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Medtronic PROTECTA XT DR D314DRG, Clinician Manual

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Index

Numerics

2:1 block rate . . . . . . . . . . . . . . . . . . . . . . . . 220

programmer calculation . . . . . . . . . . . . 252, 255

50 Hz Burst induction

delivering an atrial induction . . . . . . . . . . . . . 441
delivering a ventricular induction . . . . . . . . . . 439
DFT testing . . . . . . . . . . . . . . . . . . . . . . . 119
parameters . . . . . . . . . . . . . . . . . . . . . . . 476

50 Hz Burst pacing therapy . . . . . . . . . . . . . . . . 402

A

AAIR<=>DDDR and AAI<=>DDD modes . . . . . . . . 224
ablation

microwave . . . . . . . . . . . . . . . . . . . . . . . . 29
RF . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

[ABORT] button . . . . . . . . . . . . . . . . . . . . 436, 444
Absolute PVAB . . . . . . . . . . . . . . . . . . . . . . . 205
accelerometer . . . . . . . . . . . . . . . . . . . . . . . . 231
ACM (Atrial Capture Management) . . . . . . . . . . . 240
Active Can/SVC Coil . . . . . . . . . . . . . . 358, 382, 409
activity sensor . . . . . . . . . . . . . . . . . . . . . . . . 231
Activity Threshold . . . . . . . . . . . . . . . . . . . . . . 231
Adaptive parameters . . . . . . . . . . . . . . . . . . . . . 70

Capture Management . . . . . . . . . . . . . . . . 248
Rate Profile Optimization . . . . . . . . . . . . . . 235

[Adjust…] button . . . . . . . . . . . . . . . . . . . . . . . 60
ADL Rate . . . . . . . . . . . . . . . . . . . . . . . . . . . 232
ADL Setpoint . . . . . . . . . . . . . . . . . . . . . . . . . 232
AF/AFl feature . . . . . . . . . . . . . . . . . . . . . . . . 322
AF detection

see AT/AF detection

alert events

evaluation . . . . . . . . . . . . . . . . . . . . . . . 140

alerts

clinician-defined . . . . . . . . . . . . . . . . . . . . 133
non-programmable . . . . . . . . . . . . . . . . . . 135
programmable . . . . . . . . . . . . . . . . . . . . . 133
programming . . . . . . . . . . . . . . . . . . . . . 140
programming alert time . . . . . . . . . . . . . . . 138
selecting alert time . . . . . . . . . . . . . . . . . . 138
system-defined . . . . . . . . . . . . . . . . . . . . 135

see also Medtronic CareAlert events

alert tones

demonstrating . . . . . . . . . . . . . . . . . . . . . 139
instructing the patient . . . . . . . . . . . . . . . . . 138

amplitude

pacing . . . . . . . . . . . . . . . . . . . . . . . . . . 213
Pacing Threshold Test . . . . . . . . . . . . . . . . 425
sensing measurements, automatic . . . . . . . . . 189
sensing measurements, manual . . . . . . . . . . 432
sensing trends . . . . . . . . . . . . . . . . . . . . . 190

Analyzer (Model 2290) . . . . . . . . . . . . . . . . . . . . 21

concurrent session . . . . . . . . . . . . . . . . . . . 83
exporting lead measurements . . . . . . . . . . . . 83
lead measurements . . . . . . . . . . . . . . . . . . 113

annotations

Decision Channel . . . . . . . . . . . . . . . . . . . . 90
Marker Channel . . . . . . . . . . . . . . . . . . . 59, 87
parameter programming . . . . . . . . . . . . . . . . 59

antitachycardia pacing

atrial ATP therapies . . . . . . . . . . . . . . . . . . 396
ventricular ATP therapies . . . . . . . . . . . . . . 368

APP (Atrial Preference Pacing) . . . . . . . . . . . . . . 280
Arrhythmia Episode data

episode QRS . . . . . . . . . . . . . . . . . . . . . 173

Arrhythmia Episodes data . . . . . . . . . . . . . . . . . 166

data collection preferences . . . . . . . . . . . . . 173
episode EGM . . . . . . . . . . . . . . . . . . . . . 171
episode interval plot . . . . . . . . . . . . . . . . . 170
episode log . . . . . . . . . . . . . . . . . . . . . . . 166
episode records . . . . . . . . . . . . . . . . . . . . 168
episode text . . . . . . . . . . . . . . . . . . . . . . 172
evaluating AT/AF detection . . . . . . . . . . . . . 300
evaluating atrial therapy scheduling . . . . . . . . 395
evaluating High Rate Timeout . . . . . . . . . . . 344
evaluating Mode Switch . . . . . . . . . . . . . . . 275
evaluating Post VT/VF Shock Pacing . . . . . . . 290
evaluating PR Logic . . . . . . . . . . . . . . . . . 324
evaluating Progressive Episode Therapies . . . . 419
evaluating the Onset feature . . . . . . . . . . . . 338
evaluating the Stability feature . . . . . . . . . . . 342
evaluating VT/VF detection . . . . . . . . . . . . . 317
evaluating Wavelet . . . . . . . . . . . . . . . . . . 331
storage capacity . . . . . . . . . . . . . . . . . . . . 451
viewing . . . . . . . . . . . . . . . . . . . . . . . . . 166

ARS (Atrial Rate Stabilization) . . . . . . . . . . . . . . 278
AT/AF detection . . . . . . . . . . . . . . . . . . . . . . . 295

and Mode Switch . . . . . . . . . . . . . . . . 273, 296
and VT/VF detection . . . . . . . . . . . . . . . . . 296
AT/AF onset . . . . . . . . . . . . . . . . . . . . . . 296
confirmation . . . . . . . . . . . . . . . . . . . . . . 296

Medtronic

PROTECTA™ XT DR D314DRG

488

Clinician Manual

Summary of Contents for PROTECTA XT DR D314DRG

Page 1: ...oise Discrimination RV Lead Integrity Alert TWave Discrimination Confirmation Wavelet PR Logic OptiVol 2 0 Fluid Status Monitoring Complete Capture Management Diagnostic ACM RVCM ATP During Charging Feature and MVP Mode Clinician Manual Caution Federal law USA restricts this device to sale by or on the order of a physician ...

Page 2: ......

Page 3: ...A guide to the operation and programming of the Model D314DRG Protecta XT DR digital dual chamber implantable cardioverter defibrillator DDE DDDR PROTECTA XT DR D314DRG Clinician Manual ...

Page 4: ...agement Cardiac Compass CardioSight CareAlert CareLink ChargeSaver Checklist Conexus EnPulse EnRhythm EnTrust Flashback GEM GEM DR GEM III InCheck InSync InSync III Marquis InSync Marquis Intrinsic Jewel Kappa MVP Marker Channel Marquis Medtronic Medtronic AT500 Medtronic CareAlert Medtronic CareLink OptiVol PR Logic Paceart Protecta Quick Look Reactive ATP SessionSync SmartShock Sprint Fidelis Su...

Page 5: ...EMI for cardiac device patients 34 2 8 Potential adverse events 38 3 Clinical data 41 3 1 Adverse events and clinical trial data 41 4 Using the programmer 45 4 1 Establishing telemetry between the device and the programmer 45 4 2 Conducting a patient session 52 4 3 Display screen features 57 4 4 Delivering an emergency tachyarrhythmia therapy 62 4 5 Enabling emergency VVI pacing 63 4 6 Streamlinin...

Page 6: ... alerts and notification of clinical management and system performance events 133 6 4 Monitoring leads using RV Lead Integrity Alert 141 6 5 Viewing long term clinical trends with the Cardiac Compass Report 148 6 6 Viewing heart failure management information 154 6 7 Monitoring for thoracic fluid accumulation with OptiVol 161 6 8 Viewing Arrhythmia Episodes data and setting data collection prefere...

Page 7: ...7 7 18 Smoothing the ventricular rate during conducted AF 287 7 19 Providing overdrive pacing after a VT VF high voltage therapy 289 7 20 Responding to PVCs using Ventricular Rate Stabilization 291 8 Configuring tachyarrhythmia detection 295 8 1 Detecting atrial tachyarrhythmias 295 8 2 Detecting ventricular tachyarrhythmias 304 8 3 Discriminating VT VF from SVT using PR Logic 321 8 4 Discriminati...

Page 8: ...Inducing an arrhythmia 436 10 8 Delivering a manual therapy 444 A Quick reference 447 A 1 Physical characteristics 447 A 2 Replacement indicators 448 A 3 Projected service life 448 A 4 Energy levels and typical charge times 450 A 5 Magnet application 451 A 6 Stored data and diagnostics 451 B Device parameters 459 B 1 Emergency settings 459 B 2 Tachyarrhythmia detection parameters 459 B 3 Atrial ta...

Page 9: ...Index 488 Medtronic PROTECTA XT DR D314DRG Clinician Manual 9 ...

Page 10: ...ck whichdescribesthepaththroughtheapplicationsoftwaretospecificscreensorparameters The following conventions are used in programming blocks The symbol precedes the screen text you can select to navigate to a new screen The symbol precedes the name of a parameter you can program for a feature When a navigation step refers to a field on the screen that is labeled with both a row title and a column t...

Page 11: ...s located throughout the world to serve you and upon request to provide training to qualified hospital personnel in the use of Medtronic products In addition Medtronic maintains a professional staff of consultants to provide technical consultation to product users For more information contact your local Medtronic representative or call or write Medtronic at the appropriate address or telephone num...

Page 12: ...means that telecommunications and radio communications regulations in your country may apply to this prod uct Please go to www medtronic com radio for specific compliance infor mation related to telecommunications and radio standards for this product in your country MR Conditional The SureScan pacing system is safe for use in the MRI environment when used according to the instructions in the SureS...

Page 13: ...C REP Authorized representative in the European community Use by Lot number Reorder number Serial number Temperature limitation Adaptive Package contents Implantable device IPG device Coated IPG device ICD device Coated ICD device Medtronic PROTECTA XT DR D314DRG Clinician Manual 13 ...

Page 14: ...oated CRT device Dual chamber IPG with cardiac resynchronization therapy CRT P Product documentation Torque wrench Accessories Amplitude pulse width Atrial amplitude pulse width RV amplitude pulse width LV amplitude pulse width Upper tracking rate lower rate Rate Lower rate Medtronic PROTECTA XT DR D314DRG 14 Clinician Manual ...

Page 15: ...nterval paced sensed Refractory period Atrial refractory period Ventricular refractory period PVARP Post Ventricular Atrial Refractory Period Polarity Pacing polarity single chamber Pacing polarity dual chamber LV Pace polarity Atrial Pace polarity RV Pace polarity Medtronic PROTECTA XT DR D314DRG Clinician Manual 15 ...

Page 16: ...ngle chamber Sensing polarity dual chamber Atrial sensitivity Ventricular sensitivity VF therapies delivered stored VT therapies V pacing V V pace delay VT monitor AT AF detection VT VF detection VT FVT VF detection AT AF therapies VT VF therapies Medtronic PROTECTA XT DR D314DRG 16 Clinician Manual ...

Page 17: ...n package labeling continued Symbol Explanation VT FVT therapies CRT AT AF intervention Burst Burst CRT Burst 50 Hz Burst A ramp Ramp CRT Ramp Ramp CRT V ramp AV ramp Defibrillation Medtronic PROTECTA XT DR D314DRG Clinician Manual 17 ...

Page 18: ...ftware application is provided as an informational tool for the end user The user is responsible for accurate input of patient information into the software Medtronic makes no representation as to the accuracy or completeness of the patient information that end users enter into the Patient Information screen Medtronic SHALL NOT BE LIABLE FOR ANY DIRECT INDIRECT INCIDENTAL OR CONSEQUENTIAL DAMAGES ...

Page 19: ...T AF and provides treatment with cardioversion and antitachycardia pacing therapies The device responds to bradyarrhythmias by providing bradycardia pacing therapy The device also provides diagnostic and monitoring information that assists with system evaluation and patient care Leads The lead system used with this device must provide sensing pacing and cardioversion defibrillation therapies to th...

Page 20: ...f a programming or monitoring session The system uses radio frequency RF telemetry for wireless communication between the implanted device and programmer in the hospital or clinic Conexus telemetry operates within the Medical Implant Communications Service MICS Band which is the only band designated for implantable medical devices Using the MICS Band prevents interference with home electronics suc...

Page 21: ...e monitor communicates wirelessly with the patient s device and transmits the information over a home telephone line at times scheduled by the clinic Typically these transmissions are scheduled while the patient is asleep The monitor can also send Medtronic CareAlert Notifications to the clinic outside of the scheduled transmission times if the device has been programmed to do so The patient does ...

Page 22: ...rapy in terminating device classified atrial tachycardia AT was found to be 17 and in terminating device classified atrial fibrillation AF was found to be 16 8 in the VT AT patient population studied The effectiveness of high frequency burst pacing atrial 50 Hz Burst therapy in terminating device classified atrial tachycardia AT was found to be 11 7 and in terminating device classified atrial fibr...

Page 23: ...r post implant testing Lead compatibility Do not use another manufacturer s 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 Occurrence of stroke Following an ischemic or cerebrovascular acciden...

Page 24: ...ized 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 has been dropped on a hard surfa...

Page 25: ... therapy Before taking electrical or defibrillation efficacy measurements move objects made from conductive materials such as guide wires away from all electrodes Metal objects such as guide wires can short circuit a device and lead causing electrical current to bypass the heart and possibly damage the device and lead Patch leads Do not fold alter or remove any portion of a patch lead Doing so may...

Page 26: ... 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 Electrical 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 ...

Page 27: ...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 controls 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 ...

Page 28: ...ing The patient is without pacing support when pacing is inhibited 2 6 Warnings precautions and guidance for clinicians performing medical procedures on cardiac device patients This section is intended for physicians and other health care professionals who perform medical procedures on patients with Medtronic implanted cardiac device systems and who consult with the patients cardiologists This sec...

Page 29: ...te for the patient initiate asynchronous pacing by implementing one of the following precautions Suspend tachyarrhythmia detection by using a magnet or a programmer If a programmer is used and ablation causes a device reset the cardiac device resumes detection After the ablation procedure remove the magnet or restore device parameters If appropriate for the patient program the device to an asynchr...

Page 30: ...ging technique that is used to visualize muscles and internal organs their size structures and motion as well as any pathological lesions It also is used for fetal monitoring and to detect and measure blood flow Diagnostic ultrasound such as echocardiogram poses no risk of electromagnetic interference For precautions about therapeutic ultrasound see Diathermy treatment including therapeutic ultras...

Page 31: ...ds Do not apply unipolar electrosurgery within 15 cm 6 in of the device and leads Use short intermittent and irregular bursts at the lowest clinically appropriate energy levels Always monitor the patient during electrosurgery If the ECG tracing is not clear due to interference manually monitor the patient s rhythm take pulse alternatively monitor by some other means such as ear or finger pulse oxi...

Page 32: ...e To avoid or mitigate the effects of oversensing consider the following precautions Suspend tachyarrhythmia detection by using a magnet or a programmer After completing lithotripsy treatment remove the magnet or restore device parameters If appropriate for the patient program the device to an asynchronous pacing mode for example DOO After completing lithotripsy treatment restore device parameters...

Page 33: ...errogating the device immediately after radiotherapy treatment An electrical reset requires reprogramming of device parameters Electron beam treatments that do not produce neutrons do not cause electrical reset of the device Stereotaxis Stereotaxis is a catheter navigation platform that allows clinicians to steer catheter based diagnostic and therapeutic devices throughout the body by using magnet...

Page 34: ...ons to tshelp Medtronic com or your Medtronic representative Customers outside of the United States can contact a Medtronic representative General EMI guidelines for patients Patients should observe the following general guidelines regarding EMI Area restrictions Before entering an area where signs are posted prohibiting persons with an implanted cardiac device such as a pacemaker or ICD consult w...

Page 35: ...d held hair dryers corded electric shavers electric or ultrasonic toothbrushes base charger or back massagers Items that contain magnets such as bingo wands mechanic s extractor wands magnetic bracelets magnetic clasps magnetic chair pads or stereo speakers Remote controller of radio controlled toys Two way walkie talkies less than 3 W The following household and hobby items require special precau...

Page 36: ... interference Electric yard and hand held power tools plug in and cordless Keep a cardiac device at least 15 cm 6 in away from such tools Soldering guns and demagnetizers Keep a cardiac device at least 30 cm 12 in away from these tools Gasoline powered tools and gasoline powered yard equipment Keep a cardiac device at least 30 cm 12 in away from components of the ignition system Turn off the motor...

Page 37: ...50 W Keep a cardiac device at least 2 75 m 9 ft away from the antenna For transmission power levels higher than 250 W contact a Medtronic representative for more information Security systems When passing through security systems follow these precautions Electronic antitheft systems such as in a store or library and point of entry control systems such as gates or readers that include radio frequenc...

Page 38: ...security operator request alternative screening and then follow the security operator s instructions 2 8 Potential adverse events The 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 air embolism bleeding body rejection phenomena including local tissue react...

Page 39: ...othorax poorconnectionoftheleadtothedevice whichmayleadtooversensing undersensing or a loss of therapy threshold elevation thrombotic embolism thrombosis tissue necrosis valve damage particularly in fragile hearts venous occlusion venous perforation Additional potential adverse events associated with the use of ICD systems include but are not limited to the following events inappropriate shocks po...

Page 40: ...al intolerance to an ICD system that might include the following conditions dependency depression fear of premature battery depletion fear of shocking while conscious fear that shocking capability may be lost imagined shocking phantom shock Medtronic PROTECTA XT DR D314DRG 40 Clinician Manual ...

Page 41: ...ponse feature in Protecta XT DR Model D314DRG devices Note that the Ventricular Response Pacing VRP feature mentioned in the study is called Conducted AF Response in the Protecta XT DR Model D314DRG 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 interve...

Page 42: ... DR Model D314DRG devices InSync III Marquis clinical study This clinical study which evaluated the Conducted AF Response feature in the InSync III Marquis devices provides support for Conducted AF Response in Protecta XT DR Model D314DRG devices Jewel AF clinical study for AF patients only This clinical study evaluated the atrial tachyarrhythmia therapies and dual chamber tachyarrhythmia detectio...

Page 43: ... addition of multiple therapy discriminators in the Protecta products do not affect the overall detection performance of the Protecta XT DR Model D314DRG 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 Bachmann s B...

Page 44: ...tching Morphology TEMM algorithm provides support for the Wavelet detection feature in Protecta XT DR Model D314DRG devices TWave Discrimination VF detection performance This retrospective evaluation was conducted using induced rhythms and provides support that the TWave Discrimination algorithm does not impact time to detection in Protecta XT DR Model D314DRG devices Medtronic PROTECTA XT DR D314...

Page 45: ...Model 2090 Programmer with Conexus telemetry is designed to provide clinicians and patients with an easier and more efficient implant and follow up experience This system uses radio frequency RF telemetry for wireless communication between the implanted device and the programmer in the hospital or clinic Conexus telemetry operates within the Medical Implant Communications Service MICS band which i...

Page 46: ...ng Conexus telemetry at implant During programming and follow up sessions the system allows wireless communication between the device and programmer See Figure 3 Medtronic PROTECTA XT DR D314DRG 46 Clinician Manual ...

Page 47: ...ry for a patient session you need to activate wireless telemetry in both the programmer and the device To activate wireless telemetry in the programmer turn the programmer power on The programmer starts and the Find Patient window is displayed Select the Allow wireless communication check box on the Find Patient window The programmer searches for compatible activated devices within telemetry range...

Page 48: ...tive but the order in which the remaining patients appear in the Patient Name list does not change The Find Patient window lists patients for whom a session has not started or has ended 4 1 1 4 How to verify reliable telemetry between the device and the programmer Successful interrogation or programming of the device verifies that reliable telemetry between the device and the programmer has occurr...

Page 49: ...r so that the space between the programmer screen and the patient is relatively free of obstruction The optimal position for the programmer is between the patient and you so that you are facing the screen and the patient is beyond the screen facing both you and the programmer Shorten the distance between the programmer and the patient Signal strength may be stronger with the device placed in the p...

Page 50: ... are limited in Standby mode When the system is in Standby mode it is possible to start a session with the device either using the current programmer or another If another programmer is used to open a session with the device end the session withthecurrentprogrammerfirstasthedevicecanbeinasessionwithonlyoneprogrammer at a time Before you attempt to program interrogate or conduct testing or emergenc...

Page 51: ...u also need to use a Medtronic Model 2067 or 2067L Programming Head while in this mode After you start a patient session using nonwireless telemetry you must end the session before you can change to wireless telemetry mode 4 1 2 1 How to establish nonwireless telemetry If you are using the Medtronic CareLink Model 2090 Programmer with Conexus telemetry but choose to use it in the nonwireless mode ...

Page 52: ... patient session Because the programmer collects and stores data on a session by session basis you need to start a new session for each patient You must end the previous session before starting a session with another patient 4 2 1 Starting a patient session Caution Aprogrammerfailure forexample afaulty touch pen couldresultininappropriate programming or the inability to terminate an action or an a...

Page 53: ...ended 4 Select the appropriate patient from the Patient Name list on the Find Patient window Note The programmer lists all patients with wireless activated implantable devices within telemetry range 5 Select Start 4 2 1 2 How to start a patient session using nonwireless telemetry 1 Select Find Patient from the Select Model window 2 If you are using a Medtronic CareLink Model 2090 Programmer with C...

Page 54: ...and the programmer This could result in a temporary loss of telemetry indicator lights as shown on the programmer task bar a temporary loss in Marker transmissions and temporarily affect the ability to send programming commands Ensure that the greatest number of telemetry strength indicator lights are illuminated on the programmer task bar to help improve telemetry reliability prior to any manual ...

Page 55: ... At the start of the patient session the programmer interrogates the device You can manually interrogate the device at any time during the patient session by performing the following steps 1 Select Interrogate from the Command bar In a nonwireless session you may also interrogate the device by pressing the I button on the programming head 2 To gather information collected since the last patient se...

Page 56: ...ct Session Changes This Session a Review the programming changes made during the patient session b To print a record of the changes select Print 2 Select End Session 3 To save the session data to a disk select Save To Disk 4 To end the session and return to the Select Model screen select End Now Medtronic PROTECTA XT DR D314DRG 56 Clinician Manual ...

Page 57: ...typical display screen during a patient session are shown in Figure 6 Figure 6 Main elements of a display screen 1 Task bar 2 Status bar 3 Live Rhythm Monitor window 4 Task area 5 Command bar 6 Tool palette 4 3 1 Task bar The display screen features a task bar at the very top of the screen You can use the task bar to note the status of programmer specific features such as the Analyzer Medtronic PR...

Page 58: ...s an icon that indicates the status of the SessionSync feature For complete information on viewing the status of the SessionSync feature from the programmer task bar see Section 4 14 4 3 2 Status bar When the device has been interrogated you can use the status bar at the top of the display screen located immediately below the task bar to perform some basic functions and to note the current status ...

Page 59: ...rner of the window or by selecting Adjust For more information about the Live Rhythm Monitor see Section 4 11 Working with the Live Rhythm Monitor page 84 Figure 9 Live Rhythm Monitor window 1 The location of the square button 2 The location of the Adjust button 4 3 4 Task area The portion of the screen between the Live Rhythm Monitor window near the top of the screen and the command bar at the bo...

Page 60: ...e icon with the touch pen Each option in the tool palette is described in Table 2 Table 2 Tool palette options The Freeze button captures a segment of the Live Rhythm Monitor dis play The Strips button accesses the waveform strips saved since the start of the session The Adjust button opens a window of options for adjusting the Live Rhythm Monitor display The Checklist icon opens the Checklist scr...

Page 61: ...creen buttons Buttons with a less distinctly shaded label are inactive and do not respond if you select them Selecting a button with the touch pen causes one of the following responses Buttons such as the PROGRAM button execute a command directly Buttons such as the Save and Get buttons open a window that prompts another action The labels on these buttons end with an ellipsis A procedure may instr...

Page 62: ...ck but it must be synchronized to a ventricular event Emergency fixed burst pacing therapy delivers maximum output pacing pulses to the ventricle at the selected interval 4 4 1 Considerations for emergency tachyarrhythmia therapies Tachyarrhythmia detection during emergency tachyarrhythmia therapies The device suspends the tachyarrhythmia detection features when emergency defibrillation cardiovers...

Page 63: ... pen over the button for as long as you want to deliver the therapy 4 5 Enabling emergency VVI pacing YoucanuseemergencyVVIpacingtoquicklyenable70bpm high outputventricularpacing to restore ventricular support in an emergency situation 4 5 1 Considerations for emergency VVI pacing Parameter values Emergency VVI pacing reprograms pacing parameters to emergency settings See Section B 1 Emergency set...

Page 64: ...rammer Emergency VVI pacing is enabled and the programmer displays the Emergency screen VVI Note You can also enable emergency VVI pacing by selecting the on screen Emergency button To do so perform the following steps 1 Establish telemetry with the device 2 Select Emergency 3 Select VVI Pacing 4 Select PROGRAM Medtronic PROTECTA XT DR D314DRG 64 Clinician Manual ...

Page 65: ...t task in the checklist or return to the checklist Two standard checklists are provided the Medtronic Standard Implant checklist and the Medtronic Standard Followup checklist In addition to these standard checklists you can create customized checklists 4 6 1 How to select a checklist 1 Select the Checklist icon and review the tasks in the Task list for that checklist 1 2 To choose a different stan...

Page 66: ...t either Go To Task or 2 The Checklist screen displays check marks next to the names of any programmer screens that were visited during a session These check marks provide a general indication of the tasks that were performed during a session 2 You can select a task whether it is marked with a check mark or not If you perform the last task in a checklist the and the Go To Task buttons are inactive...

Page 67: ...s can be added more than once to a custom checklist To place a new task in a position other than at the end of the checklist highlight the task that the new task should follow and select the new task The new task appears below the highlighted task in the Tasks in this checklist box 5 To delete a task select the task in the Tasks in this checklist box and select Delete Task 6 Select the Checklist n...

Page 68: ...ded more than once to a custom checklist 5 Each selected task appears at the end of the edited checklist To place a new task in a position other than at the end of the edited checklist highlight the task that the new task should follow and select the new task The new task appears below the highlighted task in the edited checklist 6 To delete a task select the task in the Tasks in this checklist bo...

Page 69: ... window appears asking you to confirm that you want to delete the selected checklist 4 Select Delete to delete the selected checklist or Cancel to cancel the delete procedure Note After a custom checklist is deleted it cannot be restored Note The Medtronic Standard Followup and Medtronic Standard Implant checklists cannot be edited or deleted so Edit and Delete are unavailable when these checklist...

Page 70: ...s A field containing a pending value has a dashed rectangle as its border Values remain pending until they are programmed to device memory 4 7 1 Understanding the symbols used on the Parameters screen Certain combinations of parameter values are restricted because they are invalid or result in undesirable interactions The programmer recognizes these combinations and may not allow programming until...

Page 71: ...c nominal parameter value When the n symbol appears next to a parameter value it indicates that the value is the Medtronic nominal value Programmed parameter value When the P symbol appears next to a parameter value it indicates that the value is the programmed value The programmer may display a message button next to the PROGRAM button that when selected provides access to additional information ...

Page 72: ... message determines the symbol that appears on the button 4 7 2 How to access parameters with 2 values If a parameter has only 2 values such as Off and On selecting the parameter field makes the alternate value a pending value 1 Select a parameter field that contains only 2 values For example a parameter value that switches from On to Off or vice versa 2 Select PROGRAM to program the new value to ...

Page 73: ...re than 2 values A window opens showing available values for that parameter 2 Select a new value from this window This new value displays as a pending value and the window showing available values for that parameter closes You can also select Close to close the window without changing the original value of the parameter 3 Select PROGRAM to program the new value to the device memory Medtronic PROTE...

Page 74: ...that displays related secondary parameter fields In the example shown Data Collection Setup was chosen 2 Select new values for the desired secondary parameters New values display as pending values 3 Select OK to close the secondary parameters screen and return to the Parameters screen 4 Select PROGRAM to program the new values to device memory Medtronic PROTECTA XT DR D314DRG 74 Clinician Manual ...

Page 75: ...gn a name to the set of parameter values presently displayed by the Parameters screen A saved parameters set can include both programmed and pending values The Get button opens the Get Parameter Set window to retrieve a Medtronic Nominals parameter set an Initial Interrogation parameter set or a custom parameter set 4 8 1 How to save a set of parameter values 1 Select the Params icon Make the desi...

Page 76: ...edtronic Nominals cannot be customized or deleted Initial Interrogation Values The permanently programmed parameter values as determined by the first interrogation of the device during the patient session Custom sets of values All custom sets of values that were saved previously 4 9 Using TherapyGuide to select parameter values Caution TherapyGuide does not replace a physician s expert judgment Th...

Page 77: ...d from the Parameters screen or by selecting Patient TherapyGuide Figure 14 TherapyGuide window Based on a set of selected clinical conditions TherapyGuide provides suggested values for many programmable parameters The clinical conditions influencing these parameter suggestions are shown in Table 4 This table presents an overview but the Rationale window shows how the suggested values for paramete...

Page 78: ...tivity Level a The Treated Cutoff equals the VT detection interval if VT Detection Enable is On Otherwise the Treated Cutoff is the VF detection interval 4 9 2 Considerations for TherapyGuide TherapyGuide and the Patient Information screen The clinical conditions can also be programmed into device memory from the Patient Information screen Refer to Section 4 10 Viewing and entering patient informa...

Page 79: ...uesappearaspendingvalues on the Parameters screen Note Information is stored in device memory only after you select PROGRAM on the Parameters screen Note If you select Undo on the Parameters screen all pending parameter values and the pending clinical conditions are cleared 4 Review the settings and verify that the new settings are appropriate for the patient 5 To adjust any of the pending values ...

Page 80: ...d through the TherapyGuide feature displays in the Patient Information screen For more information see Section 4 9 Using TherapyGuide to select parameter values page 76 The patient s name and ID and the device serial number are printed on all full size and strip chart reports If the programmer is using wireless telemetry the patient is also identified at the bottom of the programmer screen either ...

Page 81: ...r up to 3 leads Select the Model Position and Manufacturer from lists of options Enter the Serial Number and Implant Date Implant Either export lead data from the Model 2290 Analyzer or enter lead data using the submenus Enter the results of defibrillation testing Notes Enter notes about the patient or other information History Enter the patient s clinical conditions This information is made avail...

Page 82: ...llowing steps a Enter the measurements from defibrillation testing and indicate the test method b For each lead enter lead data measured with the Analyzer Then select OK Note If an implant procedure is in progress consider making the measurements in a concurrent analyzer session Measurements can be exported directly to the Implant window see Section 4 10 2 for instructions Otherwise select a value...

Page 83: ... and the Hospital fields and select this information from the lists To add new information to a list select Modify List and Add Type in your addition and select OK 6 When all of the information has been entered select PROGRAM 4 10 2 How to export saved lead measurements to the Implant window When analyzer and device sessions are running concurrently you can export the saved lead measurements from ...

Page 84: ... from the Patient Information screen 4 11 Working with the Live Rhythm Monitor The Live Rhythm Monitor window displays ECG Leadless ECG LECG Marker Channel with marker annotations and telemetered EGM waveform traces on the programmer screen The Live Rhythm Monitor window also displays the patient heart rate and interval in the upper left corner of the window You can view live waveform traces freez...

Page 85: ... to the programmer The EGM1 EGM2 and EGM3 signals are telemetered from the device and are selected from programmable EGM sources You can choose the sources of EGM1 EGM2 and EGM3 when you set up data collection The programmer cannot display or record an EGM waveform trace until the current EGM Range setting has been interrogated from the device See Section 6 8 Viewing Arrhythmia Episodes data and s...

Page 86: ...e using the waveform adjustment button bar 3 Select the color button to change the color of a waveform 4 Select or clear the Clipping ECG Filter and Show Artifacts check boxes as desired Clipping truncates the tops and bottoms of waveform traces at a 22 mm boundary ECG Filter changes the bandwidth of waveforms to improve the clarity of the displayed ECG in the presence of interference Select the c...

Page 87: ... 1 3 How to interpret Marker Channel annotations and symbols Marker Channel annotations appear as 2 characters above or below the Marker Channel waveform trace These annotations indicate events such as pacing sensing detection and delivered therapies Real time waveform recordings also display symbols that appear above or below their associated Marker Channel annotations The symbols sometimes appea...

Page 88: ... S V P E R V R M S P P Atrial pace Atrial sense Atrial refractory sense Atrial sense in PVAB Ventricular pace Ventricular sense Ventricular refractory sense Ventricular safety pace Mode switch Marker buffer full Proactive pace Medtronic PROTECTA XT DR D314DRG 88 Clinician Manual ...

Page 89: ...harge end Atrial 50 Hz burst Figure 17 Ventricular detection and therapies Marker Channel annotations and symbols T S T F T D V T F D T P T F T F F S C E C D V P VT sense FVT sense via VT FVT sense via VF VF sense VT detection FVT detection VF detection VT monitor detection Ventricular tachy pace 50 Hz Burst induction Charge end Cardioversion defibrillation pulse Medtronic PROTECTA XT DR D314DRG C...

Page 90: ...notations Printing a report while recording a live waveform trace If you select an option from the Print menu while recording a live waveform trace the report goes to the print queue Alternatively if you start recording a live waveform trace while the programmer is printing a report the report stops printing and returns to the print queue Note This interruption to printing applies only to reports ...

Page 91: ...indow for the strip viewer 3 The Adjust window offers display options for the strip viewer which is similar to the Adjust window for the Live Rhythm Monitor 4 The Waveform adjustment button bar allows you to normalize the trace resize the trace and change the waveform source 5 The on screen calipers define time intervals 6 The Arrow buttons move the on screen calipers to show the beginning and the...

Page 92: ...in the tool palette or in the strip viewer 2 Select a strip to view 3 Select Open The strip viewer displays the selected strip 4 12 Expediting follow up sessions with Leadless ECG An analysis of a patient s real time ECG signal is an important part of most follow up assessments Connecting surface leads to the patient and acquiring an acceptable ECG signal can be a time consuming part of a follow u...

Page 93: ... from the device and is selected from the programmable LECG source You can choose the source of the LECG when you set up data collection The Leadless ECG LECG waveform trace is available for viewing recording and printing from the Live Rhythm Monitor window Select LECG from the waveform source button on the waveform adjustment button bar to display the Leadless ECG waveform trace For more informat...

Page 94: ... has interrogated If you want to save a record of all the information from the device select the All option from the interrogation window Selecting the All option provides more data for analysis if an issue needs to be investigated 4 13 1 3 How to save device data to a diskette 1 Select Interrogate to interrogate the device 2 Select Session Save to Disk 3 Insert a diskette into the programmer disk...

Page 95: ...lect Open File 7 Select the data record that displays the desired device serial number date and time 8 Select Open File The Read From Disk screen displays information from the saved session 4 14 Using SessionSync to transfer device data to the Paceart system The SessionSync feature enables you to transfer device data through your clinic network between the Medtronic CareLink Model 2090 Programmer ...

Page 96: ...d shows data transfer when SessionSync is enabled The SessionSync status icon is grayed out when the feature is disabled for example during a patient session 4 14 1 1 How to enable and disable the SessionSync feature 1 From the Desktop select Programmer Preferences 2 Select SessionSync from the index menu 3 Select Enabled to enable the SessionSync feature or select Disabled to disable the SessionS...

Page 97: ...tomatic SessionSync or Manual SessionSync 4 14 3 1 Transferring session data with Automatic SessionSync Perform the following steps to end the current session and use Automatic SessionSync to transfer session data between the Medtronic CareLink Model 2090 Programmer and the Medtronic Paceart data management system 1 Select End Session The End Session window is displayed Figure 19 End Session windo...

Page 98: ... 99 for more details about status icon indications Note If error messages appear during the data transfer process see Section 4 14 5 SessionSync error messages for a list of message descriptions 4 14 3 2 Transferring session data with Manual SessionSync Perform the following steps to use Manual SessionSync to transfer session data between the Medtronic CareLink Model 2090 Programmer and the Medtro...

Page 99: ...nic Paceart data management system Table 6 Data transferred with SessionSync Feature name Information exported Therapy Parameters Initial interrogated values Last programmed values Patient Information Last programmed values Battery and Lead Measurements Last measured values Threshold Testsa Last results for each test type conducted for each chamber tested Sensing Testsa Last results for each test ...

Page 100: ...er the icon will not be visible in the task bar Figure 20 SessionSync status icon on the programmer task bar Figure 21 SessionSync status icon indicators 1 Data management system status 2 Connection status 3 Programmer status 4 14 4 2 States of the SessionSync status icon The following table lists the states of the SessionSync status icon that appears in the programmer task bar Table 7 SessionSync...

Page 101: ...sage includes the date time and event information for the associated SessionSync event 1 From the Desktop select Programmer SessionSync Status 2 Select the Update Status button Note Events displayed on the SessionSync Status screen are not automatically updated when SessionSync Status is selected from the menu The user must manually select the Update Status button to refresh the events that are di...

Page 102: ...o print a particular report and which printer to use 4 15 1 Setting preferences for printing reports and tests Preferences allow you to select print options such as number of copies printer type and whether to print now or later They also allow you to select report options for printing reports at the beginning during or at the end of a patient session Printing preferences are applied automatically...

Page 103: ...eports Preferences 2 From the Index selection box select the Printing option 3 Select your printing preferences as desired 4 Select OK Basic printing preferences take effect immediately 4 15 1 2 How to set Initial Report preferences Medtronic PROTECTA XT DR D314DRG Clinician Manual 103 ...

Page 104: ...rogation Initial Report preferences take effect at the start of a new session and remain in effect until you change them and start a new session 4 15 1 3 How to set Final Report preferences You can select the reports you want printed as a part of the Final Report The Session Summary Report always prints when a Final Report print request is made 1 Before ending a patient session select Reports Pref...

Page 105: ... Index selection box allows you to choose how waveform traces are displayed during a selected follow up test You can choose to make the live rhythm display arrange the waveforms to show the EGM of the heart chamber being tested or to keep the waveform arrangement unchanged 1 Select Reports Preferences 2 From the Index selection box select the Tests option 3 Choose the desired option Auto arrange w...

Page 106: ...1 2 4 15 3 Printing reports during a patient session The programmer allows you to specify a particular set of reports for printing and to print a report based on the screen you are viewing 4 15 3 1 How to print a customized set of reports 1 To print a customized set of reports select Reports Available Reports 2 Select the reports you want to print A report can be printed only if its data has been ...

Page 107: ...printing preferences For more information see Section 4 15 1 3 4 15 5 Managing the Print Queue The Print Queue window indicates the printing status of reports that you select to print as you progress through a patient session When you end the patient session the Print Queue window is still available It lists any reports held from that session and other previous sessions 4 15 5 1 How to use the Pri...

Page 108: ...int Queue Status column lists the print status for each report to be printed by the programmer Printing Indicates that a report is currently being printed Deleting Indicates that a report is currently being deleted after the Delete button is selected Waiting Indicates that a report is waiting to be printed while another report is printing Hold Later Indicates that a report is on hold until you req...

Page 109: ...Medtronic CareLink Model 2090 Programmer with Conexus telemetry and a Conexus Activator or a Medtronic CareLink Model 2090 Programmer with a Model 2067 or 2067L programming head Programmer software application for the Protecta XT DR Model D314DRG device4 Model 2290 Analyzer or equivalent pacing system analyzer external defibrillator The following sterile system components and accessories are used ...

Page 110: ...instead of an RVcoil HVB may adversely affect the results of the OptiVol fluid measurements No claims of safety and performance can be made with regard to other acutely or chronically implanted lead systems that are not manufactured by Medtronic Caution Lead coils and Active Can electrodes that are in contact during a high voltage therapy may cause electrical current to bypass the heart possibly d...

Page 111: ...ge to dissipate for at least 10 min the dissipation forms the capacitors e If the reported charge time is clinically unacceptable contact a Medtronic representative 5 Program the therapy and pacing parameters to values appropriate for the patient Ensure that tachyarrhythmia detection is not programmed to On Notes Do not enable a pacing feature that affects the pacing rate for example Ventricular R...

Page 112: ... 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 device IS 1 connector block Note If you are using a lead that requires an adaptor for this device please contact your Medtronic representative for information about compatible lead a...

Page 113: ...l anode of each bipolar pacing sensing lead Lead positioning Final lead positioning should attempt to optimize pacing threshold sensing and defibrillation threshold if appropriate 5 3 2 How to verify and save the sensing and pacing values Medtronic recommends that you use a Model 2290 Analyzer to perform sensing and pacing measurements When the analyzer and the device sessions are running concurre...

Page 114: ...Select View Saved 7 Select the saved measurements that you want to export You can select a single measurement for each lead type 8 Select Export and Close The selected measurements are exported to the Implant field on the Patient Information screen in the device session 9 Select the Device icon on the task bar to return to the device session 10 Select Patient Patient Information and then select Pr...

Page 115: ...vice The torque wrench is designed to prevent damage to the device from overtightening a setscrew See Figure 22 for information about the lead connector ports on the device Figure 22 Lead connector ports 1 DF 1 connector port SVC HVX 2 DF 1 connector port RV HVB 3 Device Active Can electrode Can HVA 4 IS 1 connector port RV 5 IS 1 connector port A 5 4 1 How to connect a lead to the device 1 Insert...

Page 116: ... the side or end a The lead connector pin should be clearly visible beyond the setscrew block see Figure 24 b The lead connector ring should be completely inside the spring contact block There is no setscrew in this location see Figure 24 Figure 24 Confirming the lead connection 3b 3a 4 Tighten the setscrew by turning it clockwise until the torque wrench clicks Remove the torque wrench 5 Gently tu...

Page 117: ...y pathway impedance 20 200 Ω Defibrillation threshold 25 J 5 5 2 How to prepare for defibrillation threshold testing 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 1 Establish telemetry between the device and programmer and start a patient...

Page 118: ...when there is a magnet or programming head over the device and the Resume at DELIVER check box is selected If an error message appears remove the magnet or programming head or clear the Resume at DELIVER check box 4 Select Adjust Permanent 5 Set the Energy parameter for VF Therapy Rx1 to 10 J less than the desired final programmed value Set VF Therapies Rx2 Rx6 to the maximum value 6 Set the RV Se...

Page 119: ...ring a wireless telemetry session you cannot deliver a 50 Hz Burst induction when there is a magnet or programming head over the device and the Resume at BURST check box is selected If an error message appears remove the magnet or programming head or clear the Resume at BURST check box 5 Select Adjust Permanent 6 Set the Energy parameter for VF Therapy Rx1 to 10 J less than the desired final progr...

Page 120: ...rode is not implanted make sure the pin plug provided with the device is inserted into the SVC port to prevent electrical leakage Caution Program tachyarrhythmia detection to Off or Monitor to avoid inappropriate detection or therapy delivery while closing the surgical pocket Note Implant the device within 5 cm 2 in of the surface of the skin to optimize post implant ambulatory monitoring The side...

Page 121: ...ure holes on the device see Figure 26 Figure 26 Locating the suture holes 5 Suture the pocket incision closed 5 7 Completing the implant procedure Warning Do not program the Other 1 1 SVTs feature to On until the atrial lead has matured approximately 1 month after implant If the atrial lead dislodges and migrates to the ventricle the Other 1 1 SVTs feature could inappropriately withhold detection ...

Page 122: ... 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 patient s electrocardiogram until the patient is discharged If a lead dislodges it usually occurs during the immediate postopera...

Page 123: ...e device 2 Program the device to a mode that is not rate responsive to avoid potential rate increases while explanting the device 3 Dissect the leads and the device free from the surgical pocket Do not nick or breach the lead insulation 4 Use a torque wrench to loosen the setscrews in the connector block 5 Gently pull the leads out of the connector ports 6 Evaluate the condition of each lead see S...

Page 124: ...ocket and suture the pocket incision closed see Section 5 6 Positioning and securing the device page 120 10 Return the explanted device and any explanted leads to Medtronic for analysis and disposal Medtronic PROTECTA XT DR D314DRG 124 Clinician Manual ...

Page 125: ...ick Look II screen Assess that the device is functioning correctly Review information about arrhythmia episodes and therapies Review any observations in the Observations window You can compare the information on the Quick Look II screen with historical information about the patient contained in printed reports For information about printing reports see Section 4 15 Printing reports page 102 The pr...

Page 126: ...sues with the patient s presenting rhythm review the device settings and reprogram the device to values that are appropriate for the patient 6 1 3 Verifying the status of the implanted system To verify that the device and leads are functioning correctly review the device and lead status information lead trends data and Observations available from the Quick Look II screen For detailed information a...

Page 127: ...he results of the test to previous lead impedance measurements to determine if there have been significant changes since the last follow up session For more information see Section 10 4 Measuring lead impedance page 432 Sensing Test Compare the test results to previous P wave and R wave amplitude measurements For more information see Section 10 5 Performing a Sensing Test page 432 Pacing Threshold...

Page 128: ...evice has misidentifiedthepatient srhythm carefullyreviewthetachyarrhythmiaepisodeandsensing integrity data the Cardiac Compass trend data and the data stored for other episodes Consider adjusting the detection parameters and the SVT detection criteria as needed For more information about how to view sensing integrity data see Section 7 1 Sensing intrinsic cardiac activity page 201 Caution Use cau...

Page 129: ...erating as expected Information about arrhythmia episodes and therapies provided gives a picture of the patient s clinical status since the last follow up appointment System defined observations alert you to unexpected conditions and suggest how to optimize the device settings Note The Quick Look II screen shows information collected since the last patient session and stored in the device memory P...

Page 130: ...e and lead status Battery information The battery voltage is measured at the start of the session The battery voltage is displayed on the Quick Look II screen and is printed in the Initial Interrogation Report Battery voltage is also automatically measured daily at 2 15 AM If 3 consecutive automatic daily battery voltage measurements are less than or equal to the Recommended Replacement Time RRT v...

Page 131: ...iled trend graphs display up to 15 of the most recent daily measurements and up to 80 weekly summary measurements showing minimum maximum and average values for each week For more information about lead performance graphs see Section 6 13 Viewing detailed device and lead performance data page 186 6 2 2 2 Assessing the patient s condition Pacing and sensing information This information can help to ...

Page 132: ...regularity or device reset has occurred Lead status observations report any potential issues with the sensing integrity of the leads possible lead dislodgments and abnormal capture management results You may also be warned about possible inconsistencies in the programming of lead polarity Parameter observations warn of any inconsistencies in the programming of detection and therapy parameters One ...

Page 133: ...ic CareLink Monitor Model 2490C Upon receiving a signal the monitor transmits the alert data to the Medtronic CareLink Network if programmed to do so notification of alert event Depending on the severity of the alert condition you can set up Medtronic CareAlert Notifications through the CareLink Network to hold the alert for routine review at your office via email or the CareLink website or to imm...

Page 134: ...s detected This tone repeats every 4 hours beginning at the next scheduled 4 hour time interval and at the programmed Daily Alarm Time VF Detection Therapy Off This alert indicates that one or more of the following conditions has occurred for at least 6 hours since the last programming VF detec tion has been turned off 3 or more VF therapies have been turned off or FVT detection is programmed to F...

Page 135: ...hich the device retried the transmission every 3 hours a An Electrical Reset alert sounds immediately and then every 20 hours thereafter However if the electrical reset disables tachyarrhythmia detection and therapy the alert sounds immediately and then every 9 hours thereafter Contact your Medtronic representative if an electrical reset alert sounds 6 3 2 Operation of Medtronic CareAlert Monitori...

Page 136: ...1 The device detects an alert condition and establishes wireless communication with the monitor 2 The monitor sends the alert data to a secure server via the patient s phone line 3 If the CareLink Network is configured to do so the clinician is notified via voice message text message pager email website or live call The clinician can then consult the network for detailed information 6 3 3 Operatio...

Page 137: ...atients to call the clinic if they hear tones coming from the device Alert tones last for up to 30 s and are designed to be slightly louder than typical living room noise If both high urgency and low urgency alerts are active at the same time the high urgency alert is given priority and sounds at the appropriate time or interval Although the system provides 2 types of alert tones for high urgency ...

Page 138: ...t are intermittent the alert event may not actually be present when the alert tone sounds Also the alert time is based on the internal device clock It does not adjust for time zone changes 6 3 3 3 Programming a patient alert time Select Params icon Alert Alert Time Device Tone Alert Time Tones for some system alerts are synchronized to the time you program tones for clinician defined alerts Howeve...

Page 139: ...c field such as the field within a store theft detector Advise patients that the device operation is temporarily impaired in these situations and that they should move away from the source of the interference to restore normal device operation Patients should also understand the purpose of the patient magnet and how and when to use it Make sure that they know that current patient alerts sound when...

Page 140: ...evice Integrity Alerts 6 3 6 Evaluation of alert events The device stores alert events in the Medtronic CareAlert Events log The programmer screen refers to alert events as Alert Events and OptiVol Events For each alert event a log entry includes the date and time of the alert a description of the event and the measurement or information that caused the event Up to 15 Alert Events and the last 7 O...

Page 141: ...ime of a potential lead related issue improve opportunities for more patients to recognize the audible alert and reduce inappropriate shocks The RV Lead Integrity Alert feature is intended for patients who have a Medtronic ICD or CRT D device and a Sprint Fidelis lead Models 6949 6948 6931 and 6930 based on performance data Performance data for use of the RV Lead Integrity Alert feature in combina...

Page 142: ...ents the Sensing Integrity Counter and High Rate NS episode data It identifies a potential lead fracture if at least 2 of the following criteria have been met within the past 60 days An RV pacing lead impedance measurement is less than 50 or greater than 175 of the baseline impedance The baseline measurement is the median of the previous 13 daily measurements The ventricular Sensing Integrity Coun...

Page 143: ...r If the Patient Home Monitor alert for the RV Lead Integrity Alert is programmed to On the device also attempts to send a wireless transmission to the Medtronic CareLink Monitor 6 4 2 2 Automatic adjustments to tachyarrhythmia detection When the RV Lead Integrity Alert is triggered the device automatically programs the VF Initial Beats to Detect parameter to 30 40 if it was less If necessary the ...

Page 144: ...unter criteria are met the device also changes the criteria for storing High Rate NS episodes allowing a High Rate NS episode with EGM data to be recorded if a single ventricular interval less than 200 ms occurs This condition persists until a High Rate NS episode occurs or until the device is interrogated by a programmer 6 4 3 Programming considerations for RV Lead Integrity Alert VF Detection an...

Page 145: ...ikelihood of a lead integrity issue 6 4 5 1 CareAlert pop up window When the device is interrogated a CareAlert pop up window notifies you that an alert condition exists including the RV Lead Integrity Alert 6 4 5 2 Quick Look II observations Select Data Icon Quick Look II Check the Quick Look II Observations list to verify that there is an RV Lead Integrity warning For detailed information about ...

Page 146: ...ata Icon Device Lead Diagnostics Battery and Lead Measurements Sensing Integrity Counter Check the Sensing Integrity Counter section of the Battery and Lead Measurements screen for evidence of oversensing For more information see Section 6 13 Viewing detailed device and lead performance data page 186 6 4 5 5 Arrhythmia Episodes High Rate NS Select Data Icon Clinical Diagnostics Arrhythmia Episodes...

Page 147: ... cause of the oversensing Figure 32 High Rate NS episode record 1 Average rate information 6 4 5 6 Lead Trends Select Data icon Device Lead Diagnostics Lead Impedance Trends Check the Lead Impedance Trends for a sudden change in the RV Pacing Impedance measurement If at least 1 measurement is greater than 175 of the baseline value or is less than 50 of the baseline value then the lead impedance sh...

Page 148: ... heart rates and device therapies Dates and event annotations allow you to correlate trends from different graphs The report can also help you to assess whether device therapies or antiarrhythmic drugs are effective Cardiac Compass trend data is available only as a printed report The Cardiac Compass Report is based on data and measurements collected daily Data storage for the Cardiac Compass Repor...

Page 149: ...Available Reports Cardiac Compass Trends 6 5 2 Information provided by the Cardiac Compass Report The Cardiac Compass Report shows events that have occurred during the reporting period It also provides trend graphs that can help you to assess the frequency of VT VF arrhythmias AT AF arrhythmias pacing and rate response and information related to heart failure 6 5 2 1 Event information Figure 34 Ev...

Page 150: ...on and the beginning of the last session if applicable One or more shocks per day The report indicates a shock for any day on which the device delivered a high voltage therapy an automatic defibrillation therapy cardioversion therapy or atrial shock therapy Each annotation indicates delivery of one or more ventricular V or atrial A high voltage therapies on a single day 6 5 2 2 Assessing VT VF arr...

Page 151: ... Figure 36 AT AF arrhythmia trend graphs AT AF total hours per day This trend may help you to assess the need to adjust the patient s device or drug based therapies It may also reveal the presence of asymptomatic episodes of AT AF The device records a daily total for the time the patient spent in atrial arrhythmia The time in AT AF is calculated from the point of AT AF onset This trend may be repo...

Page 152: ...ercent pacing per day This trend provides a view of pacing over time that can help you to identify pacing changes and trends The graph displays the percentage of all events occurring during each day that are atrial paces and ventricular paces The percentages are calculated from the daily counts of AS VS AS VP AP VS and AP VP event sequences Atrial refractory events are excluded Average ventricular...

Page 153: ...egimen an objective measurement of patient response to changes in therapy an early indicator of progressive diseases like heart failure which cause fatigue and a consequent reduction in activity The patient activity trend is a 7 day average of data derived from the device rate response accelerometer It is reported only after 14 days of data have been collected 6 5 2 5 Assessing heart failure infor...

Page 154: ...grity due to lead fracture or insulation defect may adversely affect the results of the OptiVol 2 0 Fluid Index trend Note The OptiVol Fluid Status Monitoring feature has been updated to OptiVol 2 0 to account for individual patient variation including allowing the Fluid Index to increase or decrease based on recent intrathoracic impedance measurements For more information see Section 6 7 Monitori...

Page 155: ...screens and the Cardiac Compass Report Data storage for the Heart Failure Management Report is automatic No setup is required Note The time annotations displayed on the report are based on the device clock 6 6 1 How to print the Heart Failure Management Report Select Reports icon Heart Failure 6 6 2 Information provided by the Heart Failure Management Report The Heart Failure Management Report pro...

Page 156: ...ng information Arrhythmia episode information shows the number of Treated VT VF episodes and the number of treated and monitored AT AF episodes recorded since the last follow up appointment Ventricular and atrial pacing are shown as the percentage of the total time during the reporting period The battery status at the start of the session can be OK RRT Recommended Replacement Time or EOS End of Se...

Page 157: ... graphs to indicate the beginning of the current session and the beginning of the last session if applicable 6 6 2 4 Assessing OptiVol 2 0 Fluid Trends OptiVol 2 0 Fluid Index and Thoracic impedance graphs show data about intrathoracic impedance collected over the previous 14 months For more information see Section 6 7 Monitoring for thoracic fluid accumulation with OptiVol page 161 Note The OptiV...

Page 158: ...eature has been updated to OptiVol 2 0 to account for individual patient variation including allowing the Fluid Index to increase or decrease based on recent intrathoracic impedance measurements Thoracic impedance The Thoracic impedance trend allows you to compare the daily averagemeasuredthoracicimpedancetotheReferenceImpedancevalues TheReference Impedance changes slightly from day to day to slow...

Page 159: ...py cardioversion therapy or atrial shock therapy Each annotation indicates delivery of one or more ventricular V or atrial A high voltage therapies on a single day Treated VT VF episodes per day The history of ventricular tachyarrhythmias may be helpful in revealing correlations between clusters of episodes and other clinical trends Medtronic PROTECTA XT DR D314DRG Clinician Manual 159 ...

Page 160: ...urement of patient response to changes in therapy and can help you to monitor the patient s exercise regimen The patient activity trend is a 7 day average of data derived from the device rate response accelerometer It is reported only after 14 days of data have been collected Average ventricular rate The day and night heart rates provide information that may indicate autonomic dysfunction related ...

Page 161: ...increase in impedance for this pathway Notes The OptiVol Fluid Status Monitoring feature has been updated to OptiVol 2 0 to account for individual patient variation including allowing the Fluid Index to increase or decrease based on recent thoracic impedance measurements The OptiVol 2 0 Fluid Status Monitoring feature may not provide early warning for all fluid related decompensations Therefore pa...

Page 162: ...culated The device uses this control value to assess impedance variations The system provides a diagnostic plot that may indicate a patient s fluid status over time The plot is part of the Heart Failure Management and Cardiac Compass Reports See Section 6 7 5 1 Viewing OptiVol 2 0 Fluid Trends page 164 Figure 43 OptiVol 2 0 Fluid Trends 1 OptiVol Threshold 2 OptiVol 2 0 Fluid Index accumulation of...

Page 163: ...that you use this setting until you have clinical experience using OptiVol 2 0 Fluid Status Monitoring with individual patients If the patient is experiencing too many OptiVol observations the OptiVol Threshold may be set at too sensitive low a level and you should consider increasing the OptiVol Threshold If OptiVol observations are absent or are delayed when the patient has thoracic fluid accumu...

Page 164: ...tiVol Threshold Select Params icon Alert OptiVol 2 0 Fluid Settings Device Tone OptiVol Threshold 6 7 4 2 Adjusting the Reference Impedance Select Params icon Alert OptiVol 2 0 Fluid Settings Device Tone Additional Settings 6 7 5 Evaluation of OptiVol 2 0 Fluid Status Monitoring Caution Verify lead integrity when evaluating OptiVol 2 0 Fluid Status Monitoring Loss of RVcoil integrity due to lead f...

Page 165: ...ick Look II screen and on the Heart Failure Management Report when the OptiVol 2 0 Fluid Index has reached or exceeded the OptiVol Threshold since the last session If the OptiVol 2 0 Fluid Index is still greater than 0 the observation displays the date of the first day that the OptiVol 2 0 Fluid Index was equal to or greater than the threshold and ongoing If the OptiVol 2 0 Fluid Index has since r...

Page 166: ...mats including interval plot diagrams EGMs and text summaries Various filtering tools are available to give you precise control over the types of data displayed 6 8 1 How to view the Arrhythmia Episodes data Select Data icon Clinical Diagnostics Arrhythmia Episodes 6 8 2 Viewing the episode log The episode log is displayed in the upper portion of the Data Arrhythmia Episodes screen It provides the...

Page 167: ... to restrict the display to episodes with specific characteristics 5 Use the field to filter the list to episodes that are longer than a specific amount of time Avg bpm A V For AT AF VT Monitor and VT NS episodes the Avg bpm A V is an average of A V cycle length throughout the entire episode For VT VF SVT and VOS episodes the Avg bpm A V is an average of the 4 beats at detection or just prior to w...

Page 168: ...This allows the episodes that triggered the alert to be viewed Overwriting of the oldest High Rate NS episode data with new data resumes after device interrogation 6 8 3 Viewing episode records An episode record displays detailed information about the episode currently selected in the episode log An episode record is initially displayed in the lower portion of the Data Arrhythmia Episodes screen a...

Page 169: ...ck Patient Assistant you can instruct the patient to activate the device to collect data when he or she is experiencing symptoms At follow up you can view the date time and average atrial and ventricular cycle lengths at the time the patient triggered data collection This may help with diagnosis of patient symptoms when an episode is not in progress When the patient uses the Model 2696 InCheck Pat...

Page 170: ...ode text Patient Symptom detected during episode However a separate patient activated record is not created 6 8 3 1 Viewing the episode interval plot When you first select an episode from the episode log the programmer displays a graph that plots the V V and A A intervals versus time and indicates the following information programmed detection intervals point of detection or detection withheld poi...

Page 171: ...or the episode Figure 48 Episode EGM 1 The Marker Channel displays the annotated atrial and ventricular events leading up to detection 2 The Decision Channel displays an annotation conveying the type of episode detected here VT Monitor The EGM display must be maximized to display the Decision Channel annotations 3 Use the horizontal scroll bar at the bottom of the screen to view all of the episode...

Page 172: ...elected For more information about Pre arrhythmia EGM storage see Section 6 8 4 How to set data collection preferences page 173 To conserve device memory the EGM is stored only during specific parts of an episode Note Long episodes may contain gaps in the EGM to save storage memory 6 8 3 3 Viewing the episode text When you select an episode from the episode log and then select the Text option the ...

Page 173: ... each waveform For each QRS complex the match percentage and classification Match or No Match is also displayed For more information see Section 8 4 Discriminating VT VF from SVT using Wavelet page 326 Note If no template was available at the time the episode was recorded the QRS complexes appear with no match percentages or classifications 6 8 4 How to set data collection preferences Data collect...

Page 174: ...e resolution of the signal the lower the setting the higher the resolution If the signal is illegible or clipped consider changing the range selection Monitored Select a set of 2 sources to be used for episode record storage Pre arrhythmia EGM Indicate whether you want to store EGM data collected prior to an episode When Pre arrhythmia EGM storage is on the device collects up to 10 s of EGM data b...

Page 175: ...odes includes the number of premature ventricular contractions PVCs Ventricular Rate Stabilization VRS paces and monitored and non sustained episodes The count data for ventricular episodes also includes the number of episodes for which detection and therapy were withheld due to the application of supraventricular tachycardia SVT and ventricular oversensing VOS discrimination features Thecountdata...

Page 176: ...hour of premature ventricular contractions PVCs in which 2 3 or 4 consecutive ventricular events are premature PVC Singles The average number of single PVCs per hour PVCs in PVC runs are not counted as PVC singles Runs of VRS Paces The average number of times per hour that 2 or more consecutive ventricular events are Ventricular Rate Stabilization VRS pacing pulses VRS escape interval timeouts Sin...

Page 177: ...y were withheld 6 9 3 VT VF therapy counters Figure 52 VT VF therapy counters The following count data is available for VT VF therapies VT VF Therapy Summary The number of pace terminated tachyarrhythmias shock terminated tachyarrhythmias total VT VF shocks and aborted charges VT VF Therapy Efficacy Since Last Session The number and types of VF FVT and VT therapies delivered whether they were succ...

Page 178: ...verage number of treated AT AF episodes per day AT AF is defined as starting from AT AF detection Pace Terminated Episodes The percentage of pace terminated episodes for the session AT AF is defined as starting from AT AF detection of Time Atrial Pacing The percentage of time that atrial pacing was performed of Time Atrial Intervention The percentage of time that atrial pacing was performed due to...

Page 179: ...therapy count data is available for the period between the current interrogation and the last session The following data is available for AT AF therapies Fast AT AF Rx The number of episodes for which therapy was delivered by therapy type and the percentage of successfully terminated episodes per therapy AT AF Rx The number of episodes for which therapy was delivered by therapy type and the percen...

Page 180: ...he graphed data may help you assess the patient s heart rhythm and the performance of other features such as Rate Response Flashback Memory automatically records up to a total of 2000 V V and A A intervals and stored marker data for the following events the most recent interrogation the most recent VF episode the most recent VT episode the most recent AT AF episode If 2 or more episodes are detect...

Page 181: ...e Section 7 8 Treating syncope with Rate Drop Response page 256 When Rate Drop Response is programmed on the device records data about episodes that meet the programmed rate drop detection criteria You can view and print data for the last 10 episodes List of rate drop episodes The Rate Drop Response Episodes screen provides several facts about each episode Type indicates the method by which the ep...

Page 182: ...up to detection and the first few beats of intervention pacing when the device paces the heart at an elevated rate Much of the plot depicts the period before detection this enables you to study events that may precede rate drop episodes The yellow box displayed over the plot marks the period for which you can view marker channel data To view this data select Markers To view Marker Channel data for...

Page 183: ... 4 Select Print to print reports You can print a detailed report of the selected episode a summary of all episodes or both 6 12 Using rate histograms to assess heart rates Information about heart rates recorded between patient sessions can help you to monitor a patient s condition to assess the effectiveness of therapies The Rate Histograms Report shows the distribution of atrial and ventricular r...

Page 184: ...rt presents heart rate data in 3 types of histograms atrial rate ventricular rate and ventricular rate during AT AF It also presents data about the patient s conduction status The report includes data from the current and previous collection periods Data storage for the Rate Histograms Report is automatic no setup is required Medtronic PROTECTA XT DR D314DRG 184 Clinician Manual ...

Page 185: ... that the device was pacing and sensing within rate ranges There are 20 rate ranges that are each 10 bpm in length Rates slower than 40 bpm are included in the 40 range rates faster than 220 bpm are included in the 220 range Medtronic PROTECTA XT DR D314DRG Clinician Manual 185 ...

Page 186: ... AF histogram The ventricular rate during AT AF histogram shows ventricular sensed and paced events that occurred during detected atrial arrhythmias and the total time in AT AF7 This histogram may be used to monitor the effectiveness of ventricular rate control therapy and drug titration 6 13 Viewing detailed device and lead performance data The device automatically measures and records device and...

Page 187: ...iated at the start of a session when a lead impedance test is performed and every day at 2 15 AM as part of the automatic daily measurements The most recent battery voltage measurement is displayed on the Battery and Lead Measurements screen Note You may see a temporary drop in the displayed battery voltage if high voltage charging has occurred within the past 24 hours If 3 consecutive automatic d...

Page 188: ...ection reports the date measured impedance delivered energy waveform and pathway for the last delivered high voltage therapy 6 13 1 4 Sensing Integrity Counter When the device senses high frequency electrical noise the result is often a large number of ventricular sensed events with intervals near the programmed value for ventricular blanking after a ventricular sense V Blank Post VS The Sensing I...

Page 189: ...nsing amplitude measurements see Section 10 5 Performing a Sensing Test page 432 You can compare the most recent measurements to the trends of daily automatic measurements by selecting the Lead Impedance button or Sensing button to view the Lead Trends screen 6 13 2 Viewing lead impedance trends Every day at 3 00 AM the device automatically measures the lead impedance on each implanted lead using ...

Page 190: ... 5 Select Print to print a Lead Trends Report 6 13 3 Viewing sensing amplitude trends Every day at 2 15 AM the device begins to measure the amplitude of intrinsic sensed events The device attempts to measure the amplitude of 9 normal intrinsic sensed events and then records the median value from those events If the device has not collected 9 amplitudemeasurementsbymidnight nomeasurementisrecorded ...

Page 191: ...asurements that may be used to assess lead integrity The adequacy of the ventricular sensing safety margin cannot be determined by the R wave trend measurement and should be based on VF induction testing 6 13 3 1 How to view sensing amplitude trends Select Data icon Device Lead Diagnostics P R Wave Amplitude Trends Figure 60 Lead Trends screen showing the R wave amplitude trend 1 Selected measurem...

Page 192: ...screen also displays programmed values for pacing output and Capture Management parameters the last measured threshold value and a link to a detailed view of the last 15 days of threshold measurement data The details screen shows daily results from the last 15 days of threshold measurements These results include the dates times threshold measurements pacing amplitude values and notes describing th...

Page 193: ... Weekly minimum maximum and average values 4 Most recently measured values 5 Last measured threshold value 6 Capture Management and pacing output parameter values 7 Select to view threshold measurement details from the last 15 days 8 Select Print to print a Lead Trends Report Medtronic PROTECTA XT DR D314DRG Clinician Manual 193 ...

Page 194: ...about how to respond to the device status indicator warning for electrical reset is provided in Section 6 14 2 How to respond to the device status indicator warning for electrical reset page 196 Caution The device status indicators are important Please inform your Medtronic representative if any of the indicators are displayed on the programmer screen after interrogating a device To clear the disp...

Page 195: ... is a device activated safety feature that can reset device parameters to values that provide basic device functionality These basic parameters are considered safe for the majority of patients Pacing in VVI mode remains active during a reset condition In most electrical reset situations VF detection is enabled In rare cases an electrical reset may disable tachyarrhythmia detection and therapy If t...

Page 196: ...presentative 3 Select Clear in the pop up window to clear the reset indicator and the Medtronic CareAlert alarm A confirmation window appears indicating that all previously interrogated data in the programmer will be cleared 4 Select Continue 5 Interrogate the device a Note the time and date when counter data was last cleared because this indicates when the electrical reset occurred b Determine if...

Page 197: ...ies that may help reduce the energy requirements placed on the battery 6 15 1 Promoting intrinsic AV conduction Managed Ventricular Pacing MVP MVP promotes AV conduction by reducing unnecessary right ventricular pacing This primary benefit of MVP is therapeutic but it may also increase device longevity as a result of a decrease in the percentage of pacing For more information about MVP see Section...

Page 198: ... to 6 defibrillation therapies Defibrillation therapy expends a high level of energy VF therapies should be programmed to the maximum energy level For more information about defibrillation therapy see Section 9 1 Treating episodes detected as VF page 356 Atrial cardioversion You may choose to program the device to deliver automatic atrial cardioversion CV therapies to treat atrial tachyarrhythmia ...

Page 199: ...livering ATP before the first defibrillation You can program the device to deliver ATP therapy before delivering the first defibrillation therapy This can prevent delivery of high voltage therapy for rhythms that can be terminated by ATP rapid monomorphic VT for example If you program the ChargeSaver feature to On the device can also automatically switch to ATP Before Charging operation This allow...

Page 200: ...medication changes and surgical procedures Pre arrhythmia EGM storage may be set to On 1 month On 3 months or On continuous Select the setting for the shortest time period that will provide the necessary data Set Pre arrhythmia EGM storage to Off after you have obtained the data of interest Note When Pre arrhythmia EGM storage is set to Off the device begins to store EGM information for VT VF VT M...

Page 201: ...raneous sensing or to prevent the device from responding to it Blanking periods follow pacing pulses sensed events and shocks Sensing is inhibited during blanking periods Refractory periods follow pacing pulses and sensed events The device is able to sense events that occur during refractory periods but it marks them as refractory events Refractory events generally have no effect on the timing of ...

Page 202: ...resholds after certain paced and sensed events to help reduce the oversensing of T waves cross chamber events and pacing pulses The threshold adjustment depends on the type of event that precedes the adjustment During an automatic adjustment the sensing threshold automatically increases but it gradually decreases toward the programmed sensitivity value which is the minimum amplitude that can be se...

Page 203: ...emporarily less sensitive to ventricular events Note When high amplitude sensed events occur the decrease in sensitivity is limited to prevent undersensing of subsequent intrinsic events 7 1 3 Operation of blanking periods Blanking periods follow paced events sensed events and shocks Blanking periods help to prevent the device from sensing pacing pulses cardioversion and defibrillation pulses post...

Page 204: ...re nonprogrammable Table 12 Cross chamber blanking periods Parameter Value Atrial blanking after a ventricular pacing pulse 30 ms Ventricular blanking after an atrial pacing pulse 30 msa a If the RV pacing amplitude is programmed at 8 V this value is 35 ms The post shock blanking periods are also nonprogrammable After a cardioversion or defibrillation therapy is delivered the atrial and ventricula...

Page 205: ...hold is increased for the duration of the programmed PVAB interval During this time far field R waves are less likely to be sensed After the PVAB interval the atrial sensing threshold gradually returns to the programmed level Extending the PVAB interval may affect intrinsic and far field R wave sensing because it changes the time during which the sensing threshold is increased Absolute PVAB When t...

Page 206: ...trial event is blanked in the PVAB interval whether or not the far field R wave exceeds the atrial threshold 4 Except for the change in the atrial sensing threshold the Partial PVAB and Partial PVAB methods are similar With either method atrial events sensed in the PVAB interval are used by the tachyarrhythmia detection features 7 1 5 Operation of refractory periods During a refractory period the ...

Page 207: ...ce is operating in the DDIR and DDI modes the PVARP setting prevents the inhibition of atrial pacing based on sensed retrograde P waves PVARP should be programmed to a value longer than the VA interval retrograde conduction time Figure 67 Timing for fixed PVARP A P A P V P V P Marker Channel PVAB Fixed PVARP The PVARP parameter may be programmed to Auto instead of a fixed value Auto PVARP adjusts ...

Page 208: ... confirmation is active Sensing during VF Always verify that the device senses properly during VF If the device is not sensing or detecting properly disable detection and therapies and evaluate the system making sure to monitor the patient for life threatening tachyarrhythmias until you enable detection and therapies again You may need to reposition or replace the ventricular sensing lead to achie...

Page 209: ...tive value the device is more susceptible to electromagnetic interference EMI cross chamber sensing and oversensing Recommended ventricular sensing threshold Setting RV Sensitivity to 0 3 mV is recommended to maximize the probability of detecting VF and to limit the possibility of oversensing and cross chamber sensing Recommended atrial sensing threshold Setting A Sensitivity to 0 3 mV is recommen...

Page 210: ...P PVARP or A Refractory Minimum PVARP 7 1 8 Evaluation of sensing 7 1 8 1 Using the Sensing Test to evaluate sensing The Sensing Test allows you to measure P wave and R wave amplitudes These measurements may be useful for assessing lead integrity and sensing performance After the Sensing Test is complete the test results are displayed on the test screen You may view and print the results when desi...

Page 211: ...lar intervals that occurred since the last patient session the date of the first of these intervals if any occurred A large number of short ventricular intervals may indicate oversensing lead fracture or a loose setscrew Note The number of short ventricular intervals is an input to the RV Lead Integrity Alert For more information see Section 6 4 Monitoring leads using RV Lead Integrity Alert page ...

Page 212: ...d events and then records the median value from those events If the device has not collected 9 amplitudemeasurementsbymidnight nomeasurementisrecorded Thesensingamplitude trend graph shows a gap for that day 7 2 Providing pacing therapies Patients have a variety of conditions for which pacing therapy may be indicated These conditions include cardiac asystole chronic AT AF loss of atrioventricular ...

Page 213: ... is available to manage pacing output energies in the atrium and right ventricle For more information refer to Section 7 5 Managing pacing output energies with Capture Management page 238 The device provides sensing in both the atrium and right ventricle Refer to Section 7 1 Sensing intrinsic cardiac activity page 201 for information about sensing thresholds lead polarities blanking periods and re...

Page 214: ... device paces the atrium and then schedules a ventricular paced event to occur at the end of the PAV interval If a ventricular sensed event occurs during the SAV interval or the PAV interval ventricular pacing is inhibited A sensed atrial event that occurs during the Post Ventricular Atrial Refractory Period PVARP is classified as refractory does not inhibit atrial pacing and is not tracked For mo...

Page 215: ...7 7 Adjusting PVARP to changes in the patient s heart rate page 253 Figure 71 Operation of dual chamber pacing in DDIR A P A S V P V P A P A P V P V P V P 200 ms A R PAV PAV PAV ECG Marker Channel AV interval PVARP Sensor interval 1 An atrial paced event starts a PAV interval 2 AnatrialsensedeventinhibitsthescheduledatrialpacedeventbutdoesnotstartanSAVinterval is not tracked 3 An atrial event that...

Page 216: ...tection must be programmed to Off and AT AF Detection must be programmed to Monitor 7 2 4 Operation of single chamber pacing Single chamber pacing modes are used to pace either the atrium or the ventricle 7 2 4 1 AAIR DDDR and AAI DDD modes For information about the AAIR DDDR and AAI DDD modes MVP modes see Section 7 3 Reducing unnecessary ventricular pacing with MVP mode page 223 7 2 4 2 VVIR and...

Page 217: ... the AAIR mode see Figure 73 A sensed event that occurs during the Atrial Refractory Period is classified as refractory and does not inhibit atrial pacing In AAIR and AAI modes the device continues sensing ventriculareventsfortachyarrhythmiadetectionpurposes VT VFdetectioniscompromised in the AAIR and AAI modes Cross chamber blanking can cause ventricular events to go undetected and crosstalk can ...

Page 218: ...tion must be programmed to Off to program the device to the VOO mode 7 2 4 5 AOO mode The AOO mode provides atrial pacing at the programmed Lower Rate with no inhibition by intrinsic atrial events When the device is programmed to the AOO mode it provides no atrial detection even though it offers ventricular sensing AT AF Detection must be programmed to Monitor and VT Detection and VF Detection mus...

Page 219: ... rates page 220 Consider programming Non Competitive Atrial Pacing NCAP to On Pacing safety margins Pacing pulses must be delivered at an adequate safety margin above the stimulation thresholds High pacing output levels The pulse width and amplitude settings affect the longevity of the device particularly if the patient requires bradycardia pacing therapy most of the time Cross chamber sensing Pul...

Page 220: ...DDDR or DDD mode the device can track atrial rhythms only up to a certain rate Limitations on atrial tracking include the 2 1 block rate and the programmed Upper Tracking Rate as described in Section 7 2 8 1 7 2 8 1 2 1 block 2 1 block occurs when the intrinsic atrial interval is so short that every other atrial sensed event occurs during PVARP see Figure 74 These atrial events do not start an SAV...

Page 221: ... 7 7 Adjusting PVARP to changes in the patient s heart rate page 253 These features can prevent symptomatic 2 1 block during exercise while allowing nominal or longer SAV and PVARP values at resting rates to help prevent rapid ventricular pacing rates during the onset of AT AF When programming the SAV or PVARP parameters the programmer calculates and displays the 2 1 block rate When the 2 1 block ...

Page 222: ...nckebach see Figure 75 Wenckebach behavior can be further defined by how often the dropped beat occurs typically as a ratio of the number of atrial sensed events compared to ventricular paced events for example 8 7 7 6 6 5 or 3 2 Further increases in the atrial rate may eventually reach the 2 1 block rate where the ratio becomes 2 1 Figure 75 Example of Wenckebach pacing A S A S A R A S V P V P V ...

Page 223: ...ial based pacing mode that is designed to switch to a dual chamber pacing mode in the presence of AV block Specifically MVP provides the following functions AAI R mode pacing when AV conduction is intact the ability to switch to DDD R pacing during AV block periodic conduction checks while operating in DDD R mode with the ability to switch back to AAI R mode when AV conduction resumes backup ventr...

Page 224: ... of AV conduction If 2 of the 4 most recent A A intervals are missing a ventricular event the device identifies a loss of AV conduction and switches to the DDDR or DDD mode The device provides backup ventricular pacing in response to dropped ventricular events until the loss of AV conduction is identified Figure 77 Switching from AAIR mode to DDDR mode A P A P A P A P A P A P A P A P V P V P V P V...

Page 225: ... and the device switches back to the DDDR or DDD mode The time between conduction checks doubles 2 4 8 min up to a maximum of 16 hours with each failed conduction check Figure 78 Switching from DDDR mode to AAIR mode after AV conduction resumes A P A P A P A P A P A P V P A P A P V P V P V S V S V S V S V S V V intervals ECG Marker Channel 200 ms 1 The device operates in DDDR mode 2 The device per...

Page 226: ...ate in DDDR mode 7 3 2 5 Transient loss of conduction For transient loss of AV conduction the device remains in the AAIR or AAI mode and provides a backup ventricular pacing pulse in response to an A A interval that is missing a ventricular sense 7 3 2 6 Interactions with MVP mode Mode Switch Mode Switch and the MVP modes operate together to adjust the pacing mode according to the patient s atrial...

Page 227: ... to prevent unnecessary atrial pacing when the ventricular rate is faster than the pacing rate It also allows tachyarrhythmia detection features to operate without disruption from blanking periods caused by atrial pacing After cardioversion or defibrillation therapy After cardioversion or defibrillation therapy the device operates in the DDDR or DDD mode for 1 min If an AV conduction check was sch...

Page 228: ...AIR or AAI mode Permanent DDDR or DDD modes may be more appropriate for patients with symptomatic first degree AV block Operation immediately after implant The device is shipped in MVP mode initially operating in DDD mode Approximately 30 min after implant the device checks for AV conduction and switches to AAIR or AAI mode if the next A A interval includes a sensed ventricular beat SeeSection 7 3...

Page 229: ...On appears on the Quick Look II screen Otherwise the screen displays MVP Off For detailed information about viewing and interpreting all of the information available from the Quick Look II screen see Section 6 2 Viewing a summary of recently stored data page 129 7 3 5 3 Cardiac Compass Report Select Data icon Clinical Diagnostics Cardiac Compass Trends Report Only The Pacing day trend on the Cardi...

Page 230: ...ange of rates Figure 83 Rate Histograms Report 7 4 Providing rate responsive pacing Some patients exhibit heart rates that do not adapt to changes in their physical activity Their symptoms might be shortness of breath fatigue or dizziness This includes patients with chronotropic incompetence and patients with chronic or paroxysmal AF Medtronic PROTECTA XT DR D314DRG 230 Clinician Manual ...

Page 231: ...ng rate is also described as the sensor rate 7 4 2 1 Activity sensing The activity sensor is an accelerometer in the device that detects the patient s body movements Because activity detection varies from patient to patient the sensitivity to motion can be adjusted by reprogramming the Activity Threshold parameter If the Activity Threshold is lowered smaller body movements influence the pacing rat...

Page 232: ... slopes characteristic of dual slope Rate Response The ADL Setpoint determines the weighted activity counts that causes the pacing rate to reach the ADL Rate The UR Setpoint determines the weighted activity counts that causes the pacing rate to reach the Upper Sensor Rate A lower setpoint means less activity counts are required to reach upper rates Automatic Rate Response With automatic Rate Respo...

Page 233: ...based on stored sensor rate information and the selected Rate Profile Optimization settings The device continues to adjust the rate response over time The device adapts Rate Response more rapidly for the first 10 days after Rate Profile Optimization is first activated post implant or after certain Rate Response parameters are manually reprogrammed Lower Rate ADL Rate Upper Sensor Rate ADL Response...

Page 234: ... caused by handling Rate Response and Rate Profile Optimization begin operating after implant when VF Detection is programmed to On 7 4 2 6 Rate Response parameters screen The parameters screen for Rate Response shows the rate curve corresponding to the interrogated parameter values If you select pending values for the parameters the screen also shows a pending curve The pending curve reflects the...

Page 235: ... effect on Rate Profile Optimization By reprogramming the ADL Response and Exertion Response parameters you can prescribearate profilethatmatchesthepatient slifestyleoractivitylevelsineachraterange Adjust the ADL Response to prescribe how quickly the patient reaches the ADL Rate and the Exertion Response to prescribe how quickly the patient reaches the Upper Sensor Rate In both cases a lower value...

Page 236: ... 5 1 Rate Histograms Report Select Data icon Clinical Diagnostics Rate Histograms Report Only The Rate Histograms Report provides information about how Rate Response has been performing since the previous patient session In Figure 88 you can see how the histograms changed after Rate Response was programmed to be more aggressive Note that the percentage of atrial pacing has shifted from the lower r...

Page 237: ...he rate trend shows how Rate Response was operating before the patient session 1 View Flashback Memory 2 Select View Intervals Prior to Interrogation 3 Set the plot display method to Rate Note To see an updated rate trend without ending the patient session instruct the patient to complete a hall walk and then reinterrogate the device Medtronic PROTECTA XT DR D314DRG Clinician Manual 237 ...

Page 238: ...icle It monitors whether pacing pulses capture the myocardium and optionally adjusts their amplitude to changing patient conditions 7 5 2 Operation of Capture Management Capture Management is a programmable feature that is available for the right atrium ACM and right ventricle RVCM In Capture Management operation the device prepares for a pacing threshold search conducts the pacing threshold searc...

Page 239: ... margins The amplitude and pulse width parameters control the output energy of pacing pulses in each chamber The pacing output energy determines whether pacing pulses capture the myocardium It is necessary for pacing output settings to exceed the pacing threshold by a safety margin Pacing threshold variations may be caused by exercise eating sleeping drug therapy or changes in other cardiac condit...

Page 240: ... in one of these modes If ACM is programmed to the Monitor or Adaptive setting the device conducts a pacing threshold search to determine the atrial pacing threshold If ACM is programmed to the Adaptive setting the device uses the atrial pacing threshold to define a target amplitude and adjusts the pacing amplitude toward the target amplitude The target amplitude is based on the programmed setting...

Page 241: ...de or from AAI DDD mode to DDD mode 7 5 3 2 Searching for and determining the atrial pacing threshold The device conducts a pacing threshold search to determine the atrial pacing amplitude threshold at a fixed pulse width of 0 4 ms ACM varies the amplitude of test paces to find the lowest amplitude that consistently captures the atrial myocardium If the right atrium responds to a test pace the res...

Page 242: ...shown in Figure 92 this event is indicated by an AR marker Figure 92 Atrial Chamber Reset test method AS AS AS AS AS AS AS AS AS Test AP AS VS or VP Test AP Capture Loss of Capture VS or VP VS or VP VS or VP VS or VP VS or VP VS or VP VS or VP VS or VP VS or VP VS or VP VS or VP AR AV Conduction AVC method In the AVC method each test pace is preceded by 3 support cycles and followed by a backup pa...

Page 243: ...tion about target amplitudes and safety margins refer to Section 7 5 2 2 Adjustments during the acute phase The programmable acute phase corresponds to the lead maturation period During this time adequate pacing output is ensured by restricting output adjustments The acute phase begins when implant detection is complete The nominal length of the acute phase is 120 days but the Acute Phase Remainin...

Page 244: ...the pacing threshold test is suspended until the following day Whenever this happens a device check occurs again and the process is repeated The reasons for stopping a pacing threshold search are noted in the Capture Threshold trends diagnostic see Section 7 5 7 7 5 4 Operation of Right Ventricular Capture Management Right Ventricular Capture Management RVCM is available when the pacing mode is pr...

Page 245: ... 4 2 Searching for and determining the RV pacing threshold The device conducts a pacing threshold search to determine the RV pacing amplitude threshold at a fixed pulse width of 0 4 ms RVCM varies the amplitude of test paces to find thelowestamplitudethatconsistentlycapturestherightventricularmyocardium Thedevice evaluates capture by detecting the evoked response signal following each test pace If...

Page 246: ...ing the programmed RV Amplitude Safety Margin by the amplitude threshold measured at a pulse width of 0 4 ms The device calculation for the target amplitude is rounded up to the next programmable amplitude setting For information about target amplitudes and safety margins refer to Section 7 5 2 2 Adjustments during the acute phase The programmable acute phase corresponds to the lead maturation per...

Page 247: ... the Capture Threshold trends diagnostic see Section 7 5 7 7 5 5 Programming considerations for Capture Management Warning Capture Management does not program right ventricular or atrial outputs above 5 0 V or 1 0 ms If the patient needs a pacing output higher than 5 0 V or 1 0 ms you must program Amplitude and Pulse Width manually Caution Epicardial leads have not been determined appropriate for ...

Page 248: ...manually refer to Section 7 2 Providing pacing therapies page 212 Figure 95 Pacing and Capture Management parameters Note An Adaptive symbol next to the value of an Amplitude or Pulse Width parameter indicates that the programmed value can be adapted by the device The symbol does not necessarily indicate that the parameter value has been adapted Medtronic PROTECTA XT DR D314DRG 248 Clinician Manua...

Page 249: ...reshold data is collected by the automatic daily threshold tests performed by Capture Management Select the Threshold button to view the Lead Trends and Capture Threshold diagnostic screens Quick Look II Observations If there are significant observations about ACM or RVCM they are shown in the Quick Look II Observations window For detailed information about viewing and interpreting all of the info...

Page 250: ...howing minimum maximum and average values for each week From the Capture Threshold trend you can select the Last 15 days detail button to view details about the daily capture threshold searches The details screen shows daily results from the last 15 days of threshold measurements including dates times threshold measurements pacing pulse width and amplitude values Notes describe the results of each...

Page 251: ...d to potentially improve hemodynamics 7 6 1 System solution Rate Adaptive AV Rate Adaptive AV shortens AV intervals at elevated rates to maintain 1 1 tracking and AV synchrony 7 6 2 Operation of Rate Adaptive AV Rate Adaptive AV is available when the pacing mode is programmed to DDDR DDD DDIR DDI or an MVP mode AAIR DDDR or AAI DDD Rate Adaptive AV functions when the device is operating in the DDD...

Page 252: ... but is not Rate Adaptive AV If the device suspects that a tachyarrhythmia is in progress it shortens the PAV interval to allow observation of the rhythm This occurs even when Rate Adaptive AV is off 7 6 3 Programming considerations for Rate Adaptive AV 2 1 block rate programmer message The programmer calculates the dynamic 2 1 block rate based on the selected pacing parameters You can view the ca...

Page 253: ...d be short enough to avoid 2 1 block and promote AV synchrony For related information refer to Section 7 1 Sensing intrinsic cardiac activity page 201 and Section 7 2 Providing pacing therapies page 212 7 7 1 System solution Auto PVARP Auto PVARP adjusts PVARP in response to changes in the patient s heart rate or pacing rate 7 7 2 Operation of Auto PVARP Auto PVARP is available when the pacing mod...

Page 254: ...P in the DDDR or DDD mode Time 1 1 tracking heart rate 30 min 1 bpm 100 min 1 bpm 70 min 1 bpm 2 1 block Rate In a nontracking mode DDIR or DDI PVARP varies with the current pacing rate to be long enough to promote AV synchrony at a low pacing rate and short enough to prevent atrial competitive pacing at a high pacing rate The device calculates PVARP to attempt to maintain a 300 ms window of time ...

Page 255: ...e 251 When you select a new value for Minimum PVARP or Rate Adaptive AV the programmer recalculates the dynamic 2 1 block rate at exercise The device achieves 1 1 tracking up to the Upper Tracking Rate when the recalculated dynamic 2 1 block rate is above the Upper Tracking Rate You can view the programmer message about the dynamic 2 1 block rate by pressing the information icon button at the bott...

Page 256: ... Drop Response Rate Drop Response monitors the heart for significant rate drops and responds by pacing the heart at an elevated rate 7 8 2 Operation of Rate Drop Response Figure 101 Overview of Rate Drop Response Sinus rate Intervention Termination Step down Detection Rate Drop Response operates in phases During the detection phase the device monitors the heart for rate drops that conform to progr...

Page 257: ...programmed to DDD DDI or AAI DDD MVP mode Rate Drop Response functions when the device is operating in the DDD or DDI mode For the MVP mode the device operates in DDD mode during Rate Drop Response interventions Rate Drop Response does not operate during tachyarrhythmias Mode Switch episodes and Capture Management pacing threshold searches 7 8 2 1 Detection Rate Drop Response provides 2 methods fo...

Page 258: ...ied heart rate within a specified period of time These conditions are established by programming the Drop Size Drop Rate and Detection Window parameters respectively Figure 104 Low Rate Detection Intervention Rate 100 min 1 bpm Lower Rate 45 min 1 bpm Paced beats Sensed beats Detection beats With Low Rate Detection the device intervenes when the atrium is paced at the Lower Rate for the number of ...

Page 259: ... complete the device reduces the pacing rate by 5 bpm steps per minute This step down process continues until the sinus rate or the Lower Rate is reached Intervention pacing and step down pacing are immediately ended when the device senses 3 consecutive nonrefractory atrial events Note If the Lower Rate is reached at the conclusion of the step down phase and Low Rate Detection is programmed the de...

Page 260: ... Features that adjust pacing rate Features that adjust the pacing rate such as Atrial Rate Stabilization and Ventricular Rate Stabilization are unavailable when Rate Drop Response is programmed on 7 8 4 Programming Rate Drop Response Select Params icon Pacing Additional Features Rate Drop Response Rate Drop Response On Mode Lower Rate Detection Type Drop Size Drop Rate Detection Window Detection B...

Page 261: ...en rate drop episode that is detected by the Drop Detection method is shown in Figure 106 Figure 106 Drop Episode A more gradual rate drop episode that is detected by the Low Rate Detection method is shown in Figure 107 Medtronic PROTECTA XT DR D314DRG Clinician Manual 261 ...

Page 262: ...ythms to occur below the programmed Lower Rate 7 9 2 Operation of Rate Hysteresis Rate Hysteresis is available when the pacing mode is programmed to VVI or AAI and functions when the device is operating in one of these modes Rate Hysteresis allows a slower lower rate when the intrinsic rate is below the programmed Lower Rate After each sensed event the programmed hysteresis rate is applied After e...

Page 263: ...ming considerations for Rate Hysteresis Verifying adequate cardiac support The programmed hysteresis rate determines the slowest heart rate that can occur before pacing starts Ensure that the selected hysteresis rate is adequate to support the patient s cardiac condition Programming the hysteresis rate To avoid large sudden changes in heart rate you would normally select a hysteresis rate that is ...

Page 264: ...ntricular Rate Histogram Report Select Data icon Clinical Diagnostics Rate Histograms Report Only 7 10 Providing a slower pacing rate during periods of sleep Some patients have difficulty sleeping when they are paced at a rate that is intended for times when they are normally awake 7 10 1 System solution Sleep feature The Sleep feature replaces the programmed Lower Rate with a slower pacing rate d...

Page 265: ... and increases to the Activities of Daily Living Rate ADL Rate The rate profile above the ADL Rate remains the same Programming any bradycardia pacing parameter during the Sleep period cancels the Sleep operation for that day If the patient experiences an AT AF episode and the Mode Switch feature is operating during the Sleep period the device does not pace below the Lower Rate until the AT AF epi...

Page 266: ...ring the day and night which should indicate that the device is allowing a slower heart rate at night See Section 6 5 Viewing long term clinical trends with the Cardiac Compass Report page 148 for more information 7 11 Preventing competitive atrial pacing An atrial tachycardia may be initiated if an atrial paced event occurs within the vulnerable period of the atrium This can happen if the device ...

Page 267: ...l some variation in the VP VP interval may occur These variations only affect the current and next ventricular interval The NCAP interval is 400 ms for 1 pacing cycle whenever a PVC Response or a PMT Intervention occurs Figure 110 Operation of NCAP A P A R V P V P V P V P V P V P 200 ms A P A P A P A P A P ECG Marker Channel NCAP interval AP VP interval 1 The device is pacing at an elevated rate 2...

Page 268: ...r an MVP mode AAIR DDDR or AAI DDD PMT Intervention functions when the device is operating in the DDDR or DDD mode The device defines a PMT as 8 consecutive VP AS intervals occurring at less than 400 ms When the device detects a PMT the PMT Intervention feature forces a 400 ms PVARP after theninthpacedventricularevent Thiscausesthenextatrialsensetofallwithintherefractory period Because this refrac...

Page 269: ...ct pacing mode timing For tracking modes DDDR and DDD retrograde conduction following a PVC can initiateapacemaker mediatedtachycardia PMT arepetitivesequenceinwhichthedevice responds to each retrograde P wave by pacing the ventricle at an elevated rate and each ventricular pace in turn generates a retrograde P wave For nontracking modes DDIR and DDI retrograde conduction following a PVC can cause...

Page 270: ...ll be within the PVARP and will not be tracked and will not inhibit atrial pacing This prevents initiating a PMT DDDR and DDD modes and preserves AV synchrony DDIR and DDI modes If PVC Response is programmed to On and PMTs are observed consider programming PMT Intervention or evaluate the atrial and ventricular lead performance or positions or consider drug therapy to reduce retrograde conduction ...

Page 271: ... VSP functions when the device is operating in the DDDR DDD DDIR or DDI mode The device uses a 110 ms VSP window to monitor for ventricular senses that occur too soon after an atrial pacing pulse Ventricular senses in the VSP window are classified as nonphysiologic and are likely due to crosstalk If a ventricular sensed event occurs within the VSP window the device delivers a VSP pulse at the end ...

Page 272: ...y deliver VSP including atrial undersensing and occurrences of PVCs during the VSP window 7 14 3 Programming considerations for VSP Caution Do not program VSP to Off if the patient is pacemaker dependent because ventricular support may not be provided during crosstalk 7 14 4 Programming VSP Select Params icon Pacing Additional Features V Safety Pacing 7 14 5 Evaluation of VSP Figure 114 Recognizin...

Page 273: ...should be capable of withholding atrial tracking during periods of atrial tachyarrhythmia while tracking the normal sinus rate 7 15 1 System solution Mode Switch The Mode Switch feature switches the device pacing mode to a nontracking mode upon detection of an atrial tachyarrhythmia and restores the programmed pacing mode when the atrial tachyarrhythmia ends By operating in a nontracking mode the ...

Page 274: ...rogrammed tracking mode The ventricular pacing rate gradually changes from the sensor rate to the tracking rate Figure 116 Example of a Mode Switch episode 200 ms V P V P V P V P V P V P V P V P V P A S A b M S T S T S T S T S T S T S T S T S T S T S T S T S T S T S T S ECG Marker Channel 1 An atrial tachyarrhythmia episode starts causing faster ventricular pacing in response 2 When the device det...

Page 275: ...ias page 277 7 15 4 Programming Mode Switch Select Params icon Mode Switch 7 15 4 1 Programming the Atrial Interval Rate Select Params icon AT AF Interval Rate 7 15 5 Evaluation of Mode Switch performance 7 15 5 1 EGM strip Select Data icon Clinical Diagnostics Arrhythmia Episodes Select an AT AF episode from the Arrhythmia Episodes log Check the A V bpm column to evaluate the average atrial and v...

Page 276: ...ansitions The Marker Channel includes an MS marker for each Mode Switch transition either to a nontracking mode or back to a tracking mode The current operating mode is displayed in the upper left hand corner of the screen During a Mode Switch episode DDIR is displayed 7 16 Increasing the pacing output after a high voltage therapy After the heart receives a high voltage therapy there may be a temp...

Page 277: ... Shock Pacing Select Params icon Pacing Arrhythmia Post Shock A Amplitude V Amplitude A Pulse Width V Pulse Width 7 17 Using atrial intervention pacing to counteract atrial tachyarrhythmias The management of patients with atrial tachyarrhythmias is made more challenging by the different types of mechanisms known to initiate atrial tachyarrhythmias It is also made more challenging by the high incid...

Page 278: ...closely matched to the intrinsic sinus rate Post Mode Switch Overdrive Pacing PMOP works with the Mode Switch feature to deliver overdrive atrial pacing during the vulnerable phase following an AT AF episode termination 7 17 2 Operation of ARS Atrial Rate Stabilization ARS is available when the pacing mode is programmed to DDDR DDD AAIR AAI or MVP AAIR DDDR or AAI DDD mode and functions when the d...

Page 279: ...s delivered for ARS are annotated on the Marker Channel with PP proactive pace Figure 119 Example of ARS operation A P V P A P V P A P A R V P P P V P P P V P A P V P 200 ms ECG Lead I Marker Channel 1 Pacing occurs at the programmed pacing rate 2 A premature beat occurs followed by an ARS pacing pulse indicated by the PP marker The pacing pulse is delivered at the AP AR interval plus the programm...

Page 280: ...Rate AT AF Detection Interval VT VF Detection Interval and Ventricular Monitor interval 7 17 4 Programming ARS Select Params icon Pacing Arrhythmia Post Shock A Rate Stabilization On Additional A Settings Maximum Rate Interval Percentage Increment 7 17 5 Operation of APP Atrial Preference Pacing APP is available when the pacing mode is programmed to DDDR DDD AAIR AAI or MVP AAIR DDDR or AAI DDD mo...

Page 281: ...rial sensed event the device decreases the atrial pacing interval by the programmed Interval Decrement value This progression continues until the pacing rate exceeds the intrinsic rate resulting in an atrial paced rhythm It sustains this increased rate for the number of beats programmed for a Search Beats parameter then decreases the pacing rate slightly by 20 ms to search for the next intrinsic b...

Page 282: ...y 20 ms for another set of search beats 4 This cycle continues until the intrinsic rate is reached 5 Another nonrefractory atrial sensed event occurs again causing an increase in the atrial pacing rate Notes APP is suspended during mode switching including PMOP operation and during detected tachyarrhythmia episodes Generally when multiple device features attempt to control the pacing rate the feat...

Page 283: ...ial Pacing NCAP The NCAP feature may delay an atrial pacing pulse that results from APP Programming constraints To ensure reliable tachyarrhythmia detection the system regulates the values that you can select for the Maximum Rate Upper Rate AT AF Detection Interval VT VF Detection Interval and Ventricular Monitor interval 7 17 7 Programming APP Select Params icon Pacing Arrhythmia Post Shock A Pre...

Page 284: ...le feature that provides overdrive atrial pacing following the end of a mode switch After a mode switch the device increases the pacing rate beat by beat decreasing the pacing interval by 70 ms per pulse until it reaches the programmed Overdrive Rate It continues DDIR pacing at the overdrive rate for the duration of the programmed Overdrive Duration It then smooths the return to the programmed atr...

Page 285: ...de switch and gradually slows the pacing rate to the programmed rate For more information about mode switch see Section 7 15 Preventing rapid ventricular pacing during atrial tachyarrhythmias page 273 7 17 9 Programming considerations for PMOP Potential right ventricular pacing increase Since the device remains in DDIR mode during PMOP operation programming PMOP on may lead to increased right vent...

Page 286: ...tion see Section 6 9 Viewing episode and therapy counters page 175 Select Data icon Clinical Diagnostics Counters AT AF Episodes The of Time Atrial Intervention line in the AT AF Summary section of the Data Counters screen displays the total percentage of time that the patient received atrial intervention pacing The displayed percentage reflects the combined total of pacing resulting from ARS and ...

Page 287: ...Level value the device adds up to 3 bpm in response to a sensed event and subtracts 1 bpm in response to a pacing pulse The result is ventricular pacing at an average rate that closely matches the patient s intrinsic ventricular response to the AT AF episode Conducted AF Response is available when the pacing mode is programmed to DDDR DDD DDIR VVIR or an MVP mode AAIR DDDR or AAI DDD Conducted AF ...

Page 288: ... in nontracking modes Therefore when the device is programmed to DDD or DDDR mode Conducted AF Response operates only during a mode switch to DDIR mode Mode Switch must be programmed to On to program Conducted AF Response to On Conducted AF Response and VRS In DDIR and VVIR modes Conducted AF Response and VRS cannot be programmed to On at the same time 7 18 4 Programming Conducted AF Response Sele...

Page 289: ...s Trends Report This report shows the ventricular rate during AT AF episodes providing maximum and average rates for each episode For more information see Section 6 5 Viewing long term clinical trends with the Cardiac Compass Report page 148 7 19 Providing overdrive pacing after a VT VF high voltage therapy After a VT VF episode is successfully terminated by a high voltage therapy there may be a t...

Page 290: ... 25 pacing cycles use the Post Shock Pacing settings for amplitude and pulse width Note If the programmed pacing mode is an MVP mode AAIR DDDR or AAI DDD the device operates in DDDR or DDD mode for 1 min after a high voltage therapy For more information see Section 7 3 Reducing unnecessary ventricular pacing with MVP mode page 223 For all other modes the device operates in the programmed pacing mo...

Page 291: ...signed to eliminate the long pause that commonly follows a PVC VRS responds to a PVC by increasing the pacing rate then gradually slowing it back to the programmed pacing rate or intrinsic rate 7 20 2 Operation of VRS VRS operates as a constant rate smoothing function by adjusting the ventricular intervals that may follow a PVC The following programmable parameters control the pacing rate determin...

Page 292: ...V P V P V P V P 200 ms A S A P A P A P A P A P Pacing Interval ECG Marker Channel 1 A PVC occurs causing a short pacing interval 2 The device paces the ventricle at the previous pacing interval plus the programmed interval increment VRS schedules the atrial pace early to maintain AV synchrony 3 With each successive pace VRS increases the pacing interval by the programmed interval increment Notes A...

Page 293: ... cannot be programmed to On at the same time 7 20 4 Programming VRS Select Params icon Pacing Arrhythmia Post Shock V Rate Stabilization On Additional V Settings Maximum Rate Interval Increment 7 20 5 Evaluation of VRS performance The device collects and stores counter data that includes information about the frequency of PVCs and VRS operation You can view the stored data on the programmer screen...

Page 294: ...VC Singles counter reports instances of premature events that occur separately 3 Runs of VRS Paces counter reports instances of VRS pacing pulses per hour in which 2 or more consecutive ventricular events are VRS pacing pulses 4 Single VRS Paces counter reports instances of single VRS pacing pulses per hour Medtronic PROTECTA XT DR D314DRG 294 Clinician Manual ...

Page 295: ...an atrial tachyarrhythmia The accurate detection of an atrial tachyarrhythmia enables the device to respond with appropriate antitachycardia therapies and to collect diagnostic information that may help manage patients with atrial tachyarrhythmias You can programthedevicetorespondtoanatrialtachyarrhythmiabyswitchingtonontrackingDDIR mode to avoid high rate ventricular pacing When programmed to Mon...

Page 296: ...n the episode record If Mode Switch is programmed to On the device switches to a nontracking mode DDIR at AT AF onset Note The system begins to calculate the percentage of time the patient spends in AT AF when the conditions for AT AF onset are met This information is used in the Cardiac Compass Report 8 1 2 2 Detecting an atrial tachyarrhythmia episode The device accumulates evidence of an atrial...

Page 297: ...device analyzes A V pattern information to determine if one of the atrial events is actually a far field R wave Far field R waves are not counted toward AT AF detection VT VF detection takes priority over AT AF detection When VT VF is detected any ongoing AT AF detection process is postponed until after the VT VF episode terminates 8 1 2 3 Classifying atrial tachyarrhythmia episodes for treatment ...

Page 298: ...grammed AT AF or Fast AT AF interval 8 1 2 5 Identifying atrial tachyarrhythmia termination The device determines that an atrial tachyarrhythmia episode has terminated when the device identifies normal sinus rhythm or a normal paced rhythm for 5 consecutive ventricular intervals Figure 134 AT AF termination A P A P M S A P A P A P A P A P T D l T D l T D l A EGM Marker Channel V EGM V P V P V P V ...

Page 299: ... mode AT AF Detection cannot be programmed to On when the programmed pacing mode is DOO VOO or AOO 8 1 4 Programming AT AF detection 8 1 4 1 Programming AT AF detection Select Params icon AT AF Detection AT AF Interval Rate 8 1 4 2 Programming AT AF detection for 2 detection zones Select Params icon AT AF Therapies Detection On Zones 2 Fast AT AF A Interval Rate AT AF A Interval Rate 8 1 5 Evaluat...

Page 300: ... Data icon Clinical Diagnostics Arrhythmia Episodes The Data Arrhythmia Episodes screen displays recorded tachyarrhythmia episodes and triggered therapies The Plot option displays a diagram of the episode and shows the times of onset detection therapy delivery and termination The EGM option displays the episode information in the context of an EGM strip Figure 135 Episode Plot Medtronic PROTECTA X...

Page 301: ...Figure 136 Episode EGM showing AT AF Onset Figure 137 Episode EGM showing AT AF Detection Medtronic PROTECTA XT DR D314DRG Clinician Manual 301 ...

Page 302: ...38 Flashback Memory screen 8 1 5 4 Cardiac Compass Report Select Data icon Clinical Diagnostics Cardiac Compass Trends Report Only The Cardiac Compass Report provides information about AT AF episodes and ventricular rhythms and how much time the patient has spent in AT AF The V rate during AT AF trend on the Cardiac Compass Report displays information about ventricular response during atrial tachy...

Page 303: ...time the patient has spent in AT AF Figure 140 Cardiac Compass AT AF total hours day 8 1 5 5 Rate Histograms Report Select Data icon Clinical Diagnostics Rate Histograms Report Only The V Rate During AT AF Histogram Report displays information about the patient s ventricular response during AT AF Medtronic PROTECTA XT DR D314DRG Clinician Manual 303 ...

Page 304: ...apiesforthepatient thedevicemustfirstdetectthepresence of a tachyarrhythmia and classify it accurately The device must be capable of detecting several types of ventricular tachyarrhythmia with differing characteristics Ventricular fibrillation VF is typically a fast rate low amplitude rhythm with irregular intervals Ventricular tachycardia VT is typically a slower rhythm than VF but with regular i...

Page 305: ...to determine whether the tachyarrhythmia has terminated or whether it persists or changes The device can be programmed to monitor for slower non life threatening VTs without providing therapy 8 2 2 Operation of VT VF detection Figure 142 Overview of VT VF detection VT VF event classification Initial VT VF episode detection Termination Termination Therapy Therapy VT VF episode redetection The devic...

Page 306: ...ection zones by selecting a detection interval for each type of tachyarrhythmia that you want the device to detect The detection interval is called V Interval Rate on the Parameters screen When you program a detection interval for VF you are defining a zone for VF events Intervals that are shorter than or equal to the VF detection interval fall in the VF detection zone and are classified as ventri...

Page 307: ... S F S F S F S F S F S F S F S F S F S F S F S F S F S F S F S F S F D 200 ms VF event count ECG Marker Channel VF interval 1 Ventricular fibrillation starts and sensed intervals in the VF detection zone are classified as VF events marked FS 2 A sensed ventricular interval occurs outside the VF detection zone This event is not classified as a VF event 3 The programmed VF Initial Beats to Detect va...

Page 308: ...al occurs outside the VT detection zone VT detection restarts 3 The programmed VT Initial Beats to Detect value of 16 events is reached and the device detects VT indicated by the TD marker 8 2 2 3 Detecting 2 clinical VTs A fast ventricular tachyarrhythmia FVT detection zone may be used to allow different therapeutic approaches for a patient who exhibits 2 VTs of different rates To detect 2 clinic...

Page 309: ...er a less aggressive therapy such as antitachycardia pacing for the patient s fast VT To detect a VT in the VF zone program FVT Detection to via VF and select a V Interval Rate value for FVT To help ensure that the patient s fast ventricular tachycardia is classified as FVT select a value that matches the shortest ventricular interval that typically occurs during the patient s fast VT Figure 148 F...

Page 310: ...tween zones Combined Count detection Combined Count detection is designed to prevent VF detection from being delayed when ventricular tachyarrhythmia fluctuates between the VF and VT zones Combined Count detection occurs if the sum of the VT and VF events reaches 7 6 of the programmed VF Initial Beats to Detect value For example if the programmed VF Initial Beats to Detect value is 18 24 Combined ...

Page 311: ...T monitor episode and suspends the VT monitoring operation until the tachyarrhythmia terminates The programmed SVT discrimination features Onset Stability PR Logic and Wavelet are applied in the VT monitor zone 8 2 2 7 Detecting non sustained ventricular tachyarrhythmia episodes If at least 5 beats fall within any programmed ventricular tachyarrhythmia detection zone but fewer than the programmed ...

Page 312: ...Initial Beats to Detect value The SVT discrimination features are not applied during redetection with the exception of the TWave Discrimination feature and the Stability feature which are always applied after 3 consecutive VT events Figure 151 Redetecting a VT episode after therapy A R A S A S A S A S A S A R A R A R A R A R A R A R A R A R A R A R A R A R T P T P T P T P T D T P T P T P T P T P T...

Page 313: ...n the device uses the programmed VF interval to terminate a VF episode and the episode is terminated when 8 consecutive ventricular intervals are longer than or equal to the programmed VF detection interval or when 20 s elapse during which the median of the last 12 ventricular intervals is always longer than the VF detection interval 8 2 2 10 SVT discrimination features for ventricular tachyarrhyt...

Page 314: ...n reached 3 Stability also applies to the Redetection phase 8 2 2 11 Ventricular oversensing VOS discrimination features for ventricular tachyarrhythmia detection The device provides the following features designed to help prevent inappropriate ventricular tachyarrhythmia detection and therapy caused by ventricular oversensing VOS TWave Discrimination The TWave Discrimination feature withholds ina...

Page 315: ...tion and bradycardia pacing To diminish the possibility that bradycardiapacingwillinterferewithventriculartachyarrhythmiadetection theprogrammer restricts the parameter values available for pacing rates pacing intervals and detection intervals VF detection interval minimum setting Programming the VF detection interval to a value less than 300 ms may increase the chance of underdetection of VF VF d...

Page 316: ...Detection must also be programmed to On Monitored VT Beats to Detect The Monitored VT Beats to Detect value must be greater than the VF and VT Initial Beats to Detect 8 2 4 Programming ventricular tachyarrhythmia detection Select Params icon Detection V VF On VF Initial VF Redetect VF V Interval Rate FVT via VF via VT FVT V Interval Rate VT On VT Initial VT Redetect VT V Interval Rate Monitor Moni...

Page 317: ...2 5 2 Data Arrhythmia Episodes screen Select Data icon Clinical Diagnostics Arrhythmia Episodes The Plot option displays a plot diagram of the episode intervals and shows the detection and termination points Figure 154 Episode Plot The EGM option displays EGM traces leading up to the detection point and through therapy and termination Medtronic PROTECTA XT DR D314DRG Clinician Manual 317 ...

Page 318: ...Figure 155 Episode EGM The Text option provides a text summary of the episode Figure 156 Episode Text Medtronic PROTECTA XT DR D314DRG 318 Clinician Manual ...

Page 319: ...d time is plotted against interval length in milliseconds Figure 157 Flashback Memory screen 8 2 5 4 Cardiac Compass Report Select Data icon Clinical Diagnostics Cardiac Compass Trends Report Only Cardiac Compass trends data includes information about treated VT VF episodes per day ventricular rate during VF FVT or VT and non sustained VT episodes per day Medtronic PROTECTA XT DR D314DRG Clinician...

Page 320: ...F Episodes The VT VF episode counter provides a summary of VT VF activity for last session prior session and device lifetime including the number of VF FVT and VT episodes and the instances of therapy withheld by SVT and ventricular oversensing discrimination features Medtronic PROTECTA XT DR D314DRG 320 Clinician Manual ...

Page 321: ...chyarrhythmia therapy Identifying and withholding detection for conducted SVT reduces the chance of delivering an inappropriate therapy for high ventricular rates that are not ventricular in origin 8 3 1 System solution PR Logic PR Logic uses pattern and rate analysis to discriminate between SVTs and true ventricular tachyarrhythmias and to withhold inappropriate VT VF detection and therapy during...

Page 322: ...r and ventricular tachyarrhythmias the device detects and treats the ventricular tachyarrhythmia If the analysis determines that the ventricular tachyarrhythmia is a conducted SVT such as atrial fibrillation atrial flutter sinus tachycardia or junctional tachycardia the device withholds ventricular tachyarrhythmia detection and therapy Note As part of its processing PR Logic evaluates whether atri...

Page 323: ...rhythmia and delivers the zone appropriate ventricular therapy In the episode text the detected VT VF or FVT is recorded as VT SVT VF SVT or FVT SVT Note If Wavelet is programmed to On the PR Logic features do not indicate SVT and the atrial rate is faster than or equal to the ventricular rate the device performs a Wavelet QRS waveform analysis If the Wavelet analysis indicates that the rhythm is ...

Page 324: ...VF Detection is programmed to On the device also enables the PR Logic features AF Afl and Sinus Tach Detection intervals and the SVT V Limit The SVT V Limit value must be less than the VT detection interval If VT Detection is programmed to Off the SVT V Limit must be shorter than or equal to the VF detection interval for detection enhancements to be in effect in the VF zone 8 3 4 Programming PR Lo...

Page 325: ...h annotations There are 3 Decision Channel annotations specific to PR Logic that display when that feature withholds ventricular tachyarrhythmia detection AF AF Afl ST Sinus Tach SV Other 1 1 SVTs Decision Channel annotations are also displayed on the real time recording when a single annotation is printed when VT VF detection is first withheld by a PR Logic feature or if a PR Logic feature change...

Page 326: ...ed and stored template of the patient s QRS waveform in sinus rhythm VT VF detection is withheld if the current waveform sufficiently matches the template 8 4 2 Operation of Wavelet Figure 162 Using a Wavelet template to discriminate SVT from VT Template Rhythm matches template SVT VT Rhythm does not match template The device collects EGM data for sensed ventricular events and compares it to a sto...

Page 327: ...g Wavelet with PR Logic When both Wavelet and PR Logic features are programmed to On the conditions under which Wavelet withholds detections are as follows The programmed Initial Beats to Detect value is reached The PR Logic features have not indicated that the tachyarrhythmia episode is an SVT The atrial rate is faster than or equal to the ventricular rate When Wavelet is programmed to On but all...

Page 328: ... use the Wavelet test feature to collect a Wavelet template manually The Wavelet test allows you to temporarily change the pacing mode and then use a manual command to collect a Wavelet template see Section 10 3 Testing the Wavelet feature page 427 In creating and maintaining the Wavelet template the device collects electrogram waveforms only for events with intervals longer than 600 ms or than th...

Page 329: ...in the following situations R wave amplitudes on the EGM2 signal are too small relative to myopotential interference R wave amplitudes on the EGM2 signal are so large during intrinsic rhythm or SVT that they exceed the maximum EGM range and are clipped You can assess the EGM2 signal using the programmer strip chart recorder If the peak to peak R wave amplitudes on the EGM2 trace are less than 3 mV...

Page 330: ...he device is less likely to withhold detection of rapidly conducted SVTs decreased specificity but is more likely to detect true VT increased sensitivity Note In the Marquis VR Single Chamber ICD clinical study the nominal Match Threshold of 70 was used in 99 of episodes in 99 of the patients studied Missing template If Wavelet is enabled but no template is available detection will occur as if Wav...

Page 331: ... You can use the Wavelet Monitor mode to evaluate the potential effectiveness of Wavelet for the patient without enabling it for detection When Wavelet has been programmed to Monitor the device records Wavelet related data but does not use the Wavelet feature to withhold detection 8 4 5 3 Data Arrhythmia Episodes screen The stored episode data provides information related to the operation of Wavel...

Page 332: ...on 1 An episode for which detection is withheld is indicated by SVT Wavelet 2 In the Decision Channel of the EGM display ventricular events on which VT VF detection was withheld by the Wavelet feature are indicated by WV Medtronic PROTECTA XT DR D314DRG 332 Clinician Manual ...

Page 333: ...8 4 5 4 QRS complexes with a high match score Figure 166 Recorded SVT episode showing QRS complexes that match the template Medtronic PROTECTA XT DR D314DRG Clinician Manual 333 ...

Page 334: ...chycardia is characterized by a gradual ventricular rate increase while ventricular tachycardia exhibits a sudden ventricular rate increase 8 5 1 System solution Onset feature The Onset feature may help prevent detection of sinus tachycardia as VT by evaluating the acceleration of the ventricular rate If the ventricular rate increases gradually as typically happens during sinus tachycardia the dev...

Page 335: ...ss of the change in average cycle length from one set of 4 intervals to the next If you program the Onset Percent value lower a larger rate acceleration will be required for the device to detect VT If you program the Onset Percent value higher a smaller rate acceleration will be required for the device to detect VT If the ventricular rate accelerates gradually as shown in Figure 169 then the Onset...

Page 336: ...al VT event count VT interval Onset calculation ECG 1 The ventricular rate is accelerating interval cycle lengths are decreasing 2 The ventricular rate is now in the VT detection zone but the acceleration is gradual The average cycle length of any set of 4 intervals is never 81 or less of the previous set of 4 intervals 81 is the Onset Percent value in this example If the ventricular rate accelera...

Page 337: ...event 3 The average ventricular interval is now 69 of the average of the previous 4 intervals faster than the programmed Onset Percent of 81 so this interval is classified as a VT event 8 5 2 1 VT Monitor events and the Onset feature The Onset feature applies to both VT detection and VT monitoring 8 5 2 2 Ensuring appropriate detection of VT and VF events Continuing arrhythmia episodes The Onset f...

Page 338: ...ycardia episodes as ventricular tachycardia However there may be a reduced likelihood of detecting true ventricular tachycardia 8 5 4 Programming the Onset feature Select Parameters icon Detection V Onset Onset On Monitor Percent 8 5 5 Evaluation of the Onset feature The Data Arrhythmia Episodes screen and the Onset Monitor option may help you assess the performance of the Onset feature 8 5 5 1 Da...

Page 339: ... Monitor Percent You can use the Monitor setting to test the potential effectiveness of the Onset feature for the patient without programming it to On When the Onset feature is set to Monitor the device performs all of the calculations associated with the Onset feature but the calculations do not affect the classification of VT intervals If the device detects a VT or FVT via VT episode for which d...

Page 340: ...y of the ventricular rate When the device determines that the ventricular rate is not stable it does not classify ventricular intervals as VT events even if they occur in the VT detection zone 8 6 2 Operation of the Stability feature The Stability feature is applied when the device has counted at least 3 consecutive VT events The device classifies an interval as unstable if the difference between ...

Page 341: ...rammed Stability interval 50 ms in this case the device resets the VT event count 8 6 2 1 Stability criterion for VT Monitor events The VT Monitor zone has a non programmable stability criterion that can reset the VT Monitor event count but does so independently from the VT event count The VT Monitor event count must be at least 3 before this stability criterion is applied to events in the VT Moni...

Page 342: ...e Stability feature are indicated by Reset Stability 8 7 Detecting prolonged tachyarrhythmias using High Rate Timeout The SVT discrimination features PR Logic Wavelet Onset and Stability are designed to withhold detection and therapy for ventricular rates classified by the device as having a supraventricular origin For some patients there may be a need to override the SVT discrimination features a...

Page 343: ...herapy Notes When a VF Zone Only timeout occurs and the tachyarrhythmia leaves the VF zone before the timeout period expires the timeout period is reset If the tachyarrhythmia reenters the VF zone the timeout starts over from the beginning If during either High Rate Timeout period the device determines that the SVT discrimination feature no longer applies detection occurs and therapy is delivered ...

Page 344: ...T Decision Channel annotation at the point when the High Rate Timeout period expired Figure 174 Episode EGM If the High Rate Timeout All Zones period expires during an episode the Initial Type field in the episode text will include the text High Rate Timeout All Zones If the High Rate Timeout VF Zone Only period expires during an episode the Initial Type field in the episode text will include the ...

Page 345: ... clinician an observation to be viewed by the Medtronic CareLink Model 2090 Programmer and a Medtronic CareAlert Notification to warn the clinician that intervention is needed 8 8 2 Operation of the RV Lead Noise Discrimination feature When VT or VF is suspected the device compares the RV sense signal to a far field EGM signal seen on the EGM2 channel When the RV lead functions properly these sign...

Page 346: ...urs beginning at the next scheduled 4 hour time interval 12 00 AM 4 00 AM 8 00 AM The alert tone also sounds at the programmed Alert Time and when a magnet is placed over the device The alert tone continues to sound until the device is interrogated by a programmer If the Patient Home Monitor alert for the RV Lead Noise alert is programmed to On the device also attempts to send a wireless transmiss...

Page 347: ...ead Noise Discrimination event If the device is sounding an RV Lead Noise alert tone or if the programmer indicates that an RV Lead Noise Discrimination event has occurred review the alert messages and evaluate the diagnostic data to determine the likelihood of RV lead noise Notes The device records RV lead noise oversensing episode summaries only if the RV Lead Noise Discrimination feature is pro...

Page 348: ... all other detection features description of Wavelet activity if triggered programmed values for VF FVT and VT detection and redetection at time of episode status On Off of SVT discrimination features at time of episode 8 8 6 2 Episode EGM Select Data icon Clinical Diagnostics Arrhythmia Episodes EGM The Decision Channel annotation N indicating RV Lead Noise Discrimination is displayed when the fe...

Page 349: ...ts including the RV Lead Noise alert 8 8 6 4 Quick Look II observations Select Data icon Quick Look II Check the Quick Look II Observations list to verify that there is an RV lead noise warning For detailed information about viewing and interpreting all of the information available from the Quick Look II screen see Section 6 2 Viewing a summary of recently stored data page 129 Medtronic PROTECTA X...

Page 350: ...s VT VF detection when a fast ventricular rate is detected because of oversensed T waves It analyzes differences in amplitude rate and pattern to differentiate R waves from T waves It then applies additional criteria to distinguish R and T patterns from VT VF This reduces the potential to deliver inappropriate therapy for high rates that are attributable to T wave oversensing 8 9 2 Operation of TW...

Page 351: ...is confirmed VT or VF detection is withheld 4 If T wave oversensing is not confirmed VT or VF detection occurs Note TWave Discrimination is applied on initial detection and on redetection 8 9 3 Programming considerations for TWave Discrimination VT and VF redetection If the programmed VT Redetect is less than 12 and VF Redetect values are less than 12 16 TWave Discrimination may not have enough da...

Page 352: ... events for every A A event Figure 178 Episode Plot of a T wave oversensing episode 1 V V events occur at twice the frequency of A A events 8 9 5 2 Episode EGM Select Data icon Clinical Diagnostics Arrhythmia Episodes EGM In the EGM view the annotation TW is displayed in the Decision Channel when the TWave Discrimination feature withholds VT VF detection Medtronic PROTECTA XT DR D314DRG 352 Clinic...

Page 353: ...ng 3 TW annotated to indicate T wave oversensing on a per event basis 8 9 5 3 Episode Text Select Data icon Clinical Diagnostics Arrhythmia Episodes Text For T wave oversensing episodes the Episode Text screen lists the following types of information an episode summary for V Oversensing TWave including Duration A V Max Rate Medtronic PROTECTA XT DR D314DRG Clinician Manual 353 ...

Page 354: ...g emergency therapies and some EP study tests therapies are delivered manually and detection and episode storage are not needed Also certain types of surgery including electrocautery surgery RF ablation and lithotripsy can cause the device to detect tachyarrhythmias inappropriately and possibly deliver inappropriate therapy When detection is suspended the device temporarily stops the process of cl...

Page 355: ...etection during a detected VT Monitor episode andthenresumedetectionbeforetheepisodeterminates therewillbeepisodedatastorage for 2 episodes with the first episode terminated while the rate is still fast 8 10 2 How to suspend or resume detection with the programmer Figure 180 Suspend and Resume buttons The Suspend and Resume buttons can be used whenever there is telemetry with the device and the de...

Page 356: ...es The device can be programmed to deliver a sequence of up to 6 therapies to treat VF episodes each with specific energy and pathway settings If the first therapy labeled Rx1 is successful in terminating the episode the device continues monitoring for subsequent VF episodes If the device redetects the VF episode after the first therapy delivery it delivers the second VF therapy labeled Rx2 If the...

Page 357: ...hen charging starts and when VF confirmation occurs Note that if ATP During Charging is applied and Confirmation is programmed Off confirmation for VF does not occur 2 The device attempts to synchronize defibrillation to a ventricular event If this is not possible it delivers defibrillation asynchronously 9 1 2 1 Delivering high voltage therapies To deliver a defibrillation therapy the device must...

Page 358: ...es direction of current flow during the initial segment of the biphasic waveform If the parameter is set to AX B current flows from the Active Can and SVC Coil to the RV Coil If the parameter is set to B AX this current flow is reversed 9 1 2 3 Delivering ATP before the first defibrillation You can program the device to deliver ATP therapy before delivering the first defibrillation therapy This ca...

Page 359: ...lly change the value of the ATP parameter ChargeSaver Switchback and Smart Mode The effect of ChargeSaver and Switchback on ATP programming is shown in Figure 183 ChargeSaver feature If the ChargeSaver option is programmed to On the device can automatically switch from ATP During Charging operation to ATP Before Charging operation This change occurs when ATP has successfully terminated the detecte...

Page 360: ... calculated from the ventricular cycle length 60 ms if this interval is at least as long as the programmed VF detection interval The interval is provided by the Confirmation option nominally programmed to On and is used when the ventricular rhythm is stable the programmed VT Interval 60 ms or the programmed VF Interval if VT Detection is programmed to Off This interval is used if Confirmation is t...

Page 361: ...sence of VF If VF persists the device attempts to synchronize the defibrillation therapy to the second ventricular tachyarrhythmic event that occurs after charging ends provided that it is outside the ventricular refractory period and the atrial vulnerable period If this fails the device then attempts to synchronize the defibrillation therapy to the next ventricular tachyarrhythmic event that occu...

Page 362: ...nchronization is not possible the device delivers the defibrillation therapy asynchronously Once the capacitors are charged to the programmed energy the device starts a 900 ms synchronization window If a qualified sensed ventricular event occurs during this window the device delivers the defibrillation therapy synchronized to the event Otherwise the device delivers the therapy asynchronously after...

Page 363: ... therapy that is delivered in response to a detected VF Suspending VT detection helps avoid detecting transient VTs that can follow high voltage therapies For information about Combined Count detection refer to Section 8 2 Detecting ventricular tachyarrhythmias page 304 Immediately after delivering the shock the device starts a post shock blanking period of 520 ms After the post shock blanking per...

Page 364: ...ve Can feature is not used the device delivers defibrillation and cardioversion therapies between the RV Coil HVB and SVC Coil HVX electrodes only To ensure that the device can deliver defibrillation and cardioversion therapies make sure a supplementary HVX electrode is implanted and connected to the device before programming the Active Can SVC Coil parameter to Can Off Active Can SVC Coil The pro...

Page 365: ...s also programmed to On 9 1 4 Programming VF therapies The first set of programming instructions includes the ATP parameters for VF therapy Rx1 This example shows how to program one sequence of Ramp ATP Refer to Section 9 2 Treating VT and FVT episodes with antitachycardia pacing therapies page 368 for instructions on programming Burst and Ramp Select Params icon VF Therapies VF Therapy Status On ...

Page 366: ...lysis of interrogated data since the last session and programmed parameters If related informationaboutanobservationisavailable youcanselecttheobservationandthenselect the Observations button to view the related information For detailed information about viewing and interpreting all of the information available from the Quick Look II screen see Section 6 2 Viewing a summary of recently stored data...

Page 367: ...s and aborted charges for the prior session the last session and the device lifetime VT VF Therapy Efficacy Since Last Session For VF FVT and VT therapies the counters report the number and types of therapies that were delivered and successful The VT Therapy counter includes VT episodes that accelerated during the therapy or were redetected as an FVT or VF episode The FVT therapy counter includes ...

Page 368: ...P therapies The device can deliver up to 6 therapies to treat a VT or FVT episode You can program the device to deliver ATP therapies before delivering the first cardioversion therapy for each type of episode This may allow the device to terminate a ventricular tachycardia episode using an ATP therapy delivering cardioversion therapy only if the ATP therapy is unsuccessful ATP therapy options are ...

Page 369: ...ATP Rx Sequence 1 Sequence 2 Last sequence Sequence 3 Rx2 For an overview of ventricular ATP sequence delivery see Figure 189 Figure 189 Overview of ventricular ATP sequence delivery Deliver ATP sequence Ventricular tachycardia detected Monitor for ventricular tachycardia The V Amplitude V Pulse Width and V Pace Blanking parameters are the same for all ventricular ATP therapies These parameters ar...

Page 370: ...ice skips the rest of the ATP therapy and delivers the next programmed ATP or cardioversion therapy If the device detects an FVT episode it delivers the next programmed cardioversion therapy 9 2 2 2 Burst pacing therapy The programmable parameter Initial Pulses sets the number of pulses in all sequences of a Burst therapy R S1 Interval RR and Interval Dec are programmable parameters that control B...

Page 371: ...e fails to terminate the VT episode 3 The device redetects the VT episode 4 The second Burst sequence is delivered with a pacing interval of 280 ms the interval decrement being 10 ms per sequence This sequence terminates the VT episode 9 2 2 3 Ramp pacing therapy The programmable parameter Initial Pulses sets the number of pulses in the first Ramp sequence Ramp pacing intervals are controlled by t...

Page 372: ... T P T P T P T P T P T P T D 3 1 0 3 0 0 2 9 0 2 8 0 2 7 0 2 6 0 2 5 0 2 4 0 3 8 0 3 5 0 3 5 0 3 5 0 3 5 0 3 5 0 3 5 0 3 5 0 3 5 0 A S A S A S A S A S A S A S A S V S A R A R A R A R A R A R A R A R A P T S T S T S T S T S T P T P T P T P T P T P T P T P T P T D 3 5 0 3 5 0 3 5 0 3 5 0 3 5 0 3 1 0 3 0 0 2 9 0 2 8 0 2 7 0 2 6 0 2 5 0 2 4 0 2 3 0 9 1 0 200 ms V V interval ECG Marker Channel V V inte...

Page 373: ...ntage The pacing interval for the second pulse in the sequence is determined by the S1S2 Ramp RR percentage Any remaining pulses in the sequence are delivered at a pacing interval using the S2SN Ramp RR percentage If the ventricular tachycardia is redetected the device applies the programmed percentages to the new ventricular tachycardia cycle length to determine the pacing intervals for the next ...

Page 374: ...e VT episode 4 The second Ramp therapy repeats the first 3 intervals and adds another pulse with a 220 ms interval which terminates the VT episode 9 2 2 5 Optimizing ventricular ATP therapies with Smart Mode Smart Mode is a programmable option for ventricular ATP therapies You can program Smart Mode to On for all or selected ATP therapies for the first 4 VT or FVT therapies When Smart Mode is prog...

Page 375: ...ersion therapy The final FVT therapy must always be programmed to cardioversion therapy Therapy aggressiveness VT and FVT therapies must be programmed to be increasingly aggressive For example you cannot program one VT therapy as cardioversion and a subsequent VT therapy as a ventricular ATP therapy Likewise a VT cardioversion therapy cannot be followed by another VT cardioversion therapy with a l...

Page 376: ...e Note Similar programming steps apply for Burst therapies for FVT episodes 9 2 4 2 Programming Ramp pacing therapy Select Params icon VT Therapies VT Therapy Status On Therapy Type Ramp Initial Pulses R S1 Interval RR Interval Dec Sequences Smart Mode Note Similar programming steps apply for Ramp therapies for FVT episodes Medtronic PROTECTA XT DR D314DRG 376 Clinician Manual ...

Page 377: ...tude V Pulse Width V Pace Blanking 9 2 5 Evaluation of ventricular ATP therapies 9 2 5 1 The Quick Look II screen The Quick Look II screen provides information about VT VF therapies Select Data icon Quick Look II Treated VT VF episodes This section includes a count of treated VT VF episodes You can select the Treated button to view the data for treated episodes Quick Look II observations The Quick...

Page 378: ...therapy counters The VT VF therapy counters provide information that helps you to evaluate the efficacy of ventricular ATP therapies The VT VF therapy counters include the VT VF Therapy Summary for the prior session the last session and the device lifetime VT VF therapy counters also include VT VF Therapy Efficacy Since Last Session Select Data icon Clinical Diagnostics Counters VT VF Rx Figure 19...

Page 379: ... the therapy or were redetected as an FVT or VF episode The FVT therapy counter includes FVT episodes that were redetected as a VF episode 9 2 5 3 Smart Mode operation indicators The VT VF therapy counters screen provides information about the operation of Smart Mode Select Data icon Clinical Diagnostics Counters VT VF Rx Figure 194 VT VF therapy counters screen 1 The label Off SM in the VT Therap...

Page 380: ... shock is required 9 3 1 System solution ventricular cardioversion The device can respond to a VT or FVT episode by delivering ventricular cardioversion therapy to the patient s heart Cardioversion like defibrillation is intended to terminate the episode by simultaneously depolarizing the heart tissue and restoring the patient s normal sinus rhythm However unlike defibrillation cardioversion requi...

Page 381: ...hythmia events Synchronize and deliver therapy or abort therapy Tachyarrhythmia detected 9 3 2 1 Delivering high voltage therapies To deliver a cardioversion therapy the device must first charge its high voltage capacitors to the programmed energy level The length of time required to charge the capacitors depends on the programmed energy level battery depletion and the length of time since the las...

Page 382: ...nt flows from the Active Can and SVC Coil to the RV Coil If the parameter is set to B AX this current flow is reversed 9 3 2 3 Confirming VT or FVT after detection When the device begins charging its capacitors for a cardioversion therapy it monitors the cardiac rhythm to ensure that the tachyarrhythmia remains present before delivering the therapy The device confirms the continued presence of the...

Page 383: ...hyarrhythmia changes the device aborts the therapy To deliver the cardioversion therapy the device attempts to synchronize it to a nonrefractory ventricular event that meets one of the following conditions The event is the second tachyarrhythmic ventricular event after charging and it is outside the atrial vulnerable period The event is the third tachyarrhythmic ventricular event Note The system d...

Page 384: ...ging the device delivers the cardioversion therapy The device confirms the presence of the detected tachyarrhythmia differently after charging than it does during charging After charging the device aborts the cardioversion therapy if one of the following events occurs a normal event in the ventricle 3 consecutive ventricular sensed intervals less than 200 ms The presence of short ventricular sense...

Page 385: ...the charge is delivered or aborted The pacing interval remains unchanged during this time After the cardioversion therapy is delivered the device monitors for the end of the episode or redetection Immediately after delivering the shock the device starts a post shock blanking period of 520 ms and resumes bradycardia pacing If the programmed pacing mode is an MVP mode AAIR DDDR or AAI DDD the device...

Page 386: ... HVX electrode is implanted and connected to the device before programming the Active Can SVC Coil parameter to Can Off Active Can SVC Coil The programmed setting for the Active Can SVC Coil parameter applies to all features that deliver high voltage shocks Energy Programming the cardioversion therapy energy level to an optimized value can terminate the tachyarrhythmia with an appropriate safety m...

Page 387: ... observations are based on an analysis of interrogated data since the last session and programmed parameters If related informationaboutanobservationisavailable youcanselecttheobservationandthenselect the Observations button to view the related information For detailed information about viewing and interpreting all of the information available from the Quick Look II screen see Section 6 2 Viewing ...

Page 388: ...ion the last session and the device lifetime VT VF Therapy Efficacy Since Last Session For VF FVT and VT therapies the counters report the number and types of therapies that were delivered and successful The VT Therapy counter includes VT episodes that accelerated during the therapy or were redetected as an FVT or VF episode The FVT therapy counter includes FVT episodes that were redetected as a V...

Page 389: ... accordance with your programming Refer to the following sections for information about atrial detection and therapies Section 8 1 Detecting atrial tachyarrhythmias page 295 Section 9 5 Treating AT AF episodes with antitachycardia pacing page 396 Section 9 6 Treating AT AF with atrial cardioversion page 407 9 4 2 Operation of atrial therapy scheduling The device schedules the delivery of automatic...

Page 390: ...rval contained 3 or more atrial sensed events or it contained 2 atrial sensed events with intervals less than the AT AF Interval The therapy is available at this point in the episode duration When automatic atrial CV therapies become available they have priority over the delivery of ATP sequences After all possible CV therapies have been delivered the remaining ATP sequences become available again...

Page 391: ...uations Rhythm Change one type of Reactive ATP subdivides the AT AF detection zone into smaller regions The ATP therapies programmed for the AT AF zone apply to each of the smaller regions in that zone Time Interval the other type makes all ATP therapies available at specific durations during an episode Rhythm Change For Rhythm Change the device detects changes in the regularity and cycle length o...

Page 392: ...on 9 4 5 Time Interval Time Interval allows the device to schedule additional ATP therapies regardless of rhythm changes All ATP sequences become available when the episode duration value reaches a multiple of the programmed Time Interval This applies to ATP therapies for both the AT AF zone and the Fast AT AF zone This function is available only within the first 48 hours of an atrial episode 9 4 ...

Page 393: ...er of short intervals indicates that the lead may no longer be positioned in the atrium If the lead check fails all atrial therapies are disabled until they are reprogrammed You can program this option using the Disable all atrial therapies if atrial lead position is suspect parameter 9 4 3 Programming considerations for atrial therapy scheduling Atrial therapies and AT AF Detection If all atrial ...

Page 394: ... the desired values for Episode Duration Before Rx Delivery ATP and Automatic CV 7 Select the desired Automatic CV Limits delivery window and maximum shocks per day 8 Select the desired values for Reactive ATP Rhythm Change and Time Interval 9 Select whether atrial therapies should be disabled if rate acceleration occurs or if the lead position is suspect 10 Select the desired value for Duration t...

Page 395: ...formation an episode summary an event sequence the number of atrial ATP sequences that were delivered in each Reactive ATP region the number of automatic CV shocks that were delivered if any the number of patient activated shocks that were delivered if any the programmed values for AT AF Detection Duration to Stop Reactive ATP Automatic CV limits and the EGM and Sensitivity settings Medtronic PROT...

Page 396: ...vice can deliver up to 3 ATP therapies to treat an AT AF or a Fast AT AF episode Atrial ATP therapies are Burst Ramp and 50 Hz Burst each with a programmable number of sequences All atrial ATP therapies are delivered in the AOO mode The device schedules the delivery of atrial therapies throughout a sustained AT AF episode based on the programmed settings An ATP therapy may be aborted if no atrial ...

Page 397: ...ction is suspended during the delivery of an atrial ATP therapy sequence Figure 204 Overview of atrial ATP therapy delivery Rx1 Rx2 Sequence 1 Sequence 2 Last sequence Sequence 1 Sequence 2 Last sequence Sequence 3 Sequence 3 Rx3 Sequence 1 Sequence 2 Last sequence Sequence 3 For an overview of atrial ATP sequence delivery see Figure 205 9 5 2 1 Atrial ATP therapy scheduling The device prepares to...

Page 398: ...mable A A Minimum ATP Interval parameter limits the pacing intervals at which the Burst and Ramp pacing pulses are delivered If some calculated intervals are shorter than the programmed A A Minimum ATP Interval the pulses are delivered at the A A Minimum ATP Interval If the median of the last 12 A A intervals is shorter than the programmed A A Minimum ATP Interval the device does not deliver Burst...

Page 399: ...S1 Pulses are delivered at the same pacing interval which is determined by the A S1 Interval AA percentage The first additional pulse is delivered at an interval determined by the S1 S2 AA percentage The pacing interval for the subsequent pulse is calculated by subtracting the S2 S3 Decrement value from the previous interval This pulse is delivered only if the S1 S2 AA parameter is programmed on I...

Page 400: ...0 2 3 0 2 3 0 2 3 0 2 7 0 2 7 0 2 7 0 2 7 0 8 1 0 2 7 0 T Dl T Dl T Dl T Dl V S V S 1 The device detects an AT AF episode 2 The first Burst sequence is delivered with 15 pulses at pacing intervals of 240 ms The sequence continues with 2 additional pulses at intervals shorter than 240 ms The interval is decremented by 10 ms for each additional pulse This sequence fails to terminate the AT AF episod...

Page 401: ...ample of Ramp pacing operation 200 ms 2 9 0 2 9 0 2 9 0 2 9 0 2 9 0 8 1 0 8 1 0 8 1 0 6 9 0 7 9 0 8 7 0 8 7 0 8 7 0 2 9 0 2 6 0 2 5 0 2 4 0 2 3 0 2 2 0 2 1 0 3 1 0 2 8 0 2 9 0 2 9 0 2 9 0 2 9 0 2 9 0 2 9 0 2 9 0 2 9 0 2 9 0 2 9 0 T Dl T Dl T Dl T Dl A S T P T P T P T P T P T P T S T S T S T S T S T S T S T S T S T S T S T S T Dl T Dl T Dl T Dl T Dl T Dl V S V S V S V S V S V S V S V S A EGM Marker...

Page 402: ... after each 50 Hz Burst therapy sequence VOO ventricular backup pacing is available during 50 Hz Burst therapy Figure 208 Example of 50 Hz Burst pacing operation 200 ms 2 7 0 2 7 0 2 7 0 2 7 0 2 7 0 2 7 0 2 7 0 2 7 0 1 0 0 8 1 0 8 1 0 1250 8 3 0 8 2 0 8 1 0 2 1 0 2 6 0 2 7 0 2 7 0 2 7 0 2 7 0 2 7 0 2 7 0 2 7 0 2 7 0 T Dl T Dl T Dl T Dl T Dl T Dl A S T P T S T S T S T S T S T S T S T S T S T S T Dl...

Page 403: ... Note VVI Backup Pacing could be competitive with intrinsic ventricular activity during the atrial ATP sequence 9 5 2 7 Automatically disabling atrial therapies In some situations the device may automatically disable or suspend an ATP therapy VT VF detection after an AT AF therapy delivery Atrial therapies are disabled if VT VF is detected immediately after an AT AF therapy is delivered In this ca...

Page 404: ...n the AT AF Detection and Therapies window 9 5 4 1 Programming Burst pacing therapy Select Params icon AT AF Therapies AT AF Rx Anti Tachy Pacing ATP AT AF Rx Status On Therapy Type Burst Initial S1 Pulses A S1 Interval AA S1 S2 AA S2 S3 Decrement Interval Decrement Sequences Note Similar programming steps apply for Burst therapies for Fast AT AF episodes 9 5 4 2 Programming Ramp pacing therapy Se...

Page 405: ...ing Amplitude A Pacing Pulse Width VVI VOO Backup Pacing VVI VOO Backup Pacing Rate 9 5 5 Evaluation of atrial ATP therapies 9 5 5 1 The Quick Look II screen Select Data icon Quick Look II Treated AT AF episodes This section includes a count of treated AT AF episodes You can select the Treated button to view the data for treated episodes Quick Look II observations The Quick Look II observations ar...

Page 406: ... high voltage atrial therapies Select Data icon Clinical Diagnostics Counters AT AF Rx Figure 209 AT AF therapy counters The following therapy counter data is available for atrial ATP therapies AT AF therapies This counter reports the number of AT AF episodes treated per programmed therapy and the percentage of successfully terminated episodes per programmed therapy Fast AT AF therapies This count...

Page 407: ...y delivering atrial cardioversion therapy to the patient s heart Cardioversion is intended to terminate the episode by simultaneously depolarizing the heart tissue and restoring the patient s normal sinus rhythm Atrial cardioversion is delivered automatically when it is scheduled by the device Optionally it can be delivered when the patient uses the patient assistant to request it For related info...

Page 408: ... capacitor formation The delivered energy level is programmed independently for each cardioversion therapy Cardioversion pulses use a biphasic waveform in which the current pathway for the high voltage pulse is reversed midway through the pulse delivery Refer to Section A 4 Energy levels and typical charge times page 450 for the following information typical full energy capacitor charging periods ...

Page 409: ...ly or in combination B refers to the HVB electrode The Pathway setting defines direction of current flow during the initial segment of the biphasic waveform If the parameter is set to AX B current flows from the Active Can and SVC Coil to the RV Coil If the parameter is set to B AX this current flow is reversed 9 6 2 3 Scheduling an automatic atrial cardioversion The device schedules an automatic ...

Page 410: ...atment of atrial tachyarrhythmias in patients with complete heart block Figure 211 Atrial cardioversion synchronization A b V S A R A b A R A b A R A S A S A S A S A S A S A S A S A S A S C D A P A P 200 ms 4 8 0 2 4 0 2 4 0 2 4 0 2 4 0 2 4 0 2 4 0 2 4 0 2 4 0 2 4 0 2 4 0 2 4 0 2 4 0 2 5 0 2 5 0 2 5 0 2 5 0 1 5 0 9 0 0 1120 1000 1200 4 8 0 4 8 0 4 8 0 4 8 0 4 9 0 5 0 0 5 0 0 9 8 0 V S V S C E V R ...

Page 411: ... the Post Shock Pacing parameters The device resumes monitoring for atrial tachyarrhythmias after the next paced or sensed ventricular event If the device redetects the AT AF episode before the episode ends it attempts to synchronize and deliver the programmed therapy that was aborted However if the episode ends the device resumes normal detection Note If the device aborts the cardioversion therap...

Page 412: ... CV Automatic CV Status On Energy Pathway Minimum R R Interval Active Can SVC Coil Note Similar programming steps apply for Automatic CV therapies for Fast AT AF episodes 9 6 5 Evaluation of atrial cardioversion 9 6 5 1 The Quick Look II screen The Quick Look II screen provides information about AT AF therapies Select Data icon Quick Look II Treated AT AF episodes This section includes a count of ...

Page 413: ...for therapies delivered since the last session The counters also include data about atrial ATP therapies Select Data icon Clinical Diagnostics Counters AT AF Rx Figure 212 AT AF therapy counters For high voltage therapies the following therapy counter data is available Automatic Shocks Reports the number of automatic atrial shocks delivered and the number failed Patient Activated Shocks Reports th...

Page 414: ...formation see the following sections Section 8 1 Detecting atrial tachyarrhythmias page 295 Section 9 6 Treating AT AF with atrial cardioversion page 407 For additional information about the Model 2696 InCheck Patient Assistant refer to the manual provided with it 9 7 2 Operation of patient activated atrial cardioversion To request atrial cardioversion the patient first uses the patient assistant ...

Page 415: ...ating AT AF with atrial cardioversion page 407 9 7 2 1 Delivery conditions for patient activated atrial cardioversion For a patient activated atrial cardioversion to become pending the following conditions must be met The device is programmed to allow patient activated atrial cardioversion therapy The request for cardioversion therapy is received during an AT AF episode A ventricular episode or VT...

Page 416: ...lanking period the device resumes bradycardia pacing If the programmed pacing mode is an MVP mode AAIR DDDR or AAI DDD the device operates in DDDR or DDD mode for 1 min after a cardioversion therapy In other cases the device operates in the programmed pacing mode The pacing amplitude and pulse width settings are controlled by Post Shock Pacing parameters For more information refer to Section 7 16 ...

Page 417: ...the Active Can feature is not used the device delivers defibrillation and cardioversion therapies between the RV Coil HVB and SVC Coil HVX electrodes only To ensure that the device can deliver defibrillation and cardioversion therapies make sure a supplementary HVX electrode is implanted and connected to the device before programming the Active Can SVC Coil parameter to Can Off Active Can SVC Coil...

Page 418: ...es feature is programmed On the device skips therapies or modifies high voltage energy levels to ensure that each therapy delivered during a ventricular tachyarrhythmia episode is at least as aggressive as the previous therapy 9 8 2 Operation of Progressive Episode Therapies Each time the device delivers a therapy during a ventricular tachyarrhythmia episode Progressive Episode Therapies adjusts t...

Page 419: ...ring Charging However if ATP Before Charging is enabled the device skips the ATP sequence before charging and only delivers an ATP sequence during charging 9 8 3 Programming Progressive Episode Therapies Select Params icon VF Therapies Shared Settings Progressive Episode Therapies 9 8 4 Evaluation of Progressive Episode Therapies 9 8 4 1 Treated VT VF episode text Select Data icon Clinical Diagnos...

Page 420: ...isodes Plot The interval or rate plot for a ventricular tachyarrhythmia episode shows how the ventricular rate varied during an episode and how the rate compared to the programmed VF Interval Rate FVT Interval Rate and VT Interval Rate values This plot is also annotated with each therapy delivered during the episode allowing you to compare the delivered therapies to the detected rhythm Medtronic P...

Page 421: ...res that the high voltage capacitors are fully formed on a regular basis 9 9 2 Operation of Automatic Capacitor Formation Automatic Capacitor Formation forms the capacitors fully at regular intervals The capacitors are fully formed by charging the capacitors to full energy and allowing the charge to dissipate for at least 10 min The system records the date and time of each formation After each for...

Page 422: ...in The resulting full capacitor formation restarts the Minimum Auto Cap Formation Interval Extending the interval When a full energy charge is delivered or dumped prematurely before 10 min elapses the interval is automatically extended 2 months due to the resulting partial capacitor formation Therefore the device extends the capacitor formation interval with each partial formation as illustrated i...

Page 423: ...s to reduce the device charge time For more information about manually forming the capacitors see Section 10 6 Testing the device capacitors page 434 Reprogramming the interval When you reprogram the Minimum Auto Cap Formation Interval always confirmthecharge time isacceptableforthedevice Forchargetimedetails see Section A 4 Energy levels and typical charge times page 450 Either perform a manual c...

Page 424: ...evice longevity page 197 9 9 4 Programming the automatic capacitor formation interval Select Params icon VF Therapies Auto Cap Formation Minimum Auto Cap Formation Interval 9 9 5 Evaluation of charge time To evaluate the current charge performance of the device review the charge time and date displayed on the Battery and Lead Measurements screen For more information see Section 6 13 Viewing detail...

Page 425: ... and ensuring the patient is at this rate before inhibiting pacing This may help avoid sudden changes in the ventricular rate support Tachyarrhythmia detection suspended Tachyarrhythmia detection is suspended during the Underlying Rhythm Test 10 1 2 How to perform an Underlying Rhythm Test 1 Select Tests Underlying Rhythm 2 Press and hold INHIBIT Press and Hold Pacing is inhibited until this butto...

Page 426: ...lds in the two lead system The device provides independently selected outputs for Atrial and RV pacing The Atrial and RV thresholds may be measured separately and individual safety margins applied to each threshold Note Tachyarrhythmia detection is suspended during a Pacing Threshold Test 10 2 2 How to measure pacing thresholds 1 Select Tests Pacing Threshold 2 Select values for Test Type Chamber ...

Page 427: ... values select Amplitude or Pulse Width in the Permanent column on the Test Results window The Capture window opens In the Capture window select the desired values and select OK On the next window select PROGRAM 10 To print a Pacing Threshold Test Report select Print 10 3 Testing the Wavelet feature The Wavelet feature is designed to discriminate between rapid SVT and VT VF episodes by comparing a...

Page 428: ... 1 1 Considerations for evaluating a template Select temporary pacing settings To increase the likelihood that sensed events will occur during the test you can select temporary pacing settings that evoke the patient s intrinsic rhythm Patient comfort Reduce the pacing rate gradually to minimize symptoms associated with abrupt changes in heart rate DOO VOO and AOO pacing modes The Wavelet test cann...

Page 429: ...rn to the programmed values 8 After the test completes you may select Details to view details about the stored template 10 3 2 Collecting a template You can use the Wavelet test to manually collect a template if one does not exist or if the existing template no longer matches the patient s intrinsic QRS morphology Certain factors such as a change in the patient s medication or disease progression ...

Page 430: ... the EGM signal exceeds the EGM2 programmed range you may need to increase the EGM2 Range to prevent clipping of the signal If the EGM signal occupies only a small fraction of the EGM amplitude range decrease the EGM2 Range so that the signal uses a larger portion of the range You canaccesstheEGM2RangebyselectingtheParamsiconandchoosingtheDataCollection Setup field After adjusting the EGM2 Range y...

Page 431: ...t enough matching EGM signals the programmer automatically displays the Template Collection Problem window which is then used to manually collect a template a Select Close and try to collect the template again If you cannot collect a template automatically then use the Template Collection Problem window to manually select a set of waveforms for the template b Refine the template by clearing the ch...

Page 432: ...nce 1 Select Tests Lead Impedance 2 Select START Measurement Wait for confirmation of programming and an in progress message 3 If necessary end the test by selecting STOP Lead impedance measurements are not updated from a test that is stopped 4 When the test is complete the new measured impedance values for the tested polarities are displayed You may determine if the lead impedance has changed by ...

Page 433: ...urement operations Sensing Test results may differ from those reported in the sensing amplitude trend data RV Sense Polarity The ventricular sensing electrodes included in Sensing Test measurements depend on the programmed RV Sense Polarity value Maximum measured value The maximum amplitude value that the Sensing Test can measure is 20 mV If the amplitude is over 20 mV the results are displayed as...

Page 434: ...harge remaining on the capacitors After the capacitors are charged the charge remains on the capacitors until the charge is dumped delivered by a cardioversion or defibrillation therapy or allowed to dissipate for at least 10 min The Charge Dump Test screen displays the date time charge time and energy values for the last time the device capacitors were charged to full energy from any starting ene...

Page 435: ...etrieve the charge time data from the device select RETRIEVE Data 6 Evaluate the charge time For more information see Section A 4 Energy levels and typical charge times page 450 If you determine the charge time is not acceptable for the patient allow the charge to dissipate for 10 min and perform the Charge Dump Test again a If the second charge time is acceptable consider reducing the Automatic C...

Page 436: ...ions Following a manual therapy detection must be resumed manually Following an induction detection is resumed either automatically or manually Following EP study manual therapies detection remains suspended until Resume is selected or until the programming head is removed from the implanted device Following EP study inductions detection is resumed automatically with one exception If Suspend was s...

Page 437: ... the device delivers a series of VOO pacing pulses to make the T wave timing more predictable The device then simultaneously delivers a shock with a T wave the refractory period of the cardiac cycle The device allows you to specify the characteristics of the pacing pulses and high voltage shock and to implement a delay between the final pacing pulse and the shock The T Shock induction interface in...

Page 438: ...r programming head over the device and the Resume at DELIVER check box is selected If an error message appears remove the magnet or programming head or clear the Resume at DELIVER check box 5 Accept the displayed test values or select new test values 6 To view and adjust VF detection and therapy parameters select Adjust Permanent 7 Select the Enable check box 8 Select DELIVER T Shock Note If the e...

Page 439: ...r inducing VF with 50 Hz Burst Warning Monitor the patient carefully when using an EP study function Have an external defibrillator ready for use when inducing any tachyarrhythmia An induced tachyarrhythmia may degenerate to ventricular fibrillation ATP Before Charging and ATP During Charging ATP Before Charging and ATP During Charging are automatically disabled for 30 s after delivery of a 50 Hz ...

Page 440: ... with an atrial 50 Hz Burst You may use an atrial 50 Hz Burst to induce AT AF To induce AT AF the 50 Hz Burst induction delivers a rapid burst of AOO pacing pulses to the atrium You may specify the amplitude and pulse width of these pulses but the pacing interval is fixed at 20 ms As long as you press and hold the 50 Hz BURST Press and Hold button on the programmer screen the device continues deli...

Page 441: ...on and therapy or clear the check box for manual therapy 6 Accept the displayed test values or select new test values 7 If you want to provide VOO Backup pacing during the pacing burst select values for VOO Backup 8 Press and hold 50 Hz BURST Press and Hold Release the button to end the induction 9 If necessary select ABORT to abort a therapy in progress 10 7 5 Inducing AT or VT with Fixed Burst Y...

Page 442: ...test value for atrial Amplitude is greater than 6 V 10 7 5 2 How to deliver a Fixed Burst induction Figure 223 Fixed Burst induction screen 1 Select Tests EP Study 2 Select Fixed Burst from the list of inductions and therapies 3 If the Select Chamber dialog box appears select Atrium or RV 4 If you want to treat the induced episode with a manual therapy select Suspend to prevent automatic detection...

Page 443: ...ervals You may specify the chamber amplitude pulse width and pacing intervals for the induction If you perform an atrial PES induction you may choose to have the device deliver VVI Backup pacing 10 7 6 1 Considerations for inducing AT or VT with PES Warning Monitor the patient carefully when using an EP study function Have an external defibrillator ready for use when inducing any tachyarrhythmia A...

Page 444: ...ythmia therapies you initiate from the programmer During EP testing you can use manual therapies to provide backup therapy At follow up appointments manual therapies may be helpful in assessing therapy effectiveness and making any necessary adjustments as part of chronic care The available manual therapies are Defibrillation Cardioversion Ramp Burst Ramp and Burst 10 8 1 Considerations Warning Mon...

Page 445: ... the device and the programmer When using wireless telemetry verify that at least 3 of the green lights on the wireless telemetry icon are illuminated For more information see Section 4 1 Note The telemetry link may be lost during the charging period for a high voltage therapy due to electrical noise Telemetry resumes after charging completes Temporary parameter values The manual therapy functions...

Page 446: ...nd delivers a biphasic shock which is synchronized to a sensed R wave if possible The device does not confirm the presence of VF before delivering the shock For more information about defibrillation see Section 9 1 Treating episodes detected as VF page 356 Ventricular cardioversion Manual ventricular cardioversion therapy charges the capacitors and attempts to synchronize the shock to a ventricula...

Page 447: ... the can surface c The radiopaque ID which includes a Medtronic identifier symbol can be viewed in a fluoroscopic image of the device dThese 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 225 Connector and suture holes 1 DF 1 connector port SVC ...

Page 448: ...itions 100 DDD pacing at 60 bpm 2 5 V atrial and RV pacing amplitude 0 4 ms pulse width 600 Ω pacing load and 6 full energy charges The EOS may be indicated before the end of 3 months if the device exceeds these conditions A 3 Projected service life The projected service life in years for the device is shown in Table 15 The data is based on pacing outputs programmed to the specified amplitude and ...

Page 449: ...mi annual On 6 1 4 9 6 3 5 2 6 7 5 8 Quarterly On 5 6 4 6 5 8 4 8 6 1 5 3 AAI DDD MVP mode 50 Atrial 5 Ven tricular Semi annual Off 7 5 7 0 7 6 7 1 7 8 7 4 Quarterly Off 6 8 6 3 6 8 6 4 7 0 6 7 Semi annual On 7 4 6 8 7 5 7 0 7 6 7 3 Quarterly On 6 6 6 2 6 7 6 3 6 8 6 5 a Maximum energy charging frequency may include full energy therapy shocks or capacitor formations Additional full energy charges ...

Page 450: ...5 3 s 3 J 3 5 J 0 7 s 22 J 25 J 4 8 s 2 J 2 3 J 0 4 s 20 J 23 J 4 4 s 1 8 J 2 1 J 0 4 s 18 J 20 J 4 0 s 1 6 J 1 9 J 0 4 s 16 J 18 J 3 5 s 1 4 J 1 7 J 0 3 s 15 J 17 J 3 3 s 1 2 J 1 5 J 0 3 s 14 J 16 J 3 1 s 1 0 J 1 2 J 0 2 s 13 J 15 J 2 9 s 0 8 J 0 9 J 0 2 s 12 J 14 J 2 6 s 0 6 J 0 7 J 0 1 s 11 J 13 J 2 4 s 0 4 J 0 5 J 0 1 s 10 J 11 J 2 2 s a Energy delivered at connector block into a 75 Ω load bEn...

Page 451: ... log 15 entries Monitored VT episode EGM markers and intervals 2 5 min Non sustained VT episode log 15 entries Non sustained VT episode EGM markers and intervals 2 min High Rate NS episode log 5 entries High Rate NS episode EGM markers and intervals 2 min Treated AT AF episode log 100 entries Treated AT AF episode EGM markers and intervals 8 25 min Monitored AT AF episode log 50 entries Monitored ...

Page 452: ...Monitored VT VT NS 4 beats High Rate NS PVC Runs 2 4 beats PVC Singles Runs of VRS Paces Single VRS Paces Counts of each type of SVT episode VT VF therapy withheld AFib AFlutter Sinus Tach Other 1 1 SVTs Wavelet V Stability Onset Counts of each type of V Oversensing epi sode VT VF therapy withheld V Oversensing TWave V Oversensing Noise Medtronic PROTECTA XT DR D314DRG 452 Clinician Manual ...

Page 453: ... AF episode counters The AT AF episode counters are maintained for the current follow up session and the previous follow up session AT AF summary data of Time AT AF Average AT AF time day Monitored AT AF Episodes Treated AT AF Episodes Pace Terminated Episodes of Time Atrial Pacing of Time Atrial Intervention AT NS 6 beats Number of AT AF episodes Grouped by durationa Grouped by start timea a This...

Page 454: ...mber of AT AF episodes treated and the percentage of episodes terminated Grouped by detection zone and therapy Grouped by atrial cycle length Counts of different types of AT AF therapy ATP sequences delivered aborted Automatic Shocks delivered failed Patient Activated Shocks delivered failed Medtronic PROTECTA XT DR D314DRG 454 Clinician Manual ...

Page 455: ... date Voltage Last Capacitor Formation date Charge Time Energy Last Charge date Charge Time Energy Sensing Integrity Counter Since date Short V V Intervals Atrial Lead Position Check Lead Impedance A Pacing RV Pacing RV Defib SVC Defib Sensing P Wave Amplitude R Wave Amplitude Last High Voltage Therapy date Measured Impedance Delivered Energy Waveform Pathway Medtronic PROTECTA XT DR D314DRG Clini...

Page 456: ...ac Compass trend data is available only as a printed report The report shows up to 14 months of long term clinical trends Each report contains the following information Programming interrogation and remote session events with date and event annotations One or more shocks per day Treated VT VF episodes per day Ventricular rate during VT VF Non sustained VT episodes per day AT AF total minutes or ho...

Page 457: ...tion fraction and date measured Number of treated VT VF episodes V Pacing Number of AT AF episodes Atrial Pacing Time in AT AF List of observations Programming interrogation and remote session events with date and event annotations OptiVol 2 0 fluid index Thoracic impedance One or more shocks per day Treated VT VF episodes per day AT AF total minutes or hours per day Ventricular rate during AT AF ...

Page 458: ...ys the AS VS AS VP AP VS and AP VP event sequence data If a single chamber mode was programmed the report displays the percent of time spent pacing and sensing MVP modes AAIR DDDR and AAI DDD are considered dual chamber modes for this purpose bIf more than 2 of atrial sensed events are identified as far field R waves the general percentage range either 2 to 5 or 5 is reported above the atrial rate...

Page 459: ...is Off V Rate Stabilization Off a If the Active Can SVC Coil parameter is set to Can Off the HVA Can electrode is not used as part of the high voltage delivery pathway If the Active Can SVC Coil parameter is set to SVC Off the HVX SVC electrode is not used as part of the high voltage delivery pathway bIf the programmed RV Amplitude is 8 V VVI pacing is delivered at 8 V with a pulse width of 1 2 ms...

Page 460: ...rval Rate a 280 290 360 650 ms 360 ms 400 ms VT Initial Beats to Detect 12 16 52 76 100 16 16 VT Beats to Redetect 8 12 52 12 12 VT Monitor Monitor Off Off Off VT Monitor Interval Rate a 280 290 450 650 ms 450 ms 450 ms Monitored VT Beats to Detect 16 20 56 80 110 130 20 20 PR Logic Wavelet AF Aflb On Off Off Off Sinus Tachb On Off Off Off Other 1 1 SVTs On Off Off Off Wavelet Waveletb On Off Moni...

Page 461: ...lies to all sensing in this chamber for both tachyarrhythmia detection and bradycardia pacing operations dCarefully evaluate the possibility of increased susceptibility to EMI and oversensing before changing the sensitivity threshold to its minimum most sensitive setting of 0 15 mV When susceptibility to modulated interference is tested under the conditions specified in CENELEC standard EN 45502 2...

Page 462: ...C Coilc Can SVC On Can Off SVC Off Can SVC On Can SVC On Automatic CV Limits Delivery Window Start Time 00 00 01 00 02 00 03 00 23 00 03 00 03 00 Delivery Window Length 1 2 3 4 6 8 10 12 16 20 24 hr 1 hr 1 hr Maximum shocks per day 1 2 3 4 5 No Limit 1 1 Episode Duration Before Rx Delivery Episode Duration before CV 0 1 2 3 4 5 7 10 15 20 25 30 40 50 min 1 2 3 4 5 6 12 24 48 72 hr 7 days 6 hr 6 hr...

Page 463: ... Off Shared A ATP A A Minimum ATP Inter valb 100 110 120 130 400 ms 150 ms 150 ms A Pacing Amplitude 1 2 6 8 V 6 V 6 V A Pacing Pulse Width 0 1 0 2 1 5 ms 1 5 ms 1 5 ms VVI VOO Backup Pac ing Off On Always On Auto Enable On Auto Ena ble On Auto Ena ble VVI VOO Backup Pac ing Rate 60 70 120 bpm 70 bpm 70 bpm a If the Active Can SVC Coil parameter is set to Can Off the HVA Can electrode is not used ...

Page 464: ...210 240 300 ms 240 ms 240 ms Therapy Type Burst Ramp Ramp Burst Burst ChargeSaver On Off On On Switch when number of consecutive ATP successes equals 1 2 3 4 6 8 10 1 4 Smart Mode On Off On On VT FVT Therapy parameters VT Therapy Status On Off Off Off FVT Therapy Status On Off Off Off Therapy Type CV Burst Ramp Ramp Rx1 Burst Rx2 Rx6 CV Energy 0 4 0 6 1 8 2 3 16 18 20 22 24 25 26 28 30 32 35 J VT ...

Page 465: ...therapy parameters Initial Pulses 1 2 3 15 R S1 Interval RR 50 53 56 59 63 66 75 84 88 91 94 97 S1S2 Ramp RR 50 53 56 59 63 66 69 84 88 91 94 97 S2SN Ramp RR 50 53 56 59 63 66 84 88 91 94 97 Sequences 1 2 10 VT Therapies 3 FVT Therapies 1 Smart Modeb On Off Shared Settings V V Minimum ATP Inter val 150 160 200 400 ms 200 ms 200 ms V Amplitude 1 2 6 8 V 8 V 8 V V Pulse Width 0 1 0 2 1 5 ms 1 5 ms 1...

Page 466: ... Rate 80 85 130 175 bpm 130 bpm 120 bpm Paced AV 30 40 180 350 ms 180 ms 180 ms Sensed AV 30 40 150 350 ms 150 ms 150 ms PVARP Auto 150 160 500 ms Auto Auto Minimum PVARP 150 160 250 500 ms 250 ms 250 ms A Refractory Period 150 160 310 500 ms 310 ms 310 ms Table 34 Atrial parameters Parameter Programmable values Shipped Reset Atrial Amplitudea 0 5 0 75 3 5 5 5 5 6 8 V 3 5 V 4 V Atrial Pulse Widthb...

Page 467: ...width W depends on the load Rload in Ohms and programmed pulse width Wp in seconds W Wp 34 µs and W the smaller of Wp 16 µs or 124 µs 4 µs x Rload c With a 40 ms sine2 waveform When using the CENELEC waveform the rated sensing threshold value will be 1 5 times the rated sine2 sensing threshold dThis setting applies to all sensing in this chamber for both tachyarrhythmia detection and bradycardia p...

Page 468: ...sponse Pacing parameters Parameter Programmable values Shipped Reset Upper Sensor Rate 80 85 120 175 bpm 120 bpm 120 bpm ADL Rate 60 65 95 170 bpm 95 bpm 95 bpm Rate Profile Optimization On Off On Off ADL Response 1 2 3 4 5 3 3 Exertion Response 1 2 3 4 5 3 3 Activity Threshold Low Medium Low Medium High High Medium Low Medium Low Activity Acceleration 15 30 60 s 30 s 30 s Activity Deceleration Ex...

Page 469: ... 120 bpm 80 bpm 65 bpm Overdrive Duration 0 5 1 2 3 5 10 20 30 60 90 120 min 10 min 10 min Table 44 Conducted AF Response parameters Parameter Programmable values Shipped Reset Conducted AF Response Off On Off Off Response Level Low Medium High Medium Medium Maximum Rate 80 85 110 130 bpm 110 bpm 110 bpm Table 45 Ventricular Rate Stabilization parameters Parameter Programmable values Shipped Reset...

Page 470: ... x Rload Table 48 Rate Drop Response parameters Parameter Programmable values Shipped Reset Rate Drop Responsea On Off Off Off Detection Type Drop Low Rate Both Drop Drop Drop Size 10 15 25 50 bpm 25 bpm 25 bpm Drop Rate 30 40 60 100 bpm 60 bpm 60 bpm Detection Window 10 15 20 25 30 s 1 1 5 2 2 5 min 1 min 1 min Detection Beats 1 2 3 beats 3 beats 3 beats Intervention Rate 70 75 100 150 bpm 100 bp...

Page 471: ... Burden Alert Enable Off Observation only On Off Observa tion only Off Observa tion only Avg V Rate During AT AF Alert Enable Off Observation only On Off Observa tion only Off Observa tion only Patient Home Monitor AT AF Daily Burden Alert Enablec Off On Off Off Avg V Rate During AT AF Alert Enablec Off On Off Off Shared Device Tone and Patient Home Monitor AT AF Daily Burden 0 5 1 2 6 12 24 hours...

Page 472: ...or is programmed to Yes dNote that VF VT and FVT therapies could be delivered during a single episode from initial detection until episode termination Table 53 Lead Device Integrity Alerts Parameter Programmable values Shipped Reset RV Lead Device Tone Alert Urgencya Low High High RV Lead Integrity Enable On Off On Off RV Lead Noise Enable On Off On Off Patient Home Monitor RV Lead Integrity Enabl...

Page 473: ...000 3000 Ω 3000 Ω 3000 Ω RV Defibrillation Impedance Less than 20 30 40 50 Ω 20 Ω 20 Ω RV Defibrillation Impedance Greater than 100 130 160 200 Ω 200 Ω 200 Ω SVC Defibrillation Impe dance Less than 20 30 40 50 Ω 20 Ω 20 Ω SVC Defibrillation Impe dance Greater than 100 130 160 200 Ω 200 Ω 200 Ω Low Battery Voltage RRT Device Tone Alert Enable Urgency Off On Low On High On High Off Patient Home Moni...

Page 474: ...ble values Shipped Reset LECG Source Leadless ECG a Can to SVC b c RVcoil to Aring Can to SVC Can to SVC LECG Range Leadless ECG 1 2 4 8 12 16 32 mV 2 mV 8 mV EGM 1 Source RVtip to RVcoil RVtip to RVring Atip to RVring Atip to Aring Aring to RVring Aring to RVcoil Atip to Aring Atip to Aring EGM 1 Range 1 2 4 8 12 16 32 mV 8 mV 8 mV EGM 2 Wavelet Source Can to RVcoil Can to RVring RVtip to RVcoil ...

Page 475: ...ate Time clock B 8 System test parameters Table 56 System test parameters Parameter Selectable values Pacing Threshold Test parameters Test Type Amplitude Pulse Width Chamber Atrium RV Decrement after 2 3 15 pulses Modea RV test VVI VOO DDI DDD DOO Modea Atrium test AAI AOO DDI DDD DOO Lower Rateb 30 35 60 70 75 150 bpm RV Amplitude 0 25 0 5 5 5 5 6 8 V RV Pulse Width 0 03 0 06 0 1 0 2 1 5 ms A Am...

Page 476: ...rm Monophasic Biphasic Pathwaya AX B B AX a If the Active Can SVC Coil parameter is set to Can Off the HVA Can electrode is not used as part of the high voltage delivery pathway If the Active Can SVC Coil parameter is set to SVC Off the HVX SVC electrode is not used as part of the high voltage delivery pathway Table 58 50 Hz Burst induction parameters Parameter Selectable values Resume at Burst En...

Page 477: ...0 V Table 60 PES induction parameters Parameter Selectable values Resume at Deliver Enabled Disabled Chamber RV Atrium S1 1 2 8 15 S1S1 100 110 600 2000 ms S1S2 Off 100 110 400 600 ms S2S3 Off 100 110 400 410 600 msa S3S4 Off 100 110 400 410 600 msa Amplitude 1 2 3 4 5 6 8 V Pulse Width 0 10 0 20 0 50 1 50 ms VVI Backup for atrial PES On Off Pacing Rate 60 70 120 bpm V Amplitudeb c 0 50 0 75 5 00 ...

Page 478: ...thway If the Active Can SVC Coil parameter is set to SVC Off the HVX SVC electrode is not used as part of the high voltage delivery pathway Table 63 Shared manual ATP therapy parameters Parameter Selectable values Minimum Interval atrial ATP 100 110 120 130 400 ms Minimum Interval ventricular ATP 150 160 200 400 ms Amplitude 1 2 6 8 V Pulse Width 0 10 0 20 1 50 ms VVI Backup for atrial ATP therapy...

Page 479: ... 53 56 59 63 66 69 84 88 91 94 97 S2 SN RR 50 53 56 59 63 66 84 88 91 94 97 Table 67 Manual Burst therapy parameters Parameter Selectable values S1 Pulses 1 2 6 15 20 30 100 AA Interval 28 31 34 38 41 59 63 66 84 88 91 94 97 S1S2 Off 28 31 34 38 41 59 63 66 84 88 91 94 97 S2S3 Dec Off 0 10 20 80 ms B 10 Nonprogrammable parameters Table 68 Nonprogrammable parameters Parameter Value Premature event ...

Page 480: ... VVI VOO Backup Pacing pulse width 1 5 ms Fixed EP study parameters T Shock pacing amplitude 8 V T Shock pacing pulse width 1 5 ms 50 Hz burst pacing interval 20 ms Hardware parameters Pacing rate limitg protective feature 171 bpmh Input impedance 150 kΩ minimum Recommended Replacement Time RRT Battery Voltage Threshold 2 63 V a 35 ms when the ventricular pacing amplitude is programmed to 8 V bThe...

Page 481: ...r and ventricular tachyarrhythmia antitachycardia pacing ATP therapies that deliver rapid sequences of pacing pulses to terminate tachyarrhythmias AT AF Interval programmable interval used to define the AT AF detection zone The median atrial interval must be shorter than this value for an AT AF episode to be detected Atrial Preference Pacing APP atrial rhythm management feature that adapts the pac...

Page 482: ... AF episodes crosstalk condition when pacing in one chamber is sensed as intrinsic activity in another chamber Decision Channel annotations annotations to stored and telemetered EGM that document details about tachyarrhythmia detection operations defibrillation therapy intended to terminate a ventricular fibrillation episode by simultaneouslydepolarizingthehearttissueandrestoringthepatient snormal...

Page 483: ...resis a pacing operation and programmable parameter that allows a longer escape interval after a sensed event giving the heart a greater opportunity to beat on its own impedance total opposition that a circuit presents to electrical current flow the device lead impedances can be measured to assess lead system integrity Interrogate command to transmit the device parameter settings and stored data t...

Page 484: ...de from a dual chamber atrial tracking mode to a nontracking mode during an atrial tachyarrhythmia This feature prevents rapid ventricular pacing that may result from tracking a high atrial rate MVP Managed Ventricular Pacing atrial based pacing mode that is designed to switch to a dual chamber pacing mode in the presence of AV block MVP is intended to reduce unnecessary right ventricular pacing b...

Page 485: ... amplitude and pulse width to prevent loss of capture Post VT VF Shock Pacing feature that provides temporary overdrive pacing that may improve cardiac output after a high voltage therapy Pre arrhythmia EGM Storage also called EGM pre storage programmable option to record EGM from before the onset or detection of a tachyarrhythmia While this feature is operating the device records EGM continuously...

Page 486: ... status indicator displayed by the programmer to indicate when replacement of the device is recommended Sensed AV SAV interval programmable delay following an atrial sensed event that schedules a corresponding ventricular pace sensed event electrical activity across the sensing electrodes that exceeds the programmed sensitivity threshold and is identified by the device as a cardiac event Sensing I...

Page 487: ...tricular repolarization or T wave undersensing failure of the device to sense intrinsic cardiac activity Ventricular Rate Stabilization VRS ventricular rhythm management feature that eliminates a prolonged pause in the ventricular cycle following a premature ventricular contraction PVC Ventricular Safety Pacing VSP pacing therapy feature that prevents ventricular asystole due to inappropriate inhi...

Page 488: ...nsing measurements automatic 189 sensing measurements manual 432 sensing trends 190 Analyzer Model 2290 21 concurrent session 83 exporting lead measurements 83 lead measurements 113 annotations Decision Channel 90 Marker Channel 59 87 parameter programming 59 antitachycardia pacing atrial ATP therapies 396 ventricular ATP therapies 368 APP Atrial Preference Pacing 280 Arrhythmia Episode data episo...

Page 489: ...2 device check 241 Monitor setting 240 operation 240 pacing threshold search 241 parameters 467 scheduling 241 stopping a search 244 see also Capture Management atrial competition 267 atrial CV therapies automatic 407 aborted therapy 410 Active Can SVC Coil 409 411 asynchronous delivery 410 Automatic CV Limits 390 capacitor charging 409 considerations 411 delivered energy 408 evaluation 412 initia...

Page 490: ...ivery window 390 maximum shocks 390 automatic device status monitoring 194 Auto PVARP 253 considerations 255 operation 253 programming 256 auto resume detection 436 Available Reports window 106 AV conduction intrinsic and device longevity 197 how to promote 197 promoted by MVP 224 AVP see atrial vulnerable period B battery and lead measurement data 186 424 455 battery life 449 battery replacement ...

Page 491: ...ert CareAlert Notification 141 CareLink Monitor Model 2490C 21 car engine 36 cautery surgical 31 Charge Circuit Inactive 195 Charge Circuit Timeout 194 Charge Dump Test 434 performing 434 ChargeSaver 359 charge times details about 421 evaluating 424 434 optimizing 421 typical 450 Checklist icon 60 65 checklists and patient follow up 125 creating 67 deleting 69 editing 68 selecting 65 standard 65 6...

Page 492: ...ta 180 451 Heart Failure Management Report 154 457 lead impedance trends 456 lead performance trends 456 Medtronic CareAlert events 133 458 Quick Look II data 129 Rate Drop Response episodes 181 Rate Histograms Report 183 458 read from disk 94 retrieving 93 save to disk 93 saving 93 VT VF episode counters 176 452 VT VF therapy counters 177 453 Decision Channel annotations evaluating High Rate Time...

Page 493: ... source selecting 173 EGM strip see episode EGM electrical reset 195 responding to 196 electrical specifications projected service life 449 replacement indicators 448 electricity generator portable 36 electrograms EGM EGM Range setting 85 90 episode EGM 171 LECG Range setting 85 90 storage parameters 474 electrolysis 31 electromagnetic interference EMI 34 electronic antitheft systems 37 electronic...

Page 494: ...AF detection 302 evaluating Rate Response 237 evaluating VT VF detection 319 viewing 180 fluid index OptiVol 2 0 162 follow up patient assessing device and leads 127 assessing pacing therapy 127 assessing tachyarrhythmia detection 128 assessing tachyarrhythmia therapy 128 guidelines 125 optimizing capacitor charge time 421 reviewing battery and device status indicators 126 reviewing the presenting...

Page 495: ... Hz Burst ventricular 439 considerations 436 Fixed Burst 441 parameters 476 PES 443 T Shock 437 industrial equipment 36 informational messages 71 information patient 80 initial detection AT AF detection 295 VT VF detection 305 Initial Interrogation parameters set 76 Initial Interrogation Report 106 instructions programming 10 intended use 22 interlock messages 71 Interrogate button 61 interrogatio...

Page 496: ... for ARS pacing pulses 279 in episode EGM data 171 in real time waveform recordings 87 pacing 88 therapies 89 Match Threshold 326 Medical Implant Communications Service MICS Band 20 Medical Implant Communications Service MICS band 45 Medtronic CareAlert Clinical Management Alerts 471 event summary 458 Lead Device Integrity Alerts 472 magnet application 451 programming considerations 140 shared par...

Page 497: ...mpedance measurements 162 operation 162 OptiVol 2 0 Fluid Index 157 162 OptiVol 2 0 Fluid Trends 162 OptiVol event log 166 OptiVol threshold 164 programming 164 see also Cardiac Compass Report OptiVol Threshold setting 163 Other 1 1 SVTs feature 322 over counting T waves see TWave Discrimination oversensing 141 209 oversensing discrimination 314 P Paced AV interval 214 see also Rate Adaptive AV pa...

Page 498: ...hock Pacing 470 Post VT VF Shock Pacing 469 PVC Response 471 Rate Adaptive AV 468 Rate Drop Response 470 Rate Hysteresis 471 Rate Response 468 rates 466 RV pacing 467 shared Medtronic CareAlert parameters 474 Sleep feature 470 system test 475 ventricular therapies 464 VRS 469 V Safety Pacing 471 VT Monitor 459 VT VF detection 459 Parameters screen programming parameters 70 secondary 73 viewing par...

Page 499: ...e parameters 474 preferences programmer Initial Reports 106 printing 102 reports 102 tests 102 printer full size 106 programmer 106 programmer strip chart recorder 106 printing see reports see strips waveform printing preferences 102 Print Later button 106 Print Now button 106 Print Options window 106 bypassing 102 Print Options button 102 Print Queue 107 Print button 102 PR Logic 321 AF AFl featu...

Page 500: ...bol 447 radiotherapy device operational errors 33 oversensing 32 radio transmitters 37 Ramp pacing atrial ATP therapies 400 ventricular ATP therapies 371 Ramp pacing 373 Rate Adaptive AV 251 considerations 252 operation 251 Paced AV interval 214 parameters 468 programming 253 Sensed AV interval 214 Rate Drop Response 256 considerations 260 Drop Detection 257 episodes viewing 182 evaluation 260 int...

Page 501: ... Report 106 Rate Histograms Report 183 setting print options 106 Reports icon 60 103 reports preferences 102 reset parameters see parameters programmable resterilization device 23 Resume button 355 444 resuming detection 354 and EP study inductions 436 RF ablation 29 354 Rhythm Change Reactive ATP 391 Right Ventricular Capture Management RVCM 244 amplitude adjustment 246 device check 245 operation...

Page 502: ... size device 447 Sleep feature 264 considerations 265 evaluation 266 operation 265 parameters 470 programming 266 Sleep Rate 265 Smart Mode 360 368 software application 20 sources EGM 173 Stability feature 340 considerations 341 evaluation 342 operation 340 programming 341 VT Monitor events 341 status bar programmer 58 stereotaxis 33 storage device 24 stored data see data stored stored energy 450 ...

Page 503: ...tiVol 2 0 Fluid Status Monitoring 161 thresholds pacing 425 after shock therapies 277 Capture Management 239 threshold testing see Pacing Threshold Test time charge 450 Time Interval Reactive ATP 392 tones see alert tones see Medtronic CareAlert events torque wrench 115 traces waveform 59 84 adjusting 85 86 freezing 90 tracking pacing modes 214 Transcutaneous electrical nerve stimulation TENS 33 T...

Page 504: ...Active Can SVC Coil 358 and Progressive Episode Therapies 418 ATP Before Charging 358 ATP During Charging 358 canceling the therapy 360 ChargeSaver feature 359 Confirmation parameter 360 confirming presence of VF 360 considerations 364 current pathway 358 emergency 62 evaluation 366 initial synchronization 361 operation 356 pacing during and after defibrillation 363 parameters 464 programming 365 ...

Page 505: ...evice 24 waveform strips live recalling 92 recording 90 waveform traces 59 84 freezing 90 Wavelet 326 concurrent pacemaker 328 considerations 328 EGM2 channel 326 evaluating a template 428 evaluation 331 Match Threshold 326 operation 326 programming 330 template collection 328 template collection manual 428 Wavelet Monitor 331 Wavelet Test 427 collecting a template manually 429 evaluating a templa...

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Page 508: ... consultation for physicians and medical professionals Bradycardia 1 800 505 4636 Tachycardia 1 800 723 4636 Europe Africa Middle East Medtronic International Trading Sàrl Route du Molliau 31 Case Postale 84 CH 1131 Tolochenaz Switzerland Tel 41 21 802 7000 Fax 41 21 802 7900 Technical manuals www medtronic com manuals Medtronic Inc 2013 M950688A001B 2013 04 12 M950688A001 ...

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