Medtronic KDR603 Programming Guide

KAPPA 700/600 SERIES
PACEMAKERS
Software Model 9953A Vision™ Programmer Software
Pacemaker Programming Guide for EP Studies Function
Using the EP Studies Function with Medtronic.Kappa™ 700/600 Series Pacemakers
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
Software
TM
Supplement to the Medtronic.Kappa 700/600 Series Pacemaker Programming Guide
4
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™ 700/600 Series pacemakers. This booklet is a supplement to the
Pacemaker Programming Guide
Refer to the Pacemaker Programming Guide for instructions on setting up and operating your 9790 series programmer.
About this Supplement
for these pacemakers.
For information about using the 9790 programmer with Medtronic.Kappa™ 700/600 Series pacemakers, refer to the
Pacemaker Programming
.
Guide
KAPPA®700/600 SERIES PACEMAKERS
Model 9953 1.3
Pacemaker Programming Guide
EP Studies Supplement
iii
6

Additional Information

Additional Information
Instructions in this booklet reference certain procedures and functions that are described in the for the Medtronic.Kappa™ 700/600 Series pacemakers. The table below lists this information and its location.
Adjusting the live rhythm display Chapter 4
Interrogating the pacemaker Chapter 2
Clinician-selected diagnostic data collection Chapter 5
Printing reports Chapter 2
Resetting an ERI or Electrical Reset Chapter 7
Programming the pacing mode Chapter 7
Viewing saved ECG strips Chapter 4
Pacemaker Programming Guide
iv
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EP Studies Supplement

Table of Contents

1. About the EP Studies Function
2. Starting the EP Studies Function
Table of Contents
About this Supplement iii Additional Information iv
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 Information About Achievable Stimulus
Amplitudes 2-7
Adjusting the Live Rhythm Display 2-8
Protocol ECG Strip and Printed Report 2-8
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
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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
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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1-1
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 pacemakers listed below.
Table 1-1.
Medtronic.Kappa™ 700 Series KDR700/720/730 Series
Medtronic.Kappa™ 600 Series K
Applicable Pacemaker Models
KD700 Series
VDD
K
700 Series
SR
K
700 Series
DR
600 Series

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.
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About the EP Studies Function

Precautions and Considerations

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

Loss of Diagnostic EGM Collection

Starting EP Studies disables EGM collection if it applies to a programmed clinician-selected diagnostic and clears the EGM from the pacemaker memory.
If diagnostic data is interrogated prior to starting EP Studies, the collected EGM 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.
EGM collection remains off until it is reprogrammed to the desired type (see “Ending the Patient Session” on page 1-5).
Using EP Studies does not affect automatic (non-selectable) diagnostic data collection functions.
Precautions and Considerations
12

Using VOO Backup Ventricular Pacing

The VOO Backup option delivers 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.
asynchronous
pacing to the

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 “Viewing Information About Achievable Stimulus Amplitudes” on page 2-7).
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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 6.0 volts or less, as shown in the Achievable Amplitudes window (see below), will reduce battery drain and can provide a more constant output during protocol delivery.
Pulse amplitude information based on battery and lead measurements interrogated from the pacemaker can be displayed by selecting the button labeled “Amplitudes” on the protocol setup screen. The chart listing achievable amplitudes versus rate is intended as a guide for selecting stimulus amplitude settings (see “Viewing Information About Achievable Stimulus Amplitudes” on page 2-7).

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.
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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.

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.
Communication
Symbols
Missing Marker
About the EP Studies Function
Precautions and Considerations
Figure 1-1.
ECG Recording Example Showing a Missing Marker

Ending the Patient Session

Reprogramming the Pacing Mode –
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 –
stated, using EP Studies disables collection, if programmed on (see “Loss of Diagnostic EGM Collection” on page 1-3). EGM collection will remain off unless you reprogram the desired EGM collection type option. Reprogram this option
you finish using EP Studies, but
after
you end the patient session.
If you programmed the
As previously
clinician-selected
diagnostic EGM
before
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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 (Table 1-1) only if 9953A 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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1-6
If the 9953A 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.
EP Studies Supplement

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.
Elements of the PES Protocol
Optional delay period (1 to 20 sec) with or without pacing
S2 S3 S4
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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 (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.
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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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 1945 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
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The burst is synchronized to a paced or sensed event.
Figure 1-4.
Elements of the VOO Burst Protocol
Adjustable interval (148 - 1945 ms)
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About the EP Studies Function

Using VOO Backup Pacing

Using VOO Backup Pacing
Caution:
the ventricles (during atrial stimulation). These pacing stimuli may compete with intrinsic ventricular activity.
Note:
S2S3S4 Mode, and Burst Mode to AOO. Selecting VOO Backup for a PES protocol also enables it for the burst protocols.
The VOO Backup option delivers
Setting the VOO Backup option to On restricts the S1 Mode,
asynchronous
pacing to

What VOO Backup Pacing Does

VOO Backup pacing applies only to dual chamber pacemakers. Its purpose is to provide ventricular pacing support during atrial stimulation. Ventricular pacing otherwise is disabled during the execution of atrial stimulation and the inhibited delay period, if selected.
During Atrial Stimulation –
burst), each ventricular pacing pulse is synchronized to an atrial stimulus with an intervening AV interval of 50 ms. To ensure that the backup pacing rate does not exceed 105 ppm, the pacemaker automatically selects a ratio between the ventricular and atrial outputs to keep pacing rate within the range shown in Table 1-2.
Table 1-2.
A-to-A Interval (ms) Ratio (A-to-V Rate) Vent. Rate (ppm)
570 1:1 30 - 105
VOO Backup Ventricular Pacing Rate
During atrial stimulation (PES or
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313 - 563 2:1 53 - 96
211 - 305 3:1 66 - 95
156 - 203 4:1 74 - 96
148 5:1 81
During an Inhibited Delay –
during an inhibited delay period unless VOO Backup is enabled. If VOO Backup is enabled, the atrial output remains inhibited, but the ventricles are paced synchronously in the VDI mode at the programmed lower rate.
Pacemaker output is turned off
Starting the EP Studies Function
This chapter describes the requirements and procedure for starting the EP Studies function and covers some information that applies to both PES and burst protocols.
Refer to Chapters 3 and 4 for information on how to set up and execute a PES or burst protocol, respectively.
Refer to the warning and precautions in Chapter 1 before using the EP Studies function.
2
Requirements for Starting EP Studies
Start-up Procedure
Before You Proceed
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2-3
2-6
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Starting the EP Studies Function

Requirements for Starting EP Studies

Requirements for Starting EP Studies
Note the following requirements and restrictions before you begin the EP Studies start-up procedure.

Pacing Mode Restrictions

Access to the EP Studies protocols is not permitted if the present pacing mode is a DOOR, VVIR, VDIR, VOOR, AAIR, ADIR, AOOR) or a mode (ODO, OVO, OAO).
If one of these modes is presently programmed, you must reprogram the pacemaker to another mode prior to selecting the EP Studies option.
rate responsive

Pacemaker Operating-Status Restrictions

Any of the following operating conditions also prevents access to the EP Studies protocols.
mode (DDDR, DDIR, DVIR,
non-pacing
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ERI (Elective Replacement Indicator)
at ERI status, you cannot access the EP Studies protocols unless you can clear this condition (ERI/POR Reset parameter).
Electrical reset (POR)
you must clear this condition (ERI/POR Reset parameter) before you select the EP Studies function.
Implant Detection
protocols during the 30-minute Implant Detection period that begins with lead connection during pacemaker implantation.
— If an electrical reset has occurred,
— You cannot access the EP Studies
— If the pacemaker is

Positioning the Programming Head

During the start-up procedure, the programmer must perform an interrogation and transfer, or “download,” a set of instructions to the pacemaker. This process (called “initialization”) can take up to 30 seconds, during which you must hold the programming head steady over the patient’s pacemaker.

Start-up Procedure

To start the EP Studies function, complete the following four steps. This procedure assumes you have already started the patient session.
Position the programming head and continue to hold it
1.
steady for the remainder of this procedure.
Select the Tests icon in the tool palette.
2.
Starting the EP Studies Function
Start-up Procedure
2
3
From the displayed menu options select
3.
When you see the message window shown below, select
4.
Continue
Start-up Messages” on page 2-5.
Continue to hold the programming head steady until the “initializing” process is complete and the EP Studies Setup screen is displayed (see next page).
. If you see another message, refer to “Explanation of
EP Studies Supplement
EP Studies
Select Cancel if you wish to exit this procedure.
.
2-3
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Starting the EP Studies Function
Start-up Procedure
To set up a PES protocol,
see Chapter 3.
To set up a burst protocol,
see Chapter 4.
For parameter definitions and value options, see Chapter 5.
If you successfully started the EP Studies function
Note:
previously during the patient session, the PES or Burst protocol screen will be set up as you left it. The screen shown above is displayed only the first time you select the EP Studies function during a session.
This completes the start-up procedure. Refer to “Before You Proceed” on page 2-6 before setting up a PES or burst protocol.
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Starting the EP Studies Function
Start-up Procedure
Table 2-1.
1. EP Protocols - Initialization Restricted
Operation of the EP Studies function is restricted by any of the following situations:
• The pacemaker is programmed to rate responsive mode or a non-pacing mode.
• The pacemaker operating status is ERI or Electrical Reset (POR).
• The 30-minute Implant Detection period has not ended.
Action: As indicated in the text of the respective message, you must program the pacing mode temporarily to a different setting or program the ERI/POR Reset command. If Implant Detection is operating, you must wait until the 30-minute period has ended or program the following values: Lead Monitor (Atrial and Ventricular) to Monitor Only or Adaptive and Implant Detection to Off/Complete.
The ERI/POR Reset command is located under “Additional Features” on the Therapy Parameters screen. Lead Monitor is located under Pace/Sense Lead Polarity (Atrial and Ventricular) on the Therapy Parameters screen.
2. Interrogation - Not Complete
An interrogation for diagnostic data collected by the pacemaker has not occurred. If a clinician-selected diagnostic data option with EGM collection has been programmed, the collected EGM is cleared when you start EP Studies.
Action: You must select Cancel and perform an interrogation for Collected Data before you continue, otherwise the collected EGM will be lost before you have a chance to view or print it.
Explanation of Start-up Messages
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3. EP Protocols - Cannot be Initialized
The EP Studies initialization process was not successful, perhaps due to interruption of the programming process by interference or movement of the programming head.
Action: Assure that the programming head is properly positioned, then select the Retry button.
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Starting the EP Studies Function

Before You Proceed

Before You Proceed
Note the following information before you proceed to set up and execute a PES or burst protocol.

Protocol Timing Limitations

Delivery of a PES or burst protocol requires a coordinated series of automatic programming commands, telemetry responses, and processing factors that result in a certain amount of elapse time.
Start of the protocol –
selection of the sequence. This time lag accommodates the protocol programming command (as indicated by the ▼ and ▲ symbols above the ECG trace) and synchronization of the first protocol stimulus.
Delay period accuracy –
second shorter to two permanent pacing intervals longer than the selected time.
Burst Count –
burst stops upon release of the
VOO backup pacing –
transition that occurs following delivery of the last stimulus in a PES or Burst sequence can extend that ventricular pacing interval up to 1000 ms longer than the permanent lower rate interval.
START PES
One or two additional pulses will occur before a
A second or two can elapse between
button and the start of the stimulation
The delay period can be from one
BURST Press & Hold
If VOO Backup is enabled, the mode
button.
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Amplitudes
Starting the EP Studies Function
Before You Proceed
Viewing Information About Achievable Stimulus Amplitudes
To view the window shown below, which presents achievable stimulus amplitudes versus rate, select the (information) button labeled “Amplitudes” in the lower left corner of the setup screen.
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The message “Warning - Old Data” indicates that recent
Note:
pacing parameter changes may have changed the Achievable Amplitudes information since it was last viewed. Select the
Yes
button if you want the programmer to update the Achievable Amplitude data. Select
if you are not using this information.
No
The projected achievable amplitudes are based on the following:
Measured battery impedance (an indicator of battery condition) and lead impedance.
The use of single chamber pacing at a pulse width of 1.0 ms (without VOO Backup Pacing) during protocol execution.
This information is intended as a guide for selecting protocol stimulus amplitude settings that should not significantly reduce pacemaker battery output which could abort the protocol execution.
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Starting the EP Studies Function
Before You Proceed

Adjusting the Live Rhythm Display

Prior to executing a protocol, verify that the live rhythm display at the top of the screen shows the desired traces. To adjust the traces, select the
Note:
protocol, the live rhythm display adjusts to these default settings:
Lead II ECG trace with Markers
Atrial EGM if the S1 Mode or Burst Mode is an atrial mode or Ventricular EGM if the mode is ventricular and dual chamber.
button.
Adjust
Each time you select the EP Studies function or a different
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Protocol ECG Strip and Printed Report

During execution of a PES or burst protocol, the programmer automatically collects and saves a 10-second ECG strip and the protocol parameter test values.
Test Strip Icon Print Button
To view the saved ECG strip, select the Test Strip icon (or the
button in the Tool Palette). The Test Strip icon appears
Strips
only when a strip is available for viewing.
To view options for printing a protocol report, select the
button. The report includes the protocol parameter test values and an ECG strip. The programmer saves only the most recent use of the PES, Burst, and VOO Burst protocols.
Print
Setting Up and Executing a PES Protocol
This chapter describes the steps for setting up and executing a PES protocol.
Refer to Chapter 4 for instructions on setting up a burst stimulation sequence.
Refer to Chapter 5 for information on each of the PES parameters.
Setting Up a PES Protocol
3
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Executing the PES Protocol
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3-1
Setting Up and Executing a PES Protocol

Setting Up a PES Protocol

Setting Up a PES Protocol
This procedure begins at the EP Studies - PES - Setup screen. Refer to Chapter 2 if you have not yet selected the EP Studies function. Refer to Chapter 5 for information on the protocol parameters.
This procedure is divided into the three tasks illustrated below.
A. Select PES from the
Protocols list to display the PES setup options.
B. Select the desired values
to set up the stimulation sequence.
C. Select the desired
settings in the Additional Test Values box.
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Figure 3-1.
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The Basic Tasks for Setting Up a PES Protocol

A. Selecting the PES Protocol Option

If the PES - Setup screen shown above is not displayed, select
from the Protocols list.
PES
The settings you select on this screen will remain selected if you choose to exit the EP Studies function or select another protocol option.
Setting Up and Executing a PES Protocol
Setting Up a PES Protocol

B. Setting Up the Stimulation Sequence

Set up the stimulation sequence by selecting a value for each of the parameters in steps 1 through 7 below.
1.
S1 Mode
— Select the desired mode for delivery of the S1
drive train.
In steps 1 and 2, select the mode field to display the mode options.
In steps 3 and 4, select the parameter field to activate the change buttons. Select the up (∧) or down (∨) button to increase or decrease the value.
S2S3S4 Mode
2.
— Select the desired mode for delivery of the
premature stimuli.
— Set the number of S1 events in the S1 drive train.
#S1
3.
— Select a value for the S1S1 interval.
S1S1
4.
It may be necessary to adjust the Min Interval setting
Note:
(Additional Test Values) before you do steps 4, 5, 6, and 7.
— Enable S2 if desired and set a value for the S1 to S2
S1S2
5.
interval.
In steps 5, 6, and 7, select the check­box to enable or disable the respective stimulus.
30
6.
7.
Select the value field of the enabled stimulus to activate the change buttons.
— Enable S3 if desired and set a value for the S2 to S3
S2S3
interval.
— Enable S4 if desired and set a value for the S3 to S4
S3S4
interval.
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Setting Up and Executing a PES Protocol
Setting Up a PES Protocol

C. Setting Up Additional Test Values

Select a value for each of the parameters displayed in the
1.
Additional Test Values box:
Select the parameter value field to display its value options.
a. VOO Backup
(dual Chamber models) — Selecting the On option forces S1 Mode and S2S3S4 Mode to AOO. You cannot change these mode settings without first changing VOO Backup to Off.
The selected setting also applies to the Burst protocol.
b. Delay (Ty p e
and
Period
) — Select
Delay
window that lets you select the Delay Type (Off, Pace, or Inhibit) and the Delay Period (1 to 20 sec.).
Choose the desired Type and Period by selecting the respective value field.
c. Scan
(and
Scan Decrement
)— Select window that lets you select the Scan option (Off or On) and the decrement value (0 to 48 ms).
Choose the desired Scan and Scan Decrement options by selecting the respective value field.
d. Min Interval
— Changing this value may affect the
present settings for S1S1, S1S2, S2S3, and S3S4.
Select the page down arrow to display additional
2.
parameters.
to open a
to open a
Scan
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Setting Up and Executing a PES Protocol
Setting Up a PES Protocol
Select the desired values for Amplitude and Pulse Width.
3.
The selected values also apply to the burst protocols.
Caution:
Condition of the pacemaker battery should be considered in the selection of a test amplitude. If the stimulus amplitude during execution of the protocol is not within 90 percent of the selected test value, the protocol will stop. A pop-up window will state that the protocol has been aborted because the test amplitude is not being achieved.
Selecting the
Disable Check
button in the pop-up window disables the amplitude check for any additional PES or Burst tests conducted during the present EP Studies session.
To view information about achievable amplitudes based on battery and lead impedance measurements, select the button labeled “Amplitudes.”
This completes the setup procedure. Refer to the next section for information on executing the protocol.
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Setting Up and Executing a PES Protocol

Executing the PES Protocol

Executing the PES Protocol
After you have completed the protocol setup procedure, use the following steps when you want to execute the protocol.
Position the programming head and observe that the live
1.
rhythm display shows the patient’s ECG, markers, and the desired EGM trace.
Caution:
position for the duration of the protocol. The loss or interruption of telemetry during execution of the protocol will abruptly terminate the protocol without warning.
To initiate the protocol, select the
2.
The sequence begins with synchronization of the first S1 stimuli to a paced or sensed event. The status bar at the top of the screen indicates whether the protocol is “stimulating” or “delaying” and shows a countdown of the seconds remaining in the delay.
Note:
during the protocol delivery. The new settings take effect on the next automatic or manual execution of the protocol.
If you selected Scan, the protocol will continue to repeat until you select the
Continue to hold the programming head steady in
START PES
You can adjust the S1 count (#S1) and stimulus intervals
STOP & Restore
button.
button.
START PES
Button
STOP & Restore
Button
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To stop the protocol, select the
3.
Lifting the programming head also stops the protocol and returns the pacemaker to its permanently programmed state.
STOP & Restore
button.
Setting Up and Executing a Burst Protocol
This chapter describes the steps for setting up and executing a burst protocol.
Refer to Chapter 3 for instructions on setting up a PES protocol.
Refer to Chapter 5 for information on each of the burst parameters.
4
Setting Up a Burst Protocol
Executing the Burst Protocol
Setting Up and Executing a VOO Burst
4-5
4-6
4-2
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Setting Up and Executing a Burst Protocol

Setting Up a Burst Protocol

Setting Up a Burst Protocol
This procedure begins at the EP Studies -Burst - Setup screen. Refer to Chapter 2 if you have not yet selected the EP Studies function. Refer to Chapter 5 for information on the protocol parameters.
This procedure is divided into the three tasks illustrated below.
A. Select Burst from the
Protocols list to display the burst setup options.
B. Select the burst mode (if
applicable) and the burst stimulus interval.
C. Select the desired
settings in the Additional Test Values box.
4-2
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Figure 4-1.
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The Basic Tasks for Setting Up a Burst Protocol

A. Selecting the Burst Protocol Option

If the Burst - Setup screen shown above is not displayed,
select
The settings you select on this screen will remain selected if you choose to exit the EP Studies function or select another protocol option.
from the Protocols list.
Burst
Setting Up and Executing a Burst Protocol
Setting Up a Burst Protocol

B. Setting Up the Burst Parameters

Choose the desired burst setting(s).
Burst Mode
1.
— If the pacemaker is a dual chamber model,
select the desired setting for Burst Mode.
In step 1, select the mode field to display the mode options.
In step 2, select the up (∧) or down (∨) button to increase or decrease the interval value.
2.
Interval
— Select the desired interval for the burst stimuli.

C. Setting Up Additional Test Values

Select a value for each of the parameters displayed in the
1.
Additional Test Values box:
Select the parameter value field to display its value options.
a. VOO Backup
option forces Burst Mode to AOO. You cannot change this mode setting without first changing VOO Backup to Off.
(dual Chamber models) — Selecting the On
36
The selected setting also applies to PES protocol.
b. Delay
(Type and Period) — Select
Delay
to open a window that lets you choose the Delay Type (Off, Pace, or Inhibit) and the Delay Period (1 to 20 sec.).
Choose the desired Type and Period by selecting the respective value field.
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Setting Up and Executing a Burst Protocol
Setting Up a Burst Protocol
Select the page down arrow to display additional
2.
parameters.
Select the desired values for Amplitude and Pulse Width.
3.
The selected values also apply to the PES and VOO Burst protocols.
Caution:
Condition of the pacemaker battery should be considered in the selection of a test amplitude. If the stimulus amplitude during execution of the protocol is not within 90 percent of the selected test value, the protocol will stop. A pop-up window will state that the protocol has been aborted because the test amplitude is not being achieved.
Selecting the
Disable Check
button in the pop-up window disables the amplitude check for any additional PES or Burst tests conducted during the present EP Studies session.
To view information about achievable amplitudes based on battery and lead impedance measurements, select the button labeled “Amplitudes.”
This completes the setup procedure. Refer to the next section for information on executing the protocol.
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Setting Up and Executing a Burst Protocol

Executing the Burst Protocol

After you have completed the protocol setup procedure, use the following steps when you want to execute the protocol.
Position the programming head and observe that the live
1.
rhythm display shows the patient’s ECG, markers, and the desired EGM trace.
Executing the Burst Protocol
Caution:
position for the duration of the protocol. The loss or interruption of telemetry during execution of the protocol will abruptly terminate the protocol without warning.
To deliver the burst, select the
2.
and continue pressing for as long as you want the burst to continue.
The burst starts with synchronization of the first stimulus to a paced or sensed event. The status bar at the top of the screen indicates the burst stimulus count.
Note:
stimulus interval, you can adjust the interval setting during the delay period, if one has been selected.
To stop the burst, release the
3.
Continue to hold the programming head steady in
BURST Press & Hold
BURST Press & Hold Button
STOP & Restore
Button
In preparation for executing another burst at a different
BURST Press & Hold
button.
button
38
To interrupt the delay period, select the button.
Lifting the programming head also stops the burst and returns the pacemaker to its permanently programmed state.
EP Studies Supplement
STOP & Restore
4-5
Setting Up and Executing a Burst Protocol

Setting Up and Executing a VOO Burst

Setting Up and Executing a VOO Burst
VOO Burst is a simplified protocol that is quick and easy to set up. This protocol applies only to dual chamber models.

Setup Procedure

To setup the VOO Burst protocol, complete the following three steps. For details about selecting parameter settings, refer to the applicable parts of the Burst setup procedure starting on page 4-2.
Select
1.
2.
3.
The interval setting you select on this screen will remain selected if you choose to exit the EP Studies function or select another protocol option. Since Amplitude and Pulse Width are common to all protocols, these parameters will be at their most recent settings.
VOO Burst
the Protocols list to display the setup options.
Select the desired burst stimulus interval.
Select the desired settings for Amplitude and Pulse Width.
from
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Setting Up and Executing a Burst Protocol
Setting Up and Executing a VOO Burst

Executing a VOO Burst

After you have completed the protocol setup, use the following steps when you want to execute the protocol.
Position the programming head and observe that the live
1.
rhythm display shows the patient’s ECG, markers, and the desired EGM trace.
Caution:
position for the duration of the protocol. The loss or interruption of telemetry during execution of the protocol will abruptly terminate the protocol without warning.
To deliver the burst, select the
2.
and continue pressing for as long as you want the burst to continue.
The burst starts with synchronization of the first stimulus to a paced or sensed event. The status bar at the top of the screen indicates the burst stimulus count.
To stop the burst, release the
3.
Lifting the programming head also stops the burst and returns the pacemaker to its permanently programmed state.
Continue to hold the programming head steady in
BURST Press & Hold
BURST Press & Hold Button
BURST Press & Hold
button.
button
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EP Studies Supplement
4-7
Programmable Parameter Definitions and Values
This chapter describes each of the programmable parameters used by the PES and burst protocols. Included are the programmable values or options for each of these parameters.
5
PES Parameter Information
Burst Parameter Information
EP Studies Supplement
5-6
5-2
5-1
42
Programmable Parameter Definitions and Values

PES Parameter Information

PES Parameter Information

PES Parameter Definitions

S1S1 S1S2 S2S3 S3S4
S1 Mode
S2S3S4 Mode
#S1
S1S1
S1S2
S1 Mode, # S1
(Drive Train)
The mode used for delivering the S1 drive train. The first S1 interval is synchronized to a sensed or paced event. If the
permanent mode is a dual chamber mode, the first interval is synchronized to a ventricular event.
For dual chamber pacemakers, this mode (AOO or VOO) determines the chamber in which the S2, S3, and S4 premature stimuli are delivered.
The number of events in the S1 drive train. Both paced and sensed events are counted. Only events in the paced chamber are counted. If the S1 mode is a dual
chamber mode, events are counted in the chamber specified by the S2S3S4 Mode.
The interval at which S1 stimuli are delivered.
The interval between the last event of the S1 drive train and delivery of the S2 stimulus.
S2S3S4 Mode
(Prematures)
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S2S3
EP Studies Supplement
The interval between S2 and S3.
Programmable Parameter Definitions and Values
PES Parameter Information
S3S4
VOO Backup
Delay... Type
Delay... Period
The interval between S3 and S4.
If the pacemaker is a dual chamber model, this parameter provides for asynchronous backup ventricular pacing during the execution of atrial stimulation and the Inhibit delay period, if selected.
The settings for S1 Mode and S2S3S4 Mode are forced to AOO. These settings cannot be changed while VOO Backup is enabled.
During atrial stimulation, each ventricular pacing pulse is synchronized to an atrial stimulus with an intervening AV interval of 50 ms. The pacemaker automatically selects a ratio between the ventricular and atrial outputs to keep pacing rate within the range of 30 to 105 ppm (see Table 1-2 on page 1-10).
During an Inhibit delay period, ventricular pacing is delivered synchronously in the VDI mode at the programmed lower rate
Selects the type of delay period (Off, Pace, or Inhibit) that follows delivery of the stimulation sequence.
Off — No delay period will occur. Pace — The pacemaker operates in the present permanent mode and
rate during the delay period. Amplitude and pulse width are at the PES protocol settings.
Inhibit — Pacemaker output is inhibited during the delay period, unless VOO Backup is enabled (see VOO Backup above).
The number of seconds following the stimulation sequence during which the pacemaker operates according to the selected Delay Type of Pace or Inhibit. Delay period does not apply if Delay Type is Off.
44
Scan
Scan... Decrement
Min Interval
Setting Scan to On causes the PES sequence including the delay period (if selected) to repeat automatically until the protocol is terminated.
Applies only if Scan is set to On. Scan Decrement sets the amount by which the interval of the last premature stimulus in the sequence is reduced each time the sequence repeats. Scan Decrement does not apply to S1 interval.
As a safety feature, this parameter sets the minimum interval that can be used in the delivery of a PES protocol.
Increasing this parameter value after you have selected intervals for the protocol stimuli will adjust any of these intervals if they do not comply with the new Min Interval setting.
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5-3
Programmable Parameter Definitions and Values
PES Parameter Information
Amplitude (A and V)
The pulse amplitude at which stimuli in a protocol are delivered. The selected value applies to all protocols (PES, Burst, and VOO Burst.)
Pulse Width (A and V)
The pulse width at which stimuli in a protocol are delivered. The selected value applies to all protocols (PES, Burst, and VOO Burst.)
a
Atrial Amplitude and Atrial Pulse Width do not apply to the VOO Burst protocol.
a
a
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Programmable Parameter Definitions and Values

PES Parameter Values

PES Parameter Information
S1 Mode
S2S3S4 Mode
#S1 S1S1 S1S2 S2S3 S3S4
VOO Backup
Delay Type
Delay Period
Dual Chamber Models:
AAI, AAT, AOO, ADI, VVI, VVT, VOO, VDI,
• and DDD, DDI, DOO, VDD if the permanent mode is DDD
• and DDI, DOO if the permanent mode is DDI
• and VDD if the permanent mode is VDD
Single Chamber Models: AAI, AAT, AOO, ADI, or VVI, VVT, VOO, VDI (based on programmed
mode)
Dual Chamber Models: AOO, VOO Single Chamber Models: AOO or VOO (based on permanent mode)
2 to 30
148 to 1945 ms (in 7 or 8 ms steps)
148 to 1945 ms (in 7 or 8 ms steps)
148 to 1945 ms (in 7 or 8 ms steps)
148 to 1945 ms (in 7 or 8 ms steps)
Off, On (dual chamber models)
Off, Pace, Inhibit
1 to 20 seconds
Scan Decrement
Min Interval
Amplitude (A and V)
Pulse Width (A and V)
46
Scan
Off, On
0 to 48 ms (in 8 ms steps)
148 to 398 ms
0.250, 0.500, 0.750, 1.000, 1.250, 1.500, 1.750, 2.000, 2.250, 2.500,
2.750, 3.000, 3.250, 3.500, 3.750, 4.000, 4.500, 5.000, 5.500, 6.000,
7.500 V
0.03, 0.06, 0.09, 0.12, 0.15, 0.21, 0.27, 0.34, 0.40, 0.46, 0.52, 0.64,
0.76, 1.0, 1.25, 1.5 ms
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5-5
Programmable Parameter Definitions and Values

Burst Parameter Information

Burst Parameter Information

Burst Parameter Definitions

Burst Interval
Burst Mode
Of the following parameters, only Interval, V Amplitude,
Note:
and V Pulse Width apply to the VOO Burst protocol.
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5-6
Burst Mode
Interval
VOO Backup
EP Studies Supplement
The mode used for delivering the burst stimuli (not programmable in single chamber models).
The interval at which the burst stimuli are delivered.
If the pacemaker is a dual chamber model, this parameter provides for backup ventricular pacing during atrial stimulation and the Inhibit delay period, if selected.
The setting for Burst Mode is forced to AOO. This setting cannot be changed while VOO Backup is enabled.
During atrial stimulation, each ventricular pacing pulse is synchronized to an atrial stimulus with an intervening AV interval of 50 ms. The pacemaker automatically selects a ratio between the ventricular and atrial outputs to keep pacing rate within the range of 30 to 105 ppm (see Table 1-2 on page 1-10).
During an Inhibit delay period, ventricular pacing is delivered synchronously in the VDI mode at the programmed lower rate
Programmable Parameter Definitions and Values
Burst Parameter Information
Delay... Type
Delay... Period
Amplitude (A and V)
Pulse Width (A and V)
Selects the type of delay period (Off, Pace, or Inhibit) that follows delivery of the burst stimulation.
Off — No delay period will occur. Pace — The pacemaker operates in the present permanent mode and
rate during the delay period. Amplitude and pulse width are at the burst protocol settings.
Inhibit — Pacemaker output is inhibited during the delay period, unless VOO Backup is enabled (see VOO Backup above).
The number of seconds following the stimulation sequence during which the pacemaker operates according to the selected Delay Type of Pace or Inhibit. Delay period does not apply if Delay Type is Off.
The pulse amplitude at which stimuli in a protocol are delivered. The selected value applies to all protocols (PES, Burst, and VOO Burst.)
The pulse width at which stimuli in a protocol are delivered. The selected value applies to all protocols (PES, Burst, and VOO Burst.)
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EP Studies Supplement
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Programmable Parameter Definitions and Values
Burst Parameter Information

Burst Parameter Values

Of the following parameters, only Interval, V Amplitude,
Note:
and V Pulse Width apply to the VOO Burst protocol.
Burst Mode
Interval
VOO Backup
Delay Type
Delay Period
Amplitude (A and V)
Pulse Width (A and V)
Dual Chamber Models:
AOO, VOO Single Chamber Models: Fixed based on permanent mode (VOO, AOO)
148 to 1945 ms (in 7 or 8 ms steps)
Off, On (dual chamber models)
Off, Pace, Inhibit
1 to 20 seconds
0.250, 0.500, 0.750, 1.000, 1.250, 1.500, 1.750, 2.000, 2.250, 2.500,
2.750, 3.000, 3.250, 3.500, 3.750, 4.000, 4.500, 5.000, 5.500, 6.000,
7.500 V
0.03, 0.06, 0.09, 0.12, 0.15, 0.21, 0.27, 0.34, 0.40, 0.46, 0.52, 0.64,
0.76, 1.0, 1.25, 1.5 ms
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EP Studies Supplement
Index
I
Symbols
#S1 3-3, 5-2
A
access to EP Studies 1-6
Achievable Amplitudes 2-7
additional test values 3-4, 4-3
button 2-8
Adjust
adjusting the ECG display 2-8
amplitude 5-4, 5-7
selecting a value 1-4
applicable pacemaker models 1-2
B
backup pacing, VOO 2-6, 3-4, 4-3, 5-3, 5-6
description
backup ventricular pacing.
VOO
battery condition, pacemaker 1-3, 2-7
burst interval 4-3, 4-6, 5-6
burst mode 4-3, 5-6
burst parameter values 5-8
See backup pacing,
burst parameters
amplitude 5-7 burst mode 5-6 delay period 5-7 delay type 5-7 interval 5-6 pulse width 5-7 VOO backup 5-6
BURST Press & Hold
burst protocol
adjustable interval 1-8 delay period 1-8 description 1-8 executing a 4-5 parameter definitions 5-6 parameter values 5-8 setting up a 4-2 setup screen 4-2
Adjust
Amplitudes (Achievable Amplitudes) 2-7
BURST Press & Hold Print START PES STOP & Restore
2-8
2-8
button 4-5, 4-7
4-5, 4-7
3-6
3-6, 4-5
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EP Studies Supplement
I-1
Index
D
delay period 1-7, 1-8, 3-4, 4-3, 5-3, 5-7
delay type 3-4, 4-3, 5-3, 5-7
E
ECG display, adjusting the 2-8
ECG strip
missing markers 1-4 saving an 2-8 symbols 1-4
elective replacement indicator.
electrical reset 2-2
ending a patient session 1-5
EP protocols initialization 2-3
EP Studies
intended use 1-2 option 1-6 pacing mode restrictions 2-2 protocol timing limitations 2-6 requirements for starting 2-2 setup screen 2-3 starting 2-2 start-up procedure 2-3
ERI, pacemaker 2-2
error messages 2-5
executing a
burst protocol 4-5 PES protocol 3-6 VOO burst protocol 4-7
See ERI
F
fibrillation 1-2
I
implant detection 2-2
initialization, EP protocols 2-3
intended use, EP Studies 1-2
intervals
burst 4-3, 5-6 S1S1 3-3, 5-2 S1S2 3-3, 5-2 S2S3 3-3, 5-2 S3S4 3-3, 5-3 VOO burst 4-6, 5-6
M
marker telemetry 1-4
markers, missing 1-4
messages, EP Studies start-up 2-5
minimum interval 3-4, 5-3
missing markers 1-4
P
pacemaker
battery condition 1-3 ERI 2-2 loss of data collection 1-3
pacemakers, applicable models 1-2
pacing, backup ventricular.
VOO
pacing, VOO backup.
parameter definitions
burst protocol 5-6 PES 5-2
parameter values
burst 5-8 PES 5-5 VOO burst 5-8
PES parameter
definitions 5-2 values 5-5
See backup pacing,
See backup pacing, VOO
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Index
PES parameters
#S1 5-2 amplitude 5-4 delay period 5-3 delay type 5-3 min interval 5-3 pulse width 5-4 S1 mode 5-2 S1S1 interval 5-2 S1S2 interval 5-2 S2S3 interval 5-2 S2S3S4 mode 5-2 S3S4 interval 5-3 scan 5-3 scan decrement 5-3 VOO Backup 5-3
PES protocol
delay period 1-7 description 1-7 executing a 3-6 parameter definitions 5-2 parameter values 5-5 Scan option 1-7 setting up a 3-2 setup screen 3-2
POR.
See electrical reset
positioning the programming head 1-4
precautions 1-3 to 1-5
backup ventricular pacing 1-3 ending a patient session 1-5 positioning the programming head 1-4 starting the EP Studies function 1-3
button 2-8
Print
printing a session report 2-8
procedure, starting EP Studies 2-3
programmed electrical stimulation.
See PES
programmer, 9790 1-2
programming head
positioning the 1-4 precaution 1-4
protocol timing limitations 2-6
protocols
available options 1-6 burst
adjustable interval 1-8 delay period 1-8 description 1-8 executing a 4-5 parameter definitions 5-6 parameter values 5-8 setting up a 4-2 setup screen 4-2
PES
delay period 1-7 description 1-7 executing a 3-6 parameter definitions 5-2 parameter values 5-5 Scan option 1-7 setting up a 3-2 setup screen 3-2
VOO burst
adjustable interval 1-9 description 1-9 executing a 4-7 parameter values 5-8 setting up a 4-6 setup screen 4-6
pulse width 5-4, 5-7
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I-3
Index
R
restrictions for starting EP Studies
pacemaker status 2-2 pacing mode 2-2
S
S1 mode 3-3, 5-2
S1S1 interval 3-3, 5-2
S1S2 interval 3-3, 5-2
S2S3 interval 3-3, 5-2
S2S3S4 mode 3-3, 5-2
S3S4 interval 3-3, 5-3
Scan decrement 3-4, 5-3
Scan option 1-7, 3-4, 5-3
screen
burst protocol setup 4-2 EP Studies setup 2-3 PES setup 3-2 VOO burst setup 4-6
selecting
an amplitude setting 1-4 the Burst protocol option 4-2 the PES protocol option 3-2 the VOO Burst protocol option 4-6
setting up a
burst protocol 4-2 PES protocol 3-2 VOO burst protocol 4-6
START PES
start-up procedure 2-3
STOP & Restore
symbols, ECG strip 1-4
button 3-6
button 3-6, 4-5
Test Strip option 2-8
Tests icon 1-6
tests, EP Studies option 1-6
timing limitations, protocol 2-6
tool palette 2-3
U
using the programming head 1-4
V
values
burst parameters 5-8 PES parameters 5-5 VOO burst parameters 5-8
ventricular fibrillation 1-2
VOO backup pacing.
VOO backup ventricular pacing.
pacing, VOO
VOO burst interval 5-6
VOO burst parameter values 5-8
VOO burst protocol
adjustable interval 1-9 description 1-9 executing a 4-7 parameter values 5-8 setting up a 4-6 setup screen 4-6
See backup pacing, VOO
W
warning, general 1-2
See backup
T
Test icon 2-3
I-4
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EP Studies Supplement
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