Medtronic 8040 Programming Guide

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INSYNC

Device Model 8040 Programmer Software Model 9980

Device Programming Guide

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

InSync® Model 8040 Device Programming Guide

A Guide to using the 9790 series programmer and 9980 software with the InSync device

The following terms are trademarks of Medtronic. InSync, marker Channel, and Medtronic

About This Programming Guide

Information about the InSync Model 8040 device is presented in two separate guides: the InSync Model 8040 Device Programming Guide (this guide) and the InSync Model 8040 Device Reference Guide.

This programming guide provides instructions for using a 9790 series programmer with the InSync Model 8040 device. Sections describe the applicable programming and follow-up functions and present step-by-step procedures for using these functions.

Information is organized into the 9 chapters and one appendix:

Chapter 1 – Introductory information

Chapter 2 – General procedures

Chapter 3 – Starting and ending a patient session

Chapter 4 – Retrieving system data

Chapter 5 – Displaying and printing the patient’s ECG and EGM

Chapter 6 – Programming the device parameters

Chapter 7 – Determining and evaluating parameter settings

Chapter 8 – Using the diagnostic data recording function

Chapter 9 – Programmer setup options, such as setting the time

and date

Appendix A – Programmable parameters, values, and programming restrictions

The InSync Model 8040 Device Reference Guide provides information about the functions and operation of the device. The reference guide is supplemental to the Product Information Manual packaged with the InSync device.

InSync® Model 8040 Device Programming Guide iii

iv InSync® Model 8040 Device Programming Guide

Table of Contents

About This Programming Guide iii

1. Using the Programmer with an InSync Device

When to Use this Manual 1-2 Conventions Used in this Manual 1-3 General Warnings and Precautions 1-4 Display Screen Format and Interactive Features 1-7 A Guide to Using the Menu and Command Buttons 1-11

2. Procedures to Know Before You Begin

Using the Programming Head 2-2 Programming Emergency Parameters 2-5 Interrogating the InSync Device 2-6 Canceling Effects of the Programming Head Magnet 2-8 Printing Reports During a Patient Session 2-9 Automatic Printing with the Printer Trace Mode 2-12 Printing Reports After a Session Has Ended 2-13 Transferring Session Data to a Diskette 2-14 Using the HELP Options 2-17

3. Starting and Ending a Patient Session

Before You Begin 3-2 Turning the Programmer ON 3-3 Starting a Patient Session 3-4 Selecting the Desired Function 3-6 Ending a Patient Session 3-8

4. Retrieving System Data

Displaying Present Parameter Settings 4-2 Displaying a Status Summary 4-6 Displaying Battery and Lead Information 4-11 Displaying a Graph of Recorded Diagnostic Data 4-14

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

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

InSync® Model 8040 Device Programming Guide v

Freezing the ECG Trace 5-11 Displaying a Marker Channel Diagram 5-15

6. Programming the Pacing Parameters

Programming Pacing Parameters 6-2 Programming Additional Parameters 6-12

7. Determining and Evaluating Parameter Settings

Measuring Stimulation Thresholds 7-2 Determining a Setting for Sensitivity 7-21 Determining Rate Response Parameter Settings 7-28 Programming Temporary Parameter Values 7-38 Measuring Rate and AV Interval 7-41

8. Collecting and Retrieving Diagnostic Data

About the Diagnostics Function 8-2 Types of Data You Can Record 8-4 Recording Data From a Non-Paced Chamber 8-17 Programmable Parameter Options 8-19 About the Setup Options 8-22 Programming the Device to Record Data 8-24 Displaying a Graph of the Recorded Data 8-29 Printing the Diagnostic Data 8-32 Clearing Recorded Data From the Device 8-33

9. Programmer Setup Options

Setting the Time and Date 9-2 Connecting an External Recorder or Monitor 9-4 Using the CALIBRATE Option 9-5 Improving the Detection of Pacing Artifacts 9-7

A. Appendix A - Parameter Values and Restrictions

Programmable Modes and Parameters A-2 Programming Requirements and Restrictions A-6 Temporary Modes and Parameters A-9

I. Index

vi InSync® Model 8040 Device Programming Guide

Using the Programmer

General Desciption

with an InSync Device 1

This chapter introduces you to using your 9790 series programmer with the InSync device.

When to Use this Manual 1-2

Conventions Used in this Manual 1-3

General Warnings and Precautions 1-4

Display Screen Format and Interactive Features 1-7

A Guide to Using the Menu and Command Buttons 1-11

InSync® Model 8040 Device Programming Guide 1-1

When to Use this Manual

Installation of the 9980 software adds the InSync Model 8040 device to the programming and follow-up capabilities of your 9790 series programmer. Several manuals now cover the use of your programmer, each covering a specific set of implantable device models.

InSync Model 8040 device – If you select this device model, refer to this manual for instructions on using the programmer.

Other device models – If you select a device model other than the InSync Model 8040 device, refer to the appropriate programming guide supplied with the software application for that device. The front cover of each programming guide lists the device models covered in that guide.

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

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Conventions Used in this Manual

This manual uses the following text format conventions in the instructions for using the programmer.

[INTERROGATE] Boldface small capitals within brackets denote

THRESHOLD TEST Boldface capitals without brackets denote a

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

➤ This symbol identifies a single instructional

■ This symbol is used as a bullet indicating

an on-screen button.

selectable screen option other than a button.

identify instructional steps.

statement.

itemized statements or paragraphs.

InSync® Model 8040 Device Programming Guide 1-3

General Warnings and Precautions

These warnings and precautions apply in general to using a 9790 series programmer.

Warnings

Using the Programmer

Programming should be done only after careful study of the device 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 9790 series programmer must be used only for programming Medtronic devices listed as applicable units for the software being used. Direct stimulation via energy coupling may occur if the programmer is used on other implanted devices. This programmer is not compatible with programmable devices of other manufacturers.

Implantable Defibrillator

Some patients may also require therapy from an implantable defibrillator.

■

Only bipolar pacing should be used with these patients. In some cases, pacing in the unipolar configuration may cause the defibrillator to either deliver inappropriate therapy or to withhold appropriate therapy.

■

Programming Lead Monitor with the optional polarity switch is contraindicated for patients with an implanted defibrillator. When an out-of-range lead is detected, the monitor automatically reprograms selected leads to unipolar polarity. Pacing in the unipolar configuration may either cause the defibrillator to provoke inappropriate therapy or to withhold appropriate therapy.

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■

Programming the Transtelephonic Monitor On is contraindicated for patients with an implanted defibrillator. When the monitor is programmed On, the pacing polarity is temporarily set to unipolar when the magnet is applied over the implanted device. Pacing in the unipolar configuration may either cause the defibrillator to provoke inappropriate therapy or to withhold appropriate therapy.

Precautions

High Rate Stimulation

Before and after the use of high-rate stimulation, the clinician should interrogate the implanted device to determine the battery status and elective replacement indicator (ERI) condition.

High-rate stimulation over several years, or with the battery partially depleted, may trigger the ERI prematurely.

Loss of Programmer Power

If power to the programmer is unexpectedly lost, lifting the programming head from over the patient’s device cancels any temporary parameters or functions in effect and restores the device to its permanently programmed state.

Unresponsive Screen

In the unlikely event the programmer display screen becomes unresponsive or “locked,” 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 device model to continue with the application.

Programming Head

Failure to correctly align the programming head over the InSync device could result in failure of a programming transmission and failure to receive telemetry. The programming head should not be positioned over an implanted device during electrocautery or

InSync® Model 8040 Device Programming Guide 1-5

defibrillation procedures. Refer to “Using the Programming Head” in Chapter 2 for specific information about using the programming head.

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Display Screen Format and Interactive Features

This section describes the appearance of the programmer display screen and the scheme for selecting the various functions or tasks you wish to accomplish during the patient session.

Display Screen Example

Below is an example of the screen format you will see when you use the programmer with an InSync device.

Menu Buttons

Device ID

Screen Title

ECG Display

Function Display Area

Message Box

Command Buttons

Figure 1-1. Features of the Display Screen

The main elements of this screen format are as follows:

Menu Buttons – The menu buttons, which appear across the top of each screen, provide direct access to the applicable programmer functions.

Device ID – Displays the selected device family name and model number.

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Screen Title – Title of the current screen generally appears in this location.

ECG Display – This box continuously displays a low-resolution trace of the patient’s ECG.

Function Display Area – This area of the screen changes according to the selected function. It displays the data, buttons, and options that apply to the selected function.

Message Box – 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.

Command Buttons – Location of the [

MAGNET], [INTERROGATE], and [INTERROGATE ALL] buttons is

the same on all function screens where they apply. The [

EMERGENCY] programming button appears in this location on all

function screens.

PROGRAM], [CANCEL

Interactive Screen Features

The display screen has interactive features that respond to application of the touch pen, or stylus, 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 symbols enclosed within a black rectangular border. Buttons with labels ending in an ellipsis (...) open a window of additional options.

Button Examples

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Selectable options, which appear in boldface type, include device model options, parameters, parameter values, and menu options.

Selectable options appear in boldface lettering.

Selecting a Button

➤ Without touching the screen, move the tip of the stylus to a

position directly over the button; then press the stylus against the screen.

If the button is a “locking” 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 “press and hold” a button, you must press the stylus against the button and continue to press for as long as you want the related operation to continue.

Selecting an Option

➤ Without touching the screen, move the tip of the stylus to a

position directly over any part of the boldface option label (may be a word or number); then press the stylus against the screen.

InSync® Model 8040 Device Programming Guide 1-9

Audible Signals

Certain events in the operation of the programmer will result in an audible signal of one or two tones, or “beeps.” 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

PROGRAM key on the programming head indicates that the

programmer acknowledges the keystroke. If the keystroke is inappropriate, two low-tone beeps will sound.

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INTERROGATE or

A Guide to Using the Menu and Command Buttons

Using the Menu Buttons

Except for [END SESSION] and [FREEZE], selecting a menu button at the top of the screen displays a drop-down menu of related function options. A check mark (✓) next to a displayed option (see example below) indicates that option is currently selected.

Menu Buttons

Drop-down Menu

Note: To close the menu without making a selection, “click” the stylus 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 Device System Data – See Chapter 4. Selecting the [

■

Viewing a summary of interrogated data.

■

Viewing measured real-time values of battery and lead data.

■

Viewing a graph of accumulated diagnostic data.

DATA] menu button displays options for:

InSync® Model 8040 Device Programming Guide 1-11

Displaying the Patient’s ECG and EGM – See Chapter 5. Selecting the [

TESTS/ECG] menu button displays an option for

viewing and adjusting the patient’s ECG and the EGM and Marker Channel signals received from the implanted device via telemetry. The ECG display includes an option for inhibiting the output of the patient’s device.

Conducting Device System Tests – See Chapter 7. Selecting the [

■

Measuring stimulation thresholds.

■

Determining a setting for device sensitivity.

■

Determining a setting for Activity Threshold and Rate

TESTS/ECG] menu button also displays options for:

Response.

■

Programming temporary parameter settings.

■

Measuring rate and AV interval.

■

Conducting electrophysiologic studies if 9886A or 9891A software is installed. Instructions are covered in a supplement supplied with the software.

Programming Parameter Settings – See Chapter 6. Selecting the [

PARAMETERS] menu button displays options for:

■

Programming stimulating parameters and viewing present settings.

■

Accessing additional parameter options including Extended Telemetry, Transtelephonic Monitor, Serial Number, and Status Reset.

Setting Up the Diagnostics Function – See Chapter 8. Selecting the [ for programming the device to record the selected type of diagnostic data.

Ending the Patient Session – See Chapter 3. Selecting the [ session and return to the implantable device model selection screen.

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PARAMETERS] menu button also displays an option

END SESSION] menu button lets you end the patient

Special Options – 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 – See Chapter 5. Selecting the [

FREEZE] menu button freezes a 10-second segment

of the patient’s ECG and provides the option for viewing a Marker Channel diagram if the device is operating in a permanently programmed triple chamber or VDD mode.

Printing Reports – See Chapter 2. Selecting the [

PRINT] menu button displays options for printing

the various data reports generated during the patient session.

Viewing Help Information – 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.

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.

InSync® Model 8040 Device Programming Guide 1-13

Programming Emergency Parameters – See Chapter 2. Selecting the Emergency command overrides any function and immediately programs the device to a fixed set of permanent values that provide high output pacing in the VVI mode.

Canceling the Programming Head Magnet – See Chapter 2. Selecting the Cancel Magnet command cancels the effect of the programming head magnet and allows the device to operate in its permanently programmed state while the programming head is in position. For example, operation of a device permanently programmed to the DDD mode will change from the DOO magnet mode to the DDD mode when this command is executed.

Interrogating the Device – See Chapter 2. Selecting the Interrogate command from a particular function screen retrieves from the device the data related to that function.

Interrogating All Data – See Chapter 2. The Interrogate All command retrieves all data (parameter, battery/lead, and diagnostic) from the device. 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 – (Covered in the procedures). This command executes a temporary or permanent programming transmission based on the procedure being conducted. This button appears only when programming is allowed.

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Procedures to Know

General Desciption

Before You Begin 2

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.

Using the Programming Head 2-2

Programming Emergency Parameters 2-5

Interrogating the InSync Device 2-6

Canceling Effects of the Programming Head Magnet 2-8

Printing Reports During a Patient Session 2-9

Automatic Printing with the Printer Trace Mode 2-12

Printing Reports After a Session Has Ended 2-13

Transferring Session Data to a Diskette 2-14

Using the HELP Options 2-17

InSync® Model 8040 Device Programming Guide 2-1

Using the Programming Head

In many of the procedures described in the following chapters, you will be directed to position the programming head over the patient’s implanted device.

■

Always position the programming head prior to executing any command that results in a programming or telemetry interaction between the programmer and the device.

■

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

Positioning the Programming Head

Caution: Do not position the programming head over an

implanted device during electrocautery or defibrillation procedures.

For an implanted device:

1. Position the programming head directly against the patient’s

skin with the face of the programming head parallel to the device.

2. 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.

3. Move the head to the position that lights the greatest number

of green lights. This is the optimum position.

2-2 InSync® Model 8040 Device Programming Guide

Light Array

Note: Device operation returns to its permanently programmed settings about 2 seconds after you remove the programming head from its position over the implanted device.

The programmer also has a programming head position indicator light located near the upper left corner of the screen. This indicator light goes out when a telemetry link with the device has been established — or it may change from amber to green — see Using the POSITION HEAD ASSIST Option below).

Using the POSITION HEAD ASSIST Option

The Position Head Assist function facilitates using the head position light on the programmer to locate the optimum head position over the patient’s device. This function is particularly useful under conditions that adversely affect the communication link between the programmer and device.

Assist enabled – The programming head position light on the display panel changes from amber to green when the programming head is properly positioned.

Assist disabled – The amber position 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.

Note: When the Assist function is enabled (“Enhanced” option), continuous interaction between the programmer and device can cause extraneous artifacts to appear at 250 ms intervals on the patient’s ECG trace. The programmer automatically filters these artifacts so they do not appear. Although these artifacts can obscure pacing artifacts or small details on the ECG trace, they have no effect on the pacing operation of the device.

The default setting for the Assist function is Enhanced. That is, the Assist function is already 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 “Normal” option (see next).

InSync® Model 8040 Device Programming Guide 2-3

Procedure for Selecting the Position Head Assist Setting

1. Select [SPECIAL] from the menu buttons at the top of the

screen.

2. Select

POSITION HEAD ASSIST from the options displayed.

3. From the window showing two buttons:

➤ Select [

➤ Or select [

ENHANCED] to enable the Assist function.

NORMAL] to disable the Assist function.

Using PROGRAM / INTERROGATE Keys

The PROGRAM and INTERROGATE keys on the programming head have the same function as the [ buttons that appear on the display screen. Whenever the instructions in this manual direct you to select the [ [

INTERROGATE] button on the screen, you can press the

corresponding key on the programming head instead, if it is more convenient.

INTERROGATE Key

PROGRAM] and [INTERROGATE]

PROGRAM] or

PROGRAM Key

Figure 2-1. PROGRAM and INTERROGATE Keys on the

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Programming Head

Programming Emergency Parameters

The [

]

The Emergency programming command is a safety feature that overrides all other functions and immediately programs the device 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 higherthan-normal energy output. It is not intended that the device be left at

these settings.

Note: Use of the Emergency command may not be appropriate for patients who have an implanted defibrillator. Pacing in the unipolar configuration may cause the defibrillator either to deliver inappropriate therapy or to withhold appropriate therapy.

Tab le 2-1. Emergency Values

Pacing Mode Rate V. Refractory Period V. Pulse Amplitude V. Pulse Width V. Sensitivity V. Pace Polarity V. Sense Polarity Single Chamber Hysteresis

VVI 70 ppm 330 ms

7.5 V

1.5 ms

2.8 mV Unipolar Unipolar Off

EMERGENCY

button appears in th e lower left corner of all function screens.

To program Emergency parameters:

1. Position the programming head over the device.

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 [

You can press the square red button on the left side of the display panel as an alternative to the on-screen [EMERGENCY] button.

EMERGENCY].

InSync® Model 8040 Device Programming Guide 2-5

Interrogating the InSync Device

Before the programmer can display any information about the status of the patient’s device system, you must interrogate the device. The information you can retrieve by interrogating the device 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 separately 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.

Note: The [ Pacing Parameters Screen.

INTERROGATE ALL] button is available only on the

To execute the Interrogate All command:

1. Select the Pacing Parameters screen.

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 device.

3. Select the [

programming head steady until success of the interrogation is confirmed.

2-6 InSync® Model 8040 Device Programming Guide

INTERROGATE ALL] button. Continue to hold the

Auto Printout – An Interrogate All command automatically initiates printing of the following data:

1) the present stimulating 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.

Auto Save – 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 [ or you can recall the values to the screen as pending values for programming (select the [ then select the [

SAVED VALUES] button).

SAVE/NOMINAL OPTIONS...] button,

SHOW SAVED] button)

The INTERROGATE Function

From most function screens, you can interrogate the device 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.

To execute the Interrogate command:

1. Position the programming head over the device.

2. Select the [

programming head steady until success of the interrogation is confirmed.

INTERROGATE] button. Continue to hold the

InSync® Model 8040 Device Programming Guide 2-7

Canceling Effects of the Programming Head Magnet

“Cancel Magnet” is a temporary programming command that cancels the effect of the programming head magnet. It allows the device to operate in its permanently programmed mode (such as the DDD mode) while the programming head is held in position.

The [

CANCEL MAGNET] button appears near the lower right

corner of all function screens except the Battery/Lead screen described in Chapter 4.

To execute the Cancel Magnet command:

1. While the programming head is positioned over the device,

select the [

2. Watch for the “Magnet cancelled” message.

CANCEL MAGNET] button.

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.

2-8 InSync® Model 8040 Device Programming Guide

Printing Reports During a Patient Session

The [PRINT] menu button lets you select and print various reports of the data generated during a patient session. Most data is temporarily stored for the duration of the patient session and can be printed at any time during the patient session. However, some types of data, particularly graphic data, must be printed while it is displayed on the screen. All data stored in programmer memory is cleared when you start a new patient session.

Selecting a Print Option

Selecting a Print option may cause on-screen buttons, except [

EMERGENCY], 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 cancels an ECG recording in progress.

To print a report, select the [ 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.

Figure 2-2. Options for Printing Reports

InSync® Model 8040 Device Programming Guide 2-9

PRINT] menu button, and then select

About the Print Options

Current Screen Report — 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 – Selecting this option initiates a printout of all pertinent parameter values presently programmed and confirmed in the device.

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

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

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

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

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

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Activity Exercise Test – 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 – Prints the most recent parameter values obtained from using the Measure ECG function.

Waveforms – 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 – 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 – 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.

Tr a ce . .. – Selecting this option displays two buttons that let you turn the printer “Trace” mode on or off. The following section describes the printer Trace mode.

InSync® Model 8040 Device Programming Guide 2-11

Automatic Printing with the Printer Trace Mode

To turn the printer Trace mode ON or OFF:

1. Select TRACE... from the Print menu options (see Figure 2-2).

2. From the Trace window, select [

MODE OFF] as desired.

3. Select [

EXIT] to close the window.

TRACE MODE ON] or [TRACE

Turning the Trace Mode On

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.

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.

Turning the Trace mode off

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

2-12 InSync® Model 8040 Device Programming Guide

Printing Reports After a Session Has Ended

Caution: When you end a patient session you will be prompted to

print the data reports generated during the session or transfer these reports to a computer diskette. Data accumulated during the patient session is not saved and is lost if you choose not to print or transfer these reports when prompted.

Procedure

Ending a patient session displays the Print/Transfer Reports popup window shown in Figure 2-3. This window provides the option to print the data reports accumulated during the session.

Figure 2-3. Print/Transfer Reports Pop-up Window

To print the accumulated reports:

➤ Select the [PRINT REPORTS] button in the Print/Transfer

Reports window shown in Figure 2-3.

To delete the reports and proceed to the Select Model screen:

➤ Select the [CONTINUE] button.

InSync® Model 8040 Device Programming Guide 2-13

Transferring Session Data to a Diskette

Caution: When you end a patient session you will be prompted to

Procedure

Ending a patient session displays the Print/Transfer Reports popup window shown in Figure 2-4. This window provides the option to transfer the data reports accumulated during the session to a computer diskette.

Figure 2-4. Print/Transfer Reports Pop-up Window

To transfer the data reports to a diskette:

1. From the options displayed, select the [TRANSFER REPORTS

TO DISK] button. This displays the window shown below.

2-14 InSync® Model 8040 Device Programming Guide

The “Patient ID,” which will be used in a printed header identifying the data reports, defaults to the device serial number.

2. 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.

3. 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. Use a 720 Kb diskette (DS, DD) or a 1.44 Mb diskette (DS, HD)

4. Select the [

OK] button to copy the patient session reports to

the diskette. If an error message appears, refer to “Disk Error Message” below.

Note: Do not remove the diskette until the file transfer process is complete. The message box will state when data has been successfully transferred.

5. To remove the diskette, press the small, rectangular eject

button near the disk drive opening.

The name automatically assigned to the session file on the diskette will take the following format: DS######.MDS, where “######” are the first six characters of the patient ID. If 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 DS#####A.MDS, the third DS#####B.MDS, and so on.

InSync® Model 8040 Device Programming Guide 2-15

Disk Error Message

If a disk error message occurs at step 4, check the following:

■

Is the diskette the proper capacity and format? See step 3.

■

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 “Control-Z” 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 “1” until other formats become available), and the device 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.

2-16 InSync® Model 8040 Device Programming Guide

Using the HELP Options

Selecting the [HELP] Menu button displays options for viewing information about using the programmer. You can select the [

HELP] button at any time during the patient session.

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

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

Replacement Indicators – Definitions of the battery status messages that can appear for the selected device model.

Figure 2-5. Help Options

Magnet Modes – Information about the magnet modes and related stimulating rates for the InSync device model.

Programmer Info – Information about display conventions used to convey information on the programmer display screen.

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

How to Interrogate – General instructions on how to interrogate the device when it is required to display stimulating data or parameter settings.

InSync® Model 8040 Device Programming Guide 2-17

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

Parameter Information (not available for all parameters)

2-18 InSync® Model 8040 Device Programming Guide

Starting and Ending a

General Desciption

Patient Session 3

This chapter describes how to start and end a patient session and how to use the menu buttons to proceed to the desired function or task.

Before You Begin 3-2

Turning the Programmer ON 3-3

Starting a Patient Session 3-4

Selecting the Desired Function 3-6

Ending a Patient Session 3-8

InSync® Model 8040 Device Programming Guide 3-1

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 guide, Programmer Description and Setup, supplied with your 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. The stylus (should not be disconnected)

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)

3-2 InSync® Model 8040 Device Programming Guide

LA (L)

C (C)

LL (F)

( ) = IEC Coding

Figure 3-1. Connecting Skin Electrodes

Turning the Programmer ON

Procedure

If the programmer is not operating, turn it on by pressing inward on the top of the power switch. 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 Select Model screen (see next page).

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

Printer Test Failure – 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 Select Model 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 programmer’s clock/calendar function.

■

Connecting an external recorder or monitor and using the Calibrate option.

■

Setting up the stimulation artifact display function.

InSync® Model 8040 Device Programming Guide 3-3

Starting a Patient Session

The procedure for starting a patient session begins at the Select Model screen shown in the example below. This screen appears upon completion of the self test when you turn the programmer on and after you end a patient session.

Figure 3-2. Implantables Model Selection Screen

Starting a Patient Session Automatically

To start a patient session using Auto Identify:

1. Position the programming head over the patient’s implanted

device and continue to hold it steady.

2. Select the [Auto-Identify] button at the bottom of the screen.

After a few seconds of internal software loading, the programmer displays the first task screen. Proceed as described in “Selecting the Desired Function” on page 3-6.

3-4 InSync® Model 8040 Device Programming Guide

Model Not Identified – 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.

Starting a Patient Session Manually

To start a patient session by selecting the model:

1. Select Other from the View options on the Select Model

screen.

2. Select

3. Select the [Start] button.

4. After a few seconds of internal software loading, the

InSync Model 8040 from the list of models.

programmer displays the first task screen. Proceed as described in “Selecting the Desired Function” on page 3-6.

InSync® Model 8040 Device Programming Guide 3-5

Selecting the Desired Function

Selecting the device model displays the Pacing Parameters screen shown in the example below. This screen allows you to:

■

View the present parameter settings (see Chapter 4).

■

Program new parameter settings (see Chapter 6).

■

Proceed to another function.

To proceed to another function, select the appropriate button from the “menu” buttons displayed across the top of the screen.

Menu Buttons

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

Position the programming head and press

INTERROGATE] or

[

INTERROGATE ALL].

[

Figure 3-3. Parameter Programming Screen

Navigating with the Menu Buttons

Except for the [END SESSION] and [FREEZE] buttons, selecting a Menu button displays a list of function options as described on the following page.

3-6 InSync® Model 8040 Device Programming Guide

Menu Button Description and Chapter Reference Possible Options

Select this button to display options for viewing data retrieved from the device by interrogation, including: a pacing data summary, battery and lead information, and

DATA SUMMARY BATTERY/LEAD SHOW DIAGNOSTICS GRAPH

a graph of Diagnostic data. Refer to Chapter 4.

Select this button to display options for viewing the patient’s ECG and EGM and for conducting various tests such as determining the patient’s 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 Chapter 6 and 8.

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)

Select this button to end a patient session.

Select to access the: 1) Calibrate option, which applies to using an external recorder; 2) Position Head Assist

CALIBRATE (Ch 9) POSITION HEAD ASSIST(Ch 2)

option, which applies to using the Programming Head. Refer to Chapters 9 and 2, respectively.

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

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 informational help screens. Refer to Chapter 2.

An “EPS” option for conducting electrophysiologic studies also will be listed if 9886A or 9891A software has been installed. Instructions for using this function are covered in a supplement supplied with the software.

CURRENT SCREEN REPORT PARAMETER VALUES DATA SUMMARY BATTERY/LEAD DATA DIAGNOSTICS DATA TABLE THRESHOLD RESULTS SENSING RESULTS

ACTIVITY THLD RESULTS

ACTIVITY EXERCISE TEST MEASURED VALUES WAVE FOR MS WAVEFORM SEGMENT FULL REPORT TRACE...

CURRENT SCREEN REPLACEMENT INDICATORS MAGNET MODES PROGRAMMER INFO HOW TO PROGRAM HOW TO INTERROGATE

InSync® Model 8040 Device Programming Guide 3-7

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 device model to begin a new patient session.

To end a patient session:

1. 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.

2. Select [

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 Chapter 2).

Caution: You must print the accumulated reports or transfer them to a diskette when you are prompted. This data will no longer be available once you close the prompt (Print/Transfer Reports?) window.

3-8 InSync® Model 8040 Device Programming Guide

OK] to end the session, or select [CANCEL] to continue

Retrieving System

General Desciption

Data 4

This chapter describes how you can display information retrieved from an InSync device by interrogation. You can use the four procedures presented in this chapter to display:

1) The present programmed parameter settings.

2) A summary of battery and lead status and the programmed status of the Diagnostics function.

3) Real-time measurements of device battery condition and of parameters related to device output and lead system status.

4) A graphic display of the event data accumulated in device memory by the Diagnostics function if it has been programmed to collect data.

Displaying Present Parameter Settings 4-2

Displaying a Status Summary 4-6

Displaying Battery and Lead Information 4-11

Displaying a Graph of Recorded Diagnostic Data 4-14

InSync® Model 8040 Device Programming Guide 4-1

Displaying Present Parameter Settings

You can quickly display the parameter settings to which the patient’s device 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.

To display the Present Pacing Parameters:

1. Select the [PARAMETERS] menu button

2. Select the

Note: If the [

lower right corner of the present screen, you can select it as an alternative to the two-step procedure above.

PACING PARAMETERS option.

PACING PARAMETERS] button is displayed in the

Figure 4-1. Pacing Parameters Screen

If the device has been interrogated, this screen displays the present parameter settings. (Subordinate parameters are not displayed -- see next page.) To use this screen to program new parameter settings, refer to the instructions in Chapter 6.

4-2 InSync® Model 8040 Device Programming Guide

Parameters Not Displayed

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 (Rate Adaptive AV Interval)

Start Rate Stop Rate Min. Paced AV Min Sensed AV

Optimization (Rate Response Optimization)

Rate Drop (Rate Drop Response)

Sleep Funct. (Sleep Function)

Life Style

Top Ra te Bottom Rate Confirmation Beats Width Beats Intervention Rate Intervention Duration

Sleep Rate Bed Time 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 are displayed in the value window as shown in this example.

Figure 4-2. Value window example showing subordinate parameters

InSync® Model 8040 Device Programming Guide 4-3

To display the present programmed parameter settings controlling the Diagnostics function:

1. Select the [PARAMETERS] menu button.

2. Select the

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

DIAGNOSTIC PARAMETERS option.

Figure 4-3. Diagnostic Parameters Screen

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

4-4 InSync® Model 8040 Device Programming Guide

To display Additional Parameter Settings:

1. Select the [PARAMETERS] menu button.

2. Select the

ADDITIONAL PARAMETERS option.

The Additional Parameters screen appears as shown in the example below. Interrogate the device, if required, to display settings.

Figure 4-4. Additional Parameters Screen

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

Transtelephonic Monitor See Chapter 6. Extended Telemetry See Chapter 6. Device Serial Number See Chapter 6. Status Reset (command) See Chapter 6.

InSync® Model 8040 Device Programming Guide 4-5

Displaying a Status Summary

You can display a summary of device 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 device since the last patient session.

Selecting the Data Summary Screen

To display the Data Summary screen

1. Select the [DATA] menu button.

Select these buttons to view more data (see page 4-10)

Note: Impedance of the ventricular dual lead system is measured across the parallel combination of both leads.

2. Select the

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

DATA SUMMARY option.

4-6 InSync® Model 8040 Device Programming Guide

Figure 4-5. Data Summary Screen

Battery/Lead Data

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

Estimated Time to Replacement

“Estimated Time to Replacement” is a calculated estimate of the time (in months) remaining until device replacement is required. This calculated estimate is an average value based on the programmed parameter settings and the event summary data accumulated by the device since the previous patient session.

Select the [ time to replacement and the estimated maximum, average, and minimum values. Refer to “Estimated Time to Replacement” on page 4-13 for information about the messages that can appear in place of the estimated time value.

Note: Elective device replacement should not be based on the estimated time to replacement. For this decision, use only the elective replacement indicators or the battery status “Replace Stimulator” message. When battery voltage indicates that device replacement is required, the “Replace Stimulator” message automatically appears on the screen in place of the estimated time to replacement value.

MORE INFO] button for information about estimated

Lead Impedance

“Lead Impedance” is the measured electrical impedance presented by the lead and electrode/tissue interface. If the pacing mode is a dual chamber mode, the measured impedance for both atrial and the ventricular lead system is displayed.

Note: Impedance of the ventricular dual lead system is measured across the parallel combination of both leads.

InSync® Model 8040 Device Programming Guide 4-7

Diagnostic Parameters

This section of the screen shows the programmed status of the Diagnostics function by displaying the present settings of the Setup and Type parameters. No value for Setup is displayed if any changes were made to the default settings provided by the Setup option. A setting of “Off” 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 device 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.

■

Event Summary shows data collected since the last patient session. This data is automatically cleared from device

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 programmer’s calendar function. Data collection stops when ERI occurs. In this case, the ending date is labeled as the “ERI” date.

■

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

If one of the special single chamber modes (ADIR, VDIR, ADI, VDI) has been programmed, “% Total Events” data is not available, and the “invalid data” message is displayed.

4-8 InSync® Model 8040 Device Programming Guide

% 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:

AS-VS (Atrial Sense - Ventricular Sense) AS-VP (Atrial Sense - Ventricular Pace) AP-VS (Atrial Pace - Ventricular Sense) AP-VP (Atrial Pace - Ventricular Pace)

For the VDD mode, the event sequence categories are:

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

For single chamber modes, two event categories are used:

PACED and SENSED.

PVCs

If the device has been operating in a dual chamber mode, Event Summary displays the counted number of PVC “singles” and “runs.” A PVC (premature ventricular contraction) is defined by the device as a ventricular sense that follows a ventricular pace or sense without an intervening atrial pace, atrial sense, or atrial refractory sense.

SINGLES — Show the number of singly-occurring PVCs. Runs — Show the number of runs consisting of two or more PVCs.

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 is not displayed if a single chamber mode was in effect during the monitoring period.

If one of the special single chamber modes (ADIR, VDIR, ADI, VDI) has been programmed, “% Total Events” data is not available, and the “invalid data” message is displayed.

InSync® Model 8040 Device Programming Guide 4-9

Mode Switch Episodes

“Mode Switch Episodes” is displayed in the Event Summary if the Mode Switch parameter 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 “Off.”

Rate Resp. Optim. Episodes

“Rate Resp. Optim. Episodes” is displayed in the Event Summary if the Optimization parameter 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 “Off” in place of a value.

Displaying More Data

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

■

Select [BATTERY/LEAD] to view all battery and lead measurements. See next section.

■

Select [DIAGNOSTIC PARAMETERS] to view the programmed status of all Diagnostic parameters. Refer to Chapter 8.

■

Select [SHOW DIAGNOSTICS GRAPH] to display a graph of the diagnostic data recorded in device memory. (If Type is “OFF,” no data is collected for display.) Refer to Chapter 8.

4-10 InSync® Model 8040 Device Programming Guide

Displaying Battery and Lead Information

By selecting the Battery/Lead screen, you can display information about the device battery and lead system based on real-time measurements and calculations made at the time of device interrogation. This information provides a detailed status of the device battery and the output conditions pertaining to the pacing lead system.

Selecting the Battery/Lead Screen

To display the Battery/Lead screen:

1. Select the [DATA] menu button.

Note: For the ventricular dual

lead system, Output Energy, Lead Current, and Lead Impedance are measured for the parallel combination of both leads.

2. Select the

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

BATTERY/ LEAD option.

Figure 4-6. Battery and Lead Data Screen

InSync® Model 8040 Device Programming Guide 4-11

Battery/Lead Screen

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

Note: During the measurement process, the device paces at 100 ppm for several beats. (During these beats in a dual chamber mode, the AV interval is 100 ms.)

Parameter Measurements

The Battery/Lead screen displays a battery status message and real-time measurements and calculations for the device parameters listed below.

Battery Status “OK” or “Replace Stimulator”

Estimated Time To Replacement

Battery Voltage Present voltage of the device battery.

Battery Current Present current drain on the device battery

Battery Impedance Internal electrical impedance of the device

Pulse Duration Present programmed value of the pacing

Pulse Amplitude Present value of the pacing pulse amplitude.

Output Energy

Lead Current

Lead Impedance

Pacing Configuration Present programmed pacing configuration

For the ventricular dual lead system, Output Energy, Lead Current, and Lead Impedance are measured for the parallel combination of both leads.

Calculated estimate of the average time remaining until device replacement is required. See page 4-13.

averaged over a pacing cycle.

battery.

pulse width.

Output energy contained in a single pacing pulse.

Current delivered during a pacing pulse.

Electrical impedance presented by the lead and electrode/tissue interface.

(unipolar or bipolar).

4-12 InSync® Model 8040 Device Programming Guide

Estimated Time to Replacement

“Estimated Time to Replacement” is a calculated estimate of the average time (in months) remaining until device replacement is required. This calculated estimate is based on the programmed parameter settings and event summary data accumulated by the device since the previous patient session.

Select the [ time to replacement and the estimated maximum, average, and minimum values.

Note: Elective device replacement should not be based on the estimated time to replacement. For this decision, use only the elective replacement indicators or the battery status “Replace Stimulator” message. When battery voltage indicates that it is time for device replacement, the “Replace Stimulator” 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:

“Select MORE INFO ===>>>” – Estimated time to replacement information is available only by selecting the [ 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 states that there is “insufficient event summary data accumulated in the stimulator.” In this case, the estimated time to replacement calculations assume that the patient is paced 100 percent of the time.

MORE INFO] button for information about estimated

MORE INFO] button.

“Replace Stimulator” – Low battery voltage in the patient’s device has tripped the ERI (elective replacement indicator). Elective replacement of the device is now recommended.

InSync® Model 8040 Device Programming Guide 4-13

Displaying a Graph of Recorded Diagnostic Data

If the device 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

To display the Diagnostics graph screen:

1. Select the [DATA] menu button.

2. Select the

The graph is not displayed unless an appropriate interrogation has occurred. Interrogate the device, if necessary, to display the graph.

SHOW DIAGNOSTICS GRAPH option.

Figure 4-7. Diagnostic Graph Example

4-14 InSync® Model 8040 Device Programming Guide

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 print the graph, you must select

CURRENT SCREEN REPORT

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

InSync® Model 8040 Device Programming Guide 4-15

4-16 InSync® Model 8040 Device Programming Guide

Displaying and

General Desciption

Printing the Patient’s ECG and EGM 5

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

1) How to print a real-time recording of the patient’s

ECG.

2) How to select the high resolution ECG display.

3) How to inhibit device output to observe the

patient’s underlying rhythm.

4) How to freeze a 10-second segment of the patient’s

ECG and how to use the on-screen calipers.

5) How to select a Marker Channel Diagram to view

more detailed information about device operation.

InSync® Model 8040 Device Programming Guide 5-1

Printing the Patient’s ECG and EGM 5-2

Displaying the Patient’s ECG and EGM 5-5

Freezing the ECG Trace 5-11

Displaying a Marker Channel Diagram 5-15

Printing the Patient’s ECG and EGM

At any time during a patient session, you can initiate a continuous, real-time recording of the patient’s ECG as described below.

Procedure

1. To start a recording of the patient’s ECG, press the desired

paper speed button.

25 mm/s

12.5 mm/s

Paper Advance

2. To stop the recording, press the same paper speed button.

3. Before you tear off the ECG strip, press the paper advance

button to advance the paper to a perforation.

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.

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

5-2 InSync® Model 8040 Device Programming Guide

Annotations

ECG

Marker Telemetry

EGM Telemetry

Figure 5-1. ECG Printout Example with Markers and EGM

About the Recording

Annotation of Executed Commands – Information on the ECG printout includes an indication of when certain commands to the device 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 Channel™ and EGM Telemetry – If the programming head is over the patient’s device, the recording will include a trace or traces of the telemetry being received from the device. In the example above, the patient’s ECG is accompanied by “Marker” 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.

InSync® Model 8040 Device Programming Guide 5-3

ECG and EGM Trace adjustment – 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.

Missing Markers – A programming command or interrogation momentarily interrupts the transmission of Marker Channel™ telemetry. This interruption can result in missing markers. The point at which the command occurred is marked above the ECG trace by a “down” and/or “up” arrow. The down arrow (▼) indicates a transmitted command from the programmer; the up arrow (▲) indicates a telemetry response from the device.

Displaying Pacing Artifacts

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

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

For instructions on setting up artifact detection, refer to “Improving the Detection of Pacing Artifacts” in Chapter 9. The Artifact Detection option is accessible by selecting the Programmer icon in the tool palette on the Select Model screen.

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.

5-4 InSync® Model 8040 Device Programming Guide

Displaying the Patient’s ECG and EGM

By selecting the ECG/Markers/EGM screen, you can display a high resolution view of the patient’s ECG. The ECG will be accompanied by a trace of Marker Channel telemetry and EGM telemetry if such telemetry is being received from the device. This screen provides waveform trace adjustment controls and an option for inhibiting device output.

Selecting the ECG/Markers/EGM Screen

To display the ECG/Markers/EGM screen:

1. Select the [TESTS/ECG] menu button.

2. Select the

If the programmer is connected to skin electrodes on the patient, the screen displays the patient’s ECG. In this example, Marker and ventricular EGM telemetry are being received from the device.

ECG/MARKERS/EGM option.

Figure 5-2. ECG/Markers/EGM Screen

InSync® Model 8040 Device Programming Guide 5-5

Adjusting the ECG and EGM Traces

The control buttons at the left of the trace display (see below) let you adjust the displayed ECG and EGM.

To make an adjustment:

1. Select the appropriate button (see descriptions below).

2. Select the desired option from the displayed window of

options.

_________________________________________________________

Select to choose a different ECG Lead configuration.

Options: Lead I, Lead II, Lead III (Lead II is the default setting.) _________________________________________________________

Select to change the ECG amplitude scaling.

Options: 1.0, 0.5, 0.2, 0.1, 0.05 mV/mm and Automatic. “Automatic” sets scaling to the highest value that does not result in

clipping of the waveform peaks. Automatic is the default setting. _________________________________________________________

Select to turn the ECG filter ON or OFF.

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

The ON setting may improve clarity of the displayed and printed ECG in the presence of interference. “ON” is the default setting.

_________________________________________________________ Indicates the patient’s 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

“Automatic” sets scaling to the highest value that does not result in clipping of the waveform peaks. Automatic is the default setting.

_________________________________________________________

Filter ON (Bandwidth = 0.5 to 40 Hz)

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

5-6 InSync® Model 8040 Device Programming Guide

Programming the Trace Telemetry Type

Default Telemetry – Positioning the programming head over the patient’s device causes the device to transmit both Marker telemetry and EGM telemetry (atrial EGM for dual chamber modes). The examples on page 5-3 and page 5-5 show the combination of Marker telemetry and EGM telemetry.

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

1. With the programming head in position over the device,

select this button.

2. Select the desired telemetry type from the options displayed

(see below).

3. Continue to hold the programming head in place for as long

as you want to view the programmed telemetry.

Telemetry Options – The programmable options for the type of telemetry that can be displayed and recorded with the patient’s ECG are as follows:

A. EGM This option displays atrial EGM and Marker

telemetry.

V. EGM This option displays ventricular EGM and Marker

telemetry. Note: The ventricular EGM is a composite signal from the parallel combination of both ventricular leads.

(

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 trace

appears on the lower trace display in place of the EGM.

InSync® Model 8040 Device Programming Guide 5-7

More About Marker Channel™ Telemetry

Note: An interrogation or programming command momentarily

interrupts Marker Channel™ telemetry. If this interruption occurs at the moment a marker is scheduled, the marker is not displayed.

MARKER Telemetry – A trace of Marker telemetry depicts device operation by showing Pace, Sense, and Refractory Sense events as they occur within the device. 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:

Tabl e 5-1. Marker Coding

AP = Atrial Pace VP = Ventricular Pace

AS = Atrial Sense VS = Ventricular Sense

AR = Atrial Sense during

refractory

TP = Triggered Pace (AAT or VVT pacing mode)

MS = Mode Switch Episode (marks the beginning and the end)

ER = Error Marker (indicates a Marker signal that could not be decoded.

SENSOR Telemetry – Sensor telemetry transmits a single type of marker to show “Sensor-Detect” 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.

VR = Ventricular Sense during

refractory

Sensor markers appear on the lower trace display as shown in Figure 5-3. These markers are not annotated with letter codes.

5-8 InSync® Model 8040 Device Programming Guide

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

Figure 5-3. Example Display Showing Sensor Markers

Inhibiting Device Output

The [INHIBIT PACING] button, which also appears on other screens that show the ECG/Markers/EGM display, lets you temporarily stop the pacing output of the patient’s device 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.

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

PROGRAM] button or lifting the programming head away

from the site of the device 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.

Device 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.

InSync® Model 8040 Device Programming Guide 5-9

To inhibit device output:

1. Make any desired ECG trace adjustments before selecting

[

INHIBIT PACING].

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 [

MAGNET] button. (If device operation is not changed from the

magnet mode, Sense markers and the patient’s intrinsic rate cannot be displayed.)

CANCEL

3. Select [

4. To inhibit device output, press and hold [

INHIBIT PACING] to prepare the programmer.

PROGRAM].

A message indicates that inhibition is occurring. The ECG trace should show the absence of any pacing stimuli. To obtain an ECG recording, press the desired paper speed key.

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 InSync® Model 8040 Device Programming Guide

Freezing the ECG Trace

At any time during a patient session, you can freeze and display 10 seconds of the patient’s ECG and the accompanying telemetry traces. On-screen calipers let you measure event timing intervals.

Selecting the FREEZE Button

To freeze and display a 10-second segment of the ECG and telemetry trace:

➤ Select the [FREEZE] menu button.

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).

Figure 5-4. Freeze ECG Screen

InSync® Model 8040 Device Programming Guide 5-11

Changing the Freeze Window Timing

Timing of the 10-second window during which ECG and telemetry signals are frozen depends on the present Freeze Option setting.

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 Timing Options

Selecting the [FRZ OPTION...] button displays the following options:

■

Freeze Previous 10 Seconds — Freezes the 10 seconds of trace

that occurred just prior to selection of the [

■

Freeze Next 10 Seconds — Freezes the 10 seconds of trace that

occurs just after selection of the [

FREEZE] button.

■

Freeze Previous 5 + Next 5 Seconds — Freezes the 5 seconds of

trace that occurred prior to selection of the [ 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 10second trace ( between the on-screen calipers ( option). Refer to Chapter 2 for information on printing reports.

5-12 InSync® Model 8040 Device Programming Guide

WAVEFORMS print option) or the portion of the trace

FREEZE] button

WAVEFORM SEGMENT print

Adjusting the Trace Displays

The control buttons at the left of the trace display let you individually adjust the magnification of the frozen ECG and EGM waveforms and change the time scale of trace display.

To make an adjustment:

1. Select the appropriate button (see below) to display a

window of options.

2. Select the desired option from the displayed window.

_________________________________________________________

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 “MARKER” or “SENSOR.”

InSync® Model 8040 Device Programming Guide 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 traces. The small window above the displays in milliseconds the interval between the cursors.

➎

➊ ➋ ➌➍

POSITION LEFT CURSOR buttons

➜

Left Cursor Right Cursor

➜

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 [HOME] button to center the calipers on the screen one second apart. You can use this button to retrieve the calipers if they have been scrolled off the screen.

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.

➎ This box displays the time interval between the cursors.

5-14 InSync® Model 8040 Device Programming Guide

Displaying a Marker Channel Diagram

Note: To view a Marker Channel Diagram as described below:

1) the pacing mode depicted by the ECG trace on the Freeze screen must be dual chamber or VDD; and 2) pacing Marker annotations or a Marker Channel trace must be present (the selected telemetry type must be either Marker or EGM).

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.

Figure 5-5. Freeze Screen with Marker Channel™ Diagram

➤ To print the ECG trace and diagram, select the [PRINT] menu

button, and then select the option.

➤ To return to the trace of Marker or EGM plus Marker

telemetry, select the [ appears in place of the [

InSync® Model 8040 Device Programming Guide 5-15

CURRENT SCREEN REPORT

SHOW MARKERS/EGM] button, which

SHOW DIAGRAM] button.

About the Marker Channel™ Diagram

The Marker Channel Diagram (see example below) shows more details of device operation by depicting the various timing intervals, including blanking and refractory periods. The diagram is intended to further clarify operation of the device and simplify analysis of the patient’s ECG.

Figure 5-6. Example of a Marker Channel™ Diagram

Note: If events portrayed on the diagram occur in very rapid succession, the Pace and Sense marker annotations (P, S, R) may not appear, and the supplemental labels (Act., Safe, PVC, and NCAP) that define certain events may overlap. Overlapping characters or labels displayed on the screen may not appear exactly the same on the printout.

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 POSITION LEFT/RIGHT CURSOR, CALIPER

SCROLL, and WAVEFORM SCROLL buttons is the same as

described on page 5-14.

Printing the Marker Channel™ Diagram

To print the Marker Channel Diagram, select the [PRINT] menu button, and then select the You can print a diagram only while it is displayed on the screen.

5-16 InSync® Model 8040 Device Programming Guide

CURRENT SCREEN REPORT option.

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 device operation. The pacing mode in effect is printed above the ECG trace at the top of the chart.

Atrial and Ventricular Baselines – The diagram is formed along two parallel baselines labeled “A” and “V.” 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 – 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 (Pace) Output of a pacing stimulus. S (Sense) A sensed event. R (Refractory Sense) An event sensed within the refractory

period.

ER (Error) A marker that could not be decoded because of

interference or interrupted telemetry.

Act.

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

Act. An activity-driven pace. Safe A ventricular safety pace. PVC A device-defined premature ventricular contraction.

NCAP A non-competitive atrial pace.

InSync® Model 8040 Device Programming Guide 5-17

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

Solid Rectangles depict blanking periods.

Open Rectangles 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 – 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 depict A-to-V timing (based on the device’s 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 depict V-to-A timing (based on the device’s operating pacing rate) initiated by a ventricular pace or sense event. Except in the VDD mode, 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.

Horizontal Lines 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 depict interruption of a timing interval by a sense or the conclusion of a timing extension, which results in a pace.

5-18 InSync® Model 8040 Device Programming Guide

Error Conditions

Under certain conditions, the programmer may not be able to properly determine device operation from the data available. Most such conditions result i n the appearance of an error mes sage on the diagram.

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.

“Missing Event” – 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 device reed switch. In this situation, the Threshold Margin Test depicted on the diagram may be accompanied by one or more “Missing Event” messages.

“Diagram Error” – 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.

“Bad Data” – 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.

InSync® Model 8040 Device Programming Guide 5-19

5-20 InSync® Model 8040 Device Programming Guide

Programming the

General Desciption

Pacing Parameters 6

This chapter describes how to program:

- The permanent parameters controlling operation of the patient’s implanted device.

- Nominal and saved parameter values.

- Transtelephonic Monitor and Extended Telemetry parameters.

- The Status Reset command to verify or clear an ERI status or clear a full electrical reset condition.

- The device serial number in the event it is cleared from device memory by an electrical reset.

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

Programming Pacing Parameters 6-2

Programming Additional Parameters 6-12

InSync® Model 8040 Device Programming Guide 6-1

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

To select the Pacing Parameters screen:

1. Select [PARAMETERS] menu button.

2. Select

Or select the [ the lower right corner of the present screen.

PACING PARAMETERS option.

PACING PARAMETERS] button if it is displayed in

Figure 6-1. Pacing Parameter Programming Screen

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

6-2 InSync® Model 8040 Device Programming Guide

Refer to Appendix A for a list of the parameters and values available for the InSync device.

Features of the Pacing Parameters Screen

Parameter Display – Following an interrogation, the screen shows the present parameter settings. The screen displays only those parameters that are applicable to the selected device model and pertinent to the present pacing mode. Note that the parameters are divided into labeled groups according to their general function.

This button appears in the lower right corner of the screen only when one or more new parameter values have been properly selected (see “Restricted Parameter Interactions” on page 6-4). The

PROGRAM key on the programming head will respond only

when the [

Special Options – The three buttons located at the right of the parameter display may be useful during the programming procedure described on page 6-5.

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

PROGRAM] button shows on the screen.

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.

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 “Programming Nominal and Saved Values” on page 6-10.)

InSync® Model 8040 Device Programming Guide 6-3

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 Appendix A for more information on parameter programming requirements and restrictions.

Restricted Parameter Values – 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).

Parameter Interaction – If you select a restricted parameter value, the display will indicate the interacting parameter values by displaying the values in reverse video. You must select new values to resolve the conflict before programming is allowed.

Parameter Entry Requirement – 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.

6-4 InSync® Model 8040 Device Programming Guide

General Parameter Programming Procedure

For specific parameter values and information, refer to Appendix A.

To program one or more parameter values:

1. Select the desired parameter from those

displayed,

Press the stylus directly over the parameter name or its value.

Lower Rate for example.

Note: : Select

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 “Programming Parameter Subgroups” on page 6-7.

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

To clear a pending value from the screen, select that parameter or value, and then select [ window. To close the value window without selecting a value, press [

ACCEPT VALUE].

Pacing Mode first if you

CLEAR VALUE] in the value

InSync® Model 8040 Device Programming Guide 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.

4. Position the programming head and select [

Select the [

PROGRAM] button to program all pending

PROGRAM].

parameter values. 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].

6-6 InSync® Model 8040 Device Programming Guide

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 “primary” 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 ON or if you select ON, the value 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.

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 [ button to close the primary parameter value window.

ACCEPT VALUE]

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.

InSync® Model 8040 Device Programming Guide 6-7

Programming Rate Adaptive AV (Rate Adapt)

If the present setting for this parameter is ON or if you select ON, the value window will list the present settings for the subordinate parameters (as shown in this example) and provide the option to select new values.

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 four

parameters are as desired, select the [ button to close the primary parameter value window.

ACCEPT VALUE]

Programming Rate Response Optimization (Optimization)

If the present setting for this parameter is ON 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.

6-8 InSync® Model 8040 Device Programming Guide

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 [ button to close the primary parameter value window.

ACCEPT VALUE]

Programming Rate Drop Response (Rate Drop)

If the present setting for this parameter is ON 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.

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 [ button to close the primary parameter value window.

ACCEPT VALUE]

Programming the Sleep Function

If the present setting for this parameter is ON 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.

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).

InSync® Model 8040 Device Programming Guide 6-9

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 [ buttons to scroll the display of time options.

Note: Time information communicated to the device is based on the current setting of the programmer’s clock/calendar function. Verify that the current time setting of the programmer’s clock is correct before programming the Sleep Function. To verify the time, start and stop an ECG recording by pressing the desired Paper Speed key 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.

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

the [

ACCEPT VALUE] button to close the primary parameter

value window.

MORE <<<] or [MORE >>>]

Programming Nominal and Saved Values

The procedures below describe using the options available by selecting the [

SAVE/NOMINAL OPTIONS...] button.

Programming Medtronic Nominal Values

To recall Medtronic nominal settings (“Medtronic Values”) to the screen as pending values for programming:

1. Select the [

2. Select [

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.

6-10 InSync® Model 8040 Device Programming Guide

MEDTRONIC VALUES] from the window of options.

SAVE/NOMINAL OPTIONS...] button.

Saving a Set of Parameter Values

To save the displayed present parameter values (those interrogated from the patient’s device):

1. Select the [

2. Select [

SAVE/NOMINAL OPTIONS...] button.

SAVE PRESENT VALUES] 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 [

SHOW SAVED] button on the Pacing

Parameters screen.

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

INTERROGATE ALL] button as described in Chapter 2

will automatically save the present 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 [

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.

SAVE/NOMINAL OPTIONS...] button.

SAVED VALUES] from the window of options.

InSync® Model 8040 Device Programming Guide 6-11

Programming Additional Parameters

Additional parameters include the Transtelephonic Monitor and Extended Telemetry follow-up options, the device Serial Number, and the Status Reset command. To access these parameter options, select the Additional Parameters screen.

Selecting the Additional Parameters Screen

To display the Additional Parameters screen:

1. Select [PARAMETERS] menu button.

2. Select ADDITIONAL PARAMETERS option.

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

6-12 InSync® Model 8040 Device Programming Guide

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.

Warning: Do not program Transtelephonic Monitor to ON if the patient has an implantable defibrillator.

To program Transtelephonic Monitor:

1. Select Trans Tele from the parameters listed on the Additional

Parameters screen.

2. From the window of options, select

3. Position the programming head and select [

the programming head steady until you see a confirmation.

ON or OFF as desired.

PROGRAM]. Hold

Programming Extended Telemetry

Programming Extended Telemetry to ON will cause the device to continuously transmit EGM and Marker Channel telemetry for 24 hours.

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

To program Extended Telemetry:

1. Select Extend. Telem from the parameters listed on the

Additional Parameters screen.

2. From the displayed window of options, select

desired.

3. Position the programming head and select [

the programming head steady until you receive a programming confirmation.

ON or OFF as

PROGRAM]. Hold

InSync® Model 8040 Device Programming Guide 6-13

Programming the Status Reset Command

If a screen message indicates that the device Elective Replacement Indicator (ERI) has been set, you can use the Status Reset command to verify present battery status as described below.

Verifying or Clearing an ERI Status

1. Select the Status Reset from the parameters listed on the

Additional Parameters screen.

2. From the option window, select

3. Position the programming head and select [

RESET.

PROGRAM].

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

During this test, the device 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 Device Electrical Reset

The Status Reset command can also be used to clear a full electrical reset condition. Indication that a full electrical reset has occurred is VVI pacing at 65 ppm and, in some cases, a device serial number set to all zeros (000000).

Note: 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.

2. From the option window, select

6-14 InSync® Model 8040 Device Programming Guide

RESET.

3. Position the programming head and select [

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

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

PROGRAM].

Programming the Device Serial Number

Serial number programming should not be used to change the factory setting. This procedure is intended for reprogramming the original serial number in the unlikely event it is lost from device memory due to an electrical reset (see previous section about programming the Reset command).

To reprogram the device 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.

100

InSync® Model 8040 Device Programming Guide 6-15

3. If you make a mistake, select [CLEAR VALUE]. Otherwise,

select [

ACCEPT VALUE] to register the entered number as a

pending value.

4. Position the programming head and select [

the programming head steady until you receive a programming confirmation.

PROGRAM]. Hold

6-16 InSync® Model 8040 Device Programming Guide

101

Medtronic 8040 Programming Guide

Specifications and Main Features

Frequently Asked Questions

User Manual

About This Programming Guide

When to Use this Manual

Conventions Used in this Manual

General Warnings and Precautions

Warnings

Using the Programmer

Implantable Defibrillator

Precautions

High Rate Stimulation

Loss of Programmer Power

Unresponsive Screen

Programming Head

Display Screen Format and Interactive Features

Display Screen Example

Interactive Screen Features

Selecting a Button

Selecting an Option

Audible Signals

Using the Menu Buttons

Using the Command Buttons

Using the Programming Head

Positioning the Programming Head

Using the POSITION HEAD ASSIST Option

Procedure for Selecting the Position Head Assist Setting

Using PROGRAM / INTERROGATE Keys

Programming Emergency Parameters

Interrogating the InSync Device

The INTERROGATE ALL Function

The INTERROGATE Function

Printing Reports During a Patient Session

Selecting a Print Option

About the Print Options

Automatic Printing with the Printer Trace Mode

Turning the Trace Mode On

Turning the Trace mode off

Printing Reports After a Session Has Ended

Procedure

Transferring Session Data to a Diskette

Procedure

Disk Error Message

File Format

Using the HELP Options

Before You Begin

Programmer Setup Checklist

Connecting an External Monitor or Recorder

Connecting Skin Electrodes

Turning the Programmer ON

Procedure

System Self Test

System Setup Options

Starting a Patient Session

Starting a Patient Session Automatically

Starting a Patient Session Manually

Selecting the Desired Function

Navigating with the Menu Buttons

Ending a Patient Session

Displaying Present Parameter Settings

Parameters Not Displayed

Displaying a Status Summary

Selecting the Data Summary Screen

Battery/Lead Data

Estimated Time to Replacement

Lead Impedance

Diagnostic Parameters

Event Summary Data

% Total Events

PVCs

Mode Switch Episodes

Rate Resp. Optim. Episodes

Displaying More Data

Displaying Battery and Lead Information

Selecting the Battery/Lead Screen

Battery/Lead Screen

Parameter Measurements

Estimated Time to Replacement

Displaying a Graph of Recorded Diagnostic Data