Promote Accel™
Contents
1. Cardiac Resynchronisation 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 program2. 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 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 GMCRM917EN ST JUDE MEDICAL Hae MORE CONTROL LESS RISK
3. 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 5 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 High Voltage Output Mode Waveform RV Polarity Electrode Configuration Bradycardia Pacing 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 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 Paramete
4. 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 Sense Pace Connector Volume cc Defibrillation 43 DF1 IS 1 42 DF4 IS 1 DF4 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 adver
5. e 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 1 Mouchawar G Kroll M Val Mejias JE et al ICD waveform optimization a randomized prospective pair sampled multicenter study PACE 2000 23 Part Il 1992 1995 2 Sweeney MO Natale A Volosin KJ et al Prospective randomized comparison of 50 50 versus 65 65 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 dual 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
6. m 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 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 first with 10 ms interventricular delay 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 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 templat
7. ming 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 Number CD3215 36 CD3215 36Q Dimensions H x W x T mm Weight g 81 x 50x 14 82 75 x 50x 14 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
8. rs Auto Mode 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 AAI R Off DDD R DDT R DDI R VVT R VVI R AAI R AAT 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 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 Post Therapy Pacing Independently programmable fro
9. se 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 EEE uou ST JUDE MEDICAL MORE CONTROL LESS RISK Cardiac Resynchronisation Therapy CRT Devices GMCRM M9 1 Product 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 81x 50x14 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
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