Medtronic 7960I Reference Guide

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Pacemaker Information and

PROGRAMM ER

Programming Guide

9879E Software

Use to program the following pacemakers including the i series:

THERA®DR THERA®D THERA®VDD THERA®SR THERA®S

CAUTION: The Thera®VDD and Thera®VDD (i series) pacemakers are not currently approved by the FDA.

Medtronic

THERA¨Pacemaker Information And Programming Guide

A Guide To Understanding Thera¨Pacemakers And Using The 9760 and 9790 Programmers

How To Use This Guide

The 9790/9760 Pacemaker Information and Programming Guide is the reference manual of the two-manual set supporting the THERA®* pacemakers. Each Thera pacemaker also has its own product information manual packaged with the device. This guide provides comprehensive information about the Thera pacing systems: Medtronic®Thera pacemakers, 9760 and 9790 Programmers, and leads.**

Organization of this guide divides information about the Thera pacing system into three major parts as follows:

Part I — This part describes the programmer capabilities. It provides instructions on how to set up the programmer and apply its functions for programming applicable pacemaker features and retrieving data.

Part II — This part describes all pacemaker parameters and features, including pacing modes, rate response options, special therapy options, diagnostic reporting features, and information for troubleshooting the pacing system. It supplements the product information manual, which gives information needed primarily at pacemaker implantation. In this part, the clinical intent of Thera-specific features is described, as well as illustrations of operation and programming considerations useful in the follow-up setting.

NOTE: Part II provides all possible pacing and programming features for the Thera pacemaker families without any specific reference to the models. Refer to Part III to determine which features apply to specific Thera pacemaker models.

Part III — This part includes quick-reference information organized by topic or feature. To find information on a specific pacemaker model, look under each topic. Of particular help are “Modes and Parameters” and “Diagnostics,” which identify which features (presented in Part II) are applicable to each Thera pacemaker model.

* Thera, CapSure, Marker Channel, Medtronic, MemoryMod, and Teletrace are all

trademarks of Medtronic, Inc.

**Lead information provided describes pacemaker compatibility. Details are provided in the

applicable lead technical manual.

iii

Part I Using the Programmer

Chapter 1 - Using the Programmer with THERA¨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 ...................................1-4

Display Screen Format and Interactive Features..........................1-5

A Guide to Using the Menu and Command Buttons .......................1-8

Chapter 2 - Procedures to Know Before You Begin 2-1

Using the Programming Head.......................................2-2

Programming Emergency Parameters .................................2-6

Interrogating the Pacemaker........................................2-7

Canceling the Programming Head Magnet..............................2-9

Printing Reports During a Patient Session .............................2-10

Printing Reports After a Session Has Ended............................2-13

Transferring Session Data to a Diskette ...............................2-13

Using the HELP Options .........................................2-16

Chapter 3 - Starting and Ending a Patient Session 3-1

Before You Begin ...............................................3-2

Turning the Programmer ON .......................................3-3

Selecting the Pacemaker Model .....................................3-4

Selecting the Desired Function ......................................3-7

Ending a Patient Session ..........................................3-9

Chapter 4 - Retrieving Pacing System Data 4-1

Displaying Present Parameter Settings ................................4-2

Displaying a Summary of Pacemaker Status ............................4-6

Displaying Battery and Lead Information .............................4-10

Displaying a Graph of Recorded Diagnostic Data........................4-13

Chapter 5 - Displaying and Printing the PatientÕs ECG and EGM 5-1

Printing the Patient’s ECG and EGM.................................5-2

Displaying the Patient’s ECG and EGM...............................5-5

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.................................6-10

Chapter 7 - Determining and Evaluating Parameter Settings 7-1

Measuring Stimulation Thresholds ...................................7-2

Determining a Setting for Sensitivity.................................7-15

Determining Rate Response Parameter Settings .........................7-21

Programming Temporary Parameter Values............................7-30

Measuring Rate and AV Interval....................................7-33

Chapter 8 - Collecting and Retrieving Diagnostic Data 8-1

About the Diagnostics Function .....................................8-2

Types of Data You Can Record .....................................8-3

Recording Data From a Non-Paced Chamber...........................8-16

Programmable Parameter Options...................................8-18

About the Setup Options .........................................8-21

Programming the Pacemaker to Record Data ...........................8-23

Displaying a Graph of the Recorded Data .............................8-27

Printing the Diagnostic Data.......................................8-29

Clearing Recorded Data From the Pacemaker ..........................8-30

Chapter 9 - Programmer Setup Options 9-1

Setting the Time and Date .........................................9-2

Connecting an External Recorder or Monitor............................9-3

Using the CALIBRATE Option .....................................9-4

Setting Up Site Nominal Parameter Values .............................9-6

Setting the Artifact Display .......................................9-10

Part II Understanding Pacemaker Operation

Chapter 10 - Pacing Modes 10-1

Introduction ..................................................10-3

Mode Selection Decision Tree .....................................10-5

Mode Pertinency Tables..........................................10-6

DDDR Mode..................................................10-8

DDD Mode ..................................................10-10

DDIR Mode .................................................10-12

DDI Mode...................................................10-14

DVIR Mode .................................................10-16

DVI Mode...................................................10-18

VDD Mode ..................................................10-20

AAIR/ADIR Modes............................................10-22

AAI/ADI Modes ..............................................10-24

VVIR/VDIR Modes............................................10-26

VVI/VDI Modes ..............................................10-28

AAT/VVT Modes .............................................10-30

DOOR/AOOR/VOOR Modes.....................................10-32

DOO/AOO/VOO Modes ........................................10-34

ODO/ OAO/ OVO Modes .......................................10-36

Chapter 11 - Rate Response Therapy Options 11-1

Rate Responsive Pacing ..........................................11-2

Activity Threshold..............................................11-4

Activity Rate Response ..........................................11-6

Acceleration and Deceleration Times ................................11-8

Rate Response Optimization......................................11-11

Chapter 12 - Pacemaker Timing 12-1

Rates .......................................................12-2

AV Intervals ..................................................12-8

Blanking Periods ..............................................12-14

Refractory Periods .............................................12-16

High Rate Atrial Tracking .......................................12-23

Chapter 13 - Lead/Cardiac Tissue Interface 13-1

Selecting Pacing Parameters.......................................13-2

Selecting Sensing Parameters ......................................13-5

Monitoring Lead Stability ........................................13-8

Transtelephonic Capture Verification with TMT .......................13-11

Chapter 14 - Special Therapy Options 14-1

Mode Switch..................................................14-2

Non-Competitive Atrial Pacing.....................................14-7

PMT Intervention ..............................................14-9

PVC Response................................................14-11

Ventricular Safety Pacing........................................14-13

Rate Drop Response............................................14-15

vii

Sleep Function................................................14-21

Single Chamber Hysteresis.......................................14-23

Chapter 15 - Telemetry Data 15-1

Parameter Summary.............................................15-2

Battery and Lead Information ......................................15-4

Marker Channel™ Telemetry ......................................15-6

Intracardiac Electrogram (EGM)....................................15-8

Extended Telemetry............................................15-10

Chapter 16 - Miscellaneous Operations 16-1

Magnet Mode Operation .........................................16-2

Temporary Programming .........................................16-5

Electrical Reset ................................................16-6

Elective Replacement Indicator (ERI) ................................16-8

Emergency Pacing ..............................................16-9

Chapter 17 - Diagnostics 17-1

Introduction to Diagnostics........................................17-2

Event Summary................................................17-4

Rate Histogram ................................................17-6

AV Conduction Histogram........................................17-8

High Rate Episode .............................................17-10

Rate Versus Time Trend.........................................17-14

viii

Chapter 18 - Troubleshooting the Pacing System 18-1

Troubleshooting Strategy .........................................18-2

Troubleshooting Electrical Problems.................................18-3

Troubleshooting Hemodynamic Problems .............................18-5

Handling, Storage, and Resterilization................................18-7

Pacemaker Longevity............................................18-8

Replacing the Pacemaker ........................................18-10

Patient Information and Service ...................................18-11

PART III THERA¨Reference Information

Section A - Basic Description, Radiopaque Identification, Mechanical Dimensions, Lead Compatibility, and Pacemaker Connectors A-1

Basic Description ...............................................A-2

Radiopaque Identification .........................................A-4

Mechanical Dimensions ..........................................A-5

Lead Compatibility ..............................................A-7

Pacemaker Connectors ...........................................A-8

Section B - Shipping, Nominal, Electrical Reset, and

Emergency Parameters B-1

Shipping Parameter Settings .......................................B-2

Nominal Parameter Settings........................................B-4

Electrical Reset Parameter Settings ..................................B-6

Emergency Parameter Settings......................................B-9

Section C - Longevity Projections, Elective Replacement Indicator,

and Battery Specifications C-1

Longevity Projections ............................................C-2

Elective Replacement Indicator (ERI).................................C-8

Battery Specifications ............................................C-9

Section D - Magnet Mode Operations, Telemetry Functions,

Diagnostics, and Event Summaries D-1

Magnet Mode Operations .........................................D-2

Telemetry Functions .............................................D-3

Dual Chamber Pacemaker Diagnostics ................................D-4

Single Chamber Pacemaker Diagnostics...............................D-7

Event Summaries ...............................................D-9

Section E - Modes and Parameters, Programming Requirements and

Restrictions, and Timing Reference Table E-1

Dual Chamber Pacemaker Permanent Programmable Modes and Parameters.....E-2

Single Chamber Pacemaker Permanent Programmable Modes and Parameters....E-7

Programming Requirements and Restrictions ...........................E-9

Nonprogrammable Parameters .....................................E-12

Temporary Modes and Parameters ..................................E-13

Timing Reference Table .........................................E-14

Section F - General Warnings and Precautions F-1

General Warnings ...............................................F-2

General Precautions..............................................F-5

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 ........................................G-6

Section H - General Pacing Indications H-1

Indications for Permanent Pacing in Acquired Atrioventricular Block in Adults . . H-2

Indications for Permanent Pacing After Myocardial Infarction ...............H-4

Indications for Permanent Pacing in Bifascicular and Trifascicular Block .......H-5

Indications for Permanent Pacing in Sinus Node Dysfunction ...............H-6

Indications for Permanent Pacing in Hypersensitive Carotid Sinus Syndrome and

Neurovascular Syndromes ........................................H-7

Indications for Permanent Pacing in Children ...........................H-8

Glossary I-1

Index J-1

Part I

USING THE PROGRAMMER

Part I provides instructions for using the 9760 or 9790 programmer with

pacemakers, including the i series. Sections describe each of the

Thera applicable programmer functions and present step-by-step procedures for using these functions. The information in this section is organized in the following order.

Introductory information (Chapter 1) General procedures (Chapter 2) Starting and ending a patient session (Chapter 3) Retrieving pacing system data (Chapter 4) Displaying and printing the patientís ECG and EGM (Chapter 5) Programming pacing parameters (Chapter 6) Determining and evaluating parameter settings (Chapter 7) Using the diagnostic data recording function (Chapter 8) Programming setup options, such as setting the time/date (Chapter 9)

Refer to Parts II and III for information about the operation of Thera pacemakers.

CHAPTER 1

Using the Programmer with THERA® Pacemakers

About This Chapter

This chapter introduces you to using the 9760 and 9790 programmers with the TheraÆ and TheraÆ i series 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). The display screen format and interactive features (see page 1-5). A guide to using the menu and command buttons (see page 1-8).

1-1

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.

Thera Pacemakers ó If you select one of the following Thera pacemaker models (note that they are listed on the front cover), refer to Part†I of this manual for instructions on using the programmer. Refer to†Parts II and III for specific Thera pacemaker information.

NOTE: Model numbers ending in the letter i designate the TheraÆ i series of pacemakers. The instructions throughout Part I apply to both the TheraÆ and the TheraÆ i series of pacemakers unless otherwise noted.

_________________________________________________________ TheraÆ DR Models 7940, 7941, 7942

7950, 7951, 7952 7850, 7851, 7852

_________________________________________________________

7960i, 7961i, 7962i (i series)

TheraÆ

_________________________________________________________ TheraÆ

_________________________________________________________

Other Pacemaker Models ó If you select a pacemaker other than a Thera model listed above, refer to the appropriate programming guide supplied with the software presently installed in your programmer. Refer to the front cover of the manual for a list of the pacemaker families covered in that manual.

For detailed information on setting up the 9760 or 9790 programmer, refer to the respective instruction manual, Programmer Description and Setup, supplied with the programmer.

D Models 7944, 7945, 7946

7964i, 7965i, 7966i (i series)

VDD Model 8948

8968i (i series)

SR Models 8940, 8941, 8942

8960i, 8961i, 8962i (i series)

S Models 8944, 8945, 8946

8964i, 8965i, 8966i (i series)

Using the Programmer with TheraÆ 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

1., 2., 3. Boldface numbers at the left column margin identify

Small italics

Boldface capitals without brackets denote a selectable screen option other than a button.

instructional steps. This symbol identifies a single instructional

statement. This symbol is used as a bullet indicating itemized

statements or paragraphs. Small italics are used in side notes that pertain to an

adjacent figure.

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. Improper use of the programmer could result in erroneous or inadvertent programming and improper operation of the telemetry and measurement functions.

The 9760 and 9790 programmers must be used only for programming Medtronic pacemakers listed as applicable units for the software being used. Direct stimulation via energy coupling may occur if either programmer is used on other implanted devices. These programmers are not compatible with programmable devices of other manufacturers.

Precautions

Loss of Power ó If power to the programmer is unexpectedly lost, lifting the programming head from over the patientís pacemaker cancels any temporary parameters or functions in effect and restores the pacemaker to its†permanently programmed state.

Unresponsive Screen ó In the unlikely event the programmer display screen becomes unresponsive or ìlocked,î turn the programmer off, wait 5†seconds, then turn the programmer on. Normal programmer operation should resume. Following successful completion of the self test, reselect the†pacemaker model to continue with the application.

Programming Head ó Failure to correctly align the programming head over the pacemaker could result in failure of a programming transmission and failure to receive telemetry. The programming head should not be positioned over an implanted pacemaker during electrocautery or defibrillation procedures. Refer to ìUsing the Programming Headî in Chapter 2 and ìMagnet Mode Operationî in Chapter 16 for specific information about using the programming head.

Using the Programmer with TheraÆ 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 Thera family of pacemakers.

Display Screen Example

Below is an example of the screen format you will see when you use the programmer with a Thera pacemaker.

Menu Buttons

Pacemaker ID

Screen Title

ECG Display

Function Display Area

Command Buttons

Message Box

The main elements of this screen format are as follows: Menu Buttons ó The menu buttons, which appear across the top of each

screen, provide direct access to the programmer functions. These buttons replace the Main Menu screen, which applies to other pacemaker models.

Pacemaker ID ó Displays the pacemaker family name and model number. Screen Title ó Title of the current screen generally appears in this

location.

1-6 Using the Programmer

ECG Display ó This box continuously displays a low-resolution trace of the patientís ECG.

Function Display Area ó 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 ó Location of the [ [

INTERROGATE], and [PROGRAM] buttons is the same for all pacemaker

applications. The [ screens; other buttons appear when the command is applicable.

Message Box ó The message box continuously displays procedural prompts and status messages including warnings and precautions, when appropriate. It is important to read the information presented in the

Message Box whenever you are operating the programmer.

EMERGENCY] programming button appears on all

EMERGENCY], [CANCEL MAGNET],

Interactive Screen Features

The interactive display screen features that respond to application of the ìselector penî are: 1) on-screen buttons and 2) options that appear in

boldface type.* The following are some examples of buttons and options.

Buttons appear as boldface words or

INTERROGATE



symbols enclosed within a heavy, black rectangular border. Buttons with labels ending in an ellipsis (...) open a window of additional options.

Selectable options, which appear in boldface type, include pacemaker models, parameters, parameter values, and menu options.

To select a button:



SETUP...



PARAMETERS

Thera DR 7940, 7941, 7942



Lower Rate



40 70 100



THRESHOLD TEST

PROGRAM

Without touching the screen, move the tip of the selector pen to a position directly over the button; then press the pen against the screen.

If the button is a ìlockingî button (one that remains selected), the button label will change to reverse video to indicate that it is selected.

If a procedure directs you to ìpress and holdî a button, you must press the selector pen against the button and continue to press for as long as you want the related operation to continue.

*The term ìselector penî refers to both the ìlight penî used with the 9760 programmer and ††the†ìtouch penî used with the 9790 programmer.

Using the Programmer with TheraÆ 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 ìbeeps.î These signals are intended to alert the user to the success or failure of an action.

Single Beep = Success

A single beep following an Interrogate command indicates that the interrogation was successful.

A single beep following a Program command indicates that the programming was confirmed.

Two Beeps = Failure

Two beeps following an Interrogate command indicate that the interrogation was not successful.

Two beeps following a Program command indicate that the programming was not confirmed.

Two Low-Tone Beeps Two low-tone beeps sound when the selected command cannot be

executed.

Single Short Beep

A short beep that coincides with pressing the

INTERROGATE

PROGRAM

or key on the programming head indicates that the programmer acknowledges the keystroke. If the keystroke is inappropriate, two low-tone beeps will sound.

1-8 Using the Programmer

A Guide to Using the Menu and Command Buttons

Using the Menu Buttons

Menu Buttons

DATA

TESTS/ECG

Except for [ 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.

NOTE: To close the menu without making a selection, ìclickî the selector pen anywhere on the display screen outside the menu box.

Listed below is a description of the options accessible with each of the menu buttons. Refer to the listed chapter for the procedure associated with each option.

Retrieving Pacing System Data ó See Chapter 4. Selecting the [

Displaying the Patientís ECG and EGM ó See Chapter 5.

END SESSION

DATA

] menu button displays options for: Viewing a summary of interrogated data. Viewing measured real-time values of battery and lead data. Viewing a graph of accumulated diagnostic data.

] and [

FREEZE

TESTS/ECG

Selecting the [ adjusting the patientís ECG and the EGM and Marker Channelô signals received from the pacemaker via telemetry. The ECG display includes an option for inhibiting the output of the patientís pacemaker.

Conducting Pacing System Tests ó See Chapter 7.

Selecting the [

Measuring stimulation thresholds. Determining a setting for pacemaker sensitivity. Determining a setting for Activity Threshold and Rate Response. Programming temporary parameter settings.

TESTS/ECG

] menu button displays an option for viewing and

] menu button also displays options for:

Using the Programmer with TheraÆ 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

END SESSION

SPECIAL

FREEZE

Programming Parameter Settings ó See Chapter 6. Selecting the [

PARAMETERS] menu button displays options for:

Programming pacing parameters and viewing present settings. Accessing additional parameter options including Extended Telemetry, Transtelephonic Monitor, Serial Number, and Status Reset.

Setting Up the Diagnostics Function ó See Chapter 8. Selecting the [

PARAMETERS] menu button also displays an option for

programming the pacemaker to record the selected type of diagnostic data.

Ending the Patient Session ó See Chapter 3. Selecting the [

END SESSION] menu button lets you end the patient session

and return to the pacemaker model selection screen.

Special Options ó See Chapters 2 and 9. Selecting the [

SPECIAL

] menu button provides access to the following

options:

A Position Head Assist option related to using the programming head (Chapter 2). A Calibrate option that sends a Marker Channel or EGM reference signal to an externally connected recorder or monitor (Chapter 9).

Freezing the ECG Trace ó See Chapter 5.

HELP

Selecting the [

FREEZE] menu button freezes a 10-second segment of the

patientís ECG and provides the option for viewing a Marker Channel diagram if the pacemaker is operating in a permanently programmed dual chamber or VDD mode.

Printing Reports ó See Chapter 2. Selecting the [

PRINT] menu button displays options for printing the various

data reports generated during the patient session.

Viewing Help Information ó See Chapter 2. Selecting the [

HELP] menu button displays options for viewing information

about the currently displayed screen and other subjects related to using the programmer.

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 ó See Chapter 2.

EMERGENCY

CANCEL

MAGNET

Selecting the Emergency command overrides any function and immediately programs the pacemaker to a fixed set of permanent values that provide high output pacing in the VVI mode.

Canceling the Programming Head Magnet ó See Chapter 2. Selecting the Cancel Magnet command cancels the effect of the program-

ming head magnet and allows the pacemaker to operate in its permanently programmed state while the programming head is in position. For example, operation of a pacemaker permanently programmed to the DDD mode will change from the DOO magnet mode to the DDD mode when this command is executed.

INTERROGATE

INTERROGATE ALL

PACING PARAMETERS

(not pictured)

PROGRAM

Interrogating the Pacemaker ó See Chapter 2. Selecting the Interrogate command from a particular function screen

retrieves from the pacemaker the data related to that function.

Interrogating All Data ó See Chapter 2. The Interrogate All command retrieves all data (parameter, battery/lead, and

diagnostic) from the pacemaker. This button appears only on the Pacing Parameters screen.

Returning to the Pacing Parameters Screen

On screens other than the Pacing Parameters screen, this button appears in place of [

INTERROGATE ALL

]. Selecting this button returns you directly to

the Pacing Parameters screen.

Programming Command ó (Covered in the respective procedures). This command executes a temporary or permanent programming transmis-

sion based on the procedure being conducted. This button appears only when programming is allowed.

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

Canceling the effect of the programming head magnet (see page

Printing reports during a patient session (see page

Printing reports after a patient session has ended (see page 2-13). Transferring session data to a computer diskette (see page 2-13). Using the HELP options (see page

2-16

2-7

2-10

2-9

2-1

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 patientís 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.

Improper positioning of the programming head could result in the inability to program the pacemaker or to receive telemetry.

Positioning the Programming Head

CAUTION: Do not position the programming head over an implanted pacemaker during electrocautery or defibrillation procedures.

IMPORTANT: Pacemaker operation will return to its permanently programmed settings about 2 seconds after you remove the programming head from its position over the pacemaker.

For an implanted pacemaker, the programming head should be held directly against the patientís skin with the face of the programming head parallel to the pacemaker. Optimum position of the programming head may not be directly centered over the pacemaker.

9760 Programmer

Position Head Indicator Light

Light Array

Position the programming head over the pacemaker such that the Position Head indicator light on the head goes out. Refer to ìMagnet Mode Operationî in Chapter 16 for specific information about positioning the programming head.

9790 Programmer

Position the programming head so that the amber light in the light array on the head goes out and one or more green lights come on. Move the head to the position that lights the greatest number of green lights. This is the optimum position.

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. This indicator light also goes out when a telemetry link with the pacemaker has been established ó or it may change from amber to green ó see Using the POSITION HEAD ASSIST Option below).

Using the POSITION HEAD ASSIST Option

The Position Head Assist function facilitates using the programming head position lights to locate the optimum head position over the patientís pacemaker. This function is particularly useful under conditions that adversely affect the communication link between the programmer and pacemaker.

NOTE: When the Assist function is enabled (ìEnhancedî option), continuous interaction between the programmer and pacemaker can cause extraneous artifacts to appear at 250 ms intervals on the patientís ECG trace. The 9790 programmer automatically filters these artifacts so they do not appear; the 9760 programmer does not. Although these artifacts can obscure pacing artifacts or small details on the ECG trace, they have no effect on the pacing operation of the pacemaker.

9790 Programmer

If you are using a 9790 Programmer, the default setting for the Assist function is Enhanced. That is, the Assist function will already be in effect when you start a patient session. If this function results in extraneous artifacts on other monitoring devices connected to the patient, you can turn†the Assist function off by selecting the ìNormalî option as described below.

NOTE: If the Assist function is enabled, the programming head position indicator on the 9790 programmer display panel changes from amber to green when the programming head is properly positioned. If the Assist function is disabled, the amber light goes out when the programming head is positioned. The light array on the programming head operates the same with or without the Assist function.

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. As stated above, this function results in the appearance of extraneous artifacts on the patientís ECG.

Procedure for Selecting the Position Head Assist Setting

Position Head Assist Option

1. Select [

2. Select

SPECIAL

POSITION HEAD ASSIST

] from the menu buttons at the top of the screen.

from the options displayed.

3. From the window showing two buttons:

Select [

ENHANCED

Or select [

NORMAL

] to enable the Assist function.

] to disable the Assist function.

Procedures to Know Before You Begin 2-5

Programming Head 9760 Programmer

Programming Head 9790 Programmer

Using

The

PROGRAM

INTERROGATE

and

same function as the [

and

PROGRAM

INTERROGATE

Keys

keys on the programming head have the

INTERROGATE

] and [

] buttons that appear on the display screen. Whenever the instructions in this manual direct you to select the [

PROGRAM

INTERROGATE

] or [

] button on the screen, you can press the corresponding key on the programming head instead, if it is more convenient.

INTERROGATE Key

PROGRAM Key

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.

Emergency values are permanent settings that provide higher-than-normal energy output. It is not intended that the pacemaker be left at these settings.

Emergency Button

Emergency Values

Pacing Mode VVI Rate 70 ppm V. Refractory Period 330 ms V. Pulse Amplitude 7.5 V V. Pulse Width 1.5 ms V. Sensitivity 2.8 mV V. Pace Polarity Unipolar V. Sense Polarity Unipolar Single Chamber Hysteresis OFF

EMERGENCY

The [

] button appears in the lower left corner of all function

screens.*

To program Emergency parameters:

1. Position the programming head over the pacemaker.

2. Select the [

EMERGENCY

] button.*

3. Hold the programming head steady until a confirmation message

appears. If programming is not confirmed, verify that the programming head is properly positioned and then reselect [

*If you are using a 9790 programmer, you can press the square red button on the left side of ††the display panel as an alternative to the on-screen [

EMERGENCY

] button.

Procedures to Know Before You Begin 2-7

Interrogating the Pacemaker

Before the programmer can display any information about the status of the patientís pacing system, you must interrogate the pacemaker. The information you can retrieve by interrogating the pacemaker falls into three categories:

1. Parameter settings

2. Real-time measurements of battery and lead data

3. Diagnostic data. As described below, you can retrieve this information all at once or sepa-

rately as it is needed.

The INTERROGATE ALL Function

The Interrogate All feature retrieves all three types of information for use during the patient session. This feature may be most helpful at the start of a patient session, but it can be used at anytime during the session.

Interrogate All Button

Available on the Pacing Parameters Screen

To execute the Interrogate All command:

1. Select the Pacing Parameters screen (see page 4-2 or 6-2).

NOTE: The Pacing Parameters screen is the first screen to appear

following model selection at the start of a patient session.

2. Position the programming head over the pacemaker.

3. Select the [

ming head steady until success of the interrogation is confirmed.

Auto Printout ó An Interrogate All command automatically initiates printing of the following data: 1) the present programmed pacing and diagnostic parameter settings, 2) a data summary report which includes an Event Summary, and 3) Battery/Lead status data. Accumulated diagnostic data is not included in this printout.

INTERROGATE ALL

] button. Continue to hold the program-

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 [ then select the [

The INTERROGATE Function

From most function screens, you can interrogate the pacemaker for the data associated with that screen. Even when you have used the Interrogate All feature, it may be necessary to perform additional interrogations to update the programmer as you conduct the patient session.

Interrogate Button

SAVE/NOMINAL OPTIONS

SAVED VALUES] button).

] button,

...

To execute the Interrogate command:

1. Position the programming head over the pacemaker.

2. Select the [

INTERROGATE] button. Continue to hold the programming

head steady until success of the interrogation is confirmed.

Procedures to Know Before You Begin 2-9

Canceling the Programming Head Magnet

ìCancel Magnetî 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.

CANCEL MAGNET

Cancel Magnet Button

The [ function screens except the Battery/Lead screen described in Chapter 4.

To execute the Cancel Magnet command:

While the programming head is positioned over the pacemaker, select

CANCEL MAGNET

the [

] button appears near the lower right corner of all

] button.

2. Watch for the ìMagnet cancelledî message.

Continue to hold the programming head in place for as long as you want†the magnet canceled. Lifting the programming head terminates the Cancel Magnet function.

2-10 Using the Programmer

Printing Reports During a Patient Session

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. All data stored in programmer memory is cleared when you start a new patient session.

Selecting a Print Option

] menu button lets you select and print various reports of the

Print Options

Selecting a Print option may cause on-screen buttons, except [ to be unresponsive for several seconds while data is being formatted for printing. (The formatting of Diagnostic graphs may take about half a minute.) Selecting a Print option will cancel an ECG recording in progress.

To print a report, select the [ appropriate print option from the drop-down menu. All possible options will be listed, but only those in bold face type are selectable. A report cannot be selected until data for that report has been generated.

] menu button, and then select the

EMERGENCY

About the Print Options

Current Screen Report ó If data is available, selecting this option prints the report for the function associated with the presently displayed screen. For example, selecting this Print option while the Pacing Parameters screen is displayed results in the printing of a Parameter Values report. Use this option to print graphic reports, which are available only while the data is displayed. These reports include the Diagnostic Graph, Strength-Duration Curve, Activity Exercise Test results graph, and Marker Channel Diagram.

Parameter Values ó Selecting this option initiates a printout of all pertinent parameter values presently programmed and confirmed in the pacemaker.

Procedures to Know Before You Begin 2-11

Data Summary ó Selecting this option prints a summary of the interrogated data. Included are the event data accumulated since the last patient session.

Battery/Lead Data ó Selecting this option initiates a printout of the real-time measurements associated with the Battery/Lead data function.

Diagnostics Data Table ó This option prints the recorded Diagnostic data in tabular form. This is the same data the programmer uses to create and display the Diagnostic Graph.

Threshold Results ó Selecting this option prints the data accumulated during a patient session from the use of the Threshold Test function. The programmer can store up to 32 test reports for printing during a patient session.

Sensing Results ó Selecting this option prints the data accumulated from the most recent use of the Sensing Test function.

Activity Thld Results ó Selecting this option prints the results of an Activity Threshold test.

Activity Exercise Test ó While the test results screen is displayed following an Activity Exercise test, selecting this option will print the displayed test results, including the test graph. If the test results screen is not displayed, the printout will not include the graph. (Selecting Current Screen Report will also print the displayed test results and graph.)

Measured Values ó Prints the most recent parameter values obtained from using the Measure ECG function.

Waveforms ó Available only if the current screen is the Freeze screen. This option prints a 10-second chart of frozen ECG and telemetry traces.

Waveform Segment ó Available only if the current screen is the Freeze screen. This option initiates a printout of only that portion of the 10-second frozen traces selected with the on-screen calipers.

Full Report ó Prints the data accumulated for printing during the patient session. Reports included in this printout (if the data is available) are Parameter Values, Data Summary, Battery/Lead Data, Threshold Results, Sensing Results, Activity Threshold and Exercise Test results, and Measured Values. This printout does not include data, such as waveforms or graphs, which can only be printed while the respective screen is displayed.

Trace ... ó Selecting this option displays two buttons that let you turn the printer ìTraceî mode on or off. The following section describes the printer Trace mode.

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 [

OFF

] as desired.

EXIT

3. Select [

] to close the window.

Turning the Trace mode on causes the printer to automatically print information as it is generated during a patient session. The use of such commands as Program, Interrogate, Cancel Magnet, Emergency, or Measure ECG are documented on the printout if confirmation of the command execution is received. The parameters and values included in a programming, interrogation, or measurement are printed as shown in this example.

Graphic information such as a Diagnostic report is not printed by the Trace mode. Using the Trace mode does not affect the option to print specific reports manually.

During the printing of a real-time ECG recording, the Trace mode does not function. However, data generated while the programmer is printing frozen waveforms will be saved and printed when the frozen waveform printout has completed.

TRACE MODE ON

TRACE MODE

] or [

Turning the Trace mode off disables this automatic printing feature. Printing will occur only when you select a specific Print option.

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.

To print the data reports:

...

1. Select the [

button appears only if there is data present from the previous patient session.

] button on the Automatic Model Select screen. This

2. Select [

select a†pacemaker model until printing of the previous session data is complete.

PREVIOUS PATIENT DATA

] from the option window. Do not

Transferring Session Data to a Diskette

CAUTION: Selecting a pacemaker model to begin a new patient session or turning the programmer off will clear any 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 transfer the data reports accumulated during the session to a computer diskette as described below.

NOTE: When you end a patient session, the Data Transfer To Disk window (see next page) automatically may appear on the Automatic Model Select screen. If this window shows, skip steps 1 and 2 of the procedure. If you do not wish to use this function, select the [

CANCEL

] button.

2-14 Using the Programmer

To save the data reports to a diskette:

1. Select the [

] 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.

The ìPatient ID,î which will be used in a printed header identifying the data reports, defaults to the pacemaker serial number if applicable. Otherwise, the pacemaker model number will show if it is available.

3. To enter a different patient identifier, select each character of the

desired ID from the on-screen keyboard. Select the [

‹

DELETE

] button

to delete an entered character. Up to six characters of the patient ID will be used in the name of the

recorded data file.*

4. Insert a 3.5-inch computer diskette into the disk drive on the right side

of the programmer. Diskette Requirements: Use a 3.5-inch computer diskette formatted to

be IBM compatible (formatted with MS-DOS or PC-DOS). 9760 Programmer → Use a 720 Kb diskette (DS, DD) only

9790 Programmer → Use a 720 Kb diskette (DS, DD) or a 1.44 Mb

diskette (DS, HD)

5. Select the [

OK] button to copy the patient session data reports to the

diskette. If an error message appears, refer to ìDisk Error Messageî below.

*The name automatically assigned to the session file on the diskette will take the following ††format: ††less than six characters are available, the extra spaces will be filled with zeros. If you save ††more than one file for the same patient on the same diskette, letters of the alphabet will be ††added to the file name to identify the order of each file. For example, the second file will ††have the name

########################

.MDS

####################

, where ì

A.MDS

########################

, the third

î are the first six characters of the patient ID. If

####################

B.MDS

, and so on.

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.

Disk Error Message

If a disk error message occurs at step 5, check the following:

Is the diskette the proper capacity and format? See step 4. Is the diskette full or faulty? Try a new diskette. Is the diskette write protected? Check the write-protect switch on the

back of the diskette. Is the programmer in the process of printing? Selecting [OK] in this

case†may result in an error message. Wait until printing has stopped.

File Format

When you select the [OK] button, all available text reports from the last patient session are saved to a file on the diskette in ASCII format. Included in the file are all the character spacing, line feeds, and form feeds required to print the saved reports in the same format used by the programmer. An ASCII ìControl-Zî code will mark the end of the file.

The report file will include a header page showing the patient ID, file format type (which will always be ì1î until other formats become available), and the pacemaker model number.

The saved file can be printed from an IBM-compatible computer using the MS-DOS or PC-DOS PRINT command, or the file can be imported into a word processing or data base program as an ASCII or DOS text file.

Using the Auto Prompt Feature

The ìAuto Promptî options (OFF and ON) displayed in the Data Transfer to Disk window allow you to choose whether or not you want this window to appear automatically when you end a patient session.

If you want the window to appear automatically as a reminder to save the session data, select the Auto Prompt [

If you do not want the window to appear automatically, select the Auto Prompt [

OFF

] button.

2-16 Using the Programmer

Using the HELP Options

Help Options

Selecting the [ about using the programmer. You can select the [ during the patient session.

Selecting one of these Help options opens a text window of pertinent information:

Current Screen ó Information about the function screen that is presently displayed.

Replacement Indicators

can appear for the selected pacemaker model.

Magnet Modes

rates for the Thera family of pacemaker models.

Programmer Info

convey information on the programmer display screen.

HELP

] Menu button displays options for viewing information

HELP

] button at any time

ó Definitions of the battery status messages that

ó Information about the magnet modes and related pacing

ó Information about display conventions used to

How to Program ó General instructions on how to program parameter settings from the Pacing Parameters, Diagnostic Parameters, and Additional Parameters screens.

How to Interrogate ó General instructions on how to interrogate the pacemaker when it is required to display pacing data or parameter settings.

HELP

NOTE: A [ appears in the value selection window for certain programmable parameters. Select this button to view information about that parameter.

] button also

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).

3-1

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 ìProgrammer Description and Setupî 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. Programming head

2. Light pen (9760 programmer) or touch pen (9790 programmer)

3. ECG cable

4. Power cord (Connect the programmer to an appropriate power outlet.)

Connecting an External Monitor or Recorder

To connect an external monitor or recorder to the programmer, refer to the instructions provided in Chapter 9 of this manual.

Connecting Skin Electrodes

For operation of the ECG measurement and display functions, the programmer must be connected to skin electrodes on the patient. Use an electrode lead to connect each skin electrode to the appropriate port on the ECG cable. Typical electrode placement is shown below.

RA (R)

RL (N)

LA (L) C* (C)

LL (F)

( ) = IEC Coding

* Lead does not apply

to 9760 programmer.

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.

System Self Test

Turning the programmer on results in a self test that takes about a minute or less. Successful completion of the self test results in the Automatic Model Select screen (see next page).

System Test Failure ó If during the self test the programmer displays a ìSystem Test Failureî message, contact your Medtronic representative. This message indicates that programmer service is required.

Printer Test Failure ó If the self test discovers a fault within the printer, the programmer will continue to operate, but the printer will be disabled. Printer service may be required. Contact your Medtronic representative.

System Setup Options

Refer to Chapter 9 of this manual for information about the system setup options that are accessible from the Automatic Model Select screen, which is displayed upon successful completion of the self test. The system setup information covered in Chapter 9 includes:

Setting the time and date of the programmerís clock/calendar function. Connecting an external recorder or monitor and using the Calibrate

option. Setting up Site Nominal (user selected) parameter values for each of

the Thera pacemaker groups. Setting the pacing artifact display function to on or off.

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 [

To start a patient session, you must select the appropriate pacemaker model.

Automatic Model Select Screen

With the programming head in position, select this button for automatic model selection.

For manual model selection, select proper button to display model options.

END SESSION

] button to end a patient session).

NOTE: When you end a patient session, the Data Transfer to Disk window may be superimposed on the Automatic Model Select screen. If you do not wish to use the Data Transfer feature, select [

CANCEL

] to close the window

(see CAUTION below). CAUTION: Selecting a pacemaker model or turning the programmer off

will automatically clear all data reports accumulated in memory during the previous patient session.

If you wish to print these reports, refer to ìPrinting Reports After a Session Has Endedî on page 2-13.

If you wish to transfer these reports to a computer diskette, refer to ìTransferring Session Data to a Disketteî on page 2-13.

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 patientís pacemaker.

2. Select the [

INTERROGATE

AUTOMATIC MODEL SELECT

key on the programming head.

] button on the screen or the

NOTE: It is not necessary to select the applicable chamber. The

ATRIUM

[

] and [

VENTRICLE

] buttons on the Automatic Model Select

screen do not apply to Thera pacemakers.

3. Continue to hold the programming head steady until a message at the

center of the screen confirms pacemaker identification.

Model Identified ó Upon automatic identification of the pacemaker model†(which takes a few seconds), the programmer begins ìloadingî 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.

NOTE: If the pacemaker model identified is not a model from the Thera family of pacemakers, refer to the appropriate programming guide supplied with the software installed in your programmer. The front cover of each guide lists the pacemaker families covered in that guide.

Model Not Identified ó If a message states that the pacemaker model cannot be identified, reposition the programming head and repeat step†2 above or use the Manual Model Selection procedure described below. Automatic identification of the pacemaker model will not occur if the programming head is not properly positioned or if the presence of strong electrical interference interrupts telemetry between the programmer and pacemaker.

Manual Model Selection

If the pacemaker model cannot be identified by the automatic model selection feature, select the pacemaker manually as follows:

1. From the Automatic Model Select screen, select the pacemaker type:

SINGLE CHAMBER MODELS

[

2. From the list of options displayed, select the desired Thera group.

If there are more model options than can be displayed on one screen,

a†[

] button appears in the lower right corner of the option

window. Select this button to view more options.

DUAL CHAMBER MODELS

] or [

3-6 Using the Programmer

Selection of 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.

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 Thera pacemakers.

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.

To proceed to another function, select the appropriate button from the ìmenuî buttons displayed across the top of the screen. These buttons, which appear on all screens, let you quickly and easily access all functions applicable to the selected model.

Menu buttons provide easy access to all applicable functions. These buttons always appear at the top of every screen.

To display the present parameter settings as shown in this example, you must interrogate the pacemaker:

Position the programming head and press

INTERROGATE

[

INTERROGATE ALL

[

] or

Pacing Parameters Screen

Navigating with the Menu Buttons

Except for the [

END SESSION

button displays a list of function options as described on the following page.

] and [

FREEZE

] buttons, selecting a Menu

3-8 Using the Programmer

Menu Button Description and Chapter Reference Possible Options

DATA

TESTS/ECG

PARAMETERS

END SESSION

SPECIAL

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.

Select this button to display options for viewing the patientís ECG and EGM and for conducting various tests such as determining the patientís stimulation threshold. Refer to Chapters 5 and†7.*

Select this button to display options for programming pacing parameter values and for programming and using the Diagnostic function. Refer to Chapters 6 and 8.

Select this button to end a patient session.

Select to access the Calibrate option, which applies to using an external recorder, or to access the Position Head Assist option, which applies to using the Programming Head. Refer to Chapters 9 and 2, respectively.

Data Summary (Ch 4) Battery/Lead Show Diagnostics Graph

ECG/Markers/EGM (Ch 5) Threshold Test (Ch 7) Sensing Test (Ch 7) Temporary Test (Ch 7) Measure ECG (Ch 7) Activity Test (Ch 7)

Pacing Parameters (Ch 6) Diagnostic Parameters (Ch 8) Additional Parameters (Ch 6)

Calibrate (Ch 9) Position Head Assist (Ch 2)

FREEZE

Select this button to freeze a 10-second segment of the patientís ECG. Refer to Chapter 5.

HELP

Select this button to display options for selecting the type of report you want to print or the printer Trace mode. Refer to Chapter 2.

Select this button to display options for selecting

Current Screen Report Parameter Values Data Summary Battery/Lead Data Diagnostics Data Table Threshold Results Sensing Results

informational help screens. Refer to Chapter 2.

*An ìEPSî option for conducting electrophysiologic studies also will be listed if 9877A software has been installed. ††Instructions for using this function are covered in a programming guide supplement supplied with the 9877A software.

Activity Thld Results (Ch 2) Activity Exercise Test Measured Values Waveforms Waveform Segment Full Report Trace ...

Current Screen (Ch 2) Replacement Indicators Magnet Modes Programmer Info How to Program How to Interrogate

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.

Starting and Ending a Patient Session 3-9

1. Select [

Menu button.

2. Select [

end patient session.

END SESSION

] button to

To end a patient session, select [

END SESSION

] from the Menu buttons at the

top of the screen.

]

This action displays a window that allows you to verify your choice.

Select [

] to end the session, or select [

CANCEL

] to continue the session. Ending the session returns you to the Model Selection screen, which is the starting point for the next patient session.

NOTE: Once you end a patient session, you have two options to retrieve the data reports generated during that session. You can print the reports or transfer the reports to a computer diskette (see page 2-13). Selecting a pacemaker model to start a new patient session or turning the programmer off will erase all accumulated data from the programmer memory.

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. Included is a summary of certain event data automatically collected in pacemaker memory (see page 4-6).

Real-time measurements of pacemaker battery condition and of parameters related to pacemaker output and lead system status (see page 4-10).

A graphic display of the event data accumulated in pacemaker memory by the Diagnostics function if it has been programmed to collect data (see page 4-13).

4-1

4-2 Using the Programmer

Displaying Present Parameter Settings

You can quickly display the parameter settings to which the patientís 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.

Displaying Pacing Parameter Settings

1. Select [

menu button.

2. Select

PARAMETERS

PACING

option.

Pacing Parameters Screen

If the pacemaker has been interrogated, this screen displays the presently programmed pacing parameter settings. (Subordinate parameters are not displayed. See next page.)

To display the Pacing Parameters screen, select the [

PACING PARAMETERS

button if it is displayed in the lower right corner of the present screen, otherwise select the [

]

PARAMETERS

] menu button as illustrated below.

Parameter settings will not show unless an appropriate interrogation has occurred. Interrogate the pacemaker, if necessary, to display the settings.

]

To use this screen to program new pacing parameter settings, refer to the instructions in Chapter 6.

Retrieving Pacing System Data 4-3

Parameters Not Displayed ó Each parameter listed below has one or more subordinate programmable parameters that are not displayed on the Pacing Parameters screen. These parameter subsets apply only when the corresponding primary parameter is programmed to ON.

Parameter Corresponding Parameter Subset

Mode Switch Detect Rate

Rate Adapt Start Rate (Rate Adaptive AV Interval) Stop Rate

Min. Paced AV

Optimization* Lifestyle

(Rate Response Optimization)

Rate Drop* Top Rate (Rate Drop Response) Bottom Rate

Sleep Funct.* Sleep Rate (Sleep Function) Bed Time

Min. Sensed AV

Confirmation Beats Width Beats Intervention Rate Intervention Duration

Wake Time

To view the settings of the subordinate parameters, select the primary parameter to open its value window. The subordinate parameters and their present settings will be displayed in the value window as shown in this example.

Value window example showing subordinate parameters

*The Optimization, Rate Drop, and Sleep Function parameters do not apply to Thera DR ††models 7850, 7851, and 7852.

4-4 Using the Programmer

Displaying Diagnostic Parameter Settings

To display the present programmed parameter settings controlling the Diagnostics function, select the [ select the

PARAMETERS

DIAGNOSTIC PARAMETERS

] menu button, and then

option as illustrated below.

1. Select [

menu button.

2. Select

PARAMETERS

Diagnostic Parameters Screen

Interrogate the pacemaker, if required, to display settings. Refer to Chapter 8 for instructions on using the Diagnostics function.

PARAMETERS

DIAGNOSTIC

option.

]

The Diagnostic Parameters screen appears as shown in the example below. If the Diagnostics function has not been programmed to collect data, the Type parameter will show a value of OFF.

Retrieving Pacing System Data 4-5

Displaying Additional Parameters Settings

The Additional Parameters screen displays the present settings for the following parameters and provides access to the Status Reset command.

Transtelephonic Monitor (See Chapters 6 and 13) Extended Telemetry (See Chapters 6 and 15) Pacemaker Serial Number (See Chapter 6) Status Reset (See Chapter 6)

1. Select [

2. Select

PARAMETERS

menu button.

ADDITIONAL

PARAMETERS

option.

Additional Parameters Screen

Interrogate the pacemaker, if required, to display settings.

To use this screen for programming these parameters, refer to Chapter 6.

For more about Transtelephonic Monitor and Extended Telemetry, refer to Chapters 13 and 15, respectively.

To display the Additional Parameters screen, select the [ menu button, and then select the

ADDITIONAL PARAMETERS

PARAMETERS

option as

illustrated below.

]

The Additional Parameters screen appears as shown in the example below.

]

4-6 Using the Programmer

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.

Selecting the Data Summary Screen

1. Select [

menu button.

2. Select

SUMMARY

DATA

option.

]

Data Summary Screen

Select the [

LEAD PARAMETERS DIAGNOSTICS GRAPH

button to view more data.

BATTERY

DIAGNOSTIC

], [

], or [

SHOW

To display the Data Summary screen, select the [ then select the

DATA SUMMARY

option as illustrated below.

DATA

] menu button, and

The Data Summary screen appears as shown in the example below. Data will not be displayed unless an appropriate interrogation has occurred. If necessary, interrogate the pacemaker to display the summary data.

]

Retrieving Pacing System Data 4-7

Battery/Lead

This section of the screen includes a summary of pacemaker battery and lead status.

Estimated Time to Replacement

ìEstimated Time to Replacementî is a calculated estimate of the time (in months) remaining until pacemaker replacement will be required. This calculated estimate is an average value based on the programmed parameter settings and the event summary data accumulated by the pacemaker since the previous patient session.

Select the [ replacement and the estimated maximum, average, and minimum values. Refer to page 4-12 for information about the messages that can appear in place of the estimated time value.

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 ìReplace Pacerî message. When†battery voltage indicates that pacemaker replacement is required, the†ìReplace Pacerî message automatically appears on the screen in place of†the estimated time to replacement value.

Lead Impedance

ìLead Impedanceî is the measured electrical impedance presented by the pacing lead and electrode/tissue interface. If the pacing mode is a dual chamber mode, the measured impedance for both lead systems is displayed.

MORE INFO

] button for information about estimated time to

Diagnostic Parameters

This section of the screen indicates the programmed status of the Diagnostics function by displaying the present settings of the Setup and Type parameters. No value for Setup will be displayed if any changes were made to the default settings established by the Setup option. A setting of ìOffî for the Type parameter indicates that the Diagnostics function has not been programmed to collect data.

Event Summary Data

Event Summary is a non-programmable pacemaker function that operates continuously to collect the data described on the next page. You can view this event data only on the Data Summary screen and the Data Summary printout.

4-8 Using the Programmer

% Total Events

The data under this heading shows the percentage of the total number of recorded beats that fall into each of the displayed pace/sense event sequence categories.* For dual chamber pacing modes, the event sequence categories are as follows:

Event Summary shows data collected since the last patient session.

This data is automatically cleared from pacemaker memory during each patient session and cannot be recalled once the session has ended.

The listed dates, which show the period during which the event data was collected, are based on the current setting of the programmerís calendar function. Data collection stops when ERI occurs. In this case, the ending date is labeled as the ìERIî date.

Under unusual circumstances, if a data error is detected, ìinvalid dataî can show in place of certain event values. This condition should clear itself by the next patient session.*

AS-VS AS-VP AP-VS AP-VP

(Atrial Sense - Ventricular Sense) (Atrial Sense - Ventricular Pace) (Atrial Pace - Ventricular Sense) (Atrial Pace - Ventricular Pace)

For the VDD mode, the event sequence categories are:

AS-VS AS-VP VS VP

(Atrial Sense - Ventricular Sense) (Atrial Sense - Ventricular Pace) (Ventricular Sense preceded by a ventricular event) (Ventricular Pace preceded by a ventricular event)

For single chamber modes, two event categories are used:

Paced Sensed

PVCs

If the pacemaker has been operating in a dual chamber mode, Event Summary displays the counted number of PVC ìsinglesî and ìruns.î 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 Runs

ó Show the number of singly-occurring PVCs.

ó Show the number of runs consisting of two or more PVCs.

*If one of the special single chamber modes (ADIR, VDIR, ADI, VDI) has been programmed, ì% Total Eventsî data will not be available, and the ìinvalid dataî message will be displayed.

Retrieving Pacing System Data 4-9

A greater-than symbol (>) appearing in front of the displayed value indicates memory for this data is full and data collection has stopped. Since†PVC data collection applies only to dual chamber modes, this feature will not be displayed if a single chamber mode was in effect during the monitoring period.

Mode Switch Episodes

ìMode Switch Episodesî is displayed in the Event Summary if the Mode Switch parameter (see Chapter 14) applies to the pacing mode in effect during the monitoring period.

If Mode Switch is programmed ON, the number of mode switch episodes occurring during the monitoring period is displayed. If the number of episodes exceeds the range maximum (255), data collection stops, and a greater-than symbol (>) appears in front of the displayed value.

If Mode Switch is programmed OFF, the display shows ìOffî in place of a value.

Rate Resp. Optim. Episodes

ìRate Resp. Optim. Episodesî is displayed in the Event Summary if the Optimization parameter (see Chapter 11) applies to the pacing mode in effect during the monitoring period.

If Optimization is programmed ON, the number of optimization episodes occurring during the monitoring period is displayed. If the number of episodes exceeds the range maximum (255), data collection stops, and a greater-than (>) symbol appears in front of the displayed value.

If Optimization is programmed OFF, the display shows ìOffî in place of a value.

Displaying More Data

To display more data, select the appropriate button as follows:

Select [

BATTERY/LEAD

next section, ìDisplaying Battery and Lead Information.î Select [

DIAGNOSTIC PARAMETERS

Diagnostic parameters. Refer to Chapter 8. Select [

SHOW DIAGNOSTICS GRAPH

data recorded in pacemaker memory. (If the setting for Type is displayed as ìOFF,î no data has been collected for display.) Refer to Chapter 8.

] to view all battery and lead measurements. See

] to view the programmed status of all

] to display a graph of the diagnostic

4-10 Using the Programmer

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.

Selecting the Battery/Lead Screen

1. Select [

menu button.

2. Select

LEAD

DATA

BATTERY

option.

]

Battery/Lead Screen

Interrogate the pacemaker if measurements are not displayed. This process may take several seconds to complete.

To display the Battery/Lead screen, select the [ select the

BATTERY/LEAD

option as illustrated below.

DATA

] menu button, and then

Data will not appear unless an appropriate interrogation has occurred. Interrogate the pacemaker, if necessary, to display or update the battery and lead data. Interrogation may require several seconds to complete.

Retrieving Pacing System Data 4-11

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.

Battery Status ìOKî or ìReplace Pacerî Estimated Time To Calculated estimate of the average time

Replacement remaining until pacemaker replacement will be

required. See explanation below.

Battery Voltage Present voltage of the pacemaker battery. Battery Current Present current drain on the pacemaker battery

averaged over a pacing cycle.

Battery Impedance Internal electrical impedance of the pacemaker

battery.

Pulse Duration Present programmed value of the pacing pulse

width.

Pulse Amplitude Present value of the pacing pulse amplitude. Output Energy Output energy contained in a single pacing

pulse.

Lead Current Current delivered during a pacing pulse. Lead Impedance Electrical impedance presented by the pacing

lead and electrode/tissue interface.

Pacing Configuration Present programmed pacing configuration

(unipolar or bipolar).

Estimated Time to Replacement

ìEstimated Time to Replacementî is a calculated estimate of the average time (in months) remaining until pacemaker replacement will be required. This calculated estimate is based on the programmed parameter settings and event summary data accumulated by the pacemaker since the previous patient session.

4-12 Using the Programmer

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 ìReplace Pacerî message. When battery voltage indicates that it is time for pacemaker replacement, the ìReplace Pacerî message automatically appears on the screen in place of the estimated time to replacement value.

The following messages can appear in place of the estimated time value: ìSelect MORE INFO ===>>>î ó Estimated time to replacement

information is available only by selecting the [

MORE INFO] button. This

message appears when additional factors that affect the time estimate are present and require an explanation. If less than 24 hours have elapsed since the previous patient session, a message will state that there is ìinsufficient event summary data accumulated in the pacemaker.î In this case, the estimated time to replacement calculations assume that the patient is paced 100 percent of the time.

ìReplace Pacerî ó Low battery voltage in the patientís pacemaker has tripped the ERI (elective replacement indicator). Elective replacement of the pacemaker is now recommended.

Retrieving Pacing System Data 4-13

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 4-6).

Selecting the Graph Display Screen

1. Select [

2. Select

DATA

]

menu button.

SHOW

DIAGNOSTICS GRAPH

option.

Diagnostics Graph

The type of information displayed by the graph depends on the programmed status of the Diagnostics function.

Refer to Chapter 8 for information about the Diagnostics function and viewing the graph.

To display the Diagnostics graph screen, select the [ and then select the

SHOW DIAGNOSTICS GRAPH

DATA

] menu button,

option as shown below.

The graph will not be displayed unless an appropriate interrogation has occurred. Interrogate the pacemaker, if necessary, to display the graph.

To print the graph, you must select

SCREEN REPORT

the Print options while the graph is displayed (refer to Chapter 2).

CURRENT

from

CHAPTER 5

Displaying and Printing the Patient’s ECG and EGM

About This Chapter

The procedures presented in this chapter describe using the programmerís ECG display and recording functions. The procedures describe:

How to print a real-time recording of the patientís ECG accompanied by traces of Marker Channelô and EGM telemetry (see page 5-2).

How to select a high resolution display of the ECG and the Marker Channel and EGM traces when present (see page 5-5).

How to inhibit pacemaker output to observe the patientís underlying rhythm (see page 5-9).

How to freeze a 10-second segment of the patientís ECG and how to use the on-screen calipers (see page 5-10).

How to select a Marker Channel Diagram to view more detailed information about pacemaker operation (see page 5-14).

5-1

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 patientís 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. Likewise, selecting a Print option from the display screen will interrupt and cancel an ECG recording in progress.

9760 Programmer 9790 Programmer

1. To start a recording of the patientís

ECG: 9760 ó Press the printer

button. 9790 ó Press the desired paper

speed button.

2. To stop the recording, press the

same button again.

3. Before you tear off the ECG strip,

press the advance the paper to a perforation.

To change the recording speed on a 9760 programmer, press the desired

PAPER SPEED

process.

NOTE: Because the printed waveform recording provides a higher resolution, it may show artifacts and events that do not appear on the display screen.

PAPER ADVANCE

button. This can be done prior to or during the recording

RECORD

button to

Annotations

ECG

Marker Telemetry

EGM Telemetry

Displaying and Printing the Patientís ECG and EGM 5-3

ECG Printout Example with Markers and EGM (9760 Programmer Recording)

About the Recording

Annotation of Executed Commands ó Information on the ECG printout includes an indication of when certain commands to the pacemaker occurred. When confirmation of the command is received, the command name is printed at the appropriate point in the margin above the waveform grid. Parameter values are not printed except during a threshold test. A recording made during threshold measurement will show each programmed test value at the point it is programmed.

Marker Channelô and EGM Telemetry ó If the programming head is over the patientís pacemaker, the recording will include a trace or traces of the telemetry being received from the pacemaker. In the example above, the patientís ECG is accompanied by ìMarkerî telemetry and EGM telemetry. This combination of Marker and EGM telemetry (atrial EGM if the pacing mode is dual chamber) is the default setting and occurs automatically when you position the programming head. As described later in this chapter, you can select other types of telemetry to be displayed and recorded.

ECG and EGM Trace adjustment ó The ECG and EGM are recorded according to control settings accessible from the ECG/Markers/EGM display described in the next section (the ECG/Markers/EGM display appears on several screens). These control settings include ECG lead configuration (Lead I, Lead II, or Lead III), amplitude scaling, and a filter ON/OFF option.

5-4 Using the Programmer

Missing Markers ó 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 ìdownî and/or ìupî arrow. The down arrow ( the†programmer; the up arrow ( pacemaker.

Displaying Pacing Artifacts

During processing and amplification of the patientís ECG signal, the programmer automatically detects and enhances pacing artifact so that they appear on the ECG display and printout. Under certain conditions, some types of interference can trigger artifact detection causing false artifacts to appear on the patientís ECG.

9790 Programmer

With the 9790 programmer, you can turn the artifact display on or off. Turning the artifact display off allows you to monitor the patientís ECG without the appearance of pacing artifacts. Disabling this function may be advantageous in the presence of troublesome interference.

W) indicates a transmitted command from

V) indicates a telemetry response from the

For instructions on turning the artifact display on or off, refer to ìSetting the Artifact Displayî in Chapter 9. The Artifact Display options are

SETUP

accessible via the [

NOTE: With the artifact display turned off, pacing artifacts will not show on the programmer ECG display or printout. Once you turn the artifact display off, it will remain off until you repeat the procedure to turn it back†on.

...

] button on the Automatic Model Select screen.

Displaying and Printing the Patientís 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 patientís 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.

Selecting the ECG/Markers/EGM Screen

1. Select the

TESTS/ECG

[ button.

2. Select the

ECG/MARKERS/EGM

option.

] menu

ECG/Markers/EGM Screen

These buttons allow adjustment of the ECG and EGM traces and selection of the desired telemetry type.

To display this screen, select the [

ECG

the

MARKERS/EGM

option as illustrated below.

TESTS/ECG

] menu button, and then select

If the programmer is connected to skin electrodes on the patient, the screen displays the patientís ECG as shown below. In this example, Marker and ventricular EGM telemetry are being received from the pacemaker.

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

Select to change the ECG amplitude scaling.

Options: 1.0, 0.5, 0.2, 0.1, 0.05 mV/mm and Automatic.

ECG LEAD II

ìAutomaticî sets scaling to the highest value that does not result in clipping of the waveform peaks.

(Lead II is the default setting.)

____________________________

Automatic is the default setting.

____________________________

1.0 mV/mm

Filter ON

75 bpm

V. EGM

1.0 mV/mm

Select to turn the ECG filter ON or OFF.

Options: Filter OFF (Bandwidth = 0.05 to 100 Hz)

Filter ON (Bandwidth = 0.5 to 40 Hz) The ON setting may improve clarity of the displayed and printed ECG in the presence of interference. ìONî is the default setting.

____________________________

Indicates the patientís present heart rate. This is not a control. The displayed value is a beat-by-beat measurement derived from Marker Channel telemetry. For ventricular and dual chamber modes, the value will be the ventricular rate; for atrial modes, the value will be the atrial rate.

_______________________________

Select to display programmable waveform telemetry options.

(See telemetry programming procedure next page).

____________________________

Select to change the EGM amplitude scaling.

Options for: A. EGM = 1.0, 0.5, 0.2, 0.1, 0.05 mV/mm and Automatic

V. EGM = 5.0, 2.0, 1.0, 0.5, 0.2 mV/mm and Automatic (A+V)EGM = 1.0, 0.5, 0.2, 0.1, 0.05 mV/mm and Automatic

ìAutomaticî sets scaling to the highest value that does not result in clipping of the waveform peaks.

Automatic is the default setting.

____________________________________________________________

Displaying and Printing the Patientís ECG and EGM 5-7

Programming the Trace Telemetry Type

Default Telemetry

Positioning the programming head over the patientís

—

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.

Programming Procedure ó Use the following procedure to temporarily program the telemetry to another type:

ECG LEAD II

1.0 mV/mm

Filter ON

75 bpm

V. EGM

With the programming head in position over

the pacemaker, select this button. Select the desired telemetry type from the

options displayed (see below). Continue to hold the programming head in

place for as long as you want to view the programmed telemetry.

The telemetry type will return to its default

1.0 mV/mm

setting if the programming head is removed from the pacemaker site for over 30 seconds.

Telemetry Options

The programmable options for the type of telemetry

—

that can be displayed and recorded with the patientís ECG are as follows:

A. EGM

V. EGM

This option displays atrial EGM and Marker telemetry. This option displays ventricular EGM and Marker

telemetry.

(A+V) EGM

This option displays atrial and ventricular EGM telemetry combined as a single trace and Marker telemetry.*

MARKER

This option displays Marker telemetry only. The Marker trace appears in a larger format on the lower trace display in place of the EGM.

SENSOR

This option displays Sensor telemetry only. The Sensor trace appears on the lower trace display in place of the EGM.

*The (A+V) EGM option does not apply to Thera DR models 7850, 7851, 7852.

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 ó A trace of Marker telemetry depicts pacemaker operation by showing Pace, Sense, and Refractory Sense events as they occur within the pacemaker. Markers also depict triggered pacing in the AAT or VVT mode and the beginning and end of a Mode Switch episode when it occurs. These markers are intended to facilitate interpretation of the ECG. Each Marker is coded as follows:

Dual Chamber Models Single Chamber Models

AP AS AR

___________________________________________________________________

TP MS ER

= Atrial Pace = Atrial Sense = Atrial Sense

during refractory during refractory refractory

= Triggered Pace (AAT or VVT pacing mode) = Mode Switch Episode (marks the beginning and the end) = Error Marker (indicates a Marker signal that could not be decoded)

= Ventricular Pace

= Ventricular Sense

= Pace

= Sense

= Sense during

Example Display Showing Sensor Markers

While Sensor markers are displayed, heart rate is not measured. This number remains fixed.

SENSOR Telemetry

Sensor telemetry transmits a single type of marker

—

to show ìSensor-Detectî events. A Sensor-Detect event occurs each time the detected level of physical activity exceeds the programmed Activity Threshold setting. Sensor markers thus show response of the Activity sensor to physical activity of the patient and are intended to facilitate evaluation of the Activity Threshold setting.

Sensor markers appear on the lower trace display as shown in the example below. These markers are not annotated with letter codes.

Displaying and Printing the Patientís 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 patientís pacemaker for such purposes as observing the underlying rhythm.

CAUTION: The Inhibit function is intended for diagnostic and test purposes. It should be used only under conditions of careful patient monitoring and control.

IMPORTANT: At any point during use of the Inhibit function, releasing

PROGRAM

the [

] button or lifting the programming head away from the site of the pacemaker for at least two seconds will restore pacing output. In the event of a programmer malfunction or loss of power, lift the programming head immediately.

Pacemaker blanking periods are minimized during use of the Inhibit function to increase the window during which cardiac events can be sensed. Sense markers appearing below the ECG will indicate each sensed event.

Inhibit Procedure ó To inhibit pacemaker output:

1. Make any desired ECG trace adjustments before selecting [

INHIBIT

2. Position the programming head and hold it steady for the remainder of

this procedure. NOTE: To observe Sense markers and a display of the sensed rate

while you use the Inhibit function, select the [

CANCEL MAGNET

] button. (If pacemaker operation is not changed from the magnet mode, Sense markers and the patientís intrinsic rate cannot be displayed.)

INHIBIT

3. Select [

4. To inhibit pacemaker output, press and hold [

] to prepare the programmer.

PROGRAM

A message indicates that the command is causing inhibition. The ECG trace should show the absence of any pacing stimuli. To obtain an ECG recording, press the printer

RECORD

key (9760 programmer) or the

desired paper speed key (9790 programmer).

5. To restore pacing output, release [

PROGRAM

Watch for confirmation that pacing output has been restored. If confirmation is not received, lift the programming head to ensure that pacing is restored.

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 patientís 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,

FREEZE

] menu button as shown below.

To freeze 10 seconds of the patient’s ECG,

FREEZE

select the [ menu button.

]

select the [

This action displays the Freeze screen shown in the example below. The frozen trace will begin to appear immediately or after a pause of 5 or 10 seconds, depending on the selected Freeze Option (see next page).

Freeze Screen

Buttons below the trace display control the two vertical cursors to provide an on-screen caliper function.

Displaying and Printing the Patientís 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 ó 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).

The selected setting takes effect the next time you use the Freeze function and remains in effect until you change it.

Freeze Options ó Selecting the [

FRZ OPTION

...

] button displays the

following options:

Freeze Previous 10 Seconds

occurred just prior to selection of the [

Freeze Next 10 Seconds

occurs just after selection of the [

Freeze Previous 5 + Next 5 Seconds

trace that occurred prior to selection of the [

ó Freezes the 10 seconds of trace that

FREEZE

] button.

Freezes the 10 seconds of trace that

—

FREEZE

] button.

ó Freezes the 5 seconds of

FREEZE

] button plus the 5

seconds that occurs after the button selection.

Printing the Frozen Traces

Before you exit the Freeze screen, you can print the frozen 10-second trace†(

WAVEFORMS

on-screen calipers (

print option) or the portion of the trace between the

WAVEFORM SEGMENT

print option). Refer to Chapter 2

for information on printing reports.

Displaying a Marker Channel™ Diagram

SHOW DIAGRAM

This button lets you display a Marker Channel Diagram if the pacemaker is programmed to a dual chamber or VDD mode and Marker Channel telemetry is being received. Refer to the last section in this chapter for information about this diagram.

If the selected pacemaker is a Thera DR, Thera†D, or Thera VDD model, this button appears on the Freeze screen.

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

2. Select the desired option from the displayed window.

____________________________________________________________

options.

ECG LEAD II

1.0 mV/mm

Magnify 1x

25 mm/sec

V. EGM

1.0 mV/mm

Magnify 1x

Indicates the present ECG Lead configuration and ECG amplitude scaling. This is not a control.

____________________________

Select to change the frozen ECG magnification factor.

Options: 1X, 2X, and 4X

(1X is the default setting.)

____________________________

Select to change the frozen display time scale.

Options: 25, 50, 100 mm/sec (25 mm/sec is the default setting.)

____________________________

Indicates the telemetry type displayed on the lower trace display and the EGM amplitude scaling when applicable. This is not a control.

____________________________

Select to change the frozen EGM magnification factor.

Options: 1X, 2X, and 4X

(1X is the default setting.)

____________________________________________________________

*This button does not appear if the present telemetry type shown in the box above it is ††ìMARKERî or ìSENSOR.î

Displaying and Printing the Patientís 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. The small window above

POSITION LEFT CURSOR

the in milliseconds.

buttons displays the interval between the cursors

Freeze Screen — Caliper Cursors and Controls

Left Cursor

Right Cursor

➎

ýýý➊ ýýý➋ эээээээээээ➌ ээээээ➍

To use the caliper position and scroll buttons:

Alternately press and release the appropriate button to effect small movements or press and hold the button to effect larger movements.

Button action reference:

➊ These two buttons move the left cursor to the right or left.

➋ These two buttons move the right cursor to the right or left.

➌ These buttons scroll the calipers to the right or left without changing

the space between them. Select the [

second apart. You can use this button to retrieve the calipers if they have been scrolled off the screen.

] button to center the calipers on the screen one

HOME

➍ To view the portion of the frozen traces not showing on the display,

use these two buttons to scroll the waveform traces to the right or left.

• This box displays the time interval between the cursors.

5-14 Using the Programmer

Displaying a Marker Channel™ Diagram

If the selected pacemaker is a Thera DR, Thera D, or Thera VDD model, the Freeze screen includes the [ example on page 5-10. Under the proper conditions (see NOTE below), selecting this button displays a Marker Channel Diagram.

NOTE: A Marker Channel Diagram can be displayed only if the pacing mode is dual chamber or VDD and the display includes Marker telemetry annotations (the selected telemetry type can be either Marker or EGM).

Selecting the Marker Channel Diagram

SHOW DIAGRAM

] button as shown in the

Freeze Screen with Marker Channel™ Diagram

To print the ECG trace and diagram, select the

] menu button, and

[ then select the

SCREEN REPORT

CURRENT

option.

SHOW DIAGRAM

To display a Marker Channel Diagram, select the

[

SHOW DIAGRAM

] button on the Freeze screen. The diagram will be drawn on the lower trace display as shown in the example below.

SHOW MARKERS/EGM

To return to the trace of Marker or EGM plus Marker telemetry, select the [

MARKERS

place of the [

EGM

] button, which appears in

SHOW DIAGRAM

SHOW

] button.

Example of a Marker Channel™ Diagram Printout

Displaying and Printing the Patientís 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 patientís ECG.

NOTE: If events portrayed on the diagram occur in very rapid succession, the Pace and Sense marker annotations ( supplemental labels ( may overlap. Overlapping characters or labels displayed on the screen may not appear exactly the same on the printout.

Act., Safe, PVC

, and

) may not appear, and the

P, S, R

) that define certain events

NCAP

NOTE: In situations where the event rate is unusually high, the Marker Channel Diagram may be less than 10 seconds in length due to processing limitations.

Using the On-Screen Calipers

Operation of the

WAVEFORM SCROLL

of this chapter.

POSITION LEFT/RIGHT CURSOR, CALIPER SCROLL

buttons is the same as described in the previous section

, and

Printing the Marker Channel™ Diagram

To print the Marker Channel Diagram, select the [ then select the only while it is displayed on the screen.

CURRENT SCREEN REPORT

option. You can print a diagram

] menu button, and

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.

Atrial and Ventricular Baselines ó The diagram is formed along two

parallel baselines labeled ìAî and ìV.î Symbols depicting atrial activity

appear along the top side of baseline A; symbols depicting ventricular activity appear along the bottom side of baseline V. Sloped lines appearing between the two baselines depict the timing relationship between atrial and

ventricular events.

Pace and Sense Markers ó Short vertical lines extending upward from

baseline A and downward from baseline V are the event markers received via Marker Channel telemetry. Each marker is labeled according to the

event it represents.

P S R ER

(Pace) Output of a pacing stimulus. (Sense) A sensed event. (Refractory Sense) An event sensed within the refractory period. (Error) A marker that could not be decoded because of interference or interrupted telemetry.

Act.

Supplemental Marker Labels ó Supplemental labels indicate when a marker is the result of one of the following conditions:

Act. Safe PVC

NCAP

An activity-driven pace. A ventricular safety pace. A pacemaker-defined premature ventricular contraction. A non-competitive atrial pace.

Displaying and Printing the Patientís ECG and EGM 5-17

Blanking and Refractory Periods ó Rectangles on the A and V baselines depict atrial and ventricular blanking and refractory periods.

Solid Rectangles ó Depict blanking periods. Open Rectangles ó Depict refractory periods. Vertical lines appearing

within the rectangle mark the timing of sense or pace events occurring in the opposite chamber. Such lines may indicate the start of a new refractory (and blanking) period.

Timing Lines ó The sloped, horizontal, and vertical lines appearing

between the A and V baselines depict the timing relationship between the atrial and ventricular events.

Downward Sloping Lines ó Depict A-to-V timing (based on the pace-

makerís operating AV interval) initiated by an atrial pace or sense event. The course of this line results in a ventricular pace, unless it is interrupted by a ventricular sense.

Upward Sloping Lines ó Depict V-to-A timing (based on the pacemakerís

operating pacing rate) initiated by a ventricular pace or sense event. Except as stated below, the course of this line results in an atrial pace unless it is interrupted by an atrial sense or a PVC.

In the VDD pacing mode, a ventricular pace (not an atrial pace) occurs if V-to-V timing completes before an atrial sense occurs.

PS S

Horizontal Lines ó Depict any extension in the timing required to maintain a proper pace schedule. In this example, the upper tracking rate results in an extension of A-to-V timing. Another example is non-competitive atrial pacing, which shows as an extension of V-to-A timing.

Timing extensions are common in diagrams of the DDI(R) mode because of the absence of atrial tracking.

Vertical Lines ó Depict interruption of a timing interval by a sense or the conclusion of a timing extension, which results in a pace.

Error Conditions

Under certain conditions, the programmer may not be able to properly determine pacemaker operation from the data available. Most such conditions result in the appearance of an error message on the diagram.

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.

ìMissing Eventî ó This message appears if an event did not occur when it†was expected based on the interrogated data registered in programmer memory. This situation can occur in the presence of interference that interrupts telemetry.

Interruption of the diagram followed by the appearance of a Threshold Margin Test (pacing at 100 ppm for three cycles) indicates that movement of the programming head during recording of the 10-second frozen trace opened and closed the pacemaker reed switch. In this situation, the Threshold Margin Test depicted on the diagram may be accompanied by one or more ìMissing Eventî messages.

ìDiagram Errorî ó This message indicates that a particular sequence of events portrayed by the Marker trace cannot be processed and properly displayed by the Marker Channel Diagram.

ìBad Dataî ó This message indicates that the programmer has not received the information it requires to complete the Marker Channel Diagram. This can occur when there is an interruption or fault in the telemetry being received - possibly due to interference or movement of the†programming head.

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 patientís pacemaker. This procedure is conducted from the Pacing Parameters screen (see page 6-2).

How to program nominal and saved parameter values (see page 6-9). How to program the Transtelephonic Monitor and Extended Telemetry

parameters, which are related to follow-up procedures (see page 6-11). How to program the Status Reset command to verify or clear an ERI

status or clear a pacemaker full electrical reset condition (see page 6-12).

How to program the pacemaker serial number in the event it is cleared from pacemaker memory by an electrical reset (see page 6-13).

For instructions on programming the parameters of the Diagnostics function, refer to Chapter 8.

6-1

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.

Selecting the Pacing Parameters Screen

You can use either of two methods to select the Pacing Parameters screen: select the [

PACING PARAMETERS

corner of the present screen, otherwise select the [ button, and then select the

] button if it is displayed in the lower right

PACING PARAMETERS

PARAMETERS

] Menu

option as shown below.

1. Select [

menu button.

2. Select

PARAMETERS

PACING

option.

Pacing Parameters Screen

Refer to Part II of this manual for specific information about the pacing modes and the operation of certain parameters.

Refer to Section E in Part III for a list of the parameters and values available for each Thera model.

]

Present settings will not be shown unless an appropriate interrogation has occurred. Interrogate the pacemaker, if required, to display these settings.

Programming Pacing Parameters 6-3

Features of the Pacing Parameters Screen

Parameter Display ó 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.

PROGRAM

[

screen only when one or more new parameter values have been properly selected (see ìRestricted Parameter Interactionsî below). The key on the programming head will respond only when the [ button shows on the screen.

Special Options ó The three buttons located at the right of the parameter display may be useful during the programming procedure described on the next page.

] Button ó This button appears in the lower right corner of the

PROGRAM

]

SHOW PRESENT

When you select new parameter values to program, these ìpendingî values are displayed in place of the interrogated present settings. To temporarily recall the present settings, press and hold this button.

SHOW

SAVED

If you have saved a set of parameter values (see below), this button will appear on the screen. Pressing and holding this button will temporarily display these saved values.

SAVE/ NOMINAL

OPTIONS...

Selecting this button displays options for: 1) clearing all pending values from the parameter screen, 2) saving a set of parameter values, and 3) recalling the set of saved values or nominal values to the screen as pending values. (Refer to ìProgramming Nominal and Saved Valuesî in this chapter.)

Restricted Parameter Interactions

Certain combinations of parameter values are restricted because they are invalid or result in undesirable interactions. The programmer recognizes these combinations and does not allow programming until all parameter conflicts are resolved and all parameter selection requirements are met. Refer to Section E in Part III for more information on parameter programming requirements and restrictions.

Restricted Parameter Values ó Any parameter value that conflicts with the setting of a present or pending parameter is displayed in italics in the parameter value option window (see step 2 of the programming procedure).

6-4 Using the Programmer

Parameter Interaction ó If you select a restricted parameter value, the

DDIR

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.

Parameter Entry Requirement ó A solid, shaded rectangle appearing where a parameter value should be displayed indicates that a valid value for this parameter must be selected before programming is allowed.

General Parameter Programming Procedure

For specific parameter information related to each pacemaker model, refer to Sections B and†E of Part III. To program one or more parameter values:

1. Select the desired parameter from those displayed ó

Lower Rate

for example.

Press the selector pen directly over the parameter name or its value.

NOTE: Select

Pacing Mode

first if you intend to program a mode. Selecting a mode displays the programmable parameters pertinent to that mode.

2. From the window of value options, select the desired value.

Except for Hysteresis, selecting a value in italics results in a restricted parameter interaction.

If the value window displays additional parameters, refer to ìProgramming Parameter Subgroupsî on the next page.

Selecting a value closes the window. The selected value appears in place of the present value and is denoted as ìpendingî by a dashed rectangle.

To clear a pending value from the screen, select that parameter or value, and then

CLEAR VALUE

select [

] in the value window. To close the value window without selecting a value, press [

ACCEPT VALUE

Programming Pacing Parameters 6-5

3. 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.

PROGRAM

4. Position the programming head and select [

Select the [

PROGRAM] button to program all pending parameter values.

PROGRAM

Hold the programming head in position until the confirmation message appears.

NOTE: If the programming is interrupted, it is possible that one or more of the parameter groups will not be programmed and will still show pending values. In such cases, the programming will not be confirmed, and the message box will direct you to reselect [

PROGRAM].

Programming Parameter Subgroups

For certain parameters that can be programmed ON or OFF, the parameter value window displayed in step 2 of the general programming procedure will list one or more additional parameters that are subordinate to the selected ìprimaryî parameter. The procedures below cover the additional steps required to select values for these subordinate parameters.

Programming Mode Switch

If the present setting for Mode Switch is window will list the present setting for the subordinate parameter (as shown in the example below) and provide the option to select a new value. Refer to Chapter 14 for information about the operation of Mode Switch.

ON or if you select ON, the value

1. To select a value for this parameter, use the same basic procedure described in steps 1 and 2 of the general programming procedure.

2. When you have selected the desired value for Detect Rate, select the [

VALUE] button to close the

primary parameter value window.

6-6 Using the Programmer

If the present or pending value for Upper Tracking Rate is 165 ppm or above, the programmer automatically selects a pending value for Detect Rate. The values of 185 and 190 bpm are not selectable but will respectively appear as the pending value if Upper Tracking rate is 175 or 180 ppm.

Programming Rate Adaptive AV (Rate Adapt)

If the present setting for this parameter is window will list the present settings for the subordinate parameters (as shown in this example) and provide the option to select new values. Refer to Chapter 12 for information about the operation of Rate Adaptive AV.

1. To select a value for each

2. When the values for all

of the parameters, use the same basic procedure described in steps 1, 2 and 3 of the general programming procedure.

four parameters are as desired, select the [

] button to close the

VALUE

primary parameter value window.

or if you select ON, the value

Programming Rate Response Optimization (Optimization)

If the present setting for this parameter is

or if you select ON, the value

window will list the present setting for the subordinate parameter (as shown below) and provide the option to select a new value. Refer to Chapter 11 for information about the operation of Rate Response Optimization.*

1. To select a value for this

parameter, use the same basic procedure described in steps 1 and 2 of the general programming procedure.

2. When you have selected

the desired value for Lifestyle, select the

ACCEPT VALUE

[

] button to close the primary parameter value window.

*Rate Response Optimization does not apply to Thera DR models 7850, 7851, and 7852.

Programming Pacing Parameters 6-7

Programming Rate Drop Response (Rate Drop)

If the present setting for this parameter is

or if you select ON, the value window will list the present settings for the subordinate parameters (as shown below) and provide the option to select new values. Refer to Chapter†14 for information about operation of Rate Drop Response.*

1. To select a value for each

of the parameters, use the same basic procedure described in steps 1, 2 and 3 of the general programming procedure.

2. When the values for all six

parameters are as desired, select the [

ACCEPT VALUE

] button to close the primary parameter value window.

Programming the Sleep Function

If the present setting for this parameter is

or if you select ON, the value window will list the present settings for the subordinate parameters as shown below and provide the option to select new values. Refer to Chapter 14 for information about using the Sleep Function.*

1. To select a value for each

of the parameters, use the same basic procedure described in steps 1, 2 and 3 of the general programming procedure.

NOTE: The time options for Bed Time and Wake Time are based on a 24-hour clock (examples: 12:00 midnight is 00:00, 8:00 AM is 8:00, 8:00 PM is 20:00).

*Rate Drop Response and Sleep Function do not apply to the Thera DR models 7850, 7851, ††and 7852.

6-8 Using the Programmer

2. When the values for all three parameters are as desired, select the

From within the Bed Time or Wake Time value window, you can display options for all hours of the day in 15-minute increments by selecting the [

<<<

] or [MORE

] buttons to scroll the display

>>>

of time options. IMPORTANT: Time information communicated to the pacemaker

is†based on the current setting of the programmerís clock/calendar function. Verify that the current time setting of the programmerís clock is correct before programming the Sleep Function. To verify the time, start and stop an ECG recording by pressing the

RECORD key (9760

programmer) or the desired Paper Speed key (9790 programmer) or request any report printout. The time is printed at the top of the printout. Refer to Chapter 9 for instructions on setting the clock/calendar function.

[

ACCEPT VALUE] button to close the primary parameter value window.

Programming Pacing Parameters 6-9

Programming Nominal and Saved Values

The procedures below describe using the options available by selecting the

SAVE/NOMINAL OPTIONS

[

Programming Medtronic or Site Nominal Values

To recall Medtronic nominal settings (ìMedtronic Valuesî) or Site Nominal settings to the screen as pending values for programming:

...

] button.

1. Select the [

2. Select [

MEDTRONIC VALUES

SAVE/NOMINAL OPTIONS

] or [

...

] button.

SITE NOMINALS

] from the window of

options.

The respective parameter values will appear on the screen as pending values. You can directly program these values or make any desired changes prior to programming.

NOTE: The [

SITE NOMINALS

] button shows only if Site Nominal values

have been set up for the selected pacemaker model. Refer to Chapter 9.

Saving a Set of Parameter Values

To save the displayed present pacing parameter values (those interrogated from the patientís pacemaker):

1. Select the [

2. Select [

SAVE PRESENT VALUES

SAVE/NOMINAL OPTIONS

...

] button.

] from the window of options.

The displayed present parameter values will be saved in programmer memory until you save another set of present values or end the patient session. You can view the currently saved values by selecting the [

] button on the Pacing Parameters screen.

SAVED

SHOW

NOTE: Unless some parameter values have already been saved, using the

INTERROGATE ALL

[

] button as described in Chapter 2 will automatically

save the present pacing parameter settings.

Programming the Saved Set of Values

To recall the saved parameter values to the screen as pending values for programming:

1. Select the [

2. Select [

SAVED VALUES

SAVE/NOMINAL OPTIONS

] from the window of options.

...

] button.

The saved parameter values will appear on the screen as pending values. You can directly program these values or make any desired changes prior to†programming.

6-10 Using the Programmer

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.

Selecting the Additional Parameters Screen

1. Select [

menu button.

2. Select

PARAMETERS

ADDITIONAL

option.

Additional Parameters Screen

To display the Additional Parameters screen, select the [ menu button, and then select the

ADDITIONAL PARAMETERS

PARAMETERS

option as shown

below.

]

Parameter settings will not show unless an appropriate interrogation has occurred. Interrogate the pacemaker, if necessary, to display the settings.

]

Programming Pacing Parameters 6-11

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 ìEnhanced Transtelephonic Monitoringî in Chapter 13 for an explanation of this feature.

WARNING: Do not program Transtelephonic Monitor to ON if the patient†has an implantable defibrillator (see Chapter 13).

To program Transtelephonic Monitor:

1. Select

Trans Tele

from the parameters listed on the Additional

Parameters screen.

2. From the displayed window of options, select

3. Position the programming head and select [

PROGRAM

as desired.

OFF

]. Hold the programming head steady until you receive a programming confirmation.

Programming Extended Telemetry

Programming Extended Telemetry to ON will cause the pacemaker to continuously transmit EGM and Marker Channel telemetry for 24 hours. Refer to Chapter 15 for information about Extended Telemetry.

NOTE: Because Extended Telemetry increases current drain on the pacemaker battery, it should be used only when necessary.

To program Extended Telemetry:

1. Select

Extend. Telem

Parameters screen.

2. From the displayed window of options, select

3. Position the programming head and select [

programming head steady until you receive a programming confirmation.

from the parameters listed on the Additional

OFF

as desired.

PROGRAM

]. Hold the

6-12 Using the Programmer

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. Select the

Status Reset

from the parameters listed on the Additional

Parameters screen.

RESET

2. From the option window, select

3. Position the programming head and select [

PROGRAM

]. Continue to hold the programming head steady while the pacemaker automatically tests the present condition of its battery.

During this test, the pacemaker paces asynchronously at 100 ppm for several beats. (During these beats in a dual chamber mode, the AV interval will be 100 ms.)

If the test verifies the ERI status, no reset will occur. If battery voltage has recovered, the ERI status is cleared, and you

can proceed to reprogram the parameter settings.

Clearing a Pacemaker Electrical Reset

The Status Reset command can also be used to clear a full pacemaker electrical reset condition. Indication that a full electrical reset has occurred is VVI pacing at 65 ppm and, in some cases, a pacemaker serial number set†to all zeros (000000). Refer to Chapter 16 for an explanation of ìfull electrical resetî versus ìpartial electrical reset.î

IMPORTANT: If a full electrical reset has occurred , you should contact your Medtronic representative after using the Status Reset command to clear this condition.

To clear a full electrical reset condition:

1. Select the

Status Reset

from the parameters listed on the Additional

Parameters screen.

RESET

2. From the option window, select

3. Position the programming head and select [

PROGRAM

]. Continue to hold the programming head steady until confirmation is received.

All parameters, including the pacemaker serial number, can now be reprogrammed to their proper settings.

Programming Pacing Parameters 6-13

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:

1. Select

Serial Number

from the list of parameters on the Additional

Parameters screen.

2. Using the on-screen keypad, enter each digit of the original serial

number. The selected numbers will appear in the small window to the right of the keypad.

3. If you make a mistake, select [

ACCEPT VALUE

[

] to register the entered number as a pending value.

CLEAR VALUE

4. Position the programming head and select [

]. Otherwise, select

PROGRAM

]. Hold the pro-

gramming head steady until you receive a programming confirmation.

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 patientís stimulation threshold to determine appropriate values for amplitude and pulse width (see page 7-2).

Measuring the level of R-wave or P-wave sensing to determine appropriate values for pacemaker sensitivity (see page 7-15).

Conducting an Activity Threshold test and an Exercise test to formulate parameter settings for programming or optimizing an Activity pacing mode (see page 7-21).

Using temporary parameter programming to evaluate other parameter values without changing the permanent settings (see page 7-30).

Directly measuring the actual values of the pacing rate and paced AV interval (see page 7-33).

7-1

7-2 Using the Programmer

Measuring Stimulation Thresholds

The Threshold Test function lets you measure the patientís stimulation thresholds to determine appropriate settings for amplitude and pulse width. This measurement procedure begins at the Threshold Test Start screen.

Selecting the Threshold Test Start Screen

1. Select [

menu button.

2. Select

TEST

TESTS/ECG

THRESHOLD

option.

]

Threshold Test Start Screen

In this example, the programming head has been positioned over the patient’s pacemaker to display Marker Channel and EGM telemetry.

Refer to pages 5-6 and 5-7 for instructions on adjusting the ECG and telemetry traces.

Selecting a chamber/ mode option and the desired test type are the first two steps in conducting a threshold test.

To display the Threshold Test Start screen, select the [ button, and then select the

THRESHOLD TEST

option as illustrated below.

TESTS/ECG

If you have not yet interrogated the pacemaker for its present parameter settings, a message will prompt you to do so at this point. If this prompt appears, position the programming head and select [

INTERROGATE

proceed.

 

 



] menu

] to

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.

If the permanent pacing mode is DDD or DDDR, you can choose to run the threshold test in the atrium or the ventricle using either DDD or AAI/VVI as the test mode.

If the permanent mode is a dual chamber mode other than DDD or DDDR, you can choose the chamber, but the test mode will be limited to AAI/VVI.

If the permanent mode is a single chamber mode, the test chamber and mode will be fixed according to chamber being paced.

Test Type Selection

Test type buttons let you select one of four different threshold tests or the Inhibit function.

[

STRENGTH-DURATION CURVE THRESHOLDS

]

ó Select this test to use automatic, stepby-step reduction of output energy to measure stimulation thresholds for both amplitude and pulse width. This test graphically displays the results as a computed strength-duration curve. The results screen lets you select the desired voltage safety margin and directly program permanent amplitude and pulse width values.

[

AUTO AMPL THRESHOLD

tude threshold. Pressing and holding the [

] ó Select this test to measure the patientís ampli-

PROGRAM

] button results in

automatic, step-by-step reduction of the pacing pulse amplitude.

AUTO PW THRESHOLD

[ width threshold. Pressing and holding the [

] ó Select this test to measure the patientís pulse

PROGRAM

] button results in

automatic, step-by-step reduction of the pacing pulse width.

7-4 Using the Programmer

[MANUAL THRESHOLD] ó 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] ó This button is available on the Threshold Test Start

screen as a convenience option. You can use it to temporarily inhibit output of the pacemaker to view the patientís underlying rhythm or determine the intrinsic rate. Use of this feature is described on page 5-9.

Before You Begin the Test Procedure

Precautions

At any point during a threshold test, lifting the programming head from over the pacemaker for at least 2 seconds will return the pacemaker to its permanently programmed state. This action should be taken in the event of a programmer malfunction, loss of power, or absence of an appropriate command confirmation.

Be aware that movement of the programming head during an automatic threshold test may interrupt communication between the programmer and pacemaker, which will terminate the test.

A Note About Hysteresis

If Hysteresis has been programmed to ON during previous use of the AAI, ADI, AAT, VVI, VDI, or VVT pacing mode, it will be in effect when ever you return to one of these modes ó even temporarily such as during a threshold test. If a message indicates that Hysteresis is in effect, you can program it to OFF by returning to the Pacing Parameters screen. To access Hysteresis, you must select one of the single chamber modes stated above.

Waveform Display

During setup and execution of a threshold test, the screen continuously displays the patientís ECG and the telemetered waveforms being received from the pacemaker. Adjust the ECG trace so that you easily can see pacing artifacts and the resulting depolarization wave. During a threshold test, you must be able to determine whether or not capture is maintained or lost as pacemaker output is reduced, either manually or automatically.

Refer to Chapter 5, pages 5-6 to 5-8 for information about using and adjusting the waveform display and about Marker telemetry.

Selecting Pulses Per Decrement

During a threshold test (except ìManual Thresholdî), the programmer controls the number of pacing cycles it allows to occur at each threshold

Medtronic 7960I Reference Guide

Specifications and Main Features

Frequently Asked Questions

User Manual

How To Use This Guide

Table of Contents