Promote pdf
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1. Promote RF CRT MODEL 3213 36 Cardiac Resynchronization Therapy Defibrillator CRT D SPECIFICATIONS MODEL NUMBER PHYSICAL SPECIFICATIONS Volume cc Weight g Size mm Defibrillation Lead Connections Sense Pace Lead Connections High Voltage Can RESYNCHRONIZATION THERAPY 3213 36 43 82 81x 50x 14 DF 1 IS 1 Electrically active titanium can QuickOpt Timing Cycle Optimization V V Timing Interventricular Pace Delay ms Ventricular Sensing Ventricular Pacing Chamber Negative AV PV Hysteresis Search ms Shortest AV Delay ms LV Pulse Configuration AF MANAGEMENT Sensed paced AV delay Interventricular Pace delay Simultaneous RV First LV First RV First 10 80 LV First 15 80 in steps of 5 RV only not programmable RV only LV 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 Off On 15 40 in steps of 5 80 150 min POST THERAPY PACING Independently programmable from Bradycardia and ATP Post Shock Pacing Mode Off AAI VVI DDI or DDD Post Shock Base Rate min Post Shock Pacing Duration DEVICE TESTING INDUCTION METHODS 30 100 in increments of 5 Off 30 sec 1 2 5 5 7 5 or 10 min DC Fibber Pulse Duration sec Burst Fibber Cycle Length ms Shock on T Voltage Noninvasive Programmed Stimulatio2. and be programmed for bipolar pacing to minimize the possibility of the output pulses being detected by the device Ensure that a separate standby external defibrillator is immediately available during the implant procedure or induction testing The patient should avoid strong magnetic fields since they are potentially capable of inhibiting tachyarrhythmia therapies MRI for patients with implantable pulse generators has been contraindicated by MRI manufac turers Clinicians should carefully weigh the decision to use MRI with ICD CRT D patients MRI may cause device malfunction or injury to the patient Avoid lithotripsy unless the therapy site is not near the pulse generator and leads as it may damage the pulse generator Use devices emitting ionizing radiation with caution as they can damage CMOS circuitry in the pulse generator Avoid diathermy even if the device is programmed off as it may damage tissue around the implanted electrodes or may permanently damage the pulse generator Changes in the patient s disease and or medication may necessitate reevaluation of the patient s clini cal arrhythmias and require reprogramming of the device Patients may experience psychological effects such as imagined pulsing dependency fear of inappropriate shocks and fear that pacing capability may be lost Potential Adverse Events Potential adverse events associated with the Promote CRT D include but are not limited to the following acceleration of arrhythmias
3. SICIAN 818 362 6822 46 8 760 9542 Fax Consult the User s Manual for information on indications contraindications wamings and precautions 818 362 7182 F Unless otherwise noted or indicates that the name is a trademark of or licensed to St Jude Medical or one of its subsidiaries ax 2007 St Jude Medical Cardiac Rhythm Management Division All rights reserved www sjm com
4. cation and sinus node dysfunction In patients indicated for an ICD the Promote systems are also intended to e provide a reduction of the symptoms of moderate to severe heart failure NYHA Functional Class Ill or IV in those patients who remain symptomatic despite stable optimal medical therapy as defined in the clinical trials section and have a left ventricular ejection fraction less than or equal to 35 and a prolonged QRS duration 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 Promote CRT D systems include ventricular tachyarrhythmias resulting from transient or correctable factors such as drug toxicity electrolyte imbalance or acute myocardial infarction Warnings Precautions The physician should be familiar with all components of the system and the material in the User s Manual before beginning the pro cedure Do not implant the pulse generator if the acute defibrillation lead impedance is less than 20 ohms or the impedance of chronic leads is less than 15 ohms Damage to the device may result if high voltage therapy is delivered into an impedance less than 15 ohms The pulse generator provides dual chamber bradycardia pacing with ventricular resynchronization therapy if another pacemaker is used it should have a bipolar pacing reset mode
5. 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 dislodgement myocardial 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 psychologi cal intolerance to an ICD system that may include the following dependency depression fear of premature battery depletion fear of shocking while conscious fear that shocking capability may be lost and imagined shocking phantom shock Refer to the User s Manual for detailed indications contraindications warnings precautions and potential adverse events ST JUDE MEDICA aaa Cardiac Rhythm St Jude Medical AB Management Division Veddestavagen 19 15900 Valley View Court SE 175 84 Jarfalla aeeie ase Balin Eko TiO Sylmar CA 91342 USA SWEDEN CAUTION FEDERAL LAW USA RESTRICTS THIS DEVICE TO SALE DISTRIBUTION AND USE BY OR ON THE ORDER 888 SJM CRMD 46 8 474 4000 OF A PHY
6. in increments of 5 1 15 with 2 20 stimuli On Off Maximum Energy Voltage High Voltage Output Mode Waveform RV Polarity Electrode Configuration 42 J Stored 830 volts 36 J Delivered Fixed Pulse Width Fixed Tilt Biphasic Monophasic Cathode Anode RV to Can RV to SVC Can BRADYCARDIA PACING Permanent Modes Off DDD R DDI R VVI R AAI R Pacer Off Temporary Modes Off DDD DDI WI AAI AAT DOO VOO AOO Rate Adaptive Sensor Programmable Rate Parameters Auto Mode Switch AMS AMS Detection Rate min 1 AMS Base Rate Auto PMT Detection Termination Rate Responsive PVARP VREF Ventricular Intrinsic Preference VIP On Off Passive ff Base Rate min Rest Rate min Maximum Tracking Rate in Maximum Sensor Rate min Paced AV Delay ms nsed AV Delay ms Rate Responsive AV Delay Pulse Amplitude trial RV and LV V Pulse Width Atrial RV and LV ms lysteresis Rate min Rate Hysteresis with Search ff DDI R VVI R 110 300 0 45 135 Pace on PMT Off Passive Low Medium High ff 50 200 60 150 in increments of 25 160 200 in increments of 10 Bess CL gt oor Stored Electrograms Therapy Summary Episodes Summary Lifetime Diagnostics AT AF Burden Trend AF Suppression Trend Ventricular HV Lead Impedance Trend Histograms PMT Data Real Time Measurements RTM LV first with 10 ms interventricular delay Up to 45 minutes incl
7. n NIPS PATIENT NOTIFIERS Programmable Notifiers On Off Entry into Backup VVI Mode Vibration Duration Number of Vibrations per Notification Number of Notifications Time Between Notifications ELECTROGRAMS AND DIAGNOSTICS 0 5 5 0 20 100 50 830 V 0 1 36 J Delivered 2 20 stimuli with up to three extrastimuli Device at ERI Charge time Limit Reached Possible HV Circuit Damage Device Reset Atrial Lead Impedance out of range Ventricular Lead Impedance out of range On 2 4 6 8 10 12 14 16 s 2 1 16 10 22 hours 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 VI 2 VF AV Rate Branch Sudden Onset Interval Stability Morphology Discrimination MD with Manual or Automatic Template Update Continuous sensing during charging ATP Configurations width Burst Cycle Length Min Burst Cycle Length ms Number of Bursts Stimuli Add Stimuli per Burst HIGH VOLTAGE THERAPY Ramp Burst Scan pulse amplitude and pulse Adaptive Readaptive or Fixed 150 400
8. uding up to one minute programmable pre trigger data per VI VF diagnosis detection therapy 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 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 unloaded battery voltage signal amplitudes and RTM trends Not available if Negative AV PV Hysteresis Search programmed ON or when ventricular pacing is programmed to biventricular ST JUDE MEDICAL Promote RF Model 3213 36 memmmm Cardiac Resynchronization Therapy Defibrillator Indications and Usage The Promote CRT D systems 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 persist ent atrial fibrillation in patients with the above ICD indi
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