Anthem™ - Sante International SA
Contents
1. IS 1 PARAMETER SETTINGS Resynchronisation Therapy QuickOpt Timing Cycle Optimisation RV and LV Pulse Width ms RV and LV Pulse Amplitude V RV Pulse Configuration LV Pulse Configuration Ventricular Sense Configuration Ventricular Pacing Chamber First Chamber Paced Interventricular Pace Delay ms Output Sensing Negative AV Hysteresis Search ms Shortest AV PV Delay ms Atrial ACap Confirm Primary Pulse Confirmation Backup Pulse Confirmation Backup Pulse Amplitude V Searchable Intervals hrs Atrial Pulse Configuration Atrial Sense Configuration Atrial Sensitivity Fixed mV Atrial Pulse Amplitude V Atrial Pulse Width ms RVCap Confirm Searchable Interval hrs LVCap Confirm Searchable Interval hrs SenseAbility Technology A Max Sensitivity mV V Max Sensitivity mV Threshold Start Decay Delay ms Ventricular Sensitivity fixed mV Rate Timing Mode DDT Trigger DDT Timing Base Rate min Hysteresis Rate min Search Interval min Cycle Count Intervention Rate min Intervention Duration min Recovery Time Rest Rate min Maximum Tracking Rate min Sensed AV Delay ms Paced AV Delay ms Ventricular Pace Sense Refractory Fixed ms Atrial Pace Refractory Atrial Sense Refractory PVARP ms Atrial Protection Interval ms Far Field Protection Interval ms 1 0 5cc 2 LV first with 10 ms interventricular delay Sens2. Low High Off Low High 125 300 in steps of 25 2 3 4 5 10 15 20 Off Low High 125 300 in steps of 25 2 3 4 5 10 15 20 Off Low High Off Low High 2 3 4 9 Off Low High Off Battery Test Off 50 150 in steps of 25 160 200 in steps of 10 30 Sec 1 3 5 10 30 min 1 2 3 110 200 in steps of 10 225 300 in steps of 25 60 200 in steps of 10 225 250 Off On Off Atrial Pace Off Passive Atrial Pace 90 180 in steps of 5 Uncoded Unipolar Bipolar Atrial Right Ventricular 200 800 in steps of 10 2 25 in steps of 1 Off 100 800 in steps of 10 Fixed or Adaptive Off 30 95 in steps of 5 1 5 in steps of 1 AT AF Activity Exercise Lead Impedance P and R Wave A and V threshold Device at ERI Atrial Lead Impedance Out of Range Ventricular Lead Impedance Out of Range LV Lead Impedance Out of Range AT AF Burden AT AF Episode Duration High V Rate During AT AF On On 2 4 6 8 10 12 14 16 2 1 16 10 22 DE 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 that the name is a trademark of or
3. programmable LV pulse configuration LV ring RV ring LV tip RV ring LV bipolar LV unipolar tip may be adjusted noninvasively via the programmer 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 QuickOpt Timing Cycle Optimisation provides quick and effective optimisation for more patients at the push of a button EGM based AV and V V optimisation allows optimised timing without need for echo guided optimisation V V timing optimisation may help improve patient outcomes Because not all patients respond to simultaneous biventricular pacing programmable timing of right and left ventricular outputs helps to ensure appropriate therapy and may reduce the number of non responders Exclusive 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 Burden Trend provides a graphical representation of the percentage of time in AT AF and the number of AT AF episodes in the previous 52 weeks This diagnostic view can help identify long term trends regarding the time or episodes in AF and may facilitate device drug management according to the patient s response AT AF Alerts can be programmed to notify patients and their clinics when a programmed AT AF threshold or contin
4. Anthem SPECIFICATIONS m Upon interrogation the device displays the last automatically measured capture threshold results from the atrium and ventricle In addition the pacemaker automatically measures intrinsic P and R wave activity daily and displays the last test results in combination with a weekly P or R wave trend Results are displayed with follow up EGMs for quick verification 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 Exclusive SenseAbility feature with Decay Delay and Threshold Start provides the flexibility to fine tune sensing to individual patient needs and help eliminate oversensing of T waves fractionated QRS complexes and other extraneous signals A two tone audible alert allows programming for the patient to be alerted to changes in device performance or information can be sent directly to the clinician through the Merlin net Patient Care Network PCN Advanced Biventricular Pacing options 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
5. DDI R DDT R DDD R VDD R Pacing Off R wave DDI 30 130 in steps of 5 140 170 in steps of 10 Off 30 150 in steps of 5 Off 1 5 10 15 30 1 16 Off Same Base Rate 80 120 in steps of 10 Intrinsic 0 Intrinsic 10 Intrinsic 20 Intrinsic 30 1 10 Fast Medium Slow Very Slow Off 30 150 in steps of 5 90 130 in steps of 5 140 180 in steps of 10 25 30 200 in steps of 10 225 325 in steps of 25 25 30 200 in steps of 10 225 300 in steps of 25 350 125 160 400 in steps of 30 440 470 190 400 in steps of 30 440 470 93 125 157 190 400 in steps of 30 440 470 125 500 in steps of 25 125 16 3 Sensitivity is with respect to a 20 ms haversine test signal 4 Values 0 1 0 4 not available in a Unipolar Sense Configuration 5 This parameter is not programmable 6 The highest available setting for hysteresis rate is 5 min below the programmed base rate 7 In dual chamber modes the maximum Ventricular Refractory Period is 325 ms 8 Programming options dependent on pacing mode 9 During atrial NIPS in dual chamber modes the shortest Coupling Interval will be limited by the programmed AV PV Delay 10 S1 Burst Cycle is applied at the preprogrammed S1 cycle length ATRIAL FIBRILLATION Global Headquarters One Lillehei Plaza St Paul Minnesota 55117 1 651 490 4310 Fax CARDIAC RHYTHM MANAGEMENT Cardiac Rhythm Management Division 15900 Valley View Court USA Sylmar Califo
6. ation cardiac coronary sinus dissection cardiac coronary sinus perforation coronary sinus or cardiac vein thrombosis The following in addition to the above are potential complications associated with the use of rate modulated pacing systems inappropriate rapid pacing rates due to sensor failure or to the detection of signals other than patient activity loss of activity response due to sensor failure palpitations with high rate pacing Refer to the User s Manual for detailed indications contraindications warnings precautions and potential adverse events 1 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 2007 18 185 191 2 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 4 supplement 572 abstract 199 3 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 ALI aon ST JUDE MEDICAL MORE CONTROL LESS RISK PHYSICAL SPECIFICATIONS Model Telemetry Dimensions mm Weight g Volume cc Connector PM3112 Inductive 52x 52x6 21 11 5
7. ed Paced AV Delay Interventricular Paced Delay 0 05 0 1 1 5 in steps of 0 1 0 25 4 0 in steps of 0 25 4 5 7 5 in steps of 0 5 Unipolar Bipolar Unipolar Bipolar LV Tip RV Ring LV Ring RV Ring BV Unipolar Tip BV Bipolar RV Unipolar Tip RV Bipolar LV Unipolar Tip LV Bipolar RV Unipolar Ring LV Tip RV Tip BV RV only LV only temporary mode Simultaneous RV LV 10 80 in steps of 5 Off 10 to 120 in steps of 10 25 50 in steps of 5 60 120 in steps of 10 On Off Monitor Bipolar Bipolar 5 0 8 24 Unipolar tip case Bipolar tip ring Unipolar Tip tip case Bipolar tip ring Unipolar Ring ring case 0 1 0 5 in steps of 0 1 0 75 2 0 in steps of 0 25 2 5 5 0 in steps of 0 5 0 25 4 0 in steps of 0 25 4 5 7 5 in steps of 0 5 0 05 0 1 1 5 in steps of 0 1 On Off Monitor 8 24 On Off Monitor 8 24 Off On Automatic Sensitivity Control adjustment for atrial and ventricular events 0 2 1 0 in steps of 0 1 0 2 2 0 in steps of 0 1 Atrial and Ventricular Post Sense 50 62 5 75 100 Atrial Post Pace 0 2 3 0 in steps of 0 1 mV Ventricular Post Pace Auto 0 2 3 0 in steps of 0 1 mV Atrial and Ventricular Post Sense 0 30 60 95 125 160 190 220 Atrial Post Pace 0 30 60 95 125 160 190 220 Ventricular Post Pace Auto 0 30 60 95 125 160 190 220 0 5 12 5 in steps of 0 5 A00 R AAI R AAT R VOO R VVI R VVT R DOO R DVI R
8. ia Detection Rate min Post Vent Atrial Blanking PVAB ms Ventricular Safety Standby PVC Response PMT Options PMT Detection Rate min Lead Type NIPS Options Stimulation Chamber Coupling Interval ms SI Count SI S2 S3 and S4 Cycle ms Right Venticular Support Rate min Sinus Node Recovery Delay s Diagnostic Trends Patient Notifiers Programmable Notitiers On Off Device Reset Entry into Backup VVI Mode Audible Duration sec Number of Audible Alerts per Notification Number of Notifications Time Between Notifications hours St Jude Medical Japan Co Ltd 3 1 30 Minami Aoyama 7 ao 9 andares Grand Millennium Plaza Minato ku 01307 002 S o Paulo SP 183 Queen s Road Tokyo 107 0062 Brazil Central Hong Kong Japan 81 3 3423 6450 81 3 3402 5586 Fax mem ST JU Off Low Medium High Off Low Medium High 125 475 in steps of 25 On Off Passive 80 150 in steps of 5 160 180 in steps of 10 Auto 0 5 Auto 0 0 Auto 0 5 Auto 1 0 Auto 1 5 Auto 2 0 1 7 in steps of 0 5 Auto 1 Auto 0 Auto 1 Auto 2 Auto 3 1 16 Very Fast Fast Medium Slow Fast Medium Slow Very Slow Off On 10 5 15 40 in steps of 5 8 12 Off DDD R to DDI R DDD R to DDT R DDD R to VVI R DDD R to VVT R VDD R to VVI R VDD R to VVT R 40 170 in steps of 5 Off Low High 1 2 3 Off Low High Off Low High Off Low High Off
9. inus syndrome chronic symptomatic second and third degree AV block recurrent Adams Stokes syndrome symptomatic bilateral bundle branch block when tachyarrhythmia and other causes have been ruled out Atrial Pacing is indicated for patients with sinus node dysfunction and normal AV and intraventricular conduction systems Ventricular Pacing is indicated for patients with significant bradycardia and normal sinus rhythm with only rare episodes of A V block or sinus arrest chronic atrial fibrillation severe physical disability AF Suppression is indicated for suppression of paroxysmal or persistent atrial fibrillation episodes in patients with one or more of the above pacing indications Contraindications Implanted Cardioverter Defibrillator ICD Devices are contraindicated in patients with an implanted cardioverter defibrillator Rate Adaptive Pacing may be inappropriate for patients who experience angina or other symptoms of myocardial dysfunction at higher sensor driven rates An appropriate Maximum Sensor Rate should be selected based on assessment of the highest stimulation rate tolerated by the patient AF Suppression stimulation is not recommended in patients who cannot tolerate high atrial rate stimulation Dual Chamber Pacing though not contraindicated for patients with chronic atrial flutter chronic atrial fibrillation or silent atria may provide no benefit beyond that of single chamber pacing in such patients Single Chamber Ventricular De
10. licensed to St Jude Medical or one of its subsidiaries ST JUDE MEDICAL the nine squares symbol and MORE CONTROL LESS RISK are trademarks and service marks of St Jude Medical Inc and its related companies 2009 St Jude Medical Inc All Rights Reserved Item GMCRM458
11. mand Pacing is relatively contraindicated in patients who have demonstrated pacemaker syndrome have retrograde VA conduction or suffer a drop in arterial blood pressure with the onset of ventricular pacing Single Chamber Atrial Pacing is relatively contraindicated in patients who have demonstrated compromise of AV conduction Atrial Fibrillation Anthem devices are contraindicated in patient s having chronic atrial fibrillation or intermittent atrial fibrillation that does not terminate For specific contraindications associated with individual modes refer to the programmer s on screen help Warnings and Precautions To prevent permanent damage to the device and tissue damage at the electrode tissue interface Electrosurgery Do not use electrosurgical devices in the vicinity of an implanted device If electrocautery is necessary use a bipolar cauteriser or place the indifferent electrode as far from the device as possible Lithotripsy Do not focus a lithotripsy beam within 16 cm of the device Program the device to Sensor Off prior to lithotripsy to prevent inappropriate increases in pacing rate A thorough assessment of device function with special attention to the sensor should be performed following exposure to lithotripsy Therapeutic Radiation Do not use ionising radiation in the vicinity of an implanted device Radiation therapy may damage the electronic circuitry of the device Ultrasound Treatment Do not use therapeutic ult
12. rasound within 16 cm of the device Ventricular Sensing Ventricular Sensitivity should be programmed to the highest setting lowest sensitivity that will provide ventricular sensing with adequate sensing margin Left ventricular lead dislodgement to a position near the atria can result in atrial oversensing and ventricular inhibition Perform a thorough assessment of device function following exposure to any of the above 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 External Defibrillation The electronic circuitry in the device provides protection from defibrillation discharges Nevertheless do not place defibrillator paddles directly over the device or pacing lead Following defibrillation ensure that the device is operating correctly Magnetic Resonance Imaging MRI MRI for patients with implantable devices has been contraindicated by MRI manufacturers Clinicians should carefully weigh the decisions to use MRI with pacemaker patients Additional safety concerns include Magnetic and RF fields produced by MRI may increase pacing rate inhibit pacing cause asynchronous pacing or result in pacing at random rates MRI may result in changes in capture thresholds due to heating of pacing leads MRI ma
13. rnia 91342 1 651 483 2000 USA 1 818 362 6822 CARDIOVASCULAR St Jude Medical Sweden AB Veddestavagen 19 175 84 Jarfalla Sweden 46 8 474 40 00 46 8 760 95 42 Fax 1 818 364 5814 Fax St Jude Medical Coordination Center BVBA The Corporate Village Da Vincilaan 11 Box F1 1935 Zaventem Belgium 32 2774 68 11 32 2 772 83 84 Fax St Jude Medical Brasil Ltda Rua Frei Caneca 1380 55 11 5080 5400 55 11 5080 5423 Fax St Jude Medical Hong Kong Ltd Unit 2701 07 27 F COSCO Tower 852 2996 7688 852 2956 0622 Fax SJMprofessional com NEUROMODULATION Rate Modulated Rate Responsive AV PV Delay Rate Responsive PVARP VREF Shortest PVARP VREF Sensor Max Sensor Rate min Threshold Slope Reaction Time Recovery Time AF Management AF Suppression Algorithm Lower Rate Overdrive min Upper Rate Overdrive min No of Overdrive Pacing Cycles Rate Recovery ms Auto Mode Switch AMS Base Rate min Stored Electrograms Options Priority Options Channel Triggers Advanced Hysteresis AMS Entry AMS Exit AMS Entry and Exit AI AF Detection Magnet Response High Atrial Rate Rate mitr No of Consecutive Cycles High Ventricular Rate Rate mitr No of Consecutive Cycles PMT Termination Consecutive PVCs No of Consecutive PVCs Noise Reversion Other Magnet Response Ventricular Intrinsic Preference VIP ms VIP Search Interval VIP Search Cycles Atrial Tachycard
14. uous episode duration has been exceeded or when a high ventricular rate accompanies the AT AF episode AT AF Episodes Log lists up to 32 recorded AT AF episodes in the order of occurrence with each episode date and time duration and maximum rate providing insight into the patient s arrhythmias as well as showing whether the episodes are occurring more frequently or lasting longer over time Far Field Protection is designed to provide for enhanced AT AF diagnostics and allow for more accurate mode switch events The Atrial Protection Interval also provides enhanced protection against competitive atrial pacing m Up to 14 minutes of stored electrograms help identify key intrinsic and pacemaker related events and to simplify the diagnosis of complex ECG rhythms associated with heart failure patients Indications Implantation is indicated in one or more of the following permanent conditions syncope presyncope fatigue disorientation due to arrhythmia bradycardia or any combination of those symptoms Implantation is indicated for patients who would benefit from resynchronisation of the right and left ventricles or have one or more conventional indications for the implantation of a pacemaker Rate Modulated Pacing is indicated for patients with chronotropic incompetence and for those who would benefit from increased stimulation rates concurrent with physical activity Dual Chamber Pacing is indicated for those patients exhibiting sick s
15. y irreversibly damage the device Patients should be closely monitored during the MRI Assess the device function before and after exposure to MRI CT Scans CT scans due to their increased power levels and long exposure times have the remote possibility of interfering with implanted devices The potential interference is transient and occurs only when the X ray signal is present Continuous exposure may cause a temporary sensor rate increase In addition there is a remote possibility for a device to intermittently oversense while the CT scanning beam is directly over the implanted device Potential Adverse Events The following are potential complications associated with the use of any pacing system arrhythmia heart block thrombosis threshold elevation valve damage pneumothorax myopotential sensing vessel damage air embolism body rejection phenomena cardiac tamponade or perforation formation of fibrotic tissue local tissue reaction inability to interrogate or program a device because of programmer malfunction infection interruption of desired device function due to electrical interference loss of desired pacing and or sensing due to lead displacement body reaction at electrode interface or lead malfunction fracture or damage to insulation loss of normal device function due to battery failure or component malfunction device migration pocket erosion or hematoma pectoral muscle stimulation phrenic nerve or diaphragmatic stimul
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