Fortify™ DR - Sante International SA
Contents
1. Anode RV to Can RV to SVC Can Permanent Modes Temporary Modes Rate Adaptive Sensor Programmable Rate and Delay Parameters DDD R DDI R VVI R AAI R Pacer Off Off DDD DDI VVI AAI 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 Hysteresis Rate min Rate Hysteresis with Search QuickOpt Timing Cycle Optimisation Sensed Paced AV delay Auto Mode Switch AMS Off DDI R VVI R Atrial Tachycardia Detection Rate min 110 300 AMS Base Rate min Auto PMT Detection Termination Rate Responsive PVARP VREF 40 135 Atrial Pace Off Passive Off Low Medium High 45 Ventricular Intrinsic Preference VIP Off 50 200 50 150 in increments of 25 160 200 in increments of 10 Ventricular AutoCapture Pacing System ACap Confirm ATRIAL FIBRILLATION CARDIAC RHYTHM MANAGEMENT On Off On Monitor Off CARDIOVASCULAR St Jude Medical AB Post Therapy Pacing independently programmable from Bradycardia and ATP Post Shock Pacing Mode Post Shock Base Rate min Post Shock Pacing Duration min Off AAI VVI DDI DDD 30 100 in increments of 5 Off 0 5 1 2 5 5 7 5 or 10 Device Testing Induction Methods DC Fibber Pulse Duration sec Burst Fibber Cycle Length ms Noninvasive Prog2. 900 Valley View Court USA Sylmar California 91342 1 651 756 2000 USA 1651 756 3301 Fax 1 818 362 6822 1 818 364 5814 Fax Cardiac Rhythm Veddestavagen 19 175 84 Jarfalla Sweden 46 8 474 40 00 46 8 760 95 42 Fax St Jude Medical Coordination Center BVBA The Corporate Village St Jude Medical Brasil Ltda Rua Frei Caneca 1380 7 ao 9 andares Suite 1608 16 F Exchange Tower 33 Wang Chiu Road Da Vincilaan 11 Box F1 01307 002 S o Paulo SP Kowloon Bay 1935 Zaventem Brazil Kowloon Belgium 55 11 5080 5400 Hong Kong SAR 32 277468 11 55 11 5080 5423 Fax 852 2996 7688 32 2 772 83 84 Fax 852 2956 0622 Fax SJMprofessional com St Jude Medical Hong Kong Ltd St Jude Medical Japan Co Ltd 3 1 30 Minami Aoyama Minato ku Tokyo 107 0062 Japan 81 3 3423 6450 81 3 3402 5586 Fax St Jude Medical UK Ltd Capulet House Stratford Business amp Technology Park Banbury Road Stratford upon Avon CV37 7GX United Kingdom 44 1789 207600 44 1789 207601 as ST JUDE MEDICAL MORE CONTROL LESS RISK 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
3. Forty DR Implantable Cardioverter Defibrillator ICD with CorVue Congestion Monitoring MODELS CD2233 40 DF 1 AND CD2233 40Q SJ4 SPECIFICATIONS 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 Unique 40 J Safety Shock option delivered energy provides a greater DFT safety margin and may minimise 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 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 before or during charge a 4 he V Pacing alert notifies patients and their clinics when percent ventricular pacing is greater than the programmed threshold a he Low Frequency Attenuation filter is designed to enhance sensing performance and may reduce the possibility of oversensing T waves 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 effic
4. a registered and unregistered trademark or service mark owned by 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 2010 St Jude Medical Inc All Rights Reserved Printed in Belgium Item No GMCRM621UK
5. acious SVC shocking electrode can be quickly and noninvasively activated or deactivated with the touch 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 optimisation provides quick and effective optimisation for more patients at the touch 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 Unique AF Suppression 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 pr
6. ar Heart Rate Histogram AT AF Burden Exercise and Activity Trending V Rates during AMS PMT Data Information regarding PMT detections Real Time Measurements RTM Pacing lead impedances high voltage lead impedances and signal amplitudes On Off 8 18 days CorVue Congestion Monitoring CorVue Congestion Trigger 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 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 Cardiovascular 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 QHR is a trademark of Greatbatch LTD NEUROMODULATION Global Headquarters One St Jude Medical Drive Management Division St Paul Minnesota 55117 15
7. erse 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 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 Lt mee ST JUDE MEDICAL 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 PARAMETER D2233 40 D2233 400 RF RF 40 45 40 45 35 35 76 75 74x40x14 71x40x14 DF 1 SJ4 IS 1 SJ4 Electrically active titanium can Electrically active titanium can Settings AF Management AF Suppression Pacing No of Overdrive Pacing Cycles Maximum AF Suppression Rate Sensing Detection On Off 15 40 in s
8. nation whenever there are no leads connected to it when sense pace leads are connected but are not implanted in a patient If a programmer is not available use a magnet to prevent delivery of tachyarrhythmia therapy in response to detected disconnection artifacts Place the magnet over the pulse generator before disconnecting the leads Do not remove it until the leads are reconnected External Equipment for Arrhythmia Induction f external equipment is used for arrhythmia induction through the pulse generator header and leads apply rectified AC current through the high voltage ports not the sense pace ports to avoid damaging the sense pace function disconnect the external equipment from the pulse generator before any therapy is delivered otherwise damage to the device is likely to occur Place a magnet over the device until the external equipment can be disconnected 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 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 adv
9. ncy RF fields they produce Device Storage Store the pulse generator at temperatures between 10 and 45 C Do not subject it to temperatures below 20 or over 60 C After cold storage allow the device to reach room temperature before charging the capacitors programming or implanting the device because cold temperature may affect initial device function Device Communication Communication with the device can be affected by electrical interference and strong magnetic fields If this is a problem turn off nearby electrical equipment or move it away from the patient and the programmer If the problem persists contact St Jude Medical Lead Impedance Do not implant the pulse generator if the acute defibrillation lead impedance is less than 20 ohms or the lead 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 Suboptimal RF Communication The Merlin Patient Care System PCS indicates the quality of the RF communication by the telemetry strength indicator LEDs on both the programmer and the Merlin Antenna Disconnecting Leads Connecting or disconnecting sense pace leads can produce electrical artifacts that can be sensed by the pulse generator To prevent detection of artifacts reprogram the pulse generator to tachyarrhythmia therapy Off before disconnecting the leads from a pulse generator in the operating room before a post mortem exami
10. oblems 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 available for greater patient comfort and range of motion during activity AutoCapture Pacing System offers the maximum in threshold adaptability and patient safety with ventricular Beat by Beat capture confirmation The AutoCapture Pacing System automatically delivers a 5 0 V backup safety pulse when noncapture is detected ACap Confirm Pacing System periodically completes a threshold search and automatically adjusts amplitude to address patients changing atrial thresholds Designed to reduce unnecessary right ventricular pacing the Ventricular Intrinsic Preference VIP algorithm allows intrinsic conduction when possible and provides optimised ventricular support when needed Indications The devices are intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias Contraindications Contraindications for use of the pulse generator system include ventricular tachyarrhythmias resulting from transient
11. or correctable factors such as drug toxicity electrolyte imbalance or acute myocardial infarction Warnings and Precautions Implantation Procedure The physician should be familiar with all components of the system and the material in this manual before beginning the procedure Ensure that a separate standby external defibrillator is immediately available Implant the pulse generator no deeper than 5 cm to ensure reliable data transmission For patient comfort do not implant the pulse generator within 1 25 cm of bone unless you cannot avoid it Device Replacement Replace the pulse generator within three months of reaching the ERI indication Replace the pulse generator immediately upon reaching ERI if there is frequent high voltage charging and or one or more of the pacing outputs are programmed above 2 5 V Battery Incineration Do not incinerate pulse generators as they contain sealed chemical power cells and capacitors that may explode Return explanted devices to St Jude Medical High Voltage Can Ensure that tachyarrhythmia therapy is programmed Off before handling the pulse generator to avoid any risk of accidental shock Do not program tachyarrhythmia therapies On until the pulse generator is inserted in the pocket For effective defibrillation perform all defibrillation testing with the can in the pocket Magnetic Resonance Imaging MRI Avoid MRI devices because of the magnitude of the magnetic fields and the strength of the radiofreque
12. rammed Stimulation NIPS Patient Notifiers 0 5 5 0 20 100 2 25 stimuli with up to 3 extrastimuli Programmable Notifiers On Off 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 V Pacing CorVue Congestion Trigger Device Parameter 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 Electrograms and Diagnostics 10 22 Stored Electrograms 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 Lifetime Diagnostics History of bradycardia events and device initiated charging AT AF Burden Trend Trend data and counts Ventricular HV Lead Impedance Trend Multi Vector Trend Data Therapy Summary Episodes Summary Histograms Event Histogram AV Interval Histogram Mode Switch Duration Histogram Peak Filtered Rate Histogram Atrial Heart Rate Histogram Ventricul
13. teps of 5 80 150 min SenseAbility Technology Low Frequency Attenuation 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 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 25 157 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 ATP Pulse Amplitude V ATP Pulse Width ms High Voltage Therapy Ramp Burst Scan 1 or 2 schemes per VT zone ATP While Charging ATP Prior to Charging Off 50 300 bpm Adaptive Readaptive or Fixed 50 400 in increments of 5 15 2 20 On Off 7 5 independent from Bradycardia and Post Therapy Pacing 0 or 1 5 independently programmable from Bradycardia and Post Therapy Pacing 5 High Voltage Output Mode Waveform RV Polarity Electrode Configuration Bradycardia Pacing Fixed Pulse Width Fixed Tilt Biphasic Monophasic Cathode
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