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1 | User Manual | Users Manual | 420.79 KiB | / December 06 2017 |
Percepta Quad CRT-P MRI SureScan W4TR01 MR Conditional pacemaker with cardiac resynchronization therapy, SureScan technology, and Bluetooth wireless telemetry (OAE-DDDR) Device Manual Caution: Federal law (USA) restricts this device to sale by or on the order of a physician. The following list includes trademarks or registered trademarks of Medtronic in the United States and possibly in other countries. All other trademarks are the property of their respective owners. AdaptivCRT, Advisa, Advisa DR MRI, Capture Management, Cardiac Compass, CardioSync, CareAlert, CareLink, EffectivCRT, EnPulse, EnRhythm, EnRhythm MRI, Flashback, GEM, GEM III, InSync, InSync II Marquis, InSync III Marquis, InSync Marquis, Kappa, Marquis, Medtronic, Medtronic AT500, Medtronic CareAlert, Medtronic CareLink, MVP, OptiVol, Percepta, Quick Look, Reactive ATP, Revo MRI, SureScan, TherapyGuide, VectorExpress Contents 1 System overview 4 Introduction 4 1.1 System description 4 1.2 Indications and usage 5 1.3 1.4 Contraindications 5 1.5 MRI conditions for use 6 Feature summary 7 1.6 1.7 Data security 10 2 Warnings, precautions, and potential adverse events 10 2.1 General warnings and precautions 10 2.2 2.3 Handling and storage instructions 11 2.4 2.5 2.6 Explant and disposal 10 Lead evaluation and lead connection 11 Device operation 12 Potential adverse events 14 3 Clinical data 15 3.1 Adverse events and clinical trial data 15 4 Implant procedure 16 Preparing for an implant 16 4.1 Selecting and implanting the leads 18 4.2 Testing the lead system 19 4.3 4.4 Connecting the leads to the device 20 Positioning and securing the device 21 4.5 4.6 Completing the implant procedure 22 4.7 Replacing a device 23 5 Product specifications 24 Physical characteristics 24 Electrical specifications 25 Replacement indicators 26 Projected service life 27 5.1 5.2 5.3 5.4 6 Device parameters 29 6.1 Emergency settings 29 6.2 Magnet application 29 Tachyarrhythmia detection parameters 29 6.3 Atrial tachyarrhythmia therapy parameters 30 6.4 6.5 Pacing parameters 32 6.6 Data collection parameters 38 6.7 Medtronic CareAlert parameters 39 6.8 System test parameters 40 6.9 EP study parameters 42 6.10 Nonprogrammable parameters 45 3 1 System overview 1.1 Introduction This manual describes the Medtronic Model W4TR01 Percepta Quad CRT-P MRI SureScan dual chamber, implantable pulse generator with cardiac resynchronization therapy (CRT-P). The manual contains model-specific feature information, indications and contraindications, warnings and precautions, instructions for implanting the device, quick reference specifications, and parameter tables. Additional manuals and documents with information about the device:
MRI technical manual This manual provides MRI-specific procedures and warnings and precautions. Reference manual This manual contains information about device features. The reference manual applies to multiple models of CRT-P devices. Programming guide This manual explains how to use the programmer software to conduct a patient session. Explanation of symbols This document defines the symbols that may appear on the device package. Refer to the package label to see which symbols apply specifically to this device. Medical Procedure and EMI Warnings and Precautions Manual for Health Care Professionals This manual provides warnings, precautions, and guidance for health care professionals who perform medical therapies and diagnostic procedures on cardiac device patients. The manual also provides patient education information related to sources of electromagnetic interference (EMI) at home, at work, and in other environments. Radio regulatory compliance information This document provides compliance information related to the radio components of the device. 1.2 System description The Medtronic Percepta Quad CRT-P MRI SureScan Model W4TR01 dual chamber implantable pulse generator with cardiac resynchronization therapy (CRT-P) is a multiprogrammable cardiac device that monitors and regulates the patients heart rate by providing single or dual chamber rate-responsive bradycardia pacing, sequential biventricular pacing, and atrial tachyarrhythmia therapies. This device features Bluetooth wireless technology.1 The MRI SureScan feature permits a mode of operation that allows a patient with a SureScan system to be safely scanned by an MRI machine while the device continues to provide appropriate pacing. When programmed to On, MRI SureScan operation disables arrhythmia detection, magnet mode, and all user-defined diagnostics. Before performing an MRI scan, refer to the MRI technical manual. The users of this device include medical professionals (physicians, nurses, technicians, and their supporting staff) trained in surgery, cardiology, radiology, and magnetic resonance (MR) technology and able to implement the procedures documented in the instructions for use for this device. 1.2.1 Usage environments The device is intended to be used in the following environments and conditions:
The device will be implanted in a properly equipped, staffed, and sterile surgical environment. Implant will take Post-surgical patient and device follow-up care will take place in a properly equipped and staffed cardiology place under standard surgical protocols and in the patient population for which the device is indicated. clinic or office. 1 The Bluetooth word mark is a registered trademark of Bluetooth SIG, Inc. and any use of this mark by Medtronic is under license. 4 MRI procedures for patients with this device will take place in a properly equipped and staffed MR facility, and in consideration of the conditions and requirements described in Section 1.5, MRI conditions for use, page 6. After having an implant, patients may resume their lives at home, at work, and in other environments with consideration of the advice and restrictions documented in the Medical Procedure and EMI Warnings and Precautions Manual for Health Care Professionals and in the patient literature. 1.2.2 System components and accessories Contents of sterile package The package contains 1 implantable pulse generator with cardiac resynchronization therapy (CRT-P) and 1 torque wrench. Implantable device system The Percepta Quad CRT-P MRI SureScan Model W4TR01 device and the pacing leads constitute the implantable portions of the device system. Leads The lead system used with this device must provide pacing to the left ventricle (LV), sensing and pacing to the right ventricle (RV), and sensing and pacing to the atrium (A). Do not use any lead with this device without first verifying lead and connector compatibility. For information about selecting and implanting SureScan leads for this device, refer to Section 4.2, Selecting and implanting the leads, page 18. Programmers and software Medtronic programmers and software are used to program this device. Programmers from other manufacturers are not compatible with Medtronic devices, but they do not damage Medtronic devices. Medtronic pacing system analyzer A pacing system analyzer is used to measure the electrical characteristics of the implanted leads to assess their effectiveness for pacing and sensing. Medtronic patient monitor Patients use the Medtronic patient monitor, if available, to gather information from their implanted devices and communicate the information to their physicians through the Medtronic CareLink Network. For information on using the patient monitor, refer to the patient monitor literature. 1.3 Indications and usage The Percepta Quad CRT-P MRI SureScan system is indicated for:
NYHA Functional Class III and IV patients who remain symptomatic despite stable, optimal medical therapy and have LVEF 35% and a prolonged QRS duration. NYHA Functional Class I, II, or III patients who have LVEF 50%, are on stable, optimal heart failure medical therapy if indicated and have atrioventricular block (AV block) that are expected to require a high percentage of ventricular pacing that cannot be managed with algorithms to minimize right ventricular pacing. Optimization of heart failure medical therapy that is limited due to AV block or the urgent need for pacing should be done post implant. Rate adaptive pacing is provided for those patients developing a bradycardia indication who might benefit from increased pacing rates concurrent with increases in activity. Dual chamber and atrial tracking modes are indicated for patients who may benefit from maintenance of AV synchrony. Antitachycardia pacing (ATP) is indicated for termination of atrial tachyarrhythmia in patients with one or more of the above pacing indications. 1.4 Contraindications The Percepta Quad CRT-P MRI SureScan system is contraindicated for:
Concomitant implant with another bradycardia device Concomitant implant with an implantable cardioverter defibrillator 5 programmed Lower Rate. tachycardias, including atrial fibrillation or flutter. intrinsic rhythms. There are no known contraindications for the use of pacing as a therapeutic modality to control heart rate. The patients age and medical condition, however, may dictate the particular pacing system, mode of operation, and implant procedure used by the physician. Rate-responsive modes may be contraindicated in those patients who cannot tolerate pacing rates above the Dual chamber sequential pacing is contraindicated in patients with chronic or persistent supraventricular Asynchronous pacing is contraindicated in the presence (or likelihood) of competition between paced and Single chamber atrial pacing is contraindicated in patients with an AV conduction disturbance. ATP therapy is contraindicated in patients with an accessory antegrade pathway. 1.5 MRI conditions for use A complete SureScan pacing system is required for use in the MR environment. A complete SureScan pacing system includes a SureScan device with Medtronic SureScan leads or a Model 6725 pin plug for the right atrial port. To verify that components are part of a SureScan system, visit http://www.mrisurescan.com. Any other combination may result in a hazard to the patient during an MRI scan. Warning: Do not scan a patient without first programming the MRI SureScan mode to On. Scanning the patient without programming the MRI SureScan mode to On may result in patient harm or damage to the SureScan pacing system. Note: The MRI SureScan mode cannot be programmed to On if the device is recommended for replacement. Cardiology requirements Patients and their implanted systems must be screened to meet the following requirements:
The patient has no implanted lead extenders, lead adaptors, or abandoned leads. The patient has no broken leads or leads with intermittent electrical contact, as confirmed by lead impedance The SureScan pacing system is implanted in the left or right pectoral region. The pace polarity parameters are set to Bipolar for programming the MRI SureScan mode to On. The SureScan device is operating within the projected service life. For patients whose device will be programmed to an asynchronous pacing mode when the MRI SureScan mode is programmed to On, no diaphragmatic stimulation is present at a pacing output of 5.0 V and at a pulse width of 1.0 ms. Note: The LV lead is not paced during SureScan operation, so the presence of diaphragmatic stimulation on the LV lead at a pacing output of 5.0 V and a pulse width of 1.0 ms does not need to be considered. history. Caution: It is not recommended to perform an MRI scan if the right ventricular (RV) lead pacing capture threshold is greater than 2.0 V at 0.4 ms for pacemaker-dependent patients. A higher pacing capture threshold may indicate an issue with the implanted lead. Notes:
For radiology requirements, refer to the MRI technical manual. Before performing an MRI scan, refer to the MRI technical manual for MRI-specific warnings and precautions. Patient monitoring and rescue requirements Continuous patient monitoring is required during an MRI scan. In the event that patient rescue is required, an external defibrillator must be immediately available. 6 programming of the MRI SureScan feature. Training requirements A health professional who has completed cardiology SureScan training must be present during the A health professional who has completed radiology SureScan training must be present during the MRI scan. 1.6 Feature summary The following features are available in this device. For a list of the features that are enabled at shipping, see the Shipped column of the tables in Chapter 6, Device parameters, page 29. 1.6.1 Tachyarrhythmia detection and therapy features Atrial antitachycardia pacing (ATP) These therapies respond to an AT/AF episode or a Fast AT/AF episode with rapid sequences of pacing pulses to terminate detected atrial tachyarrhythmias. Auto-adjusting sensitivity This feature automatically adjusts the sensitivity thresholds after specific paced events and sensed events occur. Reactive ATP This feature allows the device to deliver atrial ATP therapies that had been unsuccessful earlier in an AT/AF episode. The device repeats the delivery of atrial ATP therapies after the programmed time interval or when the atrial rhythm changes. 1.6.2 Pacing and cardiac resynchronization features AdaptivCRT This feature adjusts CRT parameter values automatically while the patient is ambulatory. If the AdaptivCRT feature is programmed to Adaptive Bi-V and LV, the feature can switch automatically between biventricular pacing and LV-only pacing. Atrial Capture Management This feature monitors the atrial pacing threshold with daily pacing threshold searches and, if programmed to do so, adjusts the atrial pacing amplitude toward a target amplitude. Atrial intervention pacing features The system provides the following overdrive pacing techniques that are designed to counteract potential atrial tachyarrhythmia initiating mechanisms:
Atrial Preference Pacing (APP) maintains a consistent activation sequence by providing continuous pacing Atrial Rate Stabilization (ARS) adapts the atrial pacing rate in response to a PAC (premature atrial Post Mode Switch Overdrive Pacing (PMOP) works with the Mode Switch feature to deliver overdrive atrial that is slightly higher than the intrinsic rate. contraction) to avoid long sinus pauses following short atrial intervals. pacing during the vulnerable phase following an AT/AF episode termination. Automatic polarity configuration This device uses lead impedance measurements to automatically configure atrial and RV pacing and sensing polarities during Implant Detection. Automatic PVARP This feature adjusts PVARP (Post-Ventricular Atrial Refractory Period) in response to changes in the patients heart rate or pacing rate. PVARP is longer at lower tracking rates to prevent pacemaker-mediated tachycardia (PMT) and shorter at higher rates to maintain 1:1 tracking. Cardiac resynchronization therapy (CRT) recovery options There are 5 programmable features that help maintain CRT:
Ventricular Sense Response triggers ventricular pacing in response to ventricular sensing to ensure that Conducted AF Response dynamically adjusts and smooths the pacing rate to promote CRT delivery in the Atrial Tracking Recovery temporarily shortens PVARP to restore atrial tracking and CRT delivery if atrial EffectivCRT during AF dynamically adjusts the pacing rate in response to changes in the percentage of CRT pacing is delivered as programmed. presence of sensed ventricular events in non-tracking modes. tracking is lost due to PVCs or due to an atrial rhythm that is too fast to be tracked to the ventricle. effective CRT pacing to promote CRT delivery in nontracking modes. 7 Multiple point pacing (MPP) enables the device to deliver two LV pulses per pace, either simultaneously or with a programmable delay, to two pacing vectors. Each LV pulse can be programmed with its own amplitude and pulse width. CardioSync Optimization Test This feature measures the patients intrinsic AV intervals and the waveform widths of the P-wave and QRS complex. Based on the measurements, the test provides optimized values for the following CRT parameters: V. Pacing configuration, V-V Pace Delay, Paced AV, and Sensed AV. CRT ventricular pacing options The ventricular pacing configuration in the CRT device provides the programming option for biventricular pacing or RV only pacing. The biventricular pacing sequence and V-V pace delay are programmable as an additional means to improve hemodynamics. LV Capture Management This feature monitors the left ventricular pacing threshold with daily pacing threshold searches and, if programmed to do so, adjusts the LV pacing amplitude toward a target amplitude. LV Pacing Polarity This feature provides 16 pacing polarities the clinician can select from to identify a pacing polarity that provides capture at the desired site, maximizes device longevity, and avoids phrenic nerve stimulation. The LV pacing polarity selections include 12 bipolar vectors and 4 unipolar vectors. The feature also enables the clinician to change pacing location, if necessary, by programming pacing polarity. When the multiple point pacing
(MPP) feature is programmed On, the 2nd LV Pacing Polarity parameter provides additional pacing polarity options. Mode Switch This feature switches the device from a tracking mode to a nontracking mode to prevent rapid ventricular pacing that may result from a high atrial rate, and restores the programmed pacing mode when the atrial tachyarrhythmia ends. MRI SureScan This feature allows patients with an implanted MRI SureScan system, including the device and leads, to have a safe MRI procedure if the requirements provided in the MRI technical manual are followed. MVP (Managed Ventricular Pacing) When the device is not pacing for CRT, the MVP feature can promote intrinsic conduction by reducing unnecessary right ventricular pacing. This feature operates when the programmed mode is either AAIR<=>DDDR or AAI<=>DDD. Non-Competitive Atrial Pacing (NCAP) This feature prevents pacing the atrium too soon after a refractory atrial sense by delaying the scheduled atrial pace. Pacemaker-mediated Tachycardia (PMT) Intervention This feature provides automatic detection and interruption of device-defined PMTs. PVC Response This feature extends PVARP following a premature ventricular contraction (PVC) to avoid tracking a retrograde P-wave and to prevent retrograde conduction from inhibiting an atrial pace. Rate Adaptive AV (RAAV) This feature varies the Paced AV (PAV) and Sensed AV (SAV) intervals as the heart rate increases or decreases during dual chamber operation to maintain 1:1 tracking and AV synchrony. Rate Drop Response This feature monitors the heart for a significant drop in rate and responds by pacing the heart at an elevated rate for a programmed duration. Rate Profile Optimization The goal of Rate Profile Optimization is to ensure that the rate response remains appropriate for the full range of patient activities. This feature monitors the patients daily and monthly sensor rate profiles and adjusts the rate response curves over time to achieve a prescribed target rate profile. Rate-responsive pacing This feature varies the pacing rate in response to the patients physical motion as detected by the activity sensor of the device. RV Capture Management This feature monitors the right ventricular pacing threshold with daily pacing threshold searches and, if programmed to do so, adjusts the RV pacing amplitude toward a target amplitude. Sequential biventricular pacing The ventricular pacing sequence and V-V pace delay are programmable as an additional means to improve hemodynamics during CRT therapy. Sleep feature This feature causes the device to pace at a slower rate during a programmed sleep period. 8 Ventricular Rate Stabilization (VRS) This feature adjusts the pacing rate dynamically to eliminate the long pause that typically follows a premature ventricular contraction (PVC). Ventricular Safety Pacing (VSP) This feature prevents inappropriate inhibition of ventricular pacing caused by crosstalk or ventricular oversensing. 1.6.3 Monitoring and follow-up features Cardiac Compass Trends This feature provides a Cardiac Compass Trends report that shows an overview of the patients condition, with graphs that display long-term trends in heart rhythm over the last 14 months. The report also includes the OptiVol 2.0 fluid trend data. Medtronic CareAlert Monitoring If the device identifies any programmed or automatic CareAlert conditions, this feature sends a wireless alert signal to the patient monitor (if available). The patient monitor then transmits the CareAlert Event data to the Medtronic CareLink Network. If configured to do so, the Medtronic CareLink Network then sends an alert notification to the clinic. Episode data and EGM storage The system provides an arrhythmia episode log that enables you to view the summary and detailed diagnostic data quickly, including stored EGM, for the selected arrhythmia episode. Flashback memory This diagnostic feature records intervals that occur immediately prior to tachyarrhythmia episodes or the most recent interrogation and plots the interval data over time. EffectivCRT episodes data This feature compiles diagnostic information to help the clinician identify the cause of ineffective CRT pacing and reprogram the device to avoid it. Data collected includes date and time, average atrial and ventricular beats per minute, event markers, an indication of whether ATAF was present, and an indication of which ventricular paces were effective. Heart Failure Management Report This report provides an overview of the patients condition over the short and long term, with a focus on heart failure management. The report includes graphs that show OptiVol 2.0 fluid trends and trends related to heart failure over the last 14 months. Holter telemetry This function allows the implanted device to transmit an EGM with marker telemetry continuously for up to 46 hours, regardless of the use of the programming head. Implant Detection Implant Detection is a 30 min period, beginning when the device is placed in the surgical pocket. During this period, the device verifies lead connection by measuring lead impedance. When the Implant Detection period is completed, various automatic features and diagnostics are activated. Lead Monitor This feature measures lead impedances during the life of the implanted device and controls automatic configuration of lead polarities at implant. If Lead Monitor is programmed to Adaptive, the device automatically switches bipolar pacing and sensing to unipolar pacing and sensing if the integrity of a bipolar lead is compromised. MVP Mode Switches This feature lists the 10 most recent MVP Mode Switches to DDD(R). OptiVol 2.0 fluid trends This feature provides the capability to monitor the following trends:
The Thoracic Impedance trend plots thoracic impedance for up to 14 months. The OptiVol 2.0 Fluid Index trend plots the accumulated differences between the Daily Impedance and Reference Impedance values. Possible fluid accumulation in the patients thoracic cavity exists when the OptiVol 2.0 Fluid Index exceeds the OptiVol Threshold. Rate Histograms report This report shows heart rate range distributions for the patient. TherapyGuide This feature provides a set of suggested parameters based on the programmed information about the patients clinical conditions. The TherapyGuide feature does not replace a physicians expert judgment. The physician is free to accept, reject, or modify any of the suggested parameter values. VectorExpress 2.0 LV Automated Test This feature allows automated testing of clinician-selected pacing polarities to determine the patients LV capture thresholds and pacing impedances. These test results are displayed in the LV Test Results window. In addition, the device reports relative longevity information for tested LV pacing polarities, results of clinician-conducted phrenic nerve stimulation threshold tests, and RV sense to LV sense delay or RV pace to LV sense delay information for each LV electrode. The clinician then can filter, sort, and 9 view all test results, making it easier to decide on the appropriate LV pacing polarity, amplitude, and pulse width settings for the patient. An LV Notes field is available for the clinician to record comments about test results and their LV Pace Polarity selection for the patient. Ventricular Sensing Episodes This diagnostic records extended periods of ventricular sensing to help the clinician assess the continuity of CRT delivery. 1.7 Data security Medtronic has designed safeguards to protect patient information and device data for the Percepta Quad CRT-P MRI SureScan Model W4TR01 device. Bluetooth communication system The device shows its availability through Bluetooth communication. Critical data accepted or sent through the Bluetooth communication from the device is encrypted by the device before it is sent over the Bluetooth channel. The device responds only to authorized commands. Inductive telemetry communication system The Medtronic inductive telemetry communication system is used with the clinician programmer to interrogate and program the device. It can also be used to interrogate the device for remote monitoring, if available. This system uses short-range communication that protects patient information and device data. 2 Warnings, precautions, and potential adverse events 2.1 General warnings and precautions A complete SureScan pacing system is required for use in the MR environment. Before performing an MRI scan, refer to the MRI technical manual for MRI-specific warnings and precautions. A complete SureScan pacing system includes a SureScan device with Medtronic SureScan leads or a Model 6725 pin plug for the right atrial port. Any other combination may result in a hazard to the patient during an MRI scan. Refer to the Medical Procedure and EMI Warnings and Precautions Manual for information about hazards related to medical therapies and diagnostic procedures on patients with cardiac devices. This manual also includes information about sources of EMI in the patients environment. Anti-coagulation Use of the device should not change the application of established anti-coagulation protocols. Electrical isolation during implant Do not allow the patient to have contact with grounded electrical equipment that might produce electrical current leakage during implant. Electrical current leakage may induce tachyarrhythmias that may result in the patients death. External defibrillation equipment Keep external defibrillation equipment nearby for immediate use whenever tachyarrhythmias are possible or intentionally induced during device testing, implant procedures, or post-implant testing. Lead compatibility Do not use another manufacturers leads without demonstrated compatibility with Medtronic devices. If a lead is not compatible with a Medtronic device, the result may be undersensing of cardiac activity, failure to deliver necessary therapy, or a leaking or intermittent electrical connection. 2.2 Explant and disposal Consider the following information related to device explant and disposal:
Explant the implantable device postmortem. In some countries, explanting battery-operated implantable devices is mandatory because of environmental concerns; please check the local regulations. In addition, if subjected to incineration or cremation temperatures, the device may explode. Medtronic implantable devices are intended for single use only. Do not resterilize and reimplant explanted devices. 10 Contact Medtronic for Return Mailer Kits to return explanted devices for analysis and disposal. See the back cover for addresses. Note: Disposal of explanted devices or leads is subject to local, state, and federal regulations. 2.3 Handling and storage instructions Carefully observe these guidelines when handling or storing the device. 2.3.1 Device handling Checking and opening the package Before opening the sterile package tray, visually check for any signs of damage that might invalidate the sterility of the package contents. If the package is damaged The device packaging consists of an outer tray and an inner tray. Do not use the device or accessories if the outer or inner packaging tray is wet, punctured, opened, or damaged. Return the device to Medtronic because the integrity of the sterile packaging or the device functionality may be compromised. This device is not intended to be resterilized. If the package information is damaged If any information on the outer package or the sterile package is defaced or damaged so that you cannot read it, notify Medtronic so that the device can be replaced. If the printed manual is illegible If this manual is supplied in its printed form and any part of it is illegible, contact Medtronic to request a replacement manual. Sterilization Medtronic has sterilized the package contents with ethylene oxide before shipment. This device is for single use only and is not intended to be resterilized. Device temperature Allow the device to reach room temperature before it is programmed or implanted. Device temperature above or below room temperature may affect initial device function. Dropped device Do not implant the device if it is dropped on a hard surface from a height of 30 cm (12 in) or more after it is removed from its packaging. Fluid immersion Do not immerse the device in fluid or flush the connector ports at the time of implant. Doing so could adversely affect the performance of the device and lead system. Use by date Do not implant the device after the Use by date because the battery longevity could be reduced. For single use only Do not resterilize and reimplant an explanted device. 2.3.2 Device storage Avoid magnets To avoid damaging the device, store the device in a clean area away from magnets, kits containing magnets, and any sources of electromagnetic interference. Temperature limits Store and transport the package between 18C and +55C (0F and 131F). Device reset may occur at temperatures below 18C (0F). Device longevity may decrease and performance may be affected at temperatures above +55C (131F). 2.4 Lead evaluation and lead connection Refer to the lead technical manuals for specific instructions and precautions about lead handling. A Medtronic MRI SureScan system includes a Medtronic MRI SureScan device connected to Medtronic MRI SureScan leads. Before performing an MRI procedure, refer to the Medtronic MRI technical manual for additional information. Torque wrench Use only the torque wrench supplied with the device. The torque wrench is designed to prevent damage to the device from overtightening a setscrew. Other torque wrenches (for example, a blue-handled or right-angled hex wrench) have torque capabilities greater than the lead connector can tolerate. 11 Lead connection Consider the following information when connecting the lead and the device:
Cap abandoned leads to avoid transmitting electrical signals. If an atrial lead is not used, plug the unused atrial lead port with a Medtronic Model 6725 IS-1 connector port Verify lead connections. Loose lead connections may result in inappropriate sensing and failure to deliver pin plug to protect the device. arrhythmia therapy. 2.5 Device operation Leads Bipolar or unipolar atrial and right ventricular leads may be used with the Percepta Quad CRT-P MRI SureScan Model W4TR01 device, but if leads other than bipolar MRI SureScan leads are used, the system is contraindicated for MRI scans. The left ventricular lead must be a quadripolar lead, but if it is not a quadripolar MRI SureScan lead, the system is contraindicated for MRI scans. Accessories Use this device only with accessories, parts subject to wear, and disposable items that have been tested to technical standards and found safe by an approved testing agency. Maximum output for the Atrial Capture Management feature The Atrial Capture Management feature does not adjust atrial outputs to values greater than 5.0 V or 1.0 ms. If the patient needs atrial pacing output greater than 5.0 V or 1.0 ms, manually program the atrial amplitude and pulse width. If a lead dislodges partially or completely, the Atrial Capture Management feature may not prevent loss of capture. Atrial lead maturation Do not program AT/AF detection to On or enable automatic atrial ATP therapies until the atrial lead has matured (approximately 1 month after implant). If the atrial lead dislodges and migrates to the ventricle, the device could inappropriately detect AT/AF, deliver atrial ATP to the ventricle, and possibly induce a life-threatening ventricular tachyarrhythmia. Device reset Device reset can be caused by exposure to temperatures below 18C (0F) or strong electromagnetic fields. Advise patients to avoid strong electromagnetic fields. Observe temperature storage limits to avoid exposure of the device to cold temperatures. If a partial reset occurs, pacing resumes in the programmed mode with many of the programmed settings retained. If a full reset occurs, the device operates in VVI mode at 65 bpm. Device reset is indicated by a programmer warning message that is displayed immediately upon interrogation. To restore the device to its previous operation, it must be reprogrammed. Inform a Medtronic representative if your patients device has reset. Device status indicators If any of the device status indicators (for example, Device Reset) are displayed on the programmer after interrogating the device, inform a Medtronic representative immediately. If these device status indicators are displayed, therapies may not be available to the patient. Effects of myopotential sensing in unipolar sensing configurations In unipolar sensing configurations, the device may not distinguish myopotentials from cardiac signals. This may result in a loss of pacing due to inhibition. Also, unipolar atrial sensing in atrial tracking modes can result in elevated ventricular pacing rates. To address these situations, the device may be programmed to be less sensitive (using higher sensitivity values). However, the sensitivity level must be balanced against the potential to undersense true cardiac signals. Typically, this balance is easily attained for ventricular sensing using sensitivity values around 2.8 mV, but it may be difficult to attain for atrial sensing because of the smaller P-wave amplitudes. End of Service (EOS) indicator Replace the device immediately if the programmer displays an EOS indicator. The device may soon lose the ability to pace, sense, and deliver therapy adequately. Extended Upper Tracking Rate When programming Upper Tracking Rates of 190, 200, or 210 bpm, be careful to ensure that these rates are appropriate for the patient. False bipolar pathway with unipolar lead When implanting a unipolar lead, ensure that the tip setscrew is properly engaged and that all electrical contacts are sealed to prevent electrical leakage. Electrical leakage may cause the device to inappropriately identify a unipolar lead as bipolar, resulting in loss of output. Magnets Placing a magnet over the device suspends tachyarrhythmia detection and initiates asynchronous, fixed-rate bradycardia pacing. The programming head contains a magnet that can cause magnet operation to 12 occur. However, magnet operation does not occur if telemetry between the device and the programmer is established or if the MRI SureScan mode is programmed to On. Multiple point pacing (MPP) Battery longevity is shortened when the MPP feature is programmed to On. Pace polarity Pace polarity must be bipolar to program the MRI SureScan mode to On. Pacemaker-mediated tachycardia (PMT) intervention Even with the PMT Intervention feature programmed to On, PMTs may still require clinical intervention, such as device reprogramming, drug therapy, or lead evaluation. Pacing and sensing safety margins Lead maturation (at least one month after implant) may cause sensing amplitudes to decrease and pacing thresholds to increase, which can cause undersensing or a loss of capture. Provide an adequate safety margin when selecting values for pacing amplitude, pacing pulse width, and sensitivity parameters. Phrenic nerve stimulation Phrenic nerve stimulation may occur as a result of left ventricular pacing at higher amplitudes. Although this condition is not life threatening, it is recommended that you test for phrenic nerve stimulation at various pacing amplitude settings with the patient in various positions. If phrenic nerve stimulation occurs with the patient, determine the minimum pacing threshold for phrenic nerve stimulation and program the pacing amplitude to a value that minimizes stimulation but provides an adequate pacing safety margin. Also, consider the use of alternate left ventricular pacing vectors to alleviate phrenic nerve stimulation. If the LV Capture Management or 2nd LV Capture Management features are used, program the LV Maximum Adapted Amplitude or 2nd LV Maximum Adapted Amplitude to values that minimize phrenic nerve stimulation but provide an adequate pacing safety margin. Carefully consider the relative risks of phrenic nerve stimulation versus loss of capture before programming lower pacing amplitudes for the patient. Programmers Use only Medtronic programmers and application software to communicate with the device. Programmers and software from other manufacturers are not compatible with Medtronic devices. Rate control Decisions regarding rate control should not be based on the ability of the device to prevent atrial arrhythmias. Rate-responsive modes Do not program rate-responsive modes for patients who cannot tolerate rates above the programmed Lower Rate. Rate-responsive modes may cause discomfort for those patients. Right ventricular apical pacing Right ventricular apical pacing may be associated with an increased risk of atrial fibrillation, left ventricular dysfunction, and congestive heart failure. Maximum output for the RV Capture Management feature The RV Capture Management feature does not program right ventricular outputs to values greater than 5.0 V or 1.0 ms. If the patient needs right ventricular pacing output greater than 5.0 V or 1.0 ms, manually program right ventricular amplitude and pulse width. If a lead dislodges partially or completely, the RV Capture Management feature may not prevent loss of capture. Sensitivity setting Carefully evaluate the possibility of increased susceptibility to EMI and oversensing before changing the sensitivity from its nominal setting to a more sensitive setting. Shipping values Do not use shipping values or nominal values for pacing amplitude and sensitivity without verifying that the values provide adequate safety margins for the patient. Single chamber atrial modes Do not program single chamber atrial modes for patients with impaired AV nodal conduction. Ventricular pacing does not occur in these modes. Slow retrograde conduction and PMT Slow retrograde conduction may induce pacemaker-mediated tachycardia (PMT) when the VA conduction time is greater than 400 ms. Programming PMT Intervention can help prevent PMT only when the VA conduction time is less than 400 ms. Testing for cross-stimulation At implant, and regularly when atrial ATP therapy is enabled, conduct testing at the programmed atrial ATP output settings to ensure that ventricular capture does not occur. This is particularly important when the lead is placed in the inferior atrium. 13 2.5.1 Pacemaker-dependent patients Ventricular Safety Pacing Always program Ventricular Safety Pacing (VSP) to On for pacemaker-dependent patients. Ventricular Safety Pacing prevents ventricular asystole due to inappropriate inhibition of ventricular pacing caused by oversensing in the ventricle. ODO pacing mode Pacing is disabled under ODO pacing mode. Do not program the ODO mode for pacemaker-dependent patients. Instead, use the Underlying Rhythm Test to provide a brief period without pacing support. Polarity override Do not override the polarity verification prompt with bipolar polarity when a unipolar lead is connected. Overriding the polarity verification prompt results in no pacing output. Underlying Rhythm Test Use caution when using the Underlying Rhythm Test to inhibit pacing. The patient is without pacing support when pacing is inhibited. 2.6 Potential adverse events Potential adverse events associated with the use of transvenous leads and pacing systems include, but are not limited to, the following events:
acceleration of tachyarrhythmias (caused by device) bleeding cardiac dissection cardiac tamponade death erosion excessive fibrotic tissue growth fibrillation or other arrhythmias formation of hematomas or cysts heart wall or vein wall rupture infection lead abrasion and discontinuity muscle stimulation, nerve stimulation, or both myocardial irritability pericardial effusion pneumothorax threshold elevation thrombolytic and air embolism transvenous lead-related thrombosis venous occlusion air embolism body rejection phenomena including local tissue reaction cardiac perforation chronic nerve damage endocarditis erosion through the skin extrusion fluid accumulation heart block hematoma/seroma keloid formation lead migration/dislodgment myocardial damage myopotential sensing pericardial rub rejection phenomena (local tissue reaction, fibrotic tissue formation, device migration) thromboemboli thrombosis valve damage (particularly in fragile hearts) venous or cardiac perforation An additional potential adverse event associated with the use of transvenous left ventricular pacing leads is coronary sinus dissection. 14 3 Clinical data 3.1 Adverse events and clinical trial data Information regarding clinical studies and adverse events related to this device is available at www.medtronic.com/manuals. The following clinical studies are related to this device:
AdaptivCRT (Adaptive Cardiac Resynchronization Therapy) clinical study This clinical study evaluated the safety and efficacy of the AdaptivCRT algorithm to provide patient-specific selection of LV or BiV CRT pacing as well as dynamic adjustment of AV and VV delays based on periodic automatic evaluation of intrinsic electrical conduction. Advisa DR MRI system study This clinical study, which evaluated the safety and efficacy of the Advisa DR MRI SureScan pacing system in the clinical magnetic resonance imaging (MRI) environment, provides support for the MRI SureScan feature. This study supports removal of the C1-T12 positioning restriction, so that any region of the body can be scanned when the MR Conditions for Use are followed. Atrial Capture Management (ACM) study This clinical study, which evaluated the Atrial Capture Management feature in EnPulse pacemakers, provides support for the Atrial Capture Management feature in Percepta Quad CRT-P MRI SureScan Model W4TR01 devices. Atrial Fibrillation Symptoms Mediated by Pacing to Mean Rates (AF SYMPTOMS) This study evaluated the long-term effects of Conducted AF Response in patients with atrial fibrillation and intact atrioventricular (AV) conduction. It provides support for the Conducted AF Response feature in Percepta Quad CRT-P MRI SureScan Model W4TR01 devices. Note that the Ventricular Response Pacing (VRP) feature mentioned in the study is called Conducted AF Response in Percepta Quad CRT-P MRI SureScan Model W4TR01 devices Atrial Septal Pacing Efficacy Trial (ASPECT) This clinical study, which evaluated the safety and efficacy of the Medtronic AT500 DDDRP Pacing System devices, provides support for the atrial intervention pacing therapies. Atrial Therapy Efficacy and Safety Trial (ATTEST) This clinical study, which evaluated the safety and efficacy of the Medtronic AT500 DDDRP Pacing System devices, provides support for the Percepta Quad CRT-P MRI SureScan Model W4TR01 devices. BLOCK HF clinical study The Biventricular versus Right Ventricular Pacing in Heart Failure Patients with Atrioventricular Block Clinical Study investigated the safety and efficacy of biventricular pacing compared to right ventricular pacing. This study provides support for biventricular pacing in Percepta Quad CRT-P MRI SureScan Model W4TR01 devices. Cardiac Resynchronization Therapy Efficacy Enhancements (CRTee) Trial This clinical study, which evaluated the safety and efficacy of the EffectivCRT During AF feature, provides support for this feature in the Percepta Quad CRT-P MRI SureScan Model W4TR01 devices. Care-HF clinical study This clinical study, which evaluated the effects of cardiac resynchronization therapy
(CRT) in InSync and InSync III devices on the mortality and morbidity of patients with moderate or severe heart failure due to left ventricular systolic dysfunction and cardiac dyssynchrony, provides support for CRT pacing in Percepta Quad CRT-P MRI SureScan Model W4TR01 devices. EnRhythm clinical study This clinical study, which evaluated the safety and efficacy of the EnRhythm Model P1501DR devices, provides support for MVP mode pacing and the Reactive ATP feature in the Percepta Quad CRT-P MRI SureScan Model W4TR01 devices. FAST study This clinical study, which evaluated the OptiVol Fluid Monitoring feature in InSync Marquis devices to corroborate the MIDHeFT clinical data, provides support for the OptiVol Fluid Monitoring feature in Percepta Quad CRT-P MRI SureScan Model W4TR01 devices. GEM III DR Model 7275 MVP study This clinical study, which evaluated the performance of MVP mode pacing in the GEM III DR Model 7275 devices, provides support for MVP mode in the Percepta Quad CRT-P MRI SureScan Model W4TR01 devices. 15 InSync clinical study This clinical study, which was used as the historical control for the cardiac resynchronization therapy evaluation of the InSync III clinical study, provides support for CRT pacing in Percepta Quad CRT-P MRI SureScan Model W4TR01 devices. InSync III clinical study This clinical study, which evaluated the safety and efficacy of sequential biventricular CRT pacing and the general safety and efficacy of CRT in InSync III devices, provides support for CRT pacing in Percepta Quad CRT-P MRI SureScan Model W4TR01 devices. InSync III Marquis clinical study This clinical study, which evaluated the safety and efficacy of sequential biventricular CRT pacing and the Conducted AF Response feature in the InSync III Marquis devices, provides support for CRT pacing and Conducted AF Response in Percepta Quad CRT-P MRI SureScan Model W4TR01 devices. Kappa 700 clinical study This study, which evaluated the safety and clinical performance of the Kappa 700 pacemakers, provides support for the Right Ventricular Capture Management feature and other bradycardia pacing features. Left Ventricular Capture Management Software Download Clinical Trial (LVCM) This clinical study, which evaluated the accuracy of the Left Ventricular Capture Management feature in modified InSync II Marquis devices, provides support for the Left Ventricular Capture Management feature in Percepta Quad CRT-P MRI SureScan Model W4TR01 devices. Marquis MVP download study This clinical study, which evaluated the performance of MVP mode pacing in the Marquis DR Model 7274 devices, provides support for MVP mode in the Percepta Quad CRT-P MRI SureScan Model W4TR01 devices. Medtronic Impedance Diagnostics in Heart Failure Trial (MIDHeFT) This clinical study, which demonstrated the use of intrathoracic impedance as a surrogate measure of fluid status in patients with heart failure, provides support for the OptiVol Fluid Status Monitoring feature in Percepta Quad CRT-P MRI SureScan Model W4TR01 devices. Reducing Episodes by Septal Pacing Efficacy Confirmation Trial (RESPECT) This clinical study evaluated the efficacy of the intervention pacing therapies on symptomatic AT/AF episodes in subjects where the lead was placed in the Bachmanns Bundle region. The results of the study failed to demonstrate effectiveness of the intervention pacing therapies. Evaluation of the RESPECT study data indicated that the intervention pacing features did not significantly reduce the rate of symptomatic AT/AF episodes and these results did not confirm the findings from previous trials. The pre-specified subgroups were tested for therapeutic effect, but none had results suggesting benefit. When intervention pacing algorithms were programmed ON, atrial pacing percentage increased by 18.1% (P<0.001) with a modest, yet statistically significant, increase in mean heart rate of 2.4 beats per minute (P<0.001). Revo MRI SureScan pacing system clinical study This clinical study, which evaluated the safety and efficacy of the EnRhythm MRI SureScan pacing system in the clinical magnetic resonance imaging (MRI) environment, provides support for the MRI SureScan feature. This study was conducted with the C1 T12 MRI scan exclusion zone in place. 4 Implant procedure 4.1 Preparing for an implant The following implant procedures are provided for reference only. Proper surgical procedures and sterile techniques are the responsibility of the physician. Each physician must apply the information in these procedures according to professional medical training and experience. For information about replacing a previously implanted device, see Section 4.7, Replacing a device, page 23. Ensure that you have all of the necessary instruments, system components, and sterile accessories to perform the implant. 16 Connect the skin electrodes to the patient if you would like to display surface ECG signals on the programmer. See the programmer reference manual for more information. 4.1.1 Instruments, components, and accessories required for an implant The following non-implanted instruments are used to support the implant procedure:
Medtronic programmer with a programming head programmer software application for the Percepta Quad CRT-P MRI SureScan Model W4TR01 device Model 2290 Analyzer or equivalent pacing system analyzer external defibrillator The following sterile system components and accessories are used to perform the implant:
implantable device and lead system components programming head sleeve Note: If a sterilized programming head is used during an implant, a sterile programming head sleeve is not necessary. pacing system analyzer cables lead introducers appropriate for the lead system extra stylets of appropriate length and shape 4.1.2 Setting up the programmer and starting the application See the programmer reference manual for instructions about how to set up the programmer. The software application for the Percepta Quad CRT-P MRI SureScan Model W4TR01 device should be installed on the programmer. Your Medtronic representative can install this software, if necessary. Establish telemetry with the device and start a patient session. 4.1.3 Considerations for preparing for an implant Review the following information before implanting the leads or device:
Warning: Bipolar or unipolar atrial and right ventricular leads may be used with the Percepta Quad CRT-P MRI SureScan Model W4TR01 device, but if leads other than bipolar MRI SureScan leads are used, the system is contraindicated for MRI scans. The left ventricular lead must be a quadripolar lead, but if it is not a quadripolar MRI SureScan lead, the system is contraindicated for MRI scans. Before performing an MRI scan, refer to the MRI technical manual for additional information. Warning: Do not allow the patient to have contact with grounded electrical equipment that might produce electrical current leakage during implant. Electrical current leakage may induce tachyarrhythmias that may result in the patients death. Warning: Keep external defibrillation equipment nearby for immediate use. Potentially harmful spontaneous or induced tachyarrhythmias may occur during device testing, implant procedures, and post-implant testing. Caution: The device is intended for implant in the pectoral region with Medtronic transvenous leads. Implanting the device outside of the pectoral region may adversely affect the results of the OptiVol 2.0 fluid measurements. Implanting a unipolar RV lead instead of a bipolar lead will result in no OptiVol 2.0 fluid measurements. No claims of safety and efficacy can be made with regard to other acutely or chronically implanted lead systems that are not manufactured by Medtronic. Caution: Unipolar atrial leads may be used with the device, but bipolar atrial leads are recommended. If unipolar atrial leads are used, AT/AF Detection must be programmed to Monitor and the Capture Management feature must be programmed to Off. Caution: Do not implant the device after the Use by date on the package label. Battery longevity may be reduced. 17 To retain the ability to safely scan the SureScan pacing system during MRI scans, the MRI conditions for use in Section 1.5, MRI conditions for use, page 6 must be followed. Refer to the MRI technical manual for additional information. 4.1.4 How to prepare the device for implant Before opening the sterile package, perform the following steps to prepare the device for implant:
1. Interrogate the device and print an Initial Interrogation Report. Caution: If the programmer reports that a device reset occurred, do not implant the device. Contact a Medtronic representative. 2. Check the Initial Interrogation Report to confirm that the battery voltage is at least 2.85 V at room temperature. If the device has been exposed to low temperatures, then the battery voltage will be temporarily lower. Allow the device to warm to room temperature for at least 48 hours and check the battery voltage again. If an acceptable battery voltage cannot be obtained, contact a Medtronic representative. Note: The device automatically measures the battery voltage several times a day. The battery voltage reported on the Battery and Lead Measurements screen is an average of recent automatic measurement values. 3. Select Params > Data Collection Setup > Device Date/Time to select the Time Zone for the internal clock of the device. 4. Program the therapy and pacing parameters to values appropriate for the patient. Ensure that tachyarrhythmia detection is not programmed to On. Note: Do not enable a pacing feature that affects the pacing rate (for example, Ventricular Rate Stabilization) before implanting the device. Doing so may result in a pacing rate that is faster than expected. 4.2 Selecting and implanting the leads Use the guidelines in this section to select leads that are compatible with the device. The appropriate techniques for implanting the leads may vary according to physician preference and the patients anatomy or physical condition. Consult the technical manuals supplied with the leads for specific implant instructions. A complete SureScan pacing system is required for use in the MR environment. A complete SureScan pacing system includes a SureScan device with Medtronic SureScan leads or a Model 6725 pin plug. To verify that components are part of a SureScan system, visit http://www.mrisurescan.com. Any other combination may result in a hazard to the patient during an MRI scan. Caution: Unipolar atrial leads may be used with the device, but bipolar atrial leads are recommended. If unipolar atrial leads are used, the AT/AF detection feature can only be programmed to Monitor. 4.2.1 Selecting the leads Do not use any lead with this device without first verifying lead and connector compatibility. The device is typically implanted with the following leads:
1 quadripolar transvenous lead in the left ventricle (LV) for pacing 1 bipolar transvenous lead in the right ventricle (RV) for sensing and pacing 1 bipolar transvenous lead in the atrium (A) for sensing and pacing. Use of a bipolar atrial lead with ring and tip electrodes spaced 10 mm apart to reduce far-field R-wave sensing is recommended. 4.2.2 How to verify lead and connector compatibility Warning: Verify lead and connector compatibility before using a lead with this device. Using an incompatible lead may damage the connector, resulting in electrical current leakage or resulting in an intermittent electrical connection. Note: Medtronic 3.2 mm low-profile leads are not directly compatible with the IS-1 connector ports in the connector block. 18 Note: Lead adaptors compromise the ability to safely scan the SureScan pacing system during an MRI scan. Patients with lead adaptors are contraindicated for an MRI scan. Note: Using a lead adaptor may affect the accuracy of OptiVol 2.0 fluid measurements. Use the information in Table 1 to select a compatible lead. Table 1. Lead and connector compatibility Connector port A, RV LV a IS-1 refers to the international standard ISO 5841-3. b IS4-LLLL refers to the international standard ISO 27186, which defines the lead connector contacts as low voltage (L). Primary leads IS-1a bipolar, IS-1 unipolar IS4-LLLLb quadripolar 4.2.3 Implanting the leads Implant the leads according to the instructions in the technical manuals supplied with the leads unless suitable chronic leads are already in place. Warning: Pinching the lead can damage the lead conductor or insulation, which may result in the loss of sensing or pacing therapy. Transvenous leads If you use a subclavian approach to implant a transvenous lead, position the lead laterally to avoid pinching the lead body between the clavicle and the first rib. Do not implant the LV, atrial, and RV leads in the same venous access site. Medtronic recommends using the subclavian vein and the cephalic vein to separate the entry site of the leads. LV leads Due to the variability of cardiac venous systems, assess the venous anatomy before implanting the LV lead to determine an optimal LV lead position. Before placing a lead in the coronary sinus, obtain a venogram. 4.3 Testing the lead system After the leads are implanted, test the lead system to verify that the sensing and pacing values are acceptable. Refer to the literature provided with the pacing system analyzer for instructions. Note: Do not measure the intracardiac EGM telemetered from the device to assess sensing. Note: The measured pacing lead impedance is a reflection of measuring equipment and lead technology. Refer to the lead technical manual for acceptable impedance values. Bipolar leads When measuring sensing and pacing values, measure between the tip (cathode) and ring
(anode) of each bipolar pacing/sensing lead. Unipolar leads When measuring sensing and pacing values, measure between the tip (cathode) of each unipolar pacing/sensing lead and an indifferent electrode (anode) used in place of the device can. Lead positioning Final lead positioning should attempt to optimize cardiac resynchronization. Extracardiac stimulation When pacing at 10 V using an external pacing device, test for extracardiac stimulation from the LV lead. If extracardiac stimulation is present, consider repositioning the lead. 19 Table 2. Acceptable sensing and pacing values Measurements required P-wave EGM amplitude (atrial) R-wave EGM amplitude (RV) LV EGM amplitude Slew rate Acute transvenous leads 2 mV 5 mV 4 mV Capture threshold (0.5 ms pulse width) 0.5 V/s (atrial) 0.75 V/s (RV) 1.5 V (atrial) 1.0 V (RV) 3.0 V (LV) Chronic leadsa 1 mV 3 mV 1 mV 0.3 V/s (atrial) 0.5 V/s (RV) 3.0 V (atrial) 3.0 V (RV) 4.0 V (LV) a Chronic leads are leads implanted for 30 days or more. 4.4 Connecting the leads to the device The following procedure describes how to connect a lead to the device, confirm that the lead connector is fully inserted in the connector block, and verify that the lead connection is secure. Warning: After connecting the leads, verify that the lead connections are secure by gently tugging on each lead. A loose lead connection may result in inappropriate sensing, which can cause false tracking and false inhibition of pacing, or inappropriate atrial tachyarrhythmia therapy. Caution: Use only the torque wrench supplied with the device. The torque wrench is designed to prevent damage to the device from overtightening a setscrew. 4.4.1 How to connect a lead to the device 1. Insert the torque wrench into the appropriate setscrew. a. If the setscrew obstructs the port, retract the setscrew by turning it counterclockwise until the port is clear. Take care not to disengage the setscrew from the connector block (see Figure 1). b. Leave the torque wrench in the setscrew until the lead connection is secure. This action allows a pathway for venting trapped air when the lead connector is inserted into the connector port (see Figure 1). Figure 1. Inserting the torque wrench into the setscrew 20 2. Push the lead connector into the connector port until the lead connector pin is clearly visible in the pin viewing 3. Confirm that the lead is fully inserted into the connector pin cavity by viewing the device connector block from area. If necessary, sterile water may be used as a lubricant. No sealant is required. the side or end. a. The lead connector pin should be clearly visible beyond the setscrew block (see Figure 2). b. The lead connector ring should be completely inside the spring contact block. There is no setscrew in this location (see Figure 2). Figure 2. Confirming the lead connection 4. Tighten the setscrew by turning it clockwise until the torque wrench clicks. Remove the torque wrench. 5. Gently tug on the lead to confirm a secure fit. Do not pull on the lead until the setscrew has been tightened. 6. Repeat these steps for each lead. 4.5 Positioning and securing the device Caution: Program AT/AF detection to Monitor to avoid inappropriate therapy delivery while closing the pocket. Note: To optimize the ability of the device to connect to a wireless monitor, implant the device within 4 cm (1.6 in) of the surface of the skin. 4.5.1 How to position and secure the device 1. Verify that each lead connector pin or pin plug is fully inserted into the connector port and that all setscrews 2. To prevent twisting of the lead body, rotate the device to loosely wrap the excess lead length (see Figure 3). are tight. Do not kink the lead body. 21 Figure 3. Rotating the device to wrap the leads migration. Use a surgical needle to penetrate the suture hole on the device. 3. Place the device and the leads into the surgical pocket. 4. Use nonabsorbable sutures to secure the device within the pocket and minimize post-implant rotation and 5. Suture the pocket incision closed. 4.6 Completing the implant procedure Warning: Do not program AT/AF Detection to On or enable automatic atrial ATP therapies until the atrial lead has matured (approximately 1 month after implant). If the atrial lead dislodges and migrates to the ventricle, the device could inappropriately detect AT/AF, deliver atrial ATP to the ventricle, and possibly induce a life-threatening ventricular tachyarrhythmia. 4.6.1 How to complete programming the device 1. 2. Verify that the pacing, detection, and atrial ATP therapies parameters are programmed to values that are 3. Enter the patients information. If unipolar leads are implanted, you may want to manually complete the Implant Detection process. a. Select the Params icon. b. Program the Pace Polarity and Sense Polarity parameters to Unipolar. c. Select Additional Features and program the Implant Detection parameter to Off/Complete. appropriate for the patient. Note: Be sure to use the Patient Information screen to enter complete information about the implanted leads. Be sure to use the MRI SureScan System/Other Hardware screen to enter complete information about other hardware implanted in the patient, including abandoned devices or leads, and lead extenders or adaptors. This information will be used in the future if the patient needs to be evaluated for an MRI scan. For more information, see the programming guide. 4. Program the Medtronic CareAlert parameters, if applicable. 5. Program the Data Collection Setup parameters. 4.6.2 How to assess the performance of the device and leads After implanting the device, x-ray the patient as soon as possible to verify device and lead placement. Before the patient is discharged from the hospital, assess the performance of the implanted device and leads. 1. Monitor the patients electrocardiogram until the patient is discharged. If a lead dislodges, it usually occurs during the immediate postoperative period. 2. Check the pacing and sensing values, and adjust the values if necessary. Verify the safety margin for the pacing threshold. Interrogate the device, and print a Final Report to document the postoperative programmed device status. 3. 22 4.7 Replacing a device To retain the ability to safely scan the SureScan pacing system during MRI scans, the MRI conditions for use in Section 1.5, MRI conditions for use, page 6 must be followed. Refer to the Medtronic MRI technical manual for additional information. Warning: Bipolar or unipolar atrial and right ventricular leads may be used with the Percepta Quad CRT-P MRI SureScan Model W4TR01 device, but if leads other than bipolar MRI SureScan leads are used, the system is contraindicated for MRI scans. The left ventricular lead must be a quadripolar lead, but if it is not a quadripolar MRI SureScan lead, the system is contraindicated for MRI scans. Before performing an MRI scan, refer to the MRI technical manual for additional information. Warning: Abandoned leads or previously implanted non-MRI labeled leads compromise the ability to safely scan the SureScan pacing system during future MRI scans. When implanting a SureScan pacing system, consider the risks associated with removing previously implanted leads before removing the leads to maintain the ability to safely scan the SureScan pacing system. Refer to the Medtronic MRI technical manual for additional information. Warning: Keep external pacing equipment nearby for immediate use. The patient does not receive pacing therapy from the device when the lead is disconnected, or when the device is removed from the pocket while the device is operating in unipolar pacing mode. Caution: Disable tachyarrhythmia detection to avoid inappropriate therapy delivery while explanting the device. Caution: Unipolar atrial leads may be used with the device, but bipolar atrial leads are recommended. If unipolar atrial leads are used, AT/AF Detection must be programmed to Monitor and the Capture Management feature must be programmed to Off. Note: To meet the implant requirements, you may need to reposition or replace the chronic leads. For more information, see Section 4.2, Selecting and implanting the leads, page 18. Note: Any unused leads that remain implanted must be capped with a lead pin cap to avoid transmitting electrical signals. Contact your Medtronic representative for information about lead pin caps. Any capped or unused leads are considered abandoned leads in the MRI conditions for use, and their presence will contraindicate the system for MRI scanning. 4.7.1 How to explant and replace a device 1. Program the device to a mode that is not rate-responsive to avoid potential rate increases while explanting the 2. Dissect the leads and the device free from the surgical pocket. Do not nick or breach the lead insulation. 3. Use a torque wrench to loosen the setscrews in the connector block. 4. Gently pull the leads out of the connector ports. 5. Evaluate the condition of each lead (see Section 4.3, Testing the lead system, page 19). Replace a lead if the electrical integrity is not acceptable or if the lead connector pin is pitted or corroded. If you explant the lead, return the lead to Medtronic for analysis and disposal. page 20). Note: Lead adaptors may be needed to connect the leads to the replacement device. Contact a Medtronic representative for information about compatible lead adaptors. Note: Lead adaptors compromise the ability to safely perform an MRI scan on the SureScan pacing system in the future. Patients with lead adaptors are contraindicated for an MRI scan. 7. Position and secure the device in the surgical pocket, and suture the pocket incision closed (see Section 4.5, Positioning and securing the device, page 21). 8. Contact Medtronic for Return Mailer Kits to return explanted devices for analysis and disposal. See the back cover for addresses. Note: Disposal of explanted devices or leads is subject to local, state, and federal regulations. 6. Connect the leads to the replacement device (see Section 4.4, Connecting the leads to the device, device. 23 5 Product specifications 5.1 Physical characteristics Table 3. Physical characteristics Volumea Mass H x W x Db Radiopaque IDc Medtronic identifier 20.5 cm3 30 g 59 mm x 46.5 mm x 11 mm RNP 40.7 cm2 Titanium, polyurethane, silicone rubber Lithium-hybrid CFx silver vanadium oxide Surface area of titanium device can Materials in contact with human tissued Battery a Volume with connector holes unplugged. b Grommets may protrude slightly beyond the can surface. c The radiopaque ID, which includes a Medtronic-identifier symbol, can be viewed in a fluoroscopic image of the device. d These materials have been successfully tested for the ability to avoid biological incompatibility. The device does not produce an injurious temperature in the surrounding tissue during normal operation. Figure 4. Connector and suture holes 1 IS-1 connector port, A 2 IS-1 connector port, RV 3 IS4 connector port, LV 4 Suture hole 5 Suture hole 24 The Model W4TR01 shield graphics are shown in Figure 5. The IS-1 marking in Figure 5 indicates that the A and RV lead connectors conform to ISO 5841-3. The IS4-LLLL marking in Figure 5 indicates that the LV lead connector conforms to ISO 27186. Figure 5. Shield graphics: Model W4TR01 1 RA = right atrial 2 RV = right ventricular 3 LV = left ventricular 5.2 Electrical specifications Table 4. Battery characteristics Manufacturer Model Number of battery cells Chemistry Nominal voltage Mean usable capacity Mean capacity to RRT Residual usable capacity at RRT 4 IS-1 marking 5 IS4-LLLL marking Medtronic Energy and Component Center Delta 26H3 1 Lithium-hybrid CFx silver vanadium oxide 3.25 V 1.19 Ah 1.03 Ah 0.16 Ah Table 5. Current consumption Current consumption (at 100% pacing)a Current consumption (at 100% inhibition)b a Current consumption when pacing into 500 1% loads at the Beginning of Service in DDDR mode at 60 bpm, 2.5 V, 0.4 ms. b Current consumption when at the Beginning of Service in DDDR mode at 60 bpm, 2.5 V, 0.4 ms, 500 1%. 12.77 A 7.14 A 25 5.2.1 Output waveforms Figure 6. Output waveform at nominal conditions (resistive load: 500 ) 5.2.2 Variation with temperature Basic rate, test pulse rate, pulse duration, and pulse amplitude remain within expected tolerances when the device temperature is between 17C and 45C (63F to 113F). Sensitivity at nominal conditions as measured at 37C
(98.6F) can vary as much as 1% per C from 17C to 45C (63F to 113F). 5.3 Replacement indicators The battery voltage and messages about replacement status appear on the programmer display and on printed reports. The Recommended Replacement Time (RRT), Elective Replacement Indicator (ERI), and the End of Service (EOS) conditions are listed in Table 6. Table 6. Replacement indicators Recommended Replacement Time (RRT) 180 days after 3 consecutive daily automatic meas-
urements of 2.63 V or immediately after 3 consec-
utive daily automatic measurements of 2.60 V, whichever comes first 3 months after RRT 3 months after ERI Elective Replacement Indicator (ERI) End of Service (EOS) RRT date The programmer displays the date when the battery reached RRT on the Quick Look II and Battery and Lead Measurements screens. Replace at EOS If the programmer indicates that the device is at EOS, replace the device immediately. RRT operation When the device reaches RRT, it continues to operate with its programmed parameters. However, placing a magnet over the device initiates asynchronous pacing at 65 bpm rather than at 85 bpm. ERI operation When the device reaches ERI, it automatically changes the value of several parameters as shown in Table 7. Table 7. Parameter settings after ERI Pacing Mode Lower Rate V. Pacing VVI 65 bpm as programmed 26 Table 7. Parameter settings after ERI (continued) as programmed as programmed Off Off Monitora Offb Off RV Amplitude, LV Amplitude RV Pulse Width, LV Pulse Width Sleep V. Rate Stabilization AT/AF Detection Pre-arrhythmia EGM Multiple point pacing (MPP) a When AT/AF Detection is set to Monitor, AT/AF therapies are not available. b Pre-arrhythmia EGM cannot be reprogrammed after ERI. Notes:
After ERI, all pacing parameters can be programmed, including mode and rate. Reprogramming the pacing When the MRI SureScan mode is programmed to On, battery measurements are taken, but the device does parameters may reduce the duration of the ERI to EOS period. not report RRT, EOS, or ERI until the MRI SureScan mode has been programmed to Off. Prolonged Service Period The Prolonged Service Period (PSP) is the time between the RRT and EOS. The PSP is defined as 6 months assuming the following conditions, in conformance with ISO 14708: 100% DDD pacing at 60 bpm, 2.5 V atrial, RV, and LV pacing amplitudes; 0.4 ms pulse width; and 600 pacing load. The EOS may be indicated before the end of 6 months if the device exceeds these conditions. 5.4 Projected service life The projected service life estimates in Table 8 and Table 9 are based on DDD mode pacing, with pacing amplitudes programmed to the specified values, pulse width values of 0.4 ms, and a 60 bpm pacing rate. The projected service life estimates in Table 10 are based on the pacing characteristics stated in the table. All of the projected service life estimates are based on the following assumptions:
Pre-arrhythmia EGM storage programmed to On for the lifetime of the device EGM Source parameters set to nominal values A quarterly schedule of Medtronic patient monitor transmissions Typical shelf storage time before implant Projected service life estimates are based on accelerated battery discharge data and device modeling as specified. These values should not be interpreted as precise numbers. Table 8. Projected service life in years, with the AdaptivCRT feature programmed to Adaptive Bi-V or Nonadaptive CRT Percent pacing Atrial %
0%
15%
50%
100%
RV %
100%
100%
100%
100%
LV %
100%
100%
100%
100%
500 pacing impedance 2.5 V 10.1 9.9 9.4 8.7 3.5 V 7.7 7.4 6.8 6.1 600 pacing impedance 2.5 V 10.6 10.4 9.9 9.3 3.5 V 8.2 8.0 7.4 6.8 27 Table 9. Projected service life in years, with the AdaptivCRT feature programmed to Adaptive Bi-V and LV Percent pacing Atrial %
0%
15%
50%
100%
RV %
50%
50%
50%
50%
LV %
100%
100%
100%
100%
500 pacing impedance 2.5 V 10.8 10.5 9.9 9.2 3.5 V 8.6 8.2 7.5 6.7 600 pacing impedance 2.5 V 11.2 11.0 10.4 9.7 3.5 V 9.1 8.8 8.1 7.3 Table 10. Projected service life in years per conditions specified in EN 45502-2-1 and ISO 14708-2 Standard conditionsa EN 45502-2-1 100% DDDR pacing 500 1% pacing impedance 70 bpm 0.4 ms ISO 14708-2 100% DDDR pacing 600 1% pacing impedance 60 bpm 0.4 ms 2.5 V 7.4 5.0 V 2.8 9.3 4.2 a Data storage and diagnostic functions applicable to the pacing mode are On. 5.4.1 Projected service life considerations Shelf storage time These projections are based on typical shelf storage time (5 months). Assuming worst-case shelf storage time (18 months), longevity is reduced by an additional 6.4%. Pre-arrhythmia EGM storage These projections assume that Pre-arrhythmia EGM storage is programmed to On for the lifetime of the device. Programming Pre-arrhythmia EGM storage to Off increases the projected service life of the device by approximately 3.2% or 12 days per year. Capture Management The Capture Management feature can independently adapt each pacing amplitude value. An Atrial Amplitude of 1.5 V, an RV Amplitude of 2.0 V, and an LV Amplitude of 2.5 V represent typical values when using the Capture Management feature. At these settings, and with 100% atrial and biventricular pacing (at 60 bpm, 0.4 ms, and 600 ), the projected service life of the device is 10.6 years. Medtronic patient monitor remote transmissions Additional Medtronic patient monitor remote transmissions reduce projected service life. For example, with 4 remote transmissions per year, and with 100%
atrial and biventricular pacing (at 60 bpm, 2.5 V, 0.4 ms, and 600 ), the projected service life of the device is 9.3 years. Projected service life reductions for more frequent remote transmission rates are as follows:
Monthly transmissions over the life of the device reduce projected service life by 10 days, or 0.3%. Weekly transmissions over the life of the device reduce projected service life by 59 days, or 1.7%. Daily transmissions over the life of the device reduce projected service life by 394 days, or 11.5%
Multiple point pacing (MPP) It is not recommended to use multiple point pacing unless there is evidence that the patient is not responding to single site LV pacing (e.g., patient symptoms, quality of life, NYHA classification, electrocardiographic and/or echocardiographic evidence based on clinician judgment). Long-term use of multiple point pacing affects device longevity (14% median longevity reduction). 28 6 Device parameters 6.1 Emergency settings Table 11. Emergency VVI settings Selectable values VVI 70 bpm 6 V 1.5 ms Unipolar RV 240 ms Off Off Parameter Pacing Mode Lower Rate RV Amplitudea RV Pulse Widtha RV Pace Polarity V. Pacing V. Blank Post VP V. Rate Stabilization V. Sense Response a If the programmed RV Amplitude is 8 V, VVI pacing is delivered at 8 V with a pulse width of 1.2 ms. 6.2 Magnet application When a magnet is placed near the device, the pacing mode changes from the programmed mode to DOO, VOO, or AOO, and the pacing rate changes to 100 bpm for 5 beats and then changes to 85 bpm or 65 bpm, as described at the end of this section. Placing a magnet near the device suspends tachyarrhythmia detection. When the magnet is removed, the device returns to its programmed operation. Note: Magnet operation does not occur if telemetry between the device and programmer is established or if the MRI SureScan mode is programmed to On. The pacing mode will be DOO when the programmed pacing mode is a dual chamber mode or an MVP mode
(AAIR<=>DDDR, AAI<=>DDD), VOO when the programmed pacing mode is a single chamber ventricular mode, and AOO when the programmed pacing mode is a single chamber atrial mode. The pacing rate will be 85 bpm if the device conditions are normal and it will be 65 bpm if a Recommended Replacement Time (RRT) indicator or a device reset has occurred. 6.3 Tachyarrhythmia detection parameters Table 12. Tachyarrhythmia detection parameters Parameter AT/AF Detection Zones AT/AF Interval (Rate)a Fast AT/AF Interval (Rate)a VT Monitor VT Monitor Interval (Rate)a Programmable values On; Monitor 1 ; 2 150; 160 350 450 ms 150; 160 200 250 ms Monitor ; Off 280; 290 400 500 ms Shipped Monitor 350 ms 200 ms Monitor 400 ms Reset Monitor 350 ms 200 ms Off 400 ms 29 Table 12. Tachyarrhythmia detection parameters (continued) Parameter RV Sensitivityb Atrial Sensitivityc Programmable values 0.45; 0.60; 0.90; 1.20; 2.00; 2.80;
4.00; 5.60; 8.00; 11.30 mV Bipolar: 0.9 mV Unipolar: 2.80 mV 0.15; 0.30; 0.45; 0.60; 0.90; 1.20;
1.50; 1.80; 2.10; 4.0 mV; Off Bipolar: 0.3 mV Unipolar: 0.45 mV Shipped 0.9 mV Reset 2.8 mV 0.3 mV 0.45 mV a The measured intervals are truncated to a 10 ms multiple (for example, 457 ms becomes 450 ms). The device uses this truncated interval value when applying the programmed criteria and calculating interval averages. b The device complies with the requirements of ISO 14708-2 when the sensitivity threshold is programmed to 2.0 mV or higher. c The device complies with the requirements of ISO 14708-2 when the sensitivity threshold is programmed to 1.8 mV or higher. 6.4 Atrial tachyarrhythmia therapy parameters Table 13. Atrial tachyarrhythmia therapy parameters Programmable values Parameter Anti-Tachy Pacing (ATP) Fast AT/AF Rx Status Therapy Type AT/AF Rx Status Therapy Type Burst+ parameters Initial # S1 Pulses A-S1 Interval (%AA) S1-S2 (%AA) S2-S3 Decrement Interval Decrement
# Sequences Shipped Reset Off Off Off Off On; Off Ramp; Burst+
Rx1: Ramp Rx2: Burst+
Rx3: Ramp On; Off Ramp; Burst+
Rx1: Ramp Rx2: Burst+
Rx3: Ramp 1; 2; 3 11 15; 20; 25 28; 31; 34; 38; 41 59; 63; 66; 69 84 ; 88;
91; 94; 97%
28; 31; 34; 38; 41 59; 63; 66; 69 81 ; 84;
88; 91; 94; 97%; Off 0; 10; 20 80 ms; Off 0; 10 ; 20; 30; 40 ms 1; 2; 3 10 30 Table 13. Atrial tachyarrhythmia therapy parameters (continued) Parameter Ramp parameters Initial # S1 Pulses A-S1 Interval (%AA) Rx1 Rx2 Rx3 Programmable values 1; 2; 3 13 ; 14; 15; 20; 25 28; 31; 34; 38; 41 59; 63; 66 84; 88;
91 ; 94; 97%
28; 31; 34; 38; 41 59; 63; 66 84; 88;
91 ; 94; 97%
28; 31; 34; 38; 41 59; 63; 66 81 ; 84; 88;
91; 94; 97%
0; 10 40 ms 1; 2 8; 9; 10 Interval Decrement
# Sequences Stop Atrial Rx After (shared) Rx/Lead Suspect Disable Atrial ATP if it accelerates V. rate?
Disable all atrial therapies if atrial lead position is suspect? (Atrial Lead Position Check) Duration to Stop Yes ; No Yes ; No Episode Duration Before Rx Delivery Episode Duration Before ATP Reactive ATP Rhythm Change Time Interval Shared A. ATP A-A Minimum ATP Intervala A. Pacing Amplitude A. Pacing Pulse Width VVI Backup Pacing On ; Off Off 12; 24; 48 ; 72 hr;
None 0; 1 ; 2 5; 7; 10; 15; 20; 25; 30; 40; 50 min;
1; 2; 3; 4; 5; 6; 12; 24 hr
; 2; 4; 7; 12; 24; 36; 48 hr 100; 110; 150 400 ms 1; 2; 3 6 ; 8 V 0.1; 0.2 1.5 ms Off; On (Always); On (Auto-Enable) Shipped Reset Yes Yes 48 hr 1 min On Off Yes No 48 hr 1 min On Off 150 ms 6 V 1.5 ms On (Auto-
Enable) 70 bpm 150 ms 6 V 1.5 ms On (Auto-
Enable) 70 bpm VVI Backup Pacing Rate a The measured intervals are truncated to a 10 ms multiple (for example, 457 ms becomes 450 ms). The device uses this truncated interval value when applying the programmed criteria and calculating interval averages. 60; 70 120 bpm 31 6.5 Pacing parameters Table 14. Modes, rates, and intervals Parameter Mode Mode Switch Lower Ratea Upper Tracking Rate Programmable values DDDR; DDD ; AAIR<=>DDDR;
AAI<=>DDD; DDIR; DDI; AAIR; AAI;
VVIR; VVI; DOO; AOO; VOO; ODO On ; Off 30; 35 50 ; 70; 75 150 bpm Shipped DDD On 50 bpm
(1000 ms) 130 bpm Reset VVI Off 65 bpm
(920 ms) 120 bpm 80; 85 130 175 bpm; 180; 190 210 bpm 30; 40 130 350 ms 30; 40 100 350 ms Off
; 250; 260 500 ms Auto ; 150; 160 500 ms 150; 160 250 500 ms 150; 160 310 500 ms Paced AVb Sensed AVb Maximum AV Interval limit PVARP Minimum PVARP A. Refractory Period a The corresponding Lower Rate interval can be calculated as follows: Lower Rate interval (ms) = 60,000/Lower Rate. b If CRT is adaptive, Paced AV and Sensed AV cannot be selected or programmed. Table 15. Atrial parameters 180 ms 150 ms Off Auto 250 ms 310 ms 130 ms 100 ms Off Auto 250 ms 310 ms Parameter Atrial Amplitude Atrial Pulse Width Atrial Sensitivity Atrial Pace Polarity Atrial Sense Polarity Atrial Lead Monitor Min Limit Max Limit Programmable values 0.5; 0.75 3.5 5; 5.5; 6; 8 Va 0.03; 0.06; 0.1; 0.2; 0.3; 0.4 1.5 ms Off; 0.15; 0.3; 0.45; 0.6; 0.9; 1.2; 1.5; 1.8;
2.1; 4.0 mV Unipolar: 0.45 mV Bipolar: 0.3 mV Bipolar; Unipolar Bipolar; Unipolar Monitor Only; Adaptive 200 ; 300; 400; 500 1000; 1500; 2000; 3000 Shipped 3.5 V 0.4 ms 0.3 mV Reset 0.45 mV Configureb Configureb Monitor Only 200 3000 Unipolar Monitor Only 200 3000 a When Atrial Amplitude is 8 V, Atrial Pulse Width must be less than 1.3 ms. b Configure is displayed when the device is automatically configuring the lead polarity at implant. It is not a selectable value. 32 Table 16. RV parameters Parameter RV Amplitude RV Pulse Width RV Sensitivity RV Pace Polarity RV Sense Polarity RV Lead Monitor Min Limit Max Limit Programmable values 0.5; 0.75 3.5 5; 5.5; 6; 8 Va 0.03; 0.06; 0.1; 0.2; 0.3; 0.4 1.5 ms 0.45; 0.60; 0.90; 1.20; 2.00; 2.80; 4.00;
5.60; 8.00; 11.30 mV Unipolar: 2.80 mV Bipolar: 0.90 mV Bipolar; Unipolar Bipolar; Unipolar Monitor Only; Adaptive 200 ; 300; 400; 500 1000; 1500; 2000; 3000 Shipped 3.5 V 0.4 ms 0.90 mV Reset 6 V 1.5 ms 2.80 mV Configureb Configureb Monitor Only 200 3000 Unipolar Unipolar Monitor Only 200 3000 a When RV Amplitude is 8 V, RV Pulse Width must be less than 1.3 ms. b Configure is displayed when the device is automatically configuring the lead polarity at implant. It is not a selectable value. Table 17. LV parameters Parameter LV Amplitude LV Pulse Width LV Pace Polarity LV Lead Monitor Min Limit Max Limit Programmable values 0.5; 0.75 3.5 5; 5.5; 6; 8 Va 0.03; 0.06; 0.1; 0.2; 0.3; 0.4 1.5 ms LV1 to LV2; LV1 to LV3; LV1 to LV4; LV1 to Can; LV2 to LV1; LV2 to LV3; LV2 to LV4;
LV2 to Can; LV3 to LV1; LV3 to LV2; LV3 to LV4; LV3 to Can; LV4 to LV1; LV4 to LV2;
LV4 to LV3; LV4 to Can Monitor Only; Adaptive 200 ; 300; 400; 500 800; 1000; 1500; 2000; 3000 Shipped 3.5 V 0.4 ms LV1 to LV2 Reset 1.5 ms LVtip to Can Monitor Only 200 3000 Monitor Only 200 3000 a When LV Amplitude is 8 V, LV Pulse Width must be less than 1.3 ms. Table 18. 2nd LV parameters Parameter 2nd LV Amplitude 2nd LV Pulse Width 2nd LV Pace Polarity Programmable values 0.5; 0.75 3.5 5; 5.5; 6; 8 Va 0.03; 0.06; 0.1; 0.2; 0.3; 0.4 1.5 ms LV1 to LV2; LV1 to LV3; LV1 to LV4; LV1 to Can; LV2 to LV1; LV2 to LV3; LV2 to LV4;
LV2 to Can; LV3 to LV1; LV3 to LV2; LV3 to LV4; LV3 to Can; LV4 to LV1; LV4 to LV2;
LV4 to LV3; LV4 to Can Shipped 0 V 0.4 ms LV4 to Can Reset 0 V 0.4 ms LV4 to Can a When 2nd LV Amplitude is 8 V, 2nd LV Pulse Width must be less than 1.3 ms. 33 Table 19. CRT/MPP pacing parameters Parameter AdaptivCRT Programmable values Adaptive Bi-V and LV ; Adaptive Bi-V;
Nonadaptive CRT RV; RVLV; LVRV Auto ; 0; 10 80 ms On ; Off 80; 85 110 130 bpm On; Off 0 ; 10 80 ms On ; Off 95; 100 130 150 bpm On ; Off V. Pacinga V-V Pace Delay EffectivCRT During AF Maximum Rate MPP LV-LV Pace Delay V. Sense Response Maximum Rate Atrial Tracking Recovery a If CRT is adaptive, V. Pacing cannot be selected or programmed. Table 20. Atrial Capture Management parameters Parameter Atrial Capture Management Atrial Amplitude Safety Margin Atrial Minimum Adapted Amplitude Atrial Acute Phase Remain-
ing Programmable values Adaptive ; Monitor; Off 1.5x; 2.0x ; 2.5x; 3.0x 1.0; 1.5 ; 2.0; 2.5; 3.0; 3.5 V Shipped Adaptive Bi-V and LV LVRV Auto On 110 bpm Off 0 ms On 130 bpm On Reset Nonadaptive CRT RV 0 ms Off Off 0 ms Off Shipped Adaptive 2.0x 1.5 V Reset Off 2.0x 1.5 V Off; 30; 60; 90; 120 ; 150 days 120 days 120 days Table 21. RV Capture Management parameters Programmable values Adaptive ; Monitor; Off 1.5x; 2.0x ; 2.5x; 3.0x Parameter RV Capture Management RV Amplitude Safety Mar-
gin RV Minimum Adapted Amplitude RV Acute Phase Remaining Off; 30; 60; 90; 120 ; 150 days 1.0; 1.5; 2.0 ; 2.5; 3.0; 3.5 V Table 22. LV Capture Management parameters Parameter LV Capture Management LV Amplitude Safety Margin LV Maximum Adapted Amplitude Programmable values Adaptive ; Monitor; Off
+Auto ; +0.5; +1.0; +1.5; +2.0; +2.5 V 0.5; 0.75 5.0; 5.5; 6 V Shipped Adaptive 2.0x 2 V Reset Off 2.0x 2 V 120 days 120 days Shipped Adaptive
+Auto 6.0 V Reset Off 6.0 V 34 Table 23. 2nd LV Capture Management parameters Parameter 2nd LV Capture Manage-
ment 2nd LV Amplitude Safety Margin 2nd LV Maximum Adapted Amplitude Programmable values Adaptive ; Monitor; Off
+Auto ; +0.5; +1.0; +1.5; +2.0; +2.5 V 0.5; 0.75 5.0; 5.5; 6 V Table 24. Blanking periods Parameter PVAB Interval PVAB Method A. Blank Post AP A. Blank Post AS V. Blank Post VP V. Blank Post VS Programmable values 10a; 20 100; 110; 120 150 300 ms Partial
; Partial+; Absolute 150; 160 200 250 ms 100 ; 110 170 ms 150; 160 230 320 ms 120 ; 130 170; 200; 220; 250; 280; 300;
320 ms Shipped Shipped 150 ms Partial 200 ms 100 ms 230 ms 120 ms Reset Off
+Auto 6.0 V Reset 150 ms Partial 240 ms 100 ms 240 ms 120 ms a If the PVAB Method is set to Partial, the minimum selectable value for the PVAB Interval is 100 ms Table 25. Rate Response Pacing parameters Programmable values Shipped Reset Parameter Rates ADL Rate Upper Sensor Rate Profile Optimization Adjust Rate Response ADL Response Exertion Response Additional Parameters Activity Threshold Activity Acceleration Activity Deceleration ADL Setpoint UR Setpoint 60; 65 95 170 bpm 80; 85 120 175 bpm On ; Off 1; 2; 3 ; 4; 5 1; 2; 3 ; 4; 5 Low ; Medium Low; Medium High; High 15; 30 ; 60 s Exercise ; 2.5; 5; 10 min 5; 6 40; 42 80 15; 16 40; 42 80; 85 180 95 bpm 120 bpm On 3 3 Low 30 s Exercise 18 40 95 bpm 120 bpm Off 3 3 Medium Low 30 s 5 min 18 40 35 Table 26. Rate Adaptive AV parameters Parameter Rate Adaptive AVa Start Rate Stop Rate Minimum Paced AV Minimum Sensed AV Programmable values On ; Off 50; 55 90 145 bpm 55; 60 130 175 bpm 30; 40 100 200 ms 30; 40 70 200 ms a If CRT is adaptive, Rate Adaptive AV cannot be selected or programmed. Table 27. Atrial Rate Stabilization parameters Parameter A. Rate Stabilization Maximum Rate Interval Percentage Incre-
ment Programmable values On; Off 80; 85 100 150 bpm 12.5; 25 ; 50%
Table 28. Atrial Preference Pacing parameters Parameter A. Preference Pacing Maximum Rate Interval Decrement Search Beats Programmable values On; Off 80; 85 100 150 bpm 30 ; 40; 50 100; 150 ms 5; 10; 15; 20 25; 50 Table 29. Post Mode Switch Overdrive Pacing (PMOP) parameters Parameter Post Mode Switch Overdrive Rate Overdrive Duration Programmable values On; Off 70; 75; 80 120 bpm 0.5; 1; 2; 3; 5 ; 10; 20; 30; 60; 90; 120 min Table 30. Conducted AF Response parameters Parameter Conducted AF Response Response Level Maximum Rate Programmable values On ; Off Low; Medium ; High 80; 85 110 130 bpm 36 Shipped On 90 bpm 130 bpm 100 ms 70 ms Shipped Off 100 bpm 25%
Shipped Off 100 bpm 30 ms 20 Shipped Off 80 bpm 5 min Shipped On Medium 110 bpm Reset On 60 bpm 120 bpm 140 ms 110 ms Reset Off 100 bpm 25%
Reset Off 100 bpm 50 ms 5 Reset Off 65 bpm 5 min Reset Off Medium 110 bpm Table 31. Ventricular Rate Stabilization parameters Parameter V. Rate Stabilization Maximum Rate Interval Increment Programmable values On; Off 80; 85 100 120 bpm 100; 110 150 400 ms Table 32. Rate Drop Response parameters Parameter Rate Drop Responsea Detection Type Drop Detection Drop Size Drop Rate Detection Window Low Rate Detection Detection Beats Intervention Intervention Rate Intervention Duration Programmable values On; Off Drop ; Low Rate; Both 10; 15 25 50 bpm 30; 40 60 100 bpm 10; 15; 20; 25; 30 s 1 ; 1.5; 2; 2.5 min 1; 2; 3 beats 70; 75 100 150 bpm 1; 2 15 min a When Rate Drop Response is set to On, the lower rate is automatically set to 45 bpm. Table 33. Sleep parameters Parameter Sleep Sleep Rate Bed Time Wake Time Programmable values On; Off 30; 35 50 ; 55; 60; 70; 75 100 bpm 00:00; 00:10 22:00 23:50 00:00; 00:10 07:00 23:50 Table 34. Non-Competitive Atrial Pacing (NCAP) parameters Parameter Non-Comp Atrial Pacing NCAP Interval Programmable values On ; Off 200; 250; 300 ; 350; 400 ms 37 Shipped Off 100 bpm 150 ms Shipped Off Drop 25 bpm 60 bpm 1 min 3 beats 100 bpm 2 min Shipped Off 50 bpm 22:00 07:00 Shipped On 300 ms Reset Off 120 bpm 150 ms Reset Off Drop 25 bpm 60 bpm 1 min 3 beats 100 bpm 2 min Reset Off 50 bpm 22:00 07:00 Reset On 300 ms Table 35. MRI SureScan parameters Parameter MRI SureScan MRI Pacing Mode MRI Pacing Rate Programmable values On; Off DOO; AOO; VOO; ODO 60; 70; 75; 80 120 bpm Shipped Off Reset Off Table 36. Additional pacing features Parameter PMT Intervention PVC Response V. Safety Pacinga a Delivered as LV pacing when the AdaptivCRT operating value is LV. Delivered as RV pacing when RV only pacing is permanently programmed. Otherwise, delivered as BiV pacing. Programmable values On ; Off On ; Off On ; Off Shipped On On On Reset Off On On 6.6 Data collection parameters Table 37. Data collection parameters Parameter EGM 1 Source EGM 1 Range EGM 2 Source EGM 2 Range EGM 3 Source EGM 3 Range Monitored Pre-arrhythmia EGM AT/AF Daily Burden Avg. V. Rate During AT/AF Burden Avg. V. Rate During AT/AF V. Rate OptiVol Thresholda Programmable values Can to Aring (LECG); Can to RVring; Atip to Aring ; Atip to RVring; Atip to Can; Aring to RVring; RVtip to RVring; RVtip to Can; Can to LV4 1; 2; 4; 8 ; 12; 16; 32 mV Can to RVring; RVtip to RVring ; RVtip to Can; LV1 to Can; LV1 to LV2; LV2 to Can 1; 2; 4; 8 ; 12; 16; 32 mV RVtip to RVring; Can to RVring; Atip to RVring; Atip to Aring; Can to Aring
(LECG) ; LV1 to Can; LV1 to LV2; LV1 to LV3; LV1 to LV4; LV2 to Can; LV2 to LV3; LV2 to LV4; LV3 to LV4; LV3 to Can; LV4 to Can 1; 2; 4; 8 ; 12; 16; 32 mV EGM1 and EGM2 ; EGM1 and EGM3;
EGM2 and EGM3 Off; On Continuous 0.5; 1; 2; 6 ; 12; 24 hr/24hr 0.5; 1; 2; 6 ; 12; 24 hr/24hr 90; 100 130; 140; 150 bpm 30; 40; 50; 60 160; 170; 180 38 Shipped Atip to Aring Reset Atip to Aring 8 mV RVtip to RVring 8 mV RVtip to RVring 8 mV Can to Aring
(LECG) 8 mV Can to Aring
(LECG) 8 mV EGM1 and EGM2 8 mV EGM1 and EGM2 On Continuous 6 hr 6 hr 100 bpm 60 Off 6 hr 6 hr 100 bpm 60 Table 37. Data collection parameters (continued) Programmable values Reset 3 paces Shipped 10 senses 10 senses 2; 3 ; 5; 10 5; 8; 10 ; 15; 20; 30; 40; 50; 100; 150; 200
(select Time Zone) Off On; Off Parameter V. Sensing Episodes Consecutive VS to detect >=
Consecutive VP to terminate >=
Device Date/Timeb Holter Telemetry Wireless Telemetry with Monitor a Decreasing the OptiVol Threshold will make the device more sensitive to changes in the patients thoracic fluid status. Increasing the OptiVol Threshold could delay or prevent device observation of significant changes in the patients thoracic fluid status. b The times and dates stored in episode records and other data are determined by the Device Date/Time clock. c The reset value may be set to Off if there is an issue with wireless communication that requires it to be disabled. 6.7 Medtronic CareAlert parameters Table 38. Clinical Management Alerts
; 0.5; 1; 2; 4; 8; 16; 24; 36; 46 hr Off Onc Off On 3 paces Programmable values Shipped Reset Parameter AT/AF Burden and Rate Settings AT/AF Alerts AT/AF Daily Burden Enable Daily AT/AF Burden Avg. V. Rate During AT/AF Ena-
ble Daily Burden for Avg. V. Rate Avg. V. Rate During AT/AF Monitored VT Episode Detec-
ted Total VP < 90%
OptiVol 2.0 Fluid Settings Observation Conditions OptiVol Thresholdb
; On Off 0.5; 1; 2; 6 ; 12; 24 hr/24hr Off
; On 0.5; 1; 2; 6 ; 12; 24 hr/24hr 90; 100 150 bpm Off
; On
; Ona Off Off 30; 40; 50; 60 100; 120 180 Off 6 hr Off 6 hr 100 bpm Off Off Off 60 Off 6 hr Off 6 hr 100 bpm Off Off Off 60 a Alert triggered if percent of cumulative ventricular pacing is less than 90% for 7 consecutive days. b Decreasing the OptiVol Threshold makes the device more sensitive to changes in the patients thoracic fluid status. Increasing the OptiVol Threshold could delay or prevent device observation of significant changes in the patients thoracic fluid status. 39 Programmable values On ; Off Shipped On Reset Off Table 39. Lead/Device Integrity Alerts Parameter Low Battery Voltage RRT Lead Impedance Out of Range Lead Impedance A. Pacing Enable A. Pacing Less than A. Pacing Greater than RV Pacing Enable RV Pacing Less than RV Pacing Greater than LV Pacing Enable LV Pacing Less than LV Pacing Greater than 2nd LV Pacing Enable 2nd LV Pacing Less than 2nd LV Pacing Greater than Capture Management High Threshold High Threshold A. Capture Enablea RV Capture Enableb LV Capture Enablec 2nd LV Capture Enabled Off Off Off Off
; On
; On
; On
; On On On ; Off 200 200 ; 300; 400; 500 3000 1000; 1500; 2000; 3000 On On ; Off 200 200 ; 300; 400; 500 3000 1000; 1500; 2000; 3000 On On ; Off 200 ; 300; 400; 500 200 800; 1000; 1500; 2000; 3000 3000 Off Off 200 ; 300; 400; 500 200 800; 1000; 1500; 2000; 3000 3000
; On Off 200 3000 Off 200 3000 Off 200 3000 Off 200 3000 Off Off Off Off Off Off Off Off a If programmed to On, alert notification is sent if A. capture management has measured high thresholds for 3 consecutive days. b If programmed to On, alert notification is sent if RV capture management has measured high thresholds for 3 consecutive days. c If programmed to On, alert notification is sent if LV capture management has measured a high threshold for one day. d If programmed to On, alert notification is sent if 2nd LV capture management has measured a high threshold for one day. 6.8 System test parameters Table 40. System test parameters Parameter Sensing test parameters Modea AV Delay Lower Rateb Selectable values AAI; DDD; VVI; ODO 30; 40 350 ms 30; 35 60; 70; 75 120 bpm 40 Table 40. System test parameters (continued) Parameter Pacing Threshold test parameters Test Type Chamber Decrement after Pace Polarity (Atrium, RV) Pace Polarity (LV) Modea (RV or LV test) Modea (Atrium test) Lower Rateb AV Delay RV Amplitude RV Pulse Width LV Amplitude LV Pulse Width A. Amplitude A. Pulse Width V. Pace Blanking A. Pace Blanking PVARP VectorExpress LV Automated test parameters Pulse Width Test Selectable values Amplitude; Pulse Width Atrium; RV; LV 2; 3 15 pulses Unipolar; Bipolar LV1 to LV2; LV1 to LV3; LV1 to LV4; LV1 to Can; LV2 to LV1;
LV2 to LV3; LV2 to LV4; LV2 to Can; LV3 to LV1; LV3 to LV2;
LV3 to LV4; LV3 to Can; LV4 to LV1; LV4 to LV2; LV4 to LV3;
LV4 to Can VVI; VOO; DDI; DDD; DOO AAI; AOO; DDI; DDD; DOO 30; 35 60; 70; 75 125 bpm 30; 40 350 ms 0.25; 0.5 5; 5.5; 6; 8 V 0.03; 0.06; 0.1; 0.2 1.5 ms 0.25; 0.5 5; 5.5; 6; 8 V 0.03; 0.06; 0.1; 0.2 1.5 ms 0.25; 0.5 5; 5.5; 6; 8 V 0.03; 0.06; 0.1; 0.2 1.5 ms 150; 160 320 ms 150; 160 250 ms 150; 160 500 ms 0.40; 0.50 1.50 ms LV1, 2, 3, 4 to Can; LV1 to LV2, LV3, LV4; LV2 to LV1, LV3, LV4; LV3 to LV1, LV2, LV4; LV4 to LV1, LV2, LV3 CardioSync Optimization test parameters 30; 35 60; 70; 75 90 bpm Sensing Lower Rate Pacing Lower Rate 35; 40 60; 70; 75 95 bpm a The selectable values for this parameter depend on the programmed pacing mode. b When performing the test in DDD mode, the Lower Rate must be less than the programmed Upper Tracking Rate. 41 6.9 EP study parameters Table 41. 50 Hz Burst induction parameters Parameter Resume at Burst Amplitude Pulse Width VOO Backup (for atrial 50 Hz Burst)c Pacing Rate V. Amplituded,e V. Pulse Widthd Selectable values Enabled ; Disabled 1; 2; 3; 4 ; 5; 6; 8 Va 0.10; 0.20 0.50 1.50 msb On; Off 60; 70 120 bpm 0.50; 0.75 5.00; 5.50; 6.00; 8.00 V 0.10; 0.20 1.50 ms a Amplitude accuracy: 2.5 V (+0.50 V/-33%), > 2.5 V to 6.0 V (+20%/-33%), 6.0 V (+20%/-55%) to ERI;
6.0 V (+20%/-65%) at ERI; > 2.5 V (+20%/-70%) at ERI for MPP mode only. b Pulse width accuracy: +3/-3 ms at 37C. c V. Backup Pacing is delivered to the RV chamber. d The default value for this parameter is set according to the permanently programmed settings for bradycardia pacing. e Crosstalk may occur when atrial pacing amplitude is greater than 6.0 V. Table 42. Fixed Burst induction parameters Parameter Resume at Burst Chambera Interval Amplitudeb Pulse Widthb VVI Backup (for atrial Fixed Burst)c Pacing Rate V. Amplituded,e V. Pulse Widthd Selectable values Enabled ; Disabled Atrium; RV; RV+LV; LV 100; 110 600 ms 1; 2; 3; 4 ; 5; 6; 8 V 0.10; 0.20 0.50 1.50 ms On; Off 60; 70 120 bpm 0.50; 0.75 5.00; 5.50; 6.00; 8.00 V 0.10; 0.20 1.50 ms a If the chamber selected is RV+LV, the delay is set to 2.5 ms with LV pace delivered first. b Applies to all ventricular chambers paced. c V. Backup Pacing is delivered to the RV chamber. d The default value for this parameter is set according to the permanently programmed settings for bradycardia pacing. e Crosstalk may occur when atrial pacing amplitude is greater than 6.0 V. Table 43. PES induction parameters Parameter Resume at Deliver Chambera
#S1 Selectable values Enabled ; Disabled Atrium; RV; RV+LV; LV 1; 2 8 15 42 Table 43. PES induction parameters (continued) Parameter S1S1 S1S2 S2S3 S3S4 Amplitudeb Pulse Widthb VVI Backup (for atrial PES)c Pacing Rate V. Amplituded,e V. Pulse Widthd
; 100; 110 600 ms
; 100; 110 600 ms Selectable values 100; 110 600 2000 ms Off; 100; 110 400 600 ms Off Off 1; 2; 3; 4 ; 5; 6; 8 V 0.10; 0.20 0.50 1.50 ms On; Off 60; 70 120 bpm 0.50; 0.75 5.00; 5.50; 6.00; 8.00 V 0.10; 0.20 1.50 ms a If the chamber selected is RV+LV, the delay is set to 2.5 ms with LV pace delivered first. b Applies to all ventricular chambers paced. c V. Backup Pacing is delivered to the RV chamber. d The default value for this parameter is set according to the permanently programmed settings for bradycardia pacing. e Crosstalk may occur when atrial pacing amplitude is greater than 6.0 V. Table 44. Shared manual ATP therapy parameters Parameter Minimum Interval (atrial ATP) Minimum Interval (ventricular ATP) Amplitudea Pulse Widtha VVI Backup (for atrial ATP therapy)b Pacing Rate V. Amplitudec,d V. Pulse Widthc Selectable values 100; 110; 120; 130 400 ms 150; 160 200 400 ms 1; 2 6 ; 8 V 0.10; 0.20 1.50 ms On; Off 60; 70 120 bpm 0.50; 0.75 5.00; 5.50; 6.00; 8.00 V 0.10; 0.20 1.50 ms a Applies to all ventricular chambers paced. b V. Backup Pacing is delivered to the RV chamber. c The default value for this parameter is set according to the permanently programmed settings for bradycardia pacing. d Crosstalk may occur when atrial pacing amplitude is greater than 6.0 V. Table 45. Manual Ramp therapy parameters Parameter Chambera Ventricular Ramp therapy parameters
#Pulses
%RR Interval Selectable values Atrium; RV; RV+LV; LV 1; 2 6 15 50; 53; 56; 59; 63; 66 84; 88; 91; 94; 97 %
43 Table 45. Manual Ramp therapy parameters (continued) Parameter Dec/Pulse Atrial Ramp therapy parameters
#Pulses
%AA Interval Dec/Pulse Selectable values 0; 10 ; 20; 30; 40 ms 1; 2 6 15; 20; 30 100 28; 31; 34; 38; 41 59; 63; 66 84; 88; 91; 94; 97 %
0; 10 ; 20; 30; 40 ms a If the chamber selected is RV+LV, the delay is set to 2.5 ms with LV pace delivered first. Table 46. Manual Burst therapy parameters Parameter Chambera
#Pulses
%RR Interval a If the chamber selected is RV+LV, the delay is set to 2.5 ms with LV pace delivered first. Table 47. Manual Ramp+ therapy parameters Selectable values RV ; RV+LV; LV 1; 2 8 15 50; 53; 56; 59; 63; 66 84; 88 ; 91; 94; 97%
Parameter Chambera
#Pulses R-S1(%RR) S1S2(%RR) S2SN(%RR) a If the chamber selected is RV+LV, the delay is set to 2.5 ms with LV pace delivered first. Table 48. Manual Burst+ therapy parameters Selectable values RV ; RV+LV; LV 1; 2; 3 15 50; 53; 56; 59; 63; 66 75 84; 88; 91; 94; 97%
50; 53; 56; 59; 63; 66; 69 84; 88; 91; 94; 97%
50; 53; 56; 59; 63; 66 84; 88; 91; 94; 97%
Parameter
#S1 Pulses
%AA Interval S1S2 S2S3 Dec Selectable values 1; 2 6 15; 20; 30 100 28; 31; 34; 38; 41 59; 63; 66 84; 88; 91 ; 94; 97%
Off; 28; 31; 34; 38; 41 59; 63; 66 84 ; 88; 91; 94;
97%
Off; 0; 10; 20 80 ms 44 6.10 Nonprogrammable parameters Table 49. Nonprogrammable parameters Parameter Premature event threshold for counting PVCs and Runs of PVCs Fixed blanking periods Atrial blanking after a paced ventricular eventa (bipolar atrial sensing) Atrial blanking after a paced ventricular event (unipolar atrial sensing) Ventricular blanking after a paced atrial event (bipolar ventricular sensing) Ventricular blanking after a paced atrial event (unipolar ventricular sens-
ing) Fixed bradycardia pacing parameters Ventricular Safety Pacing intervalsc PVARP value applied by PVC Response and PMT Interventiond NCAP value applied by PVC Response and PMT Interventione Fixed automatic atrial ATP therapy parameters VVI Backup Pacing amplitude VVI Backup Pacing pulse width Fixed EP study parameters 50 Hz burst pacing interval Hardware parameters Pacing rate limitf (protective feature) Input impedance Effective pacing capacitance Recommended Replacement Time (RRT) Battery Voltage Threshold Value 69%
30 ms 40 ms 30 msb 40 ms 110 ms 400 ms 400 ms 6 V 1.5 ms 20 ms 200 bpmg 150 k minimum 4 F 180 days after 3 consecutive daily automatic measurements of 2.63 V or immediately after 3 consecutive daily automatic measurements of 2.60 V, which-
ever comes first a The time between biventricular pacing pulses may affect the duration of the atrial blanking period. b 35 ms when the ventricular pacing amplitude is programmed to 8 V. c The VSP interval may be shortened from 110 ms to 70 ms automatically by the device at higher pacing rates when necessary to help support ventricular tachycardia detection. d PVARP is extended to 400 ms only if the current PVARP is less than 400 ms. e The NCAP extension applies only if NCAP is enabled. f Does not apply during ATP therapies or ventricular safety pacing. g If the Upper Tracking Rate is programmed to a value greater than 180 bpm, the pacing rate limit is 230 bpm. 45 Table 50. Nonprogrammable parameters for the MRI SureScan mode Parameter Pacing amplitude Pulse width Sensitivity Input impedance AV interval Pacing rate limit Effective pacing capacitance Refractory period Blanking period ODO mode DOO, VOO, and AOO modes Value Programmed pacing amplitude value when >5 V;
5 V when programmed pacing amplitude value is 5 V Programmed pulse width value when >1 ms;
1 ms when programmed pulse width value is 1 ms Programmed value 150 k Programmed PAV value when PAV is 50 ms and 100 ms;
50 ms when PAV is <50 ms;
110 ms when PAV is >110 ms 200 bpm 4 F Programmed blanking period value 46 Medtronic, Inc. 710 Medtronic Parkway Minneapolis, MN 55432 USA www.medtronic.com
+1 763 514 4000 Medtronic USA, Inc. Toll-free in the USA (24-hour technical consultation for physicians and medical professionals) Bradycardia: +1 800 505 4636 Tachycardia: +1 800 723 4636 Europe/Middle East/Africa Medtronic International Trading Srl Route du Molliau 31 Case Postale 84 CH-1131 Tolochenaz Switzerland
+41 21 802 7000 Technical manuals www.medtronic.com/manuals 2016 Medtronic M968099A001 A 2016-11-11
*M968099A001*
frequency | equipment class | purpose | ||
---|---|---|---|---|
1 | 2017-05-08 | 2402 ~ 2480 | DTS - Digital Transmission System | Original Equipment |
app s | Applicant Information | |||||
---|---|---|---|---|---|---|
1 | Effective |
2017-05-08
|
||||
1 | Applicant's complete, legal business name |
Medtronic, Inc.
|
||||
1 | FCC Registration Number (FRN) |
0008250839
|
||||
1 | Physical Address |
8200 Coral Sea Street NE
|
||||
1 |
Mounds View, MN
|
|||||
1 |
United States
|
|||||
app s | TCB Information | |||||
1 | TCB Application Email Address |
r******@element.com
|
||||
1 | TCB Scope |
A4: UNII devices & low power transmitters using spread spectrum techniques
|
||||
app s | FCC ID | |||||
1 | Grantee Code |
LF5
|
||||
1 | Equipment Product Code |
BLEIMPLANT2
|
||||
app s | Person at the applicant's address to receive grant or for contact | |||||
1 | Name |
G******** G******
|
||||
1 | Title |
Sr. RF Regulatory Program Manager
|
||||
1 | Telephone Number |
763-5********
|
||||
1 | Fax Number |
651-3********
|
||||
1 |
G******@medtronic.com
|
|||||
app s | Technical Contact | |||||
n/a | ||||||
app s | Non Technical Contact | |||||
n/a | ||||||
app s | Confidentiality (long or short term) | |||||
1 | Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
1 | Long-Term Confidentiality Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
1 | If so, specify the short-term confidentiality release date (MM/DD/YYYY format) | 06/12/2017 | ||||
if no date is supplied, the release date will be set to 45 calendar days past the date of grant. | ||||||
app s | Cognitive Radio & Software Defined Radio, Class, etc | |||||
1 | Is this application for software defined/cognitive radio authorization? | No | ||||
1 | Equipment Class | DTS - Digital Transmission System | ||||
1 | Description of product as it is marketed: (NOTE: This text will appear below the equipment class on the grant) | Percepta CRT-P MRI SureScan, Percepta Quad CRT-P MRI SureScan, Serena CRT-P MRI SureScan, Serena Quad CRT-P MRI SureScan, Solara CRT-P MRI SureScan, Solara Quad CRT-P MRI SureScan | ||||
1 | Related OET KnowledgeDataBase Inquiry: Is there a KDB inquiry associated with this application? | Yes | ||||
1 | Modular Equipment Type | Does not apply | ||||
1 | Purpose / Application is for | Original Equipment | ||||
1 | Composite Equipment: Is the equipment in this application a composite device subject to an additional equipment authorization? | No | ||||
1 | Related Equipment: Is the equipment in this application part of a system that operates with, or is marketed with, another device that requires an equipment authorization? | No | ||||
1 | Grant Comments | Power listed is conducted. Approval is limited to the specific device configurations evaluated for SAR compliance in this filing. The highest reported SAR value for this implantable device in the body is 0.20 W/kg | ||||
1 | Is there an equipment authorization waiver associated with this application? | No | ||||
1 | If there is an equipment authorization waiver associated with this application, has the associated waiver been approved and all information uploaded? | No | ||||
app s | Test Firm Name and Contact Information | |||||
1 | Firm Name |
Element Materials Technology Minneapolis
|
||||
1 | Name |
R**** W******
|
||||
1 | Telephone Number |
503-8********
|
||||
1 | Fax Number |
503-8********
|
||||
1 |
r******@element.com
|
|||||
Equipment Specifications | |||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
1 | 1 | 15C | 2402.00000000 | 2480.00000000 | 0.0006000 |
some individual PII (Personally Identifiable Information) available on the public forms may be redacted, original source may include additional details
This product uses the FCC Data API but is not endorsed or certified by the FCC