Accent MRI™ DR - Sante International SA
Contents
1. Model LPA1200M Minimum Introducer Size 8F Minimum Introducer Size with Guidewire 0 5F ype of Lead Active fixation steroid eluting endocardial straight pacing lead Lead Connector IS 1 bipolar Lead Lengths 46 52 and 58 cm Fixation Mechanism Extendable Retractable helix Typical Number of Rotations for Helix Extension 5 10 straight stylet Lead Body Diameter 2 18 mm max 6 6 F ip to Ring Spacing 0mm Lead Tip Electrode Cathode Active TiN coated Pt Ir helix 1 8 mm extension ip Electrode Surface Area 6 8 mm Ring Electrode Anode iN coated Pt Ir Ring Electrode Surface Area 6 5 mm Mapping Capable with TiN coated Pt Ir helix Steroid Silicone plug with lt 1 mg dexamethasone sodium phosphate Inner Conductor Outer Conductor MP35N coil Inner Insulation Silicone Outer Insulation Optim lead insulation In Pack Straight stylets 1 x soft in lead 1 x soft 1 soft J shaped stylets 2 soft Helix extension retraction clip on tools 2 clip on tools Accessory Kits Available Separately Model Number Compatible Lengths Description Stylet Kit DS06002 with appropriate 46 52 and 58 cm 1 fixation tool 1 clip on tool length designation 1 J shaped soft 1 x soft 1 soft 1 firm 1 x firm DS06003 with appropriate 46 52 and 58 cm 1 clip on tool 1 J shaped soft length designation 1 x soft 1 soft 1 firm 1 x firm Locator Plus 1281 with appropriate 46 52 and 58 cm Disposable implant tool to Deflectable Stylet length designation facilita2. Channel 1 2 3 Triggers Advanced Hysteresis Off Low Hig AMS Entry AMS Exit AMS Entry and Exit Off Low Hig AT AF Detection Off Low Hig Magnet Response Off Low Hig High Atrial Rate Off Low Hig Rate min 125 300 in steps of 25 No of Consecutive Cycles 2 3 4 5 10 15 20 High Ventricular Rate Off Low Hig Rate min 125 300 in steps of 25 No of Consecutive Cycles 2 3 4 5 10 15 20 PMT Termination Off Low Hig Consecutive PVCs Off Low Hig No of Consecutive PVCs 2 3 4 5 Noise Reversion Off Low Hig Other Aand V Lead Monitoring Monitor Auto Polarity Switch A and V Low Impedance Limit Q 100 500 in steps of 25 A and V High Impedance Limit Q Lead Type Magnet Response Negative AV Hysteresis Search ms NIPS Options Stimulation Chamber Coupling Interval ms S1 Count SI S2 S3 and S4 Cycle ms Ventricular Support Rate min Sinus Node Recovery Delay sec PMT Options PMT Detection Rate min PVC Response Ventricular Intrinsic Preference VIP ms VIP Search Interval VIP Search Cycles Ventricular Safety Standby Diagnostic Trends Patient Notifiers 750 2500 in steps of 250 3000 Uncoded Unipolar Bipolar f Battery Test f 10 to 120 in steps of 10 oo Atrial Ventricular 100 800 in steps of 108 2 25 in steps of 1 f 100 800 in steps of 10 Fixed or Adaptive f 30 95 in steps of 5 2 3 4 5 f Passive Atrial Pace 0 180 in steps of 5 f Atrial Pace osoroo O
3. Hysteresis Rate min Search Interval min Cycle Count Intervention Rate min Intervention Duration min Recovery Time Maximum Tracking Rate min Mode Post Ventricular Atrial Blanking ms PVARP ms Sensed AV Delay ms Rest Rate min Shortest AV Delay ms Ventricular Blanking ms Ventricular Pace Sense Refractory Fixed ms MRI Settings 90 400 in steps of 30 440 470 93 125 157 190 400 in steps of 30 440 470 500 253 25 30 200 in steps of 10 225 300 in steps of 25 350 0 130 in steps of 5 140 170 in steps of 10 63 Off 304 150 in steps of 5 Off 1 5 10 15 30 16 in steps of 1 Off Same as Base Rate 80 120 in steps of 10 Intrinsic 0 intrinsic 10 Intrinsic 20 Intrinsic 30 10 in 1 minute intervals Fast Medium Slow Very Slow 90 130 in steps of 5 140 180 in steps of 10 AOO R AAI R AAT R VOO R VVI R VVT R VDD R DOO R DVI R DDI R DD R Pacing Off 60 200 in steps of 10 225 250 25 500 in steps of 25 25 30 200 in steps of 10 225 325 in steps of 25 Off 30 150 in steps of 5 25 50 in steps of 5 60 120 in steps of 10 Auto 12 52 in steps of 4 25 160 400 in steps of 30 440 470 MRI Mode MRI Base Rate MRI Paced AV Delay MRI Atrial Pulse Configuration MRI Atrial Pulse Amplitude MRI Atrial Pulse Width MRI RV Pulse Configuration MRI RV Pulse Amplitude MRI RV Pulse Width Output Sensing A00 V00 DOO Pacing Off 0 120
4. 5 10 15 30 V High Impedance Limit Q Cycle Count 1 16 by 1 Magnet Response Intervention Rate min Off Same as Base Rate 80 120 in steps of 10 Intrinsic 0 Lead Type Intrinsic 10 Intrinsic 20 Intrinsic 30 NIPS Options Intervention Duration min 1 10 in 1 minute intervals Stimulation Chamber Recovery Time Fast Medium Slow Very Slow Copiar Interval ms ft 30 150 j oun Rest Rate min Off 30 150 in steps of 5 SIF 2 3 and SA Cycle ms MRI Settings Diagnostic Trends MRI Mode V00 Pacing Off Patient Notifiers MRI Base Rate MRI RV Pulse Configuration MRI RV Pulse Amplitude MRI RV Pulse Width Output Sensing Monitor Auto Polarity Switch 100 500 in steps of 25 750 2500 in steps of 250 3000 Off Battery Test Uncoded Unipolar Bipolar Ventricular 100 800 in steps of 10 2 25 in steps of 1 100 800 in steps of 10 Fixed or Adaptive Exercise Lead Impedance R Wave V Threshold 30 120 bpm in steps of 5 bpm m Programmable Notifiers On Off et ay Device Reset IU Vi ty Entry into Backup VVI Mode 1 0 ms Audible Duration sec Number of Audible Alerts per Notification V Pulse Amplitude V V Pulse Width ms V Sensitivity mV V Pulse Configuration V Sense Configuration Ventricular AutoCapture Pacing System Primary Pulse Configuration Backup Pulse Configuration Backup Pulse Amplitude V Search Interval hours SenseAbility Technology Max Sensitivity mV Threshold Start Decay
5. 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 and its related companies 2011 St Jude Medical Inc All rights reserved fibrillation or silent atria may provide no benefit beyond that of single chamber pacing in such patients Single chamber ventricular demand 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 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 fibro
6. Delay ms Rate Modulated Parameters Number of Notifications 0 25 4 0 in steps of 0 25 4 5 7 5 in steps of 0 5 Time Between Notifications hours 0 05 0 1 1 5 in steps of 0 1 0 5 5 0 in steps of 0 5 6 10 in steps of 1 0 12 54 Unipolar tip case Bipolar tip ring Unipolar Tip tip case Bipolar tip ring Unipolar Ring ring case 1 0 5cc 5 This parameter is not programmable On Off Unipolar Bipolar Unipolar Bipolar 5 05 8 24 Off On Automatic Sensitivity Control adjustment for ventricular events 0 2 2 0 in steps of 0 1 Ventricular Post Sense 50 62 5 75 100 Ventricular Post Pace Auto 0 2 3 0 in steps of 0 1 mV Ventricular Post Sense 0 30 60 95 125 160 190 220 Ventricular Post Pace Auto 0 30 60 95 125 160 190 220 Maximum Sensor Rate min Rate Responsive VREF Shortest VREF Reaction Time Recovery Time Sensor Slope Threshold 80 150 in steps of 5 160 180 in steps of 10 Off Low Medium High 125 475 in steps of 25 Very Fast Fast Medium Slow Fast Medium Slow Very Slow On Off Passive Auto 1 Auto 0 Auto 1 Auto 2 Auto 3 1 16 in steps of 1 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 Device at ERI Ventricular Lead Impedance Out of Range On On 2 4 6 8 10 12 14 16 2 1 16 10 22 2 Programming options dependent on pacing mode 3 The highest available setting for hyst
7. 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 LLLI nem ST JUDE MEDICAL MORE CONTROL LESS RISK Item GMCRM739EN Accent MRI SR Single Chamber Pacemaker Product Highlights The Accent MRI pacemaker has been designed and tested for safe performance of a full body MRI scan without zone restrictions using a 1 5 T Tesla field strength MRI scanner The MRI conditional device Allows a maximum whole body averaged specific absorption rate SAR of 4 watts per kilogram W kg for high image resolution Pace S Must be used in conjunction with an MRI lead from St Jude Medical a An optional easy to use hand held device SJM MRI Activator device can be used to program the device to pre approved MRI settings pre and post MRI scan decreasing the number of workflow steps and increasing clinic efficiency State of the art features such as automaticity Ventricular AutoCapture Pacing System and SenseAbility techn
8. 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 Maximum Sensor Rate min Rate Responsive AV Delay Rate Responsive PVARP VREF Reaction Time Recovery Time 80 150 in steps of 5 160 180 in steps of 10 Off Low Medium High Off Low Medium High Very Fast Fast Medium Slow Fast Medium Slow Very Slow Sensor Shortest PVARP VREF ms Slope Threshold AF Management Pace ers 0n Off Passive 125 475 in steps of 25 Auto 1 Auto 0 Auto 1 Auto 2 Auto 3 1 16 in steps of 1 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 AF Suppression Algorithm Lower Rate Overdrive min Upper Rate Overdrive min No of Overdrive Pacing Cycles Rate Recovery ms Maximum AF Suppression Rate min Atrial Tachycardia Detection Rate min Auto Mode Switch Off On 10 53 15 40 in steps of 5 8 123 80 150 in steps of 5 160 180 in steps of 10 110 200 in steps of 10 225 300 in steps of 25 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 AMS Base Rate min 40 170 in steps of 5 Stored Electrograms Options Priority Options Off Low Hig
9. Accent MRI DR Dual Chamber Pacemaker Product Highlights The Accent MRI pacemaker has been designed and tested for safe performance of a full body MRI scan without zone restrictions using a 1 5 T Tesla field strength MRI scanner t The MRI conditional device Allows a maximum whole body averaged specific absorption rate SAR of 4 watts per kilogram W kg for high image resolution Must be used in conjunction with an MRI lead from St Jude Medical An optional easy to use hand held device SJM MRI Activator device can be used to program the device to pre approved MRI settings pre and post MRI scan decreasing the number of workflow steps and increasing clinic efficiency AT AF Alerts can be programmed to notify patients and or 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 A suite of state of the art features complete automaticity atrial and ventricular Ventricular Intrinsic Preference VIP technology QuickOpt timing cycle optimisation the AF Suppression algorithm and SenseAbility technology is designed to deliver optimal therapy for patients at implant and throughout their lives Industry leading longevity offers 9 4 years of service life 2 which is supported by a 7 year warranty The St Jude Medical MRI conditional pacing system can be scanned in patien
10. bolism temporary or permanent loss of stimulation susan ONION eat and or sensing infection valve and or vessel damage tissue necrosis MR Conditional Pacing System The St Jude Medical MRI conditional lead is part of the St Jude Medical MRI Refer to the User s Manual for more detailed indications contraindications warnings precautions and conditional pacing system Patients with an implanted St Jude Medical MRI conditional pacing system can have an MRI scan if the conditions for use as described in the MRI Procedure Information document are met potential adverse events 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 and its related companies 2011 St Jude Medical Inc All rights reserved ST JUDE MEDICAL MORE CONTROL LESS RISK Tendril MRI Pacing Lead Product Specifications
11. bpm in steps of 5 bpm 25 ms 30 200 ms in steps of 10 ms 225 300 ms in steps of 25 ms 350 ms Bipolar 5 0 V 7 5V 0 ms Bipolar 5 0 V 7 5V 0 ms ACap Confirm Primary Pulse Configuration Backup Pulse Configuration Backup Pulse Amplitude V Search Interval hours Aor V Pulse Amplitude V Aor V Pulse Width ms Aor V Pulse Configuration Aor V Sense Configuration Atrial Sensitivity mV Ventricular AutoCapture Pacing System Primary Pulse Configuration Backup Pulse Configuration Backup Pulse Amplitude V Search Interval hours AutoCapture Paced Sensed AV Delay ms Ventricular Sensitivity mV SenseAbility Technology A Max Sensitivity mV V Max Sensitivity mV Threshold Start Decay Delay ms Rate Modulated Parameters On Off Monitor Bipolar Bipolar 5 0 8 24 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 Unipolar tip case Bipolar tip ring Unipolar Tip tip case Bipolar tip ring Unipolar Ring ring case 0 1 0 4 in steps of 0 1 0 5 0 75 2 0 in steps of 0 25 2 5 4 0 in steps of 0 5 5 07 On Off Unipolar Bipolar Unipolar Bipolar 5 08 8 24 50 25 100 70 120 100 0 5 5 0 in steps of 0 5 6 10 in steps of 1 0 12 57 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
12. eresis rate will be 5 min below the programmed base rate 4 Sensitivity is with respect to a 20 ms haversine test signal 6 S1 Burst Cycle is applied at the preprogrammed S1 cycle length 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 and its related companies 2011 St Jude Medical Inc All rights reserved Item GMCRM740EN LLLI nem ST JUDE MEDICAL MORE CONTROL LESS RISK Handheld MRI r Settings Activator SJM MRI Activator Handheld Device Product Highlights The SJM MRI Activator handheld device model EX4000 is an external device that uses radio waves to communicate with a St Jude Medical MRI conditional implanted pulse generator The SJM MRI Activator device streamlines MRI patient workflow by allowing previously stored MRI settings to be easily Enabled before an MRI sca
13. es symbol and MORE CONTROL LESS RISK a E are registered and unregistered trademarks and service marks of St Jude Medical Inc and its related companies S M i 2011 St Jude Medical Inc All rights reserved T UDE E DICAL MORE CONTROL LESS RISK eld MRI Pace ttings Activato SJM MRI Activator Handheld Device Product Specifications PHYSICAL SPECIFICATIONS Model Dimensions cm Case material Power source Battery longevity Audible output level Classification with respect to electric shock Protection from electric shock IEC 60601 1 Protection against ingress of liquids Mode of operation EX4000 7 1x5 6 x 1 8 High impact plastic 1 cell 3 6 V nominal Chemistry Lithium Thionyl Chloride 3 years from manufacturing date 60 dB minimum at 10 0 cm Internally powered Type BF Ordinary equipment Non continuous 1 The SJM MRI Activator device is designed to enable disable pre programmed MRI mode quickly and easily pre and post scan do not take the SJM MRI Activator device into the MRI magnet scanner room 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 yo
14. ff 50 150 in steps of 25 160 200 in steps of 10 30 sec 1 3 5 10 30 min 1 2 3 Off On AT AF Activity Exercise Lead Impedance P and R Wave A and V Threshold Programmable Notifiers 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 1 0 5 ec Device at ERI Atrial Lead Impedance Out of Range Ventricular Lead Impedance Out of Range AT AF Burden AT AF Episode Duration V Rate During AT AF High V Rate Threshold Total Time in High V Rate On On 2 4 6 8 10 12 14 16 2 1 16 10 22 2 Programming options dependent on pacing mode 3 This parameter is not programmable 4 The highest available setting for hysteresis rate will be 5 min below the programmed base rate 5 In dual chamber modes the maximum ventricular refractory period is 325 ms 6 Values 0 1 0 4 not available in a unipolar sense configuration 7 Sensitivity is with respect to a 20 ms haversine test signal 8 During atrial NIPS in dual chamber modes the shortest Coupling Interval will be limited by the programmed AV PV delay 9 1 Burst Cycle is applied at the pre programmed S1 cycle length 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
15. m Rate modulated pacing is indicated for patients with chronotropic incompetence and for those who would benefit from increased stimulation rates concurrent with physical activity 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 Contraindications Single chamber pulse generators are contraindicated in patients with an implanted cardioverter defibrillator ICD 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 Single chamber ventricular demand 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 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
16. mber pacing is indicated for those atients exhibiting sick sinus syndrome chronic symptomatic second and third degree AV block recurrent Adams Stokes syndrome symptomatic bilateral bundle branch block when tachyarrhythmia and other causes ave 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 hysical disability AF Suppression algorithm is indicated for suppression of paroxysmal or persistent atrial ibrillation episodes in patients with one or more of the above pacing indications Contraindications Dual chamber pulse generators are contraindicated in patients with an implanted cardioverter defibrillator ICD 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 Customer Support 46 8 474 4756 Brief Summary Prior to using these devices
17. n Disabled after an MRI scant Verified at any time Ordering Information Contents SJM MRI Activator device Reorder Number Description EX4000 SJM MRI Activator EX4000 Intended Use The SJM MRI Activator handheld device is used to evaluate the status of and to enable with the performance of the activator if you are too close to the source of EMI Wireless communication and disable the previously stored MRI settings The activator is intended for use with St Jude Medical MR devices Wireless communication devices such as computers that operate on a wireless network handheld Conditional pulse generators personal computers PDA cellular phones and even cordless telephones may generate enough EMI to Contraindications Th traindicati interfere with the performance of the activator if it is used too close to the source of EMI Hospital and Medical Ontraindications here are no contraindications equipment A variety of standard hospital and medical equipment may generate enough EMI to interfere Warnings and Precautions Electromagnetic interference The activator is not magnetic and has no with the performance of the activator These include but are not limited to blood pressure monitors ECG moving parts However you should avoid equipment which generates a strong electromagnetic interference equipment external defibrillation equipment x ray machines Office equipment A variety of standard office EMI EMI could inte
18. ology are designed to deliver optimal therapy for patients at implant and throughout their lives Industry leading longevity offers 14 2 years of service life which is supported by a 7 year warranty 1 The St Jude Medical MRI conditional pacing system can be scanned in patients under the following conditions horizontal closed bore clinical scanner working in the Normal Operating Mode or First Level Controlled Operating Mode static magnetic field strength of 1 5 Tesla T only maximum gradient slew rate of 200 T m s per axis See manual for additional details before performing an MRI scan 2 V 2 5 V 0 4 ms 500 ohms 100 VVI pacing 60 bpm AutoCapture Pacing System OFF SEGMs ON 3 Terms and conditions apply refer to the warranty for details Ordering Information Contents Cardiac pulse generator Model Number PM1124 Inductive Dimensions H x W x T mm 46 x 52 x6 Radiopaque markers St Jude Medical identifier Indications Implantation of a single chamber pulse generator 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 MRI conditional pulse generator is safe for use in the MRI environment when used in a complete MRI conditional pacing system and according to the instructions in the MRI Procedure Information document for the St Jude Medical MRI conditional pacing syste
19. 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 Weight g 22 12 0 5 IS 1 Volume cc Connector Device MRI symbol 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 ibrotic 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 acing 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 s
20. rfere with communication between the activator and the implanted St Jude Medical equipment may generate enough EMI to interfere with the performance of the activator These include but MR conditional pulse generator Moving away from the source of EMI or turning it off will usually allow the are not limited to desktop or laptop computers fax machines phone systems Industrial equipment A variety activator to return to its normal mode of operation Communication equipment Communication equipment of industrial equipment may generate enough EMI to interfere with the performance of your activator These include but are not limited to arc welders induction furnaces very large or defective electric motors and such as microwave transmitters or high power amateur transmitters may generate enough EMI to interfere l i te tion Ti internal combustion engines with poorly shielded ignition systems 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 squar
21. rranty Terms and conditions apply Refer to the warranty for details 1 See manual for additional details before performing an MRI scan 2 Bench testing data on file Ordering Information Contents Cardiac pacing lead Model Number Insulation Fixation Min Introducer F Connector Length cm LPA1200M Optim Ext Ret helix 8 IS 1 bipolar 46 52 and 58 Easily identifiable unique radiopaque markers Indications The Tendril MRI lead is designed for permanent sensing and pacing in either the right atrium or Contraindications The Tendril MRI lead is contraindicated in the presence of tricuspid atresia for patients the right ventricle in combination with a compatible device with mechanical tricuspid valves and in patients who are expected to be hypersensitive to a single dose of one Active leads such as the Tendril MRI lead may be indicated for patients where permanent fixation of passive milligram of dexamethasone sodium phosphate leads is suspected to be unstable In atrial applications the use of a screw in lead such as Tendril MRI lead Adverse Events Potential complications associated with the use of Tendril MRI leads are the same as with may be indicated in the presence of an abnormal surgically altered or excised atrial appendage the use of other active fixation leads and include perforation of the myocardium cardiac tamponade phrenic This j MR Conditional lead nerve stimulation dislodgement of the pacing lead em
22. te precise lead positioning 1292 with appropriate 46 52 and 58 cm and manipulation with one hand length designation MP35N is a trademark of SPS Technologies Inc 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 and its related companies 2011 St Jude Medical Inc All rights reserved ST JUDE ME DICAL Item GMCRM741EN MORE CONTROL LESS RISK
23. tic 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 and phrenic nerve or diaphragmatic stimulation 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 and palpitations with high rate pacing Refer to the User s Manual for more detailed indications contraindications warnings precautions and potential adverse events tT mem ST JUDE MEDICAL MORE CONTROL LESS RISK Accent MRI DR Dual Chamber Pacemaker Product Specifications Model Telemetry Dimensions mm Weight g Volume cc Connector PM2124 inductive 52x 53x6 23 31 S 1 PARAMETER SETTINGS Rate Timing Atrial Pace Refractory ms Atrial Sense Refractory ms Atrial Protection Interval ms Paced AV Delay ms Base Rate min Far Field Protection Interval ms
24. timulation and phrenic nerve or diaphragmatic stimulation 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 o the detection of signals other than patient activity loss of activity response due to sensor failure and alpitations with high rate pacing Refer to the User s Manual for more detailed indications contraindications warnings precautions and otential adverse events tT mem ST JUDE MEDICAL MORE CONTROL LESS RISK Accent MRI SR Single Chamber Pacemaker Product Specifications PHYSICAL SPECIFICATIONS Pace ers Stored Electrograms Off Low High 1 2 3 Off Low High Off Low High 125 300 in steps of 25 2 3 4 5 10 15 20 Off Low High Off Low High Model PM1124 Options Telemetry Inductive Priority Options Dimensions mm 46x52x6 Channel Weight g 22 Triggers Volume cc 12 Magnet Response Connector S 1 High Ventricular Rate Rate min No of Consecutive Cycles Rate Timing Advanced Hysteresis Noise Reversion Ventricular Pace Sense Refractory Fixed ms 125 160 400 in steps of 30 440 470 500 Other Base Rate min 30 130 in steps of 5 140 170 in steps of 10 _ Mode VOO R VVI R VVT R Pacing Off Lead Monitoring Hysteresis Rate min Off 30 150 in steps of 5 V Low Impedance Limit Q Search Interval mir Off 1
25. ts under the following conditions horizontal closed bore clinical scanner working in the Normal Operating Mode or First Level Controlled Operating Mode static magnetic field strength of 1 5 Tesla T only maximum gradient slew rate of 200 T m s per axis See manual for additional details before performing an MRI scan AV 2 5 V 0 4 ms 500 ohms 100 DDD pacing 60 bpm AutoCapture Pacing System OFF SEGMs ON Terms and conditions apply refer to the warranty for details Ordering Information Contents Cardiac pulse generator Model Number PM2124 Inductive Dimensions H x W x T mm Weight g 52x53 x6 23 Radiopaque markers St Jude Medical identifier __Giviely MRI Volume cc Connector 13 1 0 5 IS 1 Device MRI symbol Indications Implantation of a dual chamber pulse generator is indicated in one or more of the following ermanent conditions syncope presyncope fatigue disorientation due to arrhythmia bradycardia or any combination of those symptoms MRI conditional pulse generator is safe for use in the MRI environment when used in a complete MRI conditional pacing system and according to the instructions in the MRI Procedure Information document for the St Jude Medical MRI conditional pacing system Rate modulated acing is indicated for patients with chronotropic incompetence and for those who would benefit from increased stimulation rates concurrent with physical activity Dual cha
26. ur 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 Item GMCRM855EN LLL mam ST JUDE MEDICAL MORE CONTROL LESS RISK Pacing Leads Tendril MRI Pacing Lead a n Product Highlights The Tendril MRI lead is designed to ensure patient safety while performing an MRI scan The Tendril MRI conditional lead must be used in conjunction with an MRI device from St Jude Medical and with a 1 5 T Tesla MRI scanner Soft silicone tip offers more compliance at the lead tip endocardium interface The soft silicone tip on the Tendril MRI LPA1200M lead reduces tip pressure by approximately 50 over 6 F leads without a soft silicone tip Though the soft silicone increases the surface area of the lead tip to 9 F the Tendril MRI lead still fits through an 8 F introducer due to the material s soft nature Four pads on the silicone tip further increase the surface area of the lead tip that is in contact with the tissue Optim lead insulation a chemical co polymer that blends the best features of polyurethane and silicone provides improved handling and increased durability Limited lifetime wa
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