KAPPA®400 SERIES
PACEMAKERS
Software Model 9952A 2.0
Vision™ Programmer Software
Pacemaker Programming Guide for EP Studies Function
Using the EP Studies Function
with Medtronic.Kappa® 400 Series
Pacemakers
Supplement to the
Medtronic.Kappa®
400 Series Pacemaker
Information and
Programming Guide
Medtronic.Vision™ Software
4
Caution: Federal law (USA)
restricts this device to sale by
or on the order of a physician.
Medtronic, Medtronic.Kappa, Medtronic.Vision, and Marker Channel are all trademarks of
Medtronic, Inc.
5
About this Supplement
This booklet covers using the EP (electrophysiologic) Studies
function of the 9790 series programmer with Medtronic.Kappa®
400 Series pacemakers. This booklet is an addendum to the
Pacemaker Information and Programming Guide, Volume I and
Volume II, for these pacemakers.
Refer to the programming guide Volume I for instructions on
setting up and operating your 9790 series programmer. For
information about the operation of a Medtronic.Kappa® 400
Series pacemaker, refer to Volume II.
About this Supplement
For information about using
the 9790 programmer with
Medtronic.Kappa® 400
Series pacemakers, refer to
Volume I of the
Pacemaker
Information and
Programming Guide
For specific information
about a Kappa® 400 Series
pacemaker, refer to
Volume II.
.
KAPPA®400 SERIES AND DX2
PACEMAKERS
Software Model 9952 2.0
Vision™ Programmer Software
Volume I, Pacemaker Programming Guide
KAPPA®400 SERIES AND DX2
PACEMAKERS
Model 9952
Volume II, Pacemaker Reference Guide
EP Studies Supplement iii
6
Additional Information
Additional Information
Instructions in this booklet reference certain procedures and
functions that are described in the Pacemaker Information and
Programming Guide for the Medtronic.Kappa® 400 Series
pacemakers. The table below lists this information and its
location.
Finding Information in the Pacemaker Information and Programming
Guide for Medtronic.Kappa® 400 Series Pacemakers
Adjusting the live rhythm display Chapter 4
Interrogating the pacemaker Chapter 2
Clinician-selected diagnostic data collection Chapters 5 and 17
Pacemaker Implant Detection function Chapter 13
Printing reports Chapter 2
Programming the ERI/POR Reset command Chapter 7
Programming the pacing mode Chapter 7
Viewing saved ECG strips Chapter 4
a
Information is contained in two volumes:
Volume I — Chapters 1 through 9
Volume II — Chapters 10 through 18 plus pacemaker reference information
a
iv EP Studies Supplement
7
Table of Contents
About this Supplement iii
Additional Information iv
1. About the EP Studies Function
Intended Use and General Warning 1-2
Precautions and Considerations 1-3
EP Studies Access and 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
2. Starting the EP Studies Function
Requirements for Starting EP Studies 2-2
Start-up Procedure 2-3
Before You Proceed 2-6
Table of Contents
Intended Use 1-2
General Warning 1-2
EP Studies Access 1-6
Protocol Options 1-6
What VOO Backup Pacing Does 1-10
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 v
8
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
A. Index
vi EP Studies Supplement
9
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
EP Studies Supplement 1-1
1-9
1-10
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 pacemakers listed below.
Table 1-1. Applicable Pacemaker Models
Medtronic.Kappa® 400 Series KDR401/403
KSR401/403
1-2 EP Studies Supplement
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General Warning
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.
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.
EP Studies Supplement 1-3
12
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.
1-4 EP Studies Supplement
13
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.
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 1-5
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
(Table 1-1) only if 9952A 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
1-6 EP Studies Supplement
15
If the 9952A software has not been installed, contact your
Medtronic representative.
Protocol Options
The EP Studies function provides 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.
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. Elements of the PES Protocol
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
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EP Studies Supplement 1-7
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 1984 ms (30 to 400 ppm).
■
Chamber selection (AOO or VOO mode) for dual chamber
models.
■
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. Elements of the Burst Protocol
Optional delay period (1 to 20 sec)
with or without pacing
Adjustable interval
(148 - 1984 ms)
*With dual chamber models, stimuli
can be delivered to the atrial chamber
or the ventricular chamber.
1-8 EP Studies Supplement
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The VOO Burst Protocol
The VOO Burst option applies only to dual chamber models and
provides for quick setup of a basic stimulation protocol for the
ventricles.
■
The burst interval is adjustable from 148 to 1984 ms (30 to
400 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
Adjustable interval
(148 - 1984 ms)
EP Studies Supplement 1-9
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