Medtronic SVDD303 Addendum

SIGMA

Series Pacemakers
Vision™ Software Model 9963A

™

Pacemaker Programming Guide for EP Studies Function

Using the EP Studies Function
with Medtronic.Sigma
Pacemakers

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

Series

™

Supplement to the
Medtronic.Sigma™
Series Pacemaker
Programming Guide

Software

4

5

About this Supplement

This booklet covers using the EP (electrophysiologic) Studies
function of the 9790 series programmer with Medtronic.Sigma™
Series pacemakers. This booklet is an addendum to the Pacemaker
Programming Guide for these pacemakers.

Additional Information

Instructions in this booklet reference certain procedures and
functions that are described in the Pacemaker Programming Guide
for the Medtronic.Sigma™ pacemakers. The table below lists this
information and its location.

Finding Information in the Pacemaker Programming Guide for

Adjusting the live rhythm display Chapter 3

Interrogating the pacemaker Chapter 2

About this Supplement

Medtronic.Sigmaô Series Pacemakers

Clinician-selected diagnostic data collection Chapter 4

Printing reports Chapter 2

Programming the ERI/POR Reset command Chapter 6

Programming the pacing mode Chapter 6

Viewing saved ECG strips Chapter 3

EP Studies Supplement for Medtronic.Sigma™ Pacemakers

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iii

Table of Contents

1. About the EP Studies Function

2. Starting the EP Studies Function

Table of Contents

About this Supplement iii
Additional Information iii

Intended Use and General Warning 1-2

Intended Use 1-2

General Warning 1-2
Precautions and Considerations 1-3
EP Studies Access and Protocol Options 1-6

EP Studies Access 1-6

Protocol Options 1-6
The PES Protocol 1-7
The Burst Protocol 1-8
The VOO Burst Protocol 1-9
Using VOO Backup Pacing 1-10

What VOO Backup Pacing Does 1-10

Requirements for Starting EP Studies 2-2
Start-up Procedure 2-3
Before You Proceed 2-6

Protocol Timing Limitations 2-6

Viewing the Pacemaker Battery Test Results 2-6

Adjusting the Live Rhythm Display 2-7

Protocol ECG Strip and Printed Report 2-7

3. Setting Up and Executing a PES Protocol

Setting Up a PES Protocol 3-2

A. Selecting the PES Protocol Option 3-2

B. Setting Up the Stimulation Sequence 3-3

C. Setting Up Additional Test Values 3-4
Executing the PES Protocol 3-6

EP Studies Supplement for Medtronic.Sigma™ Pacemakers

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Table of Contents

4. Setting Up and Executing a Burst Protocol

Setting Up a Burst Protocol 4-2

A. Selecting the Burst Protocol Option 4-2
B. Setting Up the Burst Parameters 4-3
C. Setting Up Additional Test Values 4-3

Executing the Burst Protocol 4-5
Setting Up and Executing a VOO Burst 4-6

Setup Procedure 4-6
Executing a VOO Burst 4-7

5. Programmable Parameter Definitions and Values

PES Parameter Information 5-2

PES Parameter Definitions 5-2
PES Parameter Values 5-5

Burst Parameter Information 5-6

Burst Parameter Definitions 5-6
Burst Parameter Values 5-8

Index

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EP Studies Supplement for Medtronic.Sigma™ Pacemakers

About the EP Studies
Function

This chapter introduces the EP Studies function with
important Intended Use, General Warning, and
Precaution statements. Included is a description of
each of the stimulation protocols and the backup
ventricular pacing option.

1

Intended Use and General
Warning

Precautions and
Considerations

EP Studies Access and Protocol
Options

The PES Protocol

The Burst Protocol

1-2

1-3

1-6

1-7

1-8

10

The VOO Burst Protocol

Using VOO Backup Pacing

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1-10

1-1

About the EP Studies Function

Intended Use and General Warning

Intended Use and General Warning

EP (Electrophysiologic) Studies is a special function of the
Medtronic® 9790 series programmer that allows you to use the
patient’s implanted pacemaker to noninvasively deliver high-rate
cardiac stimulation. Programmable mode, interval, and delay
parameters allow you to set up protocols for delivering either
programmed electrical stimulation (PES) or burst stimulation.

Intended Use

The EP Studies function is intended for use in measuring or
assessing conduction properties of the heart and inducing or
terminating tachyarrhythmias. The EP Studies function covered
in this supplement applies only to the Medtronic.Sigma™ Series
pacemakers.

General Warning

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1-2

The EP Studies function is intended for use only by those trained
in electrophysiologic studies. The stimulation options of this
function should be applied only under conditions of careful
patient monitoring and control. High-rate stimulation of the
ventricles can result in ventricular fibrillation. An external
defibrillator should be placed on standby and be kept
immediately available during the use of the EP Studies function.

EP Studies Supplement for Medtronic.Sigma™ Pacemakers

About the EP Studies Function

Precautions and Considerations

The following precautions and important considerations apply to
using the EP Studies function.

Loss of Clinician-Selected Data Collection

Starting EP Studies disables the clinician-selected diagnostic data
collection option (if programmed) and clears the collected data
from the pacemaker memory.

Once interrogated, the collected data is available on the
programmer throughout the patient session, but is lost when you
end the session. You should view and print the collected data
before ending the session.

This data collection remains disabled until the clinician-selected
diagnostic is reprogrammed (see “Ending the Patient Session” on
page 1-5).

Precautions and Considerations

Using EP Studies does not affect automatic (non-selectable)
diagnostic data collection functions.

Using VOO Backup Ventricular Pacing

The VOO Backup option delivers asynchronous pacing to the
ventricles during atrial stimulation. These pacing stimuli may
compete with intrinsic ventricular activity. Refer to page 1-10 for
information about using the VOO Backup pacing option.

Pacemaker Battery Condition

At reduced pacemaker battery capacity, execution of a PES or
burst protocol can result in a significant temporary decrease in
pacemaker battery voltage. See “Effects of Tripping the ERI” on
page 1-4.

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About the EP Studies Function

Precautions and Considerations

Selecting an Appropriate Amplitude Setting

Selecting an amplitude setting of 7.5 volts for high-rate
stimulation is not recommended. While this setting can provide
the maximum available output, its use can result in a significant
temporary decline in output voltage. An output setting of 5.0 volts
or less, as indicated by the pacemaker battery test, will reduce
battery drain and can provide a more constant output during
protocol delivery.

The EP Studies Pacemaker Battery Test

Results of the EP Studies Pacemaker Battery Test, which are
automatically available when you first start an EP Studies session,
should be used as a guide for selecting pulse width and amplitude
settings for the protocol stimuli. You can access the pacemaker
battery test results as needed by selecting the

Effects of Tripping the ERI

If the pacemaker ERI (Elective Replacement Indicator) trips
during a PES or burst protocol, stimulation stops and the
pacemaker reverts to the ERI pacing mode and rate settings.
Unless the ERI condition is temporary and can be reset
immediately, this situation can leave the patient in a potentially
dangerous condition with the EP Studies function unavailable.

Battery Test button.

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1-4

Positioning the Programming Head

During delivery of a PES protocol or burst stimulation, the
programming head must be held steady in its proper position
over the patient’s pacemaker. Movement of the programming
head can result in abrupt termination of the stimulation sequence.

Lifting the programming head at any time during the use of an EP
Studies function causes the pacemaker to return to its
permanently programmed state.

EP Studies Supplement for Medtronic.Sigma™ Pacemakers

Communication

Symbols

Missing Marker

About the EP Studies Function

Precautions and Considerations

Interruption of Marker Telemetry

The communication between the programmer and pacemaker
momentarily interrupts the transmission of marker telemetry.
This interruption can result in missing markers on the trace
display and the chart recording.

Symbols appearing on the recording above the ECG trace indicate
the point at which communication occurred.

▼ = Programming or interrogation command to the pacemaker.
▲ = Telemetry response from the pacemaker.

14

Figure 1-1.

ECG Recording Example Showing a Missing Marker

Ending the Patient Session

Reprogramming the Pacing Mode – If you programmed the
pacemaker from a rate responsive mode as required to access the
EP Studies function, reprogram the pacemaker to the desired
mode and parameter settings prior to ending the session.

Reprogramming Diagnostic Data Collection – As previously
stated, using EP Studies disables the clinician-selected diagnostic
data collection function, if programmed on (see “Loss of
Clinician-Selected Data Collection” on page 1-3). This data
collection function will remain disabled unless you reprogram the
desired data collection options. Reprogram these options after you
finish using EP Studies, but before you end the patient session.

EP Studies Supplement for Medtronic.Sigma™ Pacemakers

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About the EP Studies Function

EP Studies Access and Protocol Options

EP Studies Access and Protocol Options

EP Studies Access

The EP Studies function is available for the applicable pacemakers
only if 9963A software has been installed on your programmer.

To verify whether or not this software has been installed, select
the Tests icon in the tool palette (during a session). If the software
has been installed, “EP Studies” appears on the Tests menu.

Tests Icon

EP Studies

Option

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If the 9963A software has not been installed, contact your
Medtronic representative.

Protocol Options

Depending on the selected model, the EP Studies function
provides up to three protocol options for delivering cardiac
stimulation.

PES Protocol

Burst Protocol

VOO Burst

Protocol

Sections on the following pages describe each of these protocols.
Refer to Chapter 5 for a complete list of the programmable
parameters and value options.

EP Studies Supplement for Medtronic.Sigma™ Pacemakers

The PES Protocol

Selecting the PES protocol displays parameter options for setting
up a programmed stimulation sequence that includes:

■

■

■

■

■

About the EP Studies Function

The PES Protocol

A drive train of up to 30 stimuli (S1).

Up to three premature stimuli (S2, S3, and S4).

An optional delay period with or without pacing stimuli.

A “Scan” option that causes the PES sequence (and delay
period) to automatically repeat. You can set the interval of the
last premature stimulus to decrease with each repetition.

Optional asynchronous backup ventricular pacing during
atrial stimulation (dual chamber models).

S1 drive train
(2 to 30 events)*

Start of the PES sequence is
synchronized to a paced or
sensed event.

Figure 1-2.

Premature stimuli
(up to three)

*In this example, the S1 drive train is delivered in

a dual chamber mode.

Optional delay period (1 to 20 sec)
with or without pacing

S2 S3 S4

Elements of the PES Protocol

16

EP Studies Supplement for Medtronic.Sigma™ Pacemakers

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About the EP Studies Function

The Burst Protocol

The Burst Protocol

Selecting the Burst protocol displays options for setting up a
manually-delivered asynchronous burst. Options include:

■

An adjustable burst interval of 148 to 1945 ms (31 to 407 ppm).

■

Chamber selection (AOO or VOO mode) for dual chamber
models (VDD Series models are limited to the VOO mode).

■

An optional delay period with or without pacing stimuli.

■

Optional asynchronous backup ventricular pacing during
atrial stimulation (dual chamber models).

Manually delivered burst
(press and hold button)*

The burst is synchronized to
a paced or sensed event.

Figure 1-3.

Optional delay period (1 to 20 sec)
with or without pacing

Adjustable interval
(148 - 1945 ms)

*With dual chamber models, stimuli

can be delivered to the atrial chamber
or the ventricular chamber.

Elements of the Burst Protocol

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EP Studies Supplement for Medtronic.Sigma™ Pacemakers

The VOO Burst Protocol

The VOO Burst option applies only to dual chamber models (not
including VDD Series models) and provides for quick setup of a
basic stimulation protocol for the ventricles.

■

The burst interval is adjustable from 148 to 1945 ms (31 to
407 ppm).

■

No chamber selection. The burst mode is fixed as VOO.

■

The option to select a delay period does not apply.

Manually delivered burst to the ventricles
only (via press and hold button)

About the EP Studies Function

The VOO Burst Protocol

18

The burst is synchronized to
a paced or sensed event.

Figure 1-4.

Elements of the VOO Burst Protocol

EP Studies Supplement for Medtronic.Sigma™ Pacemakers

Adjustable interval
(148 - 1945 ms)

1-9