead Coectios DF1 DF4 Sese/Pace Lead Coectios IS-1 IS-1; DF4 High-Voltage Ca Electrically active titaium ca Electrically active titaium ca PARAMETERS SETTINGS AF Maagemet AF Suppressio Pacig O; Off No. of Overdrive Pacig Cycles 15-40 i icremets of 5 Maximum AF Suppressio Rate 80-150 mi -1 Sesig/Detectio SeseAbility Techology Automatic Sesitivity Cotrol adjustmet for atrial ad vetricular evets Low Frequecy Atteuatio O; Off Threshold Start (Post-Sesed; Atrial) 50; 62,5; 75; 100%; (Post-Paced; Atrial) 0,2-3,0 mv; (Post-Sesed; Vetricular) 50; 62,5; 75; 100%; (Post-Paced; Vetricular) Auto; 0,2-3,0 mv Decay Delay (Post-Sese/Post-Pace; Atrial/Vetricular) 0-220 Vetricular Sese Refractory (ms) 125; 157 Detectio Zoes VT-1; VT-2; VF SVT Discrimiators AV Rate Brach; Sudde Oset; Iterval Stability; Morphology Discrimiatio (MD) with Maual or Automatic Template Update Recofirmatio Cotiuous sesig durig chargig Atitachycardia Pacig Therapy ATP Cofiguratios Ramp; Burst; Sca; 1 or 2 schemes per VT zoe ATP i VF Zoe ATP While Chargig; ATP Prior to Chargig; Off ATP Upper Rate Cutoff 150-300 bpm Burst Cycle Legth Adaptive; Readaptive or Fixed Mi. Burst Cycle Legth (ms) 150-400 i icremets of 5 Number of Bursts 1-15 Number of Stimuli 2-20 Add Stimuli per Burst O; Off ATP Pulse Amplitude (V) 7,5 Idepedet from Bradycardia ad Post-Therapy Pacig ATP Pulse Width (ms) 1,0 or 1,5 Idepedetly programmable from Bradycardia ad Post-Therapy Pacig High-Voltage Therapy High-Voltage Output Mode Fixed Pulse Width; Fixed Tilt Waveform Biphasic; Moophasic RV Polarity Cathode (-); Aode (+) Electrode Cofiguratio RV to Ca; RV to SVC/Ca Bradycardia Pacig Permaet Modes DDD(R); DDI(R); VVI(R); AAI(R); Pacer Off Temporary Modes Off; DDD; DDI; VVI; AAI; AAT; DOO; VOO; AOO Rate-Adaptive Sesor (Post-Sese/Post-Pace; Atrial/Vetricular) 0-220 Programmable Off; Base Rate (mi -1 ); Rest Rate (mi -1 ); Maximum Trackig Rate (mi -1 ); Rate ad Delay Parameters Maximum Sesor Rate (mi -1 ); Paced AV Delay (ms); Sesed AV Delay (ms); Rate Resposive AV Delay; Pulse Amplitude (Atrial; RV) (V); Pulse Width (Atrial ad RV) (ms); Hysteresis Rate (mi -1 ); Rate Hysteresis with Search QuickOpt Timig Cycle Optimisatio Sesed/Paced AV delay Auto Mode Switch (AMS) Off; DDI(R); VVI(R) Atrial Tachycardia 110-300 Detectio Rate (mi -1 ) AMS Base Rate (mi -1 ) 40; 45;... 135 Auto PMT Detectio/Termiatio A Pace o PMT; Off; Passive Rate Resposive PVARP/VREF Off; Low; Medium; High Vetricular Itrisic Preferece (VIP ) Off; 50-200 (50-150 i icremets of 25; 450 to 200 i icremets of 10) Vetricular AutoCapture O; Off Pacig System ACap Cofirm O; Moitor; Off Post-Therapy Pacig (Idepedetly programmable from Bradycardia ad ATP) Post-Shock Pacig Mode Off; AAI; VVI; DDI; or DDD Post-Shock Base Rate (mi -1 ) 30-100 i icremets of 5 Post-Shock Pacig Duratio (mi) Off; 0,5; 1; 2,5; 7,5; or 10 Device Testig/Iductio Methods DC Fibber Pulse Duratio (sec) 0,5-5,0 Burst Fibber Cycle Legth (ms) 20-100 Noivasive Programmed 2-25 stimuli with up to three extrastimuli Stimulatio (NIPS) Patiet Notifiers Programmable Notifiers (O; Off) Device at ERI; Charge Time Limit Reached; Possible HV Circuit Damage; Atrial Lead Impedace Out of Rage; Vetricular Lead Impedace Out of Rage; High-Voltage Lead Impedace Out of Rage; AT/AF Burde; V Rate Durig AT/AF; % V pacig; CorVue Cogestio Trigger Device Parameter Reset O Etry ito Backup VVI Mode O Vibratio Duratio (sec) 2; 4; 6; 8; 10; 12; 14; 16 Number of Vibratios per Notificatio 2 Number of Notificatios 1-16 Time Betwee Notificatios (hours) 10; 22 Electrograms ad Diagostics Stored Electrograms Up to 45 miutes icludig up to oe miute programmable pre-trigger data per VT/VF diagosis/detectio electrograms; triggers iclude: diagosis; therapy; atrial episode; PMT termiatio; PC shock delivery; oise reversio; maget reversio; ad morphology template verificatio Therapy Summary Diagram of therapies delivered Episodes Summary Directory listig of up to 60 episodes with access to more details icludig stored electrograms Lifetime Diagostics History of bradycardia evets ad device-iitiated chargig AT/AF Burde Tred Tred data ad couts Vetricular HV Lead Impedace Tred Multi-Vector Tred Data Histograms Evet Histogram; AV Iterval Histogram; Mode Switch Duratio Histogram; Peak Filtered Rate Histogram; Atrial Heart Rate Histogram; Vetricular Heart Rate Histogram; AT/AF Burde; Exercise ad Activity Tredig; V Rates durig AMS PMT Data Iformatio regardig PMT detectios Real-Time Measuremets (RTM) Pacig lead impedaces; high-voltage lead impedaces; uloaded battery voltage; ad sigal amplitudes ST Moitorig ST Histogram Data; ST Deviatio Tred; ST Episode Log CorVue Cogestio Moitorig O; Off CorVue Cogestio Trigger 8-18 days *QHR is a trademark of Greatbatch, LTD. (GMCRM777EN) Brief Summary: Prior to usig these devices, please review the Istructios for Use for a complete listig of idicatios, cotraidicatios, warigs, precautios, potetial adverse evets ad directios for use. Devices depicted may ot be available i all coutries. Check with your St. Jude Medical represetative for product availability i your coutry. Uless otherwise oted, idicates that the ame is a trademark of, or licesed to, St. Jude Medical or oe of its subsidiaries. ST. JUDE MEDICAL, the ie-squares symbol ad MORE CONTROL. LESS RISK. are registered ad uregistered trademarks ad service marks of St. Jude Medical, Ic. ad its related compaies. 2011 St. Jude Medical, Ic. All rights reserved. Item GMCRM777EN
Implatable Cardioverter Defibrillator (ICD) Devices Fortify ST VR Sigle-Chamber Implatable Cardioverter Defibrillator (ICD) Product Highlights The ST moitorig diagostic provides iformatio o sigificat ST segmet chages for improved isight i decisio makig ShockGuard techology with DecisioTx programmig, desiged to reduce iappropriate therapy ad miimise the eed for programmig adjustmets at implat Uique 40 J delivered eergy safety shock optio ca provide a greater DFT safety margi The DF4 coector is desiged to simplify implats by streamliig defibrillatio coectios ito a sigle termial pi ad reducig the umber of set screws QHR * chemistry battery provides greater capacity for ehaced logevity ad stable charge times Atitachycardia pacig (ATP) while chargig ad prior to chargig i the VF zoe further exteds the programmig optios for termiatig tachyarrhythmias without a high-voltage shock The low frequecy atteuatio filter is desiged to ehace sesig performace ad may reduce the possibility of oversesig T waves DeFT Respose techology offers the most oivasive optios for maagig high DFTs The SeseAbility feature provides the flexibility to fie-tue programmig aroud T-wave oversesig without decreasig sesitivity Vibratory patiet otifier eables patiets with hearig problems to be alerted to a low battery, lead-related complicatios ad more Merli@home Trasmitter Compatible Orderig Iformatio Cotets: Cardiac pulse geerator Model Dimesios Coector Coector Number (H x W x T, mm) Weight (g) Volume (cc) Defibrillatio Sese/Pace CD1235-40 73 x 40 x 14 76 35 DF1 IS-1 CD1235-40Q 71 x 40 x 14 75 35 DF4 DF4 Idicatios: The devices are iteded to provide vetricular atitachycardia pacig ad vetricular defibrillatio for automated treatmet of life-threateig vetricular arrhythmias. Cotraidicatios: Cotraidicatios for use of the pulse geerator system iclude vetricular tachyarrhythmias resultig from trasiet or correctable factors such as drug toxicity, electrolyte imbalace, or acute myocardial ifarctio. Adverse Evets: Implatatio of the pulse geerator system, like that of ay other device, ivolves risks, some possibly life-threateig. These iclude but are ot limited to the followig: acute hemorrhage/bleedig, air emboli, arrhythmia acceleratio, cardiac or veous perforatio, cardiogeic shock, cyst formatio, erosio, exacerbatio of heart failure, extrusio, fibrotic tissue growth, fluid accumulatio, hematoma formatio, histotoxic reactios, ifectio, keloid formatio, myocardial irritability, erve damage, peumothorax, thromboemboli, veous occlusio. Other possible adverse effects iclude mortality due to: compoet failure, device-programmer commuicatio failure, lead abrasio, lead dislodgmet or poor lead placemet, lead fracture, iability to defibrillate, ihibited therapy for a vetricular tachycardia, iterruptio of fuctio due to electrical or magetic iterferece, shutig of eergy from defibrillatio paddles, system failure due to ioisig radiatio. Other possible adverse effects iclude mortality due to iappropriate delivery of therapy caused by: multiple coutig of cardiac evets icludig T waves, P waves, or supplemetal pacemaker stimuli. Amog the psychological effects of device implatatio are imagied pulsig, depedecy, fear of iappropriate pulsig, ad fear of losig pulse capability. Refer to the User s Maual for detailed idicatios, cotraidicatios, warigs, precautios ad potetial adverse evets. Brief Summary: Prior to usig these devices, please review the Istructios for Use for a complete listig of idicatios, cotraidicatios, warigs, precautios, potetial adverse evets ad directios for use. Devices depicted may ot be available i all coutries. Check with your St. Jude Medical represetative for product availability i your coutry. Uless otherwise oted, idicates that the ame is a trademark of, or licesed to, St. Jude Medical or oe of its subsidiaries. ST. JUDE MEDICAL, the ie-squares symbol ad MORE CONTROL. LESS RISK. are registered ad uregistered trademarks ad service marks of St. Jude Medical, Ic. ad its related compaies. 2011 St. Jude Medical, Ic. All rights reserved.
Implatable Cardioverter Defibrillator (ICD) Devices Fortify ST VR Sigle-Chamber Implatable Cardioverter Defibrillator (ICD) Product Specificatios PHYSICAL SPECIFICATIONS Models CD1235-40 CD1235-40Q Telemetry RF RF Delivered/Stored Eergy (J) 40/45 40/45 Volume (cc) 35 35 Weight (g) 76 75 Size (mm) 73 x 40 x 14 71 x 40 x 14 Defibrillatio Lead Coectios DF1 DF4 Sese/Pace Lead Coectios IS-1 DF4 High-Voltage Ca Electrically active titaium ca Electrically active titaium ca PARAMETERS SETTINGS Sesig/Detectio SeseAbility Techology Automatic Sesitivity Cotrol adjustmet for atrial ad vetricular evets Low Frequecy Atteuatio O; Off Threshold Start (Post-Sesed; Vetricular) 50; 62,5; 75; 100%; (Post-Paced; Vetricular) Auto; 0,2-3,0 mv Decay Delay (Post-Sese/Post-Pace; Vetricular) 0-220 Vetricular Sese Refractory (ms) 125; 157 Detectio Zoes VT-1; VT-2; VF SVT Discrimiators Sudde Oset; Iterval Stability; Morphology Discrimiatio (MD) with Maual or Automatic Template Update Recofirmatio Cotiuous sesig durig chargig Atitachycardia Pacig Therapy ATP Cofiguratios Ramp; Burst; Sca; 1 or 2 schemes per VT zoe ATP i VF Zoe ATP While Chargig; ATP Prior to Chargig; Off ATP Upper Rate Cutoff 150-300 bpm Burst Cycle Legth Adaptive; Readaptive or Fixed Mi. Burst Cycle Legth (ms) 150-400 i icremets of 5 Number of Bursts 1-15 Number of Stimuli 2-20 Add Stimuli per Burst O; Off ATP Pulse Amplitude (V) 7,5 Idepedet from Bradycardia ad Post-Therapy Pacig ATP Pulse Width (ms) 1,0 or 1,5 Idepedetly programmable from Bradycardia ad Post-Therapy Pacig High-Voltage Therapy High-Voltage Output Mode Fixed Pulse Width; Fixed Tilt Waveform Biphasic; Moophasic RV Polarity Cathode (-); Aode (+) Electrode Cofiguratio RV to Ca; RV to SVC/Ca Bradycardia Pacig Permaet Modes VVI(R); Pacer Off Temporary Modes Off; VVI; VOO Rate-Adaptive Sesor (Post-Sese/Post-Pace; Vetricular) 0-220 Programmable Off; Base Rate (mi -1 ); Rest Rate (mi -1 ); Maximum Sesor Rate (mi -1 ); Rate ad Delay Parameters Pulse Amplitude (RV) (V); Pulse Width (RV) (ms); Hysteresis Rate (mi -1 ); Rate Hysteresis with Search Vetricular AutoCapture O; Off Pacig System Post-Therapy Pacig (Idepedetly programmable from Bradycardia ad ATP) Post-Shock Pacig Mode Off; VVI Post-Shock Base Rate (mi -1 ) 30-100 i icremets of 5 Post-Shock Pacig Duratio (mi) Off; 0,5; 1; 2,5; 7,5; or 10 Device Testig/Iductio Methods DC Fibber Pulse Duratio (sec) 0,5-5,0 Burst Fibber Cycle Legth (ms) 20-100 Noivasive Programmed 2-25 stimuli with up to three extrastimuli Stimulatio (NIPS) Patiet Notifiers Programmable Notifiers (O; Off) Device at ERI; Charge Time Limit Reached; Possible HV Circuit Damage; Vetricular Lead Impedace Out of Rage; High-Voltage Lead Impedace Out of Rage; % V pacig; CorVue Cogestio Trigger Device Parameter Reset O Etry ito Backup VVI Mode O Vibratio Duratio (sec) 2; 4; 6; 8; 10; 12; 14; 16 Number of Vibratios per Notificatio 2 Number of Notificatios 1-16 Time Betwee Notificatios (hours) 10; 22 Electrograms ad Diagostics Stored Electrograms Up to 45 miutes icludig up to oe miute programmable pre-trigger data per VT/VF diagosis/detectio electrograms; triggers iclude diagosis; therapy; PC shock delivery; oise reversio; maget reversio; ad morphology template verificatio Therapy Summary Diagram of therapies delivered Episodes Summary Directory listig of up to 60 episodes with access to more details icludig stored electrograms Lifetime Diagostics History of bradycardia evets ad device-iitiated chargig Vetricular HV Lead Impedace Tred Multi-Vector Tred Data Histograms Evet Histogram; Vetricular Heart Rate Histogram; Exercise ad Activity Tredig Real-Time Measuremets (RTM) Pacig lead impedaces; high-voltage lead impedaces; uloaded battery voltage; ad sigal amplitudes ST Moitorig ST Histogram Data; ST Deviatio Tred; ST Episode Log CorVue Cogestio Moitorig O; Off CorVue Cogestio Trigger 8-18 days *QHR is a trademark of Greatbatch, LTD. (GMCRM778EN) Brief Summary: Prior to usig these devices, please review the Istructios for Use for a complete listig of idicatios, cotraidicatios, warigs, precautios, potetial adverse evets ad directios for use. Devices depicted may ot be available i all coutries. Check with your St. Jude Medical represetative for product availability i your coutry. Uless otherwise oted, idicates that the ame is a trademark of, or licesed to, St. Jude Medical or oe of its subsidiaries. ST. JUDE MEDICAL, the ie-squares symbol ad MORE CONTROL. LESS RISK. are registered ad uregistered trademarks ad service marks of St. Jude Medical, Ic. ad its related compaies. 2011 St. Jude Medical, Ic. All rights reserved. Item GMCRM778EN
Implatable Cardioverter Defibrillator (ICD) Devices Fortify DR Dual-Chamber Implatable Cardioverter Defibrillator (ICD) Product Highlights ShockGuard techology with DecisioTx programmig, desiged to reduce iappropriate therapy ad miimise the eed for programmig adjustmets at implat Uique 40 J delivered eergy safety shock optio ca provide a greater DFT safety margi The DF4 coector is desiged to simplify implats by streamliig defibrillatio coectios ito a sigle termial pi ad reducig the umber of set screws QHR * chemistry battery provides greater capacity for ehaced logevity ad stable charge times Atitachycardia pacig (ATP) while chargig ad prior to chargig i the VF zoe further exteds the programmig optios for termiatig tachyarrhythmias without a high-voltage shock The low frequecy atteuatio filter is desiged to ehace sesig performace ad may reduce the possibility of oversesig T waves DeFT Respose techology offers the most oivasive optios for maagig high DFTs Vibratory patiet otifier eables patiets with hearig problems to be alerted to a low battery, lead-related complicatios ad more The SeseAbility feature provides the flexibility to fie-tue programmig aroud T-wave oversesig without decreasig sesitivity Vetricular Itrisic Preferece (VIP ) algorithm automatically searches for itrisic coductio Merli@home Trasmitter Compatible Orderig Iformatio Cotets: Cardiac pulse geerator Model Dimesios Coector Coector Number (H x W x T, mm) Weight (g) Volume (cc) Defibrillatio Sese/Pace CD2233-40 74 x 40 x 14 76 35 DF1 IS-1 CD2233-40Q 71 x 40 x 14 75 35 DF4 IS-1; DF4 Idicatios: The devices are iteded to provide vetricular atitachycardia pacig ad vetricular defibrillatio for automated treatmet of life-threateig vetricular arrhythmias. Cotraidicatios: Cotraidicatios for use of the pulse geerator system iclude vetricular tachyarrhythmias resultig from trasiet or correctable factors such as drug toxicity, electrolyte imbalace, or acute myocardial ifarctio. Adverse Evets: Implatatio of the pulse geerator system, like that of ay other device, ivolves risks, some possibly life-threateig. These iclude but are ot limited to the followig: acute hemorrhage/bleedig, air emboli, arrhythmia acceleratio, cardiac or veous perforatio, cardiogeic shock, cyst formatio, erosio, exacerbatio of heart failure, extrusio, fibrotic tissue growth, fluid accumulatio, hematoma formatio, histotoxic reactios, ifectio, keloid formatio, myocardial irritability, erve damage, peumothorax, thromboemboli, veous occlusio. Other possible adverse effects iclude mortality due to: compoet failure, device-programmer commuicatio failure, lead abrasio, lead dislodgmet or poor lead placemet, lead fracture, iability to defibrillate, ihibited therapy for a vetricular tachycardia, iterruptio of fuctio due to electrical or magetic iterferece, shutig of eergy from defibrillatio paddles, system failure due to ioisig radiatio. Other possible adverse effects iclude mortality due to iappropriate delivery of therapy caused by: multiple coutig of cardiac evets icludig T waves, P waves, or supplemetal pacemaker stimuli. Amog the psychological effects of device implatatio are imagied pulsig, depedecy, fear of iappropriate pulsig, ad fear of losig pulse capability. Refer to the User s Maual for detailed idicatios, cotraidicatios, warigs, precautios ad potetial adverse evets. Brief Summary: Prior to usig these devices, please review the Istructios for Use for a complete listig of idicatios, cotraidicatios, warigs, precautios, potetial adverse evets ad directios for use. Devices depicted may ot be available i all coutries. Check with your St. Jude Medical represetative for product availability i your coutry. Uless otherwise oted, idicates that the ame is a trademark of, or licesed to, St. Jude Medical or oe of its subsidiaries. ST. JUDE MEDICAL, the ie-squares symbol ad MORE CONTROL. LESS RISK. are registered ad uregistered trademarks ad service marks of St. Jude Medical, Ic. ad its related compaies. 2011 St. Jude Medical, Ic. All rights reserved.
Implatable Cardioverter Defibrillator (ICD) Devices Fortify DR Dual-Chamber Implatable Cardioverter Defibrillator (ICD) Product Specificatios PHYSICAL SPECIFICATIONS Models CD2233-40 CD2233-40Q Telemetry RF RF Delivered/Stored Eergy (J) 40/45 40/45 Volume (cc) 35 35 Weight (g) 76 75 Size (mm) 74 x 40 x 14 71 x 40 x 14 Defibrillatio Lead Coectios DF1 DF4 Sese/Pace Lead Coectios IS-1 DF4 High-Voltage Ca Electrically active titaium ca Electrically active titaium ca PARAMETER AF Maageme t SETTINGS AF Suppressio Pacig O; Off No. of Overdrive Pacig Cycles 15-40 i steps of 5 Maximum AF Suppressio Rate 80-150 mi -1 Sesig/Detectio SeseAbility Techology Automatic Sesitivity Cotrol adjustmet for atrial ad vetricular evets Low Frequecy Atteuatio O; Off Threshold Start (Post-Sesed; Atrial) 50; 62,5; 75; 100%; (Post-Paced; Atrial) 0,2-3,0 mv; (Post-Sesed; Vetricular) 50; 62,5; 75; 100%; (Post-Paced; Vetricular) Auto; 0,2-3,0 mv Decay Delay (Post-Sese/Post-Pace; Atrial/Vetricular) 0-220 Vetricular Sese Refractory (ms) 125; 157 Detectio Zoes VT-1; VT-2; VF SVT Discrimiators AV Rate Brach; Sudde Oset; Iterval Stability; Morphology Discrimiatio (MD) with Maual or Automatic Template Update Recofirmatio Cotiuous sesig durig chargig Atitachycardia Pacig Therapy ATP Cofiguratios Ramp; Burst; Sca; 1 or 2 schemes per VT zoe ATP i VF Zoe ATP While Chargig; ATP Prior to Chargig; Off ATP Upper Rate Cutoff 150-300 bpm Burst Cycle Legth Adaptive; Readaptive or Fixed Mi. Burst Cycle Legth (ms) 150-400 i icremets of 5 Number of Bursts 1-15 Number of Stimuli 2-20 Add Stimuli per Burst O; Off ATP Pulse Amplitude (V) 7,5 Idepedet from Bradycardia ad Post-Therapy Pacig ATP Pulse Width (ms) 1,0 or 1,5 Idepedetly programmable from Bradycardia ad Post-Therapy Pacig High-Voltage Therapy High-Voltage Output Mode Fixed Pulse Width; Fixed Tilt Waveform Biphasic; Moophasic RV Polarity Cathode (-); Aode (+) Electrode Cofiguratio RV to Ca; RV to SVC/Ca Bradycardia Pacig Permaet Modes DDD(R); DDI(R); VVI(R); AAI(R); Pacer Off Temporary Modes Off; DDD; DDI; VVI; AAI; AAT; DOO; VOO; AOO Rate-Adaptive Sesor (Post-Sese/Post-Pace; Atrial/Vetricular) 0-220 Programmable Rate ad Off; Base Rate (mi -1 ); Rest Rate (mi -1 ); Maximum Trackig Rate (mi -1 ); Delay Parameters Maximum Sesor Rate (mi -1 ); Paced AV Delay (ms); Sesed AV Delay (ms); Rate Resposive AV Delay; Pulse Amplitude (Atrial; RV) (V); Pulse Width (Atrial ad RV) (ms); Hysteresis Rate (mi -1 ); Rate Hysteresis with Search QuickOpt Timig Cycle Optimisatio Sesed/Paced AV delay Auto Mode Switch (AMS) Off; DDI(R); VVI(R) Atrial Tachycardia 110-300 Detectio Rate (mi -1 ) AMS Base Rate (mi -1 ) 40; 45;...135 Auto PMT Detectio/Termiatio A Pace o PMT; Off; Passive Rate Resposive PVARP/VREF Off; Low; Medium; High Vetricular Itrisic Preferece (VIP ) Off; 50-200 (50-150 i icremets of 25; 160-200 i icremets of 10) Vetricular AutoCapture O; Off Pacig System ACap Cofirm O; Moitor; Off Post-Therapy Pacig (Idepedetly programmable from Bradycardia ad ATP) Post-Shock Pacig Mode Off; AAI; VVI; DDI; DDD Post-Shock Base Rate (mi -1 ) 30-100 i icremets of 5 Post-Shock Pacig Duratio (mi) Off; 0,5; 1; 2,5; 5; 7,5; or 10 Device Testig/Iductio Methods DC Fibber Pulse Duratio (sec) 0,5-5,0 Burst Fibber Cycle Legth (ms) 20-100 Noivasive Programmed 2-25 stimuli with up to three extrastimuli Stimulatio (NIPS) Patiet Notifiers Programmable Notifiers (O; Off) Device at ERI; Charge Time Limit Reached; Possible HV Circuit Damage; Atrial Lead Impedace Out of Rage; Vetricular Lead Impedace Out of Rage; High-Voltage Lead Impedace Out of Rage; AT/AF Burde; V Rate Durig AT/AF; % V pacig; CorVue Cogestio Trigger Device Parameter Reset O Etry ito Backup VVI Mode O Vibratio Duratio (sec) 2; 4; 6; 8; 10; 12; 14; 16 Number of Vibratios per Notificatio 2 Number of Notificatios 1-16 Time Betwee Notificatios (hours) 10; 22 Electrograms ad Diagostics Stored Electrograms Up to 45 miutes icludig up to oe miute programmable pre-trigger data per VT/VF diagosis/detectio electrograms; triggers iclude diagosis; therapy; atrial episode; PMT termiatio; PC shock delivery; oise reversio; maget reversio; ad morphology template verificatio Therapy Summary Diagram of therapies delivered Episodes Summary Directory listig of up to 60 episodes with access to more details icludig stored electrograms Lifetime Diagostics History of bradycardia evets ad device-iitiated chargig AT/AF Burde Tred Tred data ad couts Vetricular HV Lead Impedace Tred Multi-Vector Tred Data Histograms Evet Histogram; AV Iterval Histogram; Mode Switch Duratio Histogram; Peak Filtered Rate Histogram; Atrial Heart Rate Histogram; Vetricular Heart Rate Histogram; AT/AF Burde; Exercise ad Activity Tredig; V Rates durig AMS PMT Data Iformatio regardig PMT detectios Real-Time Measuremets (RTM) Pacig lead impedaces; high-voltage lead impedaces; uloaded battery voltage; ad sigal amplitudes CorVue Cogestio Moitorig O; Off CorVue Cogestio Trigger 8-18 days *QHR is a trademark of Greatbatch, LTD. (GMCRM779EN) Brief Summary: Prior to usig these devices, please review the Istructios for Use for a complete listig of idicatios, cotraidicatios, warigs, precautios, potetial adverse evets ad directios for use. Devices depicted may ot be available i all coutries. Check with your St. Jude Medical represetative for product availability i your coutry. Uless otherwise oted, idicates that the ame is a trademark of, or licesed to, St. Jude Medical or oe of its subsidiaries. ST. JUDE MEDICAL, the ie-squares symbol ad MORE CONTROL. LESS RISK. are registered ad uregistered trademarks ad service marks of St. Jude Medical, Ic. ad its related compaies. 2011 St. Jude Medical, Ic. All rights reserved. Item GMCRM779EN
Implatable Cardioverter Defibrillator (ICD) Devices Fortify VR Sigle-Chamber Implatable Cardioverter Defibrillator (ICD) Product Highlights ShockGuard techology with DecisioTx programmig, desiged to reduce iappropriate therapy ad miimise the eed for programmig adjustmets at implat Uique 40 J delivered eergy safety shock optio ca provide a greater DFT safety margi The DF4 coector is desiged to simplify implats by streamliig defibrillatio coectios ito a sigle termial pi ad reducig the umber of set screws QHR * chemistry battery provides greater capacity for ehaced logevity ad stable charge times Atitachycardia pacig (ATP) while chargig ad prior to chargig i the VF zoe further exteds the programmig optios for termiatig tachyarrhythmias without a high-voltage shock The low frequecy atteuatio filter is desiged to ehace sesig performace ad may reduce the possibility of oversesig T waves DeFT Respose techology offers the most oivasive optios for maagig high DFTs The SeseAbility feature provides the flexibility to fie-tue programmig aroud T-wave oversesig without decreasig sesitivity Vibratory patiet otifier eables patiets with hearig problems to be alerted to a low battery, lead-related complicatios ad more Merli@home Trasmitter Compatible Orderig Iformatio Cotets: Cardiac pulse geerator Model Dimesios Coector Coector Number (H x W x T, mm) Weight (g) Volume (cc) Defibrillatio Sese/Pace CD1233-40 73 x 40 x 14 76 35 DF1 IS-1 CD1233-40Q 71 x 40 x 14 75 35 DF4 DF4 Idicatios: The devices are iteded to provide vetricular atitachycardia pacig ad vetricular defibrillatio for automated treatmet of life-threateig vetricular arrhythmias. Cotraidicatios: Cotraidicatios for use of the pulse geerator system iclude vetricular tachyarrhythmias resultig from trasiet or correctable factors such as drug toxicity, electrolyte imbalace, or acute myocardial ifarctio. Adverse Evets: Implatatio of the pulse geerator system, like that of ay other device, ivolves risks, some possibly life-threateig. These iclude but are ot limited to the followig: acute hemorrhage/bleedig, air emboli, arrhythmia acceleratio, cardiac or veous perforatio, cardiogeic shock, cyst formatio, erosio, exacerbatio of heart failure, extrusio, fibrotic tissue growth, fluid accumulatio, hematoma formatio, histotoxic reactios, ifectio, keloid formatio, myocardial irritability, erve damage, peumothorax, thromboemboli, veous occlusio. Other possible adverse effects iclude mortality due to: compoet failure, device-programmer commuicatio failure, lead abrasio, lead dislodgmet or poor lead placemet, lead fracture, iability to defibrillate, ihibited therapy for a vetricular tachycardia, iterruptio of fuctio due to electrical or magetic iterferece, shutig of eergy from defibrillatio paddles, system failure due to ioisig radiatio. Other possible adverse effects iclude mortality due to iappropriate delivery of therapy caused by: multiple coutig of cardiac evets icludig T waves, P waves, or supplemetal pacemaker stimuli. Amog the psychological effects of device implatatio are imagied pulsig, depedecy, fear of iappropriate pulsig, ad fear of losig pulse capability. Refer to the User s Maual for detailed idicatios, cotraidicatios, warigs, precautios ad potetial adverse evets. Brief Summary: Prior to usig these devices, please review the Istructios for Use for a complete listig of idicatios, cotraidicatios, warigs, precautios, potetial adverse evets ad directios for use. Devices depicted may ot be available i all coutries. Check with your St. Jude Medical represetative for product availability i your coutry. Uless otherwise oted, idicates that the ame is a trademark of, or licesed to, St. Jude Medical or oe of its subsidiaries. ST. JUDE MEDICAL, the ie-squares symbol ad MORE CONTROL. LESS RISK. are registered ad uregistered trademarks ad service marks of St. Jude Medical, Ic. ad its related compaies. 2011 St. Jude Medical, Ic. All rights reserved.
Implatable Cardioverter Defibrillator (ICD) Devices Fortify VR Sigle-Chamber Implatable Cardioverter Defibrillator (ICD) Product Specificatios PHYSICAL SPECIFICATIONS Models CD1233-40 CD1233-40Q Telemetry RF RF Delivered/Stored Eergy (J) 40/45 40/45 Volume (cc) 35 35 Weight (g) 76 75 Size (mm) 73 x 40 x 14 71 x 40 x 14 Defibrillatio Lead Coectios DF1 DF4 Sese/Pace Lead Coectios IS-1 DF4 High-Voltage Ca Electrically active titaium ca Electrically active titaium ca PARAMETERS SETTINGS Sesig/Detectio SeseAbility Techology Automatic Sesitivity Cotrol adjustmet for vetricular evets Low Frequecy Atteuatio O; Off Threshold Start (Post-Sesed; Vetricular) 50; 62,5; 75; 100%; (Post-Paced; Vetricular) Auto; 0,2-3,0 mv Decay Delay (Post-Sese/Post-Pace; Vetricular) 0-220 Vetricular Sese Refractory (ms) 125; 157 Detectio Zoes VT-1; VT-2; VF SVT Discrimiators Sudde Oset, Iterval Stability; Morphology Discrimiatio (MD) with Maual or Automatic Template Update Recofirmatio Cotiuous sesig durig chargig Atitachycardia Pacig Therapy ATP Cofiguratios Ramp; Burst; Sca; 1 or 2 schemes per VT zoe ATP i VF Zoe ATP While Chargig; ATP Prior to Chargig; Off ATP Upper Rate Cutoff 150-300 bpm Burst Cycle Legth Adaptive; Readaptive or Fixed Mi. Burst Cycle Legth (ms) 150-400 i icremets of 5 Number of Bursts 1-15 Number of Stimuli 2-20 Add Stimuli per Burst O; Off ATP Pulse Amplitude (V) 7,5 Idepedet from Bradycardia ad Post-Therapy Pacig ATP Pulse Width (ms) 1,0 or 1,5 Idepedetly programmable from Bradycardia ad Post-Therapy Pacig High-Voltage Therapy High-Voltage Output Mode Fixed Pulse Width; Fixed Tilt Waveform Biphasic; Moophasic RV Polarity Cathode (-); Aode (+) Electrode Cofiguratio RV to Ca; RV to SVC/Ca Post-Therapy Pacig (Idepedetly programmable from Bradycardia ad ATP) Post-Shock Pacig Mode Off; VVI Post-Shock Base Rate (mi -1 ) 30-100 i icremets of 5 Post-Shock Pacig Duratio (mi) Off; 0,5; 1; 2,5; 7,5; or 10 Device Testig/Iductio Methods DC Fibber Pulse Duratio (sec) 0,5-5,0 Burst Fibber Cycle Legth (ms) 20-100 Noivasive Programmed 2-25 stimuli with up to three extrastimuli Stimulatio (NIPS) Patiet Notifiers Programmable Notifiers (O; Off) Device Parameter Reset Etry ito Backup VVI Mode Vibratio Duratio (sec) 2; 4; 6; 8; 10; 12; 14; 16 Number of Vibratios per Notificatio 2 Number of Notificatios 1-16 Time Betwee Notificatios (hours) 10; 22 Electrograms ad Diagostics Stored Electrograms Therapy Summary Episodes Summary Device at ERI; Charge Time Limit Reached; Possible HV Circuit Damage; Vetricular Lead Impedace Out of Rage; High-Voltage Lead Impedace Out of Rage; %V pacig; CorVue Cogestio Trigger O O Up to 45 miutes icludig up to oe miute programmable pre-trigger data per VT/VF diagosis/detectio electrograms; triggers iclude: diagosis; therapy; PC shock delivery; oise reversio; maget reversio; ad morphology template verificatio Diagram of therapies delivered Directory listig of up to 60 episodes with access to more details icludig stored electrograms History of bradycardia evets ad device-iitiated chargig Lifetime Diagostics Vetricular HV Lead Impedace Tred Multi-Vector Tred Data Histograms Evet Histogram; Vetricular Heart Rate Histogram; Exercise ad Activity Tredig Real-Time Measuremets (RTM) Pacig lead impedaces; high-voltage lead impedaces; uloaded battery voltage; ad sigal amplitudes ST Moitorig ST Histogram Data; ST Deviatio Tred; ad ST Episode Log CorVue Cogestio Moitorig O; Off CorVue Cogestio Trigger 8-18 days *QHR is a trademark of Greatbatch, LTD. Bradycardia Pacig Permaet Modes VVI(R); Pacer Off Temporary Modes Off; VVI; VOO Rate-Adaptive Sesor (Post-Sese/Post-Pace; Vetricular) 0-220 Programmable Off; Base Rate (mi -1 ); Rest Rate (mi -1 ); Maximum Sesor Rate (mi -1 ); Rate Parameters Pulse Amplitude (RV) (V); Pulse Width (RV) (ms); Hysteresis Rate (mi -1 ); Rate Hysteresis with Search Vetricular AutoCapture O; Off Pacig System (GMCRM780EN) Brief Summary: Prior to usig these devices, please review the Istructios for Use for a complete listig of idicatios, cotraidicatios, warigs, precautios, potetial adverse evets ad directios for use. Devices depicted may ot be available i all coutries. Check with your St. Jude Medical represetative for product availability i your coutry. Uless otherwise oted, idicates that the ame is a trademark of, or licesed to, St. Jude Medical or oe of its subsidiaries. ST. JUDE MEDICAL, the ie-squares symbol ad MORE CONTROL. LESS RISK. are registered ad uregistered trademarks ad service marks of St. Jude Medical, Ic. ad its related compaies. 2011 St. Jude Medical, Ic. All rights reserved. Item GMCRM780EN
Implatable Cardioverter Defibrillator (ICD) Devices Curret Accel DR Dual-Chamber Implatable Cardioverter Defibrillator (ICD) Product Highlights The DF4 coector is desiged to simplify implats by streamliig defibrillatio coectios ito a sigle termial pi ad reducig the umber of set screws AutoCapture Pacig System offers the maximum i threshold adaptability ad patiet safety with vetricular Beat-by-Beat capture cofirmatio. The AutoCapture Pacig System automatically delivers a 5,0 V backup safety pulse whe ocapture is detected, ad it may be programmed to either a bipolar or uipolar cofiguratio ACap Cofirm Pacig System periodically completes a threshold search ad automatically adjusts amplitude to address patiets chagig atrial thresholds DeFT Respose techology offers the most oivasive optios for maagig high DFTs The SeseAbility feature provides the flexibility to fie-tue programmig aroud T-wave oversesig without decreasig sesitivity Vibratory patiet otifier eables patiets with hearig problems to be alerted to a low battery, lead-related complicatios ad more Automatic daily high-voltage lead itegrity test is desiged to esure optimal patiet safety Merli@home Trasmitter Compatible Orderig Iformatio Cotets: Cardiac pulse geerator Model Dimesios Coector Coector Number (H x W x T, mm) Weight (g) Volume (cc) Defibrillatio Sese/Pace CD2215-36 77 x 50 x14 80 42 DF1 IS-1 CD2215-36Q 74 x 50 x 14 80 41 DF4 IS-1; DF4 Idicatios: The devices are iteded to provide vetricular atitachycardia pacig ad vetricular defibrillatio for automated treatmet of life-threateig vetricular arrhythmias. Cotraidicatios: Cotraidicatios for use of the pulse geerator system iclude vetricular tachyarrhythmias resultig from trasiet or correctable factors such as drug toxicity, electrolyte imbalace, or acute myocardial ifarctio. Adverse Evets: Implatatio of the pulse geerator system, like that of ay other device, ivolves risks, some possibly life-threateig. These iclude but are ot limited to the followig: acute hemorrhage/bleedig, air emboli, arrhythmia acceleratio, cardiac or veous perforatio, cardiogeic shock, cyst formatio, erosio, exacerbatio of heart failure, extrusio, fibrotic tissue growth, fluid accumulatio, hematoma formatio, histotoxic reactios, ifectio, keloid formatio, myocardial irritability, erve damage, peumothorax, thromboemboli, veous occlusio. Other possible adverse effects iclude mortality due to: compoet failure, device-programmer commuicatio failure, lead abrasio, lead dislodgmet or poor lead placemet, lead fracture, iability to defibrillate, ihibited therapy for a vetricular tachycardia, iterruptio of fuctio due to electrical or magetic iterferece, shutig of eergy from defibrillatio paddles, system failure due to ioisig radiatio. Other possible adverse effects iclude mortality due to iappropriate delivery of therapy caused by: multiple coutig of cardiac evets icludig T waves, P waves, or supplemetal pacemaker stimuli. Amog the psychological effects of device implatatio are imagied pulsig, depedecy, fear of iappropriate pulsig, ad fear of losig pulse capability. Refer to the User s Maual for detailed idicatios, cotraidicatios, warigs, precautios ad potetial adverse evets. Brief Summary: Prior to usig these devices, please review the Istructios for Use for a complete listig of idicatios, cotraidicatios, warigs, precautios, potetial adverse evets ad directios for use. Devices depicted may ot be available i all coutries. Check with your St. Jude Medical represetative for product availability i your coutry. Uless otherwise oted, idicates that the ame is a trademark of, or licesed to, St. Jude Medical or oe of its subsidiaries. ST. JUDE MEDICAL, the ie-squares symbol ad MORE CONTROL. LESS RISK. are registered ad uregistered trademarks ad service marks of St. Jude Medical, Ic. ad its related compaies. 2011 St. Jude Medical, Ic. All rights reserved.
Implatable Cardioverter Defibrillator (ICD) Devices Curret Accel DR Dual-Chamber Implatable Cardioverter Defibrillator (ICD) Product Specificatios PHYSICAL SPECIFICATIONS Models CD2215-36 CD2215-36Q Telemetry RF RF Delivered/Stored Eergy (J) 36/42 36/42 Volume (cc) 42 41 Weight (g) 80 80 Size (mm) 77 x 50 x 14 74 x 50 x 14 Defibrillatio Lead Coectios DF1 DF4 Sese/Pace Lead Coectios IS-1 IS-1 High-Voltage Ca Electrically active titaium ca Electrically active titaium ca PARAMETER AF Maageme t SETTINGS AF Suppressio Pacig O; Off No. of Overdrive Pacig Cycles 15-40 i steps of 5 Maximum AF Suppressio Rate 80-150 mi -1 Sesig/Detectio SeseAbility Techology Automatic Sesitivity Cotrol adjustmet for atrial ad vetricular evets Threshold Start (Post-Sesed; Atrial) 50; 62,5; 75; 100%; (Post-Paced; Atrial) 0,2-3,0 mv; (Post-Sesed; Vetricular) 50; 62,5; 75; 100%; (Post-Paced; Vetricular) Auto; 0,2-3,0 mv Decay Delay (Post-Sese/Post-Pace; Atrial/Vetricular) 0-220 Vetricular Sese Refractory (ms) 125; 157 Detectio Zoes VT-1; VT-2; VF SVT Discrimiators AV Rate Brach; Sudde Oset; Iterval Stability; Morphology Discrimiatio (MD) with Maual or Automatic Template Update Recofirmatio Cotiuous sesig durig chargig Atitachycardia Pacig Therapy ATP Cofiguratios Ramp; Burst; Sca; 1 or 2 schemes per VT zoe Burst Cycle Legth Adaptive; Readaptive or Fixed Mi. Burst Cycle Legth (ms) 150-400 i icremets of 5 Number of Bursts 1-15 Number of Stimuli 2-20 Add Stimuli per Burst O; Off ATP Pulse Amplitude (V) 7,5 Idepedet from Bradycardia ad Post-Therapy Pacig ATP Pulse Width (ms) 1,0 or 1,5 Idepedetly programmable from Bradycardia ad Post-Therapy Pacig Post-Therapy Pacig (idepedetly programmable from Bradycardia ad ATP) Post-Shock Pacig Mode Off; AAI; VVI; DDI; DDD Post-Shock Base Rate (mi -1 ) 30-100 i icremets of 5 Post-Shock Pacig Duratio (mi) Off; 0,5; 1; 2,5; 5; 7,5; or 10 Device Testig/Iductio Methods DC Fibber Pulse Duratio (sec) 0,5-5,0 Burst Fibber Cycle Legth (ms) 20-100 Noivasive Programmed 2-25 stimuli with up to 3 extrastimuli Stimulatio (NIPS) Patiet Notifiers Programmable Notifiers (O; Off) Device at ERI; Charge Time Limit Reached; Possible HV Circuit Damage; Atrial Lead Impedace Out of Rage; Vetricular Lead Impedace Out of Rage; High-Voltage Lead Impedace Out of Rage; AT/AF Burde; V Rate Durig AT/AF; Backup VVI; Log AT/AF Episode Device Parameter Reset O Etry ito Backup VVI Mode O Vibratio Duratio (sec) 2; 4; 6; 8; 10; 12; 14; 16 Number of Vibratios per Notificatio 2 Number of Notificatios 1-16 Time Betwee Notificatios (hours) 10; 22 Electrograms ad Diagostics Stored Electrograms Up to 45 miutes icludig up to 1 miute programmable pre-trigger data per VT/VF diagosis/detectio electrograms; triggers iclude: diagosis; therapy; atrial episode; PMT termiatio; PC shock delivery; oise reversio; maget reversio; ad morphology template verificatio Therapy Summary Diagram of therapies delivered Episodes Summary Directory listig of up to 60 episodes with access to more details icludig stored electrograms Lifetime Diagostics History of bradycardia evets ad device-iitiated chargig AT/AF Burde Tred Tred data ad couts Vetricular HV Lead Impedace Tred Multi-Vector Tred Data Histograms Evet Histogram; AV Iterval Histogram; Mode Switch Duratio Histogram; Peak Filtered Rate Histogram; Atrial Heart Rate Histogram; Vetricular Heart Rate Histogram; AT/AF Burde; Exercise ad Activity Tredig; V Rates durig AMS PMT Data Iformatio regardig PMT detectios Real-Time Measuremets (RTM) Pacig lead impedaces; high-voltage lead impedaces; uloaded battery voltage; ad sigal amplitudes High-Voltage Therapy High-Voltage Output Mode Fixed Pulse Width; Fixed Tilt Waveform Biphasic; Moophasic RV Polarity Cathode (-); Aode (+) Electrode Cofiguratio RV to Ca; RV to SVC/Ca Bradycardia Pacig Permaet Modes DDD(R); DDI(R); DOO(R); VVI(R); VOO(R); AAI(R); AOO(R) Temporary Modes Off; DDD; DDI; VVI; AAI; AAT; AAT(R); DOO; VOO; AOO Rate-Adaptive Sesor O; Off; Passive Programmable Rate ad Off; Base Rate (mi -1 ); Rest Rate (mi -1 ); Maximum Trackig Rate (mi -1 ); Delay Parameters Maximum Sesor Rate (mi -1 ); Paced AV Delay (ms); Sesed AV Delay (ms); Rate Resposive AV Delay; Pulse Amplitude (Atrial; RV) (V); Pulse Width (Atrial ad RV) (ms); Hysteresis Rate (mi -1 ); Rate Hysteresis with Search QuickOpt Timig Cycle Optimisatio Sesed/Paced AV delay Auto Mode Switch (AMS) DDD(R); DDI(R); DOO(R); VVI(R); VOO(R); AAI(R); AOO(R) Atrial Tachycardia Detectio Rate (mi -1 ) 110-300 AMS Base Rate (mi -1 ) 40; 45;...135 Auto PMT Detectio/Termiatio Atrial Pace; Off; Passive Rate Resposive PVARP/VREF Off; Low; Medium; High Vetricular Itrisic Preferece (VIP ) Off; 50-200 (50-150 i icremets of 25; 160-200 i icremets of 10) Vetricular AutoCapture Pacig System O; Off ACap Cofirm O; Moitor; Off (GMCRM775EN) Brief Summary: Prior to usig these devices, please review the Istructios for Use for a complete listig of idicatios, cotraidicatios, warigs, precautios, potetial adverse evets ad directios for use. Devices depicted may ot be available i all coutries. Check with your St. Jude Medical represetative for product availability i your coutry. Uless otherwise oted, idicates that the ame is a trademark of, or licesed to, St. Jude Medical or oe of its subsidiaries. ST. JUDE MEDICAL, the ie-squares symbol ad MORE CONTROL. LESS RISK. are registered ad uregistered trademarks ad service marks of St. Jude Medical, Ic. ad its related compaies. 2011 St. Jude Medical, Ic. All rights reserved. Item GMCRM775EN
Implatable Cardioverter Defibrillator (ICD) Devices Curret Accel VR Sigle-Chamber Implatable Cardioverter Defibrillator (ICD) Product Highlights The DF4 coector is desiged to simplify implats by streamliig defibrillatio coectios ito a sigle termial pi ad reducig the umber of set screws ACap Cofirm Pacig System periodically completes a threshold search ad automatically adjusts amplitude to address patiets chagig atrial thresholds DeFT Respose techology offers the most oivasive optios for maagig high DFTs The SeseAbility feature provides the flexibility to fie-tue programmig aroud T-wave oversesig without decreasig sesitivity Vibratory patiet otifier eables patiets with hearig problems to be alerted to a low battery, lead-related complicatios ad more Automatic daily high-voltage lead itegrity test is desiged to esure optimal patiet safety Merli@home Trasmitter Compatible Orderig Iformatio Cotets: Cardiac pulse geerator Model Dimesios Coector Coector Number (H x W x T, mm) Weight (g) Volume (cc) Defibrillatio Sese/Pace CD1215-36 76 x 50 x14 79 42 DF1 IS-1 CD1215-36Q 74 x 50 x 14 79 41 DF4 DF4 Idicatios: The devices are iteded to provide vetricular atitachycardia pacig ad vetricular defibrillatio for automated treatmet of life-threateig vetricular arrhythmias. Cotraidicatios: Cotraidicatios for use of the pulse geerator system iclude vetricular tachyarrhythmias resultig from trasiet or correctable factors such as drug toxicity, electrolyte imbalace, or acute myocardial ifarctio. Adverse Evets: Implatatio of the pulse geerator system, like that of ay other device, ivolves risks, some possibly life-threateig. These iclude but are ot limited to the followig: acute hemorrhage/bleedig, air emboli, arrhythmia acceleratio, cardiac or veous perforatio, cardiogeic shock, cyst formatio, erosio, exacerbatio of heart failure, extrusio, fibrotic tissue growth, fluid accumulatio, hematoma formatio, histotoxic reactios, ifectio, keloid formatio, myocardial irritability, erve damage, peumothorax, thromboemboli, veous occlusio. Other possible adverse effects iclude mortality due to: compoet failure, device-programmer commuicatio failure, lead abrasio, lead dislodgmet or poor lead placemet, lead fracture, iability to defibrillate, ihibited therapy for a vetricular tachycardia, iterruptio of fuctio due to electrical or magetic iterferece, shutig of eergy from defibrillatio paddles, system failure due to ioisig radiatio. Other possible adverse effects iclude mortality due to iappropriate delivery of therapy caused by: multiple coutig of cardiac evets icludig T waves, P waves, or supplemetal pacemaker stimuli. Amog the psychological effects of device implatatio are imagied pulsig, depedecy, fear of iappropriate pulsig, ad fear of losig pulse capability. Refer to the User s Maual for detailed idicatios, cotraidicatios, warigs, precautios ad potetial adverse evets. Brief Summary: Prior to usig these devices, please review the Istructios for Use for a complete listig of idicatios, cotraidicatios, warigs, precautios, potetial adverse evets ad directios for use. Devices depicted may ot be available i all coutries. Check with your St. Jude Medical represetative for product availability i your coutry. Uless otherwise oted, idicates that the ame is a trademark of, or licesed to, St. Jude Medical or oe of its subsidiaries. ST. JUDE MEDICAL, the ie-squares symbol ad MORE CONTROL. LESS RISK. are registered ad uregistered trademarks ad service marks of St. Jude Medical, Ic. ad its related compaies. 2011 St. Jude Medical, Ic. All rights reserved.
Curret Accel VR Sigle-Chamber Implatable Cardioverter Defibrillator (ICD) Product Specificatios Implatable Cardioverter Defibrillator (ICD) Devices PHYSICAL SPECIFICATIONS Models CD1215-36 CD1215-36Q Telemetry RF RF Delivered/Stored Eergy (J) 36/42 36/42 Volume (cc) 42 41 Weight (g) 79 79 Size (mm) 76 x 50 x 14 74 x 50 x 14 Defibrillatio Lead Coectios DF1 DF4 Sese/Pace Lead Coectios IS-1 DF4 High-Voltage Ca Electrically active titaium ca Electrically active titaium ca PARAMETERS SETTINGS Sesig/Detectio SeseAbility Techology Automatic Sesitivity Cotrol adjustmet for atrial ad vetricular evets Threshold Start (Post-Sesed; Atrial) 50; 62,5; 75; 100%; (Post-Paced; Atrial) 0,2-3,0 mv; (Post-Sesed; Vetricular) 50; 62,5; 75; 100%; (Post-Paced; Vetricular) Auto; 0,2-3,0 mv Decay Delay (Post-Sese/Post-Pace; Atrial/Vetricular) 0-220 Vetricular Sese Refractory (ms) 125; 157 Detectio Zoes VT-1; VT-2; VF SVT Discrimiators AV Rate Brach; Sudde Oset; Iterval Stability; Morphology Discrimiatio (MD) with Maual or Automatic Template Update Recofirmatio Cotiuous sesig durig chargig Atitachycardia Pacig Therapy ATP Cofiguratios Ramp; Burst; Sca; 1 or 2 schemes per VT zoe Burst Cycle Legth Adaptive; Readaptive or Fixed Mi. Burst Cycle Legth (ms) 150-400 i icremets of 5 Number of Bursts 1-15 Number of Stimuli 2-20 Add Stimuli per Burst O; Off ATP Pulse Amplitude (V) 7,5 Idepedet from Bradycardia ad Post-Therapy Pacig ATP Pulse Width (ms) 1,0 or 1,5 Idepedetly programmable from Bradycardia ad Post-Therapy Pacig Device Testig/Iductio Methods DC Fibber Pulse Duratio (sec) 0,5-5,0 Burst Fibber Cycle Legth (ms) 20-100 Noivasive Programmed 2-25 stimuli with up to 3 extrastimuli Stimulatio (NIPS) Patiet Notifiers Programmable Notifiers (O; Off) Device Parameter Reset Etry ito Backup VVI Mode Vibratio Duratio (sec) 2; 4; 6; 8; 10; 12; 14; 16 Number of Vibratios per Notificatio 2 Number of Notificatios 1-16 Time Betwee Notificatios (hours) 10; 22 Electrograms ad Diagostics Stored Electrograms Therapy Summary Episodes Summary Device at ERI; Charge Time Limit Reached; Possible HV Circuit Damage; Vetricular Lead Impedace Out of Rage; High-Voltage Lead Impedace Out of Rage; Backup VVI; Log AT/AF Episode O O Up to 45 miutes icludig up to 1 miute programmable pre-trigger data per VT/VF diagosis/detectio electrograms; triggers iclude: diagosis; therapy; PC shock delivery; oise reversio; maget reversio; ad morphology template verificatio Diagram of therapies delivered Directory listig of up to 60 episodes with access to more details icludig stored electrograms History of bradycardia evets ad device-iitiated chargig Lifetime Diagostics Vetricular HV Lead Impedace Tred Multi-Vector Tred Data Histograms Evet Histogram; Vetricular Heart Rate Histogram; Exercise ad Activity Tredig Real-Time Measuremets (RTM) Pacig lead impedaces; high-voltage lead impedaces; uloaded battery voltage; ad sigal amplitudes High-Voltage Therapy High-Voltage Output Mode Fixed Pulse Width; Fixed Tilt Waveform Biphasic; Moophasic RV Polarity Cathode (-); Aode (+) Electrode Cofiguratio RV to Ca; RV to SVC/Ca Bradycardia Pacig Permaet Modes Off; VVI(R); VOO(R) Temporary Modes Off; VVI; VOO Rate-Adaptive Sesor O; Off; Passive Programmable Rate Parameters Off; Base Rate (mi -1 ); Rest Rate (mi -1 ); Maximum Sesor Rate (mi -1 ); Pulse Amplitude (RV) (V); Pulse Width (RV) (ms); Hysteresis Rate (mi -1 ); Rate Hysteresis with Search Post-Therapy Pacig (idepedetly programmable from Bradycardia ad ATP) Post-Shock Pacig Mode Off; VVI Post-Shock Base Rate (mi -1 ) 30-100 i icremets of 5 Post-Shock Pacig Duratio (mi) Off; 0,5; 1; 2,5; 5; 7,5; or 10 (GMCRM774EN) Brief Summary: Prior to usig these devices, please review the Istructios for Use for a complete listig of idicatios, cotraidicatios, warigs, precautios, potetial adverse evets ad directios for use. Devices depicted may ot be available i all coutries. Check with your St. Jude Medical represetative for product availability i your coutry. Uless otherwise oted, idicates that the ame is a trademark of, or licesed to, St. Jude Medical or oe of its subsidiaries. ST. JUDE MEDICAL, the ie-squares symbol ad MORE CONTROL. LESS RISK. are registered ad uregistered trademarks ad service marks of St. Jude Medical, Ic. ad its related compaies. 2011 St. Jude Medical, Ic. All rights reserved. Item GMCRM774EN
Implatable Cardioverter Defibrillator (ICD) Devices Curret + DR Dual-Chamber Implatable Cardioverter Defibrillator (ICD) Product Highlights The DF4 coector is desiged to simplify implats by streamliig defibrillatio coectios ito a sigle termial pi ad reducig the umber of set screws Triple redudacy safety platform is desiged to miimise risk ad icrease security ad patiet comfort through multiple hardware ad software system safeguards DeFT Respose techology offers the most oivasive optios for maagig high DFTs The SeseAbility feature provides the flexibility to fie-tue programmig aroud T-wave oversesig without decreasig sesitivity Vibratory patiet otifier eables patiets with hearig problems to be alerted to a low battery, lead-related complicatios ad more Automatic daily high-voltage lead itegrity test is desiged to esure optimal patiet safety Merli@home Trasmitter Compatible Orderig Iformatio Cotets: Cardiac pulse geerator Model Dimesios Coector Coector Number (H x W x T, mm) Weight (g) Volume (cc) Defibrillatio Sese/Pace CD2211-36 77 x 50 x14 80 42 DF1 IS-1 CD2211-36Q 74 x 50 x 14 80 41 DF4 IS-1; DF4 Idicatios: The devices are iteded to provide vetricular atitachycardia pacig ad vetricular defibrillatio for automated treatmet of life-threateig vetricular arrhythmias. Cotraidicatios: Cotraidicatios for use of the pulse geerator system iclude vetricular tachyarrhythmias resultig from trasiet or correctable factors such as drug toxicity, electrolyte imbalace, or acute myocardial ifarctio. Adverse Evets: Implatatio of the pulse geerator system, like that of ay other device, ivolves risks, some possibly life-threateig. These iclude but are ot limited to the followig: acute hemorrhage/bleedig, air emboli, arrhythmia acceleratio, cardiac or veous perforatio, cardiogeic shock, cyst formatio, erosio, exacerbatio of heart failure, extrusio, fibrotic tissue growth, fluid accumulatio, hematoma formatio, histotoxic reactios, ifectio, keloid formatio, myocardial irritability, erve damage, peumothorax, thromboemboli, veous occlusio. Other possible adverse effects iclude mortality due to: compoet failure, device-programmer commuicatio failure, lead abrasio, lead dislodgmet or poor lead placemet, lead fracture, iability to defibrillate, ihibited therapy for a vetricular tachycardia, iterruptio of fuctio due to electrical or magetic iterferece, shutig of eergy from defibrillatio paddles, system failure due to ioisig radiatio. Other possible adverse effects iclude mortality due to iappropriate delivery of therapy caused by: multiple coutig of cardiac evets icludig T waves, P waves, or supplemetal pacemaker stimuli. Amog the psychological effects of device implatatio are imagied pulsig, depedecy, fear of iappropriate pulsig, ad fear of losig pulse capability. Refer to the User s Maual for detailed idicatios, cotraidicatios, warigs, precautios ad potetial adverse evets. Brief Summary: Prior to usig these devices, please review the Istructios for Use for a complete listig of idicatios, cotraidicatios, warigs, precautios, potetial adverse evets ad directios for use. Devices depicted may ot be available i all coutries. Check with your St. Jude Medical represetative for product availability i your coutry. Uless otherwise oted, idicates that the ame is a trademark of, or licesed to, St. Jude Medical or oe of its subsidiaries. ST. JUDE MEDICAL, the ie-squares symbol ad MORE CONTROL. LESS RISK. are registered ad uregistered trademarks ad service marks of St. Jude Medical, Ic. ad its related compaies. 2011 St. Jude Medical, Ic. All rights reserved.
Implatable Cardioverter Defibrillator (ICD) Devices Curret + DR Dual-Chamber Implatable Cardioverter Defibrillator (ICD) Product Specificatios PHYSICAL SPECIFICATIONS Models CD2211-36 CD2211-36Q Telemetry RF RF Delivered/Stored Eergy (J) 36/42 36/42 Volume (cc) 42 41 Weight (g) 80 80 Size (mm) 77 x 50 x 14 74 x 50 x 14 Defibrillatio Lead Coectios DF1 DF4 Sese/Pace Lead Coectios IS-1 DF4 High-Voltage Ca Electrically active titaium ca Electrically active titaium ca PARAMETER AF Maageme t SETTINGS AF Suppressio Pacig O; Off No. of Overdrive Pacig Cycles 15-40 i steps of 5 Maximum AF Suppressio Rate 80-150 mi -1 Sesig/Detectio SeseAbility Techology Automatic Sesitivity Cotrol adjustmet for atrial ad vetricular evets Low Frequecy Atteuatio O; Off Threshold Start (Post-Sesed; Atrial) 50; 62,5; 75; 100%; (Post-Paced; Atrial) 0,2-3,0 mv; (Post-Sesed; Vetricular) 50; 62,5; 75; 100%; (Post-Paced; Vetricular) Auto; 0,2-3,0 mv Decay Delay (Post-Sesed/Post-Paced; Atrial/Vetricular) 0-220; (Post-Paced Vetricular) Auto Vetricular Sese Refractory (ms) 125; 157 Detectio Zoes VT-1; VT-2; VF SVT Discrimiators AV Rate Brach; Sudde Oset; Iterval Stability; Morphology Discrimiatio (MD) with Maual or Automatic Template Update Recofirmatio Cotiuous sesig durig chargig Atitachycardia Pacig Therapy ATP Cofiguratios Ramp; Burst; Sca; 1 or 2 schemes per VT zoe Burst Cycle Legth Adaptive; Readaptive or Fixed Mi. Burst Cycle Legth (ms) 150-400 i icremets of 5 Number of Bursts 1-15 Number of Stimuli 2-20 Add Stimuli per Burst O; Off High-Voltage Therapy High-Voltage Output Mode Fixed Pulse Width; Fixed Tilt Waveform Biphasic; Moophasic RV Polarity Cathode (-); Aode (+) Electrode Cofiguratio RV to Ca; RV to SVC/Ca Bradycardia Pacig Permaet Modes DDD(R); DDI(R); DOO(R); VVI(R); VOO(R); AAI(R); AOO(R) Temporary Modes Off; DDD; DDI; VVI; AAI; AAT; AAT(R); DOO; VOO; AOO Rate-Adaptive Sesor O; Off; Passive Programmable Rate ad Off; Base Rate (mi -1 ); Rest Rate (mi -1 ); Maximum Trackig Rate (mi -1 ); Delay Parameters Maximum Sesor Rate (mi -1 ); Paced AV Delay (ms); Sesed AV Delay (ms); Rate Resposive AV Delay; Pulse Amplitude (Atrial; RV) (V); Pulse Width (Atrial ad RV) (ms); Hysteresis Rate (mi -1 ); Rate Hysteresis with Search QuickOpt Timig Cycle Optimisatio Sesed/Paced AV delay Auto Mode Switch (AMS) DDD(R); DDI(R); DOO(R); VVI(R); VOO(R); AAI(R); AOO(R) Atrial Tachycardia Detectio Rate (mi -1 ) 110-300 AMS Base Rate (mi -1 ) 40; 45;...135 Auto PMT Detectio/Termiatio Atrial Pace; Off; Passive Rate Resposive PVARP/VREF Off; Low; Medium; High Vetricular Itrisic Preferece (VIP ) Off; 50-200 (50-150 i icremets of 25; 160-200 i icremets of 10) Post-Therapy Pacig (idepedetly programmable from Bradycardia ad ATP) Post-Shock Pacig Mode Off; AAI; VVI; DDI; DDD Post-Shock Base Rate (mi -1 ) 30-100 i icremets of 5 Post-Shock Pacig Duratio (mi) Off; 0,5; 1; 2,5; 5; 7,5; or 10 Device Testig/Iductio Methods DC Fibber Pulse Duratio (sec) 0,5-5,0 Burst Fibber Cycle Legth (ms) 20-100 Noivasive Programmed 2-25 stimuli with up to 3 extrastimuli Stimulatio (NIPS) Patiet Notifiers Programmable Notifiers (O; Off) Device at ERI; Charge Time Limit Reached; Possible HV Circuit Damage; Atrial Lead Impedace Out of Rage; Vetricular Lead Impedace Out of Rage; High-Voltage Lead Impedace Out of Rage; AT/AF Burde; V Rate Durig AT/AF; Backup VVI; Log AT/AF Episode Device Parameter Reset O Etry ito Backup VVI Mode O Vibratio Duratio (sec) 2; 4; 6; 8; 10; 12; 14; 16 Number of Vibratios per Notificatio 2 Number of Notificatios 1-16 Time Betwee Notificatios (hours) 10; 22 Electrograms ad Diagostics Stored Electrograms Up to 45 miutes icludig up to 1 miute programmable pre-trigger data per VT/VF diagosis/detectio electrograms; triggers iclude: diagosis; therapy; atrial episode; PMT termiatio; PC shock delivery; oise reversio; maget reversio; ad morphology template verificatio Therapy Summary Diagram of therapies delivered Episodes Summary Directory listig of up to 60 episodes with access to more details icludig stored electrograms Lifetime Diagostics History of bradycardia evets ad device-iitiated chargig AT/AF Burde Tred Tred data ad couts Vetricular HV Lead Impedace Tred Multi-Vector Tred Data Histograms Evet Histogram; AV Iterval Histogram; Mode Switch Duratio Histogram; Peak Filtered Rate Histogram; Atrial Heart Rate Histogram; Vetricular Heart Rate Histogram; AT/AF Burde; Exercise ad Activity Tredig; V Rates durig AMS PMT Data Iformatio regardig PMT detectios Real-Time Measuremets (RTM) Pacig lead impedaces; high-voltage lead impedaces; uloaded battery voltage; ad sigal amplitudes (GMCRM781EN) Brief Summary: Prior to usig these devices, please review the Istructios for Use for a complete listig of idicatios, cotraidicatios, warigs, precautios, potetial adverse evets ad directios for use. Devices depicted may ot be available i all coutries. Check with your St. Jude Medical represetative for product availability i your coutry. Uless otherwise oted, idicates that the ame is a trademark of, or licesed to, St. Jude Medical or oe of its subsidiaries. ST. JUDE MEDICAL, the ie-squares symbol ad MORE CONTROL. LESS RISK. are registered ad uregistered trademarks ad service marks of St. Jude Medical, Ic. ad its related compaies. 2011 St. Jude Medical, Ic. All rights reserved. Item GMCRM781EN
Implatable Cardioverter Defibrillator (ICD) Devices Curret + VR Sigle-Chamber Implatable Cardioverter Defibrillator (ICD) Product Highlights The DF4 coector is desiged to simplify implats by streamliig defibrillatio coectios ito a sigle termial pi ad reducig the umber of set screws Triple redudacy safety platform is desiged to miimise risk ad icrease security ad patiet comfort through multiple hardware ad software system safeguards Vibratory patiet otifier eables patiets with hearig problems to be alerted to a low battery, lead-related complicatios ad more DeFT Respose techology offers the most oivasive optios for maagig high DFTs The SeseAbility feature provides the flexibility to fie-tue programmig aroud T-wave oversesig without decreasig sesitivity Automatic daily high-voltage lead itegrity test is desiged to esure optimal patiet safety Merli@home Trasmitter Compatible Orderig Iformatio Cotets: Cardiac pulse geerator Model Dimesios Coector Coector Number (H x W x T, mm) Weight (g) Volume (cc) Defibrillatio Sese/Pace CD1211-36 76 x 50 x 14 79 42 DF1 IS-1 CD1211-36Q 74 x 50 x 14 79 41 DF4 DF4 Idicatios: The devices are iteded to provide vetricular atitachycardia pacig ad vetricular defibrillatio for automated treatmet of life-threateig vetricular arrhythmias. Cotraidicatios: Cotraidicatios for use of the pulse geerator system iclude vetricular tachyarrhythmias resultig from trasiet or correctable factors such as drug toxicity, electrolyte imbalace, or acute myocardial ifarctio. Adverse Evets: Implatatio of the pulse geerator system, like that of ay other device, ivolves risks, some possibly life-threateig. These iclude but are ot limited to the followig: acute hemorrhage/bleedig, air emboli, arrhythmia acceleratio, cardiac or veous perforatio, cardiogeic shock, cyst formatio, erosio, exacerbatio of heart failure, extrusio, fibrotic tissue growth, fluid accumulatio, hematoma formatio, histotoxic reactios, ifectio, keloid formatio, myocardial irritability, erve damage, peumothorax, thromboemboli, veous occlusio. Other possible adverse effects iclude mortality due to: compoet failure, device-programmer commuicatio failure, lead abrasio, lead dislodgmet or poor lead placemet, lead fracture, iability to defibrillate, ihibited therapy for a vetricular tachycardia, iterruptio of fuctio due to electrical or magetic iterferece, shutig of eergy from defibrillatio paddles, system failure due to ioisig radiatio. Other possible adverse effects iclude mortality due to iappropriate delivery of therapy caused by: multiple coutig of cardiac evets icludig T waves, P waves, or supplemetal pacemaker stimuli. Amog the psychological effects of device implatatio are imagied pulsig, depedecy, fear of iappropriate pulsig, ad fear of losig pulse capability. Refer to the User s Maual for detailed idicatios, cotraidicatios, warigs, precautios ad potetial adverse evets. Brief Summary: Prior to usig these devices, please review the Istructios for Use for a complete listig of idicatios, cotraidicatios, warigs, precautios, potetial adverse evets ad directios for use. Devices depicted may ot be available i all coutries. Check with your St. Jude Medical represetative for product availability i your coutry. Uless otherwise oted, idicates that the ame is a trademark of, or licesed to, St. Jude Medical or oe of its subsidiaries. ST. JUDE MEDICAL, the ie-squares symbol ad MORE CONTROL. LESS RISK. are registered ad uregistered trademarks ad service marks of St. Jude Medical, Ic. ad its related compaies. 2011 St. Jude Medical, Ic. All rights reserved.
Implatable Cardioverter Defibrillator (ICD) Devices Curret + VR Sigle-Chamber Implatable Cardioverter Defibrillator (ICD) Product Specificatios PHYSICAL SPECIFICATIONS Models CD1211-36 CD1211-36Q Telemetry RF RF Delivered/Stored Eergy (J) 36/42 36/42 Volume (cc) 42 41 Weight (g) 79 79 Size (mm) 76 x 50 x 14 74 x 50 x 14 Defibrillatio Lead Coectios DF1 DF4 Sese/Pace Lead Coectios IS-1 DF4 High-Voltage Ca Electrically active titaium ca Electrically active titaium ca PARAMETERS SETTINGS Sesig/Detectio SeseAbility Techology Automatic Sesitivity Cotrol adjustmet for vetricular evets Threshold Start (Post-Sesed; Vetricular) 50; 62,5; 75; 100%; (Post-Paced, Vetricular) Auto; 0,2-3,0 mv Decay Delay (Post-Sesed/Post-Paced; Vetricular) 0-220; (Post-Paced Vetricular) Auto Vetricular Sese Refractory (ms) 125; 157 Detectio Zoes VT-1; VT-2; VF SVT Discrimiators Sudde Oset; Iterval Stability; Morphology Discrimiatio (MD) with Maual or Automatic Template Update Recofirmatio Cotiuous sesig durig chargig Atitachycardia Pacig Therapy ATP Cofiguratios Ramp; Burst; Sca; 1 or 2 schemes per VT zoe Burst Cycle Legth Adaptive; Readaptive or Fixed Mi. Burst Cycle Legth (ms) 150-400 i icremets of 5 Number of Bursts 1-15 Number of Stimuli 2-20 Add Stimuli per Burst O; Off Patiet Notifiers Programmable Notifiers (O; Off) Device at ERI; Charge Time Limit Reached; Possible HV Circuit Damage; Vetricular Lead Impedace Out of Rage; High-Voltage Lead Impedace Out of Rage; Backup VVI; Log AT/AF Episode Device Parameter Reset O Etry ito Backup VVI Mode O Vibratio Duratio (sec) 2; 4; 6; 8; 10; 12; 14; 16 Number of Vibratios per Notificatio 2 Number of Notificatios 1-16 Time Betwee Notificatios (hours) 10; 22 Electrograms ad Diagostics Stored Electrograms Up to 45 miutes icludig up to 1 miute programmable pre-trigger data per VT/VF diagosis/detectio electrograms; triggers iclude: diagosis; therapy; PC shock delivery; oise reversio; maget reversio; ad morphology template verificatio Therapy Summary Diagram of therapies delivered Episodes Summary Directory listig of up to 60 episodes with access to more details icludig stored electrograms Lifetime Diagostics History of bradycardia evets ad device-iitiated chargig Vetricular HV Lead Impedace Tred Multi-Vector Tred Data Histograms Evet Histogram; Vetricular Heart Rate Histogram; Exercise ad Activity Tredig Real-Time Measuremets (RTM) Pacig lead impedaces; high-voltage lead impedaces; uloaded battery voltage; ad sigal amplitudes High-Voltage Therapy High-Voltage Output Mode Fixed Pulse Width; Fixed Tilt Waveform Biphasic; Moophasic RV Polarity Cathode (-); Aode (+) Electrode Cofiguratio RV to Ca; RV to SVC/Ca Bradycardia Pacig Permaet Modes Off; VVI(R); VOO(R) Temporary Modes Off; VVI; VOO Rate-Adaptive Sesor O; Off; Passive Programmable Rate Parameters Off; Base Rate (mi -1 ); Rest Rate (mi -1 ); Maximum Sesor Rate (mi -1 ); Pulse Amplitude (RV) (V); Pulse Width (RV) (ms); Hysteresis Rate (mi -1 ); Rate Hysteresis with Search Post-Therapy Pacig (idepedetly programmable from Bradycardia ad ATP) Post-Shock Pacig Mode Off; VVI Post-Shock Base Rate (mi -1 ) 30-100 i icremets of 5 Post-Shock Pacig Duratio (mi) Off; 0,5; 1; 2,5; 5; 7,5; or 10 Device Testig/Iductio Methods DC Fibber Pulse Duratio (sec) 0,5-5,0 Burst Fibber Cycle Legth (ms) 20-100 Noivasive Programmed 2-25 stimuli with up to 3 extrastimuli Stimulatio (NIPS) (GMCRM782EN) Brief Summary: Prior to usig these devices, please review the Istructios for Use for a complete listig of idicatios, cotraidicatios, warigs, precautios, potetial adverse evets ad directios for use. Devices depicted may ot be available i all coutries. Check with your St. Jude Medical represetative for product availability i your coutry. Uless otherwise oted, idicates that the ame is a trademark of, or licesed to, St. Jude Medical or oe of its subsidiaries. ST. JUDE MEDICAL, the ie-squares symbol ad MORE CONTROL. LESS RISK. are registered ad uregistered trademarks ad service marks of St. Jude Medical, Ic. ad its related compaies. 2011 St. Jude Medical, Ic. All rights reserved. Item GMCRM782EN
Defibrillatio Leads
St. Jude Medical Defibrillatio Leads St. Jude Medical defibrillatio leads have bee desiged to provide the highest level of safety. All of our defibrillatio leads feature Optim isulatio, which eables a abrasio-resistat, thi-diameter lead. Additioal desig features help prevet tissue igrowth, ad redudat coductors provide a added measure of security.
Defibrillatio Leads Durata Defibrillatio Lead Product Highlights The DF4 coector is desiged to simplify implats by streamliig defibrillatio coectios ito a sigle termial pi ad reducig the umber of set screws Redudat coductors serve as a backup system i the ulikely evet of a coductor failure Symmetrically aliged cables withi the lead body ad cetrally located coil provide for additioal protectio to the ier coil Optim lead isulatio a chemical co-polymer that bleds the best features of polyurethae ad silicoe for improved hadlig ad icreased durability Two iovative desigs are iteded to help prevet tissue igrowth flatwire techology provides a low profile for the defibrillatio coils, ad silicoe backfillig completely fills the shock coil space Orderig Iformatio Cotets: Defibrillatio lead Model Mi. Shock Tip-to-Proximal Number Isulatio Fixatio Itroducer (F) Cofiguratio Sesig Coil (cm) Coector Legths (cm) 7120 Optim Ext/Ret Helix 7 Dual-coil True bipolar 17 DF1; IS-1 60; 65 7120Q Optim Ext/Ret Helix 7 Dual-coil True bipolar 17 DF4 52; 58; 65 7121 Optim Ext/Ret Helix 7 Dual-coil True bipolar 21 DF1; IS-1 60; 65; 75 7121Q Optim Ext/Ret Helix 7 Dual-coil True bipolar 21 DF4 52; 58; 65 7122 Optim Ext/Ret Helix 7 Sigle-coil True bipolar N/A DF1; IS-1 60; 65; 75 7122Q Optim Ext/Ret Helix 7 Sigle-coil True bipolar N/A DF4 52; 58; 65 7170 Optim Ties 7 Dual-coil True bipolar 17 DF1; IS-1 60; 65; 75 7170Q Optim Ties 7 Dual-coil True bipolar 17 DF4 52; 58; 65 7171 Optim Ties 7 Dual-coil True bipolar 21 DF1; IS-1 60; 65; 75 7171Q Optim Ties 7 Dual-coil True bipolar 21 DF4 52; 58; 65 7172Q Optim Ties 7 Sigle-coil True bipolar N/A DF4 52; 58; 65 Idicatios for Use: The Durata Models 7120, 7120Q, 7121, 7121Q, 7122, 7122Q, 7170, 7170Q, 7171, 7171Q ad 7172Q trasveous leads are idicated for use with compatible pulse geerators (refer to the applicable defibrillator maual for system idicatios). They provide pacig ad sesig ad deliver cardioversio/ defibrillatio therapy to the heart. A trasveous lead system may offer the patiet the beefit of avoidig a thoracotomy for lead implatatio. If the iitial lead cofiguratio is ot effective, repositioig of the lead or other lead cofiguratios should be attempted. I some patiets, a othoracotomy lead cofiguratio may ot provide reliable coversio of arrhythmias, ad the use of subcutaeous or epicardial patch defibrillatio leads should be cosidered. Cotraidicatios: Cotraidicatios for use of the Durata leads with a implatable pulse geerator iclude vetricular tachyarrhythmias resultig from trasiet or reversible factors such as drug toxicity, electrolyte imbalace, or acute myocardial ifarctio. Trasveous lead systems are cotraidicated for patiets with tricuspid valvular disease or a mechaical heart valve. Durata leads are cotraidicated for patiets for whom a sigle dose of 1.0 mg of dexamethasoe sodium phosphate is cotraidicated. The Durata 7120, 7120Q, 7121, 7121Q, 7122, 7122Q, 7170, 7170Q, 7171, 7171Q ad 7172Q leads are cotraidicated for extra firm (red color kob) stylets. The lead is ot desiged, sold, or iteded for use other tha as idicated. 1. St. Jude Medical DF1 lead coectors coform to the iteratioal coector stadard ISO 11318/Amd. 2. St. Jude Medical IS-1 lead coectors coform to the iteratioal coector stadard ISO 5841. 3. St. Jude Medical DF4 lead coectors coform to the iteratioal coector stadard ISO 27186: 2010 (E). Potetial Complicatios: Possible complicatios of the use of trasveous lead systems iclude, but are ot limited to, supravetricular or vetricular arrhythmias, coductio disturbaces, cardiac perforatio, cardiac tampoade, loss of cotractility, air embolism, heart wall rupture, myocarditis, post-operative heart failure, chroic mechaical stimulatio of the heart, tricuspid valve dysfuctio, lead fracture ecessitatig surgical removal, peumothorax, hemothorax, ifectio, tissue ecrosis ad erosio of the ski. Specific evets ad effects are summarised below: WARNING: Implated cardiac leads are subjected to a hostile eviromet withi the body due to costat, complex flexural ad torsioal forces, iteractios with leads ad/or the pulse geerator, or other forces associated with cardiac cotractios ad patiet physical activity, posture ad aatomical iflueces Cardiac leads fuctioal lifetimes ca be affected by these ad other factors. Refer to the defibrillator maual for additioal complicatios ad precautios specific to the pulse geerator. Brief Summary: Prior to usig these devices, please review the Istructios for Use for a complete listig of idicatios, cotraidicatios, warigs, precautios, potetial adverse evets ad directios for use. Devices depicted may ot be available i all coutries. Check with your St. Jude Medical represetative for product availability i your coutry. Uless otherwise oted, idicates that the ame is a trademark of, or licesed to, St. Jude Medical or oe of its subsidiaries. ST. JUDE MEDICAL, the ie-squares symbol ad MORE CONTROL. LESS RISK. are registered ad uregistered trademarks ad service marks of St. Jude Medical, Ic. ad its related compaies. 2011 St. Jude Medical, Ic. All rights reserved.
Defibrillatio Leads Durata Defibrillatio Lead Product Specificatios PHYSICAL SPECIFICATIONS True Bipolar, Active-Fixatio Defibrillatio Leads Models 7120 7120Q 7121 7121Q 7122 7122Q Fixatio Ext/Ret Helix Ext/Ret Helix Ext/Ret Helix Ext/Ret Helix Ext/Ret Helix Ext/Ret Helix Shock Cofiguratio Dual-Coil Dual-Coil Dual-Coil Dual-Coil Sigle-Coil Sigle-Coil Sesig Cofiguratio True Bipolar True Bipolar True Bipolar True Bipolar True Bipolar True Bipolar Mi. Size Itroducer 7 F 7 F 7 F 7 F 7 F 7 F Legths (cm) 60; 65 52; 58; 65 60; 65; 75 52; 58; 65 60; 65; 75 52; 58; 65 Coector DF1; IS-1 DF4 DF1; IS-1 DF4 DF1; IS-1 DF4 Body Diameter 6,8 F 6,8 F 6,8 F 6,8 F 6,8 F 6,8 F Tip-to-Aode Spacig 11 mm 11 mm 11 mm 11 mm 11 mm 11 mm Tip-to-Proximal Coil 17 cm 17 cm 21 cm 21 cm N/A N/A Tip Electrode Area 6 mm 2 6 mm 2 6 mm 2 6 mm 2 6 mm 2 6 mm 2 Steroid Plug Yes Yes Yes Yes Yes Yes Distal Shock Coil Area 367 mm 2 367 mm 2 367 mm 2 367 mm 2 367 mm 2 367 mm 2 Proximal Shock Coil Area 588 mm 2 588 mm 2 588 mm 2 588 mm 2 N/A N/A True Bipolar, Passive-Fixatio Defibrillatio Leads Models 7170 7170Q 7171 7171Q 7172Q Fixatio Ties Ties Ties Ties Ties Shock Cofiguratio Dual-Coil Dual-Coil Dual-Coil Dual-Coil Sigle-Coil Sesig Cofiguratio True Bipolar True Bipolar True Bipolar True Bipolar True Bipolar Mi. Size Itroducer 7 F 7 F 7 F 7 F 7 F Legths (cm) 60; 65; 75 52; 58; 65 60; 65; 75 52; 58; 65 52; 58; 65 Coector DF1; IS-1 DF4 DF1; IS-1 DF4 DF4 Body Diameter 6,8 F 6,8 F 6,8 F 6,8 F 6,8 F Tip-to-Aode Spacig 11 mm 11 mm 11 mm 11 mm 11 mm Tip-to-Proximal Coil 17 cm 17 cm 21 cm 21 cm N/A Tip Electrode Area 3.5 mm 2 3.5 mm 2 3.5 mm 2 3.5 mm 2 3.5 mm 2 Steroid Plug Yes Yes Yes Yes Yes Distal Shock Coil Area 367 mm 2 367 mm 2 367 mm 2 367 mm 2 367 mm 2 Proximal Shock Coil Area 588 mm 2 588 mm 2 588 mm 2 588 mm 2 N/A (GMCRM783EN) Brief Summary: Prior to usig these devices, please review the Istructios for Use for a complete listig of idicatios, cotraidicatios, warigs, precautios, potetial adverse evets ad directios for use. Devices depicted may ot be available i all coutries. Check with your St. Jude Medical represetative for product availability i your coutry. Uless otherwise oted, idicates that the ame is a trademark of, or licesed to, St. Jude Medical or oe of its subsidiaries. ST. JUDE MEDICAL, the ie-squares symbol ad MORE CONTROL. LESS RISK. are registered ad uregistered trademarks ad service marks of St. Jude Medical, Ic. ad its related compaies. 2011 St. Jude Medical, Ic. All rights reserved. Item GMCRM783EN
Pacemakers
St. Jude Medical Pacemakers The most oteworthy characteristics of St. Jude Medical pacemakers iclude logevity, the avoidace of uecessary right vetricular stimulatio, ad extesive automaticity icludig prove diagostics. Additioally, our state-of-the-art pacemakers are efficiet i that they save time ad make it possible for patiets to receive optimal therapy. Remote care optios provide the possibility of home moitorig ad icrease patiet safety. More Cotrol. The MRI coditioal pacig system provides full-featured pacig therapy with o zoe restrictios ad highpower, whole-body imagig allowig for superior quality MRI images. VIP techology prevets uecessary right vetricular pacig by cotiually moitorig a patiet s rhythm ad searchig for itrisic coductio. QuickOpt timig cycle optimisatio furthers delivery of right vetricular pacig oly whe ecessary through AV iterval optimisatio. Our advaced pacemakers feature idividually programmable alerts that iform patiets ad/or their cliic about critical chages i device performace or arrhythmia status. Less Risk. The MRI coditioal pacig system provides safe 2, full-body MRI scas. The AutoCapture pacig system provides vetricular pacig security for every beat while miimisig eergy use. The ACap cofirm algorithm automatically measures the atrial pacig threshold ad adapts the pulse amplitude. Together these features offer patiet safety ad eable quick itervetio through a capture tred display. High-quality, stored IEGM with histograms ad tredig provide further diagostic isight. The combiatio of automatic daily measuremets, capture threshold ad lead impedace moitorig offer safety ad eable more time for patiet care durig follow-up. All ecessary tests have already bee performed before the patiet comes to follow-up. 1. MRI coditioal pacemaker system; a MRI coditioal pacig system is coditioally safe for use i the MRI eviromet whe used accordig to the istructios i this maual. See the St. Jude Medical MRI Procedure iformatio documet prior to performig a MRI sca: www.sjmprofessioal.com/mri
Pacemakers Accet MRI DR Dual-Chamber Pacemaker with Wireless Telemetry Product Highlights The Accet MRI pacemaker has bee desiged ad tested for safe performace of a full-body MRI sca, without zoe restrictios, 1 usig a 1,5 T (Tesla) field-stregth MRI scaer. 1 The MRI coditioal device: Allows a maximum whole body averaged specific absorptio rate (SAR) of 4 watts per kilogram (W/kg) for high image resolutio Must be used i cojuctio with a MRI lead from St. Jude Medical A optioal, easy-to-use had-held device (SJM MRI Activator device) ca be used to program the device to pre-approved MRI settigs pre- ad post-mri sca, decreasig the umber of workflow steps ad icreasig cliic efficiecy IvisiLik wireless telemetry i cojuctio with the Merli@home trasmitter ad Merli.et Patiet Care Network (PCN), allows for daily remote moitorig ad follow-up. AT/AF Alerts ca be programmed to otify patiets ad/or their cliics whe a programmed AT/AF threshold or cotiuous episode duratio has bee exceeded, or whe a high vetricular rate accompaies the AT/AF episode A suite of state-of-the-art features complete automaticity (atrial ad vetricular), Vetricular Itrisic Preferece (VIP ) techology, QuickOpt timig cycle optimisatio, the AF Suppressio algorithm ad SeseAbility techology is desiged to deliver optimal therapy for patiets at implat ad throughout their lives Idustry-leadig logevity offers 9,1 years of service life, 2 which is supported by a 7-year warraty 3 Merli@home Trasmitter Compatible 1. The St. Jude Medical MRI coditioal pacig system ca be scaed i patiets uder the followig coditios: horizotal closed bore cliical scaer workig i the Normal Operatig Mode or First Level Cotrolled Operatig Mode; static magetic field stregth of 1,5 Tesla (T) oly; maximum gradiet slew rate of 200 T/m/s per axis. See maual for additioal details before performig a MRI sca. 2. A,V = 2,5 V @ 0,4 ms; 500 ohms; 100% DDD pacig @ 60 bpm; AutoCapture Pacig System OFF; SEGMs ON 3. Terms ad coditios apply; refer to the warraty for details. Orderig Iformatio Cotets: Cardiac pulse geerator Model Number Dimesios (H x W x T, mm) Weight (g) Volume (cc) Coector PM2224 (RF) 52 x 53 x 6 24 13,1 (± 0,5) IS-1 Radiopaque markers St. Jude Medical idetifier Device MRI symbol Idicatios: Implatatio of a dual-chamber pulse geerator is idicated i oe or more of the followig permaet coditios: sycope, presycope, fatigue, disorietatio due to arrhythmia/bradycardia or ay combiatio of those symptoms. MRI coditioal pulse geerator is safe for use i the MRI eviromet whe used i a complete MRI coditioal pacig system ad accordig to the istructios i the MRI Procedure Iformatio documet for the St. Jude Medical MRI coditioal pacig system. Rate-modulated pacig is idicated for patiets with chrootropic icompetece, ad for those who would beefit from icreased stimulatio rates cocurret with physical activity. Dual-chamber pacig is idicated for those patiets exhibitig: sick sius sydrome, chroic, symptomatic secod- ad third-degree AV block, recurret Adams-Stokes sydrome, symptomatic bilateral budle brach block whe tachyarrhythmia ad other causes have bee ruled out. Atrial pacig is idicated for patiets with sius ode dysfuctio ad ormal AV ad itravetricular coductio systems. Vetricular pacig is idicated for patiets with sigificat bradycardia ad ormal sius rhythm with oly rare episodes of A-V block or sius arrest, chroic atrial fibrillatio, severe physical disability. AF Suppressio algorithm is idicated for suppressio of paroxysmal or persistet atrial fibrillatio episodes i patiets with oe or more of the above pacig idicatios. Cotraidicatios: Dual-chamber pulse geerators are cotraidicated i patiets with a implated cardioverter defibrillator (ICD). Rate-adaptive pacig may be iappropriate for patiets who experiece agia or other symptoms of myocardial dysfuctio at higher sesor-drive rates. A appropriate Maximum Sesor Rate should be selected based o assessmet of the highest stimulatio rate tolerated by the patiet. AF Suppressio stimulatio is ot recommeded i patiets who caot tolerate high atrial-rate stimulatio. Dual-chamber pacig, though ot cotraidicated for patiets with chroic atrial flutter, chroic atrial fibrillatio, or silet atria, may provide o beefit beyod that of sigle-chamber pacig i such patiets. Sigle-chamber vetricular demad pacig is relatively cotraidicated i patiets who have demostrated pacemaker sydrome, have retrograde VA coductio, or suffer a drop i arterial blood pressure with the oset of vetricular pacig. Sigle-chamber atrial pacig is relatively cotraidicated i patiets who have demostrated compromise of AV coductio. Adverse Evets: The followig are potetial complicatios associated with the use of ay pacig system: arrhythmia, heart block, thrombosis, threshold elevatio, valve damage, peumothorax, myopotetial sesig, vessel damage, air embolism, body rejectio pheomea, cardiac tampoade or perforatio, formatio of fibrotic tissue, local tissue reactio, iability to iterrogate or program a device because of programmer malfuctio, ifectio, iterruptio of desired device fuctio due to electrical iterferece, loss of desired pacig ad/or sesig due to lead displacemet, body reactio at electrode iterface, or lead malfuctio (fracture or damage to isulatio), loss of ormal device fuctio due to battery failure or compoet malfuctio, device migratio, pocket erosio, or hematoma, pectoral muscle stimulatio, ad phreic erve or diaphragmatic stimulatio. The followig, i additio to the above, are potetial complicatios associated with the use of rate-modulated pacig systems: iappropriate, rapid pacig rates due to sesor failure or to the detectio of sigals other tha patiet activity, loss of activity-respose due to sesor failure, ad palpitatios with high-rate pacig. Refer to the User s Maual for more detailed idicatios, cotraidicatios, warigs, precautios ad potetial adverse evets. Brief Summary: Prior to usig these devices, please review the Istructios for Use for a complete listig of idicatios, cotraidicatios, warigs, precautios, potetial adverse evets ad directios for use. Devices depicted may ot be available i all coutries. Check with your St. Jude Medical represetative for product availability i your coutry. Uless otherwise oted, idicates that the ame is a trademark of, or licesed to, St. Jude Medical or oe of its subsidiaries. ST. JUDE MEDICAL, the ie-squares symbol ad MORE CONTROL. LESS RISK. are registered ad uregistered trademarks ad service marks of St. Jude Medical, Ic. ad its related compaies. 2011 St. Jude Medical, Ic. All rights reserved.
Pacemakers Accet MRI DR Dual-Chamber Pacemaker with Wireless Telemetry Product Specificatios PHYSICAL SPECIFICATIONS Model PM2224 Telemetry RF Dimesios (mm) 52 x 53 x 6 Weight (g) 24 Volume (cc) 13,1 1 Coector IS-1 Sesor O; Off; Passive Shortest PVARP/VREF (ms) 125-475 i steps of 25 Slope Auto (-1); Auto (+0); Auto (+1); Auto (+2); Auto (+3); 1-16 i steps of 1 Threshold Auto (-0,5); Auto (+0,0); Auto (+0,5); Auto (+1,0); Auto (+1,5); Auto (+2,0); 1-7 i steps of 0,5 AF Maagemet (GMCRM737EN) PARAMETER SETTINGS Rate/Timig Atrial Pace Refractory (ms) 190-400 i steps of 30; 440; 470 2 Atrial Sese Refractory (ms) 93; 125; 157; 190-400 i steps of 30; 440; 470; 500 2 Atrial Protectio Iterval (ms) 125 3 Paced AV Delay (ms) 25; 30-200 i steps of 10; 225-300 i steps of 25; 350 Base Rate (mi -1 ) 30-130 i steps of 5; 140-170 i steps of 10 Far-Field Protectio Iterval (ms) 16 3 Hysteresis Rate (mi -1 ) Off; 30 4-150 i steps of 5 Search Iterval (mi) Off; 1; 5; 10; 15; 30 Cycle Cout 1-16 i steps of 1 Itervetio Rate (mi -1 ) Off; Same as Base Rate; 80-120 i steps of 10; Itrisic +0; Itrisic +10; Itrisic +20; Itrisic +30 Itervetio Duratio (mi) 1-10 i 1 miute itervals Recovery Time Fast; Medium; Slow; Very Slow Maximum Trackig Rate (mi -1 ) 90-130 i steps of 5; 140-180 i steps of 10 Mode AOO(R); AAI(R); AAT(R); VOO(R); VVI(R); VVT(R); VDD(R); DOO(R); DVI(R); DDI(R); DDD(R); Pacig Off Post-Vetricular Atrial Blakig (ms) 60-200 i steps of 10; 225; 250 PVARP (ms) 125-500 i steps of 25 Sesed AV Delay (ms) 25; 30-200 i steps of 10; 225-325 i steps of 25 Rest Rate (mi -1 ) Off; 30-150 i steps of 5 Shortest AV Delay (ms) 25-50 i steps of 5; 60-120 i steps of 10 Vetricular Blakig (ms) Auto; 12-52 i steps of 4 Vetricular Pace/Sese Refractory 5 (Fixed) (ms) 125; 160-400 i steps of 30; 440; 470 2 MRI Settigs MRI Mode MRI Base Rate MRI Paced AV Delay MRI Atrial Pulse Cofiguratio MRI Atrial Pulse Amplitude MRI Atrial Pulse Width MRI RV Pulse Cofiguratio MRI RV Pulse Amplitude MRI RV Pulse Width Output/Sesig Brief Summary: Prior to usig these devices, please review the Istructios for Use for a complete listig of idicatios, cotraidicatios, warigs, precautios, potetial adverse evets ad directios for use. Devices depicted may ot be available i all coutries. Check with your St. Jude Medical represetative for product availability i your coutry. Uless otherwise oted, idicates that the ame is a trademark of, or licesed to, St. Jude Medical or oe of its subsidiaries. ST. JUDE MEDICAL, the ie-squares symbol ad MORE CONTROL. LESS RISK. are registered ad uregistered trademarks ad service marks of St. Jude Medical, Ic. ad its related compaies. 2011 St. Jude Medical, Ic. All rights reserved. Item GMCRM737EN AOO; VOO; DOO; Pacig Off 30-120 bpm i steps of 5 bpm 25 ms; 30-200 ms i steps of 10 ms; 225-300 ms i steps of 25 ms; 350 ms Bipolar 5,0 V; 7,5 V 1,0 ms Bipolar 5,0 V; 7,5 V 1,0 ms ACap Cofirm O; Off; Moitor Primary Pulse Cofiguratio Bipolar Backup Pulse Cofiguratio Bipolar Backup Pulse Amplitude (V) 5,0 Search Iterval (hours) 8; 24 A or V Pulse Amplitude (V) 0,25-4,0 i steps of 0,25; 4,5-7,5 i steps of 0,5 A or V Pulse Width (ms) 0,05; 0,1-1,5 i steps of 0,1 A or V Pulse Cofiguratio Uipolar (tip-case); Bipolar (tip-rig) A or V Sese Cofiguratio Uipolar Tip (tip-case); Bipolar (tip-rig); Uipolar Rig (rig-case) Atrial Sesitivity (mv) 0,1-0,4 6 i steps of 0,1; 0,5; 0,75-2,0 i steps of 0,25; 2,5-4,0 i steps of 0,5; 5,0 7 Vetricular AutoCapture Pacig System O; Off Primary Pulse Cofiguratio Uipolar; Bipolar Backup Pulse Cofiguratio Uipolar; Bipolar Backup Pulse Amplitude (V) 5,0 3 Search Iterval (hours) 8; 24 AutoCapture Paced/Sesed AV Delay (ms) 50/25; 100/70; 120/100 Vetricular Sesitivity (mv) 0,5-5,0 i steps of 0,5; 6-10 i steps of 1,0; 12,5 7 SeseAbility Techology Off; O (Automatic Sesitivity Cotrol adjustmet for atrial ad vetricular evets) A Max Sesitivity (mv) 0,2-1,0 i steps of 0,1 V Max Sesitivity (mv) 0,2-2,0 i steps of 0,1 Threshold Start (Atrial ad Vetricular Post-Sese) 50; 62,5; 75; 100% (Atrial Post-Pace) 0,2-3,0 i steps of 0,1 mv (Vetricular Post-Pace) Auto; 0,2-3,0 i steps of 0,1 mv Decay Delay (ms) (Atrial ad Vetricular Post-Sese) 0; 30; 60; 95; 125; 160; 190; 220 (Atrial Post-Pace) 0; 30; 60; 95; 125; 160; 190; 220 (Vetricular Post-Pace) Auto; 0; 30; 60; 95; 125; 160; 190; 220 Rate-Modulated Parameters Maximum Sesor Rate (mi -1 ) 80-150 i steps of 5; 160-180 i steps of 10 Rate Resposive AV Delay Off; Low; Medium; High Rate Resposive PVARP/VREF Off; Low; Medium; High Reactio Time Very Fast; Fast; Medium; Slow Recovery Time Fast; Medium; Slow; Very Slow AF Suppressio Algorithm Off; O Lower Rate Overdrive (mi -1 ) 10 3 Upper Rate Overdrive (mi -1 ) 5 3 No. of Overdrive Pacig Cycles 15-40 i steps of 5 Rate Recovery (ms) 8; 12 3 Maximum AF Suppressio Rate (mi -1 ) 80-150 i steps of 5; 160-180 i steps of 10 Atrial Tachycardia Detectio Rate (mi -1 ) 110-200 i steps of 10; 225-300 i steps of 25 Auto Mode Switch Off; DDD(R) to DDI(R); DDD(R) to DDT(R); DDD(R) to VVI(R); DDD(R) to VVT(R); VDD(R) to VVI(R); VDD(R) to VVT(R) AMS Base Rate (mi -1 ) 40-170 i steps of 5 Stored Electrograms Optios Priority Optios Chael 1; 2; 3 Triggers Advaced Hysteresis AMS Etry/AMS Exit/ AMS Etry ad Exit AT/AF Detectio Maget Respose High Atrial Rate Rate (mi -1 ) 125-300 i steps of 25 No. of Cosecutive Cycles 2; 3; 4; 5; 10; 15; 20 High Vetricular Rate Rate (mi -1 ) 125-300 i steps of 25 No. of Cosecutive Cycles 2; 3; 4; 5; 10; 15; 20 PMT Termiatio Cosecutive PVCs No. of Cosecutive PVCs 2; 3; 4; 5 Noise Reversio Other A ad V Lead Moitorig Moitor; Auto Polarity Switch A ad V Low Impedace Limit (Ω) 100-500 i steps of 25 A ad V High Impedace Limit (Ω) 750-2500 i steps of 250; 3000 Lead Type Ucoded; Uipolar; Bipolar Maget Respose Off; Battery Test Negative AV Hysteresis Search (ms) Off; -10 to -120 i steps of 10 NIPS Optios Stimulatio Chamber Atrial; Vetricular Couplig Iterval (ms) 100-800 i steps of 10 8 S1 Cout 2-25 i steps of 1 S1 9 ; S2; S3 ad S4 Cycle (ms) Off; 100-800 i steps of 10 (Fixed or Adaptive) Vetricular Support Rate (mi -1 ) Off; 30-95 i steps of 5 Sius Node Recovery Delay (sec) 1; 2; 3; 4; 5 PMT Optios Off; Passive; Atrial Pace 2 PMT Detectio Rate (mi -1 ) 90-180 i steps of 5 PVC Respose Off; Atrial Pace 2 Vetricular Itrisic Preferece, VIP (ms) Off; 50-150 i steps of 25; 160-200 i steps of 10 VIP Search Iterval 30 sec; 1; 3; 5; 10; 30 mi VIP Search Cycles 1; 2; 3 Vetricular Safety Stadby Off; O Diagostic Treds AT/AF Activity; Exercise; Lead Impedace; P ad R Wave; A ad V Threshold Patiet Notifiers Programmable Notifiers (O; Off) Device at ERI; Atrial Lead Impedace Out of Rage; Vetricular Lead Impedace Out of Rage; AT/AF Burde; AT/AF Episode Duratio; V Rate Durig AT/AF (High V Rate Threshold/ Total Time i High V Rate) Device Reset O Etry ito Backup VVI Mode O Audible Duratio (sec) 2; 4; 6; 8; 10; 12; 14; 16 Number of Audible Alerts per Notificatio 2 Number of Notificatios 1-16 Time Betwee Notificatios (hours) 10; 22 1. ± 0,5 cc 2. Programmig optios depedet o pacig mode. 3. This parameter is ot programmable. 4. The highest available settig for hysteresis rate will be 5 mi -1 below the programmed base rate. 5. I dual-chamber modes, the maximum vetricular refractory period is 325 ms. 6. Values 0,1-0,4 ot available i a uipolar sese cofiguratio. 7. Sesitivity is with respect to a 20 ms haversie test sigal. 8. Durig atrial NIPS i dual-chamber modes, the shortest Couplig Iterval will be limited by the programmed AV/PV delay. 9. S1 Burst Cycle is applied at the pre-programmed S1 cycle legth.
Pacemakers Accet MRI DR Dual-Chamber Pacemaker Product Highlights The Accet MRI pacemaker has bee desiged ad tested for safe performace of a full-body MRI sca, without zoe restrictios, 1 usig a 1,5 T (Tesla) field-stregth MRI scaer. 1 The MRI coditioal device: Allows a maximum whole body averaged specific absorptio rate (SAR) of 4 watts per kilogram (W/kg) for high image resolutio Must be used i cojuctio with a MRI lead from St. Jude Medical A optioal, easy-to-use had-held device (SJM MRI Activator device) ca be used to program the device to pre-approved MRI settigs pre- ad post-mri sca, decreasig the umber of workflow steps ad icreasig cliic efficiecy AT/AF Alerts ca be programmed to otify patiets ad/or their cliics whe a programmed AT/AF threshold or cotiuous episode duratio has bee exceeded, or whe a high vetricular rate accompaies the AT/AF episode A suite of state-of-the-art features complete automaticity (atrial ad vetricular), Vetricular Itrisic Preferece (VIP ) techology, QuickOpt timig cycle optimisatio, the AF Suppressio algorithm ad SeseAbility techology is desiged to deliver optimal therapy for patiets at implat ad throughout their lives Idustry-leadig logevity offers 9,4 years of service life, 2 which is supported by a 7-year warraty 3 1. The St. Jude Medical MRI coditioal pacig system ca be scaed i patiets uder the followig coditios: horizotal closed bore cliical scaer workig i the Normal Operatig Mode or First Level Cotrolled Operatig Mode; static magetic field stregth of 1,5 Tesla (T) oly; maximum gradiet slew rate of 200 T/m/s per axis. See maual for additioal details before performig a MRI sca. 2. A,V = 2,5 V @ 0,4 ms; 500 ohms; 100% DDD pacig @ 60 bpm; AutoCapture Pacig System OFF; SEGMs ON 3. Terms ad coditios apply; refer to the warraty for details. Orderig Iformatio Cotets: Cardiac pulse geerator Model Number Dimesios (H x W x T, mm) Weight (g) Volume (cc) Coector PM2124 (Iductive) 52 x 53 x 6 23 13,1 (± 0,5) IS-1 Radiopaque markers St. Jude Medical idetifier Device MRI symbol Idicatios: Implatatio of a dual-chamber pulse geerator is idicated i oe or more of the followig permaet coditios: sycope, presycope, fatigue, disorietatio due to arrhythmia/bradycardia or ay combiatio of those symptoms. MRI coditioal pulse geerator is safe for use i the MRI eviromet whe used i a complete MRI coditioal pacig system ad accordig to the istructios i the MRI Procedure Iformatio documet for the St. Jude Medical MRI coditioal pacig system. Rate-modulated pacig is idicated for patiets with chrootropic icompetece, ad for those who would beefit from icreased stimulatio rates cocurret with physical activity. Dual-chamber pacig is idicated for those patiets exhibitig: sick sius sydrome, chroic, symptomatic secod- ad third-degree AV block, recurret Adams-Stokes sydrome, symptomatic bilateral budle brach block whe tachyarrhythmia ad other causes have bee ruled out. Atrial pacig is idicated for patiets with sius ode dysfuctio ad ormal AV ad itravetricular coductio systems. Vetricular pacig is idicated for patiets with sigificat bradycardia ad ormal sius rhythm with oly rare episodes of A-V block or sius arrest, chroic atrial fibrillatio, severe physical disability. AF Suppressio algorithm is idicated for suppressio of paroxysmal or persistet atrial fibrillatio episodes i patiets with oe or more of the above pacig idicatios. Cotraidicatios: Dual-chamber pulse geerators are cotraidicated i patiets with a implated cardioverter defibrillator (ICD). Rate-adaptive pacig may be iappropriate for patiets who experiece agia or other symptoms of myocardial dysfuctio at higher sesor-drive rates. A appropriate Maximum Sesor Rate should be selected based o assessmet of the highest stimulatio rate tolerated by the patiet. AF Suppressio stimulatio is ot recommeded i patiets who caot tolerate high atrial-rate stimulatio. Dual-chamber pacig, though ot cotraidicated for patiets with chroic atrial flutter, chroic atrial fibrillatio, or silet atria, may provide o beefit beyod that of sigle-chamber pacig i such patiets. Sigle-chamber vetricular demad pacig is relatively cotraidicated i patiets who have demostrated pacemaker sydrome, have retrograde VA coductio, or suffer a drop i arterial blood pressure with the oset of vetricular pacig. Sigle-chamber atrial pacig is relatively cotraidicated i patiets who have demostrated compromise of AV coductio. Adverse Evets: The followig are potetial complicatios associated with the use of ay pacig system: arrhythmia, heart block, thrombosis, threshold elevatio, valve damage, peumothorax, myopotetial sesig, vessel damage, air embolism, body rejectio pheomea, cardiac tampoade or perforatio, formatio of fibrotic tissue, local tissue reactio, iability to iterrogate or program a device because of programmer malfuctio, ifectio, iterruptio of desired device fuctio due to electrical iterferece, loss of desired pacig ad/or sesig due to lead displacemet, body reactio at electrode iterface, or lead malfuctio (fracture or damage to isulatio), loss of ormal device fuctio due to battery failure or compoet malfuctio, device migratio, pocket erosio, or hematoma, pectoral muscle stimulatio, ad phreic erve or diaphragmatic stimulatio. The followig, i additio to the above, are potetial complicatios associated with the use of rate-modulated pacig systems: iappropriate, rapid pacig rates due to sesor failure or to the detectio of sigals other tha patiet activity, loss of activity-respose due to sesor failure, ad palpitatios with high-rate pacig. Refer to the User s Maual for more detailed idicatios, cotraidicatios, warigs, precautios ad potetial adverse evets. Brief Summary: Prior to usig these devices, please review the Istructios for Use for a complete listig of idicatios, cotraidicatios, warigs, precautios, potetial adverse evets ad directios for use. Devices depicted may ot be available i all coutries. Check with your St. Jude Medical represetative for product availability i your coutry. Uless otherwise oted, idicates that the ame is a trademark of, or licesed to, St. Jude Medical or oe of its subsidiaries. ST. JUDE MEDICAL, the ie-squares symbol ad MORE CONTROL. LESS RISK. are registered ad uregistered trademarks ad service marks of St. Jude Medical, Ic. ad its related compaies. 2011 St. Jude Medical, Ic. All rights reserved.
Pacemakers Accet MRI DR Dual-Chamber Pacemaker Product Specificatios PHYSICAL SPECIFICATIONS Model PM2124 Telemetry Iductive Dimesios (mm) 52 x 53 x 6 Weight (g) 23 Volume (cc) 13,1 1 Coector IS-1 Sesor O; Off; Passive Shortest PVARP/VREF (ms) 125-475 i steps of 25 Slope Auto (-1); Auto (+0); Auto (+1); Auto (+2); Auto (+3); 1-16 i steps of 1 Threshold Auto (-0,5); Auto (+0,0); Auto (+0,5); Auto (+1,0); Auto (+1,5); Auto (+2,0); 1-7 i steps of 0,5 AF Maagemet (GMCRM739EN) PARAMETER SETTINGS Rate/Timig Atrial Pace Refractory (ms) 190-400 i steps of 30; 440; 470 2 Atrial Sese Refractory (ms) 93; 125; 157; 190-400 i steps of 30; 440; 470; 500 2 Atrial Protectio Iterval (ms) 125 3 Paced AV Delay (ms) 25; 30-200 i steps of 10; 225-300 i steps of 25; 350 Base Rate (mi -1 ) 30-130 i steps of 5; 140-170 i steps of 10 Far-Field Protectio Iterval (ms) 16 3 Hysteresis Rate (mi -1 ) Off; 30 4-150 i steps of 5 Search Iterval (mi) Off; 1; 5; 10; 15; 30 Cycle Cout 1-16 i steps of 1 Itervetio Rate (mi -1 ) Off; Same as Base Rate; 80-120 i steps of 10; Itrisic +0; Itrisic +10; Itrisic +20; Itrisic +30 Itervetio Duratio (mi) 1-10 i 1-miute itervals Recovery Time Fast; Medium; Slow; Very Slow Maximum Trackig Rate (mi -1 ) 90-130 i steps of 5; 140-180 i steps of 10 Mode AOO(R); AAI(R); AAT(R); VOO(R); VVI(R); VVT(R); VDD(R); DOO(R); DVI(R); DDI(R); DDD(R); Pacig Off Post-Vetricular Atrial Blakig (ms) 60-200 i steps of 10; 225; 250 PVARP (ms) 125-500 i steps of 25 Sesed AV Delay (ms) 25; 30-200 i steps of 10; 225-325 i steps of 25 Rest Rate (mi -1 ) Off; 30-150 i steps of 5 Shortest AV Delay (ms) 25-50 i steps of 5; 60-120 i steps of 10 Vetricular Blakig (ms) Auto; 12-52 i steps of 4 Vetricular Pace/Sese Refractory 5 (Fixed) (ms) 125; 160-400 i steps of 30; 440; 470 2 MRI Settigs MRI Mode MRI Base Rate MRI Paced AV Delay MRI Atrial Pulse Cofiguratio MRI Atrial Pulse Amplitude MRI Atrial Pulse Width MRI RV Pulse Cofiguratio MRI RV Pulse Amplitude MRI RV Pulse Width Output/Sesig AOO; VOO; DOO; Pacig Off 30-120 bpm i steps of 5 bpm 25 ms; 30-200 ms i steps of 10 ms; 225-300 ms i steps of 25 ms; 350 ms Bipolar 5,0 V; 7,5 V 1,0 ms Bipolar 5,0 V; 7,5 V 1,0 ms ACap Cofirm O; Off; Moitor Primary Pulse Cofiguratio Bipolar Backup Pulse Cofiguratio Bipolar Backup Pulse Amplitude (V) 5,0 Search Iterval (hours) 8; 24 A or V Pulse Amplitude (V) 0,25-4,0 i steps of 0,25; 4,5-7,5 i steps of 0,5 A or V Pulse Width (ms) 0,05; 0,1-1,5 i steps of 0,1 A or V Pulse Cofiguratio Uipolar (tip-case); Bipolar (tip-rig) A or V Sese Cofiguratio Uipolar Tip (tip-case); Bipolar (tip-rig); Uipolar Rig (rig-case) Atrial Sesitivity (mv) 0,1-0,4 6 i steps of 0,1; 0,5; 0,75-2,0 i steps of 0,25; 2,5-4,0 i steps of 0,5; 5,0 7 Vetricular AutoCapture Pacig System O; Off Primary Pulse Cofiguratio Uipolar; Bipolar Backup Pulse Cofiguratio Uipolar; Bipolar Backup Pulse Amplitude (V) 5,0 3 Search Iterval (hours) 8; 24 AutoCapture Paced/Sesed AV Delay (ms) 50/25; 100/70; 120/100 Vetricular Sesitivity (mv) 0,5-5,0 i steps of 0,5; 6-10 i steps of 1,0; 12,5 7 SeseAbility Techology Off; O (Automatic Sesitivity Cotrol adjustmet for atrial ad vetricular evets) A Max Sesitivity (mv) 0,2-1,0 i steps of 0,1 V Max Sesitivity (mv) 0,2-2,0 i steps of 0,1 Threshold Start (Atrial ad Vetricular Post-Sese) 50; 62,5; 75; 100% (Atrial Post-Pace) 0,2-3,0 i steps of 0,1 mv (Vetricular Post-Pace) Auto; 0,2-3,0 i steps of 0,1 mv Decay Delay (ms) (Atrial ad Vetricular Post-Sese) 0; 30; 60; 95; 125; 160; 190; 220 (Atrial Post-Pace) 0; 30; 60; 95; 125; 160; 190; 220 (Vetricular Post-Pace) Auto; 0; 30; 60; 95; 125; 160; 190; 220 Rate-Modulated Parameters Maximum Sesor Rate (mi -1 ) 80-150 i steps of 5; 160-180 i steps of 10 Rate Resposive AV Delay Off; Low; Medium; High Rate Resposive PVARP/VREF Off; Low; Medium; High Reactio Time Very Fast; Fast; Medium; Slow Recovery Time Fast; Medium; Slow; Very Slow Brief Summary: Prior to usig these devices, please review the Istructios for Use for a complete listig of idicatios, cotraidicatios, warigs, precautios, potetial adverse evets ad directios for use. Devices depicted may ot be available i all coutries. Check with your St. Jude Medical represetative for product availability i your coutry. Uless otherwise oted, idicates that the ame is a trademark of, or licesed to, St. Jude Medical or oe of its subsidiaries. ST. JUDE MEDICAL, the ie-squares symbol ad MORE CONTROL. LESS RISK. are registered ad uregistered trademarks ad service marks of St. Jude Medical, Ic. ad its related compaies. 2011 St. Jude Medical, Ic. All rights reserved. Item GMCRM739EN AF Suppressio Algorithm Off; O Lower Rate Overdrive (mi -1 ) 10 3 Upper Rate Overdrive (mi -1 ) 5 3 No. of Overdrive Pacig Cycles 15-40 i steps of 5 Rate Recovery (ms) 8; 12 3 Maximum AF Suppressio Rate (mi -1 ) 80-150 i steps of 5; 160-180 i steps of 10 Atrial Tachycardia Detectio Rate (mi -1 ) 110-200 i steps of 10; 225-300 i steps of 25 Auto Mode Switch Off; DDD(R) to DDI(R); DDD(R) to DDT(R); DDD(R) to VVI(R); DDD(R) to VVT(R); VDD(R) to VVI(R); VDD(R) to VVT(R) AMS Base Rate (mi -1 ) 40-170 i steps of 5 Stored Electrograms Optios Priority Optios Chael 1; 2; 3 Triggers Advaced Hysteresis AMS Etry/AMS Exit/ AMS Etry ad Exit AT/AF Detectio Maget Respose High Atrial Rate Rate (mi -1 ) 125-300 i steps of 25 No. of Cosecutive Cycles 2; 3; 4; 5; 10; 15; 20 High Vetricular Rate Rate (mi -1 ) 125-300 i steps of 25 No. of Cosecutive Cycles 2; 3; 4; 5; 10; 15; 20 PMT Termiatio Cosecutive PVCs No. of Cosecutive PVCs 2; 3; 4; 5 Noise Reversio Other A ad V Lead Moitorig Moitor; Auto Polarity Switch A ad V Low Impedace Limit (Ω) 100-500 i steps of 25 A ad V High Impedace Limit (Ω) 750-2500 i steps of 250; 3000 Lead Type Ucoded; Uipolar; Bipolar Maget Respose Off; Battery Test Negative AV Hysteresis Search (ms) Off; -10 to -120 i steps of 10 NIPS Optios Stimulatio Chamber Atrial; Vetricular Couplig Iterval (ms) 100-800 i steps of 10 8 S1 Cout 2-25 i steps of 1 S1 9 ; S2; S3 ad S4 Cycle (ms) Off; 100-800 i steps of 10 (Fixed or Adaptive) Vetricular Support Rate (mi -1 ) Off; 30-95 i steps of 5 Sius Node Recovery Delay (sec) 1; 2; 3; 4; 5 PMT Optios Off; Passive; Atrial Pace 2 PMT Detectio Rate (mi -1 ) 90-180 i steps of 5 PVC Respose Off; Atrial Pace 2 Vetricular Itrisic Preferece, VIP (ms) Off; 50-150 i steps of 25; 160-200 i steps of 10 VIP Search Iterval 30 sec; 1; 3; 5; 10; 30 mi VIP Search Cycles 1; 2; 3 Vetricular Safety Stadby Off; O Diagostic Treds AT/AF Activity; Exercise; Lead Impedace; P ad R Wave; A ad V Threshold Patiet Notifiers Programmable Notifiers (O; Off) Device at ERI; Atrial Lead Impedace Out of Rage; Vetricular Lead Impedace Out of Rage; AT/AF Burde; AT/AF Episode Duratio; V Rate Durig AT/AF (High V Rate Threshold/ Total Time i High V Rate) Device Reset O Etry ito Backup VVI Mode O Audible Duratio (sec) 2; 4; 6; 8; 10; 12; 14; 16 Number of Audible Alerts per Notificatio 2 Number of Notificatios 1-16 Time Betwee Notificatios (hours) 10; 22 1. ± 0,5 cc 2. Programmig optios depedet o pacig mode. 3. This parameter is ot programmable. 4. The highest available settig for hysteresis rate will be 5 mi -1 below the programmed base rate. 5. I dual-chamber modes, the maximum vetricular refractory period is 325 ms. 6. Values 0,1-0,4 ot available i a uipolar sese cofiguratio. 7. Sesitivity is with respect to a 20 ms haversie test sigal. 8. Durig atrial NIPS i dual-chamber modes, the shortest Couplig Iterval will be limited by the programmed AV/PV delay. 9. S1 Burst Cycle is applied at the pre-programmed S1 cycle legth.
Pacemakers Accet MRI SR Sigle-Chamber Pacemaker with Wireless Telemetry Product Highlights The Accet MRI pacemaker has bee desiged ad tested for safe performace of a full-body MRI sca, without zoe restrictios, 1 usig a 1,5 T (Tesla) field-stregth MRI scaer. 1 The MRI coditioal device: Allows a maximum whole body averaged specific absorptio rate (SAR) of 4 watts per kilogram (W/kg) for high image resolutio Must be used i cojuctio with a MRI lead from St. Jude Medical A optioal, easy-to-use had-held device (SJM MRI Activator device) ca be used to program the device to pre-approved MRI settigs pre- ad post-mri sca, decreasig the umber of workflow steps ad icreasig cliic efficiecy IvisiLik wireless telemetry i cojuctio with the Merli@home trasmitter ad Merli.et Patiet Care Network (PCN), allows for daily remote moitorig ad follow-up State-of-the-art features such as automaticity, Vetricular AutoCapture Pacig System ad SeseAbility techology are desiged to deliver optimal therapy for patiets at implat ad throughout their lives Idustry-leadig logevity offers 13,7 years of service life, 2 which is supported by a 7-year warraty 3 Merli@home Trasmitter Compatible 1. The St. Jude Medical MRI coditioal pacig system ca be scaed i patiets uder the followig coditios: horizotal closed bore cliical scaer workig i the Normal Operatig Mode or First Level Cotrolled Operatig Mode; static magetic field stregth of 1,5 Tesla (T) oly; maximum gradiet slew rate of 200 T/m/s per axis. See maual for additioal details before performig a MRI sca. 2. V = 2,5 V @ 0,4 ms; 500 ohms; 100% VVI pacig @ 60 bpm; AutoCapture Pacig System OFF; SEGMs ON 3. Terms ad coditios apply; refer to the warraty for details. Orderig Iformatio Cotets: Cardiac pulse geerator Model Number Dimesios (H x W x T, mm) Weight (g) Volume (cc) Coector PM1224 (RF) 52 x 53 x 6 24 13,1 (± 0,5) IS-1 Radiopaque markers St. Jude Medical idetifier Device MRI symbol Idicatios: Implatatio of a sigle-chamber pulse geerator is idicated i oe or more of the followig permaet coditios: sycope, presycope, fatigue, disorietatio due to arrhythmia/bradycardia or ay combiatio of those symptoms. MRI coditioal pulse geerator is safe for use i the MRI eviromet whe used i a complete MRI coditioal pacig system ad accordig to the istructios i the MRI Procedure Iformatio documet for the St. Jude Medical MRI coditioal pacig system. Rate-modulated pacig is idicated for patiets with chrootropic icompetece, ad for those who would beefit from icreased stimulatio rates cocurret with physical activity. Atrial pacig is idicated for patiets with sius ode dysfuctio ad ormal AV ad itravetricular coductio systems. Vetricular pacig is idicated for patiets with sigificat bradycardia ad ormal sius rhythm with oly rare episodes of A-V block or sius arrest, chroic atrial fibrillatio, severe physical disability. Cotraidicatios: Sigle-chamber pulse geerators are cotraidicated i patiets with a implated cardioverter defibrillator (ICD). Rate-adaptive pacig may be iappropriate for patiets who experiece agia or other symptoms of myocardial dysfuctio at higher sesor-drive rates. A appropriate Maximum Sesor Rate should be selected based o assessmet of the highest stimulatio rate tolerated by the patiet. Sigle-chamber vetricular demad pacig is relatively cotraidicated i patiets who have demostrated pacemaker sydrome, have retrograde VA coductio, or suffer a drop i arterial blood pressure with the oset of vetricular pacig. Sigle-chamber atrial pacig is relatively cotraidicated i patiets who have demostrated compromise of AV coductio. Adverse Evets: The followig are potetial complicatios associated with the use of ay pacig system: arrhythmia, heart block, thrombosis, threshold elevatio, valve damage, peumothorax, myopotetial sesig, vessel damage, air embolism, body rejectio pheomea, cardiac tampoade or perforatio, formatio of fibrotic tissue, local tissue reactio, iability to iterrogate or program a device because of programmer malfuctio, ifectio, iterruptio of desired device fuctio due to electrical iterferece, loss of desired pacig ad/or sesig due to lead displacemet, body reactio at electrode iterface, or lead malfuctio (fracture or damage to isulatio), loss of ormal device fuctio due to battery failure or compoet malfuctio, device migratio, pocket erosio, or hematoma, pectoral muscle stimulatio, ad phreic erve or diaphragmatic stimulatio. The followig, i additio to the above, are potetial complicatios associated with the use of rate-modulated pacig systems: iappropriate, rapid pacig rates due to sesor failure or to the detectio of sigals other tha patiet activity, loss of activity-respose due to sesor failure, ad palpitatios with high-rate pacig. Refer to the User s Maual for more detailed idicatios, cotraidicatios, warigs, precautios ad potetial adverse evets. Brief Summary: Prior to usig these devices, please review the Istructios for Use for a complete listig of idicatios, cotraidicatios, warigs, precautios, potetial adverse evets ad directios for use. Devices depicted may ot be available i all coutries. Check with your St. Jude Medical represetative for product availability i your coutry. Uless otherwise oted, idicates that the ame is a trademark of, or licesed to, St. Jude Medical or oe of its subsidiaries. ST. JUDE MEDICAL, the ie-squares symbol ad MORE CONTROL. LESS RISK. are registered ad uregistered trademarks ad service marks of St. Jude Medical, Ic. ad its related compaies. 2011 St. Jude Medical, Ic. All rights reserved.
Pacemakers Accet MRI SR Sigle-Chamber Pacemaker with Wireless Telemetry Product Specificatios PHYSICAL SPECIFICATIONS Model PM1224 Telemetry RF Dimesios (mm) 52 x 53 x 6 Weight (g) 24 Volume (cc) 13,1 1 Coector IS-1 PARAMETER SETTINGS Rate/Timig Vetricular Pace/Sese Refractory (Fixed) (ms) 125; 160-400 i steps of 30; 440; 470; 500 2 Base Rate (mi -1 ) 30-130 i steps of 5; 140-170 i steps of 10 Mode VOO(R); VVI(R); VVT(R); Pacig Off Hysteresis Rate (mi -1 ) Off; 30 3-150 i steps of 5 Search Iterval (mi -1 ) Off; 1; 5; 10; 15; 30 Cycle Cout 1-16 by 1 Itervetio Rate (mi -1 ) Off; Same as Base Rate; 80-120 i steps of 10; Itrisic +0; Itrisic +10; Itrisic +20; Itrisic +30 Itervetio Duratio (mi) 1-10 i 1 miute itervals Recovery Time Fast; Medium; Slow; Very Slow Rest Rate (mi -1 ) Off; 30-150 i steps of 5 MRI Settigs MRI Mode MRI Base Rate MRI RV Pulse Cofiguratio MRI RV Pulse Amplitude MRI RV Pulse Width Output/Sesig VOO; Pacig Off 30-120 bpm i steps of 5 bpm Bipolar 5,0 V; 7,5 V 1,0 ms V Pulse Amplitude (V) 0,25-4,0 i steps of 0,25; 4,5-7,5 i steps of 0,5 V Pulse Width (ms) 0,05; 0,1-1,5 i steps of 0,1 V Sesitivity (mv) 0,5-5,0 i steps of 0,5; 6-10 i steps of 1,0; 12,5 4 V Pulse Cofiguratio Uipolar (tip-case); Bipolar (tip-rig) V Sese Cofiguratio Uipolar Tip (tip-case); Bipolar (tip-rig); Uipolar Rig (rig-case) Vetricular AutoCapture Pacig System O; Off Primary Pulse Cofiguratio Uipolar; Bipolar Backup Pulse Cofiguratio Uipolar; Bipolar Backup Pulse Amplitude (V) 5,0 5 Search Iterval (hours) 8; 24 SeseAbility Techology Off; O (Automatic Sesitivity Cotrol adjustmet for vetricular evets) Max Sesitivity (mv) 0,2-2,0 i steps of 0,1 Threshold Start (Vetricular Post-Sese) 50; 62,5; 75; 100% (Vetricular Post-Pace) Auto; 0,2-3,0 i steps of 0,1 mv Decay Delay (ms) (Vetricular Post-Sese) 0; 30; 60; 95; 125; 160; 190; 220 (Vetricular Post-Pace) Auto; 0; 30; 60; 95; 125; 160; 190; 220 Rate-Modulated Parameters Stored Electrograms Optios Priority Optios Chael 1; 2; 3 Triggers Maget Respose High Vetricular Rate Rate (mi -1 ) 125-300 i steps of 25 No. of Cosecutive Cycles 2; 3; 4; 5; 10; 15; 20 Advaced Hysteresis Noise Reversio Other Lead Moitorig Moitor; Auto Polarity Switch V Low Impedace Limit (Ω) 100-500 i steps of 25 V High Impedace Limit (Ω) 750-2500 i steps of 250; 3000 Maget Respose Off; Battery Test Lead Type Ucoded; Uipolar; Bipolar NIPS Optios Stimulatio Chamber Vetricular Couplig Iterval (ms) 100-800 i steps of 10 S1 Cout 2-25 i steps of 1 S1 6 ; S2; S3 ad S4 Cycle (ms) 100-800 i steps of 10 (Fixed or Adaptive) Diagostic Treds Exercise; Lead Impedace; R Wave; V Threshold Patiet Notifiers Programmable Notifiers (O; Off) Device at ERI; Vetricular Lead Impedace Out of Rage Device Reset O Etry ito Backup VVI Mode O Audible Duratio (sec) 2; 4; 6; 8; 10; 12; 14; 16 Number of Audible Alerts per Notificatio 2 Number of Notificatios 1-16 Time Betwee Notificatios (hours) 10; 22 1. ± 0,5 cc 2. Programmig optios depedet o pacig mode. 3. The highest available settig for hysteresis rate will be 5 mi -1 below the programmed base rate. 4. Sesitivity is with respect to a 20 ms haversie test sigal. 5. This parameter is ot programmable. 6. S1 Burst Cycle is applied at the preprogrammed S1 cycle legth. Maximum Sesor Rate (mi -1 ) 80-150 i steps of 5; 160-180 i steps of 10 Rate Resposive VREF Off; Low; Medium; High Shortest VREF 125-475 i steps of 25 Reactio Time Very Fast; Fast; Medium; Slow Recovery Time Fast; Medium; Slow; Very Slow Sesor O; Off; Passive Slope Auto (-1); Auto (+0); Auto (+1); Auto (+2); Auto (+3); 1-16 i steps of 1 Threshold Auto (-0,5); Auto (+0,0); Auto (+0,5); Auto (+1,0); Auto (+1,5); Auto (+2,0); 1-7 i steps of 0,5 (GMCRM738EN) Brief Summary: Prior to usig these devices, please review the Istructios for Use for a complete listig of idicatios, cotraidicatios, warigs, precautios, potetial adverse evets ad directios for use. Devices depicted may ot be available i all coutries. Check with your St. Jude Medical represetative for product availability i your coutry. Uless otherwise oted, idicates that the ame is a trademark of, or licesed to, St. Jude Medical or oe of its subsidiaries. ST. JUDE MEDICAL, the ie-squares symbol ad MORE CONTROL. LESS RISK. are registered ad uregistered trademarks ad service marks of St. Jude Medical, Ic. ad its related compaies. 2011 St. Jude Medical, Ic. All rights reserved. Item GMCRM738EN
Pacemakers Accet MRI SR Sigle-Chamber Pacemaker Product Highlights The Accet MRI pacemaker has bee desiged ad tested for safe performace of a full-body MRI sca, without zoe restrictios, 1 usig a 1,5 T (Tesla) field-stregth MRI scaer. 1 The MRI coditioal device: Allows a maximum whole body averaged specific absorptio rate (SAR) of 4 watts per kilogram (W/kg) for high image resolutio Must be used i cojuctio with a MRI lead from St. Jude Medical A optioal, easy-to-use had-held device (SJM MRI Activator device) ca be used to program the device to pre-approved MRI settigs pre- ad post-mri sca, decreasig the umber of workflow steps ad icreasig cliic efficiecy State-of-the-art features such as automaticity, Vetricular AutoCapture Pacig System ad SeseAbility techology are desiged to deliver optimal therapy for patiets at implat ad throughout their lives Idustry-leadig logevity offers 14,2 years of service life, 2 which is supported by a 7-year warraty 3 1. The St. Jude Medical MRI coditioal pacig system ca be scaed i patiets uder the followig coditios: horizotal closed bore cliical scaer workig i the Normal Operatig Mode or First Level Cotrolled Operatig Mode; static magetic field stregth of 1,5 Tesla (T) oly; maximum gradiet slew rate of 200 T/m/s per axis. See maual for additioal details before performig a MRI sca. 2. V = 2,5 V @ 0,4 ms; 500 ohms; 100% VVI pacig @ 60 bpm; AutoCapture Pacig System OFF; SEGMs ON 3. Terms ad coditios apply; refer to the warraty for details. Orderig Iformatio Cotets: Cardiac pulse geerator Model Number Dimesios (H x W x T, mm) Weight (g) Volume (cc) Coector PM1124 (Iductive) 46 x 52 x 6 22 12 (± 0,5) IS-1 Radiopaque markers St. Jude Medical idetifier Device MRI symbol Idicatios: Implatatio of a sigle-chamber pulse geerator is idicated i oe or more of the followig permaet coditios: sycope, presycope, fatigue, disorietatio due to arrhythmia/bradycardia or ay combiatio of those symptoms. MRI coditioal pulse geerator is safe for use i the MRI eviromet whe used i a complete MRI coditioal pacig system ad accordig to the istructios i the MRI Procedure Iformatio documet for the St. Jude Medical MRI coditioal pacig system. Rate-modulated pacig is idicated for patiets with chrootropic icompetece, ad for those who would beefit from icreased stimulatio rates cocurret with physical activity. Atrial pacig is idicated for patiets with sius ode dysfuctio ad ormal AV ad itravetricular coductio systems. Vetricular pacig is idicated for patiets with sigificat bradycardia ad ormal sius rhythm with oly rare episodes of A-V block or sius arrest, chroic atrial fibrillatio, severe physical disability. Cotraidicatios: Sigle-chamber pulse geerators are cotraidicated i patiets with a implated cardioverter defibrillator (ICD). Rate-adaptive pacig may be iappropriate for patiets who experiece agia or other symptoms of myocardial dysfuctio at higher sesor-drive rates. A appropriate Maximum Sesor Rate should be selected based o assessmet of the highest stimulatio rate tolerated by the patiet. Sigle-chamber vetricular demad pacig is relatively cotraidicated i patiets who have demostrated pacemaker sydrome, have retrograde VA coductio, or suffer a drop i arterial blood pressure with the oset of vetricular pacig. Sigle-chamber atrial pacig is relatively cotraidicated i patiets who have demostrated compromise of AV coductio. Adverse Evets: The followig are potetial complicatios associated with the use of ay pacig system: arrhythmia, heart block, thrombosis, threshold elevatio, valve damage, peumothorax, myopotetial sesig, vessel damage, air embolism, body rejectio pheomea, cardiac tampoade or perforatio, formatio of fibrotic tissue, local tissue reactio, iability to iterrogate or program a device because of programmer malfuctio, ifectio, iterruptio of desired device fuctio due to electrical iterferece, loss of desired pacig ad/or sesig due to lead displacemet, body reactio at electrode iterface, or lead malfuctio (fracture or damage to isulatio), loss of ormal device fuctio due to battery failure or compoet malfuctio, device migratio, pocket erosio, or hematoma, pectoral muscle stimulatio, ad phreic erve or diaphragmatic stimulatio. The followig, i additio to the above, are potetial complicatios associated with the use of rate-modulated pacig systems: iappropriate, rapid pacig rates due to sesor failure or to the detectio of sigals other tha patiet activity, loss of activity-respose due to sesor failure, ad palpitatios with high-rate pacig. Refer to the User s Maual for more detailed idicatios, cotraidicatios, warigs, precautios ad potetial adverse evets. Brief Summary: Prior to usig these devices, please review the Istructios for Use for a complete listig of idicatios, cotraidicatios, warigs, precautios, potetial adverse evets ad directios for use. Devices depicted may ot be available i all coutries. Check with your St. Jude Medical represetative for product availability i your coutry. Uless otherwise oted, idicates that the ame is a trademark of, or licesed to, St. Jude Medical or oe of its subsidiaries. ST. JUDE MEDICAL, the ie-squares symbol ad MORE CONTROL. LESS RISK. are registered ad uregistered trademarks ad service marks of St. Jude Medical, Ic. ad its related compaies. 2011 St. Jude Medical, Ic. All rights reserved.
Pacemakers Accet MRI SR Sigle-Chamber Pacemaker Product Specificatios PHYSICAL SPECIFICATIONS Model PM1124 Telemetry Iductive Dimesios (mm) 46 x 52 x 6 Weight (g) 22 Volume (cc) 12 1 Coector IS-1 PARAMETER SETTINGS Rate/Timig Vetricular Pace/Sese Refractory (Fixed) (ms) 125; 160-400 i steps of 30; 440; 470; 500 2 Base Rate (mi -1 ) 30-130 i steps of 5; 140-170 i steps of 10 Mode VOO(R); VVI(R); VVT(R); Pacig Off Hysteresis Rate (mi -1 ) Off; 30 3-150 i steps of 5 Search Iterval (mi -1 ) Off; 1; 5; 10; 15; 30 Cycle Cout 1-16 by 1 Itervetio Rate (mi -1 ) Off; Same as Base Rate; 80-120 i steps of 10; Itrisic +0; Itrisic +10; Itrisic +20; Itrisic +30 Itervetio Duratio (mi) 1-10 i 1 miute itervals Recovery Time Fast; Medium; Slow; Very Slow Rest Rate (mi -1 ) Off; 30-150 i steps of 5 MRI Settigs MRI Mode MRI Base Rate MRI RV Pulse Cofiguratio MRI RV Pulse Amplitude MRI RV Pulse Width Output/Sesig VOO; Pacig Off 30-120 bpm i steps of 5 bpm Bipolar 5,0 V; 7,5 V 1,0 ms V Pulse Amplitude (V) 0,25-4,0 i steps of 0,25; 4,5-7,5 i steps of 0,5 V Pulse Width (ms) 0,05; 0,1-1,5 i steps of 0,1 V Sesitivity (mv) 0,5-5,0 i steps of 0,5; 6-10 i steps of 1,0; 12,5 4 V Pulse Cofiguratio Uipolar (tip-case); Bipolar (tip-rig) V Sese Cofiguratio Uipolar Tip (tip-case); Bipolar (tip-rig); Uipolar Rig (rig-case) Vetricular AutoCapture Pacig System O; Off Primary Pulse Cofiguratio Uipolar; Bipolar Backup Pulse Cofiguratio Uipolar; Bipolar Backup Pulse Amplitude (V) 5,0 5 Search Iterval (hours) 8; 24 SeseAbility Techology Off; O (Automatic Sesitivity Cotrol adjustmet for vetricular evets) Max Sesitivity (mv) 0,2-2,0 i steps of 0,1 Threshold Start (Vetricular Post-Sese) 50; 62,5; 75; 100% (Vetricular Post-Pace) Auto; 0,2-3,0 i steps of 0,1 mv Decay Delay (ms) (Vetricular Post-Sese) 0; 30; 60; 95; 125; 160; 190; 220 (Vetricular Post-Pace) Auto; 0; 30; 60; 95; 125; 160; 190; 220 Rate-Modulated Parameters Stored Electrograms Optios Priority Optios Chael 1; 2; 3 Triggers Maget Respose High Vetricular Rate Rate (mi -1 ) 125-300 i steps of 25 No. of Cosecutive Cycles 2; 3; 4; 5; 10; 15; 20 Advaced Hysteresis Noise Reversio Other Lead Moitorig Moitor; Auto Polarity Switch V Low Impedace Limit (Ω) 100-500 i steps of 25 V High Impedace Limit (Ω) 750-2500 i steps of 250; 3000 Maget Respose Off; Battery Test Lead Type Ucoded; Uipolar; Bipolar NIPS Optios Stimulatio Chamber Vetricular Couplig Iterval (ms) 100-800 i steps of 10 S1 Cout 2-25 i steps of 1 S1 6 ; S2; S3 ad S4 Cycle (ms) 100-800 i steps of 10 (Fixed or Adaptive) Diagostic Treds Exercise; Lead Impedace; R Wave; V Threshold Patiet Notifiers Programmable Notifiers (O; Off) Device at ERI; Vetricular Lead Impedace Out of Rage Device Reset O Etry ito Backup VVI Mode O Audible Duratio (sec) 2; 4; 6; 8; 10; 12; 14; 16 Number of Audible Alerts per Notificatio 2 Number of Notificatios 1-16 Time Betwee Notificatios (hours) 10; 22 1. ± 0,5 cc 2. Programmig optios depedet o pacig mode. 3. The highest available settig for hysteresis rate will be 5 mi -1 below the programmed base rate. 4. Sesitivity is with respect to a 20 ms haversie test sigal. 5. This parameter is ot programmable. 6. S1 Burst Cycle is applied at the preprogrammed S1 cycle legth. Maximum Sesor Rate (mi -1 ) 80-150 i steps of 5; 160-180 i steps of 10 Rate Resposive VREF Off; Low; Medium; High Shortest VREF 125-475 i steps of 25 Reactio Time Very Fast; Fast; Medium; Slow Recovery Time Fast; Medium; Slow; Very Slow Sesor O; Off; Passive Slope Auto (-1); Auto (+0); Auto (+1); Auto (+2); Auto (+3); 1-16 i steps of 1 Threshold Auto (-0,5); Auto (+0,0); Auto (+0,5); Auto (+1,0); Auto (+1,5); Auto (+2,0); 1-7 i steps of 0,5 Brief Summary: Prior to usig these devices, please review the Istructios for Use for a complete listig of idicatios, cotraidicatios, warigs, precautios, potetial adverse evets ad directios for use. Devices depicted may ot be available i all coutries. Check with your St. Jude Medical represetative for product availability i your coutry. Uless otherwise oted, idicates that the ame is a trademark of, or licesed to, St. Jude Medical or oe of its subsidiaries. ST. JUDE MEDICAL, the ie-squares symbol ad MORE CONTROL. LESS RISK. are registered ad uregistered trademarks ad service marks of St. Jude Medical, Ic. ad its related compaies. 2011 St. Jude Medical, Ic. All rights reserved. Item GMCRM740EN
Hadheld MRI Pacemaker Settigs Activator SJM MRI Activator Hadheld Device Product Highlights The SJM MRI Activator hadheld device, model EX4000, is a exteral device that uses radio waves to commuicate with a St. Jude Medical MRI coditioal implated pulse geerator The SJM MRI Activator device streamlies MRI patiet workflow by allowig previously stored MRI settigs to be easily: Eabled before a MRI sca 1 Disabled after a MRI sca 1 Verified at ay time Orderig Iformatio Cotets: SJM MRI Activator device Reorder Number EX4000 Descriptio SJM MRI Activator EX4000 Iteded Use: The SJM MRI Activator hadheld device is used to evaluate the status of, ad to eable ad disable, the previously stored MRI settigs. The activator is iteded for use with St. Jude Medical MR Coditioal pulse geerators. Cotraidicatios: There are o cotraidicatios. Warigs ad Precautios: Electromagetic iterferece. The activator is ot magetic ad has o movig parts. However, you should avoid equipmet which geerates a strog electromagetic iterferece (EMI). EMI could iterfere with commuicatio betwee the activator ad the implated St. Jude Medical MR coditioal pulse geerator. Movig away from the source of EMI or turig it off will usually allow the activator to retur to its ormal mode of operatio. Commuicatio equipmet. Commuicatio equipmet such as microwave trasmitters or high-power amateur trasmitters may geerate eough EMI to iterfere with the performace of the activator if you are too close to the source of EMI. Wireless commuicatio devices. Wireless commuicatio devices such as computers that operate o a wireless etwork, hadheld persoal computers (PDA), cellular phoes, ad eve cordless telephoes may geerate eough EMI to iterfere with the performace of the activator if it is used too close to the source of EMI. Hospital ad Medical equipmet. A variety of stadard hospital ad medical equipmet may geerate eough EMI to iterfere with the performace of the activator. These iclude, but are ot limited to: blood pressure moitors, ECG equipmet, exteral defibrillatio equipmet, x-ray machies. Office equipmet. A variety of stadard office equipmet may geerate eough EMI to iterfere with the performace of the activator. These iclude, but are ot limited to: desktop or laptop computers, fax machies, phoe systems. Idustrial equipmet. A variety of idustrial equipmet may geerate eough EMI to iterfere with the performace of your activator. These iclude, but are ot limited to: arc welders; iductio furaces; very large or defective electric motors; ad iteral combustio egies with poorly shielded igitio systems. Brief Summary: Prior to usig these devices, please review the Istructios for Use for a complete listig of idicatios, cotraidicatios, warigs, precautios, potetial adverse evets ad directios for use. Devices depicted may ot be available i all coutries. Check with your St. Jude Medical represetative for product availability i your coutry. Uless otherwise oted, idicates that the ame is a trademark of, or licesed to, St. Jude Medical or oe of its subsidiaries. ST. JUDE MEDICAL, the ie-squares symbol ad MORE CONTROL. LESS RISK. are registered ad uregistered trademarks ad service marks of St. Jude Medical, Ic. ad its related compaies. 2011 St. Jude Medical, Ic. All rights reserved.
Hadheld MRI Pacemaker Settigs Activator SJM MRI Activator Hadheld Device Product Specificatios PHYSICAL SPECIFICATIONS Model EX4000 Dimesios (cm) 7,1 x 5,6 x 1,8 Case material High-impact plastic Power source 1 cell; 3,6 V (omial); Chemistry: Lithium Thioyl Chloride Battery logevity 3 years from maufacturig date Audible output level 60 db (miimum) at 10,0 cm Classificatio with respect to electric shock Iterally powered Protectio from electric shock (IEC 60601-1) Protectio agaist igress of liquids Mode of operatio Type BF Ordiary equipmet No-cotiuous 1. The SJM MRI Activator device is desiged to eable/disable pre-programmed MRI mode quickly ad easily pre- ad post-sca; do ot take the SJM MRI Activator device ito the MRI maget/scaer room. (GMCRM855EN) Brief Summary: Prior to usig these devices, please review the Istructios for Use for a complete listig of idicatios, cotraidicatios, warigs, precautios, potetial adverse evets ad directios for use. Devices depicted may ot be available i all coutries. Check with your St. Jude Medical represetative for product availability i your coutry. Uless otherwise oted, idicates that the ame is a trademark of, or licesed to, St. Jude Medical or oe of its subsidiaries. ST. JUDE MEDICAL, the ie-squares symbol ad MORE CONTROL. LESS RISK. are registered ad uregistered trademarks ad service marks of St. Jude Medical, Ic. ad its related compaies. 2011 St. Jude Medical, Ic. All rights reserved. Item GMCRM855EN
Pacemakers Accet DR RF Dual-Chamber Pacemaker Product Highlights IvisiLik wireless telemetry, i cojuctio with the Merli@home trasmitter ad Merli.et Patiet Care Network (PCN), allows for daily remote moitorig ad follow-up AT/AF alerts ca be programmed to otify patiets ad their cliics whe a programmed AT/AF threshold or ca be programmed to cotiuous episode duratio has bee exceeded, or whe a high vetricular rate accompaies the AT/AF episode A suite of state-of-the-art features complete automaticity (atrial ad vetricular), Vetricular Itrisic Preferece (VIP ) techology, QuickOpt timig cycle optimisatio, the AF Suppressio algorithm ad SeseAbility techology is desiged to deliver optimal therapy for patiets at implat ad throughout their lives. Real-time electrogram (EGM) waveform, as well as the associated evet markers that precede ad follow a specific triggerig evet, ca be programmed to automatically record up to 14 miutes of stored EGMs whe ecouterig oe or more programmable trigger optios Merli@home Trasmitter Compatible Orderig Iformatio Cotets: Cardiac pulse geerator Model Number Dimesios (H x W x T, mm) Weight (g) Volume (cc) Coector PM2212 52 x 52 x 6 23 12,8 (± 0,5) IS-1 Idicatios: Implatatio is idicated i oe or more of the followig permaet coditios: sycope, presycope, fatigue, disorietatio due to arrhythmia/bradycardia or ay combiatio of those symptoms. Rate-Modulated Pacig is idicated for patiets with chrootropic icompetece, ad for those who would beefit from icreased stimulatio rates cocurret with physical activity. Dual-Chamber Pacig is idicated for those patiets exhibitig: sick sius sydrome, chroic, symptomatic secod- ad third-degree AV block, recurret Adams-Stokes sydrome, symptomatic bilateral budle brach block whe tachyarrhythmia ad other causes have bee ruled out. Atrial Pacig is idicated for patiets with sius ode dysfuctio ad ormal AV ad itravetricular coductio systems. Vetricular Pacig is idicated for patiets with sigificat bradycardia ad ormal sius rhythm with oly rare episodes of A-V block or sius arrest, chroic atrial fibrillatio, severe physical disability. AF Suppressio algorithm is idicated for suppressio of paroxysmal or persistet atrial fibrillatio episodes i patiets with oe or more of the above pacig idicatios. Cotraidicatios: Dual-chamber pulse geerators are cotraidicated i patiets with a implated cardioverter-defibrillator. Rate-Adaptive Pacig may be iappropriate for patiets who experiece agia or other symptoms of myocardial dysfuctio at higher sesor-drive rates. A appropriate Maximum Sesor Rate should be selected based o assessmet of the highest stimulatio rate tolerated by the patiet. AF Suppressio stimulatio is ot recommeded i patiets who caot tolerate high atrial-rate stimulatio. Dual-Chamber Pacig, though ot cotraidicated for patiets with chroic atrial flutter, chroic atrial fibrillatio, or silet atria, may provide o beefit beyod that of sigle-chamber pacig i such patiets. Sigle-Chamber Vetricular Demad Pacig is relatively cotraidicated i patiets who have demostrated pacemaker sydrome, have retrograde VA coductio, or suffer a drop i arterial blood pressure with the oset of vetricular pacig. Sigle-Chamber Atrial Pacig is relatively cotraidicated i patiets who have demostrated compromise of AV coductio. Potetial Adverse Evets: The followig are potetial complicatios associated with the use of ay pacig system: arrhythmia, heart block, thrombosis, threshold elevatio, valve damage, peumothorax, myopotetial sesig, vessel damage, air embolism, body rejectio pheomea, cardiac tampoade or perforatio, formatio of fibrotic tissue/local tissue reactio, iability to iterrogate or program a device because of programmer malfuctio, ifectio, iterruptio of desired device fuctio due to electrical iterferece, loss of desired pacig ad/or sesig due to lead displacemet, body reactio at electrode iterface or lead malfuctio (fracture or damage to isulatio), loss of ormal device fuctio due to battery failure or compoet malfuctio, device migratio, pocket erosio or hematoma, pectoral muscle stimulatio, phreic erve or diaphragmatic stimulatio. The followig, i additio to the above, are potetial complicatios associated with the use of rate-modulated pacig systems: iappropriate, rapid pacig rates due to sesor failure or to the detectio of sigals other tha patiet activity, loss of activity-respose due to sesor failure, palpitatios with high-rate pacig. Refer to the User s Maual for detailed idicatios, cotraidicatios, warigs, precautios ad potetial adverse evets. Brief Summary: Prior to usig these devices, please review the Istructios for Use for a complete listig of idicatios, cotraidicatios, warigs, precautios, potetial adverse evets ad directios for use. Devices depicted may ot be available i all coutries. Check with your St. Jude Medical represetative for product availability i your coutry. Uless otherwise oted, idicates that the ame is a trademark of, or licesed to, St. Jude Medical or oe of its subsidiaries. ST. JUDE MEDICAL, the ie-squares symbol ad MORE CONTROL. LESS RISK. are registered ad uregistered trademarks ad service marks of St. Jude Medical, Ic. ad its related compaies. 2011 St. Jude Medical, Ic. All rights reserved.
Pacemakers Accet DR RF Dual-Chamber Pacemaker Product Specificatios PHYSICAL SPECIFICATIONS Model PM2212 Telemetry RF Dimesios (mm) 52 x 52 x 6 Weight (g) 23 Volume (cc) 12,8 1 Coector IS-1 PARAMETER Rate/Timig SETTINGS Atrial Pace Refractory (ms) 190-400 i steps of 30; 440; 470 2 Atrial Sese Refractory (ms) 93; 125; 157; 190-400 i steps of 30; 440; 470 2 Atrial Protectio Iterval (ms) 125 3 Paced AV Delay (ms) 25; 30-200 i steps of 10; 225-300 i steps of 25; 350 Base Rate (mi -1 ) 30-130 i steps of 5; 140-170 i steps of 10 Far-Field Protectio Iterval (ms) 163 Hysteresis Rate (mi -1 ) Off; 30 4-150 i steps of 5 Search Iterval (mi) Off; 1; 5; 10; 15; 30 Cycle Cout 1-16 i steps of 1 Itervetio Rate (mi -1 ) Off; Same Base Rate; 80-120 i steps of 10; Itrisic +0; Itrisic +10; Itrisic +20; Itrisic +30 Itervetio Duratio (mi) 1-10 i 1 miute itervals Recovery Time Fast; Medium; Slow; Very Slow Maximum Trackig Rate (mi -1 ) 90-130 i steps of 5; 140-180 i steps of 10 Mode AOO(R); AAI(R); AAT(R); VOO(R); VVI(R); VVT(R); VDD(R); DOO(R); DVI(R); DDI(R); DDD(R); Pacig Off Post Vetricular Atrial Blakig (ms) 60-200 i steps of 10; 225; 250 PVARP (ms) 125-500 i steps of 25 Sesed AV Delay (ms) 25; 30-200 i steps of 10; 225-325 i steps of 25 Rest Rate (mi -1 ) Off; 30-150 i steps of 5 Shortest AV Delay (ms) 25-50 i steps of 5; 60-120 i steps of 10 Vetricular Blakig (ms) Auto; 12-52 i steps of 4 Vetricular Pace/Sese Refractory 5 (Fixed) (ms) 125; 160-400 i steps of 30; 440; 500 2 Output/Sesig ACap Cofirm O; Off; Moitor Primary Pulse Cofiguratio Bipolar Backup Pulse Cofiguratio Bipolar Backup Pulse Amplitude (V) 5,0 Search Iterval (hours) 8; 24 A or V Pulse Amplitude (V) 0,25-4,0 i steps of 0,25; 4,5-7,5 i steps of 0,5 A or V Pulse Width (ms) 0,05; 0,1-1,5 i steps of 0,1 A or V Pulse Cofiguratio Uipolar (tip-case); Bipolar (tip-rig) A or V Sese Cofiguratio Uipolar Tip (tip-case); Bipolar (tip-rig); Uipolar Rig (rig-case) Atrial Sesitivity (mv) 0,1-0,4 6 i steps of 0,1; 0,5; 0,75-2,0 i steps of 0,25; 2,5-4,0 i steps of 0,5; 5,0 7 Vetricular AutoCapture Pacig System O; Off Primary Pulse Cofiguratio Uipolar; Bipolar Backup Pulse Cofiguratio Uipolar; Bipolar Backup Pulse Amplitude (V) 5,0 3 Search Iterval (hours) 8; 24 AutoCapture Paced/Sesed AV Delay (ms) 50/25; 100/70; 120/100 Vetricular Sesitivity (mv) 0,5-5,0 i steps of 0,5; 6-10 i steps of 1,0; 12,5 7 SeseAbility Techology Off; O (Automatic Sesitivity Cotrol adjustmet for atrial ad vetricular evets) A Max Sesitivity (mv) 0,2-1,0 i steps of 0,1 V Max Sesitivity (mv) 0,2-2,0 i steps of 0,1 Threshold Start (Atrial ad Vetricular Post-Sese) 50; 62,5; 75; 100% (Atrial Post-Pace) 0,2-3,0 i steps of 0,1 mv (Vetricular Post-Pace) Auto; 0,2-3,0 i steps of 0,1 mv Decay Delay (ms) (Atrial ad Vetricular Post-Sese) 0; 30; 60; 95; 125; 160; 190; 220 (Atrial Post-Pace) 0; 30; 60; 95; 125; 160; 190; 220 (Vetricular Post-Pace) Auto; 0; 30; 60; 95; 125; 160; 190; 220 Rate-Modulated Parameters Maximum Sesor Rate (mi -1 ) 80-150 i steps of 5; 160-180 i steps of 10 Rate Resposive AV Delay Off; Low; Medium; High Rate Resposive PVARP/VREF Off; Low; Medium; High Reactio Time Very Fast; Fast; Medium; Slow Recovery Time Fast; Medium; Slow; Very Slow Sesor O; Off; Passive Shortest PVARP/VREF (ms) 125-475 i steps of 25 Slope Auto (-1); Auto (+0); Auto (+1); Auto (+2); Auto (+3); 1-16 i steps of 1 Threshold Auto (-0,5); Auto (+0,0); Auto (+0,5); Auto (+1,0); Auto (+1,5); Auto (+2,0); 1-7 i steps of 0,5 AF Maagemet AF Suppressio Algorithm Off; O Lower Rate Overdrive (mi -1 ) 10 3 Upper Rate Overdrive (mi-1) 5 3 No. of Overdrive Pacig Cycles 15-40 i steps of 5 Rate Recovery (ms) 8; 12 3 Maximum AF Suppressio Rate (mi -1 ) 80-150 i steps of 5; 160-180 i steps of 10 Atrial Tachycardia Detectio Rate (mi -1 ) 110-200 i steps of 10; 225-300 i steps of 25 Auto Mode Switch Off; DDD(R) to DDI(R); DDD(R) to VVI(R); VDD(R) to VVI(R) AMS Base Rate (mi -1 ) 40-170 i steps of 5 Stored Electrograms Optios Priority Optios Chael 1; 2; 3 Triggers Advaced Hysteresis AMS Etry/AMS Exit/ AMS Etry ad Exit AT/AF Detectio Maget Respose High Atrial Rate Rate (mi -1 ) 125-300 i steps of 25 No. of Cosecutive Cycles 2; 3; 4; 5; 10; 15; 20 High Vetricular Rate Rate (mi -1 ) 125-300 i steps of 25 No. of Cosecutive Cycles 2; 3; 4; 5; 10; 15; 20 PMT Termiatio Cosecutive PVCs No. of Cosecutive PVCs 2; 3; 4; 5 Noise Reversio Other A ad V Lead Moitorig Moitor; Auto Polarity Switch A ad V Low Impedace Limit (Ω) 100-500 i steps of 50 A ad V High Impedace Limit (Ω) 750-2500 i steps of 250; 3000 Lead Type Ucoded; Uipolar; Bipolar Maget Respose Off; Battery Test Negative AV Hysteresis Search (ms) Off; -10 to -120 i steps of 10 NIPS Optios Stimulatio Chamber Atrial; Vetricular Couplig Iterval (ms) 100-800 i steps of 10 8 S1 Cout 2-25 i steps of 1 S1 9 ; S2; S3 ad S4 Cycle (ms) Off; 100-800 i steps of 10 (Fixed or Adaptive) Vetricular Support Rate (mi -1 ) Off; 30-95 i steps of 5 Sius Node Recovery Delay (sec) 1; 2; 3; 4; 5 PMT Optios Off; Passive; Atrial Pace 2 PMT Detectio Rate (mi -1 ) 90-180 i steps of 5 PVC Respose Off; Atrial Pace 2 Vetricular Itrisic Preferece, VIP (ms) Off; 50-150 i steps of 25; 160-200 i steps of 10 VIP Search Iterval 30 sec.; 1; 3; 5; 10; 30 mi. VIP Search Cycles 1; 2; 3 Vetricular Safety Stadby Off; O Diagostic Treds AT/AF Activity; Exercise; Lead Impedace; P ad R Wave; A ad V Threshold Patiet Notifiers Programmable Notifiers (O; Off) Device at ERI; Atrial Lead Impedace Out of Rage; Vetricular Lead Impedace Out of Rage; AT/AF Burde; AT/AF Episode Duratio; High V Rate Durig AT/AF Device Reset O Etry ito Backup VVI Mode O Audible Duratio (sec) 2; 4; 6; 8; 10; 12; 14; 16 Number of Audible Alerts per Notificatio 2 Number of Notificatios 1-16 Time Betwee Notificatios (hours) 10; 22 1. ± 0,5 cc 2. Programmig optios depedet o pacig mode. 3. This parameter is ot programmable. 4. The highest available settig for hysteresis rate will be 5 mi-1 below the programmed base rate. 5. I dual-chamber modes, the maximum vetricular refractory period is 325 ms. 6. Values 0,1-0,4 ot available i a uipolar sese cofiguratio. 7. Sesitivity is with respect to a 20 ms haversie test sigal. 8. Durig atrial NIPS i dual-chamber modes, the shortest Couplig Iterval will be limited by the programmed AV/PV delay. 9. S1 Burst Cycle is applied at the preprogrammed S1 cycle legth. (GMCRM790EN) Brief Summary: Prior to usig these devices, please review the Istructios for Use for a complete listig of idicatios, cotraidicatios, warigs, precautios, potetial adverse evets ad directios for use. Devices depicted may ot be available i all coutries. Check with your St. Jude Medical represetative for product availability i your coutry. Uless otherwise oted, idicates that the ame is a trademark of, or licesed to, St. Jude Medical or oe of its subsidiaries. ST. JUDE MEDICAL, the ie-squares symbol ad MORE CONTROL. LESS RISK. are registered ad uregistered trademarks ad service marks of St. Jude Medical, Ic. ad its related compaies. 2011 St. Jude Medical, Ic. All rights reserved. Item GMCRM790EN
Pacemakers Accet DR Dual-Chamber Pacemaker Product Highlights Iductive remote follow-up utilisig a wad, i cojuctio with the Merli@home trasmitter ad Merli.et Patiet Care Network (PCN), allows patiets to dowload iformatio ad provide the cliic with access to device measuremets A two-toe audible alert allows programmig to otify the patiet of chages i device performace or arrhythmia status, which ca provide earlier isight ito actioable cliical evets AT/AF alerts ca be programmed to otify patiets ad their cliics whe a programmed AT/AF threshold or ca be programmed to cotiuous episode duratio has bee exceeded, or whe a high vetricular rate accompaies the AT/AF episode A suite of state-of-the-art features complete automaticity (atrial ad vetricular), Vetricular Itrisic Preferece (VIP ) techology, QuickOpt timig cycle optimisatio, the AF Suppressio algorithm ad SeseAbility techology is desiged to deliver optimal therapy for patiets at implat ad throughout their lives Real-time electrogram (EGM) waveform, as well as the associated evet markers that precede ad follow a specific triggerig evet, ca be programmed to automatically record up to 14 miutes of stored EGMs whe ecouterig oe or more programmable trigger optios Orderig Iformatio Cotets: Cardiac pulse geerator Model Number Dimesios (H x W x T, mm) Weight (g) Volume (cc) Coector PM2112 46 x 52 x 6 19 10,5 (± 0,5) IS-1 Idicatios: Implatatio is idicated i oe or more of the followig permaet coditios: sycope, presycope, fatigue, disorietatio due to arrhythmia/bradycardia or ay combiatio of those symptoms. Rate-Modulated Pacig is idicated for patiets with chrootropic icompetece, ad for those who would beefit from icreased stimulatio rates cocurret with physical activity. Dual-Chamber Pacig is idicated for those patiets exhibitig: sick sius sydrome, chroic, symptomatic secod- ad third-degree AV block, recurret Adams-Stokes sydrome, symptomatic bilateral budle brach block whe tachyarrhythmia ad other causes have bee ruled out. Atrial Pacig is idicated for patiets with sius ode dysfuctio ad ormal AV ad itravetricular coductio systems. Vetricular Pacig is idicated for patiets with sigificat bradycardia ad ormal sius rhythm with oly rare episodes of A-V block or sius arrest, chroic atrial fibrillatio, severe physical disability. AF Suppressio algorithm is idicated for suppressio of paroxysmal or persistet atrial fibrillatio episodes i patiets with oe or more of the above pacig idicatios. Cotraidicatios: Dual-chamber pulse geerators are cotraidicated i patiets with a implated cardioverter-defibrillator. Rate-Adaptive Pacig may be iappropriate for patiets who experiece agia or other symptoms of myocardial dysfuctio at higher sesor-drive rates. A appropriate Maximum Sesor Rate should be selected based o assessmet of the highest stimulatio rate tolerated by the patiet. AF Suppressio stimulatio is ot recommeded i patiets who caot tolerate high atrial-rate stimulatio. Dual-Chamber Pacig, though ot cotraidicated for patiets with chroic atrial flutter, chroic atrial fibrillatio or silet atria, may provide o beefit beyod that of sigle-chamber pacig i such patiets. Sigle-Chamber Vetricular Demad Pacig is relatively cotraidicated i patiets who have demostrated pacemaker sydrome, have retrograde VA coductio or suffer a drop i arterial blood pressure with the oset of vetricular pacig. Sigle-Chamber Atrial Pacig is relatively cotraidicated i patiets who have demostrated compromise of AV coductio. Potetial Adverse Evets: The followig are potetial complicatios associated with the use of ay pacig system: arrhythmia, heart block, thrombosis, threshold elevatio, valve damage, peumothorax, myopotetial sesig, vessel damage, air embolism, body rejectio pheomea, cardiac tampoade or perforatio, formatio of fibrotic tissue/local tissue reactio, iability to iterrogate or program a device because of programmer malfuctio, ifectio, iterruptio of desired device fuctio due to electrical iterferece, loss of desired pacig ad/or sesig due to lead displacemet, body reactio at electrode iterface or lead malfuctio (fracture or damage to isulatio), loss of ormal device fuctio due to battery failure or compoet malfuctio, device migratio, pocket erosio or hematoma, pectoral muscle stimulatio, phreic erve or diaphragmatic stimulatio. The followig, i additio to the above, are potetial complicatios associated with the use of rate-modulated pacig systems: iappropriate, rapid pacig rates due to sesor failure or to the detectio of sigals other tha patiet activity, loss of activity-respose due to sesor failure, palpitatios with high-rate pacig. Refer to the User s Maual for detailed idicatios, cotraidicatios, warigs, precautios ad potetial adverse evets. Brief Summary: Prior to usig these devices, please review the Istructios for Use for a complete listig of idicatios, cotraidicatios, warigs, precautios, potetial adverse evets ad directios for use. Devices depicted may ot be available i all coutries. Check with your St. Jude Medical represetative for product availability i your coutry. Uless otherwise oted, idicates that the ame is a trademark of, or licesed to, St. Jude Medical or oe of its subsidiaries. ST. JUDE MEDICAL, the ie-squares symbol ad MORE CONTROL. LESS RISK. are registered ad uregistered trademarks ad service marks of St. Jude Medical, Ic. ad its related compaies. 2011 St. Jude Medical, Ic. All rights reserved.
Pacemakers Accet DR Dual-Chamber Pacemaker Product Specificatios PHYSICAL SPECIFICATIONS Model PM2112 Telemetry Iductive Dimesios (mm) 46 x 52 x 6 Weight (g) 19 Volume (cc) 10,5 1 Coector IS-1 PARAMETER SETTINGS Rate/Timig Atrial Pace Refractory (ms) 190-400 i steps of 30; 440; 470 2 Atrial Sese Refractory (ms) 93; 125; 157; 190-400 i steps of 30; 440; 470 2 Atrial Protectio Iterval (ms) 125 3 Paced AV Delay (ms) 25; 30-200 i steps of 10; 225-300 i steps of 25; 350 Base Rate (mi -1 ) 30-130 i steps of 5; 140-170 i steps of 10 Far-Field Protectio Iterval (ms) 16 3 Hysteresis Rate (mi -1 ) Off; 30 4-150 i steps of 5 Search Iterval (mi) Off; 1; 5; 10; 15; 30 Cycle Cout 1-16 i steps of 1 Itervetio Rate (mi -1 ) Off; Same as Base Rate; 80-120 i steps of 10; Itrisic +0; Itrisic +10; Itrisic +20; Itrisic +30 Itervetio Duratio (mi) 1-10 i 1 miute itervals Recovery Time Fast; Medium; Slow; Very Slow Maximum Trackig Rate (mi -1 ) 90-130 i steps of 5; 140-180 i steps of 10 Mode AOO(R); AAI(R); AAT(R); VOO(R); VVI(R); VVT(R); VDD(R); DOO(R); DVI(R); DDI(R); DDD(R); Pacig Off Post Vetricular Atrial Blakig (ms) 60-200 i steps of 10; 225; 250 PVARP (ms) 125-500 i steps of 25 Sesed AV Delay (ms) 25; 30-200 i steps of 10; 225-325 i steps of 25 Rest Rate (mi -1 ) Off; 30-150 i steps of 5 Shortest AV Delay (ms) 25-50 i steps of 5; 60-120 i steps of 10 Vetricular Blakig (ms) Auto, 12-52 i steps of 4 Vetricular Pace/Sese Refractory 5 (Fixed) (ms) 125; 160-400 i steps of 30; 440; 470 2 Output/Sesig ACap Cofirm O; Off; Moitor Primary Pulse Cofiguratio Bipolar Backup Pulse Cofiguratio Bipolar Backup Pulse Amplitude (V) 5,0 3 Search Iterval (hours) 8; 24 A or V Pulse Amplitude (V) 0,25-4,0 i steps of 0,25; 4,5-7,5 i steps of 0,5 A or V Pulse Width (ms) 0,05; 0,1-1,5 i steps of 0,1 A or V Pulse Cofiguratio Uipolar (tip-case); Bipolar (tip-rig) A or V Sese Cofiguratio Uipolar Tip (tip-case); Bipolar (tip-rig); Uipolar Rig (rig-case) Atrial Sesitivity (mv) 0,1-0,4 6 i steps of 0,1; 0,5; 0,75-2,0 i steps of 0,25; 2,5-4,0 i steps of 0,5; 5,0 7 Vetricular AutoCapture Pacig System O; Off Primary Pulse Cofiguratio Uipolar; Bipolar Backup Pulse Cofiguratio Uipolar; Bipolar Backup Pulse Amplitude (V) 5,0 3 Search Iterval (hours) 8; 24 AutoCapture Paced/Sesed AV Delay (ms) 50/25; 100/70; 120/100 Vetricular Sesitivity (mv) 0,5-5,0 i steps of 0,5; 6-10 i steps of 1,0; 12,5 7 SeseAbility Techology Off; O (Automatic Sesitivity Cotrol adjustmet for atrial ad vetricular evets) A Max Sesitivity (mv) 0,2-1,0 i steps of 0,1 V Max Sesitivity (mv) 0,2-2,0 i steps of 0,1 Threshold Start (Atrial ad Vetricular Post-Sese) 50; 62,5; 75; 100% (Atrial Post-Pace) 0,2-3,0 i steps of 0,1 mv (Vetricular Post-Pace) Auto; 0,2-3,0 i steps of 0,1 mv Decay Delay (ms) (Atrial ad Vetricular Post-Sese) 0; 30; 60; 95; 125; 160; 190; 220 (Atrial Post-Pace) 0; 30; 60; 95; 125; 160; 190; 220 (Vetricular Post-Pace) Auto; 0; 30; 60; 95; 125; 160; 190; 220 Rate-Modulated Parameters Maximum Sesor Rate (mi -1 ) 80-150 i steps of 5; 160-180 i steps of 10 Rate Resposive AV Delay Off; Low; Medium; High Rate Resposive PVARP/VREF Off; Low; Medium; High Reactio Time Very Fast; Fast; Medium; Slow Recovery Time Fast; Medium; Slow; Very Slow Sesor O; Off; Passive Shortest PVARP/VREF (ms) 125-475 i steps of 25 Slope Auto (-1); Auto (+0); Auto (+1); Auto (+2); Auto (+3); 1-16 i steps of 1 Threshold Auto (-0,5); Auto (+0,0); Auto (+0,5); Auto (+1,0); Auto (+1,5); Auto (+2,0); 1-7 i steps of 0,5 AF Maagemet AF Suppressio Algorithm Off; O Lower Rate Overdrive (mi -1 ) 10 3 Upper Rate Overdrive (mi -1 ) 5 3 No. of Overdrive Pacig Cycles 15-40 i steps of 5 Rate Recovery (ms) 8; 12 3 Maximum AF Suppressio Rate (mi -1 ) 80-200 i steps of 10; 225-300 i steps of 25 Atrial Tachycardia Detectio Rate (mi -1 ) 110-200 i steps of 10; 225-300 i steps of 25 Auto Mode Switch Off; DDD(R) to DDI(R); DDD(R) to DDT(R); DDD(R) to VVI(R); DDD(R) to VVT(R); VDD(R) to VVI(R); VDD(R) to VVT(R) AMS Base Rate (mi -1 ) 40-170 i steps of 5 Stored Electrograms Optios Priority Optios Chael 1; 2; 3 Triggers Advaced Hysteresis AMS Etry/AMS Exit/ AMS Etry ad Exit AT/AF Detectio Maget Respose High Atrial Rate Rate (mi -1 ) 125-300 i steps of 25 No. of Cosecutive Cycles 2; 3; 4; 5; 10; 15; 20 High Vetricular Rate Rate (mi -1 ) 125-300 i steps of 25 No. of Cosecutive Cycles 2; 3; 4; 5; 10; 15; 20 PMT Termiatio Cosecutive PVCs No. of Cosecutive PVCs 2; 3; 4; 5 Noise Reversio Other A ad V Lead Moitorig Moitor; Auto Polarity Switch A ad V Low Impedace Limit (Ω) 100-500 i steps of 25 A ad V High Impedace Limit (Ω) 750-2500 i steps of 250; 3000 Lead Type Ucoded; Uipolar; Bipolar Maget Respose Off; Battery Test Negative AV Hysteresis Search (ms) Off; -10 to -120 i steps of 10 NIPS Optios Stimulatio Chamber Atrial; Vetricular Couplig Iterval (ms) 100-800 i steps of 10 8 S1 Cout 2-25 i steps of 1 S1 9 ; S2; S3 ad S4 Cycle (ms) Off; 100-800 i steps of 10 (Fixed or Adaptive) Vetricular Support Rate (mi -1 ) Off; 30-95 i steps of 5 Sius Node Recovery Delay (sec) 1; 2; 3; 4; 5 PMT Optios Off; Passive; Atrial Pace 2 PMT Detectio Rate (mi -1 ) 90-180 i steps of 5 PVC Respose Off; Atrial Pace 2 Vetricular Itrisic Preferece, VIP (ms) Off, 50-150 i steps of 25; 160-200 i steps of 10 VIP Search Iterval 30 sec.; 1; 3; 5; 10; 30 mi. VIP Search Cycles 1; 2; 3 Vetricular Safety Stadby Off; O Diagostic Treds AT/AF Activity; Exercise; Lead Impedace; P ad R Wave; A ad V Threshold Patiet Notifiers Programmable Notifiers (O; Off) Device at ERI; Atrial Lead Impedace Out of Rage; Vetricular Lead Impedace Out of Rage; AT/AF Burde; AT/AF Episode Duratio; High V Rate Durig AT/AF Device Reset O Etry ito Backup VVI Mode O Audible Duratio (sec) 2; 4; 6; 8; 10; 12; 14; 16 Number of Audible Alerts per Notificatio 2 Number of Notificatios 1-16 Time Betwee Notificatios (hours) 10; 22 1 ± 0,5 cc 2 Programmig optios depedet o pacig mode. 3 This parameter is ot programmable. 4 The highest available settig for hysteresis rate will be 5 mi -1 below the programmed base rate. 5 I dual-chamber modes, the maximum vetricular refractory period is 325 ms. 6 Values 0,1-0,4 ot available i a uipolar sese cofiguratio. 7 Sesitivity is with respect to a 20 ms haversie test sigal. 8 Durig atrial NIPS i dual-chamber modes, the shortest Couplig Iterval will be limited by the programmed AV/PV delay. 9 S1 Burst Cycle is applied at the preprogrammed S1 cycle legth. (GMCRM811EN) Brief Summary: Prior to usig these devices, please review the Istructios for Use for a complete listig of idicatios, cotraidicatios, warigs, precautios, potetial adverse evets ad directios for use. Devices depicted may ot be available i all coutries. Check with your St. Jude Medical represetative for product availability i your coutry. Uless otherwise oted, idicates that the ame is a trademark of, or licesed to, St. Jude Medical or oe of its subsidiaries. ST. JUDE MEDICAL, the ie-squares symbol ad MORE CONTROL. LESS RISK. are registered ad uregistered trademarks ad service marks of St. Jude Medical, Ic. ad its related compaies. 2011 St. Jude Medical, Ic. All rights reserved. Item GMCRM811EN
Pacemakers Accet SR RF Sigle-Chamber Pacemaker Product Highlights IvisiLik wireless telemetry, i cojuctio with the Merli@home trasmitter ad Merli.et Patiet Care Network (PCN), allows for daily remote moitorig ad follow-up A two-toe audible alert allows programmig to otify the patiet of chages i device performace, or iformatio ca be remotely trasmitted to the cliicia through the Merli.et PCN without patiet iteractio State-of-the-art features such as automaticity, Vetricular AutoCapture pacig system ad SeseAbility techology are desiged to deliver optimal therapy for patiets at implat ad throughout their lives Real-time electrogram (EGM) waveform, as well as the associated evet markers that precede ad follow a specific triggerig evet, ca be programmed to automatically record up to 14 miutes of stored EGMs whe ecouterig oe or more programmable trigger optios Weekly lead impedace tred displays the curret measuremet, historical test results, pacig polarity ad ay polarity switches Merli@home Trasmitter Compatible Orderig Iformatio Cotets: Cardiac pulse geerator Model Number Dimesios (H x W x T, mm) Weight (g) Volume (cc) Coector PM1210 52 x 52 x 6 23 12,8 (± 0,5) IS-1 Idicatios: Implatatio is idicated i oe or more of the followig permaet coditios: sycope, presycope, fatigue, disorietatio due to arrhythmia/bradycardia, or ay combiatio of those symptoms. Rate-Modulated Pacig is idicated for patiets with chrootropic icompetece, ad for those who would beefit from icreased stimulatio rates cocurret with physical activity. Atrial Pacig is idicated for patiets with sius ode dysfuctio ad ormal AV ad itravetricular coductio systems. Vetricular Pacig is idicated for patiets with sigificat bradycardia ad ormal sius rhythm with oly rare episodes of A-V block or sius arrest, chroic atrial fibrillatio, severe physical disability. Cotraidicatios: Sigle-chamber pulse geerators are cotraidicated i patiets with a implated cardioverter-defibrillator. Rate-Adaptive Pacig may be iappropriate for patiets who experiece agia or other symptoms of myocardial dysfuctio at higher sesor-drive rates. A appropriate Maximum Sesor Rate should be selected based o assessmet of the highest stimulatio rate tolerated by the patiet. Sigle-Chamber Vetricular Demad Pacig is relatively cotraidicated i patiets who have demostrated pacemaker sydrome, have retrograde VA coductio, or suffer a drop i arterial blood pressure with the oset of vetricular pacig. Sigle-Chamber Atrial Pacig is relatively cotraidicated i patiets who have demostrated compromise of AV coductio. For specific cotraidicatios associated with idividual modes, refer to the programmer s o-scree help. Potetial Adverse Evets: The followig are potetial complicatios associated with the use of ay pacig system: arrhythmia, heart block, thrombosis, threshold elevatio, valve damage, peumothorax, myopotetial sesig, vessel damage, air embolism, body rejectio pheomea, cardiac tampoade or perforatio, formatio of fibrotic tissue/local tissue reactio, iability to iterrogate or program a device because of programmer malfuctio, ifectio, iterruptio of desired device fuctio due to electrical iterferece, loss of desired pacig ad/or sesig due to lead displacemet, body reactio at electrode iterface, or lead malfuctio (fracture or damage to isulatio), loss of ormal device fuctio due to battery failure or compoet malfuctio, device migratio, pocket erosio, or hematoma, pectoral muscle stimulatio, phreic erve or diaphragmatic stimulatio. The followig, i additio to the above, are potetial complicatios associated with the use of rate-modulated pacig systems: iappropriate, rapid pacig rates due to sesor failure or to the detectio of sigals other tha patiet activity, loss of activity-respose due to sesor failure, palpitatios with high-rate pacig. Refer to the User s Maual for detailed idicatios, cotraidicatios, warigs, precautios ad potetial adverse evets. Brief Summary: Prior to usig these devices, please review the Istructios for Use for a complete listig of idicatios, cotraidicatios, warigs, precautios, potetial adverse evets ad directios for use. Devices depicted may ot be available i all coutries. Check with your St. Jude Medical represetative for product availability i your coutry. Uless otherwise oted, idicates that the ame is a trademark of, or licesed to, St. Jude Medical or oe of its subsidiaries. ST. JUDE MEDICAL, the ie-squares symbol ad MORE CONTROL. LESS RISK. are registered ad uregistered trademarks ad service marks of St. Jude Medical, Ic. ad its related compaies. 2011 St. Jude Medical, Ic. All rights reserved.
Pacemakers Accet SR RF Sigle-Chamber Pacemaker Product Specificatios PHYSICAL SPECIFICATIONS Model PM1210 Telemetry RF Dimesios (mm) 52 x 52 x 6 Weight (g) 23 Volume (cc) 12,8 1 Coector IS-1 PARAMETER SETTINGS Rate/Timig Vetricular Pace/Sese Refractory (Fixed) (ms) 125; 160-400 i steps of 30; 440; 470 2 Base Rate (mi -1 ) 30-130 i steps of 5; 140-170 i steps of 10 Mode VOO(R); VVI(R); VVT(R); Pacig Off Hysteresis Rate (mi -1 ) Off; 30 3-150 i steps of 5 Search Iterval (mi -1 ) Off; 1; 5; 10; 15; 30 Cycle Cout 1-16 by 1 Itervetio Rate (mi -1 ) Off; 80-120 i steps of 10; Itrisic +0; Itrisic +10; Itrisic +20; Itrisic +30; Same as Base Rate Itervetio Duratio (mi) 1-10 i 1 miute itervals Recovery Time Fast; Medium; Slow; Very Slow Rest Rate (mi -1 ) Off; 30-150 i steps of 5 Output/Sesig V Pulse Amplitude (V) 0,25-4,0 i steps of 0,25; 4,5-7,5 i steps of 0,5 V Pulse Width (ms) 0,05; 0,1-1,5 i steps of 0,1 V Sesitivity (mv) 0,5-5,0 i steps of 0,5; 6-10 i steps of 1,0; 12,5 4 V Pulse Cofiguratio Uipolar (tip-case); Bipolar (tip-rig) V Sese Cofiguratio Uipolar Tip (tip-case); Bipolar (tip-rig); Uipolar Rig (rig-case) Vetricular AutoCapture Pacig System O; Off Primary Pulse Cofiguratio Uipolar; Bipolar Backup Pulse Cofiguratio Uipolar; Bipolar Backup Pulse Amplitude (V) 5,0 5 Search Iterval (hours) 8; 24 SeseAbility Techology Off; O (Automatic Sesitivity Cotrol adjustmet for vetricular evets) Max Sesitivity (mv) 0,2-2,0 i steps of 0,1 Threshold Start (Vetricular Post-Sese) 50; 62,5; 75; 100% (Vetricular Post-Pace) Auto; 0,2-3,0 i steps of 0,1 mv Decay Delay (ms) (Vetricular Post-Sese) 0; 30; 60; 95; 125; 160; 190; 220 (Vetricular Post-Pace) Auto; 0; 30; 60; 95; 125; 160; 190; 220 Rate-Modulated Parameters Stored Electrograms Optios Priority Optios Chael 1; 2; 3 Triggers Maget Respose High Vetricular Rate Rate (mi -1 ) 125-300 i steps of 25 No. of Cosecutive Cycles 2; 3; 4; 5; 10; 15; 20 Advaced Hysteresis Noise Reversio Other Lead Moitorig Moitor; Auto Polarity Switch V Low Impedace Limit (Ω) 100-500 i steps of 225 V High Impedace Limit (Ω) 750-2500 i steps of 250; 3000 Maget Respose Off; Battery Test Lead Type Ucoded; Uipolar; Bipolar NIPS Optios Stimulatio Chamber Vetricular Couplig Iterval (ms) 100-800 i steps of 10 S1 Cout 2-25 i steps of 1 S1 6 ; S2; S3 ad S4 Cycle (ms) 100-800 i steps of 10 (Fixed or Adaptive) Diagostic Treds Exercise; Lead Impedace; R Wave; V Threshold Patiet Notifiers Programmable Notifiers (O; Off) Device at ERI; Vetricular Lead Impedace Out of Rage Device Reset O Etry ito Backup VVI Mode O Audible Duratio (sec) 2; 4; 6; 8; 10; 12; 14; 16 Number of Audible Alerts per Notificatio 2 Number of Notificatios 1-16 Time Betwee Notificatios (hours) 10; 22 1 ± 0,5 cc 2 Programmig optios depedet o pacig mode. 3 The highest available settig for hysteresis rate will be 5 mi -1 below the programmed base rate. 4 Sesitivity is with respect to a 20 ms haversie test sigal. 5 This parameter is ot programmable. 6 S1 Burst Cycle is applied at the preprogrammed S1 cycle legth. Maximum Sesor Rate (mi -1 ) 80-150 i steps of 5; 160-180 i steps of 10 Rate Resposive VREF Off; Low; Medium; High Shortest VREF 125-475 i steps of 25 Reactio Time Very Fast; Fast; Medium; Slow Recovery Time Fast; Medium; Slow; Very Slow Sesor O; Off; Passive Slope Auto (-1); Auto (+0); Auto (+1); Auto (+2); Auto (+3); 1-16 i steps of 1 Threshold Auto (-0,5); Auto (+0,0); Auto (+0,5); Auto (+1,0); Auto (+1,5); Auto (+2,0); 1-7 i steps of 0,5 (GMCRM812EN) Brief Summary: Prior to usig these devices, please review the Istructios for Use for a complete listig of idicatios, cotraidicatios, warigs, precautios, potetial adverse evets ad directios for use. Devices depicted may ot be available i all coutries. Check with your St. Jude Medical represetative for product availability i your coutry. Uless otherwise oted, idicates that the ame is a trademark of, or licesed to, St. Jude Medical or oe of its subsidiaries. ST. JUDE MEDICAL, the ie-squares symbol ad MORE CONTROL. LESS RISK. are registered ad uregistered trademarks ad service marks of St. Jude Medical, Ic. ad its related compaies. 2011 St. Jude Medical, Ic. All rights reserved. Item GMCRM812EN
Pacemakers Accet SR Sigle-Chamber Pacemaker Product Highlights Iductive remote follow-up utilisig a wad, i cojuctio with the Merli@home trasmitter ad Merli.et Patiet Care Network (PCN), allows patiets to dowload iformatio ad provide the cliic with access to device measuremets A two-toe audible alert allows programmig to otify the patiet of chages i device performace or arrhythmia status, which ca provide earlier isight ito actioable cliical evets State-of-the-art features such as automaticity, Vetricular AutoCapture pacig system ad SeseAbility techology are desiged to deliver optimal therapy for patiets at implat ad throughout their lives Real-time electrogram (EGM) waveform, as well as the associated evet markers that precede ad follow a specific triggerig evet, ca be programmed to automatically record up to 14 miutes of stored EGMs whe ecouterig oe or more programmable trigger optios Weekly lead impedace tred displays the curret measuremet, historical test results, pacig polarity ad ay polarity switches Orderig Iformatio Cotets: Cardiac pulse geerator Model Number Dimesios (H x W x T, mm) Weight (g) Volume (cc) Coector PM1110 42 x 52 x 6 18 9,5 (± 0,5) IS-1 Idicatios: Implatatio is idicated i oe or more of the followig permaet coditios: sycope, presycope, fatigue, disorietatio due to arrhythmia/bradycardia, or ay combiatio of those symptoms. Rate-Modulated Pacig is idicated for patiets with chrootropic icompetece, ad for those who would beefit from icreased stimulatio rates cocurret with physical activity. Atrial Pacig is idicated for patiets with sius ode dysfuctio ad ormal AV ad itravetricular coductio systems. Vetricular Pacig is idicated for patiets with sigificat bradycardia ad ormal sius rhythm with oly rare episodes of A-V block or sius arrest, chroic atrial fibrillatio, severe physical disability. Cotraidicatios: Sigle-chamber pulse geerators are cotraidicated i patiets with a implated cardioverter-defibrillator. Rate-Adaptive Pacig may be iappropriate for patiets who experiece agia or other symptoms of myocardial dysfuctio at higher sesor-drive rates. A appropriate Maximum Sesor Rate should be selected based o assessmet of the highest stimulatio rate tolerated by the patiet. Sigle-Chamber Vetricular Demad Pacig is relatively cotraidicated i patiets who have demostrated pacemaker sydrome, have retrograde VA coductio, or suffer a drop i arterial blood pressure with the oset of vetricular pacig. Sigle-Chamber Atrial Pacig is relatively cotraidicated i patiets who have demostrated compromise of AV coductio. For specific cotraidicatios associated with idividual modes, refer to the programmer s o-scree help. Potetial Adverse Evets: The followig are potetial complicatios associated with the use of ay pacig system: arrhythmia, heart block, thrombosis, threshold elevatio, valve damage, peumothorax, myopotetial sesig, vessel damage, air embolism, body rejectio pheomea, cardiac tampoade or perforatio, formatio of fibrotic tissue/local tissue reactio, iability to iterrogate or program a device because of programmer malfuctio, ifectio, iterruptio of desired device fuctio due to electrical iterferece, loss of desired pacig ad/or sesig due to lead displacemet, body reactio at electrode iterface, or lead malfuctio (fracture or damage to isulatio), loss of ormal device fuctio due to battery failure or compoet malfuctio, device migratio, pocket erosio, or hematoma, pectoral muscle stimulatio, phreic erve or diaphragmatic stimulatio. The followig, i additio to the above, are potetial complicatios associated with the use of rate-modulated pacig systems: iappropriate, rapid pacig rates due to sesor failure or to the detectio of sigals other tha patiet activity, loss of activity-respose due to sesor failure, palpitatios with high-rate pacig. Refer to the User s Maual for detailed idicatios, cotraidicatios, warigs, precautios ad potetial adverse evets. Brief Summary: Prior to usig these devices, please review the Istructios for Use for a complete listig of idicatios, cotraidicatios, warigs, precautios, potetial adverse evets ad directios for use. Devices depicted may ot be available i all coutries. Check with your St. Jude Medical represetative for product availability i your coutry. Uless otherwise oted, idicates that the ame is a trademark of, or licesed to, St. Jude Medical or oe of its subsidiaries. ST. JUDE MEDICAL, the ie-squares symbol ad MORE CONTROL. LESS RISK. are registered ad uregistered trademarks ad service marks of St. Jude Medical, Ic. ad its related compaies. 2011 St. Jude Medical, Ic. All rights reserved.
Pacemakers Accet SR Sigle-Chamber Pacemaker Product Specificatios PHYSICAL SPECIFICATIONS Model PM1110 Telemetry Iductive Dimesios (mm) 42 x 52 x 6 Weight (g) 18 Volume (cc) 9,5 1 Coector IS-1 PARAMETER SETTINGS Rate/Timig Vetricular Pace/Sese Refractory (Fixed) (ms) 125; 160-400 i steps of 30; 440; 470 2 Base Rate (mi -1 ) 30-130 i steps of 5; 140-170 i steps of 10 Mode VOO(R); VVI(R); VVT(R); Pacig Off Hysteresis Rate (mi -1 ) Off; 30 3-150 i steps of 5 Search Iterval (mi -1 ) Off; 1; 5; 10; 15; 30 Cycle Cout 1-16 by 1 Itervetio Rate (mi -1 ) Off; 80-120 i steps of 10; Itrisic +0; Itrisic +10; Itrisic +20; Itrisic +30; Same as Base Rate Itervetio Duratio (mi) 1-10 i 1 miute itervals Recovery Time Fast; Medium; Slow; Very Slow Rest Rate (mi -1 ) Off; 30-150; i steps of 5 Output/Sesig V Pulse Amplitude (V) 0,25-4,0 i steps of 0,25; 4,5-7,5 i steps of 0,5 V Pulse Width (ms) 0,05; 0,1-1,5 i steps of 0,1 V Sesitivity (mv) 0,5-5,0 i steps of 0,5; 6-10 i steps of 1,0; 12,5 4 V Pulse Cofiguratio Uipolar (tip-case); Bipolar (tip-rig) V Sese Cofiguratio Uipolar Tip (tip-case); Bipolar (tip-rig); Uipolar Rig (rig-case) Vetricular AutoCapture Pacig System O; Off Primary Pulse Cofiguratio Uipolar; Bipolar Backup Pulse Cofiguratio Uipolar; Bipolar Backup Pulse Amplitude (V) 5,0 5 Search Iterval (hours) 8; 24 SeseAbility Techology Off; O (Automatic Sesitivity Cotrol adjustmet for vetricular evets) Max Sesitivity (mv) 0,2-2,0 i steps of 0,1 Threshold Start (Vetricular Post-Sese) 50; 62,5; 75; 100% (Vetricular Post-Pace) Auto; 0,2-3,0 i steps of 0,1 mv Decay Delay (ms) (Vetricular Post-Sese) 0; 30; 60; 95; 125; 160; 190; 220 (Vetricular Post-Pace) Auto; 0; 30; 60; 95; 125; 160; 190; 220 Rate-Modulated Parameters Stored Electrograms Optios Priority Optios Chael 1; 2; 3 Triggers Maget Respose High Vetricular Rate Rate (mi -1 ) 125-300 i steps of 25 No. of Cosecutive Cycles 2; 3; 4; 5; 10; 15; 20 Advaced Hysteresis Noise Reversio Other Lead Moitorig Moitor; Auto Polarity Switch V Low Impedace Limit (Ω) 100-500 i steps of 25 V High Impedace Limit (Ω) 750-2500 i steps of 250; 3000 Maget Respose Off; Battery Test Lead Type Ucoded; Uipolar; Bipolar NIPS Optios Stimulatio Chamber Vetricular Couplig Iterval (ms) 100-800 i steps of 10 S1 Cout 2-25 i steps of 1 S1 6 ; S2; S3 ad S4 Cycle (ms) Off; 100-800 i steps of 10 (Fixed or Adaptive) Diagostic Treds Exercise; Lead Impedace; R Wave; V Threshold Patiet Notifiers Programmable Notifiers (O; Off) Device at ERI; Vetricular Lead Impedace Out of Rage Device Reset O Etry ito Backup VVI Mode O Audible Duratio (sec) 2; 4; 6; 8; 10; 12; 14; 16 Number of Audible Alerts per Notificatio 2 Number of Notificatios 1-16 Time Betwee Notificatios (hours) 10; 22 1 ± 0,5 cc 2 Programmig optios depedet o pacig mode. 3 The highest available settig for hysteresis rate will be 5 mi -1 below the programmed base rate. 4 Sesitivity is with respect to a 20 ms haversie test sigal. 5 This parameter is ot programmable. 6 S1 Burst Cycle is applied at the preprogrammed S1 cycle legth. Maximum Sesor Rate (mi -1 ) 80-150 i steps of 5; 160-180 i steps of 10 Rate Resposive VREF Off; Low; Medium; High Shortest VREF 125-475 i steps of 25 Reactio Time Very Fast; Fast; Medium; Slow Recovery Time Fast; Medium; Slow; Very Slow Sesor O; Off; Passive Slope Auto (-1); Auto (+0); Auto (+1); Auto (+2); Auto (+3); 1-16 i steps of 1 Threshold Auto (-0,5); Auto (+0,0); Auto (+0,5); Auto (+1,0); Auto (+1,5); Auto (+2,0); 1-7 i steps of 0,5 (GMCRM813EN) Brief Summary: Prior to usig these devices, please review the Istructios for Use for a complete listig of idicatios, cotraidicatios, warigs, precautios, potetial adverse evets ad directios for use. Devices depicted may ot be available i all coutries. Check with your St. Jude Medical represetative for product availability i your coutry. Uless otherwise oted, idicates that the ame is a trademark of, or licesed to, St. Jude Medical or oe of its subsidiaries. ST. JUDE MEDICAL, the ie-squares symbol ad MORE CONTROL. LESS RISK. are registered ad uregistered trademarks ad service marks of St. Jude Medical, Ic. ad its related compaies. 2011 St. Jude Medical, Ic. All rights reserved. Item GMCRM813EN
Pacemakers Zephyr XL DR Dual-Chamber Pacemaker Product Highlights Superior logevity whe compared volume-for-volume with ay other pacemaker o the market QuickOpt timig cycle optimisatio provides quick ad effective optimisatio for more patiets at the touch of a butto Powerful tools icludig automatic daily measuremets, follow-up EGM ad treds, optimised i-cliic testig ad lead impedace tred ad polarity switch save valuable cliic time The AutoCapture pacig system offers the maximum i threshold adaptability ad patiet safety with vetricular Beat-by-Beat capture cofirmatio ACap cofirm feature periodically completes a threshold search ad adjusts the pulse amplitude accordigly i the atrium Vetricular Itrisic Preferece (VIP ) algorithm automatically searches for itrisic coductio Stored electrograms (EGMs) record a real-time EGM waveform as well as the associated evet markers that precede ad follow a specific triggerig evet Multiple algorithms ad diagostics to assist physicias i therapy decisios icludig AF Suppressio algorithm, AT/AF diagostic suite ad Auto Mode Switch algorithm ad diagostic suite Orderig Iformatio Cotets: Cardiac pulse geerator Model Number Dimesios (H x W x T, mm) Weight (g) Volume (cc) Coector 5826 44 x 52 x 6 23,5 11 (± 0,5) IS-1 Idicatios ad Usage: Implatatio of Zephyr pulse geerators is idicated i the followig permaet coditios, whe associated with symptoms icludig, but ot limited to: sycope, presycope, fatigue, disorietatio or ay combiatio of those symptoms. Rate-Modulated Pacig is idicated for patiets with chrootropic icompetece, ad for those who would beefit from icreased stimulatio rates cocurret with physical activity. Dual-Chamber Pacig (Models 5826, 5820 oly) is idicated for those patiets exhibitig: sick sius sydrome, chroic, symptomatic secod- ad third-degree AV block, recurret Adams-Stokes sydrome, symptomatic bilateral budle brach block whe tachyarrhythmia ad other causes have bee ruled out. Atrial Pacig is idicated for patiets with sius ode dysfuctio ad ormal AV ad itravetricular coductio systems. Vetricular Pacig is idicated for patiets with sigificat bradycardia ad: Normal sius rhythm with oly rare episodes of A-V block or sius arrest, chroic atrial fibrillatio, severe physical disability. AF Suppressio (Models 5826, 5820 oly) is idicated for suppressio of paroxysmal or persistet atrial fibrillatio episodes i patiets with oe or more of the above pacig idicatios. For specific idicatios associated with idividual modes, refer to Operatig Modes. Cotraidicatios: Zephyr devices are cotraidicated i patiets with a implated cardioverter-defibrillator. Rate-Adaptive Pacig may be iappropriate for patiets who experiece agia or other symptoms of myocardial dysfuctio at higher sesor-drive rates. A appropriate Maximum Sesor Rate should be selected based o assessmet of the highest stimulatio rate tolerated by the patiet. AF Suppressio (Models 5826, 5820 oly) stimulatio is ot recommeded i patiets who caot tolerate high atrial-rate stimulatio. Dual-Chamber Pacig (Models 5826, 5820 oly) though ot cotraidicated for patiets with chroic atrial flutter, chroic atrial fibrillatio or silet atria, may provide o beefit beyod that of sigle-chamber pacig i such patiets. Sigle-Chamber Vetricular Demad Pacig is relatively cotraidicated i patiets who have demostrated pacemaker sydrome, have retrograde VA coductio or suffer a drop i arterial blood pressure with the oset of vetricular pacig. Sigle-Chamber Atrial Pacig is relatively cotraidicated i patiets who have demostrated compromise of AV coductio. For specific cotraidicatios associated with idividual modes, refer to Operatig Modes. Potetial Adverse Evets: Adverse evets associated with the use of ay pacig system iclude: Air embolism, Bleedig Hematoma, Body rejectio pheomea, Cardiac tampoade or perforatio, Formatio of fibrotic tissue, local tissue reactio, Iability to iterrogate or program due to programmer or device malfuctio, Ifectio/erosio, Iterruptio of desired pulse geerator fuctio due to electrical iterferece, either electromyogeic or electromagetic, Lead malfuctio due to coductor fracture or isulatio degradatio, Loss of capture or sesig due to lead dislodgemet or reactio at the electrode/tissue iterface, Loss of desired pacig ad/or sesig due to lead displacemet, body reactio at electrode iterface, or lead malfuctio (fracture or damage to isulatio), Loss of ormal device fuctio due to battery failure or compoet malfuctio, Pacemaker migratio, pocket erosio or hematoma, Pectoral muscle or diaphragmatic stimulatio, Phreic erve stimulatio, Peumothorax/hemothorax. Refer to the User s Maual for detailed idicatios, cotraidicatios, warigs, precautios ad potetial adverse evets. Brief Summary: Prior to usig these devices, please review the Istructios for Use for a complete listig of idicatios, cotraidicatios, warigs, precautios, potetial adverse evets ad directios for use. Devices depicted may ot be available i all coutries. Check with your St. Jude Medical represetative for product availability i your coutry. Uless otherwise oted, idicates that the ame is a trademark of, or licesed to, St. Jude Medical or oe of its subsidiaries. ST. JUDE MEDICAL, the ie-squares symbol ad MORE CONTROL. LESS RISK. are registered ad uregistered trademarks ad service marks of St. Jude Medical, Ic. ad its related compaies. 2011 St. Jude Medical, Ic. All rights reserved.
Pacemakers Zephyr XL DR Dual-Chamber Pacemaker Product Specificatios PHYSICAL SPECIFICATIONS Model 5826 Dimesios (mm) 44 x 52 x 6 Weight (g) 23,5 Volume (cc) 11 1 Coector IS-1 compatible PARAMETER Rate/Timig SETTINGS Atrial Absolute Refractory Period 60; 80; 100-350 i steps of 25 Atrial Protectio Iterval (ms) 125 2 Paced AV Delay (ms) 25; 30-200 i steps of 10; 225-300 i steps of 25; 350 Base Rate (mi -1 ) 30 3 ; 40-130 i steps of 5; 140-170 i steps of 10 Far-Field Protectio Iterval (ms) 16 2 Hysteresis Rate (mi -1 ) Off; 30 3-130 i steps of 5; 140; 150 4 Search Iterval (mi) Off; 5; 10; 15; 30 Cycle Cout 1-16 i steps of 1 Itervetio Rate (mi -1 ) Off; 60; 80-120 i steps of 10; Itrisic +0; Itrisic +10; Itrisic +20; Itrisic +30 Itervetio Duratio (mi) 1-10 i 1 miute itervals Recovery Time Fast; Medium; Slow; Very Slow Maximum Trackig Rate (mi -1 ) 90-130 i steps of 5; 140-180 i steps of 10 Mode AOO(R); AAI(R); AAT(R); OAO; VOO(R); VVI(R); VVT(R); VDD(R); OVO; DOO(R); DVI(R); DDI(R); DDD(R); ODO Post Vetricular Atrial Blakig (ms) 60; 70; 80; 85; 95; 100; 110; 115; 125; 130; 140; 155; 165; 170; 180; 185; 195; 200 PVARP (ms) 125-500 i steps of 25 Sesed AV Delay (ms) 25; 30-200 i steps of 10; 225-325 i steps of 25 Rest Rate (mi -1 ) Off; 30-130 i steps of 5; 140; 150 Shortest AV Delay (ms) 30-50 i steps of 5; 60-120 i steps of 10 Vetricular Blakig (ms) Auto; 12-52 i steps of 4; 12 Vetricular Refractory (ms) 125-500 i steps of 25 5 Output/Sesig ACap Cofirm O; Off; Moitor Primary Pulse Cofiguratio Bipolar 2 Backup Pulse Cofiguratio Bipolar Backup Pulse Amplitude (V) 5,0 2 Search Iterval (hours) 8; 24 A or V Pulse Amplitude (V) 0,0-4,0 i steps of 0,25; 4,5-7,5 i steps of 0,5 A or V Pulse Width (ms) 0,05; 0,1-1,5 i steps of 0,1 A or V Pulse Cofiguratio Uipolar (tip-case); Bipolar (tip-rig) A or V Sese Cofiguratio Uipolar Tip (tip-case); Bipolar (tip-rig); Uipolar Rig (rig-case) Atrial Sesitivity (mv) 0,1-0,4 6 ; 0.5 by 0,1, 0,75-2,0 i steps of 0,25; 2,0-4,0 i steps of 0,5; 5,0 7 Vetricular AutoCapture Pacig System O; Off Primary Pulse Cofiguratio Uipolar; Bipolar Backup Pulse Cofiguratio Uipolar; Bipolar Backup Pulse Amplitude (V) 5,0 2 Search Iterval (hours) 8; 24 AutoCapture Paced/Sesed AV Delay (ms) 50/25; 100/70; 120/100 Vetricular Sesitivity (mv) 0,5-5,0 i steps of 0,5; 6-10 i steps of 1,0; 12,5 7 Rate-Modulated Parameters Maximum Sesor Rate (mi -1 ) 80-150 i steps of 5, 160-180 i steps of 10 Rate Resposive AV Delay Off; Low; Medium; High Rate Resposive PVARP/VREF Off; Low; Medium; High Reactio Time Very Fast; Fast; Medium; Slow Recovery Time Fast; Medium; Slow; Very Slow Sesor O; Off; Passive Shortest PVARP/VREF 120-350 i steps of 10 Slope Auto (-1); Auto (+0); Auto (+1); Auto (+2); Auto (+3); 1-16 i steps of 1 Threshold Auto (-0,5); Auto (+0,0); Auto (+0,5); Auto (+1,0); Auto (+1,5); Auto (+2,0); 1-7 i steps of 0,5 AF Maagemet AF Suppressio Algorithm Off; O Lower Rate Overdrive (mi -1 ) 10 2 Upper Rate Overdrive (mi -1 ) 5 2 No. of Overdrive Pacig Cycles 15-40 i steps of 5 Rate Recovery (ms) 8; 12 2 Maximum AF Suppressio Rate (mi -1 ) 80-150 i steps of 5; 160-180 i steps of 10 Atrial Tachycardia Detectio Rate (mi -1 ) 110-150 i steps of 5; 160-200 i steps of 10; 225-300 i steps of 25 Auto Mode Switch Off; DDDR to DDIR; DDD to DDI; VDDR to VVIR; VDD to VVI; DDDR to DDI; DDD to DDIR; VDDR to VVI; VDD to VVIR; DDIR AMS Base Rate (mi -1 ) Base Rate +0 to Base Rate +35 i steps of 5 Stored Electrograms Optios Samplig Optios Freeze; Cotiuous No. of Stored EGMs 1; 2; 4; 8; 12 Chael Atrial; Vetricular; Dual; Cross-Chael Triggers Advaced Hysteresis O; Off AMS Etry/AMS Exit O; Off AT/AF Detectio O; Off Maget Placemet O; Off High Atrial Rate Off; 125; 150; 175; 200; 225; 250; 275; 300 No. of Cosecutive Cycles 2; 3; 4; 5; 10; 15; 20 High Vetricular Rate Off; 125; 150; 175; 200; 225; 250; 275; 300 No. of Cosecutive Cycles 2; 3; 4; 5; 10; 15; 20 PMT Termiatio O; Off PVC Detectio O; Off No. of Cosecutive PVCs 2; 3; 4; 5 Other A ad V Lead Moitorig Off; Moitor; Auto Polarity Switch A ad V Low Impedace Limit (Ω) 200 2 A ad V High Impedace Limit (Ω) 750; 1000; 1250; 1500; 1750; 2000 Lead Type Ucoded; Uipolar; Bipolar Oly; Uipolar/Bipolar Maget Respose Off; Battery Test Negative AV Hysteresis Search (ms) Off; -10 to -110 i steps of 10 NIPS Optios Stimulatio Chamber Atrial; Vetricular Couplig Iterval 100-800 i steps of 10 8 S1 Cout 1-25 i steps of 1 S1 9 ; S2; S3 ad S4 Cycle (ms) 100-800 i steps of 10 Vetricular Support Rate (mi -1 ) Off; 30; 40; 45; 50; 55; 60; 65; 70; 75; 80; 85; 90; 95 Sius Node Recovery Delay (sec) 1; 2; 3; 4; 5 PMT Optios Off; 10 Beats > PMT; Auto Detect PMT Detectio Rate (mi -1 ) 90-150 i steps of 5; 160-180 i steps of 10 PVC Optios Off; A Pace o PVC; +PVARP o PVC (VDD mode oly) Sigal Amplitude Moitorig P-Wave Moitorig Off; O R-Wave Moitorig Off; O Vetricular Itrisic Preferece, VIP (ms) Off; 50-150 i steps of 25; 160-200 i steps of 10 VIP Search Iterval 30 sec.; 1; 3; 5; 10; 30 mi. VIP Search Cycles 1; 2; 3 Vetricular Safety Stadby Off; O 1. ± 0,5 cc 2. This parameter is ot programmable. 3. The actual pacig rate for the 30 mi -1 is 31 mi -1. 4. The highest available settig for Hysteresis Rate will be 5 mi-1 below the programmed Base Rate. 5. I dual-chamber modes, the maximum Vetricular Refractory Period is 325 ms. 6. Values 0,1-0,4 ot available i a Uipolar Sese Cofiguratio. 7. Sesitivity is with respect to a 20 ms haversie test sigal. 8. Durig atrial NIPS i dual-chamber modes, the shortest Couplig Iterval will be limited by the programmed AV/PV delay. 9. S1 Burst Cycle is applied at the preprogrammed S1 cycle legth. (GMCRM814EN) Brief Summary: Prior to usig these devices, please review the Istructios for Use for a complete listig of idicatios, cotraidicatios, warigs, precautios, potetial adverse evets ad directios for use. Devices depicted may ot be available i all coutries. Check with your St. Jude Medical represetative for product availability i your coutry. Uless otherwise oted, idicates that the ame is a trademark of, or licesed to, St. Jude Medical or oe of its subsidiaries. ST. JUDE MEDICAL, the ie-squares symbol ad MORE CONTROL. LESS RISK. are registered ad uregistered trademarks ad service marks of St. Jude Medical, Ic. ad its related compaies. 2011 St. Jude Medical, Ic. All rights reserved. Item GMCRM814EN
Pacemakers Zephyr DR Dual-Chamber Rate-Resposive Pacemaker Product Highlights QuickOpt timig cycle optimisatio provides quick ad effective optimisatio for more patiets at the touch of a butto Powerful tools icludig automatic daily measuremets, follow-up EGM ad treds, optimised i-cliic testig ad lead impedace tred ad polarity switch save valuable cliic time The AutoCapture pacig system offers the maximum i threshold adaptability ad patiet safety with vetricular Beat-by-Beat capture cofirmatio ACap cofirm feature periodically completes a threshold search ad adjusts the pulse amplitude accordigly i the atrium Vetricular Itrisic Preferece (VIP ) algorithm automatically searches for itrisic coductio Stored electrograms (EGMs) record a real-time EGM waveform as well as the associated evet markers that precede ad follow a specific triggerig evet Multiple algorithms ad diagostics to assist physicias i therapy decisios icludig AF Suppressio algorithm, AT/AF diagostic suite ad Auto Mode Switch algorithm ad diagostic suite Orderig Iformatio Cotets: Cardiac pulse geerator Model Number Dimesios (H x W x T, mm) Weight (g) Volume (cc) Coector 5820 43 x 44 x 6 18 8,5 (± 0,5) IS-1 Idicatios ad Usage: Implatatio of Zephyr pulse geerators is idicated i the followig permaet coditios, whe associated with symptoms icludig, but ot limited to: sycope, presycope, fatigue, disorietatio or ay combiatio of those symptoms. Rate-Modulated Pacig is idicated for patiets with chrootropic icompetece, ad for those who would beefit from icreased stimulatio rates cocurret with physical activity. Dual-Chamber Pacig (Models 5826, 5820 oly) is idicated for those patiets exhibitig: sick sius sydrome, chroic, symptomatic secod- ad third-degree AV block, recurret Adams-Stokes sydrome, symptomatic bilateral budle brach block whe tachyarrhythmia ad other causes have bee ruled out. Atrial Pacig is idicated for patiets with sius ode dysfuctio ad ormal AV ad itravetricular coductio systems. Vetricular Pacig is idicated for patiets with sigificat bradycardia ad: Normal sius rhythm with oly rare episodes of A-V block or sius arrest, chroic atrial fibrillatio, severe physical disability. AF Suppressio (Models 5826, 5820 oly) is idicated for suppressio of paroxysmal or persistet atrial fibrillatio episodes i patiets with oe or more of the above pacig idicatios. For specific idicatios associated with idividual modes, refer to Operatig Modes. Cotraidicatios: Zephyr devices are cotraidicated i patiets with a implated cardioverterdefibrillator. Rate-Adaptive Pacig may be iappropriate for patiets who experiece agia or other symptoms of myocardial dysfuctio at higher sesor-drive rates. A appropriate Maximum Sesor Rate should be selected based o assessmet of the highest stimulatio rate tolerated by the patiet. AF Suppressio (Models 5826, 5820 oly) stimulatio is ot recommeded i patiets who caot tolerate high atrial-rate stimulatio. Dual-Chamber Pacig (Models 5826, 5820 oly) though ot cotraidicated for patiets with chroic atrial flutter, chroic atrial fibrillatio or silet atria, may provide o beefit beyod that of sigle-chamber pacig i such patiets. Sigle-Chamber Vetricular Demad Pacig is relatively cotraidicated i patiets who have demostrated pacemaker sydrome, have retrograde VA coductio or suffer a drop i arterial blood pressure with the oset of vetricular pacig. Sigle-Chamber Atrial Pacig is relatively cotraidicated i patiets who have demostrated compromise of AV coductio. For specific cotraidicatios associated with idividual modes, refer to Operatig Modes. Potetial Adverse Evets: Adverse evets associated with the use of ay pacig system iclude: Air embolism, Bleedig Hematoma, Body rejectio pheomea, Cardiac tampoade or perforatio, Formatio of fibrotic tissue, local tissue reactio, Iability to iterrogate or program due to programmer or device malfuctio, Ifectio/erosio, Iterruptio of desired pulse geerator fuctio due to electrical iterferece, either electromyogeic or electromagetic, Lead malfuctio due to coductor fracture or isulatio degradatio, Loss of capture or sesig due to lead dislodgemet or reactio at the electrode/tissue iterface, Loss of desired pacig ad/or sesig due to lead displacemet, body reactio at electrode iterface, or lead malfuctio (fracture or damage to isulatio), Loss of ormal device fuctio due to battery failure or compoet malfuctio, Pacemaker migratio, pocket erosio or hematoma, Pectoral muscle or diaphragmatic stimulatio, Phreic erve stimulatio, Peumothorax/hemothorax. Refer to the User s Maual for detailed idicatios, cotraidicatios, warigs, precautios ad potetial adverse evets. Brief Summary: Prior to usig these devices, please review the Istructios for Use for a complete listig of idicatios, cotraidicatios, warigs, precautios, potetial adverse evets ad directios for use. Devices depicted may ot be available i all coutries. Check with your St. Jude Medical represetative for product availability i your coutry. Uless otherwise oted, idicates that the ame is a trademark of, or licesed to, St. Jude Medical or oe of its subsidiaries. ST. JUDE MEDICAL, the ie-squares symbol ad MORE CONTROL. LESS RISK. are registered ad uregistered trademarks ad service marks of St. Jude Medical, Ic. ad its related compaies. 2011 St. Jude Medical, Ic. All rights reserved.
Pacemakers Zephyr DR Dual-Chamber Rate-Resposive Pacemaker Product Specificatios PHYSICAL SPECIFICATIONS Model 5820 Dimesios (mm) 43 x 44 x 6 Weight (g) 18 Volume (cc) 8,5 1 Coector IS-1 PARAMETER Rate/Timig SETTINGS Atrial Absolute Refractory Period 60; 80; 100-350 i steps of 25 Atrial Protectio Iterval (ms) 125 2 Paced AV Delay (ms) 25; 30-200 i steps of 10; 225-300 i steps of 25 Base Rate (mi -1 ) 30 3 ; 40-130 i steps of 5; 140-170 i steps of 10 Far-Field Protectio Iterval (ms) 16 2 Hysteresis Rate (mi -1 ) Off; 30 3-130 i steps of 5; 140; 150 4 Search Iterval (mi) Off; 5; 10; 15; 30 Cycle Cout 1-16 i steps of 1 Itervetio Rate (mi -1 ) Off; 60; 80-120 i steps of 10; Itrisic +0; Itrisic +10; Itrisic +20; Itrisic +30 Itervetio Duratio (mi) 1-10 i 1 miute itervals Recovery Time Fast; Medium; Slow; Very Slow Maximum Trackig Rate (mi -1 ) 90-130 i steps of 5; 140-180 i steps of 10 Mode AOO(R); AAI(R); AAT(R); OAO; VOO(R); VVI(R); VVT(R); VDD(R); OVO; DOO(R); DVI(R); DDI(R); DDD(R); ODO PVARP (ms) 125-500 i steps of 25 Post Vetricular Atrial Blakig (ms) 60; 70; 80; 85; 95; 100; 110; 115; 125; 130; 140; 150; 165; 170; 180; 185; 195; 200 Sesed AV Delay (ms) 25; 30-200 i steps of 10; 225-325 i steps of 25 Rest Rate (mi -1 ) Off; 30-130 i steps of 5; 140; 150 Shortest AV Delay (ms) 30-50 i steps of 5; 60-120 i steps of 10 Vetricular Blakig (ms) Auto, 12-52 i steps of 4 Vetricular Refractory (ms) 125-500 i steps of 25 5 Output/Sesig ACap Cofirm O; Off; Moitor Primary Pulse Cofiguratio Bipolar 2 Backup Pulse Cofiguratio Bipolar Backup Pulse Amplitude (V) 5;0 2 Search Iterval (hours) 8; 24 A or V Pulse Amplitude (V) 0,0-4,0 i steps of 0,25; 4,5-7,5 i steps of 0,5 A or V Pulse Width (ms) 0,05; 0,1-1,5 i steps of 0,1 A or V Pulse Cofiguratio Uipolar (tip-case), Bipolar (tip-rig) A or V Sese Cofiguratio Uipolar Tip (tip-case), Bipolar (tip-rig), Uipolar Rig (rig-case) Atrial Sesitivity (mv) 0,1-0,4 6 ; 0,5 by 0,1; 0,75-2,0 i steps of 0,25; 2,0-4,0 i steps of 0,5; 5,0 7 Vetricular AutoCapture Pacig System O; Off Primary Pulse Cofiguratio Uipolar; Bipolar Backup Pulse Cofiguratio Uipolar; Bipolar Backup Pulse Amplitude (V) 5,0 2 Search Iterval (hours) 8; 24 AutoCapture Paced/Sesed AV Delay (ms) 50/25; 100/70; 120/100 Vetricular Sesitivity (mv) 0,5-5,0 i steps of 0,5; 6-10 i steps of 1,0; 12,5 5 ; 2,0 Rate-Modulated Parameters Maximum Sesor Rate (mi -1 ) 80-150 i steps of 5; 160-180 i steps of 10 Rate Resposive AV Delay Off; Low; Medium; High Rate Resposive PVARP/VREF Off; Low; Medium; High Reactio Time Very Fast; Fast; Medium; Slow Recovery Time Fast; Medium; Slow; Very Slow Sesor O; Off; Passive Shortest PVARP/VREF 120-350 i steps of 10 Slope Auto (-1); Auto (+0); Auto (+1); Auto (+2); Auto (+3); 1-16 i steps of 1 Threshold Auto (-0,5); Auto (+0,0); Auto (+0,5); Auto (+1,0); Auto (+1,5); Auto (+2,0); 1-7 i steps of 0,5 AF Maagemet AF Suppressio Algorithm Off, O Lower Rate Overdrive (mi -1 ) 10 2 Upper Rate Overdrive (mi -1 ) 5 2 No. of Overdrive Pacig Cycles 15-40 i steps of 5 Rate Recovery (ms) 8; 12 2 Maximum AF Suppressio Rate (mi -1 ) 80-150 i steps of 5; 160-180 i steps of 10 Atrial Tachycardia Detectio Rate (mi -1 ) 110-150 i steps of 5; 160-200 i steps of 10; 225-300 i steps of 25 Auto Mode Switch Off; DDDR to DDIR; DDD to DDI; VDDR to VVIR; VDD to VVI; DDDR to DDI; DDD to DDIR; VDDR to VVI; VDD to VVIR; DDIR AMS Base Rate (mi -1 ) Base Rate +0 to Base Rate +35 i steps of 5 Stored Electrograms Optios Samplig Optios Freeze, Cotiuous No. of Stored EGMs 1; 2; 4; 8; 12 Chael Atrial; Vetricular; Dual; Cross-Chael Triggers Advaced Hysteresis O; Off AMS Etry/AMS Exit O; Off AT/AF Detectio O; Off Maget Placemet O; Off High Atrial Rate Off; 125; 150; 175; 200; 225; 250; 275; 300 No. of Cosecutive Cycles 2; 3; 4; 5; 10; 15; 20 High Vetricular Rate Off; 125; 150; 175; 200; 225; 250; 275; 300 No. of Cosecutive Cycles 2; 3; 4; 5; 10; 15; 20 PMT Termiatio O; Off PVC Detectio O; Off No. of Cosecutive PVCs 2; 3; 4; 5 Other A ad V Lead Moitorig Off; Moitor; Auto Polarity Switch A ad V Low Impedace Limit (Ω) 200 2 A ad V High Impedace Limit (Ω) 750; 1000; 1250; 1500; 1750; 2000 Lead Type Ucoded; Uipolar; Bipolar Oly; Uipolar/Bipolar Maget Respose Off; Battery Test Negative AV Hysteresis Search (ms) Off; -10 to -110 i steps of 10 NIPS Optios Stimulatio Chamber Atrial; Vetricular Couplig Iterval (ms) 100-800 i steps of 10 8 S1 Cout 1-25 i steps of 1 S1 9, S2, S3 ad S4 Cycle (ms) 100-800 i steps of 10 Vetricular Support Rate (mi -1 ) Off; 30; 40; 45; 50; 55; 60; 65; 70; 75; 80; 85; 90; 95 Sius Node Recovery Delay (sec) 1; 2; 3; 4; 5 PMT Optios Off; 10 Beats > PMT, Auto Detect PMT Detectio Rate (mi -1 ) 90-150 i steps of 5; 160-180 i steps of 10 PVC Optios Off; A Pace o PVC; +PVARP o PVC (VDD mode oly) Sigal Amplitude Moitorig P-Wave Moitorig Off; O R-Wave Moitorig Off; O Vetricular Itrisic Preferece, VIP (ms) Off; 50-150 i steps of 25; 160-200 i steps of 10 VIP Search Iterval 30 sec.; 1; 3; 5; 10; 30 mi. VIP Search Cycles 1; 2; 3 Vetricular Safety Stadby Off; O 1. ± 0,5 cc 2. This parameter is ot programmable. 3. The actual pacig rate for the 30 mi -1 is 31 mi -1. 4. The highest available settig for Hysteresis Rate will be 5 mi-1 below the programmed Base Rate. 5. I dual-chamber modes, the maximum Vetricular Refractory Period is 325 ms. 6. Values 0,1-0,4 ot available i a Uipolar Sese Cofiguratio. 7. Sesitivity is with respect to a 20 ms haversie test sigal. 8. Durig atrial NIPS i dual-chamber modes, the shortest Couplig Iterval will be limited by the programmed AV/PV delay. 9. S1 Burst Cycle is applied at the preprogrammed S1 cycle legth. (GMCRM816EN) Brief Summary: Prior to usig these devices, please review the Istructios for Use for a complete listig of idicatios, cotraidicatios, warigs, precautios, potetial adverse evets ad directios for use. Devices depicted may ot be available i all coutries. Check with your St. Jude Medical represetative for product availability i your coutry. Uless otherwise oted, idicates that the ame is a trademark of, or licesed to, St. Jude Medical or oe of its subsidiaries. ST. JUDE MEDICAL, the ie-squares symbol ad MORE CONTROL. LESS RISK. are registered ad uregistered trademarks ad service marks of St. Jude Medical, Ic. ad its related compaies. 2011 St. Jude Medical, Ic. All rights reserved. Item GMCRM816EN
Pacemakers Zephyr XL SR Sigle-Chamber Rate-Resposive Pacemaker Product Highlights Superior logevity whe compared volume-for-volume with ay other pacemaker o the market Istat follow-up with automatic P- or R-wave, lead impedace measuremets ad threshold tests, resultig i 100% of follow-up completed before the patiet arrives at the cliic The AutoCapture pacig system offers the maximum i threshold adaptability ad patiet safety with vetricular Beat-by-Beat capture cofirmatio ACap cofirm feature periodically completes a threshold search ad adjusts the pulse amplitude accordigly i the atrium Stored electrograms (EGMs) record a real-time EGM waveform as well as the associated evet markers that precede ad follow a specific triggerig evet Automatic daily measuremet ad weekly tredig of itrisic P- or R-waves Automatic lead impedace measuremet. Display of weekly lead impedace tred, historical test results, pacig polarity ad ay polarity switches Physiologic-based rest rate ot subject to chages i time zoe, daylight savigs time or the patiet s schedule Advaced hysteresis maximises opportuities for the patiet s ow rhythm to prevail ad addresses abrupt rate drops Orderig Iformatio Cotets: Cardiac pulse geerator Model Number Dimesios (H x W x T, mm) Weight (g) Volume (cc) Coector 5626 42 x 52 x 6 23,5 10,4 (± 0,5) IS-1 Idicatios ad Usage: Implatatio of Zephyr pulse geerators is idicated i the followig permaet coditios, whe associated with symptoms icludig, but ot limited to: sycope, presycope, fatigue, disorietatio or ay combiatio of those symptoms. Rate-Modulated Pacig is idicated for patiets with chrootropic icompetece, ad for those who would beefit from icreased stimulatio rates cocurret with physical activity. Dual-Chamber Pacig (Models 5826, 5820 oly) is idicated for those patiets exhibitig: sick sius sydrome, chroic, symptomatic secod- ad third-degree AV block, recurret Adams-Stokes sydrome, symptomatic bilateral budle brach block whe tachyarrhythmia ad other causes have bee ruled out. Atrial Pacig is idicated for patiets with sius ode dysfuctio ad ormal AV ad itravetricular coductio systems. Vetricular Pacig is idicated for patiets with sigificat bradycardia ad: Normal sius rhythm with oly rare episodes of A-V block or sius arrest, chroic atrial fibrillatio, severe physical disability. AF Suppressio (Models 5826, 5820 oly) is idicated for suppressio of paroxysmal or persistet atrial fibrillatio episodes i patiets with oe or more of the above pacig idicatios. For specific idicatios associated with idividual modes, refer to Operatig Modes. Cotraidicatios: Zephyr devices are cotraidicated i patiets with a implated cardioverterdefibrillator. Rate-Adaptive Pacig may be iappropriate for patiets who experiece agia or other symptoms of myocardial dysfuctio at higher sesor-drive rates. A appropriate Maximum Sesor Rate should be selected based o assessmet of the highest stimulatio rate tolerated by the patiet. AF Suppressio (Models 5826, 5820 oly) stimulatio is ot recommeded i patiets who caot tolerate high atrial-rate stimulatio. Dual-Chamber Pacig (Models 5826, 5820 oly) though ot cotraidicated for patiets with chroic atrial flutter, chroic atrial fibrillatio or silet atria, may provide o beefit beyod that of sigle-chamber pacig i such patiets. Sigle-Chamber Vetricular Demad Pacig is relatively cotraidicated i patiets who have demostrated pacemaker sydrome, have retrograde VA coductio or suffer a drop i arterial blood pressure with the oset of vetricular pacig. Sigle-Chamber Atrial Pacig is relatively cotraidicated i patiets who have demostrated compromise of AV coductio. For specific cotraidicatios associated with idividual modes, refer to Operatig Modes. Potetial Adverse Evets: Adverse evets associated with the use of ay pacig system iclude: Air embolism, Bleedig Hematoma, Body rejectio pheomea, Cardiac tampoade or perforatio, Formatio of fibrotic tissue, local tissue reactio, Iability to iterrogate or program due to programmer or device malfuctio, Ifectio/erosio, Iterruptio of desired pulse geerator fuctio due to electrical iterferece, either electromyogeic or electromagetic, Lead malfuctio due to coductor fracture or isulatio degradatio, Loss of capture or sesig due to lead dislodgemet or reactio at the electrode/tissue iterface, Loss of desired pacig ad/or sesig due to lead displacemet, body reactio at electrode iterface, or lead malfuctio (fracture or damage to isulatio), Loss of ormal device fuctio due to battery failure or compoet malfuctio, Pacemaker migratio, pocket erosio or hematoma, Pectoral muscle or diaphragmatic stimulatio, Phreic erve stimulatio, Peumothorax/hemothorax. Refer to the User s Maual for detailed idicatios, cotraidicatios, warigs, precautios ad potetial adverse evets. Brief Summary: Prior to usig these devices, please review the Istructios for Use for a complete listig of idicatios, cotraidicatios, warigs, precautios, potetial adverse evets ad directios for use. Devices depicted may ot be available i all coutries. Check with your St. Jude Medical represetative for product availability i your coutry. Uless otherwise oted, idicates that the ame is a trademark of, or licesed to, St. Jude Medical or oe of its subsidiaries. ST. JUDE MEDICAL, the ie-squares symbol ad MORE CONTROL. LESS RISK. are registered ad uregistered trademarks ad service marks of St. Jude Medical, Ic. ad its related compaies. 2011 St. Jude Medical, Ic. All rights reserved.
Pacemakers Zephyr XL SR Sigle-Chamber Rate-Resposive Pacemaker Product Specificatios PHYSICAL SPECIFICATIONS Model 5626 Dimesios (mm) 42 x 52 x 6 Weight (g) 23,5 Volume (cc) 10,4 Coector IS-1 PARAMETER Rate/Timig SETTINGS A or V Refractory (ms) 125-500 i steps of 25 Base Rate (bpm) 30 2 ; 40-130 i steps of 5; 140-170 i steps of 10 Mode A00(R); AAI(R); AAT(R); OAO; VOO(R); VVI(R); VVT(R) Hysteresis Rate (bpm) Off; 30-130 i steps of 5; 140; 150 3 Search Iterval (bpm) Off; 5; 10; 15; 30 Cycle Cout 1-16 by 1 Itervetio Rate (bpm) Off; 60; 80-120 i steps of 10; Itrisic +0; Itrisic +10; Itrisic +20; Itrisic +30 Itervetio Duratio (mi) 1-10 i 1 miute itervals Recovery Time Fast; Medium; Slow; Very Slow Rest Rate (bpm) Off; 30-130 i steps of 5; 140; 150 Other Lead Moitorig Off; Moitor; Auto Polarity Switch A or V Low Impedace Limit (Ω) 200 5 A or V High Impedace Limit (Ω) 750; 1000; 1250; 1500; 1750; 2000 A or V Sigal Amplitude Moitorig Off; O Maget Respose Off; Battery Test Lead Type Ucoded; Uipolar; Bipolar Oly; Uipolar/Bipolar NIPS Optios Stimulatio Chamber Atrial or Vetricular Couplig Iterval (ms) 100-800 i steps of 10 S1 Cout 1-25 i steps of 1 S1 6 ; S2; S3 ad S4 Cycle (ms) 100-800 i steps of 10 Sius Node Recovery Delay (sec) 1-5 i steps of 1 1. ± 0,5 cc 2. The actual pacig rate for the 30 ppm is 31 ppm. 3. The highest available settig for Hysteresis Rate will be 5 ppm below the programmed Base Rate. 4. Sesitivity is with respect to a 20 ms haversie test sigal. 5. This parameter is ot programmable. 6. S1 Burst Cycle is applied at the preprogrammed S1 cycle legth. Output/Sesig A or V Pulse Amplitude (V) 0,0-4,0 i steps of 0,25; 4,5-7,5 i steps of 0,5 A or V Pulse Width (ms) 0,05; 0,1-1,5 i steps of 0,1 A or V Sesitivity (mv) 0,5-5,0 i steps of 0,5; 6-10 i steps of 1,0; 12,5 4 A or V Pulse Cofiguratio Uipolar (tip-case); Bipolar (tip-rig) A or V Sese Cofiguratio Uipolar Tip (tip-case); Bipolar (tip-rig); Uipolar Rig (rig-case) Vetricular AutoCapture Pacig System O; Off Primary Pulse Cofiguratio Uipolar; Bipolar Backup Pulse Cofiguratio Uipolar; Bipolar Backup Pulse Amplitude (V) 5,0 5 Search Iterval (hours) 8; 24 Rate-Modulated Maximum Sesor Rate (bpm) 80-150 i steps of 5; 160-180 i steps of 10 Rate Resposive VREF Off; Low; Medium; High Shortest VREF 120-350 i steps of 10 Reactio Time Very Fast; Fast; Medium; Slow Recovery Time Fast; Medium; Slow; Very Slow Sesor O; Off; Passive Slope Auto (-1); Auto (+0); Auto (+1); Auto (+2); Auto (+3); 1-16 i steps of 1 Threshold Auto (-0.5); Auto (+0.0); Auto (+0.5); Auto (+1.0); Auto (+1.5); Auto (+2.0); 1-7 i steps of 0,5 Stored Electrograms Optios Samplig Optios Freeze; Cotiuous No. of Stored EGMs 1; 2; 4; 8; 12 Chael Atrial or Vetricular Triggers Maget Placemet O; Off High Atrial Rate (bpm) Off; 125; 150; 175; 200; 225; 250; 275; 300 No. of Cosecutive Cycles 2; 3; 4; 5; 10; 15; 20 High Vetricular Rate (bpm) Off; 125; 150; 175; 200; 225; 250; 275; 300 No. of Cosecutive Cycles 2; 3; 4; 5; 10; 15; 20 Advaced Hysteresis O; Off (GMCRM815EN) Brief Summary: Prior to usig these devices, please review the Istructios for Use for a complete listig of idicatios, cotraidicatios, warigs, precautios, potetial adverse evets ad directios for use. Devices depicted may ot be available i all coutries. Check with your St. Jude Medical represetative for product availability i your coutry. Uless otherwise oted, idicates that the ame is a trademark of, or licesed to, St. Jude Medical or oe of its subsidiaries. ST. JUDE MEDICAL, the ie-squares symbol ad MORE CONTROL. LESS RISK. are registered ad uregistered trademarks ad service marks of St. Jude Medical, Ic. ad its related compaies. 2011 St. Jude Medical, Ic. All rights reserved. Item GMCRM815EN
Pacemakers Zephyr SR Sigle-Chamber Rate-Resposive Pacemaker Product Highlights Small, physiologic-shaped device maximises logevity without compromisig size Istat follow-up with automatic P- or R-wave, lead impedace measuremets ad threshold tests, resultig i 100% of follow-up completed before the patiet arrives at the cliic The AutoCapture pacig system offers the maximum i threshold adaptability ad patiet safety with vetricular Beat-by-Beat capture cofirmatio ACap cofirm feature periodically completes a threshold search ad adjusts the pulse amplitude accordigly i the atrium Stored electrograms (EGMs) record a real-time EGM waveform as well as the associated evet markers that precede ad follow a specific triggerig evet Automatic daily measuremet ad weekly tredig of itrisic P- or R-waves Automatic lead impedace measuremet. Display of weekly lead impedace tred, historical test results, pacig polarity ad ay polarity switches Physiologic-based rest rate ot subject to chages i time zoe, daylight savigs time or the patiet s schedule Advaced hysteresis maximises opportuities for the patiet s ow rhythm to prevail ad addresses abrupt rate drops Orderig Iformatio Cotets: Cardiac pulse geerator Model Number Dimesios (H x W x T, mm) Weight (g) Volume (cc) Coector 5620 41 x 44 x 6 17 8 (± 0,5) IS-1 Idicatios ad Usage: Implatatio of Zephyr pulse geerators is idicated i the followig permaet coditios, whe associated with symptoms icludig, but ot limited to: sycope, presycope, fatigue, disorietatio or ay combiatio of those symptoms. Rate-Modulated Pacig is idicated for patiets with chrootropic icompetece, ad for those who would beefit from icreased stimulatio rates cocurret with physical activity. Dual-Chamber Pacig (Models 5826, 5820 oly) is idicated for those patiets exhibitig: sick sius sydrome, chroic, symptomatic secod- ad third-degree AV block, recurret Adams-Stokes sydrome, symptomatic bilateral budle brach block whe tachyarrhythmia ad other causes have bee ruled out. Atrial Pacig is idicated for patiets with sius ode dysfuctio ad ormal AV ad itravetricular coductio systems. Vetricular Pacig is idicated for patiets with sigificat bradycardia ad: Normal sius rhythm with oly rare episodes of A-V block or sius arrest, chroic atrial fibrillatio, severe physical disability. AF Suppressio (Models 5826, 5820 oly) is idicated for suppressio of paroxysmal or persistet atrial fibrillatio episodes i patiets with oe or more of the above pacig idicatios. For specific idicatios associated with idividual modes, refer to Operatig Modes. Cotraidicatios: Zephyr devices are cotraidicated i patiets with a implated cardioverterdefibrillator. Rate-Adaptive Pacig may be iappropriate for patiets who experiece agia or other symptoms of myocardial dysfuctio at higher sesor-drive rates. A appropriate Maximum Sesor Rate should be selected based o assessmet of the highest stimulatio rate tolerated by the patiet. AF Suppressio (Models 5826, 5820 oly) stimulatio is ot recommeded i patiets who caot tolerate high atrial-rate stimulatio. Dual-Chamber Pacig (Models 5826, 5820 oly) though ot cotraidicated for patiets with chroic atrial flutter, chroic atrial fibrillatio or silet atria, may provide o beefit beyod that of sigle-chamber pacig i such patiets. Sigle-Chamber Vetricular Demad Pacig is relatively cotraidicated i patiets who have demostrated pacemaker sydrome, have retrograde VA coductio or suffer a drop i arterial blood pressure with the oset of vetricular pacig. Sigle-Chamber Atrial Pacig is relatively cotraidicated i patiets who have demostrated compromise of AV coductio. For specific cotraidicatios associated with idividual modes, refer to Operatig Modes. Potetial Adverse Evets: Adverse evets associated with the use of ay pacig system iclude: Air embolism, Bleedig Hematoma, Body rejectio pheomea, Cardiac tampoade or perforatio, Formatio of fibrotic tissue, local tissue reactio, Iability to iterrogate or program due to programmer or device malfuctio, Ifectio/erosio, Iterruptio of desired pulse geerator fuctio due to electrical iterferece, either electromyogeic or electromagetic, Lead malfuctio due to coductor fracture or isulatio degradatio, Loss of capture or sesig due to lead dislodgemet or reactio at the electrode/tissue iterface, Loss of desired pacig ad/or sesig due to lead displacemet, body reactio at electrode iterface, or lead malfuctio (fracture or damage to isulatio), Loss of ormal device fuctio due to battery failure or compoet malfuctio, Pacemaker migratio, pocket erosio or hematoma, Pectoral muscle or diaphragmatic stimulatio, Phreic erve stimulatio, Peumothorax/hemothorax. Refer to the User s Maual for detailed idicatios, cotraidicatios, warigs, precautios ad potetial adverse evets. Brief Summary: Prior to usig these devices, please review the Istructios for Use for a complete listig of idicatios, cotraidicatios, warigs, precautios, potetial adverse evets ad directios for use. Devices depicted may ot be available i all coutries. Check with your St. Jude Medical represetative for product availability i your coutry. Uless otherwise oted, idicates that the ame is a trademark of, or licesed to, St. Jude Medical or oe of its subsidiaries. ST. JUDE MEDICAL, the ie-squares symbol ad MORE CONTROL. LESS RISK. are registered ad uregistered trademarks ad service marks of St. Jude Medical, Ic. ad its related compaies. 2011 St. Jude Medical, Ic. All rights reserved.
Pacemakers Zephyr SR Sigle-Chamber Rate-Resposive Pacemaker Product Specificatios PHYSICAL SPECIFICATIONS Model 5620 Dimesios (mm) 41 x 44 x 6 Weight (g) 17 Volume (cc) 8 1 Coector IS-1 PARAMETER Rate/Timig SETTINGS A or V Refractory (ms) 125-500 i steps of 25 Base Rate (bpm) 30 2 ; 40-130 i steps of 5; 140-170 i steps of 10 Mode A00(R); AAI(R); AAT(R); OAO; VOO(R); VVI(R); VVT(R) Hysteresis Rate (bpm) Off; 30-130 i steps of 5; 140; 150 3 Search Iterval (bpm) Off; 5; 10; 15; 30 Cycle Cout 1-16 by 1 Itervetio Rate (bpm) Off; 60; 80-120 i steps of 10; Itrisic +0; Itrisic +10; Itrisic +20; Itrisic +30 Itervetio Duratio (mi) 1-10 i 1 miute itervals Recovery Time Fast; Medium; Slow; Very Slow Rest Rate (bpm) Off; 30-130 i steps of 5; 140; 150 Other Lead Moitorig Off; Moitor; Auto Polarity Switch A or V Low Impedace Limit (Ω) 200 5 A or V High Impedace Limit (Ω) 750; 1000; 1250; 1500; 1750; 2000 A or V Sigal Amplitude Moitorig Off; O Maget Respose Off; Battery Test Lead Type Ucoded; Uipolar; Bipolar Oly; Uipolar/Bipolar NIPS Optios Stimulatio Chamber Atrial or Vetricular Couplig Iterval (ms) 100-800 i steps of 10 S1 Cout 1-25 i steps of 1 S1 6 ; S2; S3 ad S4 Cycle (ms) 100-800 i steps of 10 Sius Node Recovery Delay (sec) 1-5 i steps of 1 1. ± 0,5 cc 2. The actual pacig rate for the 30 ppm is 31 ppm. 3. The highest available settig for Hysteresis Rate will be 5 ppm below the programmed Base Rate. 4. Sesitivity is with respect to a 20 ms haversie test sigal. 5. This parameter is ot programmable. 6. S1 Burst Cycle is applied at the preprogrammed S1 cycle legth. Output/Sesig A or V Pulse Amplitude (V) 0,0-4,0 i steps of 0,25; 4,5-7,5 i steps of 0,5 A or V Pulse Width (ms) 0,05; 0,1-1,5 i steps of 0,1 A or V Sesitivity (mv) 0,5-5,0 i steps of 0,5; 6-10 i steps of 1,0; 12,5 4 A or V Pulse Cofiguratio Uipolar (tip-case); Bipolar (tip-rig) A or V Sese Cofiguratio Uipolar Tip (tip-case); Bipolar (tip-rig); Uipolar Rig (rig-case) Vetricular AutoCapture Pacig System O; Off Primary Pulse Cofiguratio Uipolar; Bipolar Backup Pulse Cofiguratio Uipolar; Bipolar Backup Pulse Amplitude (V) 5,0 5 Search Iterval (hours) 8; 24 Rate-Modulated Maximum Sesor Rate (bpm) 80-150 i steps of 5; 160-180 i steps of 10 Rate Resposive VREF Off; Low; Medium; High Shortest VREF 120-350 i steps of 10 Reactio Time Very Fast; Fast; Medium; Slow Recovery Time Fast; Medium; Slow; Very Slow Sesor O; Off; Passive Slope Auto (-1); Auto (+0); Auto (+1); Auto (+2); Auto (+3); 1-16 i steps of 1 Threshold Auto (-0.5); Auto (+0.0); Auto (+0.5); Auto (+1.0); Auto (+1.5); Auto (+2.0); 1-7 i steps of 0,5 Stored Electrograms Optios Samplig Optios Freeze; Cotiuous No. of Stored EGMs 1; 2; 4; 8; 12 Chael Atrial or Vetricular Triggers Maget Placemet O; Off High Atrial Rate (bpm) Off; 125; 150; 175; 200; 225; 250; 275; 300 No. of Cosecutive Cycles 2; 3; 4; 5; 10; 15; 20 High Vetricular Rate (bpm) Off; 125; 150; 175; 200; 225; 250; 275; 300 No. of Cosecutive Cycles 2; 3; 4; 5; 10; 15; 20 Advaced Hysteresis O; Off (GMCRM817EN) Brief Summary: Prior to usig these devices, please review the Istructios for Use for a complete listig of idicatios, cotraidicatios, warigs, precautios, potetial adverse evets ad directios for use. Devices depicted may ot be available i all coutries. Check with your St. Jude Medical represetative for product availability i your coutry. Uless otherwise oted, idicates that the ame is a trademark of, or licesed to, St. Jude Medical or oe of its subsidiaries. ST. JUDE MEDICAL, the ie-squares symbol ad MORE CONTROL. LESS RISK. are registered ad uregistered trademarks ad service marks of St. Jude Medical, Ic. ad its related compaies. 2011 St. Jude Medical, Ic. All rights reserved. Item GMCRM817EN
Pacemakers Sustai XL DR Dual-Chamber Rate-Resposive Pacemaker Product Highlights Device features small, physiologic shape ad offers superior logevity (9,8 years) without compromisig size. 1 Istat follow-up with automatic P- or R-wave, lead impedace measuremets ad vetricular threshold tests. Vetricular Itrisic Preferece (VIP ) algorithm automatically searches for itrisic coductio. The AutoCapture Pacig System feature offers the maximum i threshold adaptability ad patiet safety with vetricular Beat-by-Beat capture cofirmatio. Stored electrograms (EGMs) record a real-time EGM waveform as well as the associated evet markers that precede ad follow a specific triggerig evet. The system also icludes the cliically prove Omisese accelerometer sesor, featurig auto rest rate (based o activity rather tha o preset clock settigs) ad auto rate respose. 1. A, V = 2,5 V/0,4 ms, A,V = 500 ohms, 100% DDD pacig @ 60 bpm, SEGMs ON; data o file. Orderig Iformatio Cotets: Cardiac pulse geerator Model Number Dimesios (H x W x T, mm) Weight (g) Volume (cc) Coector PM2136 44 x 52 x 6 23,5 11 IS-1 Idicatios ad Usage: Implatatio of Sustai pulse geerators is idicated i the followig permaet coditios, whe associated with symptoms icludig, but ot limited to: sycope, presycope, fatigue, disorietatio due to arrhythmia/bradycardia or ay combiatio of those symptoms. Rate-Modulated Pacig is idicated for patiets with chrootropic icompetece, ad for those who would beefit from icreased stimulatio rates cocurret with physical activity. Dual-Chamber Pacig (Models PM2134 ad PM2136 oly) is idicated for those patiets exhibitig: sick sius sydrome, chroic, symptomatic secod- ad third-degree AV block, recurret Adams-Stokes sydrome, symptomatic bilateral budle brach block whe tachyarrhythmia ad other causes have bee ruled out. Atrial Pacig is idicated for patiets with sius ode dysfuctio ad ormal AV ad itravetricular coductio systems. Vetricular Pacig is idicated for patiets with sigificat bradycardia ad: Normal sius rhythm with oly rare episodes of A-V block or sius arrest, chroic atrial fibrillatio, severe physical disability. AF Suppressio (Models PM2134 ad PM2136 oly) is idicated for suppressio of paroxysmal or persistet atrial fibrillatio episodes i patiets with oe or more of the above pacig idicatios. For specific idicatios associated with idividual modes, refer to the programmer s o-scree help. Cotraidicatios: Implated Cardioverter-Defibrillator (ICD). Because Sustai pulse geerators will be automatically programmed to a uipolar pulse cofiguratio if the device iitiates Backup VVI pacig, Sustai devices are cotraidicated i patiets with a implated cardioverter-defibrillator. Rate-Adaptive Pacig may be iappropriate for patiets who experiece agia or other symptoms of myocardial dysfuctio at higher sesor-drive rates. A appropriate Maximum Sesor Rate should be selected based o assessmet of the highest stimulatio rate tolerated by the patiet. AF Suppressio (Models PM2134 ad PM2136 oly) stimulatio is ot recommeded i patiets who caot tolerate high atrial-rate stimulatio. Dual-Chamber Pacig (Models PM2134 ad PM2136 oly) though ot cotraidicated for patiets with chroic atrial flutter, chroic atrial fibrillatio or silet atria, may provide o beefit beyod that of siglechamber pacig i such patiets. Sigle-Chamber Vetricular Demad Pacig is relatively cotraidicated i patiets who have demostrated pacemaker sydrome, have retrograde VA coductio or suffer a drop i arterial blood pressure with the oset of vetricular pacig. Sigle-Chamber Atrial Pacig is relatively cotraidicated i patiets who have demostrated compromise of AV coductio. For specific cotraidicatios associated with idividual modes, see the programmer s o-scree help. Potetial Adverse Evets: Arrhythmia, heart block, thrombosis, threshold elevatio, valve damage, peumothorax, myopotetial sesig, vessel damage, air embolism, body rejectio pheomea, cardiac tampoade or perforatio, formatio of fibrotic tissue; local tissue reactio, iability to iterrogate or program a pulse geerator because of programmer malfuctio, ifectio, iterruptio of desired pulse geerator fuctio due to electrical iterferece, loss of desired pacig ad/or sesig due to lead displacemet, body reactio at electrode iterface, or lead malfuctio (fracture or damage to isulatio), loss of ormal pacemaker fuctio due to battery failure or compoet malfuctio, pacemaker migratio, pocket erosio, or hematoma, pectoral muscle stimulatio, phreic erve or diaphragmatic stimulatio. The followig, i additio to the above, are potetial complicatios associated with the use of rate-modulated pacig systems: iappropriate, rapid pacig rates due to sesor failure or to the detectio of sigals other tha patiet activity, loss of activity-respose due to sesor failure, palpitatios with high-rate pacig. Refer to the User s Maual for detailed idicatios, cotraidicatios, warigs, precautios ad potetial adverse evets. Brief Summary: Prior to usig these devices, please review the Istructios for Use for a complete listig of idicatios, cotraidicatios, warigs, precautios, potetial adverse evets ad directios for use. Devices depicted may ot be available i all coutries. Check with your St. Jude Medical represetative for product availability i your coutry. Uless otherwise oted, idicates that the ame is a trademark of, or licesed to, St. Jude Medical or oe of its subsidiaries. ST. JUDE MEDICAL, the ie-squares symbol ad MORE CONTROL. LESS RISK. are registered ad uregistered trademarks ad service marks of St. Jude Medical, Ic. ad its related compaies. 2011 St. Jude Medical, Ic. All rights reserved.
Pacemakers Sustai XL DR Dual-Chamber Rate-Resposive Pacemaker Product Specificatios PHYSICAL SPECIFICATIONS Model PM2136 Dimesios (mm) 44 x 52 x 6 Weight (g) 23,5 Volume (cc) 11 1 Coector IS-1 PARAMETER SETTINGS Rate/Timig Atrial Absolute Refractory Period 60; 80; 100-350 i steps of 25 Atrial Protectio Iterval (ms) 125 2 Atrial Refractory (PVARP) (ms) 125-500 i steps of 25; 275 AV Delay (ms) 25; 30-200 i steps of 10; 225-300 i steps of 25; 350; 200 Base Rate (bpm) 30 3 ; 40-130 i steps of 5; 140-170 i steps of 10; 60 Far-Field Protectio Iterval (ms) 16 2 Hysteresis Rate (mi -1 ) Off; 30-130 i steps of 5; 140; 150 4 Search Iterval (mi) Off; 5; 10; 15; 30 Cycle Cout 1-16 i steps of 1 Itervetio Rate (mi -1 ) Off; 60; 80-120 i steps of 10; Itrisic +0; Itrisic +10; Itrisic +20; Itrisic +30 Itervetio Duratio (mi) 1-10 i 1 miute itervals Recovery Time Fast; Medium; Slow; Very Slow Maximum Trackig Rate (mi -1 ) 90-130 i steps of 5; 140-180 i steps of 10; 130 Mode AOO(R); AAI(R); AAT(R); OAO; VOO(R); VVI(R); VVT(R); VDD(R); OVO; DOO(R); DVI(R); DDI(R); DDD(R); ODO Post Vet. Atrial Blakig (PVAB) (ms) 60; 70; 80; 85; 95; 100; 110; 115; 125; 130; 140; 150; 155; 165; 170; 180; 185; 195; 200 PV Delay (ms) 25; 30-200 i steps of 10; 225-325 i steps of 25; 150 Rest Rate (mi -1 ) Off; 30-130 i steps of 5; 140; 150 Shortest AV/PV Delay (ms) 30-50 i steps of 5; 60-120 i steps of 10; 100 Vetricular Blakig (ms) 12-52 i steps of 4; 12 Vetricular Refractory (ms) 125-500 i steps of 25 5 ; 250 Output/Sesig A or V Pulse Amplitude (V) 0,0-4,0 i steps of 0,25; 4,5-7,5 i steps of 0,5; 2,5 A or V Pulse Width (ms) 0,05; 0,1-1,5 i steps of 0,1; 0,4 A or V Pulse Cofiguratio Uipolar (tip-case); Bipolar (tip-rig) A or V Sese Cofiguratio Uipolar Tip (tip-case); Bipolar (tip-rig); Uipolar Rig (rig-case) Atrial Sesitivity (mv) 0,1-0,4 i steps of 0,1 6 ; 0,5; 0,75-2,0 i steps of 0,25; 2,0-4,0 i steps of 0,5; 5,0 7 ; 0,5 Vetricular AutoCapture Pacig System O; Off Primary Pulse Cofiguratio Uipolar Backup Pulse Cofiguratio Uipolar; Bipolar Backup Pulse Amplitude (V) 5,0 2 Threshold Search Iterval (hours) 8; 24 Vetricular Sesitivity (mv) 0,5-5,0 i steps of 0,5; 6-10 i steps of 1,0; 12,5; 2,0 7 Rate-Modulated Parameters Maximum Sesor Rate (mi -1 ) 80-150 i steps of 5, 160-180 i steps of 10; 130 Rate Resposive AV/PV Delay Off; Low; Medium; High Rate Resposive PVARP/VREF Off; Low; Medium; High Reactio Time Very Fast; Fast; Medium; Slow Recovery Time Fast; Medium; Slow; Very Slow Sesor O; Off; Passive Shortest PVARP/VREF 120-350 i steps of 10; 170 Slope Auto (-1); Auto (+0); Auto (+1); Auto (+2); Auto (+3); 1-16 i steps of 1 Threshold Auto (-0,5); Auto (+0,0); Auto (+0,5); Auto (+1,0); Auto (+1,5); Auto (+2,0); 1-7 i steps of 0,5 AF Maagemet AF Suppressio Algorithm Off; O Lower Rate Overdrive (mi -1 ) 10 2 Upper Rate Overdrive (mi -1 ) 5 2 No. of Overdrive Pacig Cycles 15-40 i steps of 5 Rate Recovery (ms) 8; 12 Maximum AF Suppressio Rate (mi -1 ) 80-150 i steps of 5; 160-180 i steps of 10 Atrial Tachycardia Detectio Rate (mi -1 ) 110-150 i steps of 5; 160-200 i steps of 10; 225-300 i steps of 25; 180 Auto Mode Switch Off; DDDR to DDIR; DDD to DDI; VDDR to VVIR; VDD to VVI; DDDR to DDI; DDD to DDIR; VDDR to VVI; VDD to VVIR; DDIR AMS Base Rate (mi -1 ) Base Rate +0 to Base Rate +35 i steps of 5; Base Rate +20 Stored Electrograms Optios Samplig Optios Freeze; Cotiuous No. of Stored EGMs 1; 2; 4; 8; 12 Chael Atrial; Vetricular; Dual; Cross-Chael Triggers Advaced Hysteresis O; Off AMS Etry/AMS Exit O; Off AT/AF Detectio O; Off Maget Placemet O; Off High Atrial Rate Off; 125; 150; 175; 200; 225; 250; 275; 300 No. of Cosecutive Cycles 2; 3; 4; 5; 10; 15; 20 High Vetricular Rate Off; 125; 150; 175; 200; 225; 250; 275; 300 No. of Cosecutive Cycles 2; 3; 4; 5; 10; 15; 20 PMT Termiatio O; Off PVC Detectio O; Off No. of Cosecutive PVCs 2; 3; 4; 5 Other A ad V Lead Moitorig Off; Moitor; Auto Polarity Switch A ad V Low Impedace Limit (Ω) 200 2 A ad V High Impedace Limit (Ω) 750; 1000; 1250; 1500; 1750; 2000 Lead Type Ucoded; Uipolar; Bipolar Oly; Uipolar/Bipolar Maget Respose Off; Battery Test Negative AV/PV Hysteresis Search (ms) Off; -10 to -110 i steps of 10 NIPS Optios Stimulatio Chamber Atrial; Vetricular Couplig Iterval 100-800 i steps of 10 8 S1 Cout 1-25 i steps of 1 S1 9 ; S2; S3 ad S4 Cycle (ms) 100-800 i steps of 10 Vetricular Support Rate (mi -1 ) Off; 30; 40; 45; 50; 55; 60; 65; 70; 75; 80; 85; 90; 95 Sius Node Recovery Delay (sec) 1-5 i steps of 1 PMT Optios Off; 10 Beats > PMT; Auto Detect PMT Detectio Rate (mi -1 ) 90-150 i steps of 5; 160-180 i steps of 10; Off; 110 PVC Optios Off; A Pace o PVC; +PVARP o PVC (VDD mode oly) Sigal Amplitude Moitorig P-Wave Moitorig Off; O R-Wave Moitorig Off; O Vetricular Itrisic Preferece (VIP ) (ms) Off; 50-150 i steps of 25; 160-200 i steps of 10 VIP Search Iterval 30 sec.; 1; 3; 5; 10; 30 mi. VIP Search Cycles 1; 2; 3 Vetricular Safety Stadby Off; O 1. ± 0,5 cc 2. This parameter is ot programmable. 3. The actual pacig rate for the 30 bpm is 31 bpm. 4. The highest available settig for Hysteresis Rate will be 5 bpm below the programmed Base Rate. 5. I dual-chamber modes, the maximum Vetricular Refractory Period is 325 ms. 6. Values 0,1-0,4 ot available i a Uipolar Sese Cofiguratio. 7. Sesitivity is with respect to a 20 ms haversie test sigal. 8. Durig atrial NIPS i dual-chamber modes, the shortest Couplig Iterval will be limited by the programmed AV/PV delay. 9. S1 Burst Cycle is applied at the preprogrammed S1 cycle legth. (GMCRM874EN) Brief Summary: Prior to usig these devices, please review the Istructios for Use for a complete listig of idicatios, cotraidicatios, warigs, precautios, potetial adverse evets ad directios for use. Devices depicted may ot be available i all coutries. Check with your St. Jude Medical represetative for product availability i your coutry. Uless otherwise oted, idicates that the ame is a trademark of, or licesed to, St. Jude Medical or oe of its subsidiaries. ST. JUDE MEDICAL, the ie-squares symbol ad MORE CONTROL. LESS RISK. are registered ad uregistered trademarks ad service marks of St. Jude Medical, Ic. ad its related compaies. 2011 St. Jude Medical, Ic. All rights reserved. Item GMCRM874EN
Pacemakers Sustai XL SR Sigle-Chamber Rate-Resposive Pacemaker Product Highlights Device features small, physiologic shape ad offers superior logevity (12,8 years) without compromisig size. 1 Istat follow-up with automatic P- or R-wave, lead impedace measuremets ad vetricular threshold tests. The AutoCapture Pacig System feature offers the maximum i threshold adaptability ad patiet safety with vetricular Beat-by-Beat capture cofirmatio. Stored electrograms (EGMs) record a real-time EGM waveform as well as the associated evet markers that precede ad follow a specific triggerig evet. The system also icludes the cliically prove Omisese accelerometer sesor, featurig auto rest rate (based o activity rather tha o preset clock settigs) ad auto rate respose. 1. A, V = 2,5 V/0,4 ms, A,V = 500 ohms, 100% VVI pacig @ 60 bpm, SEGMs ON; data o file. Orderig Iformatio Cotets: Cardiac pulse geerator Model Number Dimesios (H x W x T, mm) Weight (g) Volume (cc) Coector PM1136 42 x 52 x 6 23 10,4 IS-1 Idicatios ad Usage: Implatatio of Sustai pulse geerators is idicated i the followig permaet coditios, whe associated with symptoms icludig, but ot limited to: sycope, presycope, fatigue, disorietatio due to arrhythmia/bradycardia or ay combiatio of those symptoms. Rate-Modulated Pacig is idicated for patiets with chrootropic icompetece, ad for those who would beefit from icreased stimulatio rates cocurret with physical activity. Atrial Pacig is idicated for patiets with sius ode dysfuctio ad ormal AV ad itravetricular coductio systems. Vetricular Pacig is idicated for patiets with sigificat bradycardia ad: Normal sius rhythm with oly rare episodes of A-V block or sius arrest, chroic atrial fibrillatio, severe physical disability. Cotraidicatios: Implated Cardioverter-Defibrillator (ICD). Because Sustai pulse geerators will be automatically programmed to a uipolar pulse cofiguratio if the device iitiates Backup VVI pacig, Sustai devices are cotraidicated i patiets with a implated cardioverter-defibrillator. Rate-Adaptive Pacig may be iappropriate for patiets who experiece agia or other symptoms of myocardial dysfuctio at higher sesor-drive rates. A appropriate Maximum Sesor Rate should be selected based o assessmet of the highest stimulatio rate tolerated by the patiet. Potetial Adverse Evets: Arrhythmia, heart block, thrombosis, threshold elevatio, valve damage, peumothorax, myopotetial sesig, vessel damage, air embolism, body rejectio pheomea, cardiac tampoade or perforatio, formatio of fibrotic tissue; local tissue reactio, iability to iterrogate or program a pulse geerator because of programmer malfuctio, ifectio, iterruptio of desired pulse geerator fuctio due to electrical iterferece, loss of desired pacig ad/or sesig due to lead displacemet, body reactio at electrode iterface, or lead malfuctio (fracture or damage to isulatio), loss of ormal pacemaker fuctio due to battery failure or compoet malfuctio, pacemaker migratio, pocket erosio, or hematoma, pectoral muscle stimulatio, phreic erve or diaphragmatic stimulatio. The followig, i additio to the above, are potetial complicatios associated with the use of rate-modulated pacig systems: iappropriate, rapid pacig rates due to sesor failure or to the detectio of sigals other tha patiet activity, loss of activity-respose due to sesor failure, palpitatios with high-rate pacig. Refer to the User s Maual for detailed idicatios, cotraidicatios, warigs, precautios ad potetial adverse evets. Brief Summary: Prior to usig these devices, please review the Istructios for Use for a complete listig of idicatios, cotraidicatios, warigs, precautios, potetial adverse evets ad directios for use. Devices depicted may ot be available i all coutries. Check with your St. Jude Medical represetative for product availability i your coutry. Uless otherwise oted, idicates that the ame is a trademark of, or licesed to, St. Jude Medical or oe of its subsidiaries. ST. JUDE MEDICAL, the ie-squares symbol ad MORE CONTROL. LESS RISK. are registered ad uregistered trademarks ad service marks of St. Jude Medical, Ic. ad its related compaies. 2011 St. Jude Medical, Ic. All rights reserved.
Pacemakers Sustai XL SR Sigle-Chamber Rate-Resposive Pacemaker Product Specificatios PHYSICAL SPECIFICATIONS Model PM1136 Dimesios (mm) 42 x 52 x 6 Weight (g) 23 Volume (cc) 10,4 1 Coector IS-1 PARAMETER Rate/Timig SETTINGS A or V Refractory (ms) 125-500 i steps of 25; 325 Base Rate (bpm) 30 2 ; 40-130 i steps of 5; 140-170 i steps of 10 Mode A00(R); AAI(R); AAT(R); OAO; VOO(R); VVI(R); VVT(R); OVO Hysteresis Rate (bpm) Off; 30-130 i steps of 5; 140; 150 3 Search Iterval (bpm) Off; 5; 10; 15; 30 Cycle Cout 1-16 i steps of 1 Itervetio Rate (bpm) Off; 60; 80-120 i steps of 10; Itrisic +0; Itrisic +10; Itrisic +20; Itrisic +30 Itervetio Duratio (mi) 1-10 i 1 miute itervals Recovery Time Fast; Medium; Slow; Very Slow Rest Rate (bpm) Off; 30-130 i steps of 5; 140; 150 Output/Sesig A or V Pulse Amplitude (V) 0,0-4,0 i steps of 0,25; 4,5-7,5 i steps of 0,5; 2,5 A or V Pulse Width (ms) 0,05; 0,1-1,5 i steps of 0,1; 0,4 A or V Sesitivity (mv) 0,5-5,0 i steps of 0,5; 6-10 i steps of 1,0; 12,5 4 A or V Pulse Cofiguratio Uipolar (tip-case); Bipolar (tip-rig) A or V Sese Cofiguratio Uipolar Tip (tip-case); Bipolar (tip-rig); Uipolar Rig (rig-case) Vetricular AutoCapture Pacig System O; Off Primary Pulse Cofiguratio Uipolar; Bipolar Backup Pulse Cofiguratio Uipolar; Bipolar Backup Pulse Amplitude (V) 5,0 5 Search Iterval (hours) 8; 24 Stored Electrograms Optios Samplig Optios Freeze; Cotiuous No. of Stored EGMs 1; 2; 4; 8; 12 Chael Atrial or Vetricular Triggers Maget Placemet O; Off High Atrial Rate Off; 125; 150; 175; 200; 225; 250; 275; 300 No. of Cosecutive Cycles 2; 3; 4; 5; 10; 15; 20 High Vetricular Rate Off; 125; 150; 175; 200; 225; 250; 275; 300 No. of Cosecutive Cycles 2; 3; 4; 5; 10; 15; 20 Advaced Hysteresis O; Off Other Lead Moitorig Off; Moitor; Auto Polarity Switch A or V Low Impedace Limit (Ω) 200 5 A or V High Impedace Limit (Ω) 750; 1000; 1250; 1500; 1750; 2000 A or V Sigal Amplitude Moitorig Off; O Maget Respose Off; Battery Test Lead Type Ucoded; Uipolar; Bipolar Oly; Uipolar/Bipolar NIPS Optios Stimulatio Chamber Atrial or Vetricular Couplig Iterval (ms) 100-800 i steps of 10 S1 Cout 1-25 i steps of 1 S1 6 ; S2; S3 ad S4 Cycle (ms) 100-800 i steps of 10 Sius Node Recovery Delay (sec) 1-5 i steps of 1 1. ± 0,5 cc 2. The actual pacig rate for the 30 ppm is 31 ppm. 3. The highest available settig for Hysteresis Rate will be 5 ppm below the programmed Base Rate. 4. Sesitivity is with respect to a 20 ms haversie test sigal. 5. This parameter is ot programmable. 6. S1 Burst Cycle is applied at the preprogrammed S1 cycle legth. Rate-Modulated Parameters Maximum Sesor Rate (bpm) 80-150 i steps of 5; 160-180 i steps of 10; 130 Rate Resposive VREF Off; Low; Medium; High Shortest VREF 120-350 i steps of 10 Reactio Time Very Fast; Fast; Medium; Slow Recovery Time Fast; Medium; Slow; Very Slow Sesor O; Off; Passive Slope Auto (-1); Auto (+0); Auto (+1); Auto (+2); Auto (+3); 1-16 i steps of 1 Threshold Auto (-0,5); Auto (+0,0); Auto (+0,5); Auto (+1,0); Auto (+1,5); Auto (+2,0); 1-7 i steps of 0,5 (GMCRM875EN) Brief Summary: Prior to usig these devices, please review the Istructios for Use for a complete listig of idicatios, cotraidicatios, warigs, precautios, potetial adverse evets ad directios for use. Devices depicted may ot be available i all coutries. Check with your St. Jude Medical represetative for product availability i your coutry. Uless otherwise oted, idicates that the ame is a trademark of, or licesed to, St. Jude Medical or oe of its subsidiaries. ST. JUDE MEDICAL, the ie-squares symbol ad MORE CONTROL. LESS RISK. are registered ad uregistered trademarks ad service marks of St. Jude Medical, Ic. ad its related compaies. 2011 St. Jude Medical, Ic. All rights reserved. Item GMCRM875EN
Pacemakers Sustai XL DC Dual-Chamber Pacemaker Product Highlights Device features small, physiologic shape ad offers superior logevity (9,8 years) without compromisig size. 1 Istat follow-up with automatic P- or R-wave, lead impedace measuremets ad vetricular threshold tests. The Vetricular Itrisic Preferece (VIP ) algorithm automatically searches for itrisic coductio. The AutoCapture Pacig System feature offers the maximum i threshold adaptability ad patiet safety with vetricular Beat-by-Beat capture cofirmatio. Stored electrograms (EGMs) record a real-time EGM waveform as well as the associated evet markers that precede ad follow a specific triggerig evet. 1. A, V = 2,5 V/0,4 ms, A,V = 500 ohms, 100% DDD pacig @ 60 bpm, SEGMs ON; data o file. Orderig Iformatio Cotets: Cardiac pulse geerator Model Number Dimesios (H x W x T, mm) Weight (g) Volume (cc) Coector PM2134 44 x 52 x 6 23,5 11 IS-1 Idicatios ad Usage: Implatatio of Sustai pulse geerators is idicated i the followig permaet coditios, whe associated with symptoms icludig, but ot limited to: sycope, presycope, fatigue, disorietatio or ay combiatio of those symptoms. Dual-Chamber Pacig (Models PM2134 ad PM2136 oly) is idicated for those patiets exhibitig: sick sius sydrome, chroic, symptomatic secod- ad third-degree AV block, recurret Adams-Stokes sydrome, symptomatic bilateral budle brach block whe tachyarrhythmia ad other causes have bee ruled out. Atrial Pacig is idicated for patiets with sius ode dysfuctio ad ormal AV ad itravetricular coductio systems. Vetricular Pacig is idicated for patiets with sigificat bradycardia ad: Normal sius rhythm with oly rare episodes of A-V block or sius arrest, chroic atrial fibrillatio, severe physical disability. AF Suppressio (Models PM2134 ad PM2136 oly) is idicated for suppressio of paroxysmal or persistet atrial fibrillatio episodes i patiets with oe or more of the above pacig idicatios. For specific idicatios associated with idividual modes, refer to the programmer s o-scree help. Cotraidicatios: Implated Cardioverter-Defibrillator (ICD). Because Sustai pulse geerators will be automatically programmed to a uipolar pulse cofiguratio if the device iitiates Backup VVI pacig, Sustai devices are cotraidicated i patiets with a implated cardioverter-defibrillator. AF Suppressio (Models PM2134 ad PM2136 oly) stimulatio is ot recommeded i patiets who caot tolerate high atrial-rate stimulatio. Dual-Chamber Pacig (Models PM2134 ad PM2136 oly) though ot cotraidicated for patiets with chroic atrial flutter, chroic atrial fibrillatio or silet atria, may provide o beefit beyod that of siglechamber pacig i such patiets. Sigle-Chamber Vetricular Demad Pacig is relatively cotraidicated i patiets who have demostrated pacemaker sydrome, have retrograde VA coductio or suffer a drop i arterial blood pressure with the oset of vetricular pacig. Sigle-Chamber Atrial Pacig is relatively cotraidicated i patiets who have demostrated compromise of AV coductio. For specific cotraidicatios associated with idividual modes, see the programmer s o-scree help. Potetial Adverse Evets: Arrhythmia, heart block, thrombosis, threshold elevatio, valve damage, peumothorax, myopotetial sesig, vessel damage, air embolism, body rejectio pheomea, cardiac tampoade or perforatio, formatio of fibrotic tissue; local tissue reactio, iability to iterrogate or program a pulse geerator because of programmer malfuctio, ifectio, iterruptio of desired pulse geerator fuctio due to electrical iterferece, loss of desired pacig ad/or sesig due to lead displacemet, body reactio at electrode iterface, or lead malfuctio (fracture or damage to isulatio), loss of ormal pacemaker fuctio due to battery failure or compoet malfuctio, pacemaker migratio, pocket erosio, or hematoma, pectoral muscle stimulatio, phreic erve or diaphragmatic stimulatio. Refer to the User s Maual for detailed idicatios, cotraidicatios, warigs, precautios ad potetial adverse evets. Brief Summary: Prior to usig these devices, please review the Istructios for Use for a complete listig of idicatios, cotraidicatios, warigs, precautios, potetial adverse evets ad directios for use. Devices depicted may ot be available i all coutries. Check with your St. Jude Medical represetative for product availability i your coutry. Uless otherwise oted, idicates that the ame is a trademark of, or licesed to, St. Jude Medical or oe of its subsidiaries. ST. JUDE MEDICAL, the ie-squares symbol ad MORE CONTROL. LESS RISK. are registered ad uregistered trademarks ad service marks of St. Jude Medical, Ic. ad its related compaies. 2011 St. Jude Medical, Ic. All rights reserved.
Pacemakers Sustai XL DC Dual-Chamber Pacemaker Product Specificatios PHYSICAL SPECIFICATIONS Model PM2134 Dimesios (mm) 44 x 52 x 6 Weight (g) 23,5 Volume (cc) 11 1 Coector IS-1 PARAMETER SETTINGS Rate/Timig Atrial Absolute Refractory Period 60; 80; 100-350 i steps of 25 Atrial Protectio Iterval (ms) 125 2 Atrial Refractory (PVARP) (ms) 125-500 i steps of 25; 275 AV Delay (ms) 25; 30-200 i steps of 10; 225-300 i steps of 25; 350; 200 Base Rate (bpm) 30 3 ; 40-130 i steps of 5; 140-170 i steps of 10; 60 Far-Field Protectio Iterval (ms) 16 2 Hysteresis Rate (mi -1 ) Off; 30-130 i steps of 5; 140; 150 4 Search Iterval (mi) Off; 5; 10; 15; 30 Cycle Cout 1-16 i steps of 1 Itervetio Rate (mi -1 ) Off; 60; 80-120 i steps of 10; Itrisic +0; Itrisic +10; Itrisic +20; Itrisic +30 Itervetio Duratio (mi) 1-10 i 1 miute itervals Recovery Time Fast; Medium; Slow; Very Slow Maximum Trackig Rate (mi -1 ) 90-130 i steps of 5; 140-180 i steps of 10; 130 Mode AOO; AAI; AAT; OAO; VOO; VVI; VVT; VDD; OVO; DOO; DVI; DDI; DDD; ODO Post Vet. Atrial Blakig (PVAB) (ms) 60; 70; 80; 85; 95; 100; 110; 115; 125; 130; 140; 150; 155; 165; 170; 180; 185; 195; 200 Rate Resposive AV/PV Delay Off; Low; Medium; High Rate Resposive PVARP/VREF Off; Low; Medium; High Shortest PVARP/VREF 120-350 i steps of 10; 170 PV Delay (ms) 25; 30-200 i steps of 10; 225-325 i steps of 25; 150 Rest Rate (mi -1 ) Off; 30-130 i steps of 5; 140; 150 Shortest AV/PV Delay (ms) 30-50 i steps of 5; 60-120 i steps of 10; 100 Vetricular Blakig (ms) 12-52 i steps of 4; 12 Vetricular Refractory (ms) 125-500 i steps of 25 5 ; 250 Output/Sesig A or V Pulse Amplitude (V) 0,0-4,0 i steps of 0,25; 4,5-7,5 i steps of 0,5; 2,5 A or V Pulse Width (ms) 0,05; 0,1-1,5 i steps of 0,1; 0,4 A or V Pulse Cofiguratio Uipolar (tip-case); Bipolar (tip-rig) A or V Sese Cofiguratio Uipolar Tip (tip-case); Bipolar (tip-rig); Uipolar Rig (rig-case) Atrial Sesitivity (mv) 0,1-0,4 i steps of 0,1 6 ; 0,5; 0,75-2,0 i steps of 0,25; 2,0-4,0 i steps of 0,5; 5,0 7 Vetricular AutoCapture Pacig System O; Off Primary Pulse Cofiguratio Uipolar Backup Pulse Cofiguratio Uipolar; Bipolar Backup Pulse Amplitude (V) 5,0 2 Threshold Search Iterval (hours) 8; 24 Vetricular Sesitivity (mv) 0,5-5,0 i steps of 0,5; 6-10 i steps of 1,0; 12,5; 2,0 7 Stored Electrograms Optios Samplig Optios Freeze; Cotiuous No. of Stored EGMs 1; 2; 4; 8; 12 Chael Atrial; Vetricular; Dual; Cross-Chael Triggers Advaced Hysteresis O; Off AMS Etry/AMS Exit O; Off AT/AF Detectio O; Off Maget Placemet O; Off High Atrial Rate Off; 125; 150; 175; 200; 225; 250; 275; 300 No. of Cosecutive Cycles 2; 3; 4; 5; 10; 15; 20 High Vetricular Rate Off; 125; 150; 175; 200; 225; 250; 275; 300 No. of Cosecutive Cycles 2; 3; 4; 5; 10; 15; 20 PMT Termiatio O; Off PVC Detectio O; Off No. of Cosecutive PVCs 2; 3; 4; 5 Other A ad V Lead Moitorig Off; Moitor; Auto Polarity Switch A ad V Low Impedace Limit (Ω) 200 2 A ad V High Impedace Limit (Ω) 750; 1000; 1250; 1500; 1750; 2000 Lead Type Ucoded; Uipolar; Bipolar Oly; Uipolar/Bipolar Maget Respose Off; Battery Test Negative AV/PV Hysteresis Search (ms) Off; -10 to -110 i steps of 10 NIPS Optios Stimulatio Chamber Atrial; Vetricular Couplig Iterval 100-800 i steps of 10 8 S1 Cout 1-25 i steps of 1 S1 9 ; S2; S3 ad S4 Cycle (ms) 100-800 i steps of 10 Vetricular Support Rate (mi -1 ) Off; 30; 40; 45; 50; 55; 60; 65; 70; 75; 80; 85; 90; 95 Sius Node Recovery Delay (sec) 1-5 i steps of 1 PMT Optios Off; 10 Beats > PMT; Auto Detect PMT Detectio Rate (mi -1 ) 90-150 i steps of 5; 160-180 i steps of 10; Off; 110 PVC Optios Off; A Pace o PVC; +PVARP o PVC (VDD mode oly) Sigal Amplitude Moitorig P-Wave Moitorig Off; O R-Wave Moitorig Off; O Vetricular Itrisic Preferece (VIP ) (ms) Off; 50-150 i steps of 25; 160-200 i steps of 10 VIP Search Iterval 30 sec.; 1; 3; 5; 10; 30 mi. VIP Search Cycles 1; 2; 3 Vetricular Safety Stadby Off; O 1. ± 0,5 cc 2. This parameter is ot programmable. 3. The actual pacig rate for the 30 bpm is 31 bpm. 4. The highest available settig for Hysteresis Rate will be 5 bpm below the programmed Base Rate. 5. I dual-chamber modes, the maximum Vetricular Refractory Period is 325 ms. 6. Values 0,1-0,4 ot available i a Uipolar Sese Cofiguratio. 7. Sesitivity is with respect to a 20 ms haversie test sigal. 8. Durig atrial NIPS i dual-chamber modes, the shortest Couplig Iterval will be limited by the programmed AV/PV delay. 9. S1 Burst Cycle is applied at the preprogrammed S1 cycle legth. AF Maagemet AF Suppressio Algorithm Off; O Lower Rate Overdrive (mi -1 ) 10 2 Upper Rate Overdrive (mi -1 ) 5 2 No. of Overdrive Pacig Cycles 15-40 i steps of 5 Rate Recovery (ms) 8; 12 Maximum AF Suppressio Rate (mi -1 ) 80-150 i steps of 5; 160-180 i steps of 10 Atrial Tachycardia Detectio Rate (mi -1 ) 110-150 i steps of 5; 160-200 i steps of 10; 225-300 i steps of 25; 180 Auto Mode Switch Off; DDD to DDI; VDD to VVI; DDI AMS Base Rate (mi -1 ) Base Rate +0 to Base Rate +35 i steps of 5; Base Rate +20 (GMCRM876EN) Brief Summary: Prior to usig these devices, please review the Istructios for Use for a complete listig of idicatios, cotraidicatios, warigs, precautios, potetial adverse evets ad directios for use. Devices depicted may ot be available i all coutries. Check with your St. Jude Medical represetative for product availability i your coutry. Uless otherwise oted, idicates that the ame is a trademark of, or licesed to, St. Jude Medical or oe of its subsidiaries. ST. JUDE MEDICAL, the ie-squares symbol ad MORE CONTROL. LESS RISK. are registered ad uregistered trademarks ad service marks of St. Jude Medical, Ic. ad its related compaies. 2011 St. Jude Medical, Ic. All rights reserved. Item GMCRM876EN
Pacemakers Sustai XL SC Sigle-Chamber Pacemaker Product Highlights Device features small, physiologic shape ad offers superior logevity (12,8 years) without compromisig size. 1 Istat follow-up with automatic P- or R-wave, lead impedace measuremets ad vetricular threshold tests. The AutoCapture Pacig System feature offers the maximum i threshold adaptability ad patiet safety with vetricular Beat-by-Beat capture cofirmatio. Stored electrograms (EGMs) record a real-time EGM waveform as well as the associated evet markers that precede ad follow a specific triggerig evet. 1. A, V = 2,5 V/0,4 ms, A,V = 500 ohms, 100% VVI pacig @ 60 bpm, SEGMs ON; data o file. Orderig Iformatio Cotets: Cardiac pulse geerator Model Number Dimesios (H x W x T, mm) Weight (g) Volume (cc) Coector PM1134 42 x 52 x 6 23 10,4 IS-1 Idicatios ad Usage: Implatatio of Sustai pulse geerators is idicated i the followig permaet coditios, whe associated with symptoms icludig, but ot limited to: sycope, presycope, fatigue, disorietatio due to arrhythmia/bradycardia or ay combiatio of those symptoms. Symptomatic bilateral budle brach block whe tachy-arrhythmia ad other causes have bee ruled out. Atrial Pacig is idicated for patiets with sius ode dysfuctio ad ormal AV ad itravetricular coductio systems. Vetricular Pacig is idicated for patiets with sigificat bradycardia ad: Normal sius rhythm with oly rare episodes of A-V block or sius arrest, chroic atrial fibrillatio, severe physical disability. Cotraidicatios: Implated Cardioverter-Defibrillator (ICD). Because Sustai pulse geerators will be automatically programmed to a uipolar pulse cofiguratio if the device iitiates Backup VVI pacig, Sustai devices are cotraidicated i patiets with a implated cardioverter-defibrillator. Potetial Adverse Evets: Arrhythmia, heart block, thrombosis, threshold elevatio, valve damage, peumothorax, myopotetial sesig, vessel damage, air embolism, body rejectio pheomea, cardiac tampoade or perforatio, formatio of fibrotic tissue; local tissue reactio, iability to iterrogate or program a pulse geerator because of programmer malfuctio, ifectio, iterruptio of desired pulse geerator fuctio due to electrical iterferece, loss of desired pacig ad/or sesig due to lead displacemet, body reactio at electrode iterface, or lead malfuctio (fracture or damage to isulatio), loss of ormal pacemaker fuctio due to battery failure or compoet malfuctio, pacemaker migratio, pocket erosio, or hematoma, pectoral muscle stimulatio, phreic erve or diaphragmatic stimulatio. Refer to the User s Maual for detailed idicatios, cotraidicatios, warigs, precautios ad potetial adverse evets. Brief Summary: Prior to usig these devices, please review the Istructios for Use for a complete listig of idicatios, cotraidicatios, warigs, precautios, potetial adverse evets ad directios for use. Devices depicted may ot be available i all coutries. Check with your St. Jude Medical represetative for product availability i your coutry. Uless otherwise oted, idicates that the ame is a trademark of, or licesed to, St. Jude Medical or oe of its subsidiaries. ST. JUDE MEDICAL, the ie-squares symbol ad MORE CONTROL. LESS RISK. are registered ad uregistered trademarks ad service marks of St. Jude Medical, Ic. ad its related compaies. 2011 St. Jude Medical, Ic. All rights reserved.
Pacemakers Sustai XL SC Sigle-Chamber Pacemaker Product Specificatios PHYSICAL SPECIFICATIONS Model PM1134 Dimesios (mm) 42 x 52 x 6 Weight (g) 23 Volume (cc) 10,4 1 Coector IS-1 PARAMETER SETTINGS Rate/Timig A or V Refractory (ms) 125-500 i steps of 25; 325 Base Rate (bpm) 30 2 ; 40-130 i steps of 5; 140-170 i steps of 10 Mode A00; AAI; AAT; OAO; VOO; VVI; VVT; OVO Hysteresis Rate (bpm) Off; 30-130 i steps of 5; 140; 150 3 Search Iterval (bpm) Off; 5; 10; 15; 30 Cycle Cout 1-16 i steps of 1 Itervetio Rate (bpm) Off; 60; 80-120 i steps of 10; Itrisic +0; Itrisic +10; Itrisic +20; Itrisic +30 Itervetio Duratio (mi) 1-10 i 1 miute itervals Recovery Time Fast; Medium; Slow; Very Slow Rate Resposive VREF Off; Low; Medium; High Rest Rate (bpm) Off; 30-130 i steps of 5; 140; 150 Shortest VREF 120-350 i steps of 10 Output/Sesig A or V Pulse Amplitude (V) 0,0-4,0 i steps of 0,25; 4,5-7,5 i steps of 0,5; 2,5 A or V Pulse Width (ms) 0,05; 0,1-1,5 i steps of 0,1; 0,4 A or V Sesitivity (mv) 0,5-5,0 i steps of 0,5; 6-10 i steps of 1,0; 12,5 4 A or V Pulse Cofiguratio Uipolar (tip-case); Bipolar (tip-rig) A or V Sese Cofiguratio Uipolar Tip (tip-case); Bipolar (tip-rig); Uipolar Rig (rig-case) Vetricular AutoCapture Pacig System O; Off Primary Pulse Cofiguratio Uipolar; Bipolar Backup Pulse Cofiguratio Uipolar; Bipolar Backup Pulse Amplitude (V) 5,0 5 Search Iterval (hours) 8; 24 Stored Electrograms Optios Samplig Optios Freeze; Cotiuous No. of Stored EGMs 1; 2; 4; 8; 12 Chael Atrial or Vetricular Triggers Maget Placemet O; Off High Atrial Rate Off; 125; 150; 175; 200; 225; 250; 275; 300 No. of Cosecutive Cycles 2; 3; 4; 5; 10; 15; 20 High Vetricular Rate Off; 125; 150; 175; 200; 225; 250; 275; 300 No. of Cosecutive Cycles 2; 3; 4; 5; 10; 15; 20 Advaced Hysteresis O; Off Other Lead Moitorig Off; Moitor; Auto Polarity Switch A or V Low Impedace Limit (Ω) 200 5 A or V High Impedace Limit (Ω) 750; 1000; 1250; 1500; 1750; 2000 A or V Sigal Amplitude Moitorig Off; O Maget Respose Off; Battery Test Lead Type Ucoded; Uipolar; Bipolar Oly; Uipolar/Bipolar NIPS Optios Stimulatio Chamber Atrial or Vetricular Couplig Iterval (ms) 100-800 i steps of 10 S1 Cout 1-25 i steps of 1 S1 6 ; S2; S3 ad S4 Cycle (ms) 100-800 i steps of 10 Sius Node Recovery Delay (sec) 1-5 i steps of 1 1. ± 0,5 cc 2. The actual pacig rate for the 30 ppm is 31 ppm. 3. The highest available settig for Hysteresis Rate will be 5 ppm below the programmed Base Rate. 4. Sesitivity is with respect to a 20 ms haversie test sigal. 5. This parameter is ot programmable. 6. S1 Burst Cycle is applied at the preprogrammed S1 cycle legth. (GMCRM877EN) Brief Summary: Prior to usig these devices, please review the Istructios for Use for a complete listig of idicatios, cotraidicatios, warigs, precautios, potetial adverse evets ad directios for use. Devices depicted may ot be available i all coutries. Check with your St. Jude Medical represetative for product availability i your coutry. Uless otherwise oted, idicates that the ame is a trademark of, or licesed to, St. Jude Medical or oe of its subsidiaries. ST. JUDE MEDICAL, the ie-squares symbol ad MORE CONTROL. LESS RISK. are registered ad uregistered trademarks ad service marks of St. Jude Medical, Ic. ad its related compaies. 2011 St. Jude Medical, Ic. All rights reserved. Item GMCRM877EN
Pacemakers Microy II SR+ Sigle-Chamber Pacemaker Product Highlights The AutoCapture pacig system offers the maximum i threshold adaptability ad patiet safety with vetricular Beat-by-Beat capture cofirmatio Automatic P/R sesitivity test suggests a programmed value for the P/R sesitivity Accelerometer sesor provides reliable rate respose with oly oe programmable parameter (Slope) Beat-by-Beat lead impedace moitorig Comprehesive diagostics ad maagemet tools, icludig measured data, rate predictio model, stimulatio threshold vs. time, sesor idicated rate vs. time ad others Orderig Iformatio Cotets: Cardiac pulse geerator Model Number Dimesios (H x W x T, mm) Weight (g) Volume (cc) Coector 2525T 33 x 33 x 6 12,8 5,9 IS-1 bipolar Idicatios: The pulse geerators are idicated for: Accepted Patiet Coditios warratig chroic cardiac pacig, which iclude: sick sius sydrome, chroic, symptomatic secod- ad third-degree AV block, recurret Adams-Stokes sydrome, symptomatic bilateral budle brach block whe tachy-arrhythmia ad other causes have bee ruled out. Atrial Pacig i patiets with sius ode dysfuctio ad ormal AV ad itravetricular coductio systems. Vetricular Pacig i patiets with sigificat bradycardia ad: ormal sius rhythm with oly rare episodes of A-V block or sius arrest requirig short periods of pacig support, chroic atrial fibrillatio, severe physical disability. Rate-Modulated Pacig i patiets who would beefit from icreased pacig rates cocurret with physical activity. Cotraidicatios: The pulse geerators are cotraidicated for: sigle-chamber Vetricular Demad Pacig i patiets who have demostrated pacemaker sydrome, have retrograde VA coductio, or who suffer a drop i arterial blood pressure with the oset of vetricular pacig, sigle-chamber Atrial Pacig i patiets who have demostrated compromise of AV coductio, rate-modulated Pacig i patiets who experiece agia or other symptoms of myocardial dysfuctio at higher sesor-drive rates, uipolar pacig i patiets with a implated cardioverter-defibrillator (ICD) sice it may ihibit or trigger ICD therapy. The pulse geerators are programmed to uipolar pacig ad may be iappropriate for patiets with a ICD. Potetial Adverse Evets: Adverse evets associated with the use of ay pacig system iclude: air embolism, bleedig/hematoma, body rejectio pheomea, cardiac tampoade or perforatio, formatio of fibrotic tissue; local tissue reactio, Iability to iterrogate or program due to programmer or device malfuctio, ifectio/erosio, iterruptio of desired pulse geerator fuctio due to electrical iterferece, either electromyogeic or electromagetic, lead malfuctio due to coductor fracture or isulatio degradatio, loss of capture or sesig due to lead dislodgmet or reactio at the electrode/tissue iterface, loss of desired pacig ad/or sesig due to lead displacemet, body reactio at electrode iterface, or lead malfuctio (fracture or damage to isulatio), loss of ormal device fuctio due to battery failure or compoet malfuctio, pacemaker migratio, pocket erosio, or hematoma, pectoral muscle or diaphragmatic stimulatio, phreic erve stimulatio, peumothorax/hemothorax. Refer to the User s Maual for detailed idicatios, cotraidicatios, warigs, precautios ad potetial adverse evets. Brief Summary: Prior to usig these devices, please review the Istructios for Use for a complete listig of idicatios, cotraidicatios, warigs, precautios, potetial adverse evets ad directios for use. Devices depicted may ot be available i all coutries. Check with your St. Jude Medical represetative for product availability i your coutry. Uless otherwise oted, idicates that the ame is a trademark of, or licesed to, St. Jude Medical or oe of its subsidiaries. ST. JUDE MEDICAL, the ie-squares symbol ad MORE CONTROL. LESS RISK. are registered ad uregistered trademarks ad service marks of St. Jude Medical, Ic. ad its related compaies. 2011 St. Jude Medical, Ic. All rights reserved.
Pacemakers Microy II SR+ Sigle-Chamber Pacemaker Product Specificatios PHYSICAL SPECIFICATIONS Model 2525T Dimesios (mm) 33 x 33 x 6 Weight (g) 12,8 Volume (cc) 5,9 Coector IS-1 Bipolar Battery Data Lithium-iodie cell; 2,80 V/0,35 Ah PARAMETER Rate/Timig SETTINGS Mode AOO(R); AAI(R); AAT(R); VOO(R); VVI*(R); VVT(R) Basic Rate (ppm) 45-160 i steps of 5; 60* Hysteresis Rate (ppm) 0; 10; 20; 30 below the basic or sesor-idicated rate; Off* Refractory Period (ms) 250; 300*; 350; 400; 450; 500; 550 Output/Sesig Pulse Amplitude (V) Auto** 0,3-4,5 i steps of 0,3; 2,4* Pulse Width (ms) 0,03; 0,06; 0,09; 0,12; 0,15; 0,18; 0,21; 0,24; 0,31*; 0,37; 0,43; 0,49; 0,58; 0,70; 0,82; 1,0 P/R Sesitivity (mv) 0,5; 0,8; 1,2; 2,0; 3,0*; 5,0; 7,5; 12 ER Sesitivity (mv) 1,6; 2,5; 4,0*; 6,0; 10,0; 15,0; 24,0 Pulse Polarity Cofiguratio Uipolar Sese Polarity Cofiguratio Bipolar Rate-Modulated Parameters VARIO O; Off* Vetricular AutoCapture Pacig System O; Off* Sesor O; Off; Passive Maximum Sesor Rate (ppm)*** 90-160 i steps of 10; 130* Slope*** 1-16 i steps of 1; 10* Reactio Time*** Very Fast; Fast; Medium*; Slow; Very Slow Recovery Time*** Very Fast; Fast; Medium*; Slow; Very Slow Fast Respose*** O; Off* * Stadard/Nomial settigs. ** Oly with AutoCapture ON. *** Iactive. Activate by programmig the sesor ON or PASSIVE. (GMCRM818EN) Brief Summary: Prior to usig these devices, please review the Istructios for Use for a complete listig of idicatios, cotraidicatios, warigs, precautios, potetial adverse evets ad directios for use. Devices depicted may ot be available i all coutries. Check with your St. Jude Medical represetative for product availability i your coutry. Uless otherwise oted, idicates that the ame is a trademark of, or licesed to, St. Jude Medical or oe of its subsidiaries. ST. JUDE MEDICAL, the ie-squares symbol ad MORE CONTROL. LESS RISK. are registered ad uregistered trademarks ad service marks of St. Jude Medical, Ic. ad its related compaies. 2011 St. Jude Medical, Ic. All rights reserved. Item GMCRM818EN
Pacemakers Verity ADx XL VDR Model 5456 Rate-resposive Pacemaker Product Highlights Exteded logevity offers the beefit of fewer device replacemets, reducig the risk of complicatios associated with surgery. The AutoCapture pacig system offers the maximum i threshold adaptability ad patiet safety with Beat-by-Beat capture cofirmatio The FastPath Summary Scree displays key parameters ad follow-up test results o oe scree ad provides oe-step avigatio to all available diagostic tools. The Programmable Back-up Pulse may be programmed to either a bipolar or uipolar cofiguratio The Auto Mode Switch algorithm reliably switches to a o atrial-trackig mode i the presece of atrial tachyarrhythmia episodes. Automatic P&R Wave Measuremets provide the optio of measurig hte amplictudes of itrisic P-waves or R-waves. It the recommeds a sesitivity settig based o a recommeded safety margi. Automatic P&R Wave Measuremets promote accurate sesitivity settigs ad save valuable cliic time. Orderig Iformatio Cotets: Cardiac pulse geerator Model Number Dimesios (H x W x T, mm) Weight (g) Volume (cc) Coector 5456 44 x 52 x 6 23,5 11 (± 0,5) IS-1 Idicatios ad Usage: Implatatio of pulse geerators is idicated i the followig permaet coditios, whe associated with symptoms icludig, but ot limited to: sycope, presycope, fatigue, disorietatio or ay combiatio of those symptoms. Rate-Modulated Pacig is idicated for patiets with chrootropic icompetece, ad for those who would beefit from icreased stimulatio rates cocurret with physical activity. Dual-Chamber Pacig (Models 5826, 5820 oly) is idicated for those patiets exhibitig: sick sius sydrome, chroic, symptomatic secod- ad third-degree AV block, recurret Adams-Stokes sydrome, symptomatic bilateral budle brach block whe tachyarrhythmia ad other causes have bee ruled out. Atrial Pacig is idicated for patiets with sius ode dysfuctio ad ormal AV ad itravetricular coductio systems. Vetricular Pacig is idicated for patiets with sigificat bradycardia ad: Normal sius rhythm with oly rare episodes of A-V block or sius arrest, chroic atrial fibrillatio, severe physical disability. AF Suppressio (Models 5826, 5820 oly) is idicated for suppressio of paroxysmal or persistet atrial fibrillatio episodes i patiets with oe or more of the above pacig idicatios. For specific idicatios associated with idividual modes, refer to Operatig Modes. Cotraidicatios: Verity devices are cotraidicated i patiets with a implated cardioverter-defibrillator. Rate-Adaptive Pacig may be iappropriate for patiets who experiece agia or other symptoms of myocardial dysfuctio at higher sesor-drive rates. A appropriate Maximum Sesor Rate should be selected based o assessmet of the highest stimulatio rate tolerated by the patiet. AF Suppressio (Models 5826, 5820 oly) stimulatio is ot recommeded i patiets who caot tolerate high atrial-rate stimulatio. Dual-Chamber Pacig (Models 5826, 5820 oly) though ot cotraidicated for patiets with chroic atrial flutter, chroic atrial fibrillatio or silet atria, may provide o beefit beyod that of sigle-chamber pacig i such patiets. Sigle-Chamber Vetricular Demad Pacig is relatively cotraidicated i patiets who have demostrated pacemaker sydrome, have retrograde VA coductio or suffer a drop i arterial blood pressure with the oset of vetricular pacig. Sigle-Chamber Atrial Pacig is relatively cotraidicated i patiets who have demostrated compromise of AV coductio. For specific cotraidicatios associated with idividual modes, refer to Operatig Modes. Potetial Adverse Evets: Adverse evets associated with the use of ay pacig system iclude: Air embolism, Bleedig Hematoma, Body rejectio pheomea, Cardiac tampoade or perforatio, Formatio of fibrotic tissue, local tissue reactio, Iability to iterrogate or program due to programmer or device malfuctio, Ifectio/erosio, Iterruptio of desired pulse geerator fuctio due to electrical iterferece, either electromyogeic or electromagetic, Lead malfuctio due to coductor fracture or isulatio degradatio, Loss of capture or sesig due to lead dislodgemet or reactio at the electrode/tissue iterface, Loss of desired pacig ad/or sesig due to lead displacemet, body reactio at electrode iterface, or lead malfuctio (fracture or damage to isulatio), Loss of ormal device fuctio due to battery failure or compoet malfuctio, Pacemaker migratio, pocket erosio or hematoma, Pectoral muscle or diaphragmatic stimulatio, Phreic erve stimulatio, Peumothorax/hemothorax. Refer to the User s Maual for detailed idicatios, cotraidicatios, warigs, precautios ad potetial adverse evets. Brief Summary: Prior to usig these devices, please review the Istructios for Use for a complete listig of idicatios, cotraidicatios, warigs, precautios, potetial adverse evets ad directios for use. Devices depicted may ot be available i all coutries. Check with your St. Jude Medical represetative for product availability i your coutry. Uless otherwise oted, idicates that the ame is a trademark of, or licesed to, St. Jude Medical or oe of its subsidiaries. ST. JUDE MEDICAL, the ie-squares symbol ad MORE CONTROL. LESS RISK. are registered ad uregistered trademarks ad service marks of St. Jude Medical, Ic. ad its related compaies. 2011 St. Jude Medical, Ic. All rights reserved.
Pacemakers Verity ADx XL VDR Model 5456 Rate-resposive Pacemaker Product Specificatios PHYSICAL SPECIFICATIONS Model 5456 Dimesios (mm) 44 x 52 x 6 Weight (g) 23.5 Volume (cc) 11 1 Coector IS-1 PARAMETER SETTINGS Rate/Timig Mode VOO(R); VVI(R); VVT(R); VDD(R); OVO; OAO; ODO Base Rate (ppm) 30 2 ; 40 130 i steps of 5; 140 170 i steps of 10; 60 Hysteresis Rate (ppm) Off; 30 130 i steps of 5; 140; 150 3 Search Iterval (mi) Off; 5; 10; 15; 30 Cycle Cout 1 3; 1 Rest Rate (ppm) Off; 30 130 i steps of 5; 140; 150 Maximum Trackig Rate (ppm) 90 130 i steps of 5; 140 180 i steps of 10; 110 PV Delay (ms) 25; 30-200 i steps of 10; 225 325 i steps of 25; 150 Shortest AV/PV Delay (ms) 30 50 i steps of 5; 60 120 i steps of 10; 70 Vetricular Refractory (ms) 125 500 i steps of 25; 250 4 Atrial Refractory (PVARP) (ms) 125 500 i steps of 25; 275 Vet. Blakig (ms) 12-52 i steps of 4; 12 Far Field Protectio Iterval (ms) 16 Output/Sesig Vetricular AutoCapture Pacig System O; Off Back-up Pulse Cofiguratio Uipolar; Bipolar Evoked Respose Sesitivity (mv) Depedet upo the Measured Evoked Respose; 49.7 V. Pulse Amplitude (V) 0.0 4.0 i steps of 0.25; 4.5 7.5 i steps of 0.5; 3.5 V. Pulse Width (ms) 0.05; 0.1 1.5 i steps of 0.1; 0.4 V. Sesitivity 5 (mv) 0.5 5.0 i steps of 0.5; 6 10 i steps of 1.0; 12.5; 2.0 V. Pulse Cofiguratio Uipolar (tip case); Bipolar (tip rig) Sese Cofiguratio (A or V) Uipolar Tip (tip case); Bipolar (tip rig); Uipolar Rig (rig case) A. Sesitivity 5 (mv) 0.1; 0.2; 0.3; 0.4; 0.5; 0.75; 1.0; 1.25; 1.5; 1.75; 2.0; 2.5; 3.0; 3.5; 4.0; 5.0 Rate-Modulated Parameters Auto Mode Switch Off, DDDR to DDIR; DDD to DDI; VDDR to VVIR; VDD to VVI; DDDR to DDI; DDD to DDIR; VDDR to VVI; VDD to VVIR AMS Base Rate (ppm) Base Rate +0 to Base Rate +35 i steps of 5; 60 Sesor O; Off; Passive Max Sesor Rate (ppm) 80-150 i steps of 5; 160-180 i steps of 10; 110 Threshold Auto (-0.5); Auto (+0.0); Auto (+0.5); Auto (+1.0); Auto (+1.5); Auto +(2.0); 1-7 i steps of 0.5 Slope Auto (-1); Auto (+0); Auto (+1); Auto (+2); Auto (+3); 1-16; 8 Reactio Time Very Fast; Fast; Medium; Slow Recovery Time Fast; Medium; Slow; Very Slow Other Maget Respose Off; Battery Test AutoItrisic Coductio Search (ms) Off; +10 to +120 i steps of 10 Negative AV/PV Hysteresis Search (ms) Off; 10 to 110 i steps of 10 Atrial Tachycardia Detectio Rate (ppm) 110 150 i steps of 5; 160 200 i steps of 10; 225 300 i steps of 25; 225 Post Vet. Atrial Blakig (PVAB) (ms) 60; 70; 80; 85; 95; 100; 110; 115; 125; 130; 140; 150; 155; 165; 170; 180; 185; 195; 200 Vet. Safety Stadby Off; O PVC Optios Off; +PVARP o PVC PMT Optios Off; 10 Beats > PMT; Auto Detect PMT Detectio Rate (ppm) 90-150 i steps of 5; 160-180 i steps of 10; 110 Lead Type Ucoded; Uipolar; Bipolar Oly; Uipolar/Bipolar 1. ± 0.5 cc 2. The actual pacig rate for the 30ppm is 31ppm. 3. The highest available settig for Hysteresis Rate will be 5 ppm below the programmed Base Rate. 4. I dual-chamber modes, the maximum Vetricular Refractory Period is 325 ms. 5. Sesitvity is with respect to a 20 ms haversie test sigal. (GMCRM941EN) Brief Summary: Prior to usig these devices, please review the Istructios for Use for a complete listig of idicatios, cotraidicatios, warigs, precautios, potetial adverse evets ad directios for use. Devices depicted may ot be available i all coutries. Check with your St. Jude Medical represetative for product availability i your coutry. Uless otherwise oted, idicates that the ame is a trademark of, or licesed to, St. Jude Medical or oe of its subsidiaries. ST. JUDE MEDICAL, the ie-squares symbol ad MORE CONTROL. LESS RISK. are registered ad uregistered trademarks ad service marks of St. Jude Medical, Ic. ad its related compaies. 2011 St. Jude Medical, Ic. All rights reserved. Item GMCRM941EN
Pacig Leads
St. Jude Medical Pacig Leads The St. Jude Medical portfolio of highly advaced bradycardia pacig leads has bee desiged for ease of implat, reliability ad performace. Optim lead isulatio used i the ewest leads is the first silicoe-polyurethae co-polymer isulatio desiged specifically for cardiac lead use. The iovative isulatio material bleds the best features of polyurethae ad silicoe, eablig the durability of polyurethae ad the flexibility of silicoe. Optios with shorter tip-to-rig spacig allow for more accurate sesig ad appropriate diagostics ad therapies. Vetricular straight or atrial J-shape active fixatio optios ad multiple legths offer the flexibility to address the eeds of patiets with varyig physical statures ad vascular aatomies. Three differet J-shape stylets ad a log tool provide optios for atrial lead placemet ad lead hadlig prefereces. Steroid elutio ad titaium itride fractal coatig o electrodes eable low thresholds.
Pacig Leads Tedril MRI Pacig Lead Product Highlights The Tedril MRI lead is desiged to esure patiet safety while performig a MRI sca 1 The Tedril MRI coditioal lead must be used i cojuctio with a MRI device from St. Jude Medical ad with a 1,5 T (Tesla) MRI scaer Soft silicoe tip offers more compliace at the lead tip-edocardium iterface The soft silicoe tip o the Tedril MRI LPA1200M lead reduces tip pressure by approximately 50% over 6 F leads without a soft silicoe tip 2 Though the soft silicoe icreases the surface area of the lead tip to 9 F, the Tedril MRI lead still fits through a 8 F itroducer due to the material s soft ature. Four pads o the silicoe tip further icrease the surface area of the lead tip that is i cotact with the tissue Optim lead isulatio a chemical co-polymer that bleds the best features of polyurethae ad silicoe provides improved hadlig ad icreased durability Limited lifetime warraty Terms ad coditios apply. Refer to the warraty for details 1. See maual for additioal details before performig a MRI sca. 2. Bech testig data o file. Orderig Iformatio Cotets: Cardiac pacig lead Model Number Isulatio Fixatio Mi. Itroducer (F) Coector Legth (cm) LPA1200M Optim Ext/Ret helix 8 IS-1 bipolar 46, 52 ad 58 Easily idetifiable uique radiopaque markers t t Idicatios: The Tedril MRI lead is desiged for permaet sesig ad pacig i either the right atrium or the right vetricle, i combiatio with a compatible device. Active leads such as the Tedril MRI lead may be idicated for patiets where permaet fixatio of passive leads is suspected to be ustable. I atrial applicatios, the use of a screw-i lead such as Tedril MRI lead may be idicated i the presece of a abormal, surgically altered or excised atrial appedage. This is a MR Coditioal lead. MR Coditioal Pacig System: The St. Jude Medical MRI coditioal lead is part of the St. Jude Medical MRI coditioal pacig system. Patiets with a implated St. Jude Medical MRI coditioal pacig system ca have a MRI sca if the coditios for use, as described i the MRI Procedure Iformatio documet, are met. Cotraidicatios: The Tedril MRI lead is cotraidicated i the presece of tricuspid atresia, for patiets with mechaical tricuspid valves, ad i patiets who are expected to be hypersesitive to a sigle dose of oe milligram of dexamethasoe sodium phosphate. Adverse Evets: Potetial complicatios associated with the use of Tedril MRI leads are the same as with the use of other active fixatio leads ad iclude: perforatio of the myocardium, cardiac tampoade, phreic erve stimulatio, dislodgemet of the pacig lead, embolism, temporary or permaet loss of stimulatio ad/or sesig, ifectio, valve ad/or vessel damage, tissue ecrosis. Refer to the User s Maual for more detailed idicatios, cotraidicatios, warigs, precautios ad potetial adverse evets. Brief Summary: Prior to usig these devices, please review the Istructios for Use for a complete listig of idicatios, cotraidicatios, warigs, precautios, potetial adverse evets ad directios for use. Devices depicted may ot be available i all coutries. Check with your St. Jude Medical represetative for product availability i your coutry. Uless otherwise oted, idicates that the ame is a trademark of, or licesed to, St. Jude Medical or oe of its subsidiaries. ST. JUDE MEDICAL, the ie-squares symbol ad MORE CONTROL. LESS RISK. are registered ad uregistered trademarks ad service marks of St. Jude Medical, Ic. ad its related compaies. 2011 St. Jude Medical, Ic. All rights reserved.
Pacig Leads Tedril MRI Pacig Lead Product Specificatios PHYSICAL SPECIFICATIONS Model LPA1200M Miimum Itroducer Size 8 F Miimum Itroducer Size with Guidewire 10,5 F Type of Lead Active-fixatio, steroid-elutig, edocardial, straight pacig lead Lead Coector IS-1 bipolar Lead Legths 46, 52 ad 58 cm Fixatio Mechaism Extedable/Retractable helix Typical Number of Rotatios for Helix Extesio 5-10 (straight stylet) Lead Body Diameter 2,18 mm (max)/6,6 F Tip-to-Rig Spacig 10 mm Lead Tip Electrode (Cathode) Active TiN-coated Pt/Ir helix (1,8 mm extesio) Tip Electrode Surface Area 6,8 mm 2 Rig Electrode (Aode) TiN-coated Pt/Ir Rig Electrode Surface Area 16,5 mm 2 Mappig Capable with TiN-coated Pt/Ir helix Steroid Silicoe plug with <1 mg dexamethasoe sodium phosphate Ier Coductor/Outer Coductor MP35N * coil Ier Isulatio Silicoe Outer Isulatio Optim lead isulatio I Pack Straight stylets J-shaped stylets Helix extesio/retractio clip-o tools 1 x-soft i lead, 1 x-soft, 1 soft 2 soft 2 clip-o tools Accessory Kits Available Separately Model Number Compatible Legths Descriptio Stylet Kit DSO6002 with appropriate 46, 52 ad 58 cm 1 fixatio tool, 1 clip-o tool, legth desigatio 1 J-shaped soft, 1 x-soft, 1 soft, 1 firm, 1 x-firm DSO6003 with appropriate 46, 52 ad 58 cm 1 clip-o tool, 1 J-shaped soft, legth desigatio 1 x-soft, 1 soft, 1 firm, 1 x-firm Locator Plus 1281 with appropriate 46, 52 ad 58 cm Disposable implat tool to Deflectable Stylet legth desigatio facilitate precise lead positioig 1292 with appropriate 46, 52 ad 58 cm ad maipulatio with oe had legth desigatio *MP35N is a trademark of SPS Techologies, Ic. (GMCRM741EN) Brief Summary: Prior to usig these devices, please review the Istructios for Use for a complete listig of idicatios, cotraidicatios, warigs, precautios, potetial adverse evets ad directios for use. Devices depicted may ot be available i all coutries. Check with your St. Jude Medical represetative for product availability i your coutry. Uless otherwise oted, idicates that the ame is a trademark of, or licesed to, St. Jude Medical or oe of its subsidiaries. ST. JUDE MEDICAL, the ie-squares symbol ad MORE CONTROL. LESS RISK. are registered ad uregistered trademarks ad service marks of St. Jude Medical, Ic. ad its related compaies. 2011 St. Jude Medical, Ic. All rights reserved. Item GMCRM741EN
Pacig Leads Tedril STS Pacig Lead Product Highlights Soft silicoe tip offers more compliace ad less tip pressure at the lead tip-edocardium iterface Small diameter lead offers improved ease of veous passage, reduced risk of veous thrombosis or rib-clavicle crush ad ability to accommodate additioal leads more easily Optim lead isulatio a chemical co-polymer that bleds the best features of polyurethae ad silicoe for improved hadlig ad icreased durability Titaium itride (TiN) fractal coatig o the tip ad rig electrodes is desiged to promote precise sesig ad to provide improved cotact with the myocardium Lubricious Fast-Pass coatig facilitates lead isertio through the itroducer ad veis to ease implatatio Fits through a 6 F itroducer Orderig Iformatio Cotets: Cardiac pacig lead Model Number Isulatio Fixatio Mi. Itroducer (F) Coector Legths (cm) 2088TC Optim Ext/Ret Helix 6 IS-1 bipolar 46; 52; 58 Idicatios: Tedril STS Lead is desiged for permaet sesig ad pacig i either the right atrium or the right vetricle, i combiatio with a compatible device. Active leads such as the Tedril STS lead may be idicated for patiets where permaet fixatio of passive leads is suspected to be ustable. I atrial applicatios, the use of screw-i leads such as Tedril STS lead may be idicated i the presece of a abormal, surgically altered or excised atrial appedage. Cotraidicatios: Tedril STS lead is cotraidicated: i the presece of tricuspid atresia, for patiets with mechaical tricuspid valves, i patiets who are expected to be hypersesitive to a sigle dose of oe milligram of dexamethasoe sodium phosphate. Adverse Evets: Potetial complicatios associated with the use of Tedril STS lead are the same as with the use of other active fixatio leads ad iclude: cardiac tampoade, diaphragmatic stimulatio, embolism, excessive bleedig, iduced vetricular ectopy, ifectio, loss of pacig ad/or sesig due to dislodgmet or mechaical malfuctio of the pacig lead, phreic erve stimulatio, thrombosis. Complicatios reported with direct subclavia veipucture iclude peumothorax, hemothorax, laceratio of the subclavia artery, arterioveous fistula, eural damage, thoracic duct ijury, caulatio of other vessels, massive hemorrhage ad, rarely, death. Refer to the User s Maual for detailed idicatios, cotraidicatios, warigs, precautios ad potetial adverse evets. Brief Summary: Prior to usig these devices, please review the Istructios for Use for a complete listig of idicatios, cotraidicatios, warigs, precautios, potetial adverse evets ad directios for use. Devices depicted may ot be available i all coutries. Check with your St. Jude Medical represetative for product availability i your coutry. Uless otherwise oted, idicates that the ame is a trademark of, or licesed to, St. Jude Medical or oe of its subsidiaries. ST. JUDE MEDICAL, the ie-squares symbol ad MORE CONTROL. LESS RISK. are registered ad uregistered trademarks ad service marks of St. Jude Medical, Ic. ad its related compaies. 2011 St. Jude Medical, Ic. All rights reserved.
Pacig Leads Tedril STS Pacig Lead Product Specificatios PHYSICAL SPECIFICATIONS Model 2088TC Miimum Itroducer Size 6 F Type of Lead Active-fixatio, bipolar, steroid-elutig, edocardial, pacig lead Lead Coector IS-1 bipolar Lead Legths 46; 52; 58 cm Fixatio Mechaism Extedable/Retractable helix Typical Number of Rotatios for Helix Extesio 6-11 (straight stylet) Lead Body Diameter 1,9 mm (max) Tip-to-Rig Spacig 10 mm Lead Tip Electrode (Cathode) Active titaium-itride-coated Pt/Ir helix (2,0 mm extesio) Tip Electrode Surface Area 6,9 mm 2 Rig Electrode (Aode) Titaium-itride-coated Pt/Ir Rig Electrode Surface Area 16 mm 2 Mappig Capable with titaium-itride-coated Pt/Ir helix Steroid < 1 mg dexamethasoe sodium phosphate Ier Coductor/Outer Coductor MP35N * coil Ier Isulatio Silicoe rubber Outer Isulatio Optim lead isulatio Lead Body Coatig Fast-Pass coatigp I Pack Straight stylets 1 x-soft i lead; 1 x-soft; 1 soft J-curved stylets 2 soft Helix extesio/retractio clip-o tools 2 clip-o tools Accessory Kits Available Separately Model Number Compatible Legths Descriptio Stylet Kit DSO6002 with appropriate 46; 52; 58 cm 1 fixatio tool; 1 clip-o tool; legth desigatio 1 J-shaped soft; 1 x-soft; 1 soft; 1 firm; 1 x-firm DSO6003 with appropriate 46; 52; 58 cm 1 clip-o tool; 1 J-shaped soft; legth desigatio 1 x-soft; 1 soft; 1 firm; 1 x-firm Locator Plus 1281 with appropriate 46; 52; 58 cm Disposable implat tool to Deflectable Stylet legth desigatio facilitate precise lead positioig 1292 with appropriate 46; 52; 58 cm ad maipulatio with oe had legth desigatio *MP35N is a trademark of SPS Techologies, Ic. (GMCRM822EN) Brief Summary: Prior to usig these devices, please review the Istructios for Use for a complete listig of idicatios, cotraidicatios, warigs, precautios, potetial adverse evets ad directios for use. Devices depicted may ot be available i all coutries. Check with your St. Jude Medical represetative for product availability i your coutry. Uless otherwise oted, idicates that the ame is a trademark of, or licesed to, St. Jude Medical or oe of its subsidiaries. ST. JUDE MEDICAL, the ie-squares symbol ad MORE CONTROL. LESS RISK. are registered ad uregistered trademarks ad service marks of St. Jude Medical, Ic. ad its related compaies. 2011 St. Jude Medical, Ic. All rights reserved. Item GMCRM822EN
Pacig Leads OptiSese Pacig Lead Product Highlights OptiSese lead techology offers optimal tip-to-rig spacig for more precise atrial sesig without iappropriately sesig extra-atrial sigals Uique 1,1 mm tip-to-rig spacig eables sesig of eve the fiest atrial arrhythmia sigals (stadard atrial leads typically have a tip-to-rig spacig of 10 mm or more) Accurate atrial sesig eables appropriate atrial diagostics ad therapies Less far-field R-wave iterferece with iovative far-field sigal reductio techology Optim lead isulatio a chemical co-polymer that bleds the best features of polyurethae ad silicoe for improved hadlig ad icreased durability Thi lead body diameter of 5,8 F ca be iserted usig a 7 F itroducer Steroid elutio ad titaium itride fractal coatig o electrodes for low thresholds Icludes three differet J-shaped stylets providig optios for differet patiet aatomies ad hadlig prefereces Orderig Iformatio Cotets: Cardiac pacig lead Model Number Isulatio Fixatio Mi. Itroducer (F) Coector Legths (cm) 1999 Optim Ext/Ret helix 7 IS-1 bipolar 40; 46; 52 Idicatios: The OptiSese lead is desiged for permaet sesig ad pacig i the atrium with a compatible pulse geerator. A active lead, such as the OptiSese, may be idicated for patiets where permaet fixatio of passive leads is suspected to be ustable. I atrial applicatios, the use of a screw-i lead, such as the OptiSese, may be idicated i the presece of a abormal, surgically altered or excised atrial appedage. Cotraidicatios: The OptiSese lead is cotraidicated: I the presece of tricuspid atresia, for patiets with mechaical tricuspid valves, i patiets who are expected to be hypersesitive to a sigle dose of oe milligram of dexamethasoe sodium phosphate. Adverse Evets: Potetial complicatios associated with the use of OptiSese leads are the same as with the use of other active fixatio leads ad iclude: cardiac tampoade, diaphragmatic stimulatio, embolism, excessive bleedig, iduced vetricular ectopy, ifectio, loss of pacig ad/or sesig due to dislodgmet or mechaical malfuctio of the pacig lead, phreic erve stimulatio, thrombosis. Complicatios reported with direct subclavia veipucture iclude peumothorax, hemothorax, laceratio of the subclavia artery, arterioveous fistula, eural damage, thoracic duct ijury, caulatio of other vessels, massive hemorrhage ad, rarely, death. Refer to the User s maual for detailed idicatios, cotraidicatios, warigs, precautios ad potetial adverse evets. Brief Summary: Prior to usig these devices, please review the Istructios for Use for a complete listig of idicatios, cotraidicatios, warigs, precautios, potetial adverse evets ad directios for use. Devices depicted may ot be available i all coutries. Check with your St. Jude Medical represetative for product availability i your coutry. Uless otherwise oted, idicates that the ame is a trademark of, or licesed to, St. Jude Medical or oe of its subsidiaries. ST. JUDE MEDICAL, the ie-squares symbol ad MORE CONTROL. LESS RISK. are registered ad uregistered trademarks ad service marks of St. Jude Medical, Ic. ad its related compaies. 2011 St. Jude Medical, Ic. All rights reserved.
Pacig Leads OptiSese Pacig Lead Product Specificatios PHYSICAL SPECIFICATIONS Model 1999 Miimum Itroducer Size 7 F Type of Lead Active-fixatio; bipolar; steroid-elutig; edocardial; atrial pacig lead Lead Coector IS-1 bipolar Lead Legths 40; 46; 52 cm Fixatio Mechaism Extedable/Retractable helix Lead Body Diameter 0,076 /1,9 mm (5,8 F) Tip-to-rig Spacig 1,1 mm Lead Tip Electrode (Cathode) Active titaium-itride-coated Pt/Ir helix (1,8 mm extesio) Tip Electrode Surface Area 6,4 mm 2 Rig Electrode (Aode) Titaium-itride-coated titaium rig Rig Electrode Surface Area 17 mm 2 Mappig Capable with titaium-itride-coated Pt/Ir helix Steroid < 1 mg dexamethasoe sodium phosphate Ier Coductor/Outer Coductor MP35N * coil Ier Isulatio Silicoe rubber Outer Isulatio Optim lead isulatio Lead Body Coatig Fast-Pass coatigparameter SETTINGS I Pack Straight Stylets 1 x-soft i lead; 1 x-soft; 1 soft J-curved Stylets 1 stadard; 1 wide; 1 arrow Helix Extesio/Retractio Clip-o Tools 2 clip-o tools Accessory Kits Available Separately Model Number Compatible Legths Descriptio Stylet Kit DS06000 with appropriate 40; 46; 52 cm 1 fixatio tool; 1 clip-o tool; 1 stadard J shape legth desigatio 1 wide J shape; 1 arrow J shape DS06001 with appropriate 40; 46; 52 cm 1 clip-o tool; 1 stadard J shape legth desigatio 1 wide J shape; 1 arrow J shape DSO6002 with appropriate 46; 52 cm 1 fixatio tool; 1 clip-o tool; legth desigatio 1 J-shaped soft; 1 x-soft; 1 soft; 1 firm; 1 x-firm DSO6003 with appropriate 40; 46; 52 cm 1 clip-o tool; 1 J-shaped soft; legth desigatio 1 x-soft; 1 soft; 1 firm; 1 x-firm Locator Plus 1281 with appropriate 46; 52 cm Disposable implat tool that facilitates Deflectable Stylet legth desigatio precise lead positioig ad allows 1292 with appropriate 46; 52 cm maipulatio with oe had legth desigatio Limited Lifetime Warraty Terms ad coditios apply; refer to the warraty for details. * MP35N is a registered trademark of SPS Techologies, Ic. (GMCRM824EN) Brief Summary: Prior to usig these devices, please review the Istructios for Use for a complete listig of idicatios, cotraidicatios, warigs, precautios, potetial adverse evets ad directios for use. Devices depicted may ot be available i all coutries. Check with your St. Jude Medical represetative for product availability i your coutry. Uless otherwise oted, idicates that the ame is a trademark of, or licesed to, St. Jude Medical or oe of its subsidiaries. ST. JUDE MEDICAL, the ie-squares symbol ad MORE CONTROL. LESS RISK. are registered ad uregistered trademarks ad service marks of St. Jude Medical, Ic. ad its related compaies. 2011 St. Jude Medical, Ic. All rights reserved. Item GMCRM824EN
Pacig Leads Tedril ST Optim Pacig Lead Product Highlights Optim lead isulatio a chemical co-polymer that bleds the best features of polyurethae ad silicoe for improved hadlig ad icreased durability Thi lead body to provide ease of passage ad a small veous space Active mappig collar eables threshold measuremets prior to extedig the helix to save time at implat Vetricular straight or atrial J-shaped active-fixatio optios Orderig Iformatio Cotets: Cardiac pacig lead Model Type of Mi. Number Lead Isulatio Fixatio Itroducer (F) Coector Legths (cm) 1888TC Straight Optim Ext/Ret Helix 6 IS-1 bipolar 46; 52; 58; 65 1882TC Atrial J Optim Ext/Ret Helix 7 IS-1 bipolar 46; 52 Idicatios: The Tedril ST Optim lead is desiged for permaet sesig ad pacig i either the atrium or the vetricle, i combiatio with a compatible pulse geerator. A active lead, such as the Tedril ST Optim, may be idicated for patiets where permaet fixatio of passive leads is suspected to be ustable. I atrial applicatios, the use of a screw-i lead, such as the Tedril SDX, may be idicated i the presece of a abormal, surgically altered or excised atrial appedage. Cotraidicatios: The Tedril ST Optim lead is cotraidicated: I the presece of tricuspid atresia, for patiets with mechaical tricuspid valves, i patiets who are expected to be hypersesitive to a sigle dose of oe milligram of dexamethasoe sodium phosphate. Adverse Evets: Potetial complicatios associated with the use of Tedril ST Optim leads are the same as with the use of other active fixatio leads ad iclude: cardiac tampoade, diaphragmatic stimulatio, embolism, excessive bleedig, iduced vetricular ectopy, ifectio, loss of pacig ad/or sesig due to dislodgmet or mechaical malfuctio of the pacig lead, phreic erve stimulatio, thrombosis. Complicatios reported with direct subclavia veipucture iclude peumothorax, hemothorax, laceratio of the subclavia artery, arterioveous fistula, eural damage, thoracic duct ijury, caulatio of other vessels, massive hemorrhage ad, rarely, death. Refer to the User s Maual for detailed idicatios, cotraidicatios, warigs, precautios ad potetial adverse evets. Brief Summary: Prior to usig these devices, please review the Istructios for Use for a complete listig of idicatios, cotraidicatios, warigs, precautios, potetial adverse evets ad directios for use. Devices depicted may ot be available i all coutries. Check with your St. Jude Medical represetative for product availability i your coutry. Uless otherwise oted, idicates that the ame is a trademark of, or licesed to, St. Jude Medical or oe of its subsidiaries. ST. JUDE MEDICAL, the ie-squares symbol ad MORE CONTROL. LESS RISK. are registered ad uregistered trademarks ad service marks of St. Jude Medical, Ic. ad its related compaies. 2011 St. Jude Medical, Ic. All rights reserved.
Pacig Leads Tedril ST Optim Pacig Lead Product Specificatios PHYSICAL SPECIFICATIONS Models 1888TC 1882TC Miimum Itroducer Size 6 F 7 F Type of Lead Trasveous, screw-i, bipolar, steroid Trasveous, screw-i, bipolar, steroid Shape Straight Atrial J Lead Legths 46; 52; 58; 65 cm 46; 52 cm Fixatio Extedable/retractable helix Extedable/retractable helix Tip-to-Rig Spacig 10 mm 10 mm Lead Tip Electrode (Cathode) Pt/Ir collar + active titaium itride coated Pt/Ir collar + active titaium itride coated Pt/Ir helix (2 mm extesio) Pt/Ir helix (2 mm extesio) Tip Electrode Surface Area 8,5 mm 2 8,5 mm 2 Rig Electrode (Aode) Titaium itride coated Pt/Ir rig Titaium itride coated Pt/Ir rig Rig Electrode Surface Area 16 mm 2 16 mm 2 Mappig Available with collar Available with collar Steroid Elutio Yes Yes Coductor MP35N * coil MP35N * coil Isulatio Optim Optim Accessory Kits Available Separately Accessory Model Available Legths Descriptio Stylet Accessory Kit Model DS06002 Number ad DS06003 with appropriate legth desigatio 46; 52; 58; 65 cm Available Legths Descriptio 4 straight stylets (1x soft; 1 soft; 1 firm; 1 x firm); 1 j; 1 uiversal clip-o tool for use with TC model Tedril ad Tedril ST leads *MP35N is a trademark of SPS Techologies, Ic. (GMCRM821EN) Brief Summary: Prior to usig these devices, please review the Istructios for Use for a complete listig of idicatios, cotraidicatios, warigs, precautios, potetial adverse evets ad directios for use. Devices depicted may ot be available i all coutries. Check with your St. Jude Medical represetative for product availability i your coutry. Uless otherwise oted, idicates that the ame is a trademark of, or licesed to, St. Jude Medical or oe of its subsidiaries. ST. JUDE MEDICAL, the ie-squares symbol ad MORE CONTROL. LESS RISK. are registered ad uregistered trademarks ad service marks of St. Jude Medical, Ic. ad its related compaies. 2011 St. Jude Medical, Ic. All rights reserved. Item GMCRM821EN
Pacig Leads Tedril SDX Pacig Lead Product Highlights Radiopaque suture sleeve, ultra-thi lead body ad Fast-Pass coatig for easy implatatio Steroid elutio ad titaium itride fractal coatig o electrodes for low thresholds Shorter tip-to-rig spacig ad silicoe isulatio for high performace ad reliability Orderig Iformatio Cotets: Cardiac pacig lead Model Number Isulatio Fixatio Mi. Itroducer (F) Coector Legth (cm) 1688TC Silicoe Rubber Ext/Ret Helix 7 IS-1 bipolar 100 Idicatios: The Tedril SDX lead is desiged for permaet sesig ad pacig i either the atrium or the vetricle, i combiatio with a compatible pulse geerator. A active lead, such as the Tedril SDX, may be idicated for patiets where permaet fixatio of passive leads is suspected to be ustable. I atrial applicatios, the use of a screw-i lead, such as the Tedril SDX, may be idicated i the presece of a abormal, surgically altered or excised atrial appedage. Cotraidicatios: The Tedril SDX lead is cotraidicated: I the presece of tricuspid atresia, for patiets with mechaical tricuspid valves, i patiets who are expected to be hypersesitive to a sigle dose of oe milligram of dexamethasoe sodium phosphate. Adverse Evets: Potetial complicatios associated with the use of Tedril SDX leads are the same as with the use of other active fixatio leads ad iclude: cardiac tampoade, diaphragmatic stimulatio, embolism, excessive bleedig, iduced vetricular ectopy, ifectio, loss of pacig ad/or sesig due to dislodgmet or mechaical malfuctio of the pacig lead, phreic erve stimulatio, thrombosis. Complicatios reported with direct subclavia veipucture iclude peumothorax, hemothorax, laceratio of the subclavia artery, arterioveous fistula, eural damage, thoracic duct ijury, caulatio of other vessels, massive hemorrhage ad, rarely, death. Refer to the User s Maual for detailed idicatios, cotraidicatios, warigs, precautios ad potetial adverse evets. Brief Summary: Prior to usig these devices, please review the Istructios for Use for a complete listig of idicatios, cotraidicatios, warigs, precautios, potetial adverse evets ad directios for use. Devices depicted may ot be available i all coutries. Check with your St. Jude Medical represetative for product availability i your coutry. Uless otherwise oted, idicates that the ame is a trademark of, or licesed to, St. Jude Medical or oe of its subsidiaries. ST. JUDE MEDICAL, the ie-squares symbol ad MORE CONTROL. LESS RISK. are registered ad uregistered trademarks ad service marks of St. Jude Medical, Ic. ad its related compaies. 2011 St. Jude Medical, Ic. All rights reserved.
Pacig Leads Tedril SDX Pacig Lead Product Specificatios PHYSICAL SPECIFICATIONS Model 1688TC Lead Coector IS-1 Bipolar Legth 100 cm Miimum Itroducer Size 7 F Type of Lead Trasveous, screw-i, bipolar, steroid Fixatio Mechaism Extedable/Retractable helix (3 facet) Exteral Lead Body Diameter 0,081 /2,1 mm (6,2 F) Tip-to-Rig Spacig 10 mm Lead Tip Electrode (Cathode) Pt/Ir collar + active titaium itride coated Pt/Ir helix (1,8 mm extesio) Tip Electrode Surface Area 8 mm 2 (collar: 2,4 mm 2 ; helix: 5,6 mm 2 ) Rig Electrode (Aode) Titaium itride coated Pt/Ir rig Rig Electrode Surface Area 16 mm 2 Mappig Available with collar Steroid 1 mg dexamethasoe sodium phosphate Ier Coductor MP35N * coil Ier Isulatio Silicoe rubber Outer Coductor MP35N * coil Outer Isulatio Silicoe rubber * MP35N is a trademark of SPS Techologies, Ic. (GMCRM823EN) Brief Summary: Prior to usig these devices, please review the Istructios for Use for a complete listig of idicatios, cotraidicatios, warigs, precautios, potetial adverse evets ad directios for use. Devices depicted may ot be available i all coutries. Check with your St. Jude Medical represetative for product availability i your coutry. Uless otherwise oted, idicates that the ame is a trademark of, or licesed to, St. Jude Medical or oe of its subsidiaries. ST. JUDE MEDICAL, the ie-squares symbol ad MORE CONTROL. LESS RISK. are registered ad uregistered trademarks ad service marks of St. Jude Medical, Ic. ad its related compaies. 2011 St. Jude Medical, Ic. All rights reserved. Item GMCRM823EN
Pacig Leads IsoFlex Optim Pacig Lead Product Highlights Straight or J-shaped lead is available i multiple legths to accommodate varyig eeds ad patiet aatomies Optim lead isulatio a chemical co-polymer that bleds the best features of polyurethae ad silicoe provides improved hadlig ad icreased durability Symmetrical lead body with coaxial multifilar coils for reliability Steroid-elutig tip for reduced iflammatio at the lead-tissue iterface ad low pacig thresholds Small tip surface area for higher impedace levels ad optimal device logevity Titaium itrade (TiN) coated tip ad rig electrode for low polarizatio values ad compatibility with the AutoCapture Pacig System algorithm Radiopaque suture sleeve for visibility uder fluoroscopy to simplify ivasive procedures Orderig Iformatio Cotets: Cardiac pacig lead Model Number Isulatio Fixatio Mi. Itroducer (F) Coector Legths (cm) 1944 (J-Shaped) Optim Ties 7 IS-1 bipolar 46; 52 1948 (Straight) Optim Ties 7 IS-1 bipolar 46; 52; 58 Idicatios: The IsoFlex lead is desiged for permaet sesig ad pacig i the atrium with a compatible pulse geerator. A active lead, such as the IsoFlex, may be idicated for patiets where permaet fixatio of passive leads is suspected to be ustable. I atrial applicatios, the use of a screw-i lead, such as the IsoFlex, may be idicated i the presece of a abormal, surgically altered or excised atrial appedage. Cotraidicatios: The IsoFlex lead is cotraidicated: I the presece of tricuspid atresia, for patiets with mechaical tricuspid valves, i patiets who are expected to be hypersesitive to a sigle dose of oe milligram of dexamethasoe sodium phosphate. Adverse Evets: Potetial complicatios associated with the use of IsoFlex leads are the same as with the use of other active fixatio leads ad iclude: cardiac tampoade, diaphragmatic stimulatio, embolism, excessive bleedig, iduced vetricular ectopy, ifectio, loss of pacig ad/or sesig due to dislodgmet or mechaical malfuctio of the pacig lead, phreic erve stimulatio, thrombosis. Complicatios reported with direct subclavia veipucture iclude peumothorax, hemothorax, laceratio of the subclavia artery, arterioveous fistula, eural damage, thoracic duct ijury, caulatio of other vessels, massive hemorrhage ad, rarely, death. Refer to the User s maual for detailed idicatios, cotraidicatios, warigs, precautios ad potetial adverse evets. Brief Summary: Prior to usig these devices, please review the Istructios for Use for a complete listig of idicatios, cotraidicatios, warigs, precautios, potetial adverse evets ad directios for use. Devices depicted may ot be available i all coutries. Check with your St. Jude Medical represetative for product availability i your coutry. Uless otherwise oted, idicates that the ame is a trademark of, or licesed to, St. Jude Medical or oe of its subsidiaries. ST. JUDE MEDICAL, the ie-squares symbol ad MORE CONTROL. LESS RISK. are registered ad uregistered trademarks ad service marks of St. Jude Medical, Ic. ad its related compaies. 2011 St. Jude Medical, Ic. All rights reserved.
Pacig Leads IsoFlex Optim Pacig Lead Product Specificatios PHYSICAL SPECIFICATIONS Model 1944 1948 Miimum Itroducer Size 7 F 7 F Type of Lead bipolar, passive fixatio lead bipolar, passive fixatio lead Lead Coector IS-1 bipolar IS-1 bipolar Lead Legths 46; 52 cm 46; 52; 58 cm Fixatio Mechaism ties ties Tip-to-rig Spacig 10 mm 10 mm Lead Tip Electrode (Cathode) Semi spherical shape, steroid coatig Semi spherical shape, steroid coatig Tip Electrode Surface Area 3,5 mm 2 Rig Electrode (Aode) Platium-iridium, coated with titaium itrade 3,5 mm 2 Rig Electrode Surface Area 16 mm 2 16 mm 2 Steroid < 1 mg dexamethasoe sodium phosphate i silicoe matrix < 1 mg dexamethasoe sodium phosphate i silicoe matrix Ier Isulatio Silicoe rubber Silicoe rubber Outer Isulatio Optim lead isulatio Optim lead isulatio Lead Body Coatig Fast-Pass coatigparameter Fast-Pass coatigparam SETTINGS I Pack Straight Stylets 1 x-soft i lead; 1 x-soft; 1 soft J-curved Stylets 1 stadard; 1 wide; 1 arrow Helix Extesio/Retractio Clip-o Tools 2 clip-o tools Accessory Kits Available Separately Model Number Compatible Legths Descriptio Stylet Kit 4064 40, 46, 52, 58 ad 85 cm X-Firm Stylets (2) Stylet Kit 4062 40, 46, 52, 58 ad 85 cm Firm Stylets (2) Stylet Kit 4060 40, 46, 52, 58 ad 85 cm Soft Stylets (2) Limited Lifetime Warraty Terms ad coditios apply; refer to the warraty for details. (GMCRM915EN) Brief Summary: Prior to usig these devices, please review the Istructios for Use for a complete listig of idicatios, cotraidicatios, warigs, precautios, potetial adverse evets ad directios for use. Devices depicted may ot be available i all coutries. Check with your St. Jude Medical represetative for product availability i your coutry. Uless otherwise oted, idicates that the ame is a trademark of, or licesed to, St. Jude Medical or oe of its subsidiaries. ST. JUDE MEDICAL, the ie-squares symbol ad MORE CONTROL. LESS RISK. are registered ad uregistered trademarks ad service marks of St. Jude Medical, Ic. ad its related compaies. 2011 St. Jude Medical, Ic. All rights reserved. Item GMCRM915EN
Pacig Leads AV Plus DX VDD Pacig Lead Product Highlights Depedig o the model, the AV Plus DX lead is available i multiple legths, affordig physicias the flexibility to address the eeds of patiets with varyig physical statures Radiopaque Suture Sleeve is desiged to be visible o fluoroscopy, helpig physicias to locate the suture sleeve durig implat Fast-Pass coatig makes the lead highly lubricious, helpig to facilitate lead isertio through the itroducer ad the veis Durable Desig utilises a bipolar coaxial multifilar lead body desig with silicoe isulatio costructio Tip electrode surface area helps to provide higher lead impedace, thereby reducig pacig curret drai ad ehacig logevity Offers a steroid-elutig plug iside the lead s tip electrode that is desiged to reduce tissue iflammatio at the electrode-tissue iterface The tip ad rig electrodes are coated with titaium itride (TiN), which is desiged to expad the electrode s virtual surface area, thus providig low polarisatio values ad improved sesig Orderig Iformatio Cotets: Cardiac pacig lead Model Number Isulatio Fixatio Mi. Itroducer (F) Coector Legths (cm) 1368 Silicoe Ties 9 IS-1 bipolar 52; 58; 65 Idicatios: The AV Plus DX VDD lead is desiged for permaet sesig ad pacig i the atrium with a compatible pulse geerator. A active lead, such as the AV Plus DX VDD, may be idicated for patiets where permaet fixatio of passive leads is suspected to be ustable. I atrial applicatios, the use of a screw-i lead, such as the AV Plus DX VDD, may be idicated i the presece of a abormal, surgically altered or excised atrial appedage. Cotraidicatios: The AV Plus DX VDD lead is cotraidicated: I the presece of tricuspid atresia, for patiets with mechaical tricuspid valves, i patiets who are expected to be hypersesitive to a sigle dose of oe milligram of dexamethasoe sodium phosphate. Adverse Evets: Potetial complicatios associated with the use of AV Plus DX VDD leads are the same as with the use of other active fixatio leads ad iclude: cardiac tampoade, diaphragmatic stimulatio, embolism, excessive bleedig, iduced vetricular ectopy, ifectio, loss of pacig ad/or sesig due to dislodgmet or mechaical malfuctio of the pacig lead, phreic erve stimulatio, thrombosis. Complicatios reported with direct subclavia veipucture iclude peumothorax, hemothorax, laceratio of the subclavia artery, arterioveous fistula, eural damage, thoracic duct ijury, caulatio of other vessels, massive hemorrhage ad, rarely, death. Refer to the User s maual for detailed idicatios, cotraidicatios, warigs, precautios ad potetial adverse evets. Brief Summary: Prior to usig these devices, please review the Istructios for Use for a complete listig of idicatios, cotraidicatios, warigs, precautios, potetial adverse evets ad directios for use. Devices depicted may ot be available i all coutries. Check with your St. Jude Medical represetative for product availability i your coutry. Uless otherwise oted, idicates that the ame is a trademark of, or licesed to, St. Jude Medical or oe of its subsidiaries. ST. JUDE MEDICAL, the ie-squares symbol ad MORE CONTROL. LESS RISK. are registered ad uregistered trademarks ad service marks of St. Jude Medical, Ic. ad its related compaies. 2011 St. Jude Medical, Ic. All rights reserved.
Pacig Leads AV Plus DX VDD Pacig Lead Product Specificatios PHYSICAL SPECIFICATIONS Model 1368 Miimum Itroducer Size 9 F Lead Coector IS-1 Bipolar Lead Legths 52; 58; 65 cm Fixatio Mechaism Ties Lead Body Diameter 2,0 mm Tip to Vetricular Rig Spacig 15 mm Tip to Atrial Rig Spacig 130 mm Lead Tip Electrode Semispherical shape, steroid coatig Tip to Electrode Surface Area 5 mm 2 Rig Electrode Platium-iridium, coated with microporous titaium itride Rig Electrode Surface Area 32 mm 2 Steroid <1 mg dexamethasoe sodium phosphate i silicoe matrix Isulatio Silicoe TTINGS Accessory Kits Available Separately Model Number Accessory Item Descriptio Traffic-Light Stylet Kit 4060 40, 46, 52, 58 ad 85 cm 2 straight, soft stylets Gree (0,014 ) Traffic-Light Stylet Kit 4062 40, 46, 52, 58 ad 85 cm 2 straight, firm stylets Yellow (0,015 ) Traffic-Light Stylet Kit 4064 40, 46, 52, 58 ad 85 cm 2 straight, x-firm stylets Red (0,016 ) Traffic-Light Stylet Kit S-65-x 65 cm 2 straight, soft, firm of x-firm stylets (GMCRM916EN) Brief Summary: Prior to usig these devices, please review the Istructios for Use for a complete listig of idicatios, cotraidicatios, warigs, precautios, potetial adverse evets ad directios for use. Devices depicted may ot be available i all coutries. Check with your St. Jude Medical represetative for product availability i your coutry. Uless otherwise oted, idicates that the ame is a trademark of, or licesed to, St. Jude Medical or oe of its subsidiaries. ST. JUDE MEDICAL, the ie-squares symbol ad MORE CONTROL. LESS RISK. are registered ad uregistered trademarks ad service marks of St. Jude Medical, Ic. ad its related compaies. 2011 St. Jude Medical, Ic. All rights reserved. Item GMCRM916EN
Accessories
Accessories Stylets Uiversal Stylet Kit Product Highlights Repositioig kit for use with LV ad HV leads Kit icludes 4 straight stylets (X-Soft: Light Gree Soft: Gree Firm: Yellow X-Firm: Red), 1 soft J-Shape stylet (Gree with White Cap), 1 Implat Tool (DS06002 oly) ad 1 Uiversal Clip-O-Tool DS06002 Stylets are 8 cm loger for compatibility with Implat Tool Orderig Iformatio Model Number Legth (cm) Implat Tool DS06002/52 52 1 icluded DS06002/58 58 1 icluded DS06002/60 60 1 icluded DS06002/65 65 1 icluded DS06002/75 75 1 icluded DS06002/85 85 1 icluded DS06003/52 52 - DS06003/58 58 - DS06003/65 65 - DS06003/75 75 - DS06003/85 85 - DS06003/100 100 - Brief Summary: Prior to usig these devices, please review the Istructios for Use for a complete listig of idicatios, cotraidicatios, warigs, precautios, potetial adverse evets ad directios for use. Devices depicted may ot be available i all coutries. Check with your St. Jude Medical represetative for product availability i your coutry. Uless otherwise oted, idicates that the ame is a trademark of, or licesed to, St. Jude Medical or oe of its subsidiaries. ST. JUDE MEDICAL, the ie-squares symbol ad MORE CONTROL. LESS RISK. are registered ad uregistered trademarks ad service marks of St. Jude Medical, Ic. ad its related compaies. 2011 St. Jude Medical, Ic. All rights reserved.
Accessories Stylets Traffic Light Stylet Product Highlights Stylets for passive-fixatio leads Each pack cotais 2 straight stylets Available i multiple stiffess levels (Soft: Gree Firm: Yellow X-Firm: Red) Orderig Iformatio Model Number Stiffess Diameter (i) Legth (cm) 4060/40 Soft 0,014 40 4060/46 Soft 0,014 46 4060/52 Soft 0,014 52 4060/58 Soft 0,014 58 4060/85 Soft 0,014 85 4062/40 Firm 0,015 40 4062/46 Firm 0,015 46 4062/52 Firm 0,015 52 4062/58 Firm 0,015 58 4062/85 Firm 0,015 85 4064/40 X-Firm 0,015 40 4064/46 X-Firm 0,015 46 4064/52 X-Firm 0,015 52 4064/58 X-Firm 0,015 58 4064/85 X-Firm 0,015 85 Brief Summary: Prior to usig these devices, please review the Istructios for Use for a complete listig of idicatios, cotraidicatios, warigs, precautios, potetial adverse evets ad directios for use. Devices depicted may ot be available i all coutries. Check with your St. Jude Medical represetative for product availability i your coutry. Uless otherwise oted, idicates that the ame is a trademark of, or licesed to, St. Jude Medical or oe of its subsidiaries. ST. JUDE MEDICAL, the ie-squares symbol ad MORE CONTROL. LESS RISK. are registered ad uregistered trademarks ad service marks of St. Jude Medical, Ic. ad its related compaies. 2011 St. Jude Medical, Ic. All rights reserved.
Accessories Stylets Atrial J Stylet Kit Product Highlights For atrial lead positioig i various patiet aatomies Stylets Specificatios: Ø 0,014" (0,35 mm) - Stadard is desiged for placemet i the atrial appedage (Taper Legth: 20 mm Curve Ø: 24 mm Curve Agle: 220 ) - Wide ca be used i large atria (Taper Legth: 36 mm Curve Ø: 29,5 mm Curve Agle: 180 ) - Narrow ca be used i the high atrial septal positio (Taper Legth: 10 mm Curve Ø: 20 mm Curve Agle: 170 ) Kit icludes 3 J-Shape stylets (Stadard: Gree Wide: Grey Narrow: Orage) 1 Implat Tool (with DS06000 oly) ad 1 Uiversal Clip-O-Tool Orderig Iformatio Model Number Legth (cm) Implat Tool DS06000/40 40 1 icluded DS06000/46 46 1 icluded DS06000/52 52 1 icluded DS06001/40 40 - DS06001/46 46 - DS06001/52 52 - Brief Summary: Prior to usig these devices, please review the Istructios for Use for a complete listig of idicatios, cotraidicatios, warigs, precautios, potetial adverse evets ad directios for use. Devices depicted may ot be available i all coutries. Check with your St. Jude Medical represetative for product availability i your coutry. Uless otherwise oted, idicates that the ame is a trademark of, or licesed to, St. Jude Medical or oe of its subsidiaries. ST. JUDE MEDICAL, the ie-squares symbol ad MORE CONTROL. LESS RISK. are registered ad uregistered trademarks ad service marks of St. Jude Medical, Ic. ad its related compaies. 2011 St. Jude Medical, Ic. All rights reserved.
Accessories Stylets Mod RVOT Stylet Product Highlights Iovative 3D desig for precise lead placemet i the Right Vetricular Outflow Track (RVOT) High tesile stailess steel costructio to reduce the likelihood of kikig Kit icludes 2 stylets (Soft: Gree, Ø 0,014" Firm: Yellow, Ø 0,015") 1 Implat Tool (with 4140 ad 4150 oly) ad 1 Uiversal Clip-O-Tool Available i 2 curvatures (Medium ad Wide) to accommodate ormal ad large heart sizes Orderig Iformatio Model Number Primary Curvature Legth (cm) Implat Tool 4140/52 Medium 52 1 icluded 4140/58 Medium 58 1 icluded 4141/52 Medium 52-4141/58 Medium 58-4141/60 Medium 60-4141/65 Medium 65-4150/52 Wide 52 1 icluded 4150/58 Wide 58 1 icluded 4151/52 Wide 52-4151/58 Wide 58-4151/60 Wide 60-4151/65 Wide 65 - Brief Summary: Prior to usig these devices, please review the Istructios for Use for a complete listig of idicatios, cotraidicatios, warigs, precautios, potetial adverse evets ad directios for use. Devices depicted may ot be available i all coutries. Check with your St. Jude Medical represetative for product availability i your coutry. Uless otherwise oted, idicates that the ame is a trademark of, or licesed to, St. Jude Medical or oe of its subsidiaries. ST. JUDE MEDICAL, the ie-squares symbol ad MORE CONTROL. LESS RISK. are registered ad uregistered trademarks ad service marks of St. Jude Medical, Ic. ad its related compaies. 2011 St. Jude Medical, Ic. All rights reserved.
Accessories Stylets High Voltage Leads Stylets Product Highlights For Riata ad Durata family of leads Available i multiple stiffess levels ad taper legths X-Firm stylet is ot recommeded for Riata ST leads Orderig Iformatio Model Number Descriptio Stiffess Diameter (i) Taper Legth (cm) S-65-XS for 65 cm leads X-Soft 0,014 4 S-65-S for 65 cm leads Soft 0,014 2 S-75-S for 75 cm leads Soft 0,014 2 S-60-F for 60 cm leads Firm 0,015 2 S-65-F for 65 cm leads Firm 0,015 2 S-75-F for 75 cm leads Firm 0,015 2 S-65-X for 65 cm leads X-Firm 0,016 2 S-75-X for 75 cm leads X-Firm 0,016 2 CRT Leads Stylets Product Highlights For QuickSite leads repositioig Kit icludes: 3 Soft Stylets (Gree), 2 Firm Stylets (Yellow), 1 X-Firm Stylet (Red) Orderig Iformatio Model Number Lead Legth (cm) Taper Legth (cm) 4078S/75/15 75 15 4078S/86/15 86 15 4078S/75/5 75 5 4078S/86/5 86 5 Brief Summary: Prior to usig these devices, please review the Istructios for Use for a complete listig of idicatios, cotraidicatios, warigs, precautios, potetial adverse evets ad directios for use. Devices depicted may ot be available i all coutries. Check with your St. Jude Medical represetative for product availability i your coutry. Uless otherwise oted, idicates that the ame is a trademark of, or licesed to, St. Jude Medical or oe of its subsidiaries. ST. JUDE MEDICAL, the ie-squares symbol ad MORE CONTROL. LESS RISK. are registered ad uregistered trademarks ad service marks of St. Jude Medical, Ic. ad its related compaies. 2011 St. Jude Medical, Ic. All rights reserved.
Accessories Itroducers Peel-Away Itroducer 14 cm Sheath Itroducer Kit 7 F 16 F Product Highlights Proprietary materials improve isertio characteristics ad reduce vessel trauma Close tolerace extrusio ad proprietary tippig process improves trackig o a guidewire Reliable peelig characteristics Sheath ca be totally occluded without kikig to prevet air ispiratio Di-Lock feature secures dilator i sheath durig isertio Orderig Iformatio Cotets: Peel-Away Sheath, Di-Lock Dilator, 12 cc syrige, 18 ga. XTW Needle, ad 50 cm Guidewire with 3 mm J Model Number Size (F) Maximum Guidewire Diameter (i) Sheath Usable Legth (cm) Uits per Box 405154 7 F-TW,038 14 1 405145 8 F-TW,038 14 1 405146 8 F,038 14 1 405147 9 F,038 14 1 405149 10 F,038 14 1 405104 6 F,038 14 5 405108 7 F,038 14 5 405112 8 F,038 14 5 405129 8 F-TW,038 14 5 405116 9 F,038 14 5 405118 9,5 F,038 14 5 405120 10 F,038 14 5 405122 10,5 F,038 14 5 405124 11 F,038 14 5 405128 12 F,038 14 5 405132 13 F,038 14 5 405144 16 F,038 14 5 U.S. Patet Number 5,098,392 Brief Summary: Prior to usig these devices, please review the Istructios for Use for a complete listig of idicatios, cotraidicatios, warigs, precautios, potetial adverse evets ad directios for use. Devices depicted may ot be available i all coutries. Check with your St. Jude Medical represetative for product availability i your coutry. Uless otherwise oted, idicates that the ame is a trademark of, or licesed to, St. Jude Medical or oe of its subsidiaries. ST. JUDE MEDICAL, the ie-squares symbol ad MORE CONTROL. LESS RISK. are registered ad uregistered trademarks ad service marks of St. Jude Medical, Ic. ad its related compaies. 2011 St. Jude Medical, Ic. All rights reserved.
Accessories Itroducers Peel-Away Itroducer 23 cm Sheath Itroducer Kit 7 F 14 F Product Highlights Proprietary materials improve isertio characteristics ad reduce vessel trauma Close tolerace extrusio ad proprietary tippig process improves trackig o a guidewire Reliable peelig characteristics Sheath ca be totally occluded without kikig to prevet air ispiratio Di-Lock feature secures dilator i sheath durig isertio Orderig Iformatio Cotets: Peel-Away Sheath, Di-Lock Dilator, ad 80 cm Guidewire with 3 mm J (10 uits per box) Model Number Size (F) Maximum Guidewire Diameter (i) Sheath Usable Legth (cm) 405269 7,038 23 405270 8,038 23 405254 9,038 23 405256 10,038 23 405258 11,038 23 405259 12,038 23 405261 14,038 23 U.S. Patet Number 5,098,392 Brief Summary: Prior to usig these devices, please review the Istructios for Use for a complete listig of idicatios, cotraidicatios, warigs, precautios, potetial adverse evets ad directios for use. Devices depicted may ot be available i all coutries. Check with your St. Jude Medical represetative for product availability i your coutry. Uless otherwise oted, idicates that the ame is a trademark of, or licesed to, St. Jude Medical or oe of its subsidiaries. ST. JUDE MEDICAL, the ie-squares symbol ad MORE CONTROL. LESS RISK. are registered ad uregistered trademarks ad service marks of St. Jude Medical, Ic. ad its related compaies. 2011 St. Jude Medical, Ic. All rights reserved.
Accessories CRT Leads Delivery Tools CPS Direct PL Peelable Outer Guide Catheter Product Highlights Uique SiteMark tugste marker stripes provide superior fluoroscopic visibility to verify torque trasfer Compatible with CPS Aim ier catheter ad CPS Lumiary bideflectable catheter with lume to modify shape ad exted reach if ecessary EvePeel stripes provide more smooth ad reliable peelig for worry-free sheath removal Orderig Iformatio Icluded: sheath with hemostasis valve attached, dilator ad 2 valve bypass tools Model Curve Shape Available Overall Ier Outer Number Legth (cm) Legth (cm) Diameter (F/mm) Diameter (F/mm) 410210 Straight (OC-STR) 47 50,7 7/2,44 9/3,00 410211 Multipurpose (OC-MP) 47 50,7 7/2,44 9/3,00 410212 115º (OC-115) 47 50,7 7/2,44 9/3,00 410213 135 (OC-135) 47 50,7 7/2,44 9/3,00 410214 Wide (OC-W) 47 50,7 7/2,44 9/3,00 410215 Extra Wide (OC-XW) 47 50,7 7/2,44 9/3,00 410216 Right Sided (OC-R) 47 50,7 7/2,44 9/3,00 410224 145º (OC-145) 47 50,7 7/2,44 9/3,00 410217 Straight (OC-STR) 54 57,7 7/2,44 9/3,00 410218 Multipurpose (OC-MP) 54 57,7 7/2,44 9/3,00 410219 115º (OC-115) 54 57,7 7/2,44 9/3,00 410220 135 (OC-135) 54 57,7 7/2,44 9/3,00 410221 Wide (OC-W) 54 57,7 7/2,44 9/3,00 410222 Extra Wide (OC-XW) 54 57,7 7/2,44 9/3,00 410223 Right Sided (OC-R) 54 57,7 7/2,44 9/3,00 410225 145º (OC-145) 54 57,7 7/2,44 9/3,00 OC-R OC-STR OC-MP OC-115 OC-135 OC-145 OC-W OC-XW Separately Available Accessories Model Number Name Type 410194 CPS Direct PL Valve Bypass Tool (Pack of 2) Valve bypass tool 410195 CPS Direct PL Ier Catheter SafeSheath Sealig Adapter Self-sealig valve 410190 CPS Implat Kit (Icludes Needle, Syrige ad 0,035" Guidewire) Implat Kit Brief Summary: Prior to usig these devices, please review the Istructios for Use for a complete listig of idicatios, cotraidicatios, warigs, precautios, potetial adverse evets ad directios for use. Devices depicted may ot be available i all coutries. Check with your St. Jude Medical represetative for product availability i your coutry. Uless otherwise oted, idicates that the ame is a trademark of, or licesed to, St. Jude Medical or oe of its subsidiaries. ST. JUDE MEDICAL, the ie-squares symbol ad MORE CONTROL. LESS RISK. are registered ad uregistered trademarks ad service marks of St. Jude Medical, Ic. ad its related compaies. 2011 St. Jude Medical, Ic. All rights reserved.
Accessories CRT Leads Delivery Tools CPS Direct SL II Slittable Outer Guide Catheter Product Highlights Itegrated hub ad hemostasis valve Icreased curve retetio ad optimized catheter body structure for improved kik resistace Soft tip to lesse risk of traumatic isertio Orderig Iformatio Icluded: dilator ad 2 valve bypass tools Model Curve Shape Available Overall Ier Outer Number Legth (cm) Legth (cm) Diameter (F/mm) Diameter (F/mm) DS2C001 Straight 47 50,7 7/2,44 9/3,00 DS2C002 115º 47 50,7 7/2,44 9/3,00 DS2C003 135º 47 50,7 7/2,44 9/3,00 DS2C004 Wide 47 50,7 7/2,44 9/3,00 DS2C005 X-Wide 47 50,7 7/2,44 9/3,00 DS2C006 Right Side 47 50,7 7/2,44 9/3,00 DS2C011 Straight 54 57,7 7/2,44 9/3,00 DS2C012 115º 54 57,7 7/2,44 9/3,00 DS2C013 135º 54 57,7 7/2,44 9/3,00 DS2C014 Wide 54 57,7 7/2,44 9/3,00 DS2C015 X-Wide 54 57,7 7/2,44 9/3,00 Straight 115 135 Wide Extra Wide Right Side Separately Available Accessories Model Number Name Type DS2A003 CPS Uiversal Slitter Slitter DS2A004 CPS Direct SL Valve Bypass Tool Valve bypass tool Brief Summary: Prior to usig these devices, please review the Istructios for Use for a complete listig of idicatios, cotraidicatios, warigs, precautios, potetial adverse evets ad directios for use. Devices depicted may ot be available i all coutries. Check with your St. Jude Medical represetative for product availability i your coutry. Uless otherwise oted, idicates that the ame is a trademark of, or licesed to, St. Jude Medical or oe of its subsidiaries. ST. JUDE MEDICAL, the ie-squares symbol ad MORE CONTROL. LESS RISK. are registered ad uregistered trademarks ad service marks of St. Jude Medical, Ic. ad its related compaies. 2011 St. Jude Medical, Ic. All rights reserved.
Accessories CRT Leads Delivery Tools CPS Aim SL Slittable Ier Catheter Caulator with Itegrated Valve Product Highlights Itegrated hemostasis valve i slittable catheter desig Hydrophilic coatig o outer catheter surface to eable smooth passage New catheter shaft /braid patter for a kik-resistat ad torqueable caulator Orderig Iformatio Model Curve Shape Available Overall Ier Outer Number Legth (cm) Legth (cm) Diameter (F/mm) Diameter (F/mm) DS2N024 CSL 65 68 5/1,83 7/2,29 DS2N025 AL2 65 68 5/1,83 7/2,29 CSL AL2 Separately Available Accessories Model Number Name Type DS2A001 CPS Aim SL Ier Catheter SafeSheath Sealig Adapter Self-sealig valve DS2A002 CPS Aim SL Valve Bypass Tool Valve bypass tool DS2A003 CPS Uiversal Slitter Slitter Brief Summary: Prior to usig these devices, please review the Istructios for Use for a complete listig of idicatios, cotraidicatios, warigs, precautios, potetial adverse evets ad directios for use. Devices depicted may ot be available i all coutries. Check with your St. Jude Medical represetative for product availability i your coutry. Uless otherwise oted, idicates that the ame is a trademark of, or licesed to, St. Jude Medical or oe of its subsidiaries. ST. JUDE MEDICAL, the ie-squares symbol ad MORE CONTROL. LESS RISK. are registered ad uregistered trademarks ad service marks of St. Jude Medical, Ic. ad its related compaies. 2011 St. Jude Medical, Ic. All rights reserved.
Accessories CRT Leads Delivery Tools CPS Courier Guidewires Product Highlights Helps physicias more easily subselect the target coroary brach vei ad deliver the LV lead to its preferred destiatio Orderig Iformatio Model Distal Uits Number Support Legth (cm) per box Diameter (i) DS2G001 Soft 195 5 0,014 DS2G002 Medium 195 5 0,014 DS2G003 Firm 195 5 0,014 DS2G004 Extra Firm 195 5 0,014 CPS Duo Stylet Guidewire System Product Highlights Eables optimal subselectio of the brach vei ad offers greater maeuverability ad cotrol of the LV lead Orderig Iformatio Model Number Type Legths (cm) Diameter DS2M001 CPS Duo Stylet 75; 86 OD: 0,014" LV lead lume compatible DS2M006 CPS Duo Guidewire 195 0,012" ID: 0,012" compatible Brief Summary: Prior to usig these devices, please review the Istructios for Use for a complete listig of idicatios, cotraidicatios, warigs, precautios, potetial adverse evets ad directios for use. Devices depicted may ot be available i all coutries. Check with your St. Jude Medical represetative for product availability i your coutry. Uless otherwise oted, idicates that the ame is a trademark of, or licesed to, St. Jude Medical or oe of its subsidiaries. ST. JUDE MEDICAL, the ie-squares symbol ad MORE CONTROL. LESS RISK. are registered ad uregistered trademarks ad service marks of St. Jude Medical, Ic. ad its related compaies. 2011 St. Jude Medical, Ic. All rights reserved.
Accessories CRT Leads Delivery Tools CPS Lumiary Bideflectable Catheter with Lume Product Highlights Two deflectable curves - a large deflectio to facilitate coroary sius caulatio ad a small deflectio for target vei subselectio Soft, atraumatic tip features bipolar mappig electrodes to cofirm CS etry CPS Direct SL outer guide catheters ca be tracked over CPS Lumiary catheter ito the target vei Orderig Iformatio Model Workig Overall Ier Lume Number Descriptio Size (cm) Legth (cm) Size (F) Diameter 402856 Large Curl (LC) 80 110 7 Up to 0,035" guidewire 402857 Extra Large Curl (XLC) 80 110 7 Up to 0,035" guidewire Large deflectio for CS Caulatio Small deflectio for subselectio of target brach vei Separately Available Accessories Model Pi Workig Number Name Desig Legth (cm) 402854 Bipolar Extesio Cable Shrouded 2 mm legth pi 210 402855 Bipolar Extesio Cable Ushrouded 2 mm legth pi 210 Brief Summary: Prior to usig these devices, please review the Istructios for Use for a complete listig of idicatios, cotraidicatios, warigs, precautios, potetial adverse evets ad directios for use. Devices depicted may ot be available i all coutries. Check with your St. Jude Medical represetative for product availability i your coutry. Uless otherwise oted, idicates that the ame is a trademark of, or licesed to, St. Jude Medical or oe of its subsidiaries. ST. JUDE MEDICAL, the ie-squares symbol ad MORE CONTROL. LESS RISK. are registered ad uregistered trademarks ad service marks of St. Jude Medical, Ic. ad its related compaies. 2011 St. Jude Medical, Ic. All rights reserved.
Accessories CRT Leads Delivery Tools CPS Veture Wire Cotrol Catheter Product Highlights Tip deflects up to 90 to steer ay 0,014" guidewire through the most challegig veous aatomies Over-the-Wire desig permits easy wire exchages, if ecessary Orderig Iformatio Model Workig Overall Guidewire Guide Catheter Number Legth (cm) Legth (cm) Compatibility (i) Compatibility (F) 1135-001 70 88 0,014 6 Radiopaque Deflectable Tip 2,2 F (0,73 mm) Distal Shaft 2,7 F (0,90 mm) Proximal Shaft 3,5 F (1,18 mm) Strai Relief Torque Hadle Distal Tip 1,7 F (0,56 mm) 8 mm 3,5 cm Tip Deflectio Cotrol Kob Catheter Hub 70 cm 88 cm Brief Summary: Prior to usig these devices, please review the Istructios for Use for a complete listig of idicatios, cotraidicatios, warigs, precautios, potetial adverse evets ad directios for use. Devices depicted may ot be available i all coutries. Check with your St. Jude Medical represetative for product availability i your coutry. Uless otherwise oted, idicates that the ame is a trademark of, or licesed to, St. Jude Medical or oe of its subsidiaries. ST. JUDE MEDICAL, the ie-squares symbol ad MORE CONTROL. LESS RISK. are registered ad uregistered trademarks ad service marks of St. Jude Medical, Ic. ad its related compaies. 2011 St. Jude Medical, Ic. All rights reserved.
Accessories Implat Tools Locator Plus Implat Tools Product Highlights Eables fast, accurate edocardial lead positioig Facilitates lead maeuverability through tortuous veous pathways Elimiates the eed for maual shapig, re-shapig, re-isertig ad swappig multiple stylets Orderig Iformatio 0.016", X-Firm Model Number Descriptio Radius (mm) Reach Legth (mm) Legth (cm) 1281/46 Locator Plus, recommeded for Atrial Use 14 40 46 1281/52 Locator Plus, recommeded for Atrial Use 14 40 52 1281/58 Locator Plus, recommeded for Atrial Use 14 40 58 1292/46 Locator Plus, recommeded for Vetricular Use 16 55 46 1292/52 Locator Plus, recommeded for Vetricular Use 16 55 52 1292/58 Locator Plus, recommeded for Vetricular Use 16 55 58 Brief Summary: Prior to usig these devices, please review the Istructios for Use for a complete listig of idicatios, cotraidicatios, warigs, precautios, potetial adverse evets ad directios for use. Devices depicted may ot be available i all coutries. Check with your St. Jude Medical represetative for product availability i your coutry. Uless otherwise oted, idicates that the ame is a trademark of, or licesed to, St. Jude Medical or oe of its subsidiaries. ST. JUDE MEDICAL, the ie-squares symbol ad MORE CONTROL. LESS RISK. are registered ad uregistered trademarks ad service marks of St. Jude Medical, Ic. ad its related compaies. 2011 St. Jude Medical, Ic. All rights reserved.
Accessories Adapters Model Number Receptacle (for adaptig from) Header Cavity (to device) 501203 5 mm uipolar (uipolar pacig oly) IS-1 uipolar 501204 6 mm uipolar IS-1 uipolar 501205 5 mm bifurcated (bipolar) IS-1 bipolar (both uipolar ad bipolar pacig compatibility) 501206 3.2 mm Medtroic (CPI, Telectroic Style or IS-1 bipolar) IS-1 bipolar 47 cm 501207 Cap ad Sleeve Kit Medtroic (CPI, Telectroic Style) St. Jude Medical (M/S header or 6 mm uipolar) Icludes: 5 mm cap 6 mm cap pi exteder Adapter Sleeve (2 sizes) 3,2-5 mm; 5-6 mm 4023 Sleeve Kit, Medtroic (CPI, Telectroic Style, 3,2 mm, IS-1 or 5 mm, 5-6 mm white tool) St. Jude Medical (M/S header or 6 mm uipolar; uipolar pacig oly; 3,2-6 mm grey tool) Adapter Sleeve (2 sizes) Tool (2 sizes) 53424 2 IS-1 bipolar IS-1 bipolar 17 cm 53421 IS-1 bipolar IS-1 bipolar 40 cm BLV/BIS-10 LV-1 bipolar IS-1 bipolar Note: Medical adhesive to cover set screw holes must be ordered separately. LV-1 is a uique Bosto Scietific (formerly Guidat) coector/termial Medtroic is a trademark of Medtroic, Ic. CPI is a trademark of Cardiac Pacemakers, Ic. Brief Summary: Prior to usig these devices, please review the Istructios for Use for a complete listig of idicatios, cotraidicatios, warigs, precautios, potetial adverse evets ad directios for use. Devices depicted may ot be available i all coutries. Check with your St. Jude Medical represetative for product availability i your coutry. Uless otherwise oted, idicates that the ame is a trademark of, or licesed to, St. Jude Medical or oe of its subsidiaries. ST. JUDE MEDICAL, the ie-squares symbol ad MORE CONTROL. LESS RISK. are registered ad uregistered trademarks ad service marks of St. Jude Medical, Ic. ad its related compaies. 2011 St. Jude Medical, Ic. All rights reserved.
Accessories Miscellaeous Model Number Device AC-0160 Test Maget 90 gauss at 1" 405 Test Maget 90 gauss at 1" 60007717-001 Vei Pick 442-2 Torque Wrech (#2) 437-246 Set of L Hex Wreches (#2, #4, #6) 4033A DF4/IS-1/DF-1 Lead Termial Cap 6201 FasTac Flex Epicardial Lead Implat Tool 4080 Lead Removal Tool DS0A001 Suture Sleeve (radiopaque 7.0 F) SS-1056 Suture Sleeve (radiopaque 6.0 F for QuickSite Leads) TV-0800 Suture Sleeve (radiopaque 8.0 F) AC-0130 Silicoe Oil 424 Medical Adhesive FL-1056 Lead Flushig Tool AC-TD Torque Driver (#2 wrech) 4071 Torque Tool ad Tip Itroducer AC-IP-2 IS-1 Port Plug AC-DP-3 DF-1 Port Plug AC-IS4PP IS4/DF4 Port Plug 4078G Custom Floppy Firm Guidewire, Straight, 5 cm Floppy Tip, 180 cm, 0.014", PTFE Coated EX3151 IS4/DF4 Coector Sleeve Brief Summary: Prior to usig these devices, please review the Istructios for Use for a complete listig of idicatios, cotraidicatios, warigs, precautios, potetial adverse evets ad directios for use. Devices depicted may ot be available i all coutries. Check with your St. Jude Medical represetative for product availability i your coutry. Uless otherwise oted, idicates that the ame is a trademark of, or licesed to, St. Jude Medical or oe of its subsidiaries. ST. JUDE MEDICAL, the ie-squares symbol ad MORE CONTROL. LESS RISK. are registered ad uregistered trademarks ad service marks of St. Jude Medical, Ic. ad its related compaies. 2011 St. Jude Medical, Ic. All rights reserved.
Implatable Cardiac Moitors
Implatable Cardiac Moitors SJM Cofirm Implatable Cardiac Moitor Model DM2100 Product Highlights Implatable, patiet-activated ad automatically activated moitorig system that records subcutaeous ECGs ad is idicated i the followig cases: Patiets with cliical sydromes or situatios at icreased risk of cardiac arrhythmias Patiets who experiece trasiet symptoms that may suggest a cardiac arrhythmia Offers simple-to-cofigure data storage optios to eable physicias to prioritise data based o idividual patiet coditios, esurig capture of sigificat evets ad to reduce the risk that uexpected evets are missed Comprehesive diagostic data reports provide a quick ad accurate summary of heart rate, assistig physicias i their diagosis ad treatmet of the patiet s coditio The small 6.5 cc size of the SJM Cofirm ICM DM2100 is desiged to reduce the risk of ifectio durig the implat procedure by requirig a smaller icisio ad a smaller subcutaeous pocket. A small device footprit may also reduce implat time ad meas less chage i body image for patiets The prove St. Jude Medical SeseAbility feature is desiged to allow accurate sesig over a wide rage of sigals, specifically offerig more sesitive QRS detectio Orderig Iformatio Cotets: Implatable Cardiac Moitor Model Number Dimesios (H x W x T, mm) Weight (g) Volume (cc) DM2100 56,3 x 18,5 x 8 12 6,5 (± 0,5) Separately Available Accessories Cotets: SJM Cofirm Exteral Patiet Activator device Model Number DM2100A Descriptio Exteral Patiet Activator Model DM2100A Idicatios: The SJM Cofirm ICM is idicated for the moitorig ad diagostic evaluatio of patiets who experiece uexplaied symptoms such as: dizziess, palpitatios, chest pai, sycope, ad shortess of breath, as well as patiets who are at risk for other cardiac arrhythmias. Cotraidicatios: There are o kow cotraidicatios for the implatatio of the SJM Cofirm ICM. However, the patiet s particular medical coditio may dictate whether or ot a subcutaeous, chroically implated device ca be tolerated. Adverse Evets: Possible adverse evets (i alphabetical order) associated with the device, iclude, but are ot limited to the followig: Allergic reactio, Bleedig, Chroic erve damage, Erosio, Excessive fibrotic tissue growth, Extrusio, Formatio of hematomas or cysts, Ifectio, Keloid formatio Refer to the User s Maual for detailed idicatios, cotraidicatios, warigs, precautios ad potetial adverse evets.
Implatable Cardiac Moitors SJM Cofirm Implatable Cardiac Moitor Model DM2100 Product Specificatios PHYSICAL SPECIFICATIONS Model DM2100 Samplig Rate (Hz) 128 Dimesios (mm) 56,3 x 18,5 x 8 Volume (cc) 6,5 Weight (g) 12 Electrode Spacig (mm) 39 Electrode Miimum Surface Area (mm 2 ) 30 PARAMETER Features Logevity Patiet Trigger Auto Activatio Trigger Tachycardia Trigger Tachycardia Cycle Cout Bradycardia Trigger Asystole (duratio) Trigger EGM Storage Patiet Trigger Auto Activatio Activity Respose Noise Respose SETTINGS 3 years Yes Yes Yes Yes Yes Yes 48 miutes Yes, Programmable Yes, Programmable Ihibit, Moitor, Off Ihibit Diagostics Episodal Diagostics Heart Rate Histogram Mea Heart Rate Remote Moitorig Patiet Activator (PA) Yes Yes No Trastelephoic moitorig (TTM)* Battery-powered PA (Model DM2100A) * Coectivity depeds upo coutry ad use of a compatible receiver uit. Please cotact your St. Jude Medical sales represetative for more details. (GMCRM897EN) Brief Summary: Prior to usig these devices, please review the Istructios for Use for a complete listig of idicatios, cotraidicatios, warigs, precautios, potetial adverse evets ad directios for use. Devices depicted may ot be available i all coutries. Check with your St. Jude Medical represetative for product availability i your coutry. Uless otherwise oted, idicates that the ame is a trademark of, or licesed to, St. Jude Medical or oe of its subsidiaries. ST. JUDE MEDICAL, the ie-squares symbol ad MORE CONTROL. LESS RISK. are registered ad uregistered trademarks ad service marks of St. Jude Medical, Ic. ad its related compaies. 2011 St. Jude Medical, Ic. All rights reserved. Item GMCRM897EN
Implatable Cardiac Moitors SJM Cofirm Implatable Cardiac Moitor Model DM2102 Product Highlights Accurately detects atrial fibrillatio (AF) ad rhythm disturbaces Implatable, patiet-activated ad automatically activated moitorig system that records subcutaeous ECGs ad is idicated i the followig cases: Patiets who have bee previously diagosed with AF or who are susceptible to developig AF Patiets with cliical sydromes or situatios at icreased risk of cardiac arrhythmias Patiets who experiece trasiet symptoms that may suggest a cardiac arrhythmia Offers simple-to-cofigure data storage optios to eable physicias to prioritise data based o idividual patiet coditios, esurig capture of sigificat evets ad to reduce the risk that uexpected evets are missed Comprehesive diagostic data reports from the provide a quick ad accurate summary of heart rate, assistig physicias i their diagosis ad treatmet of the patiet s coditio The small 6.5 cc size of the SJM Cofirm ICM DM2102 is desiged to reduce the risk of ifectio durig the implat procedure by requirig a smaller icisio ad a smaller subcutaeous pocket. A small device footprit may also reduce implat time ad meas less chage i body image for patiets The prove St. Jude Medical SeseAbility feature is desiged to allow accurate sesig over a wide rage of sigals, specifically offerig more sesitive QRS detectio Orderig Iformatio Cotets: Implatable Cardiac Moitor Model Number Dimesios (H x W x T, mm) Weight (g) Volume (cc) DM2102 56,3 x 18,5 x 8 12 6,5 (± 0,5) Separately Available Accessories Cotets: SJM Cofirm Exteral Patiet Activator device Model Number DM2100A Descriptio Exteral Patiet Activator Model DM2100A Idicatios: The SJM Cofirm ICM is idicated for the moitorig ad diagostic evaluatio of patiets who experiece uexplaied symptoms such as: dizziess, palpitatios, chest pai, sycope, ad shortess of breath, as well as patiets who are at risk for other cardiac arrhythmias. The SJM Cofirm ICM, Model DM2102, is also idicated for patiets who have bee previously diagosed with atrial fibrillatio or who are susceptible to developig atrial fibrillatio. Cotraidicatios: Customer Support: There 46-8-474-4756 are o kow cotraidicatios for the implatatio of the SJM Cofirm ICM. However, the patiet s particular medical coditio may dictate whether or ot a subcutaeous, chroically implated device ca be tolerated. Adverse Evets: Possible adverse evets (i alphabetical order) associated with the device, iclude, but are ot limited to the followig: Allergic reactio, Bleedig, Chroic erve damage, Erosio, Excessive fibrotic tissue growth, Extrusio, Formatio of hematomas or cysts, Ifectio, Keloid formatio Refer to the User s Maual for detailed idicatios, cotraidicatios, warigs, precautios ad potetial adverse evets.
Implatable Cardiac Moitors SJM Cofirm Implatable Cardiac Moitor Model DM2102 Product Specificatios PHYSICAL SPECIFICATIONS Model DM2102 Samplig Rate (Hz) 128 Dimesios (mm) 56,3 x 18,5 x 8 Volume (cc) 6,5 Weight (g) 12 Electrode Spacig (mm) 39 Electrode Miimum Surface Area (mm 2 ) 30 PARAMETER Features Logevity Patiet Trigger Auto Activatio Trigger Atrial Fibrillatio Trigger Programmable AF episode duratio Tachycardia Trigger Tachycardia Cycle Cout Bradycardia Trigger Asystole (duratio) Trigger EGM Storage Patiet Trigger Auto Activatio Activity Respose Noise Respose SETTINGS 3 years Yes Yes Yes >30 sec, >1 mi, 2 mi, >5 mi, >10 mi Yes Yes Yes Yes 48 miutes Yes, Programmable Yes, Programmable Ihibit, Moitor, Off Ihibit Diagostics Episodal Diagostics Heart Rate Histogram Mea Heart Rate Remote Moitorig Patiet Activator (PA) Yes Yes No Trastelephoic moitorig (TTM)* Battery-powered PA (Model DM2100A) * Coectivity depeds upo coutry ad use of a compatible receiver uit. Please cotact your St. Jude Medical sales represetative for more details. (GMCRM898EN) Brief Summary: Prior to usig these devices, please review the Istructios for Use for a complete listig of idicatios, cotraidicatios, warigs, precautios, potetial adverse evets ad directios for use. Devices depicted may ot be available i all coutries. Check with your St. Jude Medical represetative for product availability i your coutry. Uless otherwise oted, idicates that the ame is a trademark of, or licesed to, St. Jude Medical or oe of its subsidiaries. ST. JUDE MEDICAL, the ie-squares symbol ad MORE CONTROL. LESS RISK. are registered ad uregistered trademarks ad service marks of St. Jude Medical, Ic. ad its related compaies. 2011 St. Jude Medical, Ic. All rights reserved. Item GMCRM898EN
ICM Exteral Patiet Activator SJM Cofirm Exteral Patiet Activator Product Highlights The SJM Cofirm exteral patiet activator uses radio waves to commuicate with the Cofirm Implatable Cardiac Moitor (ICM) Iitiates recordig of the heart s electrical activity, reads stored data ad seds stored data to Merli Patiet Care System Orderig Iformatio Cotets: SJM Cofirm Exteral Patiet Activator device Model Number DM2100A Descriptio Exteral Patiet Activator Model DM2100A Iteded Use: The activator is iteded for use with SJM Cofirm Iteral Cardiac Moitor. Cotraidicatios: There are o cotraidicatios. Warigs ad Precautios: Electromagetic iterferece. The activator is ot magetic ad has o movig parts. However, you should avoid equipmet which geerates a strog electromagetic iterferece (EMI). EMI could iterfere with commuicatio betwee the activator ad the implated SJM Cofirm ICM. Movig away from the source of EMI or turig it off will usually allow the activator to retur to its ormal mode of operatio. Commuicatio equipmet. Commuicatio equipmet such as microwave trasmitters or highpower amateur trasmitters may geerate eough EMI to iterfere with the performace of the activator if you are too close to the source of EMI. Wireless commuicatio devices. Wireless commuicatio devices such as computers that operate o a wireless etwork, hadheld persoal computers (PDA), cellular phoes, ad eve cordless telephoes may geerate eough EMI to iterfere with the performace of the activator if it is used too close to the source of EMI. Hospital ad Medical equipmet. A variety of stadard hospital ad medical equipmet may geerate eough EMI to iterfere with the performace of the activator. These iclude, but are ot limited to: blood pressure moitors, ECG equipmet, exteral defibrillatio equipmet, x-ray machies. Office equipmet. A variety of stadard office equipmet may geerate eough EMI to iterfere with the performace of the activator. These iclude, but are ot limited to: desktop or laptop computers, fax machies, phoe systems. Idustrial equipmet. A variety of idustrial equipmet may geerate eough EMI to iterfere with the performace of your activator. These iclude, but are ot limited to: arc welders; iductio furaces; very large or defective electric motors; ad iteral combustio egies with poorly shielded igitio systems. Brief Summary: Prior to usig these devices, please review the Istructios for Use for a complete listig of idicatios, cotraidicatios, warigs, precautios, potetial adverse evets ad directios for use. Devices depicted may ot be available i all coutries. Check with your St. Jude Medical represetative for product availability i your coutry. Uless otherwise oted, idicates that the ame is a trademark of, or licesed to, St. Jude Medical or oe of its subsidiaries. ST. JUDE MEDICAL, the ie-squares symbol ad MORE CONTROL. LESS RISK. are registered ad uregistered trademarks ad service marks of St. Jude Medical, Ic. ad its related compaies. 2011 St. Jude Medical, Ic. All rights reserved.
ICM Exteral Patiet Activator SJM Cofirm Exteral Patiet Activator Product Specificatios PHYSICAL SPECIFICATIONS Model EX4000 Dimesios (cm) 7,1 x 5,6 x 1,8 Case material High-impact plastic Power source 1 cell; 3,6 V (omial); Chemistry: Lithium Thioyl Chloride Battery logevity 3 years from maufacturig date Audible output level 60 db (miimum) at 10,0 cm Classificatio with respect to electric shock Iterally powered Protectio from electric shock (IEC 60601-1) Protectio agaist igress of liquids Mode of operatio Type BF Ordiary equipmet No-cotiuous (GMCRM913EN) Brief Summary: Prior to usig these devices, please review the Istructios for Use for a complete listig of idicatios, cotraidicatios, warigs, precautios, potetial adverse evets ad directios for use. Devices depicted may ot be available i all coutries. Check with your St. Jude Medical represetative for product availability i your coutry. Uless otherwise oted, idicates that the ame is a trademark of, or licesed to, St. Jude Medical or oe of its subsidiaries. ST. JUDE MEDICAL, the ie-squares symbol ad MORE CONTROL. LESS RISK. are registered ad uregistered trademarks ad service marks of St. Jude Medical, Ic. ad its related compaies. 2011 St. Jude Medical, Ic. All rights reserved. Item GMCRM913EN
Coectivity ad Remote Care
Coectivity ad Remote Care The itersectio of the iteret ad mobile techologies with iovative medical device therapies has created the ability to advace patiet care through remote moitorig ad data maagemet. May compoets are ivolved i device coectivity: the Merli programmer used i the physicia s office to establish ad optimise the device settigs; the Merli.et patiet care etwork that stores device iformatio ad makes it accessible via the Iteret or trasfers the iformatio to a electroic health record; the implatable device itself that trasmits data remotely usig radiofrequecy; ad the Merli@home uit that allows patiets to trasmit data at home from their device to their physicia. St. Jude Medical offers a completely itegrated system desiged to provide icreased cofidece ad cotrol, greater isight ad improved efficiecy from implat to follow-up.
Coectivity Merli Patiet Care System (PCS) Product Highlights 15 touch scree clearly displays programmig ad diagostic screes New user iterface allows for faster patiet maagemet Cotiuous, simultaeous display of surface ECGs, itracardiac electrograms (EGMs) ad aotated evet markers allow quick iterpretatio Built-i top-load/top-exit priter quickly ad quietly prits full-page (8-ich) reports for patiet charts Itegrated cable storage speeds setup ad saves space with alwayscoected cables ad ample storage space Orderig Iformatio Model Number Part Number Descriptio 3650 Merli Patiet Care System (PCS) Merli PCS accessories Model Number Part Number Descriptio 3001 3-Lead ECG Patiet Cable 3626 5-Lead ECG Patiet Cable 3134 60000909-001 VGA Cable ad Adapter (female to male) (25 legth) 3615 60004294-001 Adapter for 3150 PSA Wad (required for use of PSA Wad Model 3150 with the Merli Patiet Care System) 3616 60005260-001 Wad Extesio Cable (4 legth) 3617 60005251-001 Exteral ECG Iput Cable (25 legth) 3620 60005254-001 Exteral Floppy Disk Drive EX3621-2GB 100006806 Flash Drive (2 GB) 3622 60005256-001 Shoulder Strap 3623 60005257-001 USB to RS232 Serial Adapter (for direct Paceart coectio) 3630 60002876-001 Merli Patiet Care System Telemetry Wad (with Maget) 3630M 60002876-097 Maget 3638 50019403-001 Atea (required to eable radio frequecy [RF] commuicatio betwee Merli PCS ad St. Jude Medical implatable devices with RF commuicatio capability) 3643 60003605-001 Thermal Paper Brief Summary: Prior to usig these devices, please review the Istructios for Use for a complete listig of idicatios, cotraidicatios, warigs, precautios, potetial adverse evets ad directios for use. Devices depicted may ot be available i all coutries. Check with your St. Jude Medical represetative for product availability i your coutry. Uless otherwise oted, idicates that the ame is a trademark of, or licesed to, St. Jude Medical or oe of its subsidiaries. ST. JUDE MEDICAL, the ie-squares symbol ad MORE CONTROL. LESS RISK. are registered ad uregistered trademarks ad service marks of St. Jude Medical, Ic. ad its related compaies. 2011 St. Jude Medical, Ic. All rights reserved.
(GMCRM827EN) Brief Summary: Prior to usig these devices, please review the Istructios for Use for a complete listig of idicatios, cotraidicatios, warigs, precautios, potetial adverse evets ad directios for use. Devices depicted may ot be available i all coutries. Check with your St. Jude Medical represetative for product availability i your coutry. Uless otherwise oted, idicates that the ame is a trademark of, or licesed to, St. Jude Medical or oe of its subsidiaries. ST. JUDE MEDICAL, the ie-squares symbol ad MORE CONTROL. LESS RISK. are registered ad uregistered trademarks ad service marks of St. Jude Medical, Ic. ad its related compaies. 2011 St. Jude Medical, Ic. All rights reserved. Item GMCRM827EN
Coectivity Merli Pacig System Aalyzer (PSA) Product Highlights Provides cofidece ad cotrol at implat by quickly deliverig accurate measuremets for optimal lead positioig ad a streamlied implat Coects directly to the Merli Patiet Care System, deliverig a seamless, ituitive iterface Fast parameter programmig ad switchig speed Able to display o exteral moitors Idepedet atrial, right vetricular ad left vetricular chaels Cotiuously displayed measuremets o a beat-by-beat basis Dedicated curret of ijury display Orderig Iformatio Model Number Part Number Descriptio EX3100 100002300 Merli Pacig System Aalyzer (PSA) Merli PSA accessories Model Number Part Number Descriptio EX3160 100031916 Merli storable pouch EX3170 100015290 For use with Medtroic-style disposable cables (Models 4051 ad 4061) EX3180 100015301 For use with Medtroic 2292 re-sterilisable cable EX3190 100019848 USB to RF atea 4051 1020752-001 Disposable Threshold Cable (Medtroic coector) 4053A 5070142-101 No-Disposable Adapter (to threshold cable Medtroic coector) 4160 60010198-001 Disposable Threshold cable for DF4 leads (Biotroik coector) 4161 60010086-001 Disposable Threshold cable for DF4 leads (Medtroic coector) PK-67-S 5030162-001 No-Disposable Adapter (to threshold cable Biotroik coector) Iteded Use: The Merli PSA is iteded to assess the pacig ad sesig performace of the lead system prior to pulse geerator implatatio, or durig ivasive lead system troubleshootig. Oly use the Merli PSA with the Merli PCS. Cotraidicatios: There are o kow cotraidicatios to the use of a lead-aalysis device. The patiet s age ad medical coditio, however, may dictate the pacig modes ad lead assessmet activities appropriate for the patiet. The Merli PSA is ot iteded for use as a temporary pacemaker or for life sustaiig pacig support. The Merli PSA is ot iteded for diagostic purposes. Cautio: Federal law (USA) restricts this device to sale by or o the order of a physicia. Refer to the User s Maual for detailed idicatios, cotraidicatios, warigs, precautios ad potetial adverse evets. Brief Summary: Prior to usig these devices, please review the Istructios for Use for a complete listig of idicatios, cotraidicatios, warigs, precautios, potetial adverse evets ad directios for use. Devices depicted may ot be available i all coutries. Check with your St. Jude Medical represetative for product availability i your coutry. Uless otherwise oted, idicates that the ame is a trademark of, or licesed to, St. Jude Medical or oe of its subsidiaries. ST. JUDE MEDICAL, the ie-squares symbol ad MORE CONTROL. LESS RISK. are registered ad uregistered trademarks ad service marks of St. Jude Medical, Ic. ad its related compaies. 2011 St. Jude Medical, Ic. All rights reserved.
(GMCRM826EN) Brief Summary: Prior to usig these devices, please review the Istructios for Use for a complete listig of idicatios, cotraidicatios, warigs, precautios, potetial adverse evets ad directios for use. Devices depicted may ot be available i all coutries. Check with your St. Jude Medical represetative for product availability i your coutry. Uless otherwise oted, idicates that the ame is a trademark of, or licesed to, St. Jude Medical or oe of its subsidiaries. ST. JUDE MEDICAL, the ie-squares symbol ad MORE CONTROL. LESS RISK. are registered ad uregistered trademarks ad service marks of St. Jude Medical, Ic. ad its related compaies. 2011 St. Jude Medical, Ic. All rights reserved. Item GMCRM826EN
Coectivity Exteral Pulse Geerator Dual-Chamber (DDD) Model 3085 Product Highlights Desiged for safe ad reliable temporary stimulatio of the heart i cases of rhythm disturbaces ad coductio defects, ad/or perioperative temporary heart stimulatio. A extesive dual-chamber feature set icludig: A full array of mode choices, icludig a special DDD + AT mode specifically available for bi-atrial stimulatio to help avoid atrial fibrillatio Atrial auto-sesig for automatic adjustmet of sesitivity Completely adjustable stimulatio parameters (voltage ad pulse width) A wide base rate rage of 30-220 ppm for appropriate pacig support for all therapy eeds, icludig those of pediatric patiets A max trackig rate of 80-230 ppm for maitaiig AV sychroy A PV delay offset for supportig maximum cardiac output Exteded PVARP for prevetio of retrograde tachycardia Crosstalk protectio to aid i prevetig far-field sesig, which ca result i asystole Cotiuous, idepedet atrial ad vetricular lead surveillace ad a audible warig i the evet of lead malfuctio Rapid atrial pacig rates (up to 1000 ppm) are available for pace-termiatio of atrial tachycardia Orderig Iformatio Cotets: Exteral pulse geerator Model Number Dimesios (H x W x T, cm) Weight (g) Battery 3085 20 x 9,6 x 3,8 490 (icludes battery) Battery 9 V, alkalie or lithium Idicatios for Use: The Model 3085 exteral pulse geerator/temporary pacemaker is desiged to be used with cardiac stimulatio lead systems for temporary atrial, vetricular or A V sequetial stimulatio. The Model 3085 has applicatios where such stimulatio modes are idicated for therapeutic, rophylactic, or diagostic purposes. Specific idicatios iclude, but are ot limited to, the followig: Sick sius sydrome; Bradycardia with cogestive heart failure; Complete heart block; Acute myocardial ifarctio complicated with heart block; Sius bradycardia; Cardiac arrest with vetricular systole; Atrial ad/or vetricular ectopic arrhythmia; Postoperatively after cardiac surgery; Temporary applicatio durig implatatio or exchage of a permaet pacemaker. Idicatio for atrial overdrive stimulatio: Supravetricular tachycardia. Cotraidicatios: There are o cotraidicatios with regards to the use of the Model 3085 for temporary cardiac stimulatio for therapy ad prevetio of arrhythmia. The state of health of the patiet, however, ca restrict the choice of operatioal mode ad stimulatio parameters. For example, a mode of operatio with atrial sesig is ot suitable or appropriate whe atrial fibrillatio occurs. This is due to excessive ad chaotic frequecy of detected fibrillatio waves. Overdrive-stimulatio therapy must oly be used i the atrium. Overdrive-stimulatio i the vetricle could cause life threateig vetricular fibrillatio Brief Summary: Prior to usig these devices, please review the Istructios for Use for a complete listig of idicatios, cotraidicatios, warigs, precautios, potetial adverse evets ad directios for use. Devices depicted may ot be available i all coutries. Check with your St. Jude Medical represetative for product availability i your coutry. Uless otherwise oted, idicates that the ame is a trademark of, or licesed to, St. Jude Medical or oe of its subsidiaries. ST. JUDE MEDICAL, the ie-squares symbol ad MORE CONTROL. LESS RISK. are registered ad uregistered trademarks ad service marks of St. Jude Medical, Ic. ad its related compaies. 2011 St. Jude Medical, Ic. All rights reserved.
Coectivity Exteral Pulse Geerator Dual-Chamber (DDD) Model 3085 Product Specificatios PHYSICAL SPECIFICATIONS Model 3085 Battery Stadard 9 V, alkalie or lithium Battery Life Alkalie Miimal 10 days (VVI, stadard parameters), Miimal 8 days (DDD, stadard parameters) Plus 1 day reserve after the first appearace of the battery chage message Battery Life Lithium Miimal 19 days (VVI, stadard parameters) Miimal 15 days (DDD, stadard parameters) Plus 1 day reserve after the first appearace of the battery chage message Weight (g) Approximately 490 (icludig battery) Size (cm) 20 x 9,6 x 3,8 (7,75 i. x 4 i. x 1,5 i.) PARAMETER SETTINGS Techology Modes DDD, DDD + AT, DOO, DAT, DVI, DAI, VVI, VOO, VAT, AAI, AOO, AAT, VDD Base Pacig Rates (ppm) 30-220 Upper Pacig Rates (MTR) (ppm) 80-230 Rapid Atrial Pacig Rates (ppm) 70-1000 AV Delay (ms) 5-400 (miimum 30 ms whe atrial Auto Sese is activated) PV Delay (ms) AV delay-30 (miimum 5 ms whe atrial Auto Sese is ot activated, miimum 30 whe atrial Auto Sese is activated) Pulse Duratio (ms) 0,05-1,50 Pulse Amplitude (V) 0,1-18 Atrial Sesitivity (mv) 0,2-20 Vetricular Sesitivity (mv) 1,0-20 Blakig Period (ms) 85 (atrial & vetricular), 55 (vetricular after atrial pacig) Atrial Refractory Period (ms) 250 400 ms ± 5% (AAI, AAT), A-V iterval plus PVARP (DDD, VDD, DAI, VAT, DAT) PVARP (ms) 100-500 (absolute: 90 ms, relative: 90 ms) Vetricular Refractory Period (ms) 250 Exteded PVARP (After PVC) (ms) 500 Crosstalk Detectio Widow (ms) 40 Emergecy Mode V00 (A00), 80 ppm, 12 V or set value whe higher, 0,75 ms (1,00 ms) or set value whe loger Ruaway Protectio (ppm) 235 (GMCRM914EN) Brief Summary: Prior to usig these devices, please review the Istructios for Use for a complete listig of idicatios, cotraidicatios, warigs, precautios, potetial adverse evets ad directios for use. Devices depicted may ot be available i all coutries. Check with your St. Jude Medical represetative for product availability i your coutry. Uless otherwise oted, idicates that the ame is a trademark of, or licesed to, St. Jude Medical or oe of its subsidiaries. ST. JUDE MEDICAL, the ie-squares symbol ad MORE CONTROL. LESS RISK. are registered ad uregistered trademarks ad service marks of St. Jude Medical, Ic. ad its related compaies. 2011 St. Jude Medical, Ic. All rights reserved. Item GMCRM914EN
Coectivity Exteral Pulse Geerator Sigle-Chamber Model 3077 Product Highlights Desiged for safe ad reliable temporary stimulatio of the heart i cases of rhythm disturbaces ad coductio defects A extesive sigle-chamber feature set, icludig mode choices, a wide base rate rage, adjustable amplitude ad sesitivity parameters, ad two modes of high-rate pacig Up to 12 volts of output available per chael make the Model 3077 temporary pacemaker oe of the highest-output devices of its kid available Desiged for ease of use: Stadard 9 volt lithium or alkalie batteries are used, ad the device features both visual ad audible battery life idicators Large, simple dial Small size ad lightweight desig Ruaway protectio limits the device to a maximum rate of 200 ppm i the ulikely evet of circuit malfuctio Orderig Iformatio Cotets: Exteral pulse geerator Model Number Dimesios (H x W x T, cm) Weight (g) Battery 3077 6 x 11,5 x 2,2 185 (icludes battery) 9 V, alkalie or lithium Idicatios for Use: Whe combied with a stimulatio lead system, the Model 3077 SSI temporary pulsegeerator ca be used wheever temporary atrial or vetricular stimulatio is idicated. The device ca beemployed for therapeutic as well as diagostic purposes or be used prophylactically. Some specific idicatios for temporary stimulatio are: - Complete (third-degree) or itermittet heart block - Symptomatic sius bradycardia - Atrial or vetricular ectopic arrhythmia - Sick sius sydrome (SSS) Customer - Atrial tachyarrhythmia Support: 46-8-474-4756 Brief Summary: Prior to usig these devices, please review the Istructios for Use for a complete listig of idicatios, cotraidicatios, warigs, precautios, potetial adverse evets ad directios for use. Devices depicted may ot be available i all coutries. Check with your St. Jude Medical represetative for product availability i your coutry. Uless otherwise oted, idicates that the ame is a trademark of, or licesed to, St. Jude Medical or oe of its subsidiaries. ST. JUDE MEDICAL, the ie-squares symbol ad MORE CONTROL. LESS RISK. are registered ad uregistered trademarks ad service marks of St. Jude Medical, Ic. ad its related compaies. 2011 St. Jude Medical, Ic. All rights reserved. - Acute myocardial ifarctio iduced heart block - Stimulatio durig a vetricular asystole - Usage durig the replacemet of a implatable pacemaker - Stimulatio ad moitorig before the implatatio of a cardiac pacemaker - Stimulatio ad moitorig followig heart surgery Cotraidicatios: The Model 3077 SSI temporary pulse geerator is cotraidicated: - I the treatmet of vetricular tachycardia- Whe overall physiological coditio of the patiet limits the selectio of the stimulatio mode ad thestimulatio parameters.
Coectivity Exteral Pulse Geerator Sigle-Chamber Model 3077 Product Specificatios PHYSICAL SPECIFICATIONS Model 3085 Battery Alkalie-38 days (72 ppm, 8,0 V), Lithium-53 days (72 ppm, 8,0 V) Weight (g) Approximately 185 (icludig battery) Size (cm) 6,0 x 11,5 x 2,2 (2.25 i. x 4,5 i. x 0,85 i.) PARAMETER SETTINGS Techology Modes VVI, VOO, AAI, AOO Base Pacig Rates (ppm) 30-180 High Pacig Rates (ppm) 360-720 Pulse Width (ms) 0,75 Pulse Amplitude (V) 0,3-12 Sesitivity (mv) 1,0-20 Refractory Period (ms) 250 Ruaway Protectio (ppm) 200 (GMCRM921EN) Brief Summary: Prior to usig these devices, please review the Istructios for Use for a complete listig of idicatios, cotraidicatios, warigs, precautios, potetial adverse evets ad directios for use. Devices depicted may ot be available i all coutries. Check with your St. Jude Medical represetative for product availability i your coutry. Uless otherwise oted, idicates that the ame is a trademark of, or licesed to, St. Jude Medical or oe of its subsidiaries. ST. JUDE MEDICAL, the ie-squares symbol ad MORE CONTROL. LESS RISK. are registered ad uregistered trademarks ad service marks of St. Jude Medical, Ic. ad its related compaies. 2011 St. Jude Medical, Ic. All rights reserved. Item GMCRM921EN
Remote Care Merli.et Patiet Care Network (PCN) Versio 5.0 Product Highlights Merli.et PCN versio 5.0 from St. Jude Medical allows more efficiet remote maagemet of patiets with implated cardiac devices, icludig pacemakers, implatable cardioverter defibrillators ad cardiac resychroizatio therapy devices. Oe-scree Follow-up allows cliicias to view, prit, schedule, export ad archive from the Recet Trasmissios page. This feature also saves time ad simplifies follow-ups by allowig cliicias to take actio o up to 50 patiet files at oce. DirectAlerts Notificatio is a physicia otificatio system that provides physicia-desigated patiet alerts betwee follow-ups. Mobile DirectAlerts Notificatio allows alert-triggered EGMs ad reports to be viewed directly o a smartphoe; otificatios are set with a doctor s idividualised security stamp. Patiets ow have a ew way to coect from home for remote follow-ups ad moitorig with Merli.et PCN Wi-Fi Coectivity. Alerts geerated from the device-based CorVue Cogestio Moitorig feature, which measures itrathoracic impedace i multiple vectors for improved accuracy, are displayed; optios for both patiet ad physicia alerts are provided. EHRDirect Export allows automatic export of trasmissio data from Merli.et PCN to a cliic s EHR system. This allows seamless itegratio of data so care teams ca make iformed cliical decisios more quickly, without the eed for expesive itermediary systems. This feature meets the Itegratig the Healthcare Eterprise (IHE ) guidelies, supportig Health Level-7 (HL7) stadards. Iductive Merli@home trasmitters ca ow be used with ewer Epic family devices ad Atlas family devices as well as other ewer devices. Goig forward, iductive Merli@home trasmitters will be issued to patiets with ewer Epic ICD or Atlas ICD implats. However, Housecall Plus trasmitters will still be available for patiets with older Epic ICDs ad Atlas ICDs. Merli.et PCN ow features device support for the Uify Quadra CRT-D ad the Accet MRI RF Pacemaker. SmartSchedule is a 18-moth, rotatig perpetual caledar that creates a automatic follow-up trasmissio schedule. Cliicias ca specify legth of time, icludig 91-day ad 182-day periods, betwee trasmissios to coordiate follow-ups with the cliic s reimbursemet caledar. DirectCall Message is a itegrated ad automated patiet commuicatio system desiged to save cliic time by reducig routie calls otherwise performed by medical office staff. DirectTred Viewer provides dyamic views of device ad cliical treds for comprehesive patiet maagemet. Merli.et PCN was the first medical device etwork to be awarded ISO 27001 certificatio, a striget worldwide iformatio security stadard. ISO 27001 IS 541672 Merli@home Trasmitter Compatible Brief Summary: Prior to usig these devices, please review the Istructios for Use for a complete listig of idicatios, cotraidicatios, warigs, precautios, potetial adverse evets ad directios for use. Devices depicted may ot be available i all coutries. Check with your St. Jude Medical represetative for product availability i your coutry. Uless otherwise oted, idicates that the ame is a trademark of, or licesed to, St. Jude Medical or oe of its subsidiaries. ST. JUDE MEDICAL, the ie-squares symbol ad MORE CONTROL. LESS RISK. are registered ad uregistered trademarks ad service marks of St. Jude Medical, Ic. ad its related compaies. 2011 St. Jude Medical, Ic. All rights reserved.
Remote Care Merli.et Patiet Care Network (PCN) Versio 5.0 Product Specificatios (GMCRM910EN) Merli.et PCN Specificatios Coectivity Direct data export to EHR EHRDirect Export eables direct export to EHR via IHE or HL7 (2.x ad 3.0) format without the eed of a itermediary system Compatible EHR/data maagemet systems All HL7-compliat EHR systems are compatible. Curretly available with: GEMMS ONE EHR; Allscripts Professioal EHR; NextGe Ambulatory EHR; EpicCare Ambulatory EHR; ad GE Cetricity EHR. Plus compatible with device maagemet solutios such as Paceart ad ScottCare OeView. Ogoig work to itegrate with other leadig EHR systems. IHE compatible YES Supports HL7 YES ISO 27001 certified YES Schedulig Olie schedulig Uscheduled trasmissios/ Patiet-iitiated trasmissios Alerts ad Notificatios Daily alert surveillace Programmable alerts Diagostic alert triggers* Therapy alert triggers* Device alert triggers* Alert otificatio optios Alert reports Trasmitters Merli@home RF (radio frequecy) Authorized users may schedule patiet follow-ups. Automated (SmartSchedule Caledar) ad maual schedulig optios available. Able to trasmit outside of fixed appoitmet time as eeded with physicia approval. Able to lock out patiets from sedig uscheduled trasmissios. DirectAlerts Notificatio available with Merli@home trasmitter for all supported devices. Evet-based or full disclosure uploads as eeded. Physicia/cliicia optio to select oly the alerts they wat to receive Cogestio Duratio Exceeded Programmed Threshold ST Episode Detected **AT/AF Episode Duratio > Threshold **AT/AF Burde > Threshold **Avg. V Rate Durig AT/AF > Threshold Percet RV Pacig > Threshold Percet BiV Pacig < Threshold High Vetricular Rate Episodes Recorded High Voltage Therapy Delivered Successful ATP Pacig Delivered Therapy Accelerated Rhythm Logevity Aalysis (requires Tech Services support) Tachy Therapy Disabled Charge Time Limit Reached Possible HV Circuit Damage Device Reset Device at ERI Device i MRI Settigs HV Lead Impedace Out of Rage Atrial Pacig Lead Impedace Out of Rage (Dual Chamber ad CRT Devices) Device Programmed to Emergecy Pacig Values Back Up VVI Possible High Voltage Lead Issue LV Pacig Lead Impedace Out of Rage (CRT Devices) RV Pacig Lead Impedace Out of Rage High Voltage Lead Impedace < Lower Limit High Voltage Lead Impedace > Upper Limit Device Parameter Reset E-mail, fax, SMS, website, voice message or smartphoe Alert Summary Report AT/AF alert report accompaies AT/AF alert For use with compatible RF devices Trasmitter stays with the patiet whe chagig cliics or whe patiet receives ew device from the same family Ability to lik/re-lik trasmitter to a patiet s device remotely Trasmitter ca be issued to patiet ad paired with his/her device before discharge for remote moitorig from day oe Available i select markets oly *Differet devices support differet alerts. Check User s Maual for full list of available alerts. ** If programmed O i patiet s device *** I versio 5.0, the iductive Merli@home trasmitter uit ca support iterrogatio of legacy devices, icludig ewer Epic ICDs ad Atlas ICDs Brief Summary: Prior to usig these devices, please review the Istructios for Use for a complete listig of idicatios, cotraidicatios, warigs, precautios, potetial adverse evets ad directios for use. Devices depicted may ot be available i all coutries. Check with your St. Jude Medical represetative for product availability i your coutry. Uless otherwise oted, idicates that the ame is a trademark of, or licesed to, St. Jude Medical or oe of its subsidiaries. ST. JUDE MEDICAL, the ie-squares symbol ad MORE CONTROL. LESS RISK. are trademarks ad service marks of St. Jude Medical, Ic. ad its related compaies. GEMMS is a trademark of Gateway Electroic Medical Maagemet Systems, LLC. Allscripts is a trademark of Allscripts, LLC. NextGe is a trademark of NextGe Healthcare Iformatio Systems, Ic. EpicCare is a trademark of Epic Systems. GE Cetricity is a trademark of GE Healthcare. Paceart is a trademark of Medtroic USA, Ic. ScottCare is a trademark of ScottCare cardiovascular Solutios. IHE is a trademark of Healthcare Iformatio ad Maagemet Systems Society Corporatio. 2011 St. Jude Medical, Ic. All Rights Reserved. Item GMCRM910EN Website Efficiecy Batch operatio Cosolidated data Data storage capabilities Data trasfers Laguages Specificatios User Iterface Desig priciples Report format Trackig of reviewed trasmissios Trasmissio status, reaso for trasmissio displayed Next trasmissio colum Number of days betwee trasmissios Idetify previous user Rapid alert viewig Cliical commets Arrhythmia ad device maagemet box Highlight trasmissios with alerts Ibox/outbox Weekly glace Educatio Iteractive practice site Patiet Commuicatio Outboud automatic commuicatio tool Multiple laguage support Patiet Start-up guide Support Materials for Patiet ad Cliic Automatic export to EHR is supported by versio 5.0 through EHRDirect Export to icrease cliic efficiecy; prit, archive, export to EHR, export to PC database up to 50 records at a time Remote trasmissios ad i-cliic data available olie All patiet trasmissios ad reports available for immediate access for a miimum of seve years Patiet data follows patiet whe chagig cliics or whe patiet receives ew device Eglish, Spaish, Frech, Germa, Italia, JapaeseMerli.et PCN Similar to Merli Patiet Care System (PCS) programmer i colors ad desig; easy to lear for ew users Similar to Merli PCS reports for easy orietatio. Viewed field o recet trasmissios allows quick idicatio of which reports have already bee viewed; pritig reports optio to mark as viewed as well Scheduled, alert-iitiated, patiet-iitiated Date ad itervals of ext scheduled trasmissio Show o recet trasmissios, patiet list, view schedule ad maual schedule pages Placig mouse over trasmissio time shows previous user Mouse-over alerts shows list of alert types ad alert episodes Free form, cliic defied or both Tally of recet trasmissios by type Customisable by admiistrator Recet trasmissios/patiet list segmets files ito ew ad old Coveiet overview of upcomig trasmissios Available Cliic-eabled DirectCall Message optios: Missed appoitmet call triggered by cliic Normal results call triggered by cliic Call cliic message triggered by cliic Remote follow-up remider call set automatically Remote follow-up missed call set automatically Emergecy cotact, if eabled set automatically DirectCall Message tool available i over 20 laguages, icludig Eglish, Spaish, Frech, Italia, Japaese, Germa, Dutch, Portuguese, Fiish, Swedish, Daish, Norwegia, Czech, Hugaria, Castilia Spaish, Polish, Turkish, Slovak, Cataloia Spaish, UK Eglish Trasmitter Quick Start Guide (QSG) w/step-by-step setup optios Various support materials available. Please meet with sales represetative for full complemet of traiig ad support materials. Merli@home RF Trasmitter Specificatios Trasmitter model umber EX 1150 Physical compoets Sigle plastic eclosure with exteral trasformer power supply Weight (w/o power supply) Less tha 2,3 kilograms Dimesios Width: 9,18 Height: 6,33 Depth: 5,06 Wad cable legth NA Power cord legth Miimum 1,5 meters Modem V.92 (56K) Custom Desig Power source AC Lie voltage 100-240V Lie frequecy 50-60 Hz Devices Supported by Merli@home RF Trasmitter*** & Merli.et PCN RF models of the Uify Family of CRT-Ds, the Promote Family of CRT-Ds, the Curret Family of ICDs, the AalyST Family of ICDs, the Fortify Family of ICDs, the Athem Family of CRT-Ps, the Accet Family of Pacemakers ad the Nuace Family of Pacemakers (Japa) Devices Supported by Merli.et PCN through USB Upload from Merli PCS The Uify Family of CRT-Ds, the Promote Family of CRT-Ds, the Atlas Family of CRT-Ds, the Curret Family of ICDs, the AalyST Family of ICDs, the Fortify Family of ICDs, the Epic Family of ICDs, the Covert Family of ICDs, the Athem Family of CRT-Ps, the Accet Family of Pacemakers ad the Nuace Family of Pacemakers (Japa)
Remote Care USB Cellular Adaptor For use with the Merli@home Trasmitter Model EX1151 Product Highlights The USB Cellular Adapter attaches to ay Merli@home trasmitter, eablig timely access to comprehesive data of the patiet s curret disease state ad implated device status through the Merli.et Patiet Care Network. Automatically searches for ad coects to the cellular etwork for use i areas where a ladlie is either available or coveiet Does ot require ay additioal hardware ad operates o the power supply of the Merli@home trasmitter Trasmissio of data occurs o the 3G ad GSM bads of the cellular etwork The USB Cellular Adaptor is simple to istall ad use o ay ew or existig Merli@home trasmitter while maitaiig the curret user iterface The USB Cellular Adaptor provide a reliable trasmissio optio that allows patiet ad cliicias to experiece the value of coectivity through the Merli.et Patiet Care Network Orderig Iformatio Cotets: USB Cellular Adaptor Model Number Dimesios (H x W x T, mm) Volume (cc) Weight (g) EX1151 65 x 25 x 13,5 19,5 30 Idicatios: The USB Cellular Adapter for use with the Merli@home trasmitter is idicated for use by patiets with supported St. Jude Medical implated devices. Cotraidicatios: The USB Cellular Adapter for use with the Merli@home trasmitter is cotraidicated for use with ay implated medical device other tha supported St. Jude Medical implated devices. Brief Summary: Prior to usig these devices, please review the Istructios for Use for a complete listig of idicatios, cotraidicatios, warigs, precautios, potetial adverse evets ad directios for use. Devices depicted may ot be available i all coutries. Check with your St. Jude Medical represetative for product availability i your coutry. Uless otherwise oted, idicates that the ame is a trademark of, or licesed to, St. Jude Medical or oe of its subsidiaries. ST. JUDE MEDICAL, the ie-squares symbol ad MORE CONTROL. LESS RISK. are registered ad uregistered trademarks ad service marks of St. Jude Medical, Ic. ad its related compaies. 2011 St. Jude Medical, Ic. All rights reserved.
Remote Care USB Cellular Adaptor For use with the Merli@home Trasmitter Model EX1151 Product Specificatios PHYSICAL SPECIFICATIONS Models EX1151 Dimesios (mm) 65 x 25 x 13,5 Volume (cc) 19,5 Weight (g) 30 TECHNICAL SPECIFICATIONS Techology USB Modem MSM 7201A UMTS with HSDPA Category 8 HSUPA Category 5 EDGE/GPRS MS Class 12 WCDMA advaced receiver o UMTS Bads (USB Port) (7,2 Mbps dowlik) (2,0 Mbps uplik) 800/850, 1900, 2100 MHz bads 800/850, 1900, 2100 MHz WCDMA Power class 3 (+24dBm) 800/850, 900 MHz GSM/GPRS/EDGE GSM Power class 4/EDGE E2 1800, 1900 MHz GSM/GPRS/EDGE GSM Power class 1/EDGE E2 Atea Diversity Support 800/850, 1900, 2100 MHz Cellular telecommuicatio mode geeratio Geeratio Acroym Title U1G AMPS Advaced Mobile Phoe System Radiocom 2000 Radiocom 2000 Frace Telecom NMT Nordic Mobile Telephoe 2G GSM Global System for Mobile Commuicatio 2,5G GPRS Geeral Packet Radio Service 2,75G EDGE Ehaced Data Rate for GSM Evolutio 3G UMTS Uiversal Mobile Telecommuicatios System 3G+/3,5G HSDPA High Speed Dowlik Packet Access HSUPA High Speed Uplik Packet Access 3,75G HSOPA High Speed OFDM Packet Access 4G LTE Log Term Evolutio Wimax (IT etwork project) Worldwide Iteroperability for Microwave Access Bold items are supported by the St. Jude Medical USB Cellular Adapter Evirometal Operatig Temperature: Storage Temperature: RoHs Compliat 0 to 45 Celsius -40 to 85 Celsius Stadards/Approvals CE FCC PTCRB A-tick GCF Idustry Caada Package Cotets USB Modem Clip USB Extesio Cable (GMCRM919EN) Brief Summary: Prior to usig these devices, please review the Istructios for Use for a complete listig of idicatios, cotraidicatios, warigs, precautios, potetial adverse evets ad directios for use. Devices depicted may ot be available i all coutries. Check with your St. Jude Medical represetative for product availability i your coutry. Uless otherwise oted, idicates that the ame is a trademark of, or licesed to, St. Jude Medical or oe of its subsidiaries. ST. JUDE MEDICAL, the ie-squares symbol ad MORE CONTROL. LESS RISK. are registered ad uregistered trademarks ad service marks of St. Jude Medical, Ic. ad its related compaies. 2011 St. Jude Medical, Ic. All rights reserved. Item GMCRM919EN
Atrial Fibrillatio Cardiac Rhythm Maagemet Cardiovascular Neuromodulatio Global Headquarters Oe St. Jude Medical Drive St. Paul, Miesota 55117 USA +1 651 756 2000 +1 651 756 3301 Fax Cardiac Rhythm Maagemet Divisio 15900 Valley View Court Sylmar, Califoria 91342 USA +1 818 362 6822 +1 818 364 5814 Fax St. Jude Medical Swede AB Veddestaväge 19 SE-175 84 Järfälla Swede +46 8 474 40 00 +46 8 760 95 42 Fax St. Jude Medical Coordiatio Ceter BVBA The Corporate Village Aveue Da Vicilaa 11 Box F1 B-1935 Zavetem, Belgium +32 2 774 68 11 +32 2 772 83 84 Fax St. Jude Medical Brasil Ltda. Rua Frei Caeca, 1380 7º ao 9º adares 01307-002 - São Paulo (SP) Brazil +55 11 5080 5400 +55 11 5080 5423 Fax St. Jude Medical (Hog Kog) Ltd. Suite 1608, 16/F Exchage Tower 33 Wag Chiu Road Kowloo Bay, Kowloo Hog Kog SAR +852 2996 7688 +852 2956 0622 Fax St. Jude Medical Japa Co., Ltd. Shiodome City Ceter 15F Miato-ku 1-5-2, Higashi-Shibashi, Miatoku, Tokyo 105-7115, Japa +81 3 6255 6370 +81 3 6255 6371 Fax SJMprofessioal.com (GMCRM966EN) Brief Summary: Prior to usig these devices, please review the User s Maual for a complete listig of idicatios, cotraidicatios, warigs, precautios, potetial adverse evets ad directios for use. Devices depicted may ot be available i all coutries. Check with your St. Jude Medical represetative for product availability i your coutry. Uless otherwise oted, idicates that the ame is a trademark of, or licesed to, St. Jude Medical or oe of its subsidiaries. ST. JUDE MEDICAL, the ie-squares symbol ad MORE CONTROL. LESS RISK. are trademarks ad service marks of St. Jude Medical, Ic. ad its related compaies. 2011 St. Jude Medical, Ic. All Rights Reserved. Item GMCRM966EN