cardiac Resynchronization therapy Defibrillator (cRt-D)
Contents
1. a serious shock if you touch the defibrillation terminals while the device is charged Additional Pacemaker Implanted These devices provide bradycardia pacing If another pacemaker is used it should have a bipolar pacing reset mode and be programmed for bipolar pacing to minimize the possibility of the output pulses being detected by the device Modifying the Device This device has been tested for compliance to FCC regulations Changes or modifications of any kind not expressly approved by St Jude Medical Inc could void the user s authority to operate this device Suboptimal Radio Frequency RF Communication The Merlin PCS indicates the quality of the RF communication by the telemetry strength indicator LEDs on both the Merlin PCS and the Merlin Antenna Please see the User s Manual for a list of potential causes to suboptimal radio communication Potential Adverse Events Possible adverse events in alphabetical order associated with the system include but are not limited to the following acceleration of arrhythmias caused by device air embolism allergic reaction bleeding cardiac tamponade chronic nerve damage death erosion exacerbation of heart failure excessive fibrotic tissue growth extracardiac stimulation phrenic nerve diaphragm chest wall extrusion fluid accumulation formation of hematomas or cysts inappropriate shocks infection keloid formation lead abrasion and discontinuity lead migration dislodgment myo2. Unify Cardiac Resynchronization Therapy Defibrillator CRT D MODELS CD3231 40 DF 1 IS 1 and CD3231 40Q SJ4 SPECIFICATIONS m Advanced Biventricular Pacing options VectSelect programmable LV pulse configuration LV ring RV coil LV tip RV coil or LV bipolar may be adjusted noninvasively via the programmer 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 Unique 40 J Safety Shock option delivered energy provides a greater DFT safety margin and may minimize the need for multiple DFT tests at implant The SJ4 connector is designed to simplify implants by streamlining defibrillation connections into a single terminal pin and reducing the number of set screws m QHR chemistry battery provides greater capacity for enhanced longevity and charge times The addition of antitachycardia pacing ATP while charging and prior to charging in the VF zone further extends the programming options for converting tachyarrhythmias prior to or while charging The BiV Pacing alert notifies clinics when percent biventricular pacing is less than the programmed threshold The Low Frequen
3. cardial damage pneumothorax shunting current or insulating myocardium during defibrillation with internal or external paddles potential mortality due to inability to defibrillate or pace thromboemboli venous occlusion venous or cardiac perforation Patients susceptible to frequent shocks despite antiarrhythmic medical management may develop psychological intolerance to an ICD or CRT D system that may include the following dependency depression fear of premature battery depletion fear of shocking while conscious fear of losing shock capability imagined shocking phantom shock Refer to the User s Manual for detailed indications contraindications warnings precautions and potential adverse events EEE mem ST JUDE MEDICAL EHE MORE CONTROL LESS RISK PHYSICAL SPECIFICATIONS Models Telemetry Delivered Stored Energy J Volume cc Weight g Size mm Defibrillation Lead Connections Sense Pace Lead Connections High Voltage Can D3231 40 RF 40 45 36 78 79x 40x 14 DF 1 IS 1 Electrically active titanium can D3231 400 RF 40 45 36 71 73 x 40x 14 SJ4 SJ4 Electrically active titanium can PARAMETERS Biventricular Pacing Settings V Triggering BiV Trigger Mode On Off QuickOpt Timing Cycle Optimization Sensed paced AV delay interventricular pace delay V V Timing Interventricular Pace Delay ms Ventricular Sensing Ventricular Pacing Chamber Negativ
4. cy Attenuation filter is designed to enhance sensing performance and may reduce the possibility of oversensing T waves BiVCap LVCap RVCap and ACap Confirm features promote patient safety by automatically ensuring capture of the myocardium in response to pacing stimuli in the left ventricle right ventricle and right atrium DeFT Response technology tools provide more clinically proven noninvasive options for managing high DFTs Programmable pulse widths allow the user to tailor the shock to the individual patient making shocks more efficacious SVC shocking electrode can be quickly and noninvasively activated or deactivated with the press of a button 40 J delivered energy provides unsurpassed energy for defibrillation Four programmable tilt options are available to accommodate variances among patients Unique SenseAbility feature with Decay Delay and Threshold Start provides the flexibility to fine tune sensing to individual patient needs m QuickOpt timing cycle optimization provides quick and effective optimization for more patients at the push of a button Unique Morphology Discrimination plus AV Rate Branch SVT discrimination feature helps reduce the risk of inappropriate ICD shocks and is intended to promote fast accurate diagnosis and delivery of therapy Clinical data states that this combination resulted in a sensitivity of 100 with a specificity of 85 m Unique AF Sup
5. e 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 AF Suppression Pacing No of Overdrive Pacing Cycles Maximum AF Suppression Rate Sensing Detection On Off 5 40 in steps of 5 80 150 ppm SenseAbility Technology Low Frequency Attenuation hreshold Start Decay Delay Ventricular Sense Refractory ms Detection Zones SVT Discriminators Reconfirmation Antitachycardia Pacing Therapy LV tip to RV coil LV bipolar LV ring to RV coil Automatic Sensitivity Control adjustment for atrial 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 0 220 125 157 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 Number of Stimuli Add Stimuli per Burst High Voltage Therapy Ramp Burst Scan 1 or 2 schemes per VT zone ATP While Charging ATP Prior to C
6. e a reduction of the symptoms of moderate to severe heart failure NYHA Functional Class III or IV in those patients who remain symptomatic despite stable optimal medical therapy as defined in the clinical trials section included in the Merlin Patient Care System PCS on screen help and have a left ventricular ejection fraction less than or equal to 35 and a prolonged QRS duration to maintain synchrony of the left and right ventricles in patients who have undergone an AV nodal ablation for chronic permanent atrial fibrillation and have NYHA Class II or Ill 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 Warnings and Precautions Resuscitation Availability Do not perform device testing unless an external defibrillator and medical personnel skilled in cardiopulmonary resuscitation CPR are readily available Lead System Do not use another manufacturer s lead system without demonstrated compatibility as undersensing cardiac activity and failure to deliver necessary therapy may result Avoiding Shock During Handling Disable tachyarrhythmia therapy Enable Disable Tachy Therapy or program tachyarrhythmia therapies Off during surgical implant and explant or post mortem procedures as well as when disconnecting leads as the device can deliver
7. esponsive AV Delay Hysteresis Rate ppm Rate Hysteresis with Search Off DDI R DDT R VVI R VVT R 110 300 40 45 135 Atrial Pace on PMT Off Passive PVARP VREF Off Low Medium High 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 ppm Post Shock Pacing Duration min Device Testing Induction Methods Off VVI DDI DDD AAI 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 Diagnostic 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 Long AT AF Episode On On 2 4 6 8 10 12 14 16 2 16 0 22 Stored Electrograms herapy Summary Episodes Summary Lifetime Diagnostics istograms Real Time Meas
8. harging Off 150 300 bpm Adaptive Readaptive or Fixed 150 400 in increments of 5 1 15 2 20 On Off 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 QHR is a registered trademark of Greatbatch LTD LV first with 10 ms interventricular delay ATRIAL FIBRILLATION Global Headquarters One St Jude Medical Drive St Paul Minnesota 55117 USA 1 651 756 2000 1 651 756 3301 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 SJMprofessional com CARDIOVASCULAR St Jude Medical AB Veddestavagen 19 175 84 Jarfalla Sweden 46 8 474 40 00 46 8 760 95 42 Fax Bradycardia Pacing Permanent Modes Temporary Modes Rate Adaptive Sensor Programmable Rate and Delay Parameters Auto Mode Switch AMS Atrial Tachycardia Detection Rate AMS Base Rate Auto PMT Detection Termination Rate Responsive Ventricular Intrinsic Preference VIP LVCap Confirm RVCap Confirm ACap Confirm 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 ppm Rest Rate ppm Maximum Tracking Rate ppm Maximum Sensor Rate ppm Paced AV Delay ms Sensed AV Delay ms Rate R
9. lar Electrophysiology 2007 18 185 191 4 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 2002 3 A131 1515 5 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 NEUROMODULATION U S Division 807 Las Cimas Parkway Suite 400 Austin Texas 78746 USA 1 512 732 7400 1 512 732 2418 Fax CAUTION FEDERAL LAW USA RESTRICTS THIS DEVICE TO SALE DISTRIBUTION AND USE BY OR ON THE ORDER OF A PHYSICIAN 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 directions for use Unless otherwise noted or indicates a registered or unregistered trademark or service mark owned by or licensed to St Jude Medical Inc 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 2010 St Jude Medical Inc All rights reserved Item No G0318 aan ST JUDE MEDICAL MORE CONTROL LESS RISK
10. pression algorithm is clinically proven to suppress episodes of paroxysmal and persistent AF Studies show a 25 decrease in symptomatic AF burden AT AF Alerts 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 Up to 45 minutes of continuous fully annotated stored electrograms including up to 60 seconds of pre trigger information per electrogram Unique Vibratory Patient Notifier allows even patients with hearing problems to be alerted to a low battery lead related complications and more Automatic Daily High Voltage HV Lead Integrity Test is designed to automatically test the HV lead on a daily basis to ensure therapy delivery for optimal patient safety Multiple hardware and software system safeguards are included for added security and patient comfort Decreased device footprint and volume with the most narrow 40 mm design Indications and Usage Unify pulse generators are intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias AF Suppression pacing is indicated for suppression of paroxysmal or persistent atrial fibrillation in patients with the above ICD indication and sinus node dysfunction In patients indicated for an ICD Unify pulse generators are also intended to provid
11. urements RTM Ventricular HV Lead Impedance Trend 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 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 Pacing lead impedances high voltage lead impedances and signal amplitudes 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 JH Mckenzie J Beau S 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 Cardiovascu
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