Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) m1bfile10/WW1/Techcom/Department/ElecPub/TempXchg.EP/CD-Rom files/Finished/EN/Priority 3/196407001B_view.pdf 1 PROGRA M M ER Pacemaker Information and Programming Guide 9879E Software Use to program the following pacemakers: PRODIGY ™ DR PRODIGY ™ D PRODIGY ™ VDD PRODIGY ™ SR PRODIGY ™ S 196407001 Rev A Refer to the “Reference man.” category in doc#163256 for Printing Instructions.
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) CAUTION: The Prodigy™ VDD pacemaker is not currently approved by the FDA. 196407001 Rev A Refer to the “Reference man.” category in doc#163256 for Printing Instructions.
Medtronic Confidential 9879EN-TOC_9501043EN/CTC.qxd 5/10/99 11:49 Page i 7 x 9 inches (178 mm x 229 mm) Medtronic® PRODIGY™ Pacemaker Information And Programming Guide A Guide To Understanding Prodigy™ Pacemakers And Using The 9760 and 9790 Programmers © Medtronic, Inc. 1995 All Rights Reserved Printed In USA 196407001 Rev A Refer to the “Reference man.” category in doc#163256 for Printing Instructions.
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) 196407001 Rev A Refer to the “Reference man.” category in doc#163256 for Printing Instructions.
9879EN-TOC_9501043EN/CTC.qxd 5/10/99 11:49 Page iii Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) How To Use This Guide The 9879 Pacemaker Information and Programming Guide is the reference manual of the two-manual set supporting Prodigy* pacemakers. Each Prodigy pacemaker also has its own product information manual packaged with the device. This guide provides comprehensive information about the Prodigy pacing system: Medtronic® Prodigy pacemakers, 9760 and 9790 Programmers, and leads.
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) 196407001 Rev A Refer to the “Reference man.” category in doc#163256 for Printing Instructions.
Medtronic Confidential 9879EN-TOC_9501043EN/CTC.qxd 5/10/99 11:49 Page v 7 x 9 inches (178 mm x 229 mm) Table of Contents Part I Using the Programmer Chapter 1 - Using the Programmer with Prodigy™ Pacemakers 1-1 When to Use Part I of this Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2 Conventions Used in Part I of this Manual. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3 General Warnings and Precautions . . . . . . . . . . . . . . . . . . . . . . . . .
Medtronic Confidential 9879EN-TOC_9501043EN/CTC.qxd 5/10/99 11:49 Page vi 7 x 9 inches (178 mm x 229 mm) Freezing the ECG Trace . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-10 Displaying a Marker Channel™ Diagram . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-14 Chapter 6 - Programming Pacing Parameters 6-1 Programming Pacing Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2 Programming Additional Parameters. . .
Medtronic Confidential 9879EN-TOC_9501043EN/CTC.qxd 5/10/99 11:49 Page vii 7 x 9 inches (178 mm x 229 mm) DDIR Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-12 DDI Mode. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-14 DVIR Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-16 DVI Mode. . . . . . . . . . . . . . . . . . . . . . . . . .
Medtronic Confidential 9879EN-TOC_9501043EN/CTC.qxd 5/10/99 11:49 Page viii 7 x 9 inches (178 mm x 229 mm) Chapter 15 - Telemetry Data 15-1 Parameter Summary. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15-2 Battery and Lead Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15-4 Marker Channel™ Telemetry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15-6 Intracardiac Electrogram (EGM). . . . .
Medtronic Confidential 9879EN-TOC_9501043EN/CTC.qxd 5/10/99 11:49 Page ix 7 x 9 inches (178 mm x 229 mm) Section B - Shipping, Nominal, Electrical Reset, and Emergency Parameters Shipping Parameter Settings . . . . . Nominal Parameter Settings. . . . . . Electrical Reset Parameter Settings Emergency Parameter Settings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-1 . . . . . . . . . . . .
9879EN-TOC_9501043EN/CTC.qxd 5/10/99 11:49 Page x Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) Section G - Hospital, Medical, Home, and Job Environment Interference G-1 Hospital or Medical Environment Interference . . . . . . . . . . . . . . . . . . . . . . . . . . G-2 Home and Job Environment Interference . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . G-5 General Recommendations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Medtronic Confidential 9879EN-I-T_9501043EN/CTC.qxd 5/10/99 11:44 Page I-1 7 x 9 inches (178 mm x 229 mm) PART I USING THE PROGRAMMER Part I provides instructions for using the programmer with Prodigy pacemakers. Sections describe each of the applicable programmer functions and present step-by-step procedures for using these functions. The information in this section is organized in the following order.
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) 196407001 Rev A Refer to the “Reference man.” category in doc#163256 for Printing Instructions.
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) CHAPTER 1 Using the Programmer with Prodigy™ Pacemakers About This Chapter This chapter introduces you to using the 9760 and 9790 programmers with the Prodigy™ family of pacemakers by providing the following information: When to use Part I of this manual (see page 1-2). The text format conventions used in Part I of this manual (see page 1-3). General warnings and precautions (see page 1-4).
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) 1-2 Using the Programmer When to Use Part I of this Manual Installation of the 9879E software adds several pacemaker family groups to the programming and follow-up capabilities of your 9760 or 9790 programmer. Several manuals now cover the use of your programmer, each covering a specific set of pacemaker families and models.
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) Using the Programmer with Prodigy™ Pacemakers 1-3 Conventions Used in Part I of this Manual Part I uses the following text format conventions in the instructions for using the programmer. [INTERROGATE] Boldface small capitals within brackets denote an on-screen button. THRESHOLD TEST Boldface capitals without brackets denote a selectable screen option other than a button. 1., 2., 3.
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) 1-4 Using the Programmer General Warnings and Precautions These warnings and precautions apply in general to using the 9760 and 9790 programmers. Warnings Pacemaker programming should be done only after careful study of the pacemaker technical manual and the applicable portions of this manual and after careful determination of appropriate parameter settings.
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) Using the Programmer with Prodigy™ Pacemakers 1-5 Display Screen Format and Interactive Features This section describes the appearance of the programmer display screen and the scheme for selecting a function when you have selected one of the model groups from the Prodigy family of pacemakers. Display Screen Example Below is an example of the screen format you will see when you use the programmer with a Prodigy pacemaker.
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) 1-6 Using the Programmer ECG Display — This box continuously displays a low-resolution trace of the patient’s ECG. Function Display Area — This area of the screen changes according to the selected function. It displays the data, buttons, and options that apply to the selected function. Command Buttons — Location of the [EMERGENCY], [CANCEL MAGNET], [INTERROGATE], and [PROGRAM] buttons is the same for all pacemaker applications.
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) Using the Programmer with Prodigy™ Pacemakers 1-7 To select an option: Without touching the screen, move the tip of the selector pen to a position directly over any part of the boldface option label (may be a word or number); then press the pen against the screen. Audible Signals Certain events in the operation of the programmer will result in an audible signal of one or two tones, or “beeps.
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) 1-8 Using the Programmer A Guide to Using the Menu and Command Buttons Using the Menu Buttons Except for [END SESSION] and [FREEZE], selecting a menu button at the top of the screen displays a menu of related function options. A check mark (ê) next to a displayed option (see example at right) indicates that option is currently selected.
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) Using the Programmer with Prodigy™ Pacemakers 1-9 Measuring rate and AV interval. Conducting electrophysiologic studies if 9877A software is installed. Instructions are covered in a supplement supplied with the software. PARAMETERS Programming Parameter Settings — See Chapter 6. Selecting the [PARAMETERS] menu button displays options for: Programming pacing parameters and viewing present settings.
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) 1-10 Using the Programmer Using the Command Buttons Listed below is a description of each of the command buttons located at the bottom of the display screen. Refer to the listed chapter for the procedure associated with using a particular command button. Programming Emergency Parameters — See Chapter 2.
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) CHAPTER 2 Procedures to Know Before You Begin About This Chapter This chapter covers some procedures that you might use at any point during a patient session. You should be familiar with these procedures before you begin a patient session. These procedures include: Using the programming head (see page 2-2). Programming Emergency parameters (see page 2-6). Interrogating the pacemaker (see page 2-7).
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) 2-2 Using the Programmer Using the Programming Head In many of the procedures described in the following chapters, you will be directed to position the programming head over the patient’s pacemaker. Always position the programming head prior to executing any command that results in a programming or telemetry interaction between the programmer and the pacemaker.
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) Procedures to Know Before You Begin 2-3 NOTE: Both programmers also have a programming head position indicator light located near the display screen: On the 9760 programmer, this indicator light is located above the upper right corner of the screen. This indicator light goes out when a telemetry link with the pacemaker has been established. On the 9790 programmer, the indicator light is located near the upper left corner of the screen.
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) 2-4 Using the Programmer 9760 Programmer If you are using a 9760 Programmer, the default setting for the Assist function is Normal. That is, the Assist function will not be in effect when you start a patient session. If you have trouble receiving telemetry or obtaining a programming confirmation, enabling the Assist function can facilitate locating a proper programming head position.
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) Procedures to Know Before You Begin 2-5 Using PROGRAM and INTERROGATE Keys The PROGRAM and INTERROGATE keys on the programming head have the same function as the [PROGRAM] and [INTERROGATE] buttons that appear on the display screen. Whenever the instructions in this manual direct you to select the [PROGRAM] or [INTERROGATE] button on the screen, you can press the corresponding key on the programming head instead, if it is more convenient.
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) 2-6 Using the Programmer Programming Emergency Parameters The Emergency programming command is a safety feature that overrides all other functions and immediately programs the pacemaker to preset emergency values intended to provide pacing support under a variety of conditions. This programming cancels any temporary function in effect and restores magnet mode operation.
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) Procedures to Know Before You Begin 2-7 Interrogating the Pacemaker Before the programmer can display any information about the status of the patient’s pacing system, you must interrogate the pacemaker. The information you can retrieve by interrogating the pacemaker falls into three categories: 1. 2. 3. Parameter settings Real-time measurements of battery and lead data Diagnostic data.
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) 2-8 Using the Programmer NOTE: Executing an Interrogate All command automatically saves the present programmed parameter settings. From a parameter programming screen, you can view the saved values applicable to that screen (select the [SHOW SAVED] button) or you can recall the values to the screen as pending values for programming (select the [SAVE/NOMINAL OPTIONS...] button, then select the [SAVED VALUES] button).
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) Procedures to Know Before You Begin 2-9 Canceling the Programming Head Magnet “Cancel Magnet” is a temporary programming command that cancels the effect of the programming head magnet. It allows the pacemaker to operate in its permanently programmed mode (such as the DDD mode) while the programming head is held in position.
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) 2-10 Using the Programmer Printing Reports During a Patient Session The [PRINT] menu button lets you select and print various reports of the data generated during a patient session. Most data is temporarily stored for the duration of the patient session and can be printed at any time during the patient session. However, some types of data, particularly graphic data, must be printed while it is displayed on the screen.
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) Procedures to Know Before You Begin 2-11 Data Summary — Selecting this option prints a summary of the interrogated data. Included are the event data accumulated since the last patient session. Battery/Lead Data — Selecting this option initiates a printout of the real-time measurements associated with the Battery/Lead data function. Diagnostics Data Table — This option prints the recorded Diagnostic data in tabular form.
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) 2-12 Using the Programmer Automatic Printing with the Printer Trace Mode To turn the printer Trace mode ON or OFF: 1. Select TRACE ... from the Print menu options. 2. From the Trace window, select [TRACE MODE ON] or [TRACE MODE OFF] as desired. 3. Select [EXIT] to close the window. Turning the Trace mode on causes the printer to automatically print information as it is generated during a patient session.
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) Procedures to Know Before You Begin 2-13 Printing Reports After a Session Has Ended CAUTION: Selecting a pacemaker model to begin a new patient session or turning the programmer off will clear all data accumulated in programmer memory from the last patient session. Procedure Once you have ended a patient session, but before you select a new pacemaker model or turn the programmer off, you can print the reports accumulated during that session.
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) 2-14 Using the Programmer To save the data reports to a diskette: 1. Select the [PRINT...] button on the Automatic Model Select screen. NOTE: This button appears only if there is data present from the previous patient session. 2. From the options displayed, select the [DATA TRANSFER TO DISK] button, which displays the window shown below.
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) Procedures to Know Before You Begin 2-15 NOTE: Do not select a pacemaker model or remove the diskette until the file transfer process is complete. The message box will state when data has been successfully transferred. 6. To remove the diskette, press the small, rectangular eject button near the disk drive opening.
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) 2-16 Using the Programmer Using the HELP Options Selecting the [HELP] Menu button displays options for viewing information about using the programmer. You can select the [HELP] button at any time during the patient session. Help Options Selecting one of these Help options opens a text window of pertinent information: Current Screen — Information about the function screen that is presently displayed.
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) CHAPTER 3 Starting and Ending a Patient Session About This Chapter This chapter describes how to start a patient session, which involves: Verifying the programmer setup and turning the programmer on (see pages 3-2 and 3-3). Selecting the pacemaker model (see page 3-4). Using the menu buttons to proceed to a desired function (see page 3-7). This chapter also describes how to properly end a patient session (see page 3-9).
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) 3-2 Using the Programmer Before You Begin Prior to using the programmer in a patient session, verify that the programmer is properly set up. Refer to Chapters 2 and 3 in the “Programmer Description and Setup” guide supplied with your 9760 or 9790 programmer for detailed instructions on setting up the programmer and preparing for a patient session. Programmer Setup Checklist Verify that the following components are properly connected: 1.
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) Starting and Ending a Patient Session 3-3 Turning the Programmer ON Procedure If the programmer is not operating, turn it on by pressing inward on the top of the power switch. 9760 programmer: The power switch is located on the right side next to the power cord. 9790 programmer: The power switch is located on the left side near the back of the programmer.
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) 3-4 Using the Programmer Selecting the Pacemaker Model The procedure for starting a patient session begins at the Automatic Model Select screen shown in the example below. This screen appears after you turn the programmer on as described in the previous section (or after you select the [END SESSION] button to end a patient session). To start a patient session, you must select the appropriate pacemaker model.
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) Starting and Ending a Patient Session 3-5 Automatic Model Selection To use the automatic model selection feature: 1. Position the programming head over the patient’s pacemaker. 2. Select the [AUTOMATIC MODEL SELECT] button on the screen or the INTERROGATE key on the programming head. NOTE: It is not necessary to select the applicable chamber.
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) 3-6 Using the Programmer NOTE: It is not necessary to select the applicable chamber. The [ATRIUM] and [VENTRICLE] buttons on the Manual Model Select screen do not apply to Prodigy pacemakers. Selecting the pacemaker model initiates loading of the appropriate application program. This process may take up to 15 seconds. Display of the Pacing Parameters screen (see next section) indicates that model selection is complete and you may proceed.
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) Starting and Ending a Patient Session 3-7 Selecting the Desired Function Selecting the pacemaker model displays the Pacing Parameters screen shown in the example below. This screen allows you to: View the present pacing parameter settings (see Chapter 4). Program new pacing parameter settings (see Chapter 6). Proceed to another function.
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) 3-8 Using the Programmer Menu Button Description and Chapter Reference Possible Options DATA Select this button to display options for viewing data retrieved from the pacemaker by interrogation, including: a pacing data summary, battery and lead information, and a graph of Diagnostic data. Refer to Chapter 4.
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) Starting and Ending a Patient Session 3-9 Ending a Patient Session The programmer accumulates and temporarily stores certain data generated during a patient session. This data facilitates parameter programming and provides for the display of session-related information. It is important to properly end each patient session so that this data will clear from programmer memory when you select a pacemaker model to begin a new patient session.
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) 196407001 Rev A Refer to the “Reference man.” category in doc#163256 for Printing Instructions.
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) CHAPTER 4 Retrieving Pacing System Data About This Chapter This chapter describes how you can display information retrieved from the pacemaker by interrogation. You can use the four procedures presented in this chapter to display the following pacemaker information: The present programmed parameter settings (see page 4-2). A summary of battery and lead status and the programmed status of the Diagnostics function.
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) 4-2 Using the Programmer Displaying Present Parameter Settings You can quickly display the parameter settings to which the patient’s pacemaker is programmed by selecting the appropriate parameter screen. There are three such screens: 1) The Pacing Parameters screen, 2) The Diagnostic Parameters screen, and 3) The Additional Parameters screen.
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) Retrieving Pacing System Data 4-3 A Note About Mode Switch — The subordinate parameter Detect Rate associated with programming Mode Switch does not show on the Pacing Parameters screen. To view the setting of this parameter, select Mode Switch to open its value window. If Mode Switch is set to ON, the present value for Detect Rate will show in the Mode Switch value window.
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) 4-4 Using the Programmer Displaying Additional Parameters Settings The Additional Parameters screen displays the present settings for the following parameters and provides access to the Status Reset command.
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) Retrieving Pacing System Data 4-5 Displaying a Summary of Pacemaker Status You can display a summary of pacemaker battery and lead status and the programmed status of the Diagnostics function by selecting the Data Summary screen. This screen includes a display of certain event data automatically accumulated by the pacemaker since the last patient session.
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) 4-6 Using the Programmer Battery/Lead This section of the screen includes a summary of pacemaker battery and lead status. Estimated Time to Replacement “Estimated Time to Replacement” is a calculated estimate of the time (in months) remaining until pacemaker replacement will be required.
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) Retrieving Pacing System Data 4-7 Event Summary Data Event Summary is a non-programmable pacemaker function that operates continuously to collect the data described below. You can view this event data only on the Data Summary screen and the Data Summary printout. Event Summary shows data collected since the last patient session.
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) 4-8 Using the Programmer PVCs If the pacemaker has been operating in a dual chamber mode, Event Summary displays the counted number of PVC “singles” and “runs.” A PVC (premature ventricular contraction) is defined by the pacemaker as a ventricular sense that follows a ventricular pace or sense without an intervening atrial pace, atrial sense, or atrial refractory sense. Singles — Show the number of singly-occurring PVCs.
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) Retrieving Pacing System Data 4-9 Displaying Battery and Lead Information By selecting the Battery/Lead screen, you can display information about the pacemaker battery and lead system based on real-time measurements and calculations made at the time of pacemaker interrogation. This information provides a detailed status of the pacemaker battery and the output conditions pertaining to the pacing lead system.
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) 4-10 Using the Programmer NOTE: During the measurement process, the pacemaker paces at 100 ppm for several beats. (During these beats in a dual chamber mode, the AV interval will be 100 ms.) Parameter Measurements The Battery/Lead screen displays a battery status message and real-time measurements and calculations for the pacemaker parameters listed below.
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) Retrieving Pacing System Data 4-11 Select the [MORE INFO] button for information about estimated time to replacement and the estimated maximum, average, and minimum values. IMPORTANT: Elective pacemaker replacement should not be based on the estimated time to replacement. For this decision, use only the elective replacement indicators or the battery status “Replace Pacer” message.
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) 4-12 Using the Programmer Displaying a Graph of Recorded Diagnostic Data If the pacemaker has been previously programmed to record data for the Diagnostics function, a graph of the data collected to date may be viewed by selecting a Data option as described below. You can also display this graph from the Diagnostic Parameters screen (see Chapter 8) or from the Data Summary screen (see page 4-5).
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) CHAPTER 5 Displaying and Printing the Patient’s ECG and EGM About This Chapter The procedures presented in this chapter describe using the programmer’s ECG display and recording functions. The procedures describe: How to print a real-time recording of the patient’s ECG accompanied by traces of Marker Channel™ and EGM telemetry (see page 5-2).
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) 5-2 Using the Programmer Printing the Patient’s ECG and EGM At any time during a patient session, you can initiate a continuous, real-time recording of the patient’s ECG as described below. Procedure The procedure is slightly different depending on whether you are operating a 9760 or 9790 programmer. NOTE: Step 1 will interrupt any report being printed.
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) Displaying and Printing the Patient’s ECG and EGM 5-3 Annotations ECG Marker Telemetry EGM Telemetry ECG Printout Example with Markers and EGM (9760 Programmer Recording) About the Recording Annotation of Executed Commands — Information on the ECG printout includes an indication of when certain commands to the pacemaker occurred.
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) 5-4 Using the Programmer Missing Markers — A programming command or interrogation momentarily interrupts the transmission of Marker Channel telemetry. This interruption can result in missing markers. The point at which the command occurred is marked above the ECG trace by a “down” and/or “up” arrow. The down arrow (W) indicates a transmitted command from the programmer; the up arrow (V) indicates a telemetry response from the pacemaker.
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) Displaying and Printing the Patient’s ECG and EGM 5-5 Displaying the Patient’s ECG and EGM By selecting the ECG/Markers/EGM screen, you can display a high resolution view of the patient’s ECG. The ECG will be accompanied by a trace of Marker Channel telemetry and EGM telemetry if such telemetry is being received from the pacemaker. This screen provides waveform trace adjustment controls and an option for inhibiting pacemaker output.
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) 5-6 Using the Programmer Adjusting the ECG and EGM Traces The control buttons at the left of the trace display (see below) let you adjust the displayed ECG and EGM. To make an adjustment: 1. Select the appropriate button (see descriptions below). 2. Select the desired option from the displayed window of options. Select to choose a different ECG Lead configuration. Options: Lead I, Lead II, Lead III (Lead II is the default setting.
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) Displaying and Printing the Patient’s ECG and EGM 5-7 Programming the Trace Telemetry Type Default Telemetry — Positioning the programming head over the patient’s pacemaker automatically causes the pacemaker to transmit both Marker telemetry and EGM telemetry (atrial EGM for dual chamber modes). The combination of Marker telemetry and EGM telemetry is displayed in the examples on pages 5-3 and 5-5.
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) 5-8 Using the Programmer More About Marker Channel™ Telemetry NOTE: An interrogation or programming command momentarily interrupts Marker Channel telemetry. If this interruption occurs at the moment a marker is scheduled, the marker is not displayed. MARKER Telemetry — A trace of Marker telemetry depicts pacemaker operation by showing Pace, Sense, and Refractory Sense events as they occur within the pacemaker.
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) Displaying and Printing the Patient’s ECG and EGM 5-9 Inhibiting Pacemaker Output INHIBIT This button, which also appears on other screens that show the ECG/Markers/EGM display, lets you temporarily stop the pacing output of the patient’s pacemaker for such purposes as observing the underlying rhythm. CAUTION: The Inhibit function is intended for diagnostic and test purposes.
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) 5-10 Using the Programmer Freezing the ECG Trace At any time during a patient session, you can freeze and display 10 seconds of the patient’s ECG and the accompanying telemetry traces. On-screen calipers let you accurately measure time intervals on these traces. Selecting the FREEZE Button To freeze and display a 10-second segment of the ECG and telemetry trace, select the [FREEZE] menu button as shown below.
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) Displaying and Printing the Patient’s ECG and EGM 5-11 Selecting a Freeze Option FRZ OPTION... Timing of the 10-second window during which ECG and telemetry signals are frozen depends on the present Freeze Option setting. Procedure — To change the present Freeze Option: 1. Select the [FRZ OPTION...] button to display the options and the present setting. 2. Select the desired timing option (see below).
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) 5-12 Using the Programmer Adjusting the Trace Displays The control buttons at the left of the trace display let you individually adjust the magnification of the frozen ECG and EGM waveforms and change the time scale of trace display. To make an adjustment: 1. Select the appropriate button (see below) to display a window of options. 2. Select the desired option from the displayed window.
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) Displaying and Printing the Patient’s ECG and EGM 5-13 Using the On-Screen Calipers The position and scroll buttons below the trace display let you control the position of two vertical cursors appearing on the trace display. With these controls, you can use the cursors as on-screen calipers to measure the time interval between events on the displayed traces.
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) 5-14 Using the Programmer Displaying a Marker Channel™ Diagram If the selected pacemaker is a Prodigy DR, Prodigy D, or Prodigy VDD model, the Freeze screen includes the [SHOW DIAGRAM] button as shown in the example on page 5-10. Under the proper conditions (see NOTE below), selecting this button displays a Marker Channel Diagram.
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) Displaying and Printing the Patient’s ECG and EGM 5-15 About the Marker Channel™ Diagram The Marker Channel Diagram (see example below) shows more details of pacemaker operation by depicting the various timing intervals, including blanking and refractory periods. The diagram is intended to further clarify operation of the pacemaker and simplify analysis of the patient’s ECG.
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) 5-16 Using the Programmer The printout lists the present parameter settings on which the diagram is based and includes definitions of the lines, labels, and symbols used in the diagram. Interpreting the Diagram Each Marker Channel Diagram is formed by a series of lines and symbols that depict pacemaker operation. The pacing mode in effect is printed above the ECG trace at the top of the chart.
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) Displaying and Printing the Patient’s ECG and EGM P R 5-17 Blanking and Refractory Periods — Rectangles on the A and V baselines depict atrial and ventricular blanking and refractory periods. S Solid Rectangles — Depict blanking periods. S S Open Rectangles — Depict refractory periods. Vertical lines appearing within the rectangle mark the timing of sense or pace events occurring in the opposite chamber.
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) 5-18 Using the Programmer If an error message appears, you should reposition the programming head and freeze another 10-second trace segment to obtain a new Marker Channel Diagram. NOTE: A Marker Channel Diagram cannot be displayed if an interrogation or programming transmission occurred during the 10-second interval of the frozen trace. Below is an explanation of the messages that indicate an error condition.
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) CHAPTER 6 Programming Pacing Parameters About This Chapter This chapter describes the following programming procedures: How to program the permanent pacing parameters controlling operation of the patient’s pacemaker. This procedure is conducted from the Pacing Parameters screen (see page 6-2). How to program nominal and saved parameter values (see page 6-6).
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) 6-2 Using the Programmer Programming Pacing Parameters To program changes to the permanent pacing parameters, begin by selecting the Pacing Parameters screen. This screen displays the present parameter settings and lets you select the parameters and values to be programmed.
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) Programming Pacing Parameters 6-3 Features of the Pacing Parameters Screen Parameter Display — Following an interrogation, the screen shows the present pacing parameter settings. The screen displays only those parameters that are applicable to the selected pacemaker model and pertinent to the present pacing mode. Note that the parameters are divided into labeled groups according to their general function.
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) 6-4 Using the Programmer DDIR Parameter Interaction — If you select a restricted parameter value, the display will indicate the interacting parameter values by displaying the values in reverse video. You must select new values to resolve the conflict before programming is allowed.
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) Programming Pacing Parameters 3. 6-5 Repeat steps 1 and 2 to include any other parameters you want to program. NOTE: If you try to exit the screen before you program the selected values, a pop-up window will provide the option to continue with this procedure or clear the pending values and exit the screen. 4. Position the programming head and select [PROGRAM]. Select the [PROGRAM] button to program all pending parameter values.
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) 6-6 Using the Programmer Programming Nominal and Saved Values The procedures below describe using the options available by selecting the [SAVE/NOMINAL OPTIONS...] button. Programming Medtronic or Site Nominal Values To recall Medtronic nominal settings (“Medtronic Values”) or Site Nominal settings to the screen as pending values for programming: 1. Select the [SAVE/NOMINAL OPTIONS...] button. 2.
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) Programming Pacing Parameters 6-7 Programming Additional Parameters Additional parameters include the Transtelephonic Monitor and Extended Telemetry follow-up options, the pacemaker Serial Number, and the Status Reset command. To access these parameter options, select the Additional Parameters screen.
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) 6-8 Using the Programmer Programming Transtelephonic Monitor Transtelephonic Monitor is a feature that can facilitate using transtelephonic monitoring during a remote patient follow-up procedure. The programmable options for this feature are ON and OFF. Refer to “Enhanced Transtelephonic Monitoring” in Chapter 13 for an explanation of this feature.
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) Programming Pacing Parameters 6-9 Programming the Status Reset Command For information about the Elective Replacement Indicator (ERI) or about Electrical Reset, refer to the respective sections in Chapter 16. Verifying or Clearing an ERI Status If a screen message indicates that the pacemaker Elective Replacement Indicator (ERI) has been set, you can use the Status Reset command to verify present battery status as follows: 1.
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) 6-10 Using the Programmer Programming the Pacemaker Serial Number Serial number programming should not be used to change the factory setting. This procedure is intended only for reprogramming the original serial number in the unlikely event it is lost from pacemaker memory due to a pacemaker electrical reset (see previous section about programming the Reset command). To reprogram pacemaker serial number: 196407001 Rev A 1.
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) CHAPTER 7 Determining and Evaluating Parameter Settings About This Chapter Capabilities of the programmer include test and measurement functions that can assist you in determining appropriate parameter values for programming the pacemaker or optimizing its operation. This chapter covers the following test procedures. Measuring the patient’s stimulation threshold to determine appropriate values for amplitude and pulse width (see page 7-2).
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) 7-2 Using the Programmer Measuring Stimulation Thresholds The Threshold Test function lets you measure the patient’s stimulation thresholds to determine appropriate settings for amplitude and pulse width. This measurement procedure begins at the Threshold Test Start screen.
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) Determining and Evaluating Parameter Settings 7-3 Threshold Test Options The first two steps in the procedure for conducting a threshold test are to select a test chamber/mode option (when applicable) and to select the desired threshold test type. The buttons for these options appear below the waveform display on the Threshold Test Start screen. Chamber/Mode Selection The chamber/mode options that appear depend on the present permanent pacing mode.
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) 7-4 Using the Programmer [MANUAL THRESHOLD] — Select this test to manually select and test specific values for amplitude and pulse width. Automatic value reduction is not used in this test. Only the selected values are tested while you press and hold the [PROGRAM] button. [INHIBIT PACING] — This button is available on the Threshold Test Start screen as a convenience option.
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) Determining and Evaluating Parameter Settings 7-5 test value before it automatically reduces the test value. As described in the test procedures that follow, you can adjust the number of pacing cycles (labeled “Pulses Per Decrement”) from 3 to 15 as desired. A value should be chosen that allows adequate time to evaluate the patient’s ECG to determine whether or not capture is maintained or lost.
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) 7-6 Using the Programmer B. Measuring the Amplitude Threshold Execution of step 2 on the previous page displays the threshold test parameter setup options as shown in this example. 1. Use the [∧ ∧] and [∨ ∨] buttons to adjust each of the parameter values to the desired test setting. Lower Rate — Adjust to a value high enough to effect consistent pacing. Loss of capture cannot be determined if the pacemaker is inhibited.
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) Determining and Evaluating Parameter Settings 7-7 This action restores permanent parameter values and displays the threshold amplitude, which is one programmable amplitude step greater than the ending test value. If the “Ending” test value is not the point at which capture was lost, you can use the [∧ ∧] and [∨ ∨] buttons to adjust the displayed threshold value. C. Measuring the Pulse Width Threshold 1.
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) 7-8 Using the Programmer NOTE: A message stating that the test results are invalid may indicate that the patient’s thresholds are too high to be used in the computation of a strength-duration curve or that product of the threshold amplitude and pulse width values for both tests (Part B and Part C) are the same (they must be different for computation of the strength-duration curve).
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) Determining and Evaluating Parameter Settings 7-9 About the Safety Margin Curves — The solid, curved lines appearing above the strength-duration curve indicate the combination of amplitude and pulse width values that provide a safety margin of two times the amplitude threshold (2X) and three times the amplitude threshold (3X). The 3X curve may not be displayed in cases where the patient has relatively high thresholds.
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) 7-10 Using the Programmer Estimated Time to Replacement The “Estimated Time to Replacement” is a calculated estimate of the average time (in months) remaining until pacemaker replacement will be required. This calculated estimate is based on the pending values selected for programming as well as data accumulated by the pacemaker since the previous patient session.
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) Determining and Evaluating Parameter Settings 7-11 Conducting an Auto Amplitude or Auto Pulse Width Threshold Test Use this procedure to measure the patient’s threshold using either amplitude or pulse width. This procedure begins at the Threshold Test Start screen (see page 7-2). 1. If the permanent pacing mode is a dual chamber mode, select the desired “chamber/mode” button — [Atrial/DDD] for example. 2.
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) 7-12 Using the Programmer Pulses Per Decrement — Adjust to the number of pacing cycles you want to occur at each test value before reduction occurs (see page 7-4). 4. Position the programming head and hold it steady in position for the remainder of this procedure. Observe that Marker telemetry appears below the ECG trace. 5. Press and hold [PROGRAM] to execute the threshold test.
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) Determining and Evaluating Parameter Settings 7-13 To save the test results for printing, select [RETURN TO START] to return to the Threshold Test Start screen, or select a menu button to exit this function. Conducting a Manual Threshold Test Use this procedure to determine the patient’s threshold by manually testing various parameter settings. This procedure begins at the Threshold Test Start screen (see page 7-2). 1.
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) 7-14 Using the Programmer NOTE: Programmed test values are not saved for printing unless you select the [SAVE TEST VALUES] button on the test parameter setup screen. If you want to save a set of tested values, select this button after you release the [PROGRAM] button. 7. To end the test and return to the Threshold Test Start screen, select [RETURN TO START], or select a menu button to exit the Threshold Test function.
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) Determining and Evaluating Parameter Settings 7-15 Determining a Setting for Sensitivity The Sensing Test can assist you in determining an appropriate setting for pacemaker sensitivity. This test measures and reports the present level of R-wave or P-wave sensing and includes the option for selecting and programming a permanent sensitivity value based on the test results.
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) 7-16 Using the Programmer Before You Begin the Test Procedure About the Sensing Test During execution of the Sensing test, the pacemaker automatically determines whether or not sensing occurs at each of up to four sensitivity settings above the selected test value. The selected test values are in effect only while the [PROGRAM] button is pressed and held.
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) Determining and Evaluating Parameter Settings 7-17 Determining the Patient’s Intrinsic Rate To properly conduct the Sensing test, it is helpful to know the rate of the patient’s intrinsic rhythm. To evaluate the patient’s intrinsic rhythm and determine its rate, use the Inhibit function as described on page 5-9. The Inhibit function is accessible via the [INHIBIT PACING] button on the Sensing Test Setup screen.
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) 7-18 Using the Programmer Sensed/Paced AV Interval — If the test mode is DDD, adjust this interval to a value long enough to accommodate normal conduction. (The selected value also applies to the Paced AV interval during execution of the test.) Sensitivity — Select a sensitivity value that provides consistent sensing. This setting can typically be left at the present permanent value. 3.
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) Determining and Evaluating Parameter Settings 7-19 Test Successful The results of a successfully executed test displays the P-wave or R-wave amplitude as being between two sensitivity settings. This information can be used to determine an appropriate permanent sensitivity setting. To program a permanent Sensitivity setting: 1. Use the [∧ ∧] or [∨ ∨] buttons to select a desired pending value.
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) 7-20 Using the Programmer To verify the test results in this case, it is recommended that you: 1. Return to the Test Setup screen (select [RETURN TO SETUP]). 2. Select a lower test value for sensitivity. 3. Repeat the test starting at step 3. Sense Markers Not Present — If telemetered Sense markers (AS or VS) are not present at the start of the Sensing test, the test will automatically terminate.
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) Determining and Evaluating Parameter Settings 7-21 Determining Rate Response Parameter Settings As part of the process of programming a rate responsive pacing mode in a Prodigy DR or SR model, you can use the two tests described in this section to help determine appropriate settings for the parameters related to rate response. You can access these tests by selecting the Activity Tests screen.
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) 7-22 Using the Programmer About the Activity Tests The Activity Threshold test and Exercise test are intended to facilitate the selection of appropriate values when rate response parameters are adjusted to meet the individual patient’s needs.* Activity Threshold Test During the Activity Threshold test, the pacemaker collects heart rate and sensor output data during a 25-second countdown while the patient is at rest.
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) Determining and Evaluating Parameter Settings 7-23 Conducting an Activity Threshold Test Preparing the Patient The following procedure involves programming and interrogating the patient’s pacemaker. The patient should be comfortably seated and be in a resting state prior to the start of this test. For this test, the patient’s pacemaker can be operating in either an Activity or non-Activity pacing mode.
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) 7-24 Using the Programmer Activity Threshold Test Results Screen Interpreting the Activity Threshold Test Results The test results window displays the following information: The percentage of heart beats recorded during the test that were paced. This value is given as a range. The number of Activity Detects that occurred during the test at each of the Activity Threshold settings.
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) Determining and Evaluating Parameter Settings 7-25 Programming the Activity Threshold To program the suggested Activity Threshold value: 1. Position the programming head. 2. Select the [PROGRAM] button. Use the [∧] or [∨] button if you want to change the value before you program.
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) 7-26 Using the Programmer Conducting an Exercise Test Preparing the Patient The following procedure involves programming and interrogating the patient’s pacemaker and having the patient complete at least two minutes of exercise. An appropriate exercise, such as a brisk walk, should be chosen. The patient should be prepared to engage in this exercise and should be at rest for several minutes before the test is started.
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) Determining and Evaluating Parameter Settings 7-27 Exercise Test Results Screen Curve shows desired sensor response rate. Patient’s heart rate during the test. UR = Upper Rate DR = Desired Rate LR = Lower Rate Appearance of a dashed vertical line indicates temporary interruption of data collection by application of the programming head (or magnet).
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) 7-28 Using the Programmer Selecting and Programming Parameter Values By observing how the desired sensor response curve changes as you adjust the parameters, you can formulate a set of parameter values that provides the appropriate rate response profile for the patient and the exercise performed. To select and program the rate response parameter values: 1. Adjust the Desired Rate.
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) Determining and Evaluating Parameter Settings 7-29 If the present permanent mode is an Activity mode, the programmed values will become the present values in effect. If the present mode is not an Activity mode, the values will be saved in pacemaker memory and will become pending values on the screen when you select an Activity mode for programming. Printing the Exercise Test Results To print the results of the Exercise test: 1.
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) 7-30 Using the Programmer Programming Temporary Parameter Values The Temporary Test function lets you evaluate different parameter settings or use high-rate pacing while having the option to quickly and easily return to the original permanent settings. The test settings remain in effect only while the [PROGRAM] button is pressed and held. Releasing [PROGRAM] returns the pacemaker to its permanently programmed state.
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) Determining and Evaluating Parameter Settings 7-31 Conducting a Temporary Parameter Test The waveform display lets you view the patient’s ECG and the telemetered waveforms while you are testing temporary parameter settings. Refer to pages 5-6 and 5-7 for information about the waveform display and its control buttons. WARNING: High-rate stimulation of the ventricles could result in ventricular tachycardia or fibrillation.
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) 7-32 Using the Programmer Test Parameters and Values The following parameters and values are available for temporary programming depending on the permanent pacing mode and the selected test mode. Pacing Mode1 DDD, ODO, AAI, AOO, OAO, AAT, VVI, VOO, OVO, VVT Lower Rate DDD test mode — 30 to 175 ppm (Lower rate values will be limited by the present Upper Tracking Rate setting.) Pacing Rate Single chamber test mode — 30 to 400 ppm Amplitude 0.
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) Determining and Evaluating Parameter Settings 7-33 Measuring Rate and AV Interval The Measure ECG test lets you directly measure the pacemaker output parameters listed below. The measurement for each parameter is averaged over several pacing cycles. Dual Chamber Modes Single Chamber Mode Pacing Rate Paced AV Interval Pacing Interval Pacing Rate Pacing Interval NOTE: For Prodigy pacemakers, this function does not include measurement of pulse width.
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) 7-34 Using the Programmer Measure Screen Select [NEW DATA] to repeat measurement if necessary. Measurement Results Measurements made using the patient’s ECG are based on data derived from the detected pacing artifacts. Accuracy of these measurements depends on the quality of the ECG signal and the stability of the artifact rate. Accuracy of measurements made using Marker Channel telemetry depends on the stability of Pace marker intervals.
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) CHAPTER 8 Collecting and Retrieving Diagnostic Data About This Chapter This chapter describes the Diagnostics function and the procedures for programming the pacemaker to record data related to the patient’s heart rate and operation of the pacemaker. Sections in this chapter cover the following information: Important points about the Diagnostic function (see page 8-2). The various types of data you can record (see page 8-3).
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) 8-2 Using the Programmer About the Diagnostics Function The Diagnostics function is a monitoring feature that lets you program the pacemaker to record in its memory any one of several types of information pertaining to the patient’s heart rate and certain pacemaker operations.
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) Collecting and Retrieving Diagnostic Data 8-3 If the pacemaker is at ERI status, programming of the Diagnostics function is not allowed. The time(s) and date(s) that appear on the display or printout of diagnostic data are based on the current settings of the programmer’s clock/calendar function. You can verify that the time and date are set correctly by selecting any report option on the Print menu.
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) 8-4 Using the Programmer Rate Histogram Programming Rate Histogram causes the pacemaker to count heart rate events according to the rate at which they occur. You can choose to have event totals include or exclude refractory sensed events.
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) Collecting and Retrieving Diagnostic Data 8-5 Lead Trend If you program Lead Trend, the pacemaker measures lead impedance every three hours and records the maximum and minimum values for each 3-day sampling period. The two dashed vertical lines indicate a temporary interruption in data collection caused by application of the programming head (or a magnet) over the pacemaker.
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) 8-6 Using the Programmer High Rate Episode If you program this Type option, the pacemaker monitors the designated chamber for “high rate episodes” as defined by the detection criteria selected during the setup procedure. The pacemaker records data for up to 15 consecutive episodes, or up to 7 episodes if the data for one is to include a short EGM.
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) Collecting and Retrieving Diagnostic Data 8-7 Detailed View of a High Rate Episode If the “Collect EGM” option was programmed, one episode will include a short EGM. This episode is marked by an asterisk (*) preceding the detection date. The number of episodes for which data can be collected in this case is limited to seven. The EGM recording, which starts when the episode detection criteria have been met, captures about 2.
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) 8-8 Using the Programmer Programmable Parameter Options Setting up the Diagnostics function, as described later in this chapter, involves programming appropriate settings for Type and other associated parameters. The programmable parameters associated with the Diagnostics function are defined below.
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) Collecting and Retrieving Diagnostic Data LEAD MONITOR 8-9 If you program Lead Monitor to “On,” data collection will automatically switch from the programmed Type to Lead Trend if the detected pacing lead impedance changes to a value outside the acceptable range of 200 to 3000 ohms. Data collection for the programmed Type stops, accumulated data is cleared, and collection of Lead Trend data begins.
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) 8-10 Using the Programmer TERMINATE # (Termination Number) This parameter sets the minimum number of consecutive heart beats that must occur below the Detection Rate before a high rate episode is considered terminated. Settings: COLLECT EGM Programming this parameter to ON causes the pacemaker to record a short EGM trace for one of the recorded high rate episodes.
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) Collecting and Retrieving Diagnostic Data 8-11 About the Setup Options The parameter list on the Diagnostic Parameters screen (see next section) includes a Setup option that can simplify the programming process. Choosing a Setup option (see list below) automatically selects an approriate pending value for Type and a typical preset value for each of the associated parameters. Instructions for using the Setup feature are presented in the next section.
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) 8-12 Using the Programmer Rate Histogram Select to obtain a Rate Histogram. Type Refract Sens Lead Monitor Lead Trend Select to monitor impedance of the pacing lead system. Type Method Lead Monitor 196407001 Rev A Rate Histogram Include Off Lead Trend Rolling Off (fixed setting) Refer to the “Reference man.” category in doc#163256 for Printing Instructions.
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) Collecting and Retrieving Diagnostic Data 8-13 Programming the Pacemaker to Record Data The procedure to program the pacemaker to begin recording the desired type of information begins at the Diagnostic Parameters screen. Selecting the Diagnostic Parameters Screen To display the Diagnostic Parameters (Diagnostics) screen, select the [PARAMETERS] menu button, and then select the DIAGNOSTIC PARAMETERS option as illustrated below. 1.
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) 8-14 Using the Programmer NOTE: If low battery voltage has set the pacemaker ERI (elective replacement indicator), the programmer will not allow you to program the Diagnostics function. Diagnostic Parameter Screen Buttons The buttons located at the right of the parameter display may be useful during the programming procedure described on the next page. SHOW PRESENT SHOW SAVED SHOW GRAPH CLEAR DATA SAVE/ NOMINAL OPTIONS...
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) Collecting and Retrieving Diagnostic Data 8-15 Programming Procedure You can program the pacemaker to begin collecting diagnostic data by using either of two procedures: 1) Using Setup, which simplifies programming, or 2) Manually selecting the Diagnostic parameter settings. NOTE: If the pacemaker is presently programmed to collect data, programming the Diagnostic function will erase any data accumulated. Display and print data before programming.
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) 8-16 Using the Programmer Data collection begins 30 seconds after you lift the programming head. (Data collection is suspended while the programming head is in position over the patient’s pacemaker.) Procedure for Manually Selecting the Parameter Settings As an alternative to using the Setup feature, you can manually select each of the parameter settings required to program the Diagnostics function.
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) Collecting and Retrieving Diagnostic Data 8-17 Displaying a Graph of the Recorded Data At any time during a patient session, you can display a graph of the Diagnostic data presently accumulated in pacemaker memory. Using Any One of Three Procedures You can display the graph of Diagnostic data by any one of the following procedures. In all cases, interrogate the pacemaker if necessary to display the graph.
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) 8-18 Using the Programmer NOTE: Atrial Lead Trend does not apply to VDD pacing. Selecting [ATRIAL LEAD TREND] will not display any data. For the Prodigy VDD model, the [ATRIAL LEAD TREND] button will not be displayed. Viewing Options for High Rate Episodes On this data displays, a Zoom In option lets you view the data collected for a particular episode in more detail. To select and view an episode: 1.
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) Collecting and Retrieving Diagnostic Data 8-19 Printing the Diagnostic Data You can print the diagnostic data retrieved from the pacemaker in either of two formats: in the same graphic format that appears on the screen, or as a table of the data used to create the graph. Printing the Graph You can print the diagnostic data in its graphic form only while the graph is displayed on the screen. To print the displayed graph: 1.
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) 8-20 Using the Programmer Clearing Recorded Data From the Pacemaker The Clear Data command lets you clear the Diagnostic data presently accumulated in pacemaker memory so that new data collection can begin. The Clear Data command does not alter the present Diagnostic parameter settings. New data collection begins 30 seconds after you lift the programming head from over the patient’s pacemaker.
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) CHAPTER 9 Programmer Setup Options About This Chapter This chapter describes the following programmer setup tasks: How to set the time and date if these settings are not correct on the display screen and printouts (see page 9-2). How to connect an external recorder or monitor (see page 9-3). How to use the Calibrate option associated with the EGM and Marker Channel signals delivered to an external recorder or monitor (see page 9-4).
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) 9-2 Using the Programmer Setting the Time and Date If the time or date displayed and printed by the programmer’s clock and calendar function is incorrect, use the following procedure to enter the correct setting. 1. Display the Automatic Model Select screen (see page 3-4) as follows: If the programmer is not operating, turn the programmer on. The start-up sequence will automatically display this screen.
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) Programmer Setup Options 9-3 Connecting an External Recorder or Monitor For the Prodigy family of pacemakers, the waveform signals available at the programmer output connectors are shown below for the 9760 and 9790 programmers. Refer to the next section of this chapter for information on the Calibrate option, which may be useful when you view Marker Channel or EGM telemetry on an externally connected recorder or monitor.
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) 9-4 Using the Programmer Using the CALIBRATE Option The Calibrate option applies to viewing Marker Channel or EGM telemetry on an externally connected recorder or monitor. Marker Channel™ Telemetry On an external recorder or monitor, the trace of Marker Channel telemetry is not annotated with letter codes. Identification of each marker must be done on the basis of its relative amplitude.
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) Programmer Setup Options 9-5 EGM/ECG Signal Calibration Depending on the displayed waveform trace, selecting the calibrate option also generates a voltage reference diagram that applies as follows: If you are using a 9760 programmer, the voltage reference diagram appears only in the telemetered EGM trace displayed or printed by an externally connected recorder or monitor.
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) 9-6 Using the Programmer Setting Up Site Nominal Parameter Values CAUTION: Programming functions, including Emergency, are not available from the Site Nominal Setup screen. The Site Nominal Setup feature allows you to choose your own set of nominal parameter values to use as an alternative to preestablished Medtronic nominal values. You can choose one set of Site Nominal parameter values for each group of models.
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) Programmer Setup Options c) 9-7 Select the pacemaker type, [SINGLE CHAMBER MODELS] or [DUAL CHAMBER MODELS]. d) Select the desired Prodigy pacemaker group from those listed. Selecting the pacemaker group results in a data loading process that will take several seconds. The Site Nominal Setup screen for Pacing Parameters is then displayed (see example below).
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) 9-8 Using the Programmer c) 4. Repeat a and b until the screen displays the parameter settings you want to use as Site Nominal values for the selected pacemaker group. To save the parameters shown on the setup screen as Site Nominal values, select the [SAVE PROPOSED] button. A message at the bottom of the screen and an audible “beep” will confirm that the values have been saved.
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) Programmer Setup Options 196407001 Rev A 9-9 [SET TO SITE VALUES] Select this button if, during modification of an existing set of Site Nominals, you want to return to the original values. This button is displayed only if there is a saved set of Site Nominal values. [HELP] Select this button for a brief description of the Site Nominal Setup feature. Refer to the “Reference man.” category in doc#163256 for Printing Instructions.
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) 9-10 Using the Programmer Setting the Artifact Display During processing and amplification of the patient’s ECG signal, the programmer automatically detects and enhances pacing artifacts so that they appear on the ECG display and printout. If you have a 9790 programmer, you can turn this artifact display feature on or off as follows: 1.
Medtronic Confidential 9879EN-II-T_9501043EN/CTC.qxd 5/10/99 11:46 Page II-1 7 x 9 inches (178 mm x 229 mm) PART II Understanding Pacemaker Operation Part II provides descriptions of Prodigy pacemaker features. This section supplements Part I (programmer procedures). Part III supplements this section with specific product information for the Prodigy DR, Prodigy D, Prodigy VDD, Prodigy SR, and Prodigy S pacemakers.
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) 196407001 Rev A Refer to the “Reference man.” category in doc#163256 for Printing Instructions.
Medtronic Confidential 9879EN-10_9501043EN/CTC.qxd 5/10/99 11:25 Page 10-1 7 x 9 inches (178 mm x 229 mm) CHAPTER 10 Pacing Modes About This Chapter This chapter provides information about the modes available with the Prodigy pacemaker.
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) 196407001 Rev A Refer to the “Reference man.” category in doc#163256 for Printing Instructions.
Medtronic Confidential 9879EN-10_9501043EN/CTC.qxd 5/10/99 11:25 Page 10-3 7 x 9 inches (178 mm x 229 mm) Pacing Modes 10-3 Introduction Pacing Mode Selection This chapter provides an introduction to Prodigy pacemaker modes as an aid to pacing mode selection. The chapter is organized as follows: ■ Mode Selection Decision Tree. This decision tree, based on the 1991 ACC/AHA guidelines for pacemaker implantation,1 provides a simple means of identifying pacing modes appropriate for given indications.
Medtronic Confidential 9879EN-10_9501043EN/CTC.
Medtronic Confidential 9879EN-10_9501043EN/CTC.qxd 5/10/99 11:25 Page 10-5 7 x 9 inches (178 mm x 229 mm) Pacing Modes 10-5 Mode Selection Decision Tree Below is a basic decision tree used to select the pacing mode. In the shaded boxes the preferred mode(s) are listed and the alternate mode(s) appears below the dashed line. Symptomatic Bradycardia (e.g.
196407001 Rev A ✓ ✓ ✓ ✓ ✓ ✓ ✓ Paced AV Interval Sensed AV Interval Rate Adaptive AV (ON/OFF) PVARP ✓ ✓ Post-Ventricular Atrial Blanking Post-Atrial Ventricular Blanking ✓ ✓ ✓ ✓ ✓ ✓ ✓ DVIR DVI VDD VVIR ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ VVI ✓ ✓ VVT ✓ ✓ ✓ ✓ AAIR ✓ ✓ ✓ AAI ✓ ✓ ✓ AAT NOTE: Standard pacing and sensing parameters (amplitude, pulse width, sensitivity, and pace/sense polarities) are not shown here but are found in Part III und
196407001 Rev A ✓ Non-Competitive Atrial Pacing (ON/OFF) ✓ Ventricular Safety Pacing (ON/OFF) ✓ ✓ ✓ ✓ ✓ ✓ Activity Rate Response Acceleration Deceleration DVIR DVI VDD VVIR ✓ ✓ ✓ VVI ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ RATE RESPONSE THERAPY OPTIONS** ✓ ✓ ✓ SPECIAL THERAPY OPTIONS* DDI * See Chapter 14 for operational descriptions of special therapy options. ** See Chapter 11 for operational descriptions of rate response features. 3 Available only in Prodigy DR models.
Medtronic Confidential 9879EN-10_9501043EN/CTC.qxd 5/10/99 11:25 Page 10-8 7 x 9 inches (178 mm x 229 mm) 10-8 Understanding Pacemaker Operations DDDR Mode Indications for the DDDR Mode The DDDR mode may be indicated for patients who have chronotropic incompetence, a stable atrial rhythm, and an anticipated moderate or high level of physical activity. Specific indications (also applicable to the DDD mode) are as follows: ■ ■ Requirement for AV synchrony over a wide range of rates.
Medtronic Confidential 9879EN-10_9501043EN/CTC.qxd 5/10/99 11:25 Page 10-9 7 x 9 inches (178 mm x 229 mm) Pacing Modes 10-9 DDDR Mode Operation In the DDDR mode, the pacemaker tracks the faster of the intrinsic atrial rate or the sensor-indicated rate. If the intrinsic rate is faster, the DDDR mode provides atrial synchronous pacing; otherwise, AV sequential pacing occurs at the sensor-indicated rate.
Medtronic Confidential 9879EN-10_9501043EN/CTC.qxd 5/10/99 11:25 Page 10-10 7 x 9 inches (178 mm x 229 mm) 10-10 Understanding Pacemaker Operations DDD Mode Indications for the DDD Mode The DDD mode may be indicated for patients with the following diagnoses: ■ Requirement for AV synchrony over a wide range of rates. Examples include the following: - Active or young patients who have atrial rates responsive to clinical need. - Patients who have significant hemodynamic need.
Medtronic Confidential 9879EN-10_9501043EN/CTC.qxd 5/10/99 11:25 Page 10-11 7 x 9 inches (178 mm x 229 mm) Pacing Modes 10-11 DDD Mode Operation 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 Lower Rate interval.
Medtronic Confidential 9879EN-10_9501043EN/CTC.qxd 5/10/99 11:25 Page 10-12 7 x 9 inches (178 mm x 229 mm) 10-12 Understanding Pacemaker Operations DDIR Mode Indications for the DDIR Mode The DDIR mode may be indicated for patients who require dual chamber pacing and who have frequent, but not constant, supraventricular arrhythmias.
9879EN-10_9501042_CTC.qxd 12/13/01 3:57 PM Medtronic Confidential Page 10-13 7 x 9 inches (178 mm x 229 mm) Pacing Modes Sensor-indicated Interval A P Sensor-indicated Sensor-indicated Interval VA Interval A S A P V P V P Parameters: Lower Rate = 60 ppm (1000 ms) Sensor-indicated Rate = 90 ppm (667 ms) Sensor-indicated Interval A P V P 10-13 A P V P PAV Interval = 200 ms 200 ms Example of DDIR Mode Operation. 196407001 Rev A Refer to the “Reference man.
9879EN-10_9501042_CTC.qxd 12/13/01 3:57 PM Medtronic Confidential Page 10-14 7 x 9 inches (178 mm x 229 mm) 10-14 Understanding Pacemaker Operations DDI Mode Indications for the DDI Mode The DDI mode may be indicated for patients who require dual chamber pacing and who have frequent, but not constant, supraventricular arrhythmias.
9879EN-10_9501042_CTC.qxd 12/13/01 3:57 PM Medtronic Confidential Page 10-15 7 x 9 inches (178 mm x 229 mm) Pacing Modes Lower Rate Interval V P Parameters: Lower Rate = 60 ppm (1000 ms) Lower Rate VA Interval Lower Rate Interval A S A P A P 10-15 A P V P V P PAV Interval = 200 ms 200 ms Example of DDI Mode Operation. 196407001 Rev A Refer to the “Reference man.” category in doc#163256 for Printing Instructions.
9879EN-10_9501042_CTC.qxd 12/13/01 3:57 PM Medtronic Confidential Page 10-16 7 x 9 inches (178 mm x 229 mm) 10-16 Understanding Pacemaker Operations DVIR Mode Indications for the DVIR Mode The DVIR mode may be indicated for patients who have chronotropic incompetence and an anticipated moderate-to-high level of physical activity. Specific indications are as follows: ■ The need for synchronous atrial-ventricular contraction in symptomatic bradycardia and slow atrial rate.
9879EN-10_9501042_CTC.qxd 12/13/01 3:57 PM Medtronic Confidential Page 10-17 7 x 9 inches (178 mm x 229 mm) Pacing Modes 10-17 DVIR Mode Operation The DVIR mode provides AV sequential pacing at the sensor-indicated rate unless inhibited by ventricular sensed events. Atrial pacing occurs at the sensor-indicated rate, with ventricular pacing at the end of the PAV interval unless inhibited. The DVIR mode ignores intrinsic atrial events. Sensing occurs only in the ventricle.
9879EN-10_9501042_CTC.qxd 12/13/01 3:57 PM Medtronic Confidential Page 10-18 7 x 9 inches (178 mm x 229 mm) 10-18 Understanding Pacemaker Operations DVI Mode Indications for the DVI Mode The DVI mode may be indicated for patients with the following conditions: ■ Need for synchronous atrial-ventricular contraction in symptomatic bradycardia and slow atrial rate. ■ Previously documented pacemaker syndrome.
9879EN-10_9501042_CTC.qxd 12/13/01 3:57 PM Medtronic Confidential Page 10-19 7 x 9 inches (178 mm x 229 mm) Pacing Modes 10-19 DVI Mode Operation The DVI mode provides dual chamber AV sequential pacing without atrial sensing/tracking. Atrial pacing occurs at the Lower Rate, with ventricular pacing at the end of the PAV interval unless inhibited. Sensing occurs only in the ventricle, and intrinsic atrial events are ignored.
9879EN-10_9501042_CTC.qxd 10-20 12/14/01 3:36 PM Page 10-20 Understanding Pacemaker Operations VDD Mode Indications for the VDD Mode The VDD mode may be indicated for patients with the following conditions: ■ Requirements for ventricular pacing when adequate atrial rates and adequate atrial sensing are present; includes the presence of complete AV block when atrial contribution is needed for hemodynamic benefit and when pacemaker syndrome has been present or is anticipated.
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9879EN-10_9501042_CTC.qxd 10-22 12/14/01 3:36 PM Page 10-22 Understanding Pacemaker Operations AAIR Mode Indications for the AAIR Mode The AAIR mode may be indicated for certain patients who have chronotropic incompetence and an anticipated moderate to high level of physical activity, normal AV conduction, and little likelihood of progression of AV block or induction of AV block as the result of drug therapy.
9879EN-10_9501042_CTC.qxd 12/14/01 3:36 PM Page 10-23 Pacing Modes 10-23 AAIR Mode Operation The AAIR mode provides atrial-based rate responsive pacing in patients with intact AV conduction. Sensing and pacing occur only in the atrium. In the absence of sensed events, the chamber is paced at the sensor-indicated rate. NOTE: In the AAIR mode, atrial refractory sensed events do not restart the programmed Upper Activity Rate interval.
9879EN-10_9501042_CTC.qxd 10-24 12/14/01 3:36 PM Page 10-24 Understanding Pacemaker Operations AAI Mode Indications for the AAI Mode The AAI mode may be indicated for patients with the following conditions: ■ Symptomatic sinus node dysfunction, provided AV conduction is shown to be adequate by appropriate studies.
9879EN-10_9501042_CTC.qxd 12/14/01 3:36 PM Page 10-25 Pacing Modes 10-25 AAI Mode Operation The AAI mode provides single chamber inhibited atrial pacing. Sensing and pacing occur only in the atrium. Pacing occurs at the programmed Lower Rate unless inhibited by sensed events.
9879EN-10_9501042_CTC.qxd 10-26 12/14/01 3:36 PM Page 10-26 Understanding Pacemaker Operations VVIR Mode Indications for the VVIR Mode The VVIR mode may be indicated for certain patients who have chronotropic incompetence and an anticipated moderate to high level of physical activity.
9879EN-10_9501042_CTC.qxd 12/14/01 3:36 PM Page 10-27 Pacing Modes 10-27 VVIR Mode Operation The VVIR mode provides ventricular rate responsive pacing in patients for whom atrial-based pacing is deemed unnecessary or inappropriate. In the absence of sensed events, the ventricle is paced at the sensor-indicated rate. NOTE: In the VVIR mode, ventricular refractory sensed events restart the programmed Upper Activity Rate interval.
9879EN-10_9501042_CTC.qxd 10-28 12/14/01 3:36 PM Page 10-28 Understanding Pacemaker Operations VVI Mode Indications for the VVI Mode The VVI mode may be indicated in the presence of the following conditions: ■ Any symptomatic bradyarrhythmias but particularly when there is no significant atrial hemodynamic contribution as in persistent or paroxysmal atrial flutter/fibrillation or the presence of giant atria.
9879EN-10_9501042_CTC.qxd 12/14/01 3:36 PM Page 10-29 Pacing Modes 10-29 VVI Mode Operation The VVI mode provides single chamber inhibited pacing at the Lower Rate unless inhibited by sensed events. Sensing occurs only in the ventricle.
9879EN-10_9501042_CTC.qxd 12/13/01 3:57 PM Page 10-30 Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) 10-30 Understanding Pacemaker Operations AAT/VVT Modes Indications for the AAT and VVT Modes Single chamber triggered modes (AAT and VVT) are diagnostic modes intended to allow synchronization of an implanted pacemaker with an external signal generator or to facilitate identification of sensed events with pacing artifacts. For specific indications, refer to the AAI and VVI mode descriptions.
9879EN-10_9501042_CTC.qxd 12/13/01 3:57 PM Medtronic Confidential Page 10-31 7 x 9 inches (178 mm x 229 mm) Pacing Modes 10-31 AAT and VVT Mode Operation Pacing occurs at the programmed rate, but a nonrefractory sensed event triggers an immediate pacing output (rather than inhibiting such output). Except that pacing outputs occur when events are sensed, the triggered modes operate identically to the corresponding inhibited modes.
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9879EN-10_9501042_CTC.qxd 12/13/01 3:57 PM Medtronic Confidential Page 10-33 7 x 9 inches (178 mm x 229 mm) Pacing Modes 10-33 DOOR, AOOR, and VOOR Mode Operation The DOOR, AOOR, and VOOR modes operate as follows: ■ The DOOR mode provides asynchronous AV sequential pacing at the sensor-indicated rate. Intrinsic events are ignored. ■ The AOOR and VOOR modes provide single chamber pacing at the sensor-indicated rate. Intrinsic events are ignored.
9879EN-10_9501042_CTC.qxd 12/13/01 3:57 PM Medtronic Confidential Page 10-34 7 x 9 inches (178 mm x 229 mm) 10-34 Understanding Pacemaker Operations DOO/AOO/VOO Modes Indications for the DOO, AOO, and VOO Modes The DOO, AOO, or VOO mode may be indicated as follows: ■ They may be used intraoperatively to reduce the likelihood of triggering pacing outputs from electrocautery.
9879EN-10_9501042_CTC.qxd 12/13/01 3:57 PM Medtronic Confidential Page 10-35 7 x 9 inches (178 mm x 229 mm) Pacing Modes 10-35 DOO, AOO, and VOO Mode Operation The DOO, AOO, and VOO modes operate as follows: • The DOO mode provides A-V sequential pacing at the programmed rate with no inhibition by intrinsic events. • The AOO and VOO modes provide pacing at the programmed rate with no inhibition by intrinsic events in the applicable chamber.
Medtronic Confidential 9879EN-10_9501043EN/CTC.qxd 5/10/99 11:25 Page 10-36 7 x 9 inches (178 mm x 229 mm) 10-36 Understanding Pacemaker Operations ODO/OAO/OVO Modes Indications for the ODO, OAO, and OVO Modes The ODO, OAO, and OVO modes are intended for pacemaker diagnostic and troubleshooting purposes, where the clinician wishes to observe underlying rhythms. They may also be used to turn the pacemaker OFF during surgery or other procedures. The patient is without pacing support in these modes.
Medtronic Confidential 9879EN-11_9501043EN/CTC.qxd 5/10/99 11:26 Page 11-1 7 x 9 inches (178 mm x 229 mm) CHAPTER 11 Rate Response Therapy Options About This Chapter This chapter describes how to use Prodigy pacemaker rate response features. The sections are as follows: ■ Rate Responsive Pacing (see page 11-2) ■ Activity Threshold (see page 11-4) ■ Activity Rate Response (see page 11-6) ■ Acceleration and Deceleration Times (see page 11-8) 11-1 196407001 Rev A Refer to the “Reference man.
Medtronic Confidential 9879EN-11_9501043EN/CTC.qxd 5/10/99 11:26 Page 11-2 7 x 9 inches (178 mm x 229 mm) 11-2 Understanding Pacemaker Operations Rate Responsive Pacing Overview Activity-based rate responsive pacing varies the pacing rate in response to the patient’s detected physical activity.
Medtronic Confidential 9879EN-11_9501043EN/CTC.qxd 5/10/99 11:26 Page 11-3 7 x 9 inches (178 mm x 229 mm) Rate Response Therapy Options 11-3 Typical Rate Response Settings The nominal rate response parameters will be found adequate for many patients (Activity Threshold = Medium, Activity Rate Response = 7, Acceleration = 0.5 minutes, and Deceleration = 5 minutes).
Medtronic Confidential 9879EN-11_9501043EN/CTC.qxd 5/10/99 11:26 Page 11-4 7 x 9 inches (178 mm x 229 mm) 11-4 Understanding Pacemaker Operations Activity Threshold Overview The programmable Activity Threshold determines the minimum intensity of detected physical activity to which the pacemaker responds. How Activity Threshold Influences Rate A piezoelectric crystal, bonded to the inside of the titanium pacemaker shield, is deflected by activity-induced pressure waves within the body.
Medtronic Confidential 9879EN-11_9501043EN/CTC.qxd 5/10/99 11:26 Page 11-5 7 x 9 inches (178 mm x 229 mm) Rate Response Therapy Options 11-5 Evaluating the Activity Threshold Setting Marker Channel telemetry may be used to record or display the activity sensor signal for evaluation (refer to “More About Marker Channel Telemetry” in Chapter 5.) Few (or no) sensor detect markers should appear when the patient is sitting quietly.
Medtronic Confidential 9879EN-11_9501043EN/CTC.qxd 5/10/99 11:26 Page 11-6 7 x 9 inches (178 mm x 229 mm) 11-6 Understanding Pacemaker Operations Activity Rate Response Overview The Activity Rate Response slope, in conjunction with the Lower Rate and Upper Activity Rate, establishes the steady-state pacing rate for a given level of detected activity (indicated by activity signals that exceed Activity Threshold).
Medtronic Confidential 9879EN-11_9501043EN/CTC.qxd 5/10/99 11:26 Page 11-7 7 x 9 inches (178 mm x 229 mm) Rate Response Therapy Options 11-7 Determining the Steady-State Pacing Rate For any Activity Rate Response slope, the steady-state rate corresponding to a given level of activity depends on Lower Rate (LR) and Upper Activity Rate (UAR). The examples that follow show the Activity Rate Response slopes for two sets of rate limits, first for an elderly patient and second for a pediatric patient.
Medtronic Confidential 9879EN-11_9501043EN/CTC.qxd 5/10/99 11:26 Page 11-8 7 x 9 inches (178 mm x 229 mm) 11-8 Understanding Pacemaker Operations Acceleration and Deceleration Times Overview Programmable Acceleration and Deceleration times control how rapidly the pacing rate changes in response to increased or decreased physical activity.
Medtronic Confidential 9879EN-11_9501043EN/CTC.qxd 5/10/99 11:26 Page 11-9 7 x 9 inches (178 mm x 229 mm) Rate Response Therapy Options 11-9 Deceleration Operation Deceleration time is the time required to achieve approximately 90% of the difference between the current rate and a lower steady-state rate consistent with the current level of activity. The illustration below shows a graphic representation of the Deceleration curves at an abrupt cessation of strenuous exercise.
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) 196407001 Rev A Refer to the “Reference man.” category in doc#163256 for Printing Instructions.
Medtronic Confidential 9879EN-12_9501043EN/CTC.qxd 5/10/99 11:27 Page 12-1 7 x 9 inches (178 mm x 229 mm) CHAPTER 12 Pacemaker Timing About This Chapter This chapter describes the programmable and nonprogrammable timing intervals that govern the operation of Prodigy pacemakers.
Medtronic Confidential 9879EN-12_9501043EN/CTC.qxd 5/10/99 11:27 Page 12-2 7 x 9 inches (178 mm x 229 mm) 12-2 Understanding Pacemaker Operations Rates Overview The following programmable rates control timing in Prodigy pacemakers: ■ Normal operating rates: - Lower Rate - Upper Tracking Rate - Upper Activity Rate ■ Other operating rates: - Hysteresis Rate (single chamber demand modes) Additionally, rates calculated by the pacemaker are used for some operations.
Medtronic Confidential 9879EN-12_9501043EN/CTC.qxd 5/10/99 11:27 Page 12-3 7 x 9 inches (178 mm x 229 mm) Pacemaker Timing 12-3 Lower Rate The programmed Lower Rate defines the slowest rate at which pacing occurs during a mode’s basic operation. In rate responsive modes, in the absence of sensor-detected activity, the sensor-indicated rate is equal to the programmed Lower Rate.
Medtronic Confidential 9879EN-12_9501043EN/CTC.qxd 5/10/99 11:27 Page 12-4 7 x 9 inches (178 mm x 229 mm) 12-4 Understanding Pacemaker Operations Selecting a Lower Rate Program the lower rate to maintain adequate heart rates during periods of inactivity or during pauses in atrial rhythms in the DDDR, DDD, VDD, AAIR, and AAI modes. NOTE: In the VDD mode, atrial tracking near the lower rate may result in V-V intervals that exceed the lower rate interval. This is normal operation.
Medtronic Confidential 9879EN-12_9501043EN/CTC.qxd 5/10/99 11:27 Page 12-5 7 x 9 inches (178 mm x 229 mm) Pacemaker Timing 12-5 In rate responsive modes, the sensor-indicated rate tracks the activity signal detected by the piezoelectric crystal sensor's frequency and amplitude. ■ In dual chamber rate responsive modes, the sensor-indicated interval is the AS-AP or AP-AP interval. ■ In single chamber rate responsive modes, the sensor-indicated interval is the A-A or V-V interval.
Medtronic Confidential 9879EN-12_9501043EN/CTC.qxd 5/10/99 11:27 Page 12-6 7 x 9 inches (178 mm x 229 mm) 12-6 Understanding Pacemaker Operations Upper Activity Rate In rate responsive modes, the programmable Upper Activity Rate provides the upper limit for the sensor-indicated rate during physical activity, particularly during vigorous exercise. In the DDDR mode, the Upper Activity Rate may be higher than, lower than, or the same as the Upper Tracking Rate.
Medtronic Confidential 9879EN-12_9501043EN/CTC.qxd 5/10/99 11:27 Page 12-7 7 x 9 inches (178 mm x 229 mm) Pacemaker Timing 12-7 Possible Atrial Competition at High Rates At high sensor-driven rates in the DDDR and DDIR modes, sensor-driven pacing may approximate the intrinsic atrial rate, with some intrinsic atrial events falling into the PVARP. This could result in asynchronous pacing with the potential for competitive atrial pacing.
Medtronic Confidential 9879EN-12_9501043EN/CTC.qxd 5/10/99 11:27 Page 12-8 7 x 9 inches (178 mm x 229 mm) 12-8 Understanding Pacemaker Operations AV Intervals Overview In dual chamber modes, the AV intervals determine the time between the occurrence of an atrial event and the scheduled delivery of a ventricular stimulus. Separate AV intervals for paced and sensed atrial events are available. The lengths of these intervals may be programmed to fixed values or (optionally) rate adaptive.
Medtronic Confidential 9879EN-12_9501043EN/CTC.qxd 5/10/99 11:27 Page 12-9 7 x 9 inches (178 mm x 229 mm) Pacemaker Timing ■ 12-9 Sensed AV Interval (SAV). SAV follows an atrial sensed event in atrial synchronous pacing modes (DDDR, DDD, and VDD).
Medtronic Confidential 9879EN-12_9501043EN/CTC.qxd 5/10/99 11:27 Page 12-10 7 x 9 inches (178 mm x 229 mm) 12-10 Understanding Pacemaker Operations Selecting PAV and SAV When programming AV intervals, the general hemodynamic goal is to assure that, to the extent possible, left-atrial systole is completed before left-ventricular systole begins. To achieve this, the AV interval durations may be adjusted independently of each other.
9879EN-12_9501043EN/CTC.qxd 5/10/99 11:27 Page 12-11 Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) Pacemaker Timing 12-11 Overview of Rate Adaptive AV Operation In the normal heart, AV conduction times tend to shorten as the heart rate increases and lengthen as the heart rate decreases. The Rate Adaptive AV (RAAV) feature, available in the DDDR, DDD, DDIR, DVIR, DOOR, and VDD modes, mimics this physiologic response.
Medtronic Confidential 9879EN-12_9501043EN/CTC.qxd 5/10/99 11:27 Page 12-12 7 x 9 inches (178 mm x 229 mm) 12-12 Understanding Pacemaker Operations The graph below shows conceptually how the SAV or PAV is adjusted at higher rates when RAAV is programmed ON.
Medtronic Confidential 9879EN-12_9501043EN/CTC.qxd 5/10/99 11:27 Page 12-13 7 x 9 inches (178 mm x 229 mm) Pacemaker Timing 12-13 RAAV Operation in the DDDR and DDD Modes The DDDR and DDD modes use both the PAV and SAV intervals: ■ DDDR Mode. Both the SAV and PAV may be adjusted. ■ DDD Mode. The PAV is not adjusted in the DDD mode because atrial pacing occurs only at the programmed Lower Rate. SAV may be adjusted. Application for RAAV RAAV is primarily intended for AV block patients.
Medtronic Confidential 9879EN-12_9501043EN/CTC.qxd 5/10/99 11:27 Page 12-14 7 x 9 inches (178 mm x 229 mm) 12-14 Understanding Pacemaker Operations Blanking Periods Blanking periods disable sensing for a programmable or nonprogrammable interval. Signals that are blanked may originate in either chamber or from outside sources such as noise from muscle movement. Note: Black bars indicate blanking 1. Non-programmable Atrial Blanking P 1 2 DDD A V 3 P 4 P 2.
Medtronic Confidential 9879EN-12_9501043EN/CTC.qxd 5/10/99 11:27 Page 12-15 7 x 9 inches (178 mm x 229 mm) Pacemaker Timing 12-15 Post-Ventricular Atrial Blanking The programmable Post-Ventricular Atrial Blanking (PVAB) period, used in the DDDR, DDD, DDIR, DDI, and VDD modes, prevents sensing of ventricular paced events or far-field R-waves on the atrial lead.
9879EN-12_9501043EN/CTC.qxd 5/10/99 11:27 Page 12-16 Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) 12-16 Understanding Pacemaker Operations Refractory Periods Overview A refractory period is an interval during which an intrinsic event sensed on a particular lead channel cannot start certain timing intervals. Each refractory period begins with a blanking period, during which no sensing occurs.
Medtronic Confidential 9879EN-12_9501043EN/CTC.qxd 5/10/99 11:27 Page 12-17 7 x 9 inches (178 mm x 229 mm) Pacemaker Timing 12-17 Post-Ventricular Atrial Refractory Period The Post-Ventricular Atrial Refractory Period (PVARP) follows a paced, sensed, or refractory sensed ventricular event in the DDDR, DDD, DDIR, DDI, and VDD modes. It is intended primarily to prevent the sensing of retrograde P-waves that might promote Pacemaker-Mediated Tachycardias (PMTs) in atrial tracking modes.
9879EN-12_9501043EN/CTC.qxd 5/10/99 11:27 Page 12-18 Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) 12-18 Understanding Pacemaker Operations Automatic PVARP Extension After a PVC The programmed PVARP duration may be overridden when a pacemakerdefined premature ventricular contraction (PVC) occurs. A pacemakerdefined PVC starts an extended PVARP to 400 ms if the programmed PVARP is less than 400 ms.
Medtronic Confidential 9879EN-12_9501043EN/CTC.qxd 5/10/99 11:27 Page 12-19 7 x 9 inches (178 mm x 229 mm) Pacemaker Timing 12-19 Total Atrial Refractory Period (TARP) In dual chamber modes that sense in the atrium, the Total Atrial Refractory Period (TARP) is the 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.
Medtronic Confidential 9879EN-12_9501043EN/CTC.qxd 5/10/99 11:27 Page 12-20 7 x 9 inches (178 mm x 229 mm) 12-20 Understanding Pacemaker Operations Ventricular Refractory Period (VRP) The programmable Ventricular Refractory Period (VRP) follows paced, sensed, and refractory sensed ventricular events (including PVCs) in all modes that sense in the ventricle. The VRP is intended to prevent sensing of the T-wave or a PVC. The first portion of the VRP is a nonprogrammable blanking period.
Medtronic Confidential 9879EN-12_9501043EN/CTC.qxd 5/10/99 11:27 Page 12-21 7 x 9 inches (178 mm x 229 mm) Pacemaker Timing 12-21 Atrial Refractory Period (Single Chamber) The programmable Atrial Refractory Period (ARP) follows paced, sensed, and refractory sensed atrial events. The ARP is used in the AAIR, AAI, and AAT modes, is intended to prevent inhibition due to far-field R-wave sensing. The first portion of the ARP is a programmable blanking period.
Medtronic Confidential 9879EN-12_9501043EN/CTC.qxd 5/10/99 11:27 Page 12-22 7 x 9 inches (178 mm x 229 mm) 12-22 Understanding Pacemaker Operations ■ Pacing occurs at the Lower Rate for all nonrate responsive modes and VVIR. Lower Rate VVIR V Act. P R R R R P Act. P 200 ms Parameters: Lower Rate = 60 ppm (1000 ms) Ventricular Refractory Period = 240 ms Upper Activity Rate = 120 ppm (500 ms) Example of noise reversion in the VVIR mode pacing at the Lower Rate.
9879EN-12_9501043EN/CTC.qxd 5/10/99 11:27 Page 12-23 Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) Pacemaker Timing 12-23 High Rate Atrial Tracking Overview In the DDDR, DDD, and VDD modes, the fastest atrial rate the pacemaker can track is determined by the Total Atrial Refractory Period (TARP), which is the sum of the SAV and the PVARP.
Medtronic Confidential 9879EN-12_9501043EN/CTC.qxd 5/10/99 11:27 Page 12-24 7 x 9 inches (178 mm x 229 mm) 12-24 Understanding Pacemaker Operations Pacemaker Wenckebach When the 2:1 block rate exceeds the programmed Upper Tracking Rate, pacemaker Wenckebach may occur. When the intrinsic rate exceeds the Upper Tracking Rate, a pacing stimulus at the expiration of the SAV would violate the Upper Tracking Rate. The pacemaker therefore extends the SAV until the Upper Tracking Rate interval expires.
Medtronic Confidential 9879EN-12_9501043EN/CTC.qxd 5/10/99 11:27 Page 12-25 7 x 9 inches (178 mm x 229 mm) Pacemaker Timing 12-25 High Rate Operation in the DDDR Mode The table that follows summarizes how the Total Atrial Refractory Period (TARP), the Upper Tracking Rate (UTR) interval, and the Upper Activity Rate (UAR) interval may interact at high atrial rates in the DDDR mode.
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) 196407001 Rev A Refer to the “Reference man.” category in doc#163256 for Printing Instructions.
Medtronic Confidential 9879EN-13_9501043EN/CTC.qxd 5/10/99 11:29 Page 13-1 7 x 9 inches (178 mm x 229 mm) CHAPTER 13 Lead/Cardiac Tissue Interface About This Chapter This chapter discusses programming and follow-up topics relating to the lead/cardiac tissue interface.
Medtronic Confidential 9879EN-13_9501043EN/CTC.qxd 5/10/99 11:29 Page 13-2 7 x 9 inches (178 mm x 229 mm) 13-2 Understanding Pacemaker Operations Selecting Pacing Parameters Overview Pacing output settings should be adequate to guarantee reliable capture, but not so high as to inappropriately deplete the pacemaker battery.
9879EN-13_9501043EN/CTC.qxd 5/10/99 11:29 Page 13-3 Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) Lead/Cardiac Tissue Interface 13-3 this range, a functional bipolar lead is not present; the programmer warns that the test failed, and Pacing Polarity remains set to unipolar. This interlock feature may be overridden to force lead Pacing Polarity to bipolar. WARNING: Do not override for an implanted lead.
Medtronic Confidential 9879EN-13_9501043EN/CTC.qxd 5/10/99 11:29 Page 13-4 7 x 9 inches (178 mm x 229 mm) 13-4 Understanding Pacemaker Operations Selecting Output Parameters Generally, a pacing voltage twice the chronic stimulation threshold voltage for a given Pulse Width provides an adequate safety margin. For most patients, pacing outputs are the major contributor to battery depletion.
Medtronic Confidential 9879EN-13_9501043EN/CTC.qxd 5/10/99 11:29 Page 13-5 7 x 9 inches (178 mm x 229 mm) Lead/Cardiac Tissue Interface 13-5 Selecting Sensing Parameters Overview Sensitivity determines the minimum intracardiac signal that the pacemaker can detect when intrinsic atrial or ventricular events occur.
Medtronic Confidential 9879EN-13_9501043EN/CTC.qxd 5/10/99 11:29 Page 13-6 7 x 9 inches (178 mm x 229 mm) 13-6 Understanding Pacemaker Operations Bipolar Sensing Polarity Confirmation Before programming from unipolar to bipolar sensing, the programmer verifies the presence of a functioning bipolar lead by testing impedance for each lead at an Amplitude of 5.0 V and a Pulse Width of 1.0 ms if the permanent settings are at or below this level.
Medtronic Confidential 9879EN-13_9501043EN/CTC.qxd 5/10/99 11:29 Page 13-7 7 x 9 inches (178 mm x 229 mm) Lead/Cardiac Tissue Interface 13-7 Selecting Sensitivity Setting(s) Atrial and ventricular Sensitivity are independently programmable in dual chamber models. In general, a 2:1 to 3:1 sensitivity safety margin (threshold sensitivity value divided by 2 or 3) will be adequate for newly implanted or chronic leads. For example, an atrial Sensitivity of 1.
9879EN-13_9501043EN/CTC.qxd 5/10/99 11:29 Page 13-8 Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) 13-8 Understanding Pacemaker Operations Monitoring Lead Stability Overview The Lead Monitor is a programmable ON/OFF feature that periodically measures the pacing impedance of each lead. It is intended for troubleshooting when an intermittent lead problem is suspected.
Medtronic Confidential 9879EN-13_9501043EN/CTC.qxd 5/10/99 11:29 Page 13-9 7 x 9 inches (178 mm x 229 mm) Lead/Cardiac Tissue Interface 13-9 How the Monitor Works Impedance for each active lead is measured every three hours. The measurement requires up to three pacing cycles during which Amplitude and Pulse Width will change to 5.0 V and 1.0 ms respectively, if the permanent settings are at or below this level.
Medtronic Confidential 9879EN-13_9501043EN/CTC.qxd 5/10/99 11:29 Page 13-10 7 x 9 inches (178 mm x 229 mm) 13-10 Understanding Pacemaker Operations The example below shows how the Lead Trend report is presented on the programmer. The report can be printed out or displayed on the programmer.
Medtronic Confidential 9879EN-13_9501043EN/CTC.qxd 5/10/99 11:29 Page 13-11 7 x 9 inches (178 mm x 229 mm) Lead/Cardiac Tissue Interface 13-11 Transtelephonic Capture Verification with TMT Overview During transtelephonic monitoring, the Threshold Margin Test (TMT) provides a check for loss of capture at 25% reduced pulse width(s). The TMT may indicate that loss of capture is possible but cannot verify that safety margin is adequate.
Medtronic Confidential 9879EN-13_9501043EN/CTC.qxd 5/10/99 11:29 Page 13-12 7 x 9 inches (178 mm x 229 mm) 13-12 Understanding Pacemaker Operations Single Chamber and VDD Mode TMT Operation Applying the magnet over the pacemaker initiates TMT. As illustrated below for ventricular operation, the pacemaker delivers three asynchronous pulses at a rate of 100 ppm. The first two pulses are delivered at the programmed Pulse Width. The third pulse is delivered at a 25% reduction of the programmed Pulse Width.
Medtronic Confidential 9879EN-13_9501043EN/CTC.qxd 5/10/99 11:29 Page 13-13 7 x 9 inches (178 mm x 229 mm) Lead/Cardiac Tissue Interface 13-13 Enhanced Transtelephonic Monitoring The Transtelephonic Monitor is a programmable ON/OFF feature intended for use with remote pacemaker monitoring services. Programming the feature OFF does not effect conventional transtelephonic monitoring.
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) 196407001 Rev A Refer to the “Reference man.” category in doc#163256 for Printing Instructions.
Medtronic Confidential 9879EN-14_9501043EN/CTC.qxd 5/10/99 11:31 Page 14-1 7 x 9 inches (178 mm x 229 mm) CHAPTER 14 Special Therapy Options About This Chapter This chapter describes Prodigy pacemaker features intended for special patient therapies.
Medtronic Confidential 9879EN-14_9501043EN/CTC.qxd 5/10/99 11:31 Page 14-2 7 x 9 inches (178 mm x 229 mm) 14-2 Understanding Pacemaker Operations Mode Switch Overview Mode Switch is a programmable ON/OFF feature designed to prevent the tracking of paroxysmal atrial tachycardias in the DDDR, DDD, and VDD modes. (Mode Switch is not recommended for patients known to have chronic refractory atrial tachyarrhythmias: atrial tachycardia, atrial fibrillation, or atrial flutter.
Medtronic Confidential 9879EN-14_9501043EN/CTC.qxd 5/10/99 11:31 Page 14-3 7 x 9 inches (178 mm x 229 mm) Special Therapy Options 14-3 Mode Switch Operation If the pacemaker detects an atrial tachycardia in the DDDR, DDD, or VDD mode, it switches to the appropriate non-atrial tracking mode after approximately 15 seconds. To avoid an abrupt drop in ventricular rate, it smoothly reduces the pacing rate from the atrial synchronous rate to the sensor-indicated rate.
Medtronic Confidential 9879EN-14_9501043EN/CTC.qxd 5/10/99 11:31 Page 14-4 7 x 9 inches (178 mm x 229 mm) 14-4 Understanding Pacemaker Operations Preset Parameter Settings When Mode Switch is programmed ON, several parameters are automatically set to the following values: ■ Upper Activity Rate is set equal to the Upper Tracking Rate.
Medtronic Confidential 9879EN-14_9501043EN/CTC.qxd 5/10/99 11:31 Page 14-5 7 x 9 inches (178 mm x 229 mm) Special Therapy Options 14-5 Non-Competitive Atrial Pacing Overview Non-Competitive Atrial Pacing (NCAP) is intended to prevent triggering of atrial tachycardias by an atrial pacing stimulus that falls within the atrium’s relative refractory period. This feature may be programmed ON/OFF in the DDDR mode only.
Medtronic Confidential 9879EN-14_9501043EN/CTC.qxd 5/10/99 11:31 Page 14-6 7 x 9 inches (178 mm x 229 mm) 14-6 Understanding Pacemaker Operations How NCAP Affects Ventricular Timing When an atrial pacing stimulus is delayed by the NCAP operation, the pacemaker attempts to maintain a stable ventricular rate by shortening the PAV interval that follows. It will not, however, shorten the PAV interval to less than 80 ms.
Medtronic Confidential 9879EN-14_9501043EN/CTC.qxd 5/10/99 11:31 Page 14-7 7 x 9 inches (178 mm x 229 mm) Special Therapy Options 14-7 PMT Intervention Overview A pacemaker-mediated tachycardia may occur when retrograde P-waves (due to a loss of AV synchrony) are sensed and tracked in an atrial tracking mode. Pacemaker-Mediated Tachycardia (PMT) Intervention provides an automatic way for the pacemaker to detect and interrupt pacemaker-defined PMTs.
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Medtronic Confidential 9879EN-14_9501043EN/CTC.qxd 5/10/99 11:31 Page 14-9 7 x 9 inches (178 mm x 229 mm) Special Therapy Options 14-9 Ventricular Safety Pacing Overview Ventricular Safety Pacing (VSP) is intended to prevent ventricular asystole due to inappropriate inhibition of ventricular pacing. Such inhibition may be caused by crosstalk or ventricular oversensing. The feature is programmable ON or OFF in the DDDR, DDD, DDIR, DDI, DVIR, and DVI modes.
Medtronic Confidential 9879EN-14_9501043EN/CTC.qxd 5/10/99 11:31 Page 14-10 7 x 9 inches (178 mm x 229 mm) 14-10 Understanding Pacemaker Operations How VSP Operates When VSP is programmed ON, a ventricular sense within 110 ms after an atrial pacing pulse results in a ventricular pacing pulse at 110 ms (see illustration below) or at the programmed PAV interval, whichever expires first.
Medtronic Confidential 9879EN-14_9501043EN/CTC.qxd 5/10/99 11:31 Page 14-11 7 x 9 inches (178 mm x 229 mm) Special Therapy Options 14-11 Single Chamber Hysteresis Overview Single Chamber Hysteresis lets the pacemaker track an intrinsic rhythm below the programmed Lower Rate. This prevents the pacemaker from overriding slow but appropriate intrinsic rhythms that may develop during extended periods of inactivity such as sleep. Hysteresis is programmed to a rate below the Lower Rate.
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Medtronic Confidential 9879EN-15_9501043EN/CTC.qxd 5/10/99 11:32 Page 15-1 7 x 9 inches (178 mm x 229 mm) CHAPTER 15 Telemetry Data About This Chapter This chapter describes telemetered information available from the pacemaker for routine monitoring and problem solving.
Medtronic Confidential 9879EN-15_9501043EN/CTC.qxd 5/10/99 11:32 Page 15-2 7 x 9 inches (178 mm x 229 mm) 15-2 Understanding Pacemaker Operations Parameter Summary Overview When interrogated by the programmer, the pacemaker telemeters its permanently programmed parameter settings along with battery status and device identification. Parameters Reported The programmer will report only parameters pertinent to the programmed mode.
Medtronic Confidential 9879EN-15_9501043EN/CTC.qxd 5/10/99 11:32 Page 15-3 7 x 9 inches (178 mm x 229 mm) Telemetry Functions 15-3 Possible Variation from Programmed Values In general, the reported parameters will be set to the same values from the previous programming session. Exceptions are as follows: ■ Electrical Reset.
Medtronic Confidential 9879EN-15_9501043EN/CTC.qxd 5/10/99 11:32 Page 15-4 7 x 9 inches (178 mm x 229 mm) 15-4 Understanding Pacemaker Operations Battery and Lead Information Overview The pacemaker can telemeter measured and calculated values for battery parameters, pacing output(s), and lead(s) to the programmer. These data may be used both for routine assessment of pacing system performance and for evaluating suspected problems.
Medtronic Confidential 9879EN-15_9501043EN/CTC.qxd 5/10/99 11:32 Page 15-5 7 x 9 inches (178 mm x 229 mm) Telemetry Functions 15-5 Preserving Battery and Lead Data The Battery/Lead Data Report should be printed out at every follow-up session and kept in the patient record. Significant changes in chronic lead data could indicate a lead dislodgement or fracture. Battery status changes could indicate that the battery is nearing depletion.
Medtronic Confidential 9879EN-15_9501043EN/CTC.qxd 5/10/99 11:32 Page 15-6 7 x 9 inches (178 mm x 229 mm) 15-6 Understanding Pacemaker Operations Marker Channel™ Telemetry Overview Marker Channel telemetry provides simple depictions of paced and sensed events that aid in the evaluation of pacemaker timing and operations. The annotations are most useful when considered in conjunction with a simultaneous ECG and/or EGM. Marker Channel telemetry is available in all modes.
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Medtronic Confidential 9879EN-15_9501043EN/CTC.qxd 5/10/99 11:32 Page 15-8 7 x 9 inches (178 mm x 229 mm) 15-8 Understanding Pacemaker Operations Intracardiac Electrogram (EGM) Overview The intracardiac electrogram (EGM) is a real-time waveform as detected by the atrial or ventricular lead(s) accompanied by Marker Channel annotation. Pacing stimuli are not detected by the EGM circuitry, but the programmer inserts simulated pacing pulses in the appropriate locations on the EGM recording.
Medtronic Confidential 9879EN-15_9501043EN/CTC.qxd 5/10/99 11:32 Page 15-9 7 x 9 inches (178 mm x 229 mm) Telemetry Functions 15-9 Uses for Electrogram The intracardiac electrogram shows intracardiac waveforms and their timing as the pacemaker sees them.
Medtronic Confidential 9879EN-15_9501043EN/CTC.qxd 5/10/99 11:32 Page 15-10 7 x 9 inches (178 mm x 229 mm) 15-10 Understanding Pacemaker Operations Extended Telemetry Overview Extended Telemetry is a programmable ON/OFF feature intended for frequent patient monitoring in the permanently programmed mode during a 24-hour period. ■ When Extended Telemetry is programmed ON, the pacemaker continuously transmits telemetry data regardless of whether the programming head is applied or not.
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Medtronic Confidential 9879EN-16_9501043EN/CTC.qxd 5/10/99 11:33 Page 16-2 7 x 9 inches (178 mm x 229 mm) 16-2 Understanding Pacemaker Operations Magnet Mode Operation Overview When the programming head (or other powerful magnet) is placed over the pacemaker, an internal reed switch closes to initiate Magnet Mode operation. Magnet application initiates a Threshold Margin Test and may temporarily suspend the operation of specific features.
Medtronic Confidential 9879EN-16_9501043EN/CTC.qxd 5/10/99 11:33 Page 16-3 7 x 9 inches (178 mm x 229 mm) Miscellaneous Operations 16-3 Magnet Mode remains in effect as long as the programming head (or other magnet) remains in position unless canceled by a programmer command. When the magnet is removed, the pacemaker resumes programmed operation within two seconds.
Medtronic Confidential 9879EN-16_9501043EN/CTC.qxd 5/10/99 11:33 Page 16-4 7 x 9 inches (178 mm x 229 mm) 16-4 Understanding Pacemaker Operations Special Operation with Extended Telemetry When the Extended Telemetry feature is programmed ON, the pacemaker responds to magnet application by sending telemetry data, as described in the “Extended Telemetry” section of Chapter 15.
Medtronic Confidential 9879EN-16_9501043EN/CTC.qxd 5/10/99 11:33 Page 16-5 7 x 9 inches (178 mm x 229 mm) Miscellaneous Operations 16-5 Temporary Programming Overview Pacing mode and certain other parameters may be programmed temporarily for diagnostic purposes or to test their effects on pacing operations prior to permanent programming. Permanent settings are restored automatically when the programming head is removed or the telemetry link is broken.
Medtronic Confidential 9879EN-16_9501043EN/CTC.qxd 5/10/99 11:33 Page 16-6 7 x 9 inches (178 mm x 229 mm) 16-6 Understanding Pacemaker Operations Electrical Reset Overview Under extreme conditions, a momentary interruption of electrical power to the pacemaker’s control circuitry may cause an electrical reset. Pacing parameters are reset to specific values when power is restored.
Medtronic Confidential 9879EN-16_9501043EN/CTC.qxd 5/10/99 11:33 Page 16-7 7 x 9 inches (178 mm x 229 mm) Miscellaneous Operations 16-7 Full Electrical Reset If a full electrical reset occurs, all programmed values are lost. When power is restored, the pacemaker automatically performs the following reset recovery operations: ■ Mode is set to VVI at 65 ppm. ■ In bipolar models, the pacemaker determines whether a functioning bipolar lead is present in the ventricle.
Medtronic Confidential 9879EN-16_9501043EN/CTC.qxd 5/10/99 11:33 Page 16-8 7 x 9 inches (178 mm x 229 mm) 16-8 Understanding Pacemaker Operations Elective Replacement Indicator (ERI) Overview The Elective Replacement Indicator (ERI) is reported upon interrogation with the programmer when the pacemaker battery is nearly depleted. When the ERI is set, the pacemaker is automatically reprogrammed to a distinctive set of parameters. For the Prodigy pacemaker, ERI is permanent VVI mode at 65 ppm.
Medtronic Confidential 9879EN-16_9501043EN/CTC.qxd 5/10/99 11:33 Page 16-9 7 x 9 inches (178 mm x 229 mm) Miscellaneous Operations 16-9 Emergency Pacing Overview Emergency pacing provides VVI pacing at high output settings in emergency situations for pacemaker-dependent patients. For Further Information Refer to “Emergency Parameter Settings,” Section B in Part III, for more information. 196407001 Rev A Refer to the “Reference man.” category in doc#163256 for Printing Instructions.
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) 196407001 Rev A Refer to the “Reference man.” category in doc#163256 for Printing Instructions.
Medtronic Confidential 9879EN-17_9501043EN/CTC.qxd 5/10/99 11:34 Page 17-1 7 x 9 inches (178 mm x 229 mm) CHAPTER 17 Diagnostics About This Chapter This chapter describes diagnostic capabilities of Prodigy pacemakers, as follows: ■ Introduction to Prodigy Diagnostics (see page 17-2) ■ Event Summary (see page 17-4) ■ Rate Histogram (see page 17-6) ■ High Rate Episode (see page 17-8) 17-1 196407001 Rev A Refer to the “Reference man.” category in doc#163256 for Printing Instructions.
Medtronic Confidential 9879EN-17_9501043EN/CTC.qxd 5/10/99 11:34 Page 17-2 7 x 9 inches (178 mm x 229 mm) 17-2 Understanding Pacemaker Operations Introduction to Prodigy™ Diagnostics Overview The Prodigy pacemaker offers both background and programmable diagnostics intended for evaluation of the patient’s intrinsic rhythms and the pacemaker’s operation. All Event Summary diagnostics run continuously in the background. Only one of the three programmable diagnostics can be selected at a time.
Medtronic Confidential 9879EN-17_9501043EN/CTC.qxd 5/10/99 11:34 Page 17-3 7 x 9 inches (178 mm x 229 mm) Diagnostics 17-3 Exceptional Conditions Under exceptional conditions, the pacemaker may discontinue or suspend the programmed diagnostic: ■ If the Lead Monitor is programmed ON and abnormal lead impedance is detected (Chapter 13), the pacemaker automatically activates the Lead Trend diagnostic, overriding any other diagnostic choice. Any previously collected data are overwritten.
Medtronic Confidential 9879EN-17_9501043EN/CTC.qxd 5/10/99 11:34 Page 17-4 7 x 9 inches (178 mm x 229 mm) 17-4 Understanding Pacemaker Operations Event Summary Overview The Event Summary reports certain pacing and sensing statistics automatically collected by the pacemaker and telemetered to the programmer at interrogation. The summary data complements and supplements data collected by the programmable diagnostics. This data is displayed on the Data Summary screen of the programmer or may be printed.
Medtronic Confidential 9879EN-17_9501043EN/CTC.qxd 5/10/99 11:34 Page 17-5 7 x 9 inches (178 mm x 229 mm) Diagnostics ■ 17-5 Mode Switches. Counts mode changes from the DDDR, DDD, or VDD mode to a non-atrial tracking mode (available only when Mode Switch is programmed ON). The maximum count is 255.
Medtronic Confidential 9879EN-17_9501043EN/CTC.qxd 5/10/99 11:34 Page 17-6 7 x 9 inches (178 mm x 229 mm) 17-6 Understanding Pacemaker Operations Rate Histogram Overview The Rate Histogram counts and collects atrial and/or ventricular events and classifies them by rate range and the percentage paced out of the total beats counted.
Medtronic Confidential 9879EN-17_9501043EN/CTC.qxd 5/10/99 11:34 Page 17-7 7 x 9 inches (178 mm x 229 mm) Diagnostics 17-7 Events Displayed Outside Lower and Upper Rate Limits The diagnostic’s displayed rate for each event is based on the interval from the previous event. When refractory sensed events are included, AR-AP or VR-VP intervals result in displayed paced beats which are significantly higher than the actual pacing rate.
Medtronic Confidential 9879EN-17_9501043EN/CTC.qxd 5/10/99 11:34 Page 17-8 7 x 9 inches (178 mm x 229 mm) 17-8 Understanding Pacemaker Operations High Rate Episode Overview The High Rate Episode monitor is intended for detection and assessment of episodes of atrial or ventricular tachycardia. It can record data for up to 15 High Rate Episodes, or 7 High Rate Episodes and one Electrogram (EGM) associated with an episode.
Medtronic Confidential 9879EN-17_9501043EN/CTC.qxd 5/10/99 11:34 Page 17-9 7 x 9 inches (178 mm x 229 mm) Diagnostics 17-9 How High Rate Episodes Are Defined For the purposes of this diagnostic, a “high rate episode” begins when a specified number of sequential heart beats exceeds a specified rate. The episode ends when a specified number of sequential heartbeats occur below the specified rate. The table that follows describes the programmable parameters that define a high rate episode.
Medtronic Confidential 9879EN-17_9501043EN/CTC.qxd 5/10/99 11:34 Page 17-10 7 x 9 inches (178 mm x 229 mm) 17-10 Understanding Pacemaker Operations Collecting EGM Data If the EGM option is programmed ON, an approximately two second EGM with simulated pacing pulses is recorded for one episode, and the number of episodes for which data can be recorded is reduced to seven. The episode for which the EGM is recorded is selected as follows: ■ Frozen Episodes.
Medtronic Confidential 9879EN-17_9501043EN/CTC.qxd 5/10/99 11:34 Page 17-11 7 x 9 inches (178 mm x 229 mm) Diagnostics 17-11 Example of High Rate Episodes Display Example of Detailed View of High Rate Episode For Further Information Refer to Chapter 8, “Collecting and Retrieving Diagnostic Data,” for information on configuring the High-Rate Episode diagnostic and collecting its data. 196407001 Rev A Refer to the “Reference man.” category in doc#163256 for Printing Instructions.
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) 196407001 Rev A Refer to the “Reference man.” category in doc#163256 for Printing Instructions.
Medtronic Confidential 9879EN-18_9501043EN/CTC.qxd 5/10/99 11:35 Page 18-1 7 x 9 inches (178 mm x 229 mm) CHAPTER 18 Troubleshooting the Pacing System About This Chapter This chapter describes how to isolate and correct problems with the Prodigy pacing system.
Medtronic Confidential 9879EN-18_9501043EN/CTC.qxd 5/10/99 11:35 Page 18-2 7 x 9 inches (178 mm x 229 mm) 18-2 Understanding Pacemaker Operations Troubleshooting Strategy Overview When troubleshooting pacemaker problems, the clinician must consider both electrical problems and the effect of various parameter settings on cardiac hemodynamics. Determining the nature of the troubleshooting problem is the first step toward solving it.
Medtronic Confidential 9879EN-18_9501043EN/CTC.qxd 5/10/99 11:35 Page 18-3 7 x 9 inches (178 mm x 229 mm) Troubleshooting the Pacing System 18-3 Troubleshooting Electrical Problems Defining Electrical Problems When investigating an electrical problem, the clinician will need data from a wide variety of sources, including the following: ■ Patient Data. Determine the patient’s medical history, especially the underlying cardiac rhythm. ■ Pacemaker Data.
Medtronic Confidential 9879EN-18_9501043EN/CTC.qxd 5/10/99 11:35 Page 18-4 7 x 9 inches (178 mm x 229 mm) 18-4 Understanding Pacemaker Operations output settings (refer to “Measuring Stimulation Thresholds” in Chapter 7). If a lead problem is suspected, the Prodigy pacemaker’s Lead Trend diagnostic can provide trend data on the integrity of the lead. ■ No output.
Medtronic Confidential 9879EN-18_9501043EN/CTC.qxd 5/10/99 11:35 Page 18-5 7 x 9 inches (178 mm x 229 mm) Troubleshooting the Pacing System 18-5 Troubleshooting Hemodynamic Problems Defining a Hemodynamic Problem When investigating a hemodynamic problem, data will be needed from many sources, including: ■ Patient Data. Determine the patient’s condition and daily routine.
Medtronic Confidential 9879EN-18_9501043EN/CTC.qxd 5/10/99 11:35 Page 18-6 7 x 9 inches (178 mm x 229 mm) 18-6 Understanding Pacemaker Operations ■ Changes in Patient Condition. A common example is the development of chronic atrial flutter or fibrillation post-implant.
Medtronic Confidential 9879EN-18_9501043EN/CTC.qxd 5/10/99 11:35 Page 18-7 7 x 9 inches (178 mm x 229 mm) Troubleshooting the Pacing System 18-7 Handling, Storage, and Resterilization Handling and Storage Do not implant the pacemaker if the package is damaged, or if the pacemaker has been dropped from a height of 30 cm (12 inches) or more. Damaged packages must be returned to the manufacturer. Storage temperature range from -18˚C (0˚F) to 55˚C (131˚F).
Medtronic Confidential 9879EN-18_9501043EN/CTC.qxd 5/10/99 11:35 Page 18-8 7 x 9 inches (178 mm x 229 mm) 18-8 Understanding Pacemaker Operations Pacemaker Longevity Background The Elective Replacement Indicator (ERI) establishes the point in time when the physician should schedule replacement of the pacemaker as soon as possible.
Medtronic Confidential 9879EN-18_9501043EN/CTC.qxd 5/10/99 11:35 Page 18-9 7 x 9 inches (178 mm x 229 mm) Troubleshooting the Pacing System 18-9 Distinguishing ERI from Full Electrical Reset Like the Elective Replacement Indicator (ERI), a full electrical reset puts a Prodigy pacemaker in VVI mode at 65 ppm, as described in the section “Electrical Reset” in Chapter 16.
Medtronic Confidential 9879EN-18_9501043EN/CTC.qxd 5/10/99 11:35 Page 18-10 7 x 9 inches (178 mm x 229 mm) 18-10 Understanding Pacemaker Operations Replacing the Pacemaker To replace the pacemaker: 1. Program the old pacemaker to a nonrate responsive pacing mode prior to explantation. This avoids any potential rate increase while handling the pacemaker. 2. Insert the proper white-handled hex wrench through each slit in the rubber grommets and loosen each set screw by turning counterclockwise. 3.
Medtronic Confidential 9879EN-18_9501043EN/CTC.qxd 5/10/99 11:35 Page 18-11 7 x 9 inches (178 mm x 229 mm) Troubleshooting the Pacing System 18-11 Patient Information and Service Patient Registration Information A registration form is included in the shipping package for each Medtronic implantable pacemaker. Upon completion by the physician, the form serves as a permanent record of facts related to the implanted device.
Medtronic Confidential 9879EN-18_9501043EN/CTC.qxd 5/10/99 11:35 Page 18-12 7 x 9 inches (178 mm x 229 mm) 18-12 Understanding Pacemaker Operations Assistance Information Medtronic representatives and engineers, located throughout the world, are highly trained and available to serve you. Upon request, representatives will train qualified hospital personnel in the use of Medtronic products.
Medtronic Confidential 9879EN-III-T_9501043EN/CTC.qxd 5/10/99 11:47 Page III-1 7 x 9 inches (178 mm x 229 mm) PART III Prodigy™ Reference Information Part III provides functional, parameter, and precautionary product information for the Prodigy DR, Prodigy D, Prodigy VDD, Prodigy SR, and Prodigy S pacemakers. This section supplements Part I (programmer procedures) and Part II (pacemaker operations and features).
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) 196407001 Rev A Refer to the “Reference man.” category in doc#163256 for Printing Instructions.
Medtronic Confidential 9879EN-A_9501043EN/CTC.qxd 5/10/99 11:36 Page A-1 7 x 9 inches (178 mm x 229 mm) SECTION A Basic Description, Radiopaque Identification, Mechanical Dimensions, Lead Compatibility, and Pacemaker Connectors Section A contains basic descriptions, radiopaque identifications, mechanical dimensions, lead compatibility, and pacemaker connectors for each of the Prodigy pacemakers listed below.
Medtronic Confidential 9879EN-A_9501043EN/CTC.qxd 5/10/99 11:36 Page A-2 7 x 9 inches (178 mm x 229 mm) A-2 Prodigy Reference Information Basic Description The Medtronic Prodigy family of pacemakers consists of multiprogrammable, implantable pacemakers. The five pacemakers in the Prodigy family offer a wide range of therapeutic features and diagnostic capabilities based on a common platform.
9879EN-A_9501043EN/CTC.qxd 5/10/99 11:36 Page A-3 Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) Basic Description, Radiopaques, Dimensions, Lead Compatibility, and Connectors A-3 Prodigy SR pacemakers are single chamber, activity-based rate responsive VVIR/AAIR pacemakers. ■ Model 8160 is compatible with IS-1* bipolar/unipolar leads. ■ Model 8161 is compatible with 5 or 6 mm unipolar leads. ■ Model 8162 is compatible with low-profile 3.2 mm bipolar leads and IS-1* bipolar/unipolar leads.
Medtronic Confidential 9879EN-A_9501043EN/CTC.qxd 5/10/99 11:36 Page A-4 7 x 9 inches (178 mm x 229 mm) A-4 Prodigy Reference Information Radiopaque Identification A standard X-ray displays the pacemaker’s radiopaque code block as black characters on a white background (see radiopaque illustration below). This code identifies the Prodigy models as follows: Model Radiopaque I.D.
Medtronic Confidential 9879EN-A_9501043EN/CTC.qxd 5/10/99 11:36 Page A-5 7 x 9 inches (178 mm x 229 mm) Basic Description, Radiopaques, Dimensions, Lead Compatibility, and Connectors A-5 Mechanical Dimensions Prodigy Model 196407001 Height (mm) Length (mm) Thickness (mm) Mass (g) Vol (cc) Prodigy DR 7860 7861 7862 44.7 50.3 46.7 47.9 47.9 47.9 7.5 7.5 7.5 27.1 28.5 28.0 12.1 14.2 13.0 Prodigy D 7864 7865 7866 44.7 50.3 46.7 47.9 47.9 47.9 7.5 7.5 7.5 26.9 28.3 27.8 12.1 14.2 13.
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Medtronic Confidential 9879EN-A_9501043EN/CTC.qxd 5/10/99 11:36 Page A-7 7 x 9 inches (178 mm x 229 mm) Basic Description, Radiopaques, Dimensions, Lead Compatibility, and Connectors A-7 Pacemaker Connectors Prodigy DR (7860) Prodigy D (7864) Prodigy VDD* (8168) Ø 1.93 mm (2x) Ø 3.5 mm (2x) 19.1 mm (2x) 25.9 mm (2x) Bipolar Connector (IS-1†) Prodigy DR (7861) Prodigy D (7865) Ø 2.46 mm (2x) Ø 4.5 mm (2x) Ø 6.0 mm (2x) Ø 5.0 mm (2x) 17.9 mm (2x) 26.4 mm (2x) 6.
Medtronic Confidential 9879EN-A_9501043EN/CTC.qxd 5/10/99 11:36 Page A-8 7 x 9 inches (178 mm x 229 mm) A-8 Prodigy Reference Information Prodigy DR (7862) Prodigy D (7866) Ø 1.88 mm (2x) Ø 3.5 mm (2x) 16.7 mm (2x) 25.6 mm (2x) Bipolar Connector (low-profile 3.2 mm) Prodigy SR (8160) Prodigy S (8164) Ø 1.93 mm Ø 3.5 mm 17.5 mm 24.
Medtronic Confidential 9879EN-A_9501043EN/CTC.qxd 5/10/99 11:36 Page A-9 7 x 9 inches (178 mm x 229 mm) Basic Description, Radiopaques, Dimensions, Lead Compatibility, and Connectors A-9 Prodigy SR (8161) Prodigy S (8165) Ø 2.46 mm Ø 6.0 mm Ø 4.5 mm Ø 5.0 mm 17.9 mm 26.4 mm Unipolar Connector (5/6 mm) Prodigy SR (8162) Prodigy S (8166) Ø 1.88 mm Ø 3.5 mm 17.5 mm 26.4 mm Bipolar Connector (low-profile 3.2 mm) Prodigy SR (8158) 22.9 mm 13.7 mm Ø 5.1 mm (2x) Ø 1.7 mm (2x) 16.8 mm 25.
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) 196407001 Rev A Refer to the “Reference man.” category in doc#163256 for Printing Instructions.
Medtronic Confidential 9879EN-B_9501043EN/CTC.qxd 5/10/99 11:37 Page B-1 7 x 9 inches (178 mm x 229 mm) SECTION B Shipping, Nominal, Electrical Reset, and Emergency Parameters Section B contains tables which present parameter settings for Shipping, Nominal, Electrical Reset, and Emergency conditions.
Medtronic Confidential 9879EN-B_9501043EN/CTC.qxd 5/10/99 11:37 Page B-2 7 x 9 inches (178 mm x 229 mm) B-2 Prodigy Reference Information Shipping Parameter Settings NOTE: Parameter settings not appearing for a specific Prodigy pacemaker are not applicable to that device. Some parameter settings are dependent on mode or other parameters.
Medtronic Confidential 9879EN-B_9501043EN/CTC.qxd 5/10/99 11:37 Page B-3 7 x 9 inches (178 mm x 229 mm) Shipping, Nominal, Electrical Reset, and Emergency Parameters Parameter Ventricular Amplitude Pulse Width Sensitivity Blanking (PAVB) Pacing Polarity Prodigy DR Prodigy D Prodigy VDD (7860/61/62) (7864/65/66) 3.5 V 0.4 ms 2.
Medtronic Confidential 9879EN-B_9501043EN/CTC.qxd 5/10/99 11:37 Page B-4 7 x 9 inches (178 mm x 229 mm) B-4 Prodigy Reference Information Nominal Parameter Settings NOTE: Parameter settings not appearing for a specific Prodigy pacemaker are not applicable to that device. Some parameter settings are dependent on mode or other parameters.
Medtronic Confidential 9879EN-B_9501043EN/CTC.qxd 5/10/99 11:37 Page B-5 7 x 9 inches (178 mm x 229 mm) Shipping, Nominal, Electrical Reset, and Emergency Parameters Parameter Rate Response Activity Rate Response Activity Threshold Acceleration Deceleration Prodigy DR Prodigy D Prodigy VDD (7860/61/62) (7864/65/66) (8168) Prodigy SR (8158) (8160/61/62) 7 7 Medium Medium 0.5 min 5 min 0.
Medtronic Confidential 9879EN-B_9501043EN/CTC.qxd 5/10/99 11:37 Page B-6 7 x 9 inches (178 mm x 229 mm) B-6 Prodigy Reference Information Electrical Reset Parameter Settings NOTE: Parameter settings not appearing for a specific Prodigy pacemaker are not applicable to that device. Some parameter settings are dependent on mode or other parameters.
Medtronic Confidential 9879EN-B_9501043EN/CTC.qxd 5/10/99 11:37 Page B-7 7 x 9 inches (178 mm x 229 mm) Shipping, Nominal, Electrical Reset, and Emergency Parameters Parameter Ventricular Amplitude Pulse Width Sensitivity Prodigy DR Prodigy D Prodigy VDD (7860/61/62) (7864/65/66) (8168) 5.0V 0.4 ms 2.8 mV 5.0V 0.4 ms 2.
Medtronic Confidential 9879EN-B_9501043EN/CTC.qxd 5/10/99 11:37 Page B-8 7 x 9 inches (178 mm x 229 mm) B-8 Prodigy Reference Information Emergency Parameter Settings 5 196407001 Rev A Parameter Prodigy DR Prodigy D Prodigy VDD Prodigy SR5 Prodigy S5 Mode VVI Pacing Rate 70 ppm Ventricular Refractory Period 330 ms Ventricular Amplitude Pulse Width Sensitivity Pacing Polarity Sensing Polarity 7.5V 1.5 ms 2.
Medtronic Confidential 9879EN-C_9501043EN/CTC.qxd 5/10/99 11:38 Page C-1 7 x 9 inches (178 mm x 229 mm) SECTION C Longevity Projections, Elective Replacement Indicator, and Battery Specifications Section C contains information on longevity projections and elective replacement indicator operations and messages that aid in determining when to replace Prodigy pacemakers. In addition, battery specifications are given.
Medtronic Confidential 9879EN-C_9501043EN/CTC.qxd 5/10/99 11:38 Page C-2 7 x 9 inches (178 mm x 229 mm) C-2 Prodigy Reference Information Longevity Projections Projected Longevity from Implant to ERI The following tables show the estimated time from implant to the elective replacement indicator (ERI) being set at nominal and low output settings for Prodigy pacemakers. The estimated time varies based on the lead impedance, the programmed amplitudes, and the percent paced.
Medtronic Confidential 9879EN-C_9501043EN/CTC.qxd 5/10/99 11:38 Page C-3 7 x 9 inches (178 mm x 229 mm) Longevity Projections, Elective Replacement Indicator, and Battery Specifications C-3 Prodigy VDD Pacemakers’ Projected Longevity from Implant to ERI Programmed Settings Percent Paced Projected Longevity (Years) Prodigy VDD (8168) VDD Rate: 60 ppm Mode: Pulse Width: 4.0 ms Lead Impedance 600 ohms Nominal Amplitude: 3.5 V Low Amplitude: 2.5 V 100% 9.8 50% 11.2 100% 11.5 50% 12.
Medtronic Confidential 9879EN-C_9501043EN/CTC.qxd 5/10/99 11:38 Page C-4 7 x 9 inches (178 mm x 229 mm) C-4 Prodigy Reference Information Projected Longevity From ERI to Erratic Pacing The following tables show the estimated time from the ERI to erratic pacing for the Prodigy pacemakers. Regardless of the patients programmed settings, virtually all (i.e., 99.9%) Prodigy DR, Prodigy D, and Prodigy VDD pacemakers will achieve a minimum (min) of 3.
Medtronic Confidential 9879EN-C_9501043EN/CTC.qxd 5/10/99 11:38 Page C-5 7 x 9 inches (178 mm x 229 mm) Longevity Projections, Elective Replacement Indicator, and Battery Specifications C-5 Prodigy VDD Pacemaker’s Projected Longevity from ERI to Erratic Pacing Previously Programmed Settings Percent Paced Rate (ppm) Nominal Settings Mode: VDD Amplitude: 3.5 V Pulse Width: 0.4 ms Single Chamber Settings Mode: VVIR/VVI Amplitude: 3.5 V Pulse Width: 0.
Medtronic Confidential 9879EN-C_9501043EN/CTC.qxd 5/10/99 11:38 Page C-6 7 x 9 inches (178 mm x 229 mm) C-6 Prodigy Reference Information Elective Replacement Indicator (ERI) The Elective Replacement Indicator (ERI) is set when the battery voltage drops below 2.62 V (all models). Listed below are the ERI for nonmagnet and magnet modes for the Prodigy pacemakers.
Medtronic Confidential 9879EN-C_9501043EN/CTC.qxd 5/10/99 11:38 Page C-7 7 x 9 inches (178 mm x 229 mm) Longevity Projections, Elective Replacement Indicator, and Battery Specifications C-7 Battery Specifications 196407001 Prodigy DR (7860/61/62) Prodigy D (7864/65/66) Prodigy VDD (8168) Prodigy SR (8158, 8160/61/62) Prodigy S (8164/65/66) Type Lithium-iodine Lithium-iodine Voltage 2.8 V 2.8 V Available Capacity 1.5 amp-hr 1.1 amp-hr Average Projected Capacity 1.2 amp-hr 0.
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) 196407001 Rev A Refer to the “Reference man.” category in doc#163256 for Printing Instructions.
Medtronic Confidential 9879EN-D_9501043EN/CTC.qxd 5/10/99 11:39 Page D-1 7 x 9 inches (178 mm x 229 mm) SECTION D Magnet Mode Operations, Telemetry Functions, Diagnostics, and Event Summaries Section D contains Prodigy magnet mode operations, telemetry functions, and diagnostics that are available for patient follow-up sessions.
Medtronic Confidential 9879EN-D_9501043EN/CTC.qxd 5/10/99 11:39 Page D-2 7 x 9 inches (178 mm x 229 mm) D-2 Prodigy Reference Information Magnet Mode Operations Listed below are the magnet mode operations in dual and single chamber modes for the Prodigy pacemakers.
Medtronic Confidential 9879EN-D_9501043EN/CTC.qxd 5/10/99 11:39 Page D-3 7 x 9 inches (178 mm x 229 mm) Magnet Mode Operations, Telemetry Functions, Diagnostics, and Event Summaries D-3 Telemetry Functions Listed below are Marker Channel telemetries, battery and lead telemetry, diagnostics, and event summaries for each of the Prodigy pacemakers.
Medtronic Confidential 9879EN-D_9501043EN/CTC.qxd 5/10/99 11:39 Page D-4 7 x 9 inches (178 mm x 229 mm) D-4 Prodigy Reference Information Dual Chamber Pacemaker Diagnostics NOTE: Prodigy diagnostics are programmed using the diagnostic setups listed below that set the diagnostic type and associated parameters listed under “setup values”. Alternately, other programmable values can be selected for the diagnostic type and parameters. Diagnostic Setup A.
Medtronic Confidential 9879EN-D_9501043EN/CTC.qxd 5/10/99 11:39 Page D-5 7 x 9 inches (178 mm x 229 mm) Magnet Mode Operations, Telemetry Functions, Diagnostics, and Event Summaries Diagnostic Setup Setup Values Rate Histogram Type: Refractory: Lead Monitor2: Rate Histogram Include OFF Lead Trend Type: Method: Lead Trend Rolling Lead Monitor2: D-5 Other Programmable Values Exclude ON, ON + Polar. SW.
Medtronic Confidential 9879EN-D_9501043EN/CTC.qxd 5/10/99 11:39 Page D-6 7 x 9 inches (178 mm x 229 mm) D-6 Prodigy Reference Information Single Chamber Pacemaker Diagnostics NOTE: Prodigy diagnostics are programmed using the diagnostic setups listed below that set the diagnostic type and associated parameters listed under “setup values”. Alternately, other programmable values can be selected for the diagnostic type and parameters.
Medtronic Confidential 9879EN-D_9501043EN/CTC.qxd 5/10/99 11:39 Page D-7 7 x 9 inches (178 mm x 229 mm) Magnet Mode Operations, Telemetry Functions, Diagnostics, and Event Summaries D-7 Event Summaries Prodigy DR Prodigy D Prodigy VDD Prodigy SR Prodigy S ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ PVC and PVC Run Events ✓ ✓ ✓ Mode Switch Event ✓ Percent Total Events AV Sequence Pace/Sense 196407001 Rev A Refer to the “Reference man.” category in doc#163256 for Printing Instructions.
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) 196407001 Rev A Refer to the “Reference man.” category in doc#163256 for Printing Instructions.
Medtronic Confidential 9879EN-E_9501043EN/CTC.qxd 5/10/99 11:40 Page E-1 7 x 9 inches (178 mm x 229 mm) SECTION E Modes and Parameters, Programming Requirements and Restrictions, and Timing Reference Table Section E provides programmable, nonprogrammable, and temporary parameter capabilities for the Prodigy pacemakers. The parameters are divided into the dual chamber pacemakers and the single chamber pacemakers listed below.
Medtronic Confidential 9879EN-E_9501043EN/CTC.qxd 5/10/99 11:40 Page E-2 7 x 9 inches (178 mm x 229 mm) E-2 Prodigy Reference Information Dual Chamber Pacemaker Permanent Programmable Modes and Parameters In the table below are the Prodigy DR, Prodigy D, and Prodigy VDD permanent programmable modes and parameters. Parameters listed under separate columns apply only to the specific Prodigy model. Parameters common to two or three Prodigy models are listed once under the respective models.
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Medtronic Confidential 9879EN-E_9501043EN/CTC.qxd 5/10/99 11:40 Page E-4 7 x 9 inches (178 mm x 229 mm) E-4 Prodigy Reference Information Parameter Prodigy DR (7860/61/62) Prodigy D (7864/65/66) Ventricular Amplitude* Prodigy VDD (8168) Notes 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 7.5 V Pulse Width 0.03, 0.06, 0.09, 0.12 ms 0.15, 0.20, 0.25, … 1.0 ms 1.1, 1.2, 1.3, 1.4, 1.5 ms Sensitivity 1.0, 1.4, 2.0, 2.8, 4.0, 5.6, 8.0, 11.
Medtronic Confidential 9879EN-E_9501043EN/CTC.qxd 5/10/99 11:40 Page E-5 7 x 9 inches (178 mm x 229 mm) Programmable, Nonprogrammable, and Temporary Parameters, Restrictions, and Timing Parameter Lead Monitor Prodigy D (7864/65/66) ON, OFF, ON + Polar. SW. - A+V, ON + Polar. SW. - A, ON + Polar. SW.
Medtronic Confidential 9879EN-E_9501043EN/CTC.qxd 5/10/99 11:40 Page E-6 7 x 9 inches (178 mm x 229 mm) E-6 Prodigy Reference Information Single Chamber Pacemaker Permanent Programmable Modes and Parameters In the table below are the Prodigy SR and Prodigy S permanent programmable modes and parameters. Parameters listed under separate columns apply only to the specific Prodigy model. Parameters common to both Prodigy models are listed once.
Medtronic Confidential 9879EN-E_9501043EN/CTC.qxd 5/10/99 11:40 Page E-7 7 x 9 inches (178 mm x 229 mm) Programmable, Nonprogrammable, and Temporary Parameters, Restrictions, and Timing Parameter Rate Response Activity Rate Response Activity Threshold Acceleration Deceleration Lead Monitor Prodigy S 1, 2, 3, … 10 Not Applicable Rate responsive modes Low, Medium/Low, Medium, Medium/High, High 0.25 min, 0.5 min, 1.0 min 2.5 min, 5.0 min, 10 min ON, OFF, ON + Polar. SW.
Medtronic Confidential 9879EN-E_9501043EN/CTC.qxd 5/10/99 11:40 Page E-8 7 x 9 inches (178 mm x 229 mm) E-8 Prodigy Reference Information Programming Requirements and Restrictions The following requirements and restrictions insure that parameter settings selected for programming do not form an invalid combination or cause an undesirable interaction.
Medtronic Confidential 9879EN-E_9501043EN/CTC.qxd 5/10/99 11:40 Page E-9 7 x 9 inches (178 mm x 229 mm) Programmable, Nonprogrammable, and Temporary Parameters, Restrictions, and Timing E-9 Detect Rate must be at least 10 bpm greater than the Upper Tracking Rate, except for the combination of 175 bpm (Detect Rate) and 170 ppm (Upper Tracking Rate), which is valid. If the Upper Tracking Rate is 165 ppm or above, a pending value for Detect Rate is automatically selected by the programmer.
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Medtronic Confidential 9879EN-E_9501043EN/CTC.qxd 5/10/99 11:40 Page E-12 7 x 9 inches (178 mm x 229 mm) E-12 Prodigy Reference Information Timing Reference Table Event Modes Timing Description 1. A-sense outside refractory period DDD, DDDR, VDD Starts atrial refractory (including the associated 50 to 100 ms atrial blanking) period and SAV. 2.
Medtronic Confidential 9879EN-E_9501043EN/CTC.qxd 5/10/99 11:40 Page E-13 7 x 9 inches (178 mm x 229 mm) Programmable, Nonprogrammable, and Temporary Parameters, Restrictions, and Timing Event 196407001 E-13 Modes Timing Description 11. A-pace DDD, DDDR, DDI, DDIR Starts atrial refractory (including the associated 50 to 100 ms atrial blanking) period, programmed Ventricular Blanking Period, and PAV. 12.
Medtronic Confidential 9879EN-E_9501043EN/CTC.qxd 5/10/99 11:40 Page E-14 7 x 9 inches (178 mm x 229 mm) E-14 Prodigy Reference Information Event Modes Timing Description 20.
Medtronic Confidential 9879EN-E_9501043EN/CTC.qxd 5/10/99 11:40 Page E-15 7 x 9 inches (178 mm x 229 mm) Programmable, Nonprogrammable, and Temporary Parameters, Restrictions, and Timing Event 196407001 E-15 Modes Timing Description 27.
9879EN-E_9501043EN/CTC.qxd 5/10/99 11:40 Page E-16 Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) E-16 Prodigy Reference Information The Prodigy pacemaker’s timing in dual chamber modes can be summarized by the following rules: ■ In the DDDR, DDIR, DVIR, DDD, DDI, and DVI modes, an atrial pace starts a PAV that times out only in the absence of a sensed ventricular event. That is, the VA interval always begins with the next sensed or paced ventricular event, whichever comes first.
Medtronic Confidential 9879EN-F_9501043EN/CTC.qxd 5/10/99 11:41 Page F-1 7 x 9 inches (178 mm x 229 mm) SECTION F General Warnings and Precautions Section F contains general warnings and precautions that the clinician should consider when programming Prodigy pacemakers. Specific mode or parameter warnings and precautions are covered under the specific topic in Section II of this manual.
9879EN-F_9501043EN/CTC.qxd 5/10/99 11:41 Page F-2 Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) F-2 Prodigy Reference Information General Warnings General Warning Medtronic implantable pacemakers and leads are implanted in the extremely hostile environment of the human body. This environment places severe limitations on the design and function of the pacemaker and lead.
Medtronic Confidential 9879EN-F_9501043EN/CTC.qxd 5/10/99 11:41 Page F-3 7 x 9 inches (178 mm x 229 mm) Warnings and Precautions F-3 Implantable Defibrillator Some pacemaker patients may also require therapy from an implantable defibrillator. Only bipolar pacing should be used with these patients. In some cases, pacing in the unipolar configuration may cause the defibrillator either to deliver inappropriate therapy or withhold appropriate therapy.
9879EN-F_9501043EN/CTC.qxd 5/10/99 11:41 Page F-4 Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) F-4 Prodigy Reference Information ■ Prodigy SR (Model 8161) Prodigy S (Model 8165) These models are unipolar-only devices and should not be used in patients having an implantable defibrillator. ■ Prodigy SR (Models 8158, 8160, 8162) Prodigy S (Models 8164, 8166) These models implanted with unipolar lead(s) should not be used in patients having an implantable defibrillator.
Medtronic Confidential 9879EN-F_9501043EN/CTC.qxd 5/10/99 11:41 Page F-5 7 x 9 inches (178 mm x 229 mm) Warnings and Precautions F-5 General Precautions Failure Mechanisms The clinician should be aware that all pacemakers ultimately cease to function. There is minimal risk that they may also fail at any time due to random component or battery failure(s) which cannot be predicted prior to occurrence.
Medtronic Confidential 9879EN-F_9501043EN/CTC.qxd 5/10/99 11:41 Page F-6 7 x 9 inches (178 mm x 229 mm) F-6 Prodigy Reference Information Crosstalk and Self-Inhibition Crosstalk occurs in dual chamber systems (except with the Prodigy VDD pacemaker) when atrial pacing output pulses are sensed by the ventricular lead. Special circuitry in Prodigy pacemakers prevents crosstalk and selfinhibition during normal operation.
Medtronic Confidential 9879EN-F_9501043EN/CTC.qxd 5/10/99 11:41 Page F-7 7 x 9 inches (178 mm x 229 mm) Warnings and Precautions F-7 Potential Effects of Pressure on the Pacemaker Clinical studies of activity rate responsive pacemakers have reported instances of increased sensitivity to muscle motion (such as heart contractions) when external pressure is exerted on the device.
Medtronic Confidential 9879EN-F_9501043EN/CTC.qxd 5/10/99 11:41 Page F-8 7 x 9 inches (178 mm x 229 mm) F-8 Prodigy Reference Information Effects of Myopotentials During Unipolar Pacing Myopotentials could affect the operation of Prodigy models programmed to unipolar sensing, especially atrial Sensitivity settings of 0.5 thru 1.0 mV and ventricular Sensitivity setting of 1.0 and 1.4 mV.
Medtronic Confidential 9879EN-F_9501043EN/CTC.qxd 5/10/99 11:41 Page F-9 7 x 9 inches (178 mm x 229 mm) Warnings and Precautions F-9 Potential Complications Prodigy pacemaker/lead system may operate inappropriately or fail completely due to several potential complications.
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) 196407001 Rev A Refer to the “Reference man.” category in doc#163256 for Printing Instructions.
Medtronic Confidential 9879EN-G_9501043EN/CTC.qxd 5/10/99 11:43 Page G-1 7 x 9 inches (178 mm x 229 mm) SECTION G Hospital, Medical, Home, and Job Environment Interference Section G contains information on potential effects of electromagnetic interference on Prodigy pacemakers in the hospital or medical environment and in the home or job environment. Also, general recommendations are given for follow-up frequency (Medicare guidelines).
Medtronic Confidential 9879EN-G_9501043EN/CTC.qxd 5/10/99 11:43 Page G-2 7 x 9 inches (178 mm x 229 mm) G-2 Prodigy Reference Information Hospital or Medical Environment Interference Prodigy pacemakers are designed to ensure immunity from most common sources of electromagnetic interference (EMI). Because many different EMI sources exist or could become common in the future, it is impossible to characterize all EMI sources.
Medtronic Confidential 9879EN-G_9501043EN/CTC.qxd 5/10/99 11:43 Page G-3 7 x 9 inches (178 mm x 229 mm) Hospital, Medical, Home or Job Environment Interference G-3 a) Magnetic and radio frequency (RF) fields produced by MRI may adversely affect the operation of the pacemaker, including total inhibition of pacing output. b) Magnetic fields may activate magnet mode operation and cause asynchronous pacing.
Medtronic Confidential 9879EN-G_9501043EN/CTC.qxd 5/10/99 11:43 Page G-4 7 x 9 inches (178 mm x 229 mm) G-4 Prodigy Reference Information Electrocautery Electrocautery can induce ventricular fibrillation. The electrocautery tip should never be used within 15 cm (6 inches) of an implanted Prodigy pacemaker/lead system. The use of electrocautery may cause a temporary pause in output, the rate exceed the 200 ppm rate limit, set the elective replacement indicator or electrically reset the device.
Medtronic Confidential 9879EN-G_9501043EN/CTC.qxd 5/10/99 11:43 Page G-5 7 x 9 inches (178 mm x 229 mm) Hospital, Medical, Home or Job Environment Interference G-5 Home and Job Environment Interference Based on laboratory tests of Prodigy pacemakers, the device should not be affected by the normal operation of electrical equipment, household appliances, electric machine shop tools, microwave ovens, spark-ignited internal combustion engines, low-powered radio, and microwave frequency transmitters.
9879EN-G_9501043EN/CTC.qxd 5/10/99 11:43 Page G-6 Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) G-6 Prodigy Reference Information The following information provides a general guideline to patients having an implanted pacemaker who desire to operate a cellular phone: ■ Maintain a minimum separation of 6 inches (15 centimeters) between a hand-held personal cellular phone and the implanted device.
Medtronic Confidential 9879EN-H_9501043EN/CTC.qxd 5/10/99 11:45 Page H-1 7 x 9 inches (178 mm x 229 mm) SECTION H General Pacing Indications The indications for long-term cardiac pacing as recommended by the American Heart Association Task Force on Assessment of Diagnostic and Therapeutic Cardiovascular Procedures (Committee on Pacemaker Implantation)1 are presented below.
Medtronic Confidential 9879EN-H_9501043EN/CTC.qxd 5/10/99 11:45 Page H-2 7 x 9 inches (178 mm x 229 mm) H-2 Prodigy Reference Information Indications for Permanent Pacing in Acquired Atrioventricular Block in Adults Class I: 196407001 Rev A ■ Complete heart block, permanent or intermittent, at any anatomic level, associated with any one of the following complications: - Symptomatic bradycardia.
9879EN-H_9501043EN/CTC.qxd 5/10/99 11:45 Page H-3 Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) General Pacing Indications H-3 Class II: ■ Asymptomatic complete heart block, permanent or intermittent, at any anatomic site with a ventricular rate of > 40 bpm or faster. ■ Asymptomatic Type II second-degree AV block, permanent or intermittent. ■ Asymptomatic Type I second-degree AV block at intra-His or infraHis levels. Class III: 196407001 Rev A ■ First degree AV block.
Medtronic Confidential 9879EN-H_9501043EN/CTC.qxd 5/10/99 11:45 Page H-4 7 x 9 inches (178 mm x 229 mm) H-4 Prodigy Reference Information Indications for Permanent Pacing After Myocardial Infarction Class I: ■ Persistent advanced second-degree AV block or complete heart block after acute myocardial infarction with block in the His-Purkinje system (bilateral bundle branch block). ■ Patients with transient advanced AV block and associated bundle branch block.
Medtronic Confidential 9879EN-H_9501043EN/CTC.qxd 5/10/99 11:45 Page H-5 7 x 9 inches (178 mm x 229 mm) General Pacing Indications H-5 Indications for Permanent Pacing in Bifascicular and Trifascicular Block Class I: ■ Bifascicular block with intermittent complete heart block associated with symptomatic bradycardia. ■ Bifascicular or trifascicular block with intermittent Type II seconddegree AV block without symptoms attributable to the heart block.
Medtronic Confidential 9879EN-H_9501043EN/CTC.qxd 5/10/99 11:45 Page H-6 7 x 9 inches (178 mm x 229 mm) H-6 Prodigy Reference Information Indications for Permanent Pacing in Sinus Node Dysfunction Class I: ■ Sinus node disfunction with documented symptomatic bradycardia. In some patients this will occur as a consequence of long-term (essential) drug therapy of a type and dose for which there are no acceptable alternative.
9879EN-H_9501043EN/CTC.qxd 5/10/99 11:45 Page H-7 Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) General Pacing Indications H-7 Indications for Permanent Pacing in Hypersensitive Carotid Sinus Syndrome and Neurovascular Syndromes Class I: ■ Recurrent syncope associated with clear, spontaneous events provoked by carotid sinus stimulation; minimal carotid sinus pressure induces asystole of > 3 seconds (in the absence of any medication that depresses the sinus node or AV conduction).
Medtronic Confidential 9879EN-H_9501043EN/CTC.qxd 5/10/99 11:45 Page H-8 7 x 9 inches (178 mm x 229 mm) H-8 Prodigy Reference Information Indications for Permanent Pacing in Children Class I: ■ Second or third-degree heart block with symptomatic bradycardia. ■ Advanced second or third-degree AV block with moderate to marked exercise intolerance. ■ External ophthalmoplegia with bifascicular block. ■ Sinus node dysfunction with symptomatic bradycardia.
Medtronic Confidential 9879EN-H_9501043EN/CTC.qxd 5/10/99 11:45 Page H-9 7 x 9 inches (178 mm x 229 mm) General Pacing Indications H-9 Class III: 196407001 Rev A ■ Asymptomatic postoperative bifascicular block. ■ Asymptomatic postoperative bifascicular block with first-degree AV block. ■ Transient surgical AV block that returns to normal conduction in one week. ■ Asymptomatic Type I second-degree AV block.
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) 196407001 Rev A Refer to the “Reference man.” category in doc#163256 for Printing Instructions.
Medtronic Confidential 9879EN-Glos_9501043EN/CTC.qxd 5/10/99 11:42 Page I-1 7 x 9 inches (178 mm x 229 mm) GLOSSARY About This Glossary The following terms have meanings pertaining to 1) certain general pacing concepts, 2) Medtronic products, and 3) special usage in this guide. I-1 196407001 Rev A Refer to the “Reference man.” category in doc#163256 for Printing Instructions.
9879EN-Glos_9501043EN/CTC.qxd 5/10/99 11:42 Page I-2 Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) I-2 Prodigy Reference Information activity - 1) patient body motion as detected by the pacemaker’s piezoelectric crystal sensor in rate responsive modes. 2) type of rate responsive pacemaker that increases or decreases pacing rate in proportion to levels of detected patient body motion. artifact - the pacemaker’s electrical output recorded as a vertical spike on the electrocardiogram.
9879EN-Glos_9501043EN/CTC.qxd 5/10/99 11:42 Page I-3 Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) Glossary I-3 current - in pacemakers, the continuing flow of electricity through the pacemaker circuit (esp. through the lead conductor) as measured in milliamperes; high current is associated with high voltage, low current with low voltage. Current cannot be directly controlled, but can be indirectly controlled by altering the voltage or the resistance (impedance).
9879EN-Glos_9501043EN/CTC.qxd 5/10/99 11:42 Page I-4 Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) I-4 Prodigy Reference Information escape rate - a pacing rate which is a function of the “escape interval” (see above); the slowest pacing rate possible. exit block - failure of a pacemaker to capture the heart because the patient’s stimulation threshold exceeds the output of the pacemaker. freeze - to stop and collect a portion of the patient’s ECG trace on a fullscreen programmer.
Medtronic Confidential 9879EN-Glos_9501043EN/CTC.qxd 5/10/99 11:42 Page I-5 7 x 9 inches (178 mm x 229 mm) Glossary I-5 noise - any electromagnetic interference, myopotentials, or crosstalk detected by a pacemaker’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.
9879EN-Glos_9501043EN/CTC.qxd 5/10/99 11:42 Page I-6 Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) I-6 Prodigy Reference Information radiopaque ID - a small metallic plate (inside the pacemaker connector) bearing both the Medtronic logo and a code for identifying the pacemaker under fluoroscopy. real-time measurement - a pacing system function that presents measured and calculated data at the time of the clinician’s query via programmer telemetry.
9879EN-Glos_9501043EN/CTC.qxd 5/10/99 11:42 Page I-7 Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) Glossary I-7 strength-duration - refers to a curve that is a plot of at least two pacemaker stimulation-threshold test results, each test defining amplitude (strength) and pulse width (duration). The narrower the pulse width, the greater the voltage required to stimulate the heart, and vice versa. (See “Strength-Duration Test.
9879EN-Glos_9501043EN/CTC.qxd 5/10/99 11:42 Page I-8 Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) I-8 Prodigy Reference Information Wenckebach operation - in dual chamber atrial tracking modes, an upper rate operation which limits the average ventricular pacing rate when intrinsic atrial rates rise above the programmed Upper Tracking Rate. The pacemaker does this by gradually prolonging the pacemaker’s AV interval until one atrial event falls into the PVARP and is not tracked.
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Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) 196407001 Rev A Refer to the “Reference man.” category in doc#163256 for Printing Instructions.
Medtronic Confidential 7 x 9 inches (178 mm x 229 mm) Europe Medtronic Europe S.A./N.V. Woluwe Office Garden Woluwedal 26 1932 St. Stevens Woluwe Belgium Telephone: (32-2) 716 88 11 FAX: (32-2) 716 88 15 Latin America Medtronic, Inc.