ADAPTA / VERSA / SENSIA / RELIA™

1 ADAPTA / VERSA / SENSIA / RELIA A family of implantable pulse generatorsPacemaker Reference GuideReference ManualCaution: Federal law (USA) restricts this device to sale by or on the order of a / VERSA / SENSIA / RELIA Reference ManualA reference guide for ADAPTA / VERSA / SENSIA /Relia pacemakersThe 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 , ADAPTA , Capture Management, Intrinsic, Marker Channel, Medtronic, MVP,Quick Look, QuickLink, Relia, SENSIA , TherapyGuide, VersaContents1 Pacing Rationale for mode MVP DDDR DDD DDIR DDI DVIR DVI VDD AAIR / ADIR AAI / ADI VVIR / VDIR VVI / VDI AAT / VVT DOOR / AOOR / VOOR DOO / AOO / VOO ODO / OAO / OVO Rate Introduction to rate responsive Preset rate response at Rate Profile Optimization Individualizing Rate Profile Activity sensor Manual control of Rate Profile / VERSA / SENSIA / RELIA Reference Manual54 Pacemaker AV Rate Adaptive Search AV+ and Blanking Refractory High rate atrial Lead/cardiac tissue

2 Implant Automatic polarity Lead Lead impedance Capture Management and Sensing Assurance and Manually selecting pacing Manually selecting sensing Transtelephonic follow-up Special therapy Mode Switch and Managed Ventricular Pacing (MVP).. Conducted AF Non-competitive atrial PMT PVC Ventricular Safety Sinus Atrial Preference Rate Drop Response and Sleep Single Chamber Telemetry Establishing / VERSA / SENSIA / RELIA 6 Reference Parameter Patient Using TherapyGuide to select parameter Battery and lead Marker Channel Intracardiac Extended Miscellaneous Magnet mode Temporary Electrical Recommended Replacement Time (RRT/ERI).

3 Emergency Introduction to Heart Rate AV Conduction Search AV+ Sensor Indicated Rate High Rate Ventricular Rate Histogram During Atrial Atrial Arrhythmia Atrial Arrhythmia Custom Rate Key Parameter Troubleshooting the pacing Troubleshooting the pacing Troubleshooting electrical Troubleshooting hemodynamic Emergency Emergency / VERSA / SENSIA / RELIA Reference Manual7B Telemetry and diagnostic Magnet Mode Telemetry Automatic Clinician-selectable Cardiac event Rate Response programming Rate Response programming Patient Patient counseling

4 / VERSA / SENSIA / RELIA 8 Reference Manual1 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 How to use this guideProduct information about ADAPTA / VERSA / SENSIA /Relia pacemakers and the associatedsoftware for the programmer is presented in two separate Pacemaker Reference Guide (PRG) provides detailed information on the Pacemaker Programming Guide (PPG)

5 Contains instructions on how to use theprogrammer and the programming / VERSA / SENSIA / RELIA Reference 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, andmechanical and electrical specifications.

6 Provides general warnings and cautions, potential interference sources, and generalindications for pacing. Contains a glossary of 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, andproperly 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 viewthis information. How to measure stimulation thresholds and sensing levels.

7 How to use TherapyGuide to obtain suggested parameter values. How to program parameter values and verify rate response parameters settings. How to run EP 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 / VERSA / SENSIA / RELIA 10 Reference Manual2 Pacing Pacing mode selectionThis chapter provides an introduction to pacemaker modes as an aid to pacing modeselection.

8 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 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 descriptions These descriptions provide indications and contraindications formodes available with the pacemaker and brief descriptions of how these modes NBG pacing codesThe pacemaker modes are defined in NBG Each five-letter NBG code describes aspecific type of operation for implantable pacemakers.

9 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 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: 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.)

10 NBG s five-letter code supersedes the ICHD / VERSA / SENSIA / RELIA Reference Manual11 Figure 1. NBG pacing codesChamber PacedChamber SensedMode of ResponseProgrammable/Rate ResponseDDDRV = VentricleA = AtriumD = Dual ChamberS = Single ChamberO = NoneT = TriggeredI = InhibitedD = Double (both)O = NoneV = VentricleA = AtriumD = Dual ChamberS = Single ChamberO = NoneP = ProgrammableM = MultiprogrammableC = CommunicatingR = Rate ResponsiveO = 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 , Rate response , page 28, Chapter 4, Pacemaker timing , page 43, and Chapter 6, Special therapy options , page / VERSA / SENSIA / RELIA 12 Reference Rationale for mode selectionTherapyGuide offers a simple clinically-focused method for a clinician to obtain suggestedparameter values.