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Cardiac Rhythm Management International Product Catalog

1. Product Specifications Models Telemetry Delivered Stored Energy J Volume cc Weight g Size mm Defibrillation Lead Connections Sense Pace Lead Connections High Voltage Can CD3211 36 D3211 360 RF RF 36 42 36 42 43 42 82 82 81x 50x 14 75x 50x 14 DFI DF4 IS 1 IS 1 DF4 Electrically active titanium can Electrically active titanium can PARAMETER SETTINGS Biventricular Pacing V Triggering BiV Trigger Mode On Off QuickOpt Timing Cycle Optimisation Sensed paced AV delay Interventricular Pace delay V V Timing Interventricular Pace Delay ms Ventricular Sensing Ventricular Pacing Chamber Negative AV Hysteresis Search ms Shortest AV Delay ms VectSelect LV Pulse Configuration AF Management Simultaneous RV First LV First RV First 10 80 LV First 15 80 in increments of 5 RV only not programmable RV only biventricular Off 10 to 120 25 120 LV tip to RV coil LV bipolar LV ring to RV coil AF Suppression Pacing No of Overdrive Pacing Cycles Maximum AF Suppression Rate Sensing Detection On Off 15 40 in steps of 5 80 150 min SenseAbility Technology Threshold Start Decay Delay Ventricular Sense Refractory ms Detection Zones SVT Discriminators Reconfirmation Antitachycardia Pacing Therapy Automatic Sensitivity Control adjustment for atrial and ventricular events Post Sensed Atrial 50 62 5 75 100 Post Paced At
2. Auto Mode Switch AMS Base Rate min Stored Electrograms Off On 10 53 15 40 in steps of 5 8 128 80 150 in steps of 5 160 180 in steps of 10 110 200 in steps of 10 225 300 in steps of 25 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 40 170 in steps of 5 Options Priority Options Channel Triggers Advanced Hysteresis AMS Entry AMS Exit AMS Entry and Exit AT AF Detection Magnet Response High Atrial Rate Rate min No of Consecutive Cycles High Ventricular Rate Off Low Hig 32 3 Off Low Hig Off Low Hig Off Low Hig Off Low Hig Off Low Hig 125 300 in steps of 25 2 3 4 5 10 15 20 Off Low Hig Rate min 125 300 in steps of 25 No of Consecutive Cycles 2 3 4 5 10 15 20 PMT Termination Off Low Hig Consecutive PVCs Off Low Hig No of Consecutive PVCs 2 3 4 5 Noise Reversion Off Low Hig Other Aand V Lead Monitoring Monitor Auto Polarity Switch A and V Low Impedance Limit Q Aand V High Impedance Limit Q Lead Type Magnet Response Negative AV Hysteresis Search ms NIPS Options Stimulation Chamber Coupling Interval ms 1 Count SI S2 S3 and S4 Cycle ms Ventricular Support Rate min Sinus Node Recovery Delay sec PMT Options PMT Detection Rate min PVC Response Ventricular Intrinsic Preference VIP ms VIP Search Interval VIP Search Cycles Ventricular Safet
3. EBEN mam ST JUDE MEDICAL MORE CONTROL LESS RISK Sustain XL DR Dual Chamber Rate Responsive Pacemaker Product Highlights Device features small physiologic shape and offers superior longevity 9 8 years without compromising size Instant follow up with automatic P or R wave lead impedance measurements and ventricular threshold tests Ventricular Intrinsic Preference VIP algorithm automatically searches for intrinsic conduction The AutoCapture Pacing System feature offers the maximum in threshold adaptability and patient safety with ventricular Beat by Beat capture confirmation Stored electrograms EGMs record a real time EGM waveform as well as the associated event markers that precede and follow a specific triggering event The system also includes the clinically proven Omnisense accelerometer sensor featuring auto rest rate based on activity rather than on preset clock settings and auto rate response 1 A V 2 5V 0 4 ms AV 500 ohms 100 DDD pacing 60 bpm SEGMs ON data on file Ordering Information Contents Cardiac pulse generator Model Number PM2136 Dimensions H x W x T mm 44 x52 x6 Indications and Usage Implantation of Sustain pulse generators is indicated in the following permanent conditions when associated with symptoms including but not limited to syncope presyncope fatigue disorientation due to arrhythmia bradycardia or any comb
4. MRI Mode MRI Base Rate MRI Paced AV Delay MRI Atrial Pulse Configuration MRI Atrial Pulse Amplitude MRI Atrial Pulse Width MRI RV Pulse Configuration MRI RV Pulse Amplitude MRI RV Pulse Width Output Sensing A00 V00 DOO Pacing Off 0 120 bpm in steps of 5 bpm 25 ms 30 200 ms in steps of 10 ms 225 300 ms in steps of 25 ms 350 ms Bipolar 5 0V 75V 0 ms Bipolar 5 0V 75V 0 ms ACap Confirm Primary Pulse Configuration Backup Pulse Configuration Backup Pulse Amplitude V Search Interval hours Aor V Pulse Amplitude V Aor V Pulse Width ms Aor V Pulse Configuration Aor V Sense Configuration Atrial Sensitivity mV Ventricular AutoCapture Pacing System Primary Pulse Configuration Backup Pulse Configuration Backup Pulse Amplitude V Search Interval hours AutoCapture Paced Sensed AV Delay ms Ventricular Sensitivity mV SenseAbility Technology A Max Sensitivity mV V Max Sensitivity mV Threshold Start Decay Delay ms Rate Modulated Parameters On Off Monitor Bipolar Bipolar 5 0 8 24 0 25 4 0 in steps of 0 25 4 5 7 5 in steps of 0 5 0 05 0 1 1 5 in steps of 0 1 Unipolar tip case Bipolar tip ring Unipolar Tip tip case Bipolar tip ring Unipolar Ring ring case 0 1 0 4 in steps of 0 1 0 5 0 75 2 0 in steps of 0 25 2 5 4 0 in steps of 0 5 5 07 On Off Unipolar Bipolar Unipolar Bipolar 5 08 8 24 50 25 100 70 120 100 0 5 5 0
5. ACap confirm feature periodically completes a threshold search and adjusts the pulse amplitude accordingly in the atrium Ventricular Intrinsic Preference VIP algorithm automatically searches for intrinsic conduction Stored electrograms EGMs record a real time EGM waveform as well as the associated event markers that precede and follow a specific triggering event Multiple algorithms and diagnostics to assist physicians in therapy decisions including AF Suppression algorithm AT AF diagnostic suite and Auto Mode Switch algorithm and diagnostic suite Ordering Information Contents Cardiac pulse generator Model Number Dimensions H x W x T mm Weight g Volume cc Connector 5820 43 x 44x6 18 8 5 0 5 IS 1 Indications and Usage Implantation of Zephyr pulse generators is indicated in the following permanent Dual Chamber Pacing Models 5826 5820 only though not contraindicated for patients with chronic atrial conditions when associated with symptoms including but not limited to syncope presyncope fatigue flutter chronic atrial fibrillation or silent atria may provide no benefit beyond that of single chamber pacing in disorientation or any combination of those symptoms Rate Modulated Pacing is indicated for patients with such patients Single Chamber Ventricular Demand Pacing is relatively contraindicated in patients who have chronotropic incompetence and for those who would benefit from increased stimulation
6. Contents Cardiac pulse generator Model Number 2525T Dimensions H x W x T mm 33x33x6 Indications The pulse generators are indicated for Accepted Patient Conditions warranting chronic cardiac pacing which include sick sinus syndrome chronic symptomatic second and third degree AV block recurrent Adams Stokes syndrome symptomatic bilateral bundle branch block when tachy arrhythmia and other causes have been ruled out Atrial Pacing in patients with sinus node dysfunction and normal AV and intraventricular conduction systems Ventricular Pacing in patients with significant bradycardia and normal sinus rhythm with only rare episodes of A V block or sinus arrest requiring short periods of pacing support chronic atrial fibrillation severe physical disability Rate Modulated Pacing in patients who would benefit from increased pacing rates concurrent with physical activity Contraindications The pulse generators are contraindicated for single Chamber Ventricular Demand Pacing in patients who have demonstrated pacemaker syndrome have retrograde VA conduction or who suffer a drop in arterial blood pressure with the onset of ventricular pacing single Chamber Atrial Pacing in patients who have demonstrated compromise of AV conduction rate Modulated Pacing in patients who experience angina or Customer Support 46 8 474 4756 Brief Summary Prior to using these devices please review the Instructions for Use for a complete lis
7. Indications The devices are intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias Cardiac Resynchronisation Therapy Defibrillators CRT Ds are also intended to resynchronise the right and left ventricles in patients with congestive heart failure Contraindications Contraindications for use of the pulse generator system include ventricular tachyarrhythmias resulting from transient or correctable factors such as drug toxicity electrolyte imbalance or acute myocardial infarction Adverse Events Implantation of the pulse generator system like that of any other device involves risks some possibly life threatening These include but are not limited to the following acute hemorrhage bleeding air emboli arrhythmia acceleration cardiac or venous perforation cardiogenic shock cyst formation erosion Customer Support 46 8 474 4756 Brief Summary Prior to using these devices please review the Instructions for Use for a complete listing of indications contraindications warnings precautions potential adverse events and directions for use Devices depicted may not be available in all countries Check with your St Jude Medical representative for product availability in your country Unless otherwise noted indicates that the name is a trademark of or licensed to St Jude Medical or one of its subsidiaries ST JUDE MEDICAL the ni
8. Radiopaque suture sleeve ultra thin lead body and Fast Pass coating for easy implantation Pacing Leads Steroid elution and titanium nitride fractal coating on electrodes for low thresholds Shorter tip to ring spacing and silicone insulation for high performance and reliability Ordering Information Contents Cardiac pacing lead Model Number 1688TC Fixation Ext Ret Helix Insulation Silicone Rubber Indications The Tendril SDX lead is designed for permanent sensing and pacing in either the atrium or the ventricle in combination with a compatible pulse generator An active lead such as the Tendril SDX may be indicated for patients where permanent fixation of passive leads is suspected to be unstable In atrial applications the use of a screw in lead such as the Tendril SDX may be indicated in the presence of an abnormal surgically altered or excised atrial appendage Contraindications The Tendril SDX lead is contraindicated In the presence of tricuspid atresia for patients with mechanical tricuspid valves in patients who are expected to be hypersensitive to a single dose of one milligram of dexamethasone sodium phosphate Customer Support 46 8 474 4756 Brief Summary Prior to using these devices please review the Instructions for Use for a complete listing of indications contraindications warnings precautions potential adverse events and directions for use Devices depicted may n
9. body reaction at electrode interface or lead malfunction fracture or damage to insulation loss of normal pacemaker function due to battery failure or component malfunction pacemaker migration pocket erosion or hematoma pectoral muscle stimulation phrenic nerve or diaphragmatic stimulation Contraindications mplanted Cardioverter Defibrillator ICD Because Sustain pulse generators will be automatically programmed to a unipolar pulse configuration if the device initiates Backup VVI pacing Sustain devices are contraindicated in patients with an implanted cardioverter defibrillator AF Suppression Models PM2134 and PM2136 only stimulation is not recommended in patients who cannot tolerate high atrial rate Refer to the User s Manual for detailed indications contraindications warnings precautions and potential stimulation Dual Chamber Pacing Models PM2134 and PM2136 only though not contraindicated for patients adverse events Customer Support 46 8 474 4756 Brief Summary Prior to using these devices please review the Instructions for Use for a complete listing of indications contraindications warnings precautions potential adverse events and directions for use Devices depicted may not be available in all countries Check with your St Jude Medical representative for product availability in your country Unless otherwise noted indicates that the name is a trademark of or licensed to St Jude Medical or one of its subs
10. Off Low High Off Low High 125 300 in steps of 25 2 3 4 5 10 15 20 Advanced Hysteresis Off Low High Noise Reversion Off Low High Other Lead Monitoring Monitor Auto Polarity Switch V Low Impedance Limit Q 100 500 in steps of 25 V High Impedance Limit Q Magnet Response Lead Type NIPS Options Stimulation Chamber Coupling Interval ms S1 Count SI5 S2 3 and S4 Cycle ms Diagnostic Trends Patient Notifiers 150 2500 in steps of 250 3000 Off Battery Test Uncoded Unipolar Bipolar Ventricular 100 800 in steps of 10 2 25 in steps of 1 Off 100 800 in steps of 10 Fixed or Adaptive Exercise Lead Impedance R Wave V Threshold Programmable Notifiers On Off Device Reset Entry into Backup VVI Mode Audible Duration sec Number of Audible Alerts per Notification Number of Notifications Time Between Notifications hours 120 5cc Device at ERI Ventricular Lead Impedance Out of Range On On 2 4 6 8 10 12 14 16 2 1 16 10 22 2 Programming options dependent on pacing mode 3 The highest available setting for hysteresis rate will be 5 min below the programmed base rate 4 Sensitivity is with respect to a 20 ms haversine test signal 5 This parameter is not programmable 6 S1 Burst Cycle is applied at the preprogrammed S1 cycle length LLL mam ST JUDE MEDICAL MORE CONTROL LESS RISK Zephyr XL DR Dual Chamber Pacemaker Product Highlights
11. Post Sensed Ventricular 50 62 5 75 100 Post Paced Ventricular Auto 0 2 3 0 mV Post Sensed Post Paced Atrial Ventricular 0 220 125 157 VI 1 VT 2 VF AV Rate Branch Sudden Onset Interval Stability Morphology Discrimination MD with Manual or Automatic Template Update Continuous sensing during charging ATP Configurations ATP in VF Zone ATP Upper Rate Cutoff Burst Cycle Length Min Burst Cycle Length ms Number of Bursts Stimuli Add Stimuli per Burst High Voltage Therapy Ramp Burst Scan 1 or 2 schemes per zone ATP While Charging ATP Prior to Charging Off 150 300 bpm Adaptive Readaptive or Fixed 150 400 in increments of 5 1 15 with 2 20 Stimuli On Of High Voltage Output Mode Waveform RV Polarity Electrode Configuration Fixed Pulse Width Fixed Tilt Biphasic Monophasic Cathode Anode RV to Can RV to SVC Can Bradycardia Pacing nisation Therapy CRT Devices Permanent Modes Temporary Modes Rate Adaptive Sensor Programmable Rate and Delay Parameters Auto Mode Switch AMS Off DDD R DDT R DDI R VVT R VVI R AAI R Off DDD R DDT R DDI R VVT R VVI R AAI R AAT DOO V00 A00 On Off Passive Off Base Rate min Rest Rate min Maximum Tracking Rate min Maximum Sensor Rate min Paced AV Delay ms Sensed AV Delay ms Rate Responsive AV Delay Hysteresis Rate min Rate Hysteresis with Search Off DDI R DDT R VVI
12. Transmitter 4 RV Coil may be adjusted noninvasively via the programmer Goppatible The CorVue congestion monitoring feature monitors the intrathoracic impedance in multiple vectors for improved accuracy and it provides the option for both patient and physician alerts AO J delivered energy provides unsurpassed energy for defibrillation Dual DF4 header option for defibrillation lead DF4 LLHH and LV pacing lead IS4 LLLL reduce pocket bulk QHR chemistry battery provides greater capacity for enhanced longevity and charge times Triggered pacing with BiV Trigger Mode helps maintain a high percentage of BiV pacing by triggering pacing in both the left and right ventricles in response to a sensed ventricular event Negative AV hysteresis with search promotes ventricular pacing by automatically reducing the AV delay when intrinsic activity is present thereby promoting a high degree of ventricular pacing Ordering Information Contents Cardiac pulse generator Dimensions Connector Connector Model Number H x W x T mm Weight g Volume cc Defibrillation Sense Pace CD3239 40 81x 51x14 88 46 DF1 IS 1 CD3239 40Q 74x 51x 14 87 44 DF4 IS 1 DF4 Indications The devices are intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias Cardiac Resynchronisation Therapy devices CRT Ds are also intended to resynchronise the right and lef
13. 0 5 IS 1 Dimensions H x W x T mm Weight g 52x53 x6 24 Radiopaque markers St Jude Medical identifier Device MRI symbol MRI Indications Implantation of a single chamber pulse generator is indicated in one or more of the following permanent conditions syncope presyncope fatigue disorientation due to arrhythmia bradycardia or any combination of those symptoms MRI conditional pulse generator is safe for use in the MRI environment when used in a complete MRI conditional pacing system and according to the instructions in the MRI Procedure Information document for the St Jude Medical MRI conditional pacing system Rate modulated pacing is indicated for patients with chronotropic incompetence and for those who would benefit from increased stimulation rates concurrent with physical activity Atrial pacing is indicated for patients with sinus node dysfunction and normal AV and intraventricular conduction systems Ventricular pacing is indicated for patients with significant bradycardia and normal sinus rhythm with only rare episodes of A V block or sinus arrest chronic atrial fibrillation severe physical disability Contraindications Single chamber pulse generators are contraindicated in patients with an implanted cardioverter defibrillator ICD Rate adaptive pacing may be inappropriate for patients who experience angina or other symptoms of myocardial dysfunction at higher sensor driven rates An appropriate Maximum S
14. 2011 St Jude Medical Inc All rights reserved histotoxic reactions infection keloid formation myocardial irritability nerve damage pneumothorax thromboemboli venous occlusion Other possible adverse effects include mortality due to component failure device programmer communication failure lead abrasion lead dislodgment or poor lead placement lead fracture inability to defibrillate inhibited therapy for a ventricular tachycardia interruption of function due to electrical or magnetic interference shunting of energy from defibrillation paddles system failure due to ionising radiation Other possible adverse effects include mortality due to inappropriate delivery of therapy caused by multiple counting of cardiac events including T waves P waves or supplemental pacemaker stimuli Among the psychological effects of device implantation are imagined pulsing dependency fear of inappropriate pulsing and fear of losing pulse capability Refer to the User s Manual for detailed indications contraindications warnings precautions and potential adverse events ST JUDE MEDICAL MORE CONTROL LESS RISK Cardiac Resy Unify Quadra Cardiac Resynchronisation Therapy Defibrillator CRT D Product Specifications Models Telemetry Delivered Energy J Volume cc Weight g Size mm Defibrillation Lead Connections LV Lead Connections Sense Pace Lead Connections High Voltage Can D3251 40 D3251 400 RF RF
15. 225 300 in steps of 25 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 min 40 170 in steps of 5 Stored Electrograms Options Priority Options Off Low Hig Channel 1 2 3 Triggers Advanced Hysteresis Off Low Hig AMS Entry AMS Exit AMS Entry and Exit Off Low Hig AT AF Detection Off Low Hig Magnet Response Off Low Hig High Atrial Rate Off Low Hig Rate min 125 300 in steps of 25 No of Consecutive Cycles 2 3 4 5 10 15 20 High Ventricular Rate Off Low Hig Rate min 125 300 in steps of 25 No of Consecutive Cycles 2 3 4 5 10 15 20 PMT Termination Off Low Hig Consecutive PVCs Off Low Hig No of Consecutive PVCs 2 3 4 5 Noise Reversion Off Low Hig Other Aand V Lead Monitoring Monitor Auto Polarity Switch A and V Low Impedance Limit Q 100 500 in steps of 25 Aand V High Impedance Limit Q Lead Type Magnet Response Negative AV Hysteresis Search ms NIPS Options Stimulation Chamber Coupling Interval ms 1 Count SI 2 S3 and S4 Cycle ms Ventricular Support Rate mirr Sinus Node Recovery Delay sec PMT Options PMT Detection Rate min PVC Response Ventricular Intrinsic Preference VIP ms VIP Search Interval VIP Search Cycles Ventricular Safety Standby Diagnostic Trends Patient Notifiers 750 2500 in steps of 250 3000 Uncoded Unipolar Bipolar f Battery Test f 10 t
16. 40 40 40 38 83 81 83x 41x14 76x41 x 14 DF1 DF4 LLHH IS4 LLLL IS4 LLLL IS 1 IS 1 Electrically active titanium can Electrically active titanium can PARAMETER Biventricular Pacing SETTINGS VectSelect Quartet LV Pulse Configuration V Triggering BiV Trigger Mode 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 On Off QuickOpt Timing Cycle Optimisation Sensed paced AV delay interventricular pace delay V V Timing Interventricular Pace Delay ms Ventricular Sensing Ventricular Pacing Chamber Simultaneous RV First LV First RV First 10 80 LV First 15 80 in increments of 5 RV only not programmable RV only biventricular Negative AV Hysteresis Search ms Off 10 to 120 Shortest AV Delay ms 25 120 AF Management AF Suppression Pacing On Off No of Overdrive Pacing Cycles 15 40 in steps of 5 Maximum AF Suppression Rate 80 150 min Sensing Detection SenseAbility Technology Low Frequency Attenuation Sense Filter Threshold Start Decay Delay Ventricular Sense Refractory ms Detection Zones SVT Discriminators Reconfirmation Antitachycardia Pacing Therapy Automatic Sensitivity Control adjustment for atrial and ventricular events On Off Post Sensed Atrial 50 62 5 75 100 Post Paced Atrial 0 2 3 0 mV
17. AT AF Burden Exercise and Activity Trending V Rates during AMS nformation regarding PMT detections Pacing lead impedances high voltage lead impedances unloaded battery voltage and signal amplitudes ST JUDE MEDICAL MORE CONTROL LESS RISK Current Accel VR Single Chamber Implantable Cardioverter Defibrillator ICD Product Highlights The DF4 connector is designed to simplify implants by streamlining defibrillation connections into a single terminal pin and reducing the number of set screws ACap Confirm Pacing System periodically completes a threshold search and automatically adjusts amplitude to address patients changing atrial thresholds DeFT Response technology offers the most noninvasive options for managing high DFTs Implantable Cardioverter Defibrillator ICD Devices 3 Lot Unox Wm od Merlin home Transmitter Compatible The SenseAbility feature provides the flexibility to fine tune programming around T wave oversensing without decreasing sensitivity Vibratory patient notifier enables patients with hearing problems to be alerted to a low battery lead related complications and more Automatic daily high voltage lead integrity test is designed to ensure optimal patient safety Ordering Information Contents Cardiac pulse generator Model Dimensions Connector Connector Number H x W x T mm Weight g Volume cc Defibrillation Sense Pace CD1215 36 7
18. Auto 4 0 0 Auto 0 5 Auto 1 0 Auto 4 1 5 Auto 2 0 1 7 in steps of 0 5 Customer Support 46 8 474 4756 Brief Summary Prior to using these devices please review the Instructions for Use for a complete listing of indications contraindications warnings precautions potential adverse events and directions for use Devices depicted may not be available in all countries Check with your St Jude Medical representative for product availability in your country Unless otherwise noted indicates that the name is a trademark of or licensed to St Jude Medical or one of its subsidiaries ST JUDE MEDICAL the nine squares symbol and MORE CONTROL LESS RISK are registered and unregistered trademarks and service marks of St Jude Medical Inc and its related companies 2011 St Jude Medical Inc All rights reserved Item GMCRM814EN EBEN mam ST JUDE MEDICAL MORE CONTROL LESS RISK Zephyr DR Dual Chamber Rate Responsive Pacemaker Product Highlights QuickOpt timing cycle optimisation provides quick and effective optimisation for more patients at the touch of a button Powerful tools including automatic daily measurements follow up EGM and trends optimised in clinic testing and lead impedance trend and polarity switch save valuable clinic time The AutoCapture pacing system offers the maximum in threshold adaptability and patient safety with ventricular Beat by Beat capture confirmation
19. Congestion Trigger On On 2 4 6 8 10 12 14 16 2 1 16 10 22 Stored Electrograms Therapy Summary Episodes Summary Lifetime Diagnostics AT AF Burden Trend Ventricular HV Lead Impedance Trend Histograms PMT Data Real Time Measurements RTM CorVue Congestion Monitoring CorVue Congestion Trigger Up to 45 minutes including up to 1 minute programmable pre trigger data per VT VF diagnosis detection electrograms triggers include diagnosis therapy atrial episode PMT termination PC shock delivery noise reversion magnet reversion and morphology template verification Diagram of therapies delivered Directory listing of up to 60 episodes with access to more details including stored electrograms History of bradycardia events and device initiated charging Trend data and counts Multi Vector Trend Data Event Histogram AV Interval Histogram Mode Switch Duration Histogram Peak Filtered Rate Histogram Atrial Heart Rate Histogram Ventricular Heart Rate Histogram AT AF Burden Exercise and Activity Trending V Rates During AMS Information regarding PMT detections Pacing lead impedances high voltage lead impedances signal amplitudes On Off 8 18 days QHR is a trademark of Greatbatch LTD LV first with 10ms interventricular delay n o K Customer Support 46 8 474 4756 Brief Summary Prior to using these devices pl
20. Connector IS 1 Volume cc 8 0 5 Dual Chamber Pacing Models 5826 5820 only though not contraindicated for patients with chronic atrial flutter chronic atrial fibrillation or silent atria may provide no benefit beyond that of single chamber pacing in such patients Single Chamber Ventricular Demand Pacing is relatively contraindicated in patients who have demonstrated pacemaker syndrome have retrograde VA conduction or suffer a drop in arterial blood pressure with the onset of ventricular pacing Single Chamber Atrial Pacing is relatively contraindicated in patients who have demonstrated compromise of AV conduction For specific contraindications associated with individual modes refer to Operating Modes Potential Adverse Events Adverse events associated with the use of any pacing system include Air embolism Bleeding Hematoma Body rejection phenomena Cardiac tamponade or perforation Formation of fibrotic tissue local tissue reaction Inability to interrogate or program due to programmer or device malfunction Infection erosion Interruption of desired pulse generator function due to electrical interference either electromyogenic or electromagnetic Lead malfunction due to conductor fracture or insulation degradation Loss of capture or sensing due to lead dislodgement or reaction at the electrode tissue interface Loss of desired pacing and or sensing due to lead displacement body reaction at electrode interface or lead malf
21. Customer Support 46 8 474 4756 Brief Summary Prior to using these devices please review the Instructions for Use for a complete listing of indications contraindications warnings precautions potential adverse events and directions for use Devices depicted may not be available in all countries Check with your St Jude Medical representative for product availability in your country Unless otherwise noted indicates that the name is a trademark of or licensed to St Jude Medical or one of its subsidiaries ST JUDE MEDICAL the nine squares symbol and MORE CONTROL LESS RISK m are registered and unregistered trademarks and service marks of St Jude Medical Inc and its related companies S M B 2011 St Jude Medical Inc All rights reserved T JUDE E DICAL MORE CONTROL LESS RISK Accessories CPS Venture Wire Control Catheter N Product Highlights Tip deflects up to 90 to steer any 0 014 guidewire through the most challenging venous anatomies Over the Wire design permits easy wire exchanges if necessary Ordering Information Model Working Overall Guidewire Guide Catheter Number Length cm Length cm Compatibility in Compatibility F 1135 001 70 88 0 014 6 Radiopaque Deflectable Tip 22F Distal Shaft Proximal Shaft 0 73 mm 2 7F 3 5 F Strain 0 90 mm 1 18 mm Relief a Torque Handle d N t oe x ee Di
22. Hysteresis Search ms Off 10 to 120 in steps of 10 Opti Shortest AV PV Delay ms 25 50 in steps of 5 60 120 in steps of 10 rimi p iiach Atrial ACap Confirm On Off Monitor pete aii ni ru ig Primary Pulse Confirmation Bipolar cnannei i5 Backup Pulse Confirmation Bipolar Triggers Backup Pulse Amplitude V 5 0 Advanced Hysteresis Off Low Hig Searchable Intervals hrs 8 24 pe rus se eg Off Lou Atrial Pulse Configuration Unipolar tip case Bipolar tip ring AE Decal i i oW n Atrial Sense Configuration Unipolar Tip tip case Bipolar tip ring Unipolar Ring ring case j desea i Low us Atrial Sensitivity Fixed mV 0 1 0 5 in steps of 0 1 0 75 2 0 in steps of 0 25 2 5 5 0 in steps of 0 5 MEA oru di rows pe Atrial Pulse Amplitude V 0 25 4 0 in steps of 0 25 4 5 7 5 in steps of 0 5 trial Rate 106 ont ie enii Atrial Pulse Width ms 0 05 0 1 1 5 in steps of 0 1 ate mir 300 in steps o RVCap Confirm On Off Monitor No of Consecutive Cycles 2 3 4 5 l0 15 20 Searchable Interval hrs 8 24 High Ventricular Rate Off Low H ig LVCap Confirm On Off Monitor Rate min 125 300 in steps of 25 Searchable Interval hrs 8 uA No of Consecutive Cycles 2 3 4 5 10 15 20 SenseAbility Technology Off On Automatic Sensitivity Control adjustment for atrial and ud jii C r ventricular events pid S P 2 ru A Max Sensitivity mV 0 2 1 0 in steps of 0 1 v0 onsecutive PVCs on V
23. Inc All rights reserved T U DE E D ICAL Item GMCRM818EN MORE CONTROL LESS RISK Verity ADx XL VDR Model 5456 Rate responsive Pacemaker Product Highlights Extended longevity offers the benefit of fewer device replacements reducing the risk of complications associated with surgery The AutoCapture pacing system offers the maximum in threshold adaptability and patient safety with Beat by Beat capture confirmation Pace The FastPath Summary Screen displays key parameters and follow up test results on one screen and provides one step navigation to all available diagnostic tools The Programmable Back up Pulse may be programmed to either a bipolar or unipolar configuration The Auto Mode Switch algorithm reliably switches to a non atrial tracking mode in the presence of atrial tachyarrhythmia episodes Automatic P amp R Wave Measurements provide the option of measuring hte amplictudes of intrinsic P waves or R waves It then recommends a sensitivity setting based on a recommended safety margin Automatic P amp R Wave Measurements promote accurate sensitivity settings and save valuable clinic time Ordering Information Contents Cardiac pulse generator Model Number 5456 Dimensions H x W x T mm 44 x52 x6 Indications and Usage Implantation of pulse generators is indicated in the following permanent conditions when associated with symptoms including but not limited t
24. Intrinsic 0 ntrinsic 10 Intrinsic 20 Intrinsic 30 10 in 1 minute intervals Fast Medium Slow Very Slow 90 130 in steps of 5 140 180 in steps of 10 130 A00 AAI AAT 0A0 V00 VVI VVT VDD OVO DOO DVI DDI DDD ODO 60 70 80 85 95 100 110 115 125 130 140 150 55 165 170 180 185 195 200 Off Low Medium High Off Low Medium High 20 350 in steps of 10 170 25 30 200 in steps of 10 225 325 in steps of 25 150 Off 30 130 in steps of 5 140 150 0 50 in steps of 5 60 120 in steps of 10 100 2 52 in steps of 4 12 25 500 in steps of 25 250 A or V Pulse Amplitude V Aor V Pulse Width ms Aor V Pulse Configuration A or V Sense Configuration Atrial Sensitivity mV 0 0 4 0 in steps of 0 25 4 5 7 5 in steps of 0 5 2 5 0 05 0 1 1 5 in steps of 0 1 0 4 Unipolar tip case Bipolar tip ring Unipolar Tip tip case Bipolar tip ring Unipolar Ring ring case 0 1 0 4 in steps of 0 15 0 5 0 75 2 0 in steps of 0 25 2 0 4 0 in steps of 0 5 5 07 Options Sampling Options No of Stored EGMs Channel Triggers Advanced Hysteresis AMS Entry AMS Exit AT AF Detection Magnet Placement High Atrial Rate No of Consecutive Cycles High Ventricular Rate Freeze Continuous 1 2 4 8 12 Atrial Ventricular Dual Cross Channel On Off On Off On Off On Off Off 125 150 175 200 225 250 275 300 2 3 4 5 10 15 20 Off 125 150 175 200 225
25. LLLI c M Verity ADx XL VDR Model 5456 Rate responsive Pacemaker Product Specifications Model 5456 Dimensions mm 44x 52x6 Weight g 23 5 Volume cc 11 Connector IS 1 Rate Timing Mode VOO R VVI R WT R VDD R OVO 0A0 ODO Base Rate ppm 30 40 130 in steps of 5 140 170 in steps of 10 60 Hysteresis Rate ppm Off 30 130 in steps of 5 140 150 Search Interval min Off 5 10 15 30 Cycle Count 1 3 1 Rest Rate ppm Off 30 130 in steps of 5 140 150 Maximum Tracking Rate ppm 90 130 in steps of 5 140 180 in steps of 10 110 PV Delay ms 25 30 200 in steps of 10 225 325 in steps of 25 150 Shortest AV PV Delay ms 30 50 in steps of 5 60 120 in steps of 10 70 Ventricular Refractory ms 125 500 in steps of 25 250 Atrial Refractory PVARP ms 125 500 in steps of 25 275 Vent Blanking ms 12 52 in steps of 4 12 Far Field Protection Interval ms 16 Output Sensing Ventricular AutoCapture Pacing System On Off Back up Pulse Configuration Unipolar Bipolar Evoked Response Sensitivity mV Dependent upon the Measured Evoked Response 49 7 V Pulse Amplitude V 0 0 4 0 in steps of 0 25 4 5 7 5 in steps of 0 5 3 5 V Pulse Width ms 0 05 0 1 1 5 in steps of 0 1 0 4 V Sensitivity mV 0 5 5 0 in steps of 0 5 6 10 in steps of 1 0 12 5 2 0 V Pulse Configuration Unipolar tip case Bipolar tip ring Sense Configuration A or V Unipola
26. MRI Mode V00 Pacing Off Patient Notifiers MRI Base Rate MRI RV Pulse Configuration MRI RV Pulse Amplitude MRI RV Pulse Width Output Sensing Monitor Auto Polarity Switch 100 500 in steps of 25 750 2500 in steps of 250 3000 Off Battery Test Uncoded Unipolar Bipolar Ventricular 100 800 in steps of 10 2 25 in steps of 1 100 800 in steps of 10 Fixed or Adaptive Exercise Lead Impedance R Wave V Threshold 30 120 bpm in steps of 5 bpm m Programmable Notifiers 0n Off dep T Device Reset y T ty Entry into Backup VVI Mode 1 0 ms Audible Duration sec Number of Audible Alerts per Notification V Pulse Amplitude V V Pulse Width ms V Sensitivity mV V Pulse Configuration V Sense Configuration Ventricular AutoCapture Pacing System Primary Pulse Configuration Backup Pulse Configuration Backup Pulse Amplitude V Search Interval hours SenseAbility Technology Max Sensitivity mV Threshold Start Decay Delay ms Rate Modulated Parameters Number of Notifications 0 25 4 0 in steps of 0 25 4 5 7 5 in steps of 0 5 Time Between Notifications hours 0 05 0 1 1 5 in steps of 0 1 0 5 5 0 in steps of 0 5 6 10 in steps of 1 0 12 54 Unipolar tip case Bipolar tip ring Unipolar Tip tip case Bipolar tip ring Unipolar Ring ring case 1 30 5cc 5 This parameter is not programmable On Off Unipolar Bipolar Unipolar Bipolar 5 05 8 24 Off On Automatic Sensitivit
27. PHYSICAL SPECIFICATIONS Stored Electrograms Model PM1136 Options Dimensions mm 42x52x6 Sampling Options Freeze Continuous Weight g 23 No of Stored EGMs 1 2 4 8 12 Volume cc 10 4 Channel Atrial or Ventricular Connector IS 1 Triggers Magnet Placement 0n Off High Atrial Rate Off 125 150 175 200 225 250 275 300 Rate Timing No of Consecutive Cycles 2 3 4 5 10 15 20 High Ventricular Rate Off 125 150 175 200 225 250 275 300 Aor V Refractory ms 125 500 in steps of 25 325 No of Consecutive Cycles 2 3 4 5 10 15 20 Base Rate bpm 307 40 130 in steps of 5 140 170 in steps of 10 Advanced Hysteresis On Off Mode A0O R AAI R AAT R 0A0 VOO R VVI R VVT R OVO Hysteresis Rate bpm Search Interval bpm Cycle Count Intervention Rate bpm Intervention Duration min Recovery Time Rest Rate bpm Output Sensing Off 30 130 in steps of 5 140 150 Other Off 5 10 15 30 1 16 in steps of 1 Off 60 80 120 in steps of 10 Intrinsic 0 Intrinsic 10 Intrinsic 20 Intrinsic 30 1 10 in 1 minute intervals Fast Medium Slow Very Slow Off 30 130 in steps of 5 140 150 Lead Monitoring Off Monitor Auto Polarity Switch Aor V Low Impedance Limit Q 200 Aor V High Impedance Limit Q 750 1000 1250 1500 1750 2000 Aor V Signal Amplitude Monitoring Off On Magnet Response Off Battery Test Lead Type Uncoded Unipolar Bipolar Only Unipolar Bipolar NIPS Options
28. PMT Options PMT Detection Rate min PVC Response Ventricular Intrinsic Preference VIP ms VIP Search Interval VIP Search Cycles Ventricular Safety Standby Diagnostic Trends AT AF Patient Notifiers 00 500 in steps of 50 750 2500 in steps of 250 3000 Uncoded Unipolar Bipolar f Battery Test ff 10 to 120 in steps of 10 oc Atrial Ventricular 00 800 in steps of 10 2 25 in steps of 1 ff 100 800 in steps of 10 Fixed or Adaptive 1 30 95 in steps of 5 2 3 4 5 f Passive Atrial Pace 90 180 in steps of 5 Off Atrial Pace oc e e 1 50 150 in steps of 25 160 200 in steps of 10 30 sec 1 3 5 10 30 min 1 2 3 Off On Activity Exercise Lead Impedance P and R Wave A and V Threshold Programmable Notifiers Device Reset Entry into Backup Audible Duration sec Number of Audible Alerts per Notification Number of Notifications Time Between Notifications hours 1 x 0 5 cc On Off Device at ERI Atrial Lead Impedance Out of Range Ventricular Lead Impedance Out of Range AT AF Burden AT AF Episode Duration High V Rate During AT AF On WI Mode On 2 4 6 8 10 12 14 16 2 1 16 10 22 2 Programming options dependent on pacing mode 3 This parameter is not programmable 4 The highest available setting for hysteresis rate will be 5 min 1 below the programmed base rate 5 In dual chamber modes the maximum ventricular refractory period is 325
29. St Jude uL y Medical or one of its subsidiaries ST JUDE MEDICAL the nine squares symbol and MORE CONTROL LESS RISK are registered and unregistered trademarks and service marks of St Jude Medical Inc and its related companies S M B 9 2011 St Jude Medical Inc All rights reserved T U DE E D ICAL MORE CONTROL LESS RISK Item GMCRM918EN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR ICD DEVICES St Jude Medical Implantable Cardioverter Defibrillators Our new generation of implantable cardioverter defibrillators ICDs feature a triple redundancy safety platform designed to minimise risk and increase security and patient comfort through multiple hardware and software system safeguards More Control Individually tailored therapy helps ensure successful therapy St Jude Medical ICDs allow for comprehensive control over therapy delivery and make it possible to fine tune programming to meet individual patient needs Comfortable simple controls along with advanced automaticity enable efficient patient care and help improve the patient s quality of life Less Risk A progressive approach to safety based on the concept of redundant proven designs along with innovative functions offers the best prospects for optimal patient therapy LLL mem ST JUDE MEDICAL 558 MORE CONTROL LESS RISK Implantable Fortify ST DR Dual Chamber Implantable Cardioverter Defibrillator ICD Product Highlights T
30. Stimulation Chamber Coupling Interval ms Atrial or Ventricular 100 800 in steps of 10 A or V Pulse Amplitude V Aor V Pulse Width ms A or V Sensitivity mV A or V Pulse Configuration A or V Sense Configuration Ventricular AutoCapture Pacing System Primary Pulse Configuration Backup Pulse Configuration Backup Pulse Amplitude V Search Interval hours Rate Modulated Parameters 0 0 4 0 in steps of 0 25 4 5 7 5 in steps of 0 5 2 5 0 05 0 1 1 5 in steps of 0 1 0 4 0 5 5 0 in steps of 0 5 6 10 in steps of 1 0 12 5 Unipolar tip case Bipolar tip ring Unipolar Tip tip case Bipolar tip ring Unipolar Ring ring case On Off S1 Count S15 2 S3 and S4 Cycle ms Sinus Node Recovery Delay sec 1 25 in steps of 1 100 800 in steps of 10 1 5 in steps of 1 1 0 5cc Unipolar Bipolar 2 The actual pacing rate for the 30 ppm is 31 ppm Es 3 The highest available setting for Hysteresis Rate will be 5 ppm below the programmed Base Rate Unipolar Bipolar 4 Sensitivity is with respect to a 20 ms haversine test signal 5 05 5 This parameter is not programmable 8 24 6 S1 Burst Cycle is applied at the preprogrammed S1 cycle length Maximum Sensor Rate bpm Rate Responsive VREF Shortest VREF Reaction Time Recovery Time Sensor Slope Threshold Customer Support 46 8 474 4756 80 150 in steps of 5 160 180 in steps of 10 130 Off Low Medium High 120 350 in steps of 10 Very
31. easy to use hand held device SJM MRI Activator device can be used to program the device to pre approved MRI settings pre and post MRI scan decreasing the number of workflow steps and increasing clinic efficiency Merlin home Transmitter Compatible InvisiLink wireless telemetry in conjunction with the Merlin home transmitter and Merlin net Patient Care Network PCN allows for daily remote monitoring and follow up m The St Jude Medical MRI conditional pacing system can be scanned in patients under the following conditions horizontal closed bore clinical scanner working in the Normal Operating Mode or First Level Controlled Operating Mode static magnetic field strength of 1 5 Tesla T only maximum gradient slew rate of 200 T m s per axis See manual for additional details before performing an MRI scan 2 V 2 5 V 0 4 ms 500 ohms 100 VVI pacing 60 bpm AutoCapture Pacing System OFF SEGMs ON State of the art features such as automaticity Ventricular AutoCapture Pacing System and SenseAbility technology are designed to deliver optimal therapy for patients at implant and throughout their lives Industry leading longevity offers 13 7 years of service life which is supported by a 7 year warranty Ww Terms and conditions apply refer to the warranty for details Ordering Information Contents Cardiac pulse generator Model Number PM1224 RF Volume cc Connector 13 1
32. such as the OptiSense may be indicated for patients where the use of other active fixation leads and include cardiac tamponade diaphragmatic stimulation embolism permanent fixation of passive leads is suspected to be unstable In atrial applications the use of a screw in excessive bleeding induced ventricular ectopy infection loss of pacing and or sensing due to dislodgment lead such as the OptiSense may be indicated in the presence of an abnormal surgically altered or excised or mechanical malfunction of the pacing lead phrenic nerve stimulation thrombosis Complications reported atrial appendage with direct subclavian venipuncture include pneumothorax hemothorax laceration of the subclavian artery arteriovenous fistula neural damage thoracic duct injury cannulation of other vessels massive hemorrhage Contraindications The OptiSense lead is contraindicated In the presence of tricuspid atresia for patients and rarely death with mechanical tricuspid valves in patients who are expected to be hypersensitive to a single dose of one milligram of dexamethasone sodium phosphate Refer to the User s manual for detailed indications contraindications warnings precautions and potential adverse events Customer Support 46 8 474 4756 Brief Summary Prior to using these devices please review the Instructions for Use for a complete listing of indications contraindications warnings precautions potential adverse events and dire
33. voltage and signal amplitudes ST JUDE MEDICAL MORE CONTROL LESS RISK Implantable Cardioverter Defibrillator ICD Devices Current DR Dual Chamber Implantable Cardioverter Defibrillator ICD Product Highlights The DF4 connector is designed to simplify implants by streamlining defibrillation connections into a single terminal pin and reducing the number of set screws Triple redundancy safety platform is designed to minimise risk and increase security and patient comfort through multiple hardware and software system safeguards DeFT Response technology offers the most noninvasive options for managing Merlin home Transmitter high DFTs Compatible The SenseAbility feature provides the flexibility to fine tune programming around T wave oversensing without decreasing sensitivity Vibratory patient notifier enables patients with hearing problems to be alerted to a low battery lead related complications and more Automatic daily high voltage lead integrity test is designed to ensure optimal patient safety Ordering Information Contents Cardiac pulse generator Model Dimensions Connector Connector Number H x W x T mm Weight g Volume cc Defibrillation Sense 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 Indications The devices are intended to provide ventricular antitachycardia pacing and ventricular defibril lation for automated treatment of l
34. 0 7 5 12 ER Sensitivity mV 1 6 2 5 4 0 6 0 10 0 15 0 24 0 Pulse Polarity Configuration Unipolar Sense Polarity Configuration Bipolar Rate Modulated Parameters VARIO On Off Ventricular AutoCapture Pacing System On Off Sensor On Off Passive Maximum Sensor Rate ppm 90 160 in steps of 10 130 Slope 1 16 in steps of 1 10 Reaction Time Very Fast Fast Medium Slow Very Slow Recovery Time Very Fast Fast Medium Slow Very Slow Fast Response On Off Standard Nominal settings Only with AutoCapture ON Inactive Activate by programming the sensor ON or PASSIVE T o Customer Support 46 8 474 4756 Brief Summary Prior to using these devices please review the Instructions for Use for a complete listing of e y indications contraindications warnings precautions potential adverse events and directions for use Devices depicted may not be available in all countries Check with your St Jude Medical representative for product availability o in your country Unless otherwise noted indicates that the name is a trademark of or licensed to St Jude E Medical or one of its subsidiaries ST JUDE MEDICAL the nine squares symbol and MORE CONTROL LESS RISK are registered and unregistered trademarks and service marks of St Jude Medical Inc and its related companies S M B 9 2011 St Jude Medical
35. 1 16 10 22 Stored Electrograms Therapy Summary Episodes Summary Lifetime Diagnostics AT AF Burden Trend Ventricular HV Lead Impedance Trend Histograms PMT Data Real Time Measurements RTM CorVue Congestion Monitoring CorVue Congestion Trigger QHR is a trademark of Greatbatch LTD LV first with 10 ms interventricular delay Up to 45 minutes including up to one minute programmable pre trigger data per VT VF diagnosis detection electrograms triggers include diagnosis therapy atrial episode PMT termination PC shock delivery noise reversion magnet reversion and morphology template verification Diagram of therapies delivered Directory listing of up to 60 episodes with access to more details including stored electrograms History of bradycardia events and device initiated charging Trend data and counts Multi Vector Trend Data Event Histogram AV Interval Histogram Mode Switch Duration Histogram Peak Filtered Rate Histogram Atrial Heart Rate Histogram Ventricular Heart Rate Histogram AT AF Burden Exercise and Activity Trending V Rates During AMS Information regarding PMT detections Pacing lead impedances high voltage lead impedances signal amplitudes On Off 8 18 days GMCRM 766 E Customer Support 46 8 474 4756 Brief Summary Prior to using these devices please review the Instructions for Use for a complete listing of indications contraindications warnings precautions p
36. 10 4 IS 1 Volume cc Connector Potential Adverse Events Arrhythmia heart block thrombosis threshold elevation valve damage pneumothorax myopotential sensing vessel damage air embolism body rejection phenomena cardiac tamponade or perforation formation of fibrotic tissue local tissue reaction inability to interrogate or program a pulse generator because of programmer malfunction infection interruption of desired pulse generator function due to electrical interference loss of desired pacing and or sensing due to lead displacement body reaction at electrode interface or lead malfunction fracture or damage to insulation loss of normal pacemaker function due to battery failure or component malfunction pacemaker migration pocket erosion or hematoma pectoral muscle stimulation phrenic nerve or diaphragmatic stimulation The following in addition to the above are potential complications associated with the use of rate modulated pacing systems inappropriate rapid pacing rates due to sensor failure or to the detection of signals other than patient activity loss of activity response due to sensor failure palpitations with high rate pacing Refer to the User s Manual for detailed indications contraindications warnings precautions and potential adverse events LLL mam ST JUDE MEDICAL MORE CONTROL LESS RISK Pace ers Sustain XL SR Single Chamber Rate Responsive Pacemaker Product Specifications
37. 2 The actual pacing rate for the 30ppm is 31ppm 3 The highest available setting for Hysteresis Rate will be 5 ppm below the programmed Base Rate 4 In dual chamber modes the maximum Ventricular Refractory Period is 325 ms 5 Sensitvity is with respect to a 20 ms haversine test signal Customer Support 46 8 474 4756 Brief Summary Prior to using these devices please review the Instructions for Use for a complete listing of indications contraindications warnings precautions potential adverse events and directions for use Devices depicted may not be available in all countries Check with your St Jude Medical representative for product availability in your country Unless otherwise noted indicates that the name is a trademark of or licensed to St Jude Medical or one of its subsidiaries ST JUDE MEDICAL the nine squares symbol and MORE CONTROL LESS RISK Pacem G LL 2011 St Jude Medical Inc All rights reserved Item GMCRM941EN MORE CONTROL LESS RISK aan are registered and unregistered trademarks and service marks of St Jude Medical Inc and its related companies EUH ST J l J DE ME DIC AL EEE PACING LEADS St Jude Medical Pacing Leads The St Jude Medical portfolio of highly advanced bradycardia pacing leads has been designed for ease of implant reliability and performance Optim lead insulation used in the newest leads is the first silicone polyurethane co polymer insulation des
38. 25 stimuli with up to 3 extrastimuli Programmable Notifiers On Off Device Parameter Reset Entry into Backup VVI Mode Vibration Duration sec Number of Vibrations per Notification Number of Notifications Time Between Notifications hours Electrograms and Diagnostics Device at ERI Charge Time Limit Reached Possible HV Circuit Damage Atrial Lead Impedance Out of Range Ventricular Lead Impedance Out of Range High Voltage Lead Impedance Out of Range AT AF Burden V Rate During AT AF Backup VVI Long AT AF Episode On On 2 4 6 8 10 12 14 16 2 16 0 22 Stored Electrograms Therapy Summary Episodes Summary Lifetime Diagnostics AT AF Burden Trend Ventricular HV Lead Impedance Trend Histograms PMT Data Real Time Measurements RTM p to 45 minutes including up to 1 minute programmable pre trigger data per VT VF diagnosis detection electrograms triggers include diagnosis therapy atrial episode PMT termination PC shock delivery noise reversion magnet reversion and morphology template verification Diagram of therapies delivered Directory listing of up to 60 episodes with access to more details including stored electrograms istory of bradycardia events and device initiated charging Trend data and counts Multi Vector Trend Data Event Histogram AV Interval Histogram Mode Switch Duration Histogram Peak Filtered Rate Histogram Atrial Heart Rate Histogram Ventricular eart Rate Histogram
39. 405147 9F 038 14 1 405149 10 F 038 14 1 405104 6F 038 14 5 405108 7F 038 14 5 405112 8F 038 14 5 405129 8 F TW 038 14 5 405116 9F 038 14 5 405118 9 5 F 038 14 5 405120 10 F 038 14 5 405122 10 5 F 038 14 5 405124 11F 038 14 5 405128 12F 038 14 5 405132 13F 038 14 5 405144 l6F 038 14 5 d U S Patent Number 5 098 392 f Jd Customer Support 46 8 474 4756 Brief Summary Prior to using these devices please review the Instructions for Use for a complete listing of indications contraindications warnings precautions potential adverse events and directions for use Devices depicted may not be available in all countries Check with your St Jude Medical representative for product availability in your country Unless otherwise noted indicates that the name is a trademark of or licensed to St Jude Medical or one of its subsidiaries ST JUDE MEDICAL the nine squares symbol and MORE CONTROL LESS RISK EBEN are registered and unregistered trademarks and service marks of St Jude Medical Inc and its related companies S I M B 2011 St Jude Medical Inc All rights reserved EUN JUDE E DICAL MORE CONTROL LESS RISK Accessories Peel Away Introducer 23 cm Sheath Introducer Kit 7 F 14F Product Highlights Proprietary materials improve insertion characteristics and reduce vessel trauma Close tolerance extrusion and proprietary ti
40. 86 92 Indications and Usage The Quartet lead has application as part of a St Jude Medical biventricular system Contraindications The use of the Quartet lead is contraindicated in patients who Are expected to be hypersensitive to a single dose of 1 0 mg of dexamethasone sodium phosphate Are unable to undergo an emergency thoracotomy procedure Have coronary venous vasculature that is inadequate for lead placement as indicated by venogram Customer Support 46 8 474 4756 Brief Summary Prior to using these devices please review the Instructions for Use for a complete listing of indications contraindications warnings precautions potential adverse events and directions for use Devices depicted may not be available in all countries Check with your St Jude Medical representative for product availability in your country Unless otherwise noted indicates that the name is a trademark of or licensed to St Jude Medical or one of its subsidiaries ST JUDE MEDICAL the nine squares symbol and MORE CONTROL LESS RISK ann are registered and unregistered trademarks and service marks of St Jude Medical Inc and its related companies S I M hi 2011 St Jude Medical Inc All rights reserved EUN JUDE E DICAL MORE CONTROL LESS RISK Left Heart Leads Quartet Left Heart Lead Product Specifications MODEL 14580 Parameter Description Connector IS4 LLLL Lead Length 75 86 92 cm Maximum Lead Size 5 1 F 1
41. Chamber Paced Interventricular Pace Delay ms Output Sensing Sensed Paced AV Delay Interventricular Paced Delay 0 05 0 1 1 5 in steps of 0 1 0 25 4 0 in steps of 0 25 4 5 7 5 in steps of 0 5 Unipolar Bipolar Unipolar Bipolar LV Tip RV Ring LV Ring RV Ring BV Unipolar Tip BV Bipolar RV Unipolar Tip RV Bipolar LV Unipolar Tip LV Bipolar RV Unipolar Ring LV Tip RV Tip BV RV only LV only temporary mode Simultaneous RV LV 10 80 in steps of 5 Negative AV Hysteresis Search ms Shortest AV PV Delay ms Atrial ACap Confirm Primary Pulse Confirmation Backup Pulse Confirmation Backup Pulse Amplitude V Searchable Intervals hrs Atrial Pulse Configuration Atrial Sense Configuration Atrial Sensitivity Fixed mV Atrial Pulse Amplitude V Atrial Pulse Width ms RVCap Confirm Searchable Interval hrs LVCap Confirm Searchable Interval hrs SenseAbility Technology A Max Sensitivity mV V Max Sensitivity mV Threshold Start Decay Delay ms Ventricular Sensitivity fixed mV Off 10 to 120 in steps of 10 25 50 in steps of 5 60 120 in steps of 10 On Off Monitor Bipolar Bipolar 5 8 24 Unipolar tip case Bipolar tip ring Unipolar Tip tip case Bipolar tip ring Unipolar Ring ring case 0 1 0 5 in steps of 0 1 0 75 2 0 in steps of 0 25 2 5 5 0 in steps of 0 5 0 25 4 0 in steps of 0 25 4 5 7 5 in steps of 0 5 0 05 0 1 1 5 in
42. Contraindications Contraindications for use of the pulse generator system include ventricular tachyarrhythmias resulting from transient or correctable factors such as drug toxicity electrolyte imbalance or acute myocardial infarction Adverse Events Implantation of the pulse generator system like that of any other device involves risks some possibly life threatening These include but are not limited to the following acute hemorrhage bleeding air emboli arrhythmia acceleration cardiac or venous perforation cardiogenic shock cyst formation erosion exacerbation of heart failure extrusion fibrotic tissue growth fluid accumulation hematoma formation Customer Support 46 8 474 4756 Brief Summary Prior to using these devices please review the Instructions for Use for a complete listing of indications contraindications warnings precautions potential adverse events and directions for use Devices depicted may not be available in all countries Check with your St Jude Medical representative for product availability in your country Unless otherwise noted indicates that the name is a trademark of or licensed to St Jude Medical or one of its subsidiaries ST JUDE MEDICAL the nine squares symbol and MORE CONTROL LESS RISK are registered and unregistered trademarks and service marks of St Jude Medical Inc and its related companies 2011 St Jude Medical Inc All rights reserved Connector Connector Volume cc Defibri
43. Contraindications Contraindications for use of the pulse generator system include ventricular tachyarrhythmias resulting from transient or correctable factors such as drug toxicity electrolyte imbalance or acute myocardial infarction Adverse Events Implantation of the pulse generator system like that of any other device involves risks some possibly life threatening These include but are not limited to the following acute hemorrhage bleeding air emboli arrhythmia acceleration cardiac or venous perforation cardiogenic shock cyst formation erosion exacerbation of heart failure extrusion fibrotic tissue growth fluid accumulation hematoma formation Customer Support 46 8 474 4756 Brief Summary Prior to using these devices please review the Instructions for Use for a complete listing of indications contraindications warnings precautions potential adverse events and directions for use Devices depicted may not be available in all countries Check with your St Jude Medical representative for product availability in your country Unless otherwise noted indicates that the name is a trademark of or licensed to St Jude Medical or one of its subsidiaries ST JUDE MEDICAL the nine squares symbol and MORE CONTROL LESS RISK are registered and unregistered trademarks and service marks of St Jude Medical Inc and its related companies 2011 St Jude Medical Inc All rights reserved histotoxic reactions infection keloid
44. Cycles PMT Termination Consecutive PVCs No of Consecutive PVCs Noise Reversion Other an n ae e e zzz 5i i Dx co e e 3 9 eps of 25 4 5 10 15 20 Dx FR oo RR we O05 wn Eur Se ne T Sa eps of 25 15 20 Omoomocov mcoooco Magnet Response Ventricular Intrinsic Preference VIP ms VIP Search Interval VIP Search Cycles of the Atrial Tachycardia Detection Rate min Post Vent Atrial Blanking PVAB ms Ventricular Safety Standby PVC Response PMT Options PMT Detection Rate min Lead Type NIPS Options Stimulation Chamber Coupling IntervaP ms S1 Count SE 2 S3 and S4 Cycle ms Right Ventricular Support Rate mim Sinus Node Recovery Delay s Diagnostic Trends Patient Notifiers eo f Battery Test f 50 150 in steps of 25 160 200 in steps of 10 0 sec 1 3 5 10 30 min 32 3 wo 0 200 in steps of 10 225 300 in steps of 25 0 200 in steps of 10 225 250 f On f Atrial Pace f Passive Atrial Pace 0 180 in steps of 5 ncoded Unipolar Bipolar cooooo rial Right Ventricular 00 800 in steps of 10 2 25 in steps of 1 Off 100 800 in steps of 10 Fixed or Adaptive M zx Off 30 95 in steps of 5 1 5 in steps of 1 AT AF Activity Exercise Lead Impedance P and R Wave A and V threshold Programmable Notifiers 0n Off Device Reset Entry into Backup VVI Mode Audible Duration sec Number of Audibl
45. Disabled Charge Time Limit Reached Possible HV Circuit Damage Device Reset Device at ERI Device in MRI Settings HV Lead Impedance Out of Range Atrial Pacing Lead Impedance Out of Range Dual Chamber and CRT Devices Device Programmed to Emergency Pacing Values Back Up WI Possible High Voltage Lead Issue LV Pacing Lead Impedance Out of Range CRT Devices RV Pacing Lead Impedance Out of Range High Voltage Lead Impedance lt Lower Limit High Voltage Lead Impedance gt Upper Limit Device Parameter Reset E mail fax SMS website voice message or smartphone Alert Summary Report AT AF alert report accompanies AT AF alert Daily alert surveillance Programmable alerts Diagnostic alert triggers Therapy alert triggers Device alert triggers Alert notification options Alert reports Transmitters Merlin home RF radio frequency For use with compatible RF devices Transmitter stays with the patient when changing clinics or when patient receives new device from the same family Ability to link re link transmitter to a patient s device remotely Transmitter can be issued to patient and paired with his her device before discharge for remote monitoring from day one t Available in select markets only Different devices support different alerts Check User s Manual for full list of available alerts If programmed On in patient s device In version 5 0 the inductive Merlin home transmitter unit can support interro
46. Electrode Pt Ir TiN coated ring shaped two grooves Steroid Dexamethasone sodium phosphate Tip Electrode Surface Area 5 0 mm Ring Electrode Surface Area 7 4 mm Tip to Ring Electrode Spacing 20 mm Lead Body Insulation Optim insulation Lead Body Coating Fast Pass coating Conductors Distal coil MP35N Proximal cables MP35N Suture Sleeve Attached MP35N is a trademark of SPS Technologies Inc 2 7 Customer Support 46 8 474 4756 Brief Summary Prior to using these devices please review the Instructions for Use for a complete listing of indications contraindications warnings precautions potential adverse events and directions for use Devices depicted may not be available in all countries Check with your St Jude Medical representative for product availability in your country Unless otherwise noted indicates that the name is a trademark of or licensed to St Jude Medical or one of its subsidiaries ST JUDE MEDICAL the nine squares symbol and MORE CONTROL LESS RISK are registered and unregistered trademarks and service marks of St Jude Medical Inc and its related companies 2011 St Jude Medical Inc All rights reserved Item GMCRM772EN GMCRM 7 ST JUDE MEDICAL MORE CONTROL LESS RISK Left Heart Leads QuickSite Left Heart Lead Product Highlights Superb deliverability combined with exceptional stability and performance Low profile 5 6 F proximal lead b
47. Hysteresis Rate min Rate Hysteresis with Search Off DDI R DDT R VVI R VVT R 110 300 40 45 135 A Pace on PMT Off Passive Off Low Medium High Ventricular Intrinsic Preference VIP Off 50 200 50 150 in increments of 25 160 200 in increments of 10 BiVCap Confirm LVCap Confirm RVCap Confirm ACap Confirm Setup On Monitor Off On Monitor Off Post Therapy Pacing Independently programmable from Bradycardia and ATP Post Shock Pacing Mode Post Shock Base Rate min Post Shock Pacing Duration min Device Testing Induction Methods Off AAI VVI DDI or DDD 30 100 in increments of 5 Off 0 5 1 2 5 5 7 5 or 10 DC Fibber Pulse Duration sec Burst Fibber Cycle Length ms Noninvasive Programmed Stimulation NIPS Patient Notifiers 0 5 5 0 20 100 2 25 stimuli with up to three extrastimuli Programmable Notifiers 0n Off Device Reset Entry into Backup VVI Mode Vibration Duration sec Number of Vibrations per Notification Number of Notifications Time Between Notifications hours Electrograms and Diagnostics Device at ERI Charge Time Limit Reached Possible HV Circuit Damage Atrial Lead Impedance Out of Range RV Lead Impedance Out of Range LV Lead Impedance Out of Range High Voltage Lead Impedance Out of Range AT AF Burden V Rate During AT AF V pacing CorVue Congestion Trigger On On 2 4 6 8 10 12 14 16 2
48. Length ms Number of Bursts Number of Stimuli Add Stimuli per Burst ATP Pulse Amplitude V ATP Pulse Width ms High Voltage Therapy Ramp Burst Scan 1 or 2 schemes per VT zone Adaptive Readaptive or Fixed 50 400 in increments of 5 15 2 20 On Off 7 5 Independent from Bradycardia and Post Therapy Pacing 0 or 1 5 Independently programmable from Bradycardia and Post Therapy Pacing High Voltage Output Mode Waveform RV Polarity Electrode Configuration Bradycardia Pacing Fixed Pulse Width Fixed Tilt Biphasic Monophasic Cathode Anode RV to Can RV to SVC Can Permanent Modes Temporary Modes Rate Adaptive Sensor Programmable Rate and Delay Parameters DD R DDI R DOO R VVI R VOO R AAI R AOO R Off DDD DDI VVI AAI AAT AAT R D00 V00 A00 On Off Passive Off Base Rate min Rest Rate min Maximum Tracking Rate min Maximum Sensor Rate min Paced AV Delay ms Sensed AV Delay ms Rate Responsive AV Delay Pulse Amplitude Atrial RV V Pulse Width Atrial and RV ms Hysteresis Rate min Rate Hysteresis with Search E QuickOpt Timing Cycle Optimisation Sensed Paced AV delay Auto Mode Switch AMS DDD R DDI R DOO R VVI R VOO R AAI R AOO R Atrial Tachycardia Detection Rate min 110 300 AMS Base Rate min Auto PMT Detection Termination Rate Responsive PVARP VREF 40 45 135 Atrial Pace Off Passive Off
49. MORE CONTROL LESS RISK are registered and unregistered trademarks and service marks of St Jude Medical Inc and its related companies 2011 St Jude Medical Inc All rights reserved Weight g Volume cc Connector 21 11 5 IS 1 patients Single Chamber Ventricular Demand Pacing is relatively contraindicated in patients who have demonstrated pacemaker syndrome have retrograde VA conduction or suffer a drop in arterial blood pressure with the onset of ventricular pacing Single Chamber Atrial Pacing is relatively contraindicated in patients who have demonstrated compromise of AV conduction Atrial Fibrillation Anthem devices are contraindicated in patients having chronic atrial fibrillation or intermittent atrial fibrillation that does not terminate For specific contraindications associated with individual modes refer to the programmer s on screen help Potential Adverse Events The following are potential complications associated with the use of any pacing system air embolism body rejection phenomena cardiac tamponade or perforation hematoma bleeding hematoma seroma formation of fibrotic tissue local tissue reaction inability to interrogate or program due to programmer or device malfunction infection erosion interruption of desired pulse generator function due to electrical interference either electromyogenic or electromagnetic lead malfunction due to conductor fracture or insulation degradation loss of capture or sensi
50. MORE CONTROL LESS RISK are registered and unregistered trademarks and service marks of St Jude Medical Inc and its related companies 2011 St Jude Medical Inc All rights reserved Win ST JUDE MEDICAL MORE CONTROL LESS RISK Accessories Model Ne pus AC 0160 Test Magnet 90 gauss at 1 405 Test Magnet 90 gauss at 1 60007717 001 Vein Pick 442 2 Torque Wrench 2 E TORGUEWRENGH a 437 246 Set of L Hex Wrenches 2 4 6 4033A DFA IS 1 DF 1 Lead Terminal Cap a 6201 FasTac Flex Epicardial Lead Implant Tool 4080 Lead Removal Tool DSOA001 Suture Sleeve radiopaque 7 0 F L IHHE SS 1056 Suture Sleeve radiopaque 6 0 F for QuickSite Leads EHHH TV 0800 Suture Sleeve radiopaque 8 0 F EHHH AC 0130 Silicone Oil 424 Medical Adhesive FL 1056 Lead Flushing Tool AC TD Torque Driver 2 wrench 4071 Torque Tool and Tip Introducer AC IP 2 IS 1 Port Plug HE 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 ISA DF4 Connector Sleeve Customer Support 46 8 474 4756 Brief Summary Prior to using these devices please review the Instructions for Use for a complete listing of indications contraindications warnings precautions potential adverse events and direction
51. Max Sensitivity mV 0 2 2 0 in steps of 0 1 OISEAEVEISION Low Hig Threshold Start Atrial and Ventricular Post Sense 50 62 5 75 100 Atrial Post Pace 0 2 3 0 in steps of 0 1 mV Other Ventricular Post Pace Auto 0 2 3 0 in steps of 0 1 mV Decay Delay ms Atrial and Ventricular Post Sense 0 30 60 95 125 160 190 220 Magnet Response Off Battery Test Atrial Post Pace 0 30 60 95 125 160 190 220 Ventricular Intrinsic Ventricular Post Pace Auto 0 30 60 95 125 160 190 220 Preference VIP ms Off 50 150 in steps of 25 160 200 in steps of 10 Ventricular Sensitivity fixed mV 0 5 12 5 in steps of 0 54 VIP Search Interval 30 sec 1 3 5 10 30 min VIP Search Cycles 1 2 3 Rate Timing of the Atrial Tachycardia Detection Rate min 110 200 in steps of 10 225 300 in steps of 25 Mode A00 R AAI R AAT R VOO R VVI R VVT R DOO R Post Vent Atrial Blanking DVI R DDI R DDT R DDD R VDD R Pacing Off PVAB ms 60 200 in steps of 10 225 250 DT Trigger R wave Ventricular Safety Standby Off On DDT Timing DDI PVC Response Off Atrial Pace Base Rate min 30 130 in steps of 5 140 170 in steps of 10 PMT Options D Off Passive Atrial Pace Hysteresis Rate min Off 30 150 in steps of 5 PMT Detection Rate min 90 180 in steps of 5 Search Interval min Off 1 5 10 15 30 Lead Type Uncoded Unipolar Bipolar Cycle Count 1 16 NIPS Options ne ntervention Rate min Off Same Base
52. Medical or one of its subsidiaries ST JUDE MEDICAL the nine squares symbol and MORE CONTROL LESS RISK are registered and unregistered trademarks and service marks of St Jude Medical Inc and its related companies 2011 St Jude Medical Inc All rights reserved ST JUDE MEDICAL MORE CONTROL LESS RISK Connectivity External Pulse Generator Single Chamber Model 3077 Product Specifications Model 3085 Battery Alkaline 38 days 72 ppm 8 0 V Lithium 53 days 72 ppm 8 0 V Weight g Approximately 185 including battery Size cm 6 0x 11 5 x 2 2 2 25 in x 4 5 in x 0 85 in Technology Modes VVI VOO AAI A00 Base Pacing Rates ppm 30 180 High Pacing Rates ppm 360 720 Pulse Width ms 0 75 Pulse Amplitude V 0 3 12 Sensitivity mV 1 0 20 Refractory Period ms 250 Runaway Protection ppm 200 Customer Support 46 8 474 4756 Brief Summary Prior to using these devices please review the Instructions for Use for a complete listing of indications contraindications warnings precautions potential adverse events and directions for use Devices depicted may not be available in all countries Check with your St Jude Medical representative for product availability in your country Unless otherwise noted indicates that the name is a trademark of or licensed to St Jude Medical or one of its subsidiaries ST JUDE MEDICAL the nine squares symbol and MORE CONTROL LESS RISK are registered an
53. Output Sensing ACap Confirm On Off Monitor Primary Pulse Configuration Bipolar Backup Pulse Configuration Bipolar Backup Pulse Amplitude V 5 0 Search Interval hours 8 24 Aor V Pulse Amplitude V 0 0 4 0 in steps of 0 25 4 5 7 5 in steps of 0 5 Aor V Pulse Width ms 0 05 0 1 1 5 in steps of 0 1 Aor V Pulse Configuration A or V Sense Configuration Unipolar tip case Bipolar tip ring Unipolar Tip tip case Bipolar tip ring Unipolar Ring ring case 0 1 0 45 0 5 by 0 1 0 75 2 0 in steps of 0 25 2 0 4 0 in steps of 0 5 5 07 Ventricular AutoCapture Pacing System On Off Primary Pulse Configuration Unipolar Bipolar Backup Pulse Configuration Unipolar Bipolar Backup Pulse Amplitude V 5 0 Search Interval hours 8 24 AutoCapture Paced Sensed AV Delay ms 50 25 100 70 120 100 Ventricular Sensitivity mV Atrial Sensitivity mV Rate Modulated Parameters Maximum Sensor Rate min 80 150 in steps of 5 160 180 in steps of 10 60 70 80 85 95 100 110 115 125 130 140 0 5 5 0 in steps of 0 5 6 10 in steps of 1 0 12 57 Pace ers AF Management AF Suppression Algorithm Off On Lower Rate Overdrive min 10 Upper Rate Overdrive min 5 No of Overdrive Pacing Cycles 15 40 in steps of 5 Rate Recovery ms 8 12 Maximum AF Suppression Rate min Atrial Tachycardia Detection Rate min Auto Mode Switch AMS Base Rate min Stored Electrograms 80 150 in step
54. Rate 80 120 in steps of 10 Intrinsic 0 Stimulation Chamber Atrial Right Ventricular Intrinsic 10 Intrinsic 20 Intrinsic 30 Coupling IntervaP ms 200 800 in steps of 10 intervention Duration min 1 10 S1 Count 2 25 in steps of 1 Recovery Time Fast Medium Slow Very Slow SI 2 53 and S4 Cycle ms Off 100 800 in steps of 10 Fixed or Adaptive Rest Rate min Off 30 150 in steps of 5 Right Ventricular Maximum Tracking Rate min 90 130 in steps of 5 140 180 in steps of 10 Support Rate min Off 30 95 in steps of 5 Sensed AV Delay ms 25 30 200 in steps of 10 225 325 in steps of 25 Sinus Node Recovery Delay s l instepsofl Paced AV Delay ms 25 30 200 in steps of 10 225 300 in steps of 25 350 Diagnostic Trends AT AF Activity Exercise Lead Impedance P and R Wave A and V threshold Ventricular Pace Sense Refractory Fixed ms Atrial Pace Refractory Atrial Sense Refractory PVARP ms 125 160 400 in steps of 30 440 4708 190 400 in steps of 30 440 4708 93 125 157 190 400 in steps of 30 440 470 125 500 in steps of 25 Patient Notifiers Programmable Notifiers 0n Off Device at ERI Atrial Lead Impedance Out of Range Ventricular Lead Impedance Out of Range LV Lead Impedance Atrial Protection Interval ms 125 Out of Range AT AF Burden AT AF Episode Duration Far Field Protection Interval ms 5 16 High V Rate During AT AF 1405ce Device Reset On 2 LV first with 10
55. ST JUDE MEDICAL the nine squares symbol and MORE CONTROL LESS RISK are registered and unregistered trademarks and service marks of St Jude Medical Inc and its related companies 2011 St Jude Medical Inc All rights reserved LLL mem ST JUDE MEDICAL EEE MORE CONTROL LESS RISK 7 4 EN GMCRM Sustain XL DR Dual Chamber Rate Responsive Pacemaker Product Specifications Model PM2136 Dimensions mm 44x52x6 Weight g 23 5 Volume cc nu Connector IS 1 PARAMETER SETTINGS Rate Timing Atrial Absolute Refractory Period Atrial Protection Interval ms Atrial Refractory PVARP ms AV Delay ms Base Rate bpm Far Field Protection Interval ms Hysteresis Rate min Search Interval min Cycle Count Intervention Rate min Intervention Duration min Recovery Time Maximum Tracking Rate min Mode Post Vent Atrial Blanking PVAB ms PV Delay ms Rest Rate min Shortest AV PV Delay ms Ventricular Blanking ms Ventricular Refractory ms Output Sensing 60 80 100 350 in steps of 25 125 125 500 in steps of 25 275 25 30 200 in steps of 10 225 300 in steps of 25 350 200 305 40 130 in steps of 5 140 170 in steps of 10 60 16 Off 30 130 in steps of 5 140 150 Off 5 10 15 30 1 16 in steps of 1 Off 60 80 120 in steps of 10 Intrinsic 0 Intrinsic 10 Intrinsic 20 Intrinsic 30 1 10 in 1 minute intervals Fast Medium Slow Very Slow 90 1
56. ST JUDE MEDICAL the nine squares symbol and MORE CONTROL LESS RISK are registered and unregistered trademarks and service marks of St Jude Medical Inc and its related companies 2011 St Jude Medical Inc All rights reserved ST JUDE MEDICAL MORE CONTROL LESS RISK Defibrillation Leads Durata Defibrillation Lead Product Specifications PHYSICAL SPECIFICATIONS True Bipolar Active Fixation Defibrillation Leads Models 7120 71200 7121 71210 7122 71220 Fixation Ext Ret Helix Ext Ret Helix Ext Ret Helix Ext Ret Helix Ext Ret Helix Ext Ret Helix Shock Configuration Dual Coil Dual Coil Dual Coil Dual Coil Single Coil Single Coil Sensing Configuration True Bipolar True Bipolar True Bipolar True Bipolar True Bipolar True Bipolar Min Size Introducer TE TF 7F 7F 7F TF Lengths cm 60 65 52 58 65 60 65 75 52 58 65 60 65 75 52 58 65 Connector 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 Anode Spacing 11 mm 11 mm 11 mm 11 mm 11 mm 11 mm Tip to Proximal Coil 17 cm 17 cm 21cm 21cm N A N A Tip Electrode Area 6mm 6mm 6mm 6mm 6 mm 6mm Steroid Plug Yes Yes Yes Yes Yes Yes Distal Shock Coil Area 367 mm 367 mm 367 mm 367 mm 367 mm 367 mm Proximal Shock Coil Area 588 mm 588 mm 588 mm 588 mm N A NA True Bipolar Passive Fixation Defibrillation Leads Models 7170 71700 nn 71710 71720 Fixation Tines Tines Tines Tines Tines Shock Configuration Dua
57. Summary Lifetime Diagnostics AT AF Burden Trend Ventricular HV Lead Impedance Trend Histograms PMT Data Real Time Measurements RTM Up to 45 minutes including up to 1 minute programmable pre trigger data per VT VF diagnosis detection electrograms triggers include diagnosis therapy atrial episode PMT termination PC shock delivery noise reversion magnet reversion and morphology template verification Diagram of therapies delivered Directory listing of up to 60 episodes with access to more details including stored electrograms History of bradycardia events and device initiated charging Trend data and counts Multi Vector Trend Data Event Histogram AV Interval Histogram Mode Switch Duration Histogram Peak Filtered Rate Histogram Atrial Heart Rate Histogram Ventricular Heart Rate Histogram AT AF Burden Exercise and Activity Trending V Rates During AMS Information regarding PMT detections Pacing lead impedances high voltage lead impedances unloaded battery voltage and signal amplitudes LV first with 10 ms interventricular delay Customer Support 46 8 474 4756 Brief Summary Prior to using these devices please review the Instructions for Use for a complete listing of indications contraindications warnings precautions potential adverse events and directions for use Devices depicted may not be available in all countries Check with your St Jude Medical representative for product availability in your count
58. V00 A00 Post Sense Post Pace Atrial Ventricular 0 220 Off Base Rate min Rest Rate min Maximum Tracking Rate min Maximum Sensor Rate min Paced AV Delay ms Sensed AV Delay ms Rate Responsive AV Delay Pulse Amplitude Atrial RV V Pulse Width Atrial and RV ms Hysteresis Rate min Rate Hysteresis with Search QuickOpt Timing Cycle Optimisation Sensed Paced AV delay Auto Mode Switch AMS Off DDI R VVI R Atrial Tachycardia 110 300 Detection Rate min AMS Base Rate min 40 45 135 Auto PMT Detection Termination Rate Responsive PVARP VREF A Pace on PMT Off Passive Off Low Medium High Ventricular Intrinsic Preference VIP Off 50 200 50 150 in increments of 25 450 to 200 in increments of 10 Ventricular AutoCapture On Off Pacing System ACap Confirm On Monitor Off QHR is a trademark of Greatbatch LTD Customer Support 46 8 474 4756 Brief Summary Prior to using these devices please review the Instructions for Use for a complete listing of indications contraindications warnings precautions potential adverse events and directions for use Devices depicted may not be available in all countries Check with your St Jude Medical representative for product availability in your country Unless otherwise noted indicates that the name is a trademark of or licensed to St Jude Medical or one of its subsidiaries ST JUDE MEDICAL the nine squares symbol a
59. a complete listing of indications contraindications warnings precautions potential adverse events and directions for use Devices depicted may not be available in all countries Check with your St Jude Medical representative for product availability in your country Unless otherwise noted indicates that the name is a trademark of or licensed to St Jude Medical or one of its subsidiaries ST JUDE MEDICAL the nine squares symbol and MORE CONTROL LESS RISK ann are registered and unregistered trademarks and service marks of St Jude Medical Inc and its related companies S I M i 2011 St Jude Medical Inc All rights reserved EUN JUDE E DICAL Item GMCRM811EN MORE CONTROL LESS RISK Accent SR RF Single Chamber Pacemaker Product Highlights InvisiLink wireless telemetry in conjunction with the Merlin home transmitter and Merlin net Patient Care Network PCN allows for daily remote monitoring and follow up A two tone audible alert allows programming to notify the patient of changes in device performance or information can be remotely transmitted to the clinician through the Merlin net PCN without patient interaction State of the art features such as automaticity Ventricular AutoCapture pacing system and SenseAbility technology are designed to deliver optimal therapy for patients at implant and throughout their lives Real time electrogram EGM waveform as well as the associated ev
60. by streamlining defibrillation connections into a single terminal pin and reducing the number of set screws Merlin home QHR chemistry battery provides greater capacity for enhanced longevity and Transmitter Compatible stable charge times Antitachycardia pacing ATP while charging and prior to charging in the VF zone further extends the programming options for terminating tachyarrhythmias without a high voltage shock The low frequency attenuation filter is designed to enhance sensing performance and may reduce the possibility of oversensing T waves DeFT Response technology offers the most noninvasive options for managing high DFTs Vibratory patient notifier enables patients with hearing problems to be alerted to a low battery lead related complications and more The SenseAbility feature provides the flexibility to fine tune programming around T wave oversensing without decreasing sensitivity Ventricular Intrinsic Preference VIP algorithm automatically searches for intrinsic conduction Ordering Information Contents Cardiac pulse generator Model Dimensions Connector Connector Number H x W x T mm Weight g Volume cc Defibrillation Sense Pace CD2233 40 74 x 40 x 14 76 35 DF1 IS 1 CD2233 40Q 71 x40x 14 75 35 DF4 IS 1 DF4 Indications The devices are intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias
61. comprehensive patient management Merlin net PCN was the first medical device network to be awarded ISO 27001 certification a stringent worldwide information security standard DON Merlin home ANAB i Transmitter Compatible ISO 27001 IS 541672 Customer Support 46 8 474 4756 Brief Summary Prior to using these devices please review the Instructions for Use for a complete listing of indications contraindications warnings precautions potential adverse events and directions for use Devices depicted may not be available in all countries Check with your St Jude Medical representative for product availability in your country Unless otherwise noted indicates that the name is a trademark of or licensed to St Jude Medical or one of its subsidiaries ST JUDE MEDICAL the nine squares symbol and MORE CONTROL LESS RISK are registered and unregistered trademarks and service marks of St Jude Medical Inc and its related companies EUH ST JUDE ME DICAL EEE 2011 St Jude Medical Inc All rights reserved MORE CONTROL LESS RISK GMCRMOS9 1 Merlin net Patient Care Network PCN Version 5 0 Product Specifications Merlin net PCN Specifications Connectivity EHRDirect Export enables direct export to EHR via IHE or HL7 2 x and 3 0 format without the need of an intermediary system Compatible EHR data management systems All HL7 compliant EHR systems are compatible Currently avai
62. defined or both Tally of recent transmissions by type Customisable by administrator Recent transmissions patient list segments files into new and old Convenient overview of upcoming transmissions Interactive practice site Patient Communication Available Outbound automatic communication tool Multiple language support Patient Clinic enabled DirectCall Message options Missed appointment call triggered by clinic Normal results call triggered by clinic Call clinic message triggered by clinic Remote follow up reminder call sent automatically Remote follow up missed call sent automatically Emergency contact if enabled sent automatically DirectCall Message tool available in over 20 languages including English Spanish French Italian Japanese German Dutch Portuguese Finnish Swedish Danish Norwegian Czech Hungarian Castilian Spanish Polish Turkish Slovak Catalonian Spanish UK English Start up guide Transmitter Quick Start Guide QSG w step by step setup options Support Materials for Patient and Clinic Various support materials available Please meet with sales representative for full complement of training and support materials Merlin home RF Transmitter Specifications Transmitter model number Physical components Weight w o power supply Dimensions Wand cable length Power cord length Modem Power source Line voltage Line frequency EX 1
63. detailed indications contraindications warnings precautions and potential adverse events LLL mem ST JUDE MEDICAL EEE MORE CONTROL LESS RISK nisation Therapy CRT GMCRMB8 89 EN PHYSICAL SPECIFICATIONS Model Number Dimensions mm Weight g Volume cm3 Connector PARAMETER 5596 49x52x6 25 11 5 IS 1 SETTINGS Resynchronization Therapy QuickOpt Timing Cycle Optimization RV and LV Pulse Width ms RV and LV Pulse Amplitude V RV Pulse Configuration LV Pulse Configuration Ventricular Sense Configuration Ventricular Pacing Chamber First Chamber Paced Interventricular Pace Delay ms Ventricular Sensitivity mV Negative AV PV Hysteresis Search ms Shortest AV PV Delay ms Atrial Output Sensing Sensed paced AV delay Interventricular Pace delay 0 05 0 1 1 5 in steps of 0 1 0 0 4 0 in steps of 0 25 4 5 7 5 in steps of 0 5 Unipolar Bipolar Unipolar Bipolar LV Tip RV ring BV Unipolar Tip BV Bipolar RV Unipolar Tip RV Bipolar LV Unipolar Tip LV Bipolar RV Unipolar Ring LV tip RV tip BV RV only LV only Simultaneous RV LV 20 80 in steps of 5 0 5 5 0 in steps of 0 5 6 10 in steps of 1 0 12 5 Off 10 to 110 in steps of 10 30 50 in steps of 5 60 120 in steps of 10 Atrial Pulse Configuration Atrial Sense Configuration Atrial Sensitivity mV Atrial Amplitude Atrial Pulse Width Unipolar tip case Bipolar tip
64. dysfunction at higher sensor driven rates An appropriate Maximum Sensor Rate should be selected based on assessment of the highest stimulation rate tolerated by the patient Single Chamber Ventricular Demand Pacing is relatively contraindicated in patients who have demonstrated pacemaker syndrome have retrograde VA conduction or suffer a drop in arterial blood pressure with the onset of ventricular pacing Single Chamber Atrial Pacing is relatively contraindicated in patients who have demonstrated compromise of AV conduction For specific contraindications associated with individual modes refer to the programmer s on screen help Customer Support 46 8 474 4756 Brief Summary Prior to using these devices please review the Instructions for Use for a complete listing of indications contraindications warnings precautions potential adverse events and directions for use Devices depicted may not be available in all countries Check with your St Jude Medical representative for product availability in your country Unless otherwise noted indicates that the name is a trademark of or licensed to St Jude Medical or one of its subsidiaries ST JUDE MEDICAL the nine squares symbol and MORE CONTROL LESS RISK are registered and unregistered trademarks and service marks of St Jude Medical Inc and its related companies 2011 St Jude Medical Inc All rights reserved Weight g 52x 52x6 23 Volume cc Connector 12 8 0 5 IS 1 Pot
65. in steps of 0 5 6 10 in steps of 1 0 12 57 Off On Automatic Sensitivity Control adjustment for atrial and ventricular events 0 2 1 0 in steps of 0 1 0 2 2 0 in steps of 0 1 Atrial and Ventricular Post Sense 50 62 5 75 100 Atrial Post Pace 0 2 3 0 in steps of 0 1 mV Ventricular Post Pace Auto 0 2 3 0 in steps of 0 1 mV Atrial and Ventricular Post Sense 0 30 60 95 125 160 190 220 Atrial Post Pace 0 30 60 95 125 160 190 220 Ventricular Post Pace Auto 0 30 60 95 125 160 190 220 Maximum Sensor Rate min Rate Responsive AV Delay Rate Responsive PVARP VREF Reaction Time Recovery Time 80 150 in steps of 5 160 180 in steps of 10 Off Low Medium High Off Low Medium High Very Fast Fast Medium Slow Fast Medium Slow Very Slow Sensor Shortest PVARP VREF ms Slope Threshold AF Management Pace ers 0n Off Passive 125 475 in steps of 25 Auto 1 Auto 0 Auto 1 Auto 2 Auto 3 1 16 in steps of 1 Auto 0 5 Auto 0 0 Auto 0 5 Auto 1 0 Auto 1 5 Auto 2 0 1 7 in steps of 0 5 AF Suppression Algorithm Lower Rate Overdrive min Upper Rate Overdrive min No of Overdrive Pacing Cycles Rate Recovery ms Maximum AF Suppression Rate min Atrial Tachycardia Detection Rate mir Auto Mode Switch Off On 10 53 15 40 in steps of 5 8 12 80 150 in steps of 5 160 180 in steps of 10 110 200 in steps of 10
66. in steps of 1 Intervention Rate min Off Same as Base Rate 80 120 in steps of 10 Intrinsic 0 ntrinsic 10 Intrinsic 20 Intrinsic 30 Intervention Duration min 10 in 1 minute intervals Recovery Time Fast Medium Slow Very Slow Maximum Tracking Rate min 90 130 in steps of 5 140 180 in steps of 10 Mode AO0 R AAI R AAT R VOO R VVI R VVT R VDD R DOO R DVI R DDI R DDD R Pacing Off Post Ventricular Atrial Blanking ms 60 200 in steps of 10 225 250 PVARP ms 25 500 in steps of 25 Sensed AV Delay ms 25 30 200 in steps of 10 225 325 in steps of 25 Rest Rate min Off 30 150 in steps of 5 Shortest AV Delay ms 25 50 in steps of 5 60 120 in steps of 10 Ventricular Blanking ms Ventricular Pace Sense Refractory Auto 12 52 in steps of 4 Fixed ms 125 160 400 in steps of 30 440 470 MRI Settings MRI Mode A00 V00 DOO Pacing Off MRI Base Rate MRI Paced AV Delay 30 120 bpm in steps of 5 bpm 25 ms 30 200 ms in steps of 10 ms 225 300 ms in steps of 25 ms 350 ms MRI Atrial Pulse Configuration Bipolar MRI Atrial Pulse Amplitude 50V 75V MRI Atrial Pulse Width 1 0 ms MRI RV Pulse Configuration Bipolar MRI RV Pulse Amplitude 5 0V 7 5V MRI RV Pulse Width 1 0 ms Output Sensing ACap Confirm On Off Monitor Primary Pulse Configuration Bipolar Backup Pulse Configuration Bipolar Backup Pulse Amplitude V 5 0 Search Interval hours 8 24 Aor V Pulse Amplitude V 0 25 4
67. or one of its subsidiaries ST JUDE MEDICAL the nine squares symbol and MORE CONTROL LESS RISK LLL are registered and unregistered trademarks and service marks of St Jude Medical Inc and its related companies S I M a 2011 St Jude Medical Inc All rights reserved EUN JUDE E DICAL MORE CONTROL LESS RISK CARDIAC RESYNCHRONISATION THERAPY CRI DEVICES Exclusive St Jude Medical Innovations Enable Delivery of Optimal Cardiac Resynchronisation Therapy From design and development to market release exclusive technical innovations reduce life threatening risk and enable delivery of individually tailored cardiac resynchronisation therapies CRT D and CRT P Simplified implantation and remote monitoring benefit physicians and patients alike More Control Comprehensive noninvasive programming techniques and algorithms such as QuickOpt and DeFT Response enable physicians to better meet the needs of their patients These features provide the flexibility and control needed for individual therapy success Improvements such as wireless telemetry help save time and improve efficiencies in the clinic Less Risk The latest functions of St Jude Medical CRT devices provide the possibility to deliver optimal therapy to patients with less risk LLL mem ST JUDE MEDICAL 558 MORE CONTROL LESS RISK Cardiac Resynchronisation Therapy CRT Devices Unify Quadra Cardiac Resynchronisation Therapy Defibrillator C
68. physical disability Contraindications Single chamber pulse generators are contraindicated in patients with an implanted cardioverter defibrillator ICD Rate adaptive pacing may be inappropriate for patients who experience angina or other symptoms of myocardial dysfunction at higher sensor driven rates An appropriate Maximum Sensor Rate should be selected based on assessment of the highest stimulation rate tolerated by the patient Single chamber ventricular demand pacing is relatively contraindicated in patients who have demonstrated pacemaker syndrome have retrograde VA conduction or suffer a drop in arterial blood pressure with the onset of ventricular pacing Single chamber atrial pacing is relatively contraindicated in patients who have demonstrated compromise of AV conduction Customer Support 46 8 474 4756 Brief Summary Prior to using these devices please review the Instructions for Use for a complete listing of indications contraindications warnings precautions potential adverse events and directions for use Devices depicted may not be available in all countries Check with your St Jude Medical representative for product availability in your country Unless otherwise noted indicates that the name is a trademark of or licensed to St Jude Medical or one of its subsidiaries ST JUDE MEDICAL the nine squares symbol and MORE CONTROL LESS RISK are registered and unregistered trademarks and service marks of St Jude Medi
69. polarity switches Ordering Information Contents Cardiac pulse generator Volume cc Connector 9 5 0 5 IS 1 Model Number PM1110 Dimensions H x W x T mm Weight g 42x52 x6 18 Indications Implantation is indicated in one or more of the following permanent conditions syncope presyncope fatigue disorientation due to arrhythmia bradycardia or any combination of those symptoms Rate Modulated Pacing is indicated for patients with chronotropic incompetence and for those who would benefit from increased stimulation rates concurrent with physical activity Atrial Pacing is indicated for patients with sinus node dysfunction and normal AV and intraventricular conduction systems Ventricular Pacing is indicated for patients with significant bradycardia and normal sinus rhythm with only rare episodes of A V block or sinus arrest chronic atrial fibrillation severe physical disability Contraindications Single chamber pulse generators are contraindicated in patients with an implanted cardioverter defibrillator Rate Adaptive Pacing may be inappropriate for patients who experience angina or other symptoms of myocardial dysfunction at higher sensor driven rates An appropriate Maximum Sensor Rate should be selected based on assessment of the highest stimulation rate tolerated by the patient Single Chamber Ventricular Demand Pacing is relatively contraindicated in patients who have demonstrated pacemaker syndrome have retrograde VA co
70. protection to the inner coil Optim lead insulation a chemical co polymer that blends the best features of polyurethane and silicone for improved handling and increased durability Two innovative designs are intended to help prevent tissue ingrowth flat wire technology provides a low profile for the defibrillation coils and silicone backfilling completely fills the shock coil space Ordering Information Contents Defibrillation lead Model Min Shock Tip to Proximal Number Insulation Fixation Introducer F Configuration Sensing Coil cm Connector Lengths 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 Single coil True bipolar N A DF1 IS 1 60 65 75 7122Q Optim Ext Ret Helix 7 Single coil True bipolar N A DF4 52 58 65 7170 Optim Tines 7 Dual coil True bipolar 17 DF1 IS 1 60 65 75 7170Q Optim Tines 7 Dual coil True bipolar 17 DFA 52 58 65 7171 Optim Tines 7 Dual coil True bipolar 21 DF1 IS 1 60 65 75 7171Q Optim Tines 7 Dual coil True bipolar 21 DF4 52 58 65 7172Q Optim Tines 7 Single coil True bipolar N A DF4 52 58 65 Mo mee ai M A a E os Se erry yaa defibrillator manual for system indications They provide pacing and sensing and deliver
71. rates concurrent with demonstrated pacemaker syndrome have retrograde VA conduction or suffer a drop in arterial blood pressure physical activity Dual Chamber Pacing Models 5826 5820 only is indicated for those patients exhibiting with the onset of ventricular pacing Single Chamber Atrial Pacing is relatively contraindicated in patients sick sinus syndrome chronic symptomatic second and third degree AV block recurrent Adams Stokes who have demonstrated compromise of AV conduction syndrome symptomatic bilateral bundle branch block when tachyarrhythmia and other causes have been ruled out Atrial Pacing is indicated for patients with sinus node dysfunction and normal AV and intraventricular For specific contraindications associated with individual modes refer to Operating Modes conduction systems Ventricular Pacing is indicated for patients with significant bradycardia and Normal Potential Adverse Events Adverse events associated with the use of any pacing system include Air sinus rhythm with only rare episodes of A V block or sinus arrest chronic atrial fibrillation severe physical embolism Bleeding Hematoma Body rejection phenomena Cardiac tamponade or perforation Formation disability AF Suppression Models 5826 5820 only is indicated for suppression of paroxysmal or persistent of fibrotic tissue local tissue reaction Inability to interrogate or program due to programmer or device atrial fibrillation episodes in patients with one
72. significant bradycardia and normal sinus rhythm with only rare episodes of A V block or sinus arrest chronic atrial fibrillation severe physical disability AF Suppression algorithm is indicated for suppression of paroxysmal or persistent atrial Volume cc Connector 13 1 0 5 IS 1 Device MRI symbol fibrillation or silent atria may provide no benefit beyond that of single chamber pacing in such patients Single chamber ventricular demand pacing is relatively contraindicated in patients who have demonstrated pacemaker syndrome have retrograde VA conduction or suffer a drop in arterial blood pressure with the onset of ventricular pacing Single chamber atrial pacing is relatively contraindicated in patients who have demonstrated compromise of AV conduction Adverse Events The following are potential complications associated with the use of any pacing system arrhythmia heart block thrombosis threshold elevation valve damage pneumothorax myopotential sensing vessel damage air embolism body rejection phenomena cardiac tamponade or perforation formation of fibrotic tissue local tissue reaction inability to interrogate or program a device because of programmer malfunction infection interruption of desired device function due to electrical interference loss of desired pacing and or sensing due to lead displacement body reaction at electrode interface or lead malfunction fracture or damage to insulation loss of normal
73. silicone rubber Distal 7 cm silicone rubber Conductors Two ETFE insulated low resistance cables Two ETFE insulated low resistance cables multifilar MP35N coil multifilar MP35N coil Stylets 6 0 36 mm 0 014 diameter PTFE coated stainless steel stylets with 15 cm distal tapers Soft 0 15 mm 0 006 diameter green knob 3 stylets Firm 0 20 mm 0 008 diameter yellow knob 2 stylets Extra Firm 0 25 mm 0 010 diameter red knob 1 stylet Guidewire PTFE coated 180 cm long 0 36 mm 0 014 diameter with 5 cm floppy tip two torque tools included Lead Flushing Tools 2 White ABS coupling with Luer Lock connector Stylet Guide funnel Vein Pick MP35N is a trademark of SPS Technologies Inc 3 7 Customer Support 46 8 474 4756 Brief Summary Prior to using these devices please review the Instructions for Use for a complete listing of indications contraindications warnings precautions potential adverse events and directions for use Devices depicted may not be available in all countries Check with your St Jude Medical representative for product availability in your country Unless otherwise noted indicates that the name is a trademark of or licensed to St Jude Medical or one of its subsidiaries ST JUDE MEDICAL the nine squares symbol and MORE CONTROL LESS RISK are registered and unregistered trademarks and service marks of St Jude Medical Inc and its related co
74. steps of 0 1 On Off Monitor 8 24 On Off Monitor 8 24 Off On Automatic Sensitivity Control adjustment for atrial and ventricular events 0 2 1 0 in steps of 0 1 0 2 2 0 in steps of 0 1 Atrial and Ventricular Post Sense 50 62 5 75 100 Atrial Post Pace 0 2 3 0 in steps of 0 1 mV Ventricular Post Pace Auto 0 2 3 0 in steps of 0 1 mV Atrial and Ventricular Post Sense 0 30 60 95 125 160 190 220 Atrial Post Pace 0 30 60 95 125 160 190 220 Ventricular Post Pace Auto 0 30 60 95 125 160 190 220 0 5 12 5 in steps of 0 554 Rate Timing Mode A00 R AAL R AAT R VOO R VVI R VVT R DOO R DVI R DDI R DDT R DDD R VDD R Pacing Off DDT Trigger R wave DDT Timing DDI Base Rate min Hysteresis Rate min Search Interval min Cycle Count Intervention Rate min Intervention Duration min Recovery Time Rest Rate min Maximum Tracking Rate min Sensed AV Delay ms Paced AV Delay ms Ventricular Pace Sense Refractory Fixed ms Atrial Pace Refractory Atrial Sense Refractory PVARP ms Atrial Protection Interval ms Far Field Protection Interval ms 120 5cc 2 LV first with 10 ms interventricular delay 30 130 in steps of 5 140 170 in steps of 10 Off 30 150 in steps of 55 Off 1 5 10 15 30 1 16 Off Same Base Rate 80 120 in steps of 10 Intrinsic 0 Intrinsic 10 Intrinsic 20 Intrinsic 30 1 10 Fast Medium Sl
75. to deliver optimal therapy for patients at implant and throughout their lives Real time electrogram EGM waveform as well as the associated event markers that precede and follow a specific triggering event can be programmed to automatically record up to 14 minutes of stored EGMs when encountering one or more programmable trigger options Ordering Information Contents Cardiac pulse generator Model Number PM2112 Dimensions H x W x T mm 46 x 52 x6 Indications Implantation is indicated in one or more of the following permanent conditions syncope presyncope fatigue disorientation due to arrhythmia bradycardia or any combination of those symptoms Rate Modulated Pacing is indicated for patients with chronotropic incompetence and for those who would benefit from increased stimulation rates concurrent with physical activity Dua Chamber Pacing is indicated for those patients exhibiting sick sinus syndrome chronic symptomatic second and third degree AV block recurrent Adams Stokes syndrome symptomatic bilateral bundle branch block when tachyarrhythmia and other causes have been ruled out Atrial Pacing is indicated for patients with sinus node dysfunction and normal AV and intraventricular conduction systems Ventricular Pacing is indicated for patients with significant bradycardia and normal sinus rhythm with only rare episodes of A V block or sinus arrest chronic atrial fibrillation severe physical disability AF Suppressi
76. will be 5 min below the programmed base rate 4 Sensitivity is with respect to a 20 ms haversine test signal 5 This parameter is not programmable 6 S1 Burst Cycle is applied at the preprogrammed S1 cycle length LLL mam ST JUDE MEDICAL MORE CONTROL LESS RISK Pacemakers Accent SR Single Chamber Pacemaker D H St June MEDICAE r Syrnar CA UGA ACCENT SR PM1110 SSR Product Highlights Inductive remote follow up utilising a wand in conjunction with the Merlin home transmitter and Merlin net Patient Care Network PCN allows patients to download information and provide the clinic with access to device measurements A two tone audible alert allows programming to notify the patient of changes in device performance or arrhythmia status which can provide earlier insight into actionable clinical events State of the art features such as automaticity Ventricular AutoCapture pacing system and SenseAbility technology are designed to deliver optimal therapy for patients at implant and throughout their lives Real time electrogram EGM waveform as well as the associated event markers that precede and follow a specific triggering event can be programmed to automatically record up to 14 minutes of stored EGMs when encountering one or more programmable trigger options Weekly lead impedance trend displays the current measurement historical test results pacing polarity and any
77. 0 ACap Confirm Primary Pulse Configuration Backup Pulse Configuration Backup Pulse Amplitude V Search Interval hours Aor V Pulse Amplitude V Aor V Pulse Width ms Aor V Pulse Configuration A or V Sense Configuration Atrial Sensitivity mV Ventricular AutoCapture Pacing System Primary Pulse Configuration Backup Pulse Configuration Backup Pulse Amplitude V Search Interval hours AutoCapture Paced Sensed AV Delay ms Ventricular Sensitivity mV SenseAbility Technology A Max Sensitivity mV V Max Sensitivity mV Threshold Start Decay Delay ms Rate Modulated Parameters On Off Monitor Bipolar Bipolar 5 0 8 24 0 25 4 0 in steps of 0 25 4 5 7 5 in steps of 0 5 0 05 0 1 1 5 in steps of 0 1 Unipolar tip case Bipolar tip ring Unipolar Tip tip case Bipolar tip ring Unipolar Ring ring case 0 1 0 4 in steps of 0 1 0 5 0 75 2 0 in steps of 0 25 2 5 4 0 in steps of 0 5 5 07 On Off Unipolar Bipolar Unipolar Bipolar 5 0 8 24 50 25 100 70 120 100 0 5 5 0 in steps of 0 5 6 10 in steps of 1 0 12 5 Off On Automatic Sensitivity Control adjustment for atrial and ventricular events 0 2 1 0 in steps of 0 1 0 2 2 0 in steps of 0 1 Atrial and Ventricular Post Sense 50 62 5 75 100 Atrial Post Pace 0 2 3 0 in steps of 0 1 mV Ventricular Post Pace Auto 0 2 3 0 in steps of 0 1 mV Atrial and Ventricular Post Sense 0 30 60 95 125 160 190 220
78. 0 LV tip to RV coil LV bipolar LV ring to RV coil AF Suppression Pacing No of Overdrive Pacing Cycles Maximum AF Suppression Rate Sensing Detection On Off 15 40 in steps of 5 80 150 min SenseAbility Technology Threshold Start Decay Delay Ventricular Sense Refractory ms Detection Zones SVT Discriminators Reconfirmation Antitachycardia Pacing Therapy Automatic Sensitivity Control adjustment for atrial and ventricular events Post Sensed Atrial 50 62 5 75 100 Post Paced Atrial 0 2 3 0 mV Post Sensed Ventricular 50 62 5 75 100 Post Paced Ventricular Auto 0 2 3 0 mV Post Sense Post Pace Atrial Ventricular 0 220 125 157 VT 1 VT 2 VF AV Rate Branch Sudden Onset Interval Stability Morphology Discrimination MD with Manual or Automatic Template Update Continuous sensing during charging ATP Configurations Burst Cycle Length Min Burst Cycle Length ms Number of Bursts Stimuli Add Stimuli per Burst High Voltage Therapy Ramp Burst Scan 1 or 2 schemes per zone Adaptive Readaptive or Fixed 150 400 in increments of 5 1 15 with 2 20 Stimuli On Off High Voltage Output Mode Waveform RV Polarity Electrode Configuration Bradycardia Pacing Fixed Pulse Width Fixed Tilt Biphasic Monophasic Cathode Anode RV to Can RV to SVC Can Permanent Modes Temporary Modes Rate Adaptive Sensor Programmable Rate and Delay Parameters Auto Mod
79. 0 60010198 001 Disposable Threshold cable for DF4 leads Biotronik connector 4161 60010086 001 Disposable Threshold cable for DF4 leads Medtronic connector PK 67 S 5030162 001 Non Disposable Adapter to threshold cable Biotronik connector Intended Use The Merlin PSA is intended to assess the pacing and sensing performance of the lead system prior to pulse generator implantation or during invasive lead system troubleshooting Only use the Merlin PSA with the Merlin PCS Contraindications There are no known contraindications to the use of a lead analysis device The patient s age and medical condition however may dictate the pacing modes and lead assessment activities appropriate for the patient Customer Support 46 8 474 4756 Brief Summary Prior to using these devices please review the Instructions for Use for a complete listing of indications contraindications warnings precautions potential adverse events and directions for use Devices depicted may not be available in all countries Check with your St Jude Medical representative for product availability in your country Unless otherwise noted indicates that the name is a trademark of or licensed to St Jude Medical or one of its subsidiaries ST JUDE MEDICAL the nine squares symbol and MORE CONTROL LESS RISK are registered and unregistered trademarks and service marks of St Jude Medical Inc and its related companies 2011 St Jude Medical Inc All rights reser
80. 0 Audible Duration sec 2 4 6 8 10 12 14 16 Atrial Post Pace 0 30 60 95 125 160 190 220 Number of Audible Alerts Ventricular Post Pace Auto 0 30 60 95 125 160 190 220 per Notification g 2 Rate Modulated Parameters Number of Notifications 1 16 Time Between Notifications hours 10 22 Maximum Sensor Rate min 80 150 in steps of 5 160 180 in steps of 10 12 0 5cc Rate Responsive AV Delay Off Low Medium High 2 Programming options dependent on pacing mode Rate Responsive PVARP VREF Off Low Medium High 3 This parameter is not programmable Reaction Time Very Fast Fast Medium Slow n s d mare for Linea will m pedis ue base rate n a in dual chamber modes the maximum ventricular refractory perio Recovery Time Fast Medium Slow Very Slow 6 Values 0 1 0 4 not available in a unipolar sense onmia Sensor 0n Off Passive 7 Sensitivity is with respect to a 20 ms haversine test signal Shortest PVARP VREF ms 125 475 in steps of 25 8 During atrial NIPS in dual chamber modes the shortest Coupling Interval will be limited by the programmed AV PV delay Slope Auto 1 Auto 0 Auto 1 Auto 2 9 S1 Burst Cycle is applied at the preprogrammed S1 cycle length Auto 3 1 16 in steps of 1 Threshold Auto 0 5 Auto 4 0 0 Auto 0 5 Auto 1 0 Auto 1 5 Auto 4 2 0 1 7 in steps of 0 5 Customer Support 46 8 474 4756 Brief Summary Prior to using these devices please review the Instructions for Use for
81. 0 in steps of 0 25 4 5 7 5 in steps of 0 5 Aor V Pulse Width ms Aor V Pulse Configuration Aor V Sense Configuration 0 05 0 1 1 5 in steps of 0 1 Unipolar tip case Bipolar tip ring Unipolar Tip tip case Bipolar tip ring Unipolar Ring ring case 0 1 0 4 in steps of 0 1 0 5 0 75 2 0 in steps of 0 25 2 5 4 0 in steps of 0 5 5 07 Atrial Sensitivity mV Ventricular AutoCapture Pacing System On Off Primary Pulse Configuration Unipolar Bipolar Backup Pulse Configuration Unipolar Bipolar Backup Pulse Amplitude V 5 08 Search Interval hours 8 24 AutoCapture Paced Sensed AV Delay ms 50 25 100 70 120 100 Ventricular Sensitivity mV 0 5 5 0 in steps of 0 5 6 10 in steps of 1 0 12 57 SenseAbility Technology Off On Automatic Sensitivity Control adjustment for atrial and ventricular events A Max Sensitivity mV 0 2 1 0 in steps of 0 1 V Max Sensitivity mV 0 2 2 0 in steps of 0 1 Threshold Start Atrial and Ventricular Post Sense 50 62 5 75 100 Atrial Post Pace 0 2 3 0 in steps of 0 1 mV Ventricular Post Pace Auto 0 2 3 0 in steps of 0 1 mV Decay Delay ms Atrial and Ventricular Post Sense 0 30 60 95 125 160 190 220 Atrial Post Pace 0 30 60 95 125 160 190 220 Ventricular Post Pace Auto 0 30 60 95 125 160 190 220 Rate Modulated Parameters Maximum Sensor Rate min 80 150 in steps of 5 160 180 in steps of 10 Rate Responsive AV Delay O
82. 1 0 12 54 A or V Pulse Configuration Unipolar tip case Bipolar tip ring A or V Sense Configuration Unipolar Tip tip case Bipolar tip ring Unipolar Ring ring case Ventricular AutoCapture Pacing System On Off Primary Pulse Configuration Unipolar Bipolar Backup Pulse Configuration Unipolar Bipolar Backup Pulse Amplitude V 5 05 Search Interval hours 8 24 Rate Modulated Maximum Sensor Rate bpm 80 150 in steps of 5 160 180 in steps of 10 Rate Responsive VREF Off Low Medium High Shortest VREF 120 350 in steps of 10 Reaction Time Very Fast Fast Medium Slow Recovery Time Fast Medium Slow Very Slow Sensor On Off Passive Slope Auto 1 Auto 4 0 Auto 1 Auto 2 Auto 4 3 1 16 in steps of 1 Threshold Auto 0 5 Auto 4 0 0 Auto 0 5 Auto 1 0 Auto 4 1 5 Auto 2 0 1 7 in steps of 0 5 Stored Electrograms Options Sampling Options Freeze Continuous No of Stored EGMs 1 2 4 8 12 Channel Atrial or Ventricular Triggers Magnet Placement On Off High Atrial Rate bpm Off 125 150 175 200 225 250 275 300 No of Consecutive Cycles 2 3 4 5 10 15 20 High Ventricular Rate bpm Off 125 150 175 200 225 250 275 300 No of Consecutive Cycles 2 3 4 5 10 15 20 Advanced Hysteresis On Off Customer Support 46 8 474 4756 Brief Summary Prior to using these devices please review the Instructions for Use for a complete listing of indications contraindications warnings pre
83. 150 Single plastic enclosure with external transformer power supply Less than 2 3 kilograms Width 9 18 eight 6 33 Depth 5 06 NA Minimum 1 5 meters V 92 56K Custom Design AC 00 240V 50 60 Hz Devices Supported by Merlin home RF Transmitter amp Merlin net PCN RF models of the Unify Family of CRT Ds the Promote Family of CRT Ds the Current Family of ICDs the AnalyST Family of ICDs the Fortify Family of ICDs the Anthem Family of CRT Ps the Accent Family of Pacemakers and the Nuance Family of Pacemakers Japan Devices Supported by Merlin net PCN through USB Upload from Merlin PCS The Unify Family of CRT Ds the Promote Family of CRT Ds the Atlas Family of CRT Ds the Current Family of ICDs the AnalyST Family of ICDs the Fortify Family of ICDs the Epic Family of ICDs the Convert Family of ICDs the Anthem Family of CRT Ps the Accent Family of Pacemakers and the Nuance Family of Pacemakers Japan mem ST JUDE MEDICAL MORE CONTROL LESS RISK USB Cellular Adaptor For use with the Merlin home Transmitter Model EX1151 Product Highlights The USB Cellular Adapter attaches to any Merlin home transmitter enabling timely access to comprehensive data of the patient s current disease state and implanted device status through the Merlin net Patient Care Network Automatically searches for and connects to the cellular network f
84. 175 200 225 250 275 300 2 3 4 5 10 15 20 Off 125 150 175 200 225 250 275 300 2 3 4 5 10 15 20 On Off Brief Summary Prior to using these devices please review the Instructions for Use for a complete listing of Other Pace Lead Monitoring Aor V Low Impedance Limit Q Aor V High Impedance Limit Q Aor V Signal Amplitude Monitoring Magnet Response Lead Type NIPS Options Stimulation Chamber Coupling Interval ms S1 Count S15 2 S3 and S4 Cycle ms Sinus Node Recovery Delay sec 1 x0 5cc Off Monitor Auto Polarity Switch 2005 750 1000 1250 1500 1750 2000 Off On Off Battery Test Uncoded Unipolar Bipolar Only Unipolar Bipolar Atrial or Ventricular 100 800 in steps of 10 1 25 in steps of 1 100 800 in steps of 10 1 5 in steps of 1 2 The actual pacing rate for the 30 ppm is 31 ppm 3 The highest available setting for Hysteresis Rate will be 5 ppm below the programmed Base Rate 4 Sensitivity is with respect to a 20 ms haversine test signal 5 This parameter is not programmable 6 S1 Burst Cycle is applied at the preprogrammed S1 cycle length indications contraindications warnings precautions potential adverse events and directions for use Devices depicted may not be available in all countries Check with your St Jude Medical representative for product availability in your country Unless otherwise noted indicates that the name is a trademark of o
85. 2 straight stylets Available in multiple stiffness levels Soft Green Firm Yellow X Firm Red Ordering Information Model Number Stiffness Diameter in Length 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 Customer Support 46 8 474 4756 Brief Summary Prior to using these devices please review the Instructions for Use for a complete listing of indications contraindications warnings precautions potential adverse events and directions for use Devices depicted may not be available in all countries Check with your St Jude Medical representative for product availability in your country Unless otherwise noted indicates that the name is a trademark of or licensed to St Jude Medical or one of its subsidiaries ST JUDE MEDICAL the nine squares symbol and MORE CONTROL LESS RISK aan are registered and unregistered trademarks and service marks of St Jude Medical Inc and its related companies S I M hi 2011 St Jude Medical Inc All rights reserved EUN JUDE E DICAL MORE CONTROL LESS RISK Accessories Atrial J Stylet Kit Product Highlights For atrial lead positioning in various patient ana
86. 20 350 in steps of 10 On Off Passive 80 150 in steps of 5 160 180 in steps of 10 Auto 0 5 Auto 0 0 Auto 0 5 Auto 1 0 Auto 1 5 Auto 2 0 1 7 in steps of 0 5 Auto 1 Auto 0 Auto 1 Auto 4 2 Auto 3 1 16 Very Fast Fast Medium Slow Fast Medium Slow Very Slow Options Sampling Options No of Stored EGMs Channel Triggers Magnet Placement High Atrial Rate ms No of Consecutive Cycles AMS Entry Exit High Ventricular Rate ms PVC No of Consecutive PVCs PMT Detection AT AF Detection Advanced Hysteresis Other Magnet Response Autolntrinsic Conduction Search ms Atrial Tachycardia Detection Rate min Post Vent Atrial Blanking PVAB ms Ventricular Safety Standby PVC Options PMT Options PMT Detection Rate min Lead Type NIPS Options Stimulation Chamber Coupling Interval ms S1 Count S1 S2 S3 and S4 Cycle ms Right Venticular Support Rate min Sinus Node Recovery Delay s 0 x0 cm Freeze Continuous 1 2 4 8 12 Single Dual On Of Off 125 300 in steps of 25 2 3 4 5 10 15 20 On Of Off 125 300 in steps of 25 On Of 2 3 4 5 On Of On Of On Of Off Battery Test Off 10 to 120 in steps of 10 110 150 in steps of 5 160 200 in steps of 10 225 300 in steps of 25 60 70 80 85 95 100 110 115 125 130 140 150 155 165 170 180 185 195 200 Off On Off PVARP on PVC Off 10 Beats gt PMT Auto
87. 24 Options Telemetry RF Priority Options Dimensions mm 52x53x6 Channel Weight g 24 Triggers Volume cc 13 1 Magnet Response Connector I1 High Ventricular Rate Rate min No of Consecutive Cycles Rate Timing Advanced Hysteresis Noise Reversion Ventricular Pace Sense Refractory Fixed ms 125 160 400 in steps of 30 440 470 500 Other Base Rate min 30 130 in steps of 5 140 170 in steps of 10 a Mode VOO R VVI R VVT R Pacing Off Lead Monitoring Hysteresis Rate min Off 30 150 in steps of 5 V Low Impedance Limit 2 Search Interval mim Off 1 5 10 15 30 V High Impedance Limit Q Cycle Count 1 16 by1 Magnet Response Intervention Rate min Off Same as Base Rate 80 120 in steps of 10 Intrinsic 0 Lead Type Intrinsic 10 Intrinsic 20 Intrinsic 30 NIPS Options Intervention Duration min 1 10 in 1 minute intervals Stimulation Chamber Recovery Time Fast Medium Slow Very Slow poe Interval ms in 30 150 i oun Rest Rate min Off 30 150 in steps of 5 SIF 2 S3 and S4 Cycle ms MRI Settings Diagnostic Trends MRI Mode V00 Pacing Off Patient Notifiers MRI Base Rate MRI RV Pulse Configuration MRI RV Pulse Amplitude MRI RV Pulse Width Output Sensing Monitor Auto Polarity Switch 100 500 in steps of 25 750 2500 in steps of 250 3000 Off Battery Test Uncoded Unipolar Bipolar Ventricular 100 800 in steps of 10 2 25 in steps of 1 100 800 in steps of 10 Fixed or Adaptive Exercis
88. 25 160 200 in steps of 10 30 sec 1 3 5 10 30 min 12 3 Off On 6 E 1 GMCRMSB Rate Responsive PVARP VREF Reaction Time Recovery Time Off Low Medium High Very Fast Fast Medium Slow Fast Medium Slow Very Slow 3 The actual pacing rate for the 30 min is 31 min 4 The highest available setting for Hysteresis Rate will be 5 min 1 below the programmed Base Rate 5 In dual chamber modes the maximum Ventricular Refractory Period is 325 ms Sensor On Off Passive 6 Values 0 1 0 4 not available in a Unipolar Sense Configuration Shortest PVARP VREF 120 350 in steps of 10 7 Sensitivity is with respect to a 20 ms haversine test signal Slope Auto 1 Auto 0 Auto 1 Auto 2 Auto 3 8 During atrial NIPS in dual chamber modes the shortest Coupling Interval will be limited by the programmed AV PV delay 1 16 in steps of 1 9 1 Burst Cycle is applied at the preprogrammed S1 cycle length Threshold Auto 0 5 Auto 4 0 0 Auto 0 5 Auto 1 0 Auto 1 5 Auto 2 0 1 7 in steps of 0 5 Customer Support 46 8 474 4756 Brief Summary Prior to using these devices please review the Instructions for Use for a complete listing of indications contraindications warnings precautions potential adverse events and directions for use Devices depicted may not be available in all countries Check with your St Jude Medical representative for product availability in your country Unl
89. 250 275 300 No of Consecutive Cycles 2 3 4 5 10 15 20 PMT Termination On Off PVC Detection On Off No of Consecutive PVCs 2 3 4 5 Other Aand V Lead Monitoring Off Monitor Auto Polarity Switch A and V Low Impedance Limit Q A and V High Impedance Limit Q Lead Type Magnet Response Negative AV PV Hysteresis Search ms NIPS Options Stimulation Chamber Coupling Interval S1 Count S15 S2 S3 and 4 Cycle ms Ventricular Support Rate min Sinus Node Recovery Delay sec PMT Options PMT Detection Rate min PVC Options Signal Amplitude Monitoring P Wave Monitoring R Wave Monitoring Ventricular Intrinsic Preference VIP ms VIP Search Interval VIP Search Cycles Ventricular Safety Standby 1 x 0 5 cc 2 This parameter is not programmable 2002 750 1000 1250 1500 1750 2000 Uncoded Unipolar Bipolar Only Unipolar Bipolar Off Battery Test Off 10 to 110 in steps of 10 Atrial Ventricular 100 800 in steps of 108 1 25 in steps of 1 100 800 in steps of 10 Off 30 40 45 50 55 60 65 70 75 80 85 90 95 1 5 in steps of 1 Off 10 Beats gt PMT Auto Detect 90 150 in steps of 5 160 180 in steps of 10 Off 110 Off A Pace on PVC PVARP on PVC VDD mode only Off On Off On Off 50 150 in steps of 25 160 200 in steps of 10 30 sec 1 3 5 10 30 min 1 2 3 Off On Ventricular AutoCapture Pacing System On Off Primary Pulse Configuration Unipolar 3 The act
90. 30 in steps of 5 140 180 in steps of 10 130 AO0 R AAI R AAT R OAO VOO R VVI R VVT R VDD R OVO DOO R DVI R DDI R DDD R ODO 60 70 80 85 95 100 110 115 125 130 140 150 155 165 170 180 185 195 200 25 30 200 in steps of 10 225 325 in steps of 25 150 Off 30 130 in steps of 5 140 150 30 50 in steps of 5 60 120 in steps of 10 100 12 52 in steps of 4 12 125 500 in steps of 25 250 Aor V Pulse Amplitude V Aor V Pulse Width ms Aor V Pulse Configuration Aor V Sense Configuration Atrial Sensitivity mV Ventricular AutoCapture Pacing System Primary Pulse Configuration Backup Pulse Configuration Backup Pulse Amplitude V Threshold Search Interval hours Ventricular Sensitivity mV Rate Modulated Parameters 0 0 4 0 in steps of 0 25 4 5 7 5 in steps of 0 5 2 5 0 05 0 1 1 5 in steps of 0 1 0 4 Unipolar tip case Bipolar tip ring Unipolar Tip tip case Bipolar tip ring Unipolar Ring ring case 0 1 0 4 in steps of 0 15 0 5 0 75 2 0 in steps of 0 25 2 0 4 0 in steps of 0 5 5 07 0 5 On Off Unipolar Unipolar Bipolar 5 0 8 24 0 5 5 0 in steps of 0 5 6 10 in steps of 1 0 12 5 2 07 Maximum Sensor Rate min Rate Responsive AV PV Delay Rate Responsive PVARP VREF Reaction Time Recovery Time Sensor Shortest PVARP VREF Slope Threshold 80 150 in steps of 5 160 180 in steps of 10 130 Off Low Medium High Off Low Me
91. 36 D1215 360 DC Fibber Pulse Duration sec 0 5 5 0 Telemetry RF RF Burst Fibber Cycle Length ms 20 100 Delivered Stored Energy J 36 42 36 42 Noninvasive Programmed 2 25 stimuli with up to 3 extrastimuli Volume cc 42 4 Stimulation NIPS Weight g 79 79 Size mm 76x 50x 14 74x 50x 14 Patient Notifiers Defibrillation Lead Connections DFI DF4 E E F m Sense Pace Lead Connections IS 1 DFA Programmable Notifiers On Off Device at ERI Charge Time Limit Reached Possible HV Circuit Damage High Voltage Can Electrically active titanium can Electrically active titanium can Ventricular Lead Impedance Out of Range High Voltage Lead Impedance Out of Range Backup VVI Long AT AF Episode Device Parameter Reset on Entry into Backup VVI Mode On Sensing Detection Vibration Duration sec 2 4 6 8 10 12 14 16 SenseAbility Technology Automatic Sensitivity Control adjustment for atrial and ventricular events Number of Vibrations per Notification 2 Threshold Start Post Sensed Atrial 50 62 5 75 100 Number of Notifications 16 Post Paced Atrial 0 2 3 0 mV Time Between Notifications hours 0 22 Post Sensed Ventricular 50 62 5 75 100 a P Post Paced Ventricular Auto 0 2 3 0 mV Picci Coe pans en Denali Decay Delay Post Sense Post Pace Atrial Ventricular 0 220 Stored Electrograms pto 45 minutes including up to 1 minute programmable pre trigger Ventricular Sense Refractory ms 125 157 data per VI VF diag
92. 6 x 50 x14 79 42 DF1 IS 1 CD1215 36Q 74x 50x 14 79 Al DF4 DF4 Indications The devices are intended to provide ventricular antitachycardia pacing and ventricular defibril lation for automated treatment of life threatening ventricular arrhythmias Contraindications Contraindications for use of the pulse generator system include ventricular tachyarrhythmias resulting from transient or correctable factors such as drug toxicity electrolyte imbalance or acute myocardial infarction Adverse Events Implantation of the pulse generator system like that of any other device involves risks some possibly life threatening These include but are not limited to the following acute hemorrhage bleeding air emboli arrhythmia acceleration cardiac or venous perforation cardiogenic shock cyst formation erosion exacerbation of heart failure extrusion fibrotic tissue growth fluid accumulation hematoma formation histotoxic reactions infection keloid formation myocardial irritability nerve damage pneumothorax Customer Support 46 8 474 4756 Brief Summary Prior to using these devices please review the Instructions for Use for a complete listing of indications contraindications warnings precautions potential adverse events and directions for use Devices depicted may not be available in all countries Check with your St Jude Medical representative for product availability in your country Unless otherwise noted indicates that the name
93. 70 mm 0 067 at the ring 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 Introducer Size Minimum 5 F ID Minimum S curve Height 16 mm Tip Electrode Pt Ir TiN coated ring shaped two grooves Steroid Dexamethasone sodium phosphate Tip Electrode Surface Area 4 9 mm Ring Electrode Surface Area 7 4 mm Electrode Spacing Distal tip 1 Mid 2 20 mm Distal tip 1 Mid 3 30 mm Distal tip 1 Proximal 4 47 mm Lead Body Insulation Optim insulation Lead Body Coating Fast Pass coating Conductors Distal coil MP35N LT Proximal cables ETFE MP35N LT Suture Sleeve Attached MP35N is a trademark of SPS Technologies Inc E ie 7 Customer Support 46 8 474 4756 Brief Summary Prior to using these devices please review the Instructions for Use for a complete listing of indications contraindications warnings precautions potential adverse events and directions for use Devices depicted may not be available in all countries Check with your St Jude Medical representative for product availability in your country Unless otherwise noted indicates that the name is a trademark of or licensed to St Jude Medical or one of its subsidiaries ST JUDE MEDICAL the nine squares symbol and MORE CONTROL LESS RISK are registered and unregistered trademarks and service marks of St Jude Medical Inc and its related companies 2011 St Jude Medical Inc All righ
94. AL SPECIFICATIONS Model 1688TC Lead Connector S 1 Bipolar Length 00cm Minimum Introducer Size TF Type of Lead Transvenous screw in bipolar steroid Fixation Mechanism Extendable Retractable helix 3 facet External Lead Body Diameter 0 081 2 1 mm 6 2 F Tip to Ring Spacing 0 mm Lead Tip Electrode Cathode Pt Ir collar active titanium nitride coated Pt Ir helix 1 8 mm extension Tip Electrode Surface Area 8 mm collar 2 4 mm helix 5 6 mm Ring Electrode Anode Titanium nitride coated Pt Ir ring Ring Electrode Surface Area 6 mm Mapping Available with collar Steroid lt mg dexamethasone sodium phosphate Inner Conductor MP35N coil Inner Insulation Silicone rubber Outer Conductor MP35N coil Outer Insulation Silicone rubber MP35N is a trademark of SPS Technologies Inc 3 Customer Support 46 8 474 4756 Brief Summary Prior to using these devices please review the Instructions for Use for a complete listing of indications contraindications warnings precautions potential adverse events and directions for use Devices depicted may not be available in all countries Check with your St Jude Medical representative for product availability in your country Unless otherwise noted indicates that the name is a trademark of or licensed to St Jude Medical or one of its subsidiaries ST JUDE MEDICAL the nine squares symbol and MORE CONTROL LESS RISK are registered and unregistered trad
95. AT AF Burden V Rate During AT AF V pacing CorVue Congestion Trigger On On 2 4 6 8 10 12 14 16 2 1 16 10 22 Stored Electrograms Therapy Summary Episodes Summary Lifetime Diagnostics AT AF Burden Trend Ventricular HV Lead Impedance Trend istograms PMT Data Real Time Measurements RTM CorVue Congestion Monitoring CorVue Congestion Trigger Up to 45 minutes including up to one minute programmable pre trigger data per VT VF diagnosis detection electrograms triggers include diagnosis therapy atrial episode PMT termination PC shock delivery noise reversion magnet reversion and morphology template verification Diagram of therapies delivered Directory listing of up to 60 episodes with access to more details including stored electrograms History of bradycardia events and device initiated charging Trend data and counts Multi Vector Trend Data Event Histogram AV Interval Histogram Mode Switch Duration Histogram Peak Filtered Rate Histogram Atrial Heart Rate Histogram Ventricular Heart Rate Histogram AT AF Burden Exercise and Activity Trending V Rates During AMS Information regarding PMT detections Pacing lead impedances high voltage lead impedances unloaded battery voltage and signal amplitudes On Off 8 18 days QHR is a trademark of Greatbatch LTD V first with 10 ms interventricular delay EBEN mem ST JUDE MEDICAL ann MORE CONTROL LESS RISK Cardiac Resy
96. Atrial Post Pace 0 30 60 95 125 160 190 220 Ventricular Post Pace Auto 0 30 60 95 125 160 190 220 Maximum Sensor Rate min Rate Responsive AV Delay Rate Responsive PVARP VREF Reaction Time Recovery Time Sensor Shortest PVARP VREF ms Slope Threshold Customer Support 46 8 474 4756 80 150 in steps of 5 160 180 in steps of 10 Off Low Medium High Off Low Medium High Very Fast Fast Medium Slow Fast Medium Slow Very Slow On Off Passive 125 475 in steps of 25 Auto 1 Auto 0 Auto 1 Auto 2 Auto 3 1 16 in steps of 1 Auto 0 5 Auto 0 0 Auto 0 5 Auto 1 0 Auto 1 5 Auto 2 0 1 7 in steps of 0 5 Brief Summary Prior to using these devices please review the Instructions for Use for a complete listing of indications contraindications warnings precautions potential adverse events and directions for use Devices depicted may not be available in all countries Check with your St Jude Medical representative for product availability in your country Unless otherwise noted indicates that the name is a trademark of or licensed to St Jude Medical or one of its subsidiaries ST JUDE MEDICAL the nine squares symbol and MORE CONTROL LESS RISK are registered and unregistered trademarks and service marks of St Jude Medical Inc and its related companies 2011 St Jude Medical Inc All rights reserved Item GMCRM790EN AF Management Pac
97. CARDIAC RHYTHM MANAGEMENT INTERNATIONAL PRODUCT CATALOG JANUARY 2012 aaa H ST JUDE MEDICAL MORE CONTROL LESS RISK A Comprehensive Portfolio of Cardiac Rhythm Management Products St Jude Medical offers comprehensive solutions for the diagnosis and treatment of cardiac arrhythmias Our product portfolio ranges from proven pacemakers implantable cardioverter defibrillators ICDs and cardiac resynchronisation therapy systems to innovative and reliable lead technologies Additionally we offer high performance products for atrial fibrillation AF including mapping and surgical and catheter ablation systems Other St Jude Medical products include remote care solutions heart valves and vascular closure devices High performance devices with long lasting batteries expansive data storage and fast processors pave the way for disease management These systems not only monitor device status but also take the patient and disease progression into account In combination with telemedicine capabilities patient monitoring can start in the patient s bedroom and extend beyond the parameters of rhythm management alone Advanced disease management features include ST segment monitoring m CorVue congestion monitoring AT AF alerts Our corporate mission is to develop medical technology and services that make it possible for physicians worldwide to treat cardiac and neurological diseases and chronic pain with more control Reducing risk f
98. Chamber Pacemaker Product Highlights InvisiLink wireless telemetry in conjunction with the Merlin home transmitter and Merlin net Patient Care Network PCN allows for daily remote monitoring and follow up AT AF episode m AT AF alerts can be programmed to notify patients and their clinics when a programmed AT AF threshold or can be programmed to continuous episode duration has been exceeded or when a high ventricular rate accompanies the Merlin home Transmitter Compatible A suite of state of the art features complete automaticity atrial and ventricular Ventricular Intrinsic Preference VIP technology QuickOpt timing cycle optimisation the AF Suppression algorithm and SenseAbility technology is designed to deliver optimal therapy for patients at implant and throughout their lives Real time electrogram EGM waveform as well as the associated event markers that precede and follow a specific triggering event can be programmed to automatically record up to 14 minutes of stored EGMs when encountering one or more programmable trigger options Ordering Information Contents Cardiac pulse generator Model Number PM2212 Dimensions H x W x T mm 52x52x6 Indications Implantation is indicated in one or more of the following permanent conditions syncope presyncope fatigue disorientation due to arrhythmia bradycardia or any combination of those symptoms Rate Modu
99. Connector PM2124 inductive 52x 53x6 23 31 S 1 PARAMETER SETTINGS Rate Timing Atrial Pace Refractory ms Atrial Sense Refractory ms Atrial Protection Interval ms Paced AV Delay ms Base Rate min Far Field Protection Interval ms Hysteresis Rate min Search Interval min Cycle Count Intervention Rate min Intervention Duration min Recovery Time Maximum Tracking Rate min Mode Post Ventricular Atrial Blanking ms PVARP ms Sensed AV Delay ms Rest Rate min Shortest AV Delay ms Ventricular Blanking ms Ventricular Pace Sense Refractory Fixed ms MRI Settings 90 400 in steps of 30 440 470 93 125 157 190 400 in steps of 30 440 470 500 253 25 30 200 in steps of 10 225 300 in steps of 25 350 0 130 in steps of 5 140 170 in steps of 10 63 Off 304 150 in steps of 5 Off 1 5 10 15 30 16 in steps of 1 Off Same as Base Rate 80 120 in steps of 10 Intrinsic 0 intrinsic 10 Intrinsic 20 Intrinsic 30 10 in 1 minute intervals Fast Medium Slow Very Slow 90 130 in steps of 5 140 180 in steps of 10 AOO R AAL R AAT R VOO R VVI R VVT R VDD R DOO R DVI R DDI R DD R Pacing Off 60 200 in steps of 10 225 250 25 500 in steps of 25 25 30 200 in steps of 10 225 325 in steps of 25 Off 30 150 in steps of 5 25 50 in steps of 5 60 120 in steps of 10 Auto 12 52 in steps of 4 25 160 400 in steps of 30 440 470
100. DI R DDT R VVI R VVT R Atrial Tachycardia Detection Rate min 110 300 AMS Base Rate min Auto PMT Detection Termination Rate Responsive PVARP VREF 40 45 135 Atrial Pace Off Passive Off Low Medium High Ventricular Intrinsic Preference VIP Off 50 200 50 150 in increments of 25 160 200 in increments of 10 Post Therapy Pacing independently programmahle from Bradycardia and ATP Post Shock Pacing Mode Post Shock Base Rate min Post Shock Pacing Duration min Device Testing Induction Methods Off AAI VVI DDI or DDD 30 100 in increments of 5 Off 0 5 1 2 5 5 7 5 or 10 DC Fibber Pulse Duration sec Burst Fibber Cycle Length ms Noninvasive Programmed Stimulation NIPS Patient Notifiers 0 5 5 0 20 100 2 25 stimuli with up to 3 extrastimuli Programmable Notifiers On Off Device Parameter Reset Entry into Backup VVI Mode Vibration Duration sec Number of Vibrations per Notification Number of Notifications Time Between Notifications hours Electrograms and Diagnostics Device at ERI Charge Time Limit Reached Possible HV Circuit Damage Atrial Lead Impedance Out of Range RV Lead Impedance Out of Range LV Lead Impedance Out of Range High Voltage Lead Impedance Out of Range AT AF Burden V Rate During AT AF Backup VVI Long AT AF Episode On On 2 4 6 8 10 12 14 16 2 1 16 10 22 Stored Electrograms Therapy Summary Episodes
101. DICAL the nine squares symbol and MORE CONTROL LESS RISK are registered and unregistered trademarks and service marks of St Jude Medical Inc and its related companies 2011 St Jude Medical Inc All rights reserved ann ST JUDE MEDICAL MORE CONTROL LESS RISK Item GMCRM914EN Connectivity External Pulse Generator hoa Single Chamber dnd Model 3077 Yf Product Highlights Designed for safe and reliable temporary stimulation of the heart in cases of rhythm disturbances and conduction defects An extensive single chamber feature set including mode choices a wide base rate range adjustable amplitude and sensitivity parameters and two modes of high rate pacing Up to 12 volts of output available per channel make the Model 3077 temporary pacemaker one of the highest output devices of its kind available Designed for ease of use Standard 9 volt lithium or alkaline batteries are used and the device features both visual and audible battery life indicators Large simple dial Small size and lightweight design Runaway protection limits the device to a maximum rate of 200 ppm in the unlikely event of circuit malfunction Ordering Information Contents External pulse generator Model Number Dimensions H x W x T cm Weight g Battery 3077 6x11 5x2 2 185 includes battery 9 V alkaline or lithium Indications for Use When combined with a stimulation lead system the Model 3077 SSI
102. Detect 90 150 in steps of 5 160 180 in steps of 10 Uncoded Unipolar Unipolar Bipolar Atrial Right Ventricular 200 800 in steps of 10 1 25 in steps of 1 100 800 in steps of 10 Off 30 40 95 in steps of 5 1 5 in steps of 1 The actual pacing rate for the 30 min setting is 31 min The highest available setting for Hysteresis Rate is 5 min below the programmed Base Rate LV first with 10 ms interventricular delay T Indual chamber modes the maximum Ventricular Refractory Period is 325 ms Sensitivity is with respect to a 20 ms haversine test signal v Values 0 1 0 4 not available in a Unipolar Sense Configuration During atrial NIPS in dual chamber modes the shortest Coupling Interval will be limited by the programmed AV PV Delay X S1 Burst Cycle is applied at the preprogrammed S1 cycle length A This parameter is not programmable EBEN mem ST JUDE MEDICAL ann MORE CONTROL LESS RISK LEFT HEART AND EPICARDIAL LEADS St Jude Medical Left Heart Lead Technology We place great importance in left heart leads because they help ensure that the capabilities of the St Jude Medical high performance CRT D and CRT devices are fully utilised Through a systematic development effort St Jude Medical has combined the safety of proven leads with innovative technology More Control When used with the Unify Quadra CRT D device and the Promote Quadra CRT D device the Quartet left vent
103. EDICAL the nine squares symbol and MORE CONTROL LESS RISK are registered and unregistered trademarks and service marks of St Jude Medical Inc and its related companies 2011 St Jude Medical Inc All rights reserved ST JUDE MEDICAL MORE CONTROL LESS RISK Tendril MRI Pacing Lead Product Specifications Model LPA1200M Minimum Introducer Size 8F Minimum Introducer Size with Guidewire 0 5F ype of Lead Active fixation steroid eluting endocardial straight pacing lead Lead Connector IS 1 bipolar Lead Lengths 46 52 and 58 cm Fixation Mechanism Extendable Retractable helix Typical Number of Rotations for Helix Extension 5 10 straight stylet Lead Body Diameter 2 18 mm max 6 6 F ip to Ring Spacing 0mm Lead Tip Electrode Cathode Active TiN coated Pt Ir helix 1 8 mm extension ip Electrode Surface Area 6 8 mm Ring Electrode Anode iN coated Pt Ir Ring Electrode Surface Area 6 5 mm Mapping Capable with TiN coated Pt Ir helix Steroid Silicone plug with lt 1 mg dexamethasone sodium phosphate Inner Conductor Outer Conductor MP35N coil Inner Insulation Silicone Outer Insulation Optim lead insulation In Pack Straight stylets 1 x soft in lead 1 x soft 1 soft J shaped stylets 2 soft Helix extension retraction clip on tools 2 clip on tools Accessory Kits Available Separately Model Number Compatible Lengths Description Stylet Kit DS06002 with appropriate 46 52 and 58 cm 1 fixation tool 1 cli
104. F devices is indicated for maintaining synchrony of the left and right ventricles in patients who have undergone an AV nodal ablation for chronic atrial fibrillation and have NYHA Class II or Ill heart failure the reduction of the symptoms of moderate to severe heart failure NYHA Class Ill or IV in those patients who remain symptomatic despite stable optimal medical therapy and have a left ventricular ejection fraction lt 35 and a prolonged QRS duration implantation of Accent Accent RF Anthem and Anthem RF devices is indicated in one or more of the following permanent conditions syncope presyncope fatigue disorientation or any combination of those symptoms Rate Modulated Pacing is indicated for patients with chronotropic incompetence and for those who would benefit from increased stimulation rates concurrent with physical activity Dual Chamber Pacing is indicated for those patients exhibiting sick sinus syndrome chronic symptomatic second and third degree AV block recurrent Adams Stokes syndrome symptomatic bilateral bundle branch block when tachyarrhythmia and other causes have been ruled out Atrial Pacing is indicated for patients with sinus node dysfunction and normal AV and intraventricular conduction systems Ventricular Pacing is indicated for patients with significant bradycardia and normal sinus rhythm with only rare episodes of A V block or sinus arrest chronic atrial fibrillation severe physical disability AF Suppressio
105. Fast Fast Medium Slow Fast Medium Slow Very Slow On Off Passive Auto 1 Auto 0 Auto 1 Auto 2 Auto 3 1 16 in steps of 1 Auto 0 5 Auto 0 0 Auto 0 5 Auto 1 0 Auto 1 5 Auto 2 0 1 7 in steps of 0 5 Brief Summary Prior to using these devices please review the Instructions for Use for a complete listing of indications contraindications warnings precautions potential adverse events and directions for use Devices depicted may not be available in all countries Check with your St Jude Medical representative for product availability in your country Unless otherwise noted indicates that the name is a trademark of or licensed to St Jude Medical or one of its subsidiaries ST JUDE MEDICAL the nine squares symbol and MORE CONTROL LESS RISK are registered and unregistered trademarks and service marks of St Jude Medical Inc and its related companies 2011 St Jude Medical Inc All rights reserved Item GMCRM875EN LLL mam ST JUDE MEDICAL MORE CONTROL LESS RISK Pace Sustain XL DC Dual Chamber Pacemaker Product Highlights Device features small physiologic shape and offers superior longevity 9 8 years without compromising size s compos ce v EH St JUDE MEDICAL Sytner lt Instant follow up with automatic P or R wave lead impedance measurements and ventricular threshold tests The Ventricular Intrinsic Preference VIP
106. IS4 LLLL IS4 LLLL IS 1 IS 1 Electrically active titanium can Electrically active titanium can PARAMETER Biventricular Pacing SETTINGS VectSelect Quartet LV Pulse Configuration V Triggering BiV Trigger Mode 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 On Off QuickOpt Timing Cycle Optimisation Sensed paced AV delay interventricular pace V V Timing Interventricular Pace Delay ms Ventricular Sensing Ventricular Pacing Chamber Negative AV Hysteresis Search ms Shortest AV Delay ms AF Management Simultaneous RV First LV First RV First 10 80 LV First 15 80 in increments of 5 RV only not programmable RV only biventricular Off 10 to 120 25 120 AF Suppression Pacing No of Overdrive Pacing Cycles Maximum AF Suppression Rate Sensing Detection On Off 15 40 in steps of 5 80 150 min SenseAbility Technology Low Frequency Attenuation Threshold Start Decay Delay Ventricular Sense Refractory ms Detection Zones SVT Discriminators Reconfirmation Antitachycardia Pacing Therapy Automatic Sensitivity Control adjustment for atrial and ventricular events On Off Post Sensed Atrial 50 62 5 75 100 Post Paced Atrial 0 2 3 0 mV Post Sensed Ventricular 50 62 5 75 100 Post Paced Ventricu
107. Jude Medical MR devices Wireless communication devices such as computers that operate on a wireless network handheld Conditional pulse generators personal computers PDA cellular phones and even cordless telephones may generate enough EMI to Contraindications Th traindicati interfere with the performance of the activator if it is used too close to the source of EMI Hospital and Medical Ontraindications here are no contraindications equipment A variety of standard hospital and medical equipment may generate enough EMI to interfere Warnings and Precautions Electromagnetic interference The activator is not magnetic and has no with the performance of the activator These include but are not limited to blood pressure monitors ECG moving parts However you should avoid equipment which generates a strong electromagnetic interference equipment external defibrillation equipment x ray machines Office equipment A variety of standard office EMI EMI could interfere with communication between the activator and the implanted St Jude Medical equipment may generate enough EMI to interfere with the performance of the activator These include but MR conditional pulse generator Moving away from the source of EMI or turning it off will usually allow the are not limited to desktop or laptop computers fax machines phone systems Industrial equipment A variety activator to return to its normal mode of operation Communication equipment Communica
108. Kit 4060 40 46 52 58 and 85 cm 2 straight soft stylets Green 0 014 Traffic Light Stylet Kit 4062 40 46 52 58 and 85 cm 2 straight firm stylets Yellow 0 015 Traffic Light Stylet Kit 4064 40 46 52 58 and 85 cm 2 straight x firm stylets Red 0 016 Traffic Light Stylet Kit S 65 x 65cm 2 straight soft firm of x firm stylets ul c o Customer Support 46 8 474 4756 Brief Summary Prior to using these devices please review the Instructions for Use for a complete listing of jy indications contraindications warnings precautions potential adverse events and directions for use Devices m depicted may not be available in all countries Check with your St Jude Medical representative for product availability in your country Unless otherwise noted indicates that the name is a trademark of or licensed to St Jude Medical or one of its subsidiaries ST JUDE MEDICAL the nine squares symbol and MORE CONTROL LESS RISK are registered and unregistered trademarks and service marks of St Jude Medical Inc and its related companies S M B 9 2011 St Jude Medical Inc All rights reserved T U DE E D ICAL Item GMCRM916EN MORE CONTROL LESS RISK ACCESSORIES Accessories Universal Stylet Kit Product Highlights Repositioning kit for use with LV and HV leads Kit includes 4 straight stylets X Soft Light Green Soft Green Firm Yell
109. L Item GMCRM898EN MORE CONTROL LESS RISK SJM Confirm External Patient Activator Product Highlights The SJM Confirm external patient activator uses radio waves to communicate with the Confirm Implantable Cardiac Monitor ICM Initiates recording of the heart s electrical activity reads stored data and sends stored data to Merlin Patient Care System HH sr June MEDICA SIM CONT Ordering Information Contents SJM Confirm External Patient Activator device Model Number DM2100A Description Intended Use The activator is intended for use with SJM Confirm Internal Cardiac Monitor Contraindications There are no contraindications Warnings and Precautions Electromagnetic interference The activator is not magnetic and has no moving parts However you should avoid equipment which generates a strong electromagnetic interference EMI EMI could interfere with communication between the activator and the implanted SJM Confirm ICM Moving away from the source of EMI or turning it off will usually allow the activator to return to its normal mode of operation Communication equipment Communication equipment such as microwave transmitters or high power amateur transmitters may generate enough EMI to interfere with the performance of the activator if you are too close to the source of EMI Wireless communication devices Wireless communication devices such as Customer Support 46 8 474 4756 Brief Summary Pr
110. Low Medium High Ventricular Intrinsic Preference VIP Off 50 200 50 150 in increments of 25 160 200 in increments of 10 Ventricular AutoCapture Pacing System ACap Confirm On Off On Monitor Off Customer Support 46 8 474 4756 Brief Summary Prior to using these devices please review the Instructions for Use for a complete listing of indications contraindications warnings precautions potential adverse events and directions for use Devices depicted may not be available in all countries Check with your St Jude Medical representative for product availability in your country Unless otherwise noted indicates that the name is a trademark of or licensed to St Jude Medical or one of its subsidiaries ST JUDE MEDICAL the nine squares symbol and MORE CONTROL LESS RISK are registered and unregistered trademarks and service marks of St Jude Medical Inc and its related companies 2011 St Jude Medical Inc All rights reserved Item GMCRM775EN fibrillator ICD Devices Post Therapy Pacing independently programmable from Bradycardia and ATP Post Shock Pacing Mode Post Shock Base Rate min Post Shock Pacing Duration min Device Testing Induction Methods Off AAI VVI DDI DDD 30 100 in increments of 5 Off 0 5 1 2 5 5 7 5 or 10 DC Fibber Pulse Duration sec Burst Fibber Cycle Length ms Noninvasive Programmed Stimulation NIPS Patient Notifiers 0 5 5 0 20 100 2
111. Min Burst Cycle Length ms Number of Bursts Number of Stimuli Add Stimuli per Burst ATP Pulse Amplitude V ATP Pulse Width ms High Voltage Therapy Ramp Burst Scan 1 or 2 schemes per VT zone ATP While Charging ATP Prior to Charging Off 150 300 bpm Adaptive Readaptive or Fixed 150 400 in increments of 5 1 15 2 20 On Off 7 5 Independent from Bradycardia and Post Therapy Pacing 1 0 or 1 5 Independently programmable from Bradycardia and Post Therapy Pacing High Voltage Output Mode Waveform RV Polarity Electrode Configuration Bradycardia Pacing Fixed Pulse Width Fixed Tilt Biphasic Monophasic Cathode Anode RV to Can RV to SVC Can Permanent Modes Temporary Modes Rate Adaptive Sensor Programmable Rate and Delay Parameters Ventricular AutoCapture Pacing System VVI R Pacer Off Off VVI VOO Post Sense Post Pace Ventricular 0 220 Off Base Rate min Rest Rate min Maximum Sensor Rate min Pulse Amplitude RV V Pulse Width RV ms Hysteresis Rate min Rate Hysteresis with Search On Off Post Therapy Pacing Independently programmable from Bradycardia and ATP Post Shock Pacing Mode Post Shock Base Rate min Post Shock Pacing Duration min Device Testing Induction Methods Off VVI 30 100 in increments of 5 Off 0 5 1 2 5 7 5 or 10 DC Fibber Pulse Duration sec Burst Fibber Cycle Length ms Noninvasive Programmed S
112. OL LESS RISK GMCRM 7 PACEMAKERS St Jude Medical Pacemakers The most noteworthy characteristics of St Jude Medical pacemakers include longevity the avoidance of unnecessary right ventricular stimulation and extensive automaticity including proven diagnostics Additionally our state of the art pacemakers are efficient in that they save time and make it possible for patients to receive optimal therapy Remote care options provide the possibility of home monitoring and increase patient safety More Control The MRI conditional pacing system provides full featured pacing therapy with no zone restrictions and high power whole body imaging allowing for superior quality MRI images VIP technology prevents unnecessary right ventricular pacing by continually monitoring a patient s rhythm and searching for intrinsic conduction QuickOpt timing cycle optimisation furthers delivery of right ventricular pacing only when necessary through AV interval optimisation Our advanced pacemakers feature individually programmable alerts that inform patients and or their clinic about critical changes in device performance or arrhythmia status Less Risk The MRI conditional pacing system provides safe full body MRI scans The AutoCapture pacing system provides ventricular pacing security for every beat while minimising energy use The ACap confirm algorithm automatically measures the atrial pacing threshold and adapts the p
113. On Off Unipolar Bipolar Unipolar Bipolar 5 05 8 24 Off On Automatic Sensitivity Control adjustment for ventricular events 0 2 2 0 in steps of 0 1 Ventricular Post Sense 50 62 5 75 100 Ventricular Post Pace Auto 0 2 3 0 in steps of 0 1 mV Ventricular Post Sense 0 30 60 95 125 160 190 220 Ventricular Post Pace Auto 0 30 60 95 125 160 190 220 Maximum Sensor Rate min Rate Responsive VREF Shortest VREF Reaction Time Recovery Time Sensor Slope Threshold Customer Support 46 8 474 4756 80 150 in steps of 5 160 180 in steps of 10 Off Low Medium High 125 475 in steps of 25 Very Fast Fast Medium Slow Fast Medium Slow Very Slow On Off Passive Auto 1 Auto 4 0 Auto 1 Auto 2 Auto 3 1 16 in steps of 1 Auto 0 5 Auto 4 0 0 Auto 4 0 5 Auto 1 0 Auto 1 5 Auto 2 0 1 7 in steps of 0 5 Brief Summary Prior to using these devices please review the Instructions for Use for a complete listing of indications contraindications warnings precautions potential adverse events and directions for use Devices depicted may not be available in all countries Check with your St Jude Medical representative for product availability in your country Unless otherwise noted indicates that the name is a trademark of or licensed to St Jude Medical or one of its subsidiaries ST JUDE MEDICAL the nine squares symbol and MORE CONTROL LESS RISK are
114. Plus recommended for Atrial Use 14 40 58 1292 46 Locator Plus recommended for Ventricular Use 16 55 46 1292 52 Locator Plus recommended for Ventricular Use 16 55 52 1292 58 Locator Plus recommended for Ventricular Use 16 55 58 Customer Support 46 8 474 4756 Brief Summary Prior to using these devices please review the Instructions for Use for a complete listing of indications contraindications warnings precautions potential adverse events and directions for use Devices depicted may not be available in all countries Check with your St Jude Medical representative for product availability in your country Unless otherwise noted indicates that the name is a trademark of or licensed to St Jude Medical or one of its subsidiaries ST JUDE MEDICAL the nine squares symbol and MORE CONTROL LESS RISK a are registered and unregistered trademarks and service marks of St Jude Medical Inc and its related companies S M B 2011 St Jude Medical Inc All rights reserved T JUDE E DICAL MORE CONTROL LESS RISK Accessories Model Receptacle Header Cavity Number for adapting from to device 5 mm unipolar E qe ror 501203 unipolar pacing only IS 1 unipolar Q 0 p 501204 6 mm unipolar IS 1 unipolar Q gp A A oS IS 1 bipolar 5 mm bifurcated both unipolar and O i o gt 991209 bipolar bipolar pacing co
115. R VVT R Atrial Tachycardia Detection Rate min 110 300 AMS Base Rate min Auto PMT Detection Termination Rate Responsive PVARP VREF 40 45 135 Atrial Pace Off Passive Off Low Medium High Ventricular Intrinsic Preference VIP Off 50 200 50 150 in increments of 25 160 200 in increments of 10 BiVCap Confirm LVCap Confirm RVCap Confirm ACap Confirm Setup On Monitor Off Setup On Monitor Off On Monitor Off Post Therapy Pacing independently programmable from Bradycardia and ATP Post Shock Pacing Mode Post Shock Base Rate min Post Shock Pacing Duration min Device Testing Induction Methods Off AAI VVI DDI or DDD 30 100 in increments of 5 Off 0 5 1 2 5 5 7 5 or 10 DC Fibber Pulse Duration sec Burst Fibber Cycle Length ms Noninvasive Programmed Stimulation NIPS Patient Notifiers 0 5 5 0 20 100 2 25 stimuli with up to 3 extrastimuli Programmable Notifiers On Off Device Parameter Reset Entry into Backup VVI Mode Vibration Duration sec Number of Vibrations per Notification Number of Notifications Time Between Notifications hours Electrograms and Diagnostics Device at ERI Charge Time Limit Reached Possible HV Circuit Damage Atrial Lead Impedance Out of Range RV Lead Impedance Out of Range LV Lead Impedance Out of Range High Voltage Lead Impedance Out of Range AT AF Burden V Rate During AT AF V Pacing CorVue
116. RE CONTROL LESS RISK Pacing Leads OptiSense Pacing Lead Product Highlights OptiSense lead technology offers optimal tip to ring spacing for more precise atrial sensing without inappropriately sensing extra atrial signals Unique 1 1 mm tip to ring spacing enables sensing of even the finest atrial arrhythmia signals standard atrial leads typically have a tip to ring spacing of 10 mm or more Accurate atrial sensing enables appropriate atrial diagnostics and therapies Less far field R wave interference with innovative far field signal reduction technology Optim lead insulation a chemical co polymer that blends the best features of polyurethane and silicone for improved handling and increased durability Thin lead body diameter of 5 8 F can be inserted using a 7 F introducer Steroid elution and titanium nitride fractal coating on electrodes for low thresholds Includes three different J shaped stylets providing options for different patient anatomies and handling preferences Ordering Information Contents Cardiac pacing lead Model Number Insulation Fixation Min Introducer F Connector Lengths cm 1999 Optim Ext Ret helix 7 IS 1 bipolar 40 46 52 Indications The OptiSense lead is designed for permanent sensing and pacing in the atrium with a Adverse Events Potential complications associated with the use of OptiSense leads are the same as with compatible pulse generator An active lead
117. RE CONTROL LESS RISK are registered and unregistered trademarks and service marks of St Jude Medical Inc and its related companies 2011 St Jude Medical Inc All rights reserved Item GMCRM780EN ST JUDE MEDICAL MORE CONTROL LESS RISK Current Accel DR Dual Chamber Implantable Cardioverter Defibrillator ICD Product Highlights The DF4 connector is designed to simplify implants by streamlining defibrillation connections into a single terminal pin and reducing the number of set screws AutoCapture Pacing System offers the maximum in threshold adaptability and patient safety with ventricular Beat by Beat capture confirmation The Implantable Cardioverter Defibrillator ICD Devices AutoCapture Pacing System automatically delivers a 5 0 V backup safety pulse when noncapture is detected and it may be programmed to either a bipolar or unipolar configuration Merlin home Transmitter ACap Confirm Pacing System periodically completes a threshold search Compatible and automatically adjusts amplitude to address patients changing atrial thresholds DeFT Response technology offers the most noninvasive options for managing high DFTs The SenseAbility feature provides the flexibility to fine tune programming around T wave oversensing without decreasing sensitivity Vibratory patient notifier enables patients with hearing problems to be alerted to a low battery lead related com
118. RISK Sustain XL SC Single Chamber Pacemaker Product Specifications E 7 7 PHYSICAL SPECIFICATIONS Model PM1134 Dimensions mm 42x52x6 Weight g 23 Volume cc 10 4 Connector IS 1 PARAMETER SETTINGS Rate Timing A or V Refractory ms 125 500 in steps of 25 325 Base Rate bpm 307 40 130 in steps of 5 140 170 in steps of 10 Mode A00 AAI AAT 0A0 V00 VVI VVT OVO Hysteresis Rate bpm Off 30 130 in steps of 5 140 150 Search Interval bpm Off 5 10 15 30 Cycle Count 16 in steps of 1 Intervention Rate bpm Intervention Duration min Recovery Time Rate Responsive VREF Rest Rate bpm Shortest VREF Output Sensing Off 60 80 120 in steps of 10 Intrinsic 0 intrinsic 10 Intrinsic 20 Intrinsic 30 10 in 1 minute intervals Fast Medium Slow Very Slow Off Low Medium High Off 30 130 in steps of 5 140 150 20 350 in steps of 10 Aor V Pulse Amplitude V Aor V Pulse Width ms A or V Sensitivity mV A or V Pulse Configuration A or V Sense Configuration Ventricular AutoCapture Pacing System Primary Pulse Configuration Backup Pulse Configuration Backup Pulse Amplitude V Search Interval hours Customer Support 46 8 474 4756 0 4 0 in steps of 0 25 4 5 7 5 in steps of 0 5 2 5 05 0 1 1 5 in steps of 0 1 0 4 5 5 0 in steps of 0 5 6 10 in steps of 1 0 12 54 nipolar tip case Bipolar tip ring Unipolar Tip tip case B
119. RM ST JUDE MEDICAL MORE CONTROL LESS RISK Wo GMC RM9 66EN MIN ATRIAL FIBRILLATION Global Headquarters One St Jude Medical Drive St Paul Minnesota 55117 USA 1 651 756 2000 1 651 756 3301 Fax St Jude Medical Coordination Center BVBA The Corporate Village Avenue Da Vincilaan 11 Box F1 B 1935 Zaventem Belgium 32 2 77468 11 32 2 772 83 84 Fax CARDIAC RHYTHM MANAGEMENT Cardiac Rhythm Management Division 15900 Valley View Court Sylmar California 91342 USA 1 818 362 6822 1 818 364 5814 Fax St Jude Medical Brasil Ltda Rua Frei Caneca 1380 7 ao 9 andares 01307 002 S o Paulo SP Brazil 55 11 5080 5400 55 11 5080 5423 Fax SJMprofessional com CARDIOVASCULAR St Jude Medical Sweden AB Veddestav gen 19 SE 175 84 J rf lla Sweden 46 8 474 40 00 46 8 760 95 42 Fax St Jude Medical Hong Kong Ltd Suite 1608 16 F Exchange Tower 33 Wang Chiu Road Kowloon Bay Kowloon Hong Kong SAR 852 2996 7688 852 2956 0622 Fax NEUROMODULATION St Jude Medical Japan Co Ltd Shiodome City Center 15F Minato ku 1 5 2 Higashi Shinbashi Minato ku Tokyo 105 7115 Japan 81 3 6255 6370 81 3 6255 6371 Fax Ean mam ST JUDE MEDICAL MORE CONTROL LESS RISK Brief Summary Prior to using these devices please review the User s Manual for a complete listing of indications contraindications warnings precautions potential adverse events and d
120. ROL LESS RISK are registered and unregistered trademarks and service marks of St Jude Medical Inc and its related companies 2011 St Jude Medical Inc All rights reserved Weight g Connector 10 5 0 5 IS 1 Volume cc Single Chamber Ventricular Demand Pacing is relatively contraindicated in patients who have demonstrated pacemaker syndrome have retrograde VA conduction or suffer a drop in arterial blood pressure with the onset of ventricular pacing Single Chamber Atrial Pacing is relatively contraindicated in patients who have demonstrated compromise of AV conduction Potential Adverse Events The following are potential complications associated with the use of any pacing system arrhythmia heart block thrombosis threshold elevation valve damage pneumothorax myopotential sensing vessel damage air embolism body rejection phenomena cardiac tamponade or perforation formation of fibrotic tissue local tissue reaction inability to interrogate or program a device because of programmer malfunction infection interruption of desired device function due to electrical interference loss of desired pacing and or sensing due to lead displacement body reaction at electrode interface or lead malfunction fracture or damage to insulation loss of normal device function due to battery failure or component malfunction device migration pocket erosion or hematoma pectoral muscle stimulation phrenic nerve or diaphragmatic stim
121. RT D Product Highlights The Unify Quadra CRT D and Quartet quadripolar LV pacing lead feature four pacing electrodes and 10 pacing vectors to provide more options and greater control to minimise implant complications such as diaphragmatic stimulation and high pacing thresholds Downsized device for a smaller footprint The CorVue Congestion Monitoring feature monitors the intrathoracic impedance in multiple vectors for improved accuracy and it provides Merlin home Transmitter the option for both patient and physician alerts Compatible ShockGuard technology with DecisionTx programming designed to reduce inappropriate therapy and minimise the need for programming adjustments at implant 40 J delivered energy provides unsurpassed energy for defibrillation Streamlined header connectors IS4 LLLL DF4 LLHH reduce pocket bulk QHR chemistry battery provides greater capacity for enhanced longevity and improved charge time performance Ordering Information Contents Cardiac pulse generator Model Number Dimensions H x W x T mm Weight g Volume cc Connector CD3251 40 83x 41x 14 83 40 DF1 IS4 IS 1 CD3251 40Q 76x41 x 14 81 38 DFA IS4 IS 1 Indications The devices are intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias Cardiac Resynchronisation Therapy Defibrillators CRT Ds are also intended to resy
122. Specifications fibrillator ICD Devices Post Therapy Pacing Independently programmable from Bradycardia and ATP models 102235 pire M Post Shock Pacing Mode Off AAI WWI DDI or DDD Telemetry RE ii Post Shock Base Rate min 30 100 in increments of 5 Deieredstored Energy 1 1s 4049 Post Shock Pacing Duration min Off 0 5 1 2 5 7 5 or 10 Volume cc 35 35 Weight g 76 15 Device Testing Induction Methods Size mm 74x40x14 71x40x14 DC Fibber Pulse Duration sec 0 5 5 0 Defibrillation Lead Connections DF1 DF4 Burst Fibber Cycle Length ms 20 100 Sense Pace Lead Connections IS 1 IS 1 DF4 High Voltage Can Electrically active titanium can Electrically active titanium can PARAMETERS SETTINGS AF Management Noninvasive Programmed Stimulation NIPS Patient Notifiers 2 25 stimuli with up to three extrastimuli Programmable Notifiers 0n Off Device at ERI Charge Time Limit Reached Possible HV Circuit Damage AF Suppression Pacing On Off Atrial Lead Impedance Out of Range Ventricular Lead Impedance Out No of Overdrive Pacing Cycles 15 40 in increments of 5 of Range High Voltage Lead Impedance Out of Range AT AF Burden Maximum AF Suppression Rate 80 150 min V Rate During AT AF V pacing CorVue Congestion Trigger Sensing Detection Device Parameter Reset On Entry into Backup VVI Mode On SenseAbility Technology Automatic Sensitivity Control adjustment for atrial and ventric
123. Superior longevity when compared volume for volume with any other pacemaker on the market 5826 S N 123456 QuickOpt timing cycle optimisation provides quick and effective optimisation for more patients at the touch of a button m Powerful tools including automatic daily measurements follow up EGM and trends optimised in clinic testing and lead impedance trend and polarity switch save valuable clinic time 8 The AutoCapture pacing system offers the maximum in threshold adaptability and patient safety with ventricular Beat by Beat capture confirmation ACap confirm feature periodically completes a threshold search and adjusts the pulse amplitude accordingly in the atrium a Ventricular Intrinsic Preference VIP algorithm automatically searches for intrinsic conduction Stored electrograms EGMs record a real time EGM waveform as well as the associated event markers that precede and follow a specific triggering event a Multiple algorithms and diagnostics to assist physicians in therapy decisions including AF Suppression algorithm AT AF diagnostic suite and Auto Mode Switch algorithm and diagnostic suite Ordering Information Contents Cardiac pulse generator Model Number Dimensions H x W x T mm Weight g Volume cc Connector 5826 44 x 52 x6 23 5 11 0 5 IS 1 Indications and Usage Implantation of Zephyr pulse generators is indicated in the following permanent Dual Chamber Pacing M
124. VCs 2 3 4 5 Other A and V Lead Monitoring Off Monitor Auto Polarity Switch A and V Low Impedance Limit G2 A and V High Impedance Limit Q Lead Type Magnet Response Negative AV PV Hysteresis Search ms NIPS Options Stimulation Chamber Coupling Interval S1 Count S1 S2 S3 and S4 Cycle ms Ventricular Support Rate min Sinus Node Recovery Delay sec PMT Options PMT Detection Rate min PVC Options Signal Amplitude Monitoring P Wave Monitoring R Wave Monitoring Ventricular Intrinsic Preference VIP ms VIP Search Interval VIP Search Cycles Ventricular Safety Standby 1 0 5cc 2 This parameter is not programmable 200 750 1000 1250 1500 1750 2000 Uncoded Unipolar Bipolar Only Unipolar Bipolar Off Battery Test Off 10 to 110 in steps of 10 Atrial Ventricular 100 800 in steps of 10 1 25 in steps of 1 100 800 in steps of 10 Off 30 40 45 50 55 60 65 70 75 80 85 90 95 1 5 in steps of 1 Off 10 Beats gt PMT Auto Detect 90 150 in steps of 5 160 180 in steps of 10 Off 110 Off A Pace on PVC PVARP on PVC VDD mode only Off On Off On Off 50 150 in steps of 25 160 200 in steps of 10 30 sec 1 3 5 10 30 min 1 2 3 Off 0n 3 The actual pacing rate for the 30 bpm is 31 bpm 4 The highest available setting for Hysteresis Rate will be 5 bpm below the programmed Base Rate 5 In dual chamber modes the maximum Ventricular Refractory Period is 325 ms 6 Valu
125. Volume cc Connector PARAMETER Rate Timing PM2212 RF 52x52x6 23 2 8 S 1 SETTINGS Atrial Pace Refractory ms Atrial Sense Refractory ms Atrial Protection Interval ms Paced AV Delay ms Base Rate min Far Field Protection Interval ms Hysteresis Rate min Search Interval min Cycle Count Intervention Rate min Intervention Duration min Recovery Time Maximum Tracking Rate min Mode Post Ventricular Atrial Blanking ms PVARP ms Sensed AV Delay ms Rest Rate min Shortest AV Delay ms Ventricular Blanking ms Ventricular Pace Sense Refractory Fixed ms Output Sensing 90 400 in steps of 30 440 470 93 125 157 190 400 in steps of 30 440 470 253 25 30 200 in steps of 10 225 300 in steps of 25 350 30 130 in steps of 5 140 170 in steps of 10 63 Off 304 150 in steps of 5 Off 1 5 10 15 30 16 in steps of 1 Off Same Base Rate 80 120 in steps of 10 Intrinsic 0 ntrinsic 10 Intrinsic 20 Intrinsic 30 10 in 1 minute intervals Fast Medium Slow Very Slow 90 130 in steps of 5 140 180 in steps of 10 AO0 R AAI R AAT R VOO R VVI R VVT R VDD R DOO R DVI R DDI R DD R Pacing Off 60 200 in steps of 10 225 250 25 500 in steps of 25 25 30 200 in steps of 10 225 325 in steps of 25 Off 30 150 in steps of 5 25 50 in steps of 5 60 120 in steps of 10 Auto 12 52 in steps of 4 125 160 400 in steps of 30 440 50
126. agnet reversion and morphology template verification Diagram of therapies delivered Directory listing of up to 60 episodes with access to more details including stored electrograms 15 Lifetime Diagnostics History of bradycardia events and device initiated charging 2 20 Ventricular HV Lead Impedance Trend Multi Vector Trend Data On Off Event Histogram Ventricular Heart Rate Histogram Exercise and Activity Trending Pacing lead impedances high voltage lead impedances unloaded battery voltage and signal amplitudes ST Histogram Data ST Deviation Trend and ST Episode Log On Off 8 18 days QHR is a trademark of Greatbatch LTD Off Base Rate min Rest Rate min Maximum Sensor Rate min Rate Parameters Pulse Amplitude RV V Pulse Width RV ms Hysteresis Rate min Rate Hysteresis with Search Ventricular AutoCapture On Off Pacing System Customer Support 46 8 474 4756 Brief Summary Prior to using these devices please review the Instructions for Use for a complete listing of indications contraindications warnings precautions potential adverse events and directions for use Devices depicted may not be available in all countries Check with your St Jude Medical representative for product availability in your country Unless otherwise noted indicates that the name is a trademark of or licensed to St Jude Medical or one of its subsidiaries ST JUDE MEDICAL the nine squares symbol and MO
127. algorithm automatically searches for intrinsic conduction The AutoCapture Pacing System feature offers the maximum in threshold adaptability and patient safety with ventricular Beat by Beat capture confirmation Stored electrograms EGMs record a real time EGM waveform as well as the associated event markers that precede and follow a specific triggering event 1 A V2 2 5 V 0 4 ms AV 500 ohms 100 DDD pacing 60 bpm SEGMs ON data on file Ordering Information Contents Cardiac pulse generator Model Number Dimensions H x W x T mm Weight g Volume cc Connector PM2134 44 x 52 x6 23 5 11 IS 1 Indications and Usage Implantation of Sustain pulse generators is indicated in the following permanent with chronic atrial flutter chronic atrial fibrillation or silent atria may provide no benefit beyond that of single conditions when associated with symptoms including but not limited to syncope presyncope fatigue chamber pacing in such patients Single Chamber Ventricular Demand Pacing is relatively contraindicated disorientation or any combination of those symptoms Dual Chamber Pacing Models PM2134 and PM2136 in patients who have demonstrated pacemaker syndrome have retrograde VA conduction or suffer a drop only is indicated for those patients exhibiting sick sinus syndrome chronic symptomatic second and in arterial blood pressure with the onset of ventricular pacing Single Chamber Atrial Pacing is relatively thir
128. aneous RV First LV First RV First 10 80 LV First 15 80 in increments of 5 RV only not programmable RV only biventricular Off 10 to 120 25 120 LV tip to RV coil LV bipolar LV ring to RV coil AF Suppression Pacing No of Overdrive Pacing Cycles Maximum AF Suppression Rate Sensing Detection On Off 15 40 in steps of 5 80 150 min SenseAbility Technology Low Frequency Attenuation Sense Filter Threshold Start Decay Delay Ventricular Sense Refractory ms Detection Zones SVT Discriminators Reconfirmation Antitachycardia Pacing Therapy Automatic Sensitivity Control adjustment for atrial and ventricular events On Off Post Sensed Atrial 50 62 5 75 100 Post Paced Atrial 0 2 3 0 mV Post Sensed Ventricular 50 62 5 75 100 Post Paced Ventricular Auto 0 2 3 0 mV Post Sense Post Pace Atrial Ventricular 0 220 25 157 VT 1 VT 2 VF AV Rate Branch Sudden Onset Interval Stability Morphology Discrimination MD with Manual or Automatic Template Update Continuous sensing during charging ATP Configurations ATP in VF Zone ATP Upper Rate Cutoff Burst Cycle Length Min Burst Cycle Length ms Number of Bursts Stimuli Add Stimuli per Burst High Voltage Therapy Ramp Burst Scan 1 or 2 schemes per zone ATP While Charging ATP Prior to Charging Off 50 300 bpm Adaptive Readaptive or Fixed 50 400 in increments of 5 15 with 2 20 Stimuli On Off High Voltag
129. ardia Cycle Count Yes Bradycardia Trigger Yes Asystole duration Trigger Yes EGM Storage 48 minutes Patient Trigger Yes Programmable Auto Activation Yes Programmable Activity Response Inhibit Monitor Off Noise Response Inhibit Diagnostics Episodal Diagnostics Yes Heart Rate Histogram Yes Mean Heart Rate No Remote Monitoring Transtelephonic monitoring TTM Patient Activator PA Battery powered PA Model DM2100A Connectivity depends upon country and use of a compatible receiver unit Please contact your St Jude Medical sales representative for more details N ul o M H 0 Customer Support 46 8 474 4756 Brief Summary Prior to using these devices please review the Instructions for Use for a complete listing of n y indications contraindications warnings precautions potential adverse events and directions for use Devices depicted may not be available in all countries Check with your St Jude Medical representative for product availability UO in your country Unless otherwise noted indicates that the name is a trademark of or licensed to St Jude uL y Medical or one of its subsidiaries ST JUDE MEDICAL the nine squares symbol and MORE CONTROL LESS RISK mn are registered and unregistered trademarks and service marks of St Jude Medical Inc and its related companies S M B y 2011 St Jude Medical Inc All rights reserved uon T U DE E D ICA
130. are system safeguards Vibratory patient notifier enables patients with hearing problems to be alerted to a low battery lead related complications and more Merlin home Transmitter Compatible DeFT Response technology offers the most noninvasive options for managing high DFTs The SenseAbility feature provides the flexibility to fine tune programming around T wave oversensing without decreasing sensitivity Automatic daily high voltage lead integrity test is designed to ensure optimal patient safety Ordering Information Contents Cardiac pulse generator Model Dimensions Connector Connector Number H x Wx T mm Weight g Volume cc Defibrillation Sense Pace CD1211 36 76 x 50 x 14 79 42 DF1 IS 1 CD1211 36Q 74 x 50x 14 79 Al DF4 DF4 Indications The devices are intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias Contraindications Contraindications for use of the pulse generator system include ventricular tachyarrhythmias resulting from transient or correctable factors such as drug toxicity electrolyte imbalance or acute myocardial infarction Adverse Events Implantation of the pulse generator system like that of any other device involves risks some possibly life threatening These include but are not limited to the following acute hemorrhage bleeding air emboli arrhythmia acceleration cardiac or venous perfor
131. aries ST JUDE MEDICAL the nine squares symbol and MORE CONTROL LESS RISK are registered and unregistered trademarks and service marks of St Jude Medical Inc and its related companies 2011 St Jude Medical Inc All rights reserved Item GMCRM781EN fibrillator ICD Devices Post Therapy Pacing independently programmable from Bradycardia and ATP Post Shock Pacing Mode Post Shock Base Rate min Post Shock Pacing Duration min Device Testing Induction Methods Off AAI VVI DDI DDD 30 100 in increments of 5 Off 0 5 1 2 5 5 7 5 or 10 DC Fibber Pulse Duration sec Burst Fibber Cycle Length ms Noninvasive Programmed Stimulation NIPS Patient Notifiers 0 5 5 0 20 100 2 25 stimuli with up to 3 extrastimuli Programmable Notifiers On Off Device Parameter Reset Entry into Backup VVI Mode Vibration Duration sec Number of Vibrations per Notification Number of Notifications Time Between Notifications hours Electrograms and Diagnostics Device at ERI Charge Time Limit Reached Possible HV Circuit Damage Atrial Lead Impedance Out of Range Ventricular Lead Impedance Out of Range High Voltage Lead Impedance Out of Range AT AF Burden V Rate During AT AF Backup VVI Long AT AF Episode On On 2 4 6 8 10 12 14 16 2 1 16 10 22 Stored Electrograms Therapy Summary Episodes Summary Lifetime Diagnostics AT AF Burden Trend Ventricular HV Lead Impedanc
132. aries ST JUDE MEDICAL the nine squares symbol and MORE CONTROL LESS RISK are registered and unregistered trademarks and service marks of St Jude Medical Inc and its related companies 2011 St Jude Medical Inc All rights reserved Item GMCRM776EN Rate Modulated Rate Responsive AV PV Delay Rate Responsive PVARP VREF Shortest PVARP VREF Sensor Max Sensor Rate min Threshold Slope Reaction Time Recovery Time Off Low Medium High Off Low Medium High 125 475 in steps of 25 On Off Passive 80 150 in steps of 5 160 180 in steps of 10 Auto 0 5 Auto 4 0 0 Auto 0 5 Auto 1 0 Auto 1 5 Auto 2 0 1 7 in steps of 0 5 Auto 1 Auto 0 Auto 1 Auto 2 Auto 3 1 16 Very Fast Fast Medium Slow Fast Medium Slow Very Slow AF Management AF Suppression Algorithm Off On Lower Rate Overdrive min 10 Upper Rate Overdrive min7 5 5 No of Overdrive Pacing Cycles 15 40 in steps of 5 Rate Recovery ms 8 12 Auto Mode Switch AMS Base Rate min Stored Electrograms 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 40 170 in steps of 5 Options Priority Options Channel Triggers Advanced Hysteresis AMS Entry AMS Exit AMS Entry and Exit AT AF Detection Magnet Response High Atrial Rate Rate mir No of Consecutive Cycles High Ventricular Rate Rate mir No of Consecutive
133. aries ST JUDE MEDICAL the nine squares symbol and MORE CONTROL LESS RISK are registered and unregistered trademarks and service marks of St Jude Medical Inc and its related companies 2011 St Jude Medical Inc All rights reserved Item GMCRM827EN mem ST JU EEE DE MEDICAL MORE CONTROL LESS RISK Connectivity Merlin Pacing System Analyzer PSA Product Highlights Provides confidence and control at implant by quickly delivering accurate measurements for optimal lead positioning and a streamlined implant Connects directly to the Merlin Patient Care System delivering a seamless intuitive interface Fast parameter programming and switching speed Able to display on external monitors Independent atrial right ventricular and left ventricular channels Continuously displayed measurements on a beat by beat basis Dedicated current of injury display Ordering Information Model Number Part Number Description EX3100 100002300 Merlin Pacing System Analyzer PSA Merlin PSA accessories Model Number Part Number Description EX3160 100031916 Merlin storable pouch EX3170 100015290 For use with Medtronic style disposable cables Models 4051 and 4061 EX3180 100015301 For use with Medtronic 2292 re sterilisable cable EX3190 100019848 USB to RF antenna 4051 1020752 001 Disposable Threshold Cable Medtronic connector 4053A 5070142 101 Non Disposable Adapter to threshold cable Medtronic connector 416
134. ary Prior to using these devices please review the Instructions for Use for a complete listing of indications contraindications warnings precautions potential adverse events and directions for use Devices depicted may not be available in all countries Check with your St Jude Medical representative for product availability in your country Unless otherwise noted indicates that the name is a trademark of or licensed to St Jude Medical or one of its subsidiaries ST JUDE MEDICAL the nine squares symbol and MORE CONTROL LESS RISK are registered and unregistered trademarks and service marks of St Jude Medical Inc and its related companies 2011 St Jude Medical Inc All rights reserved histotoxic reactions infection keloid formation myocardial irritability nerve damage pneumothorax thromboemboli venous occlusion Other possible adverse effects include mortality due to component failure device programmer communication failure lead abrasion lead dislodgment or poor lead placement lead fracture inability to defibrillate inhibited therapy for a ventricular tachycardia interruption of function due to electrical or magnetic interference shunting of energy from defibrillation paddles system failure due to ionising radiation Other possible adverse effects include mortality due to inappropriate delivery of therapy caused by multiple counting of cardiac events including T waves P waves or supplemental pacemaker stimuli Among
135. ary Modes Rate Adaptive Sensor Programmable Rate and Delay Parameters DDD R DDI R DOO R VVI R VOO R AAI R AOO R Off DDD DDI VVI AAI AAT AAT R DOO V00 A00 On Off Passive Off Base Rate min Rest Rate min Maximum Tracking Rate min Maximum Sensor Rate min Paced AV Delay ms Sensed AV Delay ms Rate Responsive AV Delay Pulse Amplitude Atrial RV V Pulse Width Atrial and RV ms Hysteresis Rate min Rate Hysteresis with Search QuickOpt Timing Cycle Optimisation Sensed Paced AV delay Auto Mode Switch AMS DDD R DDI R DOO R VVI R VOO R AAI R AOO R Atrial Tachycardia Detection Rate min 110 300 AMS Base Rate min Auto PMT Detection Termination Rate Responsive PVARP VREF 40 45 135 Atrial Pace Off Passive Off Low Medium High Ventricular Intrinsic Preference VIP Off 50 200 50 150 in increments of 25 160 200 in increments of 10 Customer Support 46 8 474 4756 Brief Summary Prior to using these devices please review the Instructions for Use for a complete listing of indications contraindications warnings precautions potential adverse events and directions for use Devices depicted may not be available in all countries Check with your St Jude Medical representative for product availability in your country Unless otherwise noted indicates that the name is a trademark of or licensed to St Jude Medical or one of its subsidi
136. associated with the use of any pacing system arrhythmia heart block thrombosis threshold elevation valve damage pneumothorax myopotential sensing vessel damage air embolism body rejection phenomena cardiac tamponade or perforation formation of fibrotic tissue local tissue reaction inability to interrogate or program a device because of programmer malfunction infection interruption of desired device function due to electrical interference loss of desired pacing and or sensing due to lead displacement body reaction at electrode interface or lead malfunction fracture or damage to insulation loss of normal device function due to battery failure or component malfunction device migration pocket erosion or hematoma pectoral muscle stimulation and phrenic nerve or diaphragmatic stimulation The following in addition to the above are potential complications associated with the use of rate modulated pacing systems inappropriate rapid pacing rates due to sensor failure or to the detection of signals other than patient activity loss of activity response due to sensor failure and palpitations with high rate pacing Refer to the User s Manual for more detailed indications contraindications warnings precautions and potential adverse events tT mem ST JUDE MEDICAL MORE CONTROL LESS RISK Accent MRI DR Dual Chamber Pacemaker Product Specifications Model Telemetry Dimensions mm Weight g Volume cc
137. ation cardiogenic shock cyst formation erosion exacerbation of heart failure extrusion fibrotic tissue growth fluid accumulation hematoma formation histotoxic reactions infection keloid formation myocardial irritability nerve damage pneumothorax Customer Support 46 8 474 4756 Brief Summary Prior to using these devices please review the Instructions for Use for a complete listing of indications contraindications warnings precautions potential adverse events and directions for use Devices depicted may not be available in all countries Check with your St Jude Medical representative for product availability in your country Unless otherwise noted indicates that the name is a trademark of or licensed to St Jude Medical or one of its subsidiaries ST JUDE MEDICAL the nine squares symbol and MORE CONTROL LESS RISK are registered and unregistered trademarks and service marks of St Jude Medical Inc and its related companies 2011 St Jude Medical Inc All rights reserved thromboemboli venous occlusion Other possible adverse effects include mortality due to component failure device programmer communication failure lead abrasion lead dislodgment or poor lead placement lead fracture inability to defibrillate inhibited therapy for a ventricular tachycardia interruption of function due to electrical or magnetic interference shunting of energy from defibrillation paddles system failure due to ionising radia
138. ations contraindications warnings precautions and potential adverse events ST JUDE MEDICAL MORE CONTROL LESS RISK 5 EN 7 GMCRM7Z7 Implantable Cardiove Product Specifications Models Telemetry Delivered Stored Energy J Volume cc Weight g Size mm Defibrillation Lead Connections Sense Pace Lead Connections High Voltage Can PARAMETER D2215 36 CD2215 360 RF RF 36 42 36 42 42 A 80 80 77x50x14 74x50x14 DFI DF4 IS 1 IS 1 Electrically active titanium can Electrically active titanium can SETTINGS AF Management AF Suppression Pacing No of Overdrive Pacing Cycles Maximum AF Suppression Rate Sensing Detection On Off 15 40 in steps of 5 80 150 min SenseAbilit Technology Threshold Start Decay Delay Ventricular Sense Refractory ms Detection Zones SVT Discriminators Reconfirmation Antitachycardia Pacing Therapy Automatic Sensitivity Control adjustment for atrial and ventricular events Post Sensed Atrial 50 62 5 75 100 Post Paced Atrial 0 2 3 0 mV Post Sensed Ventricular 50 62 5 75 100 Post Paced Ventricular Auto 0 2 3 0 mV Post Sense Post Pace Atrial Ventricular 0 220 25 157 VT 1 VT 2 VF AV Rate Branch Sudden Onset Interval Stability Morphology Discrimination MD with Manual or Automatic Template Update Continuous sensing during charging ATP Configurations Burst Cycle Length Min Burst Cycle
139. ations associated with individual modes refer to the programmer s on screen help Potential Adverse Events The following are potential complications associated with the use of any pacing system air embolism body rejection phenomena cardiac tamponade or perforation hematoma bleeding hematoma seroma formation of fibrotic tissue local tissue reaction inability to interrogate or program due to programmer or device malfunction infection erosion interruption of desired pulse generator function due to electrical interference either electromyogenic or electromagnetic lead malfunction due to conductor fracture or insulation degradation loss of capture or sensing due to lead dislodgement or reaction at the electrode tissue interface loss of desired pacing and or sensing due to lead displacement body reaction at electrode interface or lead malfunction fracture or damage to insulation loss of normal device function due to battery failure or component malfunction pacemaker migration or pocket erosion pectoral muscle or diaphragmatic stimulation phrenic nerve stimulation pneumothorax hemothorax endocarditis excessive bleeding induced atrial or ventricular arrhythmias myocardial irritability pericardial effusion pericardial rub pulmonary edema rise in threshold and exit block valve damage cardiac coronary sinus dissection cardiac coronary sinus perforation coronary sinus or cardiac vein thrombosis Refer to the User s Manual for
140. available in all countries Check with your St Jude Medical representative for product availability o in your country Unless otherwise noted indicates that the name is a trademark of or licensed to St Jude Medical or one of its subsidiaries ST JUDE MEDICAL the nine squares symbol and MORE CONTROL LESS RISK are registered and unregistered trademarks and service marks of St Jude Medical Inc and its related companies o 2011 St Jude Medical Inc All rights reserved Item GMCRM782EN ST JUDE MEDICAL MORE CONTROL LESS RISK DEFIBRILLATION LEADS St Jude Medical Defibrillation Leads St Jude Medical defibrillation leads have been designed to provide the highest level of safety All of our defibrillation leads feature Optim insulation which enables an abrasion resistant thin diameter lead Additional design features help prevent tissue ingrowth and redundant conductors provide an added measure of security LLL mem ST JUDE MEDICAL 558 MORE CONTROL LESS RISK Defibrillation Leads Durata Defibrillation Lead Product Highlights a RR The DF4 connector is designed to simplify implants by streamlining defibrillation connections into a single terminal pin and reducing the number of set screws Redundant conductors serve as a backup system in the unlikely event of a conductor failure Symmetrically aligned cables within the lead body and centrally located coil provide for additional
141. cal Inc and its related companies 2011 St Jude Medical Inc All rights reserved Weight g 22 12 0 5 IS 1 Volume cc Connector Device MRI symbol Adverse Events The following are potential complications associated with the use of any pacing system arrhythmia heart block thrombosis threshold elevation valve damage pneumothorax myopotential sensing vessel damage air embolism body rejection phenomena cardiac tamponade or perforation formation of ibrotic tissue local tissue reaction inability to interrogate or program a device because of programmer malfunction infection interruption of desired device function due to electrical interference loss of desired acing and or sensing due to lead displacement body reaction at electrode interface or lead malfunction fracture or damage to insulation loss of normal device function due to battery failure or component malfunction device migration pocket erosion or hematoma pectoral muscle stimulation and phrenic nerve or diaphragmatic stimulation The following in addition to the above are potential complications associated with the use of rate modulated pacing systems inappropriate rapid pacing rates due to sensor failure or 0 the detection of signals other than patient activity loss of activity response due to sensor failure and alpitations with high rate pacing Refer to the User s Manual for more detailed indications contraindications warnings precautions a
142. cal or one of its subsidiaries ST JUDE MEDICAL the nine squares symbol and MORE CONTROL LESS RISK are registered and unregistered trademarks and service marks of St Jude Medical Inc and its related companies 2011 St Jude Medical Inc All rights reserved ST JUDE MEDICAL MORE CONTROL LESS RISK Tendril STS Pacing Lead Product Specifications Model 2088TC Minimum Introducer Size 6F Type of Lead Active fixation bipolar steroid eluting endocardial pacing lead Lead Connector IS 1 bipolar Lead Lengths 46 52 58cm Fixation Mechanism Extendable Retractable helix Typical Number of Rotations for Helix Extension 6 11 straight stylet Lead Body Diameter 1 9 mm max Tip to Ring Spacing 10 mm Lead Tip Electrode Cathode Active titanium nitride coated Pt Ir helix 2 0 mm extension Tip Electrode Surface Area 6 9 mm Ring Electrode Anode Titanium nitride coated Pt Ir Ring Electrode Surface Area 16 mm Mapping Capable with titanium nitride coated Pt Ir helix Steroid lt 1 mg dexamethasone sodium phosphate Inner Conductor Outer Conductor MP35N coil Inner Insulation Silicone rubber Outer Insulation Optim lead insulation Lead Body Coating Fast Pass coating In Pack Straight stylets 1 x soft in lead 1 x soft 1 soft J curved stylets 2 soft Helix extension retraction clip on tools 2 clip on tools Accessory Kits Available Separately Model Number Compatible Lengths Description St
143. cardioversion 3 St Jude Medical DF4 lead connectors conform to the international connector standard ISO 27186 2010 E defibrillation therapy to the heart A transvenous lead system may offer the patient the benefit of avoiding a thoracotomy for lead implantation If the initial lead configuration is not effective repositioning of the lead or other lead configurations should be attempted In some patients a nonthoracotomy lead configuration may not provide reliable conversion of arrhythmias and the use of subcutaneous or epicardial patch defibrillation leads should be considered Potential Complications Possible complications of the use of transvenous lead systems include but are not limited to supraventricular or ventricular arrhythmias conduction disturbances cardiac perforation cardiac tamponade loss of contractility air embolism heart wall rupture myocarditis post operative heart failure chronic mechanical stimulation of the heart tricuspid valve dysfunction lead fracture necessitating surgical removal pneumothorax hemothorax infection tissue necrosis and erosion of the skin Specific events and Contraindications Contraindications for use of the Durata leads with an implantable pulse generator include effects are summarised below ventricular tachyarrhythmias resulting from transient or reversible factors such as drug toxicity electrolyte imbalance or acute myocardial infarction Transvenous lead systems are contraindicated fo
144. cated in patients with an implanted cardioverter defibrillator Rate Adaptive Pacing may be inappropriate for patients who experience angina or other symptoms of myocardial dysfunction at higher sensor driven rates An appropriate Maximum Sensor Rate should be selected based on assessment of the highest stimulation rate tolerated by the patient AF Suppression Models 5826 5820 only stimulation is not recommended in patients who cannot tolerate high atrial rate stimulation Refer to the User s Manual for detailed indications contraindications warnings precautions and potential adverse events Customer Support 46 8 474 4756 Brief Summary Prior to using these devices please review the Instructions for Use for a complete listing of indications contraindications warnings precautions potential adverse events and directions for use Devices depicted may not be available in all countries Check with your St Jude Medical representative for product availability in your country Unless otherwise noted indicates that the name is a trademark of or licensed to St Jude Medical or one of its subsidiaries ST JUDE MEDICAL the nine squares symbol and MORE CONTROL LESS RISK m are registered and unregistered trademarks and service marks of St Jude Medical Inc and its related companies HUN ST JUDE ME DICAL EEE 2011 St Jude Medical Inc All rights reserved MORE CONTROL LESS RISK E 4 GMCRMB8 1 Ze
145. cautions potential adverse events and directions for use Devices depicted may not be available in all countries Check with your St Jude Medical representative for product availability in your country Unless otherwise noted indicates that the name is a trademark of or licensed to St Jude Medical or one of its subsidiaries ST JUDE MEDICAL the nine squares symbol and MORE CONTROL LESS RISK are registered and unregistered trademarks and service marks of St Jude Medical Inc and its related companies 2011 St Jude Medical Inc All rights reserved Item GMCRM817EN Pace ers Other Lead Monitoring Off Monitor Auto Polarity Switch Aor V Low Impedance Limit Q 2005 Aor V High Impedance Limit Q 750 1000 1250 1500 1750 2000 Aor V Signal Amplitude Monitoring Off On Magnet Response Off Battery Test Lead Type Uncoded Unipolar Bipolar Only Unipolar Bipolar NIPS Options Stimulation Chamber Atrial or Ventricular Coupling Interval ms 100 800 in steps of 10 S1 Count 1 25 in steps of 1 S15 2 3 and S4 Cycle ms 100 800 in steps of 10 Sinus Node Recovery Delay sec 1 5 in steps of 1 1 x 0 5 cc 2 The actual pacing rate for the 30 ppm is 31 ppm 3 The highest available setting for Hysteresis Rate will be 5 ppm below the programmed Base Rate 4 Sensitivity is with respect to a 20 ms haversine test signal 5 This parameter is not programmable 6 S1 Burst Cycle is applied at the preprogrammed S1 cycle length
146. cessories CPS Direct PL Peelable Outer Guide Catheter Product Highlights Unique SiteMark tungsten marker stripes provide superior fluoroscopic visibility to verify torque transfer Compatible with CPS Aim inner catheter and CPS Luminary bideflectable catheter with lumen to modify shape and extend reach if necessary EvenPeel stripes provide more smooth and reliable peeling for worry free sheath removal M Ordering In formation Included sheath with hemostasis valve attached dilator and 2 valve bypass tools Model Number 410210 410211 410212 410213 410214 410215 410216 410224 410217 410218 410219 410220 410221 410222 410223 410225 Separately Available Accessories Model Number 410194 410195 410190 Curve Shape Straight OC STR Multipurpose OC MP 115 OC 115 135 OC 135 Wide OC W Extra Wide OC XW Right Sided OC R 145 OC 145 Straight OC STR Multipurpose OC MP 115 OC 115 135 OC 135 Wide OC W Extra Wide OC XW Right Sided OC R 145 OC 145 OC Name Available Length cm 47 47 47 47 47 47 47 47 54 54 54 54 54 54 54 54 LUCCI OC MP OC 115 CPS Direct PL Valve Bypass Tool Pack of 2 CPS Direct PL Inner Catheter SafeSheath Sealing Adapter CPS Implant Kit Includes Needle Syringe and 0 035 Guidewire Customer Support 46 8 474 4756 Brief Summary Prior to using these devices please review t
147. coded Unipolar Bipolar Only Unipolar Bipolar Off Battery Test Off 10 to 110 in steps of 10 Atrial Ventricular 100 800 in steps of 10 1 25 in steps of 1 100 800 in steps of 10 Off 30 40 45 50 55 60 65 70 75 80 85 90 95 1 2 3 4 5 Off 10 Beats gt PMT Auto Detect 90 150 in steps of 5 160 180 in steps of 10 Off A Pace on PVC PVARP on PVC VDD mode only Off On Off On Off 50 150 in steps of 25 160 200 in steps of 10 30 sec 1 3 5 10 30 min 1 2 3 Off On 1 0 5cc Rate Responsive AV Delay Off Low Medium High 2 This parameter is not programmable Rate Responsive PVARP VREF Off Low Medium High 3 The actual pacing rate for the 30 min is 31 min Reaction Time Very Fast Fast Medium Slow 4 The highest available setting for Hysteresis Rate will be 5 min 1 below the programmed Base Rate Recovery Time Fast Medium Slow Very Slow 5 In dual chamber modes the maximum Ventricular Refractory Period is 325 ms Sensor On Off Passive 6 Values 0 1 0 4 not available in a Unipolar Sense Configuration Shortest PVARP VREF 120 350 in steps of 10 7 Sensitivity is with respect to a 20 ms haversine test signal Slope Auto 1 Auto 0 Auto 1 Auto 2 Auto 3 8 During atrial NIPS in tual chamber modes the shortest Coupling Interval will be limited by the programmed AV PV delay 1 16 in steps of 1 9 S1 Burst Cycle is applied at the preprogrammed S1 cycle length Threshold Auto 0 5
148. communications System WCDMA advanced receiver on UMTS 800 850 1900 2100 MHz bands 364 3 56 HSDPA High Speed Downlink Packet Access Bands HSUPA High Speed Uplink Packet Access 800 850 1900 2100 MHz WCDMA Power class 3 24dBm 3 756 HSOPA High Speed OFDM Packet Access 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 AG LTE Long Term Evolution Wimax IT network project Worldwide Interoperability for Microwave Access Antenna Diversity Support 800 850 1900 2100 MHz Bold items are supported by the St Jude Medical USB Cellular Adapter Environmental Operating Temperature 0 to 45 Celsius Storage Temperature 40 to 85 Celsius Brief Summary Prior to using these devices please review the Instructions for Use for a complete listing of indications contraindications warnings precautions potential adverse events and directions for use Devices depicted may not be available in all countries Check with your St Jude Medical representative for product availability in your country Unless otherwise noted indicates that the name is a trademark of or licensed to St Jude Medical or one of its subsidiaries ST JUDE MEDICAL the nine squares symbol and MORE CONTROL LESS RISK are registered and unregistered trademarks and service marks of St Jude Medical Inc and its related companies 2011 St Jude Medical Inc All rights reserved EEE Item GMCRM919EN GMC
149. ctions for use Devices depicted may not be available in all countries Check with your St Jude Medical representative for product availability in your country Unless otherwise noted indicates that the name is a trademark of or licensed to St Jude Medical or one of its subsidiaries ST JUDE MEDICAL the nine squares symbol and MORE CONTROL LESS RISK are registered and unregistered trademarks and service marks of St Jude Medical Inc and its related companies 2011 St Jude Medical Inc All rights reserved ST JUDE MEDICAL MORE CONTROL LESS RISK OptiSense Pacing Lead Product Specifications Model 1999 Minimum Introducer Size TF ype of Lead Active fixation bipolar steroid eluting endocardial atrial pacing lead Lead Connector IS 1 bipolar Lead Lengths 40 46 52cm Fixation Mechanism Extendable Retractable helix Lead Body Diameter 0 076 1 9 mm 5 8 F ip to ring Spacing 1 1 mm Lead Tip Electrode Cathode Active titanium nitride coated Pt Ir helix 1 8 mm extension ip Electrode Surface Area 6 4 mm Ring Electrode Anode Titanium nitride coated titanium ring Ring Electrode Surface Area 17 mm Mapping Capable with titanium nitride coated Pt Ir helix Steroid lt 1 mg dexamethasone sodium phosphate nner Conductor Outer Conductor MP35N coil nner Insulation Silicone rubber Outer Insulation Optim lead insulation Lead Body Coating Fast Pass coating In Pack Straight Stylets 1 x soft in lead 1 x s
150. d MORE CONTROL LESS RISK are registered and unregistered trademarks and service marks of St Jude Medical Inc and its related companies 2011 St Jude Medical Inc All rights reserved Item GMCRM917EN nisation Therapy CRT Devices Post Therapy Pacing Independently programmable from Bradycardia and ATP Post Shock Pacing Mode Post Shock Base Rate min Post Shock Pacing Duration min Device Testing Induction Methods Off AAI VVI DDI or DDD 30 100 in increments of 5 Off 0 5 1 2 5 5 7 5 or 10 DC Fibber Pulse Duration sec Burst Fibber Cycle Length ms Noninvasive Programmed Stimulation NIPS Patient Notifiers 0 5 5 0 20 100 2 25 stimuli with up to three extrastimuli Programmable Notifiers On Off Device Parameter Reset Entry into Backup VVI Mode Vibration Duration sec Number of Vibrations per Notification Number of Notifications Time Between Notifications hours Electrograms and Diagnostics Device at ERI Charge Time Limit Reached Possible HV Circuit Damage Atrial Lead Impedance Out of Range RV Lead Impedance Out of Range LV Lead Impedance Out of Range High Voltage Lead Impedance Out of Range AT AF Burden On On 2 4 6 8 10 12 14 16 2 16 0 22 Stored Electrograms Therapy Summary Episodes Summary Lifetime Diagnostics AT AF Burden Trend Ventricular HV Lead Impedance Trend Histograms PMT Data Real Time Measurements RTM LV fir
151. d degree AV block recurrent Adams Stokes syndrome symptomatic bilateral bundle branch block when contraindicated in patients who have demonstrated compromise of AV conduction tachyarrhythmia and other causes have been ruled out Atrial Pacing is indicated for patients with sinus node dysfunction and normal AV and intraventricular conduction systems Ventricular Pacing is indicated for For specific contraindications associated with individual modes see the programmer s on screen help patients with significant bradycardia and Normal sinus rhythm with only rare episodes of A V block or sinus Potential Adverse Events Arrhythmia heart block thrombosis threshold elevation valve damage arrest chronic atrial fibrillation severe physical disability AF Suppression Models PM2134 and PM2136 pneumothorax myopotential sensing vessel damage air embolism body rejection phenomena cardiac only is indicated for suppression of paroxysmal or persistent atrial fibrillation episodes in patients with one tamponade or perforation formation of fibrotic tissue local tissue reaction inability to interrogate or program or more of the above pacing indications For specific indications associated with individual modes refer to the a pulse generator because of programmer malfunction infection interruption of desired pulse generator programmer s on screen help function due to electrical interference loss of desired pacing and or sensing due to lead displacement
152. d signal amplitudes ST Histogram Data ST Deviation Trend ST Episode Log On Off 8 18 days r gzg 5 QHR is a trademark of Greatbatch LTD 8 EN ra Customer Support 46 8 474 4756 7 Brief Summary Prior to using these devices please review the Instructions for Use for a complete listing of indications contraindications warnings precautions potential adverse events and directions for use Devices depicted may not be available in all countries Check with your St Jude Medical representative for product availability in your country Unless otherwise noted indicates that the name is a trademark of or licensed to St Jude Medical or one of its subsidiaries ST JUDE MEDICAL the nine squares symbol and MORE CONTROL LESS RISK are registered and unregistered trademarks and service marks of St Jude Medical Inc and its related companies 2011 St Jude Medical Inc All rights reserved Item GMCRM778EN ST JUDE MEDICAL MORE CONTROL LESS RISK Implantable Fortify DR Dual Chamber Implantable Cardioverter Defibrillator ICD Product Highlights ShockGuard technology with DecisionTx programming designed to reduce inappropriate therapy and minimise the need for programming adjustments at implant Unique 40 J delivered energy safety shock option can provide a greater DFT safety margin Cardioverter Defibrillator ICD Devices The DF4 connector is designed to simplify implants
153. d stimulation rates concurrent with physical activity Dual Chamber Pacing is indicated for those patients exhibiting sick sinus syndrome chronic symptomatic second and third degree AV block recurrent Adams Stokes syndrome symptomatic bilateral bundle branch block when tachyarrhythmia and other causes have been ruled out Atrial Pacing is indicated for patients with sinus node dysfunction and normal AV and intraventricular conduction systems Ventricular Pacing is indicated for patients with significant bradycardia and normal sinus rhythm with only rare episodes of A V block or sinus arrest chronic atrial fibrillation severe physical disability AF Suppression is indicated for suppression of paroxysmal or persistent atrial fibrillation episodes in patients with one or more of the above pacing indications Contraindications Implanted Cardioverter Defibrillator ICD Devices are contraindicated in patients with an implanted cardioverter defibrillator Rate Adaptive Pacing may be inappropriate for patients who experience angina or other symptoms of myocardial dysfunction at higher sensor driven rates An appropriate Maximum Sensor Rate should be selected based on assessment of the highest stimulation rate tolerated by the patient AF Suppression stimulation is not recommended in patients who cannot tolerate high atrial rate stimulation Dual Chamber Pacing though not contraindicated for patients with chronic atrial flutter chronic atrial fibrillat
154. d trademarks and service marks of St Jude Medical Inc and its related companies 2011 St Jude Medical Inc All rights reserved Weight g 23 5 Connector IS 1 Volume cc 10 4 x 0 5 Dual Chamber Pacing Models 5826 5820 only though not contraindicated for patients with chronic atrial flutter chronic atrial fibrillation or silent atria may provide no benefit beyond that of single chamber pacing in such patients Single Chamber Ventricular Demand Pacing is relatively contraindicated in patients who have demonstrated pacemaker syndrome have retrograde VA conduction or suffer a drop in arterial blood pressure with the onset of ventricular pacing Single Chamber Atrial Pacing is relatively contraindicated in patients who have demonstrated compromise of AV conduction For specific contraindications associated with individual modes refer to Operating Modes Potential Adverse Events Adverse events associated with the use of any pacing system include Air embolism Bleeding Hematoma Body rejection phenomena Cardiac tamponade or perforation Formation of fibrotic tissue local tissue reaction Inability to interrogate or program due to programmer or device malfunction Infection erosion Interruption of desired pulse generator function due to electrical interference either electromyogenic or electromagnetic Lead malfunction due to conductor fracture or insulation degradation Loss of capture or sensing due to lead dislodgement or r
155. d unregistered trademarks and service marks of St Jude Medical Inc and its related companies 2011 St Jude Medical Inc All rights reserved GMCRMS S9 ST JUDE MEDICAL MORE CONTROL LESS RISK Item GMCRM921EN Remote Care Merlin net Patient Care Network PCN Version 5 0 Product Highlights Merlin net PCN version 5 0 from St Jude Medical allows more efficient remote management of patients with implanted cardiac devices including pacemakers implantable cardioverter defibrillators and cardiac resynchronization therapy devices One screen Follow up allows clinicians to view print schedule export and archive from the Recent Transmissions page This feature also saves time and simplifies follow ups by allowing clinicians to take action on up to 50 patient files at once DirectAlerts Notification is a physician notification system that provides physician designated patient alerts between follow ups Mobile DirectAlerts Notification allows alert triggered EGMs and reports to be viewed directly on a smartphone notifications are sent with a doctor s individualised security stamp Patients now have a new way to connect from home for remote follow ups and monitoring with Merlin net PCN Wi Fi Connectivity Alerts generated from the device based CorVue Congestion Monitoring feature which measures intrathoracic impedance in multiple vectors for improved accuracy are displayed options f
156. d with the use of Tendril MRI leads are the same as with may be indicated in the presence of an abnormal surgically altered or excised atrial appendage the use of other active fixation leads and include perforation of the myocardium cardiac tamponade phrenic This j MR Conditional lead nerve stimulation dislodgement of the pacing lead embolism temporary or permanent loss of stimulation susan ONION eat and or sensing infection valve and or vessel damage tissue necrosis MR Conditional Pacing System The St Jude Medical MRI conditional lead is part of the St Jude Medical MRI Refer to the User s Manual for more detailed indications contraindications warnings precautions and conditional pacing system Patients with an implanted St Jude Medical MRI conditional pacing system can have an MRI scan if the conditions for use as described in the MRI Procedure Information document are met potential adverse events Customer Support 46 8 474 4756 Brief Summary Prior to using these devices please review the Instructions for Use for a complete listing of indications contraindications warnings precautions potential adverse events and directions for use Devices depicted may not be available in all countries Check with your St Jude Medical representative for product availability in your country Unless otherwise noted indicates that the name is a trademark of or licensed to St Jude Medical or one of its subsidiaries ST JUDE M
157. device function due to battery failure or component fibrillation episodes in patients with one or more of the above pacing indications Contraindications Dual chamber pulse generators are contraindicated in patients with an implanted cardioverter defibrillator ICD Rate adaptive pacing may be inappropriate for patients who experience angina or other symptoms of myocardial dysfunction at higher sensor driven rates An appropriate Maximum Sensor Rate should be selected based on assessment of the highest stimulation rate tolerated by the patient AF Suppression stimulation is not recommended in patients who cannot tolerate high atrial rate stimulation Dual chamber pacing though not contraindicated for patients with chronic atrial flutter chronic atrial Customer Support 46 8 474 4756 Brief Summary Prior to using these devices please review the Instructions for Use for a complete listing of indications contraindications warnings precautions potential adverse events and directions for use Devices depicted may not be available in all countries Check with your St Jude Medical representative for product availability in your country Unless otherwise noted indicates that the name is a trademark of or licensed to St Jude Medical or one of its subsidiaries ST JUDE MEDICAL the nine squares symbol and MORE CONTROL LESS RISK are registered and unregistered trademarks and service marks of St Jude Medical Inc and its related co
158. dications contraindications warnings precautions potential adverse events and directions for use Devices depicted may not be available in all countries Check with your St Jude Medical representative for product availability in your country Unless otherwise noted indicates that the name is a trademark of or licensed to St Jude Medical or one of its subsidiaries ST JUDE MEDICAL the nine squares symbol and MORE CONTROL LESS RISK are registered and unregistered trademarks and service marks of St Jude Medical Inc and its related companies 2011 St Jude Medical Inc All rights reserved thromboemboli venous occlusion Other possible adverse effects include mortality due to component failure device programmer communication failure lead abrasion lead dislodgment or poor lead placement lead fracture inability to defibrillate inhibited therapy for a ventricular tachycardia interruption of function due to electrical or magnetic interference shunting of energy from defibrillation paddles system failure due to ionising radiation Other possible adverse effects include mortality due to inappropriate delivery of therapy caused by multiple counting of cardiac events including T waves P waves or supplemental pacemaker stimuli Among the psychological effects of device implantation are imagined pulsing dependency fear of inappropriate pulsing and fear of losing pulse capability Refer to the User s Manual for detailed indic
159. dium High Very Fast Fast Medium Slow Fast Medium Slow Very Slow On Off Passive 120 350 in steps of 10 170 Auto 1 Auto 4 0 Auto 1 Auto 2 Auto 3 1 16 in steps of 1 Auto 0 5 Auto 0 0 Auto 4 0 5 Auto 1 0 Pace ers AF Management AF Suppression Algorithm Off On Lower Rate Overdrive min 10 Upper Rate Overdrive min 52 No of Overdrive Pacing Cycles 15 40 in steps of 5 Rate Recovery ms 8 12 Maximum AF Suppression Rate min Atrial Tachycardia Detection Rate min Auto Mode Switch AMS Base Rate min Stored Electrograms 80 150 in steps of 5 160 180 in steps of 10 110 150 in steps of 5 160 200 in steps of 10 225 300 in steps of 25 180 Off DDDR to DDIR DDD to DDI VDDR to VVIR VDD to VVI DDDR to DDI DDD to DDIR VDDR to VVI VDD to VVIR DDIR Base Rate 0 to Base Rate 35 in steps of 5 Base Rate 20 Options Sampling Options No of Stored EGMs Channel Triggers Advanced Hysteresis AMS Entry AMS Exit AT AF Detection Magnet Placement High Atrial Rate No of Consecutive Cycles High Ventricular Rate No of Consecutive Cycles Freeze Continuous 1 2 4 8 12 Atrial Ventricular Dual Cross Channel On Off On Off On Off On Off Off 125 150 175 200 225 250 275 300 2 3 4 5 10 15 20 Off 125 150 175 200 225 250 275 300 2 3 4 5 10 15 20 PMT Termination On Off PVC Detection On Off No of Consecutive P
160. dy rejection phenomena cardiac tamponade or perforation formation of fibrotic tissue local tissue reaction inability to interrogate or program a device because of programmer malfunction infection interruption of desired device function due to electrical interference loss of desired pacing and or sensing due to lead displacement body reaction at electrode interface or lead malfunction fracture or damage to insulation loss of normal device function due to battery failure or component malfunction device migration pocket erosion or hematoma pectoral muscle stimulation and phrenic nerve or diaphragmatic stimulation The following in addition to the above are potential complications associated with the use of rate modulated pacing systems inappropriate rapid pacing rates due to sensor failure or to the detection of signals other than patient activity loss of activity response due to sensor failure and palpitations with high rate pacing Refer to the User s Manual for more detailed indications contraindications warnings precautions and potential adverse events ST JUDE MEDICAL MORE CONTROL LESS RISK Pace Accent MRI SR Single Chamber Pacemaker with Wireless Telemetry Product Specifications ers PHYSICAL SPECIFICATIONS Stored Electrograms Off Low High 12 3 Off Low High Off Low High 125 300 in steps of 25 2 3 4 5 10 15 20 Off Low High Off Low High Model PM12
161. e AF Suppression Algorithm Lower Rate Overdrive mir Upper Rate Overdrive min 1 No of Overdrive Pacing Cycles Rate Recovery ms Maximum AF Suppression Rate mim Atrial Tachycardia Detection Rate min Auto Mode Switch AMS Base Rate min Stored Electrograms Off On 10 53 15 40 in steps of 5 8 123 80 150 in steps of 5 160 180 in steps of 10 110 200 in steps of 10 225 300 in steps of 25 Off DDD R to DDI R DDD R to VVI R VDD R to VVI R 40 170 in steps of 5 Options Priority Options Off Low Hig Channel 1 2 3 Triggers Advanced Hysteresis Off Low Hig AMS Entry AMS Exit AMS Entry and Exit Off Low Hig AT AF Detection Off Low Hig Magnet Response Off Low Higl High Atrial Rate Off Low Hig Rate mir 125 300 in steps of 25 No of Consecutive Cycles 2 3 4 5 10 15 20 High Ventricular Rate Off Low Hig Rate mir 125 300 in steps of 25 No of Consecutive Cycles 2 3 4 5 10 15 20 PMT Termination Off Low Hig Consecutive PVCs Off Low Hig No of Consecutive PVCs 2 3 4 5 Noise Reversion Off Low Hig Other A and V Lead Monitoring Monitor Auto Polarity Switch Aand V Low Impedance Limit Q Aand V High Impedance Limit Q Lead Type Magnet Response Negative AV Hysteresis Search ms NIPS Options Stimulation Chamber Coupling Interval ms 1 Count SI S2 S3 and S4 Cycle ms Ventricular Support Rate min Sinus Node Recovery Delay sec
162. e Lead Impedance R Wave V Threshold 30 120 bpm in steps of 5 bpm Programmable Notifiers On Off nee T Device Reset Sab Entry into Backup VVI Mode 0 ms Audible Duration sec Number of Audible Alerts per Notification V Pulse Amplitude V V Pulse Width ms V Sensitivity mV V Pulse Configuration V Sense Configuration Ventricular AutoCapture Pacing System Primary Pulse Configuration Backup Pulse Configuration Backup Pulse Amplitude V Search Interval hours SenseAbility Technology Max Sensitivity mV Threshold Start Decay Delay ms Rate Modulated Parameters Number of Notifications 25 4 0 in steps of 0 25 4 5 7 5 in steps of 0 5 Time Between Notifications hours 05 0 1 1 5 in steps of 0 1 5 5 0 in steps of 0 5 6 10 in steps of 1 0 12 54 nipolar tip case Bipolar tip ring nipolar Tip tip case Bipolar tip ring Unipolar Ring ring case 1 x 0 5 cc 5 This parameter is not programmable On Off nipolar Bipolar nipolar Bipolar 5 05 8 24 Off On Automatic Sensitivity Control adjustment for ventricular events 0 2 2 0 in steps of 0 1 Ventricular Post Sense 50 62 5 75 100 Ventricular Post Pace Auto 0 2 3 0 in steps of 0 1 mV Ventricular Post Sense 0 30 60 95 125 160 190 220 Ventricular Post Pace Auto 0 30 60 95 125 160 190 220 Maximum Sensor Rate min Rate Responsive VREF Shortest VREF Reaction Time Recovery Time S
163. e cc 35 35 Weight g 76 75 Device Testing Induction Methods Size mm 74x40x14 71x40x14 DC Fibber Pulse Duration sec 0 5 5 0 Defibrillation Lead Connections DF1 DFA Burst Fibber Cycle Length ms 20 100 Sense Pace Lead Connections IS 1 DF4 High Voltage Can PARAMETER Electrically active titanium can Electrically active titanium can SETTINGS Noninvasive Programmed Stimulation NIPS Patient Notifiers 2 25 stimuli with up to three extrastimuli AF Management Programmable Notifiers On Off Device at ERI Charge Time Limit Reached Possible HV Circuit Damage AF Suppression Pacin On Off Atrial Lead Impedance Out of Range Ventricular Lead Impedance Out No rii Pacin x cles 15 40 in steps of 5 of Range High Voltage Lead Impedance Out of Range AT AF Burden Hakimin AF Su la 80 150 d V Rate During AT AF V pacing CorVue Congestion Trigger Fe Device Parameter Reset On Sensing Detection i Entry into Backup VVI Mode On SenseAbility Technology Automatic Sensitivity Control adjustment for atrial and ventricular events Vibration Duration sec 2 4 6 8 10 12 14 16 Low Frequency Attenuation On Off Number of Vibrations per Notification 2 hreshold Start Post Sensed Atrial 50 62 5 75 100 Number of Notifications 1 16 Post Paced Atrial 0 2 3 0 mV Time Between Notifications hours 10 22 Post Sensed Ventricular 50 62 5 75 100 Electrograms and Diagnostics Decay Dela BAT RU 0 220 Stored Electrogram
164. e Alerts per Notification Number of Notifications Time Between Notifications hours Device at ERI Atrial Lead Impedance Out of Range Ventricular Lead Impedance Out of Range LV Lead Impedance Out of Range AT AF Burden AT AF Episode Duration High V Rate During AT AF On On 2 4 6 8 10 12 14 16 2 1 16 10 22 EBEN mem ST JUDE MEDICAL ann MORE CONTROL LESS RISK Cardiac Resynchronisation Therapy CRT Frontier Il Cardiac Resynchronisation Therapy Pacemaker Product Highlights QuickOpt Timing Cycle Optimisation provides quick and effective AF optimization at the touch of a button Continuous Biventricular Pacing 8 JUDE MEDICAL Sytner CA USA FRONTER L 5596 DODRV S N 884186 AF Suppression algorithm helps control atrial rhythm and maintains AV synchrony Negative AV PV Hysteresis is designed to ensure biventricular pacing by temporarily shortening the AV PV delay upon sensing ventricular activity DDT Biventricular Trigger Mode provides triggered pacing in the presence of intrinsic R waves or PVCs to help promote biventricular pacing Mode Switch Base Rate helps manage ventricular activity during AF episodes Exclusive AF Suppression Algorithm is clinically proven to reduce AF burden and improve quality of life AT AF Burden Trend provides weekly count of the percent of time in AF and identifies long term trends for device or drug ma
165. e Output Mode Waveform RV Polarity Electrode Configuration Bradycardia Pacing Fixed Pulse Width Fixed Tilt Biphasic Monophasic Cathode Anode RV to Can RV to SVC Can Permanent Modes Temporary Modes Rate Adaptive Sensor Programmable Rate and Delay Parameters Auto Mode Switch AMS AMS Detection Rate min Customer Support 46 8 474 4756 Off DDD R DDT R DDI R VVT R VVI R AAI R Off DDD R DDT R DDI R VVT R VVI R AAI R AAT DOO V00 A00 On Off Passive Off Base Rate min Rest Rate min Maximum Tracking Rate min Maximum Sensor Rate min Paced AV Delay ms Sensed AV Delay ms Rate Responsive AV Delay Pulse Amplitude Atrial RV and LV V Pulse Width Atrial RV and LV ms Hysteresis Rate min Rate Hysteresis with Search Off DDI R DDT R VVI R VVT R 110 300 Brief Summary Prior to using these devices please review the Instructions for Use for a complete listing of indications contraindications warnings precautions potential adverse events and directions for use Devices depicted may not be available in all countries Check with your St Jude Medical representative for product availability in your country Unless otherwise noted indicates that the name is a trademark of or licensed to St Jude Medical or one of its subsidiaries ST JUDE MEDICAL the nine squares symbol and MORE CONTROL LESS RISK are registered and unregistered trade
166. e Switch AMS AMS Detection Rate min Atrial Tachycardia Base Rate Auto PMT Detection Termination Rate Responsive PVARP VREF Off DDD R DDT R DDI R VVT R VVI R AAK R Off DDD R DDT R DDI R VVT R VVI R AAI R AAT DOO V00 A00 On Off Passive Off Base Rate min Rest Rate min Maximum Tracking Rate min Maximum Sensor Rate min Paced AV Delay ms Sensed AV Delay ms Rate Responsive AV Delay Pulse Amplitude Atrial RV and LV V Pulse Width Atrial RV and LV ms Hysteresis Rate min Rate Hysteresis with Search Off DDI R DDT R VVI R VVT R 110 300 40 45 135 A Pace on PMT Off Passive Off Low Medium High Ventricular Intrinsic Preference VIP Off 50 200 50 150 in increments of 25 160 200 in increments of 10 LV Cap Confirm RV Cap Confirm ACap Confirm Customer Support 46 8 474 4756 Setup On Monitor Off On Monitor Off Brief Summary Prior to using these devices please review the Instructions for Use for a complete listing of indications contraindications warnings precautions potential adverse events and directions for use Devices depicted may not be available in all countries Check with your St Jude Medical representative for product availability in your country Unless otherwise noted indicates that the name is a trademark of or licensed to St Jude Medical or one of its subsidiaries ST JUDE MEDICAL the nine squares symbol an
167. e Trend Histograms PMT Data Real Time Measurements RTM Up to 45 minutes including up to 1 minute programmable pre trigger data per VT VF diagnosis detection electrograms triggers include diagnosis therapy atrial episode PMT termination PC shock delivery noise reversion magnet reversion and morphology template verification Diagram of therapies delivered Directory listing of up to 60 episodes with access to more details including stored electrograms History of bradycardia events and device initiated charging Trend data and counts Multi Vector Trend Data Event Histogram AV Interval Histogram Mode Switch Duration Histogram Peak Filtered Rate Histogram Atrial Heart Rate Histogram Ventricular Heart Rate Histogram AT AF Burden Exercise and Activity Trending V Rates during AMS Information regarding PMT detections Pacing lead impedances high voltage lead impedances unloaded battery voltage and signal amplitudes ST JUDE MEDICAL MORE CONTROL LESS RISK Implantable Cardioverter Defibrillator ICD Devices Current VR Single Chamber Implantable Cardioverter Defibrillator ICD Product Highlights The DF4 connector is designed to simplify implants by streamlining defibrillation connections into a single terminal pin and reducing the number of set screws Triple redundancy safety platform is designed to minimise risk and increase security and patient comfort through multiple hardware and softw
168. eaction at the electrode tissue interface Loss of desired pacing and or sensing due to lead displacement body reaction at electrode interface or lead malfunction fracture or damage to insulation Loss of normal device function due to battery failure or component malfunction Pacemaker migration pocket erosion or hematoma Pectoral muscle or diaphragmatic stimulation Phrenic nerve stimulation Pneumothorax hemothorax Refer to the User s Manual for detailed indications contraindications warnings precautions and potential adverse events LLL mem ST JUDE MEDICAL EEE MORE CONTROL LESS RISK MI 5 GMCRMB8 1 Lr Zephyr XL SR Single Chamber Rate Responsive Pacemaker Product Specifications Model Dimensions mm Weight g Volume cc Connector 5626 42x52x6 23 5 10 4 IS 1 PARAMETER Rate Timing SETTINGS Aor V Refractory ms Base Rate bpm Mode Hysteresis Rate bpm Search Interval bpm Cycle Count Intervention Rate bpm Intervention Duration min Recovery Time Rest Rate bpm Output Sensing 125 500 in steps of 25 307 40 130 in steps of 5 140 170 in steps of 10 A00 R AAI R AAT R 0A0 VOO R VVI R VVT R Off 30 130 in steps of 5 140 150 Off 5 10 15 30 1 16 by 1 Off 60 80 120 in steps of 10 Intrinsic 0 Intrinsic 10 Intrinsic 20 Intrinsic 30 1 10 in 1 minute intervals Fast Medium Slow Very Slow Off 30 130 in steps
169. ease review the Instructions for Use for a complete listing of es y indications contraindications warnings precautions potential adverse events and directions for use Devices depicted may not be available in all countries Check with your St Jude Medical representative for product availability O in your country Unless otherwise noted indicates that the name is a trademark of or licensed to St Jude uL y Medical or one of its subsidiaries ST JUDE MEDICAL the nine squares symbol and MORE CONTROL LESS RISK m are registered and unregistered trademarks and service marks of St Jude Medical Inc and its related companies S M B 9 2011 St Jude Medical Inc All rights reserved EGE T UDE E DICAL EEE Item GMCRM798EN MORE CONTROL LESS RISK Cardiac Resynchronisation Therapy CRT Devices Promote Quadra Cardiac Resynchronisation Therapy Defibrillator CRT D Product Highlights The Promote Quadra CRT D and Quartet quadripolar LV pacing lead feature four pacing electrodes and 10 pacing vectors to provide more options and greater control to minimise implant complications such as diaphragmatic stimulation and high pacing thresholds VectSelect Quartet programmable LV pulse configuration 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 Merlin home
170. eck with your St Jude Medical representative for product availability in your country Unless otherwise noted indicates that the name is a trademark of or licensed to St Jude Medical or one of its subsidiaries ST JUDE MEDICAL the nine squares symbol and MORE CONTROL LESS RISK are registered and unregistered trademarks and service marks of St Jude Medical Inc and its related companies 2011 St Jude Medical Inc All rights reserved Item GMCRM824EN GMCRM 8 2 ST JUDE MEDICAL MORE CONTROL LESS RISK Tendril ST Optim Pacing Lead Product Highlights Optim lead insulation a chemical co polymer that blends the best features of polyurethane and silicone for improved handling and increased durability Pacing Leads Thin lead body to provide ease of passage and a small venous space Active mapping collar enables threshold measurements prior to extending the helix to save time at implant Ventricular straight or atrial J shaped active fixation options Ordering Information Contents Cardiac pacing lead Model Type of Number Lead Insulation Fixation 1888TC Straight Optim Ext Ret Helix 1882TC Atrial J Optim Ext Ret Helix Indications The Tendril ST Optim lead is designed for permanent sensing and pacing in either the atrium or the ventricle in combination with a compatible pulse generator An active lead such as the Tendril ST Optim may be indicated for patients where pe
171. ed in patients who Are expected to be hypersensitive to a single dose of 1 0 mg of dexamethasone sodium phosphate Are unable to undergo an emergency thoracotomy procedure Have coronary venous vasculature that is inadequate for lead placement as indicated by venogram Customer Support 46 8 474 4756 Brief Summary Prior to using these devices please review the Instructions for Use for a complete listing of indications contraindications warnings precautions potential adverse events and directions for use Devices depicted may not be available in all countries Check with your St Jude Medical representative for product availability in your country Unless otherwise noted indicates that the name is a trademark of or licensed to St Jude Medical or one of its subsidiaries ST JUDE MEDICAL the nine squares symbol and MORE CONTROL LESS RISK a are registered and unregistered trademarks and service marks of St Jude Medical Inc and its related companies HUN ST JUDE ME DICAL EEE 2011 St Jude Medical Inc All rights reserved MORE CONTROL LESS RISK Left Heart Leads QuickFlex u Left Heart Lead Product Specifications PHYSICAL SPECIFICATIONS MODEL 1258T Parameter Description Connector IS 1 Bipolar Lead Length 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 Introducer Size Minimum 5 F ID Minimum S Curve Height 16 mm Tip
172. ef Summary Prior to using these devices please review the Instructions for Use for a complete listing of es Y indications contraindications warnings precautions potential adverse events and directions for use Devices depicted may not be available in all countries Check with your St Jude Medical representative for product availability UO in your country Unless otherwise noted indicates that the name is a trademark of or licensed to St Jude uL y Medical or one of its subsidiaries ST JUDE MEDICAL the nine squares symbol and MORE CONTROL LESS RISK mn are registered and unregistered trademarks and service marks of St Jude Medical Inc and its related companies S M B y 2011 St Jude Medical Inc All rights reserved uon T U DE E D ICAL Item GMCRM897EN MORE CONTROL LESS RISK Implantable Cardiac Monitors SJM Confirm Implantable Cardiac Monitor Model DM2102 Product Highlights Accurately detects atrial fibrillation AF and rhythm disturbances Implantable patient activated and automatically activated monitoring system that records subcutaneous ECGs and is indicated in the following cases Patients who have been previously diagnosed with AF or who are susceptible to developing AF Patients with clinical syndromes or situations at increased risk of cardiac arrhythmias Patients who experience transient symptoms that may suggest a cardiac arrhythmia Offers si
173. elay ms 25 30 200 in steps of 10 225 300 in steps of 25 350 Base Rate min 30 130 in steps of 5 140 170 in steps of 10 Options Far Field Protection Interval ms 16 Priority Options Off Low High Hysteresis Rate min Off 30 150 in steps of 5 Channel h 3 Search Interval min Off 1 5 10 15 30 Triggers Cycle Count 1 16 in steps of 1 Advanced Hysteresis Off Low High Intervention Rate min Off Same as Base Rate 80 120 in steps of 10 Intrinsic 0 AMS Entry AMS Exit Intrinsic 10 Intrinsic 20 Intrinsic 30 AMS Entry and Exit Off Low High Intervention Duration min 1 10 in 1 minute intervals AT AF Detection Off Low High Recovery Time Fast Medium Slow Very Slow Magnet Response Off Low High Maximum Tracking Rate min 90 130 in steps of 5 140 180 in steps of 10 High Atrial Rate Off Low High Mode AO0 R AAI R AAT R VOO R VVI R Rate mirr 125 300 in steps of 25 VVT R VDD R DOO R DVI R DDI R No of Consecutive Cycles 2 3 4 5 10 15 20 DDD R Pacing Off High Ventricular Rate Off Low High Post Ventricular Atrial Blanking ms 60 200 in steps of 10 225 250 Rate min 125 300 in steps of 25 PVARP ms 125 500 in steps of 25 No of Consecutive Cycles 2 3 4 5 10 15 20 Sensed AV Delay ms 25 30 200 in steps of 10 225 325 in steps of 25 PMT Termination Off Low High Rest Rate min Off 30 150 in steps of 5 Consecutive PVCs Off Low High Shortest AV Delay ms 25 50 in ste
174. emarks and service marks of St Jude Medical Inc and its related companies 2011 St Jude Medical Inc All rights reserved Item GMCRM823EN ST JUDE MEDICAL MORE CONTROL LESS RISK IsoFlex Optim Pacing Lead Product Highlights Pacing Leads Straight or J shaped lead is available in multiple lengths to accommodate varying needs and patient anatomies Optim lead insulation a chemical co polymer that blends the best features of polyurethane and silicone provides improved handling and increased durability Symmetrical lead body with coaxial multifilar coils for reliability Steroid eluting tip for reduced inflammation at the lead tissue interface and low pacing thresholds Small tip surface area for higher impedance levels and optimal device longevity Titanium nitrade TIN coated tip and ring electrode for low polarization values and compatibility with the AutoCapture Pacing System algorithm Radiopaque suture sleeve for visibility under fluoroscopy to simplify invasive procedures Ordering Information Contents Cardiac pacing lead Model Number Insulation Fixation Min Introducer F Connector Lengths cm 1944 J Shaped Optim Tines 7 IS 1 bipolar 46 52 1948 Straight Optim Tines 7 IS 1 bipolar 46 52 58 Indications The IsoFlex lead is designed for permanent sensing and pacing in the atrium with a compatible pulse generator An active lead such as the IsoFlex may be indicated for
175. ensor Slope Threshold 80 150 in steps of 5 160 180 in steps of 10 Off Low Medium High 125 475 in steps of 25 Very Fast Fast Medium Slow Fast Medium Slow Very Slow On Off Passive Auto 1 Auto 0 Auto 1 Auto 2 Auto 3 1 16 in steps of 1 Auto 0 5 Auto 0 0 Auto 0 5 Auto 1 0 Auto 1 5 Auto 2 0 1 7 in steps of 0 5 Device at ERI Ventricular Lead Impedance Out of Range On On 2 4 6 8 10 12 14 16 2 1 16 10 22 2 Programming options dependent on pacing mode 3 The highest available setting for hysteresis rate will be 5 min below the programmed base rate 4 Sensitivity is with respect to a 20 ms haversine test signal 6 S1 Burst Cycle is applied at the preprogrammed S1 cycle length Customer Support 46 8 474 4756 Brief Summary Prior to using these devices please review the Instructions for Use for a complete listing of indications contraindications warnings precautions potential adverse events and directions for use Devices depicted may not be available in all countries Check with your St Jude Medical representative for product availability in your country Unless otherwise noted indicates that the name is a trademark of or licensed to St Jude Medical or one of its subsidiaries ST JUDE MEDICAL the nine squares symbol and MORE CONTROL LESS RISK are registered and unregistered trademarks and service marks of St Jude Medical Inc and its related com
176. ensor Rate should be selected based on assessment of the highest stimulation rate tolerated by the patient Single chamber ventricular demand pacing is relatively contraindicated in patients who have demonstrated pacemaker syndrome have retrograde VA conduction or suffer a drop in arterial blood pressure with the onset of ventricular pacing Single chamber atrial pacing is relatively contraindicated in patients who have demonstrated compromise of AV conduction Customer Support 46 8 474 4756 Brief Summary Prior to using these devices please review the Instructions for Use for a complete listing of indications contraindications warnings precautions potential adverse events and directions for use Devices depicted may not be available in all countries Check with your St Jude Medical representative for product availability in your country Unless otherwise noted indicates that the name is a trademark of or licensed to St Jude Medical or one of its subsidiaries ST JUDE MEDICAL the nine squares symbol and MORE CONTROL LESS RISK are registered and unregistered trademarks and service marks of St Jude Medical Inc and its related companies 2011 St Jude Medical Inc All rights reserved Adverse Events The following are potential complications associated with the use of any pacing system arrhythmia heart block thrombosis threshold elevation valve damage pneumothorax myopotential sensing vessel damage air embolism bo
177. ent markers that precede and follow a specific triggering event can be programmed to automatically record up to 14 minutes of stored EGMs when encountering one or more programmable trigger options Weekly lead impedance trend displays the current measurement historical test Pacemakers PMIZI0 Merlin home Transmitter Compatible results pacing polarity and any polarity switches Ordering Information Contents Cardiac pulse generator Model Number PM1210 Dimensions H x W x T mm Indications Implantation is indicated in one or more of the following permanent conditions syncope presyncope fatigue disorientation due to arrhythmia bradycardia or any combination of those symptoms Rate Modulated Pacing is indicated for patients with chronotropic incompetence and for those who would benefit from increased stimulation rates concurrent with physical activity Atrial Pacing is indicated for patients with sinus node dysfunction and normal AV and intraventricular conduction systems Ventricular Pacing is indicated for patients with significant bradycardia and normal sinus rhythm with only rare episodes of A V block or sinus arrest chronic atrial fibrillation severe physical disability Contraindications Single chamber pulse generators are contraindicated in patients with an implanted cardioverter defibrillator Rate Adaptive Pacing may be inappropriate for patients who experience angina or other symptoms of myocardial
178. ential Adverse Events The following are potential complications associated with the use of any pacing system arrhythmia heart block thrombosis threshold elevation valve damage pneumothorax myopotential sensing vessel damage air embolism body rejection phenomena cardiac tamponade or perforation formation of fibrotic tissue local tissue reaction inability to interrogate or program a device because of programmer malfunction infection interruption of desired device function due to electrical interference loss of desired pacing and or sensing due to lead displacement body reaction at electrode interface or lead malfunction fracture or damage to insulation loss of normal device function due to battery failure or component malfunction device migration pocket erosion or hematoma pectoral muscle stimulation phrenic nerve or diaphragmatic stimulation The following in addition to the above are potential complications associated with the use of rate modulated pacing systems inappropriate rapid pacing rates due to sensor failure or to the detection of signals other than patient activity loss of activity response due to sensor failure palpitations with high rate pacing Refer to the User s Manual for detailed indications contraindications warnings precautions and potential adverse events ST JUDE MEDICAL MORE CONTROL LESS RISK L 2 1 IM GMCRMSB Accent SR RF Single Chamber Pacema
179. er Pacing though not contraindicated for patients with chronic atrial flutter chronic atrial fibrillation or silent atria may provide no benefit beyond that of single chamber pacing in such patients Customer Support 46 8 474 4756 Brief Summary Prior to using these devices please review the Instructions for Use for a complete listing of indications contraindications warnings precautions potential adverse events and directions for use Devices depicted may not be available in all countries Check with your St Jude Medical representative for product availability in your country Unless otherwise noted indicates that the name is a trademark of or licensed to St Jude Medical or one of its subsidiaries ST JUDE MEDICAL the nine squares symbol and MORE CONTROL LESS RISK are registered and unregistered trademarks and service marks of St Jude Medical Inc and its related companies 2011 St Jude Medical Inc All rights reserved Weight g 23 12 8 0 5 IS 1 Volume cc Connector Single Chamber Ventricular Demand Pacing is relatively contraindicated in patients who have demonstrated pacemaker syndrome have retrograde VA conduction or suffer a drop in arterial blood pressure with the onset of ventricular pacing Single Chamber Atrial Pacing is relatively contraindicated in patients who have demonstrated compromise of AV conduction Potential Adverse Events The following are potential complications associated with
180. ere are no contraindications with regards to the use of the Model 3085 for temporary cardiac stimulation for therapy and prevention of arrhythmia The state of health of the patient however can restrict the choice of operational mode and stimulation parameters For example a mode of operation with atrial sensing is not suitable or appropriate when atrial fibrillation occurs This is due to excessive and chaotic frequency of detected fibrillation waves Overdrive stimulation therapy must only be used in the atrium Overdrive stimulation in the ventricle could cause life threatening ventricular fibrillation ST JUDE MEDICAL MORE CONTROL LESS RISK External Pulse Generator Dual Chamber DDD Model 3085 Product Specifications Model Battery Battery Life Alkaline Battery Life Lithium Weight g Size cm 3085 Standard 9 V alkaline or lithium Minimal 10 days VVI standard parameters Minimal 8 days DDD standard parameters Plus 1 day reserve after the first appearance of the battery change message Minimal 19 days VVI standard parameters Minimal 15 days DDD standard parameters Plus 1 day reserve after the first appearance of the battery change message Approximately 490 including battery 20 x 9 6 x 3 8 7 75 in x 4 in x 1 5 in PARAMETER SETTINGS Technology Modes DDD DDD AT DOO DAT DVI DAI VVI VOO VAT AAI A00 AAT VDD Base Pacing Rates ppm 30 220 Upper Pacing Rates MTR pp
181. ers On Off Monitor Bipolar Bipolar 5 0 8 24 0 0 4 0 in steps of 0 25 4 5 7 5 in steps of 0 5 0 05 0 1 1 5 in steps of 0 1 Unipolar tip case Bipolar tip ring Unipolar Tip tip case Bipolar tip ring Unipolar Ring ring case 0 1 0 46 0 5 by 0 1 0 75 2 0 in steps of 0 25 2 0 4 0 in steps of 0 5 5 0 On Off Unipolar Bipolar Unipolar Bipolar 5 02 8 24 50 25 100 70 120 100 0 5 5 0 in steps of 0 5 6 10 in steps of 1 0 12 55 2 0 Maximum Sensor Rate min Rate Responsive AV Delay 80 150 in steps of 5 160 180 in steps of 10 Off Low Medium High AF Suppression Algorithm Lower Rate Overdrive min Upper Rate Overdrive min No of Overdrive Pacing Cycles Rate Recovery ms Maximum AF Suppression Rate min Atrial Tachycardia Detection Rate min Auto Mode Switch AMS Base Rate min Stored Electrograms Off On 10 52 15 40 in steps of 5 8 12 80 150 in steps of 5 160 180 in steps of 10 110 150 in steps of 5 160 200 in steps of 10 225 300 in steps of 25 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 Base Rate 0 to Base Rate 35 in steps of 5 Options Sampling Options No of Stored EGMs Channel Triggers Advanced Hysteresis AMS Entry AMS Exi AT AF Detection Magnet Placement High Atrial Rate No of Consecutive Cycles Freeze Continuous 1 2 4 8 12 Atrial Ve
182. erse events Customer Support 46 8 474 4756 Brief Summary Prior to using these devices please review the Instructions for Use for a complete listing of indications contraindications warnings precautions potential adverse events and directions for use Devices depicted may not be available in all countries Check with your St Jude Medical representative for product availability in your country Unless otherwise noted indicates that the name is a trademark of or licensed to St Jude Medical or one of its subsidiaries ST JUDE MEDICAL the nine squares symbol and MORE CONTROL LESS RISK a are registered and unregistered trademarks and service marks of St Jude Medical Inc and its related companies HUN ST JUDE ME DICAL EEE 2011 St Jude Medical Inc All rights reserved MORE CONTROL LESS RISK Pace ers Zephyr DR Dual Chamber Rate Responsive Pacemaker Product Specifications PHYSICAL SPECIFICATIONS AF Management Model Dimensions mm Weight g Volume cc Connector 5820 43x 4x6 18 8 5 IS 1 PARAMETER Rate Timing SETTINGS Atrial Absolute Refractory Period Atrial Protection Interval ms Paced AV Delay ms Base Rate min Far Field Protection Interval ms Hysteresis Rate min Search Interval min Cycle Count Intervention Rate min Intervention Duration min Recovery Time Maximum Tracking Rate min Mode PVARP ms Post Ventricular Atrial Blan
183. ersion 5 0 through EHRDirect Export to increase clinic efficiency print archive export to EHR export to PC database up to 50 records at a time Remote transmissions and in clinic data available online All patient transmissions and reports available for immediate access for a minimum of seven years Patient data follows patient when changing clinics or when patient receives new device English Spanish French German Italian Japanese Design principles Report format Tracking of reviewed transmissions Transmission status reason for transmission displayed Next transmission column Number of days between transmissions Identify previous user Rapid alert viewing Clinical comments Arrhythmia and device management box Highlight transmissions with alerts Inbox outbox Weekly glance Education Similar to Merlin Patient Care System PCS programmer in colors and design easy to learn for new users Similar to Merlin PCS reports for easy orientation Viewed field on recent transmissions allows quick indication of which reports have already been viewed printing reports option to mark as viewed as well Scheduled alert initiated patient initiated Date and intervals of next scheduled transmission Shown on recent transmissions patient list view schedule and manual schedule pages Placing mouse over transmission time shows previous user Mouse over alerts shows list of alert types and alert episodes Free form clinic
184. es 0 1 0 4 not available in a Unipolar Sense Configuration 7 Sensitivity is with respect to a 20 ms haversine test signal 8 During atrial NIPS in dual chamber modes the shortest Coupling Interval will be limited by the programmed AV PV delay 9 S1 Burst Cycle is applied at the preprogrammed S1 cycle length Auto 4 1 5 Auto 2 0 1 7 in steps of 0 5 Customer Support 46 8 474 4756 Brief Summary Prior to using these devices please review the Instructions for Use for a complete listing of indications contraindications warnings precautions potential adverse events and directions for use Devices depicted may not be available in all countries Check with your St Jude Medical representative for product availability in your country Unless otherwise noted indicates that the name is a trademark of or licensed to St Jude Medical or one of its subsidiaries ST JUDE MEDICAL the nine squares symbol and MORE CONTROL LESS RISK are registered and unregistered trademarks and service marks of St Jude Medical Inc and its related companies 2011 St Jude Medical Inc All rights reserved Item GMCRM874EN EBEN mam ST JUDE MEDICAL MORE CONTROL LESS RISK Sustain XL SR Single Chamber Rate Responsive Pacemaker Product Highlights Device features small physiologic shape and offers superior longevity 12 8 years without compromising size nstant follow up with automatic P or R wave lead impedance measure
185. es that the name is a trademark of or licensed to St Jude Medical or one of its subsidiaries ST JUDE MEDICAL the nine squares symbol and MORE CONTROL LESS RISK EBEN are registered and unregistered trademarks and service marks of St Jude Medical Inc and its related companies HOH ST J l J DE ME DIC TAL EEE 2011 St Jude Medical Inc All rights reserved Item GMCRM913EN MORE CONTROL LESS RISK CONNECTIVITY AND REMOTE CARE Connectivity and Remote Care The intersection of the internet and mobile technologies with innovative medical device therapies has created the ability to advance patient care through remote monitoring and data management Many components are involved in device connectivity the Merlin programmer used in the physician s office to establish and optimise the device settings the Merlin net patient care network that stores device information and makes it accessible via the Internet or transfers the information to an electronic health record the implantable device itself that transmits data remotely using radiofrequency and the Merlin home unit that allows patients to transmit data at home from their device to their physician St Jude Medical offers a completely integrated system designed to provide increased confidence and control greater insight and improved efficiency from implant to follow up LLL msa ST JUDE MEDICAL MORE CONTROL LESS RISK Connectivity Merlin Patien
186. ess otherwise noted indicates that the name is a trademark of or licensed to St Jude Medical or one of its subsidiaries ST JUDE MEDICAL the nine squares symbol and MORE CONTROL LESS RISK are registered and unregistered trademarks and service marks of St Jude Medical Inc and its related companies 2011 St Jude Medical Inc All rights reserved Item GMCRM816EN EBEN mam ST JUDE MEDICAL MORE CONTROL LESS RISK Zephyr XL SR Single Chamber Rate Responsive Pacemaker 9 0 compatwie ST JuDE MEDICAL Syrmar CA USA ZEPHYR XL SR 5626 SSIR S N 123456 Product Highlights Superior longevity when compared volume for volume with any other pacemaker on the market m Instant follow up with automatic P or R wave lead impedance measurements and threshold tests resulting in 100 of follow up completed before the patient arrives at the clinic The AutoCapture pacing system offers the maximum in threshold adaptability and patient safety with ventricular Beat by Beat capture confirmation ACap confirm feature periodically completes a threshold search and adjusts the pulse amplitude accordingly in the atrium Stored electrograms EGMs record a real time EGM waveform as well as the associated event markers that precede and follow a specific triggering event m Automatic daily measurement and weekly trending of intrinsic P or R waves Automatic lead impedance measurement Display of week
187. ff Low Medium High Rate Responsive PVARP VREF Off Low Medium High Reaction Time Recovery Time Customer Support 46 8 474 4756 Very Fast Fast Medium Slow Fast Medium Slow Very Slow Brief Summary Prior to using these devices please review the Instructions for Use for a complete listing of indications contraindications warnings precautions potential adverse events and directions for use Devices depicted may not be available in all countries Check with your St Jude Medical representative for product availability in your country Unless otherwise noted indicates that the name is a trademark of or licensed to St Jude Medical or one of its subsidiaries ST JUDE MEDICAL the nine squares symbol and MORE CONTROL LESS RISK are registered and unregistered trademarks and service marks of St Jude Medical Inc and its related companies 2011 St Jude Medical Inc All rights reserved Item GMCRM737EN Sensor Shortest PVARP VREF ms Slope Threshold AF Management Pace ers On Off Passive 125 475 in steps of 25 Auto 1 Auto 0 Auto 1 Auto 2 Auto 3 1 16 in steps of 1 Auto 0 5 Auto 0 0 Auto 0 5 Auto 1 0 Auto 1 5 Auto 4 2 0 1 7 in steps of 0 5 AF Suppression Algorithm Lower Rate Overdrive min Upper Rate Overdrive min No of Overdrive Pacing Cycles Rate Recovery ms Maximum AF Suppression Rate mir Atrial Tachycardia Detection Rate min
188. formation myocardial irritability nerve damage pneumothorax thromboemboli venous occlusion Other possible adverse effects include mortality due to component failure device programmer communication failure lead abrasion lead dislodgment or poor lead placement lead fracture inability to defibrillate inhibited therapy for a ventricular tachycardia interruption of function due to electrical or magnetic interference shunting of energy from defibrillation paddles system failure due to ionising radiation Other possible adverse effects include mortality due to inappropriate delivery of therapy caused by multiple counting of cardiac events including T waves P waves or supplemental pacemaker stimuli Among the psychological effects of device implantation are imagined pulsing dependency fear of inappropriate pulsing and fear of losing pulse capability Refer to the User s Manual for detailed indications contraindications warnings precautions and potential adverse events ST JUDE MEDICAL MORE CONTROL LESS RISK 9 7 Implantable Cardiove Product Specifications fibrillator ICD Devices PHYSICAL SPECIFICATIONS Post Therapy Pacing Independently programmable from Bradycardia and ATP nl aa adc Post Shock Pacing Mode Off AAI VVI DDI DDD Post Shock Base Rate min 30 100 in increments of 5 Delivered Stored Energy 40 45 20 08 Post Shock Pacing Duration min Off 0 5 1 2 5 5 7 5 or 10 Volum
189. formation document for the St Jude Medical MRI conditional pacing system Rate modulated acing is indicated for patients with chronotropic incompetence and for those who would benefit from increased stimulation rates concurrent with physical activity Dual chamber pacing is indicated for those atients exhibiting sick sinus syndrome chronic symptomatic second and third degree AV block recurrent Adams Stokes syndrome symptomatic bilateral bundle branch block when tachyarrhythmia and other causes ave been ruled out Atrial pacing is indicated for patients with sinus node dysfunction and normal AV and intraventricular conduction systems Ventricular pacing is indicated for patients with significant bradycardia and normal sinus rhythm with only rare episodes of A V block or sinus arrest chronic atrial fibrillation severe hysical disability AF Suppression algorithm is indicated for suppression of paroxysmal or persistent atrial ibrillation episodes in patients with one or more of the above pacing indications Contraindications Dual chamber pulse generators are contraindicated in patients with an implanted cardioverter defibrillator ICD Rate adaptive pacing may be inappropriate for patients who experience angina or other symptoms of myocardial dysfunction at higher sensor driven rates An appropriate Maximum Sensor Rate should be selected based on assessment of the highest stimulation rate tolerated by the patient AF Suppression stimulation is not
190. gation of legacy devices including newer Epic ICDs and Atlas ICDs Customer Support 46 8 474 4756 Brief Summary Prior to using these devices please review the Instructions for Use for a complete listing of indications contraindications warnings precautions potential adverse events and directions for use Devices depicted may not be available in all countries Check with your St Jude Medical representative for product availability in your country Unless otherwise noted indicates that the name is a trademark of or licensed to St Jude Medical or one of its subsidiaries ST JUDE MEDICAL the nine squares symbol and MORE CONTROL LESS RISK are trademarks and service marks of St Jude Medical Inc and its related companies GEMMS is a trademark of Gateway Electronic Medical Management Systems LLC Allscripts is a trademark of Allscripts LLC NextGen is a trademark of NextGen Healthcare Information Systems Inc EpicCare is a trademark of Epic Systems GE Centricity is a trademark of GE Healthcare Paceart is a trademark of Medtronic USA Inc ScottCare is a trademark of ScottCare cardiovascular Solutions IHE is a trademark of Healthcare Information and Management Systems Society Corporation 2011 St Jude Medical Inc All Rights Reserved Item GMCRM91OEN Website Efficiency Batch operation Consolidated data Data storage capabilities Data transfers Languages User Interface Automatic export to EHR is supported by v
191. gnosis of complex ECG rhythms associated with heart failure Ordering Information Contents Cardiac pulse generator Model Number Dimensions H x W x T mm Weight g Volume cc Connector PM3212 58x52x6 25 13 7 IS 1 Indications Implantation of Anthem and Anthem RF devices is indicated for maintaining synchrony of the patients Single Chamber Ventricular Demand Pacing is relatively contraindicated in patients who have left and right ventricles in patients who have undergone an AV nodal ablation for chronic atrial fibrillation demonstrated pacemaker syndrome have retrograde VA conduction or suffer a drop in arterial blood pressure and have NYHA Class Il or Ill heart failure the reduction of the symptoms of moderate to severe heart failure with the onset of ventricular pacing Single Chamber Atrial Pacing is relatively contraindicated in patients NYHA Class III or IV in those patients who remain symptomatic despite stable optimal medical therapy who have demonstrated compromise of AV conduction Atrial Fibrillation Anthem devices are contraindicated and have a left ventricular ejection fraction lt 35 and a prolonged QRS duration implantation of Accent in patients having chronic atrial fibrillation or intermittent atrial fibrillation that does not terminate For Accent RF Anthem and Anthem RF devices is indicated in one or more of the following permanent conditions specific contraindications associated with individual modes refer to the pro
192. grammer s on screen help syncope presyncope fatigue disorientation or any combination of those symptoms Rate Modulated Pacing is indicated for patients with chronotropic incompetence and for those who would benefit from R otential Adverse Events The following are potential complications associated with the use of any pacing increased stimulation rates concurrent with physical activity Dual Chamber Pacing is indicated for those System air embolism body rejection phenomena cardiac tamponade or perforation hematoma bleeding patients exhibiting sick sinus syndrome chronic symptomatic second and third degree AV block recurrent hematoma seroma formation of fibrotic tissue local tissue reaction inability to interrogate or program due to Adams Stokes syndrome symptomatic bilateral bundle branch block when tachyarrhythmia and other causes programmer or device malfunction infection erosion interruption of desired pulse generator function due to have been ruled out Atrial Pacing is indicated for patients with sinus node dysfunction and normal AV and electrical interference either electromyogenic or electromagnetic lead malfunction due to conductor fracture intraventricular conduction systems Ventricular Pacing is indicated for patients with significant bradycardia or insulation degradation loss of capture or sensing due to lead dislodgement or reaction at the electrode and normal sinus rhythm with only rare episode
193. gy safety shock option can provide a greater DFT safety margin Cardioverter Defibrillator ICD Devices ICD The DF4 connector is designed to simplify implants by streamlining defibrillation connections into a single terminal pin and reducing the number of set screws Merlin home Transmitter QHR chemistry battery provides greater capacity for enhanced longevity and Compatible stable charge times Antitachycardia pacing ATP while charging and prior to charging in the VF zone further extends the programming options for terminating tachyarrhythmias without a high voltage shock The low frequency attenuation filter is designed to enhance sensing performance and may reduce the possibility of oversensing T waves DeFT Response technology offers the most noninvasive options for managing high DFTs The SenseAbility feature provides the flexibility to fine tune programming around T wave oversensing without decreasing sensitivity Vibratory patient notifier enables patients with hearing problems to be alerted to a low battery lead related complications and more Ordering Information Contents Cardiac pulse generator Model Dimensions Number H x W x T mm Weight g CD1233 40 73 x 40 x 14 76 CD1233 40Q 71x 40x 14 75 Indications The devices are intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias
194. h a compatible pulse generator An active lead such as the AV Plus DX VDD may be indicated for patients where permanent fixation of passive leads is suspected to be unstable In atrial applications the use of a screw in lead such as the AV Plus DX VDD may be indicated in the presence of an abnormal surgically altered or excised atrial appendage Contraindications The AV Plus DX VDD lead is contraindicated In the presence of tricuspid atresia for patients with mechanical tricuspid valves in patients who are expected to be hypersensitive to a single dose of one milligram of dexamethasone sodium phosphate adverse events Customer Support 46 8 474 4756 Brief Summary Prior to using these devices please review the Instructions for Use for a complete listing of indications contraindications warnings precautions potential adverse events and directions for use Devices depicted may not be available in all countries Check with your St Jude Medical representative for product availability in your country Unless otherwise noted indicates that the name is a trademark of or licensed to St Jude Medical or one of its subsidiaries ST JUDE MEDICAL the nine squares symbol and MORE CONTROL LESS RISK are registered and unregistered trademarks and service marks of St Jude Medical Inc and its related companies 2011 St Jude Medical Inc All rights reserved Adverse Events Potential complications associated with the use
195. he Instructions for Use for a complete listing of indications contraindications warnings precautions potential adverse events and directions for use Devices depicted may not be available in all countries Check with your St Jude Medical representative for product availability in your country Unless otherwise noted indicates that the name is a trademark of or licensed to St Jude Medical or one of its subsidiaries ST JUDE MEDICAL the nine squares symbol and MORE CONTROL LESS RISK are registered and unregistered trademarks and service marks of St Jude Medical Inc and its related companies 2011 St Jude Medical Inc All rights reserved Connector Sense Pace Connector Volume cc Defibrillation 43 DFl IS 1 42 DF4 IS 1 DFA exacerbation of heart failure extrusion fibrotic tissue growth fluid accumulation hematoma formation histotoxic reactions infection keloid formation myocardial irritability nerve damage pneumothorax thromboemboli venous occlusion Other possible adverse effects include mortality due to component failure device programmer communication failure lead abrasion lead dislodgment or poor lead placement lead fracture inability to defibrillate inhibited therapy for a ventricular tachycardia interruption of function due to electrical or magnetic interference shunting of energy from defibrillation paddles system failure due to ionising radiation Other possible adverse effects include morta
196. he Instructions for Use for a complete listing of indications contraindications warnings precautions potential adverse events and directions for use Devices depicted may not be available in all countries Check with your St Jude Medical representative for product sally in your country Unless otherwise noted indicates that the name is a trademark of or licensed to St Ju Medical or one of its subsidiaries ST JUDE MEDICAL the nine squares symbol and MORE CONTROL LESS RISK are registered and unregistered trademarks and service marks of St Jude Medical Inc and its related companies 2011 St Jude Medical Inc All rights reserved Overall Length cm 50 7 50 7 50 7 50 7 50 7 50 7 50 7 50 7 57 7 57 7 57 7 57 7 57 7 57 7 57 7 57 7 OC 145 Inner Diameter F mm 712 44 712 44 712 44 712 44 712 44 712 44 712 44 712 44 712 44 712 44 712 44 712 44 712 44 712 44 712 44 712 44 OC XW Type Valve bypass tool Self sealing valve Implant Kit Outer Diameter F mm 9 3 00 9 3 00 9 3 00 9 3 00 9 3 00 9 3 00 9 3 00 9 3 00 9 3 00 9 3 00 9 3 00 9 3 00 9 3 00 9 3 00 9 3 00 9 3 00 FH ST JUDE MEDICAL MORE CONTROL LESS RISK Accessories CPS Direct SL H Slittable Outer Guide Catheter Product Highlights Integrated hub and hemostasis valve Increased curve retention and optimized catheter body structure for improved kink resistance Soft tip to lessen risk of
197. he ST monitoring diagnostic provides information on significant ST segment changes for improved insight in decision making ShockGuard technology with DecisionTx programming designed to reduce inappropriate therapy and minimise the need for programming adjustments at Cardioverter Defibrillator ICD Devices implant Unique 40 J delivered energy safety shock option can provide a greater DFT Merlin home fet Transmitter seis Han Compatible The DF4 connector is designed to simplify implants by streamlining defibrillation connections into a single terminal pin and reducing the number of set screws QHR chemistry battery provides greater capacity for enhanced longevity and stable charge times Antitachycardia pacing ATP while charging and prior to charging in the VF zone further extends the programming options for terminating tachyarrhythmias without a high voltage shock The low frequency attenuation filter is designed to enhance sensing performance and may reduce the possibility of oversensing T waves DeFT Response technology offers the most noninvasive options for managing high DFTs Vibratory patient notifier enables patients with hearing problems to be alerted to a low battery lead related complications and more The SenseAbility feature provides the flexibility to fine tune programming around T wave oversensing without decreasing sensitivity Ordering Information Contents Cardiac pulse generator Model Di
198. hythmia heart block thrombosis threshold elevation valve damage pneumothorax myopotential sensing vessel damage air embolism body rejection phenomena cardiac tamponade or perforation formation of fibrotic tissue local tissue reaction inability to interrogate or program a pulse generator because of programmer malfunction infection interruption of desired pulse generator function due to electrical interference loss of desired pacing and or sensing due to lead displacement body reaction at electrode interface or lead malfunction fracture or damage to insulation loss of normal pacemaker function due to battery failure or component malfunction pacemaker migration pocket erosion or hematoma pectoral muscle stimulation phrenic nerve or diaphragmatic stimulation Refer to the User s Manual for detailed indications contraindications warnings precautions and potential adverse events depicted may not be available in all countries Check with your St Jude Medical representative for product availability in your country Unless otherwise noted indicates that the name is a trademark of or licensed to St Jude Medical or one of its subsidiaries ST JUDE MEDICAL the nine squares symbol and MORE CONTROL LESS RISK are registered and unregistered trademarks and service marks of St Jude Medical Inc and its related companies 2011 St Jude Medical Inc All rights reserved LLL mam ST JUDE MEDICAL MORE CONTROL LESS
199. ial fibrillation severe physical disability AF Suppression Models 5826 5820 only is indicated for suppression of paroxysmal or persistent atrial fibrillation episodes in patients with one or more of the above pacing indications For specific indications associated with individual modes refer to Operating Modes Contraindications Zephyr devices are contraindicated in patients with an implanted cardioverter defibrillator Rate Adaptive Pacing may be inappropriate for patients who experience angina or other symptoms of myocardial dysfunction at higher sensor driven rates An appropriate Maximum Sensor Rate should be selected based on assessment of the highest stimulation rate tolerated by the patient AF Suppression Models 5826 5820 only stimulation is not recommended in patients who cannot tolerate high atrial rate stimulation Customer Support 46 8 474 4756 Brief Summary Prior to using these devices please review the Instructions for Use for a complete listing of indications contraindications warnings precautions potential adverse events and directions for use Devices depicted may not be available in all countries Check with your St Jude Medical representative for product availability in your country Unless otherwise noted indicates that the name is a trademark of or licensed to St Jude Medical or one of its subsidiaries ST JUDE MEDICAL the nine squares symbol and MORE CONTROL LESS RISK are registered and unregistere
200. ical representative for product availability in your country Unless otherwise noted indicates that the name is a trademark of or licensed to St Jude Medical or one of its subsidiaries ST JUDE MEDICAL the nine squares symbol and MORE CONTROL LESS RISK are registered and unregistered trademarks and service marks of St Jude Medical Inc and its related companies 2011 St Jude Medical Inc All rights reserved thromboemboli venous occlusion Other possible adverse effects include mortality due to component failure device programmer communication failure lead abrasion lead dislodgment or poor lead placement lead fracture inability to defibrillate inhibited therapy for a ventricular tachycardia interruption of function due to electrical or magnetic interference shunting of energy from defibrillation paddles system failure due to ionising radiation Other possible adverse effects include mortality due to inappropriate delivery of therapy caused by multiple counting of cardiac events including T waves P waves or supplemental pacemaker stimuli Among the psychological effects of device implantation are imagined pulsing dependency fear of inappropriate pulsing and fear of losing pulse capability Refer to the User s Manual for detailed indications contraindications warnings precautions and potential adverse events ST JUDE MEDICAL MORE CONTROL LESS RISK EN 7 7 Implantable Cardiove Product
201. ication between Merlin PCS and St Jude Medical implantable devices with RF communication capability 3643 60003605 001 Thermal Paper Customer Support 46 8 474 4756 Brief Summary Prior to using these devices please review the Instructions for Use for a complete listing of indications contraindications warnings precautions potential adverse events and directions for use Devices depicted may not be available in all countries Check with your St Jude Medical representative for product availability in your country Unless otherwise noted indicates that the name is a trademark of or licensed to St Jude Medical or one of its subsidiaries ST JUDE MEDICAL the nine squares symbol and MORE CONTROL LESS RISK are registered and unregistered trademarks and service marks of St Jude Medical Inc and its related companies 2011 St Jude Medical Inc All rights reserved EEE mam ST JUDE MEDICAL MORE CONTROL LESS RISK Customer Support 46 8 474 4756 Brief Summary Prior to using these devices please review the Instructions for Use for a complete listing of indications contraindications warnings precautions potential adverse events and directions for use Devices depicted may not be available in all countries Check with your St Jude Medical representative for product availability in your country Unless otherwise noted indicates that the name is a trademark of or licensed to St Jude Medical or one of its subsidi
202. idiaries ST JUDE MEDICAL the nine squares symbol and MORE CONTROL LESS RISK a are registered and unregistered trademarks and service marks of St Jude Medical Inc and its related companies S M B 2011 St Jude Medical Inc All rights reserved T JUDE E DICAL MORE CONTROL LESS RISK GMCRMB876 EN Sustain XL DC Dual Chamber Pacemaker Product Specifications PHYSICAL SPECIFICATIONS Stored Electrograms Model Dimensions mm Weight g Volume cc Connector PARAMETER Rate Timing PM2134 44x52x6 23 5 1 IS 1 SETTINGS Atrial Absolute Refractory Period Atrial Protection Interval ms Atrial Refractory PVARP ms AV Delay ms Base Rate bpm Far Field Protection Interval ms Hysteresis Rate min Search Interval min Cycle Count Intervention Rate min Intervention Duration min Recovery Time Maximum Tracking Rate min Mode Post Vent Atrial Blanking PVAB ms Rate Responsive AV PV Delay Rate Responsive PVARP VREF Shortest PVARP VREF PV Delay ms Rest Rate min Shortest AV PV Delay ms Ventricular Blanking ms Ventricular Refractory ms Output Sensing 60 80 100 350 in steps of 25 25 25 500 in steps of 25 275 25 30 200 in steps of 10 225 300 in steps of 25 350 200 305 40 130 in steps of 5 140 170 in steps of 10 60 6 Off 30 130 in steps of 5 140 150 Off 5 10 15 30 16 in steps of 1 Off 60 80 120 in steps of 10
203. ied at the pre programmed S1 cycle length Customer Support 46 8 474 4756 Brief Summary Prior to using these devices please review the Instructions for Use for a complete listing of indications contraindications warnings precautions potential adverse events and directions for use Devices depicted may not be available in all countries Check with your St Jude Medical representative for product availability in your country Unless otherwise noted indicates that the name is a trademark of or licensed to St Jude Medical or one of its subsidiaries ST JUDE MEDICAL the nine squares symbol and MORE CONTROL LESS RISK are registered and unregistered trademarks and service marks of St Jude Medical Inc and its related companies 2011 St Jude Medical Inc All rights reserved EBEN mam ST JUDE MEDICAL MORE CONTROL LESS RISK Item GMCRM739EN Pace s Accent MRI SR Single Chamber Pacemaker with Wireless Telemetry Product Highlights The Accent MRI pacemaker has been designed and tested for safe performance of a full body MRI scan without zone restrictions using a 1 5 T Tesla field strength MRI scanner The MRI conditional device m St JUDE MEDICAL Syra CA LBA GENL Mi Allows a maximum whole body averaged specific absorption rate SAR of 4 watts per kilogram W kg for high image resolution Must be used in conjunction with an MRI lead from St Jude Medical An optional
204. ife threatening ventricular arrhythmias Contraindications Contraindications for use of the pulse generator system include ventricular tachyarrhythmias resulting from transient or correctable factors such as drug toxicity electrolyte imbalance or acute myocardial infarction Adverse Events Implantation of the pulse generator system like that of any other device involves risks some possibly life threatening These include but are not limited to the following acute hemorrhage bleeding air emboli arrhythmia acceleration cardiac or venous perforation cardiogenic shock cyst formation erosion exacerbation of heart failure extrusion fibrotic tissue growth fluid accumulation hematoma formation histotoxic reactions infection keloid formation myocardial irritability nerve damage pneumothorax Customer Support 46 8 474 4756 Brief Summary Prior to using these devices please review the Instructions for Use for a complete listing of indications contraindications warnings precautions potential adverse events and directions for use Devices depicted may not be available in all countries Check with your St Jude Medical representative for product availability in your country Unless otherwise noted indicates that the name is a trademark of or licensed to St Jude Medical or one of its subsidiaries ST JUDE MEDICAL the nine squares symbol and MORE CONTROL LESS RISK are registered and unregistered trademarks and service ma
205. igh atrial rate Refer to the User s Manual for detailed indications contraindications warnings precautions and potential stimulation Dual Chamber Pacing though not contraindicated for patients with chronic atrial flutter adverse events chronic atrial fibrillation or silent atria may provide no benefit beyond that of single chamber pacing in such Customer Support 46 8 474 4756 Brief Summary Prior to using these devices please review the Instructions for Use for a complete listing of indications contraindications warnings precautions potential adverse events and directions for use Devices depicted may not be available in all countries Check with your St Jude Medical representative for product availability in your country Unless otherwise noted indicates that the name is a trademark of or licensed to St Jude Medical or one of its subsidiaries ST JUDE MEDICAL the nine squares symbol and MORE CONTROL LESS RISK ann are registered and unregistered trademarks and service marks of St Jude Medical Inc and its related companies S I M i 2011 St Jude Medical Inc All rights reserved EUN JUDE E DICAL MORE CONTROL LESS RISK Product Specifications chronisation Therapy CRT Rate Modulated Model PM3212 Telemetry RF Rate Responsive AV PV Delay Off Low Medium High Dimensions mm 58x52x6 Rate Responsive PVARP VREF Off Low Medium High Weight g 25 Shortest PVARP VREF 125 475 in steps
206. igned specifically for cardiac lead use The innovative insulation material blends the best features of polyurethane and silicone enabling the durability of polyurethane and the flexibility of silicone Options with shorter tip to ring spacing allow for more accurate sensing and appropriate diagnostics and therapies Ventricular straight or atrial J shape active fixation options and multiple lengths offer the flexibility to address the needs of patients with varying physical statures and vascular anatomies Three different J shape stylets and a long tool provide options for atrial lead placement and lead handling preferences Steroid elution and titanium nitride fractal coating on electrodes enable low thresholds LLL mem ST JUDE MEDICAL 558 MORE CONTROL LESS RISK Pacing Leads Tendril MRI Pacing Lead LL Product Highlights The Tendril MRI lead is designed to ensure patient safety while performing an MRI scan The Tendril MRI conditional lead must be used in conjunction with an MRI device from St Jude Medical and with a 1 5 T Tesla MRI scanner Soft silicone tip offers more compliance at the lead tip endocardium interface The soft silicone tip on the Tendril MRI LPA1200M lead reduces tip pressure by approximately 50 over 6 F leads without a soft silicone tip Though the soft silicone increases the surface area of the lead tip to 9 F the Tendril MRI lead still fits through an 8 F introd
207. imal therapy for patients at implant and throughout their lives Industry leading longevity offers 9 4 years of service life which is supported by a 7 year warranty The St Jude Medical MRI conditional pacing system can be scanned in patients under the following conditions horizontal closed bore clinical scanner working in the Normal Operating Mode or First Level Controlled Operating Mode static magnetic field strength of 1 5 Tesla T only maximum gradient slew rate of 200 T m s per axis See manual for additional details before performing an MRI scan AV 2 5 V 0 4 ms 500 ohms 100 DDD pacing 60 bpm AutoCapture Pacing System OFF SEGMs ON Terms and conditions apply refer to the warranty for details Ordering Information Contents Cardiac pulse generator Model Number PM2124 Inductive Dimensions H x W x T mm Weight g 52x53x6 23 Radiopaque markers St Jude Medical identifier Gmbh MRI Volume cc Connector 13 1 x 06 5 IS 1 Device MRI symbol Indications Implantation of a dual chamber pulse generator is indicated in one or more of the following ermanent conditions syncope presyncope fatigue disorientation due to arrhythmia bradycardia or any combination of those symptoms MRI conditional pulse generator is safe for use in the MRI environment when used in a complete MRI conditional pacing system and according to the instructions in the MRI Procedure In
208. in Rate Hysteresis with Search Post Therapy Pacing independently programmable from Bradycardia and ATP Post Shock Pacing Mode Post Shock Base Rate min Post Shock Pacing Duration min Customer Support 46 8 474 4756 Off VVI 30 100 in increments of 5 Off 0 5 1 2 5 5 7 5 or 10 Brief Summary Prior to using these devices please review the Instructions for Use for a complete listing of indications contraindications warnings precautions potential adverse events and directions for use Devices depicted may not be available in all countries Check with your St Jude Medical representative for product availability in your country Unless otherwise noted indicates that the name is a trademark of or licensed to St Jude Medical or one of its subsidiaries ST JUDE MEDICAL the nine squares symbol and MORE CONTROL LESS RISK are registered and unregistered trademarks and service marks of St Jude Medical Inc and its related companies 2011 St Jude Medical Inc All rights reserved Item GMCRM774EN GMCRM 7 and morphology template verification Diagram of therapies delivered Directory listing of up to 60 episodes with access to more details including stored electrograms History of bradycardia events and device initiated charging Multi Vector Trend Data Event Histogram Ventricular Heart Rate Histogram Exercise and Activity Trending Pacing lead impedances high voltage lead impedances unloaded battery
209. ination of those symptoms Rate Modulated Pacing is indicated for patients with chronotropic incompetence and for those who would benefit from increased stimulation rates concurrent with physical activity Dual Chamber Pacing Models PM2134 and PM2136 only is indicated for those patients exhibiting sick sinus syndrome chronic symptomatic second and third degree AV block recurrent Adams Stokes syndrome symptomatic bilateral bundle branch block when tachyarrhythmia and other causes have been ruled out Atrial Pacing is indicated for patients with sinus node dysfunction and normal AV and intraventricular conduction systems Ventricular Pacing is indicated for patients with significant bradycardia and Normal sinus rhythm with only rare episodes of A V block or sinus arrest chronic atrial fibrillation severe physical disability AF Suppression Models PM2134 and PM2136 only is indicated for suppression of paroxysmal or persistent atrial fibrillation episodes in patients with one or more of the above pacing indications For specific indications associated with individual modes refer to the programmer s on screen help Contraindications mplanted Cardioverter Defibrillator ICD Because Sustain pulse generators will be automatically programmed to a unipolar pulse configuration if the device initiates Backup VVI pacing Sustain devices are contraindicated in patients with an implanted cardioverter defibrillator Rate Adaptive Pacing may be inappro
210. insic Preference VIP Off 50 200 50 150 in increments of 25 160 200 in increments of 10 Ventricular AutoCapture On Off Pacing System ACap Confirm On Monitor Off voltage and signal amplitudes CorVue Congestion Monitoring On Off CorVue Congestion Trigger 8 18 days QHR is a trademark of Greatbatch LTD Customer Support 46 8 474 4756 Brief Summary Prior to using these devices please review the Instructions for Use for a complete listing of indications contraindications warnings precautions potential adverse events and directions for use Devices depicted may not be available in all countries Check with your St Jude Medical representative for product availability in your country Unless otherwise noted indicates that the name is a trademark of or licensed to St Jude Medical or one of its subsidiaries ST JUDE MEDICAL the nine squares symbol and MORE CONTROL LESS RISK are registered and unregistered trademarks and service marks of St Jude Medical Inc and its related companies 2011 St Jude Medical Inc All rights reserved Item GMCRM779EN GMCRM 7 ST JUDE MEDICAL MORE CONTROL LESS RISK Implantable Fortify VR Single Chamber Implantable Cardioverter Defibrillator Product Highlights ShockGuard technology with DecisionTx programming designed to reduce inappropriate therapy and minimise the need for programming adjustments at implant Unique 40 J delivered ener
211. interference shunting of energy from defibrillation paddles system failure due to ionising radiation Other possible adverse effects include mortality due to inappropriate delivery of therapy caused by multiple counting of cardiac events including T waves P waves or supplemental pacemaker stimuli Among the psychological effects of device implantation are imagined pulsing dependency fear of inappropriate pulsing and fear of losing pulse capability Refer to the User s Manual for detailed indications contraindications warnings precautions and potential adverse events ST JUDE MEDICAL MORE CONTROL LESS RISK EN 7 GMCRM 76 Product Specifications PHYSICAL SPECIFICATIONS Models Telemetry Delivered Stored Energy J Volume cc Weight g Size mm Defibrillation Lead Connections Sense Pace Lead Connections High Voltage Can CD3235 40 CD3235 400 RF RF 40 45 40 45 36 36 78 71 79x 40x 14 73x 40x 14 DFI DF4 IS 1 IS 1 DF4 Electrically active titanium can Electrically active titanium can PARAMETER Biventricular Pacing SETTINGS V Triggering BiV Trigger Mode On Off QuickOpt Timing Cycle Optimisation Sensed paced AV delay Interventricular Pace delay V V Timing Interventricular Pace Delay ms Ventricular Sensing Ventricular Pacing Chamber Negative AV Hysteresis Search ms Shortest AV Delay ms VectSelect LV Pulse Configuration AF Management Simult
212. ion hematoma formation histotoxic reactions infection keloid formation myocardial irritability nerve damage pneumothorax thromboemboli venous occlusion Other possible adverse effects include mortality due to component failure device programmer communication failure lead abrasion lead dislodgment or poor lead placement lead fracture inability to defibrillate inhibited therapy for a ventricular tachycardia interruption of function due to electrical or magnetic interference shunting of energy from defibrillation paddles system failure due to ionising radiation Other possible adverse effects include mortality due to inappropriate delivery of therapy caused by multiple counting of cardiac events including T waves P waves or supplemental pacemaker stimuli Among the psychological effects of device implantation are imagined pulsing dependency fear of inappropriate pulsing and fear of losing pulse capability Refer to the User s Manual for detailed indications contraindications warnings precautions and potential adverse events tT mem ST JUDE MEDICAL MORE CONTROL LESS RISK brillator Product Specifications PHYSICAL SPECIFICATIONS Models Telemetry Delivered Energy J Volume cc Weight g Size mm Defibrillation Lead Connections LV Lead Connections Sense Pace Lead Connections High Voltage Can D3239 40 D3239 400 RF RF 40 40 46 44 88 87 81x51x14 74x51x14 DF1 DF4 LLHH
213. ion or silent atria may provide no benefit beyond that of single chamber pacing in such Customer Support 46 8 474 4756 Brief Summary Prior to using these devices please review the Instructions for Use for a complete listing of indications contraindications warnings precautions potential adverse events and directions for use Devices depicted may not be available in all countries Check with your St Jude Medical representative for product availability in your country Unless otherwise noted indicates that the name is a trademark of or licensed to St Jude Medical or one of its subsidiaries ST JUDE MEDICAL the nine squares symbol and MORE CONTROL LESS RISK are registered and unregistered trademarks and service marks of St Jude Medical Inc and its related companies 2011 St Jude Medical Inc All rights reserved Weight g Volume cc Connector 25 11 5 0 5 IS 1 patients Single Chamber Ventricular Demand Pacing is relatively contraindicated in patients who have demonstrated pacemaker syndrome have retrograde VA conduction or suffer a drop in arterial blood pressure with the onset of ventricular pacing Single Chamber Atrial Pacing is relatively contraindicated in patients who have demonstrated compromise of AV conduction Atrial Fibrillation Anthem devices are contraindicated in patients having chronic atrial fibrillation or intermittent atrial fibrillation that does not terminate For specific contraindic
214. ior to using these devices please review the Instructions for Use for a complete listing of indications contraindications warnings precautions potential adverse events and directions for use Devices depicted may not be available in all countries Check with your St Jude Medical representative for product availability in your country Unless otherwise noted indicates that the name is a trademark of or licensed to St Jude Medical or one of its subsidiaries ST JUDE MEDICAL the nine squares symbol and MORE CONTROL LESS RISK are registered and unregistered trademarks and service marks of St Jude Medical Inc and its related companies 2011 St Jude Medical Inc All rights reserved External Patient Activator Model DM2100A computers that operate on a wireless network handheld personal computers PDA cellular phones and even cordless telephones may generate enough EMI to interfere with the performance of the activator if it is used too close to the source of EMI Hospital and Medical equipment A variety of standard hospital and medical equipment may generate enough EMI to interfere with the performance of the activator These include but are not limited to blood pressure monitors ECG equipment external defibrillation equipment x ray machines Office equipment A variety of standard office equipment may generate enough EMI to interfere with the performance of the activator These include but are not limited to desktop or
215. ipolar tip ring Unipolar Ring ring case On Off nipolar Bipolar nipolar Bipolar 5 05 8 24 GMCRMSB Brief Summary Prior to using these devices please review the Instructions for Use for a complete listing of indications contraindications warnings precautions potential adverse events and directions for use Devices depicted may not be available in all countries Check with your St Jude Medical representative for product availability in your country Unless otherwise noted indicates that the name is a trademark of or licensed to St Jude Medical or one of its subsidiaries ST JUDE MEDICAL the nine squares symbol and MORE CONTROL LESS RISK are registered and unregistered trademarks and service marks of St Jude Medical Inc and its related companies 2011 St Jude Medical Inc All rights reserved Item GMCRM877EN Stored Electrograms Pace ers Options Sampling Options No of Stored EGMs Channel Triggers Magnet Placement High Atrial Rate No of Consecutive Cycles High Ventricular Rate No of Consecutive Cycles Freeze Continuous 1 2 4 8 12 Atrial or Ventricular On Off Off 125 150 175 200 225 250 275 300 2 3 4 5 10 15 20 Off 125 150 175 200 225 250 275 300 2 3 4 5 10 15 20 Advanced Hysteresis On Off Other Lead Monitoring Off Monitor Auto Polarity Switch Aor V Low Impedance Limit Q Aor V High Impedance Limit Q Aor V Signal Am
216. irections for use Devices depicted may not be available in all countries Check with your St Jude Medical representative for product availability in your country Unless otherwise noted indicates that the name is a trademark of or licensed to St Jude Medical or one of its subsidiaries ST JUDE MEDICAL the nine squares symbol and MORE CONTROL LESS RISK are trademarks and service marks of St Jude Medical Inc and its related companies 2011 St Jude Medical Inc All Rights Reserved Item GMCRM966EN
217. is a trademark of or licensed to St Jude Medical or one of its subsidiaries ST JUDE MEDICAL the nine squares symbol and MORE CONTROL LESS RISK are registered and unregistered trademarks and service marks of St Jude Medical Inc and its related companies 2011 St Jude Medical Inc All rights reserved thromboemboli venous occlusion Other possible adverse effects include mortality due to component failure device programmer communication failure lead abrasion lead dislodgment or poor lead placement lead fracture inability to defibrillate inhibited therapy for a ventricular tachycardia interruption of function due to electrical or magnetic interference shunting of energy from defibrillation paddles system failure due to ionising radiation Other possible adverse effects include mortality due to inappropriate delivery of therapy caused by multiple counting of cardiac events including T waves P waves or supplemental pacemaker stimuli Among the psychological effects of device implantation are imagined pulsing dependency fear of inappropriate pulsing and fear of losing pulse capability Refer to the User s Manual for detailed indications contraindications warnings precautions and potential adverse events ST JUDE MEDICAL MORE CONTROL LESS RISK fibrillator ICD Devices EN 4 7 Product Specifications PHYSICAL SPECIFICATIONS Device Testing Induction Methods Models D1215
218. ith only rare episodes of A V block or sinus arrest chronic atrial fibrillation severe physical disability Contraindications mplanted Cardioverter Defibrillator ICD Because Sustain pulse generators will be automatically programmed to a unipolar pulse configuration if the device initiates Backup VVI pacing Sustain devices are contraindicated in patients with an implanted cardioverter defibrillator Rate Adaptive Pacing may be inappropriate for patients who experience angina or other symptoms of myocardial dysfunction at higher sensor driven rates An appropriate Maximum Sensor Rate should be selected based on assessment of the highest stimulation rate tolerated by the patient Customer Support 46 8 474 4756 Brief Summary Prior to using these devices please review the Instructions for Use for a complete listing of indications contraindications warnings precautions potential adverse events and directions for use Devices depicted may not be available in all countries Check with your St Jude Medical representative for product availability in your country Unless otherwise noted indicates that the name is a trademark of or licensed to St Jude Medical or one of its subsidiaries ST JUDE MEDICAL the nine squares symbol and MORE CONTROL LESS RISK are registered and unregistered trademarks and service marks of St Jude Medical Inc and its related companies 2011 St Jude Medical Inc All rights reserved Weight g 23
219. ive or Fixed Min Burst Cycle Length ms 150 400 in increments of 5 Number of Bursts 1 15 Number of Stimuli 2 20 Add Stimuli per Burst On Off High Voltage Therapy igh Voltage Output Mode Waveform RV Polarity Electrode Configuration Bradycardia Pacing Permanent Modes emporary Modes Rate Adaptive Sensor Programmable Rate Parameters Fixed Pulse Width Fixed Tilt Biphasic Monophasic Cathode Anode RV to Can RV to SVC Can Off VVI R VOO R Off VVI VOO 0n Off Passive Off Base Rate min Rest Rate min Maximum Sensor Rate min Pulse Amplitude RV V Pulse Width RV ms Hysteresis Rate min Rate Hysteresis with Search Post Therapy Pacing independently programmable from Bradycardia and ATP Post Shock Pacing Mode Post Shock Base Rate min Post Shock Pacing Duration min Device Testing Induction Methods Off VVI 30 100 in increments of 5 Off 0 5 1 2 5 5 7 5 or 10 DC Fibber Pulse Duration sec Burst Fibber Cycle Length ms Noninvasive Programmed Stimulation NIPS 0 5 5 0 20 100 2 25 stimuli with up to 3 extrastimuli m N o S Customer Support 46 8 474 4756 m Brief Summary Prior to using these devices please review the Instructions for Use for a complete listing of e ry indications contraindications warnings precautions potential adverse events and directions for use Devices depicted may not be
220. ker Product Specifications PHYSICAL SPECIFICATIONS Model Telemetry Dimensions mm Weight g Volume cc Connector PARAMETER Rate Timing PM1210 RF 52x52x6 23 12 8 IS 1 SETTINGS Ventricular Pace Sense Refractory Fixed ms Base Rate min Mode Hysteresis Rate min Search Interval min Cycle Count Intervention Rate mir Intervention Duration min Recovery Time Rest Rate min Output Sensing 125 160 400 in steps of 30 440 470 30 130 in steps of 5 140 170 in steps of 10 VOO R VVI R VVT R Pacing Off Off 303 150 in steps of 5 Off 1 5 10 15 30 1 16 by Off 80 120 in steps of 10 Intrinsic 0 Intrinsic 10 Intrinsic 20 Intrinsic 30 Same as Base Rate 1 10 in 1 minute intervals Fast Medium Slow Very Slow Off 30 150 in steps of 5 V Pulse Amplitude V V Pulse Width ms V Sensitivity mV V Pulse Configuration V Sense Configuration Ventricular AutoCapture Pacing System Primary Pulse Configuration Backup Pulse Configuration Backup Pulse Amplitude V Search Interval hours SenseAbility Technology Max Sensitivity mV Threshold Start Decay Delay ms Rate Modulated Parameters 0 25 4 0 in steps of 0 25 4 5 7 5 in steps of 0 5 0 05 0 1 1 5 in steps of 0 1 0 5 5 0 in steps of 0 5 6 10 in steps of 1 0 12 54 Unipolar tip case Bipolar tip ring Unipolar Tip tip case Bipolar tip ring Unipolar Ring ring case
221. king ms Sensed AV Delay ms Rest Rate min Shortest AV Delay ms Ventricular Blanking ms Ventricular Refractory ms Output Sensing 0 80 100 350 in steps of 25 25 25 30 200 in steps of 10 225 300 in steps of 25 305 40 130 in steps of 5 140 170 in steps of 10 e Off 305 130 in steps of 5 140 150 Off 5 10 15 30 16 in steps of 1 Off 60 80 120 in steps of 10 Intrinsic 0 ntrinsic 10 Intrinsic 20 Intrinsic 30 10 in 1 minute intervals Fast Medium Slow Very Slow 90 130 in steps of 5 140 180 in steps of 10 AQO R AAI R AAT R OAO VOO R VVI R WT R VDD R OVO DOO R DVI R DDI R DDD R ODO 125 500 in steps of 25 60 70 80 85 95 100 110 115 125 130 140 150 165 170 180 185 195 200 25 30 200 in steps of 10 225 325 in steps of 25 Off 30 130 in steps of 5 140 150 30 50 in steps of 5 60 120 in steps of 10 Auto 12 52 in steps of 4 125 500 in steps of 255 ACap Confirm Primary Pulse Configuration Backup Pulse Configuration Backup Pulse Amplitude V Search Interval hours Aor V Pulse Amplitude V A or V Pulse Width ms Aor V Pulse Configuration A or V Sense Configuration Atrial Sensitivity mV Ventricular AutoCapture Pacing System Primary Pulse Configuration Backup Pulse Configuration Backup Pulse Amplitude V Search Interval hours AutoCapture Paced Sensed AV Delay ms Ventricular Sensitivity mV Rate Modulated Paramet
222. l Classification with respect to electric shock Protection from electric shock IEC 60601 1 Protection against ingress of liquids Mode of operation EX4000 7 1x5 6 x 1 8 High impact plastic 1 cell 3 6 V nominal Chemistry Lithium Thionyl Chloride 3 years from manufacturing date 60 dB minimum at 10 0 cm Internally powered Type BF Ordinary equipment Non continuous 1 The SJM MRI Activator device is designed to enable disable pre programmed MRI mode quickly and easily pre and post scan do not take the SJM MRI Activator device into the MRI magnet scanner room Customer Support 46 8 474 4756 Brief Summary Prior to using these devices please review the Instructions for Use for a complete listing of indications contraindications warnings precautions potential adverse events and directions for use Devices depicted may not be available in all countries Check with your St Jude Medical representative for product availability in your country Unless otherwise noted indicates that the name is a trademark of or licensed to St Jude Medical or one of its subsidiaries ST JUDE MEDICAL the nine squares symbol and MORE CONTROL LESS RISK are registered and unregistered trademarks and service marks of St Jude Medical Inc and its related companies 2011 St Jude Medical Inc All rights reserved Item GMCRM855EN LLL mam ST JUDE MEDICAL MORE CONTROL LESS RISK Pace S Accent DR RF Dual
223. l Coil Dual Coil Dual Coil Dual Coil Single Coil Sensing Configuration True Bipolar True Bipolar True Bipolar True Bipolar True Bipolar Min Size Introducer TF TF 7F 7F IE Lengths cm 60 65 75 52 58 65 60 65 75 52 58 65 52 58 65 Connector 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 Anode Spacing 11 mm 11 mm 11 mm 11 mm 11 mm Tip to Proximal Coil 17 cm 17 cm 21 cm 21cm N A Tip Electrode Area 35 mm 3 5 mm 3 5 mm 3 5 mm 3 5 mm Steroid Plug Yes Yes Yes Yes Yes Distal Shock Coil Area 367 mm 367 mm 367 mm 367 mm 367 mm Proximal Shock Coil Area 588 mm 588 mm 588 mm 588 mm NWA N 3 UN 8 Customer Support 46 8 474 4756 Brief Summary Prior to using these devices please review the Instructions for Use for a complete listing of indications contraindications warnings precautions potential adverse events and directions for use Devices depicted may not be available in all countries Check with your St Jude Medical representative for product availability in your country Unless otherwise noted indicates that the name is a trademark of or licensed to St Jude Medical or one of its subsidiaries ST JUDE MEDICAL the nine squares symbol and MORE CONTROL LESS RISK are registered and unregistered trademarks and service marks of St Jude Medical Inc and its related companies 2011 St Jude Medical Inc All rights reserved ST JUDE ME DICAL Item GMCRM783EN MORE CONTR
224. l representative for product availability in your country Unless otherwise noted indicates that the name is a trademark of or licensed to St Jude Medical or one of its subsidiaries ST JUDE MEDICAL the nine squares symbol and MORE CONTROL LESS RISK a are registered and unregistered trademarks and service marks of St Jude Medical Inc and its related companies S M B 2011 St Jude Medical Inc All rights reserved T JUDE E DICAL MORE CONTROL LESS RISK Left Heart Leads QuickSite Left Heart Lead Product Specifications MODELS 1056T 1058T Parameter Description Description Connector IS 1 Bipolar IS 1 Bipolar Lead Length 75 cm 86 cm 75 cm 86 cm Maximum Lead Body Size 6 0 F 2 mm 0 079 at PU SR transition 6 0 F 2 mm 0 079 at PU SR transition Proximal Polyurethane Lead Body Size 5 6 F 1 85 mm 0 073 5 6 F 1 85 mm 0 073 Distal Silicone Rubber Lead Body Size 5 0 F 1 68 mm 0 066 5 0 F 1 68 mm 0 066 LV Lead Delivery System Introducer Size Minimum 7 F ID Minimum 7 F ID Minimum S curve height 8mm 16mm Tip Electrode Pt Ir TiN coated two grooves blunt tip Pt Ir TiN coated two grooves blunt tip Steroid Dexamethasone sodium phosphate Dexamethasone sodium phosphate Tip Electrode Surface Area 4 8 mm 48mm Ring Electrode Surface Area 147 mm 147 mm Tip to Ring Electrode Spacing 15mm 20mm Lead Body Insulation Proximal polyurethane 55D Proximal polyurethane 55D Distal 8 cm
225. l rights reserved Item GMCRM915EN ST JUDE MEDICAL MORE CONTROL LESS RISK AV Plus DX VDD Pacing Lead Product Highlights Depending on the model the AV Plus DX lead is available in multiple lengths Pacing Leads affording physicians the flexibility to address the needs of patients with varying physical statures Radiopaque Suture Sleeve is designed to be visible on fluoroscopy helping physicians to locate the suture sleeve during implant Fast Pass coating makes the lead highly lubricious helping to facilitate lead insertion through the introducer and the veins Durable Design utilises a bipolar coaxial multifilar lead body design with silicone insulation construction Tip electrode surface area helps to provide higher lead impedance thereby reducing pacing current drain and enhancing longevity Offers a steroid eluting plug inside the lead s tip electrode that is designed to reduce tissue inflammation at the electrode tissue interface The tip and ring electrodes are coated with titanium nitride TiN which is designed to expand the electrode s virtual surface area thus providing low polarisation values and improved sensing Ordering Information Contents Cardiac pacing lead Model Number Insulation Fixation Min Introducer F Connector Lengths cm 1368 Silicone Tines 9 IS 1 bipolar 52 58 65 Indications The AV Plus DX VDD lead is designed for permanent sensing and pacing in the atrium wit
226. la T only maximum gradient slew rate of 200 T m s per axis See manual for additional details before performing an MRI scan 2 V 2 2 5 V Q 0 4 ms 500 ohms 100 VVI pacing 60 bpm AutoCapture Pacing System OFF SEGMs ON 3 Terms and conditions apply refer to the warranty for details Ordering Information Contents Cardiac pulse generator Model Number PM1124 Inductive Dimensions H x W x T mm 46 x 52 x6 Radiopaque markers St Jude Medical identifier Indications Implantation of a single chamber pulse generator is indicated in one or more of the following permanent conditions syncope presyncope fatigue disorientation due to arrhythmia bradycardia or any combination of those symptoms MRI conditional pulse generator is safe for use in the MRI environment when used in a complete MRI conditional pacing system and according to the instructions in the MRI Procedure Information document for the St Jude Medical MRI conditional pacing system Rate modulated pacing is indicated for patients with chronotropic incompetence and for those who would benefit from increased stimulation rates concurrent with physical activity Atrial pacing is indicated for patients with sinus node dysfunction and normal AV and intraventricular conduction systems Ventricular pacing is indicated for patients with significant bradycardia and normal sinus rhythm with only rare episodes of A V block or sinus arrest chronic atrial fibrillation severe
227. lable with GEMMS ONE EHR Allscripts Professional EHR NextGen Ambulatory EHR EpicCare Ambulatory EHR and GE Centricity EHR Plus compatible with device management solutions such as Paceart and ScottCare OneView Ongoing work to integrate with other leading EHR systems Direct data export to EHR IHE compatible YES Supports HL7 YES ISO 27001 certified YES Scheduling Authorized users may schedule patient follow ups Automated SmartSchedule Calendar and manual scheduling options available Able to transmit outside of fixed appointment time as needed with physician approval Able to lock out patients from sending unscheduled transmissions Online scheduling Unscheduled transmissions Patient initiated transmissions Alerts and Notifications DirectAlerts Notification available with Merlin home transmitter for all supported devices Event based or full disclosure uploads as needed Physician clinician option to select only the alerts they want to receive Congestion Duration Exceeded Programmed Threshold ST Episode Detected AT AF Episode Duration gt Threshold AT AF Burden gt Threshold Avg V Rate During AT AF gt Threshold Percent RV Pacing gt Threshold Percent BiV Pacing lt Threshold High Ventricular Rate Episodes Recorded High Voltage Therapy Delivered Successful ATP Pacing Delivered Therapy Accelerated Rhythm Longevity Analysis requires Tech Services support Tachy Therapy
228. laptop computers fax machines phone systems Industrial equipment A variety of industrial equipment may generate enough EMI to interfere with the performance of your activator These include but are not limited to arc welders induction furnaces very large or defective electric motors and internal combustion engines with poorly shielded ignition systems LLL mam ST JUDE MEDICAL MORE CONTROL LESS RISK ICM External Patient Activator SJM Confirm External Patient Activator Product Specifications PHYSICAL SPECIFICATIONS Model Dimensions cm Case material Power source Battery longevity Audible output level Classification with respect to electric shock Protection from electric shock IEC 60601 1 Protection against ingress of liquids Mode of operation Customer Support 46 8 474 4756 EX4000 71x5 6x18 High impact plastic 1 cell 3 6 V nominal Chemistry Lithium Thionyl Chloride 3 years from manufacturing date 60 dB minimum at 10 0 cm Internally powered Type BF Ordinary equipment Non continuous Brief Summary Prior to using these devices please review the Instructions for Use for a complete listing of indications contraindications warnings precautions potential adverse events and directions for use Devices depicted may not be available in all countries Check with your St Jude Medical representative for product availability in your country Unless otherwise noted indicat
229. lar Auto 0 2 3 0 mV Post Sense Post Pace Atrial Ventricular 0 220 125 157 VT 1 VT 2 VF AV Rate Branch Sudden Onset Interval Stability Morphology Discrimination MD with Manual or Automatic Template Update Continuous sensing during charging ATP Configurations ATP in VF Zone ATP Upper Rate Cutoff Burst Cycle Length Min Burst Cycle Length ms Number of Bursts Stimuli Add Stimuli per Burst High Voltage Therapy Ramp Burst Scan 1 or 2 schemes per zone ATP While Charging ATP Prior to Charging Off 50 300 bpm Adaptive Readaptive or Fixed 50 400 in increments of 5 15 with 2 20 Stimuli On Off igh Voltage Output Mode Waveform RV Polarity Electrode Configuration Bradycardia Pacing Fixed Pulse Width Fixed Tilt Biphasic Monophasic Cathode Anode RV to Can RV to SVC Can Permanent Modes Temporary Modes Rate Adaptive Sensor Programmable Rate and Delay Parameters Auto Mode Switch AMS AMS Detection Rate min AMS Base Rate Auto PMT Detection Termination Rate Responsive PVARP VREF Off DDD R DDT R DDI R VVT R VVI R AAI R Off DDD R DDT R DDI R VVT R VVI R AAI R AAT DOO V00 A00 On Off Passive Off Base Rate min Rest Rate min Maximum Tracking Rate min Maximum Sensor Rate min Paced AV Delay ms Sensed AV Delay ms Rate Responsive AV Delay Pulse Amplitude Atrial RV and LV V Pulse Width Atrial RV and LV ms
230. lated Pacing is indicated for patients with chronotropic incompetence and for those who would benefit from increased stimulation rates concurrent with physical activity Dual Chamber Pacing is indicated for those patients exhibiting sick sinus syndrome chronic symptomatic second and third degree AV block recurrent Adams Stokes syndrome symptomatic bilateral bundle branch block when tachyarrhythmia and other causes have been ruled out Atrial Pacing is indicated for patients with sinus node dysfunction and normal AV and intraventricular conduction systems Ventricular Pacing is indicated for patients with significant bradycardia and normal sinus rhythm with only rare episodes of A V block or sinus arrest chronic atrial fibrillation severe physical disability AF Suppression algorithm is indicated for suppression of paroxysmal or persistent atrial fibrillation episodes in patients with one or more of the above pacing indications Contraindications Dual chamber pulse generators are contraindicated in patients with an implanted cardioverter defibrillator Rate Adaptive Pacing may be inappropriate for patients who experience angina or other symptoms of myocardial dysfunction at higher sensor driven rates An appropriate Maximum Sensor Rate should be selected based on assessment of the highest stimulation rate tolerated by the patient AF Suppression stimulation is not recommended in patients who cannot tolerate high atrial rate stimulation Dual Chamb
231. le Charging ATP Prior to Charging Off Ventricular HV Lead Impedance Trend Multi Vector Trend Data ATP Upper Rate Cutoff 150 300 bpm Histograms Event Histogram AV Interval Histogram Mode Switch Duration Histogram Burst Cycle Length Adaptive Readaptive or Fixed Peak Filtered Rate Histogram Atrial Heart Rate Histogram Ventricular Min Burst Cycle Length ms 150 400 in increments of 5 Heart Rate Histogram AT AF Burden Exercise and Activity Trending V Number of Bursts 1 15 Rates during AMS Number of Stimuli 2 20 PMT Data Information regarding PMT detections Add Stimuli per Burst On Off Real Time Measurements RTM Pacing lead impedances high voltage lead impedances unloaded battery ATP Pulse Amplitude V 7 5 Independent from Bradycardia and Post Therapy Pacing voltage and signal amplitudes ATP Pulse Width ms 1 0 or 1 5 Independently programmable from Bradycardia ST Monitoring ST Histogram Data ST Deviation Trend ST Episode Log and Post Therapy Pacing CorVue Congestion Monitoring On Off High Voltage Therapy CorVue Congestion Trigger 8 18 days igh Voltage Output Mode Waveform RV Polarity Electrode Configuration Bradycardia Pacing Fixed Pulse Width Fixed Tilt Biphasic Monophasic Cathode Anode RV to Can RV to SVC Can Permanent Modes Temporary Modes Rate Adaptive Sensor Programmable Rate and Delay Parameters DDD R DDI R VVI R AAI R Pacer Off Off DDD DDI VVI AAI AAT DOO
232. lity due to inappropriate delivery of therapy caused by multiple counting of cardiac events including T waves P waves or supplemental pacemaker stimuli Among the psychological effects of device implantation are imagined pulsing dependency fear of inappropriate pulsing and fear of losing pulse capability Refer to the User s Manual for detailed indications contraindications warnings precautions and potential adverse events EEE mem ST JUDE MEDICAL EEE MORE CONTROL LESS RISK 7 GMCRMO9 1 Cardiac Resynchr Product Specifications PHYSICAL SPECIFICATIONS Models Telemetry Delivered Energy J Volume cc Weight g Size mm Defibrillation Lead Connections Sense Pace Lead Connections High Voltage Can D3215 36 D3215 360 RF RF 36 36 43 42 82 82 81x50x 14 75x 50x 14 DFI DF4 IS 1 IS 1 DF4 Electrically active Electrically active titanium can titanium can PARAMETER SETTINGS V Triggering BiV Trigger Mode On Off QuickOpt Timing Cycle Optimisation Sensed paced AV delay Interventricular Pace delay V V Timing Interventricular Pace Delay ms Ventricular Sensing Ventricular Pacing Chamber Negative AV Hysteresis Search ms Shortest AV Delay ms VectSelect LV Pulse Configuration AF Management Simultaneous RV First LV First RV First 10 80 LV First 15 80 in increments of 5 RV only not programmable RV only biventricular Off 10 to 120 25 12
233. llation Sense Pace 35 DF1 IS 1 35 DF4 DF4 histotoxic reactions infection keloid formation myocardial irritability nerve damage pneumothorax thromboemboli venous occlusion Other possible adverse effects include mortality due to component failure device programmer communication failure lead abrasion lead dislodgment or poor lead placement lead fracture inability to defibrillate inhibited therapy for a ventricular tachycardia interruption of function due to electrical or magnetic interference shunting of energy from defibrillation paddles system failure due to ionising radiation Other possible adverse effects include mortality due to inappropriate delivery of therapy caused by multiple counting of cardiac events including T waves P waves or supplemental pacemaker stimuli Among the psychological effects of device implantation are imagined pulsing dependency fear of inappropriate pulsing and fear of losing pulse capability Refer to the User s Manual for detailed indications contraindications warnings precautions and potential adverse events ST JUDE MEDICAL MORE CONTROL LESS RISK Product Specifications PHYSICAL SPECIFICATIONS Models Telemetry Delivered Stored Energy J Volume cc Weight g Size mm Defibrillation Lead Connections Sense Pace Lead Connections High Voltage Can PARAMETERS SETTINGS Sensing Detection fibrillator ICD Devices Post Therapy Pacing Independentl
234. lridium Titanium nitride coated anode plate titanium MP35N multifilar coil Silicone rubber medical grade 316L stainless steel lt 1 mg dexamethasone sodium phosphate Silicone rubber 1084T 35 cm 10 mm 62 mm 3 5mm 2 5 27 ohms 46 ohms 27 cm 27 cm IS 1 Bi Titanium nitride coated Platinum lridium Titanium nitride coated titanium MP35N multifilar coil Silicone rubber medical grade 316L stainless steel lt 1 mg dexamethasone sodium phosphate Silicone rubber Epicardial Pacing Leads 1084T 54 cm 10 mm 62 mm 3 5 mm 2 5 41 ohms 75 ohms 27 cm 27 cm IS 1 Bi Titanium nitride coated Platinum lridium Titanium nitride coated titanium MP35N multifilar coil Silicone rubber medical grade 316L stainless steel lt 1 mg dexamethasone sodium phosphate Silicone rubber 1 slit suture sleeve detached from lead m 1 _ L Customer Support 46 8 474 4756 Brief Summary Prior to using these devices please review the Instructions for Use for a complete listing of e y indications contraindications warnings precautions potential adverse events and directions for use Devices depicted may not be available in all countries Check with your St Jude Medical representative for product availability UO in your country Unless otherwise noted indicates that the name is a trademark of or licensed to
235. ly lead impedance trend historical test results pacing polarity and any polarity switches Physiologic based rest rate not subject to changes in time zone daylight savings time or the patient s schedule Advanced hysteresis maximises opportunities for the patient s own rhythm to prevail and addresses abrupt rate drops Ordering Information Contents Cardiac pulse generator Model Number 5626 Dimensions H x W x T mm 42x52x6 Indications and Usage Implantation of Zephyr pulse generators is indicated in the following permanent conditions when associated with symptoms including but not limited to syncope presyncope fatigue disorientation or any combination of those symptoms Rate Modulated Pacing is indicated for patients with chronotropic incompetence and for those who would benefit from increased stimulation rates concurrent with physical activity Dual Chamber Pacing Models 5826 5820 only is indicated for those patients exhibiting Sick sinus syndrome chronic symptomatic second and third degree AV block recurrent Adams Stokes syndrome symptomatic bilateral bundle branch block when tachyarrhythmia and other causes have been ruled out Atrial Pacing is indicated for patients with sinus node dysfunction and normal AV and intraventricular conduction systems Ventricular Pacing is indicated for patients with significant bradycardia and Normal sinus rhythm with only rare episodes of A V block or sinus arrest chronic atr
236. m 80 230 Rapid Atrial Pacing Rates ppm 70 1000 AV Delay ms PV Delay ms Pulse Duration ms Pulse Amplitude V Atrial Sensitivity mV Ventricular Sensitivity mV Blanking Period ms Atrial Refractory Period ms PVARP ms Ventricular Refractory Period ms Extended PVARP After PVC ms Crosstalk Detection Window ms Emergency Mode Runaway Protection ppm Customer Support 46 8 474 4756 5 400 minimum 30 ms when atrial Auto Sense is activated AV delay 30 minimum 5 ms when atrial Auto Sense is not activated minimum 30 when atrial Auto Sense is activated 0 05 1 50 0 1 18 0 2 20 1 0 20 85 atrial amp ventricular 55 ventricular after atrial pacing 250 400 ms 5 AAI AAT A V interval plus PVARP DDD VDD DAI VAT DAT 100 500 absolute 90 ms relative 90 ms 250 500 40 VOO A00 80 ppm 12 V or set value when higher 0 75 ms 1 00 ms or set value when longer 235 Brief Summary Prior to using these devices please review the Instructions for Use for a complete listing of indications contraindications warnings precautions potential adverse events and directions for use Devices Connectivity depicted may not be available in all countries Check with your St Jude Medical representative for product availability in your country Unless otherwise noted indicates that the name is a trademark of or licensed to St Jude Medical or one of its subsidiaries ST JUDE ME
237. marks and service marks of St Jude Medical Inc and its related companies 2011 St Jude Medical Inc All rights reserved Item GMCRM767EN Atrial Tachycardia Base Rate Auto PMT Detection Termination Rate Responsive PVARP VREF LV Cap Confirm RV Cap Confirm ACap Confirm 40 45 135 A Pace on PMT Off Passive Off Low Medium High Ventricular Intrinsic Preference VIP Off 50 200 50 150 in increments of 25 160 200 in increments of 10 Setup On Monitor Off On Monitor Off Post Therapy Pacing Independently programmable from Bradycardia and ATP Post Shock Pacing Mode Post Shock Base Rate min Post Shock Pacing Duration min Device Testing Induction Methods Off AAI VVI DDI or DDD 30 100 in increments of 5 Off 0 5 1 2 5 5 7 5 or 10 DC Fibber Pulse Duration sec Burst Fibber Cycle Length ms Noninvasive Programmed Stimulation NIPS Patient Notifiers 0 5 5 0 20 100 2 25 stimuli with up to three extrastimuli Programmable Notifiers On Off Device Parameter Reset Entry into Backup VVI Mode Vibration Duration sec Number of Vibrations per Notification Number of Notifications Time Between Notifications hours Electrograms and Diagnostics Device at ERI Charge Time Limit Reached Possible HV Circuit Damage Atrial Lead Impedance Out of Range RV Lead Impedance Out of Range LV Lead Impedance Out of Range High Voltage Lead Impedance Out of Range
238. mensions Connector Connector Number H x W x T mm Weight g Volume cc Defibrillation Sense Pace CD2235 40 74 x 40 x 14 76 35 DF1 IS 1 CD2235 40Q 71x40x14 75 35 DF4 IS 1 DF4 Indications The devices are intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias Contraindications Contraindications for use of the pulse generator system include ventricular tachyarrhythmias resulting from transient or correctable factors such as drug toxicity electrolyte imbalance or acute myocardial infarction Adverse Events Implantation of the pulse generator system like that of any other device involves risks some possibly life threatening These include but are not limited to the following acute hemorrhage bleeding air emboli arrhythmia acceleration cardiac or venous perforation cardiogenic shock cyst formation erosion exacerbation of heart failure extrusion fibrotic tissue growth fluid accumulation hematoma formation histotoxic reactions infection keloid formation myocardial irritability nerve damage pneumothorax Customer Support 46 8 474 4756 Brief Summary Prior to using these devices please review the Instructions for Use for a complete listing of indications contraindications warnings precautions potential adverse events and directions for use Devices depicted may not be available in all countries Check with your St Jude Med
239. ments and ventricular threshold tests Pace S The AutoCapture Pacing System feature offers the maximum in threshold adaptability and patient safety with ventricular Beat by Beat capture confirmation Stored electrograms EGMs record a real time EGM waveform as well as the associated event markers that precede and follow a specific triggering event The system also includes the clinically proven Omnisense accelerometer sensor featuring auto rest rate based on activity rather than on preset clock settings and auto rate response 1 A V 2 5 V 0 4 ms AV 500 ohms 100 VVI pacing 60 bpm SEGMs ON data on file Ordering Information Contents Cardiac pulse generator Model Number PM1136 Dimensions H x W x T mm 42 x52 x6 Indications and Usage Implantation of Sustain pulse generators is indicated in the following permanent conditions when associated with symptoms including but not limited to syncope presyncope fatigue disorientation due to arrhythmia bradycardia or any combination of those symptoms Rate Modulated Pacing is indicated for patients with chronotropic incompetence and for those who would benefit from increased stimulation rates concurrent with physical activity Atrial Pacing is indicated for patients with sinus node dysfunction and normal AV and intraventricular conduction systems Ventricular Pacing is indicated for patients with significant bradycardia and Normal sinus rhythm w
240. min Cycle Count Intervention Rate mir Intervention Duration min Recovery Time Rest Rate min Output Sensing 125 160 400 in steps of 30 440 470 30 130 in steps of 5 140 170 in steps of 10 VOO R VVI R VVT R Pacing Off Off 303 150 in steps of 5 Off 1 5 10 15 30 1 16 by Off 80 120 in steps of 10 Intrinsic 0 Intrinsic 10 Intrinsic 20 Intrinsic 30 Same as Base Rate 1 10 in 1 minute intervals Fast Medium Slow Very Slow Off 30 150 in steps of 5 V Pulse Amplitude V V Pulse Width ms V Sensitivity mV V Pulse Configuration V Sense Configuration Ventricular AutoCapture Pacing System Primary Pulse Configuration Backup Pulse Configuration Backup Pulse Amplitude V Search Interval hours SenseAbility Technology Max Sensitivity mV Threshold Start Decay Delay ms Rate Modulated Parameters 0 25 4 0 in steps of 0 25 4 5 7 5 in steps of 0 5 0 05 0 1 1 5 in steps of 0 1 0 5 5 0 in steps of 0 5 6 10 in steps of 1 0 12 54 Unipolar tip case Bipolar tip ring Unipolar Tip tip case Bipolar tip ring Unipolar Ring ring case On Off Unipolar Bipolar Unipolar Bipolar 5 05 8 24 Off On Automatic Sensitivity Control adjustment for ventricular events 0 2 2 0 in steps of 0 1 Ventricular Post Sense 50 62 5 75 100 Ventricular Post Pace Auto 0 2 3 0 in steps of 0 1 mV Ventricular Post Sense 0 30 60 95 125 160 190 220 Ventric
241. mpanies 2011 St Jude Medical Inc All rights reserved malfunction device migration pocket erosion or hematoma pectoral muscle stimulation and phrenic nerve or diaphragmatic stimulation The following in addition to the above are potential complications associated with the use of rate modulated pacing systems inappropriate rapid pacing rates due to sensor failure or to the detection of signals other than patient activity loss of activity response due to sensor failure and palpitations with high rate pacing Refer to the User s Manual for more detailed indications contraindications warnings precautions and potential adverse events ST JUDE MEDICAL MORE CONTROL LESS RISK 7 GMCRM 3 Accent MRI DR Dual Chamber Pacemaker with Wireless Telemetry Product Specifications PHYSICAL SPECIFICATIONS Model PM2224 Telemetry RF Dimensions mm 52x53x6 Weight g 24 Volume cc 31 Connector S 1 PARAMETER SETTINGS Rate Timing 90 400 in steps of 30 440 470 93 125 157 190 400 in steps of 30 440 470 500 Atrial Pace Refractory ms Atrial Sense Refractory ms Atrial Protection Interval ms 253 Paced AV Delay ms 25 30 200 in steps of 10 225 300 in steps of 25 350 Base Rate min 30 130 in steps of 5 140 170 in steps of 10 Far Field Protection Interval ms 6 Hysteresis Rate min Off 30 150 in steps of 5 Search Interval min Off 1 5 10 15 30 Cycle Count 16
242. mpanies 2011 St Jude Medical Inc All rights reserved ST JUDE ME DICAL Item GMCRM773EN MORE CONTROL LESS RISK GMCRM7Z7 Epicardial Pacing Leads Myodex Bipolar Steroid eluting Epicardial Pacing Lead Product Highlights Active fixation sutureless design Full 3 5 mm helix penetration helps provide stable fixation Superb deliverability combined with exceptional stability and performance Low pacing thresholds with steroid elution Precise sensing and low polarisation Easy to implant with the Faslac Lead Implant Tool Ordering Information Contents Epicardial lead Model Number Insulation Connector Lengths cm 1084T Silicone IS 1 bipolar 25 35 54 LLL mam ST JUDE MEDICAL MORE CONTROL LESS RISK Myodex Bipolar Steroid eluting Epicardial Lead Product Specifications PHYSICAL SPECIFICATIONS MODELS 1084T 25 cm Electrode surface area Helix penetration depth Number of helix turns to implant Lead resistance Introducer length Tunneler length Connector type Electrode material Conductor material Insulation material Connector pin material Steroid plug Suture sleeve and pin cap material ACCESSORIES PACKAGED WITH THE MYODEX LEAD 1 FasTac introducer ltunneler 1 bidirectional tunneler tip 1 connector pin cap 10 mm cathode 62 mm anode 35 mm 2 5 20 ohms cathode 38 ohms anode 27 cm 27 cm IS 1 Bi Titanium nitride coated helix Platinum
243. mpanies S M B 2011 St Jude Medical Inc All rights reserved T JUDE E DICAL MORE CONTROL LESS RISK Accessories Mond RVOT Stylet Product Highlights Innovative 3D design for precise lead placement in the Right Ventricular Outflow Track RVOT High tensile stainless steel construction to reduce the likelihood of kinking Kit includes 2 stylets Soft Green 0 014 Firm Yellow 0 015 1 Implant Tool with 4140 and 4150 only and 1 Universal Clip On Tool Available in 2 curvatures Medium and Wide to accommodate normal and large heart sizes Ordering Information Model Number Primary Curvature Length cm Implant Tool 4140 52 Medium 52 1 included 4140 58 Medium 58 1 included 4141 52 Medium 52 4141 58 Medium 58 4141 60 Medium 60 4141 65 Medium 65 4150 52 Wide 52 1 included 4150 58 Wide 58 1 included 4151 52 Wide 52 4151 58 Wide 58 4151 60 Wide 60 4151 65 Wide 65 Customer Support 46 8 474 4756 Brief Summary Prior to using these devices please review the Instructions for Use for a complete listing of indications contraindications warnings precautions potential adverse events and directions for use Devices depicted may not be available in all countries Check with your St Jude Medical representative for product availability in your country Unless otherwise noted indicates that the name is a trademark of or licensed to St Jude Medical o
244. mpatibility D 3 2 mm Medtronic IS 1 bipolar SES 501206 CPI Telectronic Style or 47 eae OOF IS 1 bipolar Cap and Sleeve Kit St Jude Medical Asie Adapter gt leeve 2 sizes 501207 Medtronic M S header or 6 tiie j jJ E 32 5 mm CPI Telectronic Style 6 mm unipolar FAM 0 5 6 mm St Jude Medical Adapter Sleeve 2 sizes Tool 2 sizes Sleeve Kit Medtronic 4023 CPI Telectronic Style 3 2 mm MEE CENE SPUR NN IS 1 or 5 mm 5 6 mm white tool 3 2 6 mm grey tool 53424 2 IS 1 bipolar IS 1 bipolar 17 cm 53421 IS 1 bipolar IS 1 bipolar 40 cm BLV BIS 10 IV 1 bipolar IS 1 bipolar oe Note Medical adhesive to cover set screw holes must be ordered separately LV 1 is a unique Boston Scientific formerly Guidant connector terminal Medtronic is a trademark of Medtronic Inc CPI is a trademark of Cardiac Pacemakers Inc Customer Support 46 8 474 4756 Brief Summary Prior to using these devices please review the Instructions for Use for a complete listing of indications contraindications warnings precautions potential adverse events and directions for use Devices depicted may not be available in all countries Check with your St Jude Medical representative for product availability in your country Unless otherwise noted indicates that the name is a trademark of or licensed to St Jude Medical or one of its subsidiaries ST JUDE MEDICAL the nine squares symbol and
245. mple to configure data storage options to enable physicians to prioritise data based on individual patient conditions ensuring capture of significant events and to reduce the risk that unexpected events are missed a Comprehensive diagnostic data reports from the provide a quick and accurate summary of heart rate assisting physicians in their diagnosis and treatment of the patient s condition The small 6 5 cc size of the SJM Confirm ICM DM2102 is designed to reduce the risk of infection during the implant procedure by requiring a smaller incision and a smaller subcutaneous pocket A small device footprint may also reduce implant time and means less change in body image for patients The proven St Jude Medical SenseAbility feature is designed to allow accurate sensing over a wide range of signals specifically offering more sensitive QRS detection Ordering Information Contents Implantable Cardiac Monitor Volume cc 6 5 0 5 Model Number DM2102 Dimensions H x W x T mm Weight g 56 3x 185 x8 12 Separately Available Accessories Contents SJM Confirm External Patient Activator device Model Number DM2100A Description External Patient Activator Model DM2100A Adverse Events Possible adverse events in alphabetical order associated with the device include but are Indications The SJM Confirm ICM is indicated for the monitoring and diagnostic evaluation of patients not limited to the following Allergic reac
246. ms 6 Values 0 1 0 4 not available in a unipolar sense configuration 7 Sensitivity is with respect to a 20 ms haversine test signal 8 During atrial NIPS in dual chamber modes the shortest Coupling Interval will be limited by the programmed AV PV delay 9 S1 Burst Cycle is applied at the preprogrammed S1 cycle length EBEN mem ST JUDE MEDICAL ann MORE CONTROL LESS RISK Pacemakers Accent DR a Dual Chamber Pacemaker Ol ga as me R oly HI H Sr Jupe MEDICAE Sma CA LSA Product Highlights Inductive remote follow up utilising a wand in conjunction with the Merlin home transmitter and Merlin net Patient Care Network PCN allows patients to download information and provide the clinic with access to device measurements SCENT DR A two tone audible alert allows programming to notify the patient of changes in device performance or arrhythmia status which can provide earlier insight into actionable clinical events AT AF alerts can be programmed to notify patients and their clinics when a programmed AT AF threshold or can be programmed to continuous episode duration has been exceeded or when a high ventricular rate accompanies the AT AF episode A suite of state of the art features complete automaticity atrial and ventricular Ventricular Intrinsic Preference VIP technology QuickOpt timing cycle optimisation the AF Suppression algorithm and SenseAbility technology is designed
247. ms interventricular delay Entry into Backup VVI Mode On 3 Sensitivity is with respect to a 20 ms haversine test signal 4 Values 0 1 0 4 not available in a Unipolar Sense Configuration 5 This parameter is not programmable Audible Duration sec Number of Audible Alerts 2 4 6 8 10 12 14 16 6 The highest available setting for hysteresis rate is 5 min below the programmed base rate per Notification 2 H 7 In dual chamber modes the maximum Ventricular Refractory Period is 325 ms Number of Notifications 1 16 8 Programming options dependent on pacing mode E 9 During atrial NIPS in dual chamber modes the shortest Coupling Interval will be limited by the programmed AV PV Delay Time Between Notifications hours 10 22 a 9 10 S1 Burst Cycle is applied at the preprogrammed S1 cycle length Customer Support 46 8 474 4756 Brief Summary Prior to using these devices please review the Instructions for Use for a complete listing of indications contraindications warnings precautions potential adverse events and directions for use Devices depicted may not be available in all countries Check with your St Jude Medical representative for product availability in your country Unless otherwise noted indicates that the name is a trademark of or licensed to St Jude Medical or one of its subsidiaries ST JUDE MEDICAL the nine squares symbol and MORE CONTROL LESS RISK are registered and unregistered t
248. mulation embolism excessive bleeding induced ventricular ectopy infection loss of pacing and or sensing due to dislodgment or mechanical malfunction of the pacing lead phrenic nerve stimulation thrombosis Complications reported with direct subclavian venipuncture include pneumothorax hemothorax laceration of the subclavian artery arteriovenous fistula neural damage thoracic duct injury cannulation of other vessels massive hemorrhage and rarely death Refer to the User s manual for detailed indications contraindications warnings precautions and potential adverse events ST JUDE MEDICAL MORE CONTROL LESS RISK Pacing Leads EN 5 GMC RM9 1 TM IsoFlex Pacing Lead Optim Product Specifications Model 1944 Minimum Introducer Size ype of Lead Lead Connector Lead Lengths Fixation Mechanism ip to ring Spacing Lead Tip Electrode Cathode ip Electrode Surface Area Ring Electrode Anode Ring Electrode Surface Area Steroid nner Insulation Outer Insulation Lead Body Coating In Pack 7F ipolar passive fixation lead S 1 bipolar 46 52cm ines 0 mm Semi spherical shape steroid coating 35mm Platinum iridium coated with titanium nitrade 6 mm mg dexamethasone sodium phosphate in silicone matrix Silicone rubber Optim lead insulation Fast Pass coating Straight Stylets J curved Stylets x soft in lead 1 x soft 1 soft standard 1
249. n Distal 7 cm silicone rubber Lead Body Coating Conductors Distal coil Proximal cables Suture Sleeve MP35N is a trademark of SPS Technologies Inc Customer Support 46 8 474 4756 1156T Description IS 1 Bipolar 75 cm 86 cm 6 0 F 2 mm 0 079 5 6 F 1 85 mm 0 073 5 0 F 1 68 mm 0 066 4 0 F 1 33 mm 0 052 Minimum 7 F ID 8mm Pt Ir TiN coated ring shaped two grooves Dexamethasone sodium phosphate 4 9 mm 7 4 mm 20mm Proximal polyurethane 55D Distal 7 cm silicone rubber Fast Pass coating MP35N MP35N Attached 1158T Description IS 1 Bipolar 75 cm 86 cm 6 0 F 2 mm 0 079 5 6 F 1 85 mm 0 073 5 0 F 1 68 mm 0 066 4 0 F 1 33 mm 0 052 Minimum 7 F ID 16 mm Pt Ir TiN coated ring shaped two grooves Dexamethasone sodium phosphate 49 mm 74mm 20mm Proximal polyurethane 55D Fast Pass coating MP35N MP35N Attached Brief Summary Prior to using these devices please review the Instructions for Use for a complete listing of indications contraindications warnings precautions potential adverse events and directions for use Devices depicted may not be available in all countries Check with your St Jude Medical representative for product availability in your country Unless otherwise noted indicates that the name is a trademark of or licensed to St Jude Medical or one of its subsidiaries ST JUDE MEDICAL the nine sq
250. n defects and or perioperative temporary heart stimulation An extensive dual chamber feature set including A full array of mode choices including a special DDD AT mode specifically available for bi atrial stimulation to help avoid atrial fibrillation Atrial auto sensing for automatic adjustment of sensitivity Connectivity ge I gt was Completely adjustable stimulation parameters voltage and pulse width A wide base rate range of 30 220 ppm for appropriate pacing support for all therapy needs including those of pediatric patients A max tracking rate of 80 230 ppm for maintaining AV synchrony A PV delay offset for supporting maximum cardiac output Extended PVARP for prevention of retrograde tachycardia Crosstalk protection to aid in preventing far field sensing which can result in asystole Continuous independent atrial and ventricular lead surveillance and an audible warning in the event of lead malfunction Rapid atrial pacing rates up to 1000 ppm are available for pace termination of atrial tachycardia Ordering Information Contents External pulse generator Model Number Dimensions H x W x T cm Weight g Battery 3085 20x9 6x 3 8 490 includes battery Battery 9 V alkaline or lithium Indications for Use The Model 3085 external pulse generator temporary pacemaker is designed to be used with cardiac stimulation lead systems for temporar
251. n is indicated for suppression of paroxysmal or persistent atrial fibrillation episodes in patients with one or more of the above pacing indications Contraindications Implanted Cardioverter Defibrillator ICD Devices are contraindicated in patients with an implanted cardioverter defibrillator Rate Adaptive Pacing may be inappropriate for patients who experience angina or other symptoms of myocardial dysfunction at higher sensor driven rates An appropriate Maximum Sensor Rate should be selected based on assessment of the highest stimulation rate tolerated by the patient AF Suppression stimulation is not recommended in patients who cannot tolerate high atrial rate stimulation Dual Chamber Pacing though not contraindicated for patients with chronic atrial flutter chronic atrial fibrillation or silent atria may provide no benefit beyond that of single chamber pacing in such Customer Support 46 8 474 4756 Brief Summary Prior to using these devices please review the Instructions for Use for a complete listing of indications contraindications warnings precautions potential adverse events and directions for use Devices depicted may not be available in all countries Check with your St Jude Medical representative for product availability in your country Unless otherwise noted indicates that the name is a trademark of or licensed to St Jude Medical or one of its subsidiaries ST JUDE MEDICAL the nine squares symbol and
252. n steps of 25 25 6 AF Suppression Lower Rate Overdrive min Upper Rate Overdrive min No of Overdrive Pacing Cycles Rate Recovery ms Auto Mode Switch AMS Base Rate min Customer Support 46 8 474 4756 Off On 0 5 5 40 in steps of 5 8 12 Off DDDR to DDIR DDD to DDI DDT D to DDT 1 DDT D to DDTR I DDTR D to DDTR 1 DDTR D to DDT 1 DDDR to DDI DDD to DDIR Base Rate 0 to Base Rate 35 in steps of 5 Brief Summary Prior to using these devices please review the Instructions for Use for a complete listing of indications contraindications warnings precautions potential adverse events and directions for use Devices depicted may not be available in all countries Check with your St Jude Medical representative for product availability in your country Unless otherwise noted indicates that the name is a trademark of or licensed to St Jude Medical or one of its subsidiaries ST JUDE MEDICAL the nine squares symbol and MORE CONTROL LESS RISK are registered and unregistered trademarks and service marks of St Jude Medical Inc and its related companies 2011 St Jude Medical Inc All rights reserved Item GMCRM889EN Rate Modulated Rate Responsive AV PV Delay Rate Responsive PVARP VREF Shortest PVARP VREF Sensor Max Sensor Rate min Threshold Slope Reaction Time Recovery Time Stored Electrograms Off Low Medium High Off Low Medium High 1
253. nagement 1 Carlson M et al A new pacemaker algorithm for the treatment of atrial fibrillation results of the Atrial Dynamic Overdrive Pacing Trial ADOPT JACC 2003 42 627 33 2 Attuel P et al and the INOVA Study Group Quality of life in permanently paced AF patients The INOVA Study Europace 2003 Abstract A42 6 3 Davy et al and the INOVA Study Group Permanent atrial overdrive tolerance in patients with symptomatic paroxysmal AF The INOVA Study Europace 2003 Abstract A42 3 Ordering Information Contents Cardiac pulse generator Model Number Dimensions H x W x T mm 5596 49 x52 x6 Indications Implantation of Frontier II device is indicated for maintaining synchrony of the left and right ventricles in patients who have undergone an AV nodal ablation for chronic atrial fibrillation and have NYHA Class Il or Ill heart failure the reduction of the symptoms of moderate to severe heart failure NYHA Class Ill or IV in those patients who remain symptomatic despite stable optimal medical therapy and have a left ventricular ejection fraction lt 35 and a prolonged QRS duration implantation of Accent Accent RF Anthem and Anthem RF devices is indicated in one or more of the following permanent conditions syncope presyncope fatigue disorientation or any combination of those symptoms Rate Modulated Pacing is indicated for patients with chronotropic incompetence and for those who would benefit from increase
254. nchronisation Therapy CRT Devices Promote Accel Cardiac Resynchronisation Therapy Defibrillator CRT D Product Highlights The DF4 connector is designed to simplify implants by streamlining defibrillation connections into a single terminal pin and reducing the number of set screws LV RV and Atrial Capture Confirmation features ensure capture of the myocardium in response to pacing stimuli in the left ventricle right ventricle and right atrium LVCap RVCap and ACap Confirm help ensure patient safety and therapy delivery by automatically monitoring and adjusting capture thresholds according to changing patient needs Advanced Biventricular Pacing options Merlin home Transmitter Compatible Triggered Pacing with BiV Trigger Mode helps maintain a high percentage of BiV pacing by triggering pacing in both the left and right ventricles in response to a sensed ventricular event VectSelect programmable LV pulse configuration LV ring RV coil LV tip RV coil or LV bipolar may be adjusted noninvasively via the programmer Negative AV hysteresis with search promotes ventricular acing by automatically reducing the AV delay when intrinsic activity is present thereby promoting a high degree of ventricular pacing DeFT Response technology offers the most noninvasive options for managing high DFTs The SenseAbility feature provides the flexibility to fine tune programming around T wa
255. nchronise the right and left ventricles in patients with congestive heart failure Contraindications Contraindications for use of the pulse generator system include ventricular tachyarrhythmias resulting from transient or correctable factors such as drug toxicity electrolyte imbalance or acute myocardial infarction Adverse Events Implantation of the pulse generator system like that of any other device involves risks some possibly life threatening These include but are not limited to the following acute hemorrhage bleeding air emboli arrhythmia acceleration cardiac or venous perforation cardiogenic shock cyst formation erosion exacerbation of heart failure extrusion fibrotic tissue growth fluid accumulation hematoma formation Customer Support 46 8 474 4756 Brief Summary Prior to using these devices please review the Instructions for Use for a complete listing of indications contraindications warnings precautions potential adverse events and directions for use Devices depicted may not be available in all countries Check with your St Jude Medical representative for product availability in your country Unless otherwise noted indicates that the name is a trademark of or licensed to St Jude Medical or one of its subsidiaries ST JUDE MEDICAL the nine squares symbol and MORE CONTROL LESS RISK are registered and unregistered trademarks and service marks of St Jude Medical Inc and its related companies
256. nd otential adverse events tT mem ST JUDE MEDICAL MORE CONTROL LESS RISK Accent MRI SR Single Chamber Pacemaker Product Specifications PHYSICAL SPECIFICATIONS Pace ers Stored Electrograms Off Low High 1 2 3 Off Low High Off Low High 125 300 in steps of 25 2 3 4 5 10 15 20 Off Low High Off Low High Model PM1124 Options Telemetry Inductive Priority Options Dimensions mm 46x52x6 Channel Weight g 22 Triggers Volume cc 12 Magnet Response Connector I1 High Ventricular Rate Rate min No of Consecutive Cycles Rate Timing Advanced Hysteresis Noise Reversion Ventricular Pace Sense Refractory Fixed ms 125 160 400 in steps of 30 440 470 500 Other Base Rate min 30 130 in steps of 5 140 170 in steps of 10 Mode V0O R VVI R VVT R Pacing Off Lead Monitoring Hysteresis Rate min Off 30 150 in steps of 5 V Low Impedance Limit Q Search Interval mir Off 1 5 10 15 30 V High Impedance Limit Q Cycle Count 1 16 by 1 Magnet Response Intervention Rate mirr Off Same as Base Rate 80 120 in steps of 10 Intrinsic 0 Lead Type Intrinsic 10 Intrinsic 20 Intrinsic 30 NIPS Options Intervention Duration min 1 10 in 1 minute intervals Stimulation Chamber Recovery Time Fast Medium Slow Very Slow Copiar Interval ms in 30 150 i oun Rest Rate min Off 30 150 in steps of 5 SIF 2 3 and SA Cycle ms MRI Settings Diagnostic Trends
257. nd MORE CONTROL LESS RISK are registered and unregistered trademarks and service marks of St Jude Medical Inc and its related companies 2011 St Jude Medical Inc All rights reserved Item GMCRM777EN GMCRM T ST JUDE MEDICAL MORE CONTROL LESS RISK Implantable Cardiovert Fortify ST VR Single Chamber Implantable Cardioverter Defibrillator ICD Product Highlights The ST monitoring diagnostic provides information on significant ST segment changes for improved insight in decision making ShockGuard technology with DecisionTx programming designed to reduce inappropriate therapy and minimise the need for programming adjustments at implant Unique 40 J delivered energy safety shock option can provide a greater DFT safety margin Devices Defibrillator IC Merlin home Transmitter ibl The DF4 connector is designed to simplify implants by streamlining Eu defibrillation connections into a single terminal pin and reducing the number of set screws QHR chemistry battery provides greater capacity for enhanced longevity and stable charge times Antitachycardia pacing ATP while charging and prior to charging in the VF zone further extends the programming options for terminating tachyarrhythmias without a high voltage shock The low frequency attenuation filter is designed to enhance sensing performance and may reduce the possibility of oversensing T waves DeFT Response technology offer
258. nduction or suffer a drop in arterial blood pressure with the onset of ventricular pacing Single Chamber Atrial Pacing is relatively contraindicated in patients who have demonstrated compromise of AV conduction For specific contraindications associated with individual modes refer to the programmer s on screen help Customer Support 46 8 474 4756 Brief Summary Prior to using these devices please review the Instructions for Use for a complete listing of indications contraindications warnings precautions potential adverse events and directions for use Devices depicted may not be available in all countries Check with your St Jude Medical representative for product availability in your country Unless otherwise noted indicates that the name is a trademark of or licensed to St Jude Medical or one of its subsidiaries ST JUDE MEDICAL the nine squares symbol and MORE CONTROL LESS RISK are registered and unregistered trademarks and service marks of St Jude Medical Inc and its related companies 2011 St Jude Medical Inc All rights reserved Potential Adverse Events The following are potential complications associated with the use of any pacing system arrhythmia heart block thrombosis threshold elevation valve damage pneumothorax myopotential sensing vessel damage air embolism body rejection phenomena cardiac tamponade or perforation formation of fibrotic tissue local tissue reaction inability to interrogate o
259. ne squares symbol and MORE CONTROL LESS RISK are registered and unregistered trademarks and service marks of St Jude Medical Inc and its related companies 2011 St Jude Medical Inc All rights reserved exacerbation of heart failure extrusion fibrotic tissue growth fluid accumulation hematoma formation histotoxic reactions infection keloid formation myocardial irritability nerve damage pneumothorax thromboemboli venous occlusion Other possible adverse effects include mortality due to component failure device programmer communication failure lead abrasion lead dislodgment or poor lead placement lead fracture inability to defibrillate inhibited therapy for a ventricular tachycardia interruption of function due to electrical or magnetic interference shunting of energy from defibrillation paddles system failure due to ionising radiation Other possible adverse effects include mortality due to inappropriate delivery of therapy caused by multiple counting of cardiac events including T waves P waves or supplemental pacemaker stimuli Among the psychological effects of device implantation are imagined pulsing dependency fear of inappropriate pulsing and fear of losing pulse capability Refer to the User s Manual for detailed indications contraindications warnings precautions and potential adverse events tT mem ST JUDE MEDICAL MORE CONTROL LESS RISK sm 8 GMCRM 76 brillator
260. nfirm ICM Refer to the User s Manual for detailed indications contraindications warnings precautions and potential However the patient s particular medical condition may dictate whether or not a subcutaneous chronically adverse events implanted device can be tolerated Customer Support 46 8 474 4756 tT mam ST JUDE MEDICAL MORE CONTROL LESS RISK Implantable Cardiac Monitors SJM Confirm Implantable Cardiac Monitor Model DM2100 Product Specifications Model DM2100 Sampling Rate Hz 128 Dimensions mm 56 3x18 5x8 Volume cc 6 5 Weight g 12 Electrode Spacing mm 39 Electrode Minimum Surface Area mm 30 Features Longevity 3 years Patient Trigger Yes Auto Activation Trigger Yes Tachycardia Trigger Yes Tachycardia Cycle Count Yes Bradycardia Trigger Yes Asystole duration Trigger Yes EGM Storage 48 minutes Patient Trigger Yes Programmable Auto Activation Yes Programmable Activity Response Inhibit Monitor Off Noise Response Inhibit Diagnostics Episodal Diagnostics Yes Heart Rate Histogram Yes Mean Heart Rate No Remote Monitoring Transtelephonic monitoring TTM Patient Activator PA Battery powered PA Model DM2100A Connectivity depends upon country and use of a compatible receiver unit Please contact your St Jude Medical sales representative for more details i o Customer Support 46 8 474 4756 Bri
261. nformation Contents Cardiac pulse generator Connector IS 1 Volume cc 10 4 Model Number PM1134 Dimensions H x W x T mm Weight g 42x 52x6 23 Indications and Usage Implantation of Sustain pulse generators is indicated in the following permanent conditions when associated with symptoms including but not limited to syncope presyncope fatigue disorientation due to arrhythmia bradycardia or any combination of those symptoms Symptomatic bilateral bundle branch block when tachy arrhythmia and other causes have been ruled out Atrial Pacing is indicated for patients with sinus node dysfunction and normal AV and intraventricular conduction systems Ventricular Pacing is indicated for patients with significant bradycardia and Normal sinus rhythm with only rare episodes of A V block or sinus arrest chronic atrial fibrillation severe physical disability Contraindications mplanted Cardioverter Defibrillator ID Because Sustain pulse generators will be automatically programmed to a unipolar pulse configuration if the device initiates Backup VVI pacing Sustain devices are contraindicated in patients with an implanted cardioverter defibrillator Customer Support 46 8 474 4756 Brief Summary Prior to using these devices please review the Instructions for Use for a complete listing of indications contraindications warnings precautions potential adverse events and directions for use Devices Potential Adverse Events Arr
262. ng Ring Electrode Surface Area 16 mm 16 mm Mapping Available with collar Available with collar Steroid Elution Yes Yes Conductor MP35N coil MP35N coil Insulation Optim Optim Accessory Kits Available Separately ACCESSORY MODEL AVAILABLE LENGTHS DESCRIPTION Stylet Kit DS06002 and DS06003 with appropriate length designation 46 52 58 65 cm 4 straight stylets 1x soft 1 soft 1 firm 1 x firm 1 j 1 universal clip on tool for use with TC model Tendril and Tendril ST leads MP35N is a trademark of SPS Technologies Inc 4 2 Customer Support 46 8 474 4756 Brief Summary Prior to using these devices please review the Instructions for Use for a complete listing of indications contraindications warnings precautions potential adverse events and directions for use Devices depicted may not be available in all countries Check with your St Jude Medical representative for product availability in your country Unless otherwise noted indicates that the name is a trademark of or licensed to St Jude Medical or one of its subsidiaries ST JUDE MEDICAL the nine squares symbol and MORE CONTROL LESS RISK are registered and unregistered trademarks and service marks of St Jude Medical Inc and its related companies 2011 St Jude Medical Inc All rights reserved ST JUDE ME DICAL Item GMCRM821EN MORE CONTROL LESS RISK GMCRMSB Tendril SDX Pacing Lead Product Highlights
263. ng due to lead dislodgement or reaction at the electrode tissue interface loss of desired pacing and or sensing due to lead displacement body reaction at electrode interface or lead malfunction fracture or damage to insulation loss of normal device function due to battery failure or component malfunction pacemaker migration or pocket erosion pectoral muscle or diaphragmatic stimulation phrenic nerve stimulation pneumothorax hemothorax endocarditis excessive bleeding induced atrial or ventricular arrhythmias myocardial irritability pericardial effusion pericardial rub pulmonary edema rise in threshold and exit block valve damage cardiac coronary sinus dissection cardiac coronary sinus perforation coronary sinus or cardiac vein thrombosis Refer to the User s Manual for detailed indications contraindications warnings precautions and potential adverse events LLL mem ST JUDE MEDICAL EEE MORE CONTROL LESS RISK 6 E N 7 GMCRM 7 onisatio hera Product Specifications PHYSICAL SPECIFICATIONS Model Telemetry Dimensions mm Weight g Volume cc Connector PM3112 Inductive 52x52x6 21 115 IS 1 PARAMETER Resynchronisation Therapy SETTINGS QuickOpt Timing Cycle Optimisation RV and LV Pulse Width ms RV and LV Pulse Amplitude V RV Pulse Configuration LV Pulse Configuration Ventricular Sense Configuration Ventricular Pacing Chamber First
264. nosis detection electrograms triggers include Detection Zones VT 1 VT 2 VF diagnosis therapy PC shock delivery noise reversion magnet reversion SVT Discriminators Reconfirmation Antitachycardia Pacing Therapy AV Rate Branch Sudden Onset Interval Stability Morphology Discrimination MD with Manual or Automatic Template Update Continuous sensing during charging Therapy Summary Episodes Summary Lifetime Diagnostics Ventricular HV Lead Impedance Trend ATP Configurations Ramp Burst Scan 1 or 2 schemes per VT zone Histograms Burst Cycle Length Adaptive Readaptive or Fixed Min Burst Cycle Length ms 150 400 in increments of 5 Real Time Measurements RTM Number of Bursts 1 15 Number of Stimuli 2 20 Add Stimuli per Burst On Off ATP Pulse Amplitude V ATP Pulse Width ms High Voltage Therapy 7 5 Independent from Bradycardia and Post Therapy Pacing 1 0 or 1 5 Independently programmable from Bradycardia and Post Therapy Pacing High Voltage Output Mode Waveform RV Polarity Electrode Configuration Bradycardia Pacing Fixed Pulse Width Fixed Tilt Biphasic Monophasic Cathode Anode RV to Can RV to SVC Can Permanent Modes Temporary Modes Rate Adaptive Sensor Programmable Rate Parameters Off VVI R VOO R Off VVI VOO On Off Passive Off Base Rate min Rest Rate min Maximum Sensor Rate min Pulse Amplitude RV V Pulse Width RV ms Hysteresis Rate m
265. ntricular Dual Cross Channel On Off On Off On Off On Off Off 125 150 175 200 225 250 275 300 2 3 4 5 10 15 20 High Ventricular Rate Off 125 150 175 200 225 250 275 300 No of Consecutive Cycles 2 3 4 5 10 15 20 PMT Termination On Off PVC Detection On Off No of Consecutive PVCs 2 3 4 5 Other A and V Lead Monitoring Off Monitor Auto Polarity Switch A and V Low Impedance Limit Q A and V High Impedance Limit Q Lead Type Magnet Response Negative AV Hysteresis Search ms NIPS Options Stimulation Chamber Coupling Interval ms S1 Count S1 S2 S3 and S4 Cycle ms Ventricular Support Rate min Sinus Node Recovery Delay sec PMT Options PMT Detection Rate min PVC Options Signal Amplitude Monitoring P Wave Monitoring R Wave Monitoring Ventricular Intrinsic Preference VIP ms VIP Search Interval VIP Search Cycles Ventricular Safety Standby 1 x 0 5 cc 2 This parameter is not programmable 200 750 1000 1250 1500 1750 2000 Uncoded Unipolar Bipolar Only Unipolar Bipolar Off Battery Test Off 10 to 110 in steps of 10 Atrial Ventricular 100 800 in steps of 108 1 25 in steps of 1 100 800 in steps of 10 Off 30 40 45 50 55 60 65 70 75 80 85 90 95 1 2 3 4 5 Off 10 Beats gt PMT Auto Detect 90 150 in steps of 5 160 180 in steps of 10 Off A Pace on PVC PVARP on PVC VDD mode only On Off On Off 50 150 in steps of
266. o 120 in steps of 10 oo Atrial Ventricular 100 800 in steps of 105 2 25 in steps of 1 f 100 800 in steps of 10 Fixed or Adaptive f 30 95 in steps of 5 2 3 4 5 f Passive Atrial Pace 0 180 in steps of 5 f Atrial Pace oOwoo oo Off 50 150 in steps of 25 160 200 in steps of 10 30 sec 1 3 5 10 30 min 1 2 3 Off On AT AF Activity Exercise Lead Impedance P and R Wave A and V Threshold Programmable Notifiers On Off Device Reset Entry into Backup VVI Mode Audible Duration sec Number of Audible Alerts per Notification Number of Notifications Time Between Notifications hours 1 0 5 ec Device at ERI Atrial Lead Impedance Out of Range Ventricular Lead Impedance Out of Range AT AF Burden AT AF Episode Duration V Rate During AT AF High V Rate Threshold Total Time in High V Rate On On 2 4 6 8 10 12 14 16 2 1 16 10 22 2 Programming options dependent on pacing mode 3 This parameter is not programmable 4 The highest available setting for hysteresis rate will be 5 min below the programmed base rate 5 In dual chamber modes the maximum ventricular refractory period is 325 ms 6 Values 0 1 0 4 not available in a unipolar sense configuration 7 Sensitivity is with respect to a 20 ms haversine test signal 8 During atrial NIPS in dual chamber modes the shortest Coupling Interval will be limited by the programmed AV PV delay 9 S1 Burst Cycle is appl
267. o syncope presyncope fatigue disorientation or any combination of those symptoms Rate Modulated Pacing is indicated for patients with chronotropic incompetence and for those who would benefit from increased stimulation rates concurrent with physical activity Dual Chamber Pacing Models 5826 5820 only is indicated for those patients exhibiting sick sinus syndrome chronic symptomatic second and third degree AV block recurrent Adams Stokes syndrome symptomatic bilateral bundle branch block when tachyarrhythmia and other causes have been ruled out Atrial Pacing is indicated for patients with sinus node dysfunction and normal AV and intraventricular conduction systems Ventricular Pacing is indicated for patients with significant bradycardia and Normal sinus rhythm with only rare episodes of A V block or sinus arrest chronic atrial fibrillation severe physical disability AF Suppression Models 5826 5820 only is indicated for suppression of paroxysmal or persistent atrial fibrillation episodes in patients with one or more of the above pacing indications For specific indications associated with individual modes refer to Operating Modes Contraindications Verity devices are contraindicated in patients with an implanted cardioverter defibrillator Rate Adaptive Pacing may be inappropriate for patients who experience angina or other symptoms of myocardial dysfunction at higher sensor driven rates An appropriate Maximum Sensor Rate should be
268. o an emergency thoracotomy procedure Have coronary venous vasculature that is inadequate for lead placement as indicated by venogram Customer Support 46 8 474 4756 Brief Summary Prior to using these devices please review the Instructions for Use for a complete listing of indications contraindications warnings precautions potential adverse events and directions for use Devices depicted may not be available in all countries Check with your St Jude Medical representative for product availability in your country Unless otherwise noted indicates that the name is a trademark of or licensed to St Jude Medical or one of its subsidiaries ST JUDE MEDICAL the nine squares symbol and MORE CONTROL LESS RISK a are registered and unregistered trademarks and service marks of St Jude Medical Inc and its related companies S M B 2011 St Jude Medical Inc All rights reserved T JUDE E DICAL MORE CONTROL LESS RISK Left Heart Leads 4 7 GMCRM7Z7 QuickFlex Left Heart Lead Product Specifications PHYSICAL SPECIFICATIONS MODELS Parameter Connector Lead Length Maximum Lead Body Size Proximal Polyurethane Lead Body Size Distal Silicone Rubber Lead Body Size Tip Electrode Size LV Lead Delivery System Introducer Size Minimum S Curve Height Tip Electrode Steroid Tip Electrode Surface Area Ring Electrode Surface Area Tip to Ring Electrode Spacing Lead Body Insulatio
269. o pre approved MRI settings pre and post MRI scan decreasing the number of workflow steps and increasing clinic efficiency InvisiLink wireless telemetry in conjunction with the Merlin home transmitter and Merlin net Patient Care Network PCN allows for daily remote monitoring and follow up AT AF Alerts can be programmed to notify patients and or their clinics when a programmed AT AF threshold or continuous episode duration has been exceeded or when a high ventricular rate accompanies the AT AF episode A suite of state of the art features complete automaticity atrial and ventricular Ventricular Intrinsic Preference VIP technology QuickOpt timing cycle optimisation the AF Suppression algorithm and SenseAbility technology is designed to deliver optimal therapy for patients at implant and throughout their lives Industry leading longevity offers 9 1 years of service life which is supported by a 7 year warranty N w Merlin home Transmitter Compatible The St Jude Medical MRI conditional pacing system can be scanned in patients under the following conditions horizontal closed bore clinical scanner working in the Normal Operating Mode or First Level Controlled Operating Mode static magnetic field strength of 1 5 Tesla T only maximum gradient slew rate of 200 T m s per axis See manual for additional details before performing an MRI scan AV 2 5 V 0 4 ms 500
270. odels 5826 5820 only though not contraindicated for patients with chronic atrial conditions when associated with symptoms including but not limited to syncope presyncope fatigue flutter chronic atrial fibrillation or silent atria may provide no benefit beyond that of single chamber pacing in disorientation or any combination of those symptoms Rate Modulated Pacing is indicated for patients with such patients Single Chamber Ventricular Demand Pacing is relatively contraindicated in patients who have chronotropic incompetence and for those who would benefit from increased stimulation rates concurrent with demonstrated pacemaker syndrome have retrograde VA conduction or suffer a drop in arterial blood pressure physical activity Dual Chamber Pacing Models 5826 5820 only is indicated for those patients exhibiting with the onset of ventricular pacing Single Chamber Atrial Pacing is relatively contraindicated in patients sick sinus syndrome chronic symptomatic second and third degree AV block recurrent Adams Stokes who have demonstrated compromise of AV conduction syndrome symptomatic bilateral bundle branch block when tachyarrhythmia and other causes have been ruled out Atrial Pacing is indicated for patients with sinus node dysfunction and normal AV and intraventricular For specific contraindications associated with individual modes refer to Operating Modes conduction systems Ventricular Pacing is indicated for patients with significant b
271. ody 5 0 F distal lead body Steerable tip the distal tip can be controlled to maneuver through venous anatomy Compatible with over the wire or stylet approaches Composite construction proximal polyurethane section and cable coil conductors are designed to offer exceptional push and torque while the flexible distal silicone portion is designed for improved tracking in tortuous anatomy Ordering Information Contents Left heart lead Model Insulation Insulation S Curve Minimum Number Proximal Distal Height mm Introducer F Connector Lengths cm 1056T Polyurethane Silicone 8 7 IS 1 bipolar 75 86 1058T Polyurethane Silicone 16 7 IS 1 bipolar 75 86 Indications and Usage The QuickSite leads have application as part of a St Jude Medical biventricular system Contraindications The use of QuickSite leads is contraindicated in patients who Are expected to be hypersensitive to a single dose of 1 0 mg of dexamethasone sodium phosphate Are unable to undergo an emergency thoracotomy procedure Have coronary venous vasculature that is inadequate for lead placement as indicated by venogram Customer Support 46 8 474 4756 Brief Summary Prior to using these devices please review the Instructions for Use for a complete listing of indications contraindications warnings precautions potential adverse events and directions for use Devices depicted may not be available in all countries Check with your St Jude Medica
272. of 25 Volume cc 137 Sensor On Off Passive Connector IS 1 Max Sensor Rate min 80 150 in steps of 5 160 180 in steps of 10 Threshold Auto 0 5 Auto 4 0 0 Auto 0 5 Auto 1 0 Auto 41 5 Auto 2 0 1 7 in steps of 0 5 Resynchronisation Therapy Slope Auto 1 Auto 0 Auto 1 Auto 2 Auto 3 1 16 QuickOpt Timing Cycle Reaction Time Recovery Time Very Fast Fast Medium Slow Fast Medium Slow Very Slow Optimisation Sensed Paced AV Delay Interventricular Paced Delay RV and LV Pulse Width ms 0 05 0 1 1 5 in steps of 0 1 AFM t RV and LV Pulse Amplitude V 0 25 4 0 in steps of 0 25 4 5 7 5 in steps of 0 5 ium RV Pulse Configuration Unipolar Bipolar mer A LV Pulse Configuration Unipolar Bipolar LV Tip RV Ring LV Ring RV Ring oe Nisi M Ventricular Sense Configuration BV Unipolar Tip BV Bipolar RV Unipolar Tip RV Bipolar Tid fate vede rins 5 LV Unipolar Tip LV Bipolar RV Unipolar Ring LV Tip RV Tip Nees Oveddrive Paste Cus Ten Gears Ventricular Pacing Chamber BV RV only LV only temporary mode Rate Recovery ms E vy 3 12 P First Chamber Paced nterventricular Pace Delay ms Simultaneous RV LV 10 80 in steps of 5 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 min 40 170 in steps of 5 Output Sensing Negative AV Stored Electrograms
273. of 5 140 150 A or V Pulse Amplitude V Aor V Pulse Width ms A or V Sensitivity mV A or V Pulse Configuration Aor V Sense Configuration Ventricular AutoCapture Pacing System Primary Pulse Configuration Backup Pulse Configuration Backup Pulse Amplitude V Search Interval hours Rate Modulated 0 0 4 0 in steps of 0 25 4 5 7 5 in steps of 0 5 0 05 0 1 1 5 in steps of 0 1 0 5 5 0 in steps of 0 5 6 10 in steps of 1 0 12 54 Unipolar tip case Bipolar tip ring Unipolar Tip tip case Bipolar tip ring Unipolar Ring ring case On Off Unipolar Bipolar Unipolar Bipolar 5 05 8 24 Maximum Sensor Rate bpm Rate Responsive VREF Shortest VREF Reaction Time Recovery Time Sensor Slope Threshold Stored Electrograms 80 150 in steps of 5 160 180 in steps of 10 Off Low Medium High 120 350 in steps of 10 Very Fast Fast Medium Slow Fast Medium Slow Very Slow On Off Passive Auto 1 Auto 0 Auto 1 Auto 2 Auto 3 1 16 in steps of 1 Auto 0 5 Auto 0 0 Auto 4 0 5 Auto 1 0 Auto 1 5 Auto 2 0 1 7 in steps of 0 5 Options Sampling Options No of Stored EGMs Channel Triggers Magnet Placement High Atrial Rate bpm No of Consecutive Cycles High Ventricular Rate bpm No of Consecutive Cycles Advanced Hysteresis Customer Support 46 8 474 4756 Freeze Continuous 1 2 4 8 12 Atrial or Ventricular On Off Off 125 150
274. of AV Plus DX VDD leads are the same as with the use of other active fixation leads and include cardiac tamponade diaphragmatic stimulation embolism excessive bleeding induced ventricular ectopy infection loss of pacing and or sensing due to dislodgment or mechanical malfunction of the pacing lead phrenic nerve stimulation thrombosis Complications reported with direct subclavian venipuncture include pneumothorax hemothorax laceration of the subclavian artery arteriovenous fistula neural damage thoracic duct injury cannulation of other vessels massive hemorrhage and rarely death Refer to the User s manual for detailed indications contraindications warnings precautions and potential ST JUDE MEDICAL MORE CONTROL LESS RISK Pacing Leads AV Plus DX VDD Pacing Lead Product Specifications Model 1368 Minimum Introducer Size 9F Lead Connector IS 1 Bipolar Lead Lengths 52 58 65 cm Fixation Mechanism Tines Lead Body Diameter 2 0 mm Tip to Ventricular Ring Spacing 15 mm Tip to Atrial Ring Spacing 130 mm Lead Tip Electrode Semispherical shape steroid coating Tip to Electrode Surface Area 5 mm Ring Electrode Platinum iridium coated with microporous titanium nitride Ring Electrode Surface Area 32 mm Steroid lt 1 mg dexamethasone sodium phosphate in silicone matrix Insulation Silicone Accessory Kits Available Separately Model Number Accessory Item Description Traffic Light Stylet
275. of Stimuli 2 20 PMT Data Information regarding PMT detections Add Stimuli per Burst On Off Real Time Measurements RTM Pacing lead impedances high voltage lead impedances unloaded battery ATP Pulse Amplitude V ATP Pulse Width ms High Voltage Therapy 7 5 Independent from Bradycardia and Post Therapy Pacing 1 0 or 1 5 Independently programmable from Bradycardia and Post Therapy Pacing 3 igh Voltage Output Mode Waveform RV Polarity Electrode Configuration Bradycardia Pacing Fixed Pulse Width Fixed Tilt Biphasic Monophasic Cathode Anode RV to Can RV to SVC Can Permanent Modes emporary Modes Rate Adaptive Sensor Programmable Rate and Delay Parameters DDD R DDI R VVI R AAI R Pacer Off Off DDD DDI VVI AAI AAT DOO V00 A00 Post Sense Post Pace Atrial Ventricular 0 220 Off Base Rate min Rest Rate min Maximum Tracking Rate min Maximum Sensor Rate min Paced AV Delay ms Sensed AV Delay ms Rate Responsive AV Delay Pulse Amplitude Atrial RV V Pulse Width Atrial and RV ms Hysteresis Rate min Rate Hysteresis with Search QuickOpt Timing Cycle Optimisation Sensed Paced AV delay Auto Mode Switch AMS Off DDI R VVI R Atrial Tachycardia 110 300 Detection Rate min AMS Base Rate min 40 45 135 Auto PMT Detection Termination Rate Responsive PVARP VREF A Pace on PMT Off Passive Off Low Medium High Ventricular Intr
276. of the patient s condition The small 6 5 cc size of the SJM Confirm ICM DM2100 is designed to reduce the risk of infection during the implant procedure by requiring a smaller incision and a smaller subcutaneous pocket A small device footprint may also reduce implant time and means less change in body image for patients The proven St Jude Medical SenseAbility feature is designed to allow accurate sensing over a wide range of signals specifically offering more sensitive QRS detection Ordering Information Contents Implantable Cardiac Monitor Model Number Dimensions H x W x T mm Weight g Volume cc DM2100 56 3x18 5 x8 12 6 5 0 5 Contents SJM Confirm External Patient Activator device Model Number Description DM2100A External Patient Activator Model DM2100A Indications The SJM Confirm ICM is indicated for the monitoring and diagnostic evaluation of patients Adverse Events Possible adverse events in alphabetical order associated with the device include but are who experience unexplained symptoms such as dizziness palpitations chest pain syncope and shortness of not limited to the following Allergic reaction Bleeding Chronic nerve damage Erosion Excessive fibrotic breath as well as patients who are at risk for other cardiac arrhythmias tissue growth Extrusion Formation of hematomas or cysts Infection Keloid formation Contraindications There are no known contraindications for the implantation of the SJM Co
277. oft 1 soft J curved Stylets 1 standard 1 wide 1 narrow Helix Extension Retraction Clip on Tools 2 clip on tools Accessory Kits Available Separately Model Number Compatible Lengths Description Stylet Kit DS06000 with appropriate 40 46 52cm 1 fixation tool 1 clip on tool 1 standard J shape length designation 1 wide J shape 1 narrow J shape DS06001 with appropriate 40 46 52 cm 1 clip on tool 1 standard J shape ength designation 1 wide J shape 1 narrow J shape DS06002 with appropriate 46 52cm 1 fixation tool 1 clip on tool length designation 1 J shaped soft 1 x soft 1 soft 1 firm 1 x firm DS06003 with appropriate 40 46 52 cm 1 clip on tool 1 J shaped soft length designation 1 x soft 1 soft 1 firm 1 x firm Locator Plus 281 with appropriate 46 52cm Disposable implant tool that facilitates Deflectable Stylet length designation precise lead positioning and allows 292 with appropriate 46 52cm manipulation with one hand length designation Limited Lifetime Warranty Terms and conditions apply refer to the warranty for details MP35N is a registered trademark of SPS Technologies Inc EN 4 Customer Support 46 8 474 4756 Brief Summary Prior to using these devices please review the Instructions for Use for a complete listing of indications contraindications warnings precautions potential adverse events and directions for use Devices depicted may not be available in all countries Ch
278. ohms 100 DDD pacing 60 bpm AutoCapture Pacing System OFF SEGMs ON Terms and conditions apply refer to the warranty for details Ordering Information Contents Cardiac pulse generator Model Number PM2224 RF Dimensions H x W x T mm Weight g 52x53 x6 24 Radiopaque markers St Jude Medical identifier Gm MRI Indications Implantation of a dual chamber pulse generator is indicated in one or more of the following permanent conditions syncope presyncope fatigue disorientation due to arrhythmia bradycardia or any combination of those symptoms MRI conditional pulse generator is safe for use in the MRI environment when used in a complete MRI conditional pacing system and according to the instructions in the MRI Procedure Information document for the St Jude Medical MRI conditional pacing system Rate modulated pacing is indicated for patients with chronotropic incompetence and for those who would benefit from increased stimulation rates concurrent with physical activity Dual chamber pacing is indicated for those patients exhibiting sick sinus syndrome chronic symptomatic second and third degree AV block recurrent Adams Stokes syndrome symptomatic bilateral bundle branch block when tachyarrhythmia and other causes have been ruled out Atrial pacing is indicated for patients with sinus node dysfunction and normal AV and intraventricular conduction systems Ventricular pacing is indicated for patients with
279. ollowing acute hemorrhage bleeding air emboli arrhythmia acceleration cardiac or venous perforation cardiogenic shock cyst formation erosion Customer Support 46 8 474 4756 Brief Summary Prior to using these devices please review the Instructions for Use for a complete listing of indications contraindications warnings precautions potential adverse events and directions for use Devices depicted may not be available in all countries Check with your St Jude Medical representative for product availability in your country Unless otherwise noted indicates that the name is a trademark of or licensed to St Jude Medical or one of its subsidiaries ST JUDE MEDICAL the nine squares symbol and MORE CONTROL LESS RISK are registered and unregistered trademarks and service marks of St Jude Medical Inc and its related companies 2011 St Jude Medical Inc All rights reserved exacerbation of heart failure extrusion fibrotic tissue growth fluid accumulation hematoma formation histotoxic reactions infection keloid formation myocardial irritability nerve damage pneumothorax thromboemboli venous occlusion Other possible adverse effects include mortality due to component failure device programmer communication failure lead abrasion lead dislodgment or poor lead placement lead fracture inability to defibrillate inhibited therapy for a ventricular tachycardia interruption of function due to electrical or magnetic
280. on algorithm is indicated for suppression of paroxysmal or persistent atrial fibrillation episodes in patients with one or more of the above pacing indications Contraindications Dual chamber pulse generators are contraindicated in patients with an implanted cardioverter defibrillator Rate Adaptive Pacing may be inappropriate for patients who experience angina or other symptoms of myocardial dysfunction at higher sensor driven rates An appropriate Maximum Sensor Rate should be selected based on assessment of the highest stimulation rate tolerated by the patient AF Suppression stimulation is not recommended in patients who cannot tolerate high atrial rate stimulation Dual Chamber Pacing though not contraindicated for patients with chronic atrial flutter chronic atrial fibrillation or silent atria may provide no benefit beyond that of single chamber pacing in such patients Customer Support 46 8 474 4756 Brief Summary Prior to using these devices please review the Instructions for Use for a complete listing of indications contraindications warnings precautions potential adverse events and directions for use Devices depicted may not be available in all countries Check with your St Jude Medical representative for product availability in your country Unless otherwise noted indicates that the name is a trademark of or licensed to St Jude Medical or one of its subsidiaries ST JUDE MEDICAL the nine squares symbol and MORE CONT
281. or both patient and physician alerts are provided EHRDirect Export allows automatic export of transmission data from Merlin net PCN to a clinic s EHR system This allows seamless integration of data so care teams can make informed clinical decisions more quickly without the need for expensive intermediary systems This feature meets the Integrating the Healthcare Enterprise IHE guidelines supporting Health Level 7 HL7 standards Inductive Merlin home transmitters can now be used with newer Epic family devices and Atlas family devices as well as other newer devices Going forward inductive Merlin home transmitters will be issued to patients with newer Epic ICD or Atlas ICD implants However Housecall Plus transmitters will still be available for patients with older Epic ICDs and Atlas ICDs Merlin net PCN now features device support for the Unify Quadra CRT D and the Accent MRI RF Pacemaker SmartSchedule is an 18 month rotating perpetual calendar that creates an automatic follow up transmission schedule Clinicians can specify length of time including 91 day and 182 day periods between transmissions to coordinate follow ups with the clinic s reimbursement calendar DirectCall Message is an integrated and automated patient communication system designed to save clinic time by reducing routine calls otherwise performed by medical office staff DirectTrend Viewer provides dynamic views of device and clinical trends for
282. or every patient stands at the center of our efforts to advance medicine and improve therapeutic results To meet our objectives of more control and less risk we partner with physicians to develop tools and techniques that simplify patient care and facilitate reproducible outcomes Our efforts extend to physician training and education We sponsor more than 170 programs with various themes geared toward physicians specialising in many areas of cardiology Descriptions and specifications for the St Jude Medical comprehensive portfolio of cardiac rhythm management products can be found throughout this catalogue LLL mem ST JUDE MEDICAL EEE MORE CONTROL LESS RISK Table of Contents Cardiac Resynchronisation Therapy CRT Devices Left Heart and Epicardial Leads Implantable Cardioverter Defibrillator ICD Devices Defibrillation Leads Pacemakers Pacing Leads Accessories Implantable Cardiac Monitors Connectivity and Remote Care Customer Support 46 8 474 4756 Brief Summary Prior to using these devices please review the Instructions for Use for a complete listing of indications contraindications warnings precautions potential adverse events and directions for use Devices depicted may not be available in all countries Check with your St Jude Medical representative for product availability in your country Unless otherwise noted indicates that the name is a trademark of or licensed to St Jude Medical
283. or more of the above pacing indications For specific indications malfunction Infection erosion Interruption of desired pulse generator function due to electrical interference associated with individual modes refer to Operating Modes either electromyogenic or electromagnetic Lead malfunction due to conductor fracture or insulation degradation Loss of capture or sensing due to lead dislodgement or reaction at the electrode tissue interface Loss of desired pacing and or sensing due to lead displacement body reaction at electrode interface or lead malfunction fracture or damage to insulation Loss of normal device function due to battery failure or component malfunction Pacemaker migration pocket erosion or hematoma Pectoral muscle or diaphragmatic stimulation Phrenic nerve stimulation Pneumothorax hemothorax Contraindications Zephyr devices are contraindicated in patients with an implanted cardioverter defibrillator Rate Adaptive Pacing may be inappropriate for patients who experience angina or other symptoms of myocardial dysfunction at higher sensor driven rates An appropriate Maximum Sensor Rate should be selected based on assessment of the highest stimulation rate tolerated by the patient AF Suppression Models 5826 5820 only stimulation is not recommended in patients who cannot tolerate high atrial rate stimulation Refer to the User s Manual for detailed indications contraindications warnings precautions and potential adv
284. or use in areas where a landline is neither available nor convenient Does not require any additional hardware and operates on the power supply of the Merlin home transmitter Transmission of data occurs on the 3G and GSM bands of the cellular network The USB Cellular Adaptor is simple to install and use on any new or existing Merlin home transmitter while maintaining the current user interface The USB Cellular Adaptor provide a reliable transmission option that allows patient and clinicians to experience the value of connectivity through the Merlin net Patient Care Network Ordering Information Contents USB Cellular Adaptor Model Number Dimensions H x W x T mm Volume cc Weight g EX1151 65 x 25 x 13 5 19 5 30 Indications The USB Cellular Adapter for use with the Merlin home transmitter is indicated for use by Contraindications The USB Cellular Adapter for use with the Merlin home transmitter is contraindicated patients with supported St Jude Medical implanted devices for use with any implanted medical device other than supported St Jude Medical implanted devices Customer Support 46 8 474 4756 Brief Summary Prior to using these devices please review the Instructions for Use for a complete listing of indications contraindications warnings precautions potential adverse events and directions for use Devices depicted may not be available in all countries Check with your St Jude Medical representative for p
285. ot be available in all countries Check with your St Jude Medical representative for product availability in your country Unless otherwise noted indicates that the name is a trademark of or licensed to St Jude Medical or one of its subsidiaries ST JUDE MEDICAL the nine squares symbol and MORE CONTROL LESS RISK are registered and unregistered trademarks and service marks of St Jude Medical Inc and its related companies 2011 St Jude Medical Inc All rights reserved Min Introducer F Connector Length cm 7 IS 1 bipolar 100 Adverse Events Potential complications associated with the use of Tendril SDX leads are the same as with the use of other active fixation leads and include cardiac tamponade diaphragmatic stimulation embolism excessive bleeding induced ventricular ectopy infection loss of pacing and or sensing due to dislodgment or mechanical malfunction of the pacing lead phrenic nerve stimulation thrombosis Complications reported with direct subclavian venipuncture include pneumothorax hemothorax laceration of the subclavian artery arteriovenous fistula neural damage thoracic duct injury cannulation of other vessels massive hemorrhage and rarely death Refer to the User s Manual for detailed indications contraindications warnings precautions and potential adverse events ST JUDE MEDICAL MORE CONTROL LESS RISK Tendril SDX Pacing Lead Product Specifications PHYSIC
286. otential adverse events and directions for use Devices depicted may not be available in all countries Check with your St Jude Medical representative for product availability in your country Unless otherwise noted indicates that the name is a trademark of or licensed to St Jude Medical or one of its subsidiaries ST JUDE MEDICAL the nine squares symbol and MORE CONTROL LESS RISK are registered and unregistered trademarks and service marks of St Jude Medical Inc and its related companies 2011 St Jude Medical Inc All rights reserved EBEN mam ST JUDE MEDICAL Item GMCRM876EN MORE CONTROL LESS RISK Pace Sustain XL SC Single Chamber Pacemaker 12 0 comparve ST JUDE MEDICAL Symar CA USA Product Highlights Device features small physiologic shape and offers superior longevity 12 8 years without compromising size ER SUSTAIN XL ATA S SAN 12 nstant follow up with automatic P or R wave lead impedance measurements and ventricular threshold tests The AutoCapture Pacing System feature offers the maximum in threshold adaptability and patient safety with ventricular Beat by Beat capture confirmation Stored electrograms EGMs record a real time EGM waveform as well as the associated event markers that precede and follow a specific triggering event 1 A V 2 5 V 0 4 ms AV 500 ohms 100 VVI pacing 60 bpm SEGMs ON data on file Ordering I
287. otential adverse events and directions for use Devices depicted may not be available in all countries Check with your St Jude Medical representative for product availability in your country Unless otherwise noted indicates that the name is a trademark of or licensed to St Jude Medical or one of its subsidiaries ST JUDE MEDICAL the nine squares symbol and MORE CONTROL LESS RISK are registered and unregistered trademarks and service marks of St Jude Medical Inc and its related companies 2011 St Jude Medical Inc All rights reserved Item GMCRM766EN LLLI mem ST JUDE MEDICAL EEE MORE CONTROL LESS RISK Cardiac Resynchronisation T Unify Cardiac Resynchronisation Therapy Defibrillator CRT D Product Highlights Smallest footprint of any HV device available The CorVue congestion monitoring feature monitors the intrathoracic impedance in multiple vectors for improved accuracy and it provides the option for both patient and physician alerts AO J delivered energy provides unsurpassed energy for defibrillation ShockGuard technology with DecisionTx programming designed to reduce inappropriate therapy and minimise the need for programming adjustments at Merlin home Transmitter implant Compatible DF connector is designed simplifies the implant by decreasing the defibrillation connections into a single terminal pin and reducing the number of set screws QHR chemistry batter
288. ow X Firm Red 1 soft J Shape stylet Green with White Cap 1 Implant Tool DSO6002 only and 1 Universal Clip On Tool DS06002 Stylets are 8 cm longer for compatibility with Implant Tool Ordering Information Model Number Length cm Implant Tool DS06002 52 52 1 included DS06002 58 58 1 included DS06002 60 60 1 included DS06002 65 65 1 included DS06002 75 75 1 included DS06002 85 85 1 included DS06003 52 52 DS06003 58 58 DS06003 65 65 DS06003 75 75 DS06003 85 85 DS06003 100 100 Customer Support 46 8 474 4756 Brief Summary Prior to using these devices please review the Instructions for Use for a complete listing of indications contraindications warnings precautions potential adverse events and directions for use Devices depicted may not be available in all countries Check with your St Jude Medical representative for product availability in your country Unless otherwise noted indicates that the name is a trademark of or licensed to St Jude Medical or one of its subsidiaries ST JUDE MEDICAL the nine squares symbol and MORE CONTROL LESS RISK mn are registered and unregistered trademarks and service marks of St Jude Medical Inc and its related companies S M B 2011 St Jude Medical Inc All rights reserved T JUDE E DICAL MORE CONTROL LESS RISK Accessories Traffic Light Stylet Product Highlights Stylets for passive fixation leads Each pack contains
289. ow Very Slow Off 30 150 in steps of 5 90 130 in steps of 5 140 180 in steps of 10 25 30 200 in steps of 10 225 325 in steps of 25 25 30 200 in steps of 10 225 300 in steps of 25 350 125 160 400 in steps of 30 440 470 190 400 in steps of 30 440 470 93 125 157 190 400 in steps of 30 440 470 125 500 in steps of 25 125 16 3 Sensitivity is with respect to a 20 ms haversine test signal 4 Values 0 1 0 4 not available in a Unipolar Sense Configuration 5 This parameter is not programmable 6 The highest available setting for hysteresis rate is 5 min below the programmed base rate 7 In dual chamber modes the maximum Ventricular Refractory Period is 325 ms 8 Programming options dependent on pacing mode 9 During atrial NIPS in dual chamber modes the shortest Coupling Interval will be limited by the programmed AV PV Delay 10 S1 Burst Cycle is applied at the preprogrammed S1 cycle length Customer Support 46 8 474 4756 Brief Summary Prior to using these devices please review the Instructions for Use for a complete listing of indications contraindications warnings precautions potential adverse events and directions for use Devices depicted may not be available in all countries Check with your St Jude Medical representative for product availability in your country Unless otherwise noted indicates that the name is a trademark of or licensed to St Jude Medical or one of its subsidi
290. p on tool length designation 1 J shaped soft 1 x soft 1 soft 1 firm 1 x firm DS06003 with appropriate 46 52 and 58 cm 1 clip on tool 1 J shaped soft length designation 1 x soft 1 soft 1 firm 1 x firm Locator Plus 1281 with appropriate 46 52 and 58 cm Disposable implant tool to Deflectable Stylet length designation facilitate precise lead positioning 1292 with appropriate 46 52 and 58 cm and manipulation with one hand length designation MP35N is a trademark of SPS Technologies Inc Customer Support 46 8 474 4756 Brief Summary Prior to using these devices please review the Instructions for Use for a complete listing of indications contraindications warnings precautions potential adverse events and directions for use Devices depicted may not be available in all countries Check with your St Jude Medical representative for product availability in your country Unless otherwise noted indicates that the name is a trademark of or licensed to St Jude Medical or one of its subsidiaries ST JUDE MEDICAL the nine squares symbol and MORE CONTROL LESS RISK are registered and unregistered trademarks and service marks of St Jude Medical Inc and its related companies 2011 St Jude Medical Inc All rights reserved ST JUDE ME DICAL Item GMCRM741EN MORE CONTROL LESS RISK Tendril STS Pacing Lead Product Highlights Soft silicone tip offers more compliance and less tip pressure at the lead
291. p to 45 minutes including up to 1 minute programmable pre trigger SenseAbility Technology Automatic Sensitivity Control adjustment for ventricular events data per VT VF diagnosis detection electrograms triggers include Threshold Start Post Sensed Ventricular 50 62 5 75 100 diagnosis therapy PC shock delivery noise reversion magnet reversion Post Paced Ventricular Auto 0 2 3 0 mV and morphology template verification Decay Delay Post Sensed Post Paced Ventricular 0 220 Therapy Summary Diagram of therapies delivered Post Paced Ventricular Auto Episodes Summary Directory listing of up to 60 episodes with access to more details including Ventricular Sense Refractory ms Detection Zones SVT Discriminators Reconfirmation Antitachycardia Pacing Therapy 125 157 stored electrograms VT VT 2 VF Lifetime Diagnostics History of bradycardia events and device initiated charging j Ventricular HV Lead Impedance Trend Multi Vector Trend Data istograms Event Histogram Ventricular Heart Rate Histogram Exercise and Activity Trending Pacing lead impedances high voltage lead impedances unloaded battery voltage and signal amplitudes Sudden Onset Interval Stability Morphology Discrimination MD with Manual or Automatic Template Update Continuous sensing during charging Real Time Measurements RTM ATP Configurations Ramp Burst Scan 1 or 2 schemes per VT zone Burst Cycle Length Adaptive Readapt
292. panies 2011 St Jude Medical Inc All rights reserved EBEN mam ST JUDE MEDICAL Item GMCRM738EN MORE CONTROL LESS RISK Accent MRI SR Single Chamber Pacemaker Product Highlights The Accent MRI pacemaker has been designed and tested for safe performance of a full body MRI scan without zone restrictions using a 1 5 T Tesla field strength MRI scanner The MRI conditional device Allows a maximum whole body averaged specific absorption rate SAR of 4 watts per kilogram W kg for high image resolution Pace S Must be used in conjunction with an MRI lead from St Jude Medical a An optional easy to use hand held device SJM MRI Activator device can be used to program the device to pre approved MRI settings pre and post MRI scan decreasing the number of workflow steps and increasing clinic efficiency State of the art features such as automaticity Ventricular AutoCapture Pacing System and SenseAbility technology are designed to deliver optimal therapy for patients at implant and throughout their lives Industry leading longevity offers 14 2 years of service life which is supported by a 7 year warranty 1 The St Jude Medical MRI conditional pacing system can be scanned in patients under the following conditions horizontal closed bore clinical scanner working in the Normal Operating Mode or First Level Controlled Operating Mode static magnetic field strength of 1 5 Tes
293. patients where permanent fixation of passive leads is suspected to be unstable In atrial applications the use of a screw in lead such as the IsoFlex may be indicated in the presence of an abnormal surgically altered or excised atrial appendage Contraindications The lsoFlex lead is contraindicated In the presence of tricuspid atresia for patients with mechanical tricuspid valves in patients who are expected to be hypersensitive to a single dose of one milligram of dexamethasone sodium phosphate Customer Support 46 8 474 4756 Brief Summary Prior to using these devices please review the Instructions for Use for a complete listing of indications contraindications warnings precautions potential adverse events and directions for use Devices depicted may not be available in all countries Check with your St Jude Medical representative for product availability in your country Unless otherwise noted indicates that the name is a trademark of or licensed to St Jude Medical or one of its subsidiaries ST JUDE MEDICAL the nine squares symbol and MORE CONTROL LESS RISK are registered and unregistered trademarks and service marks of St Jude Medical Inc and its related companies 2011 St Jude Medical Inc All rights reserved Adverse Events Potential complications associated with the use of IsoFlex leads are the same as with the use of other active fixation leads and include cardiac tamponade diaphragmatic sti
294. phyr XL DR Dual Chamber Pacemaker Product Specifications PHYSICAL SPECIFICATIONS Model 5826 Dimensions mm 44x52x6 Weight g 23 5 Volume cc 1 Connector IS 1 compatible PARAMETER SETTINGS Rate Timing Atrial Absolute Refractory Period 60 80 100 350 in steps of 25 Atrial Protection Interval ms 125 Paced AV Delay ms 25 30 200 in steps of 10 225 300 in steps of 25 350 Base Rate min 305 40 130 in steps of 5 140 170 in steps of 10 Far Field Protection Interval ms 162 Hysteresis Rate min Off 303 130 in steps of 5 140 1504 Search Interval min Off 5 10 15 30 Cycle Count 1 16 in steps of 1 ntervention Rate min Off 60 80 120 in steps of 10 Intrinsic 0 Intrinsic 10 Intrinsic 20 Intrinsic 30 ntervention Duration min 1 10 in 1 minute intervals Recovery Time Fast Medium Slow Very Slow Maximum Tracking Rate min 90 130 in steps of 5 140 180 in 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 Ventricular Atrial Blanking ms 155 165 170 180 185 195 200 PVARP ms 125 500 in steps of 25 Sensed AV Delay ms 25 30 200 in steps of 10 225 325 in steps of 25 Rest Rate min Off 30 130 in steps of 5 140 150 Shortest AV Delay ms 30 50 in steps of 5 60 120 in steps of 10 Ventricular Blanking ms Ventricular Refractory ms Auto 12 52 in steps of 4 12 125 500 in steps of 25
295. plications and more Automatic daily high voltage lead integrity test is designed to ensure optimal patient safety Ordering Information Contents Cardiac pulse generator Model Dimensions Connector Connector Number H x W x T mm Weight g Volume cc Defibrillation Sense 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 Indications The devices are intended to provide ventricular antitachycardia pacing and ventricular defibril lation for automated treatment of life threatening ventricular arrhythmias Contraindications Contraindications for use of the pulse generator system include ventricular tachyarrhythmias resulting from transient or correctable factors such as drug toxicity electrolyte imbalance or acute myocardial infarction Adverse Events Implantation of the pulse generator system like that of any other device involves risks some possibly life threatening These include but are not limited to the following acute hemorrhage bleeding air emboli arrhythmia acceleration cardiac or venous perforation cardiogenic shock cyst formation erosion exacerbation of heart failure extrusion fibrotic tissue growth fluid accumulation hematoma formation histotoxic reactions infection keloid formation myocardial irritability nerve damage pneumothorax Customer Support 46 8 474 4756 Brief Summary Prior to using these devices please review the Instructions for Use for a complete listing of in
296. plitude Monitoring Magnet Response Lead Type NIPS Options Stimulation Chamber Coupling Interval ms S1 Count S15 S2 3 and S4 Cycle ms Sinus Node Recovery Delay sec 1 5 0 5 cc 2 The actual pacing rate for the 30 ppm is 31 ppm 2005 750 1000 1250 1500 1750 2000 Off 0n Off Battery Test Uncoded Unipolar Bipolar Only Unipolar Bipolar Atrial or Ventricular 100 800 in steps of 10 1 25 in steps of 1 100 800 in steps of 10 1 5 in steps of 1 3 The highest available setting for Hysteresis Rate will be 5 ppm below the programmed Base Rate 4 Sensitivity is with respect to a 20 ms haversine test signal 5 This parameter is not programmable 6 S1 Burst Cycle is applied at the preprogrammed S1 cycle length tT mam ST JUDE MEDICAL MORE CONTROL LESS RISK Microny Il SR Single Chamber Pacemaker Product Highlights The AutoCapture pacing system offers the maximum in threshold adaptability and patient safety with ventricular Beat by Beat capture confirmation P R sensitivity parameter Slope Beat by Beat lead impedance monitoring Automatic P R sensitivity test suggests a programmed value for the Accelerometer sensor provides reliable rate response with only one programmable Comprehensive diagnostics and management tools including measured data rate prediction model stimulation threshold vs time sensor indicated rate vs time and others Ordering Information
297. pping process improves tracking on a guidewire Reliable peeling characteristics Sheath can be totally occluded without kinking to prevent air inspiration Di Lock feature secures dilator in sheath during insertion Ordering Information Contents Peel Away Sheath Di Lock Dilator and 80 cm Guidewire with 3 mm J 10 units per box Model Maximum Guidewire Sheath Usable Number Size F Diameter in Length 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 _ ne U S Patent Number 5 098 392 Customer Support 46 8 474 4756 Brief Summary Prior to using these devices please review the Instructions for Use for a complete listing of indications contraindications warnings precautions potential adverse events and directions for use Devices depicted may not be available in all countries Check with your St Jude Medical representative for product availability in your country Unless otherwise noted indicates that the name is a trademark of or licensed to St Jude Medical or one of its subsidiaries ST JUDE MEDICAL the nine squares symbol and MORE CONTROL LESS RISK a are registered and unregistered trademarks and service marks of St Jude Medical Inc and its related companies S M B 2011 St Jude Medical Inc All rights reserved T JUDE E DICAL MORE CONTROL LESS RISK Ac
298. priate for patients who experience angina or other symptoms of myocardial dysfunction at higher sensor driven rates An appropriate Maximum Sensor Rate should be selected based on assessment of the highest stimulation rate tolerated by the patient AF Suppression Models PM2134 and PM2136 only stimulation is not recommended in patients who cannot tolerate high atrial rate stimulation Customer Support 46 8 474 4756 Brief Summary Prior to using these devices please review the Instructions for Use for a complete listing of indications contraindications warnings precautions potential adverse events and directions for use Devices Connector IS 1 Weight g Volume cc 23 5 11 Dual Chamber Pacing Models PM2134 and PM2136 only though not contraindicated for patients with chronic atrial flutter chronic atrial fibrillation or silent atria may provide no benefit beyond that of single chamber pacing in such patients Single Chamber Ventricular Demand Pacing is relatively contraindicated in patients who have demonstrated pacemaker syndrome have retrograde VA conduction or suffer a drop in arterial blood pressure with the onset of ventricular pacing Single Chamber Atrial Pacing is relatively contraindicated in patients who have demonstrated compromise of AV conduction For specific contraindications associated with individual modes see the programmer s on screen help Potential Adverse Events Arrhythmia heart block thrombosis thre
299. ps of 5 60 120 in steps of 10 No of Consecutive PVCs 253 4 5 Ventricular Blanking ms Auto 12 52 in steps of 4 Noise Reversion Off Low High Ventricular Pace Sense Refractory ane Fixed ms 125 160 400 in steps of 30 440 470 Dther Dutput Sensing Aand V Lead Monitoring Monitor Auto Polarity Switch m 7 A and V Low Impedance Limit Q 00 500 in steps of 25 ACap Confirm On Off Monitor A and V High Impedance Limit Q 750 2500 in steps of 250 3000 Primary Pulse Configuration Bipolar Lead Type ncoded Unipolar Bipolar Backup Pulse Configuration Bipolar Magnet Response Off Battery Test Backup Pulse Amplitude V 5 0 Negative AV Hysteresis Search ms Off 10 to 120 in steps of 10 Search Interval hours 8 24 NIPS Options A or V Pulse Amplitude V 0 25 4 0 in steps of 0 25 4 5 7 5 in steps of 0 5 Stimulation Chamber Atrial Ventricular A or V Pulse Width ms 0 05 0 1 1 5 in steps of 0 1 Coupling Interval ms 00 800 in steps of 108 A or V Pulse Configuration Unipolar tip case Bipolar tip ring SI Count 2 25 in steps of 1 Aor V Sense Configuration Unipolar Tip tip case Bipolar tip ring SI S2 S3 and S4 Cycle ms Off 100 800 in steps of 10 Fixed or Adaptive n Unipolar Ring ring case i Ventricular Support Rate min Off 30 95 in steps of 5 Atrial Sensitivity mV 0 1 0 4 in steps of 0 1 0 5 0 75 2 0 in steps of 0 25 Sinus Node Recovery Delay sec 23 4 5 2 5 4 0 in steps of 0 5 5 0 PMT Option
300. r St Jude Medical representative for product availability in your country Unless otherwise noted indicates that the name is a trademark of or licensed to St Jude Medical or one of its subsidiaries ST JUDE MEDICAL the nine squares symbol and MORE CONTROL LESS RISK aan are registered and unregistered trademarks and service marks of St Jude Medical Inc and its related companies S I M i 2011 St Jude Medical Inc All rights reserved EUN JUDE E DICAL MORE CONTROL LESS RISK Accessories CPS Luminary Bideflectable Catheter with Lumen Product Highlights Two deflectable curves a large deflection to facilitate coronary sinus cannulation and a small deflection for target vein subselection Soft atraumatic tip features bipolar mapping electrodes to confirm CS entry CPS Direct SL outer guide catheters can be tracked over CPS Luminary catheter into the target vein Ordering Information Model Working Overall Inner Lumen Number Description Size cm Length 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 deflection Small deflection for CS Cannulation for subselection of target branch vein Separately Available Accessories Model Pin Working Number Name Design Length cm 402854 Bipolar Extension Cable Shrouded 2 mm length pin 210 402855 Bipolar Extension Cable Unshrouded 2 mm length pin 210
301. r Tip tip case Bipolar tip ring Unipolar Ring ring case A Sensitivity 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 in steps of 5 60 Sensor On Off Passive Max Sensor Rate ppm 80 150 in steps of 5 160 180 in 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 in steps of 0 5 Slope Auto 1 Auto 0 Auto 1 Auto 2 Auto 3 1 16 8 Reaction Time Very Fast Fast Medium Slow Recovery Time Fast Medium Slow Very Slow Other Magnet Response Off Battery Test Autolntrinsic Conduction Search ms Off 10 to 120 in steps of 10 Negative AV PV Hysteresis Search ms Off 10 to 110 in steps of 10 Atrial Tachycardia Detection Rate ppm 110 150 in steps of 5 160 200 in steps of 10 225 300 in steps of 25 225 Post Vent Atrial Blanking PVAB ms 60 70 80 85 95 100 110 115 125 130 140 150 155 165 170 180 185 195 200 Vent Safety Standby Off On PVC Options Off PVARP on PVC PMT Options Off 10 Beats gt PMT Auto Detect PMT Detection Rate ppm 90 150 in steps of 5 160 180 in steps of 10 110 Lead Type Uncoded Unipolar Bipolar Only Unipolar Bipolar 1 x 0 5 cc
302. r licensed to St Jude Medical or one of its subsidiaries ST JUDE MEDICAL the nine squares symbol and MORE CONTROL LESS RISK are registered and unregistered trademarks and service marks of St Jude Medical Inc and its related companies 2011 St Jude Medical Inc All rights reserved Item GMCRM815EN LLL mam ST JUDE MEDICAL MORE CONTROL LESS RISK Zephyr SR Single Chamber Rate Responsive Pacemaker Product Highlights Small physiologic shaped device maximises longevity without compromising size Instant follow up with automatic P or R wave lead impedance measurements and threshold tests resulting in 100 of follow up completed before the patient arrives at the clinic S N 123456 m The AutoCapture pacing system offers the maximum in threshold adaptability and patient safety with ventricular Beat by Beat capture confirmation ACap confirm feature periodically completes a threshold search and adjusts the pulse amplitude accordingly in the atrium a Stored electrograms EGMs record a real time EGM waveform as well as the associated event markers that precede and follow a specific triggering event Automatic daily measurement and weekly trending of intrinsic P or R waves a Automatic lead impedance measurement Display of weekly lead impedance trend historical test results pacing polarity and any polarity switches Physiologic based rest rate not subject to changes in time
303. r one of its subsidiaries ST JUDE MEDICAL the nine squares symbol and MORE CONTROL LESS RISK m are registered and unregistered trademarks and service marks of St Jude Medical Inc and its related companies S M B 2011 St Jude Medical Inc All rights reserved T JUDE E DICAL MORE CONTROL LESS RISK Accessories High Voltage Leads Stylets Product Highlights For Riata and Durata family of leads Available in multiple stiffness levels and taper lengths X Firm stylet is not recommended for Riata ST leads Ordering Information Model Number Description Stiffness Diameter in Taper Length cm S 65 XS for 65 cm leads X Soft 0 014 4 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 repositioning Kit includes 3 Soft Stylets Green 2 Firm Stylets Yellow 1 X Firm Stylet Red Ordering Information Model Number Lead Length cm Taper Length cm 4078S 75 15 75 15 4078S 86 15 86 15 4078S 75 5 15 5 40788 86 5 86 5 Customer Support 46 8 474 4756 Brief Summary Prior to using these devices please review the Instructions for Use for a complete listing of indications contraindications warning
304. r patients with h d fA tricuspid valvular disease or a mechanical heart valve Durata leads are contraindicated for patients for whom complex flexural and torsional forces interactions with leads and or the pulse generator or other forces a single dose of 1 0 mg of dexamethasone sodium phosphate is contraindicated The Durata 7120 71200 associated with cardiac contractions and patient physical activity posture and anatomical influences Cardiac 7121 71210 7122 71220 7170 71700 7171 71710 and 71720 leads are contraindicated for extra firm red leads functional lifetimes can he affected by these and other factors color knob stylets The lead is not designed sold or intended for use other than as indicated Refer to the defibrillator manual for additional complications and precautions specific to the pulse generator WARNING Implanted cardiac leads are subjected to a hostile environment within the body due to constant Customer Support 46 8 474 4756 Brief Summary Prior to using these devices please review the Instructions for Use for a complete listing of indications contraindications warnings precautions potential adverse events and directions for use Devices depicted may not be available in all countries Check with your St Jude Medical representative for product availability in your country Unless otherwise noted indicates that the name is a trademark of or licensed to St Jude Medical or one of its subsidiaries
305. r program a device because of programmer malfunction infection interruption of desired device function due to electrical interference loss of desired pacing and or sensing due to lead displacement body reaction at electrode interface or lead malfunction fracture or damage to insulation loss of normal device function due to battery failure or component malfunction device migration pocket erosion or hematoma pectoral muscle stimulation phrenic nerve or diaphragmatic stimulation The following in addition to the above are potential complications associated with the use of rate modulated pacing systems inappropriate rapid pacing rates due to sensor failure or to the detection of signals other than patient activity loss of activity response due to sensor failure palpitations with high rate pacing Refer to the User s Manual for detailed indications contraindications warnings precautions and potential adverse events ST JUDE MEDICAL MORE CONTROL LESS RISK Pace ers Accent SR Single Chamber Pacemaker Product Specifications PHYSICAL SPECIFICATIONS Stored Electrograms L 3 4 IM GMCRMSB Model Telemetry Dimensions mm Weight g Volume cc Connector PARAMETER Rate Timing PM1110 Inductive 42x52x6 18 9 5 IS 1 SETTINGS Ventricular Pace Sense Refractory Fixed ms Base Rate min Mode Hysteresis Rate min Search Interval
306. rademarks and service marks of St Jude Medical Inc and its related companies 2011 St Jude Medical Inc All rights reserved Item GMCRM769EN GMCRM 76 EBEN mem ST JUDE MEDICAL ann MORE CONTROL LESS RISK Cardiac Resynchronisation Therapy CRT Anthem Cardiac Resynchronisation Therapy Pacemaker Product Highlights AT AF Alerts can be programmed to notify patients and their clinics when a programmed AT AF threshold or continuous episode duration has been exceeded or when a high ventricular rate accompanies the AT AF episode Exclusive AF Suppression algorithm is clinically proven to suppress episodes of paroxysmal and persistent AF St JUDE MEDICAL nor CA USA AT AF burden trend provides a graphical representation of the percentage of time in AT AF and the number of AT AF episodes in the previous 52 weeks Exclusive SenseAbility feature with Decay Delay and Threshold Start provides the flexibility to fine tune sensing to individual patient needs and help eliminate oversensing of T waves fractionated QRS complexes and other extraneous signals Up to 14 minutes of stored electrograms help identify key intrinsic and pacemaker related events and simplify the diagnosis of complex ECG rhythms associated with heart failure Ordering Information Contents Cardiac pulse generator Model Number Dimensions H x W x T mm PM3112 52x52x6 Indications Implantation of Anthem and Anthem R
307. radycardia and Normal Potential Adverse Events Adverse events associated with the use of any pacing system include Air sinus rhythm with only rare episodes of A V block or sinus arrest chronic atrial fibrillation severe physical embolism Bleeding Hematoma Body rejection phenomena Cardiac tamponade or perforation Formation disability AF Suppression Models 5826 5820 only is indicated for suppression of paroxysmal or persistent of fibrotic tissue local tissue reaction Inability to interrogate or program due to programmer or device atrial fibrillation episodes in patients with one or more of the above pacing indications For specific indications malfunction Infection erosion Interruption of desired pulse generator function due to electrical interference associated with individual modes refer to Operating Modes either electromyogenic or electromagnetic Lead malfunction due to conductor fracture or insulation degradation Loss of capture or sensing due to lead dislodgement or reaction at the electrode tissue interface Loss of desired pacing and or sensing due to lead displacement body reaction at electrode interface or lead malfunction fracture or damage to insulation Loss of normal device function due to battery failure or component malfunction Pacemaker migration pocket erosion or hematoma Pectoral muscle or diaphragmatic stimulation Phrenic nerve stimulation Pneumothorax hemothorax Contraindications Zephyr devices are contraindi
308. recommended in patients who cannot tolerate high atrial rate stimulation Dual chamber pacing though not contraindicated for patients with chronic atrial flutter chronic atrial Customer Support 46 8 474 4756 Brief Summary Prior to using these devices please review the Instructions for Use for a complete listing of indications contraindications warnings precautions potential adverse events and directions for use Devices depicted may not be available in all countries Check with your St Jude Medical representative for product availability in your country Unless otherwise noted indicates that the name is a trademark of or licensed to St Jude Medical or one of its subsidiaries ST JUDE MEDICAL the nine squares symbol and MORE CONTROL LESS RISK are registered and unregistered trademarks and service marks of St Jude Medical Inc and its related companies 2011 St Jude Medical Inc All rights reserved fibrillation or silent atria may provide no benefit beyond that of single chamber pacing in such patients Single chamber ventricular demand pacing is relatively contraindicated in patients who have demonstrated pacemaker syndrome have retrograde VA conduction or suffer a drop in arterial blood pressure with the onset of ventricular pacing Single chamber atrial pacing is relatively contraindicated in patients who have demonstrated compromise of AV conduction Adverse Events The following are potential complications
309. registered and unregistered trademarks and service marks of St Jude Medical Inc and its related companies 2011 St Jude Medical Inc All rights reserved Item GMCRM812EN Stored Electrograms Pace ers Options Priority Options Off Low High Channel 1 2 3 Triggers Magnet Response Off Low High High Ventricular Rate Off Low High Rate min 125 300 in steps of 25 No of Consecutive Cycles 2 3 4 5 10 15 20 Advanced Hysteresis Off Low High Noise Reversion Off Low High Other Lead Monitoring Monitor Auto Polarity Switch V Low Impedance Limit Q 00 500 in steps of 225 V High Impedance Limit Q Magnet Response Lead Type NIPS Options Stimulation Chamber Coupling Interval ms 1 Count SI 2 S3 and S4 Cycle ms Diagnostic Trends Patient Notifiers 750 2500 in steps of 250 3000 Off Battery Test ncoded Unipolar Bipolar Ventricular 00 800 in steps of 10 2 25 in steps of 1 00 800 in steps of 10 Fixed or Adaptive Exercise Lead Impedance R Wave V Threshold Programmable Notifiers On Off Device Reset Entry into Backup VVI Mode Audible Duration sec Number of Audible Alerts per Notification Number of Notifications Time Between Notifications hours 120 5cc Device at ERI Ventricular Lead Impedance Out of Range On On 2 4 6 8 10 12 14 16 2 1 16 10 22 2 Programming options dependent on pacing mode 3 The highest available setting for hysteresis rate
310. rial 0 2 3 0 mV Post Sensed Ventricular 50 62 5 75 10075 Post Paced Ventricular Auto 0 2 3 0 mV Post Sensed Post Paced Atrial Ventricular 0 220 Post Paced Ventricular Auto 25 157 VT 1 VT 2 VF AV Rate Branch Sudden Onset Interval Stability Morphology Discrimination MD with Manual or Automatic Template Update Continuous sensing during charging ATP Configurations Burst Cycle Length Min Burst Cycle Length ms Number of Bursts Stimuli Add Stimuli per Burst High Voltage Therapy Ramp Burst Scan 1 or 2 schemes per zone Readaptive or Fixed 50 400 in increments of 5 15 with 2 20 Stimuli On Off igh Voltage Output Mode Waveform RV Polarity Electrode Configuration Bradycardia Pacing Fixed Pulse Width Fixed Tilt Biphasic Monophasic Cathode Anode RV to Can RV to SVC Can Permanent Modes Temporary Modes Rate Adaptive Sensor Programmable Rate and Delay Parameters Auto Mode Switch AMS Off DDD R DDT R DDI R VVT R VVI R AAI R DOO R VOO R AOO R Off DDD R DDT R DDI R VVT R VVI R AAI R AAT R DOO V00 A00 On Off Passive Off Base Rate min Rest Rate min Maximum Tracking Rate min Maximum Sensor Rate min Paced AV Delay ms Sensed AV Delay ms Rate Responsive AV Delay Pulse Amplitude Atrial RV and LV V Pulse Width Atrial RV and LV ms Hysteresis Rate min Rate Hysteresis with Search Off D
311. ricular pacing lead enables 10 pacing configuration options to provide better management of pacing complications intra and post operatively Less Risk Optim lead insulation combines the biostability and flexibility of high performance silicone and the strength tear resistance and abrasion resistance of polyurethane The combination enables an abrasion resistant thin diameter lead LLL msa ST JUDE MEDICAL MORE CONTROL LESS RISK Left Heart Leads Quartet Left Heart Lead Product Highlights Four pacing electrodes to provide more options and greater control in pacing y vector selection Superb deliverability with exceptional stability and performance Low profile 4 7 F lead body 4 0 F lead tip Optim lead insulation a chemical co polymer that blends the best features of polyurethane and silicone for improved handling and increased durability Steerable tip distal tip angle can be controlled to maneuver through venous anatomy Flexible lead body narrow ring electrodes provide lead tip flexibility Allows Direct To Target placement through CPS Aim SL inner catheter to deliver leads to small acute venous anatomies that may have been unreachable in the past Compatible with over the wire or stylet approaches Ordering Information Contents Left heart lead Model Insulation S Curve Minimum Number Height mm Introducer F Connector Lengths cm 1458Q Optim 16 5 IS4 LLLL 75
312. rillation episodes in patients with one or more of the above pacing indications For specific indications associated with individual modes refer to Operating Modes Contraindications Zephyr devices are contraindicated in patients with an implanted cardioverter defibrillator Rate Adaptive Pacing may be inappropriate for patients who experience angina or other symptoms of myocardial dysfunction at higher sensor driven rates An appropriate Maximum Sensor Rate should be selected based on assessment of the highest stimulation rate tolerated by the patient AF Suppression Models 5826 5820 only stimulation is not recommended in patients who cannot tolerate high atrial rate stimulation Customer Support 46 8 474 4756 Brief Summary Prior to using these devices please review the Instructions for Use for a complete listing of indications contraindications warnings precautions potential adverse events and directions for use Devices depicted may not be available in all countries Check with your St Jude Medical representative for product availability in your country Unless otherwise noted indicates that the name is a trademark of or licensed to St Jude Medical or one of its subsidiaries ST JUDE MEDICAL the nine squares symbol and MORE CONTROL LESS RISK are registered and unregistered trademarks and service marks of St Jude Medical Inc and its related companies 2011 St Jude Medical Inc All rights reserved Weight g 17
313. ring Unipolar Tip tip case Bipolar tip ring Unipolar Ring ring case 0 1 0 5 in steps of 0 1 0 75 2 0 in steps of 0 25 2 5 5 0 in steps of 0 5 0 0 4 0 in steps of 0 25 4 5 7 5 in steps of 0 5 0 05 0 1 1 5 in steps of 0 1 Rate Timing Mode AQO 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 R wave DDT Timing DDD DDI Base Rate min Hysteresis Rate min Search Interval min Cycle Count Intervention Rate min Intervention Duration min Recovery Time Rest Rate min Maximum Tracking Rate min AV Delay ms PV Delay ms Ventricular Refractory ms Atrial Refractory PVARP ms Ventricular Absolute Refractory Period ms Ventricular Blanking ms Atrial Absolute Refractory Period ms Atrial Protection Interval ms Far Field Protection Interval ms AF Management 30 40 130 in steps of 5 140 170 in steps of 10 Off 30 130 in steps of 5 140 150 Off 5 10 15 30 1 16 Off 60 80 120 in steps of 10 Intrinsic 0 Intrinsic 10 Intrinsic 20 Intrinsic 30 1 10 Fast Medium Slow Very Slow Off 30 130 in steps of 5 140 150 90 130 in steps of 5 140 180 in steps of 10 25 30 200 in steps of 10 225 300 in steps of 25 350 25 30 200 in steps of 10 225 325 in steps of 25 25 500 in steps of 25 25 500 in steps of 25 60 240 in steps of 10 2 52 in steps of 4 60 80 100 350 i
314. rks of St Jude Medical Inc and its related companies 2011 St Jude Medical Inc All rights reserved thromboemboli venous occlusion Other possible adverse effects include mortality due to component failure device programmer communication failure lead abrasion lead dislodgment or poor lead placement lead fracture inability to defibrillate inhibited therapy for a ventricular tachycardia interruption of function due to electrical or magnetic interference shunting of energy from defibrillation paddles system failure due to ionising radiation Other possible adverse effects include mortality due to inappropriate delivery of therapy caused by multiple counting of cardiac events including T waves P waves or supplemental pacemaker stimuli Among the psychological effects of device implantation are imagined pulsing dependency fear of inappropriate pulsing and fear of losing pulse capability Refer to the User s Manual for detailed indications contraindications warnings precautions and potential adverse events ST JUDE MEDICAL MORE CONTROL LESS RISK Product Specifications PHYSICAL SPECIFICATIONS Models Telemetry Delivered Stored Energy J Volume cc Weight g Size mm Defibrillation Lead Connections Sense Pace Lead Connections High Voltage Can PARAMETER AF Management D2211 36 CD2211 360 RF RF 36 42 36 42 42 4 80 80 77x50x14 74x50x14 DFI DF4 IS 1 DF4 Electrically acti
315. rmanent fixation of passive leads is suspected to be unstable In atrial applications the use of a screw in lead such as the Tendril SDX may be indicated in the presence of an abnormal surgically altered or excised atrial appendage Contraindications The Tendril ST Optim lead is contraindicated In the presence of tricuspid atresia for patients with mechanical tricuspid valves in patients who are expected to be hypersensitive to a single dose of one milligram of dexamethasone sodium phosphate Customer Support 46 8 474 4756 Brief Summary Prior to using these devices please review the Instructions for Use for a complete listing of indications contraindications warnings precautions potential adverse events and directions for use Devices depicted may not be available in all countries Check with your St Jude Medical representative for product availability in your country Unless otherwise noted indicates that the name is a trademark of or licensed to St Jude Medical or one of its subsidiaries ST JUDE MEDICAL the nine squares symbol and MORE CONTROL LESS RISK are registered and unregistered trademarks and service marks of St Jude Medical Inc and its related companies 2011 St Jude Medical Inc All rights reserved Min Introducer F Connector Lengths cm 6 IS 1 bipolar 46 52 58 65 7 IS 1 bipolar 46 52 Adverse Events Potential complications associated with the use of Tendril ST Optim leads are
316. roduct availability in your country Unless otherwise noted indicates that the name is a trademark of or licensed to St Jude Medical or one of its subsidiaries ST JUDE MEDICAL the nine squares symbol and MORE CONTROL LESS RISK a are registered and unregistered trademarks and service marks of St Jude Medical Inc and its related companies S M B 2011 St Jude Medical Inc All rights reserved B on T UDE E DICAL MORE CONTROL LESS RISK USB Cellular Adaptor For use with the Merlin home Transmitter Model EX1151 Product Specifications PHYSICAL SPECIFICATIONS CELLULAR TELECOMMUNICATION MODE GENERATION E N 9 1 9 RoHs Compliant Standards Approvals CE FCC PTCRB A tick GCF Industry Canada Package Contents USB Modem Clip USB Extension Cable Customer Support 46 8 474 4756 Models EX1151 Generation Acronym Title Dimensions mm 65x 25x 13 5 Volume cc 19 5 UIG AMPS Advanced Mobile Phone System Weight g 30 Radiocom 2000 Radiocom 2000 France Telecom NMT Nordic Mobile Telephone TECHNICAL SPECIFICATIONS 26 GSM Global System for Mobile Communication Technology USB Modem USB Port 2 56 GPRS General Packet Radio Service MSM 7201A i UMTS with HSDPA Category 8 7 2 Mbps downlink 2 756 EDGE Enhanced Data Rate for GSM Evolution HSUPA Category 5 2 0 Mbps uplink 2 5 ER EDGE GPRS MS Class 12 36 UMTS Universal Mobile Tele
317. ry Unless otherwise noted indicates that the name is a trademark of or licensed to St Jude Medical or one of its subsidiaries ST JUDE MEDICAL the nine squares symbol and MORE CONTROL LESS RISK are registered and unregistered trademarks and service marks of St Jude Medical Inc and its related companies 2011 St Jude Medical Inc All rights reserved Item GMCRM768EN EBEN mem ST JUDE MEDICAL EEE MORE CONTROL LESS RISK Cardiac Resynchronisation Therapy CRT Anthem RF Cardiac Resynchronisation Therapy Pacemaker Product Highlights InvisiLink wireless telemetry in conjunction with the Merlin home wireless transmitter and Merlin net Patient Care Network PCN allows for daily remote monitoring and follow up ST JUDE MEDICAL Sym CA USA ANTHEM RE AGR DDORV AT AF Alerts can be programmed to notify patients and their clinics when a programmed AT AF threshold or continuous episode duration has been exceeded or when a high ventricular rate accompanies the AT AF episode Exclusive AF Suppression algorithm is clinically proven to suppress episodes Merlin home of paroxysmal and persistent AF Transmitter Compatible AT AF burden trend provides a graphical representation of the percentage of time in AT AF and the number of AT AF episodes in the previous 52 weeks Up to 14 minutes of stored electrograms help identify key intrinsic and pacemaker related events and simplify the dia
318. s precautions potential adverse events and directions for use Devices depicted may not be available in all countries Check with your St Jude Medical representative for product availability in your country Unless otherwise noted indicates that the name is a trademark of or licensed to St Jude Medical or one of its subsidiaries ST JUDE MEDICAL the nine squares symbol and MORE CONTROL LESS RISK m are registered and unregistered trademarks and service marks of St Jude Medical Inc and its related companies S M B 2011 St Jude Medical Inc All rights reserved T JUDE E DICAL MORE CONTROL LESS RISK Accessories Peel Away Introducer 14 cm Sheath Introducer Kit 7 F 16F Product Highlights Proprietary materials improve insertion characteristics and reduce vessel trauma Close tolerance extrusion and proprietary tipping process improves tracking on a guidewire Reliable peeling characteristics Sheath can be totally occluded without kinking to prevent air inspiration Di Lock feature secures dilator in sheath during insertion Ordering Information Contents Peel Away Sheath Di Lock Dilator 12 cc syringe 18 ga XTW Needle and 50 cm Guidewire with 3 mm J Model Maximum Guidewire Sheath Usable Units Number Size F Diameter in Length cm per Box 405154 OO 7 F TW 7 038 i MEM 14 MEM 1 405145 8 F TW 038 14 1 405146 8F 038 14 1
319. s Off Passive Atrial Pace Ventricular AutoCapture PMT Detection Rate min 90 180 in steps of 5 Pacing System ue On Off PVC Response Off Atrial Pace Primary Pulse Configuration Unipolar Bipolar Ventricular Intrinsic Backup Pulse Configuration Unipolar Bipolar Preference VIP ms Off 50 150 in steps of 25 160 200 in steps of 10 Backup Pulse Amplitude V 5 0 VIP Search Interval 30 sec 1 3 5 10 30 min Search Interval hours 8 24 VIP Search Cycles 1 2 3 AutoCapture Ventricular Safety Standby Off On Paced Sensed AV Delay ms 50 25 100 70 120 100 Diagnostic Trends AT AF Activity Exercise Lead Impedance P and R Wave A and V Threshold Ventricular Sensitivity mV 0 5 5 0 in steps of 0 5 6 10 in steps of 1 0 12 57 s m SenseAbility Technology Off On Automatic Sensitivity Control adjustment for atrial Patient Notifiers and ventricular events J A Max Sensitivity mV 0 2 1 0 in steps of 0 1 Programmable Notifiers 0n Off Device at ERI Atrial Lead Impedance Out of Range V Max Sensitivity mV 0 2 2 0 in steps of 0 1 Ventricular Lead Impedance Out of Range AT AF Burden Threshold Start Atrial and Ventricular Post Sense 50 62 5 75 100 AT AF Episode Duration High V Rate During AT AF Atrial Post Pace 0 2 3 0 in steps of 0 1 mV Device Reset On Ventricular Post Pace Auto 0 2 3 0 in steps of 0 1 mV Entry into Backup VVI Mode On Decay Delay ms Atrial and Ventricular Post Sense 0 30 60 95 125 160 190 22
320. s Up to 45 minutes including up to one minute programmable pre trigger imr tiles Refractory ms 125 157 i data per VT VF diagnosis detection electrograms triggers include Detection Zones y Vr VI 2 VE diagnosis therapy atrial episode PMT termination PC shock delivery SVT Discriminators Reconfirmation Antitachycardia Pacing Therapy AV Rate Branch Sudden Onset Interval Stability Morphology Discrimination MD with Manual or Automatic Template Update Continuous sensing during charging noise reversion magnet reversion and morphology template verification Diagram of therapies delivered Directory listing of up to 60 episodes with access to more details including stored electrograms History of bradycardia events and device initiated charging Therapy Summary Episodes Summary Lifetime Diagnostics ATP Configurations Ramp Burst Scan 1 or 2 schemes per VT zone AT AF Burden Trend Trend data and counts ATP in VF Zone ATP While Charging ATP Prior to Charging Off Ventricular HV Lead Impedance Trend Multi Vector Trend Data ATP Upper Rate Cutoff 150 300 bpm Histograms Event Histogram AV Interval Histogram Mode Switch Duration Histogram Burst Cycle Length Adaptive Readaptive or Fixed Peak Filtered Rate Histogram Atrial Heart Rate Histogram Ventricular Min Burst Cycle Length ms 150 400 in increments of 5 Heart Rate Histogram AT AF Burden Exercise and Activity Trending Number of Bursts 1 15 V Rates during AMS Number
321. s for use Devices depicted may not be available in all countries Check with your St Jude Medical representative for product availability in your country Unless otherwise noted indicates that the name is a trademark of or licensed to St Jude Medical or one of its subsidiaries ST JUDE MEDICAL the nine squares symbol and MORE CONTROL LESS RISK are registered and unregistered trademarks and service marks of St Jude Medical Inc and its related companies 2011 St Jude Medical Inc All rights reserved tT mam ST JUDE MEDICAL MORE CONTROL LESS RISK IMPLANTABLE CARDIAC MONITORS Implantable Cardiac Monitors SJM Confirm Implantable Cardiac Monitor Model DM2100 ST JUDE MEDICAL SIM CONFIRM Product Highlights Implantable patient activated and automatically activated monitoring system that records subcutaneous ECGs and is indicated in the following cases Patients with clinical syndromes or situations at increased risk of cardiac arrhythmias Patients who experience transient symptoms that may suggest a cardiac arrhythmia Offers simple to configure data storage options to enable physicians to prioritise data based on individual patient conditions ensuring capture of significant events and to reduce the risk that unexpected events are missed Comprehensive diagnostic data reports provide a quick and accurate summary of heart rate assisting physicians in their diagnosis and treatment
322. s of 5 160 180 in steps of 10 110 150 in steps of 5 160 200 in steps of 10 225 300 in steps of 25 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 Base Rate 0 to Base Rate 35 in steps of 5 Options Sampling Options No of Stored EGMs Channel Triggers Advanced Hysteresis AMS Entry AMS Exit AT AF Detection Magnet Placement High Atrial Rate No of Consecutive Cycles Freeze Continuous 1 2 4 8 12 Atrial Ventricular Dual Cross Channel On Off On Off On Off On Off Off 125 150 175 200 225 250 275 300 2 3 4 5 10 15 20 High Ventricular Rate Off 125 150 175 200 225 250 275 300 No of Consecutive Cycles 2 3 4 5 10 15 20 PMT Termination On Off PVC Detection On Off No of Consecutive PVCs 2 3 4 5 Other Aand V Lead Monitoring Off Monitor Auto Polarity Switch A and V Low Impedance Limit Q A and V High Impedance Limit Q Lead Type Magnet Response Negative AV Hysteresis Search ms NIPS Options Stimulation Chamber Coupling Interval S1 Count S18 2 S3 and 4 Cycle ms Ventricular Support Rate min Sinus Node Recovery Delay sec PMT Options PMT Detection Rate min PVC Options Signal Amplitude Monitoring P Wave Monitoring R Wave Monitoring Ventricular Intrinsic Preference VIP ms VIP Search Interval VIP Search Cycles Ventricular Safety Standby 200 750 1000 1250 1500 1750 2000 Un
323. s of A V block or sinus arrest chronic atrial fibrillation severe tissue interface loss of desired pacing and or sensing due to lead displacement body reaction at electrode physical disability AF Suppression is indicated for suppression of paroxysmal or persistent atrial fibrillation interface or lead malfunction fracture or damage to insulation loss of normal device function due to battery episodes in patients with one or more of the above pacing indications failure or component malfunction pacemaker migration or pocket erosion pectoral muscle or diaphragmatic stimulation phrenic nerve stimulation pneumothorax hemothorax endocarditis excessive bleeding induced Contraindications Implanted Cardioverter Defibrillator ICD Devices are contraindicated in patients atrial or ventricular arrhythmias myocardial irritability pericardial effusion pericardial rub pulmonary with an implanted cardioverter defibrillator Rate Adaptive Pacing may be inappropriate for patients who edema rise in threshold and exit block valve damage cardiac coronary sinus dissection cardiac coronary experience angina or other symptoms of myocardial dysfunction at higher sensor driven rates An appropriate sinus perforation coronary sinus or cardiac vein thrombosis Maximum Sensor Rate should be selected based on assessment of the highest stimulation rate tolerated by E V 5 the patient AF Suppression stimulation is not recommended in patients who cannot tolerate h
324. s the most noninvasive options for managing high DFTs The SenseAbility feature provides the flexibility to fine tune programming around T wave oversensing without decreasing sensitivity Vibratory patient notifier enables patients with hearing problems to be alerted to a low battery lead related complications and more Ordering Information Contents Cardiac pulse generator Model Dimensions Connector Connector Number H x W x T mm Weight g Volume cc Defibrillation Sense Pace CD1235 40 73 x 40 x 14 76 35 DF1 IS 1 CD1235 40Q 71x 40x 14 75 35 DF4 DF4 Indications The devices are intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias Contraindications Contraindications for use of the pulse generator system include ventricular tachyarrhythmias resulting from transient or correctable factors such as drug toxicity electrolyte imbalance or acute myocardial infarction Adverse Events Implantation of the pulse generator system like that of any other device involves risks some possibly life threatening These include but are not limited to the following acute hemorrhage bleeding air emboli arrhythmia acceleration cardiac or venous perforation cardiogenic shock cyst formation erosion exacerbation of heart failure extrusion fibrotic tissue growth fluid accumulation hematoma formation Customer Support 46 8 474 4756 Brief Summ
325. security and patient comfort through multiple hardware and software system safeguards Merlin home Triggered pacing with BiV Trigger Mode helps maintain a high percentage of Due BiV pacing by triggering pacing in both the left and right ventricles in response i to a sensed ventricular event Negative AV hysteresis with search promotes ventricular pacing by automatically reducing the AV delay when intrinsic activity is present thereby promoting a high degree of ventricular pacing AT AF Alerts can be programmed to notify patients and their clinics when a programmed AT AF threshold or continuous episode duration has been exceeded or when a high ventricular rate accompanies the AT AF episode Vibratory patient notifier enables patients with hearing problems to be alerted to a low battery lead related complications and more QuickOpt timing cycle optimisation provides quick and effective optimisation for more patients at the push of a button VectSelect programmable LV pulse configuration LV ring RV coil LV tip RV coil or LV bipolar may be adjusted noninvasively via the programmer DeFT Response technology tools provide more clinically proven noninvasive options for managing high DFTs Ordering Information Contents Cardiac pulse generator Model Dimensions Connector Connector Number H x W x T mm Weight g Volume cc Defibrillation Sense Pace CD3211 36 81x50x 14 82 43 DF1 IS 1 CD3211 36Q 75x 50x 14 82 42 DF4 IS 1 DF4
326. selected based on assessment of the highest stimulation rate tolerated by the patient AF Suppression Models 5826 5820 only stimulation is not recommended in patients who cannot tolerate high atrial rate stimulation Customer Support 46 8 474 4756 Brief Summary Prior to using these devices please review the Instructions for Use for a complete listing of indications contraindications warnings precautions potential adverse events and directions for use Devices depicted may not be available in all countries Check with your St Jude Medical representative for product availability in your country Unless otherwise noted indicates that the name is a trademark of or licensed to St Jude Medical or one of its subsidiaries ST JUDE MEDICAL the nine squares symbol and MORE CONTROL LESS RISK are registered and unregistered trademarks and service marks of St Jude Medical Inc and its related companies 2011 St Jude Medical Inc All rights reserved Weight g 23 5 11 0 5 IS 1 Volume cc Connector Dual Chamber Pacing Models 5826 5820 only though not contraindicated for patients with chronic atrial flutter chronic atrial fibrillation or silent atria may provide no benefit beyond that of single chamber pacing in such patients Single Chamber Ventricular Demand Pacing is relatively contraindicated in patients who have demonstrated pacemaker syndrome have retrograde VA conduction or suffer a drop in arterial blood pres
327. shold elevation valve damage pneumothorax myopotential sensing vessel damage air embolism body rejection phenomena cardiac tamponade or perforation formation of fibrotic tissue local tissue reaction inability to interrogate or program a pulse generator because of programmer malfunction infection interruption of desired pulse generator function due to electrical interference loss of desired pacing and or sensing due to lead displacement body reaction at electrode interface or lead malfunction fracture or damage to insulation loss of normal pacemaker function due to battery failure or component malfunction pacemaker migration pocket erosion or hematoma pectoral muscle stimulation phrenic nerve or diaphragmatic stimulation The following in addition to the above are potential complications associated with the use of rate modulated pacing systems inappropriate rapid pacing rates due to sensor failure or to the detection of signals other than patient activity loss of activity response due to sensor failure palpitations with high rate pacing Refer to the User s Manual for detailed indications contraindications warnings precautions and potential adverse events depicted may not be available in all countries Check with your St Jude Medical representative for product availability in your country Unless otherwise noted indicates that the name is a trademark of or licensed to St Jude Medical or one of its subsidiaries
328. st with 10 ms interventricular delay p to 45 minutes including up to one minute programmable pre trigger data per VT VF diagnosis detection electrograms triggers include diagnosis therapy atrial episode PMT termination PC shock delivery noise reversion magnet reversion and morphology template verification Diagram of therapies delivered Directory listing of up to 60 episodes with access to more details including stored electrograms istory of bradycardia events and device initiated charging rend data and counts Multi Vector Trend Data Event Histogram AV Interval Histogram Mode Switch Duration Histogram Peak Filtered Rate Histogram Atrial Heart Rate Histogram Ventricular eart Rate Histogram AT AF Burden Exercise and Activity Trending V Rates During AMS nformation regarding PMT detections Pacing lead impedances high voltage lead impedances unloaded battery voltage and signal amplitudes 1 Mouchawar G Kroll M Val Mejias JE et al ICD waveform optimization a randomized prospective pair sampled multicenter study PACE 2000 23 Part 11 1992 1995 2 Sweeney MO Natale A Volosin KJ et al Prospective randomized comparison of 5026 5096 versus 6526 6596 tilt biphasic waveform on defibrillation in humans PACE 2001 24 60 65 3 Baker et al Acute evaluation of programmer guided AV PV and VV delay optimization comparing an IEGM method and echocardiogram for cardiac resynchronization therapy in heart failure patients and d
329. stal Tip sel Catheter 1 7F l Tip Deflection Hub 0 56 mm 3 5 cm Control Knob 70cm d i 88 cm i Customer Support 46 8 474 4756 Brief Summary Prior to using these devices please review the Instructions for Use for a complete listing of indications contraindications warnings precautions potential adverse events and directions for use Devices depicted may not be available in all countries Check with your St Jude Medical representative for product availability in your country Unless otherwise noted indicates that the name is a trademark of or licensed to St Jude Medical or one of its subsidiaries ST JUDE MEDICAL the nine squares symbol and MORE CONTROL LESS RISK ann are registered and unregistered trademarks and service marks of St Jude Medical Inc and its related companies S I M i 2011 St Jude Medical Inc All rights reserved EUN JUDE E DICAL MORE CONTROL LESS RISK Accessories Locator Plus Implant Tools Product Highlights Enables fast accurate endocardial lead positioning Facilitates lead maneuverability through tortuous venous pathways Eliminates the need for manual shaping re shaping re inserting and swapping multiple stylets Ordering Information 0 016 X Firm Model Number Description Radius mm Reach Length mm Length cm 1281 46 Locator Plus recommended for Atrial Use 14 40 46 1281 52 Locator Plus recommended for Atrial Use 14 40 52 1281 58 Locator
330. stered trademarks and service marks of St Jude Medical Inc and its related companies S M B 2011 St Jude Medical Inc All rights reserved uon T JUDE E DICAL MORE CONTROL LESS RISK Accessories CPS Aim SL Slittable Inner Catheter Cannulator with Integrated Valve Product Highlights Integrated hemostasis valve in slittable catheter design Hydrophilic coating on outer catheter surface to enable smooth passage New catheter shaft braid pattern for a kink resistant and torqueable cannulator Ordering Information Model Curve Shape Available Overall Number Length cm Length cm DS2NO24 CSL 65 68 DS2NO25 AL2 65 68 CSL AL2 Separately Available Accessories Model Number Name DS2A001 CPS Aim SL Inner Catheter SafeSheath Sealing Adapter DS2A002 CPS Aim SL Valve Bypass Tool DS2A003 CPS Universal Slitter Customer Support 46 8 474 4756 Brief Summary Prior to using these devices please review the Instructions for Use for a complete listing of indications contraindications warnings precautions potential adverse events and directions for use Devices depicted may not be available in all countries Check with your St Jude Medical representative for product availability in your country Unless otherwise noted indicates that the name is a trademark of or licensed to St Jude Medical or one of its subsidiaries ST JUDE MEDICAL the nine squares symbol and MORE CONTROL LESS RISK are regis
331. sure with the onset of ventricular pacing Single Chamber Atrial Pacing is relatively contraindicated in patients who have demonstrated compromise of AV conduction For specific contraindications associated with individual modes refer to Operating Modes Potential Adverse Events Adverse events associated with the use of any pacing system include Air embolism Bleeding Hematoma Body rejection phenomena Cardiac tamponade or perforation Formation of fibrotic tissue local tissue reaction Inability to interrogate or program due to programmer or device malfunction Infection erosion Interruption of desired pulse generator function due to electrical interference either electromyogenic or electromagnetic Lead malfunction due to conductor fracture or insulation degradation Loss of capture or sensing due to lead dislodgement or reaction at the electrode tissue interface Loss of desired pacing and or sensing due to lead displacement body reaction at electrode interface or lead malfunction fracture or damage to insulation Loss of normal device function due to battery failure or component malfunction Pacemaker migration pocket erosion or hematoma Pectoral muscle or diaphragmatic stimulation Phrenic nerve stimulation Pneumothorax hemothorax Refer to the User s Manual for detailed indications contraindications warnings precautions and potential adverse events LLL mem ST JUDE MEDICAL EEE MORE CONTROL LESS RISK N LL E
332. t Care System PCS Product Highlights 15 touch screen clearly displays programming and diagnostic screens New user interface allows for faster patient management Continuous simultaneous display of surface ECGs intracardiac electrograms EGMs and annotated event markers allow quick interpretation Built in top load top exit printer quickly and quietly prints full page 8 inch reports for patient charts Integrated cable storage speeds setup and saves space with always connected cables and ample storage space Ordering Information Model Number 3650 Merlin PCS accessories Model Number Part Number Part Number Description Merlin Patient Care System PCS Description 3001 3 Lead ECG Patient Cable 3626 5 Lead ECG Patient Cable 3134 60000909 001 VGA Cable and Adapter female to male 25 length 3615 60004294 001 Adapter for 3150 PSA Wand required for use of PSA Wand Model 3150 with the Merlin Patient Care System 3616 60005260 001 Wand Extension Cable 4 length 3617 60005251 001 External ECG Input Cable 25 length 3620 60005254 001 External 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 connection 3630 60002876 001 Merlin Patient Care System Telemetry Wand with Magnet 3630M 60002876 097 Magnet 3638 50019403 001 Antenna required to enable radio frequency RF commun
333. t ventricles in patients with congestive heart failure Contraindications Contraindications for use of the pulse generator system include ventricular tachyarrhythmias resulting from transient or correctable factors such as drug toxicity electrolyte imbalance or acute myocardial infarction Adverse Events Implantation of the pulse generator system like that of any other device involves risks some possibly life threatening These include but are not limited to the following acute hemorrhage bleeding air emboli arrhythmia acceleration cardiac or venous perforation cardiogenic shock cyst formation erosion Customer Support 46 8 474 4756 Brief Summary Prior to using these devices please review the Instructions for Use for a complete listing of indications contraindications warnings precautions potential adverse events and directions for use Devices depicted may not be available in all countries Check with your St Jude Medical representative for product availability in your country Unless otherwise noted indicates that the name is a trademark of or licensed to St Jude Medical or one of its subsidiaries ST JUDE MEDICAL the nine squares symbol and MORE CONTROL LESS RISK are registered and unregistered trademarks and service marks of St Jude Medical Inc and its related companies 2011 St Jude Medical Inc All rights reserved exacerbation of heart failure extrusion fibrotic tissue growth fluid accumulat
334. temporary Acute myocardial infarction induced heart block pulsegenerator can be used whenever temporary atrial or ventricular stimulation is indicated The device can Stimulation duri tricul tol beemployed for therapeutic as well as diagnostic purposes or be used prophylactically STIMULATION curing a ventHicular aSystol Some specific indications for temporary stimulation are Usage during the replacement of an implantable pacemaker Complete third degree or intermittent heart block Stimulation and monitoring before the implantation of a cardiac pacemaker Stimulation and monitoring following heart surgery Contraindications The Model 3077 SSI temporary pulse generator is contraindicated In the treatment of ventricular tachycardia When overall physiological condition of the patient limits the selection of the stimulation mode and thestimulation parameters Symptomatic sinus bradycardia Atrial or ventricular ectopic arrhythmia Sick sinus syndrome SSS Customer Rynia 8 474 4756 Brief Summary Prior to using these devices please review the Instructions for Use for a complete listing of indications contraindications warnings precautions potential adverse events and directions for use Devices depicted may not be available in all countries Check with your St Jude Medical representative for product availability in your country Unless otherwise noted indicates that the name is a trademark of or licensed to St Jude
335. tered and unregistered trademarks and service marks of St Jude Medical Inc and its related companies 2011 St Jude Medical Inc All rights reserved Inner Diameter F mm 5 1 83 5 1 83 Type Self sealing valve Valve bypass tool Slitter Outer Diameter F mm 712 29 712 29 tT mem ST JUDE MEDICAL MORE CONTROL LESS RISK Accessories CPS Courier Guidewires Product Highlights Helps physicians more easily subselect the target coronary branch vein and deliver the LV lead to its preferred destination b b bj Ordering Information Model Distal Units Number Support Length cm per box Diameter in 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 Enables optimal subselection of the branch vein and offers greater maneuverability and control of the LV lead Ordering Information Model Number Type Lengths cm Diameter DS2M001 CPS Duo Stylet 75 86 OD 0 014 LV lead lumen compatible ID 0 012 compatible DS2M006 CPS Duo Guidewire 195 0 012 Customer Support 46 8 474 4756 Brief Summary Prior to using these devices please review the Instructions for Use for a complete listing of indications contraindications warnings precautions potential adverse events and directions for use Devices depicted may not be available in all countries Check with you
336. test signal 8 During atrial NIPS in dual chamber modes the shortest Coupling Interval will be limited by the programmed AV PV delay 9 S1 Burst Cycle is applied at the pre programmed S1 cycle length LLLI mam ST JUDE MEDICAL MORE CONTROL LESS RISK Accent MRI DR Dual Chamber Pacemaker Product Highlights The Accent MRI pacemaker has been designed and tested for safe performance of a full body MRI scan without zone restrictions using a 1 5 T Tesla field strength MRI scanner The MRI conditional device Allows a maximum whole body averaged specific absorption rate SAR of 4 watts per kilogram W kg for high image resolution Must be used in conjunction with an MRI lead from St Jude Medical An optional easy to use hand held device SJM MRI Activator device can be used to program the device to pre approved MRI settings pre and post MRI scan decreasing the number of workflow steps and increasing clinic efficiency AT AF Alerts can be programmed to notify patients and or their clinics when a programmed AT AF threshold or continuous episode duration has been exceeded or when a high ventricular rate accompanies the AT AF episode A suite of state of the art features complete automaticity atrial and ventricular Ventricular Intrinsic Preference VIP technology QuickOpt timing cycle optimisation the AF Suppression algorithm and SenseAbility technology is designed to deliver opt
337. the psychological effects of device implantation are imagined pulsing dependency fear of inappropriate pulsing and fear of losing pulse capability Refer to the User s Manual for detailed indications contraindications warnings precautions and potential adverse events ST JUDE MEDICAL MORE CONTROL LESS RISK Implantable Cardioverter ibrillator Devices Product Specifications Models Telemetry Delivered Stored Energy J Volume cc Weight g Size mm Defibrillation Lead Connections Sense Pace Lead Connections High Voltage Can CD1235 40 CD1235 400 RF RF 40 45 40 45 35 35 76 75 73x40x14 71x40x14 DFI DF4 IS 1 DFA Electrically active titanium can Electrically active titanium can PARAMETERS SETTINGS Sensing Detection SenseAbility Technology Low Frequency Attenuation Threshold Start Decay Delay Ventricular Sense Refractory ms Detection Zones SVT Discriminators Reconfirmation Antitachycardia Pacing Therapy Automatic Sensitivity Control adjustment for atrial and ventricular events On Off Post Sensed Ventricular 50 62 5 75 100 Post Paced Ventricular Auto 0 2 3 0 mV Post Sense Post Pace Ventricular 0 220 125 157 VT VT 2 VF Sudden Onset Interval Stability Morphology Discrimination MD with Manual or Automatic Template Update Continuous sensing during charging ATP Configurations ATP in VF Zone ATP Upper Rate Cutoff Burst Cycle Length
338. the same as with the use of other active fixation leads and include cardiac tamponade diaphragmatic stimulation embolism excessive bleeding induced ventricular ectopy infection loss of pacing and or sensing due to dislodgment or mechanical malfunction of the pacing lead phrenic nerve stimulation thrombosis Complications reported with direct subclavian venipuncture include pneumothorax hemothorax laceration of the subclavian artery arteriovenous fistula neural damage thoracic duct injury cannulation of other vessels massive hemorrhage and rarely death Refer to the User s Manual for detailed indications contraindications warnings precautions and potential adverse events ST JUDE MEDICAL MORE CONTROL LESS RISK Tendril ST Optim Pacing Lead Product Specifications PHYSICAL SPECIFICATIONS Models 1888TC 1882TC Minimum Introducer Size 6F TF Type of Lead Transvenous screw in bipolar steroid Transvenous screw in bipolar steroid Shape Straight Atrial J Lead Lengths 46 52 58 65 cm 46 52cm Fixation Extendable retractable helix Extendable retractable helix Tip to Ring Spacing 10 mm 10mm Lead Tip Electrode Cathode Pt Ir collar active titanium nitride coated Pt Ir collar active titanium nitride coated Pt Ir helix 2 mm extension Pt Ir helix 2 mm extension Tip Electrode Surface Area 8 5 mm 8 5 mm Ring Electrode Anode Titanium nitride coated Pt Ir ring Titanium nitride coated Pt Ir ri
339. the use of any pacing system arrhythmia heart block thrombosis threshold elevation valve damage pneumothorax myopotential sensing vessel damage air embolism body rejection phenomena cardiac tamponade or perforation formation of fibrotic tissue local tissue reaction inability to interrogate or program a device because of programmer malfunction infection interruption of desired device function due to electrical interference loss of desired pacing and or sensing due to lead displacement body reaction at electrode interface or lead malfunction fracture or damage to insulation loss of normal device function due to battery failure or component malfunction device migration pocket erosion or hematoma pectoral muscle stimulation phrenic nerve or diaphragmatic stimulation The following in addition to the above are potential complications associated with the use of rate modulated pacing systems inappropriate rapid pacing rates due to sensor failure or to the detection of signals other than patient activity loss of activity response due to sensor failure palpitations with high rate pacing Refer to the User s Manual for detailed indications contraindications warnings precautions and potential adverse events LLL mem ST JUDE MEDICAL EEE MORE CONTROL LESS RISK 9OEN 7 Accent DR RF Dual Chamber Pacemaker Product Specifications PHYSICAL SPECIFICATIONS Model Telemetry Dimensions mm Weight g
340. timulation NIPS Patient Notifiers 0 5 5 0 20 100 2 25 stimuli with up to three extrastimuli Programmable Notifiers On Off Device Parameter Reset Entry into Backup VVI Mode Vibration Duration sec Number of Vibrations per Notification Number of Notifications Time Between Notifications hours Electrograms and Diagnostics Device at ERI Charge Time Limit Reached Possible HV Circuit Damage Ventricular Lead Impedance Out of Range High Voltage Lead Impedance Out of Range V pacing CorVue Congestion Trigger On On 2 4 6 8 10 12 14 16 2 1 16 10 22 Stored Electrograms Therapy Summary Episodes Summary Lifetime Diagnostics Ventricular HV Lead Impedance Trend Histograms Real Time Measurements RTM ST Monitoring CorVue Congestion Monitoring CorVue Congestion Trigger Up to 45 minutes including up to one minute programmable pre trigger data per VT VF diagnosis detection electrograms triggers include diagnosis therapy PC shock delivery noise reversion magnet reversion and morphology template verification Diagram of therapies delivered Directory listing of up to 60 episodes with access to more details including stored electrograms History of bradycardia events and device initiated charging Multi Vector Trend Data Event Histogram Ventricular Heart Rate Histogram Exercise and Activity Trending Pacing lead impedances high voltage lead impedances unloaded battery voltage an
341. ting of indications contraindications warnings precautions potential adverse events and directions for use Devices depicted may not be available in all countries Check with your St Jude Medical representative for product availability in your country Unless otherwise noted indicates that the name is a trademark of or licensed to St Jude Medical or one of its subsidiaries ST JUDE MEDICAL the nine squares symbol and MORE CONTROL LESS RISK are registered and unregistered trademarks and service marks of St Jude Medical Inc and its related companies 2011 St Jude Medical Inc All rights reserved Weight g 12 8 5 9 Connector IS 1 bipolar Volume cc other symptoms of myocardial dysfunction at higher sensor driven rates unipolar pacing in patients with an implanted cardioverter defibrillator ICD since it may inhibit or trigger ICD therapy The pulse generators are programmed to unipolar pacing and may be inappropriate for patients with an ICD Potential Adverse Events Adverse events associated with the use of any pacing system include air embolism bleeding hematoma body rejection phenomena cardiac tamponade or perforation formation of fibrotic tissue local tissue reaction Inability to interrogate or program due to programmer or device malfunction infection erosion interruption of desired pulse generator function due to electrical interference either electromyogenic or electromagnetic lead malfunction d
342. tion Bleeding Chronic nerve damage Erosion Excessive fibrotic who experience unexplained symptoms such as dizziness palpitations chest pain syncope and shortness of breath as well as patients who are at risk for other cardiac arrhythmias The SJM Confirm ICM Model DM2102 is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation EUREPZIR SUR RAS Hab Ad a own contraindications for the implantation of the SJM Confirm ICM However the patient s particular medical condition may dictate whether or not a subcutaneous chronically implanted device can be tolerated tissue growth Extrusion Formation of hematomas or cysts Infection Keloid formation Refer to the User s Manual for detailed indications contraindications warnings precautions and potential adverse events EEE mam ST JUDE MEDICAL MORE CONTROL LESS RISK Implantable Cardiac Monitors SJM Confirm Implantable Cardiac Monitor Model DM2102 Product Specifications Model DM2102 Sampling Rate Hz 128 Dimensions mm 56 3x18 5x8 Volume cc 6 5 Weight g 12 Electrode Spacing mm 39 Electrode Minimum Surface Area mm 30 Features Longevity 3 years Patient Trigger Yes Auto Activation Trigger Yes Atrial Fibrillation Trigger Yes Programmable AF episode duration gt 30 sec gt 1 min 2 min gt 5 min gt 10 min Tachycardia Trigger Yes Tachyc
343. tion Other possible adverse effects include mortality due to inappropriate delivery of therapy caused by multiple counting of cardiac events including T waves P waves or supplemental pacemaker stimuli Among the psychological effects of device implantation are imagined pulsing dependency fear of inappropriate pulsing and fear of losing pulse capability Refer to the User s Manual for detailed indications contraindications warnings precautions and potential adverse events ST JUDE MEDICAL MORE CONTROL LESS RISK fibrillator ICD Devices Product Specifications Patient Notifiers Models CD1211 36 D1211 36Q Programmable Notifiers On Off Device at ERI Charge Time Limit Reached Possible HV Circuit Damage Telemetry RF RF Ventricular Lead Impedance Out of Range High Voltage Lead Impedance Delivered Stored Energy J 36 42 36 42 Out of Range Backup VVI Long AT AF Episode Volume cc 42 4 Device Parameter Reset On Weight g 79 19 Entry into Backup VVI Mode On Size mm 76x50x14 74x50x14 Vibration Duration sec 2 4 6 8 10 12 14 16 Defibrillation Lead Connections DF1 DF4 Number of Vibrations per Notification 2 Sense Pace Lead Connections IS 1 DF4 Number of Notifications 16 High Voltage Can Electrically active titanium can Electrically active titanium can Time Between Notifications hours 0 22 PARAMETERS SETTINGS Electrograms and Diagnostics Sensing Detection Stored Electrograms U
344. tion equipment of industrial equipment may generate enough EMI to interfere with the performance of your activator These include but are not limited to arc welders induction furnaces very large or defective electric motors and such as microwave transmitters or high power amateur transmitters may generate enough EMI to interfere l i te 1 tion Ti internal combustion engines with poorly shielded ignition systems Customer Support 46 8 474 4756 Brief Summary Prior to using these devices please review the Instructions for Use for a complete listing of indications contraindications warnings precautions potential adverse events and directions for use Devices depicted may not be available in all countries Check with your St Jude Medical representative for product availability in your country Unless otherwise noted indicates that the name is a trademark of or licensed to St Jude Medical or one of its subsidiaries ST JUDE MEDICAL the nine squares symbol and MORE CONTROL LESS RISK a are registered and unregistered trademarks and service marks of St Jude Medical Inc and its related companies S M B 2011 St Jude Medical Inc All rights reserved T UDE E DICAL MORE CONTROL LESS RISK eld MRI Pace ttings Activato SJM MRI Activator Handheld Device Product Specifications PHYSICAL SPECIFICATIONS Model Dimensions cm Case material Power source Battery longevity Audible output leve
345. tip endocardium interface u Pacing Leads Small diameter lead offers improved ease of venous passage reduced risk of venous thrombosis or rib clavicle crush and ability to accommodate additional leads more easily Optim lead insulation a chemical co polymer that blends the best features of polyurethane and silicone for improved handling and increased durability Titanium nitride TIN fractal coating on the tip and ring electrodes is designed to promote precise sensing and to provide improved contact with the myocardium and veins to ease implantation Fits through a 6 F introducer Lubricious Fast Pass coating facilitates lead insertion through the introducer Ordering Information Contents Cardiac pacing lead Model Number 2088TC Fixation Ext Ret Helix Insulation Optim Indications Tendril STS Lead is designed for permanent sensing and pacing in either the right atrium or the right ventricle in combination with a compatible device Active leads such as the Tendril STS lead may be indicated for patients where permanent fixation of passive leads is suspected to be unstable In atrial applications the use of screw in leads such as Tendril STS lead may be indicated in the presence of an abnormal surgically altered or excised atrial appendage Contraindications Tendril STS lead is contraindicated in the presence of tricuspid atresia for patients with mechanical tricuspid valves in patien
346. tomies Stylets Specifications 0 014 0 35 mm Standard is designed for placement in the atrial appendage Taper Length 20 mm Curve 24 mm Curve Angle 220 Wide can be used in large atria Taper Length 36 mm Curve 29 5 mm Curve Angle 180 Narrow can be used in the high atrial septal position Taper Length 10 mm Curve 20 mm Curve Angle 170 Kit includes 3 J Shape stylets Standard Green Wide Grey Narrow Orange 1 Implant Tool with DSO6000 only and 1 Universal Clip On Tool Ordering Information Model Number Length cm Implant Tool DS06000 40 40 1 included DS06000 46 46 1 included DS06000 52 52 1 included DS06001 40 40 DS06001 46 46 DS06001 52 52 arent E uu Customer Support 46 8 474 4756 Brief Summary Prior to using these devices please review the Instructions for Use for a complete listing of indications contraindications warnings precautions potential adverse events and directions for use Devices depicted may not be available in all countries Check with your St Jude Medical representative for product availability in your country Unless otherwise noted indicates that the name is a trademark of or licensed to St Jude Medical or one of its subsidiaries ST JUDE MEDICAL the nine squares symbol and MORE CONTROL LESS RISK m are registered and unregistered trademarks and service marks of St Jude Medical Inc and its related co
347. traumatic insertion Ordering Information Included dilator and 2 valve bypass tools Model Curve Shape Available Overall Inner Outer Number Length cm Length cm Diameter F mm Diameter F mm DS2C001 Straight 47 50 7 712 44 9 3 00 DS2C002 115 47 50 7 712 44 9 3 00 DS2C003 135 47 50 7 712 44 9 3 00 DS2C004 Wide 47 50 7 712 44 9 3 00 DS2C005 X Wide 47 50 7 712 44 9 3 00 DS2C006 Right Side 47 50 7 712 44 9 3 00 DS2C011 Straight 54 57 7 712 44 9 3 00 DS2C012 115 54 57 7 712 44 9 3 00 DS2C013 135 54 57 7 712 44 9 3 00 DS2C014 Wide 54 57 7 712 44 9 3 00 DS2C015 X Wide 54 57 7 712 44 9 3 00 CCCYXOC Straight 115 135 Wide Extra Wide Right Side Separately Available Accessories Model Number Name Type DS2A003 CPS Universal Slitter Slitter DS2A004 CPS Direct SL Valve Bypass Tool Valve bypass tool Customer Support 46 8 474 4756 Brief Summary Prior to using these devices please review the Instructions for Use for a complete listing of indications contraindications warnings precautions potential adverse events and directions for use Devices depicted may not be available in all countries Check with your St Jude Medical representative for product availability in your country Unless otherwise noted indicates that the name is a trademark of or licensed to St Jude Medical or one of its subsidiaries ST JUDE MEDICAL the nine squares symbol and MORE CONTROL LESS RISK m are registered and unregi
348. tries Check with your St Jude Medical representative for product availability in your country Unless otherwise noted indicates that the name is a trademark of or licensed to St Jude Medical or one of its subsidiaries ST JUDE MEDICAL the nine squares symbol and MORE CONTROL LESS RISK are registered and unregistered trademarks and service marks of St Jude Medical Inc and its related companies 2011 St Jude Medical Inc All rights reserved Item GMCRM740EN EBEN mam ST JUDE MEDICAL MORE CONTROL LESS RISK Handheld MRI r Settings Activator SJM MRI Activator Handheld Device Product Highlights The SJM MRI Activator handheld device model EX4000 is an external device that uses radio waves to communicate with a St Jude Medical MRI conditional implanted pulse generator The SJM MRI Activator device streamlines MRI patient workflow by allowing previously stored MRI settings to be easily Enabled before an MRI scan Disabled after an MRI scant Verified at any time Ordering Information Contents SJM MRI Activator device Reorder Number Description EX4000 SJM MRI Activator EX4000 Intended Use The SJM MRI Activator handheld device is used to evaluate the status of and to enable with the performance of the activator if you are too close to the source of EMI Wireless communication and disable the previously stored MRI settings The activator is intended for use with St
349. ts reserved Item GMCRM770EN GMCRM 7 ST JUDE MEDICAL MORE CONTROL LESS RISK Left Heart Leads QuickFlex Left Heart Lead Product Highlights Superb deliverability combined with exceptional stability and performance Low profile 5 6 F proximal lead body 5 0 F distal lead body 4 0 F lead tip Steerable tip distal tip angle can be controlled to maneuver through venous anatomy Flexible lead body E Expanded tip to ring electrode spacing of 20 mm Shorter tip and ring electrodes reduce the length of rigid portions of the lead body Compatible with over the wire or stylet approaches Composite construction proximal polyurethane section and cable coil conductors are designed to offer exceptional push and torque while the flexible distal silicone portion is designed for improved tracking in tortuous anatomy Ordering Information Contents Left heart lead Model Insulation Insulation S Curve Minimum Number Proximal Distal Height mm Introducer F Connector Lengths cm 1156T Polyurethane Silicone 8 7 IS 1 bipolar 75 86 1158T Polyurethane Silicone 16 7 IS 1 bipolar 75 86 Indications and Usage The QuickFlex lead has application as part of a St Jude Medical biventricular system Contraindications The use of QuickFlex leads is contraindicated in patients who Are expected to be hypersensitive to a single dose of 1 0 mg of dexamethasone sodium phosphate Are unable to underg
350. ts who are expected to be hypersensitive to a single dose of one milligram of dexamethasone sodium phosphate Customer Support 46 8 474 4756 Brief Summary Prior to using these devices please review the Instructions for Use for a complete listing of indications contraindications warnings precautions potential adverse events and directions for use Devices Min Introducer F 6 IS 1 bipolar Connector Lengths cm 46 52 58 Adverse Events Potential complications associated with the use of Tendril STS lead are the same as with the use of other active fixation leads and include cardiac tamponade diaphragmatic stimulation embolism excessive bleeding induced ventricular ectopy infection loss of pacing and or sensing due to dislodgment or mechanical malfunction of the pacing lead phrenic nerve stimulation thrombosis Complications reported with direct subclavian venipuncture include pneumothorax hemothorax laceration of the subclavian artery arteriovenous fistula neural damage thoracic duct injury cannulation of other vessels massive hemorrhage and rarely death Refer to the User s Manual for detailed indications contraindications warnings precautions and potential adverse events depicted may not be available in all countries Check with your St Jude Medical representative for product availability in your country Unless otherwise noted indicates that the name is a trademark of or licensed to St Jude Medi
351. ual chamber ICD implants Journal of Cardiovascular Electrophysiology Vol 18 No 2 Feb 2007 4 Chan et al Tissue Doppler guided optimization of A V and V V delay of biventricular pacemaker improves response to cardiac resynchronization therapy in heart failure patients J Cardiac Failure 2004 10 4 supplement 572 abstract 199 5 Sperzel J Meine M et al A new automatic update function of the morphology template used for SVT VT discrimination in an ICD Europace Supplements Vol 3 July 2002 A 131 1515 6 Carlson MD et al A new pacemaker algorithm for the treatment of atrial fibrillation results of the Atrial Dynamic Overdrive Pacing Trial ADOPT JACC 2003 42 627 633 7 Sharma AD O Neill PG Fain E et al Shock on T versus DC for induction of ventricular fibrillation a randomized prospective comparison 21st Annual Scientific Session North American Society of Pacing and Electrophysiology NASPE Poster presentation published in meeting proceedings Washington D C U S A May 2000 EBEN mem ST JUDE MEDICAL EEE MORE CONTROL LESS RISK Cardiac Resynchronisation Therapy CRT Devices Promote Cardiac Resynchronisation Therapy Defibrillator CRT D Product Highlights The DF4 connector is designed to simplify implants by streamlining defibrillation connections into a single terminal pin and reducing the number of set screws Triple redundancy safety platform is designed to minimise risk and increase
352. ual pacing rate for the 30 bpm is 31 bpm 4 The highest available setting for Hysteresis Rate will be 5 bpm below the programmed Base Rate Backup Pulse Configuration Unipolar Bipolar 5 In dual chamber modes the maximum Ventricular Refractory Period is 325 ms Backup Pulse Amplitude V 5 0 6 Values 0 1 0 4 not available in a Unipolar Sense Configuration Threshold Search Interval hours 8 24 7 Sensitivity is with respect to a 20 ms haversine test signal 2 p 3 8 During atrial NIPS in dual chamber modes the shortest Coupling Interval will be limited by the programmed AV PV delay Ventricular Sensitivity mV 0 5 5 0 in steps of 0 5 6 10 in steps of 1 0 12 5 2 07 9 81 Burst Cycle is applied at the preprogrammed S1 cycle length AF Management AF Suppression Algorithm Off On Lower Rate Overdrive min 10 Upper Rate Overdrive min 5 No of Overdrive Pacing Cycles 15 40 in steps of 5 Rate Recovery ms 8 12 Maximum AF Suppression Rate min 80 150 in steps of 5 160 180 in steps of 10 Atrial Tachycardia Detection Rate min 110 150 in steps of 5 160 200 in steps of 10 225 300 in steps of 25 180 Off DDD to DDI VDD to VVI DDI Base Rate 0 to Base Rate 35 in steps of 5 Base Rate 20 Auto Mode Switch AMS Base Rate min Customer Support 46 8 474 4756 Brief Summary Prior to using these devices please review the Instructions for Use for a complete listing of indications contraindications warnings precautions p
353. uares symbol and MORE CONTROL LESS RISK are registered and unregistered trademarks and service marks of St Jude Medical Inc and its related companies 2011 St Jude Medical Inc All rights reserved Item GMCRM771EN ST JUDE MEDICAL MORE CONTROL LESS RISK Left Heart Leads QuickFlex yu Left Heart Lead Product Highlights Superb deliverability combined with exceptional stability and performance Low profile 4 3 F lead body 4 0 F lead tip Optim lead insulation a chemical co polymer that blends the best features of polyurethane and silicone for improved handling and increased durability Steerable tip distal tip angle can be controlled to maneuver through venous anatomy Flexible lead body Tip to ring electrode spacing of 20 mm Shorter tip and ring electrodes reduce the length of rigid portions of the lead body Allows Direct To Target placement through CPS Aim SL inner catheter to deliver leads to small acute venous anatomies that may have been unreachable in the past Compatible with over the wire or stylet approaches Ordering Information Contents Left heart lead Model Insulation S Curve Minimum Number Height mm Introducer F Connector Lengths cm 1258T Optim 16 5 IS 1 bipolar 75 86 92 Indications and Usage The QuickFlex lead has application as part of a St Jude Medical biventricular system Contraindications The use of QuickFlex leads is contraindicat
354. ucer due to the material s soft nature Four pads on the silicone tip further increase the surface area of the lead tip that is in contact with the tissue Optim lead insulation a chemical co polymer that blends the best features of polyurethane and silicone provides improved handling and increased durability Limited lifetime warranty Terms and conditions apply Refer to the warranty for details 1 See manual for additional details before performing an MRI scan 2 Bench testing data on file Ordering Information Contents Cardiac pacing lead Model Number Insulation Fixation Min Introducer F Connector Length cm LPA1200M Optim Ext Ret helix 8 IS 1 bipolar 46 52 and 58 Easily identifiable unique radiopaque markers Indications The Tendril MRI lead is designed for permanent sensing and pacing in either the right atrium or Contraindications The Tendril MRI lead is contraindicated in the presence of tricuspid atresia for patients the right ventricle in combination with a compatible device with mechanical tricuspid valves and in patients who are expected to be hypersensitive to a single dose of one Active leads such as the Tendril MRI lead may be indicated for patients where permanent fixation of passive milligram of dexamethasone sodium phosphate leads is suspected to be unstable In atrial applications the use of a screw in lead such as Tendril MRI lead Adverse Events Potential complications associate
355. ue to conductor fracture or insulation degradation loss of capture or sensing due to lead dislodgment or reaction at the electrode tissue interface loss of desired pacing and or sensing due to lead displacement body reaction at electrode interface or lead malfunction fracture or damage to insulation loss of normal device function due to battery failure or component malfunction pacemaker migration pocket erosion or hematoma pectoral muscle or diaphragmatic stimulation phrenic nerve stimulation pneumothorax hemothorax Refer to the User s Manual for detailed indications contraindications warnings precautions and potential adverse events LLL mam ST JUDE MEDICAL MORE CONTROL LESS RISK Microny Il SR Single Chamber Pacemaker Product Specifications PHYSICAL SPECIFICATIONS Model 2525T Dimensions mm 33x33x6 Weight g 128 Volume cc 59 Connector IS 1 Bipolar Battery Data Lithium iodine cell 2 80 V 0 35 Ah Rate Timing Mode AOO R AAI R AAT R VOO R VVI R VVT R Basic Rate ppm 45 160 in steps of 5 60 Hysteresis Rate ppm 0 10 20 30 below the basic or sensor indicated rate Off Refractory Period ms 250 300 350 400 450 500 550 Output Sensing Pulse Amplitude V Auto 0 3 4 5 in 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 Sensitivity mV 0 5 0 8 1 2 2 0 3 0 5
356. ular Post Pace Auto 0 30 60 95 125 160 190 220 Maximum Sensor Rate min Rate Responsive VREF Shortest VREF Reaction Time Recovery Time Sensor Slope Threshold Customer Support 46 8 474 4756 80 150 in steps of 5 160 180 in steps of 10 Off Low Medium High 125 475 in steps of 25 Very Fast Fast Medium Slow Fast Medium Slow Very Slow On Off Passive Auto 1 Auto 4 0 Auto 1 Auto 2 Auto 3 1 16 in steps of 1 Auto 0 5 Auto 4 0 0 Auto 0 5 Auto 1 0 Auto 1 5 Auto 2 0 1 7 in steps of 0 5 Brief Summary Prior to using these devices please review the Instructions for Use for a complete listing of indications contraindications warnings precautions potential adverse events and directions for use Devices depicted may not be available in all countries Check with your St Jude Medical representative for product availability in your country Unless otherwise noted indicates that the name is a trademark of or licensed to St Jude Medical or one of its subsidiaries ST JUDE MEDICAL the nine squares symbol and MORE CONTROL LESS RISK are registered and unregistered trademarks and service marks of St Jude Medical Inc and its related companies 2011 St Jude Medical Inc All rights reserved Item GMCRM813EN Options Priority Options Channel Triggers Magnet Response High Ventricular Rate Rate mir No of Consecutive Cycles Off Low High 1 2 3
357. ular events Vibration Duration sec 2 4 6 8 10 12 14 16 Low Frequency Attenuation On Off Number of Vibrations per Notification 2 Threshold Start Post Sensed Atrial 50 62 5 75 100 Number of Notifications 1 16 Post Paced Atrial 0 2 3 0 mV Time Between Notifications hours 10 22 Post Sensed Ventricular 50 62 5 75 100 Elactrasrais and Diagnostics Post Paced Ventricular Auto 0 2 3 0 mV E Decay Delay Post Sense Post Pace Atrial Ventricular 0 220 Stored Electrograms Up to 45 minutes including up to one minute programmable pre trigger Ventricular Sense Refractory ms 125 157 data per VI VF diagnosis detection electrograms triggers include Detection Zones VT 1 VT 2 VF diagnosis therapy atrial episode PMT termination PC shock delivery SVT Discriminators Reconfirmation Antitachycardia Pacing Therapy AV Rate Branch Sudden Onset Interval Stability Morphology Discrimination MD with Manual or Automatic Template Update Continuous sensing during charging Therapy Summary Episodes Summary Lifetime Diagnostics noise reversion magnet reversion and morphology template verification Diagram of therapies delivered Directory listing of up to 60 episodes with access to more details including stored electrograms History of bradycardia events and device initiated charging ATP Configurations Ramp Burst Scan 1 or 2 schemes per VT zone AT AF Burden Trend Trend data and counts ATP in VF Zone ATP Whi
358. ulation The following in addition to the above are potential complications associated with the use of rate modulated pacing systems inappropriate rapid pacing rates due to sensor failure or to the detection of signals other than patient activity loss of activity response due to sensor failure palpitations with high rate pacing Refer to the User s Manual for detailed indications contraindications warnings precautions and potential adverse events ST JUDE MEDICAL MORE CONTROL LESS RISK es 1 1 GMCRMSB Pace ers Accent DR Dual Chamber Pacemaker Product Specifications AF Management TN s AF Suppression Algorithm Off On Dimensions lini 46x52x6 Lower Rate Overdrive mim 10 Weight g 19 Upper Rate Overdrive min 5 Voll ents 105 No of Overdrive Pacing Cycles 15 40 in steps of 5 olume cc Rate Recovery ms 8 123 Connector IS 1 Maximum AF AR M 20 200 fn steps of iad d Rate Timing Detection Rate min 110 200 in steps of 10 225 300 in steps of 25 Auto Mode Switch Off DDD R to DDI R DDD R to DDT R DDD R to VVI R Atrial Pace Refractory ms 190 400 in steps of 30 440 4702 DDD R to VVT R VDD R to VVI R VDD R to VVT R Atrial Sense Refractory ms 93 125 157 190 400 in steps of 30 440 4702 AMS Base Rate min 40 170 in steps of 5 Atrial Protection Interval ms 1258 Stored Electrograms Paced AV D
359. ulse amplitude Together these features offer patient safety and enable quick intervention through a capture trend display High quality stored IEGM with histograms and trending provide further diagnostic insight The combination of automatic daily measurements capture threshold and lead impedance monitoring offer safety and enable more time for patient care during follow up All necessary tests have already been performed before the patient comes to follow up Customer Support 46 8 474 4756 1 MRI conditional pacemaker system an MRI conditional pacing system is conditionally safe for use in the MRI environment when used according to the instructions in this manual See the St Jude Medical MRI Procedure information document prior to performing an MRI scan BEB www SJMprofessional com MRI ST JUDE MEDICAL MORE CONTROL LESS RISK Accent MRI DR Dual Chamber Pacemaker with Wireless Telemetry Product Highlights The Accent MRI pacemaker has been designed and tested for safe performance of a full body MRI scan without zone restrictions using a 1 5 T Tesla field strength MRI scanner The MRI conditional device Allows a maximum whole body averaged specific absorption rate SAR of 4 watts per kilogram W kg for high image resolution Must be used in conjunction with an MRI lead from St Jude Medical An optional easy to use hand held device SJM MRI Activator device can be used to program the device t
360. unction fracture or damage to insulation Loss of normal device function due to battery failure or component malfunction Pacemaker migration pocket erosion or hematoma Pectoral muscle or diaphragmatic stimulation Phrenic nerve stimulation Pneumothorax hemothorax Refer to the User s Manual for detailed indications contraindications warnings precautions and potential adverse events LLL mem ST JUDE MEDICAL EEE MORE CONTROL LESS RISK 7 GMCRMB8 1 Zephyr SR Single Chamber Rate Responsive Pacemaker Product Specifications PHYSICAL SPECIFICATIONS Model 5620 Dimensions mm ALx44x6 Weight g 17 Volume cc 8 Connector IS 1 Rate Timing A or V Refractory ms 125 500 in steps of 25 Base Rate bpm 30 40 130 in steps of 5 140 170 in steps of 10 Mode AO00 R AAL R AAT R 0A0 VOO R VVI R VVT R Hysteresis Rate bpm Off 30 130 in steps of 5 140 150 Search Interval bpm Off 5 10 15 30 Cycle Count 1 16 by Intervention Rate bpm Off 60 80 120 in steps of 10 Intrinsic 0 Intrinsic 10 Intrinsic 20 Intrinsic 30 Intervention Duration min 1 10 in 1 minute intervals Recovery Time Fast Medium Slow Very Slow Rest Rate bpm Off 30 130 in steps of 5 140 150 Output Sensing Aor V Pulse Amplitude V 0 0 4 0 in steps of 0 25 4 5 7 5 in steps of 0 5 Aor V Pulse Width ms 0 05 0 1 1 5 in steps of 0 1 Aor V Sensitivity mV 0 5 5 0 in steps of 0 5 6 10 in steps of
361. ve oversensing without decreasing sensitivity Vibratory patient notifier enables patients with hearing problems to be alerted to a low battery lead related complications and more Automatic daily high voltage lead integrity test is designed to ensure optimal patient safety Ordering Information Contents Cardiac pulse generator Model Number CD3215 36 CD3215 36Q Dimensions H x W x T mm Weight g 81x50x 14 82 75x50x14 82 Indications The devices are intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias Cardiac Resynchronisation Therapy Defibrillators CRT Ds are also intended to resynchronise the right and left ventricles in patients with congestive heart failure Contraindications Contraindications for use of the pulse generator system include ventricular tachyarrhythmias resulting from transient or correctable factors such as drug toxicity electrolyte imbalance or acute myocardial infarction Adverse Events Implantation of the pulse generator system like that of any other device involves risks some possibly life threatening These include but are not limited to the following acute hemorrhage bleeding air emboli arrhythmia acceleration cardiac or venous perforation cardiogenic shock cyst formation erosion Customer Support 46 8 474 4756 Brief Summary Prior to using these devices please review t
362. ve titanium can Electrically active titanium can SETTINGS AF Suppression Pacing No of Overdrive Pacing Cycles Maximum AF Suppression Rate Sensing Detection On Off 15 40 in steps o 80 150 min e SenseAbility Technology Low Frequency Attenuation Threshold Start Decay Delay Ventricular Sense Refractory ms Detection Zones SVT Discriminators Reconfirmation Antitachycardia Pacing Therapy Automatic Sensitivity Control adjustment for atrial and ventricular events On Off Post Sensed Atrial 50 62 5 75 100 Post Paced Atrial 0 2 3 0 mV Post Sensed Ventricular 50 62 5 75 100 Post Paced Ventricular Auto 0 2 3 0 mV Post Sensed Post Paced Atrial Ventricular 0 220 Post Paced Ventricular Auto 125 157 VT 1 VT 2 VF AV Rate Branch Sudden Onset Interval Stability Morphology Discrimination MD with Manual or Automatic Template Update Continuous sensing during charging ATP Configurations Burst Cycle Length Min Burst Cycle Length ms Number of Bursts Number of Stimuli Add Stimuli per Burst High Voltage Therapy Ramp Burst Scan 1 or 2 schemes per VT zone Adaptive Readaptive or Fixed 150 400 in increments of 5 1 15 2 20 On Off igh Voltage Output Mode Waveform RV Polarity Electrode Configuration Bradycardia Pacing Fixed Pulse Width Fixed Tilt Biphasic Monophasic Cathode Anode RV to Can RV to SVC Can Permanent Modes empor
363. ved The Merlin PSA is not intended for use as a temporary pacemaker or for life sustaining pacing support The Merlin PSA is not intended for diagnostic purposes Caution Federal law USA restricts this device to sale by or on the order of a physician Refer to the User s Manual for detailed indications contraindications warnings precautions and potential adverse events ST JUDE MEDICAL MORE CONTROL LESS RISK Customer Support 46 8 474 4756 Brief Summary Prior to using these devices please review the Instructions for Use for a complete listing of indications contraindications warnings precautions potential adverse events and directions for use Devices depicted may not be available in all countries Check with your St Jude Medical representative for product availability in your country Unless otherwise noted indicates that the name is a trademark of or licensed to St Jude Medical or one of its subsidiaries ST JUDE MEDICAL the nine squares symbol and MORE CONTROL LESS RISK are registered and unregistered trademarks and service marks of St Jude Medical Inc and its related companies 2011 St Jude Medical Inc All rights reserved Item GMCRM826EN mem ST JU EEE DE MEDICAL MORE CONTROL LESS RISK External Pulse Generator Dual Chamber DDD Model 3085 Product Highlights Designed for safe and reliable temporary stimulation of the heart in cases of rhythm disturbances and conductio
364. wide 1 narrow Helix Extension Retraction Clip on Tools 2 clip on tools Accessory Kits Available Separately Model Number Compatible Lengths Stylet Kit 4064 Stylet Kit 4062 Stylet Kit 4060 Limited Lifetime Warranty 40 46 52 58 and 85 cm 40 46 52 58 and 85 cm 40 46 52 58 and 85 cm Terms and conditions apply refer to the warranty for details Customer Support 46 8 474 4756 1948 7F bipolar passive fixation lead IS 1 bipolar 46 52 58 cm tines 10 mm Semi spherical shape steroid coating 3 5 mm 16 mm lt 1 mg dexamethasone sodium phosphate in silicone matrix Silicone rubber Optim lead insulation Fast Pass coating Description X Firm Stylets 2 Firm Stylets 2 Soft Stylets 2 Brief Summary Prior to using these devices please review the Instructions for Use for a complete listing of indications contraindications warnings precautions potential adverse events and directions for use Devices depicted may not be available in all countries Check with your St Jude Medical representative for product availability in your country Unless otherwise noted indicates that the name is a trademark of or licensed to St Jude Medical or one of its subsidiaries ST JUDE MEDICAL the nine squares symbol and MORE CONTROL LESS RISK are registered and unregistered trademarks and service marks of St Jude Medical Inc and its related companies 2011 St Jude Medical Inc Al
365. y Morphology Discrimination MD with Time Between Notifications hours 10 22 Manual or Automatic Template Update Continuous sensing during charging ATP Configurations ATP in VF Zone ATP Upper Rate Cutoff Burst Cycle Length Min Burst Cycle Length ms Number of Bursts Number of Stimuli Add Stimuli per Burst ATP Pulse Amplitude V ATP Pulse Width ms High Voltage Therapy 50 300 bpm Adaptive Readaptive or Fixed 50 400 in increments of 5 and Post Therapy Pacing igh Voltage Output Mode Waveform RV Polarity Electrode Configuration Bradycardia Pacing Fixed Pulse Width Fixed Tilt Biphasic Monophasic Cathode Anode RV to Can RV to SVC Can Permanent Modes emporary Modes Rate Adaptive Sensor Programmable VVI R Pacer Off Off VVI VOO Ramp Burst Scan 1 or 2 schemes per VT zone ATP While Charging ATP Prior to Charging Off 7 5 Independent from Bradycardia and Post Therapy Pacing 0 or 1 5 Independently programmable from Bradycardia Post Sense Post Pace Ventricular 0 220 Electrograms and Diagnostics Stored Electrograms Therapy Summary Episodes Summary Histograms Real Time Measurements RTM ST Monitoring CorVue Congestion Monitoring CorVue Congestion Trigger Up to 45 minutes including up to one minute programmable pre trigger data per VT VF diagnosis detection electrograms triggers include diagnosis therapy PC shock delivery noise reversion m
366. y Control adjustment for ventricular events 0 2 2 0 in steps of 0 1 Ventricular Post Sense 50 62 5 75 100 Ventricular Post Pace Auto 0 2 3 0 in steps of 0 1 mV Ventricular Post Sense 0 30 60 95 125 160 190 220 Ventricular Post Pace Auto 0 30 60 95 125 160 190 220 Maximum Sensor Rate min Rate Responsive VREF Shortest VREF Reaction Time Recovery Time Sensor Slope Threshold 80 150 in steps of 5 160 180 in steps of 10 Off Low Medium High 125 475 in steps of 25 Very Fast Fast Medium Slow Fast Medium Slow Very Slow On Off Passive Auto 1 Auto 4 0 Auto 4 1 Auto 2 Auto 3 1 16 in steps of 1 Auto 0 5 Auto 4 0 0 Auto 4 0 5 Auto 1 0 Auto 1 5 Auto 2 0 1 7 in steps of 0 5 Device at ERI Ventricular Lead Impedance Out of Range On On 2 4 6 8 10 12 14 16 2 1 16 10 22 2 Programming options dependent on pacing mode 3 The highest available setting for hysteresis rate will be 5 min below the programmed base rate 4 Sensitivity is with respect to a 20 ms haversine test signal 6 S1 Burst Cycle is applied at the preprogrammed S1 cycle length Customer Support 46 8 474 4756 Brief Summary Prior to using these devices please review the Instructions for Use for a complete listing of indications contraindications warnings precautions potential adverse events and directions for use Devices depicted may not be available in all coun
367. y Standby Diagnostic Trends Patient Notifiers 00 500 in steps of 25 150 2500 in steps of 250 3000 ncoded Unipolar Bipolar Off Battery Test Off 10 to 120 in steps of 10 Atrial Ventricular 00 800 in steps of 108 2 25 in steps of 1 Off 100 800 in steps of 10 Fixed or Adaptive Off 30 95 in steps of 5 2 3 4 5 Off Passive Atrial Pace 90 180 in steps of 5 Off Atrial Pace Off 50 150 in steps of 25 160 200 in steps of 10 30 sec 1 3 5 10 30 min 1 2 3 Off On AT AF Activity Exercise Lead Impedance P and R Wave A and V Threshold Programmable Notifiers 0n Off Device Reset Entry into Backup VVI Mode Audible Duration sec Number of Audible Alerts per Notification Number of Notifications Time Between Notifications hours 1 2 0 5cc Device at ERI Atrial Lead Impedance Out of Range Ventricular Lead Impedance Out of Range AT AF Burden AT AF Episode Duration V Rate During AT AF High V Rate Threshold Total Time in High V Rate On On 2 4 6 8 10 12 14 16 2 1 16 10 22 2 Programming options dependent on pacing mode 3 This parameter is not programmable 4 The highest available setting for hysteresis rate will be 5 min below the programmed base rate 5 In dual chamber modes the maximum ventricular refractory period is 325 ms 6 Values 0 1 0 4 not available in a unipolar sense configuration 7 Sensitivity is with respect to a 20 ms haversine
368. y atrial ventricular or A V sequential stimulation The Model 3085 has applications where such stimulation modes are indicated for therapeutic rophylactic or diagnostic purposes Specific indications include but are not limited to the following Sick sinus syndrome Bradycardia with congestive heart failure Complete heart block Acute myocardial infarction complicated with heart block Sinus bradycardia Cardiac arrest with ventricular systole Atrial and or ventricular ectopic arrhythmia Postoperatively after cardiac surgery Temporary application during implantation or exchange of a permanent pacemaker Indication for atrial overdrive stimulation Supraventricular tachycardia Customer Support 46 8 474 4756 Brief Summary Prior to using these devices please review the Instructions for Use for a complete listing of indications contraindications warnings precautions potential adverse events and directions for use Devices depicted may not be available in all countries Check with your St Jude Medical representative for product availability in your country Unless otherwise noted indicates that the name is a trademark of or licensed to St Jude Medical or one of its subsidiaries ST JUDE MEDICAL the nine squares symbol and MORE CONTROL LESS RISK are registered and unregistered trademarks and service marks of St Jude Medical Inc and its related companies 2011 St Jude Medical Inc All rights reserved Contraindications Th
369. y programmable from Bradycardia and ATP CD1233 40 D1233 400 Post Shock Pacing Mode Off VVI RF RF Post Shock Base Rate min 30 100 in increments of 5 40 45 40 45 Post Shock Pacing Duration min Off 0 5 1 2 5 7 5 or 10 35 35 76 15 Device Testing Induction Methods 73x 40x 14 71x40x14 DFL DF4 DC Fibber Pulse Duration sec 0 5 5 0 IS DFA Burst Fibber Cycle Length ms 20 100 Electrically active titanium can SenseAbility Technology Low Frequency Attenuation Threshold Start Decay Delay Ventricular Sense Refractory ms Detection Zones SVT Discriminators Reconfirmation Antitachycardia Pacing Therapy Electrically active titanium can Automatic Sensitivity Control adjustment for ventricular events Noninvasive Programmed Stimulation NIPS Patient Notifiers 2 25 stimuli with up to three extrastimuli Programmable Notifiers On Off Device at ERI Charge Time Limit Reached Possible HV Circuit Damage Ventricular Lead Impedance Out of Range High Voltage Lead Impedance On Off Out of Range V pacing CorVue Congestion Trigger Post Sensed Ventricular 50 62 5 75 100 Device Parameter Reset On Post Paced Ventricular Auto 0 2 3 0 mV Entry into Backup VVI Mode On Post Sense Post Pace Ventricular 0 220 Vibration Duration sec 2 4 6 8 10 12 14 16 125 157 Number of Vibrations per Notification 2 VT 1 VT 2 VF Number of Notifications 1 16 Sudden Onset Interval Stabilit
370. y provides greater capacity for enhanced longevity and charge times Triggered pacing with BiV Trigger Mode helps maintain a high percentage of BiV pacing by triggering pacing in both the left and right ventricles in response to a sensed ventricular event Negative AV hysteresis with search promotes ventricular pacing by automatically reducing the AV delay when intrinsic activity is present thereby promoting a high degree of ventricular pacing Ordering Information Contents Cardiac pulse generator Model Dimensions Connector Connector Number H x W x T mm Weight g Volume cc Defibrillation Sense Pace CD3235 40 79 x 40x 14 78 36 DF1 IS 1 CD3235 40Q 73 x 40 x 14 77 36 DF4 DFA IS 1 Indications The devices are intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias Cardiac Resynchronisation Therapy Defibrillators CRT Ds are also intended to resynchronise the right and left ventricles in patients with congestive heart failure Contraindications Contraindications for use of the pulse generator system include ventricular tachyarrhythmias resulting from transient or correctable factors such as drug toxicity electrolyte imbalance or acute myocardial infarction Adverse Events Implantation of the pulse generator system like that of any other device involves risks some possibly life threatening These include but are not limited to the f
371. ylet Kit DS06002 with appropriate 46 52 58cm 1 fixation tool 1 clip on tool length designation 1J shaped soft 1 x soft 1 soft 1 firm 1 x firm DS06003 with appropriate 46 52 58cm 1 clip on tool 1 J shaped soft length designation 1 x soft 1 soft 1 firm 1 x firm Locator Plus 1281 with appropriate 46 52 58 cm Disposable implant tool to Deflectable Stylet length designation facilitate precise lead positioning 1292 with appropriate 46 52 58 cm and manipulation with one hand length designation MP35N is a trademark of SPS Technologies Inc D n N N Customer Support 46 8 474 4756 Brief Summary Prior to using these devices please review the Instructions for Use for a complete listing of es y indications contraindications warnings precautions potential adverse events and directions for use Devices depicted may not be available in all countries Check with your St Jude Medical representative for product availability UO in your country Unless otherwise noted indicates that the name is a trademark of or licensed to St Jude uL y Medical or one of its subsidiaries ST JUDE MEDICAL the nine squares symbol and MORE CONTROL LESS RISK are registered and unregistered trademarks and service marks of St Jude Medical Inc and its related companies S M B 9 2011 St Jude Medical Inc All rights reserved T UDE E DICAL Item GMCRM822EN MO
372. zone daylight savings time or the patient s schedule Advanced hysteresis maximises opportunities for the patient s own rhythm to prevail and addresses abrupt rate drops Ordering Information Contents Cardiac pulse generator Model Number 5620 Dimensions H x W x T mm 41x44x6 Indications and Usage Implantation of Zephyr pulse generators is indicated in the following permanent conditions when associated with symptoms including but not limited to syncope presyncope fatigue disorientation or any combination of those symptoms Rate Modulated Pacing is indicated for patients with chronotropic incompetence and for those who would benefit from increased stimulation rates concurrent with physical activity Dual Chamber Pacing Models 5826 5820 only is indicated for those patients exhibiting Sick sinus syndrome chronic symptomatic second and third degree AV block recurrent Adams Stokes syndrome symptomatic bilateral bundle branch block when tachyarrhythmia and other causes have been ruled out Atrial Pacing is indicated for patients with sinus node dysfunction and normal AV and intraventricular conduction systems Ventricular Pacing is indicated for patients with significant bradycardia and Normal sinus rhythm with only rare episodes of A V block or sinus arrest chronic atrial fibrillation severe physical disability AF Suppression Models 5826 5820 only is indicated for suppression of paroxysmal or persistent atrial fib

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