Medtronic W1DR01 Programming Guide

AZURE MRI™ SURESCAN™ / ASTRA MRI™
SURESCAN™ SW030

Programmer software

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

AZURE MRI™ SURESCAN™ / ASTRA MRI™
SURESCAN™ SW030

Programming Guide

A guide to programming the Azure™ MRI SureScan™ and Astra™ MRI SureScan™
pacemakers using the Medtronic SW030 application software on a Medtronic programmer

The following list includes trademarks or registered trademarks of Medtronic in the United
States and possibly in other countries. All other trademarks are the property of their respective
owners.

Astra, Azure, Capture Management, Cardiac Compass, CareAlert, CareLink,
CareLink Encore, Conexus, Flashback, Marker Channel, Medtronic, Medtronic CareAlert,
Medtronic CareLink, MVP, Paceart, Quick Look, SessionSync, SureScan, TherapyGuide

Medtronic

AZURE MRI™ SURESCAN™ / ASTRA MRI™ SURESCAN™

SW030

Contents

1 Software overview .................................................... 7

1.1 Introduction ......................................................... 7

1.2 Software description .................................................. 8

1.3 Intended use ........................................................ 8

1.4 Contraindications .................................................... 8

1.5 Warnings and precautions ............................................. 8

1.6 Potential adverse events .............................................. 8

2 Patient session ...................................................... 10

2.1 Conducting a patient session ......................................... 10

2.2 Starting a patient session ............................................ 10

2.3 Interrogating the device during a patient session ......................... 11

2.4 Responding to device status indicator warnings ......................... 12

2.5 Quick Look II screen ................................................. 14

2.6 Programmer screen ................................................. 16

2.7 Enabling emergency VVI pacing ...................................... 22

2.8 Patient information .................................................. 23

2.9 Parameters ........................................................ 26

2.10 Using a checklist to complete tasks .................................... 32

2.11 Printing reports ..................................................... 35

2.12 Exporting data to the Paceart system .................................. 38

2.13 Saving and retrieving device data ..................................... 38

2.14 Ending a patient session ............................................. 41

3 Diagnostic data ..................................................... 42

3.1 Diagnostic data overview ............................................ 42

3.2 CareAlert Events .................................................... 42

3.3 Clinical diagnostic data .............................................. 42

3.4 Device and lead performance data .................................... 46

4 System test and EP study features .................................... 49

4.1 Overview of system test and EP study features .......................... 49

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4.2 Performing an Underlying Rhythm Test ................................. 50

4.3 Measuring pacing thresholds ......................................... 50

4.4 Measuring lead impedance ........................................... 52

4.5 Performing a Sensing Test ........................................... 53

4.6 Performing a Magnet Test ............................................ 54

4.7 Arrhythmia inductions with EP Study Tests .............................. 55

4.8 Manual therapy ..................................................... 59

Glossary ................................................................. 62

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AZURE MRI™ SURESCAN™ / ASTRA MRI™ SURESCAN™

SW030

1 Software overview

1.1 Introduction

This manual describes the Medtronic Model SW030 programmer software and explains how
to use a programmer to conduct a patient session.

Throughout this manual the word “device” refers to the implanted pacemaker. The names of
screen titles and interactive screen elements are shown in bold type. Navigation paths to
software screens or programmable parameters are shown with a “>” character between
steps in the path (for example, Data > Device/Lead Diagnostics > Lead Impedance
Trends > Open Data).

The software features described in this manual apply to the Azure XT DR MRI SureScan
devices. To determine which features are available for another model in the Azure MRI
SureScan or Astra MRI SureScan families, refer to the device reference manual. If this
manual is supplied in its printed form and any part of it is illegible, contact a Medtronic
representative to request a replacement manual.

Additional manuals and documents with information about the programmer and implanted
device:

MRI technical manual – This manual provides MRI-specific procedures and warnings and
precautions.

Reference manual – This manual contains information about device features. The
reference manual applies to multiple models of IPG devices.

Programmer reference manual – This manual contains information about the features of
the programmer. There are separate programmer reference manuals for the Medtronic
CareLink 2090 programmer and the Medtronic CareLink Encore 29901 programmer.

Device manual – This manual contains model-specific feature information, indications and
contraindications, warnings and precautions, instructions for implanting the device, quick
reference specifications, and parameter tables.

Explanation of symbols – This document defines the symbols that may appear on the
device package. Refer to the package label to see which symbols apply specifically to this
device.

Medical Procedure and EMI Warnings and Precautions Manual for Health Care
Professionals – This manual provides warnings, precautions, and guidance for health care

professionals who perform medical therapies and diagnostic procedures on cardiac device
patients. The manual also provides patient education information related to sources of
electromagnetic interference (EMI) at home, at work, and in other environments.

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Radio regulatory compliance information – This document provides compliance
information related to the radio components of the device.

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1.2 Software description

The Medtronic Model SW030 software runs on the Medtronic CareLink 2090 and Medtronic
CareLink Encore 29901 programmers and communicates with an implanted device to
program settings and view stored data. The software is compatible with implantable
pacemakers from the Azure MRI SureScan and Astra MRI SureScan families.

The programmer and software should be used only by healthcare professionals or
Medtronic personnel in a clinical or hospital environment.

1.3 Intended use

The Medtronic Model SW030 software is intended to be used to adjust programmable
parameters and evaluate the performance of the implanted Azure MRI SureScan or Astra
MRI SureScan pacemaker system. For information about indications for the implantable
devices that are compatible with this software, refer to the appropriate device manual.

1.4 Contraindications

No contraindications related to the use of this software are known; however,
contraindications related to the use of the implantable devices and programmers that are
compatible with this software can be found in the appropriate manual for the compatible
device.

1.5 Warnings and precautions

There are no general warnings or precautions related to the use of this software. Specific
warnings and precautions are listed in the sections to which they pertain.

For information regarding warnings and precautions related to the use of the implantable
devices and programmers that are compatible with this software, refer to the appropriate
manual for the compatible device.

1.6 Potential adverse events

There are no known potential adverse events related to the use of this software.

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For information regarding potential adverse events related to the use of the implantable
devices and programmers that are compatible with this software, refer to the appropriate
manual for the compatible device.

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2 Patient session

2.1 Conducting a patient session

During a patient session, you can use the programmer to view or enter information about the
patient and device, and to program the device.

Use the programmer to perform the following tasks:

●

review the presenting rhythm

●

verify the status and clinical effectiveness of the implanted system

●

view or enter patient information

●

program parameters

●

print, save, or export data

2.2 Starting a patient session

To start a patient session, use a Medtronic programmer and a programming head that is
appropriate for the programmer model.

Note: If you are using the Medtronic CareLink Programmer with Conexus telemetry, you
must use the programmer in the nonwireless telemetry mode.

For information about setting up the programmer for a patient session, using the
programming head, or compatible programming heads, refer to the programmer reference
manual.

The programmer interrogates the patient’s device at the start of a patient session. End the
previous session before starting a session with another patient.

You can expect reliable telemetry between the implanted device and the programmer in a
typical examination room or operating room.

Note: During an initial interrogation, only emergency programmer functions are available.

Caution: A programmer failure (for example, a faulty touch pen) could result in inappropriate

programming or the inability to terminate an action or activity in progress. In the event of a
programmer failure, immediately turn off the programmer power to deactivate telemetry and
terminate any programmer-controlled activity in progress.

Use the following steps to start a patient session:

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1. Turn on the programmer power.

2. Place the programming head over the device to establish telemetry between the device
and the programmer.

The amber light on the programming head turns off and 1 or more of the green indicator
lights on the programming head illuminate when telemetry is established.

3. To ensure that reliable telemetry has been established, position the programming head
so at least 2 of the green lights illuminate.

To find the optimal position for the programming head, move it around the implanted
device until the greatest number of green lights illuminate.

Note: If the programming head slides off the patient, the session does not terminate.
Place the programming head back over the device.

4. Press the “I” button on the programming head or tap Find Patient….

The patient session starts and the interrogation occurs. Successful interrogation or
programming of the device verifies that the device and the programmer are
communicating reliably.

For the device to transmit EGM traces and Marker Channel data, you must keep the
programming head over the device during the patient session.

If you are having trouble maintaining consistent, reliable telemetry between a patient’s
implanted device and the programmer, remove any sources of electromagnetic interference
(EMI) that may be affecting the telemetry signal. For more information about EMI, refer to the
Medical Procedure and EMI Warnings and Precautions Manual for Health Care
Professionals.

If programming is disrupted by EMI or loss of telemetry, you must reestablish telemetry and
program the device again.

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Note: The programming head contains a magnet that suspends tachyarrhythmia detection
and initiates magnet mode pacing until telemetry between the device and programmer is
established.

2.3 Interrogating the device during a patient session

You can manually interrogate the device at any time during the patient session.

1. Tap Interrogate… or press the “I” button on the programming head.

The Interrogate How Much? window is displayed.

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2. Choose the data you would like to gather:

●

To gather information collected since the last patient session, tap Since Last
Session.

●

To gather all the information stored in the device, tap All.

3. Tap Start.

2.4 Responding to device status indicator warnings

The device automatically monitors for internal conditions that affect device operation and
require attention. If any such conditions occur, a device status indicator is recorded in
memory, and a device status indicator warning is displayed on the programmer screen when
the device is interrogated.

Device status indicator warnings are displayed both as a window on the programmer screen
and in the Observations box on the Quick Look II screen.

Caution: Inform your Medtronic representative if a device status indicator warning is
displayed.

●

Take the following actions to respond to device status indicator messages:

Indicator warning Action

Warning - Device
Reset

SERIOUS DEVICE
MEMORY FAILURE

AT/AF Therapies
Disabled

Attention − Atrial
Lead Not Detected
During Implant

If the device is not yet implanted, do not implant the device. Contact a
Medtronic representative.
If the device is implanted, follow the procedure in Section 2.4.1.

Contact a Medtronic representative. Immediate replacement of the

device is recommended.

1. Contact a Medtronic representative.

2. Tap Clear to clear the device status indicator.

3. Review arrhythmia episode records and evaluate atrial lead integ­rity.

4. Adjust therapy parameters as needed.

Tap Clear. If an atrial lead is not present, consider programming Atrial
Sensitivity to Off and changing the pacing mode to VVI(R) to maximize
longevity.

2.4.1 Responding to a device reset warning for an implanted device

A device reset is a safety feature that can automatically change parameter values or clear
diagnostic data in response to a problem with device memory. If a device status indicator

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warning for a reset is displayed, you must clear the device status indicator and may need to
reprogram the device to desired parameters.

After a device reset, a device status indicator is recorded. For a device reset that requires
attention, the device status indicator warning describes how data was affected by the reset.
Read the message accompanying the indicator and follow the screen instructions carefully.
If the message indicates that the device parameters were affected by the reset, you must
reprogram the device to restore the previous settings.

If the programmer displays a device reset message for an implanted device, perform the
following steps:

1. Remove any sources of electromagnetic interference (EMI).

2. Notify a Medtronic representative.

3. Tap Clear in the window to clear the device status indicator.

A confirmation window appears indicating that all previously interrogated data in the
programmer will be cleared.

4. Tap Continue.

Note: If a device reset occurred while the MRI SureScan parameter was programmed
to On, the MRI SureScan window appears. Program the MRI SureScan parameter to
Off before continuing with the next step.

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5. Interrogate the device.

6. The time and date that the device reset occurred can be found in the CareAlert Events
log.

Note: If your device does not have a CareAlert Events log, the information can be found
in the counter data.

7. Save your session data to a disk or a USB flash drive.

You should give a copy of this saved data file to your Medtronic representative; it will be
helpful in determining the events leading up to the reset.

8. Verify the programmed device parameters and reprogram them as necessary.

Note: If the device parameters were affected by the reset, the device will automatically
pace in VVI mode at 65 bpm until parameters are reprogrammed.

9. Verify that the device date and time are correct. If necessary, a Medtronic
representative can reprogram the date and time.

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10. Check the Battery and Lead Measurements screen to verify that the battery voltage
is acceptable.

11. Conduct lead impedance and pacing threshold tests as desired.

2.5 Quick Look II screen

The Quick Look II screen provides a summary of the most important indicators of the
system’s operation and patient’s condition since the last patient session. It includes links to
more detailed status and diagnostic information stored in the device.

The Quick Look II screen provides the following information:

●

Device and lead status information indicating whether the system is operating as
expected.

●

Information about arrhythmia episodes and provided therapies to help assess the
patient’s clinical status since the last follow-up appointment.

●

System-defined observations alert you to unexpected conditions, providing
suggestions of how to optimize the device settings.

Note: The Quick Look II screen shows information collected since the last patient session
and stored in the device memory. Programming changes made during the current session
may also affect the Quick Look II observations.

You can update the Quick Look II data during a session by reinterrogating the device.

The Quick Look II screen is automatically displayed after the patient session is started. To
access the Quick Look II screen from another screen, tap Data > Quick Look II.

2.5.1 Information on the Quick Look II screen

The Quick Look II screen provides a summary of the most important indicators of the
system operation and patient’s condition. It includes links to more detailed status and
diagnostic information stored in the device.

Available information:

To view relevant details about a section of the screen, tap the button.

Remaining Longevity – The Remaining Longevity estimate shows the estimated time
remaining until Recommended Replacement Time (RRT).

To access the Battery and Lead Measurements screen, tap the button next to the
Remaining Longevity field.

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Lead status and trends – Information about lead status allows you to assess the
performance and integrity of leads and identify any unusual conditions. The “Last Measured”
column shows the most recently measured lead impedance for each lead. To see more
details, tap the button in the “Last Measured” column.

The lead trend graphs show lead impedance, capture threshold, and sensing amplitude
measurements recorded over the last 12 months. To see more details, tap the button
beside any of the lead trend graphs.

The graph legends contain the last measured values. To see more details about these
values, tap the button.

Pacing and sensing information – This information can help to assess the patient’s AV
conduction status and evaluate the effectiveness of programmed device settings.

Notes:

●

“MVP On” and “MVP Off” refer to the currently programmed pacing mode, not the usage
of MVP mode pacing since the last session. If the device was programmed to an MVP
mode during the reporting period, a high percentage of ventricular pacing may indicate
that the patient has heart block.

●

The paced and sensed event counters do not count all events recorded by the device.
Some device features (for example, Ventricular Safety Pacing) affect the way events are
counted. Also, due to rounding, percentages may not add up to 100%.

Arrhythmia episode information – This section shows the number of treated and
monitored arrhythmia episodes that have occurred since the last patient session. To access
the Arrhythmia Episodes data screen, tap the button next to either the Treated or

Monitored field.

Cardiac Compass trend data – The Cardiac Compass Trends screen provides a picture of

the patient’s condition during the last 14 months. The trend information can help to assess
whether device therapies or antiarrhythmic drugs are effective. To access the Cardiac
Compass Trends screen, tap the button next to the Cardiac Compass field.

Rate Histograms data – The Rate Histograms screen provides information about heart
rates recorded between patient sessions. This data can help you to monitor a patient’s
condition and assess the effectiveness of therapies. To access the Rate Histograms screen,
tap the button next to the Rate Histograms field.

Observations – Observations are based on an analysis of programmed parameters and
data collected since the last session. Observations alert you to unexpected conditions
related to device and lead status, parameter settings, arrhythmia episodes, and clinical
status.

If you select one of the displayed observations, the button becomes active if more
information about the selected observation is available. You can use the button to look at
relevant details.

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2.6 Programmer screen

The programmer screen is divided into areas to view information, navigate among screens,
and perform tasks.

The screen includes the following areas:

●

Task bar at the top of the screen (See the programmer reference manual for information
about the task bar.)

●

Status bar below the task bar

●

Live Rhythm Monitor area

●

Task area that changes according to the task or function you select

●

Navigation icons on the right

2.6.1 Status bar

When the device has been interrogated, you can use the status bar at the top of the display
screen (located immediately below the task bar) to perform some basic functions and to note
the current status of the device.

The status bar displays the following items:

●

Currently active pacing mode

●

Programmed detection and therapy configuration

●

Resume and Suspend buttons for resuming or suspending detection

●

The word SUSPENDED when automatic detection is suspended

●

An indicator (A) if an episode is in progress while AT/AF detection is On

●

Either the current implant detection, episode, therapy, or manual operation status, or the
device name and model number

2.6.2 Live Rhythm Monitor window

The Live Rhythm Monitor window displays ECG waveform traces, Marker Channel
telemetry with marker annotations and intervals, and telemetered EGM waveform traces.

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You can view live waveform traces, freeze waveform traces, record live waveform traces to
the programmer’s strip chart recorder or Electronic Strip chart (eStrip) recorder, whichever
is available, and recall any saved waveform strips prior to ending a patient session. In
addition to waveform traces, the Live Rhythm Monitor window shows the following
information:

●

If telemetry has been established with the device, heart rate and interval are displayed.

●

If parameters are programmed, an annotation appears above the waveform trace
showing the point at which programming occurred.

The Live Rhythm Monitor window appears in partial-screen view by default. You can
expand this to full-screen view by tapping the small square button in the upper-right corner
of the window or by tapping the Adjust… button. The display of waveform traces in the Live
Rhythm Monitor window varies depending on which sources you select during data
collection setup and how you arrange traces in the full-screen view.

2.6.2.1 Live waveform types

The Live Rhythm Monitor can display up to 6 different waveforms during a patient session.

Waveforms are available from ECG and EGM signals:

●

The ECG Lead I, ECG Lead II, and ECG Lead III waveforms display ECG signals that are
detected using skin electrodes attached to the patient. The ECG cable attached to these
electrodes must be connected to the programmer.

●

The EGM1, EGM2, and EGM3 signals are telemetered from the device and are selected
from programmable EGM sources. You can choose the sources of EGM1, EGM2, and
EGM3 when you set up data collection. The programmer cannot display or record an
EGM waveform trace until the current EGM Range setting has been interrogated from
the device.

2.6.2.2 Adjusting the Live Rhythm Monitor display

Use the Live Rhythm Monitor Adjust… window selections to change the waveform display.

1. Tap Adjust….

The full-screen Live Rhythm Monitor window and the Adjust… window are
displayed.

2. Adjust the size, source, and print selection options for each waveform trace using the
waveform adjustment buttons to the left of each waveform trace.

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Button Description

AZURE MRI™ SURESCAN™ / ASTRA MRI™ SURESCAN™

SW030

Increase the size of the waveform trace.

Restore the waveform trace to its default size.

Decrease the size of the waveform trace.

Display a waveform trace, marker annotation, or marker intervals.

Identifies a waveform trace selected for printing. Tap the button to clear the selec­tion and choose a different trace.

Select the waveform trace for printing. You can select up to 2 waveform traces for
printing.

Change the color of the waveform trace.

3. Adjust the appearance of all waveform traces by using the controls in the Adjust…
window.

Optional adjustment Steps

Truncate the tops and bottoms of waveform
traces at a 22 mm boundary.

Change the bandwidth of waveforms to
improve the clarity of the displayed ECG in the
presence of interference.

Display pacing artifacts superimposed over
waveform traces.

Control how quickly the waveform is drawn
across the display.

Tap Clipping.

Tap ECG Filter and select the check box to set
the bandwidth to 0.5 to 40 Hz, or clear the
check box to set the bandwidth to 0.05 to
100 Hz.

Tap Show Artifacts.

Tap Sweep Speed and select a speed (12.5,
25, 50, or 100 mm/s).
Selecting a fast Sweep Speed produces a
wide waveform. Selecting a slow Sweep
Speed produces a narrow waveform.

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Optional adjustment Steps

Equalize the spacing between the waveform
traces and resize each trace to its default set­ting.

Add a reference signal to the analog output,
the screen, or the real-time strip recorder or
Electronic Strip Chart (eStrip) recorder,
whichever is available.

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Tap Normalize.

Tap (Calibrate).

4. Tap OK.

The Adjust… window closes and the Live Rhythm Monitor window returns to its
previous size.

2.6.2.3 Marker Channel data

Marker Channel annotations on the waveform trace indicate events such as pacing, sensing,
detection, and delivered therapies.

The device continuously transmits Marker Channel data and supplementary marker data
while telemetry is established and the programming head is positioned over the device.
Marker Channel annotations appear as 2 characters above or below the Marker Channel
waveform trace.

Real-time printed waveform recordings also display symbols that appear above or below
their associated Marker Channel annotations. The symbols sometimes appear
compressed, depending on the printout speed of the programmer strip chart recorder. The
symbols do not appear on screens or in episode recordings.

Notes:

●

Any interruption in telemetry with the device may result in missing marker annotations
and symbols on the waveform trace display.

●

The device stops transmitting marker data when you lift the programming head, unless
the Holter telemetry feature is programmed to On. If Holter telemetry is programmed to
On, the device transmits Marker Channel data and supplementary marker data
regardless of the position of the programming head.

2.6.2.4 Live waveform trace recordings

At any time during a patient session, you can record a continuous, live waveform trace of the
patient’s ECG and EGM in one of two ways:

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1. On an internal strip chart recorder, if available on your Medtronic programmer.

Note: The printed waveform strip is of a higher resolution than the programmer display
and may show artifacts and events that do not appear on the programmer display.

2. On an Electronic Strip Chart (eStrip) recorder, if available on your Medtronic
programmer.

Depending on the Medtronic programmer model used, a printout of the live waveform trace
includes the following information:

●

ECG and EGM traces

●

an indication of an executed command when confirmation of the command is received

●

test values during system tests

●

telemetry markers that show telemetry from the programmer to the device
(programming the device) and telemetry from the device to the programmer (confirming
the programming)

●

Decision Channel annotations

EGM waveform trace

The programmer cannot display or record an EGM waveform trace until the current EGM
Range setting has been interrogated from the device. If you program an EGM Range setting
during a recording, the programmer marks the change with a vertical dotted line on the paper
recording. EGM and Marker Channel telemetry can be momentarily interrupted during
interrogation or programming.

Simultaneous report printing and live waveform trace recording

If you attempt to print a report to the strip chart printer while performing a live waveform trace
recording, the report is sent to the print queue. Printing to an external printer is not affected.

2.6.2.5 Freezing live waveform traces

The Freeze feature enables you to freeze the last 15 s of all waveform traces displayed in the
Live Rhythm Monitor window.

You can use controls in the frozen strip viewer to view earlier or later portions of the strip, see
frozen waveform strips that are not visible in the window, and measure a time interval.

1. Tap Freeze.

The live waveform trace is frozen and displayed in the frozen strip viewer.

2. To modify or navigate the frozen strip viewer, select from the following options in the
frozen strip viewer:

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Optional task Steps

Open the Adjust… window for the fro-
zen strip viewer.

Normalize or resize the trace, or
change the waveform source.

Measure time intervals on the wave­form trace.

Open a list of other frozen strips. Tap Strips… to open a list of other frozen strips. Tap a

Delete the on-screen frozen strip (if it
was previously saved).

Print the on-screen frozen strip. Tap Print….

View earlier or later portions of the
strip.

View frozen waveform strips that are
not visible in the window.

Save the on-screen frozen strip. Tap Save.

AZURE MRI™ SURESCAN™ / ASTRA MRI™ SURESCAN™

Tap Adjust… to open the Adjust… window. The
Adjust… window offers display options for the frozen
strip viewer that are similar to the Adjust… window for
the Live Rhythm Monitor.

Use the waveform adjustment buttons.

Use the Caliper controls. The caliper measurement is
the time interval between the on-screen calipers.
The arrow buttons move the on-screen calipers to
show the beginning and the end of a time interval.

strip to view and tap Open to display the selected
strip.

Tap Delete.

Scroll horizontally using the horizontal scroll bar.

Scroll vertically using the vertical scroll bar.

SW030

3. To close the frozen strip viewer, tap Close.

2.6.2.6 Recalling saved waveform strips

Before ending a patient session, you can recall any waveform strip collected and saved
during the session in order to view, adjust, and print the waveform strip.

1. Tap Strips… on the main screen or in the frozen strip viewer.

The Strips… window is displayed.

2. Tap a strip to view.

3. Tap Open.

The frozen strip viewer displays the selected strip.

2.6.3 Navigation icons

Navigation icons on the right side of the screen provide access to the main programmer
screens.

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After a patient session is started, the navigation icons are available on all but the Emergency
or Live Rhythm Monitor Adjust… windows.

Table 1. Navigation icons

Opens the Checklist screen for simplified navigation
through a set of follow-up tasks.

Navigates to the next task in the Checklist.

Displays options for viewing device information and diag­nostic data.

Displays the Parameters screen for viewing and program­ming device parameters.

Displays options for performing system tests and EP stud­ies.

Displays options for printing reports.

Displays options for accessing the TherapyGuide or
Patient Information screen.

Displays options for adjusting preferences, viewing param­eter changes made during the session, saving data, and
ending the session.

2.7 Enabling emergency VVI pacing

Use emergency VVI pacing to quickly enable 70 bpm, high-output ventricular unipolar
pacing to restore ventricular support in an emergency situation.

Note: MRI SureScan feature operation is disabled when emergency VVI pacing is
programmed.

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1. During a patient session, verify that telemetry is established between the device and
the programmer.

2. Tap the on-screen Emergency button.

Emergency VVI pacing is enabled, and the programmer displays the Emergency
screen.

Note: You can also enable emergency VVI pacing by pressing the red mechanical
emergency VVI button on the programmer.

To terminate emergency VVI pacing, you must reprogram pacing parameters from the

Parameters screen.

2.8 Patient information

You can enter patient-related information and program it into device memory. This
information can then be viewed and printed during a patient session.

Patient information is typically entered at the time of implant and can be revised at any time.
After you enter the patient’s information and program it into device memory, patient
information is used in the following ways:

●

Clinical conditions (Date of Birth and History) are available to the TherapyGuide feature.

●

Clinical conditions are included in the Initial Interrogation Report and in the Save to
Media file.

●

Clinical conditions can be printed from the Patient Information screen.

●

The patient’s name and ID and the device serial number are included on all reports.

Some entries may appear shortened after they are entered. For example, the Patient field
can display most but not all of the characters that can be entered. The full entry is provided
on the Patient Information Report. When displayed or printed from other screens, the text
entry may be shortened.

If you start a concurrent Medtronic analyzer session during the device session, you can
export analyzer lead measurements. The exported measurements appear as pending
parameter values in the Implant window, which is accessed from the Patient Information
screen. You program these pending values from the Patient Information screen.

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Note: The Patient Information screen should not be used in the place of the patient’s
medical chart. The Patient Information screen of the programmer software application is
provided as an informational tool for the end user. The user is responsible for accurate input
of patient information into the software. Medtronic makes no representation as to the
accuracy or completeness of the patient information that end users enter into the Patient
Information screen. MEDTRONIC SHALL NOT BE LIABLE FOR ANY DIRECT, INDIRECT,
INCIDENTAL, OR CONSEQUENTIAL DAMAGES TO ANY THIRD PARTY WHICH RESULT
FROM THE USE OF THE PATIENT INFORMATION SUPPLIED BY END USERS TO THE
SOFTWARE.

2.8.1 Entering and viewing patient information

Enter information about the patient, the device, and the leads into the Patient Information
screen.

1. Tap Patient > Patient Information.

The Patient Information screen is displayed.

2. Tap each text field to enter or change its content:

Field Description

Patient Enter the patient’s name (up to 29 characters).

ID Enter the patient ID (up to 15 characters).

Date of Birth Select the patient’s date of birth.

Serial Number Displays the serial number of the implanted device. This field is not

selectable.

Lead 1…, Lead 2… Enter detailed information for the lead or leads.

If the lead information is not listed, tap Modify List… and add the
information.

Implant… Either export lead data from the Medtronic analyzer, or enter lead

data using the fields.
Note: If an implant procedure is in progress, consider making the
measurements in a concurrent analyzer session. Measurements can
be exported directly to the Implant window. Otherwise, select a
value for each parameter.

MRI SureScan Sys­tem/Other Hard­ware…

Notes Enter notes about the patient or other information (up to 80 charac-

Select this field to access the MRI SureScan System/Other Hard­ware screen, which lets you enter information about leads and other
hardware that may affect the decision to perform an MRI scan of this
patient.

ters).

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Field Description

History… Enter the patient’s clinical conditions. This information is made avail-

EF, on Select the ejection fraction from a table of values and select the

Physi­cian/Phone/Hospital

Last Update Displays the last date that changes made to patient information were

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able to the TherapyGuide feature.
Note: Entering this information from either the Patient Information
screen or the TherapyGuide screen updates the information on
both screens.

measurement date.

Select the physician’s name, phone number, and hospital from a list.
To add physician information to the list, tap Modify List… and add
the information.

programmed into memory. This field is not selectable.

3. Tap PROGRAM.

2.8.2 Entering and viewing information about the MRI SureScan system and other implanted hardware

Enter information about the leads and other implanted hardware, such as abandoned
devices and leads, lead extenders, or lead adaptors into the MRI SureScan System/Other
Hardware screen.

1. Tap Patient > Patient Information > MRI SureScan System/Other Hardware….

The MRI SureScan System/Other Hardware screen is displayed.

2. Tap each text field to enter or change its content:

Field Description

MR Conditional
Device Implanted

MR Conditional
Lead 1 Implanted

Lead 1 Model Enter the model information for Lead 1.

MR Conditional
Lead 2 Implanted

Lead 2 Model Enter the model information for Lead 2.

Other Devices Enter information to specify any other in-use or abandoned devices.

Displays the MR conditional status of the implanted device. This field is
not selectable.

Specify whether Lead 1 is MR conditional by selecting Yes, No, or
Unknown.
Note: Selecting this parameter value from either the Patient Information
screen or the MRI SureScan System/Other Hardware screen sets the
parameters pending on both screens.

Specify whether Lead 2 is MR conditional by selecting Yes, No, or
Unknown.
Note: Selecting this parameter value from either the Patient Information
screen or the MRI SureScan System/Other Hardware screen sets the
parameters pending on both screens.

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Field Description

Other Leads Enter information to specify any other in-use or abandoned leads.

Lead Extend­ers/Adaptors

Other Hardware
Notes

Last Update Displays the last date that changes made to patient information were

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Enter information to specify any in-use or abandoned lead extenders or
adaptors.

Enter up to 50 characters of notes about other implanted hardware.
Note: The presence of other hardware in the patient may have an
impact on whether the patient can have an MRI scan.

programmed into memory. This field is not selectable.

3. Tap OK.

The Patient Information screen is displayed.

4. Tap PROGRAM.

2.9 Parameters

Parameters are settings that control device functions and data collection. You view and
program parameters from the Parameters screen.

All device parameters that you can view and program appear as active fields. Some active
fields pertain to only 1 parameter, while other fields provide access to groups of parameters.
If a parameter cannot be programmed, no active field appears next to its name. All
permanent parameter changes can be programmed from the Parameters screen.

After you select new values for parameters, the new values are designated as pending
values. A field containing a pending value has a dashed rectangle as its border. Values
remain pending until you program them to device memory.

Parameter sets

Parameter sets are collections of parameter values that have been stored for quick retrieval.
They include the following types:

Medtronic Nominals – Parameter values suggested for the device by Medtronic. The
Medtronic Nominals cannot be customized or deleted.

Initial Interrogation Values – The permanently programmed parameter values as
determined by the first interrogation of the device during the patient session. The Initial
Interrogation Values cannot be customized or deleted.

Custom sets of values – Sets of parameter values that you create for a particular clinical
situation. For example, you may want to save a set of parameter values for an initial implant
setting, for a specific disease state, or for situations in which you need to repeatedly program
a particular set of parameters. The set of parameter values that you save can include both

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programmed and pending values. To delete a custom parameter set, use the Delete button
in the Get Parameter Set window.

2.9.1 Accessing and programming parameters

Use the Parameters screen to view and program parameters.

1. Tap the Params icon.

The Parameters screen is displayed.

2. Make the desired parameter selections.

New values are displayed as pending values.

3. Tap PROGRAM.

The pending values are programmed to device memory.

2.9.2 Parameter symbols

Symbols can appear next to parameter values to convey their status or other information.

Table 2. Symbols that appear with parameter values

Symbol Explanation

Interlock – Indicates that the parameter value conflicts with the setting of another

present or pending value. Select another value or resolve the conflicting parameter
value before programming the parameter.

Warning – Indicates that a warning message is available regarding that value. The
message can be viewed either by tapping the message button or by reselecting that
parameter. In the latter case, the warning is displayed as a warning note in the selec­tion window. These parameter values can be programmed.

Adaptive – Indicates that the programmed value can be changed automatically by the
device. The symbol does not necessarily indicate that the parameter value has been
adapted from a previously programmed value, only that it is able to be adapted.

Nominal – Indicates that the value is the Medtronic nominal value.
Note: If the nominal value is also the programmed value, the Programmed symbol is

displayed instead of the Nominal symbol.

Programmed – Indicates that the value is the programmed value.

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The programmer may display a message button next to the PROGRAM button that, when
tapped, provides access to additional information about the pending parameters. The
message button has one of the symbols described in the following table. When the message
button is tapped, the programmer opens a second window displaying one or more
messages. If there are multiple messages regarding the pending parameter values, the most
significant message determines which symbol appears on the button.

Table 3. Symbols that appear on the message button

Symbol Explanation

Interlock – Indicates that a parameter interlock exists. Programming is restricted until

you resolve the conflict. Tap this button for a message that describes the conflict.

Warning – Indicates that there is a warning associated with programming one or more
of the pending parameter values. Tap this button to view the warning message and
recommendations.

Informational – Indicates that there is an informational message regarding one or
more of the parameter values. Tap this button to view the message.

2.9.3 Creating a custom parameter set

You can create and save sets of parameter values to the programmer and retrieve them
either in the current patient session or in subsequent patient sessions.

This capability allows you to save and quickly access a custom set of parameter values for
a particular clinical situation. For example, you may want to save a set of parameter values
for an initial implant setting, for a specific disease state, or for situations in which you need to
repeatedly program a particular set of parameters. The set of parameter values that you save
can include both programmed and pending values.

1. Tap the Params icon.

The Parameters screen is displayed.

2. Make the desired parameter selections.

3. Tap Save….

The Parameter Set Name window is displayed.

4. Enter a name for the parameter set, and tap either OK or ENTER.

If a parameter set exists with that name, confirm that you want to replace the existing set
with a new set or change the name of the new parameter set.

The parameter set is saved for future retrieval and the parameter values appear as pending
values on the Parameters screen.

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2.9.4 Retrieving a parameter set

Use the Get… button to retrieve a Medtronic Nominals parameter set, an Initial Interrogation
parameter set, or a custom parameter set.

1. Tap Params > Get….

The Get Parameter Set window opens.

2. Use the following optional tasks to manage parameter sets:

Optional task Steps

Retrieve a parameter set. Tap the parameter set you want to retrieve.

Program the selected parameter set. Tap Set Pending to use the parameters from

the selected set. The Get Parameter Set
window closes and the new parameter values
appear as pending values on the Parameters
screen. Tap PROGRAM to program the pend­ing values to device memory.

Remove an unneeded parameter set from the
list.

Select the parameter set you want to remove
and tap Delete.

2.9.5 Parameter values suggested by the TherapyGuide feature

The TherapyGuide feature provides a set of suggested parameter values based on the
programmed information about the patient’s clinical conditions. TherapyGuide suggestions
are based on clinical studies, literature, current practice, and physician feedback.

Caution: The TherapyGuide feature does not replace a physician’s expert judgment. The
physician’s knowledge of the patient’s medical condition takes precedence over the set of
inputs presented to the TherapyGuide feature. The physician is free to accept, reject, or
modify any of the suggested parameter values.

When retrieved, suggested parameter values that are different than the programmed values
appear as pending values on the Parameters screen. The suggested parameter values are
stored in device memory only after you tap PROGRAM on the Parameters screen.

The clinical conditions can be entered in the TherapyGuide window or on the Patient

Information screen. If the clinical conditions were previously entered using the Patient
Information screen at implant or during a follow-up visit, they are displayed in the
TherapyGuide window.

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How programming suggestions are determined

The following table shows the clinical conditions that influence TherapyGuide suggestions.
This table presents an overview, but the Rationale window shows how the suggested
parameter values relate to specific settings for the clinical conditions. If a parameter is not
influenced by the clinical conditions, the TherapyGuide feature may either recommend the
Medtronic nominal value for that parameter or make no recommendation.

Table 4. Clinical conditions that influence TherapyGuide programming suggestions

Programming suggestions Clinical condition parameters

Pacing Mode Atrial Status, AV Conduction, Reflex Syncope

Lower Rate Atrial Status, Date of Birth, Reflex Syncope

Upper Tracking Rate Date of Birth

AV Intervals Date of Birth

Rate Response (including Upper Sensor Rate) Atrial Status, Heart Failure, Date of Birth, Activity

Level

Rate Drop Response Atrial Status, Reflex Syncope

VT Monitor Date of Birth

AT/AF Detection Date of Birth

2.9.5.1 Using the TherapyGuide feature

Use the TherapyGuide feature to obtain suggested parameter values.

1. Tap Params > TherapyGuide….

The TherapyGuide window is displayed.

2. Enter or change the clinical conditions as needed.

Note: If the patient’s clinical conditions have been previously entered, the information
appears in this window, including the date the clinical conditions were last updated.

3. Tap Get Suggestions.

The TherapyGuide window closes, and suggested changes to parameter values
appear as pending values on the Parameters screen.

4. Review the pending parameter values and adjust them as needed using the following
options:

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Optional task Steps

View rationale for TherapyGuide sugges­tions.

Clear all pending parameter values and
pending clinical conditions.

Adjust specific pending values. Tap the value you want to adjust. The parameter

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Tap TherapyGuide > Rationale….

Tap Undo.

value window opens for that parameter. Tap
Undo Pending or select a different parameter
value. Tap OK to return to the Parameters
screen.

5. Tap PROGRAM to program the pending parameter values and clinical conditions to
device memory.

2.9.6 Setting data collection preferences

Use the Data Collection Setup screen to control the collection of EGM data for arrhythmia
episodes, to adjust the device clock, to set Observation Conditions, and to enable telemetry
features.

Notes:

●

Data collection is automatic and cannot be turned off.

●

The signal displayed on the Live Rhythm Monitor for EGM1, EGM2, and EGM3 sources
is controlled by the EGM Source and EGM Range parameters on this Data Collection
Setup screen.

●

Pre-arrhythmia EGM storage works by keeping the EGM circuitry enabled at all times,
and therefore it reduces device longevity. If you select On − 1 month or On − 3 months,
Pre-arrhythmia EGM storage is automatically turned off after the time period expires.
Refer to the reference manual for the implanted device for more information about the
operation of Pre-arrhythmia EGM storage.

1. Tap Params > Data Collection Setup….

2. Set your preferences using the following fields and controls:

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Field Description

EGM Source For each EGM channel, define the source electrodes between which

EGM Range For each EGM channel, select a range. The EGM range setting affects

Monitored Select a set of 2 sources to be used for monitored episode record stor-

Pre-arrhythmia
EGM

AT/AF Settings… Select the thresholds for AT/AF Daily Burden and Avg. V. Rate During

Device
Date/Time… >
Time Zone

Holter Telemetry Select a duration for the Holter telemetry feature to operate, or disable

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the device records EGM signals.
Note: The cardiac interval measurements of the device are always
based on the signals sensed through the programmed sensing polarity
(not the stored diagnostic EGM). Therefore, your selection of EGM
sources does not affect bradycardia pacing or tachyarrhythmia detec­tion.

the resolution of the EGM signal; the lower the setting, the higher the
resolution. If the EGM signal is illegible or clipped, consider changing
the range selection.

age.

Indicate whether you want to store EGM data collected prior to an epi­sode.

AT/AF that will trigger QuickLook II Observations.

Note: The AT/AF Settings… field will not appear on the screen if
Wireless Telemetry with Monitor is programmed to On.

Select the appropriate Time Zone offset from Coordinated Universal
Time (UTC) to adjust the device time.

Holter telemetry. When Holter telemetry is enabled, the device contin­uously transmits EGM and Marker Channel data for the selected dura­tion regardless of the presence of the programming head.

Turn the Wireless Telemetry with Monitor feature on or off.
Note: Wireless telemetry and Medtronic CareAlert Monitoring (if avail­able) can only be used when Wireless Telemetry with Monitor is pro­grammed to On.

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3. Tap OK.

The Data Collection Setup window closes and new values are displayed as pending
values.

4. Tap PROGRAM.

2.10 Using a checklist to complete tasks

Use the Checklist feature to cycle through common tasks that are performed during an
implant session or a follow-up session. You can use Medtronic standard checklists or your
own custom checklists.

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When you select a task from a checklist, the associated programmer screen for that task
appears. Once you complete a task, you can either go back to the Checklist screen or
continue on to the screen associated with the next task.

1. Tap the Checklist icon.

The Checklist screen is displayed.

2. Tap a checklist from the Checklist field to display the tasks associated with that
checklist. You can choose from the following checklists:

●

Medtronic Standard Followup Checklist

●

Medtronic Standard Implant Checklist

●

Custom checklists you have created

The tasks included in that checklist appear in the Task list.

Check marks appear next to the names of any programmer screens that were visited
during a session.

3. Advance through the checklist tasks using the following actions:

Action Steps

Begin the first checklist task. Tap Go to Task or tap the button next to the

Checklist icon. The screen for the first task

appears. Complete the task on the screen.

Advance through the tasks. Use the button to continue from one task to

the next.

Return to the Task list. Tap the Checklist icon.

Repeat a Task. Tap the task in the checklist, then tap Go To

Task or tap the button next to the Checklist
icon.

Perform a task out of order. Tap the task in the checklist, then tap Go To

Task or tap the button next to the Checklist
icon.

Once you have completed the last task on the Task list, the button and the Go To Task
button become inactive. However, if you select a task in the list, both buttons become active
again and you can use them to move among the task screens.

2.10.1 Creating and editing a custom checklist

Use the Checklist screen to create customized checklists that reflect your personal
workflow.

To create a new checklist, use the following steps:

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1. Tap the Checklist icon.

The Checklist screen is displayed.

2. Tap New….

The Checklist - New window opens.

3. Use the following options to add and modify tasks on your custom checklist:

Optional task Steps

Add a task to your checklist. Tap the task you want to add in the box on the

left. The selected task appears in the box on
the right.

Add the same task more than once. Tap the task again in the box on the left. The

task appears again in the box on the right.

Add a task between other tasks. Highlight the task on your checklist that the

new task should follow. Tap the new task in the
box on the left. The new task appears in the
box on the right.

Delete a task from your checklist. Highlight the task you want to delete on your

checklist and tap Delete.

4. Tap the Checklist name field and enter a name.

5. Tap Save.

Your new custom checklist is saved. The Checklist − New window closes and returns
to the Checklist screen. Your new custom checklist is available to select in the
Checklist field.

Use the following options to manage custom checklists:

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Optional task Steps

Edit a custom checklist. Tap the checklist in the Checklist field and tap

Edit…. Add or delete tasks as needed, then tap
Save.

Rename a custom checklist. Tap the checklist in the Checklist field and tap

Edit…. Change the name and tap Save.

Delete a custom checklist. Tap the checklist in the Checklist field and tap

Delete.
Note: After a custom checklist has been deleted,

it cannot be restored.

Note: The Medtronic Standard Followup Checklist and the Medtronic Standard Implant
Checklist cannot be edited or deleted.

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2.11 Printing reports

You can print reports at the beginning of a session, during a session, at the end of a session,
and after a session. By setting printing preferences, you can identify the reports to print,
whether to print them now or later, and which printer to use.

During a patient session, you can print a report on a specific programmer screen by selecting
the Print… button or the Print icon. If the printing preferences window appears, select
printing preferences as desired. If the printing preferences window does not appear, the
report prints according to the previously set printing preferences.

2.11.1 Setting printing preferences

Use the Preferences window to select print options, such as number of copies, printer type,
and whether to print now or later.

1. After starting a patient session, tap Reports > Preferences… > Printing.

2. Select or deselect the check box next to Pop up these options when any Print
button is selected:

●

To apply the printing preferences automatically whenever you print a report, leave
the check box blank.

●

To be prompted to set printing preferences each time you print a report, select the
check box.

3. Select the number of copies, choose a printer, and tap OK.

Note: You can save reports as PDF files by choosing Save to PDF File. Reports are
saved to an attached USB flash drive (or to a disk, if the programmer has a disk drive,
a disk is inserted in the disk drive, and a USB flash drive is not connected).

Your preferences take effect immediately.

2.11.2 Enabling printing of an Initial Interrogation Report

You can set a preference to have the software application print an Initial Interrogation Report
automatically after the first interrogation in a patient session. You can also specify the data
to include in the report.

Initial Report preferences take effect at the start of a new session and remain in effect until
you change them and start a new session.

1. After starting a patient session, tap Reports > Preferences… > Initial Report.

2. Select the check box next to Print Initial Interrogation Report after first
interrogation.

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3. Select the reports to include in the Initial Interrogation Report, if desired, and tap OK.

Notes:

●

The Quick Look II Report is always included in the Initial Interrogation Report and
cannot be deselected.

●

To print an Initial Interrogation Report for a patient session that is in progress, end
and restart the patient session.

The selected preferences are stored and the Preferences window closes. The Initial
Interrogation Report prints automatically after interrogation.

2.11.3 Printing a set of reports during a patient session

Use the Available Reports window to specify a customized set of reports for printing.

1. Tap Reports > Available Reports….

2. Select the reports you want to print.

Note: A report can be printed only if its data has been collected. If no data has been
collected, the name of the report appears gray.

3. Tap Print Options… if it is available, and select printing preferences as desired.

4. Tap one of the following buttons:

●

Print Now prints the reports immediately.

●

Print Later adds the print request to the print queue.

2.11.4 Printing a Final Report for the patient session

You can print a Final Report summarizing selected data at the end of a patient session.

The Session Summary Report is always included in the Final Report. You can select
additional reports to include in the Final Report using the Preferences window.

●

Tap Reports > Final Report….

The result depends on the following print preference you have specified in the
Preferences window.

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Print Preference Result

Pop up these options when
any Print button is selected

box is checked

Pop up these options when
any Print button is selected

box is unchecked

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The Final Report window is displayed

●

Specify the number of copies to print and select the
printer. If you select Full Size for the printer, select the file
format from the list of available options.

●

Tap Print Now to print the Final Report immediately.

●

Tap Print Later to add the Final Report to the print queue.

The Final Report prints immediately.

2.11.4.1 Setting Final Report preferences

Use the Preferences window to select the reports you want printed as part of the Final
Report.

Your Final Report preferences remain in effect between sessions and across all applications.

Note: The Session Summary is always included in the Final Report and cannot be
deselected.

1. Before ending a patient session, tap Reports > Preferences… > Final Report.

2. Select the reports to include in the Final Report.

3. If this is the first time you are establishing Final Report preferences, select All Settings
in the Parameters section.

4. Select OK.

2.11.5 Print Queue window

The Print Queue window indicates the status of print jobs. It is available during a patient
session and outside of a patient session.

The Print Queue window during a patient session

The Print Queue window indicates the printing status of reports that you select to print as
you progress through a patient session. To display the Print Queue window during a patient
session, select Reports > Print Queue.

The Print Queue window outside of a patient session

When you end a patient session, the Print Queue window is still available. It lists any reports
held from that session and other sessions. To display the Print Queue window when you are
not in a patient session, select the Print Queue icon from the Select Model screen.

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Printing or deleting a print job

You can print or delete a print job from the queue. A report cannot be deleted if its status is
“Printing” or “Waiting”.

A status of “Hold-Later” indicates one of the following situations:

●

A report is on hold until you request that it be printed (using the Print button).

●

The printing of a report was interrupted by the start of a recording.

●

The printer is not operational (because it is out of paper, for example).

2.12 Exporting data to the Paceart system

The SessionSync feature provides network connectivity between the programmer and the
Medtronic Paceart data management system. Using your clinic’s network, the programmer
can send downloaded device data through the SessionSync feature to the data
management system for later analysis and patient management.

For information about the SessionSync feature, see the programmer reference manual.

2.13 Saving and retrieving device data

You can save interrogated device data from a patient session to a disk or to a USB flash drive.
Later, while no patient session is in progress, you can use the Read From Media application
on the programmer to retrieve, view, and print previously saved data.

The Save to Media feature stores session data in a format that can only be retrieved using the
Read from Media application.

Note: You can also save reports and frozen waveform strips as PDF files by checking the
Save to PDF File option when printing.

The Medtronic CareLink 2090 programmer has a disk drive for 90 mm (3.5 inch) disks plus
a USB port for USB flash drives, and the Medtronic CareLink Encore 29901 programmer has
a USB port only. If your programmer has a USB port only, please disregard the information
about using a disk drive.

Any programmer equipped with a disk drive can read device data from or write device data
to a disk. However, if a USB flash drive is inserted into the programmer, it overrides the disk
drive for saving and retrieving device data. Disks may be used only when no USB flash drive
is inserted.

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Interrogate the device before saving data to a USB flash drive or a disk because the
programmer saves only the data it has interrogated. If the Interrogate How Much? window
is displayed, select All to save a record of all the information from the device. If an issue
needs to be investigated, selecting the All option provides more data for analysis.

During the save operation, the Emergency button remains displayed, and the Emergency
function is available. If an error occurs during a save operation, there may be a delay in
initiating the Emergency screen. Do not save to media during EP studies or when it is
possible that the Emergency function will be needed immediately. If the Emergency function
is used during a save operation, the device aborts the save operation.

Do not insert or remove a USB flash drive during the following operations:

●

programming a device

●

performing a Save To Media operation

●

performing a Read From Media operation

●

saving a report or a frozen waveform strip as a PDF file

2.13.1 Saving device data

You can save interrogated device data from a patient session to a disk or to a USB flash drive.

To ensure the integrity and security of patient information, use a USB flash drive or a disk that
is reserved for storing programmer data.

If you are saving to a USB flash drive, insert only one writable USB flash drive at a time.
Inserting additional USB flash drives results in an error during data-saving operations and
the USB indicator becomes unavailable. Insert a USB flash drive only if the programmer is
powered on.

You can save to a disk if your programmer has a disk drive. If you are saving to a disk, the disk
must be a formatted, IBM-compatible, 90 mm (3.5 inch) disk. If you save data to a disk that
is corrupt or is not IBM-formatted, the programmer may become unresponsive. If this
situation occurs, remove the disk, turn off the programmer, and then turn it on again. Normal
operation should resume. Inform your Medtronic representative of this occurrence.

1. Tap Interrogate to interrogate the device.

2. Tap Session > Save to Media….

3. Insert a USB flash drive into any available USB port on the programmer or insert a disk
into the programmer disk drive.

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4. Tap Save.

If you are saving to a USB flash drive, a slight delay may occur while the USB flash drive
is authorized. The USB indicator on the task bar turns green to indicate that the USB
flash drive is available for use and the disk icon becomes unavailable.

While a Save To Media action is in progress, the progress indicator and the message “Save
To Media - In Progress” are displayed. Before removing a USB flash drive, wait a few seconds
after the progress indicator shows 100%.

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2.13.2 Retrieving device data

Use the Read From Media application on the programmer to view saved data, print reports,
and display all programmed parameter values.

You can use the Read From Media application only outside of a patient session. When you
retrieve stored data, the programmer presents the data in a slightly different way than what
is seen during a patient session. Because you are not in a live patient session, the Live
Rhythm Monitor window is replaced with the device model and the words Read From Media.

Note: You cannot use the programmer to view reports that have been saved using the Save
to PDF File option. Reports that have been saved using the Save to PDF File option can

only be viewed on a computer equipped to display PDF files.

Warning: The Read From Media application is designed only for viewing saved data while
no patient session is in progress. You cannot program a device or deliver emergency
therapies from the Read From Media application.

Use the following steps to retrieve device data:

1. Insert a USB flash drive or a disk that contains information saved during a patient
session.

2. From the Select Model screen, select the product category from the View list.

3. Select the Read From Media version of the device application.

4. Tap Start.

A warning message is displayed informing you that programming a device and
emergency operations are not possible while you are in the Read From Media
application.

5. Tap OK.

6. Tap Open File….

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7. Select the data record that displays the desired device serial number, date, and time
and tap Open File.

The Read From Media application displays information from the saved session.

2.14 Ending a patient session

Use the Session icon to review changes made during a session, and use the End
Session… button to save session data or end the patient session.

Note: Session data may be lost once a session has ended. Print session data or save the

session data to a USB flash drive or disk prior to ending the session to avoid permanent loss
of session data.

1. To review or print a list of changes made during this session, tap Session > Changes

This Session.

Note: Selecting Print… will allow you to print the list of changes made during this

session.

2. Tap End Session….

The End Session? window is displayed.

3. Choose one of the following options:

●

To save the session data to a USB flash drive or a disk, tap Save To Media….

●

To end the session and return to the Select Model screen, tap End Now.

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3 Diagnostic data

3.1 Diagnostic data overview

The implanted device collects and stores a variety of data about the patient’s condition and
the performance of the implanted system. The programmer software allows you to access
the stored data and use it to help manage patient care.

The following categories of data are available:

●

CareAlert events, which include both clinical status events and system performance
events

●

Clinical diagnostic data

●

Device and lead performance data

3.2 CareAlert Events

Important clinical management and system performance events may occur between
scheduled patient sessions, eliciting a CareAlert notification (if remote monitoring is
available). You can program notifications for certain CareAlert events.

You can program CareAlert notifications for clinical management events and lead and device
integrity events. The CareAlert notification for a device reset occurs automatically and is not
programmable. CareAlert notification settings can be programmed during implant, at patient
discharge, or during a patient follow-up appointment. Changes to CareAlert notification
settings take effect immediately in the implanted device upon successful completion of
programming.

3.2.1 Viewing CareAlert events

The implanted device stores alert events in the Medtronic CareAlert Events log. For each
event, a log entry includes the date and time of the alert, a description of the event, and the
measurement or information that caused the event. Up to 15 events are stored.

●

To view the most recent Medtronic CareAlert Events, select Data > CareAlert Events.

3.3 Clinical diagnostic data

You can use a variety of diagnostic data that has been collected and stored by the device to
help you assess the patient’s clinical condition and the effectiveness of therapies.

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3.3.1 Viewing Arrhythmia Episodes data

Use the Arrhythmia Episodes screen to view summary and detailed diagnostic data for
arrhythmia episodes.

When viewing the most recent VT, Fast A&V, or AT/AF record details screen, you can tap the
Flashback button to display a graph showing atrial and ventricular intervals that occurred
immediately prior to the episode.

1. Tap Data > Clinical Diagnostics > Arrhythmia Episodes > Open Data.

The Arrhythmia Episodes screen is displayed with events listed in the episode log,
which appears in the upper portion of the Arrhythmia Episodes screen.

Note: Data will not display for episodes that occur during a device session. These
episodes are labeled as Episode in progress and are not available to view in the
episode records until an interrogation is performed. To view the episode information for
an Episode in progress, interrogate the device after episode termination.

2. Use the following filtering tools to specify which data to display:

Filtering tool Steps

Specify the types of episodes (VT/VF,
AT/AF, and Fast A&V) you want to display.

Display episodes with specific characteris­tics, choosing from All Selected Types,

Treated, Any Rx Failed, All Rx Failed,
Monitored, Symptom, or EGM.

Display episodes that are longer than a spe­cific amount of time.

Select the applicable check boxes to display the
episodes.

Tap the box next to View to display a type of
episode.

Tap the box next to > and choose the maximum
episode duration.

Note: For each episode type, when the log capacity is reached, data from the most
recent episodes overwrites the oldest episode data in the log.

3. To view detailed information about an episode, tap the episode in the episode log.

Details about the episode are displayed in the episode record area, in the lower portion
of the Arrhythmia Episodes screen.

4. Use the following options to control the data displayed in the episode record area:

Action Steps

Move to a specific area of the EGM view. Use the horizontal scroll bar to change the

displayed area.

Select a specific portion of an episode for
which to view EGM data.

Tap Plot. Use the arrow buttons to adjust the
location of the yellow box to select a portion of
the episode. Tap EGM to see the selected
data in the EGM format.

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Action Steps

Change the format of the data for the selected
episode.

Maximize or minimize the plot, EGM, or text
display.

Switch the y-axis between interval and rate. Tap the white Interval/Rate box (in Plot view)

Show or hide plot intervals as desired. Tap the Plot: check boxes in the legend.

Display a selected atrial interval. Tap EGM and maximize the display by tapping

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Tap Plot, EGM, or Text to view the data in that
format.

Use the or buttons to change the size of
the displayed episode in the window.

at the top of the y-axis.

the button. Tap the white Atrial Interval box
on the y-axis to change the atrial interval
shown on the display.

3.3.2 Viewing Flashback Memory data

Use the Flashback Memory screen to view a graph showing atrial and ventricular intervals
that occur immediately prior to tachyarrhythmia episodes or the most recent interrogation.
This data may help to assess the patient’s heart rhythm and the performance of other
features such as Rate Response.

1. Tap Data > Clinical Diagnostics > Flashback Memory > Open Data or tap the
Flashback button on the record detail view for the most recent VT, Fast A&V, or AT/AF
episodes on the Arrhythmia Episodes screen.

2. Use the following options to control the data displayed:

Action Steps

Select the interval to view. Select an option under View Intervals Prior

to:.

Show or hide plot intervals as desired. Tap the Plot: check boxes.

Switch the y-axis between interval and rate. Tap the white Interval/Rate box at the top of

the y-axis.

Shrink or enlarge the region to display when
the view is maximized.

Reposition the region to display when the view
is maximized.

Maximize or minimize the view of the selected
region.

Use the zoom region resize buttons to adjust
the location of the yellow box to select a por­tion of the interval. Tap to shrink the region
to display and tap to enlarge the region to
display. Tap to maximize the view of the
selected data in the yellow box.

Use the arrow buttons to adjust the location of
the yellow box to select a portion of the inter­val. Tap to maximize the view of the data in
the yellow box.

Use the or buttons to change the size of
the displayed interval in the window.

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3.3.3 Viewing Rate Drop Response Episodes data

Use the Rate Drop Response Episodes screen to help you analyze rate drop episodes
and the events leading up to them.

1. Tap Data > Clinical Diagnostics > Rate Drop Response Episodes > Open Data.

The Rate Drop Response Episodes screen is displayed with events listed in the
episode log, which appears in the upper portion of the Rate Drop Response
Episodes screen.

2. To view detailed information about an episode, tap the episode in the episode log.

Details about the episode are displayed in the episode record area, in the lower portion
of the Rate Drop Response Episodes screen.

3. Use the following options to control the data displayed in the episode record area:

Action Steps

Move to a specific area of the Markers view. Use the horizontal scroll bar to change the

displayed area.

Select a portion of the plot that will be expan­ded when entering the Markers view.

Change the format of the data for the selected
episode.

Maximize or minimize the plot, markers, or text
display.

Switch the y-axis between interval and rate. Tap the white Interval/Rate box (in Plot view)

Show or hide plot intervals as desired. Tap the Plot: check boxes (in Plot view) in the

Display a selected atrial interval. Tap Markers and maximize the display by

Tap Plot and use the arrow buttons to adjust
the location of the yellow Marker Channel box
to select a portion of the plot. Tap Markers to
see the selected data in the Markers view.

Tap Plot, Markers, or Text to view the data in
that format.

Use the or buttons to change the size of
the displayed episode in the window.

at the top of the y-axis.

legend.

tapping the button. Tap the white Atrial
Interval box on the y-axis to change the atrial
interval shown on the display.

3.3.4 Viewing MVP Mode Switches

Use the MVP Mode Switches screen to view a list of the 10 most recent MVP mode switches
to DDD(R). This information can help you assess the mode switches.

●

Tap Data > Clinical Diagnostics > MVP Mode Switches > Open Data.

The MVP Mode Switches data is displayed.

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3.3.5 Viewing Cardiac Compass Trends data

Use the Cardiac Compass Trends screen to view data about the patient’s condition during
the last 14 months. The trend information can help you to assess whether device therapies
or antiarrhythmic drugs are effective.

●

Tap Data > Clinical Diagnostics > Cardiac Compass Trends > Open Data.

The Cardiac Compass Trends data is displayed.

3.3.6 Viewing Rate Histograms data

Use the Rate Histograms screen to view information about heart rates recorded between
patient sessions. This data can help you to monitor a patient’s condition and assesses the
effectiveness of therapies.

●

Tap Data > Clinical Diagnostics > Rate Histograms > Open Data.

The Rate Histograms data is displayed.

3.3.7 Viewing Counters data

Use Counters data for information about the number of times VT/VF episodes and AT/AF
episodes and therapies have occurred.

1. Tap Data > Clinical Diagnostics > Counters > Open Data.

The Counters screen is displayed.

2. Use the options near the top of the screen to specify which counters to display (VT/VF

Episodes, AT/AF Episodes, or AT/AF Rx).

3.4 Device and lead performance data

The device automatically measures and records device and lead performance data every
day. Detailed views of this data are available from the Battery and Lead Measurements
screen and the Lead Trends screen.

3.4.1 Viewing battery and lead measurements

Use the Battery and Lead Measurements screen to view the most recent values for key
measures of device and lead performance.

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Warning: Replace the device immediately if the programmer displays an End of Service
(EOS) indicator. The device may lose the ability to pace, sense, and deliver therapy
adequately after the EOS indicator appears.

Note: If the programmer displays the Recommended Replacement Time (RRT) indicator,
contact your Medtronic representative and your patient to schedule a replacement
procedure.

1. Tap Data > Device/Lead Diagnostics > Battery and Lead Measurements > Open
Data.

The Battery and Lead Measurements window is displayed.

●

For lead impedance measurements, the screen displays the most recent manually
performed measurements or the most recent daily automatic measurements.

●

For sensing amplitude measurements, the screen displays the most recent daily
automatic measurements. Measurements performed with the manual Sensing
Test are not displayed on the Battery and Lead Measurements screen.

2. Optionally, tap the button near the Lead Impedance or the Sensing data to compare
the most recent measurements to the trends of daily automatic measurements.

The Lead Trends window is displayed.

3.4.2 Viewing lead impedance trends

Use the Lead Trends screen to view a graph displaying the automatic daily lead impedance
measurements. Significant or sudden changes in lead impedance may indicate a problem
with the lead.

The graph displays up to 15 of the most recent automatic daily measurements and up to 60
weekly summary measurements. Gaps in the trend graph occur if the device was unable to
perform automatic lead impedance measurements.

1. Tap Data > Device/Lead Diagnostics > Lead Impedance Trends > Open Data.

The Lead Trends screen is displayed.

2. Select the measurement trend to display.

3. Select the polarity to display.

3.4.3 Viewing capture threshold trends

Use the Lead Trends screen to view a graph of capture threshold trend data. You can use
this data to evaluate Capture Management operation and the appropriateness of the current

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pacing output values. In addition, sudden or significant changes in pacing threshold may
indicate a problem with a lead.

The graph displays up to 15 of the most recent automatic daily measurements and up to 60
weekly summary measurements. Gaps in the trend graph occur if the device was unable to
perform a daily capture threshold measurement.

The capture threshold data is collected only when the Capture Management parameter is
programmed to Adaptive or Monitor.

1. Tap Data > Device/Lead Diagnostics > Capture Threshold Trends > Open Data.

The Lead Trends screen is displayed.

2. Select the chamber to display.

3. Optionally, tap the button to view details of the last 15 days of threshold measurement
data.

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3.4.4 Viewing sensing amplitude trends

Use the Lead Trends screen to view a graph displaying the automatic daily sensing
amplitude measurements. Significant or sudden changes in sensing amplitude may indicate
a problem with the lead.

The sensing amplitude graph displays up to 15 of the most recent automatic daily
measurements and up to 60 weekly summary measurements. The daily measurements are
the median values of the amplitudes of 9 normal intrinsic sensed events. Gaps in the trend
graph occur if the device was unable to collect 9 amplitude measurements on a given day.

1. Tap Data > Device/Lead Diagnostics > P/R Wave Amplitude Trends > Open Data.

The Lead Trends screen is displayed.

2. Select the amplitude measurement type to display.

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4 System test and EP study features

4.1 Overview of system test and EP study features

System test features include manual tests of the patient’s condition and the device’s
functionality. Electrophysiology (EP) study features include arrhythmia induction protocols
and manual therapy delivery.

System test features

●

Underlying Rhythm Test: evaluate the patient’s intrinsic heart rhythm.

●

Pacing Threshold Test: Determine the patient’s pacing stimulation thresholds.

●

Lead Impedance Test: Test the integrity of the implanted lead system.

●

Sensing Test: Measure P-wave and R-wave amplitudes.

●

Magnet test: Observe and document magnet mode operation.

Electrophysiology (EP) study features

●

Arrhythmia induction protocols: 50 Hz Burst, Fixed Burst, and Programmed Electrical
Stimulation (PES).

●

Manual therapies: Ramp, Burst, Ramp+, and Burst+.

4.1.1 Setting test preferences for the Live Rhythm Monitor

You can choose to make the live rhythm display arrange the waveforms to show the EGM of
the heart chamber being tested, or to keep the waveform arrangement unchanged.

1. Tap Reports > Preferences > Tests

Waveform display options become available on the Preferences screen.

2. Select one of the following options:

Option Steps

Automatically display the EGM for the heart chamber being
tested.

Leave the waveform display unchanged during a test. Select Do not auto-arrange

3. Tap OK.

Test preferences are saved and the Preferences screen closes.

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Select Auto-arrange wave-

forms.

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4.2 Performing an Underlying Rhythm Test

The Underlying Rhythm Test enables you to evaluate the patient’s intrinsic heart rhythm by
temporarily inhibiting the pacing output of the device.

Caution: While the Underlying Rhythm Test is in progress, patients are not receiving pacing
support because the device is temporarily programmed to a nonpacing mode. Pacing is
inhibited as long as you press and hold the INHIBIT Press and Hold button. Carefully
consider the implications of performing this test on pacemaker-dependent patients.

Considerations for performing an underlying rhythm test:

●

For all patients, consider lowering the programmed Lower Rate and ensuring that the
patient is at this rate before inhibiting pacing. These actions may help avoid sudden
changes in the ventricular rate support.

●

Tachyarrhythmia detection is suspended during the Underlying Rhythm Test

Use the following steps to perform an underlying rhythm test:

1. Tap Tests > Underlying Rhythm.

2. Verify the Permanent Values for Mode and Lower Rate.

●

Consider lowering the programmed lower rate to help avoid sudden changes in
ventricular rate support.

●

Tap Params > Lower Rate and select an appropriate rate. Tap PROGRAM to
program any pending changes. The device will pace at the lower rate shown on the
Parameters screen.

●

Tap Tests > Underlying Rhythm to return to the Tests - Underlying Rhythm
screen.

3. Press and hold INHIBIT Press and Hold.

4. Observe the display of the heart’s intrinsic rhythm.

Note: Pacing is inhibited until this button is released.

5. Release the button.

6. If Lower Rate was changed prior to conducting the underlying rhythm test, return to the

Parameters screen to return the rate to its original value.

4.3 Measuring pacing thresholds

The Pacing Threshold Test enables you to determine the patient’s pacing stimulation
thresholds. Pacing threshold information may be used to determine appropriate amplitude

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and pulse width settings to ensure capture while minimizing output to maximize battery
longevity.

Considerations for measuring pacing thresholds:

●

The selectable and default values provided by the Pacing Threshold Test depend on the
programmed values for bradycardia pacing therapy.

●

After performing a Pacing Threshold Test, make sure that the permanently programmed
pulse width and amplitude parameters provide an adequate safety margin above the
pacing threshold.

●

Tachyarrhythmia detection is suspended during the Pacing Threshold Test.

1. Tap Tests > Pacing Threshold.

2. Review the displayed values and consider the following options:

Optional task Steps

Change the values for Test Type, Chamber,
or Decrement after.

Change the Test Value for Pace Polarity,

Mode, Lower Rate, AV Delay, Amplitude, or
Pulse Width.

Change the values for V. Pace Blanking, A.
Pace Blanking, or PVARP.

Tap the field next to the parameter you wish to
change and select the desired value for that
parameter.

Tap the field next to the parameter you wish to
change and select the desired value for that
parameter.

Tap Additional Settings… and then tap the
field next to the parameter you wish to change.
Select the desired value for that parameter.

3. Initiate the Pacing Threshold Test. Press and hold TEST Press and Hold.

4. Observe the Live Rhythm Monitor for loss of capture.

5. When capture is lost, immediately release TEST Press and Hold.

The device resumes its original pacing values and displays the Test Results window.

6. Verify the detected pacing threshold at which loss of capture occurred.

Note: If necessary, change the value for the detected pacing threshold by tapping that
value in the Threshold column on the Test Results window.

7. If desired, use the following options to view or change data in the Test Results window:

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Optional task Steps

Change the programmed value for Pace
Polarity.

Change the programmed values for Ampli­tude or Pulse Width.

View the ending value and permanent value
for V. Pace Blanking, A. Pace Blanking, and
PVARP parameters.

View a test strip from the most recent pacing
threshold test.

Print a Pacing Threshold Test Report. Tap Print….

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Tap the Pace Polarity value in the Perma-

nent column. Select the desired value. Tap
PROGRAM to program a pending value.

Tap the value in the Permanent column to
display the Capture window. Select the
desired values and tap OK. Tap PROGRAM to
program the pending values.

Tap Additional Settings… to view the val­ues. Tap OK to return to the Test Results
window.

Tap the Test Strip icon to view the test strip.
Tap Close to return to the Test Results win-
dow.

8. When you have finished viewing or changing data on the Test Results window, tap

Close to return to the Pacing Threshold Test screen.

4.4 Measuring lead impedance

The Lead Impedance Test enables you to test the integrity of the implanted lead system by
measuring the impedance of the atrial and ventricular pacing electrodes.

Considerations for measuring lead impedance:

●

Impedance measurements are made with low-voltage subthreshold pulses that do not
capture the heart.

●

During a sequence of lead impedance measurements, the device may sense the
subthreshold test pulses as atrial refractory events or atrial sensed events. The test
pulses may also cause small variations on 1 or more of the EGM channels.

●

Tachyarrhythmia detection is suspended during the Lead Impedance Test.

After performing the Lead Impedance Test, you can determine if the lead impedance has
changed by comparing the measured values to the values reported on the Lead Trends
Pacing Impedance screen and to the impedance values measured during previous follow-up
appointments, if they were recorded in the patient’s chart.

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1. Tap Tests > Lead Impedance.

2. Tap START Measurement.

a. Wait for confirmation of programming and a message indicating that measurements

are in progress.

b. If necessary, end the test by tapping STOP. Lead impedance measurements are

not updated from a test that is stopped.

When the test is complete, the new measured impedance values for the tested
polarities are displayed.

3. To view the measurements for all available lead polarities, tap the All Measured
Polarities button.

4.5 Performing a Sensing Test

The Sensing Test enables you to measure P-wave and R-wave amplitudes, which may be
useful for assessing lead integrity and sensing performance.

Caution: Use caution when selecting temporary pacing settings for pacemaker-dependent
patients. These patients may not receive adequate pacing support while amplitude
measurements are being obtained.

The Sensing Test allows you to temporarily program pacing parameters to increase the
likelihood that sensed events will occur. Sensing amplitude measurements taken during a
Sensing Test may include events that are atypical or a result of oversensing (for example,
PVCs or far-field R-waves). These events are excluded from the daily automatic sensing
amplitude measurements the device collects and reports in the sensing amplitude trends.
Because of this difference in measurement operations, Sensing Test results may differ from
those reported in the sensing amplitude trend data.

Considerations for performing a Sensing Test

●

During a Sensing Test, reduce the pacing rate gradually to minimize patient symptoms
associated with abrupt changes in heart rate.

●

The Sensing Test ends automatically after a few seconds and restores the programmed
settings if no intrinsic events occur and no changes are made to the pacing rate.

●

Do not adjust the values for A. Sensitivity and RV Sensitivity based on the results of the
Sensing Test.

●

Tachyarrhythmia detection is suspended during the Sensing Test.

Use the following steps to perform a sensing test:

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1. Tap Tests > Sensing.

Note: You must program the device to a pacing mode other than an asynchronous
pacing mode before performing a Sensing Test. The Sensing Test does not function
when the device is programmed to an asynchronous pacing mode (VOO, for example),
or when polarities are programmed to Configure.

2. Verify the programmed Test Value parameters for Mode and AV Delay or accept the
values displayed.

Note: The pacing modes available under Test Value depend on the programmed
pacing mode.

3. Tap START Measurement.

4. Observe the Live Rhythm Monitor for an intrinsic rhythm. If consistent pacing is still
occurring, decrease the Lower Rate using the down arrow button next to the value for

Lower Rate.

Notes:

●

If necessary, abort the test by tapping STOP and Restore.

●

After the test has started, you may continue to decrease the pacing rate until the
intrinsic heart rhythm prevails. The device measures amplitudes only on intrinsic
events. The maximum amplitude value that the Sensing Test can measure is 20 mV.
If the amplitude is over 20 mV, the results are displayed as >20 mV.

The sensing test automatically stops when it is complete. When the test is complete, the
measurement results are displayed on the test screen and the pacing settings return to the
programmed values.

To compare the Sensing Test measurements with the automatic daily sensing amplitude
measurements, tap the P/R Wave Amplitude Trends button.

4.6 Performing a Magnet Test

To observe and document magnet mode operation while the device is in a telemetry session,
use the Magnet Test.

During magnet mode operation, the device provides asynchronous pacing at a fixed rate.
While the device is in a telemetry session, you cannot initiate magnet mode operation by
placing a magnet over the device. The Magnet Test can automatically record Live Rhythm
Monitor strips showing magnet mode and non-magnet mode operation.

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Note: At any time during a Magnet test, lifting the programming head from over the patient’s
pacemaker for at least 2 s restores operation of the pacemaker to its permanent status. This
action should be taken in the event of programmer malfunction, loss of power, or the absence
of an appropriate command confirmation.

1. Tap Tests > Magnet.

2. The Magnet Strip check box is selected by default. If you want the test to also
automatically record a strip showing non-magnet operation, select the Non-Magnet
Strip check box.

3. Select Strip Durations values for the automatically collected strips.

4. Tap START Test.

Note: If necessary, you can stop the Magnet test by tapping STOP Test.

5. Tap the Magnet Strip icon or the Non-Magnet Strip icon to view the collected strip in
the frozen strip viewer.

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4.7 Arrhythmia inductions with EP Study Tests

The system provides several electrophysiology study (EP Study) test functions that may be
used to induce arrhythmias in order to evaluate the effectiveness of tachyarrhythmia
therapies.

The available arrhythmia induction methods are 50 Hz Burst, Fixed Burst, and Programmed
Electrical Stimulation (PES).

Warning: Monitor the patient carefully when using an EP study function. Have an external
defibrillator ready for use when inducing any tachyarrhythmia. An induced tachyarrhythmia
may degenerate to ventricular fibrillation.

Considerations for inducing an arrhythmia

Telemetry – Ensure that there is a telemetry link between the device and the programmer

before performing an EP study function. Successful interrogation or programming confirms
proper communication between the device and the programmer.

Resuming detection – Tachyarrhythmia detection is automatically suspended during all EP
Study tests. If detection is manually suspended before the induction, it is not resumed
automatically when the induction is delivered. All EP study inductions provide the option to
resume detection automatically after the induction is delivered.

Select the check box for Resume at BURST or Resume at DELIVER to enable automatic
resume for an induction. To resume detection after a manual therapy or after an induction

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delivered with automatic resume disabled, tap Resume or remove the programming head
from the implanted device.

Aborting an induction or therapy – As a safety measure, the programmer displays an
ABORT button that may be selected to immediately abort any induction or tachyarrhythmia

therapy in progress. A burst induction may also be aborted by releasing the Press and Hold
button. When a manual therapy is delivered, the device automatically aborts any induction
or automatic therapy in progress.

Temporary parameter values – The EP study functions use test values that do not change
the programmed parameters of the device. The test values take effect when the induction or
therapy begins. After the induction or therapy, the device reverts to its programmed
parameter values for bradycardia pacing and tachyarrhythmia therapy.

Programming head buttons – The programming head buttons are disabled during the
following situations:

●

The Program button on the programming head is disabled during EP study inductions
and manual therapies. Use the appropriate button on the programmer screen to deliver
an induction or manual therapy.

●

The Interrogate button on the programming head is disabled during EP study inductions
only. Use the Interrogate button on the programmer screen to interrogate the device
while the EP study induction screen is active.

4.7.1 Inducing AT/AF with an atrial 50 Hz Burst

You can use a 50 Hz Burst to induce AT/AF by delivering a rapid burst of AOO pacing pulses
to the atrium.

You can specify the amplitude and pulse width of these pulses, but the pacing interval is fixed
at 20 ms.

You can also use an atrial 50 Hz Burst to manually treat AF episodes.

Warning: Monitor the patient carefully when using an EP study function. Have an external
defibrillator ready for use when inducing any tachyarrhythmia. An induced tachyarrhythmia
may degenerate to ventricular fibrillation.

Use the following steps to induce AT/AF with a 50 Hz burst:

1. Tap Tests > EP Study.

2. Tap 50 Hz Burst in the list of inductions and therapies.

3. Set up the test using the following options:

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Optional task Steps

Maintain automatic detection and therapy
during the test.

Treat the induced episode with a manual ther­apy.

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Select the Resume at BURST check box.

Clear the Resume at BURST check box, then
tap the Suspend button at the top of the
screen to prevent automatic detection.

4. Verify the displayed test values. If needed, select new test values by tapping the value
you wish to change.

Note: If you want to provide VOO Backup pacing during the pacing burst, select values
for VOO Backup.

5. Press and hold 50 Hz BURST Press and Hold. As long as you press and hold the
50 Hz BURST Press and Hold button on the programmer screen, the device
continues delivering the induction (up to a maximum of 10 s). Release the button to end
the induction.

Note: If necessary, tap ABORT to abort a therapy in progress.

4.7.2 Inducing AT or VT with Fixed Burst induction

You can use a Fixed Burst induction to induce AT or VT by delivering a set of asynchronous
AOO or VOO pacing pulses.

Warning: Monitor the patient carefully when using an EP study function. Have an external
defibrillator ready for use when inducing any tachyarrhythmia. An induced tachyarrhythmia
may degenerate to ventricular fibrillation.

The pacing pulses are delivered at a uniform, selectable interval to the designated chamber.
You can also specify the amplitude and pulse width of the pulses.

If you perform an atrial Fixed Burst induction, you may choose to have the device deliver VVI
Backup pacing. However, VVI Backup pacing during an atrial Fixed Burst induction may be
inhibited by crosstalk if the test value for atrial Amplitude is greater than 6 V.

Use the following steps to induce AT or VT with a Fixed Burst induction:

1. Tap Tests > EP Study.

2. Tap Fixed Burst in the list of inductions and therapies.

3. If the Chamber Selection window appears, tap Atrium or RV to select a chamber in
which to perform the test.

4. Set up the test using the following options:

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Optional task Steps

Maintain automatic detection and therapy
during the test.

Treat the induced episode with a manual ther­apy.

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SW030

Select the Resume at BURST check box.

Clear the Resume at BURST check box, then
tap the Suspend button at the top of the
screen to prevent automatic detection.

5. Verify the displayed test values. If needed, select new test values by tapping the value
you wish to change.

6. Press and hold Fixed BURST Press and Hold. Release the button to end the
induction.

Note: If necessary, tap ABORT to abort a therapy in progress.

4.7.3 Inducing AT or VT with a Programmed Electrical Stimulation (PES)

You can use Programmed Electrical Stimulation (PES) to induce AT or VT by delivering a
selectable number of pacing pulses and individually-selectable intervals.

Warning: Monitor the patient carefully when using an EP study function. Have an external
defibrillator ready for use when inducing any tachyarrhythmia. An induced tachyarrhythmia
may degenerate to ventricular fibrillation.

PES delivers a selectable number of pacing pulses at the S1S1 interval and then delivers up
to 3 asynchronous pacing pulses at S1S2, S2S3, and S3S4 intervals. You can specify the
chamber, amplitude, pulse width, and pacing intervals for the induction.

If you perform an atrial PES induction, you may choose to have the device deliver VVI Backup
pacing. However, VVI Backup pacing during an atrial PES induction may be inhibited by
crosstalk if the test value for atrial Amplitude is greater than 6 V.

Use the following steps to induce AT or VT with a PES:

1. Tap Tests > EP Study.

2. Tap PES in the list of inductions and therapies.

3. If the Chamber Selection window appears, tap Atrium or RV to select a chamber in
which to perform the test.

4. Set up the test using the following options:

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Optional task Steps

Maintain automatic detection and therapy
during the test.

Treat the induced episode with a manual ther­apy.

AZURE MRI™ SURESCAN™ / ASTRA MRI™ SURESCAN™

SW030

Select the Resume at DELIVER check box.

Clear the Resume at DELIVER check box,
then tap the Suspend button at the top of the
screen to prevent automatic detection.

5. Verify the displayed test values. If needed, select new test values by tapping the value
you wish to change.

6. Tap DELIVER PES. Release the button to end the induction.

Note: If necessary, tap ABORT to abort a therapy in progress.

4.8 Manual therapy

During EP testing, you can initiate tachyarrhythmia therapies manually from the
programmer.

Warning: Monitor the patient carefully when delivering a manual therapy. Have an external
defibrillator nearby and ready for immediate use. Potentially harmful tachyarrhythmias may
occur during device testing.

During follow-up appointments, manual therapies may be helpful in assessing therapy
effectiveness and making any necessary adjustments as part of chronic care. The available
manual therapies include Atrial Burst+, Atrial Ramp, Ventricular Ramp, Ventricular Burst,
and Ventricular Ramp+ pacing therapies.

Considerations for manual therapy

VVI Backup pacing inhibition by crosstalk – If the test value for Atrial Amplitude is greater

than 6 V, VVI Backup pacing during a manual atrial ATP therapy may be inhibited by
crosstalk.

Aborting an induction or therapy – As a safety precaution, you can select the ABORT
button displayed on the programmer to terminate any induction, manual therapy, or
automatic therapy in progress. When a manual therapy is delivered, the device automatically
aborts any induction or automatic therapy already in progress.

Detection suspended during manual therapy – Tachyarrhythmia detection is
automatically suspended when delivering a manual therapy. Detection stays suspended
until you tap Resume or the telemetry session between the programmer and device ends.

Temporary parameter values – The EP study functions use test values that do not change
the programmed parameters of the device. The test values take effect when the induction or

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therapy begins. After the induction or therapy, the device reverts to its programmed
parameter values for bradycardia pacing and tachyarrhythmia therapy.

Programming head buttons – The Program button on the programming head is disabled
during manual therapies. Tap the appropriate DELIVER button to deliver a manual therapy.

Telemetry – Ensure that there is a telemetry link between the device and the programmer
before performing a manual therapy. Successful interrogation or programming confirms
proper communication between the device and the programmer.

Operation of manual therapies

Manual ATP therapies deliver one sequence of the selected therapy. Each therapy provides
a set of adjustable parameters to apply during therapy delivery.

Atrial Burst+ pacing therapy – Manual Atrial Burst+ pacing therapy delivers the selected
number of initial atrial pulses, followed by up to 2 additional pulses in AOO mode. All of the
initial atrial pulses are delivered at the same pacing interval, which is determined as a
percentage of the atrial tachycardia cycle length using the selected %AA Interval value. If
the S1S2 option is selected, an additional atrial pulse is delivered at an interval determined
using the selected percentage. If the S2S3 Dec option is also selected, another atrial pulse
is delivered at an interval that is calculated by subtracting the selected decrement value from
the previous interval.

Atrial Ramp pacing therapy – Manual Atrial Ramp pacing therapy delivers the selected
number of pacing pulses to the atrium in AOO mode. The pacing interval for the first pulse of
the Ramp sequence is determined as a percentage of the atrial tachycardia cycle length
using the selected %AA Interval value. Each subsequent pulse in the sequence is delivered
at progressively shorter intervals by subtracting the selected interval decrement
(Dec/Pulse) from each pulse.

Ventricular Ramp pacing therapy – Manual Ventricular Ramp pacing therapy delivers the
selected number of pacing pulses in VVI mode. The pacing interval for the first pulse of the
Ramp sequence is determined as a percentage of the ventricular tachycardia cycle length
using the selected %RR Interval value. Each subsequent pulse in the sequence is delivered
at progressively shorter intervals by subtracting the selected interval decrement
(Dec/Pulse) from each pulse.

Ventricular Burst pacing therapy – Manual Ventricular Burst pacing therapy delivers the
selected number of pacing pulses in VOO mode. The pacing interval for the Burst sequence
is determined as a percentage of the ventricular tachycardia cycle length using the selected
%RR Interval value. The pulses within the sequence are delivered at the same pacing
interval.

Ventricular Ramp+ pacing therapy – Manual Ventricular Ramp+ pacing therapy delivers
the selected number of pacing pulses in VOO mode. The pacing interval for the first pulse of
the Ramp+ sequence is determined as a percentage of the ventricular tachycardia cycle

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length using the selected R-S1(%RR) value. The second pulse is delivered at an interval
determined using the selected S1S2(%RR) percentage. Any remaining pulses in the
sequence are delivered at the selected S2SN(%RR) percentage.

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4.8.1 Delivering a manual therapy

You can use manual therapies to provide backup therapy during EP testing and to assess
therapy effectiveness during follow-up appointments.

1. Tap Tests > EP Study.

2. Tap the desired manual therapy from the list of inductions and therapies.

3. If the Select Chamber window appears, tap Atrium or RV as appropriate.

4. If you want to treat the induced episode with a manual therapy, tap Suspend to prevent
automatic detection.

5. Accept the displayed test values or select new test values.

6. Tap DELIVER.

Note: If necessary, tap ABORT to terminate the manual therapy.

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Glossary

antitachycardia pacing (ATP) – therapies that deliver rapid sequences of pacing pulses to

terminate tachyarrhythmias.

AT/AF detection – feature that analyzes the atrial rate and its effect on the ventricular rhythm
to determine whether the patient is currently experiencing an atrial tachyarrhythmia.
Depending on programming, the device delivers a programmed sequence of atrial therapies
or continues monitoring without delivering therapy.

Burst pacing – manual antitachycardia pacing (ATP) therapy that delivers ventricular
pacing pulses with an interval that is a programmable percentage of the tachycardia cycle
length.

Burst+ pacing – antitachycardia pacing (ATP) therapy that delivers sequences of atrial
pacing pulses with an interval that is a programmable percentage of the tachycardia cycle
length, followed by up to 2 premature stimuli delivered at programmable intervals. With each
sequence of Burst+ pacing delivered, the device shortens the pacing interval by a
programmable interval.

Capture Management – feature that monitors pacing thresholds with daily pacing threshold
searches and, if programmed to do so, adjusts the pacing amplitudes toward a target
amplitude.

Cardiac Compass Trends – overview of the patient’s condition over the last 14 months with
graphs that display long-term clinical trends in heart rhythm, such as frequency of
arrhythmias, heart rates, and device therapies.

crosstalk – condition when pacing in one chamber is sensed as intrinsic activity in another
chamber.

Decision Channel annotations – annotations to stored and telemetered EGM that
document details about tachyarrhythmia detection operations.

device reset – automatic device operation to recover from a disruption in device memory
and control circuitry. Programmed parameters may be set to default reset values. This
operation triggers a device status indicator.

device status indicator – value recorded in device memory to signify a condition or
problem that may affect device operation and that requires attention.

electromagnetic interference (EMI) – energy transmitted from external sources by
radiation, conduction, or induction that may interfere with device operations, such as
sensing, or may potentially damage device circuitry.

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EOS (End of Service) – battery status indicator displayed by the programmer to indicate
that the device should be replaced immediately and that it may not operate per
specifications.

ERI (Elective Replacement Indicator) – battery status indicator for when replacement of
the device is recommended. Key device parameters are automatically switched. For
example, pacing mode switches to VVI and Lower Rate goes to 65 bpm.

event – a sensed or paced beat.

Flashback Memory – diagnostic feature that records the intervals that immediately

preceded tachyarrhythmia episodes or that preceded the last interrogation of the device and
plots the interval data over time.

Holter telemetry – telemetry feature that transmits EGM and Marker Channel data
continuously for a programmable number of hours, regardless of whether telemetry actually
exists between the device and programmer.

last session – refers to the last time the device was successfully interrogated before the
current interrogation. A session ends 8 hours after the last interrogation.

Marker Channel recording – a pacing system feature used to simplify ECG interpretation
by identifying pacing and/or sensing operations.

Mode Switch – feature that switches the device pacing mode from a dual chamber atrial
tracking mode to a nontracking mode during an atrial tachyarrhythmia. This feature prevents
rapid ventricular pacing that may result from tracking a high atrial rate and restores the
programmed pacing mode when the atrial tachyarrhythmia ends.

MR Conditional – an item that has been demonstrated to pose no known hazards in a
specified MR environment with specified conditions of use.

MRI SureScan – a feature that permits a mode of operation that allows a patient with a
SureScan system to be safely scanned by an MRI machine while the device continues to
provide appropriate pacing.

MVP (Managed Ventricular Pacing) – atrial-based pacing mode that is designed to switch
to a dual chamber pacing mode in the presence of AV block. The MVP feature is intended to
reduce unnecessary right ventricular pacing by promoting intrinsic conduction. The MVP
modes are AAIR<=>DDDR and AAI<=>DDD.

oversensing – inappropriate sensing of cardiac events or noncardiac signals. Examples
include far-field R-waves, T-waves, myopotentials, and electromagnetic interference.

pacing threshold – minimum pacing output that consistently captures the heart.

PVC (premature ventricular contraction) – a sensed ventricular event that directly follows

any other ventricular event with no atrial event between them.

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Quick Look II data – overview data summarizing the most important indicators of system
operation and the patient’s condition, including information about device and lead status,
pacing therapy, arrhythmia episodes, and system-defined observations.

Ramp pacing – antitachycardia pacing (ATP) therapy that delivers pacing pulses with
progressively shorter pacing intervals per pulse. Each sequence of Ramp pacing that is
delivered during a therapy includes an additional pacing pulse.

Ramp+ pacing – manual antitachycardia pacing (ATP) therapy that delivers ventricular
pacing pulses at programmable intervals that are based on percentages of the tachycardia
cycle length.

Rate Drop Response – feature that monitors the heart for a significant drop in rate and
responds by pacing the heart at an elevated rate for a programmed duration.

Rate Drop Response episodes data – feature that displays beat-to-beat data that is useful
in analyzing Rate Drop Response episodes and the events leading up to those episodes.

Rate Histograms – diagnostic feature that shows range distributions for a patient’s heart
rate.

Rate Response – feature that adjusts the cardiac pacing rate in response to changes in
sensed patient activity.

Remaining Longevity estimate – an estimate of remaining device longevity that is
displayed on the Quick Look II and Battery and Lead Measurements screens. On both
screens, this information includes a graphical display for easy reference and the estimated
number of years or months of remaining longevity. On the Battery and Lead Measurements
screen, the Minimum and Maximum number of years or months of remaining device
longevity are also provided.

Resume – programming command that reinstates automatic tachyarrhythmia detection.

RRT (Recommended Replacement Time) – battery status indicator displayed by the

programmer to indicate when replacement of the device is recommended.

sensed event – electrical activity across the sensing electrodes that exceeds the
programmed sensitivity threshold and is identified by the device as a cardiac event.

sensor rate – the pacing rate determined by the level of patient activity and the programmed
rate response parameters; this rate is adjusted between the Upper Sensor Rate and the
operating Lower Rate.

Suspend – programming command that temporarily deactivates the tachyarrhythmia
detection functions.

Ventricular Safety Pacing (VSP) – pacing therapy feature that prevents inappropriate
inhibition of ventricular pacing caused by crosstalk or ventricular oversensing.

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64 Programming Guide

Medtronic, Inc.

*M964376A001*

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Minneapolis, MN 55432
USA
www.medtronic.com
[phone]

Medtronic USA, Inc.

Toll-free in the USA (24-hour technical consultation for
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Technical manuals

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© 2016 Medtronic
M964376A001 C
2016-11-08