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1. 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 security and patient comfort through multiple hardware and software system safeguards Triggered pacing with BiV Trigger Mode helps maintain a high percentage of Merlin home Transmitter Compatibl BiV pacing by triggering pacing in both the left and right ventricles in response Tae 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
2. AAI R DOO R VOO R AOO R Off DDD R DDT R DDI R VVT R VVI R AAI R 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 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 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 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
3. 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 Wx T mm Weight g Volume cc Defibrillation Sense Pace CD3211 36 81x 50x 14 82 43 DF1 IS 1 CD3211 36Q 75x 50x 14 82 42 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 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 compl
4. acing On Off No of Overdrive Pacing Cycles 5 40 in steps of 5 Maximum AF Suppression Rate 80 150 min Sensing Detection 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 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 iscrimination 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 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 Mode Switch AMS Off DDD R DDT R DDI R VVT R VVI R
5. al 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 a o o Cardiac Resynchronisation Therapy CRT Devices tion The bril 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 81x50x 14 75x 50x14 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 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 Management AF Suppression P
6. and its related companies 2011 St Jude Medical Inc All rights reserved Item GMCRM768EN 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 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 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 detect
7. ete 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 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 supplement
8. ion electrograms triggers include diagnosis therapy atrial episode PMT termination PC shock delivery noise reversion magnet reversion and morphology template verification iagram of therapies delivered irectory 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 leart 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 mem ST JUDE MEDICAL Hae MORE CONTROL LESS RISK
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