Medtronic SVDD303 Programming Guide

SIGMA

™

300/200/100Software 1.1

Vision™Software Model 9963

Pacemaker Programming Guide

Medtronic.Sigma 300/200/100 Series
Pacemaker Programming Guide

A guide to using the
9790 Series
programmer for
Medtronic.Sigma
300/200/100 Series
pacemakers



Refer to the Medtronic.Sigma
300/200/100 Series Pacemaker
Reference Guide for information
on the pacemakers.

The following terms are trademarks of Medtronic, Inc.

Marker Channel, Medtronic, Medtronic.Sigma, Medtronic.Vision, Auto-PVARP, Quick Look, Quick Secure, Sigma, Significant Events,
and Vision.

Created by Cardiovascular Technical Communications



Medtronic, Inc. 1999

All Rights Reserved

How to Use This Guide

Information is Contained in Two Guides

Product information about Medtronic.Sigma Series software and
pacemakers is presented in two separate guides.

The Pacemaker Programming Guide (PPG) accompanies
Medtronic.Sigma Series software and contains instructions on
how to use the programmer and the programming software.

The Pacemaker Reference Guide (PRG) is a supplementary guide
that provides detailed information on Medtronic.Sigma Series
pacemakers.

Note:

Refer to the technical manual supplied with the pacemaker

for information about which features are supported by a
Medtronic.Sigma pacemaker.

About this Guide

How to Use This Guide

This guide presents the following information to use the 9790
programmer.

■

How to setup and configure the programmer and access
on-line help.

■

How to start a patient session, use the various follow-up
features during the session, and properly end the session.

■

How to view and print the patient’s ECG and EGM waveform
traces.

■

How to configure the pacemaker to collect diagnostic data
and how to retrieve and view this information.

■

How to measure stimulation thresholds and sensing levels.

■

How to program parameter values and verify rate response
parameters settings.

Medtronic.Sigma 300/200/100 Series Pacemaker Programming Guide

iii

How to Use This Guide

About the Pacemaker Reference Guide

This supplementary guide describes in detail, how the pacemaker
operates and specifies the capabilities of each model.

■

Describes the pacing modes, rate response options, special
therapy features, telemetry types, and data collection options.
In some cases, guidelines are given on how to configure the
pacemaker operation.

■

Contains troubleshooting information for electrical and
hemodynamic problems.

■

Specifies parameter and data collection capabilities, longevity
projections, and mechanical and electrical specifications.

■

Provides general warning and cautions, potential interference
sources, and general indications for pacing.

■

Contains a glossary of terms.

iv

Medtronic.Sigma 300/200/100 Series Pacemaker Programming Guide

Table of Contents

1. Programmer Basics

Table of Contents

How to Use This Guide iii

Information is Contained in Two Guides iii
About this Guide iii
About the Pacemaker Reference Guide iv

Setting Up the 9790 Programmer 1-2

Programmer Setup Check List 1-2

Connecting an External Monitor/Recorder 1-4
Connecting the Programmer to Skin Electrodes 1-6
Positioning and Using the Programming Head 1-7

When to Position the Programming Head 1-7

Effect of the Programming Head on Pacemaker

Operation 1-9

Observing Magnet Mode Operation 1-10

Alternative PROGRAM and

INTERROGATE Buttons 1-10

Automatic Interrogation at the

Start of a Session 1-11
About the Display Screen 1-12

Features and Conventions of the Display Screen 1-12

Using the On-Screen Keyboard 1-18

Audible Tones 1-20
Programming Emergency Parameters 1-21
Recording an ECG Strip 1-22

About the ECG Recording 1-23
Using the On-line Help Feature 1-25

Entering the Help System 1-26

Using the Links in Help 1-27

Exiting the Help System 1-28

Searching for Information in Help 1-28

2. Conducting a Patient Session

Important Reminders About
Medtronic.Sigma Pacemakers 2-2

Medtronic.Sigma 300/200/100 Series Pacemaker Programming Guide

v

Table of Contents

New Programmer Features 2-2
Automated Monitoring and Collection of Patient

Diagnostic Data 2-3

Starting a Patient Session 2-4

The Starting Point of a Patient Session 2-4
The Tool Palette Between Sessions 2-5
About Automatic Interrogation 2-6
Procedure for Starting a Patient Session 2-7

Proceeding with Task Selection 2-10

The First Task Screen 2-10

Selecting Another Task or Function 2-10
Interrogating the Pacemaker 2-12
Taking a Quick Look at Pacemaker Operation 2-13

The Quick Look Screen 2-13

Viewing Data on the Quick Look Screen 2-14
Viewing Battery and Lead Measurements 2-17

Battery and Lead Measurements Screen 2-17

Pacemaker Battery Measurements 2-18

Lead System Measurements 2-19

Updating the Displayed Data 2-20
Checking the Present Parameter Settings 2-21

The Therapy Parameters Screen 2-21
Viewing Patient Information Stored in the Pacemaker 2-22
Recording an ECG Strip of Magnet Operation 2-23

The Magnet Test Setup Screen 2-23

Procedure for Conducting a Magnet Test 2-24

Collecting an ECG Strip 2-25

About the Collected ECG Strips 2-25
Checking the Patient’s Underlying Rhythm 2-26

The Underlying Rhythm Test Screen 2-26

Procedure for Checking the Patient’s Underlying

Rhythm 2-27

Collected ECG Strips 2-29
Printing Data Reports 2-30

Using the Print Button 2-30

Printing Additional Reports 2-32

Using the Continuous Print “Trace” Mode 2-33

vi

Medtronic.Sigma 300/200/100 Series Pacemaker Programming Guide

Table of Contents

Printing Reports Held in the Print Queue 2-33

Ending a Patient Session 2-35

Saving a Session on Diskette 2-37
Options for Clearing Pacemaker Data 2-39

3. Viewing the Patient’s ECG and EGM Traces

Viewing the ECG and Other Rhythm Waveforms 3-2

Expanding the Live Rhythm Monitor Window 3-3
About the Waveform Traces 3-4

Adjusting and Configuring the Display 3-7

Adjusting Waveform Size 3-9
Selecting a Trace Source 3-9
Color Coding the Waveform Traces 3-11
Selecting a Different Sweep Speed 3-12
Programming a Different Telemetry Mode 3-13
Selecting the ECG Filter 3-14
Enabling Artifact Enhancement 3-15
Arranging the Waveforms 3-15

Freezing and Analyzing a Waveform Strip 3-18

Using the On-Screen Calipers 3-19
Adjusting the Frozen Traces 3-21
Displaying a Marker Channel Diagram 3-22
Saving a Frozen Waveform Strip 3-27
Printing the Frozen Strip 3-27

Recalling and Viewing Waveform Strips 3-28

4. Collecting Diagnostic Data

About Data Collected by the Pacemaker 4-2

Types of Collected Data 4-2
Important Points about Using the Data Function 4-4

Displaying Collected Data 4-7

About the Collected Data - Graphs and Tables Screen 4-7
Automatically Collected Data 4-8

Choosing Clinician-Selected Detailed Data Collection 4-17

Off 4-17
Custom Rate Trend (Rate versus Time) 4-17
High Rate Detail (Atrial or Ventricular) 4-21

Medtronic.Sigma 300/200/100 Series Pacemaker Programming Guide

vii

Table of Contents

Programming Data Collection 4-23

Setup Options 4-23
Clearing Data From the Pacemaker 4-26

5. Evaluating Parameter Settings

Measuring Stimulation Thresholds 5-2

The Threshold Test Setup Screen 5-2

Setting Up a Threshold Measurement Test 5-3

Executing a Strength-Duration Threshold Test 5-6

Executing an Auto Decrement (Amplitude or Pulse Width)

Threshold Test 5-13

Conducting a Manual Threshold Test 5-15
Determining a Sensitivity Setting 5-18

The Sensing Test Setup Screen 5-18

Checking the Patient’s Intrinsic Rate 5-19

Executing an Automatic Sensing Test 5-20

Automatic Sensing Test Results 5-23

Executing a Manual Sensing Test 5-24
Using Temporary Programming to Evaluate

Parameter Settings 5-27

The Temporary Test Setup Screen 5-27

Procedure for Conducting a

Temporary Test 5-28

Programming a High Temporary Pacing Rate 5-30

viii

6. Programming Pacemaker Parameters

Programming Parameters 6-2

Selecting the Therapy Parameters Screen 6-2

Programming, Printing, and Clearing Parameter

Values 6-3

Parameter Restrictions 6-4

How to Program Parameters 6-6

How to Program Subordinate Parameters 6-8
Saving/Retrieving a Set of Parameter Values 6-13

Saving a Set of Parameter Values 6-14

Retrieving a Saved or Nominal Set of Parameter

Values 6-15

Medtronic.Sigma 300/200/100 Series Pacemaker Programming Guide

Table of Contents

7. Rate Response Setup

Using Exercise Test to Verify Rate Response 7-2

Overview of the Exercise Test 7-2
Selecting the Exercise Test 7-3
Starting the Exercise Test 7-3
Evaluating the Results of the Exercise Test 7-5
Adjusting Rate Response 7-6

8. Miscellaneous Setup Options - Programmer and Pacemaker

Selecting System Operating Preferences 8-2
Adjusting Programmer Time and Date 8-4
Improving the Detection of Pacing Artifacts 8-5
Checking the Software Version 8-6
Starting the Demonstrations Option 8-7
Programming Patient Data into Pacemaker Memory 8-9
Connecting an External Printer 8-11

Printer Compatibility 8-11
Materials You Will Need 8-13
Connecting the Printer 8-14

A. Appendix: Parameter Values and Restrictions

Programmable Modes and Parameters A-2
Automatic Diagnostics A-13
Clinician-Selectable Diagnostics A-15
Programming Restrictions A-18

I. Index

Medtronic.Sigma 300/200/100 Series Pacemaker Programming Guide

ix

Table of Contents

x

Medtronic.Sigma 300/200/100 Series Pacemaker Programming Guide

Programmer Basics

This chapter provides an overview of setting up the
programmer and covers information you should be
familiar with before you begin a patient session.

This information includes such things as using the
programming head and stylus, programming
Emergency parameters, and recording an ECG strip.
Sections include an introduction to features of the
display screen and use of the on-line Help system.

1

Setting Up the 9790
Programmer

1-2

1

For more detailed information on setting up your
programmer, refer to Programmer Description and
Setup, a guide supplied with your 9790 series
programmer.

Medtronic.Sigma 300/200/100 Series Pacemaker Programming Guide

Connecting the Programmer to
Skin Electrodes

Positioning and Using the
Programming Head

About the Display Screen

Programming Emergency
Parameters

Recording an ECG Strip

Using the On-line Help
Feature

1-25

1-6

1-7

1-12

1-21

1-22

1-1

Programmer Basics

Setting Up the 9790 Programmer

Setting Up the 9790 Programmer

The following topics summarize the basic steps for setting up
your 9790 series programmer. For more complete information on
setting up your programmer, refer to the guide, Programmer
Description and Setup, supplied with your programmer.

Programmer Setup Check List

Verify that the components illustrated below are properly
connected to the programmer.

Selector Pen

disconnect the stylus.

1-2

Note:

Programming Head

Medtronic.Sigma 300/200/100 Series Pacemaker Programming Guide

(Stylus)

Do not

ECG Cable

Figure 1-1.

The Programmer

Programmer Basics

Setting Up the 9790 Programmer

Figure 1-2.

Figure 1-3.

Power Cord

Programming Head

Figure 1-4.

ECG Cable

Medtronic.Sigma 300/200/100 Series Pacemaker Programming Guide

1-3

Programmer Basics

Setting Up the 9790 Programmer

Connecting an External Monitor/Recorder

To connect an external monitor or recorder to your programmer,
you need the optional adaptor shown below. Connect the adaptor
to the analog output port on the right side of the programmer.

Calibrate Button

w

Warning:

Peripheral equipment connected to the 9790
programmer must be certified according to the applicable IEC
standards (IEC 950 for data processing equipment and IEC 601-1
for medical equipment). The system formed by connecting
peripheral equipment to the 9790 programmer must comply with
IEC 601-1-1 for medical electrical systems. It is the responsibility
of the person who connects the peripheral equipment to comply
with IEC standards. It is the responsibility of the user to keep
peripheral equipment that is certified to IEC 950 at least two
meters away from the patient. Contact the peripheral equipment
manufacturer for information about IEC certification.

Connector Type:
Output Signal:

(switchable)

ABCD

±

1V

BNC

±1 Volt or ±5mV

Signal Output Adaptor

±

5mV

Connecting Optional Adaptor to the Analog

Output Port on the Programmer.

Figure 1-5.

1-4

Medtronic.Sigma 300/200/100 Series Pacemaker Programming Guide

Adaptor Output Signals

(after model selection):

- Patient’s ECG (upper most ECG

A

on display)

- Telemetered EGM (upper most EGM

B

on display)

- Telemetered EGM (other EGM

C

if programmed)

- Marker Channel Telemetry

D

Connecting the Optional External Adaptor

Programmer Basics

Setting Up the 9790 Programmer

Using the Calibrate Button

Selecting the Calibrate button located next to the analog output
port adds a reference signal (as shown in Figure 1-6 and
Figure 1-7) to the trace of Marker Channel and EGM telemetry.

The Marker Channel signal shows the relative marker amplitudes,
which are not annotated with character codes on an external
device. The EGM calibration signal acts as a voltage reference for
the displayed EGM.

Atrial Pace (AP)

Atrial Sense (AS)

Atrial Refractory Sense (AR)

Vent. Refractory Sense (VR)

Vent. Sense (VS)

Vent. Pace (VP)

Figure 1-6.

5 mV

1 mV

Figure 1-7.

Marker Channel Signals

EGM Calibration Signals

Medtronic.Sigma 300/200/100 Series Pacemaker Programming Guide

1-5

Programmer Basics

Connecting the Programmer to Skin Electrodes

Connecting the Programmer to Skin Electrodes

At the start of a patient session, the programmer must be
connected to skin electrodes on the patient. The ECG display and
measurement functions will not operate without detection of the
surface ECG signal.

Use an electrode lead to connect each skin electrode to the
appropriate port on the ECG cable. Typical electrode placement is
shown below. Use standard procedures for attaching disposable
skin electrodes to the patient.

RA (R)

RL (N)

Figure 1-8.

Refer to the guide, Programmer Description and Setup, supplied
with your 9790 programmer for more details on this procedure.

Connecting the Programmer to Skin Electrodes

LA (L)

C (C)

LL (F)

( ) = IEC Coding

1-6

Medtronic.Sigma 300/200/100 Series Pacemaker Programming Guide

Programmer Basics

Positioning and Using the Programming Head

Positioning and Using the Programming Head

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

When to Position the Programming Head

You must position the programming head over the patient’s
pacemaker whenever a procedure initiates communication
between the programmer and pacemaker. Examples are:

■

At the start of a patient session when you select the

[Auto-Identify] or [Start] button. The programmer

automatically initiates an interrogation that takes a number of
seconds to complete.

■

Prior to executing any command that results in a telemetry or
programming transmission.

■

To view or record Marker Channel or EGM telemetry.

Caution:

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

Medtronic.Sigma 300/200/100 Series Pacemaker Programming Guide

1-7

Programmer Basics

Positioning and Using the Programming Head

How to Position the Programming Head

♦

The programming head must be properly positioned as described
below. An incorrectly positioned programming head can result in
the failure of a transmitted command and the loss of telemetry.

1.

Hold the programming head directly against the patient’s
skin with the face of the programming head parallel to the
pacemaker.

1-8

Figure 1-9.

2.

Position the programming head so that the amber light in

Positioning the Programming Head

the light array goes out and one or more of the green lights
come on. Move the head a little in each direction to find the
position that lights the greatest number of green lights. This
is the optimum position.

Light Array

Figure 1-10.

Green

Amber/Green

Light Array Indicator

Medtronic.Sigma 300/200/100 Series Pacemaker Programming Guide

The present pacing mode
shows in the status bar at

the top of the screen.

Programmer Basics

Positioning and Using the Programming Head

Effect of the Programming Head on
Pacemaker Operation

If model selection and application (software) loading are
complete, positioning the programming head over a
Medtronic.Sigma pacemaker does not put the pacemaker in the
magnet mode of operation, as is the case with previous
pacemaker models. The programmer automatically sends a
Cancel Magnet command to the pacemaker, which causes it to
continue to operate as programmed.

An exception to this operation can occur if the programming head
does not establish a telemetry link with the pacemaker (because of
strong electrical interference or because the programming head is
improperly positioned). In such cases, positioning the
programming head would result in magnet mode operation until
a telemetry link is established. You can easily verify the present
pacing mode by observing the Status Line at the top of the screen.

Pacemaker operation returns to its programmed state about
2 seconds after you remove the programming head from its
position over the pacemaker.

Medtronic.Sigma 300/200/100 Series Pacemaker Programming Guide

1-9

Programmer Basics

Positioning and Using the Programming Head

Observing Magnet Mode Operation

To observe Magnet mode operation during a patient session, you
must conduct the Magnet test described in Chapter 2. Initiating
the Magnet test results in a Threshold Margin Test (TMT) and
causes the pacemaker to operate in the Magnet mode.

Note:

Between patient sessions before you select the pacemaker,
positioning the programming head over a Medtronic.Sigma
pacemaker will result in magnet mode operation.

Alternative

INTERROGATE

To initiate the Program and Interrogate commands, you have the
option to use the on-screen
the Program
head.

[Interrogate]

Note:

The

[P] or [I] button on the programming head is active only

when its counterpart is displayed as an active button on the
display screen.

PROGRAM

Buttons

[P] and Interrogate [I] buttons on the programming

Button

Figure 1-11.

Alternative Program and Interrogate

Programming Head Buttons

and

[Program] and [Interrogate] buttons or

Light Array

[Program]

Button

1-10

Medtronic.Sigma 300/200/100 Series Pacemaker Programming Guide

Programmer Basics

Positioning and Using the Programming Head

Automatic Interrogation at the Start of a Session

At the start of a session when you select [Start] or [Auto Identify],
the programmer automatically interrogates the patient’s
pacemaker for all the data contained within the pacemaker. For
this process, you must position the programming head and hold
it steady in place until the interrogation is complete.

At the bottom center of the screen you will see an indicator
showing the progress of the interrogation. Because this
interrogation retrieves all the data stored in the pacemaker,
including diagnostic data, the process may take a number of
seconds.

Medtronic.Sigma 300/200/100 Series Pacemaker Programming Guide

1-11

Programmer Basics

About the Display Screen

About the Display Screen

The programmer display screen is an interactive device that not
only displays information in the form of both text and graphics,
but functions as a control panel by displaying buttons and menu
options that you can select using the stylus.

Features and Conventions of the
Display Screen

This section describes the features and conventions of the display
screen. The Therapy Parameters screen below shows the main
elements of the typical screen.

Status Bar

Live Rhythm

Monitor Window

1-12

Task area

Active Field Button Tool PaletteCommand Bar

Figure 1-12.

Medtronic.Sigma 300/200/100 Series Pacemaker Programming Guide

Main Elements of a Display Screen Example

Status Bar

Programmer Basics

About the Display Screen

Note:

For information on changing the language in the screens
(for example, from English to German), see “Selecting System
Operating Preferences” on page 8-2.

The Status Bar

The status bar at the top of the screen shows:

■

The present pacing mode.

■

When any one of a number of test conditions is occurring.

■

The pacemaker model.

The Live Rhythm Monitor Window

Live Rhythm Monitor

Window

Medtronic.Sigma 300/200/100 Series Pacemaker Programming Guide

This window is a partial view of the full-screen display of ECG,
Marker Channel, and telemetered EGM waveform traces. You can
expand this window to its full size by selecting the small square
button in the upper-right corner of the window or by selecting the

[Adjust...] button.

■

Heart rate and rate interval show if the programming head is
positioned over the pacemaker.

■

Annotations above the waveform trace show the point of
programmed parameter changes.

1-13

Programmer Basics

About the Display Screen

The waveform trace or traces that show in this window depend on
the selected task screen and how traces have been arranged in the
full-screen view. Refer to “Viewing the ECG and Other Rhythm
Waveforms” on page 3-2 for information about the live rhythm
monitor.

1-14

Medtronic.Sigma 300/200/100 Series Pacemaker Programming Guide

Programmer Basics

About the Display Screen

The Task Area

The portion of screen between the live rhythm monitor window at
the top and the command bar at the bottom changes according to
the task or function you select. The example in Figure 1-12 shows
the Therapy Parameters screen for programming pacemaker
parameter settings. This task area would appear much different if
you selected, for example, the Threshold Test Setup screen.

The Command Bar

The bar at the bottom of the screen always shows the command
buttons for programming “emergency” parameters settings,
interrogating the pacemaker, and ending the patient session.

For complete information on these functions, see “Programming
Emergency Parameters” on page 1-21, “Interrogating the
Pacemaker” on page 2-12, and “Ending a Patient Session” on
page 2-35.

Active fields show as

unshaded areas on

the screen.

Medtronic.Sigma 300/200/100 Series Pacemaker Programming Guide

Active Fields

Unshaded areas, or boxes, appearing in the task area are “active
fields” that respond to the stylus.

Selecting a value, word, name, or phrase that appears in an active
field opens a menu or window of alternative options for whatever
is represented in that field.

1-15

Programmer Basics

S

About the Display Screen

electing an active field

opens a menu or window of

alternative options, or in

some cases, an

on-screen keyboard.

For example, touching the mode value “DDDR” in the Mode field
with the tip of the stylus opens a window of mode options.
Selecting any one of these options replaces the original DDDR
value with the selected one.

Selecting some fields (those with terms ending in an ellipsis, such
as “Rate Response...”) opens a window displaying additional
fields. Some fields that require entry of information, such as
patient data, open an on-screen keyboard. How to use this
keyboard is described later in this section.

Buttons

Buttons like those shown below let you operate the programmer
using the stylus. You can “press” a button by touching it with the
tip of the stylus.

Buttons having a less

distinct shaded label are

not presently active.

1-16

Medtronic.Sigma 300/200/100 Series Pacemaker Programming Guide

Buttons may directly execute a command, such as the

[Program]

button, or they may open a window that prompts another action.
Usually such buttons have a label ending with an ellipsis, such as
the

[Save...] or [Get...] buttons shown above.

Buttons

Icons

Programmer Basics

About the Display Screen

A procedure may instruct you to “press and hold” a button. In
such cases you should touch the tip of the stylus to the button and
continue to maintain pressure against the button until it is time to
“release” the button.

The Tool Palette

The collection of buttons and icons along the edge of the screen is
referred to as the “tool palette.” These are the controls you will use
to choose the task or function screen you want displayed. Once
you have started a patient session, the tool palette is always
displayed, making it quick and easy to move to the desired task or
function.

Each of the icons acts like a button. To select an icon, touch the
icon with the stylus. The “<” symbol adjacent to four of the icons
indicates that selecting one of these icons opens a menu of related
options. The icons without the < symbol directly open a task
screen.

Refer to Table 2-2 on page 2-11 for a brief explanation of the
purpose of each button and icon in the tool palette.

Note:

The Demo icon is available only when the programmer is
operating in the Demo mode.

Medtronic.Sigma 300/200/100 Series Pacemaker Programming Guide

1-17

Programmer Basics

About the Display Screen

Using the On-Screen Keyboard

Certain fields on the screen allow you to enter data, such as the
patient’s name or chart number. Selecting such a field
automatically displays the on-screen keyboard shown below. By
touching the letter or character buttons with the stylus, you can
use this display feature like an actual keyboard.

Text Entry Window

Space Bar

Figure 1-13.

Keyboard Screen

Cursor

Position Keys

The function of the on-screen keyboard buttons are very similar to
the keys on a computer keyboard or typewriter.

1-18

Medtronic.Sigma 300/200/100 Series Pacemaker Programming Guide