Promote Quadra™
Contents
1. 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 Transmitter tibl 4 RV Coil may be adjusted noninvasively via the programmer Compatible 1 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 hysteres2. 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 Device Reset On Entry into Backup VVI Mode On Vibration Duration sec 2 4 6 8 10 12 14 16 Number of Vibrations per Notification 2 Number of Notifications 1 16 Time Between Notifications hours 10 22 Electrograms and Diagnostics Stored Electrograms 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 Therapy Summary iagram of therapies delivered Episodes Summary irectory listing of up to 60 episodes with access to more details including stored electrograms Lifetime Diagnostics History of bradycardia events and device initiated charging AT AF Burden Trend rend data and counts Ventricular HV Lead Impedance Trend Multi Vector Trend Data Histograms 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 PMT Data information regarding PMT detections R
3. 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 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
4. 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 Sense Ability Technology Low Frequency Attenuation hreshold Start Decay Delay Ventricular Sense Refractory ms Detection Zones SVT Discriminators Reconfirmation 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 0 220 125 157 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 Post Therapy Pacing Independently programmable from Bradycardia and ATP Post Shock Pacing Mode Off AAI VVI DDI or DDD Post Shock Base Rate min 30 100 in increments of 5 Post Shock Pacing Duration min Off 0 5 1 2 5 5 7 5 or 10 Device Testing Induction Methods DC Fibber Pulse Duration sec 0 5 5 0 Burst Fibber Cycle Length ms 20 100 Noninvasive Programmed Stimulation NIPS Patient Notifiers 2 25 stimuli with up to three extrastimuli Programmable Notifiers On Off Device at ERI
5. ase Rate 40 45 135 Auto PMT Detection Termination A Pace on PMT Off Passive Rate Responsive PVARP VREF 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 Setup On Monitor Off ACap Confirm 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 s 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 z are registered and unregistered trademarks and service marks of St Jude Medical Ine and is related companies H M o S201 St Jude Medical Inc All rights reserved j P H ST JUDE E DICAL Item GMCRM766EN MORE CONTROL LESS RISK
6. eal Time Measurements RTM Pacing lead impedances high voltage lead impedances signal amplitudes CorVue Congestion Monitoring On Off Antitachycardia Pacing Therapy CorVue Congestion Trigger 8 18 days ATP Configurations Ramp Burst Scan 1 or 2 schemes per zone ATP in VF Zone ATP While Charging ATP Prior to Charging Off QHR is a trademark of Greatbatch LTD ATP Upper Rate Cutoff 50 300 bpm LV first with 10 ms interventricular delay Burst Cycle Length Adaptive Readaptive or Fixed Min Burst Cycle Length ms 50 400 in increments of 5 Number of Bursts Stimuli 15 with 2 20 Stimuli Add Stimuli per Burst On Off High Voltage Therapy High Voltage Output Mode Fixed Pulse Width Fixed Tilt Waveform Biphasic Monophasic RV Polarity Cathode Anode Electrode Configuration RV to Can RV to SVC Can Bradycardia Pacing Permanent Modes Off DDD R DDT R DDI R VVT R VVI R AAI R Temporary Modes Off DDD R DDT R DDI R VVT R VVI R AAI R AAT DOO V00 A00 Rate Adaptive Sensor On Off Passive Programmable Rate and Off Base Rate min Rest Rate min Maximum Tracking Rate min Delay Parameters 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 Auto Mode Switch AMS Off DDI R DDT R VVI R VVT R AMS Detection Rate min 110 300 AMS B
7. is 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 81x51x 14 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 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
8. 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 Cardiac Resynchronisation Therapy CRT Devices 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 CD3239 40 CD3239 400 RF RF 40 40 46 44 88 87 81x51 x14 74x51x14 DF1 DF4 LLHH IS4 LLLL IS4 LLLL IS 1 IS 1 Electrically active titanium can Electrically active titanium can PARAMETER SETTINGS Biventricular Pacing 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
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