ADAPTA / VERSA / SENSIA / RELIA™manuals.medtronic.com/content/dam/emanuals/crdm/CONTRIB_244… ·...

ADAPTA® / VERSA® / SENSIA® / RELIA™A family of implantable pulse generatorsPacemaker Reference Guide

Reference ManualCaution: Federal law (USA) restricts this device to sale by or on the order of a physician.

ADAPTA® / VERSA® / SENSIA® / RELIA™Reference Manual

A reference guide for Adapta/Versa/Sensia/Relia pacemakers

The following list includes trademarks or registered trademarks of Medtronic in the UnitedStates and possibly in other countries. All other trademarks are the property of their respectiveowners.Achieve, Adapta, Capture Management, Intrinsic, Marker Channel, Medtronic, MVP,Quick Look, QuickLink, Relia, Sensia, TherapyGuide, Versa

Contents

1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 92 Pacing modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 112.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 112.2 Rationale for mode selection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 132.3 MVP modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 132.4 DDDR mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 132.5 DDD mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 152.6 DDIR mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 162.7 DDI mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 172.8 DVIR mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 182.9 DVI mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 182.10 VDD mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 192.11 AAIR / ADIR modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 202.12 AAI / ADI modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 212.13 VVIR / VDIR modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 222.14 VVI / VDI modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 232.15 AAT / VVT modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 242.16 DOOR / AOOR / VOOR modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 252.17 DOO / AOO / VOO modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 262.18 ODO / OAO / OVO modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 273 Rate response . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 283.1 Introduction to rate responsive pacing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 283.2 Preset rate response at implant . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 293.3 Rate Profile Optimization operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 303.4 Individualizing Rate Profile Optimization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 363.5 Activity sensor operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 373.6 Manual control of Rate Profile Optimization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41

Medtronic ADAPTA® / VERSA® / SENSIA® / RELIA™

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4 Pacemaker timing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 434.1 Rates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 434.2 AV intervals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 504.3 Rate Adaptive AV . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 524.4 Search AV+ and diagnostic . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 554.5 Blanking periods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 584.6 Refractory periods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 604.7 High rate atrial tracking . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 685 Lead/cardiac tissue interface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 715.1 Implant Detection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 715.2 Automatic polarity configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 725.3 Lead Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 765.4 Lead impedance data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 785.5 Capture Management and diagnostic . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 795.6 Sensing Assurance and diagnostic . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 995.7 Manually selecting pacing parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1035.8 Manually selecting sensing parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1055.9 Transtelephonic follow-up features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1086 Special therapy options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1116.1 Mode Switch and diagnostic . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1116.2 Managed Ventricular Pacing (MVP) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1176.3 Conducted AF Response . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1226.4 Non-competitive atrial pacing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1236.5 PMT intervention . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1256.6 PVC Response . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1276.7 Ventricular Safety Pacing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1296.8 Sinus Preference . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1306.9 Atrial Preference Pacing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1336.10 Rate Drop Response and diagnostic . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1376.11 Sleep Function . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1436.12 Single Chamber Hysteresis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1457 Telemetry data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1477.1 Establishing telemetry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 147


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7.2 Parameter summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1477.3 Patient information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1497.4 Using TherapyGuide to select parameter values . . . . . . . . . . . . . . . . . . . . . . . . 1507.5 Battery and lead information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1517.6 Marker Channel telemetry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1537.7 Intracardiac electrograms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1547.8 Extended Telemetry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1568 Miscellaneous operations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1578.1 Magnet mode operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1578.2 Temporary programming . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1588.3 Electrical reset . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1598.4 Recommended Replacement Time (RRT/ERI) . . . . . . . . . . . . . . . . . . . . . . . . . 1618.5 Emergency pacing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1629 Diagnostics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1639.1 Introduction to diagnostics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1639.2 Heart Rate Histograms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1669.3 AV Conduction Histograms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1689.4 Search AV+ Histogram . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1709.5 Sensor Indicated Rate Profile . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1719.6 High Rate Episodes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1739.7 Ventricular Rate Histogram During Atrial Arrhythmias . . . . . . . . . . . . . . . . . . . . 1799.8 Atrial Arrhythmia Trend . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1809.9 Atrial Arrhythmia Durations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1819.10 Custom Rate Trend . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1819.11 Key Parameter History . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18310 Troubleshooting the pacing system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18510.1 Troubleshooting the pacing system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18510.2 Troubleshooting electrical problems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18510.3 Troubleshooting hemodynamic problems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 187A Emergency settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 189A.1 Emergency settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 189


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B Telemetry and diagnostic values . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 190B.1 Magnet Mode operations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 190B.2 Telemetry functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 191B.3 Automatic diagnostics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 193B.4 Clinician-selectable diagnostics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 194B.5 Cardiac event counters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 198C Rate Response programming guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 199C.1 Rate Response programming guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 199D Patient counseling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 201D.1 Patient counseling information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 201Glossary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 202Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 209


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1 Introduction

1.1 IntroductionThe information in the Adapta/Versa/Sensia/Relia Pacemaker Reference Guide (PRG)applies to the following Adapta/Versa/Sensia/Relia pacemakers:

● Adapta ADDR01/03/06● Adapta S ADDRS1● Adapta L ADDRL1● Adapta ADD01● Adapta ADVDD01● Adapta ADSR01/03/06● Versa VEDR01● Sensia SEDR01● Sensia L SEDRL1● Sensia SED01● Sensia SESR01● Sensia SES01● Relia REDR01● Relia RED01● Relia RESR01● Relia RES01● Relia REVDD01

1.1.1 How to use this guideProduct information about Adapta/Versa/Sensia/Relia pacemakers and the associatedsoftware for the programmer is presented in two separate guides.The Pacemaker Reference Guide (PRG) provides detailed information on the pacemakers.The Pacemaker Programming Guide (PPG) contains instructions on how to use theprogrammer and the programming software.


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1.1.1.1 About the Pacemaker Reference GuideThe Pacemaker Reference Guide (PRG) describes in detail how the pacemakers operateand specifies the capabilities of the pacemakers. The PRG includes the followinginformation:

● Describes the pacing modes, rate response options, special therapy features, telemetrytypes, and data collection options. In some cases, guidelines are given on how toconfigure the pacemaker operation.

● Contains troubleshooting information for electrical and hemodynamic problems.● Specifies parameter and data collection capabilities, longevity projections, and

mechanical and electrical specifications.● Provides general warnings and cautions, potential interference sources, and general

indications for pacing.● Contains a glossary of terms.

1.1.1.2 About the Pacemaker Programming GuideThe Pacemaker Programming Guide describes how to program Adapta/Versa/Sensia/Reliapacemakers using a programmer. The PPG presents the following information:

● How to set up and configure the programmer.● How to start a patient session, use the various follow-up features during the session, and

properly end the session.● How to view and print the patient’s ECG and EGM waveform traces.● How to configure the pacemaker to collect diagnostic data and how to retrieve and view

this information.● How to measure stimulation thresholds and sensing levels.● How to use TherapyGuide to obtain suggested parameter values.● How to program parameter values and verify rate response parameters settings.● How to run EP Studies.

1.1.1.3 The Implant Manuals supplement these guidesFor each pacemaker model in the Adapta/Versa/Sensia/Relia family, there is an implantmanual. The Pacemaker Programming Guide and the Pacemaker Reference Guide do notspecify which features apply to each individual pacemaker model. Refer to the applicableimplant manual for specific capabilities of individual models.


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2 Pacing modes

2.1 Introduction2.1.1 Pacing mode selectionThis chapter provides an introduction to pacemaker modes as an aid to pacing modeselection. The chapter is organized as follows:Definition of basic pacing modes – The names for most of the pacing modes are definedon the 1991 ACC/AHA guidelines for pacemaker implantation.1Rationale for mode selection – In order to get pacing mode suggestions, the use ofTherapyGuide is recommended. TherapyGuide is a programmer feature that suggestsparameter settings based on a patient’s clinical conditions. For models which do not containTherapyGuide, refer to the device implant manual for guidance in mode selection.Mode descriptions – These descriptions provide indications and contraindications formodes available with the pacemaker and brief descriptions of how these modes operate.

2.1.2 NBG pacing codesThe pacemaker modes are defined in NBG Code.2 Each five-letter NBG code describes aspecific type of operation for implantable pacemakers. For simplicity, this manual uses onlythe first three or four letters, such as DDD, DDIR, DVIR, and so forth. Figure 1 describes thefirst four letters of the NBG code.

1 Dreifus LS, Fisch C, Griffin JC, et al. Guidelines for implantation of cardiac pacemakers and antiarrhythmiadevices. A report of the American College of Cardiology/American Heart Association Task Force onAssessment of Diagnostic and Therapeutic Cardiovascular Procedures (Committee on PacemakerImplantation). Journal of the American College of Cardiology. 1991; 18: 1-13.

2 Bernstein A., et al., “The NASPE/BPEG Pacemaker Code,” PACE, 10(4), Jul-Aug 1987. (“NBG” stands for TheNorth American Society of Pacing and Electrophysiology [NASPE] and the British Pacing andElectrophysiology Group [BPEG] Generic. NBG’s five-letter code supersedes the ICHD Code.


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Figure 1. NBG pacing codesChamber Paced

Chamber Sensed

Mode of Response

Programmable/Rate Response

DDDR

V = Ventricle

A = Atrium

D = Dual Chamber

S = Single Chamber

O = None

T = Triggered

I = Inhibited

D = Double (both)

O = None

V = Ventricle

A = Atrium

D = Dual Chamber

S = Single Chamber

O = None

P = Programmable

M = Multiprogrammable

C = Communicating

R = Rate Responsive

O = None

2.1.3 Further informationThe mode descriptions in this chapter provide only a basic overview of each mode. Forfurther details on the rate response, timing, and therapy capabilities, refer to Section 3.1.1,“Rate response”, page 28, Chapter 4, “Pacemaker timing”, page 43, and Chapter 6,“Special therapy options”, page 111.


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2.2 Rationale for mode selectionTherapyGuide offers a simple clinically-focused method for a clinician to obtain suggestedparameter values. At implant or an early follow-up appointment, the clinician entersinformation about the patient’s clinical conditions. Based on those inputs the programmersuggests parameter settings. The suggestions are based on clinical studies, literature,current practice, and the consensus of physicians.TherapyGuide does not replace a physician’s expert judgment. The physician is free toaccept, reject, or modify any of the suggested parameter values.For more information about TherapyGuide, refer to Section 7.4, “Using TherapyGuide toselect parameter values”, page 150.For each pacemaker model, TherapyGuide suggests a programmable mode. It bases thesuggestion on clinical conditions such as the condition of the sinus node and the quality ofAV conduction.TherapyGuide offers a Rationale screen that shows the basis for each setting of pacingmodes and of other parameters. To access the screen, perform the following steps:

1. Interrogate the pacemaker (before or after implant).2. Select the Params icon. On the Therapy Parameters screen, select the [TherapyGuide]

button to open the TherapyGuide window.3. Select the [Rationale…] button to open the Rationale window.4. Select [Close] twice to return to the Therapy Parameters screen.

Note: It is not necessary to do any parameter programming at this time. Refer tothe Adapta/Versa/Sensia/Relia Pacemaker Programming Guide for instructions onprogramming parameters using TherapyGuide.

2.3 MVP modesTwo MVP modes are available: AAIR<=>DDDR and AAI<=>DDD.Note: For information about AAIR<=>DDDR and AAI<=>DDD modes, refer to Section 6.2,“Managed Ventricular Pacing (MVP)”, page 117.

2.4 DDDR modeNote: For information about the AAIR<=>DDDR mode, refer to Section 6.2, “ManagedVentricular Pacing (MVP)”, page 117.


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In the DDDR mode, the pacemaker tracks the faster of the intrinsic atrial rate or thesensor-indicated rate. If the intrinsic rate is faster, the DDDR mode provides atrialsynchronous pacing; otherwise, AV sequential pacing occurs at the sensor-indicated rate.

● Rate limits for atrial tracking (Upper Tracking Rate)3 and sensor tracking (Upper SensorRate) are separately programmable.

● The AV intervals that follow sensed atrial events (SAV) and paced atrial events (PAV) areseparately programmable, and they can be programmed to shorten with increasingrates (Rate Adaptive AV) or to change with intrinsic conduction times (Search AV+).

● A nonrefractory sensed event in either chamber inhibits pacing in that chamber. Aventricular nonrefractory sensed event in the VA interval that is not preceded by an atrialsense (AS or AR) is a pacemaker-defined PVC and starts a new VA interval.

Figure 2. Example of DDDR mode operation

VP

VS

VS

VP

AP

AS

AP

200 ms

AP

AS

VP

1 Sensor-indicated interval

Parameters:Lower Rate = 60 bpm (1000 ms) PAV Interval = 200 ms PVARP = 280 msSensor-indicated Rate =90 bpm (667 ms)

SAV Interval = 170 ms

3 The Total Atrial Refractory Period (TARP) may limit the tracking rate to a lesser value. Refer to Chapter 4,“Pacemaker timing”, page 43 for more information on TARP.


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2.5 DDD modeNote: For information about the AAI<=>DDD mode, refer to Section 6.2, “ManagedVentricular Pacing (MVP)”, page 117.The DDD mode provides atrial synchronous pacing in the presence of intrinsic atrial activity;otherwise, AV sequential pacing occurs at the Lower Rate.

● Each atrial paced or nonrefractory atrial sensed event starts an AV interval and a lowerrate interval. The AV intervals that follow sensed atrial events (SAV) and paced atrialevents (PAV) are separately programmable, and the SAV may be optionallyprogrammed to shorten with increasing rate (Rate Adaptive AV) or to change withintrinsic conduction times (Search AV+).

● A ventricular paced event may track an atrial sensed event up to the programmed UpperTracking Rate.4

● A ventricular nonrefractory sensed event in the VA interval that is not preceded by anatrial sense (AS or AR) is a pacemaker-defined PVC and starts a new VA interval.

Figure 3. Example of DDD mode operation

VP

VS

VS

AP

AS

AP

AP

200 ms

1 Lower rate interval

Parameters:Lower Rate = 60 bpm (1000 ms) PAV Interval = 200 ms


4 The Total Atrial Refractory Period (TARP) may limit the tracking rate to a lesser value.


Reference Manual 15

2.6 DDIR modeThe DDIR mode provides dual chamber, sensor-driven, atrioventricular (AV) sequentialpacing for heart rate variation without atrial tracking.

● Atrial pacing occurs at the sensor-indicated rate. If it is not inhibited, ventricular pacingoccurs at the end of the PAV interval.

● The AV intervals that follow paced atrial events (PAV) are separately programmable, andthey can be programmed to shorten with increasing rates (Rate Adaptive AV) or tochange with intrinsic conduction times (Search AV+).

● An atrial event sensed outside the PVARP will inhibit a scheduled atrial stimulus but willnot start an AV interval. That is, ventricular paced events after such sensed atrial eventsoccur at the sensor-indicated rate. The following ventriculoatrial (VA) interval may beextended slightly to avoid an increasing atrial paced rate.

● A ventricular nonrefractory sensed event in the VA interval starts a new VA interval.Figure 4. Example of DDIR mode operation

VP

AP

AS

AP

AP

VP

VP

VP

AP

AP

200 ms

1 Sensor-indicated interval2 Sensor-indicated VA interval

Parameters:Lower Rate = 60 bpm (1000 ms) PAV Interval = 200 msSensor-indicated Rate = 90 bpm (667 ms)


16 Reference Manual

2.7 DDI modeThe DDI mode provides dual chamber atrioventricular (AV) sequential pacing with atrialsensing but without atrial tracking.

● Atrial pacing occurs at the Lower Rate. If it is not inhibited, ventricular pacing occurs atthe end of the PAV interval.

● The AV intervals that follow paced atrial events (PAV) are separately programmable, andthey can be programmed to change with intrinsic conduction times (Search AV+).

● An atrial event sensed outside the PVARP will inhibit a scheduled atrial stimulus but willnot start an AV interval. Ventricular paced events after such sensed atrial events occurat the Lower Rate.

● A ventricular nonrefractory sensed event in the ventriculoatrial (VA) interval starts a newVA interval.

Figure 5. Example of DDI mode operation

VP

AP

AS

AP

AP

VP

VP

200 ms

1 Lower Rate interval2 Lower Rate VA interval



Reference Manual 17

2.8 DVIR modeThe DVIR mode provides AV sequential pacing at the sensor-indicated rate unless inhibitedby ventricular sensed events.

● Atrial pacing occurs at the sensor-indicated rate. If it is not inhibited, ventricular pacingoccurs at the end of the PAV interval.

● The AV intervals that follow paced atrial events (PAV) are separately programmable, andthey can be programmed to shorten with increasing rates (Rate Adaptive AV) or tochange with intrinsic conduction times (Search AV+).

● The DVIR mode ignores intrinsic atrial events. Sensing occurs only in the ventricle. Aventricular nonrefractory sensed event during the ventriculoatrial (VA) interval starts anew VA interval.

Figure 6. Example of DVIR mode operation

VP

VS

VS

AP

200 ms

AP

AP

AP

VP

1 Sensor-indicated interval2 Sensor-indicated VA Interval


2.9 DVI modeThe DVI mode provides dual chamber AV sequential pacing without atrial sensing/tracking.

● Atrial pacing occurs at the Lower Rate. If it is not inhibited, ventricular pacing occurs atthe end of the PAV interval.


18 Reference Manual

● The AV intervals that follow paced atrial events (PAV) are separately programmable, andthey can be programmed to change with intrinsic conduction times (Search AV+).

● Sensing occurs only in the ventricle, and intrinsic atrial events are ignored. A ventricularnonrefractory sensed event during the VA interval starts a new ventriculoatrial (VA)interval.

Figure 7. Example of DVI mode operation

VP

VS

VS

AP

200 ms

AP

AP

VP

1 Lower Rate interval2 Lower Rate VA interval


2.10 VDD modeThe VDD mode provides atrial synchronous pacing (or VVI pacing at the Lower Rate). Theventricle is paced synchronously up to the programmed Upper Tracking Rate.5 Sensingoccurs in both the atrium and ventricle, but pacing occurs only in the ventricle.

● To promote atrial synchronous pacing at slow rates, a sensed atrial event occurring nearthe end of the Lower Rate interval will be followed by the programmed SAV interval. Theresult is an extension of the ventricular lower rate.

● The AV intervals that follow sensed atrial events (SAV) are separately programmable,and they can be programmed to shorten with increasing rates (Rate Adaptive AV) or tochange with intrinsic conduction times (Search AV+).

5 The Total Atrial Refractory Period (TARP) may limit the tracking rate to a lesser value.


Reference Manual 19

● A ventricular nonrefractory sensed event in the V-V interval that is not preceded by anatrial sense (AS or AR) is a pacemaker-defined PVC, and it starts a new V-V interval.

Figure 8. Example of VDD mode operation

200 ms

VP

AS

AS

VP

VP

AS

AS

1 Lower Rate interval2 SAV interval

Parameters:Lower Rate = 60 bpm (1000 ms) SAV Interval = 200 msUpper Tracking Rate = 120 bpm (500 ms) PVARP = 250 ms

2.11 AAIR / ADIR modesNote: For information about the AAIR<=>DDDR mode, refer to Section 6.2, “ManagedVentricular Pacing (MVP)”, page 117.The AAIR mode provides atrial-based rate responsive pacing in patients with intact AVconduction. Sensing and pacing occur only in the atrium. In the absence of sensed events,the chamber is paced at the sensor-indicated rate.The ADIR mode operates the same as the AAIR mode except that events sensed in theventricle are recorded by the diagnostics. When used in conjunction with Marker Channelrecordings and concurrent ECG, this mode may be used to observe the conductedventricular rhythm without affecting atrial pacing.Note: In the AAIR and ADIR modes, atrial refractory sensed events do not restart the UpperSensor Rate interval.


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Figure 9. Example of AAIR mode operation

AP

AS

AP

AP

AR

200 ms


Parameters:Sensor-indicated Rate = 75 bpm (800 ms) Atrial Refractory Period = 250 msUpper Sensor Rate = 100 bpm (600 ms)

2.12 AAI / ADI modesNote: For information about the AAI<=>DDD mode, refer to Section 6.2, “ManagedVentricular Pacing (MVP)”, page 117.The AAI mode provides single chamber inhibited atrial pacing. Sensing and pacing occuronly in the atrium. Pacing occurs at the programmed Pacing Rate unless inhibited by sensedevents.The ADI mode operates the same as the AAI mode except that events sensed in the ventricleare recorded by the diagnostics. When used in conjunction with Marker Channel recordingsand concurrent ECG, this mode may be used to observe the conducted ventricular rhythmwithout affecting atrial pacing.


Reference Manual 21

Figure 10. Example of AAI mode operation

AP

AS

AP

AP

AR

200 ms

1 Pacing Rate interval

Parameters:Pacing Rate = 75 bpm (800 ms) Atrial Refractory Period = 250 ms

2.13 VVIR / VDIR modesThe VVIR mode provides ventricular rate responsive pacing in patients for whomatrial-based pacing is deemed unnecessary or inappropriate. In the absence of sensedevents, the ventricle is paced at the sensor-indicated rate.The VDIR mode operates the same as the VVIR mode except that events sensed in theatrium are recorded by the diagnostics. When used in conjunction with Marker Channelrecordings and concurrent ECG, this mode may be used to observe the underlying atrialrhythm without affecting ventricular pacing.Note: In the VVIR and VDIR modes, ventricular refractory sensed events restart the UpperSensor Rate interval.


22 Reference Manual

Figure 11. Example of VVIR mode operation

VP

200 ms

VP

VP

VR

VP

1 Sensor-indicated interval2 Upper Sensor Rate interval

Parameters:Lower Rate = 60 bpm (1000 ms) Upper Sensor Rate = 120 bpm (500 ms)Sensor-indicated Rate = 90 bpm (667 ms) Ventricular Refractory Period = 300 ms

2.14 VVI / VDI modesThe VVI mode provides single chamber inhibited pacing at the programmed Pacing Rateunless inhibited by sensed events. Sensing occurs only in the ventricle.The VDI mode operates the same as the VVI mode except that events sensed in the atriumare recorded by the diagnostics. When used in conjunction with Marker Channel recordingsand concurrent ECG, this mode may be used to observe the underlying atrial rhythm withoutaffecting ventricular pacing.


Reference Manual 23

Figure 12. Example of VVI mode operation


Parameters:Pacing Rate = 60 bpm (1000 ms)Ventricular Refractory Period = 300 ms

2.15 AAT / VVT modesIn the AAT and VVT modes, pacing occurs at the programmed Lower Rate, but anonrefractory sensed event triggers an immediate pacing output (rather than inhibiting suchoutput). With the exception that pacing outputs occur when events are sensed, the triggeredmodes operate identically to the corresponding inhibited modes.Note: Programmed triggered pacing will not occur faster than 300 ms (200 bpm) from theprevious paced event. Temporary programmed triggered pacing is not limited to 300 ms(200 bpm).


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Figure 13. Example of VVT mode operation

200 ms

VP

VP

TP

VR

VP


Parameters:Pacing Rate = 60 bpm (1000 ms)Ventricular Refractory Period = 300 ms

2.16 DOOR / AOOR / VOOR modesThe DOOR, AOOR, and VOOR modes operate as follows:

● The DOOR mode provides asynchronous AV sequential pacing at the sensor-indicatedrate. Intrinsic events are ignored.

● The AOOR and VOOR modes provide single chamber pacing at the sensor-indicatedrate. Intrinsic events are ignored.


Reference Manual 25

Figure 14. Example of DOOR mode operation

VP

200 ms

AP

VP

AP

VP

AP

AP

VP

AP



2.17 DOO / AOO / VOO modesCaution: Sensing is disabled in DOO / AOO / VOO modes.The DOO, AOO, and VOO modes operate as follows:

● The DOO mode provides AV sequential pacing at the programmed Lower Rate with noinhibition by intrinsic events.

● The AOO and VOO modes provide pacing at the programmed Lower Rate with noinhibition by intrinsic events in the applicable chamber.

In addition to being directly programmable, the DOO mode is the Magnet mode of thecorresponding dual chamber modes, except for the VDD mode, which is the VOO mode.AOO and VOO modes are the Magnet modes of the corresponding atrial and ventricularsingle chamber modes, respectively.


26 Reference Manual

Figure 15. Example of DOO mode operation

VP

200 ms

AP

VP

AP

VP

AP

AP

1 Lower Rate interval


2.18 ODO / OAO / OVO modesWarning: ODO / OAO/ OVO modes disable pacing. Never program these modes forpacemaker-dependent patients. For pacemaker-dependent patients, use the programmer’sinhibit function for brief interruption of outputs.In the ODO, OAO, and OVO modes, sensing occurs in the designated chamber or chambers.When used in conjunction with Marker Channel telemetry and concurrent ECG, thesemodes may be used to observe underlying rhythms.

● Blanking periods in these modes are automatically minimized to maximize the sensingwindow or windows. Thus, Marker Channel telemetry may display sense markers forcardiac events (for example, far-field R waves) that otherwise would not appear due tolonger blanking.

● No timing intervals or refractory periods are used.


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3 Rate response

3.1 Introduction to rate responsive pacing3.1.1 Rate responseThe pacemaker may provide appropriate rate response for patients who require cardiacpacing support at both submaximal and maximal rates. Submaximal rates are moderatepacing rates near the Activities of Daily Living Rate (ADL Rate) obtained during typical dailyactivities, such as walking or daily chores. Maximal rates are rates (at or near the UpperSensor Rate) obtained during vigorous activities. To achieve appropriate rate response, thepacemaker provides activity sensor-driven pacing with rate response control in both the ADLrate range and the exertion rate range.The pacemaker provides appropriate rate response by employing the following operations:

● Three programmable rates control the submaximal and maximal rate ranges: LowerRate, ADL Rate (Activities of Daily Living Rate), and Upper Sensor Rate. The ADL Rateis equivalent to the average target rate that the patient achieves for moderate activities.

● Independent control of rate response is provided in both the ADL and exertion rateranges.

3.1.2 Automatic featuresFor models in a rate responsive mode, the pacemaker automatically enables rate responseafter implant and automatically adjusts rate response, if necessary, once each day.

● During the first 30 minutes after implant, pacing occurs at the implanted mode butwithout rate response. 30 minutes after implant, rate response operation is enabled.

● Once each day, rate response is assessed and adjusted, if necessary, in the ADL andexertion rate ranges. The assessment is based on comparing the pacemaker’s historicalsensor-indicated rate profiles against a clinician prescribed target rate profile of thepatient. If the rate profiles differ, rate response is adjusted slightly in the appropriate raterange, and the assessment is repeated again the next day.


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3.1.3 For further informationRefer to Section 3.3, “Rate Profile Optimization operation”, page 30 for information on howthe pacemaker optimizes rate response.

3.2 Preset rate response at implant3.2.1 OverviewPacemakers shipped in rate responsive modes operate in a non-rate-responsive mode untilimplant detection is completed, which is typically 30 minutes after implant. Thereafter, thepacemakers automatically enable rate responsive pacing. Consequently, no programmingis required for rate response operation.

3.2.2 Three pacing rate controlsIf customization of rate response is desired, three pacing rates are provided to control theADL and exertion rate ranges:

● Lower Rate defines the slowest rate at which pacing occurs in the absence of a sinus rateor physical activity.

● ADL Rate (Activities of Daily Living Rate) is the approximate rate that the patient’s heartis expected to reach during moderate exercise.

● Upper Sensor Rate provides the upper limit for the sensor-driven rate during vigorousexercise.

Refer to Section 4.1, “Rates”, page 43 for additional considerations when selectingpacemaker rates.

3.2.3 Starting rate response immediatelyIn situations where the clinician wishes to start rate responsive pacing before the 30-minuteimplant detection period is completed, perform the following steps:

1. After the device is implanted, program Implant Detection to “Off/Complete.”2. Configure pace and sense lead polarities and Lead Monitor.3. Verify that Rate Profile Optimization is On.4. Verify that the parameter values for Lower Rate, ADL Rate, and Upper Sensor Rate are

appropriate.5. Verify that the parameter values for ADL Response, Exertion Response, Activity

Threshold, Activity Acceleration, and Activity Deceleration are appropriate.


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3.2.4 For further informationRefer to Section 3.3, “Rate Profile Optimization operation”, page 30 and Section 3.4,“Individualizing Rate Profile Optimization”, page 36.

3.3 Rate Profile Optimization operation3.3.1 OverviewWhen Rate Profile Optimization is programmed On, the pacemaker can adapt ADL andexertion rate response levels once each day by comparing the patient’s current sensor rateprofiles against a target rate profile. This feature is intended to provide automatic andindependent monitoring of rate response at both moderate rates for daily patient activities,such as walking and daily chores, and at exertion rates for vigorous patient activities.Optimization can be individualized to the patient’s activity levels. Refer to Section 3.4,“Individualizing Rate Profile Optimization”, page 36.Optimization can also operate in the background when a non-rate responsive mode isprogrammed. This can provide appropriate rate response to patient activity if rate responseis needed later or for certain therapy features, such as mode switching to a non-atrial trackingrate responsive mode.

3.3.2 Rate control in the ADL and exertion rate rangesThe pacemaker maintains linear rate control between the activity sensor signal and thesensor-indicated rate from the Lower Rate to the ADL Rate. Refer to Section 3.5.2, “HowActivity Threshold influences rate”, page 38. It maintains independent linear rate control inthe exertion rate range. Optimization controls how rapidly and to what level thesensor-indicated rate increases and decreases in these two rate ranges. The threeprogrammable rate controls [Lower Rate, ADL Rate (Activities of Daily Living Rate), andUpper Sensor Rate] define the rate ranges (see Figure 16).

● Moderate pacing rates are achieved during typical daily patient activities. These rates (inthe ADL rate range) are at or near the ADL Rate.

● Exertion pacing rates are achieved during vigorous activities. These rates (in theexertion rate range) are at or near the Upper Sensor Rate

Figure 16 shows a graph of sensor-indicated rate as a function of increasing activity. Thesensor-indicated rate curve has two slopes. The first slope, which controls how aggressivelythe pacing rate increases from the Lower Rate to the ADL Rate, is determined by theprogrammed ADL Response parameter. The second slope, which controls howaggressively the pacing rate approaches the Upper Sensor Rate, is determined by theprogrammed Exertion Response parameter.


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When you program new values for rates or Rate Profile Optimization, immediate changesoccur. The new values are predictions based on automatic diagnostic data and the selectedRate Profile Optimization settings. The pacemaker continues to adjust Rate Response overtime.Note: If the patient does not have any data in the Sensor Indicated Rate Profile diagnostic,optimization does not adjust immediately when these parameters are programmed. 24hours of diagnostic data are required.Figure 16. A sensor-indicated rate curve

Upper Sensor Rate

ADL Rate

Increasing activityLower Rate

1 ADL rate range2 Exertion rate range

3.3.3 Optimization using rate profilesOptimization of rate response occurs independently in both the ADL rate range and theexertion rate range. The sensor-indicated rate curve is assessed daily based on thefollowing rate profile data:Sensor rate profile – An actual rate versus time distribution of the patient’s averagedsensor-indicated rates. Once each day, the pacemaker collects a daily sensor rate profileand cumulates the data into a long-term average. Both the daily and long-term rate profilesare assessed each day to determine if adjustments to rate response are required. Thelong-term sensor rate profile is automatically stored in the Sensor Indicated Rate Profilediagnostic.Target rate profile – A programmable rate versus time distribution of the patient’s desiredrates. The ADL Response and Exertion Response parameters define the percentage of timethat the sensor-indicated rate stays in the ADL rate range and in the exertion rate range,respectively.


Reference Manual 31

Figure 17 shows a typical rate profile (either a sensor rate profile or a target rate profile).Figure 17. Example of a rate profile

30%

20%

10%

Lower Rate ADL Rate Upper Sensor Rate

Perce

ntage

of tim

e


3.3.4 Daily optimization of rate responseOnce each day, the pacemaker evaluates the percentage of time the sensor rate is in the ADLand exertion rate ranges by comparing the daily and long-term sensor rate profiles againstthe target rate profile. This operation follows the sequence shown in Figure 18.

● The pacemaker calculates the sensor indicated rate based on the activity sensor signal.● From the actual sensor indicated rate values, it generates a daily sensor rate profile. It

also merges that data into a long-term sensor rate profile.● It compares the target rate profile to the daily and long-term sensor rate profiles. Refer to

Figure 19 and Figure 20 for details.● If the sensor rate profiles match the target rate profile or if the daily and long-term sensor

rate profiles contradict each other, no rate response adjustments occur.● Otherwise it makes an automatic adjustment to rate response, which affects the

calculation of the sensor-indicated rate in either or both of the rate ranges.● This sequence repeats each day.


32 Reference Manual

As a result of this operation, the pacemaker automatically adjusts rate response in the ADLand exertion ranges, if necessary, based on the following criteria:

● If the sensor rate profiles show a higher percentage of time spent pacing than the targetrate profile, rate response for the pertinent rate range is set to be less responsive.Conversely, if a lower percentage of time spent pacing is profiled than targeted for, rateresponse is set to be more responsive.

● If the sensor rate profiles match the target rate profile or the daily and long-term sensorrate profiles contradict each other, no rate response adjustments occur.

Figure 18. Daily operation of Rate Profile Optimization

CompareCompare

Daily sensor rate profile

Long-term sensor rate profile

Adjust ADL rate response as needed

based on comparison

Adjust exertion rate response as needed

based on comparison

Sensor signal processing

Target rate profile

Rate calculation

The goal of this operation is to keep the patient’s sensor rate profiles equivalent to the targetrate profile. This is shown in two examples.


Reference Manual 33

In Figure 19, a comparison of the sensor rate profile and target rate profile shows that pacingin the ADL rate range occurs for a larger percentage of time than was targeted. In the sensorrate curve, rate response is adjusted to be less aggressive in this range.The same comparison shows that pacing in the exertion rate range occurs for a smallerpercentage of time than was targeted. In the sensor rate curve, rate response is adjusted tobe more aggressive in this range.Figure 19. Result of comparing rate profiles: first example

Perce

ntage

of tim

e

Increa

sing r

ate

Rate response is made more aggressive

Increasing rate Increasing rate

= Target rate profile

= Sensor rate profile = New rate response curve

= Old rate response curve

Rate response is made less aggressive


The example in Figure 20 is the opposite of the one in Figure 19. Lower than targeted pacingin the ADL rate range results in a rate response adjustment to make rate response moreaggressive in this range. Higher than targeted pacing in the exertion rate range results in rateresponse that is less aggressive in this range.


34 Reference Manual

Figure 20. Result of comparing rate profiles: second example

Increasing activity

= Target rate profile

= Sensor rate profile

= Old rate response curve

= New rate response curve

Increa

sing r

ate

Perce

ntage

of tim

e

Rate response is made more aggressive

Rate response is made less aggressive

Increasing rate


Note: Two additional cases are possible:● Lower than targeted pacing in both the ADL and exertion rate range. Rate response is

adjusted to be more aggressive in both ranges.● Higher than targeted pacing in both the ADL and exertion rate range. Rate response is

adjusted to be less aggressive in both ranges.

3.3.5 Adaptations in Optimization operationThe pacemaker adapts rate response more rapidly for the first ten days after Optimization isfirst activated post-implant or after certain rate response parameters are manuallyreprogrammed (e.g., Lower Rate, ADL Rate, Upper Sensor Rate, ADL Response, orExertion Response). The intent is to quickly match rate response to the target rate profileprescribed by the parameter changes.When you program new values for rates or Rate Profile Optimization, immediate changesoccur. The new values are predictions based on automatic diagnostic data and the selectedRate Profile Optimization settings. The pacemaker continues to adjust Rate Response overtime.Note: If the patient does not have any data in the Sensor Indicated Rate Profile diagnostic,optimization does not adjust immediately when these parameters are programmed.


Reference Manual 35

Optimization is skipped on any day that a device interrogation or parameter programmingoccurs.

3.4 Individualizing Rate Profile Optimization3.4.1 OverviewThe clinician can prescribe a target rate profile using the ADL Response and ExertionResponse parameters to match the patient’s life-style or activity levels. The programmableADL Response parameter alters the targeted rate distribution in the ADL rate range, whilethe Exertion Response parameter alters the rate distribution in the exertion rate range.

3.4.2 ADL rate profilesThe nominal setting for the ADL Response parameter is “3.” Programming a higher numberredefines the target rate profile to spend more time pacing at or above the ADL Rate, therebyincreasing rate responsiveness in the ADL rate range. Programming a lower numberredefines the rate profile to spend less time pacing at or above the ADL Rate, therebydecreasing rate responsiveness.

3.4.3 Exertion rate profilesThe nominal setting for the Exertion Response parameter is “3.” Programming a highernumber redefines the target rate profile to spend more time pacing near the Upper SensorRate, thereby increasing rate responsiveness in the exertion rate range. Programming alower number redefines the rate profile to spend less time pacing near the Upper SensorRate, thereby decreasing rate responsiveness.

3.4.4 Programming guidelinesIf it is necessary to adjust rate response from the nominal setting, first verify that the three ratecontrols are appropriate for the patient. Refer to Section 3.2.2, “Three pacing rate controls”,page 29.If these rate control settings are appropriate, the ADL Response and/or Exertion Responsesettings can then be adjusted based on the guidelines in Table 1.


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Table 1. ADL Response and Exertion Response guidelinesRate region Patient Select these settings

ADL ResponseLower Rate to ADL Rate Reached ADL Rate too quickly Lower number (less rate

response)Reached ADL Rate too slowly Higher number (more rate

response)Exertion Response

ADL Rate to Upper Sensor Rate Reached Upper Sensor Ratetoo quickly

Lower number (less rateresponse)

Reached Upper Sensor Ratetoo slowly

Higher number (more rateresponse)a

a If a higher Exertion Response setting has not produced the desired rate response, increase the ADL Responsesetting.

For more detailed programming guidelines, refer to Table 29, page 199 andTable 30, page 200, which list the targeted time spent pacing for the five ADL Response andExertion Response settings.

3.5 Activity sensor operation3.5.1 OverviewActivity sensor based pacing is controlled by the following programmable parameters:

● Activity Threshold determines the minimum intensity of detected physical activity towhich the pacemaker responds.

● Activity Acceleration and Activity Deceleration times control how rapidly the pacing ratechanges in response to increased or decreased activity. One programmable ActivityDeceleration setting, “Exercise,” provides an extended deceleration period followingprolonged exercise.

Note that Activity Threshold, Activity Acceleration, and Activity Deceleration areautomatically set to shipping settings 30 minutes after implant or can be manuallyprogrammed.


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3.5.2 How Activity Threshold influences rateA transducer, bonded to the pacemaker circuitry, is deflected by physical motion. The activitysensor converts detected motion into electrical signals. The programmed Activity Thresholdscreens out activity signals below the selected setting. Detected sensor signals vary frompatient to patient. Only sensor signals whose amplitude exceeds the programmed ActivityThreshold (as shown in Figure 21) are used in computing the sensor-indicated rate. Thelower the Activity Threshold, the smaller the signal required to influence the sensor-indicatedrate.Figure 21. Activity sensor signal (threshold set to medium/low)

Activity Sensor Ouput

TimeActivity Threshold = Medium/ Low

High

High

Med/High

Med/High

Med/Low

Med/Low

Low

Low

3.5.3 Evaluating the Activity Threshold settingActivities such as walking increase the pacing rate; sitting results in pacing at or near theprogrammed Lower Rate. Use Table 2 as a guide for selecting an appropriate setting.Table 2. Activity Threshold guidelines

Programmable set-tings Typical rate performanceLow Responds to most body activity, including minimal exertion.Medium/Low Limited response to minimal exertion; responds to moderate or greater

exertion.


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Table 2. Activity Threshold guidelines (continued)Programmable set-tings Typical rate performanceMedium/High Limited response to moderate body movements and exertion.High Responds to only vigorous body movements and exertion.

3.5.4 How Activity Acceleration and Deceleration influence rateActivity Acceleration and Activity Deceleration times control how rapidly the pacing ratechanges in response to increased or decreased physical activity. One programmableActivity Deceleration setting, “Exercise,” provides an extended deceleration period followingprolonged exercise.

● Activity Acceleration time is the time required to achieve approximately 90% of thedifference between the current rate and a higher steady-state rate consistent with thecurrent level of activity. Figure 22 shows a graphic representation of the accelerationcurves at the onset of strenuous exercise.

● Activity Deceleration time is the time required to achieve approximately 90% of thedifference between the current rate and a lower steady-state rate consistent with thecurrent level of activity. Figure 23 shows a graphic representation of the decelerationcurves at an abrupt cessation of strenuous exercise.

Figure 22. Activity Acceleration curves

210 4 53

15 s30 s60 s

Upper Sensor Rate

Lower Rate

Time (min)

Activity Acceleration programmable settings

Rate range


Reference Manual 39

Figure 23. Activity Deceleration curves

6543210 7 8 9 10

2.5 min5 min10 min

Upper Sensor Rate

Lower Rate

Time (min)

Activity Deceleration programmable settings

Rate range

3.5.5 Exercise Deceleration operationActivity Deceleration programmed to “Exercise” extends the rate slowing period following anexercise episode, providing up to 20 minutes of rate deceleration. When it is programmedon, the pacemaker uses activity sensor data to detect periods of vigorous, prolongedexercise. At the end of such an exercise period, the pacemaker uses a longer decelerationcurve for the central portion of the programmed rate range. The actual deceleration rate isdetermined dynamically based on the intensity and duration of exercise and the new level ofactivity. Figure 24 shows the composite deceleration curve that applies after the abruptcessation of sustained exercise.


40 Reference Manual

Figure 24. Exercise Deceleration

121086420 14 16 18 20 22

Upper Sensor Rate

Lower Rate

Time (min)

Rate range

1 5 min deceleration curve2 Begins exercise deceleration

3 Ends exercise deceleration4 5 min deceleration curve

3.6 Manual control of Rate Profile Optimization3.6.1 OverviewAs an alternative to automatic Rate Profile Optimization, a programmer assisted Exercisetest can be used to manually set rate response for the ADL and exertion rate ranges. TheExercise test is used to immediately set rate response to certain levels. Rate responseparameters remain set to their programmed values if Optimization is Off. When Optimizationis On, it can adjust these parameters once each day.

3.6.2 Evaluate and program rate responseThe Exercise test is used to evaluate the patient’s rate response and allow the programmerto customize two rate response control parameters:

● ADL Setpoint (Activities of Daily Living Setpoint) determines the minimum sensorresponse to pace at the ADL Rate, which falls within the ADL rate range.

● UR Setpoint (Upper Rate Setpoint) determines the minimum sensor response to pace atthe Upper Sensor Rate, which is at the upper limit of the exertion rate range.

Note: The programmed ADL Setpoint setting must be less than the UR Setpoint setting.


Reference Manual 41

Refer to the Adapta/Versa/Sensia/Relia Pacemaker Programming Guide for programminginstructions.


42 Reference Manual

4 Pacemaker timing

4.1 Rates4.1.1 OverviewThe following programmable rates control timing in the pacemaker:

● Normal operating rates:– Lower Rate– ADL Rate– Upper Tracking Rate– Upper Sensor Rate

● Other operating rates:– Sleep Rate (for Sleep function)– Hysteresis Rate (for single chamber demand and triggered modes)– Sinus Preference Zone (for Sinus Preference)– Intervention Rate (for Rate Drop Response)– Overdrive Rate (for Post Mode Switch Overdrive Pacing)– Maximum Rate (for Conducted AF Response)– Maximum Rate (for Atrial Preference Pacing)

Additionally, rates calculated by the pacemaker are used for some operations. These are:● Sensor-indicated rate● Mean atrial rate

The other operating rates are described in Chapter 6, “Special therapy options”, page 111along with the functions that use them. The normal rates are described in this chapter.

4.1.2 A-A and V-V timingA-A timing – In all modes that pace the atrium, the pacemaker times from atrial event to atrialevent (A-A timing). This timing method mimics a natural sinus rhythm, producing A-Aintervals that are nearly equal, except when timing is interrupted by one of the following:

● PACs in DDIR and DDI modes● PVCs in DDDR, DDD, DDIR, DDI modes (PVC Response operation)


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● A ventricular sensed event during the VA interval in the DVIR and DVI modes● An atrial refractory sensed event that triggers an NCAP extension

VA intervals vary due to adjustments by A-A timing operations in order to achievesensor-indicated or lower rate operation in the presence of varying AV conduction.V-V timing – In modes that do not pace the atrium (e.g., VDD or VDIR) or single chamberventricular modes, the pacemaker times from ventricular event to ventricular event (V-Vtiming).

4.1.3 Lower RateThe programmed Lower Rate defines the slowest rate at which pacing occurs during amode’s basic operation. In rate responsive modes, in the absence of sensor-detectedactivity, the sensor-indicated rate is equal to the programmed Lower Rate.Figure 25. Example of Lower Rate operation

200 ms

P

PV

DDDA

S

S

P

S

P

P

1 Lower Rate interval

Parameters: Lower Rate = 60 bpm (1000 ms) PVARP = 300 msPAV Interval = 200 ms Ventricular Refractory Period =

240 msSAV Interval = 180 ms


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4.1.4 Operating lower rateUnder certain circumstances, the programmed Lower Rate may be overridden by anoperating lower rate that is higher or lower than the programmed value. The following ratesmay become the operating lower rate:

● Switching from and back to atrial tracking mode (for Mode Switch)● Conducted AF Response determined rate● Sinus Preference Zone (for Sinus Preference)● Sleep Rate (for Sleep function)● Intervention Rate (for Rate Drop Response)● Hysteresis Rate (for single chamber modes)● Threshold Margin Test rate of 100 bpm● Magnet Mode rate of 85 bpm● Recommended Replacement Time (RRT/ERI) rate of 65 bpm● Overdrive Rate (for Post Mode Switch Overdrive Pacing function)● Rate determined by Atrial Preference Pacing● Rate determined by Capture Management (ACM and VCM)● Sensor indicated rate

4.1.5 Selecting a Lower RateProgram the Lower Rate to maintain adequate heart rates during periods of inactivity orduring pauses in atrial rhythms when the pacemaker is operating in the DDDR, DDD, VDD,AAIR, ADIR, AAI, and ADI modes.Note: In the VDD mode, atrial tracking near the Lower Rate may result in V-V intervals thatexceed the Lower Rate interval. This is normal operation.Lower Rates from 120 to 130 bpm are intended for pediatric patients. Lower Rates below50 bpm and above 100 bpm are primarily intended for diagnostic purposes.


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4.1.6 Sensor-indicated rateThe sensor-indicated rate is the basic pacing rate when the pacemaker is operating in a rateresponsive mode (DDDR, DDIR, DVIR, DOOR, VVIR, VDIR, VOOR, AAIR, ADIR, or AOOR).It is determined by the pacemaker based on the sensor-detected level of patient activity andthe programmed rate response parameters. The sensor-indicated rate will never be greaterthan the Upper Sensor Rate or less than the Lower Rate.Figure 26. Example of sensor-indicated rate operation

200 ms

PV

DDDRA

S

SS P

PPP

Sensor Sensor Sensor

1 Sensor-Indicated interval

Parameters: Sensor-Indicated Rate =90 bpm (667 ms)

PVARP = 300 ms

PAV Interval = 200 ms Ventricular Refractory Period =220 ms


In rate responsive modes, the sensor-indicated rate tracks the activity sensor, which isdetected by the transducer sensor’s frequency and amplitude.

● In dual chamber rate responsive modes, the sensor-indicated interval is the AS-AP orAP-AP interval.

● In single chamber rate responsive modes, the sensor-indicated interval is the A-A or V-Vinterval. In these modes, sensor-indicated rate intervals start with a sensed or pacedevent in the chamber being paced.


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4.1.7 Sensor indicated rate effect on other intervalsThe sensor-indicated rate is used to determine the values of certain other timing intervals.These intervals are:

● Rate adaptive paced AV (PAV) interval● Sensor-varied PVARP (even in non-rate responsive DDD and VDD modes)● PVARP extension (sensor-corroboration before PMT intervention)

4.1.8 ADL RateThe ADL Rate (Activities of Daily Living Rate) is the target rate which the patient’s heart rateis expected to reach during moderate exercise.

4.1.9 Upper Tracking RateThe programmable Upper Tracking Rate is the maximum rate at which the ventricle may bepaced in response to sensed atrial events when the pacemaker is operating in the DDDR,DDD, and VDD modes. Sensed atrial events below the Upper Tracking Rate will be trackedat a 1:1 ratio, but sensed events above the Upper Tracking Rate will result in pacemakerWenckebach (for example, 6:5, 4:3, 3:2, or 2:1 block). The Upper Tracking Rate usuallyshould be programmed to a value less than the 2:1 block rate. Refer to Section 4.7, “High rateatrial tracking”, page 68 for details.Figure 27. Example of Upper Tracking Rate (Wenckebach) operation

200 ms

S

P

DDDA

V

S

P

1 Upper Tracking Rate


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Parameters:Sensor-indicated Rate =75 bpm (800 ms)

Upper Tracking Rate = 100 bpm(600 ms)


4.1.10 Upper Sensor RateIn rate responsive modes, the programmable Upper Sensor Rate provides the upper limit forthe sensor-indicated rate during physical activity, particularly during vigorous exercise. In theDDDR mode, the Upper Sensor Rate may be higher than, lower than, or the same as theUpper Tracking Rate.

4.1.11 Programming considerations and restrictionsADL Rate – It is recommended that the ADL Rate be at least 10 bpm less than the UpperSensor Rate or 20 bpm greater than the Lower Rate. However, programming the ADL Rateabove or below these limits is permitted.Upper rates – Programming a combination of high Upper Sensor Rate and Upper TrackingRate and a long refractory period may result in a shorter “sensing window.” Loss of sensingin such cases could result in competitive pacing (unless Non-Competitive Atrial Pacing isprogrammed On). See Section 6.4, “Non-competitive atrial pacing”, page 123 for moreinformation.

● Programming the Upper Tracking Rate to a value greater than the Upper Sensor Ratepermits the atrial rhythm to be tracked to a rate higher than the sensor-driven rate.

● The Upper Sensor Rate and/or Upper Tracking Rate must be greater than the LowerRate. The Upper Sensor Rate must be greater than the ADL Rate.

4.1.12 Rate limitAn internal circuit, independent of the pacing timers, limits single chamber atrial orventricular pacing rates to 200 bpm (±20 bpm) for most single component failures. For dualchamber modes, atrial and ventricular rates are limited independently to 200 bpm(±20 bpm). The rate limit is automatically disabled during temporary pacing in the AAI, ADI,AAT, AOO, VVI, VDI, VVT, and VOO modes to allow high rate pacing for diagnostic ortherapeutic purposes.Note: When the Upper Tracking Rate is programmed to 190, 200, or 210, the circuit limit is227 bpm (±17 bpm).


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4.1.13 Possible atrial competition at high ratesAt high sensor-driven rates when the pacemaker is operating in the DDDR and DDIR modes,sensor-driven pacing may approximate the intrinsic atrial rate, with some intrinsic atrialevents falling into the PVARP. This could result in asynchronous pacing with the potential forcompetitive atrial pacing. Consider the potential for asynchronous pacing at high ratesbefore selecting an Upper Sensor Rate, especially for patients known to be susceptible toinduction of atrial tachyarrhythmias. Weigh the benefits of high rate sensor-driven pacingagainst the potential for competitive pacing.Note: Use of the Rate Adaptive AV feature and sensor-varied or automatic PVARP canreduce the likelihood of the type of asynchronous pacing described above. When thepacemaker is operating in the DDDR mode, Sinus Preference and NCAP can also beconsidered.

4.1.14 Mean atrial rateThe mean atrial rate (MAR) is a running average of the atrial rate for use by the Rate AdaptiveAV and automatic PVARP features. The average uses all A-A intervals (except AS-AP orAR-AP intervals). In order to respond quickly to rapidly increasing atrial rates, the averagegives preference to shorter A-A intervals over longer intervals when calculating the MAR.Figure 28 shows how the MAR tracks an increasing intrinsic atrial rate.Figure 28. Increasing mean atrial rate

60

80

100

120

140

160

180

200

0 5 10 15 20 25 30 35

Time (seconds)

Rate

(min-1

)

MAR

Intrinsic rate


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4.2 AV intervals4.2.1 OverviewIn dual chamber modes, the AV intervals determine the time between the occurrence of anatrial event and the scheduled delivery of a ventricular stimulus. Separate AV intervals forpaced and sensed atrial events are available. The lengths of these intervals may beprogrammed to fixed values or (optionally) rate adaptive or therapeutically determined.Paced AV Interval (PAV) – PAV follows an atrial pace when the pacemaker is operating inthe DDDR, DDD, DDIR, DDI, DVIR, DVI, DOOR, and DOO modes. The PAV interval durationmay differ from the programmed value due to one of the following operations:

● Rate Adaptive AV● Search AV+● Ventricular Safety Pacing● Non-Competitive Atrial Pacing

Figure 29. Example of PAV interval operation

P

DDDP P

A

V

P

1 PAV interval2 PAV

Sensed AV Interval (SAV) – SAV follows an atrial sensed event when the pacemaker isoperating in an atrial synchronous pacing mode (DDDR, DDD, and VDD). The SAV intervalduration may differ from the programmed value due to one of the following operations:

● Rate Adaptive AV● Automatic PVARP● Search AV+● Wenckebach


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For Wenckebach operation, the SAV is extended to avoid violation of the Upper TrackingRate or the total atrial refractory period while tracking a fast intrinsic atrial rate.Figure 30. Example of SAV Interval operation

S

P P

DDDA

V

S

1 SAV interval2 SAV

4.2.2 Selecting PAV and SAVUsing MVP or Search AV+ should eliminate the need to manually adjust the AV intervals formost patients. It is recommended that MVP or Search AV+ be used to reduce pacing in theright ventricle.However, when programming AV intervals in patients with third degree block, the generalhemodynamic goal is to assure that, to the extent possible, left-atrial systole is completedbefore left-ventricular systole begins. To achieve this, the AV interval durations may beadjusted independently of each other.

● To accommodate the difference in interatrial conduction times, the SAV usually shouldbe programmed to a shorter duration than the PAV, typically 30 to 50 ms shorter. If an SAVgreater than the PAV is selected, the programmer notes that this is not usual, but theselected values may be programmed if clinically warranted.

● When the SAV is longer than the PAV, a V pace following an atrial sense will always occurafter the full SAV, even when the sensor-indicated rate or Lower Rate interval expiresfirst.

● In certain patients, short AV intervals may be used as a prophylaxis for AV nodal oraccessory pathway reentrant tachycardias in dual chamber modes.


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● Long PAV intervals (greater than or equal to 250 ms) should be used with caution. Ifintrinsic ventricular events occur and are not sensed, a long PAV may result in pacing intothe ventricle’s relative refractory period, including the T wave, or loss of AV synchrony,which may precipitate retrograde activation of the atria with correspondinghemodynamic consequences and symptoms. Long PAV intervals may also result fromsome Search AV+ settings (see Section 4.4, “Search AV+ and diagnostic”, page 55and Section 4.5.3, “Ventricular blanking”, page 59.

4.3 Rate Adaptive AV4.3.1 OverviewIn the normal heart, AV conduction times tend to shorten as the heart rate increases and tolengthen as the heart rate decreases. The Rate Adaptive AV (RAAV) feature, available whenthe pacemaker is operating in the DDDR, DDD, DDIR, DVIR, DOOR, and VDD modes,mimics this physiologic response. When RAAV is programmed On, the pacemaker shortensAV intervals for atrial rates within a programmed rate range. This feature provides increasedopportunity for atrial sensing, as follows:

● Shortened SAV intervals increase the tracking range at fast atrial rates by shortening theTotal Atrial Refractory Period (TARP) and increasing the 2:1 block rate. Refer toSection 4.6.9, “Total Atrial Refractory Period (TARP)”, page 64 and Section 4.7, “Highrate atrial tracking”, page 68 for more information.

● Shortened PAV intervals lengthen the atrial sensing window of the VA interval at highersensor-driven rates.

Note: RAAV will not shorten PAV intervals to less than 30 ms or shorten SAV intervals to lessthan 10 ms.

4.3.2 Programming for Rate Adaptive AVFor RAAV operation, the SAV and PAV are programmed (as applicable) to the values desiredfor low rates. Three additional programmable parameters control how AV intervals areadjusted at higher rates:Start Rate – RAAV operation of shortening SAV and PAV intervals begins at this rate.Stop Rate – The shortest SAV and PAV occur at this rate and at all higher rates, up to theupper rate limits.Maximum Offset – The maximum amount of time (in ms) by which the SAV and PAVintervals can be shortened.


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The PAV minus the Maximum Offset gives the shortest PAV interval at the Stop Rate (e.g.,200 ms - 100 ms = 100 ms). Subtracting the Maximum Offset from the SAV gives the shortestSAV interval (e.g., 170 ms - 100 ms = 70 ms).Figure 31 shows how the SAV and PAV intervals are linearly shortened as the rate increasesfrom below the Start Rate to above the Stop Rate.Figure 31. Rate Adaptive AV operation (DDDR Mode)

Programmed

Start rate

PAV

PAV SAV

SAV

Rate (min-1)

AV In

terva

l (ms)

Stop rate

MinimumRate Adaptive

1 Shortest PAV (PAV minus Maximum Offset)2 Shortest SAV (SAV minus Maximum Offset)

Parameters: Programmed SAV =170 ms

Start Rate = 80 bpm Maximum Offset =−30 ms

Programmed PAV =200 ms

Stop Rate = 150 bpm


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4.3.3 RAAV operationsShortening of the AV interval(s) occurs when the appropriate rate exceeds the programmedStart Rate, as follows:SAV – The mean atrial rate determines SAV adjustments. Because of how the mean atrialrate is calculated:

● SAV adjustments will lag during rapid increases or decreases in intrinsic atrial rates.● The SAV is not adjusted for isolated events (PACs).● AS-AP or AR-AP intervals may affect the SAV value since these intervals are not used in

the mean atrial rate calculation.PAV – The sensor-indicated rate determines PAV adjustments.The approximate difference between programmed SAV and PAV is maintained as the SAVand PAV intervals are adjusted.

4.3.4 Programming considerations and restrictionsSearch AV+ – RAAV can be enabled while Search AV+ is enabled. Search AV+ will operateusing the AV intervals determined by the RAAV rather than the programmed AV intervals.

4.3.5 RAAV and sick sinus syndromeIf RAAV is activated for a sick sinus syndrome patient who has AV conduction, consider thefollowing:

● The rate at which AV conduction is lost should not be too low (i.e., below 90 bpm).● Review of the AV Conduction Histogram diagnostic data may aid in appropriate

programming of Start Rate and Stop Rate to maintain AV conduction as long as possible.


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4.4 Search AV+ and diagnostic4.4.1 OverviewThe Search AV+ feature is intended to promote intrinsic ventricular activation in patients withintact or intermittent AV conduction and prevent inappropriate therapy in patients withoutconduction. Search AV+ is available when the pacemaker is programmed to the DDDR,DDD, DDIR, DDI, DVIR, DVI, or VDD mode. The pacemaker searches for the patient’sintrinsic AV conduction time and adjusts the SAV and PAV intervals either longer or shorterto promote intrinsic activation of the ventricles. When Rate Adaptive AV is active, thepacemaker also adjusts the SAV and PAV intervals relative to the rate adaptive values. If thepacemaker does not observe intrinsic ventricular activation during its periodic searches overthe course of a week, it turns off the Search AV+ feature.

4.4.2 Programming to Search AV+Programming Search AV+ to “On” requires setting the Max Increase to AV parameter. Thisparameter defines the maximum amount of time (in ms) by which the operating SAV and PAVintervals can be lengthened to allow ventricular sensing to occur. The operating SAV andPAV intervals will adapt to the observed conduction time, but will not exceed the MaxIncrease to AV parameter.

4.4.3 Search AV+ operationThe pacemaker attempts to keep intrinsic conducted events in an “AV delay window” thatprecedes scheduled paced events. The AV delay window is set to promote intrinsicconduction to the ventricles, but end early enough to avoid fusion or pseudo-fusion beats ifpacing is necessary (see Figure 32).


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Figure 32. Search AV+ operation

200 ms

PAV is now 212 ms

PAV is now 204 ms

1 Previous 16 AV events, 8 or more VS events are within 15 ms of the scheduled VP, thus PAV andSAV are extended by 62 ms to promote intrinsic conduction.

2 Previous 16 AV events, 8 or more VS events occur 55 ms before the scheduled VP, thus PAV andSAV are shortened by 8 ms to limit long AV delays if ventricular pacing is needed.

Parameters: DDDR SAV = 120 msLower Rate = 60 bpm PAV = 150 msSensor-Indicated Rate =90 bpm

Max. Increase to AV= 170 ms

To determine when intrinsic conducted events occur, the pacemaker assesses the 16 mostrecent AV conduction sequences that start with a nonrefractory atrial sense (when thepacemaker is operating in the DDDR, DDD, and VDD modes) or an atrial pace (when thepacemaker is operating in the DDDR, DDD, DDIR, DDI, DVIR, and DVI modes) and end witha ventricular pace or a nonrefractory ventricular sense.Search criteria of AV conduction times – The measured AV conduction times areclassified as on time, too short or too long.

● Too long means 8 or more of the last 16 ventricular sensed events occurred within 15 msof the scheduled ventricular pace, or 8 or more of the last 16 ventricular events werepaced events.

● Too short means 8 or more of the last 16 ventricular sensed events occurred more than55 ms before the scheduled ventricular pace.

Adjustment of SAV and PAV intervals – If AV conduction times are classified as too long,the pacemaker lengthens the operating SAV and PAV intervals by 62 ms for the next 16pacing cycles to promote intrinsic conduction. The maximum that the SAV and PAV can belengthened is limited by the Search AV+ Maximum Increase to AV parameter.


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If the previous 16 AV intervals are classified as too short, the pacemaker shortens theoperating SAV and PAV intervals by 8 ms for the next 16 pacing cycles. The maximum thatSAV and PAV can be shortened is limited by the programmed SAV and PAV values or theRAAV Maximum Offset parameter, if RAAV is On.

4.4.4 Suspension of Search AV+ operationSearch AV+ promotes conduction in patients with intrinsic conduction and preventsinappropriate therapy for patients without intrinsic conduction. If AV conduction is not found,Search AV+ suspends operation for progressively longer periods: 15 minutes, 30 minutes, 1,2, 4, 8, and 16 hours. If AV conduction is not found following 10 consecutive 16-hoursuspensions (approximate duration, 1 week), the device automatically turns Search AV+ toOff.

4.4.5 Programming considerations and restrictionsBoth Automatic PVARP and Rate Adaptive AV can shorten the AV intervals at higher ratesand potentially lead to ventricular pacing.Automatic PVARP – When automatic PVARP is active and Search AV+ is set to On, thepacemaker will ignore conduction times that are the result of automatic PVARP shorteningof the SAV interval.Rate Adaptive AV – RAAV can be enabled while Search AV+ is enabled. Search AV+ willoperate using the RAAV-determined AV intervals rather than the programmed AV intervals.MVP modes – Search AV+ is not pertinent and cannot be enabled if the pacemaker isprogrammed to an MVP mode (AAIR<=>DDDR or AAI<=>DDD).

4.4.6 Recording AV interval adaptationsAV interval diagnostics record data about AV operations for the Search AV+ feature.

4.4.6.1 Automatic Search AV+ HistogramProgramming Search AV+ parameters automatically initiates recording of data by theSearch AV+ Histogram diagnostic. This histogram shows the percentage of A-VS, VS fromSearch, and A-VP intervals versus rate. A histogram can be displayed or printed from theData icon.


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4.4.6.2 Clearing AV interval dataAV interval data is normally cleared by the pacemaker one hour after a programmingsession.However, you can select the option to clear data immediately. Be sure to save the sessiondata or print the episode report before ending the patient session.

4.4.6.3 Search AV+ and compromised ventricular functionConsider turning Search AV+ off if intrinsic ventricular activation is not desired.

4.5 Blanking periodsBlanking periods disable sensing for a programmable or nonprogrammable interval. Signalsthat are blanked may originate in either chamber or from outside sources such as noise frommuscle movement.Figure 33. Example of dual chamber blanking operation

P

P PDDD

A

V

1 Nonprogrammable Atrial Blanking2 Programmable Post-Ventricular Atrial

Blanking

3 Programmable Ventricular Blanking4 Nonprogrammable Ventricular Blanking

Note: Black bars indicate blanking periods.

4.5.1 Nonprogrammable blanking periodsImmediately following a sensed or paced event in either chamber, sensing for that chamberis blanked for a nonprogrammable period that may typically vary from 50 to 100 ms. Theactual duration of the blanking period is determined dynamically by the pacemaker, basedon the strength and duration of the signal. Dynamic blanking prevents sensing the samesignal twice, while minimizing total blanking time.


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4.5.2 Post-Ventricular Atrial BlankingThe programmable Post-Ventricular Atrial Blanking (PVAB) period, used when thepacemaker is operating in the DDDR, DDD, DDIR, DDI, VDD, VDIR, and VDI modes,prevents sensing of ventricular paced events or far-field R waves on the atrial lead. Anyventricular event (paced or sensed) starts the PVAB, which is also the first portion of thePost-Ventricular Atrial Refractory period (PVARP). The PVAB is limited to values equal to orless than the programmed PVARP, except in VDIR and VDI modes where PVARP does notapply.Note: PVAB is programmed to a value less than or equal to PVARP.

4.5.3 Ventricular blankingThe programmable Ventricular Blanking period, which follows an atrial pacing stimulus whenthe pacemaker is operating in the DDDR, DDD, DDIR, DDI, DVIR, and DVI modes, preventsventricular inhibition or ventricular safety pacing due to sensing of the atrial stimulus on theventricular lead (crosstalk). The Ventricular Blanking period also applies to the ADIR and ADImodes to prevent sensing of the atrial stimulation.

● Long blanking periods (36 ms or greater) increase the possibility of unsensed ventricularevents.

● Long blanking periods used in conjunction with long PAV intervals (250 ms or greater)may result in pacing into the T wave when intrinsic ventricular events are blanked and notsensed. PAV values (200 ms or less) should reduce the possibility of T wave pacing.

● Long PAV intervals may also result from some Search AV+ operation (See Section 4.4,“Search AV+ and diagnostic”, page 55). To minimize the possibility of undersensingintrinsic events, Search AV+ reduces ventricular blanking to 20 ms unless VentricularSafety Pacing is observed.

4.5.4 Single chamber atrial blankingThe programmable single chamber atrial blanking period, used when the pacemaker isoperating in the AAIR, ADIR, AAI, ADI, and AAT mode, prevents sensing of far-field R waves.It is started by a paced, sensed, or refractory sensed atrial event.Note: Atrial Blanking must be programmed at least 50 ms less than the Atrial RefractoryPeriod.


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4.6 Refractory periods4.6.1 OverviewA refractory period is an interval during which an intrinsic event sensed on a particular leadchannel cannot start certain timing intervals. Each refractory period begins with a blankingperiod, during which no sensing occurs. During the unblanked portion of a refractory period,sensing occurs, but sensed events may not directly affect timing operations. Refractoryperiods are intended to prevent certain timing intervals from being started by inappropriatesignals such as retrograde P waves, far-field R waves, or electrical noise.Though they may not start timing intervals, refractory sensed events are monitored by thepacemaker, and they affect the operation of PVC Response, Mode Switch, Rate Adaptive AVoperation, automatic PVARP, Non-Competitive Atrial Pacing, and other features for whichthe periodicity or number of sensed events are pertinent. Refractory sensed events areincluded on Marker Channel recordings.

4.6.2 Post-Ventricular Atrial Refractory PeriodThe Post-Ventricular Atrial Refractory Period (PVARP) follows a paced, sensed, or refractorysensed ventricular event when the pacemaker is operating in the DDDR, DDD, DDIR, DDI,and VDD modes. It is intended primarily to prevent the sensing of retrograde P waves thatmight promote Pacemaker-Mediated Tachycardias (PMTs) in atrial tracking modes. Whenthe pacemaker is operating in the DDIR and DDI modes, PVARP prevents atrial inhibitionfrom retrograde P waves.The first portion of the PVARP is the programmable Post-Ventricular Atrial Blanking period(PVAB). During the remainder of the PVARP, intrinsic atrial events may be sensed asrefractory sensed events (AR) and identified on Marker Channel recordings, but they do notaffect stimulus timing.

● When the pacemaker is operating in the DDDR, DDD, and VDD modes, an SAV is notstarted.

● When the pacemaker is operating in the DDDR, DDD, DDIR, and DDI modes, thescheduled atrial pace is not inhibited.


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Figure 34. Example of PVARP operation

P

DDDA

V

P P

1 PVARP

The duration of the PVARP may be selected as follows:● The PVARP should be programmed to a value greater than the patient’s ventriculoatrial

(VA) retrograde time when retrograde conduction is present.● Excessively long PVARPs may induce 2:1 block at high intrinsic rates when the

pacemaker is operating in an atrial tracking mode (DDDR, DDD, or VDD).● To reduce the 2:1 block point, PVARP can be set to vary based on the sensor-indicated

rate (sensor-varied PVARP) or the mean atrial rate (automatic PVARP).

4.6.3 Sensor-varied PVARPWhen sensor-varied PVARP is programmed, the pacemaker determines a value for thePVARP based on the sensor-indicated rate. The intended purpose of the sensor-variedPVARP depends upon the mode:

● When the pacemaker is operating in the DDDR, DDD, and VDD modes, sensor-variedPVARP is intended to do the following:– Enhance protection against PMT at lower rates by providing longer PVARPs at low

sensor-indicated rates.– Allow tracking of higher atrial rates (that is, provide a higher 2:1 block rate) by

shortening the PVARP at high sensor-indicated rates.● When the pacemaker is operating in the DDIR mode, the sensor-varied PVARP is

intended to promote AV synchrony by preventing inhibition of atrial pacing by an atrialsense early in the VA interval. It also reduces the likelihood of competitive atrial pacingat high sensor-indicated rates.


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Figure 35. Sensor-varied PVARP operation (DDDR Mode)

400 ms 300 ms 400 ms

200 ms

1 Upper Sensor Rate2 Lower Rate

3 PAV4 PVARP

4.6.4 Determining sensor-varied PVARPThe pacemaker determines the duration of the sensor-varied PVARP as follows:

● When the pacemaker is operating in the DDDR, DDD, and VDD modes, thesensor-varied PVARP is limited to 400 ms at low rates and the programmed PVAB at highrates (as shown in Figure 35).

● When the pacemaker is operating in the DDIR mode, PVARP is the pacing interval,minus the PAV interval, minus 300 ms. At high rates, PVARP is limited by theprogrammed PVAB.

● When the pacemaker is operating in the DDDR, DDD, DDIR, and VDD modes, thesensor-varied PVARP is automatically adjusted to maintain a 300 ms sensing window(as shown in Figure 35).


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4.6.5 Automatic PVARPWhen automatic PVARP is programmed, the pacemaker determines a value for the PVARPbased on the mean atrial rate (which is an average of all A-A intervals except those startingwith an atrial sense or atrial refractory sense and ending with an atrial pace). When thepacemaker is operating in the DDDR, DDD, and VDD modes, automatic PVARP is intendedto provide a higher 2:1 block rate by shortening the PVARP and SAV (if necessary) at highertracking rates and protect against PMTs at lower rates by providing a longer PVARP.

4.6.6 Determining automatic PVARPThe pacemaker determines the duration of the automatic PVARP as follows:

● After every four pacing cycles, a 2:1 block rate is calculated that is 30 bpm above thecurrent mean atrial rate.

● PVARP is then adjusted so the Total Atrial Refractory Period equals the calculated 2:1block rate. The programmable Minimum PVARP parameter controls the minimum valuethat PVARP can be shortened to.

● If the minimum PVARP value is reached and the 2:1 block rate is still too low, the SAVinterval can be shortened to increase the 2:1 block rate. The minimum SAV that can beset is the rate adaptive SAV value (i.e., the programmed SAV value minus the RAAVMaximum Offset value).

The minimum adjustable 2:1 block rate is 100 bpm. The maximum adjustable 2:1 block rateis the Upper Tracking Rate plus 35 bpm. If Mode Switch is On, the maximum 2:1 block ratecan be the Detect Rate if this rate is less than the Upper Tracking Rate calculation.

4.6.7 Programming restrictions for automatic PVARPRate Drop Response – Automatic PVARP is not available when Rate Drop Response isprogrammed On.

4.6.8 Spontaneous PVARP extensionThe programmed PVARP duration, the sensor-varied PVARP, and the automatic PVARPmay be overridden by the PVC Response and PMT Intervention features, as follows:

● When the PVC Response feature is programmed On and a pacemaker-defined PVCoccurs, the PVARP is forced to 400 ms for one cycle if a lesser value is in effect.

● When PMT Intervention is programmed On and a pacemaker-defined PMT is detected,the PVARP is forced to 400 ms for one cycle after the ninth paced ventricular event of thePMT.


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Refer to Section 6.5, “PMT intervention”, page 125 and Section 6.6, “PVC Response”,page 127 for further details on the PMT Intervention and PVC Response features and theirinteractions with PVARP.

4.6.9 Total Atrial Refractory Period (TARP)In dual chamber modes that sense in the atrium, the Total Atrial Refractory Period (TARP) isthe sum of two intervals, as follows:AV Interval – The AV interval begins with an atrial event and ends with a ventricular event.The first portion is a nonprogrammable blanking period. Its complete duration is determinedas follows:

● When the pacemaker is operating in the DDDR, DDD, and VDD modes, the PAV or SAVinterval is the AV interval.

● When the pacemaker is operating in the DDIR and DDI modes, the AV interval starts withthe first atrial sensed event in the VA interval or with an atrial pacing stimulus; it endswhen the PAV expires, even when ventricular pacing is inhibited.

Post-Ventricular Atrial Refractory Period (PVARP) – The PVARP is described onSection 4.6.2.Figure 36. Total Atrial Refractory Period

1 TARP2 SAV + PVARP

3 SAV4 PVARP

During atrial tracking, TARP = SAV + PVARP, and its duration determines the rate at which2:1 block occurs. Refer to Section 4.7, “High rate atrial tracking”, page 68 for moreinformation.


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4.6.10 Ventricular Refractory PeriodThe programmable Ventricular Refractory Period (VRP) follows paced, sensed, andrefractory sensed ventricular events (including PVCs) in all dual chamber and ventricularmodes that sense in the ventricle. The VRP is intended to prevent sensing of the T wave ora PVC. The first portion of the VRP is a nonprogrammable blanking period. A ventricularrefractory sensed event affects pacemaker timing as follows:

● Ventricular blanking and refractory periods restart in all modes.● When the pacemaker is operating in the DDDR, DDD, and VDD modes, the upper

tracking rate interval, PVARP, and PVAB also restart.● When the pacemaker is operating in the VVIR and VDIR modes, the upper sensor rate

interval restarts.Note: In dual chamber modes, the VRP should be programmed shorter than the PVARP.Figure 37. Example of Ventricular Refractory Period operation

P

DDDA

V

P P

1 VRP

In dual chamber modes, a ventricular refractory sensed event does not affect a scheduledsensor-driven or lower rate atrial output. Thus, a sensor-driven atrial output pulse will initiatea PAV with a ventricular output pulse following, unless inhibited.

4.6.11 Atrial Refractory Period (single chamber)The programmable Atrial Refractory Period (ARP) follows paced, sensed, and refractorysensed atrial events. The ARP is used in the AAIR, ADIR, AAI, ADI, and AAT modes. It isintended to prevent inhibition due to far-field R wave sensing. The first portion of the ARP isa programmable blanking period. The ARP should be programmed to a value long enough(180 ms or greater) to prevent far-field R wave sensing but short enough to ensure atrialsensing up to the programmed Upper Sensor Rate.


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If the pacemaker is programmed to an MVP mode (AAIR<=>DDDR or AAI<=>DDD) and isoperating in AAIR or AAI mode, the ARP is automatically adjusted to 75% of the cardiac cyclelength, up to a maximum of 600 ms.

4.6.12 Noise reversionWhen sensing occurs during the Atrial Refractory Period (ARP) or Ventricular RefractoryPeriod (VRP), the refractory period (and its blanking period) are restarted. The operationassociated with continuous refractory sensing in the ARP or VRP is called noise reversion.Multiple restarts of the ARP or VRP (continuous noise reversion) do not inhibit scheduledpacing. Pacemaker behavior during continuous noise reversion is as follows:

● Pacing occurs at the sensor-indicated rate for all rate responsive modes (except VVIRand VDIR).

● Pacing occurs at the programmed Lower Rate for all non-rate responsive modes(including VVIR and VDIR).

On the ECG, noise reversion may be difficult to distinguish from loss of sensing, but MarkerChannel recordings will show refractory sense markers when noise reversion occurs.Figure 38. Example of noise reversion in DDDR at sensor-indicated rate.

DDDRAV

P P P

P R R R P P

200 ms

Sensor Sensor Sensor


Parameters: Lower Rate = 60 bpm (1000 ms± 17 ms)

Upper Sensor Rate = 120 bpm(500 ms ± 17 ms)

PAV Interval = 200 ms Ventricular Refractory Period =240 ms

PVARP = 300 ms PVAB = 200 ms


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Note: In DDDR mode, the sensor-indicated rate occurs anywhere between the Lower Rateand the Upper Sensor Rate, depending on patient activity.Note: If an atrial refractory sensed event occurs, the pacemaker does not restart therefractory period. However, an atrial refractory sensed event will start a short blanking periodof 50 to 100 ms depending on the signal strength and duration of the atrial event.Figure 39. Example of noise reversion in VVIR at lower rate.

200 ms

Sensor PV

R R R R P

VVIR

1 Lower Rate

Parameters: Lower Rate = 60 bpm (1000 ms±17 ms)

Ventricular Refractory Period =240 ms

Upper Sensor Rate = 120 bpm(500 ms ±17 ms)

4.6.13 Preventing noise sensingNoise reversion may be caused by electromagnetic interference (EMI), myopotentials,excessively high output settings, or low sensitivity settings. When it has been identified,noise reversion usually can be reduced or eliminated by one of the following actions:

● Remove patient from EMI environment.● Reprogram sensitivity to a less sensitive setting (higher numerical value) or program

Sensing Assurance to On, to monitor and if necessary, adjust the sensitivity value. Referto Section 5.6, “Sensing Assurance and diagnostic”, page 99.

● Reprogram sensing polarity to bipolar polarity (if available).● Reduce the amplitude and/or pulse width in the same or opposite chamber.


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● Program Capture Management to Adaptive to monitor capture thresholds, and, ifnecessary, adjust amplitude and pulse width values. Refer to Section 5.5, “CaptureManagement and diagnostic”, page 79.

4.7 High rate atrial tracking4.7.1 OverviewWhen the pacemaker is operating in the DDDR, DDD, and VDD modes, the fastest atrial ratethe pacemaker can track is determined by the Total Atrial Refractory Period (TARP), whichis the sum of the SAV and the PVARP. Pacemaker behavior at high atrial rates in these modesis determined by the relationship between the TARP and the interval corresponding to theUpper Tracking Rate. In the DDDR mode, the interval corresponding to the Upper SensorRate also must be considered.

4.7.2 2:1 blockWhen the intrinsic atrial interval is shorter than the TARP, some atrial events will fall in thePVARP and not be tracked. At the rate where this first occurs, ventricular tracking occurs onlyon alternate beats, and 2:1 block ensues. When the pacemaker is operating in the DDD andVDD modes, the ventricular pacing rate drops precipitously.

● When sensor-varied PVARP or automatic PVARP is selected, the 2:1 block rate mayoccur at a higher rate during activity due to shortening of the PVARP and the SAV(automatic PVARP only), thus increasing atrial tracking.

● When Rate Adaptive AV operation is selected, the SAV shortens at high atrial rates,shortening the TARP and raising the 2:1 block rate.

● When the 2:1 block rate is less than the Upper Tracking Rate, the Upper Tracking Ratecannot be achieved.

● When the pacemaker is operating in DDDR mode, pacing at the sensor-indicated ratemay prevent a precipitous rate drop at the 2:1 block point when activity is present.

● For patients with a documented propensity for prolonged or sustained atrial fibrillation orflutter, the clinician can select Upper Tracking Rate, SAV, and PVARP values that induce2:1 block at a desired rate (2:1 block rate = 60,000/TARP). Alternatives for controllingrates in these patients include use of the Mode Switch feature and DDIR mode pacing.

● When the pacemaker is operating in the DDDR mode, atrial competition may occur if theUpper Sensor Rate exceeds the 2:1 block rate.


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4.7.3 Pacemaker WenckebachWhen the 2:1 block rate exceeds the programmed Upper Tracking Rate, pacemakerWenckebach may occur. When the intrinsic rate exceeds the Upper Tracking Rate, a pacingstimulus at the expiration of the SAV would violate the upper tracking rate. The pacemakertherefore extends the SAV until the upper tracking rate interval expires. Subsequent SAVsrequire greater extension, until an atrial event falls in the PVARP and is not tracked.

● When the pacemaker is operating in the DDDR, DDD, and VDD modes, the result isnormally a fixed ratio between atrial and ventricular rates (3:2, 4:3, and so forth).

● When the pacemaker is operating in the DDDR mode, the pacemaker Wenckebach ratemay be smoothed by sensor-driven ventricular pacing, thereby overriding the fixed ratio.

Figure 40 shows how pacemaker Wenckebach operation occurs in the DDDR, DDD, or VDDmodes.Figure 40. Example of pacemaker Wenckebach operation

S

P

DDDRA

V

S

P

S

P

S

P P

R

200 ms

PSensor

1 Upper Tracking Rate interval2 SAV interval

Parameters: Sensor-Indicated Rate =90 bpm (667 ms)

PVARP = 300 ms

PAV Interval = 230 ms Upper Tracking Rate = 100 bpm(600 ms)


4.7.4 High rate operation in the DDDR modeTable 3 summarizes how the total atrial refractory period (TARP), the Upper Tracking Rate(UTR) interval, and the Upper Sensor Rate (USR) interval may interact at high atrial rateswhen the pacemaker is operating in the DDDR mode.


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Table 3. Upper rates interaction with TARPRelationshipBetween TARP andUpper Rate Intervals

Wenckebach Before2:1 Block

Achieve Upper Track-ing Rate

Potential Atrial Com-petition

TARP > both USR andUTR intervals

no no yesa

USR interval > TARP >UTR interval

no no no

USR interval > UTRinterval > TARP

yes yes no

UTR interval > bothUSR interval and TARP

yes yes yesa

a Unless the Non-Competitive Atrial Pacing is On, see Section 6.4, “Non-competitive atrial pacing”, page 123.


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5 Lead/cardiac tissue interface

5.1 Implant Detection5.1.1 OverviewImplant Detection is a 30 min period, beginning at lead connection, during which thepacemaker verifies that each lead has been connected by measuring lead impedance. After30 min of continuous lead connection, the pacemaker completes Implant Detection andactivates the following features (see Figure 41):

● Operating polarity (automatic configuration occurs during Implant Detection)● MVP operations including conduction checks and mode changes● Adaptive sensitivity settings (Sensing Assurance)● Rate responsive pacing, including adaptive rate profile optimization (Rate Profile

Optimization)● Adaptive ventricular output settings for threshold management (Capture Management)● Diagnostic data collection

Figure 41. Implant Detection period

Implant 30 minutes

1 Lead connection verified2 Leads connected3 Lead polarities confirmed, Rate Response enabled, Adaptive features activated, and Data

collection activated

Implant Detection is available in all pacing modes and is turned on at shipment.Note: Search AV+ initializes 60 min after Implant Detection is complete.


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Note: Automatic polarity configuration does not occur during Implant Detection if the LeadMonitor parameter is programmed to Monitor Only before implant. Automatic configurationwill take place if Lead Monitor is programmed to Adaptive before implant or remains set to itsshipping setting of Configure.

5.1.2 Verifying lead connection during Implant DetectionAt the time of lead connection, the pacemaker begins verifying that each lead is present bymeasuring the impedance of each pacing pulse. When a pace is delivered, the pacemakerdetermines if the impedance is within the acceptable range, which is programmablebetween 200 to 40006 Ω for both bipolar and unipolar configurations.

● High impedance paces cause Implant Detection to reset.● Low impedance paces (and continuous sensing) are considered acceptable for the

purpose of determining lead connection and configuring polarity.

5.2 Automatic polarity configuration5.2.1 OverviewDuring Implant Detection, bipolar pacemakers automatically configure pacing and sensingpolarities through the Lead Monitor feature. Bipolar pacemakers are shipped with the Atrialand Ventricular Lead Monitor set to Configure, enabling automatic polarity determinationshortly after lead connection.Unipolar-only pacemakers are configured to unipolar pacing and sensing polarity at the timeof manufacture and remain unipolar during the operational life of the pacemaker.

6 The acceptable maximum impedance limit for a valid lead (bipolar or unipolar) can be changed by programmingthe Notify If > (Greater Than) parameter, which is part of the Lead Monitor and is found under the programmedlead polarities. The minimum impedance limit of 200 Ω is nonprogrammable.


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5.2.2 Measuring lead impedance during configurationBipolar pacemakers, using either bipolar or unipolar leads, automatically configure pacingand sensing polarities by measuring the impedance of each pace during the configurationperiod. (Lead Monitor must be set to Configure or Adaptive. See Section 5.3, “Lead Monitor”,page 76.) Impedance measurement during configuration is as follows:

● The pacemaker issues a bipolar pace and immediately checks the pace for highimpedance.– If the pace is within range, it is considered an acceptable bipolar pace.– If high impedance is found, the pacemaker immediately follows the bipolar pace with

a backup unipolar pace.● If a unipolar backup pace is issued, the pacemaker checks it for high impedance.

– If the pace is within range, it is considered an acceptable unipolar pace.– If high impedance is found, the pacemaker assumes a lead is not attached and

restarts Implant Detection.Notes:

● During polarity configuration, the pacemaker also detects low impedance paces butdoes not follow them with unipolar backup paces. To avoid possible loss-of-capture dueto continuous low impedance pacing, the pacemaker sets unipolar polarity when 3 of 16paces are detected as low impedance during the first phase of configuration (see “InitialConfiguration Phase”, page 74).

● If the pacemaker assumes a lead is not present (a high impedance unipolar pace isdetected) in one chamber of a dual chamber pacemaker, Implant Detection will restart.

5.2.3 How polarities are automatically configuredAtrial and ventricular lead polarities are configured independently in dual chamber bipolarmodels, with the exception of pacemakers in the VDD Series, which have fixed bipolar atrialsensing only.Operating pacing and sensing polarities for bipolar pacemakers are configuredautomatically in two phases during Implant Detection. (See Figure 42.) During these phasesthe pacemaker continues to measure impedance as described above.


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Figure 42. Automatic configuration of bipolar models

ImplantLeads connected

Implant detection

Initial configuration phase

Confirmation phase

Lead polarities configured

Lead polarities confirmed

30 minutes5 minutes

Initial Configuration Phase – The pacemaker sets lead polarities five minutes after leadconnection unless a high impedance unipolar pace has reset Implant Detection, aprevalence of low impedance bipolar paces has set unipolar pacing, or if continuous sensinghas occurred.The pacemaker sets initial polarities as follows:

● The pacemaker delivers three asynchronous paces at magnet rate.● If at least two of the three paces are determined to be bipolar, the pacemaker remains set

to bipolar polarity (with backup unipolar paces) for the Confirmation Phase.● If at least two of the three paces are determined to be unipolar, the pacemaker sets

polarity to unipolar. Unipolar polarity becomes the operating polarity for pacing andsensing, and no Confirmation Phase is required.

Note: If one of the asynchronous paces in a given chamber is a high impedance unipolarpace, the pacemaker restarts Implant Detection in both chambers. Polarity configurationrestarts only in the affected chamber, however.Confirmation Phase – Twenty-five minutes after initial configuration, the pacemakerconfirms final operating polarity for leads configured bipolar in the Initial ConfigurationPhase. During this 25-minute Confirmation Phase, the pacemaker measures the lead forhigh and low impedance paces. If 8 of 16 paces (or the programmed number of paces out ofsixteen) are out of range, the lead will automatically be reconfigured to unipolar polarity.At the end of twenty-five minutes, operating polarity for leads detected as bipolar during theInitial Configuration Phase is determined as follows:

● The pacemaker delivers three asynchronous paces at magnet rate.


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● If at least two of the three paces are determined to be bipolar, the pacemaker setsoperating polarity to bipolar (or Adaptive operation if Lead Monitor was programmed toAdaptive prior to implant). See Section 5.3, “Lead Monitor”, page 76.

● If at least two of the three paces are determined to be unipolar, the pacemaker setsoperating pace and sense polarities to unipolar.Note: If a high impedance unipolar pace occurs in a given chamber at any time duringthe 25-minute Confirmation Phase, the pacemaker restarts Implant Detection in bothchambers. Polarity configuration restarts only in the affected chamber, however.

Leads configured unipolar during the Initial Configuration Phase continue to operate in theunipolar configuration. If bipolar polarity switches to unipolar during the Confirmation Phase,the operating polarity remains unipolar with no additional confirmation throughasynchronous pacing.Warning: If, at implant, the setscrews, both tip and ring, for a 3.2 mm connector pacemakerare not properly engaged and all electrical contacts are not sealed, leakage between the tipand ring contacts may occur. Such leakage may cause the pacemaker to falsely identify aunipolar lead as bipolar, resulting in a loss of output. The same result could occur for allbipolar models if the electrical contacts were not properly sealed when using lead extendersor adaptors.

5.2.4 When automatic configuration is completeThirty minutes after lead connection, Implant Detection and automatic configuration arecomplete. If, after this time period, the leads are detached and lead polarity type is changed,automatic configuration and Implant Detection do not restart automatically at reinsertion.The clinician must reprogram Implant Detection to On/Restart, which automatically resetsLead Monitor to Configure.The Lead Monitor feature (see Section 5.3, “Lead Monitor”, page 76) monitors and reportson lead stability when Implant Detection and automatic configuration are complete. It isautomatically set by the pacemaker as follows:

● Bipolar models are shipped with Lead Monitor set to Configure. However, after ImplantDetection ends, Lead Monitor is automatically set to Monitor Only for bipolar andunipolar configurations.

● Bipolar models with Lead Monitor programmed to Adaptive before implant are set toAdaptive if polarity was determined to be bipolar. If polarity for these models wasdetermined to be unipolar, they are set to Monitor Only.

● Unipolar models are shipped with Lead Monitor set to Monitor Only and continue tooperate at that setting both during and after Implant Detection.


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5.2.5 Manually setting polaritiesTo manually program atrial or ventricular lead polarities at implant, the clinician first must“turn off” the Configure setting under Lead Monitor by choosing the Monitor Only settinginstead. Implant Detection still provides the 30-minute detection period, followed byautomatic feature and diagnostics activation, when the pacemaker is programmedmanually.

5.2.6 Programming interactions● Programming Implant Detection to Off /Complete before completion of the 30-minute

automatic polarity configuration period requires the clinician to manually program LeadMonitor and polarities. The pacemaker’s automatic features are activated when ImplantDetection is turned off.

● Manually programming Implant Detection to On/Restart restarts lead detection, polarityconfiguration (Lead Monitor is set to Configure), and automatic feature activation.

● Initiating a programming session at any time during Implant Detection causes ImplantDetection to be restarted.

● If a dual chamber pacemaker is programmed to a single chamber mode, only one leadis configured. If the mode is reprogrammed to a dual chamber mode, the clinician willneed to change the Lead Monitor from Configure to Monitor Only or Adaptive for theunconfigured lead, and then program pace and sense polarity for it manually.

5.3 Lead Monitor5.3.1 OverviewThe Lead Monitor feature measures lead impedances during the life of the pacemaker.When programmed to do so, Lead Monitor also enables the pacemaker to switch bipolarpacing and sensing to unipolar when bipolar lead integrity is in doubt. It also controlsautomatic configuration of lead polarities at implant. Lead Monitor is available in all pacingmodes.Caution: If the Lead Monitor detects out-of-range lead impedance, investigate lead integritymore thoroughly.

5.3.2 How lead monitoring worksThe Lead Monitor feature monitors lead impedance of paced chambers, as defined by themode, by measuring the impedance of each pacing pulse to see if it falls within theprogrammed impedance range for a stable lead.


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The three programmable values under Atrial or Ventricular Lead Monitor are as follows:● Configure – provides automatic configuration of polarity (see Section 5.2.3, “How

polarities are automatically configured”, page 73).● Adaptive

– monitors bipolar paces for high impedance and provides unipolar backup paceswhen high impedance is detected.

– switches pacing and sensing polarity from bipolar to unipolar when the pacemakerdetects a prevalence of high or low impedance paces (see Monitor Sensitivityparameter in Table 4). The Lead Monitor setting changes to Monitor Only whenpolarity switches.

– provides automatic polarity configuration when selected prior to implant.● Monitor Only – monitors either unipolar or bipolar paces to determine if they are out of

range but does not switch polarity when an out-of-range lead is indicated.Lead Monitor is activated at lead connection, and it is automatically set to its operating valueof Monitor Only or Adaptive at the end of Implant Detection. See Section 5.2.4, “Whenautomatic configuration is complete”, page 75.When Lead Monitor is set to Adaptive or Monitor Only and a lead is determined to be out ofrange, the pacemaker issues a lead warning that appears on the programmer screen at thenext interrogation.Lead Monitor programmable parameters – The programmable parameters for the LeadMonitor feature are shown below.Table 4. Programmable parameters for Lead Monitor

General Parameters MeaningAtrial Lead Monitor Monitors lead impedance in the atrium; option to provide unipolar

backup paces and to switch from bipolar to unipolar polarity for anout-of-range lead; provides automatic configuration of polarity atimplant.

Ventricular Lead Monitor Monitors lead impedance in the ventricle; option to provide unipolarbackup paces and to switch from bipolar to unipolar polarity for anout-of-range lead; provides automatic configuration of polarity atimplant.

Notify If < (Less Than) Nonprogrammable minimum boundary for acceptable atrial and ven-tricular bipolar lead impedance. Fixed at 200 Ω.

Notify If > (Greater Than) Maximum boundary for acceptable atrial and ventricular bipolar leadimpedance.

Monitor Sensitivity Number of high or low impedance paces out of 16 that define anout-of-range lead on each channel.


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Lead Monitor should not be programmed to Adaptive for patients with implantabledefibrillators. When a prevalence of out-of-range lead impedance paces is detected, themonitor automatically reprograms the selected lead(s) to unipolar polarity. Pacing in theunipolar configuration may cause the defibrillator either to provoke inappropriate therapy orto withhold appropriate therapy.

5.4 Lead impedance dataLead impedance data is recorded automatically.

5.4.1 Automatic Lead Impedance (Chronic Lead Trend)The automatic Lead Impedance diagnostic data is based on measurements taken everythree hours for each chamber that is being paced. The maximum, average, and minimumlead impedances are recorded every seven days for the most recent 14 months.The following data is continuously updated:

● Initial impedance (recorded at implant or when Chronic Lead Trend is cleared)● Lifetime minimum impedance (recorded since implant)● Lifetime maximum impedance (recorded since implant)● High impedance paces● Low impedance paces

If the maximum number of high impedance paces or low impedance paces is reached, thatvalue will remain until the data is cleared. All other diagnostic data collection will continue.Note: To avoid high output pacing, Chronic Lead Trend data collection can be programmedto Off. The outputs are increased to make lead impedance measurements every 3 hours.

5.4.2 Clearing Lead Impedance dataAutomatic (Chronic) Lead Impedance Trend data is retained by the pacemaker unless youuse the Clear Data function on the programmer. Note that the data should be cleared onlywhen a lead is replaced. Be sure to save the session data or print the trend report beforeending the patient session.

5.4.3 For further informationRefer to the Adapta/Versa/Sensia/Relia Pacemaker Programming Guide for informationabout collecting and displaying lead impedance trends.


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5.5 Capture Management and diagnostic5.5.1 OverviewWhen Capture Management is enabled, the pacemaker automatically monitors pacingthresholds at periodic intervals. Once the threshold is determined, the pacemakerdetermines a target output based on the programmable safety margin and programmableminimum amplitude.

● If programmed to Adaptive, the pacemaker reprograms outputs toward the target.● If programmed to Monitor Only, the pacemaker does not reprogram outputs.

Caution: Epicardial leads have not been determined appropriate for use with the VentricularCapture Management feature. Program Ventricular Capture Management to Off if implantingan epicardial lead.Note: The pacemaker enables Capture Management once Implant Detection is completed.Note: In the event of partial or complete lead dislodgment, Capture Management may notprevent loss-of-capture.

5.5.1.1 Ventricular Capture Management (VCM)At programmable intervals, the pacemaker performs a ventricular pacing threshold searchto determine the ventricular threshold, which is the combination of minimum amplitude andminimum pulse width that consistently results in capture of the ventricular myocardium.

5.5.1.2 Atrial Capture Management (ACM)At programmable intervals, the pacemaker performs an atrial pacing threshold search todetermine the atrial amplitude threshold, which is the minimum amplitude that consistentlyresults in capture of the atrial myocardium.

5.5.1.3 Initiating the pacing threshold searchScheduling the search – A pacing threshold search is initiated according to the scheduleprogrammed by the clinician. The Capture Test Frequency parameter under CaptureManagement allows the clinician to schedule the search at fixed time intervals. The cliniciancan also program the Day At Rest value that allows the pacemaker to determine when to runthe search.


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If a pacing threshold search is scheduled to occur once per Day At Rest, the pacemaker triesto initiate the first pacing threshold search 12 hours after Implant Detection is complete. Itthen runs subsequent searches at 24-hour intervals from the time of the last successfullycompleted search.If a search cannot be completed, the pacemaker retries after 30 minutes.

5.5.1.4 Programmable Capture Management parametersCapture Management can be programmed to Adaptive, Monitor Only, or Off. When CaptureManagement is programmed to Adaptive, the parameters in Table 5 are used to controlCapture Management operation. They can also be programmed for diagnostic use whenCapture Management is programmed to Monitor Only.Table 5. Programmable parameters for Capture Management

General parameters MeaningAmplitude Margin The safety margin applied to the pacing threshold search results for

Amplitude.Minimum Adapted Amplitude The lower limit to which the operating Amplitude can be adapted.Capture Test Frequency Determines how often the pacing threshold search will be initiated.V. Acute Phase Days Remain-ing

Time in days during which output settings can be adapted bothupward and downward, but not below the permanently programmedventricular outputs.

A. Acute Phase DaysRemaining

Time in days during which output settings can be adapted bothupward and downward, but not below the permanently programmedatrial outputs.

V. Sensing During Search The polarity used for ventricular sensing during ventricular pacingthreshold searches. See page 86.

5.5.2 Ventricular Capture Management (VCM)Checking for stable rhythm – Before a pacing threshold search can be initiated, thepacemaker determines if the patient is pacing or sensing at a low rate. A low rate is desirableduring the pacing threshold search to reduce the risk of competition from forced pacing with


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fast intrinsic rhythms. To make the determination, the pacemaker looks for intrinsic orrate-related events indicating:

● Out of 8 measured V-V intervals no more than 2 are faster than:– 100 bpm if the upper sensor rate and upper tracking rate are ≥135 bpm– 95 bpm if the upper sensor rate and upper tracking rate are ≥125 bpm– 90 bpm if the upper sensor rate and upper tracking rate are <125 bpm

● the sensor rate, checked at the end of the 8 intervals, is at or below the ADL rate.● in dual chamber modes, at least 1 valid AV interval (AS-VS, AS-VP, AP-VS, AP-VP)

occurred during the 8 measured intervals.The pacemaker also looks for automatic feature interaction indicating:

● Rate Drop Response is not in an intervention state.● Mode Switch is not changing between a tracking and a nontracking mode.● Battery measurements● Atrial Preference Pacing● Sleep function

If the stable rhythm check is successful, the pacing threshold search is initiated. If any of thecriteria for the stable rhythm check is not met, the pacemaker defers the pacing thresholdsearch until the next scheduled search period. See “Scheduling the search”, page 79.

5.5.3 The ventricular pacing threshold searchThe pacemaker performs the pacing threshold search at a given Amplitude and Pulse Widthsetting through a series of support cycles and test paces. Each series has three sets ofsupport cycles, with each set followed by a test pace and an automatic backup pace (seeFigure 43).

● The support cycles are pacing cycles at the programmed Amplitude and Pulse Widththat may or may not include ventricular paced events. The pacing threshold searchbegins with the support cycles.

● A test pace follows each set of support cycles and is delivered at a test Amplitude orPulse Width. Amplitude and Pulse Width settings above the threshold cause capture ofthe myocardium; settings below the threshold result in loss-of-capture.

● A backup pace automatically follows each test pace regardless of capture orloss-of-capture for that pace. It is delivered 110 ms after the test pace at the programmedAmplitude and a 1.0 ms Pulse Width setting.


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Figure 43. Pacing threshold search

S S S T B S S S T B S S S T B

S = Support cyclesT = Test PacesB = Backup Paces

The pacemaker may use one to three of the test paces in a series to determine if a particularAmplitude or Pulse Width is above or below the patient’s stimulation threshold.

● When the first of the three test paces indicates capture (CAP), or the last two test pacesindicate capture following loss-of-capture (LOC) on the first pace, the series isdetermined to be above the threshold. See Table 6.

● When two of the three test paces indicate loss-of-capture, the series is determined to bebelow the threshold. See Table 6.

Table 6. Above/below threshold determinationSeries of 3 test paces ResultsCAPa Above thresholdLOCb, CAP, CAP Above thresholdLOC, LOC Below thresholdLOC, CAP, LOC Below threshold

a CAP = captureb LOC = loss-of-capture

Not all test paces qualify for use in the determination series. If a test pace meets abort criteria(see page 86), the pace is ignored, the Amplitude and Pulse Width remain the same, andthe next test pace is used in the determination series instead. For example, if a ventricularintrinsic sense inhibits the test pace during the test cycle, that intended pace will be ignoredand not evaluated for capture.If a support pace meets abort criteria, e.g., a ventricular safety pace occurs on a supportpace, the pace is counted in the support/test cycle, but causes the next test pace to beignored. The test pace following the ignored test pace remains at the Amplitude and PulseWidth and is used in the determination series.Modifying Amplitude and Pulse Width during the search – When modifying firstAmplitude and then Pulse Width during the pacing threshold search, the pacemaker is


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looking for two points that lie on the strength duration curve. These points define theboundary between settings that capture the myocardium and those that do not.Amplitude modification operates as follows:

1. The test Amplitude is set at the last Amplitude result from the previous pacing thresholdsearch or at 0.75 V if no previous search has been done. Pulse Width is set at 0.4 ms.

2. The pacemaker initiates a series of support cycles and test paces to determine whetherthe Amplitude setting is above or below the patient’s stimulation threshold.

3. If the test Amplitude is above the patient’s threshold, the pacemaker will reduce it by onesetting and repeat the test series. The process of reducing the Amplitude setting andretesting continues until a point below the patient’s threshold is found, indicatingloss-of-capture.

4. The pacemaker then increments and retests the Amplitude one setting at a time untilthe setting is above the patient’s stimulation threshold for three consecutive test series,indicating capture is recovered. The setting at which capture is recovered is called theamplitude threshold.

Pulse Width modification operates as follows:1. The test Pulse Width is set at the last Pulse Width setting from the previous search or

at 0.21 ms if no previous search has been done. Amplitude is set at two times theamplitude threshold determined during the Amplitude search. The upper Pulse Widthlimit for the test pulse is 0.4 ms.

2. The pacemaker performs the actions detailed in Step 2 through Step 4 for Amplitudemodification above, but for Pulse Width. The Pulse Width setting that is in operationwhen capture is recovered at two times the amplitude threshold is designated the pulsewidth threshold.

If the clinician uses the in-office Capture Management test, the programmer uses theamplitude threshold and pulse width threshold to construct a strength duration curve. (SeeFigure 44).


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Figure 44. Modifying Amplitude and Pulse Width

Ampli

tude (

V)

1.00.4

13 24

3

124

Loss-of-capture

Starting Amplitude

Amplitude reduced by one setting (2)

Amplitude threshold (4)

Pulse Width reduced by one setting (2)

Pulse Width threshold (4)

Starting Pulse Width (at 2 times the amplitude threshold)

Loss-of-capture

Pulse width (ms)

Pacing therapy during the search – During a pacing threshold search, the pacemakermust provide ventricular test paces (which may affect normal pacing operation). To ensureventricular pacing, if necessary, the pacemaker may adapt timing in both tracking andnontracking modes.Note: If an MVP mode is programmed (AAIR<=>DDDR or AAI<=>DDD), CaptureManagement sets the pacing mode to DDDR or DDD and suspends MVP mode changes forthe duration of the pacing threshold search.When operating in tracking modes:

● The pacemaker shortens the AV interval for each support cycle and test pace based oncalculations using the shortest AV interval measured during the stable rhythm check.

● The test pace is always followed by a backup pace after 110 ms.● PVARP is fixed at 350 ms for support cycles, but PVARP, PVAB, and the ventricular

refractory period are timed from the backup pace on test paces.● Ventricular Safety Pacing is disabled on test pace cycles.


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Figure 45. Rate modulation in DDD/tracking modes

110 ms

Atrial paceSupport AV Support AV Support AV (-)15 ms

Support pace Support pace

Atrial pace

Test pace

Atrial pace

Backup pace

When operating in nontracking modes:● The lower rate is not changed on support cycles.● The lower rate on test paces is set to the fastest V-V interval seen on any support cycle

or seen during the stable rhythm check plus 15 bpm or minus 150 ms, whichever resultsin a faster rate.

Figure 46. Rate modulation in nontracking modes110 msSupport pace

Test pace Backup pace

Support pace

Because the pacing threshold search operates as the highest priority feature in control ofpacing cycle parameters, the following pacing features are disabled during the search:

● Sensing Assurance● Rate Drop Response detection● AV modulation (Search AV+, Rate Adaptive AV)● NCAP operation● Lead Monitor● Auto PVARP and sensor-varied PVARP operations● Ventricular Safety Pacing on test paces● Atrial Preference Pacing● Sinus Preference


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When the pacing threshold search aborts – Sometimes the pacing threshold searchcannot be performed as scheduled. The pacemaker ensures that false events will notinfluence the determination of capture and loss-of-capture during the search by aborting thesearch immediately when the following occur:

● The sensor rate is greater than the ADL rate.● Mode Switch occurs.

The pacemaker allows the following to occur several times before aborting the search:● Upper tracking rate extension on a test pace.● Nonrefractory ventricular senses in a tracking mode.● V-V rate greater than 90 to 100 bpm on support cycles, depending on the value of the

upper sensor rate and upper tracking rate (see “Checking for stable rhythm”, page 80).● Ventricular Safety Pacing during the support cycles.● Consecutive ventricular refractory events.

Other conditions can also cause the pacing threshold search to abort:● Pacemaker RRT/ERI or low battery is detected.● Noise reversion is detected.● Initiation of a programming or transtelephonic session.● Capture is not determined during the entire search, indicating possible high thresholds.● Loss-of-capture does not occur during the entire search, indicating a possible lead

problem or undetected intrinsic events.When a pacing threshold search cannot be completed, the pacemaker will automaticallyinitiate another search within 30 minutes (or within 15 minutes, if the Capture Test Frequencyparameter is programmed for every 15 minutes). See “Scheduling the search”, page 79. Iffour search attempts abort during one test period, however, the pacing threshold test issuspended until the next test period.When the pacing threshold search aborts, a message indicating why the search could not beperformed is stored in the Capture Management Detail diagnostic (if enabled).Preventing undersensing of ventricular evoked response events during the search –To minimize the likelihood of undersensing of ventricular evoked response events during apacing threshold search, the clinician can program the V. Sensing During Search parameterto Adaptive, if the Ventricular Sense Polarity parameter is set to Bipolar. Then, when anout-of-range measurement (see Figure 48) occurs, the pacing threshold search will beautomatically repeated, using the Unipolar sensing setting.


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If the second search is successful, the out-of-range measurement is ignored. If the secondsearch results in another out-of-range measurement, outputs will remain at 5 V and 1 ms.If the V. Sensing During Search parameter is set to Bipolar or Unipolar, ventricular sensingduring the pacing threshold search will be done at that setting.

5.5.3.1 Automatic ventricular output adaptationCapture Management can be programmed (Adaptive setting) to provide automaticadaptation of ventricular Amplitude and Pulse Width based on pacing threshold searchresults. Following each search, the pacemaker creates a target output by applying aprogrammable safety margin (Amplitude Margin parameter) to the amplitude thresholddetermined during the search. The pacemaker’s calculation for the target is always roundedup to the next programmable setting. The pacemaker then adapts outputs toward this target.Adaptation can take place only within an output range that is defined by a programmablelower limit (Minimum Adapted Amplitude parameter) and the upper threshold limit of 5.0 Vand 1.0 ms. The minimum pulse width for ventricular capture management is 0.4 ms.

● Amplitude is adapted only when a pacing threshold search is successful; otherwise, itremains as programmed.

● If the operating Amplitude is below the target, it is immediately adapted to the target.(See Figure 47.)


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Figure 47. Adapting outputs upward to the target

P= Pulse width (ms)

A=Am

plitud

e (V)

Output Range

2

1

.2 .4 .6 .8 1.0

3

5

4

P

A

1 Target (when 2.0X margins applied)2 Operating Amplitude and Pulse Width3 The bottom line indicates the Programmed Minimum Adapted Amplitude

● If the operating Amplitude is above the target, the pacemaker adapts the Amplitudedownward one programmable setting per successful pacing threshold search. If thetarget is below the programmed minimum output limit, the adaptation stops at theminimum limit.

● A High Threshold Condition warning is issued if the amplitude threshold is greater than2.5 V. The pacemaker responds by adapting to an Amplitude of 5.0 V and Pulse Widthof 1.0 ms.

● If the amplitude threshold multiplied by the safety margin indicates an amplitude targetgreater than 5.0 V, the pacemaker responds by adapting to the highest possible CaptureManagement settings, an Amplitude of 5.0 V and Pulse Width of 1.0 ms. (SeeFigure 48.)


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Figure 48. Limiting high thresholds

1.2

2

1

.2 .4 .6 .8 1.0

3

5

4

6Am

plitud

e (V)

Pulse width (ms)Output Range

1 Target (when 3X margin applied)2 Output adapted to 5.0 V, 1.0 ms limit3 Operating Amplitude and Pulse Width

4 Amplitude threshold5 The bottom line indicates the Programmed

Minimum Adapted Amplitude

5.5.3.2 Considerations when programming parametersIn a small percentage of patients, the following conditions can influence thresholdsmeasured by Capture Management and can lead to possible symptoms:Lead fixation – With poor lead fixation, modulations in pacing timing and rate can influencethresholds.


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Intrinsic event rejection – In rare instances, combinations of morphology and rhythm mayresult in a low threshold measurement. This may occur if the pacing threshold search isunable to differentiate between myocardial contractions caused by the pacing pulse andthose caused by physiologic means.Evoked response detection – In rare instances, the pacemaker may not detect theelectronic waveform created by the contracting myocardium immediately following a pacingpulse. In such instances, a high threshold measurement may result. See page 86The Capture Management Threshold Test and manual threshold measurements providedata that can help in programming the parameters that control outputs (see Section 5.5.1.4,“Programmable Capture Management parameters”, page 80).

5.5.3.3 Programming interactionsWarning: Capture Management will not program ventricular 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, program Amplitude andPulse Width manually.The pacemaker must be programmed to a mode that permits pacing and sensing in theventricle (but not VVT mode) in order to use the Ventricular Capture Management feature.

5.5.4 Atrial Capture Management (ACM)Checking for stable rhythm – Before a pacing threshold search can be initiated, thepacemaker determines if the patient is pacing or sensing at a low rate. A low rate is desirableduring the pacing threshold search to reduce the risk of competition from forced pacing withfast intrinsic rhythms. A Pacing Threshold Search (PTS) is performed when a stable atrialrhythm is observed for eight pacing cycles and the sensor rate is less than the ADL rate.

● ACM does not operate during Mode Switch episodes.● ACM operates in DDDR and DDD modes.7● The sensed atrial rate must not be faster than 87 bpm.● The paced atrial rate must be slower than 90 bpm.

7 If the device is programmed to an MVP mode (AAIR<=>DDDR or AAI<=>DDD), the pacemaker changes themode to DDDR or DDD during ACM operations.


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5.5.4.1 The atrial pacing threshold searchConducting the search – The pacemaker performs the pacing threshold search through aseries of support cycles followed by a test pace applied at a slightly faster rate.

● Beginning at one setting below the last measured value (or at 0.75 V if no previoussearch has been done), the amplitude is reduced in one setting decrements at 0.4 mspulse width until loss-of-capture is detected. When two of the three test paces indicateloss-of-capture, the series is determined to be below the threshold.

● The pacemaker then increments and retests the amplitude one setting at a time until thesetting is above the patient’s stimulation threshold for three consecutive test series,indicating capture is recovered. The setting at which capture is recovered is called theamplitude threshold. The threshold criteria are shown in Table 7.

Table 7. Above/below threshold determination for a single test seriesSeries of up to 3 test paces ResultsCAP, CAPa Above thresholdLOCb, CAP, CAP Above thresholdLOC, LOC Below thresholdCAP, LOC, CAP Above thresholdLOC, CAP, LOC Below threshold

a CAP = captureb LOC = loss-of-capture

Not all test paces qualify for use in the determination series. If sensed events surrounding thetest pace meet abort criteria, the pace is ignored, the Amplitude remains the same, and thenext test pace is used in the determination series instead. If a support cycle meets abortcriteria, the previous set of support cycles is discarded, and a new set of support cycles isstarted.Atrial Capture Management (ACM) observes the timing of sensed P and R waves (notevoked response) to evaluate capture.ACM automatically selects one of two methods for evaluating atrial capture, based on thepatient’s rhythm at the time of the PTS. If the patient has a stable sinus rhythm, the deviceselects the Atrial Chamber Reset (ACR) method. Otherwise, the device selects the AVConduction (AVC) method.


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5.5.4.2 Atrial Chamber Reset (ACR) MethodAtrial Chamber Reset runs during stable sinus rhythm. It evaluates capture by observing theresponse of the intrinsic rhythm to the atrial test pace. If the test pace does not capture, thesinus node is not reset, and an atrial refractory sensed event (AR) is observed after the testpace. If no AR is observed within the AV interval, ACR concludes that the test pace capturedthe myocardium. (See Figure 49.)Figure 49. Atrial Chamber Reset test method

AS

VP

VP VP VP VP VP VP

VP VP VPVS or VP VP

AS

AS

AS

AS AP

AP ARAS

AS

AS

AS

AS

1 test2 CAP

3 LOC

5.5.4.3 Atrial-Ventricular Conduction (AVC) MethodAtrial-Ventricular Conduction method runs when stable 1:1 AV conduction is observed withatrial pacing. The atrial pacing rate is increased by 15 bpm (but no faster than 101 bpm) andthe AV interval is lengthened to try to achieve a stable AP-VS rhythm.AVC evaluates capture by observing the conducted ventricular response to the atrial testpace. Each atrial test pace is followed by a backup pace at programmed amplitude and a1.0 ms pulse width to maintain rhythm stability during the test. If a conducted VS event isobserved at approximately the expected AP-VS interval following the atrial test pace, AVCconcludes that the test pace captured the myocardium. (See Figure 50.)


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Figure 50. Atrial-Ventricular Conduction test method

70 ms

AP AP

VS VS VP

AP-VS

Scheduled VP

Overdrive rate interval Overdrive rate interval - prematurity

Last support AP-VS interval 85 ms

Capture

Loss of Capture

1 Test AP2 Backup AP

3 (Expected VS from Test AP)4 (Expected VS from Backup AP)

5.5.4.4 Pacing therapy during the searchBecause the pacing threshold search operates as the highest priority feature in control ofpacing cycle parameters, the following pacing features are disabled during the search:

● Sensing Assurance● Rate Drop Response detection● AV modulation (Search AV+, Rate Adaptive AV)● Blanked Flutter Search● Lead Monitor● Lower rate modulation (APP, Sinus Preference, Conducted AF Response)


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Note: If an MVP mode is programmed (AAIR<=>DDDR or AAI<=>DDD), the capturemanagement sets the pacing mode to DDDR or DDD and suspends MVP mode changes forthe duration of the pacing threshold search.When the pacing threshold search aborts – Sometimes the pacing threshold searchcannot be performed as scheduled. The pacemaker ensures that false events do notinfluence the determination of capture and loss-of-capture during the search by aborting thesearch immediately when the following occur:

● Fast atrial rate (>87 bpm with ACR, >100 bpm with AVC)● Ventricular pacing (AVC)● Undesirable cardiac events (PVCs, PACs)● Mode Switch occurs.

The pacemaker allows the following to occur several times before aborting the search:● fast or variable intrinsic rate or ectopic events● slow intrinsic rate8 and a lack of AV conduction● Variable AV conduction time● Unexpected sensed events before or after the test pace● Ventricular Safety Pacing

Other conditions can also cause the pacing threshold search to abort:● Pacemaker RRT/ERI or low battery is detected.● Initiation of a programming or transtelephonic session occurs.● Capture is not determined during the entire search, indicating possible high thresholds.● Loss-of-capture does not occur during the entire search, indicating undetected intrinsic

events.

5.5.4.5 Automatic atrial threshold adaptationCapture Management can be programmed (Adaptive setting) to provide automaticadaptation of atrial amplitude based on pacing threshold search results.

8 Turning the Sleep Function to On may allow ACM to run with slower intrinsic rates.


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The pacemaker applies the programmable amplitude safety margin to the amplitudethreshold value measured at a 0.4 ms pulse width to determine the target amplitude. If theoperating amplitude is above the target, the pacemaker adapts the amplitude down towardthe target in one-step decrements. If the operating amplitude is below the target, theamplitude is immediately adapted to the target.

● Outputs are not adapted below the programmable minimum amplitude. During theprogrammable Acute Phase following implant detection, outputs are not adapted belowthe programmed outputs or the default shipping settings (3.5 V, 0.4 ms).

● A High Threshold Warning is issued if the amplitude threshold is greater than 2.5 V. Thepacemaker responds by adapting to an Amplitude of 5.0 V and Pulse Width of 1.0 ms.

● A High Threshold warning is issued if the target amplitude is greater than 5.0 V andoutputs are adapted to 5.0 V and 1.0 ms (See Figure 51).


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Figure 51. Limiting high atrial thresholds

1.2

2

1

.2 .4 .6 .8 1.0

3

5

4

6Am

plitud

e (V)

Pulse width (ms)Output Range

1 Target (when 3X margin applied)2 Output adapted to 5.0 V, 1.0 ms limit3 Operating Amplitude and Pulse Width

4 Amplitude Threshold5 The bottom line indicates the Programmed

Minimum Adapted Amplitude

5.5.4.6 Programming interactionsWarning: Capture Management will not program atrial outputs above 5.0 V or 1.0 ms. If thepatient needs a pacing output higher than 5.0 V or 1.0 ms, program Amplitude and PulseWidth manually.


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The pacemaker must be programmed to DDDR, DDD, AAIR<=>DDDR, or AAI<=>DDDmode in order to use the Atrial Capture Management feature.

5.5.5 Recording Capture Management dataProgramming Capture Management also initiates automatic data collection. In addition, youmay collect detailed information about every Capture Management search.

5.5.5.1 Summary Capture Management dataThe automatic Capture Management trend records pacing threshold history. Every 7 days,the pacemaker collects the following Capture Management data automatically for 14months:

● Maximum Threshold● Average Threshold● Maximum Amplitude● Type of Capture Management search (Adaptive or Monitor Only)

Figure 52 shows a typical summary Capture Management trend.Figure 52. Summary Capture Management data

0

1

2

3

4

5

11/16 12/16 01/15 02/14 03/16 04/15 05/15 06/14

Average to max. threshold

Amplitude (V @ 0.4ms)

Date (Month/Day)

Monitor only "What if"

Max. adapted

Threshold > 2.5V


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5.5.5.2 Detail Capture Management dataCapture Management Detail data provides a record of the pacing threshold, pulse width, andamplitude in the selected chamber. For the most recent 668 ventricular or 359 atrial CaptureManagement searches, the pacemaker records the following information for the selectedchamber:

● Date and Time● Threshold Amplitude● Threshold Pulse Width (VCM only)● Method of Search (ACM only)● Adapted or Monitor Only (suggested) Amplitude (with programmed margin applied)● Adapted or Monitor Only (suggested) Ventricular Pulse Width

A beat-to-beat trend for the most recent Capture Management search is available.Recording stops if more than 1000 events occur during the search. Clinicians have the optionto record an EGM (atrial, ventricular, or summed EGM). Figure 53 shows an example of adetailed Capture Management trend.Figure 53. Detail Capture Management trend

01

2

3

4

5

09/04/0308/03/03

Amplitude (V)

Date

Threshold

Monitor only "What if"

Adapted

Aborted search

The data collected can be displayed or printed from the Data icon.

5.5.5.3 Clearing Capture Management dataAutomatic Capture Management Trend data can be cleared from the Clear Data screen byselecting the option to clear lead impedance trend data for the respective chamber.However, the clinician-selected Capture Management Detail data is cleared automaticallyone hour after the end of a programming session.


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Also, you can select the option to clear data immediately. Be sure to save the session dataor print the report before ending the patient session.

5.5.5.4 For further informationRefer to the Adapta/Versa/Sensia/Relia Pacemaker Programming Guide for informationabout collecting and displaying Capture Management data.

5.6 Sensing Assurance and diagnostic5.6.1 OverviewThe Sensing Assurance feature automatically adjusts atrial and ventricular sensitivitieswithin defined limits. At the completion of Implant Detection, the pacemaker enablesSensing Assurance and begins monitoring the peak amplitude of sensed signals. Inresponse to monitoring, the pacemaker automatically increases or decreases Sensitivity tomaintain an adequate sensing margin with respect to the patient’s sensed P and R waves.

5.6.2 Monitoring sensitivity thresholdsThe pacemaker monitors each nonrefractory sensed event (AS or VS) by measuring the ratioof the peak amplitude of the P or R wave to the Sensitivity setting. The pacemaker thencompares the measured sensing margin to a target sensing margin.Sensing Assurance provides the following target sensing margins:

● Atrial bipolar sensing: 4:1 ratio to 5.6:1 ratio● Atrial unipolar sensing: 2.8:1 ratio to 4:1 ratio● Ventricular (unipolar or bipolar) sensing: 2.8:1 ratio to 4:1 ratio


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Figure 54. Maintaining a sensing margin of 3:1

2.8 mV4 mV

1 mV

Atrial Unipolar Sensing

1 Target sensing margin2 Sensitivity setting

5.6.3 Qualifying sensed eventsWhen monitoring nonrefractory sensed events, the pacemaker checks each event to see ifit qualifies for use in determining Sensitivity threshold adjustments. Events are disqualifiedwhen:

● The pacemaker is monitoring a high level of continuous interference● A second event occurs in either chamber within 40 ms after a sensed event

5.6.4 Adjusting sensing thresholdsTo adjust sensing thresholds, the pacemaker keeps a record of many sensed events.Non-PVC, nonrefractory senses that fall below the target sensing margin (low events) areassigned a negative value, and those that are above the target sensing margin (high events)are assigned a positive value. When the accumulated value of the events exceeds the upperor lower limits of a counter, the pacemaker will adjust the sensitivity by one setting:

● Many low events indicate an adjustment of one setting to a more sensitive (smallernumerical) setting.

● Many high events indicate an adjustment of one setting to a less sensitive (largernumerical) setting.

At least 17 low events are required to cause an adjustment to the next more sensitive setting,and 36 high events are required to cause an adjustment to the next less sensitive setting.Adjustments occur more gradually if a mixture of low and high events are occurring or ifpaced events are intermingled with sensed events. If fewer than 60% of events are high (orlow), or if the pace to sense ratio is greater than 5:1, no sensitivity adjustment is made.


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Pacemaker-defined PVCs will cause ventricular sensitivity adjustments that are slower thanthose for non-PVC, non-refractory senses.

5.6.4.1 Adjustments during periods of infrequent sensingThe pacemaker maintains a long-term running average of the sensitivity adjustments.During periods when the pacing percentage is near 100%, the pacemaker may adjust thethresholds toward the long-term average. If persistent undersensing or persistent noisereversion pacing (due to continuous interference) is occurring, the pacemaker will adjust thethreshold toward the long-term average.Sensitivity in the VDD mode will be increased if there is an absence of atrial sensing forseveral pacing cycles.

5.6.4.2 Threshold adjustment limits for Sensing AssuranceAutomatic Sensitivity adjustments are restricted to the following ranges of settings:Table 8. Restricted Sensing Assurance settings

Sensing type Lower limit Upper limitAtrial

Bipolara 0.18 mV 0.5 mVVDD mode 0.18 mV 0.35 mVUnipolar 0.5 mV 1.4 mV

VentricularBipolar and unipolar 2.0 mV 5.6 mV

a For SR Series and S Series bipolar models the lower limit is 0.25 mV.

5.6.5 Programming considerationsWhile Sensing Assurance is On, the clinician cannot manually program a lower or higherSensitivity setting than those shown in Table 8.Ventricular Safety Pacing (VSP) must be programmed On for ventricular Sensing Assuranceoperation.Sensing Assurance will not adjust Sensitivity during temporary operation.Sensing Assurance will adjust Sensitivity only if the programmed mode allows both sensingand pacing in a chamber, with the exceptions that adjustments are allowed in the VDD,AAI<=>DDD, and AAIR<=>DDDR modes, and they are not allowed in the AAT/VVT modes.


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While Sensing Assurance is designed to adapt sensitivity margins in response to changesin sensed event amplitudes, Sensing Assurance may not eliminate all sources ofoversensing.

5.6.6 Recording Sensing Assurance dataProgramming Sensing Assurance to On also initiates automatic data collection.

5.6.6.1 Summary Sensing Assurance dataAutomatic Sensitivity Trend data indicates the performance of the Sensing Assurancefeature. Every seven days, the pacemaker records the following information for bothchambers:

● Minimum sensitivity● Maximum sensitivity● Whether Sensitivity adjustments reach the upper limit (least sensitive) or the lower limit

(most sensitive)Figure 55 shows typical summary Sensing Assurance dataFigure 55. Summary Sensing Assurance data

0.18

0.25

0.35

0.50

0.70

1.00

09/25 10/25 11/24 12/24 01/23 02/22 03/24 04/23

Sensitivity (mV)

Date

minmax

Limited at bound

5.6.6.2 Clearing Sensing Assurance dataSummary and Detailed Sensing Assurance data is normally cleared by the pacemaker onehour after a programming session.Also, you can select the option to clear data immediately. Be sure to print the report beforeending the patient session.



5.6.6.3 For further informationRefer to the Adapta/Versa/Sensia/Relia Pacemaker Programming Guide for informationabout collecting and displaying Sensing Assurance data.

5.7 Manually selecting pacing parameters5.7.1 OverviewPacing output settings should be adequate to guarantee reliable capture, but not so high asto inappropriately deplete the pacemaker battery. Whether selecting pacing outputs atimplant or follow-up, the same considerations apply:

● Select pacing polarity for leads (only if manual programming is desired).● Determine stimulation thresholds.● Select appropriate outputs (pulse width and amplitude).

5.7.2 Manually selecting pacing polarityAtrial and ventricular pacing polarities can be manually programmed for each chamber whenused with bipolar leads.Bipolar pacing polarity – The lead tip is the active electrode; the lead ring is the commonelectrode. Bipolar pacing is less likely to produce muscle stimulation, but it produces smallerpacing artifacts on the ECG.Unipolar pacing polarity – The lead tip is the active electrode; the noninsulatedpacemaker case is the common electrode. Unipolar pacing produces large pacing artifactsthat aid in ECG interpretation. However, it is more likely to cause muscle stimulation,especially at high pacing amplitudes.

5.7.3 Muscle stimulation with unipolar pacingUnder certain circumstances, e.g., high output settings, pacemaker-induced musclestimulation may occur at the pocket site with the unipolar-only models and bipolar modelsprogrammed to unipolar pacing. Pacemaker-induced muscle stimulation may be effectivelycontrolled and/or eliminated by programming Pulse Width to a narrower setting orprogramming a lower Amplitude.



5.7.4 Bipolar pacing polarity confirmationBefore programming from unipolar to bipolar pacing, the programmer verifies the presenceof a bipolar lead by testing lead impedance for each lead. Testing is done under magnetoperation for four seconds at an Amplitude of 5.0 V and a Pulse Width of 1.0 ms if theprogrammed settings are at or below this level. If the programmed settings are above thesevalues, the measurement will be made at the programmed settings.

● If bipolar lead impedance is between 200 Ω and the programmed maximum impedancelevel (not to exceed 4000 Ω), a bipolar lead is assumed to be present.

● If bipolar lead impedance is outside this range, a unipolar lead is assumed to be present.The programmer displays a warning that the test failed, and pacing polarity remains setto unipolar. This interlock feature may be overridden to force lead pacing polarity tobipolar.

Warning: Overriding the bipolar verification prompt with bipolar polarity when a unipolarlead is connected results in no pacing output.

5.7.5 Determining stimulation threshold at implantAt implant, use a pacing system analyzer to determine threshold values for capture. Refer tothe manual for the pacing system analyzer for detailed instructions.

5.7.6 Verifying stimulation threshold at follow-upMedtronic programmers provide both automatic and manual threshold tests for determiningthe patient’s stimulation threshold at follow-up. Stimulation threshold resolution isdetermined by the available increments of amplitude and pulse width.The Strength-Duration test constructs a strength-duration graph that shows the amplitudesafety margin.The Capture Management test provides ventricular pacing thresholds that are automaticallydetermined by the pacemaker through the Capture Management feature.

5.7.7 Selecting output parametersGenerally, to provide an adequate safety margin, select a pacing voltage twice the chronicstimulation threshold voltage for a given pulse width. For most patients, pacing outputs arethe major contributor to battery depletion.

● To maximize battery longevity, select the lowest amplitude and pulse width settings thatprovide at least a 2:1 voltage safety margin.



● When amplitudes greater than 2.5 V are required during the maturation phase of thelead(s), threshold(s) and output setting(s) should be carefully reevaluated at the firstfollow-up.

Notes:● Amplitudes of 5.0, 5.5, 6.0, and 7.5 V substantially reduce expected battery longevity.

These amplitudes should be limited to short-term uses such as “Emergency” settingsand electrophysiologic studies or long-term uses for specific indications such as exitblock.

● High output pacing at 7.5 V may affect ECG or intracardiac electrogram (EGM) waveformquality and potentially cause crosstalk or self-inhibition.

5.7.8 For further informationRefer to the appropriate implant manual for the following information:

● Projected service life for further information on pacemaker longevity under variouspacing scenarios.

● Programmable modes and parameters for further information on amplitude and pulsewidth parameter settings.

● Crosstalk for further information on crosstalk or self-inhibition.

5.8 Manually selecting sensing parameters5.8.1 OverviewSensitivity determines the minimum intracardiac signal that the pacemaker can detect whenintrinsic atrial or ventricular events occur. Whether selecting sensing parameters at implantor verifying sensing at follow-up, the same considerations apply:

● Select sensing polarity for leads (only if manual programming is desired).● Determine sensing thresholds.● Select appropriate sensitivity settings.

Warning: Carefully evaluate the possibility of increased susceptibility to EMI andoversensing before changing the sensitivity threshold to its most sensitive setting of 0.18 mV.When susceptibility to interference is tested under the conditions specified in standards ISO14708-2:2012 clause 27 and ISO 14117:2012, the device may sense the interference if thesensitivity threshold is programmed to any programmable sense threshold.



5.8.2 Manually selecting sensing polarityAtrial and ventricular sensing polarities can be manually programmed for each chamberwhen used with bipolar leads.Bipolar sensing polarity – The lead tip and lead ring electrode are the poles of the sensingcircuit. Because bipolar sensing is more localized, it reduces the likelihood of sensingmyopotentials and electromagnetic interference. It may also permit sensitivity to beprogrammed to a more sensitive setting.Unipolar sensing polarity – The lead tip and noninsulated pacemaker case are thesensing electrodes. Unipolar sensing may allow sensing of smaller intrinsic signals thandoes bipolar sensing and therefore, can be selected when intrinsic cardiac signals aredifficult to detect with bipolar sensing. Oversensing due to myopotentials is more commonwith unipolar sensing than with bipolar sensing.

5.8.3 Bipolar sensing polarity confirmationBefore programming from unipolar to bipolar sensing, the programmer verifies the presenceof a bipolar lead by testing impedance for each lead. Testing is done under magnet operationfor four seconds at an Amplitude of 5.0 V and a Pulse Width of 1.0 ms if the programmedsettings are at or below this level. If the programmed settings are above these values, themeasurement will be made at the programmed settings.

● If bipolar lead impedance is between 200 Ω and the programmed maximum impedancelevel (not to exceed 4000 Ω), a bipolar lead is assumed to be present.

● If bipolar lead impedance is outside this range, a unipolar lead is assumed to be present.The programmer warns that the test failed, and sensing polarity remains set to unipolar.This interlock feature may be overridden and lead sensing polarity forced to bipolar.

5.8.4 Determining sensing threshold(s) at implantAt implant, use a pacing system analyzer to determine sensing threshold values for thepacemaker. Refer to the manual for the pacing system analyzer for detailed instructions.Before connecting a bipolar lead, measure the sensing potentials in the unipolar and thebipolar configurations. Adequate intracardiac signal should be present in bothconfigurations to ensure proper sensing in either.



5.8.5 Verifying sensing threshold(s) at follow-upIntracardiac signal amplitudes decrease during the lead maturation process. Medtronicprogrammers provide an automatic sensitivity test that allows the follow-up clinician to verifya patient’s sensitivity settings. The automatic test measures the amplitude of sensed P or Rwaves on the atrial or ventricular channel. The test provides the sensitivity setting just aboveand below the point at which P waves or R waves are sensed.

5.8.6 Selecting sensitivity settingsAtrial and Ventricular Sensitivity are independently programmable. In general, a 2:1 to 3:1sensitivity safety margin (threshold sensitivity value divided by 2 or 3) is adequate for newlyimplanted or chronic leads. For example, an atrial sensitivity of 1.0 mV should be satisfactoryfor intrinsic atrial signals between 2.0 mV and 3.0 mV.

● Always perform an atrial sensing test to determine the appropriate atrial sensitivitysetting.

● Excessively sensitive (low) settings can cause some or all of the following problems:– oversensing due to electromagnetic interference (EMI), myopotentials, T waves, or

crosstalk– undersensing due to overloading of the sensing circuit– noise reversion operation

● Atrial Sensitivity with bipolar sensing polarity allows 0.18 mV, 0.25 mV, and 0.35 mV atrialsensitivity settings. To prevent oversensing of muscle noise or electromagneticinterference, unipolar sensing is limited to values no less than 0.5 mV.

● Ventricular Sensitivity at 1.0 mV or 1.4 mV with wide atrial pulse widths or high atrialamplitudes may result in ventricular safety pacing (if On) with some lead systems at highsensor-driven pacing rates. Reprogramming Ventricular Sensitivity to a less sensitivesetting (higher numerical value) is one option under such circumstances. Other optionsinclude programming a longer ventricular blanking period.

5.8.7 Effects of myopotentials during unipolar pacingMyopotentials could affect the operation of the unipolar-only models and bipolar modelsprogrammed to unipolar sensing, especially with atrial sensitivity settings of 0.5 through1.0 mV and ventricular sensitivity setting of 1.0 and 1.4 mV.Myopotentials sensed on the atrial channel outside of the Total Atrial Refractory Period(SAV + PVARP) start sensed AV intervals in the DDDR, DDD, and VDD modes.



Continuous myopotentials cause reversion to asynchronous operation when sensed inthe refractory period:

● on the ventricular channel at intervals less than the ventricular refractory period in theDDDR, DDD, DDIR, DDI, DVIR, DVI, VDD, VVIR, VDIR, VVI, VDI, and VVT modes

● on the atrial channel at intervals less than the atrial refractory period in the AAIR, ADIR,AAI, ADI, and AAT modes

In the VVIR and VDIR modes, the resulting asynchronous pacing occurs at the Lower Rate,otherwise such asynchronous pacing occurs at the sensor-indicated rate for rate responsemodes or the Lower Rate for nonrate response modes.

5.8.8 For further informationIn the manual for the pacing system analyzer, refer to sensitivity threshold test procedures.Refer to Section 4.6.12, “Noise reversion”, page 66 for a description of noise reversionoperation. Refer to Programmable modes and parameters in the appropriate implant manualfor sensitivity parameter settings.

5.9 Transtelephonic follow-up features5.9.1 OverviewWhen using transtelephonic monitoring, the clinician can do the following:

● Verify capture with the Threshold Margin Test (TMT)● Enhance communication with transtelephonic equipment by means of the

Transtelephonic Monitor feature

5.9.2 The Threshold Margin Test (TMT)Applying the magnet over the pacemaker initiates a Threshold Margin Test (TMT). Duringtranstelephonic monitoring, the TMT provides a check for loss-of-capture at reducedamplitudes. The TMT may indicate that loss-of-capture is possible but cannot verify that thesafety margin is adequate.In single chamber atrial or ventricular modes, the VDD mode, or dual chamber modes atRRT/ERI, TMT reduces amplitude in the pertinent paced chamber while pacing at a rate of100 bpm.



5.9.3 Threshold Margin Test operationAs Figure 56 shows, a dual chamber pacemaker delivers three asynchronous AV sequentialpulses at a rate of 100 bpm with a paced AV interval of 100 ms. The first two sequences ofpulses are delivered at the programmed Amplitude. The third sequence is delivered at a 20%reduction of the programmed Amplitude. At the completion of the TMT, pacing is forced to arate of 85 bpm in the magnet mode. If RRT/ERI or an electrical reset has occurred, pacing isforced to 65 bpm in the magnet mode.Figure 56. TMT operation

200 ms

Rate = 100 min-1 PAV = 100 ms

1 Magnet Applied2 Threshold Margin Test3 DDD Operation

4 Asynchronous (DOO) Pacing Rate = 85 bpm5 Amplitude Reduced by 20%

Parameters: Mode = DDDLower Rate = 60 bpmPAV = 180 ms

Warning: A loss-of-capture at a 20% reduction in amplitude indicates that the stimulationsafety margin is inadequate. As soon as possible, reevaluate the patient’s threshold andreprogram outputs for a 2:1 stimulation safety margin. Imminent loss of ventricular capturefor a pacemaker-dependent patient may constitute an emergency situation.Note: If follow-up is performed with the programming head, the clinician must perform aMagnet test in order to obtain a TMT. Placing the programming head over the pacemakerdoes not initiate a TMT.



5.9.4 Enhanced Transtelephonic MonitoringThe Transtelephonic Monitor is a programmable On or Off feature intended for use withremote pacemaker monitoring services. Programming the feature Off does not affectconventional transtelephonic monitoring.When the Transtelephonic Monitor is On, the pacemaker delays the Threshold Margin Testfor five seconds upon magnet application to enhance communication with transtelephonicequipment. If the pacing polarity is programmed to bipolar, it is temporarily set to unipolar toprovide improved ECG artifact detection for the remote monitoring equipment. Theprogrammed polarity is restored when the magnet is removed.When Transtelephonic Monitor is Off, the Threshold Margin Test is not delayed upon magnetapplication, and conventional transtelephonic monitoring can occur.Warning: Programming Transtelephonic Monitor On is contraindicated for patients with animplantable defibrillator. When it is programmed On, pacing polarity is temporarily set tounipolar when the magnet is applied over the pacemaker. Pacing in the unipolarconfiguration may cause the defibrillator either to provoke inappropriate therapy or towithhold appropriate therapy.

5.9.5 For further informationRefer to the Adapta/Versa/Sensia/Relia Pacemaker Programming Guide for programminginstructions regarding Transtelephonic Monitor.



6 Special therapy options

6.1 Mode Switch and diagnostic6.1.1 OverviewMode Switch is a programmable On or Off feature designed to prevent the tracking ofparoxysmal atrial tachycardias when the pacemaker is operating in the DDDR, DDD, andVDD modes. Mode Switch has a programmable Detect Rate that specifies when to switchmodes and a Detect Duration setting to screen out short tachycardia episodes. It also has aprogrammable Blanked Flutter Search setting to switch modes if 2:1 blanking of a rapid atrialarrhythmia is detected.Note: Mode Switch is not recommended for patients known to have chronic refractory atrialtachyarrhythmias, such as atrial tachycardia, atrial fibrillation, or atrial flutter.When the pacemaker detects an atrial tachyarrhythmia, it switches from the programmedatrial tracking mode to a non-atrial tracking mode and remains in this mode until the atrialtachyarrhythmia ceases. Then the pacemaker switches back to the atrial tracking mode (seeTable 9), unless Post Mode Switch Overdrive Pacing (PMOP) has been programmed.Table 9. Mode switching modes

Atrial tracking mode Non-Atrial tracking modeDDDR DDIRDDD DDIRVDD VDIR

AAIR<=>DDDR DDIRAAI<=>DDD DDIR

6.1.2 Operation with other pacemaker functionsManaged Ventricular Pacing (MVP) – Mode Switch can be programmed concurrently withMVP in the AAIR<=>DDDR and AAI<=>DDD modes. During atrial tachyarrhythmias, thepacemaker switches to DDIR pacing regardless of the current operating MVP mode.Post Mode Switch Overdrive Pacing (PMOP) – PMOP is available when the pacemakeris operating in DDDR and DDD modes. PMOP allows Mode Switch to provide extendedDDIR pacing at a higher rate after the atrial arrhythmia subsides. In PMOP, after theprogrammed Overdrive Period (at a programmed Overdrive Rate) has elapsed, thepacemaker returns to tracking the atrium in DDDR or DDD mode, as originally programmed.



6.1.3 How atrial tachyarrhythmia is definedThe pacemaker defines an atrial tachyarrhythmia based on the programmable Detect Rateand Detect Duration:Detect Rate – The rates above which pacemaker-defined atrial tachyarrhythmia starts. Notethat ventricular tracking is limited by the Upper Tracking Rate or the Total Atrial RefractoryPeriod, even when the atrial rate rises above the Detect Rate.Detect Duration – The minimum duration (in seconds) that the atrial tachyarrhythmia mustpersist above the Detect Rate before the rate is considered tachyarrhythmic.

6.1.4 How atrial tachyarrhythmia is detectedWhen the A–A rate exceeds the Detect Rate and is sustained for the Detect Duration, thepacemaker assumes that atrial tachyarrhythmia is in progress.In monitoring for rapid atrial rates, the pacemaker monitors for rapid consecutive A–Aintervals. If the Blanked Flutter Search parameter is On, the pacemaker also monitors forA–A intervals that may indicate 2:1 blanking of atrial events.

1. The pacemaker first monitors for any four of the last seven consecutive A–A intervalsthat are shorter than the detect rate interval. These include all A–A intervals exceptAS–AP and AR–AP intervals and AP–AR–AP sequences, which are classified asfar-field R waves.

2. If no rapid A–A intervals are detected (as described in Step 1) and Blanked FlutterSearch is On, the pacemaker next monitors for eight consecutive A–A intervals

● that are less than twice the total atrial blanking period (which is the SAV + PVAB)and

● where one half of the A–A interval is less than the detect rate intervalIf these criteria are met, the pacemaker will extend PVARP and the VA interval touncover any blanked AS events. If an A-A interval shorter than the detect rate intervalis detected, 2:1 sensing of an atrial tachyarrhythmia is assumed. Otherwise, thepacemaker resumes monitoring for 2:1 sensing of atrial tachyarrhythmias in 90seconds.

3. Once rapid consecutive A–A intervals are detected or 2:1 blanking of atrial events isdetected, the Detect Duration delay timer is started. The pacemaker will not switchmodes until this timer expires.To meet the Detect Duration delay, the pacemaker monitors that every eighth A–Ainterval is less than the detect rate interval. Once the Detect Duration timer expires, thepacemaker switches modes.



6.1.5 Switching to non-atrial tracking modeWhen an atrial tachyarrhythmia is detected, the pacemaker switches to the appropriatenon-atrial tracking mode, as shown in Table 9. To avoid an abrupt drop in the ventricular rate,it smoothly reduces the pacing rate from the atrial synchronous rate to the sensor-indicatedrate over several pacing cycles.After the rate transition is completed, the pacemaker continues sensor-driven pacing in theventricle, operating in the non-atrial tracking mode until the atrial tachyarrhythmia ceases(see Figure 57 and Figure 58).Figure 57. DDDR mode switching operation (without PMOP)

Atrial tachyarrhythmia is detected

Atrial tachyarrhythmia has ceased

Atrial rate

Ventricular rate

Sensor rate

Sensor rateDetect rate

Upper tracking rate

1 DDDR Mode2 V. Rate Adjust Mode

3 DDIR Mode4 Atrial Tracking Mode



Figure 58. DDDR mode switching operation (with PMOP)

Atrial tachyarrhythmia is detected

Atrial tachyarrhythmia has ceased

Ventricular rate

Sensor rate

Detect rate

Upper tracking rate

Atrial rate

Intervention rate

1 DDDR Mode2 V. Rate Adjust Mode3 DDIR Mode

4 PMOP Adjust Period5 PMOP Overdrive Period6 Atrial Tracking Mode

6.1.6 Switching back to atrial tracking modeWhen the last seven A-A intervals are longer than the upper tracking rate interval or when fiveconsecutive atrial paces occur, the pacemaker assumes atrial tachyarrhythmia has ceasedand begins to switch back to the programmed atrial tracking mode (DDDR, DDD, or VDD).See Figure 57.

6.1.6.1 DDDR and DDD modesWhen DDDR or DDD mode is programmed, abrupt changes in ventricular rate are avoidedby smoothly varying the pacing rate during mode switches.PMOP not programmed – If PMOP is not programmed, after the atrial tachyarrhythmiaends, the pacing rate is smoothly varied until the rate corresponds to the intrinsic atrial rate.Then the pacemaker switches to the programmed atrial tracking mode.PMOP programmed – If PMOP is programmed, after the atrial tachyarrhythmia ends, thepacing rate is smoothly modulated until the programmed Overdrive Rate is reached. Thepacemaker maintains the Overdrive Rate in DDIR mode for a programmed duration(Overdrive Period). When the Overdrive Period expires, the rate is gradually modulated until



the Lower Rate or Sensor Rate is reached, and then the pacemaker switches back to theprogrammed atrial tracking mode.

6.1.6.2 VDD modeIf VDD mode is programmed, after the atrial tachyarrhythmia ends, the pacemakerimmediately switches from VDIR back to VDD.

6.1.6.3 Mode switching interruptionThe typical mode switching sequence may be interrupted by either of these twooccurrences:

● The atrial tachyarrhythmia episode ceases before the pacemaker completes the ratetransition to the appropriate non-atrial tracking mode.

● The atrial tachyarrhythmia episode ceases briefly but resumes before the atrial trackingmode is restored.

In either case, the pacemaker responds by adjusting the rate transition in the appropriatedirection. The criteria for switching to the atrial tracking mode are unaffected.

6.1.7 Programming restrictionsWhen Mode Switch is On, several rates, timing intervals, and pacing therapies are limited tocertain values as follows:Mode Switch Detect Rate – The Mode Switch Detect Rate must be at least 10 bpm greaterthan the Upper Tracking Rate and the Upper Sensor Rate.PMOP Overdrive Rate – When Mode Switch is On and the PMOP Overdrive Period is setto any value, the PMOP Overdrive Rate is limited to a value greater than the Lower Rate butlower than the Upper Tracking Rate.Rate Drop Response – Rate Drop Response is disabled for mode switching from DDDmode or AAI<=>DDD mode.PVAB – The PVAB period is limited to a maximum of 200 ms.SAV and PAV intervals – The SAV and PAV intervals are limited to a maximum of 350 ms.When SAV or PAV are programmed above 310 ms or Search AV+ allows the SAV interval toextend greater than 310 ms, the pacemaker issues a warning to indicate that mode switchcan be delayed or prevented.Sensor-varied PVARP – Sensor-varied PVARP is not allowed for DDDR and DDD modeswitching.



6.1.8 Recording Mode Switch episode dataProgramming Mode Switch therapy parameters also initiates automatic data collection ofsummary data for up to 16 atrial high rate episodes that are based on mode switch criteria.When a pacemaker is programmed for mode switch therapy, the Atrial Arrhythmia diagnosticidentifies atrial high rate episodes, based on the parameters defined for mode switchtherapy. In addition to the automatic data collection of summary high rate data, thepacemaker can collect detailed data for as many as 16 atrial high rate episodes, includingEGM data for as many as 8 of these episodes.The collected data can be displayed or printed from the Data icon.

6.1.8.1 Automatic summary mode switch dataThe High Rate diagnostic automatically records the number of atrial arrhythmia episodesthat were detected during the collection period and the percentage of time spent in atrial highrate. The High Rate diagnostic also records the following summary data for each episode.

● Date and time of episode● Duration● Maximum atrial and ventricular rate● Average ventricular rate during episode● Sensor rate● Whether there is additional EGM or Trend data available

If the High Rate Collection Method is programmed by the clinician to Rolling, it also recordsthe summary information above for the first, fastest (highest rate), and longest atrial high rateepisodes plus the 13 most recent mode switch episodes. If the Collection Method is set toFrozen, summary data for the first 16 atrial high rate episodes in the collection period arerecorded.

6.1.8.2 Detailed mode switch dataMore detailed data about mode switch episodes can be collected when the High Rate Detaildiagnostic is chosen as the clinician-selected diagnostic. This diagnostic collects detaileddata from up to 16 high rate episodes (either 16 atrial high rate episodes, 16 ventricular highrate episodes, or 8 episodes of each type). For each episode, the diagnostic shows pacedand sensed events on a trend (beat-to-beat) graph. Figure 59 shows a typical mode switchepisode rate trend.



Figure 59. Mode switch episode rate trend

<4080

120160200240280

0 5 10 15

Rate (min-1) Atrial

seconds

Recording of a mode switch episode

Sensed

MS +30s

Paced

The High Rate Detail diagnostic also collects EGM data for 1, 2, 4, or 8 high rate episodes,for atrial, ventricular, or both atrial and ventricular episodes, depending upon clinicianselections.The clinician-selected Collection Type (Rolling or Frozen) parameter determines whichepisodes are used for collecting the high rate detail data. For more information about theHigh Rate Detail diagnostic, see Section 9.6, “High Rate Episodes”, page 173.

6.1.8.3 Clearing mode switch episode dataSummary and detailed mode switch episode data is normally cleared by the pacemaker onehour after a programming session.You can clear data immediately, using the Data Collection Setup/Clear menu option. Be sureto save the session data or print the report before ending the patient session.

6.2 Managed Ventricular Pacing (MVP)The MVP modes promote intrinsic conduction by reducing unnecessary right ventricularpacing. These modes provide atrial-based pacing with ventricular backup. If AV conductionis lost, the pacemaker switches to DDDR or DDD mode. Periodic conduction checks areperformed, and if AV conduction resumes, the pacemaker switches back to AAIR or AAImode.



6.2.1 Programming guidelinesReview the following information related to programming MVP modes.Selecting MVP modes – On the mode selection screen, the MVP modes are programmedby selecting AAIR<=>DDDR or AAI<=>DDD.Status display – On the programmer status bar the current operating mode is displayed, asfollows:

● In AAIR<=>DDDR mode, either AAIR+ or DDDR is displayed.● In AAI<=>DDD mode, either AAI+ or DDD is displayed.

In each case, the atrial mode is followed by a “+” symbol to indicate that backup ventricularpacing is available.V-V cycle variations – Depending on the patient’s intrinsic rhythm and conduction, MVPallows V-V cycle variations and occasional pauses of up to twice the lower rate interval. SeeFigure 60 and Figure 62.PAV and SAV – For MVP modes, it is not necessary to program longer PAV and SAV valuesto promote intrinsic AV conduction. PAV and SAV apply only when loss of AV conduction isdetected.Lower Rate programming – Upon abrupt loss of AV conduction, prior to switching to DDDRor DDD mode, ventricular pacing support can be as low as one-half the programmed LowerRate for two consecutive intervals. For patients with sinus bradycardia or frequent loss of AVconduction, program the Lower Rate to 50 bpm or higher.Complete heart block – For patients with complete heart block, the pacemaker will dropone beat every 16 hours (AV conduction check). See Figure 62. If this is undesirable,permanent DDDR or DDD modes may be more appropriate.Long PR intervals – For patients with long PR intervals, the pacemaker will remain in theAAIR or AAI mode. Permanent DDDR or DDD modes may be more appropriate for patientswith symptomatic first-degree AV block.

6.2.2 Programming restrictionsSearch AV+ – Search AV+ is not pertinent and cannot be enabled if the pacemaker isprogrammed to an MVP mode.Lower Rate and Sleep Rate – The Lower Rate and Sleep Rate parameters must be set to35 bpm or greater when the pacemaker is programmed to an MVP mode.Sinus Preference – Sinus Preference cannot be enabled if the programmed mode isAAIR<=>DDDR. Sinus Preference is only available if the programmed pacing mode isDDDR.



Rate Drop Response – Rate Drop Response can be enabled in AAI<=>DDD mode but notin AAIR<=>DDDR mode.

6.2.3 How MVP operatesThe MVP modes, AAIR<=>DDDR and AAI<=>DDD, provide AAIR or AAI mode pacing whilemonitoring AV conduction. For persistent loss of AV conduction, the pacemaker switches toDDDR or DDD mode. If AV conduction resumes, the pacemaker switches back to AAIR orAAI mode.For transient loss of AV conduction, the pacemaker remains in the AAIR or AAI mode andprovides a backup ventricular pace in response to an A-A interval that is missing a ventricularsense.If two of the four most recent nonrefractory A-A intervals are missing a ventricular event, thepacemaker identifies a persistent loss of AV conduction and switches to the DDDR or DDDmode (Figure 60).When MVP is operating in DDDR or DDD mode, the pacemaker operates as follows:

● All programmable parameters associated with DDDR or DDD mode apply.● The pacemaker performs periodic one-cycle checks for AV conduction and the

opportunity to resume AAIR or AAI therapy. See Figure 61 and Figure 62.● The first check for AV conduction occurs after 1 min. Subsequent checks occur at

progressively longer intervals (2, 4, 8 … min) up to 16 hours and then occur every 16hours thereafter.

When MVP is operating in AAIR or AAI mode, the pacemaker operates as follows:● Only programmable parameters associated with AAIR or AAI mode apply.● Ventricular backup paces occur following A-A intervals without a valid ventricular sense.

The backup paces are timed 80 ms after the A-A escape interval. A ventricular sensethat occurs within 80 ms after the A-A interval is considered invalid and does not inhibitthe backup pace.

● Atrial pacing is inhibited and new VA escape intervals are started in response to PVCsand PVC runs after the A-A interval.



Figure 60. 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 P

V S

V S

V-V intervals

ECG

Marker Channel

200 ms

1 The pacemaker operates in AAIR mode.2 At the onset of AV block, the pacemaker supplies ventricular backup paces.3 The pacemaker switches to DDDR mode.

Figure 61. Switching from DDDR mode to AAIR mode

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 pacemaker operates in DDDR mode.2 The pacemaker performs an AV conduction check. AV conduction is detected.3 The pacemaker switches to AAIR mode.



Figure 62. Remaining in DDDR mode after an AV conduction check

A P

A P

A P

A P

A P

A P

A P

A P

V P

V P

V P

V P

V P

V P

V-V intervals

ECG

Marker Channel

1 Remaining in DDDR mode after an AV conduction check.2 The pacemaker performs an AV conduction check. AV conduction is not detected.3 The pacemaker continues to operate in DDDR mode.

6.2.4 Interaction with other pacemaker functionsMode Switch – If Mode Switch is enabled, it continues to operate by switching to DDIRduring AT/AF episodes.Atrial Refractory Period (ARP) – While operating in AAIR or AAI mode, the AtrialRefractory Period (ARP) varies as a function of the current heart rate. ARP is 75% of thecardiac cycle length, up to a maximum of 600 ms.Temporary MVP suspension – Several features suspend MVP mode changes and set thepacing mode to DDDR or DDD until their operations are complete:

● Rate Drop Response, while delivering a rate drop intervention therapy● Lead Monitor, while waiting to gather at least one ventricular lead impedance

measurement per day, which requires a ventricular pace● Capture Management, while the pacemaker performs threshold searches● Magnet Mode

Blanking Period – While operating in the AAIR or AAI mode, the pacemaker blanking will be100 ms in the atrial chamber following an atrial pace or sense, 80 ms in the ventricle followingan atrial pace, and 100 ms in the Ventricle following a ventricular pace or sense. Otherblanking periods, such as PVAB are programmable.



6.3 Conducted AF ResponseConducted AF Response is designed to regularize the ventricular rate during AF. Thepacemaker modifies the pacing rate on a beat-by-beat basis to pace close to the meanintrinsic ventricular rate. Long pauses are eliminated, thereby reducing the ventricular rateirregularity.When programmed “On”, Conducted AF Response is activated by a Mode Switch episode(from DDDR, DDD, AAIR<=>DDDR, or AAI<=>DDD modes) or is active continuously (inDDIR, VDIR, or VVIR modes).Note: This feature was named Ventricular Response Pacing in previous pacemakers.

6.3.1 How Conducted AF Response is definedThe programmable parameters below define Conducted AF Response operation.Table 10. Defining Conducted AF Response operation

Parameter DescriptionConducted AF Response On; OffMaximum Rate Sets a limit on the ventricular pacing rate.

6.3.2 Programming restrictionsSearch AV+ – Conducted AF Response cannot be enabled concurrently with Search AV+when the programmed pacing mode is DDIR or VDIR.

6.3.3 Interactions with other pacemaker featuresRate Response Pacing – Conducted AF Response will not cause the pacing rate to beslower than the rate response sensor-indicated rate, or faster than the programmablemaximum response rate.



6.3.4 For more informationSee Section 9.7, “Ventricular Rate Histogram During Atrial Arrhythmias”, page 179.

6.4 Non-competitive atrial pacing6.4.1 OverviewNon-Competitive Atrial Pacing (NCAP) is intended to prevent triggering of atrial tachycardiasby an atrial pacing stimulus that falls within the atrium’s relative refractory period. This featureis available when the pacemaker is operating in the DDDR and DDD modes.Figure 63. The atrium’s relative refractory period

1 Pace atrium safely, no capture2 Relative refractory period, atrial pace may induce atrial tachycardia3 Pace atrium safely, capture

6.4.2 How NCAP affects atrial timingWhen NCAP is programmed to On, a refractory sensed atrial event falling in the PVARPstarts a 300 ms NCAP period, during which no atrial pacing may occur:

● If a sensor-driven or lower rate pacing stimulus is scheduled to occur during the NCAPperiod, the VA interval is extended until the NCAP period expires.

● If no pacing stimulus is scheduled to occur during the NCAP period, timing is unaffected;pacing occurs at the end of the VA interval unless inhibited.

● An atrial refractory sensed event occurring during the NCAP period starts a new NCAPperiod.



6.4.3 How NCAP affects ventricular timingWhen an atrial pacing stimulus is delayed by the NCAP operation, the pacemaker attemptsto maintain a stable ventricular rate by shortening the PAV interval that follows. It will not,however, shorten the PAV interval to less than 30 ms. When a relatively high Lower Rate andlong PVARP are programmed, NCAP operation may result in ventricular pacing slightlybelow the Lower Rate.Figure 64. Non-Competitive Atrial Pacing Operation

200 msP

P P P

P

DDDRA

V

R

300 ms 30 msSensor Sensor

1 Sensor-indicated interval2 NCAP

Parameters: Sensor-Indicated Rate = 120 bpm (500 ms)PAV Interval = 150 msPVARP Interval = 230 msPost-Ventricular Atrial Blanking (PVAB) = 180 msVentricular Refractory Period = 230 ms

6.4.4 NCAP availabilityThe Non-Competitive Atrial Pacing is available when the pacemaker is operating in theDDDR and DDD modes. Its availability is also dependent on the following:

● When Mode Switch is programmed On, NCAP operations are temporarily disabled if thepacemaker mode switches to the non-atrial tracking mode. The NCAP feature isreenabled upon return to the atrial tracking mode.



● Even when NCAP is programmed Off, the NCAP operation is invoked automatically forcycles on which PMT Intervention or PVC Response operations occur.

6.4.5 For further informationRefer to Section 6.1, “Mode Switch and diagnostic”, page 111, Section 6.5, and Section 6.6,“PVC Response”, page 127 for more information on these therapy features.

6.5 PMT intervention6.5.1 OverviewA Pacemaker-Mediated Tachycardia (PMT) may occur when retrograde P waves (due to aloss of AV synchrony) are sensed and tracked in an atrial tracking mode. PMT Interventionprovides an automatic way for the pacemaker to detect and interrupt pacemaker-definedPMTs.To ensure that retrograde P waves (rather than fast intrinsic rates) are being tracked, thepacemaker verifies that the sensor rate is at a moderate rate or less before intervening. Thisfeature is available when the pacemaker is operating in the DDDR, DDD, and VDD modes.Caution: Even with the feature turned On, PMTs may still require clinical intervention suchas pacemaker reprogramming, magnet application, drug therapy, or lead evaluation.

6.5.2 How the pacemaker defines PMTThe pacemaker assumes that a PMT may be present when it detects a ninth ventricular pacefollowing eight consecutive VA intervals that meet all of the following conditions:

● Duration less than 400 ms● Start with a ventricular paced event● End with an atrial sensed event



6.5.3 Sensor corroboration before interveningOn the eighth consecutive VA interval, the pacemaker verifies that retrograde P waves arebeing tracked, and not a fast intrinsic atrial rate, by checking the rate of the activity sensor.

● If the sensor rate is at or below the ADL Rate, a pacemaker-defined PMT episode isassumed to be present, and therapy intervention will ensue.

● If the sensor rate is above the ADL Rate, a rapid sinus rate is assumed to be present, andno therapy intervention will ensue.

● The pacemaker will continue to monitor each series of eight consecutive VA intervalsand the sensor rate.

6.5.4 PMT therapy interventionWhen a pacemaker-defined PMT is detected, the pacemaker intervenes, forcing a 400 msPVARP after the ninth paced ventricular event (see Figure 65). If a PMT is indeed in progress,the extended PVARP ensures that the next atrial sensed event within 400 ms will berefractory. By interrupting atrial tracking for one cycle, the PMT may be stopped.Note: A sinus tachycardia could cause PMT therapy intervention, resulting in a single P wavefalling in the PVARP and, therefore, not being tracked by the pacemaker.Figure 65. PMT Intervention

PVARP PVARP PVARP PVARP

200 ms

PVARP = 400 ms

Parameters: PVARP = 280 ms

6.5.5 Automatic therapy suspensionAfter therapy intervention, PMT Intervention is automatically suspended for 90 seconds.This prevents unnecessary intervention in the presence of fast intrinsic atrial rates.



6.5.6 Interactions with other featuresThe PMT Intervention feature interacts with other pacemaker features in the following ways:

● Non-Competitive Atrial Pacing (NCAP) is automatically enabled for one cycle after theninth ventricular pace of a pacemaker-defined PMT episode. The NCAP feature mayshorten the ensuing PAV to maintain a stable ventricular rate.

● If Mode Switch is On, PMT Intervention is temporarily disabled if the pacemakerswitches to the non-atrial tracking mode. It is reenabled upon return to the atrial trackingmode.

6.5.7 Patient intervention for PMTWhen sensor-varied PVARP is active, the patient can often terminate a PMT simply byresting quietly, causing the sensor-indicated rate to drop and the PVARP to extend. WhenPVARP becomes longer than the retrograde time, the PMT may terminate.

6.5.8 For further informationRefer to Section 6.4, “Non-competitive atrial pacing”, page 123 and Section 6.1, “ModeSwitch and diagnostic”, page 111 for more information on these therapies.

6.6 PVC Response6.6.1 OverviewThe Premature Ventricular Contraction (PVC) Response feature is available when thepacemaker is operating in the DDDR, DDD, DDIR, DDI, and VDD modes. The feature, whichis programmable On or Off, is intended for the following purposes:Operation in DDDR, DDD, and VDD modes – PVC Response is intended to preventtracking of retrograde P waves generated by PVCs. This response helps prevent initiation ofpacemaker-mediated tachycardia.Operation in DDIR and DDI modes – PVC Response prevents inhibition of atrial pacingthat can result from retrograde P waves generated by PVCs.



6.6.2 How the pacemaker defines a PVCThe pacemaker defines a PVC as any ventricular sensed event (refractory or nonrefractory)that follows a ventricular event (pace, refractory sense, or non-refractory sense) without anintervening atrial event (pace, refractory sense, or non-refractory sense). In the VDD mode,a ventricular paced event delivered at the Lower Rate and not preceded by an atrial sensedevent is also considered a PVC.

6.6.3 Extending PVARPWhen PVC Response is On, a pacemaker-defined PVC starts an extended PVARP of400 ms if the programmed value or the operating value is less than 400 ms (sensor-variedPVARP or automatic PVARP). This extended PVARP causes retrograde P waves within400 ms to be identified as refractory sensed events.Figure 66. PVC Response operation

PVARP

PVC

PVARPPVARP = 400 ms

Sensor-indicated VA interval

6.6.4 Interaction with other featuresPVC Response interacts with other pacemaker features as follows:

● The PVC Response feature always enables Non-Competitive Atrial Pacing (NCAP) forone cycle when NCAP is programmed Off. This occurs even when the PVARP extensionoccurs.

● If Mode Switching is On, PVC Response is temporarily disabled when the pacemakerswitches to the non-atrial tracking mode. It is reenabled upon return to the atrial trackingmode.

6.6.5 PVCs automatically countedThe pacemaker automatically counts PVCs and runs of two or more consecutive PVCs. Bothcounts are included in the automatic Heart Rate Histogram diagnostic report.



Note: Pacemaker-defined PVCs do not necessarily correspond to physiological PVCs. Forexample, atrial undersensing or ventricular oversensing may result in two consecutiveventricular senses with no intervening atrial event. If high PVC counts occur, the causeshould be further investigated before any therapeutic decision is made.

6.6.6 For further informationRefer to Section 6.4, “Non-competitive atrial pacing”, page 123 and Section 6.1, “ModeSwitch and diagnostic”, page 111 for more information on these therapies. For informationon the automatic Heart Rate Histogram diagnostic, refer to Section 9.2, “Heart RateHistograms”, page 166.

6.7 Ventricular Safety Pacing6.7.1 OverviewVentricular Safety Pacing (VSP) can be programmed to On or Off and is intended to preventventricular asystole due to inappropriate inhibition of ventricular pacing. Such inhibition maybe caused by crosstalk or ventricular oversensing. The feature is available when thepacemaker is operating in the DDDR, DDD, DDIR, DDI, DVIR, and DVI modes.

● Crosstalk occurs when the ventricular lead senses atrial stimuli. When crosstalk occurs,the pacemaker may interpret the atrial paced event as a ventricular depolarization andinappropriately fail to pace the ventricle.

● Frequent VSP may be caused by a loss of atrial sensing.Warning: VSP should always be programmed to On for pacemaker-dependent patients.

6.7.2 How VSP operatesWhen VSP is operating, a ventricular sense within 110 ms after an atrial pacing pulse resultsin a ventricular pacing pulse at 110 ms or at the PAV interval, whichever expires first. If thesensed event was, in fact, a ventricular depolarization, the ventricular pacing pulse at 110 msfalls harmlessly into the absolute refractory period of the ventricle.



Figure 67. Ventricular Safety Pacing (VSP)

P

DDDRA

V

S

110ms

PPP

PP

200 ms

1 Sensor2 Safety

6.8 Sinus Preference6.8.1 OverviewThe Sinus Preference feature is intended to improve cardiac hemodynamics, primarily atlower rates, by providing preference to sinus activation of the heart over sensor-drivenpacing. This occurs when the sinus rate and sensor-indicated rate are nearly the same. Thefeature permits a slower intrinsic escape rate by occasionally searching for the sinus ratebelow the sensor-indicated rate or when intrinsic atrial events are tracked (sinusbreakthrough). This feature is available when the pacemaker is programmed to the DDDRmode.

6.8.2 How Sinus Preference is definedSinus Preference operation permits the sensor-driven pacing rate to gradually drop to alower escape rate. If the sinus rate is not present at the lower escape rate for eight pacedbeats, the rate is gradually raised back to the sensor-indicated pacing rate. The operation isrepeated for the next scheduled time. The two italicized terms represent the twoprogrammable parameters below.



Table 11. Defining Sinus Preference operationParameter DescriptionSinus Preference Zone The maximum drop in rate from the sensor-indi-

cated rate while searching for or tracking thesinus rate.Note: The difference between the sensor-indi-cated rate and Sinus Preference Zone is heldconstant as the sensor rate varies.

Search Interval The amount of time between sinus search oper-ations.

6.8.3 Programming restrictionsAtrial Preference Pacing – Atrial Preference Pacing and Sinus Preference cannot beenabled concurrently.MVP mode – Sinus Preference cannot be enabled if the programmed mode isAAIR<=>DDDR. Sinus Preference is only available if the programmed pacing mode isDDDR.

6.8.4 How Sinus Preference operatesSinus Preference operates in two modalities: sinus search operation and sinusbreakthrough operation.During sinus search operation, the pacemaker searches for a sinus rate that is slightlybelow the sensor-indicated rate. When the Search Interval expires, the pacemaker graduallydrops the pacing rate until the sinus rate is sensed or until the rate drops to the SinusPreference Zone limit.

● If the sinus rate is sensed, ventricular rate is tracked to the sinus rate.● If no sinus rate is present in the Sinus Preference Zone, the pacemaker paces at the

Sinus Preference Zone limit for eight beats, whereupon rate is gradually increased to thesensor-indicated rate.

At the end of the Sinus Preference episode, the search interval is restarted and once theinterval expires, the sinus search operation is repeated.



Figure 68. Example of Sinus Search operation

TimeLower rate

Zone limit8 beats

Atrial paced events

Atrial sensed eventsSensor rate

1 Start of search interval2 Begins sinus tracking

3 Sinus Preference Zone

During sinus breakthrough operation, the pacemaker tracks the sinus rate to a rate that isbelow the sensor-indicated rate. The pacemaker can track the sinus rate down to the SinusPreference Zone limit, but never below the Lower Rate.Once the sinus rate falls below the Sinus Preference Zone limit, the pacemaker paces at thisrate for eight beats, whereupon, the rate is gradually increased to the sensor-indicated rate.Note that even though the search interval does not start the sinus breakthrough operation,the search interval is reset once sinus breakthrough tracking ends.Figure 69. Example of Sinus Breakthrough operation

Time

8 beats

Atrial paced events

Atrial sensed events

Lower rate

Zone limit

Sensor rate

1 Sinus Preference Zone2 Begins sinus tracking



6.8.5 Interaction with other featuresIf Mode Switch is On, Sinus Preference is temporarily disabled when the pacemakerswitches to the non-atrial tracking mode. It is enabled once the pacemaker returns to theatrial tracking mode.

6.8.6 For further informationRefer to Section 6.1, “Mode Switch and diagnostic”, page 111 for more information on modeswitching.

6.9 Atrial Preference Pacing6.9.1 OverviewAtrial Preference Pacing is designed to reduce the incidence of atrial tachyarrhythmias byproviding rate-variable continuous pacing, closely matched to the intrinsic sinus ratewhenever it exceeds the sensor-indicated rate.

6.9.2 How Atrial Preference Pacing is definedAtrial Preference Pacing gradually accelerates until atrial pacing replaces intrinsic atrialactivation. After a programmable period of 100% atrial pacing, the pacemaker graduallydecreases to match the sinus rate more closely. The next sinus beat reinitiates preferencepacing.Table 12. Defining Atrial Preference Pacing operation

Parameter DescriptionA. Preference Pacing On; OffMaximum Rate Sets a maximum rate for Atrial Preference Pac-

ing.Interval Decrement In response to an atrial sensed event, the atrial

pacing interval decreases by this value, per beat,to accelerate the pacing rate.

Search Beats After this number of consecutive paces, the atrialrate decelerates in search of sinus activation.



6.9.3 Programming guidelinesReview the following information before programming Atrial Preference Pacing.Pacemaker service life – When Atrial Preference Pacing is enabled, the pacemaker tendsto provide a higher ratio of paced to sensed events, which may decrease the service life ofthe pacemaker.Interval Decrement parameter – When choosing a value for the Interval Decrementparameter, be aware of these considerations:

● A larger value (for example, 100 ms) provides a more aggressive response to a sinus rateincrease. This means that Atrial Preference Pacing occurs more often, more quickly, andlasts longer than with a smaller Interval Decrement value.

● A smaller value decreases the response to isolated PACs and sinus variability near thelower (or sensor) rate. Atrial Preference Pacing reacts more slowly to a sustained rateincrease.

6.9.4 Programming restrictionsReview the following information before programming Atrial Preference Pacing.Single Chamber Hysteresis – Atrial Preference Pacing and Single Chamber Hysteresiscannot be enabled concurrently.Sleep Function – Atrial Preference Pacing and the Sleep Function cannot be enabledconcurrently.Sinus Preference – Atrial Preference Pacing and Sinus Preference cannot be enabledconcurrently.Rate Drop Response – Atrial Preference Pacing and Rate Drop Response cannot beenabled concurrently.

6.9.5 How Atrial Preference Pacing operatesAtrial Preference Pacing is available when the pacemaker is operating in the DDDR, DDD,AAIR, or AAI modes. When Atrial Preference Pacing is enabled, the pacemaker responds tochanges in the atrial rate by accelerating its pacing rate until a steady paced rhythm, slightlyfaster than the intrinsic rate, is obtained. Compare Figure 70 and Figure 71.



Figure 70. DDDR operation without Atrial Preference Pacing

1 2 1

Heart Rate

Time

Sensor-indicated rateSinus rate

1 Intrinsic activation when the sinus rate exceeds the sensor-indicated rate.2 Atrial pacing at the sensor-indicated rate when that rate exceeds the sinus rate.



Figure 71. DDDR operation with Atrial Preference Pacing

1 2 1

Heart Rate

Time

Sensor-indicated rateSinus rate

Overdrive Atrial Pacing rate

1 Atrial pacing slightly faster than the sinus rate when the sinus rate exceeds the sensor-indicatedrate.

2 Atrial pacing at the sensor-indicated rate when that rate exceeds the sinus rate.

On every nonrefractory atrial sensed event, the pacemaker shortens its pacing escapeinterval by the programmed Interval Decrement value, accelerating the pacing rate. If thenext atrial event is another nonrefractory sensed event, the pacing interval is againdecremented.This progression continues until the pacing rate exceeds the intrinsic rate, resulting in anatrial paced rhythm; however, the programmed Maximum Rate value provides a rate limit forAtrial Preference Pacing.When the number of consecutive paced atrial events reaches the programmed SearchBeats value, the pacemaker adds 20 ms to the pacing escape interval, slowing the pacingrate. After the same number of consecutive paces at the new rate, the escape interval isagain extended.



This progression continues until one of the following conditions occurs:● The pacing rate reaches the Lower Rate.● The pacing rate reaches the sensor-indicated rate.● Pacing is interrupted by intrinsic atrial activity.

At the next nonrefractory atrial sensed event or when any atrial sensed event occurs duringthe deceleration, rate acceleration under Atrial Preference Pacing resumes as describedabove.

6.9.6 Interaction with other featuresMode Switch – Atrial Preference Pacing is suspended during mode switching (includingPMOP).Non-Competitive Atrial Pacing (NCAP) – The NCAP feature may delay an atrial pace thatresults from Atrial Preference Pacing.Capture Management – Atrial Preference Pacing will not increase the pacing rate if an atrialsense occurs during either ACM or VCM).

6.10 Rate Drop Response and diagnostic6.10.1 OverviewRate Drop Response (RDR) is intended to provide backup pacing and prevent associatedsymptoms in patients who experience occasional episodes of significant drop in heart rate(e.g., syncope from cardioinhibitory and mixed forms of carotid sinus syndrome).When a rate drop episode is detected, the pacemaker intervenes with an elevated rate for abrief period of time. RDR can be set to intervene following a drop in heart rate which meetsprogrammed criteria, Lower Rate pacing occurs, or both. RDR is available only in theAAI<=>DDD, DDD and DDI modes.



6.10.2 How the pacemaker intervenesWhen a drop of a specified size below a specified rate is detected or a drop to the Lower Rateis detected, the pacemaker intervenes by pacing at a programmed Intervention Rate for aprogrammed Intervention Duration:

● When the Intervention Duration expires, the pacemaker slowly reduces the pacing rateby approximately 5 bpm steps per minute until the intrinsic rate is sensed or the LowerRate is reached, whichever is higher.

● When the intervention cycle ends, standard operations for the programmed moderesumes.

Note that the intervention cycle may be terminated at any time by the occurrence of threeconsecutive nonrefractory sensed atrial events.

6.10.3 How the drop detection option defines a specified rate dropA pacemaker-defined RDR rate drop is when the sensed or paced ventricular rate drops bythe programmed Drop Size or more to below the programmed Drop Rate within theprogrammed Detection Window (see Figure 72).Note: Episodes with variability in the presyncope rate are detected by RDR as long as therate drop meets the Drop Size and Detection Window criteria.If the intrinsic ventricular rate drops too slowly to meet the RDR detection criteria, thepacemaker paces at the Lower Rate if the intrinsic rate drops below the Lower Rate.RDR can also be set to intervene when the rate drops below the Lower Rate by programmingRDR to Both.



Figure 72. RDR intervention (drop detection at specified rate in DDD mode)

Drop rate at 70 min-1

Lower rate at 55 min-1

Drop size at 25 min-1

Intervention rate at 100 min-1

Ventricular beats

Time

Ventricular beats (drop size)Paced atrial beats

1 Programmable detection window2 Intervention duration

3 Detection window

6.10.4 How the low rate detection operatesA pacemaker-defined RDR episode at the Lower Rate is when the heart rate drops to theLower Rate and the atrium or ventricle is paced at the Lower Rate for a consecutive numberof Detection Beats (see Figure 73).Note that detecting a low rate RDR episode in the ventricle is applicable to the DDI modeonly.



Figure 73. RDR intervention (low rate detection in DDD mode)

Time

Paced atrial beats (detection beats)Sensed atrial beats

Paced atrial beats

Lower rate at 40 min-1

Intervention rate at 100 min-1

6.10.5 Programming guidelinesDDD and DDI modes – RDR therapy is typically used in the DDI mode for patients with intactAV conduction. RDR is used in the DDD mode for patients with complete or transient AVblock during rate drop episodes.AV intervals – Program the Paced AV interval to 150 ms for a therapeutic paced AV delayduring RDR therapy intervention. While RDR therapy intervention is not in progress, intrinsicactivation of the ventricles should be accomplished by using either MVP mode, or DDDmode with Search AV+ enabled.Drop detect operation – For predictable rate drops, configure RDR to the shortest rate dropprofile before syncope occurs by programming Drop Detection:

● Set Lower Rate below the normal sinus rate at rest.● Set Drop Rate above the rate where syncope occurs.● Set Drop Size at the shortest observed rate drop prior to syncope.● Set Detection Window long enough to detect the slowest expected rate drop.



Low rate detect operation – For unpredictable rate drops, configure RDR to lower ratedetection by programming Low Rate Detection:

● Set Lower Rate below the normal sinus rate at rest. Be sure to consider the patient’sheart rate during sleep. See Section 6.11, “Sleep Function”, page 143.

● Set Detection Beats to the desired number of paced beats (at the lower rate) to confirmthe low rate episode.

Both operations – For a mix of predictable and unpredictable rate drops, configure RDR toboth operations by programming Both. Select values for Drop Rate, Drop Size, DetectionWindow, Lower Rate, and Detection Beats as indicated above.Therapy intervention – Set the Intervention Rate at a sufficient rate and the InterventionDuration to a long enough duration to prevent syncope and/or minimize associatedsymptoms.Sleep Function – Program the Sleep Function On if undesirable symptoms occur (due toRDR intervention) while the patient sleeps. RDR is temporarily disabled during sleep timeswhen the Sleep Function is active.Note: Patients that are prone to rate drop episodes during sleep times should not have theSleep Function On so RDR can intervene, if necessary.

6.10.6 Programming restrictionsRate Drop Response subordinate parameters – The Drop Rate cannot be less than theprogrammed Lower Rate. The Intervention Rate cannot be greater than the programmedUpper Tracking Rate and must be greater than the programmed Lower Rate.Capture Management – When both Capture Management and RDR are operating, RDRwill be suspended during the pacing threshold search. Programming Capture Managementto search for pacing thresholds at night can mitigate the interaction.Mode Switch – Mode Switch is unavailable when RDR is programmed On.Rate Adaptive AV, Sensor-Varied, and Automatic PVARP – Rate Adaptive AV,sensor-varied PVARP, and automatic PVARP are unavailable when RDR is programmed on.Atrial Preference Pacing – Rate Drop Response and Atrial Preference Pacing cannot beenabled concurrently.

6.10.7 Recording of Rate Drop EpisodesProgramming Rate Drop Response therapy parameters automatically initiates recording ofepisode summary data. You may also select to record detailed information about the firstepisode and the four most recent episodes.



6.10.7.1 Summary of Rate Drop EpisodesThe Rate Drop Response Episodes diagnostic records a summary of both low rate detectand specified drop detect episodes. Specifically, it collects the following for the first and thenine most recent episodes:

● Type of episode● Date and time● Rate that resulted in a RDR intervention

It also counts both types of episodes up to a maximum of 255 for each episode type.The data can be displayed and printed from the Data icon.

6.10.7.2 Detail Rate Drop Episode dataThe clinician selected Rate Drop Response Detail diagnostic records a detailedbeat-to-beat rate trend of cardiac events proceeding Rate Drop Response intervention.Episodes are defined by the programmed Rate Drop Response therapy parameters. Abeat-to-beat trend is collected for the first and the four most recent episodes. Each trend canhave a maximum of 680 events and is frozen when the detection criteria are met. Figure 74shows a typical detail rate drop response trend.Figure 74. Detail Rate Drop Response trend

<406080

100120140160180

185180175

Rate (bpm)Atrial

seconds

Sensed

Paced

Data can be displayed and printed from the Data icon.



6.10.7.3 Clearing Rate Drop Episode dataRate Drop Episode data is normally cleared by the pacemaker one hour after a programmingsession.You can select the option to clear data immediately. Be sure to save the session data or printthe episode report before ending the patient session.

6.10.7.4 For further informationRefer to the Adapta/Versa/Sensia/Relia Pacemaker Programming Guide for diagnosticretrieval instructions.

6.11 Sleep Function6.11.1 OverviewThe Sleep Function suspends the programmed Lower Rate and replaces it with a Sleep Rate(slower than the Lower Rate) during a specified sleep period. The slower pacing rate duringthe sleep period is intended to reduce the paced rhythm during sleep. This feature isavailable in all pacing modes.

6.11.2 How the Sleep Function worksFigure 75. Sleep Function operation

Time

Sleep rate

Lower rate

Rate

1 30 min2 Bed time

3 Wake time



The Sleep Function is controlled by three programmable parameters: Bed Time, Wake Time,and Sleep Rate. The Sleep Function works as follows:

1. During the 30 min following the programmed Bed Time, the pacemaker graduallyreduces the operating rest rate from the Lower Rate to the Sleep Rate.

2. The Sleep Rate remains in effect as the operating rest rate until the programmed WakeTime.

3. During the 30 min following the programmed Wake Time, the pacemaker graduallyraises the operating rest rate from the Sleep Rate to the Lower Rate.

Notes:● To ensure that the Bed Time and Wake Time parameters are accurate, keep your

programmer set to the correct time.● Bed Time and Wake Time values are defined in a 12-hour format.

In rate responsive modes, the sensor-indicated rate drops to the Sleep Rate, but increasesas usual in the presence of sensor-indicated activity.

6.11.3 Interrupting the Sleep FunctionApplying a magnet or the programming head over the pacemaker during the sleep periodcauses the pacemaker to abandon Sleep operation and restores the programmed LowerRate. The Sleep Function resumes at the next scheduled Bed Time.

6.11.4 Programming considerationsWhen setting Bed Time and Wake Time, consider time zone changes resulting from travel,daylight savings time, and variations in the patient’s sleep patterns (such as variable workshifts). Bed Time and Wake Time must differ by at least one hour.When Sleep Function is active, Rate Drop Response therapy intervention is temporarilydisabled.

6.11.5 Programming restrictionsAtrial Preference Pacing – Atrial Preference Pacing and Sleep Function cannot be enabledconcurrently.



6.11.6 Evaluating Sleep Function operationThe clinician selected Custom Rate Trend or automatic Heart Rate Histogram diagnosticsmay be used to evaluate the operation of the Sleep Function. Refer to Section 9.10, “CustomRate Trend”, page 181 and Section 9.2, “Heart Rate Histograms”, page 166.

6.12 Single Chamber Hysteresis6.12.1 OverviewSingle Chamber Hysteresis lets the pacemaker track an intrinsic rhythm below theprogrammed Lower Rate. This prevents the pacemaker from overriding slow but appropriateintrinsic rhythms that may develop during extended periods of inactivity such as sleep.Hysteresis is programmed to a rate below the Lower Rate. The feature, which is programmedto a Hysteresis Rate or Off, is available in AAI, ADI, VVI, VDI, AAT, and VVT modes.

6.12.2 How hysteresis worksWhen the Single Chamber Hysteresis Rate is programmed, a sensed event temporarilysuspends the Lower Rate, and the pacemaker determines its escape rate from thehysteresis rate instead. As long as the intrinsic rate remains above the hysteresis rate,pacing is inhibited. The first occurrence of an escape pace at the Hysteresis Rate suspendshysteresis operations and reestablishes the Lower Rate as the escape rate.Figure 76. Single chamber hysteresis operation

VP

VS

VP

VP

VP

200 ms

1 Lower Rate interval2 Hysteresis Rate interval



Parameters: Mode = VVIPacing Rate = 70 bpm (857 ms)Hysteresis Rate = 60 bpm (1000 ms)Ventricular Refractory Period = 300 ms

6.12.3 Programming considerationsHysteresis is intended for patients with a predominately normal sinus rhythm withoutventricular irritability. Some patients may experience undesirable cardiac arrhythmias nearthe Hysteresis Rate (such as bigeminal beats). Therefore, verify adequate cardiac supportat the Hysteresis Rate before programming. The difference between the Hysteresis Rateand the Lower Rate is typically not greater than 30 bpm.

6.12.4 Programming restrictionsAtrial Preference Pacing – Atrial Preference Pacing and Single Chamber Hysteresiscannot be enabled concurrently.

6.12.5 Interactions with other pacemaker functionsSleep Function – Hysteresis is inoperative when the Sleep Function is operating and if theSleep Rate is programmed to a rate equal to or lower than the Hysteresis Rate.



7 Telemetry data

7.1 Establishing telemetryTelemetry is established by placing the programming head over the implant site and movingthe head along the axis as shown in Figure 77.Figure 77. Positioning the programming head

7.1.1 For further informationRefer to the Adapta/Versa/Sensia/Relia Pacemaker Programming Guide for instructions onpositioning and using the programming head.

7.2 Parameter summary7.2.1 OverviewWhen interrogated by the programmer, the pacemaker telemeters the programmedparameter settings along with battery status and device identification. Some features enablethe pacemaker to alter previously programmed values (see Section 7.2.3, “Possiblevariation from programmed values”, page 148).



7.2.2 Parameters reportedThe programmer reports only parameters pertinent to the programmed mode. Dependingon the programmed mode, the telemetered parameters and pacemaker data may include:

● Mode● Pacing rates● AV intervals● Refractory periods● Blanking periods● Pulse amplitudes● Pulse widths● Sensitivities● Polarities● Rate Response features● Therapy features● Device identification● Serial number● Battery / lead values

7.2.3 Possible variation from programmed valuesIn general, parameters will be set to their values from the previous programming session.Exceptions are as follows:Rate Profile Optimization – If programmed On, rate response parameters can changeeach day, as described in Section 3.1.1, “Rate response”, page 28.Lead Monitor – Bipolar polarities can revert to backup unipolar polarities if an out-of-rangelead is detected, as described in Section 5.3, “Lead Monitor”, page 76.Capture Management – The pacemaker can check for atrial and ventricular capture. Ifenabled, it can adjust the amplitude and pulse width, as described in Section 5.5, “CaptureManagement and diagnostic”, page 79.Sensing Assurance – If this feature is active, the pacemaker can change the sensitivity forone or both leads to track changes in the sensed amplitude. Refer to Section 5.6, “SensingAssurance and diagnostic”, page 99.



Search AV+ – If the pacemaker does not observe intrinsic ventricular activation during itsperiodic searches over the course of a week, it turns off the Search AV+ feature.Electrical Reset – If the pacemaker has undergone a full or partial electrical reset, thereported parameters will differ from their previously programmed settings, as described inSection 8.3, “Electrical reset”, page 159.Recommended Replacement Time (RRT/ERI) – If RRT/ERI is set, the reportedparameters will be the RRT/ERI values, as described in Section 8.4, “RecommendedReplacement Time (RRT/ERI)”, page 161.Note: If one of the AV Therapies (e.g., Search AV+) is active, the pacemaker can change theoperating values (not the programmed values) of SAV and PAV.

7.2.4 For further informationRefer to the Adapta/Versa/Sensia/Relia Pacemaker Programming Guide for instructions onretrieving pacemaker parameters and data.

7.3 Patient information7.3.1 OverviewThe pacemaker can store information about the patient. After an interrogation, you candisplay and print this data from the programmer by selecting the Patient Information optionunder the Patient icon.This information can be revised and reprogrammed during a patient session. In addition, itcan be used to generate a warning message (for example, if Transtelephonic Monitoring isprogrammed for a patient having an implanted defibrillator).

7.3.2 Parameters reportedThe types of patient data stored in the pacemaker are as follows:

● Notes● Patient Identification

– Name– Age– I.D. Number– Chart Number



● Indications for ImplantThe History window allows you to program the clinical conditions that are made availableto TherapyGuide (see Section 7.4, “Using TherapyGuide to select parameter values”,page 150).

● Atrial and Ventricular Leads Implanted– Lead Manufacturer– Lead Model– Lead Serial Number– Lead Implant Date

● Device Implanted– Serial Number– Implant Date

● Physician information– Name– Phone No.

7.4 Using TherapyGuide to select parameter valuesCaution: TherapyGuide does not replace a physician’s expert judgment. The physician’sknowledge of the patient’s medical condition goes beyond the set of inputs presented toTherapyGuide. The physician is free to accept, reject, or modify any of the suggestedparameter values.TherapyGuide offers a simple clinically-focused method for a clinician to obtain suggestedparameter values. At implant or an early follow-up appointment, the clinician entersinformation about the patient’s clinical conditions. Based on those inputs the programmersuggests parameter values. The suggestions are based on clinical studies, literature,current practice, and the consensus of physicians.Table 13 shows an example of how programming suggestions are determined bycombinations of clinical conditions. The programmable features (and certain clinicalconditions) shown in the table do not apply to all pacemaker models. To learn which of thefollowing features apply, refer to the Implant Manual for that pacemaker.



Table 13. Example of how programming suggestions are determinedProgramming suggestions Clinical conditionsMode/Mode Switch Atrial Status

AV ConductionReflex SyncopeLead Chamber

Rate Response Heart FailureAgeActivity LevelReflex Syncope

Lower Rate Atrial StatusAgeReflex Syncope

Upper Tracking Rate AgeAV intervals (including RAAV and Search AV+) Atrial Status

AV ConductionAtrial Preference Pacing and Post Mode SwitchOverdrive Pacing

Atrial StatusReflex Syncope

Rate Drop Response Atrial StatusReflex Syncope

From the TherapyGuide window, You can perform the following functions:● Select the clinical conditions that describe your patient.● Get Suggestions, and program the parameters that TherapyGuide makes pending to

pacemaker memory.● View a Rationale window, and learn what parameter settings are suggested by specific

clinical conditions.The clinical conditions can be printed from the Patient Information screen. They are alsoincluded in the Initial Interrogation report and in the Save to Disk file.Refer to the Adapta/Versa/Sensia/Relia Pacemaker Programming Guide for moreinformation about using TherapyGuide.

7.5 Battery and lead information7.5.1 OverviewThe pacemaker can telemeter measured and calculated values for battery parameters,pacing outputs, and leads to the programmer. This data may be used both for routineassessment of pacing system performance and for evaluating suspected problems.



7.5.2 Telemetered dataThe battery and atrial and ventricular lead data are as follows:

● Battery status:– Message “OK” or “Replace Pacer”– Date of Implant– Estimated Time to Replacement (years or months)– Voltage (V)– Current (µA)– Impedance (Ω)

● Atrial and/or ventricular outputs and leads:– Pulse Width (ms)– Amplitude (V)– Output Energy (µJ)– Measured Current (mA)– Measured Impedance (Ω)– Pace Polarity (unipolar/bipolar)

7.5.3 Conditions and variance in measurementsMeasurement conditions – When the pacemaker measures lead information, ittemporarily sets Amplitudes to 5.0 V, Pulse Widths to 1.0 ms, Rate to 100 bpm, and AVinterval to 100 ms for several beats.Battery measurements – As the battery is depleted, the measured battery voltagegradually drops, and the battery impedance gradually increases.

7.5.4 Chronic Lead Impedance TrendThe automatic diagnostic Chronic Lead Impedance Trend tracks changes in lead data.Significant changes in chronic lead data could indicate a lead dislodgment or fracture.



7.5.5 For further informationRefer to the Adapta/Versa/Sensia/Relia Pacemaker Programming Guide for instructions onretrieving battery and lead data.

7.6 Marker Channel telemetry7.6.1 OverviewMarker Channel telemetry provides simple depictions of paced and sensed events that aidin evaluating pacemaker timing and operations. These annotations are most useful whenused in conjunction with a simultaneous ECG and/or EGM. Marker Channel telemetry isavailable in all modes.

7.6.2 Standard Marker Channel telemetryWhen Extended Markers is programmed as Standard, telemetry provides annotated verticalmarkers of paced, sensed, and refractory sensed events. Atrial markers and ventricularmarkers have distinctive placements and heights to denote the type of event marked.Marker Channel telemetry can be used to identify which ECG events are treated as paced orsensed events by the pacemaker and to measure timing intervals, as shown in Table 14.Table 14. Marker Channel annotations

AP - Atrial paceAS - Atrial senseAR - Atrial sense in refractoryVP - Ventricular paceVS - Ventricular senseVR - Ventricular sense in refractoryTP - Triggered pace (AAT and VVT pacing mode)MS - Mode switch (switch to non-atrial tracking mode and back to atrial tracking mode)ER - Error marker (flags a marker signal that could not be decoded)



7.6.3 Therapy Trace telemetryWhen Extended Markers is programmed to Therapy Trace, telemetry provides informationwhen certain therapy features modify timing intervals. The standard Marker Channelannotations appear on-screen, but the added Therapy Trace markers can be used with aspecial external monitor to evaluate the operation of pacemaker features. They include:

● A/V Sense Margin markers● Lead Monitor markers● Capture Management markers

Note that Therapy Trace markers are not available when temporary parameters are in effect.

7.7 Intracardiac electrograms7.7.1 OverviewThe pacemaker can be configured to telemeter intracardiac electrograms (EGM). Anintracardiac EGM is a real-time waveform of cardiac activity as detected by one or bothleads. Depending on the programmed Mode and Telemetry Mode, the EGM options are:

● Atrial EGM● Ventricular EGM● Dual EGM● Summed EGM

The programming head must be held in place over the pacemaker while telemetering EGMs.To inhibit pacing and display intrinsic events only on the Intracardiac EGM, enable theprogrammer Inhibit function.Warning: Use caution when using the programmer to inhibit pacing. The patient is withoutpacing support when pacing is inhibited.

7.7.2 Intracardiac electrogram recordingPacing stimuli are not detected by the Intracardiac EGM circuitry, but the programmer insertssimulated pacing pulses in the appropriate locations on the Intracardiac EGM recordingaccompanied by Marker Channel annotation. The Intracardiac EGM can be displayed on theprogrammer or printed as shown in Figure 78.Note: The simulated pacing pulses on the Intracardiac EGM should not be interpreted asrepresenting the actual amplitude of paced events. Use an ECG to determine such events.



Figure 78. Intracardiac electrogram with Marker Channel recordings

V P

V P

V P

V P

V P

V P

V P

V P

V P

V P

V S

A S

A S

A S

A S

A S

A S

A S

V S

ECG LEAD II Ø.2 mV/mm

A EGM Ø.2 mV/mm

MARKER CHANNEL

1 mV/mm 1 mV/mmV EGM Ø.5 mV/mm

Emergency successful

Programming successfulCHART SPEED 25.Ø mm/s

Adapta ADDRØ1/Ø3/Ø6 Ø7/11/Ø5 3:Ø2:41 PM

7.7.3 Uses for the Intracardiac ElectrogramThe Intracardiac Electrogram shows intracardiac waveforms and event timing as thepacemaker sees them. It may be used as follows:

● Atrial and ventricular waveforms may be evaluated for the following:– Relative amplitude of intrinsic signals– Myopotentials or electromagnetic interference (EMI)– Loss of atrial capture– Retrograde P waves– Retrograde conduction time (Summed or Dual EGM)– AV conduction time (Summed or Dual EGM)– Supraventricular tachycardias

● Timing intervals may be evaluated as follows:– Appropriate Paced AV and Sensed AV parameters may be determined by measuring

AV conduction times.– Appropriate Post-Ventricular Atrial Refractory Period (PVARP) in the DDDR, DDD,

DDIR, DDI, and VDD modes may be determined by measuring retrograde conductiontimes.



Note: Do not use absolute intracardiac amplitudes measured from the Intracardiac EGM toassess the programmed Sensitivity. Test for sensing thresholds instead.

7.7.4 For further informationRefer to the Adapta/Versa/Sensia/Relia Pacemaker Programming Guide for additionalinformation on accessing Intracardiac Electrograms.

7.8 Extended Telemetry7.8.1 OverviewExtended Telemetry is a programmable On or Off feature intended for frequent patientmonitoring in the programmed mode during a 48-hour period.

● When Extended Telemetry is On, the pacemaker continuously transmits an EGM withmarker telemetry regardless of whether the programming head is applied or not.

● Extended Telemetry is automatically programmed Off by the pacemaker after 48 hours.(A programmer command can terminate the feature before automatic shutoff.)

7.8.2 Extended Telemetry optionsWhen Extended Telemetry is On, one of the following extended telemetry types may beselected for automatic transmission:

● Marker Channel annotations (Standard markers)● Therapy Trace markers

For a description of these marker types, refer to Section 7.6, “Marker Channel telemetry”,page 153.

7.8.3 Additional battery drainBecause Extended Telemetry continuously transmits an EGM, it significantly increasespacemaker battery current drain.

● Generally, longevity will be reduced by approximately one day for each day thatExtended Telemetry is On.

● Extended Telemetry should not be used when Recommended Replacement Time(RRT/ERI) is set.



8 Miscellaneous operations

8.1 Magnet mode operation8.1.1 OverviewWhen the programming head is placed over the pacemaker, Magnet Mode is automaticallycancelled and the programmed mode is maintained.Magnet Mode operations begin in two ways:

● When you run Magnet test with the programmer.● If a transtelephonic magnet is placed over the pacemaker (closing the magnetic reed

switch).A Threshold Margin Test (TMT) automatically occurs when Magnet mode starts. TheTranstelephonic Monitor feature, if programmed On, enhances the communication oftranstelephonic information.

8.1.2 Magnet Mode operationWhen initiating the Magnet Mode, the pacemaker switches to an asynchronous mode andpaces at the magnet rate.

● Magnet Modes are as follows: DOO in modes with dual chamber pacing, VOO in theVDD mode, and VOO/AOO in single chamber modes.

● Magnet rate for normal operation is 85 bpm (1000 ms) for all modes.● Magnet rate is 65 bpm (923 ms) when Recommended Replacement Time (RRT/ERI) is

set or a full electrical reset has occurred.Note: For the purpose of determining Magnet Modes, the AAI<=>DDD and AAIR<=>DDDRmodes are considered dual chamber modes.Magnet Mode remains in effect as long as the Magnet Test is operating or thetranstelephonic magnet is over the pacemaker. When the Magnet test is stopped or thetranstelephonic magnet is removed, the pacemaker resumes programmed operation within2 seconds.Note: When Emergency VVI pacing is active, the pacemaker automatically starts MagnetMode operation for the first application of the programming head, and it remains in MagnetMode until the programming head is removed.



8.1.3 Threshold Margin TestThe pacemaker performs a Threshold Margin Test (TMT) when Magnet mode starts to allowa check for loss-of-capture. A TMT is performed at 100 bpm with the amplitude reduced by20% on the third pulse.Warning: A loss-of-capture at a 20% reduction in amplitude indicates that the stimulationsafety margin is inadequate. As soon as possible, reevaluate the patient’s threshold andreprogram outputs for a 2:1 stimulation safety margin. Imminent loss of ventricular capturefor a pacemaker-dependent patient may constitute an emergency situation.

8.1.4 Transtelephonic Monitor featureThe Transtelephonic Monitor feature, if programmed On, enhances the communication oftranstelephonic information by delaying the TMT for five seconds upon application of themagnet. Programming the feature Off does not affect conventional transtelephonicmonitoring.

8.1.5 Special operation with Extended TelemetryWhen the Extended Telemetry feature is On, the pacemaker responds to the programminghead or magnet application by sending telemetry data, as described in Section 7.8,“Extended Telemetry”, page 156.

8.1.6 For further informationSection 5.9, “Transtelephonic follow-up features”, page 108 provides a detailed discussionof the transtelephonic follow-up features:

● Threshold Margin Test● Extended Telemetry

8.2 Temporary programming8.2.1 OverviewPacing mode and certain other parameters may be programmed temporarily for diagnosticpurposes or to test their effects on pacing operations prior to programming. Programmedsettings are restored automatically when the programming head is removed or the telemetrylink is broken.



8.2.2 Temporarily programmable parametersSix pacing parameters may be programmed temporarily:

● Mode● Rate● Pulse Amplitudes● Pulse Widths● Sensitivities● AV Intervals

Note: Available temporary parameter values are dependent on the programmed mode and,if a test is in progress, the type of test. Refer to the appropriate implant manual for detailedtemporary parameter values.

8.2.3 Temporary refractory period settingsDuring Temporary test operation, refractory periods for dual and single chamber modesremain set to the programmed values, except for the following conditions:

● For temporary single chamber modes programmed at rates above 180 bpm, therefractory period is set to 150 ms.

● For temporary DDD and VDD modes (if the programmed mode is dual chamber),PVARP programmed as Auto or Varied is temporarily set to 340 ms.

Note that Atrial Blanking is temporarily set to 100 ms for single chamber atrial modes anddual chamber modes.

8.2.4 For further informationRefer to the appropriate implant manual for additional information on temporaryprogrammable parameters.

8.3 Electrical reset8.3.1 OverviewAn electrical reset is a device-activated safety feature that can reset device parameters tovalues that provide basic device functionality. These basic parameters are considered safefor the vast majority of patients. Pacing remains active during a reset condition.



An electrical reset may occur when the device is exposed to extreme conditions, such ascold temperatures (before implant); intense, direct x-ray exposure; electrocautery; orexternal defibrillation.Two types of electrical reset are possible:Partial reset – Polarity, pacing mode, rates, and certain other parameters are preserved.Full reset – Pacing resumes in the VVI mode at 65 bpm with reset parameters.The programmer detects and reports any reset condition when the pacemaker isinterrogated. A full reset also may be inferred when the ECG shows VVI pacing at 65 bpm andthe battery is not depleted. In this case, Recommended Replacement Time (RRT/ERI) is notset.

8.3.2 Partial electrical resetIf a partial electrical reset occurs, the pacemaker automatically preserves the followingparameters to their programmed states:

● Pacing Mode● Pacing and Sensing Polarities● Lower Rate, Upper Tracking Rate, and Upper Sensor Rate● Amplitudes, Pulse Widths, and Capture Management operation● Sensitivities and Sensing Assurance operation● Mode Switch selection● Rate Profile Optimization● Implant Detection● Lead Monitor selection● RAAV and Search AV+ operation● PVARP setting● RRT/ERI status● Other therapy features

All other parameters are changed to their electrical reset values, as described in Section B.



8.3.3 Full electrical resetIf a full electrical reset occurs, all programmed values are lost and set to electrical resetvalues. Refer to the appropriate implant manual for parameter values. When power isrestored, the pacemaker is initially set to the VVI mode at 65 bpm.While pacing in the VVI mode, the pacemaker automatically restarts the implant detectionsequence. Optionally, the pacemaker can be manually programmed by first using theprogrammer’s reset command.Note: If after interrogating the pacemaker a message appears on the programmer screen orprintout indicating the date/time memory has been altered or the model has changed toSES01(Adapta, Versa, Sensia) or RES01 (Relia), contact your Medtronic representative forfurther information.

8.4 Recommended Replacement Time (RRT/ERI)8.4.1 OverviewThe Recommended Replacement Time (RRT/ERI) is reported upon interrogation with theprogrammer when the pacemaker battery is nearly depleted. When the RRT/ERI is set, thepacemaker is automatically reprogrammed to a distinctive set of parameters (VVI mode at65 bpm).

8.4.2 Basis for setting RRT/ERIRRT/ERI is set when the battery voltage drops below a certain limit and remains there. TheRRT/ERI criteria for the pacemaker are listed in the applicable Implant Manual. WhenRRT/ERI is set, diagnostic data collection is suspended, but data previously collected isretained in the pacemaker’s memory.Note: Exposing the pacemaker to extreme cold temperatures can inadvertently setRRT/ERI. Usually, the pacemaker can reset an RRT/ERI caused by cold temperatures whenit is warmed to room temperature. If the pacemaker does not reset the RRT/ERI duringwarm-up, use the programmer reset command to reset it.Caution: When RRT/ERI is set and verified, the pacemaker must be replaced within threemonths. For details, refer to “Prolonged service period” in the applicable Implant Manual.



8.4.3 RRT/ERI verificationWhen the programmer detects that RRT/ERI is set, it displays a message. A programmercommand can be used to reset the RRT/ERI. First a stress test is performed to determine thebattery’s condition. If the battery fails the stress test, the programmer does not resetRRT/ERI. Because RRT/ERI is set only after multiple voltage measurements, it is unlikely tobe set prematurely, except when the device is exposed to cold temperatures for extendedperiods.

8.5 Emergency pacingEmergency pacing provides VVI pacing at 70 bpm at high output settings in emergencysituations for pacemaker-dependent patients. Refer to Section A.1, “Emergency settings”,page 189 for more information.



9 Diagnostics

9.1 Introduction to diagnosticsDiagnostics provide data to evaluate the patient’s intrinsic rhythm and the pacemaker’soperation. The pacemaker offers two types of diagnostics to aid in this evaluation:

● Diagnostics that run in the background automatically.● Clinician-selected diagnostics of which only one can be active at a time.

Most of the diagnostics are available in all pacing modes, while some are pertinent only todual chamber modes or certain therapy features. Four diagnostic modes are also available:ADIR, ADI, VDIR, and VDI. These modes offer the opportunity to record events in thenon-paced chamber.The pacemaker automatically clears diagnostic data one hour after a patient session andthen restarts data collection of the background diagnostics and the one clinician-selecteddiagnostic.Refer to the Adapta/Versa/Sensia/Relia Pacemaker Programming Guide for informationabout displaying diagnostic data and which diagnostic data is available for each model.

9.1.1 Automatic diagnosticsThe automatic diagnostics consist of summary data collection types that run continuously inthe background of normal pacing operation. These diagnostics monitor intrinsic and pacedevents, lead integrity, and certain therapy episodes. In most cases, the diagnostics are fullyautomatic and require no intervention by the clinician, although a few have programmableoptions. Listed below are brief summaries of the automatic diagnostics and sections of themanual that provide detailed information about each diagnostic.Heart Rate Histograms – Collects short and long term heart rate and percent-paced dataof the atrium and ventricle. See Section 9.2, “Heart Rate Histograms”, page 166.AV Conduction Histograms – Collects short and long term AV conduction sequences. SeeSection 9.3, “AV Conduction Histograms”, page 168.Search AV+ Histograms – Collects conduction sequences resulting from the Search AV+function. See Section 4.4.6.1, “Automatic Search AV+ Histogram”, page 57.Sensor Indicated Rate Profile – Automatically collects sensor rate data for theprogrammed rate responsive mode. See Section 9.5, “Sensor Indicated Rate Profile”,page 171.



High Rate Episodes – Collects summary data about atrial and ventricular high rateepisodes. If the pacemaker is programmed for mode switch therapy, the atrial high rateepisode data collected are based on mode switch criteria. Otherwise, the atrial high rateepisodes are based on criteria defined specifically for collection of atrial high rate data. SeeSection 9.6, “High Rate Episodes”, page 173.Atrial Arrhythmia Trend – Collects data indicating how much time in each day of thecollection period that the patient spent in atrial arrhythmia episodes. See Section 9.8, “AtrialArrhythmia Trend”, page 180.Ventricular Rate Histogram During Atrial Arrhythmias – Collects data about ventricularrates during atrial arrhythmia episodes, to show how successfully ventricular rate is beingcontrolled. See Section 9.7, “Ventricular Rate Histogram During Atrial Arrhythmias”,page 179.Atrial Arrhythmia Durations – Collects data about the duration of atrial arrhythmiaepisodes and shows (on the Initial Interrogation Report) the number of episodes thatoccurred in each of eight categories, based on duration lengths. See Section 9.9, “AtrialArrhythmia Durations”, page 181.Lead Impedance – Collects long-term lead impedance trend and performance data. Leadimpedance trend data is collected every 7 days for the most recent 14 months andperformance data is continually collected until it is manually cleared. See Section 5.4.1,“Automatic Lead Impedance (Chronic Lead Trend)”, page 78.Rate Drop Response Episodes – Collects basic data on rate drops and rate drop responsetherapy intervention. See Section 6.10.7.1, “Summary of Rate Drop Episodes”, page 142.Capture Management Trend – Collects threshold, pulse width, and amplitude data every7 days for the most recent 14 months. See Section 5.5.5.1, “Summary Capture Managementdata”, page 97.Sensitivity Trend – Collects data about the operation of the Sensing Assurance featureevery seven days. See Section 5.6.6.1, “Summary Sensing Assurance data”, page 102.Key Parameter History – Records key parameter values for the last eight programmingsessions. See. Section 9.11, “Key Parameter History”, page 183.

9.1.2 Clinician-selected diagnosticsThe clinician-selected diagnostics consist of programmable types that collect detailed dataon specific intrinsic episodes, patient symptoms, and lead and rate trends. Some of theclinician-selected diagnostics provide more detailed data to an equivalent automaticdiagnostic. Only one clinician-selected diagnostic can be active at a time. Listed below is abrief summary of each of the clinician-selected diagnostics.



High Rate Detail – Collects rate trend (beat-to-beat) data from up to 16 atrial or ventricularhigh rate episodes, or from up to 8 high rate episodes of each type. This diagnostic alsocollects EGM data for one or more episodes. These diagnostics correspond to andsupplement the data collected in the automatic high rate episodes diagnostic. If thepacemaker is programmed for automatic mode switch therapy, atrial high rate episodescollected are based on the therapy parameters for mode switching. See Section 9.6.2,“Programmable data collection”, page 175 and Section 6.1.8.2, “Detailed mode switchdata”, page 116.Atrial Capture Management Detail – Records the atrial pacing threshold for every capturemanagement search. Data can include an electrogram. See Section 5.5.5.2, “Detail CaptureManagement data”, page 98.Ventricular Capture Management Detail – Records the ventricular pacing threshold forevery capture management search. Data can include an electrogram. See Section 5.5.5.2,“Detail Capture Management data”, page 98.Rate Drop Response Detail – Collects detailed data on rate drop response therapy in theDDD, DDI, or AAI <=> DDD modes. A rate trend for the first and the four most recent episodesis available. It supplements the automatic Rate Drop Response episodes diagnostic. SeeSection 6.10.7.2, “Detail Rate Drop Episode data”, page 142.Custom Rate Trend – Collects heart rate and percent-paced trends over a beat-to-beat,1-hour, or 24-hour period. See Section 9.10, “Custom Rate Trend”, page 181.

9.1.3 Battery and lead dataThe pacemaker reports the status of battery voltage, estimated time to replacement, andother parameters. It also reports the status of atrial and ventricular lead impedance, polarity,and other parameters. Refer to Chapter 7, “Telemetry data”, page 147 for more information.

9.1.4 Suspending and clearing of dataThe pacemaker automatically suspends all diagnostic data collection while theprogramming head or magnet is applied to the pacemaker.Note: If a magnet has been applied, data collection resumes when the magnet is removed.Applying a magnet does not clear diagnostic data.Interrogating the pacemaker automatically clears diagnostic data one hour after the end ofthe programming session unless you select the option to clear data immediately. Datacollection resumes after the clearing of diagnostic data.



Note: Automatic chronic trend diagnostic data (Atrial Lead Trend, Ventricular Lead Trend,and Atrial Arrhythmia Trend) can be cleared from the Clear Data screen. Clearing theVentricular Chronic Lead Trend also clears the automatically collected Ventricular CaptureManagement trend. Clearing the Atrial Chronic Lead Trend also clears the Atrial CaptureManagement trend. The Sensor Indicated Rate Profile is only cleared when programmingcertain rate response parameters or another rate responsive mode.When the Recommended Replacement Time (RRT/ERI) is tripped, all diagnostic datacollection is suspended. At RRT/ERI, the previously collected diagnostic data are retained.When a partial or full electrical reset occurs, all diagnostic data is lost.

9.2 Heart Rate HistogramsThe Heart Rate Histogram shows the range of the patient’s heart rate (to a resolution of10 bpm) recorded since the last patient session and the relative percentage of heart beatsdistributed over that range. This histogram is intended as an aid for evaluating rate responseparameter settings and chronotropic incompetence.This example shows typical data for a long-term ventricular heart rate histogram.The graph shows the percentage of all sensed and paced events in each rate range.Figure 79. Ventricular Heart Rate Histogram

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9.2.1 Automatic data collectionThe Heart Rate Histograms can be displayed for two intervals of data collection:

● Short-term heart rate histograms represent data collected over the last 3 to 6 days.● Long-term heart rate histograms represent data collected since the last follow-up.



Heart Rate Histograms show what percentage of the rate events counted during themonitoring period fall into each 10 bpm segment in the range of 40 bpm to 180 bpm. (The “<40” bpm group also includes events occurring below 40 bpm; the “180 >” bpm group alsoincludes events occurring above 180 bpm.) Each 10 bpm event group is coded to show thepercentage of paced events and the percentage of sensed events. See Figure 79 .Both atrial and ventricular histograms display the pertinent programmed parameter settings.Ventricular histograms also display the recorded number of single PVCs and PVC runs. Atrialhistograms display the number of PAC runs.

9.2.1.1 Event countersHistograms have the following ventricular or atrial information in dual chamber modes(including VDD, VDIR, VDI, ADIR, and ADI modes):Premature Ventricular Contraction (PVC) – Counts pacemaker-defined PVCs (a VSevent following a ventricular event with no intervening atrial event) and runs of two or moreconsecutive PVCs with no intervening atrial event.Premature Atrial Contraction (PAC) – Counts pacemaker- defined PAC (an AS eventfollowing an atrial event with no intervening ventricular event) runs of two or moreconsecutive PACs with no intervening ventricular event.Note: Counting ceases when any counter reaches its maximum count, but this is unlikelysince each counter can store several years of data.

9.2.2 Retrieving the atrial and ventricular rate histogramsIf data were collected during device operation in a dual chamber mode (including ADIR, ADI,VDIR, VDI, and VDD modes), both atrial and ventricular histograms can be viewed byselecting the Histogram field at the top of the display.Refer to the Adapta/Versa/Sensia/Relia Pacemaker Programming Guide for information oncollecting rate histogram data.



9.3 AV Conduction HistogramsThe AV Conduction Histogram diagnostic counts and collects paced and sensed AVconduction sequences. The diagnostic classifies specific types of AV sequences by raterange and the percentage of the total AV sequences counted in dual chamber modes. Thepacemaker automatically collects the histogram data without any programming by theclinician. The AV Conduction Histogram is intended for purposes such as the following:

● To determine whether programmed PAV and SAV intervals are promoting or inhibiting AVconduction in sick sinus syndrome patients, and the rates where transitions occur.

● To determine at what upper rates the programmed Rate Adaptive AV operation limits AVconduction.

This example shows short-term AV histogram data.The graph shows the percentage of all AV sequences (AS-VS, AS-VP, AP-VS AP-VP) in eachrate range.Figure 80. Example of AV conduction histogram data

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9.3.1 Automatic data collectionThe diagnostic collects all AV sequences between 40 and 180 bpm and classifies AVsequences by rate range and sequence type (bin). Events below 40 bpm are counted in thelowest event group; rates above 180 bpm are counted in the highest event group. Thesequence type categories are as follows:

● AS-VS, AS-VP, AP-VS, and AP-VP (dual chamber modes, including MVP modes)● AS-VS and AS-VP (VDD, VDIR, and VDI modes)● AS-VS and AP-VS (ADIR and ADI modes)



Atrial and ventricular refractory sensed events are not counted. Ventricular safety pacedevents are counted as atrial paced to ventricular paced events (AP-VP).There are two types of AV Conduction Histograms collected:Short Term AV Conduction Histogram – Contains the last three-to six days of rate rangedata and sequence types.Long Term AV Conduction Histogram – Contains the summation of rate range data andsequence types since the last programming session.

9.3.1.1 Total eventsThe percentages of the types of AV event sequences are indicated as follows:

● Dual chamber modes (including MVP modes): AS-VS, AS-VP, AP-VS, and AP-VP● VDD, VDIR, and VDI modes: AS-VS and AS-VP● ADIR and ADI modes: AS-VS and AP-VS

Note: Counting ceases when any counter reaches its maximum count but this is unlikelysince each counter can store several years of data.

9.3.2 Retrieving the AV Conduction HistogramWhen an interrogation of the pacemaker is performed, the programmer retrieves thehistogram data and presents the short- term and long-term histograms on rate distributionprofile graphs. For each rate range, the percentage of AV sequences in each category ispresented. The diagnostic information can be displayed from the Graphs and Tables screen.



9.3.3 For further informationRefer to the Adapta/Versa/Sensia/Relia Pacemaker Programming Guide for information oncollecting AV conduction histogram data.

9.4 Search AV+ HistogramThe Search AV+ feature is intended to promote intrinsic ventricular activation in patients withintact or intermittent AV conduction and prevent inappropriate therapy in patients withoutconduction. Search AV+ is available when the pacemaker is programmed to the DDDR,DDD, DDIR, DDI, DVIR, DVI, or VDD mode. The pacemaker searches for the patient’sintrinsic AV conduction time and adjusts the SAV and PAV intervals either longer or shorterto promote intrinsic activation of the ventricles. When Rate Adaptive AV is active, thepacemaker also adjusts the SAV and PAV intervals relative to the rate adaptive values. If thepacemaker does not observe intrinsic ventricular activation during its periodic searches overthe course of a week, it turns off the Search AV+ feature. For more information on SearchAV+, see Section 4.4, “Search AV+ and diagnostic”, page 55.This diagnostic is intended to show the amount of ventricular sensing which is due to theextension of the AV interval by Search AV+.

9.4.1 Automatic data collectionThe Search AV+ Histogram data is automatically collected when Search AV+ is programmedOn. This histogram shows the percentage of A-VS, VS from Search, and A-VP intervalsversus rate.Search AV+ Histogram data can be displayed from the Graphs and Tables screen.This example shows Search AV+ histogram data.The graph shows the percentage of all AV sequences (A-VS, VS from Search, A-VP) in eachrate range.



Figure 81. Example of Search AV+ histogram data

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9.4.2 For further informationRefer to the Adapta/Versa/Sensia/Relia Pacemaker Programming Guide for information oncollecting Search AV+ Histogram data.

9.5 Sensor Indicated Rate ProfileThe Sensor Indicated Rate Profile records sensor rates regardless of the programmed modeand classifies them by rate ranges. The pacemaker automatically collects the data withoutany programming by the clinician. This diagnostic is intended for evaluating the Rate ProfileOptimization feature.This example shows a typical sensor indicated rate profile graph.The percentage of time in each rate range is shown.



Figure 82. Sensor Indicated Rate Profile data

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9.5.1 Automatic data collectionThe diagnostic records the sensor-indicated rate every two seconds. Rates are recorded inrate groups (bins) between the rates of 40 and 180 bpm. Rates below 40 bpm are countedin the lowest rate group; rates above 180 bpm are counted in the highest rate group.Note: Sensor Indicated Rate Profile data is normally retained by the pacemaker, regardlessof any other diagnostic programming. The data is only cleared when reprogramming rateresponse parameters or another rate responsive mode.

9.5.2 Retrieving the Sensor Rate ProfileWhen an interrogation of the pacemaker is performed, the programmer retrieves the profiledata and presents a chronic rate profile graph. The report can be displayed from the Graphsand Tables screen.

9.5.3 For further informationRefer to the Adapta/Versa/Sensia/Relia Pacemaker Programming Guide for information oncollecting Sensor Indicated Rate Profile data.



9.6 High Rate EpisodesThe High Rate Episodes diagnostics are used to detect episodes of atrial or ventriculartachycardia, and to record summary and detailed data that are useful in the assessment ofthese episodes.

9.6.1 Automatic data collectionThe automatic High Rate Episodes diagnostics automatically record two types of summarydata: data for the overall collection period (see Section 9.6.1.1, “Collection period summarydata”, page 173) and data for up to 32 specific high rate episodes (see Section 9.6.1.2,“Specific High Rate Episode data”, page 173). In addition, detailed data for some of thesehigh rate episodes can also be collected, if the High Rate Detail diagnostic is chosen as theclinician-selected diagnostic (see Section 9.6.2, “Programmable data collection”,page 175).

9.6.1.1 Collection period summary dataAutomatically-collected high rate data includes the following summary data for the entirecollection period:

● A count of all atrial and ventricular high rate episodes that occurred during the collectionperiod.

● Percentage of time during the collection period spent in atrial high rate.● Number of premature atrial contraction runs.● Number of premature ventricular contractions, both singles and runs.

9.6.1.2 Specific High Rate Episode dataFor up to 16 atrial high rate episodes and up to 16 ventricular high rate episodes, thepacemaker automatically records the data listed below, using a programmable datacollection type (either rolling or frozen):

● Date, time, and duration of each episode.● Maximum atrial and ventricular rate during the episode.● Average ventricular rate.● Sensor rate when the high rate was detected (displayed only in reports).● Whether EGM or trend data was collected for each episode.



9.6.1.3 Data collection period and collection capacityThe collection period for the high rate episodes is indicated by the starting date and endingdate when the pacemaker is interrogated. The maximum number of high rate episodes thepacemaker will count is 16,777,215 atrial episodes and 16,777,215 ventricular episodes.Once a limit is reached, the count for that episode type is frozen.

9.6.1.4 Definition of high rate episodesIf the pacemaker is programmed for mode switch therapy, atrial high rate episodes aredefined by the therapy parameters for mode switch therapy (see Section 6.1, “Mode Switchand diagnostic”, page 111). If the pacemaker is not programmed for mode switch therapy,atrial high rate episodes are defined by criteria selected by the clinician on the DataCollection/Setup screen. Ventricular high rate criteria are defined on the DataCollection/Setup screen.Note: For atrial high rate episodes, the initial interrogation report and the High Rate Episodediagnostic screens indicate if the episodes are based upon mode switch criteria.

9.6.1.5 Rolling or frozen data collectionEither rolling or frozen data collection can be selected for recording summary data for highrate episodes. This clinician selection applies to data collection for both atrial and ventricularhigh rate episodes. With rolling data collection, the first, fastest, longest, and most recent 13episodes of each type that have occurred since the data collection was reset are recorded.With frozen data collection, the first 16 high rate episodes of each type during the collectionperiod are recorded.

9.6.1.6 Supraventricular tachycardia episode filterThe pacemaker can be programmed to filter out detection of conducted supraventriculartachycardia episodes and thus improve detection of true episodes of ventricular tachycardia,using the SVT Filter. The filter removes ventricular high rate episodes that are detectedduring mode switch episodes, and is effective only when mode switch therapy is enabled.Clinicians can set this filter on the Data Collection Setup screen.



9.6.2 Programmable data collectionThe High Rate Detail diagnostic allows clinicians to program the pacemaker to collect moredetailed onset and termination data for some of the atrial and/or ventricular high rateepisodes for which summary data was automatically collected. Detailed data consists of thefollowing:

● Marker Channel and beat-to-beat data for up to 16 atrial or ventricular episodes, or up to8 episodes of each type

● EGM data for an allocated number of episodes

9.6.2.1 Marker Channel dataThis data represents detailed rate trend from the onset of an atrial high rate episode, basedon mode switch (MS) therapy criteria.“Seconds” indicates when each sensed and paced event occurred.Figure 83. Atrial high rate detailed episode data

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For each high rate episode for which detailed data is collected, this diagnostic collectsMarker Channel and beat-to-beat (see Figure 83) data for the following:

● Up to 40 pre-onset events● Up to 20 post-onset events● Up to 10 pre-termination events



Pre-onset data and pre-termination data are temporarily stored in rolling buffers andcollected as detailed data only after the detection or termination criteria are met (seeSection 9.6.3.1, “Detection criteria”, page 177). For any high rate episode, the number ofpost-onset and pre-termination events for which data is collected depends upon the durationof the episode. For episodes of short duration, the post-onset data and pre-termination datamay overlap.When the High Rate Detail diagnostic is selected, Marker Channel or beat-to-beat trend dataare collected for up to either 16 atrial high rate episodes or 16 ventricular high rate episodes,or for 8 episodes of each type (as described in Table 15).Table 15. Marker Channel data collection

Collection type High rate collection type Episodes collectedFrozen AHR only First 16

VHR only First 16VHR and AHR First 8 AHR and first 8 VHR

Rolling AHR only First 1 + last 13VHR only First 1 + last 13VHR and AHR Last 8 AHR and last 8 VHR

9.6.2.2 EGM dataThe specific data collected for High Rate Detail is controlled by these diagnostic parameters:

● High Rate Type: AHR, VHR, or both● EGM Type: AEGM, VEGM, Summed, or Off● EGM Allocation: how many episodes with EGM collection and how the EGM is aligned

relative to the episode onset● Pre-detection Timeout: the time limit in which pre-onset EGM can be collected

For single-chamber pacemakers, High Rate Detail data is available for the paced chamber.Each choice for EGM Allocation represents a number of episodes and the number ofseconds of pre-onset and post-onset EGM to be collected for each episode. If High RateType set to AHR&VHR, the number of episodes is split evenly between atrial episodes andventricular episodes.Note: If EGM data is being collected for an AHR or VHR episode while an episode of theother type occurs, no EGM data is collected for the second episode.



Refer to Section B.4, “Clinician-selectable diagnostics”, page 194 for EGM Allocationvalues related to the settings of High Rate Type and Collection Method. These values arepresented in three sections of Section B.4, “Clinician-selectable diagnostics”, page 194:one section for Adapta and Versa models, one section for Sensia models, and one sectionfor Relia models.Note: If Rolling collection is programmed and several episodes of one type occur beforeepisodes of the other type occur, EGM collection for the first type will use all allocated EGMstorage until the other episode type occurs. For example, if an allocation of 4 EGM episodesis programmed and both AHR and VHR High Rate Types are selected, an occurrence of 4consecutive VHR episodes results in EGM collection for all 4 VHR episodes. If any AHRepisodes subsequently occur, EGM data for the first 2 AHR episodes replaces the EGM dataof the oldest 2 VHR episodes. Thereafter, EGM data are allocated equally between the 2triggers.EGM can be collected with a programmable Pre-detection Timeout of 1 to 12 weeks, in1-week increments, or of 14 to 24 weeks, in 2-week increments. If episodes occur before theprogrammable timeout, pre-onset and post-onset EGM can be collected. If episodes occurafter the programmable timeout, only post-onset EGM can be collected.Note: If pre-onset EGM and Rolling collection are programmed, and the EGM Pre-detectionTimeout expires, EGM collection will occur for an extra episode. For example, if EGMAllocation is programmed to “4 for 4/4 secs”, the user would go from 4 episodes with EGM(prior to the timeout) to 5 episodes with EGM (after the timeout).

9.6.3 How high rate episodes are definedThe automatic and clinician-selected capabilities of the diagnostics can be programmed tocollect summary and detailed data about specific ventricular high rate episodes and atrialhigh rate episodes. Detection and termination criteria for these episodes are described in thefollowing paragraphs.

9.6.3.1 Detection criteriaClinician-defined atrial high rate episodes – Begin when, during a specified number ofseconds (A. Detection Duration), 4 of 7 atrial intervals are shorter than a specified duration(A. Min. Detection Rate).Mode Switch defined atrial high rate episodes – Begin when the pacemaker’s ModeSwitch therapy switches from a tracking mode to a non-tracking mode. The programmableparameter Collection Delay After Mode Switch allows the collection diagnostic to ignoremode switch episodes of very short durations (0-60 seconds).



Ventricular high rate episodes – Begin when a specified number of sequential heart beats(V. Events to Detect) exceeds a specified rate (V. Min. Detection Rate). If the clinician has setthe SVT Filter to On, ventricular high rate detection criteria are disabled during Mode Switchepisodes.

9.6.3.2 Termination criteriaClinician-defined atrial high rate episodes – Terminate when a specified number ofconsecutive atrial intervals (A. Events to Terminate) is longer than a specified rate (AtrialTermination Rate).Mode Switch defined atrial high rate episodes – Terminate when the pacemaker’s ModeSwitch therapy switches from a non-tracking mode back to a tracking mode (Mode Switchtherapy ends).Ventricular high rate episodes – Terminate when a specified number of consecutiveventricular intervals (V. Events to Terminate) is longer than a specified rate (VentricularTermination Rate).

9.6.4 Limitation to detect high rate atrial eventsIn the DDDR, DDD, DDIR, DDI, VDD, VDIR, and VDI modes, atrial sensing is blanked for aprogrammable interval (the Post-Ventricular Atrial Blanking period) following any ventricularevent. Detection of atrial high rate episodes in these modes may be inhibited by blanking andmay result in a periodic rate drop on the diagnostic report.

9.6.5 Retrieving atrial and ventricular high rate diagnosticsWhen a full interrogation of the pacemaker is performed, the programmer retrieves theautomatic diagnostic data and clinician-selected diagnostic data (if previouslyprogrammed). The data can be displayed from the Graphs and Tables screen or from theObservations box on the Quick Look II screen.

9.6.6 For further informationRefer to the Adapta/Versa/Sensia/Relia Pacemaker Programming Guide for programmingand collecting the automatic high rate episodes data and the clinician-selected high ratedetail diagnostic.



9.7 Ventricular Rate Histogram During Atrial ArrhythmiasThis histogram shows a profile of ventricular rates recorded during the atrial high rateepisodes that have been recorded since the last patient session. This information can showhow well ventricular rate is being controlled during atrial arrhythmias and for evaluating theConducted AF Response function. For more information, see Section 6.3, “Conducted AFResponse”, page 122.Figure 84. Ventricular Rate Histogram During Atrial Arrhythmias

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1 Ventricular beats are recorded as paced or sensed2 Ventricular beats are counted according to the 20 bpm rate range into which they fall

9.7.1 Automatic data collectionDuring atrial arrhythmias, the pacemaker collects both atrial and ventricular rate data. Thishistogram shows what percent of the total number ventricular beats counted during theseepisodes fall into each of eight 20 bpm rate groups in the measured rate range. The beatswithin each rate group are coded to show the proportion of paced and sensed beats.Information included with the histogram lists the pertinent programmed parameter settingsand summary information about the recorded arrhythmias during which the ventricular rateinformation was recorded.

9.7.2 Refractory Sense Setup optionData collection can be set to include or exclude refractory senses (events sensed during therefractory period). Refer to the Adapta/Versa/Sensia/Relia Pacemaker Programming Guide.



9.7.3 Retrieving Ventricular Rate Histogram During ArrhythmiasWhen an interrogation of the pacemaker is performed, the programmer retrieves theautomatic diagnostic data and clinician-selected diagnostic data (if previouslyprogrammed). The data can be displayed from the Graphs and Tables screen or by selectingthe QuickLink [>>]button next to AT/AF on the Quick Look II screen.

9.8 Atrial Arrhythmia TrendThe Atrial Arrhythmia Trend diagnostic shows a log of how much time each day the patientspends in atrial arrhythmias. Collected over a period of weeks or months, this informationindicates when there is an upward or downward trend in these episodes.Daily measurements of the length of time high rate episodes have been detectedIf mode switch therapy is enabled, mode switch criteria define the arrhythmias. Otherwise,atrial high rate (AHR) detection criteria are used.Figure 85. Atrial Arrhythmia Rate Trend

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1 Daily measurements of the length of time high rate episodes have been detected. If mode switchtherapy is enabled, mode switch criteria define the arrhythmias. Otherwise, atrial high rate (AHR)detection criteria are used.

9.8.1 Automatic data collectionThis display is a graph of daily measurements showing the times when the pacemakerdetects atrial arrhythmias. Included with the trend display is the time period covered by theaccumulated data, the pertinent programmed parameter settings, and the date of the lastfollow-up (patient) session.



The Atrial Arrhythmia Trend can show up to 6 months of collected data and is a rolling trendthat continues to update. An option lets you clear the accumulated data if desired. Refer tothe Adapta/Versa/Sensia/Relia Pacemaker Programming Guide.

9.8.2 Retrieving Atrial Arrhythmia Trend diagnosticsWhen an interrogation of the pacemaker is performed, the programmer retrieves theautomatic diagnostic data and clinician-selected diagnostic data (if previouslyprogrammed). The data can be displayed from the Graphs and Tables screen or by selectingthe QuickLink [>>]button next to AT/AF on the Quick Look II screen.

9.9 Atrial Arrhythmia DurationsThe Atrial Arrhythmia Durations diagnostic collects data about the duration of episodes ofatrial arrhythmia and counts the number of episodes that occurred for each of eightcategories, based on episode durations (see the sample data in Table 16). This data isdisplayed in the Initial Interrogation Report only. When a pacemaker is programmed formode switch therapy, this diagnostic collects atrial high rate data based on the criteria formode switch therapy (not upon the delay criteria used to filter out brief mode switchepisodes, in the Atrial Arrhythmia diagnostic).Table 16. Atrial Arrhythmia Durations

Duration Count=>72 hr 2

24 hr - <72 hr 112 hr - <24 hr 04 hr - <12 hr 01 hr - <4 hr 12

10 min - <1 hr 501 min - <10 min 65

<1 min 390

9.10 Custom Rate TrendCustom Rate Trend is a clinician-selected diagnostic that records heart rate data as afunction of time and classifies the rates by percent paced out of the total beats counted. It isintended for patient and pacemaker assessment tasks such as the following:

● Assessing chronotropic incompetence● Evaluating programmed rate response parameters



Figure 86. 24-Hour Rate Trend Detailed Data

<406080

100120140160180

08:15 16:1512:15 20:15 08:1504:1500:15Time (hours:minutes)

Rate (min-1)Vent

maxmin

9.10.1 Data collectionThe diagnostic collects paced, sensed, and optionally, refractory sensed atrial and/orventricular rates over a beat-to-beat, 1-hour, or 24-hour period. Data collection resolutiondepends on the sampling period. The diagnostic collects:

● Percent paced information and classifies by percent paced ranges.● Ventricular safety paced events as paced events.

9.10.2 Programmable data collection optionsThe following programmable options control how the Custom Rate Trend diagnostic collectsdata:Table 17. Programmable options for Custom Rate Trend diagnostic

Parameter MeaningDuration Rate sampling occurs on either:

Every beat-to-beat (paced and sensed)Every 2 s over a 1-hour periodEvery 60 s over a 24-hour period



Table 17. Programmable options for Custom Rate Trend diagnostic (continued)Parameter MeaningInclude Refractory Senses? Determines whether refractory sensed events are counted.Collection The Frozen method collects data for the programmed Duration and

then stops. The Rolling method collects data continuously, overwrit-ing the oldest data.

9.10.3 Retrieving Custom Rate TrendWhen a full interrogation of the pacemaker is performed, the programmer retrieves thediagnostic data and presents a trend graph. The data can be displayed from the Graphs andTables screen.

9.10.4 For further informationRefer to the Adapta/Versa/Sensia/Relia Pacemaker Programming Guide for furtherinformation on programming the Custom Rate Trend diagnostic and collecting its data.

9.11 Key Parameter HistoryKey Parameter History provides a record of programmed values. Information is collectedautomatically.

9.11.1 Automatic parameter value recordingValues for the 8 most recent programming sessions are recorded for the followingparameters:

● Mode● Mode Switch● Lower Rate● ADL Rate● Upper Tracking Rate● Upper Sensor Rate● Paced AV Interval (PAV)● Sensed AV Interval (SAV)● Atrial Amplitude



● Atrial Pulse Width● Atrial Sensitivity● Ventricular Amplitude● Ventricular Pulse Width● Ventricular Sensitivity

9.11.2 Retrieving Key Parameter History informationWhen an interrogation of the pacemaker is performed, the programmer retrieves KeyParameter History information. Information is displayed from the Patient icon.

9.11.3 For further informationRefer to the Adapta/Versa/Sensia/Relia Pacemaker Programming Guide for moreinformation about displaying and printing Key Parameter History information.



10 Troubleshooting the pacing system

10.1 Troubleshooting the pacing system10.1.1 OverviewWhen troubleshooting pacemaker problems, consider both electrical problems and theeffect of various parameter settings on cardiac hemodynamics. Determining the nature ofthe troubleshooting problem is the first step toward solving it. The following questions mayhelp pinpoint the type of problem:

● Is the pacing system operating per design?● Is this operation appropriate for this patient?

The answer to the first question helps determine whether the patient has a conductiondisorder or the pacemaker has an electrical problem. The answer to the second questionhelps assess the hemodynamic appropriateness of the pacemaker’s settings. For example,when a DDD pacemaker tracks an atrial tachycardia, it is operating as it was intended toperform. While its electrical function is appropriate, the hemodynamic result may not beappropriate (for example, if the patient also has angina).While troubleshooting may sometimes be challenging, the steps in the troubleshootingprocess are simple, and they are the same for each type of problem:

1. Define the problem.2. Identify the cause of the problem.3. Correct the problem.

10.2 Troubleshooting electrical problems10.2.1 Defining electrical problemsWhen investigating an electrical problem, the clinician will need data from a wide variety ofsources, including the following:Patient data – Determine the patient’s medical history, especially the underlying cardiacrhythm.Pacemaker data – Determine the device model and serial number and, especially, itsRRT/ERI characteristics.Lead data – Determine the lead type and serial number and, most importantly, theimpedance data on each lead.



Note: Much of this data may be available under Patient Information or Key ParameterHistory, both stored in the pacemaker. Refer to Section 7.3, “Patient information”, page 149.

10.2.2 Identifying the cause of an electrical problemElectrical problems have only six potential causes. Pinpointing the actual cause, however, issometimes difficult. During the problem-identification phase of troubleshooting, one shouldconsider not only the surface ECG, but also the Intracardiac Electrograms and MarkerChannel recordings.The six causes of electrical problems are as follows:Undersensing – If the pacemaker fails to reset or start timing operations when P or R wavesare apparent on the surface ECG, undersensing is the likely cause. If undersensing isoccurring, Marker Channel telemetry will fail to display appropriate sense markers (AS, AR,VS, and VR). One possible cause would be inappropriate programming of the sensitivitysetting(s). Refer to the Adapta/Versa/Sensia/Relia Pacemaker Programming Guide.Oversensing – If the pacemaker resets or starts timing intervals when no P or R waves areapparent on the surface ECG, oversensing is the likely cause. If so, Marker Channeltelemetry will display inappropriate sense markers. A sensitivity setting programmed to avery low number might be the cause. Refer to the Adapta/Versa/Sensia/Relia PacemakerProgramming Guide.Noncapture – When pacing occurs with no evidence of a depolarization after each pacingartifact/spike on the surface ECG, loss-of-capture has occurred. Investigate the outputsettings. Are the amplitude and pulse width settings adequate to consistently capturecardiac tissue? When capture is lost, a threshold test may be used to determine appropriateoutput settings. Refer to the Adapta/Versa/Sensia/Relia Pacemaker Programming Guide.No Output – If pacing artifacts do not appear on the ECG, even though Marker Channeltelemetry shows pacing markers (AP or VP), output to the cardiac tissue may becompromised. If pacing stimuli are not being delivered (digitized ECGs sometimes misspacing artifacts), a lead wire fracture or a faulty lead connection might be the source of theproblem. Determine the lead impedance and compare to values from previous follow-upsessions.Altered Parameter – If the pacing mode or other parameters differ from what appears on thelatest entry in the patient’s record (e.g., the pacemaker is in the VVI mode), battery depletionor full electrical reset might be the cause. In addition, many parameters can be changed bypacemaker features. Refer to Section 7.2.3, “Possible variation from programmed values”,page 148.Undesirable Side Effects – This category covers a broad range of situations. For example,a patient’s pectoralis muscle might be stimulated at the programmed pacing rate due to highamplitude output(s) with a unipolar pacemaker. Or, another patient might have all the classic



symptoms of pacemaker syndrome, due to retrograde P waves that may occur with the lossof AV synchrony.

10.2.3 Correcting an electrical problemFour types of solutions apply to electrical problems, two non-invasive and two invasive:Reprogramming – For example, pocket stimulation can occur with unipolar pacing. It maybe necessary to program the device to bipolar pacing.Changing the patient’s medication or diet – Some anti-arrhythmic drugs, for example,may alter the patient’s stimulation threshold. Diet may alter the patient’s electrolyte balance,having a direct effect on the stimulation threshold.Repositioning the lead – If a lead slips out of position, it may be impossible to pace and/orsense consistently. If this is confirmed, the lead must be repositioned or replaced.Replacing the lead or the pacemaker – If the lead wire is fractured or the battery isdepleted, there is no other recourse than to replace one or both.

10.3 Troubleshooting hemodynamic problems10.3.1 Defining a hemodynamic problemWhen investigating a hemodynamic problem, data will be needed from many sources,including:Patient Data – Determine the patient’s condition and daily routine. Is the patient active orrelatively sedentary? Is the patient on drug therapy? If the problem is activity-related, whatis the patient doing when the problem occurs, and what are the symptoms?Pacemaker Data – Determine the device’s model and serial number, its diagnosticcapabilities, and its programmed settings.Note: Much of this data may be available under Patient Information or Key ParameterHistory, both stored in the pacemaker. Refer to Section 7.3, “Patient information”, page 149.

10.3.2 Identifying the cause of a hemodynamic problemIdentifying the cause of a hemodynamic problem can be challenging. Diagnostic features,however, simplify the evaluation of such problems by providing current and long-terminformation about pacemaker settings and function. The three most common causes ofhemodynamic problems are listed below:



Pacemaker syndrome – This occurs when pacemaker mode or parameter settings resultin a loss of AV synchrony. Most commonly, the problem is related to an inappropriate AVinterval, but it may also result from premature onset of 2:1 block or loss of atrial capture orsensing. Use of the AV Conduction Histogram (see Section 9.3, “AV ConductionHistograms”, page 168), Atrial Intracardiac Electrogram, or the Marker Channel recordingcan help determine the exact cause.Inappropriate rate response – This may result when programmed rate response settingsdo not match the patient’s activity needs—especially if Rate Profile Optimization is Off.Review Heart Rate Histograms and Sensor Indicated Rate Profile and/or perform a simpleExercise Test to verify rate response settings. (Refer to the Adapta/Versa/Sensia/ReliaPacemaker Programming Guide.) To validate and fine-tune the patient’s rate responseprescription, the pacemaker offers several diagnostic tools, including Rate Histograms andCustom Rate Trends. Refer to Section 9.2, “Heart Rate Histograms”, page 166.Changes in patient condition – A common example is the development of chronic atrialflutter or fibrillation post-implant. If the clinician suspects this condition, the pacemaker’sHigh Rate Episodes diagnostic can provide information on atrial tachycardias that aresensed, including the rates at which they occur and the number of occurrences. Refer toSection 9.6, “High Rate Episodes”, page 173.

10.3.3 Correcting a hemodynamic problemSolutions to hemodynamic problems are invariably non-invasive.Change the patient’s medication – In patients with intermittent atrial tachycardias, drugtherapy can reduce the frequency of SVTs.Reprogram – In dual chamber modes, if the patient experiences intermittent sudden atrialtachycardia, it may be necessary to program the Mode Switch feature On. The High RateEpisodes diagnostic can provide information on the duration and time of each episode alongwith the maximum atrial rate. Refer to Section 9.6, “High Rate Episodes”, page 173.Alter rate response settings – A patient who feels light-headed while walking up a flight ofstairs may have a rate response setting that is not responsive enough. A possible solutionmay be to change the patient’s ADL Rate or target rate profile used by Rate ProfileOptimization by changing the ADL Response setting. The Exercise test can be used tomonitor and fine-tune the rate response prescription. Refer tothe Adapta/Versa/Sensia/Relia Pacemaker Programming Guide.



A Emergency settings

A.1 Emergency settingsEmergency pacing provides VVI pacing at high output settings in emergency situations forpacemaker-dependent patients. Table 18 lists the emergency settings. The settings apply toall pacemakers.Table 18. Emergency settings

Parameter SettingMode VVIPacing Rate 70 bpmVentricular

Amplitude 7.5 VPulse Width 1.5 msSensitivity 2.8 mVPacing Polarity UnipolarSensing Polarity UnipolarLead Monitor Monitor Only

Ventricular Refractory Period 330 msSingle Chamber Hysteresis OffVentricular Capture Management Off



B Telemetry and diagnostic values

B.1 Magnet Mode operationsListed in Table 19 are the Magnet Mode operations in dual and single chamber modes.Note: For the purpose of this table, the AAI<=>DDD and AAIR<=>DDDR modes areconsidered dual chamber modes.Table 19. Magnet mode operations

Dual chamber modes DOO mode at 85 bpmVDD mode VOO mode at 85 bpmSingle chamber modes VOO/AOO mode at 85 bpm

When the programming head is placed over the pacemaker, Magnet Mode is automaticallycancelled and the programmed mode is maintained. Magnet Mode is established by placingthe programming head over the pacemaker until the head light indicates telemetry ispossible and starting the Magnet test.Placing a transtelephonic magnet over the pacemaker and moving it along the axis willimmediately start the Magnet Mode.Figure 87 shows the axis for all pacemaker models.Figure 87. Positioning the magnet or programming head

1 Axis for all models



B.2 Telemetry functionsTelemetry functions include the following:

● Marker Channel and Extended Telemetry● Electrograms—listed in Table 20● Battery and lead information—listed in Table 21 and Table 22● Patient data telemetry

B.2.1 Marker Channel and extended telemetry● Standard● Therapy Trace

B.2.2 Electrograms (EGM)Table 20. Electrograms

Type of Electrograma SeriesIntracardiac

Atrial EGM AllbVentricular EGM AllcSummed EGM Dual-chamber modelsDual EGM Dual-chamber models

a For single-chamber models (SR Series and S Series), EGM collection options are OFF and EGM.b Applies to dual-chamber models and to single-chamber models that are set to atrial mode.c Applies to dual-chamber models and to single-chamber models that are set to ventricular mode.

B.2.3 Battery and Lead InformationTable 21. Battery information telemetry

Battery Status ValueMessage “OK” or “Replace Pacer”Voltage VCurrent µAImpedance ΩEstimated Time to Replace Years or Months



Table 22. Lead information telemetrya

Lead Status ValueAmplitude VPulse Width µsOutput Energy µJMeasured Current mAMeasured Impedance ΩPace Polarity Unipolar/Bipolar

a Lead information is identical for the atrial and ventricular chambers.

B.2.4 Patient dataThe types of patient data stored in the pacemaker are as follows:

● Notes● Patient Identification

– Name– Age– I.D. Number– Chart Number

● Indications for ImplantThe History window allows you to program the clinical conditions that are made availableto TherapyGuide.

● Atrial and Ventricular Leads Implanted– Lead Manufacturer– Lead Model– Lead Serial Number– Lead Implant Date

● Device Implanted– Serial Number– Implant Date

● Physician Information– Name– Phone No.



The clinical conditions for Therapy Guide are programmed in device memory. SeeSection 7.4, “Using TherapyGuide to select parameter values”, page 150.

B.3 Automatic diagnosticsThe automatic diagnostics listed in Table 23 are automatically collected by the pacemaker.Note that some of the diagnostics have programmable parameters that are accessed byselecting Data Collection Setup under the Data icon.Note: The diagnostics in this section are categorized by mode prefixes contained in themodel number (for example, DR Series). The diagnostic parameters shown can apply to amodel in that series, provided that the pacemaker was manufactured with that diagnostic. Tofind applicable diagnostics for a specific model, refer to the Implant Manual for thatpacemaker.Table 23. Automatic diagnostics

Parameter Series SettingsHeart Rate Histograms (Shortand Long Term, Atrial and Ven-tricular)

Alla

Include Refractory Senses Include, ExcludeAV Conduction Histograms(Short and Long Term)

DR Series, D Series, VDDSeries

Search AV+ Histogram DR Series, D Series, VDDSeries

Sensor Indicated Rate Profile DR Series, D Series, VDDSeries, SR Series

Atrial High Rate Episodes(Mode Switch On)


Collection Delay after ModeSwitch

0, 1, 2 … 20, 25, 30 … 60 s

Collection Method Frozen, RollingAtrial High Rate Episodes(Mode Switch Off)

Allb

Detection Rate 80, 85, 90 … 180, 200, 220,240 … 320, 330, 350, 370, 380,400 bpm

Detection Durationc 1, 2, 3 … 20, 25, 30 … 50, 55,60 s

Termination Beats 5, 6, 7 … 20 beatsCollection Methodd Frozen, Rolling



Table 23. Automatic diagnostics (continued)Parameter Series SettingsVentricular High Rate Episodes Allb

Detection Rate 80, 85, 90 … 180, 200, 220,240 … 320, 330, 350, 370, 380,400 bpm

Detection Durationc 2, 3, 4 … 198, 199, 200 beatsTermination Beats 5, 6, 7 … 20 beatsSVT Filter DR Series, D Series, VDD

SeriesOff, On

Collection Methodd Frozen, RollingAtrial Arrhythmia Trend DR Series, D Series, VDD

Series, SR SeriesAtrial Arrhythmia Durations DR Series, D Series, VDD

Series, SR SeriesVentricular Rate During AtrialArrhythmias


Rate Drop Response Episodes DR Series, D Series Based on programmed therapyChronic Lead Trends AllLead Monitor Counters AllSensitivity Trends All Monitors chambers with Sens-

ing AssuranceCapture Management Trend Based on use of Capture Man-

agementAtrial Capture Management DR Series, D SeriesVentricular Capture Man-agement

All

Key Parameter History Alla For single chamber models (SR Series and S Series), Heart Rate Histograms are available for the paced

chamber. For all models, Heart Rate Histograms can be programmed to include or exclude refractory sensedevents.

b For single chamber models (SR Series and S Series), High Rate Episode is available for the paced chamber.c For single chamber models (SR Series and S Series), Detection Duration is 2 to 200 beats.dCollection Method applies to Atrial High Rate Episodes and Ventricular High Rate Episodes.

B.4 Clinician-selectable diagnosticsNote: The diagnostics in this section are categorized by mode prefixes contained in themodel number (for example, DR Series). The diagnostic parameters shown can apply to amodel in that series, provided that the pacemaker was manufactured with that diagnostic. Tofind applicable diagnostics for a specific model, refer to the Implant Manual for thatpacemaker.



The clinician-selected diagnostics listed in Table 24 through Table 27 are programmed byselecting Data Collection/Setup under the Data icon. Table 24 lists the parameters for allclinician-selectable diagnostics except for High Rate Detail. To learn which set ofparameters applies to a specific model, refer to the Implant Manual for that pacemaker.The parameters settings for High Rate Detail diagnostics are presented in Table 25 throughTable 27. Table 25 applies to Adapta and Versa pacemakers, which collect 48 seconds ofEGM. Table 26 applies to Sensia pacemakers, which collect 24 seconds of EGM. Table 27applies to Relia pacemakers, which collect 16 seconds of EGM.Notes:

● For each clinician-selectable diagnostic with EGM collection, there is an automaticdiagnostic that collects corresponding trend data.

● The parameters settings for the automatic High Rate Episode diagnostics also apply tothe corresponding clinician-selectable High Rate Detail diagnostics.

Table 24. Common clinician-selectable diagnosticsDiagnostic and parameters Series Parameter settingsCustom Rate Trend All

Duration Beat-to-Beat, 1 Hour, 24 hoursCollection Method Frozen, RollingInclude Refractory Senses? Include, Exclude

Ventricular Capture Manage-ment Detail

All

EGM Collection Off, Atrial EGM, VentricularEGM, Summed EGMa

Atrial Capture ManagementDetail

DR Series, D Series

EGM Collection Off, Atrial EGM, VentricularEGM, Summed EGM

Rate Drop Response Detail DR Series, D SeriesInclude Refractory Senses? Include, Exclude

a For single chamber models (SR Series and S Series), EGM Collection options are limited to OFF and EGM.

Table 25. High Rate Detail for Adapta and Versa modelsDiagnostic and parameters Series Parameter settingsHigh Rate Detaila Allb

High Rate Typec AHR and VHR, AHR, VHREGM Type Off, Atrial EGM, Ventricular

EGM, Summed EGMd



Table 25. High Rate Detail for Adapta and Versa models (continued)Diagnostic and parameters Series Parameter settings

Allocation (CollectionMethode = Frozen, HighRate Type = AHR and VHR)

2 for 0/24, 2 for 24/0, 2 for 12/12,4 for 0/12, 4 for 12/0, 4 for 6/6, 8for 0/6, 8 for 6/0, 8 for 3/3 (num-ber of episodes for pre-onsetseconds/post onset secondscollected)

Allocation (CollectionMethode = Frozen, HighRate Type = AHR only orVHR only)

1 for 0/48, 1 for 48/0, 1 for 24/24,2 for 0/24, 2 for 24/0, 2 for 12/12,4 for 0/12, 4 for 12/0, 4 for 6/6, 8for 0/6, 8 for 6/0, 8 for 3/3 (num-ber of episodes for pre-onsetseconds/post onset secondscollected)

Allocation (CollectionMethode = Rolling, HighRate Type = AHR and VHR)

2 for 16/0, 2 for 8/8, 2 for 0/24, 4for 8/0, 4 for 4/4, 4 for 0/12, 8 for4/0, 8 for 2/2, 8 for 0/6 (numberof episodes for pre-onset sec-onds/post onset seconds col-lected)

Allocation (CollectionMethode = Rolling, HighRate Type = AHR only orVHR only)

1 for 24/0, 1 for 12/12, 1 for 0/48,2 for 16/0, 2 for 8/8, 2 for 0/24, 4for 8/0, 4 for 4/4, 4 for 0/12, 8 for4/0, 8 for 2/2, 8 for 0/6 (numberof episodes for pre-onset sec-onds/post onset seconds col-lected)

Pre-detection Timeout 1, 2, 3 … 12, 14, 16 … 24 weeksa High rate detection rate, detection duration, and termination criteria are set by parameters for the automatic

diagnostic (Atrial High Rate Episodes or Ventricular High Rate Episodes - see Section B.3, “Automaticdiagnostics”, page 193).

b For single chamber models (SR Series and S Series), High Rate Detail is available for the paced chamber.c For single chamber models (SR Series), High Rate Type is not displayed.dFor single chamber models (SR Series), EGM Collection options are limited to OFF and EGM.e Collection Method is set in either of the High Rate Episodes automatic diagnostics.

Table 26. High Rate Detail for Sensia modelsDiagnostic and parameters Series Parameter settingsHigh Rate Detaila Allb

High Rate Typec AHR and VHR, AHR, VHREGM Type Off, Atrial EGM, Ventricular

EGM, Summed EGMd



Table 26. High Rate Detail for Sensia models (continued)Diagnostic and parameters Series Parameter settings

Allocation (CollectionMethode = Frozen, HighRate Type = AHR and VHR)

2 for 12/0, 2 for 0/12, 2 for 6/6, 4for 0/6, 4 for 6/0, 4 for 3/3 (num-ber of episodes for pre-onsetseconds/post onset secondscollected)


1 for 0/24, 1 for 24/0, 1 for 12/12,2 for 12/0, 2 for 0/12, 2 for 6/6, 4for 0/6, 4 for 6/0, 4 for 3/3 (num-ber of episodes for pre-onsetseconds/post onset secondscollected)

Allocation (CollectionMethode = Rolling, HighRate Type = AHR and VHR)

2 for 8/0, 2 for 4/4, 2 for 0/12, 4for 4/0, 4 for 2/2, 4 for 0/6 (num-ber of episodes for pre-onsetseconds/post onset secondscollected)





b For single chamber models (SR Series and S Series), High Rate Detail is available for the paced chamber.c For single chamber models (SR Series and S Series), High Rate Type is not displayed.dFor single chamber models (SR Series and S Series), EGM Collection options are limited to OFF and EGM.e Collection Method is set in either of the High Rate Episodes automatic diagnostics.

Table 27. High Rate Detail for Relia modelsDiagnostic and parameters Series Parameter settingsHigh Rate Detaila Allb

High Rate Typec AHR, VHREGM Type Off, Atrial EGM, Ventricular

EGM, Summed EGMd





Table 27. High Rate Detail for Relia models (continued)Diagnostic and parameters Series Parameter settings





b For single chamber models (SR Series and S Series), High Rate Detail is available for the paced chamber.c For single chamber models (SR Series and S Series), High Rate Type is not displayed.dFor single chamber models (SR Series and S Series), EGM Collection options are limited to OFF and EGM.e Collection Method is set in either of the High Rate Episodes automatic diagnostics.

B.5 Cardiac event countersTable 28. Cardiac event counters

Type of counter SeriesAutomatic Event Countersa (AS-VS, AS-VP,AP-VS, AP-VP)

All

Percent Paced Events AllPercent Sensed Events AllAV Conduction Events DR Series, D Series, VDD SeriesPremature Ventricular Contraction (PVC), sin-gles and runs

DR Series, D Series, VDD Series

Premature Atrial Contraction (PAC), runs only DR Series, D Series, VDD SeriesLead Performance All

a For single-chamber pacing modes, the event counters are Paced and Sensed.



C Rate Response programming guidelines

C.1 Rate Response programming guidelinesFor basic information about Rate Profile Optimization, refer to Section 3.3, “Rate ProfileOptimization operation”, page 30 and Section 3.4, “Individualizing Rate ProfileOptimization”, page 36.To adjust Rate Response (via Optimization):

1. Verify that the three rates are appropriate for the patient. The Lower Rate should providesufficient cardiac support at rest; the ADL Rate should be set for rate support duringtypical daily activities; and the Upper Sensor Rate should limit the rate during vigorousexercise.

2. If these rates are appropriate, the ADL Response and/or Exertion Responseparameters can then be adjusted based on the guidelines in Table 29 and Table 30.

Note: The ADL Response setting tells Optimization the amount of time to target the sensorrate in the ADL rate range (rates at or near the ADL Rate). The Exertion Response settingtells Optimization the amount of time to target the sensor rate in the exertion rate range (ratesat or near the Upper Sensor Rate).Table 29. ADL Response programming guidelines

Evaluating ADLrate response

ADLResponse val-ues

Targeted minutes per day sen-sor rate is in the ADL rate range

Rate Responsetoo aggressive

→ Select lowernumber

12

→→

8 min15 min

Rate Responsetoo low

→ Selecthigher num-ber

345

→→→

30 min60 min100 min



Table 30. Exertion Response programming guidelinesEvaluating exer-tion rateresponse

ExertionResponse val-ues

Targeted minutes per weeksensor rate is in the exertionrate rangea

Rate Responsetoo aggressive

→ Select lowernumber

12

→→

21 min21 min

Rate Responsetoo low

→ Selecthigher num-berb

345

→→→

21 min51 min101 min

a The exertion rate range extends from the rate in parentheses to a programmed Upper Sensor Rate of 130 bpmor greater.

b If a higher Exertion Response value has not produced the desired rate response, increase the ADL Responsevalue.



D Patient counseling

D.1 Patient counseling informationD.1.1 Patient counseling informationThe clinician may wish to discuss the following topics with the patient before discharge.

● Review the signs and symptoms that should be reported to the patient’s physician.● Review instructions to the patient concerning physical activity.● Advise the patient on the frequency of follow-up care.● Inform the patient of cautions regarding sources of electromagnetic interference (EMI).● Educate the patient about the consequences of device manipulation (Twiddler’s

syndrome).

D.1.2 Device registration formA device registration form is included with each device in the shipping package. The formserves as a permanent record of facts related to the implanted device. Return a completedcopy of this form to Medtronic. Note that in some areas, the device package may not containthe registration form.

D.1.3 Establish a patient recordAt the time of implant, document the patient’s pacemaker programmed parameter settingsfor later reference. A patient record gives an accurate account of the patient’s medical historyat subsequent follow-ups when evaluating the pacemaker’s performance.The Patient Information and Key Parameter History reports can provide data for this patientrecord. These data contain demographic information on the patient and values for certainparameters for the last eight programming sessions, respectively. Refer to Section 7.3,“Patient information”, page 149 for more information.Note that the registration form should not serve this purpose since the form is intended forregistering the patient and pacemaker with Medtronic.



Glossary2:1 block rate – the rate at which intrinsic atrial events are sensed as refractory in the TARPcausing synchronization of ventricular pacing to every other atrial event. Determined by theTotal Atrial Refractory Period (TARP: the sum of the SAV interval and the PVARP). Theoperation results in a ventricular rate one half as fast as the atrial rate.activities of daily living (ADL) – 1 the target rate which the patient’s heart rate is expectedto reach during moderate exercise. 2 the pacemaker’s ADL Response setting thatdetermines rate responsiveness in the ADL rate range.activity – 1 patient body motion as detected by the pacemaker’s accelerometer in rateresponsive modes. 2 type of rate responsive sensor that increases or decreases pacing ratein proportion to levels of detected patient body motion.acute phase – lead maturation period beginning at lead implantation during whichmyocardial stimulation thresholds begin at low voltages, rise, and decline to a plateau. Theacute phase normally ends within 6 to 12 weeks post-implant when local tissue reaction tothe lead subsides.ADL rate range – rates at or near the ADL Rate that are achieved during moderate activities.arrhythmia – any variation from the normal rhythm of the heartbeat; it may be an abnormalityof either the rate, regularity, or site of impulse origination or the sequence of activation.artifact – the pacemaker’s electrical output recorded as a vertical spike on theelectrocardiogram.atrial kick – contribution of an atrial contraction to ventricular late end-diastolic filling volumeand pressure.Atrial Preference Pacing (APP) – atrial rhythm management feature that adapts the pacingrate to slightly higher than the intrinsic sinus rate.atrial tracking – a pacing operation (in the DDDR, DDD, and VDD modes) in which theventricles are paced in synchrony with sensed atrial events.AV synchrony – the activation sequence of the heart in which the atria contract first andthen, after an appropriate delay, the ventricles. Pacemakers which utilize the atrium forsensing and/or pacing are designed to replicate the heart’s normal contraction sequence.battery capacity – a battery’s capability for current delivery, expressed in ampere hours,i.e., current x time. The battery capacity is one determinant of pacemaker longevity, alongwith current drain.blanking – a time interval during which the pacemaker’s sensing circuitry is turned off andno sensing can occur.



calibrate – a reference signal sent to an externally connected recorder or monitor used tofacilitate the measurement of telemetered EGM or ECG tracings.capture – Depolarization of the atria or ventricles by an electrical stimulus delivered by anartificial pacemaker.capture test frequency – Capture Management operation that automatically performsventricular and atrial pacing threshold measurements at programmed times. Duringmeasurement the pacemaker causes test paces to be delivered and monitors them forcapture or loss-of-capture.chronotropic incompetence – inability of the heart to vary its rate appropriately inresponse to exercise.clipping – the truncation of displayed waveform peaks which can occur on theECG/Markers/EGM screen when the selected amplitude scaling is set too high.configuration – the programmable state for a pacemaker operation option. Specificallyapplies to polarity, i.e., unipolar or bipolar configuration.confirmation – programmer display of message(s) to verify programming and storage ofselected pacing parameter values after engaging the [PROGRAM] button.crosstalk – in dual chamber pacemakers, the sensing of a pacing stimulus delivered in theopposite chamber, which results in undesirable pacemaker response, e.g., false inhibition orresetting of the refractory period.current – in pacemakers, the continuing flow of electricity through the pacemaker circuit(especially through the lead conductor) as measured in milliamperes; high current isassociated with high voltage, low current with low voltage. Current cannot be directlycontrolled, but can be indirectly controlled by altering the voltage or the resistance(impedance).current drain – 1 depletion of electricity from the pacemaker battery measured inmicrojoules. Depletion is caused by the continuous low-level “self-discharge” from thebattery; by pacing and sensing circuit efficiency; and by the following programmable factorsunder the control of the follow-up clinician: a) pacing rate; b) output voltage (amplitude); c)pulse duration (pulse width); d) percent of time pacing, and e) other programmablefeatures. 2 one determinant of pacemaker longevity along with battery capacity. Currentdrain is inversely proportional to pacemaker longevity.demand modes – any pacemaker mode which, after sensing a spontaneousdepolarization, withholds its pacing stimulus.



electrical reset – automatic setting of pacing parameters to specific values uponpacemaker detection of a momentary interruption of electrical power to the pacemaker’scontrol circuitry; can be either a partial or a full reset. partial reset - pacing mode, polarity,and certain other parameter settings are preserved; all other parameters are changed totheir Electrical Reset values. full reset - pacing resumes in the VVI mode with all valueschanged to Electrical Reset values.electrogram – in pacing, the recording of the cardiac waveforms as taken at the lead(electrode) site within the heart. Electrograms may be transmitted from implantedpacemakers by telemetry.electromagnetic interference (EMI) – radiated or conducted energy - either electrical ormagnetic - which can interfere with or disrupt the function of a pacemaker.emergency – for the pacing system, programming [EMERGENCY] delivers maximal energyoutput in the VVI mode in an attempt to provide pacing support to the ventricle. Note:Programming [EMERGENCY] for single chamber systems applied in the atrium results inemergency AAI pacing.episode – usually applied to a series of cardiac events; here used to mean certainpacemaker-defined series of cardiac events such as PMT episodes, Rate Drop episodes,and Mode Switch episodes, which are reported via programmer automatic diagnostics.escape interval – a pacemaker-defined time between a paced or sensed cardiac event andthe subsequent scheduled pacing stimulus; the longest interval associated with the basepacing rate.escape rate – a pacing rate which is a function of the “escape interval” (see above); theslowest pacing rate possible.evoked response detection – the act of detecting the electrical signal generated by thecontracting myocardium immediately following a pacing pulse.exertion – the pacemaker’s Exertion Response setting that determines rate responsivenessin the exertion rate range.exertion rate range – rates at or near the Upper Sensor Rate that are achieved duringvigorous exercise.exit block – failure of a pacemaker to capture the heart because the patient’s stimulationthreshold exceeds the output of the pacemaker.freeze – to stop and collect a portion of the patient’s ECG trace.fusion beat – an intrinsic depolarization that occurs coincidentally with a paceddepolarization. The intrinsic and paced waveforms “fuse” on the ECG.hysteresis – a pacing operation and programmable parameter that allows a longer escapeinterval after a sensed event, giving the heart a greater opportunity to beat on its own.



impedance – the total opposition that a circuit presents to current flow in the pacing system.implant detection – a temporary function which causes the cessation of pacing outputpulses.inhibit – a temporary function which causes the cessation of pacing output pulses.interlock – a safety restriction in the pacemaker programmer software that aids in the choiceof proper values, usually by initiating a screen message informing the user of important valueinterrelationships.interrogate – a programmer command used to retrieve and display information about thestatus of the patient’s pacing system.intrinsic event rejection – the ability of the Capture Management pacing threshold searchto differentiate between myocardial contractions caused by the pacing pulse and thosecaused by physiologic means.lead fixation – contact between the lead electrode and the myocardial tissue.longevity – duration of the normal service life of the pacemaker.Marker Channel recording – a pacing system feature used to simplify ECG interpretationby identifying pacing and/or sensing operations.mean atrial rate – a running average of the atrial rate that is continuously calculated by thepacemaker for use by the Rate Adaptive AV and automatic PVARP features. The averageuses all A-A intervals except those beginning with either an atrial sense or atrial refractorysense and ending with an atrial pace.MVP (Managed Ventricular Pacing) – promotes intrinsic conduction by reducingunnecessary right ventricular pacing. MVP operates when the programmed mode is eitherAAIR<=>DDDR or AAI<=>DDD.myopotential – a term used to describe electrical signals that originate in body muscles;these signals may be sensed by the pacemaker and falsely interpreted as cardiacdepolarizations.noise – any electromagnetic interference, myopotentials, or crosstalk detected by apacemaker’s sensing amplifier.noise reversion – continuous restarting of the refractory period (and its blanking period)caused by continuous sensing at intervals less than the refractory period.nominal – in pacing, the term describes a set of programmable parameter valuesconsidered reasonable for the majority of uncomplicated patients.nonrefractory – describes atrial or ventricular events sensed outside of a refractory period(in dual chamber modes, outside of AV intervals and Post Ventricular Atrial RefractoryPeriod; in single chamber modes outside of the Atrial Refractory Period or VentricularRefractory Period).



oversensing – inappropriate sensing of noncardiac signals, e.g., myopotentials,electromagnetic interference, crosstalk, etc., which can cause inhibition of the pacemakerstimulus.pacemaker-defined PVC (premature ventricular contraction) – any ventricular sensedevent (refractory or nonrefractory) that follows a ventricular event (pace, refractory sense, ornonrefractory sense) without an intervening atrial event (pace, refractory sense, ornonrefractory sense).pacemaker-mediated tachycardia (PMT) – a paced rhythm, usually rapid, which canoccur with loss of AV synchrony. This rhythm begins with and is sustained by retrogradeconduction of ventricular events to the atria. The pacemaker senses this retrograde atrialdepolarization, starts an AV interval, and then delivers a stimulus to the ventricle. Thiscauses a ventricular depolarization with retrograde conduction to the atria. The cycle repeatsitself to produce tachycardia.pacemaker syndrome – a collection of signs and symptoms (often described as dizzinessand/or weakness) related to the adverse hemodynamic effects of ventricular pacing, usuallyattributed to the absence of synchrony between the atrial and ventricular contractions.pacing cycles – a recurring set of events that consists of a paced or sensed atrial eventfollowed by a paced or sensed ventricular event.PMOP (Post Mode Switch Overdrive Pacing) – PMOP enables the pacemaker to provideextended DDIR (non-atrial tracking) pacing for a programmed duration and rate following amode switch. For example, a patient can be paced at an Overdrive Rate of 80 bpm for 10minutes following a mode switch episode.PMT – see “pacemaker-mediated tachycardia” earlier.pseudofusion – a spontaneous cardiac depolarization with a superimposed stimulus. Thepacing stimulus is delivered after the chamber has already spontaneously depolarized.radiopaque ID – a small metallic plate (inside the pacemaker connector) bearing both theMedtronic logo and a code for identifying the pacemaker under fluoroscopy.rate profile – 1 a historical rate profile of the sensor-indicated rate that rate response isadjusted from. 2 a desired target rate profile that rate response is adjusted toward.real-time measurement – a pacing system function that presents measured and calculateddata at the time of the clinician’s query via programmer telemetry.retrograde conduction – the propagation of ventricular depolarization to the atria, alsoknown as “VA conduction.”



safety margin – 1 the difference between the measured stimulation threshold and theprogrammed amplitude or the programmed pulse width. Output settings that produce amargin of twice the stimulation threshold are necessary because of threshold variability dueto exercise, eating, sleeping, drug therapy, and other changes in cardiac condition. 2 safetymargin, output - a ratio of the programmed output divided by the stimulation threshold toachieve adequate pacing voltage and duration to prevent loss-of-capture.sensing threshold – the minimum signal strength (highest sensitivity setting) that allowscontinuous sensing of intrinsic depolarizations.sensitivity – the degree to which a pacemaker’s sense amplifiers are responsive to levels ofelectrical activity in the heart (or other electrical signals).sensor-indicated rate – the pacing rate determined by the sensor-detected level of patientactivity and on programmed rate response parameters; this rate is never greater than theUpper Sensor Rate or less than the operating Lower Rate.status reset – a pacing system command which attempts to reset an electrical reset or theRRT/ERI status.stimulation threshold – the desired sensing margin against which the pacemakercompares the P and R wave amplitudes of sensed events when making automatic Sensitivityadjustments. Used by the Sensing Assurance feature.strength-duration – the desired sensing margin against which the pacemaker comparesthe P and R wave amplitudes of sensed events when making automatic Sensitivityadjustments. Used by the Sensing Assurance feature.target sensing margin – the desired sensing margin against which the pacemakercompares the P and R wave amplitudes of sensed events when making automatic Sensitivityadjustments. Used by the Sensing Assurance feature.telemetry – the transmission of data from the pacemaker to the programmer and from theprogrammer to the pacemaker by radio waves. Information transmitted includesprogrammed status, real-time measurements, and diagnostic data.temporary (settings) – parameters programmed for brief diagnostic purposes or to quicklytest their effects on pacing operations prior to programming. Programmed settings arerestored automatically when the programming head is removed or the telemetry link isbroken.test pace – A pace delivered at a given amplitude or pulse width during the pacing thresholdsearch. The pacemaker evaluates the test pace for capture or loss-of-capture.trigger – in pacing, to start a process, operation, or a collection of data.triggered mode – a pacemaker mode that, upon detecting a spontaneous depolarization orother signal, delivers an electrical stimulus to the heart.



troubleshooting – a strategy and methodology for isolating and correcting problems withthe pacing system.undersensing – failure of the pacemaker to sense the P or R wave may cause thepacemaker to not withhold pacing output pulses.value window – rectangular display listing specific programmable options for a selectedparameter from a programmer screen.Wenckebach operation – in dual chamber atrial tracking modes, an upper rate operationwhich limits the average ventricular pacing rate when intrinsic atrial rates rise above theUpper Tracking Rate. The pacemaker does this by gradually prolonging the pacemaker’s AVinterval until one atrial event falls into the PVARP and is not tracked. Since no AV interval isstarted by the refractory event, there will be no ventricular output synchronized to this atrialevent.



IndexNumerics2:1 block, increasing rate . . . . . . . . . . . . . . . . . . 68AAAT

contraindications . . . . . . . . . . . . . . . . . . . . 24indications . . . . . . . . . . . . . . . . . . . . . . . . 24

A-A timing . . . . . . . . . . . . . . . . . . . . . . . . . . . 43Activities of Daily Living (ADL) response . . . . . . 36, 199

rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47setpoint . . . . . . . . . . . . . . . . . . . . . . . . . . 41

activity sensoracceleration . . . . . . . . . . . . . . . . . . . . . . . 39activity threshold . . . . . . . . . . . . . . . . . . . . 38deceleration . . . . . . . . . . . . . . . . . . . . . . . 39exercise deceleration . . . . . . . . . . . . . . . . . . 40threshold . . . . . . . . . . . . . . . . . . . . . . . . . 38threshold guidelines . . . . . . . . . . . . . . . . . . 38

Adaptive parameterCapture Management . . . . . . . . . . . . . . . . . 80Lead Monitor . . . . . . . . . . . . . . . . . . . . . . . 77

ADLsee Activities of Daily Living (ADL) response

artifactsintracardiac . . . . . . . . . . . . . . . . . . . . . . 154

Atrial Arrhythmia Durations . . . . . . . . . . . . . . . . 181parameters and settings . . . . . . . . . . . . . . . 194

Atrial Arrhythmia Trend . . . . . . . . . . . . . . . . . . . 180displaying . . . . . . . . . . . . . . . . . . . . . . . . 181parameters and settings . . . . . . . . . . . . . . . 194

atrial blanking period . . . . . . . . . . . . . . . . . . . . . 59Atrial Capture Management . . . . . . . . . . . . . . . . . 90

parameters and settings . . . . . . . . . . . . . . . 194atrial competition

at high rates . . . . . . . . . . . . . . . . . . . . . . . 49atrial high rate diagnostics

see High Rate Detailsee High Rate Episodes

atrial high rate trend . . . . . . . . . . . . . . . . . . . . 180Atrial Preference Pacing (APP) . . . . . . . . . . . . . . 133

guidelines . . . . . . . . . . . . . . . . . . . . . . . 134interactions . . . . . . . . . . . . . . . . . . . . . . . 137restrictions . . . . . . . . . . . . . . . . . . . . . . . 134

atrial rate histogramsee Heart Rate Histogram

atrial refractory period . . . . . . . . . . . . . . . . . . . . 65noise reversion . . . . . . . . . . . . . . . . . . . . . 66

atrial tracking2:1 block . . . . . . . . . . . . . . . . . . . . . . . . . 68high rates . . . . . . . . . . . . . . . . . . . . . . . . . 68Wenckebach . . . . . . . . . . . . . . . . . . . . . . . 69

automatic polarity configuration . . . . . . . . . . . . . . 72operation . . . . . . . . . . . . . . . . . . . . . . . . . 73overview . . . . . . . . . . . . . . . . . . . . . . . . . 72programming interactions . . . . . . . . . . . . . . . 76turning off automatic configuration . . . . . . . . . . 76with Lead Monitor . . . . . . . . . . . . . . . . . . . . 75

automatic stimulation threshold adaptation . . . . . . 87, 94programmable parameters . . . . . . . . . . . . . . 80when high thresholds are indicated . . . . . . . . . 88

AV Conduction Histogram . . . . . . . . . . . . . . . . . 168data collection . . . . . . . . . . . . . . . . . . . . . 168displaying . . . . . . . . . . . . . . . . . . . . . . . . 169event counters . . . . . . . . . . . . . . . . . . . . . 169example data . . . . . . . . . . . . . . . . . . . . . 168long term . . . . . . . . . . . . . . . . . . . . . . . . 169short term . . . . . . . . . . . . . . . . . . . . . . . 169

AV Conduction Histogramsparameters and settings . . . . . . . . . . . . . . . 193

AV interval . . . . . . . . . . . . . . . . . . . . . . . . . . . 50blanking . . . . . . . . . . . . . . . . . . . . . . . . . 58PAV . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50RAAV . . . . . . . . . . . . . . . . . . . . . . . . . . . 52SAV . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50

Bbattery

depletion indicator . . . . . . . . . . . . . . . . . . 161diagnostic data . . . . . . . . . . . . . . . . . . . . 165

blanking periods . . . . . . . . . . . . . . . . . . . . . . . . 58atrial . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59AV interval . . . . . . . . . . . . . . . . . . . . . . . . 58PVAB . . . . . . . . . . . . . . . . . . . . . . . . . . . 59ventricular . . . . . . . . . . . . . . . . . . . . . . . . 58ventricular (after atrial pace) . . . . . . . . . . . . . . 59

CCapture Management . . . . . . . . . . . . . . . . . . . . 79

Adaptive parameter . . . . . . . . . . . . . . . . . . . 80automatic threshold adaptation . . . . . . . . . . 87, 94follow-up threshold test . . . . . . . . . . . . . . . 104monitor only parameter . . . . . . . . . . . . . . . . 80



overview . . . . . . . . . . . . . . . . . . . . . . . . . 79pacing threshold search . . . . . . . . . . . . . . . . 79parameters and settings . . . . . . . . . . . . . . . 194programmable parameters . . . . . . . . . . . . . . 80programming interactions . . . . . . . . . . . . . 90, 96

Capture Management diagnosticsdetail (clinician-selected) . . . . . . . . . . . . . . . 98parameters and settings . . . . . . . . . . . . . . . 195trend (automatic) . . . . . . . . . . . . . . . . . . . . 97

Chronic Lead Trend . . . . . . . . . . . . . . . . . . . . . . 78parameters and settings . . . . . . . . . . . . . . . 194

clearing diagnostic data . . . . . . . . . . . . . . . . . . 165clinical conditions

see TherapyGuideclinician-selected diagnostics . . . . . . . . . . . . . . . 194Conducted AF Response . . . . . . . . . . . . . . . . . 122

interactions . . . . . . . . . . . . . . . . . . . . . . . 122restrictions . . . . . . . . . . . . . . . . . . . . . . . 122

configuration, polarity . . . . . . . . . . . . . . . . . . . . 72configure, Lead Monitor . . . . . . . . . . . . . . . . . . . 77Custom Rate Trend . . . . . . . . . . . . . . . . . . . . . 181

parameters and settings . . . . . . . . . . . . . . . 195Ddata, diagnostic

see diagnosticsDDI


DDIRcontraindications . . . . . . . . . . . . . . . . . . . . 16indications . . . . . . . . . . . . . . . . . . . . . . . . 16

diagnostic dataatrial high rate trend . . . . . . . . . . . . . . . . . 180ventricular rate histogram collected during atrial

arrhythmias . . . . . . . . . . . . . . . . . . . . . 179diagnostics . . . . . . . . . . . . . . . . . . . . . . . . . . 163

automatically collected data . . . . . . . . . . 163, 193clearing data . . . . . . . . . . . . . . . . . . . . . . 165clinician-selected . . . . . . . . . . . . . . . . . . . 164parameters and settings, automatic . . . . . . . . 193suspending collection . . . . . . . . . . . . . . . . 165

EEGM

see electrograms (EGM)electrical reset . . . . . . . . . . . . . . . . . . . . . . . . 159electrograms (EGM) . . . . . . . . . . . . . . . . . . . . 154

intracardiac . . . . . . . . . . . . . . . . . . . 154, 191emergency pacing . . . . . . . . . . . . . . . . . . . . . 162

parameters and settings . . . . . . . . . . . . . . . 189

episodeshigh rate . . . . . . . . . . . . . . . . . . . . . . . . 173Mode Switch . . . . . . . . . . . . . . . . . . . . . . 116Rate Drop Response . . . . . . . . . . . . . . . . . 142

event counters . . . . . . . . . . . . . . . . . . . . . . . . 198automatic . . . . . . . . . . . . . . . . . . . . . . . . 198AV conduction events . . . . . . . . . . . . . 169, 198lead performance . . . . . . . . . . . . . . . . . . . 198PAC events . . . . . . . . . . . . . . . . . . . . 167, 198percent paced events . . . . . . . . . . . . . . . . 198PVC events . . . . . . . . . . . . . . . . . . . . 167, 198

exercise test . . . . . . . . . . . . . . . . . . . . . . . . . . 41exertion response . . . . . . . . . . . . . . . . . . . . 36, 199Extended Markers . . . . . . . . . . . . . . . . . . 153, 191Extended Telemetry . . . . . . . . . . . . . . . . . 156, 191Ffollow-up

sensitivity test . . . . . . . . . . . . . . . . . . . . . 107stimulation threshold tests . . . . . . . . . . . . . . 104

HHeart Rate Histograms . . . . . . . . . . . . . . . . . . . 166

parameters and settings . . . . . . . . . . . . . . . 193High Rate Detail . . . . . . . . . . . . . . . . . . . . . . . 175

Allocation . . . . . . . . . . . . . . . . . . . . . . . . 176EGM collection examples . . . . . . . . . . . . . . 177EGM Type . . . . . . . . . . . . . . . . . . . . . . . 176example data . . . . . . . . . . . . . . . . . . . . . 175High Rate Type . . . . . . . . . . . . . . . . . . . . 176parameters and settings . . . . . . . . . 195, 196, 197

High Rate Episodes . . . . . . . . . . . . . . . . . . . . 173defining episodes . . . . . . . . . . . . . . . . . . . 177displaying . . . . . . . . . . . . . . . . . . . . . . . . 178limitations due to blanking . . . . . . . . . . . . . . 178parameters and settings, atrial with Mode Switch Off

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 193parameters and settings, atrial with Mode Switch On

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 193parameters and settings, ventricular . . . . . . . . 194

high ratesatrial tracking . . . . . . . . . . . . . . . . . . . . . . 68TARP . . . . . . . . . . . . . . . . . . . . . . . . . . . 69Upper Sensor Rate . . . . . . . . . . . . . . . . . . . 69Upper Tracking Rate . . . . . . . . . . . . . . . . . . 69

high rate trend, atrial . . . . . . . . . . . . . . . . . . . . 180histograms

AV Conduction . . . . . . . . . . . . . . . . . . . . . 168Heart Rate . . . . . . . . . . . . . . . . . . . . . . . 166Search AV+ . . . . . . . . . . . . . . . . . . . . 57, 170Ventricular Rate During Atrial Arrhythmias . . . . 179



hysteresis . . . . . . . . . . . . . . . . . . . . . . . . . . 145emergency settings . . . . . . . . . . . . . . . . . . 189guidelines . . . . . . . . . . . . . . . . . . . . . . . 146interactions . . . . . . . . . . . . . . . . . . . . . . . 146restrictions . . . . . . . . . . . . . . . . . . . . . . . 146

Iimplant

rate response . . . . . . . . . . . . . . . . . . . . . . 29Implant Detection . . . . . . . . . . . . . . . . . . . . . . . 71

automatic feature activation . . . . . . . . . . . . . . 71measuring lead impedance . . . . . . . . . . . . . . 72overview . . . . . . . . . . . . . . . . . . . . . . . . . 71programming interactions . . . . . . . . . . . . . . . 76

indicationsfor modes . . . . . . . . . . . . . . . . . . . . . . . . . 11

Initial Interrogation ReportTherapyGuide conditions . . . . . . . . . . . . . . 151

initializationstopping . . . . . . . . . . . . . . . . . . . . . . . . . 29

interrogating parameters . . . . . . . . . . . . . . . . . . 147KKey Parameter History . . . . . . . . . . . . . . . . . . . 183

parameters and settings . . . . . . . . . . . . . . . 194Llead diagnostic data . . . . . . . . . . . . . . . . . . . . 165Lead Impedance Trend (automatic) . . . . . . . . . . . . 78Lead Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . 76

adaptive parameter . . . . . . . . . . . . . . . . . . . 77configure parameter . . . . . . . . . . . . . . . . . . 77monitor only parameter . . . . . . . . . . . . . . . . 77overview . . . . . . . . . . . . . . . . . . . . . . . . . 76programmable parameters . . . . . . . . . . . . . . 77with automatic polarity configuration . . . . . . . . . 75

Lead Monitor Countersparameters and settings . . . . . . . . . . . . . . . 194

leadsautomatic polarity configuration . . . . . . . . . . . 72Lead Impedance Trend (automatic) . . . . . . . . . 78Lead Monitor . . . . . . . . . . . . . . . . . . . . . . . 76

Lower Rate . . . . . . . . . . . . . . . . . . . . . . . . . . . 44operating . . . . . . . . . . . . . . . . . . . . . . . . . 45selecting . . . . . . . . . . . . . . . . . . . . . . . . . 45

MMagnet mode . . . . . . . . . . . . . . . . . . . . . . . . 157Magnet Mode . . . . . . . . . . . . . . . . . . . . . . . . 190

Managed Ventricular Pacing (MVP) . . . . . . . . . . . 117guidelines . . . . . . . . . . . . . . . . . . . . . . . 118interactions . . . . . . . . . . . . . . . . . . . . . . . 121Mode Switch . . . . . . . . . . . . . . . . . . . . . . 111restrictions . . . . . . . . . . . . . . . . . . . . . . . 118

manual programmingpacing output settings . . . . . . . . . . . . . . . . 104pacing polarity . . . . . . . . . . . . . . . . . . . . . 103sensing polarity . . . . . . . . . . . . . . . . . . . . 106sensitivity settings . . . . . . . . . . . . . . . . . . . 107

Marker Channel telemetry . . . . . . . . . . . . . . 153, 191markers

standard . . . . . . . . . . . . . . . . . . 153, 156, 191Therapy Trace . . . . . . . . . . . . . . . 154, 156, 191

mean atrial rate . . . . . . . . . . . . . . . . . . . . . . . . 49modes

AAI/ADI . . . . . . . . . . . . . . . . . . . . . . . . . . 21AAIR/ADIR . . . . . . . . . . . . . . . . . . . . . . . . 20AAT . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24AOO . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26AOOR . . . . . . . . . . . . . . . . . . . . . . . . . . . 25DDD . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15DDDR . . . . . . . . . . . . . . . . . . . . . . . . . . . 13DDI . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17DDIR . . . . . . . . . . . . . . . . . . . . . . . . . . . 16DOO . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26DOOR . . . . . . . . . . . . . . . . . . . . . . . . . . . 25DVI . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18DVIR . . . . . . . . . . . . . . . . . . . . . . . . . . . 18MVP modes . . . . . . . . . . . . . . . . . . . . . . . 13NGBG Codes . . . . . . . . . . . . . . . . . . . . . . 11OAO . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27ODO . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27OVO . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27selection . . . . . . . . . . . . . . . . . . . . . . . . . 13VDD . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19VOO . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26VOOR . . . . . . . . . . . . . . . . . . . . . . . . . . . 25VVIR/VDIR . . . . . . . . . . . . . . . . . . . . . . . . 22VVI/VDI . . . . . . . . . . . . . . . . . . . . . . . . . . 23VVT . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24

Mode Switch . . . . . . . . . . . . . . . . . . . . . . . . . 111interactions . . . . . . . . . . . . . . . . . . . . . . . 111restrictions . . . . . . . . . . . . . . . . . . . . . . . 115

Mode Switch diagnosticsdetail (clinician-selected) . . . . . . . . . . . . . . 116episodes (automatic) . . . . . . . . . . . . . . . . . 116example data . . . . . . . . . . . . . . . . . . . . . 117



monitor only parameterCapture Management . . . . . . . . . . . . . . . . . 80Lead Monitor . . . . . . . . . . . . . . . . . . . . . . . 77

muscle stimulation, precaution . . . . . . . . . . . . . . 103MVP

see Managed Ventricular Pacing (MVP)myopotentials, precaution . . . . . . . . . . . . . . . . . 107Nnoise reversion . . . . . . . . . . . . . . . . . . . . . . . . 66

preventing . . . . . . . . . . . . . . . . . . . . . . . . 67Non-Competitive Atrial Pacing (NCAP) . . . . . . . . . 123

interactions . . . . . . . . . . . . . . . . . . . . . . . 124Ooptimization

adjusting . . . . . . . . . . . . . . . . . . . . . . 36, 199ADL response . . . . . . . . . . . . . . . . . . . . . . 36ADL setpoint . . . . . . . . . . . . . . . . . . . . . . . 41after implant . . . . . . . . . . . . . . . . . . . . . . . 35exertion response . . . . . . . . . . . . . . . . . . . . 36guidelines . . . . . . . . . . . . . . . . . . . . . . . . 36manual programming . . . . . . . . . . . . . . . . . . 41operation . . . . . . . . . . . . . . . . . . . . . . . . . 32programming . . . . . . . . . . . . . . . . . . . . . . . 36sensor rate profile . . . . . . . . . . . . . . . . . . . . 31target rate profile . . . . . . . . . . . . . . . . . . . . 31Upper Rate (UR) setpoint . . . . . . . . . . . . . . . 41

output settingsprogramming manually . . . . . . . . . . . . . . . . 104

PPaced AV (PAV) interval . . . . . . . . . . . . . . . . . . . 50

selecting . . . . . . . . . . . . . . . . . . . . . . . . . 51Pacemaker-Mediated Tachycardia (PMT) Intervention

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 125interactions . . . . . . . . . . . . . . . . . . . . . . . 127patient initiated . . . . . . . . . . . . . . . . . . . . 127PVARP . . . . . . . . . . . . . . . . . . . . . . . . . . 63

pacing parameters, manual selection . . . . . . . . . . 103pacing threshold search . . . . . . . . . . . . . . . . . . . 79

operation . . . . . . . . . . . . . . . . . . . . . . . . . 91pacing therapy during the search . . . . . . . . . . . 84when the search aborts . . . . . . . . . . . . . . . . 94

pacing, troubleshootingelectrical . . . . . . . . . . . . . . . . . . . . . . . . 185hemodynamic . . . . . . . . . . . . . . . . . . . . . 187

parametersemergency settings . . . . . . . . . . . . . . . . . . 189history . . . . . . . . . . . . . . . . . . . . . . . . . . 183temporary . . . . . . . . . . . . . . . . . . . . . . . 159using TherapyGuide . . . . . . . . . . . . . . . . . 150

patientdata . . . . . . . . . . . . . . . . . . . . . . . . . . . 192demographic data . . . . . . . . . . . . . . . . . . . 149

patient’s clinical conditionssee TherapyGuide

PAVsee Paced AV (PAV) interval

PMOPsee Post Mode Switch Overdrive Pacing (PMOP)

PMTsee Pacemaker-Mediated Tachycardia (PMT)Intervention

polarityautomatic configuration . . . . . . . . . . . . . . . . 72manually programming pacing polarity . . . . . . 103manually programming sensing polarity . . . . . . 106

Post Mode Switch Overdrive Pacing (PMOP) . . 111, 114Post-Ventricular Atrial Refractory Blanking (PVAB)

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59, 61Post-Ventricular Atrial Refractory Period (PVARP) . . . . 60

PMT Intervention . . . . . . . . . . . . . . . . . . . . 63PVC Response . . . . . . . . . . . . . . . . . . . . . 63restrictions . . . . . . . . . . . . . . . . . . . . . . . . 63sensor-varied . . . . . . . . . . . . . . . . . . . . . . 61

Premature Ventricular Contraction (PVC) Response. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 127

Heart Rate Histogram . . . . . . . . . . . . . . . . 128interactions . . . . . . . . . . . . . . . . . . . . . . . 128PVARP . . . . . . . . . . . . . . . . . . . . . . . . . . 63

programmable diagnosticssee diagnostics, clinician-selected

PVABsee Post-Ventricular Atrial Refractory Blanking (PVAB)

PVARPsee Post-Ventricular Atrial Refractory Period (PVARP)

RRAAV

see Rate Adaptive AV (RAAV) featureRate Adaptive AV (RAAV) feature . . . . . . . . . . . . . 52

considerations and restrictions . . . . . . . . . . . . 54parameters . . . . . . . . . . . . . . . . . . . . . . . . 52sick sinus syndrome . . . . . . . . . . . . . . . . . . 54

Rate Drop Response . . . . . . . . . . . . . . . . . . . . 137guidelines . . . . . . . . . . . . . . . . . . . . . . . 140restrictions . . . . . . . . . . . . . . . . . . . . 141, 144

Rate Drop Response Detailparameters and settings . . . . . . . . . . . . . . . 195



Rate Drop Response diagnosticsdetail (clinician-selected) . . . . . . . . . . . . . . 142episodes (automatic) . . . . . . . . . . . . . . . . . 142example data . . . . . . . . . . . . . . . . . . . . . 142

Rate Drop Response Episodesparameters and settings . . . . . . . . . . . . . . . 194

Rate Profile Optimizationoptimization . . . . . . . . . . . . . . . . . . . . . . . 30

rate responseActivities of Daily Living (ADL) response . . . . . . 36adjusting . . . . . . . . . . . . . . . . . . . . . . 36, 199at implant . . . . . . . . . . . . . . . . . . . . . . . . . 29exertion . . . . . . . . . . . . . . . . . . . . . . . . . . 30exertion response . . . . . . . . . . . . . . . . . . . . 36guidelines . . . . . . . . . . . . . . . . . . . . . . . . 36operation . . . . . . . . . . . . . . . . . . . . . . . . . 32optimization . . . . . . . . . . . . . . . . . . . . . . . 37programming . . . . . . . . . . . . . . . . . . . . . . . 36sensor rate profile . . . . . . . . . . . . . . . . . . . . 31target rate profile . . . . . . . . . . . . . . . . . . . . 31

ratesADL . . . . . . . . . . . . . . . . . . . . . . . . . . 29, 47limit . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48lower . . . . . . . . . . . . . . . . . . . . . . . . . . . 44Lower Rate . . . . . . . . . . . . . . . . . . . . . . . . 29mean atrial . . . . . . . . . . . . . . . . . . . . . . . . 49sensor-indicated . . . . . . . . . . . . . . . . . . . . 46Upper Sensor Rate . . . . . . . . . . . . . . . . . 29, 48upper tracking . . . . . . . . . . . . . . . . . . . . . . 47

rate trendsee Custom Rate Trend diagnostics

Recommended Replacement Time (RRT/ERI)indicator . . . . . . . . . . . . . . . . . . . . . . . . 161suspending diagnostic data collection . . . . . . . 166

refractory periods . . . . . . . . . . . . . . . . . . . . . . . 60atrial . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65PVARP . . . . . . . . . . . . . . . . . . . . . . . . . . 60TARP . . . . . . . . . . . . . . . . . . . . . . . . . . . 64ventricular . . . . . . . . . . . . . . . . . . . . . . . . 65

resetfull . . . . . . . . . . . . . . . . . . . . . . . . . . . . 161partial . . . . . . . . . . . . . . . . . . . . . . . . . . 160

RRT/ERIsee Recommended Replacement Time indicator (RRT/ERI)

SSAV

see Sensed AV (SAV) intervalSearch AV+ . . . . . . . . . . . . . . . . . . . . . . . . . . 55

considerations and restrictions . . . . . . . . . . . . 57

Search AV+ Histogram . . . . . . . . . . . . . . . . . 57, 170parameters and settings . . . . . . . . . . . . . . . 193

Sensed AV (SAV) interval . . . . . . . . . . . . . . . . . . 50selecting . . . . . . . . . . . . . . . . . . . . . . . . . 51

sensingprogramming sensitivity manually . . . . . . . . . 107thresholds . . . . . . . . . . . . . . . . . . . . . . . 106

Sensing Assurance diagnosticstrend (automatic) . . . . . . . . . . . . . . . . . . . 102

Sensing Assurance function . . . . . . . . . . . . . . . . . 99sensing parameters, manual selection . . . . . . . . . 105Sensitivity Detail

see Sensing Assurance diagnosticssensitivity settings . . . . . . . . . . . . . . . . . . . . . . 107sensitivity trend

parameters and settings . . . . . . . . . . . . . . . 194sensor, activity

see activity sensorsensor-indicated rate . . . . . . . . . . . . . . . . . . . . . 46Sensor Indicated Rate Profile . . . . . . . . . . . . . . . 171

clearing data . . . . . . . . . . . . . . . . . . . . . . 172data collection . . . . . . . . . . . . . . . . . . . . . 172displaying . . . . . . . . . . . . . . . . . . . . . . . . 172example data . . . . . . . . . . . . . . . . . . . . . 172parameters and settings . . . . . . . . . . . . . . . 193

sensor-varied PVARP . . . . . . . . . . . . . . . . . . . . 61Single Chamber Hysteresis

see HysteresisSinus Preference . . . . . . . . . . . . . . . . . . . . . . 130

interactions . . . . . . . . . . . . . . . . . . . . . . . 133Sleep Function . . . . . . . . . . . . . . . . . . . . . . . 143

considerations . . . . . . . . . . . . . . . . . . . . . 144stimulation threshold tests

Capture Management test . . . . . . . . . . . . . . 104Strength-Duration test . . . . . . . . . . . . . . . . 104

Strength-Duration test . . . . . . . . . . . . . . . . . . . 104Ttarget rate profile . . . . . . . . . . . . . . . . . . . . . . . 31TARP

see Total Atrial Refractory Period (TARP)telemetry

battery . . . . . . . . . . . . . . . . . . . . . . 151, 191establishing . . . . . . . . . . . . . . . . . . . . . . 147Extended Markers . . . . . . . . . . . . 153, 156, 191Extended Telemetry . . . . . . . . . . . . . . . . . 191lead . . . . . . . . . . . . . . . . . . . . . . . . 151, 191Marker Channel . . . . . . . . . . . . . . . . . . . . 153measured . . . . . . . . . . . . . . . . . . . . . . . . 152



parameters . . . . . . . . . . . . . . . . . . . . . . . 147patient data . . . . . . . . . . . . . . . . . . . . . . 192variance . . . . . . . . . . . . . . . . . . . . . . . . 152

temporaryparameters . . . . . . . . . . . . . . . . . . . . . . . 159refractory period . . . . . . . . . . . . . . . . . . . . 159

TherapyGuide . . . . . . . . . . . . . . . . . . . . . . 13, 150programming suggestions . . . . . . . . . . . . . . 151

thresholdautomatic stimulation threshold adaptation . . . 87, 94sensing . . . . . . . . . . . . . . . . . . . . . . . . . 106stimulation threshold tests . . . . . . . . . . . . . . 104

threshold margin test (TMT) . . . . . . . . . . . . . . . . 108TMT

see threshold margin test (TMT)Total Atrial Refractory Period (TARP) . . . . . . . . . . . 64

limits atrial tracking . . . . . . . . . . . . . . . . . . . 68transtelephonic features . . . . . . . . . . . . . . . . . . 108

overview . . . . . . . . . . . . . . . . . . . . . . . . 108threshold margin test (TMT) . . . . . . . . . . . . . 108transtelephonic monitor . . . . . . . . . . . . . . . 110

trendsAtrial Arrhythmia . . . . . . . . . . . . . . . . . . . . 180Capture Management . . . . . . . . . . . . . . . . . 97Lead Impedance Trend (automatic) . . . . . . . . . 78Mode Switch . . . . . . . . . . . . . . . . . . . . . . 116Sensing Assurance . . . . . . . . . . . . . . . . . . 102

trends, diagnostic dataatrial high rate trend . . . . . . . . . . . . . . . . . 180

troubleshootingelectrical problems . . . . . . . . . . . . . . . . . . 185hemodynamic problems . . . . . . . . . . . . . . . 187

Uunipolar pacing

muscle stimulation precaution . . . . . . . . . . . 103myopotentials precaution . . . . . . . . . . . . . . 107

Upper Rate (UR) setpoint . . . . . . . . . . . . . . . . . . 41Upper Sensor Rate . . . . . . . . . . . . . . . . . . . . . . 48Upper Tracking Rate . . . . . . . . . . . . . . . . . . . 47, 48UR setpoint

see Upper Rate (UR) setpointVventricular blanking period . . . . . . . . . . . . . . . . . . 58

after atrial pace . . . . . . . . . . . . . . . . . . . . . 59Ventricular Capture Management . . . . . . . . . . . . . 80

emergency settings . . . . . . . . . . . . . . . . . . 189parameters and settings . . . . . . . . . . . . . . . 194

ventricular high rate diagnosticssee High Rate Detailsee High Rate Episodes

ventricular rate during atrial arrhythmiasparameters and settings . . . . . . . . . . . . . . . 194

ventricular rate histogramsee Heart Rate Histogram

ventricular refractory period . . . . . . . . . . . . . . . . . 65emergency settings . . . . . . . . . . . . . . . . . . 189noise reversion . . . . . . . . . . . . . . . . . . . . . 66

Ventricular Response Pacingsee Conducted AF Response

Ventricular Safety Pacing (VSP) . . . . . . . . . . . . . 129VVT


V-V timing . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43WWenckebach . . . . . . . . . . . . . . . . . . . . . . . . . . 69



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