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ADAPTA® / VERSA® / SENSIA® / RELIA™
Family of implantable pulse generators
Pacemaker Programming Guide
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
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ADAPTA® / VERSA® / SENSIA® / RELIA™
Pacemaker Programming Guide
A guide to using a programmer with Adapta/Versa/Sensia/Relia pacemakers
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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.
Adapta, Capture Management, Intrinsic, Marker Channel, Medtronic, MVP, Paceart,
Quick Look, QuickLink, Relia, Sensia, SessionSync, TherapyGuide, Versa
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Contents
1 Introduction .......................................................... 7
1.1 Introduction ......................................................... 7
2 Using the programmer ................................................ 9
2.1 The display screen ................................................... 9
2.2 Setting up your programmer .......................................... 13
2.3 Streamlining implant and follow-up sessions with Checklist ............... 19
2.4 Connecting the programmer to skin electrodes .......................... 24
2.5 Positioning and using the programming head ........................... 25
2.6 Enabling emergency VVI pacing ...................................... 28
2.7 Recording an ECG strip .............................................. 29
3 Conducting a patient session ........................................ 32
3.1 Therapy and programmer features ..................................... 32
3.2 Automatically adapting parameters .................................... 33
3.3 Starting a patient session ............................................ 34
3.4 Proceeding with session tasks ........................................ 39
3.5 Interrogating the pacemaker .......................................... 43
3.6 Taking a quick look at pacemaker operation ............................. 44
3.7 Viewing Battery and Lead Measurements .............................. 48
3.8 Checking the present parameter settings ............................... 50
3.9 Viewing and programming patient information stored in the pacemaker ..... 52
3.10 Recording an ECG Strip of magnet operation ........................... 53
3.11 Checking the patient’s underlying rhythm ............................... 55
3.12 Printing reports ..................................................... 57
3.13 Saving or transferring session data .................................... 60
3.14 Ending a patient session ............................................. 64
4 Viewing the patient’s ECG and EGM traces ............................ 73
4.1 Viewing the ECG and other rhythm waveforms .......................... 73
4.2 Adjusting and arranging the waveform traces ............................ 77
4.3 Waveform strips .................................................... 87
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5 Collecting diagnostic data ........................................... 91
5.1 About diagnostic data collection ....................................... 91
5.2 Viewing the collected data ........................................... 94
5.3 Automatically collected data displays .................................. 96
5.4 Clinician-selected detailed data displays .............................. 111
5.5 Programming data collection options ................................. 121
5.6 Clearing data from the pacemaker .................................... 124
6 Evaluating parameter settings ....................................... 126
6.1 Measuring stimulation thresholds ..................................... 126
6.2 Determining a sensitivity setting ...................................... 144
6.3 Using temporary programming to evaluate parameter settings ............ 149
7 Programming pacemaker parameters ................................ 153
7.1 Programming parameters ........................................... 153
7.2 Using TherapyGuide to select parameter values ........................ 162
7.3 Saving/retrieving a set of parameter values ............................ 165
7.4 Retrieving Key Parameter History information .......................... 169
8 Rate Response setup ............................................... 171
8.1 Programming Rate Response parameters ............................. 171
8.2 Using Exercise test to verify Rate Response ........................... 172
9 Using the EP Studies function ....................................... 179
9.1 About the EP Studies function ....................................... 179
9.2 Starting the EP Studies function ...................................... 185
9.3 Setting up and executing a PES protocol .............................. 191
9.4 Setting up and executing a Burst protocol ............................. 194
9.5 Setting up and executing a VOO Burst ................................ 197
9.6 PES parameter definitions and values ................................. 198
9.7 Burst parameter definitions and values ................................ 201
Index ................................................................... 203
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1 Introduction
1.1 Introduction
The information in the Adapta/Versa/Sensia/Relia Pacemaker Programming Guide (PPG)
applies to the following Adapta/Versa/Sensia/Relia pacemakers:
●
Adapta ADDR01/03/06
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Adapta S ADDRS1
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Adapta L ADDRL1
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Adapta ADD01
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Adapta ADVDD01
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Adapta ADSR01/03/06
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Versa VEDR01
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Sensia SEDR01
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Sensia L SEDRL1
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Sensia SED01
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Sensia SESR01
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Sensia SES01
●
Relia REDR01
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Relia RED01
●
Relia RESR01
●
Relia RES01
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Relia REVDD01
1.1.1 How to use this guide
Product information about Adapta/Versa/Sensia/Relia pacemakers and the associated
software for the programmer is presented in two separate guides.
The Pacemaker Reference Guide (PRG) provides detailed information on the pacemakers.
The Pacemaker Programming Guide (PPG) contains instructions on how to use the
programmer and the programming software.
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1.1.1.1 About the Pacemaker Reference Guide
The Pacemaker Reference Guide (PRG) describes in detail how the pacemakers operate
and specifies the capabilities of the pacemakers. The PRG includes the following
information:
●
Describes the pacing modes, rate response options, special therapy features, telemetry
types, and data collection options. In some cases, guidelines are given on how to
configure the pacemaker operation.
●
Contains troubleshooting information for electrical and hemodynamic problems.
●
Specifies parameter and data collection capabilities, longevity projections, and
mechanical and electrical specifications.
●
Provides general warnings and cautions, potential interference sources, and general
indications for pacing.
●
Contains a glossary of terms.
1.1.1.2 About the Pacemaker Programming Guide
The Pacemaker Programming Guide describes how to program Adapta/Versa/Sensia/Relia
pacemakers using a programmer. The PPG presents the following information:
●
How to set up and configure the programmer.
●
How to start a patient session, use the various follow-up features during the session, and
properly end the session.
●
How to view and print the patient’s ECG and EGM waveform traces.
●
How to configure the pacemaker to collect diagnostic data and how to retrieve and view
this information.
●
How to measure stimulation thresholds and sensing levels.
●
How to use TherapyGuide to obtain suggested parameter values.
●
How to program parameter values and verify rate response parameters settings.
●
How to run EP Studies.
1.1.1.3 The Implant Manuals supplement these guides
For each pacemaker model in the Adapta/Versa/Sensia/Relia family, there is an implant
manual. The Pacemaker Programming Guide and the Pacemaker Reference Guide do not
specify which features apply to each individual pacemaker model. Refer to the applicable
implant manual for specific capabilities of individual models.
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2 Using the programmer
2.1 The display screen
The programmer display screen is an interactive device that not only displays information in
the form of both text and graphics but also functions as a control panel by displaying buttons
and menu options that you can select using the touch pen.
2.1.1 Features and conventions of the display screen
This section describes the features and conventions of the display screen. The Therapy
Parameters screen below shows the main elements of the typical screen.
Figure 1. Main elements of a display screen
1 Status bar
2 Live Rhythm Monitor window
3 Task area
4 Buttons
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5 Command bar
6 Active fields
7 TherapyGuide
8 Tool palette
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2.1.1.1 The status bar
The status bar at the top of the screen shows this information:
●
The current pacing mode
●
When any one of a number of test conditions is occurring
●
The pacemaker model
2.1.1.2 The Live Rhythm Monitor window
This window is a partial view of the full-screen display of ECG, Marker Channel, and
telemetered EGM waveform traces. You can expand this window to its full size by selecting
the small square button in the upper-right corner of the window or by selecting the [Adjust…]
button.
●
Heart rate and rate interval show if the programming head is positioned over the
pacemaker.
●
Annotations above the waveform trace show the point of programmed parameter
changes.
Figure 2. Live Rhythm Monitor window
1 Location of the square button
2 Location of the [Adjust…] button
The waveform trace or traces that show in this window depend on the selected task screen
and how traces have been arranged in the full-screen view. Refer to Section 4.1, “Viewing the
ECG and other rhythm waveforms”, page 73 for information about the Live Rhythm
Monitor.
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2.1.1.3 The task area
The portion of screen between the Live Rhythm Monitor window at the top and the command
bar at the bottom changes according to the task or function you select. The example in
Figure 1 shows the Therapy Parameters screen for programming pacemaker parameter
settings. This task area would appear much different if you selected, for example, the
Threshold Test Setup screen.
2.1.1.4 Buttons
Buttons like those shown below allow you to operate the programmer using the touch pen.
You can “press” a button by touching it with the tip of the touch pen.
Buttons may directly execute a command, such as the [PROGRAM] button, or they may
open a window that prompts another action. Usually such buttons have a label ending with
an ellipsis, such as the [Save…] or [Get…] buttons shown above.
A procedure may instruct you to “press and hold” a button. In such cases you should touch
the tip of the touch pen to the button and continue to maintain pressure against the button
until it is time to “release” the button.
2.1.1.5 The command bar
The bar at the bottom of the screen always shows the command buttons for programming
emergency parameters settings, interrogating the pacemaker, and ending the patient
session.
For complete information on these functions, see Section 3.5, “Interrogating the
pacemaker”, page 43, Section 2.6, “Enabling emergency VVI pacing”, page 28, and
Section 3.14, “Ending a patient session”, page 64.
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2.1.1.6 Active fields
Unshaded areas, or boxes, that appear in the task area are active fields that respond to the
touch pen.
Selecting a value, word, name, or phrase that appears in an active field opens a menu or
window of alternative options for whatever is represented in that field.
For example, touching the mode value “DDDR” in the Mode field with the tip of the touch pen
opens a window of mode options. Selecting any one of these options replaces the original
DDDR value with the selected one, which becomes a pending value.
Selecting some fields (those with terms ending in an ellipsis, such as “Rate Response…”)
opens a window displaying additional fields. Some fields that require entry of information,
such as patient data, open an on-screen keyboard.
2.1.1.7 TherapyGuide
TherapyGuide offers a simple, clinically focused method to obtain suggested parameter
values. At implant or at an early follow-up appointment, information can be entered about the
patient’s clinical conditions. Based on those inputs, the programmer suggests parameter
values. The suggestions are based on clinical studies, literature, current practice, and
physician feedback.
For more information about TherapyGuide, see Section 7.2.
2.1.1.8 The tool palette
The collection of buttons and icons along the edge of the screen is referred to as the tool
palette. These are the controls you use to choose the task or function screen you want
displayed. Once you have started a patient session, the tool palette is always displayed,
making it quick and easy to move to the desired task or function.
Each of the icons acts like a button. To select an icon, touch the icon with the touch pen. The
< symbol adjacent to some of the icons indicates that selecting one of these icons opens a
menu of related options. The icons without the < symbol directly open a task screen.
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Table 1. Tool palette for the desktop
Tool Selecting the tool (button or icon)
Freezes a segment of the live rhythm display.
A frozen strip can be viewed and printed (but not saved) between patient sessions. Markers and EGM traces are not present between patient sessions.
Accesses the rhythm strips saved during the patient session.
No saved strips are available between patient sessions.
Opens a window of options for adjusting the Live Rhythm Monitor.
Additional adjustment options are present during a patient session.
Displays the Select Model screen. Use this screen to select a pacemaker model
and start a patient session.
Displays the Print Queue screen. Use this screen to select a printer and to print
or delete print jobs.
Displays the programmer setup options, including Preferences, Time and Date,
Artifact Detection, Software, Programmer Profile, Other Software, and Tools.
Starts an Analyzer session.
Note: When some functions are active on the display, selecting a tool button or icon will have
no effect. Closing the active window restores operation of the tool palette.
The tool palette for the desktop differs from the tool palette during a patient session. For a
description of the icons and buttons available during a patient session, see Section 3.3,
“Starting a patient session”, page 34.
2.2 Setting up your programmer
2.2.1 Adjusting the programmer time and date
If the time or date displayed and printed by the programmer is incorrect, use the following
procedure to enter the correct settings.
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Figure 3. Programmer time and date adjustment
1. Select Programmer > Preferences.
2. From the Programmer Time and Date screen, select the arrow buttons to increase or
decrease the value for the unit of time you want to change. Press and release the button
for single unit changes, or press and hold the button to effect greater changes.
Note: Time must be entered on the basis of a 24-hour clock, with 00:00 being midnight
and 12:00 being noon.
3. When all fields show the correct time and date, press the [Apply] button. Select another
tool palette icon to close the Programmer Time and Date window.
2.2.2 Using audible tones
Certain events in the operation of the programmer result in an audible signal. The following
tones alert the user to the success or failure of an action.
●
A two-tone beep (low-to-high) indicates confirmation of an Interrogate or a Program
command.
●
A single low-tone beep indicates that an Interrogate, Program, or Emergency command
was not confirmed. It may also indicate that the selected command cannot be executed.
●
A single, short beep coincides with pressing the Interrogate or the Program button. It
also occurs upon automatic identification of the pacemaker.
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2.2.2.1 How to turn the audible tones on or off
1. Select Programmer > Preferences.
2. From the Preferences screen, select the [Audio ON] or [Audio OFF] button as desired.
2.2.3 SessionSync
SessionSync provides network connectivity between the programmer and the Medtronic
Paceart data management system. By utilizing your clinic’s network, the programmer can
send downloaded device data through SessionSync to the data management system.
The SessionSync status icon and the SessionSync status screen provide information on the
connection status of the programmer to the data management system. Details about the
SessionSync icon and connection status are provided in Section 2.2.4.
You must configure the programmer’s network settings to allow for this data transfer.
See the programmer manual for instructions on connecting the Ethernet cable to the
network.
This section describes:
●
Configuring the SessionSync network connection
●
Disabling SessionSync
●
Viewing SessionSync status
●
States of the SessionSync Status icon
2.2.3.1 How to configure the SessionSync network connection
1. Select Programmer > SessionSync Network Configuration....
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Figure 4. SessionSync network configuration
2. Enter the Clinic Name.
3. Enter the IP address or hostname of the SessionSync Gateway.
4. Select [OK].
Note: If you do not have your SessionSync Gateway address, contact your clinic’s technical
support or Medtronic technical support.
2.2.3.2 How to enable or disable SessionSync
1. Select Programmer > Preferences.
2. Select SessionSync from the Index menu.
3. Select [Enabled] to enable SessionSync, or Select [Disabled] to disable SessionSync.
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Note: The SessionSync status icon will be grayed out when the feature is disabled.
SessionSync functions are not available within a patient session unless you have enabled
this feature prior to starting a patient session.
Figure 5. Session Sync preferences
2.2.3.3 How to view SessionSync status
The SessionSync Status screen displays information on the data files being transferred to
the data management system using SessionSync. Each status message includes the date,
time, and event information for the associated SessionSync event.
1. Select Programmer > SessionSync Status.
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Figure 6. SessionSync status
2. Select the [Update Status] button.
Note: SessionSync status does not dynamically update when the window is open. To update
it, select the [Update Status] button.
2.2.4 States of the SessionSync Status icon
For programmers configured with the SessionSync feature, the SessionSync Status icon
appears in the task bar. It indicates connectivity and transfer status of session data between
the programmer and the Medtronic Paceart data management system.
Refer to the programmer manual for complete information on this feature.
Figure 7. Parts of the SessionSync Status icon
1 Programmer status
2 Connection status
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The parts of the SessionSync Status icon change colors to indicate data ready for transfer,
a valid connection between the programmer and the data management system, and
successful data transfer to the data management system. Refer to Table 2 for details.
The Transfer Queue mentioned in the table is the list of session data files that have been
saved to the programmer’s hard disk but are waiting for transfer.
Note: When the whole icon is grayed out, SessionSync has been disabled under the
programmer preferences.
Table 2. SessionSync Status icon states
Part of SessionSync Status
icon Color What the color indicates
Programmer Gray No session data files in the Transfer Queue
Blue Session data files in the Transfer Queue
No valid connection between the program-
Connection Not visible
Green Valid connection between the programmer
Red circle with a
line through it
Data Management System Gray
Blue All session data has been successfully trans-
mer and the data management system
and the data management system
A device application in use that does not
support SessionSync
No session data has been transferred to the
data management system.
ferred to the data management system.
2.3 Streamlining implant and follow-up sessions with Checklist
Checklist allows you to catalog and list tasks that are performed during implant and follow-up
sessions. You start with the first task and continue through each task in sequential order.
When you select a task in the checklist, the programmer displays the screen associated with
the task. When you complete the task, you can either proceed directly to the screen
associated with the next task in the checklist or return to the checklist. Two standard
checklists are provided: the Medtronic Standard Implant checklist and the Medtronic
Standard Followup checklist. In addition to these standard checklists, you can create
customized checklists.
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2.3.1 How to select a checklist
1. Select the Checklist icon and review the tasks in the Task list for that checklist.
1
2. To choose a different standard or custom checklist, select the desired checklist from the
Checklist field.
2.3.2 How to use a checklist
1
When starting a new session, the checklist used during the last programming session becomes the active
checklist.
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1. To start using the checklist, select either [Go To Task] or the Checklist double-arrow [>>]
button.
2. Perform the selected task from the Task list.
●
To continue to the next task, select [>>] next to the Checklist icon.
●
To perform a task out of order or to repeat a task from the selected checklist, first
select the Checklist icon. Next, select the task from the Task list, and select either
[Go To Task] or [>>].
2
The Checklist screen displays check marks next to the names of any programmer screens
that were visited during a session. These check marks provide a general indication of the
tasks that were performed during a session.
2.3.3 How to create a custom checklist
1. Select the Checklist icon.
2. Select [New…] from the Checklist screen.
3. Select the tasks in the “Select from these tasks” box on the left to create a custom
checklist.
2
You can select a task whether it is marked with a check mark or not. If you perform the last task in a checklist, the
[>>] and the [Go To Task] buttons are inactive. You can still select an earlier task from the Checklist screen and
use [>>] to cycle through all the tasks that come after the task you selected.
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4. The selected tasks appear at the end of the checklist in the “Tasks in this checklist” box
on the right. Tasks can be added more than once to a custom checklist. To place a new
task in a position other than at the end of the checklist, highlight the task that the new
task should follow, and select the new task. The new task appears below the highlighted
task in the “Tasks in this checklist” box.
5. To delete a task, select the task in the “Tasks in this checklist” box and select [Delete
Task].
6. Select the “Checklist name” field, and enter a name for the checklist.
7. Select [Save].
2.3.4 How to edit a custom checklist
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1. Select the Checklist icon.
2. Select the custom checklist to edit.
3. Select [Edit…].
4. Select the tasks in the “Select from these tasks” box on the left to add new tasks to the
list in the “Tasks in this checklist” box on the right. Tasks can be added more than once
to a custom checklist.
5. Each selected task appears at the end of the edited checklist. To place a new task in a
position other than at the end of the edited checklist, highlight the task that the new task
should follow, and select the new task. The new task appears below the highlighted task
in the edited checklist.
6. To delete a task, select the task in the “Tasks in this checklist” box and select [Delete
Task].
7. To rename the edited checklist, select the “Checklist name” field, and enter a new name
for the list.
8. Select [Save].
2.3.5 How to delete a custom checklist
1. Select the Checklist icon.
2. Select the custom checklist that you want to delete from the Checklist menu.
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( ) = IEC coding
Labeled C on some cables
1
RA (R) LA (L)
V1 (C)
RL (N)
LL (F)
Medtronic ADAPTA® / VERSA® / SENSIA® / RELIA™
3. Select [Delete]. A window appears, asking you to confirm that you want to delete the
selected checklist.
4. Select [Delete] to delete the selected checklist or [Cancel] to cancel the delete
procedure.
Note: After a custom checklist is deleted it cannot be restored.
Note: The Medtronic Standard Followup and Medtronic Standard Implant checklists cannot
be edited or deleted, so [Edit…] and [Delete] are unavailable when these checklists are
selected.
2.4 Connecting the programmer to skin electrodes
At the start of a patient session, the programmer must be connected to skin electrodes on the
patient. The ECG display and measurement functions will not operate without detection of
the surface ECG signal.
Use an electrode lead to connect each skin electrode to the appropriate port on the ECG
cable. Typical electrode placement is shown below. Use standard procedures for attaching
disposable skin electrodes to the patient.
Figure 8. Connecting the programmer to skin electrodes
Refer to your programmer manual for more details on this procedure.
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2.5 Positioning and using the programming head
In many of the procedures described in the following chapters, you will be directed to position
the programming head over the patient’s implanted device.
2.5.1 When to position the programming head
During a patient session, properly position the programming head over the implanted device
before any of the following actions:
●
Selection of any command that initiates a programming transmission. The programming
head must be held in position until completion of the transmission, which is usually
indicated by a confirmation message.
●
Selection of any command that initiates data transmission from the implantable device.
The programming head should be held steady until data reception is complete, which is
usually indicated by a confirmation message.
●
Selection of a measurement function that requires the implantable device to be
operating asynchronously as a result of the programming head magnet.
For any temporarily programmed state or function or for reception of continuous data such
as Marker Channel telemetry or EGM waveforms, the programming head must be held in
place over the implanted device for the duration of the function or until termination is desired.
Lifting the programming head cancels a temporary program and terminates continuous
telemetry. The implantable device reverts to permanently programmed values.
Caution: Do not position the programming head over an implanted device during
electrocautery or defibrillation procedures.
2.5.1.1 How to position the programming head
The programming head must be properly positioned as described below to establish
telemetry with the device. An incorrectly positioned programming head can result in the
failure of a transmitted command and the loss of telemetry.
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Figure 9. Positioning the programming head
1. Hold the programming head directly against the patient’s skin with the face of the
programming head parallel to the implanted device.
2. Position the programming head so that the amber light in the light array goes out and
one or more of the green lights come on. Move the head a little in each direction to find
the position that lights the greatest number of green lights, indicating that telemetry has
been established with the device. This is the optimum position.
Figure 10. Light array indicator
1 Light array
2 Green
3 Amber/green
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2.5.2 Effect of the programming head on pacemaker operation
If model selection and application (software) loading are complete, positioning the
programming head over a pacemaker does not put the pacemaker in the magnet mode of
operation. The programmer automatically sends a Cancel Magnet command to the
pacemaker, which causes it to continue to operate as programmed.
An exception to this operation can occur if the programming head does not establish a
telemetry link with the pacemaker (because of strong electrical interference or because the
programming head is improperly positioned). In such cases, positioning the programming
head would result in magnet mode operation until a telemetry link is established. You can
easily verify the present pacing mode by observing the Status Line at the top of the screen.
Pacemaker operation returns to its programmed state about two seconds after you remove
the programming head from its position over the pacemaker.
2.5.3 Observing magnet mode operation
To observe magnet mode operation during a patient session, you must conduct the Magnet
test described in Section 2.7, “Recording an ECG strip”, page 29. Initiating the Magnet test
results in a Threshold Margin Test (TMT) and causes the pacemaker to operate in the
magnet mode.
Note: Before you select the pacemaker model, positioning the programming head over the
pacemaker results in magnet mode operation.
2.5.4 Program and Interrogate buttons
To initiate the Program and Interrogate commands, you have the option to use the on-screen
[PROGRAM] and [Interrogate] buttons or the Program [P] and Interrogate [I] buttons on the
programming head.
Figure 11. Alternative Program and Interrogate programming head buttons
1 [I] or Interrogate button
2 Light array
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Note: The [I] or [P] button on the programming head is active only when its counterpart is
displayed as an active button on the display screen.
2.5.5 Automatic interrogation at the start of a session
At the start of the session, the programmer automatically interrogates the patient’s
pacemaker for most of the data stored in the pacemaker. For this process, you must position
the programming head over the implanted device and hold it steady in place until the
interrogation is complete.
At the bottom center of the screen you will see an indicator showing the progress of the
interrogation. Because this interrogation retrieves most of the data stored in the pacemaker,
the process may take about a minute.
2.6 Enabling emergency VVI pacing
You can use emergency VVI pacing to quickly enable 70 bpm, high-output ventricular pacing
to restore ventricular support in an emergency situation.
2.6.1 Considerations for emergency VVI pacing
Parameter values – Emergency VVI pacing reprograms pacing parameters to emergency
settings. For a list of the emergency VVI parameter settings, see the implant manual for the
device. To terminate emergency VVI pacing, you must reprogram pacing parameters from
the Parameters screen.
2.6.2 How to enable emergency VVI pacing
1. During a patient session, establish telemetry with the device.
2. Press the red VVI button on the programmer to enable emergency VVI pacing.
Depending on your model of Medtronic programmer, the emergency VVI button is:
●
a mechanical red button to the left of the programmer screen, on the programmer
bezel.
●
a red button on the programmer button panel, above the programmer screen.
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Note: On all programmers, an [Emergency] button is implemented in the software and is
available on the display screen (see the following procedure for instructions regarding this
button).
How to enable emergency VVI pacing with the on-screen [Emergency] button –
Perform the following steps to enable emergency VVI pacing with the on-screen
[Emergency] button:
1. Establish telemetry with the device.
2. Select [Emergency].
3. Select OK when the Emergency Program – Successful pop-up window appears. The
parameters change automatically to the VVI mode.
2.7 Recording an ECG strip
At any time during a patient session, you can initiate a continuous, real-time ECG recording
by pressing the desired paper speed button.
Figure 12. Printer buttons on the programmer
1 50 mm/s
2 25 mm/s
50, 25, or 12.5 mm/s – Three buttons allow for selection of a desired paper speed for ECG,
Marker Channel telemetry, and EGM recording. Pressing a button selects the printer speed
and turns on the adjacent indicator light. Pressing a lit button stops the printout. The selected
paper speed is printed once along the top edge of the chart recording. Paper speed for text
printing is not affected by these buttons.
Paper advance – Pressing the paper advance button advances the printer paper to its next
perforation for tearing off.
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To stop the recording, press the same paper speed button again. Before you tear off the ECG
strip, press the paper advance button to advance the strip to a perforation.
2.7.1 About the ECG recording
Because the printed recording provides a higher resolution, it may show artifacts and events
that do not appear on the display.
Annotation of executed commands – Information on the ECG printout includes an
indication of when certain commands to the pacemaker occurred. When confirmation of the
command is received, the command name is printed at the appropriate point in the margin
above the waveform grid. A recording made during the use of the following test functions
shows the programmed test values as they are programmed: Magnet, Underlying Rhythm,
Threshold, Sensing, EP Studies, and Temporary.
Figure 13. Example ECG printout with Marker and EGM telemetry
1 Annotations
2 ECG trace
3 Marker telemetry
4 EGM telemetry
5 Telemetry from the programmer to the device
(programming the device)
6 Telemetry from the device to the programmer
(confirming the programming)
Marker Channel and EGM telemetry – If the programming head is positioned over the
patient’s pacemaker, the recording includes a trace or traces of the telemetry being received
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from the pacemaker. In this example, the patient’s ECG is accompanied by Marker and EGM
telemetry.
ECG and EGM trace adjustment – The ECG and EGM are recorded according to control
settings accessible from the Live Rhythm Monitor window on the programmer screen (see
Section 4.2, “Adjusting and arranging the waveform traces”, page 77). The ECG source
(Lead I, II, or III) and the EGM source are each selected using the button bars appearing with
each waveform trace.
Missing markers – A programming command or interrogation momentarily interrupts the
transmission of Marker Channel telemetry. This interruption may result in missing markers.
The point at which the command occurred is marked above the ECG trace by a down or up
arrow. The down arrow indicates a transmitted command from the programmer; the up arrow
indicates a telemetry response from the pacemaker.
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3 Conducting a patient session
3.1 Therapy and programmer features
3.1.1 Therapy features
Note: Certain features described in the beginning of this chapter are not offered by all
models in the Adapta/Versa/Sensia/Relia series. To find applicable features for a specific
model, refer to the Implant Manual for that pacemaker.
Atrial Preference Pacing – Atrial rhythm management feature that adapts the pacing rate
to slightly higher than the intrinsic sinus rate.
MVP (Managed Ventricular Pacing) – Promotes intrinsic conduction by reducing
unnecessary right ventricular pacing. MVP operates when the programmed mode is either
AAIR<=>DDDR or AAI<=>DDD.
Rate Response User Interface – Provides a graphical display to aid in programming rate
response. When Rate Profile Optimization parameters are programmed, rate response
undergoes an immediate change.
TherapyGuide – Provides a set of suggested parameter values based on patient conditions
that were identified by the physician. TherapyGuide does not replace a physician’s expert
judgment. The physician is free to accept, reject, or modify any of the suggested parameter
values.
3.1.2 Programmer features
Auto cancel magnet – Cancels the magnet automatically when you place the programmer
head over the pacemaker. With Magnet Test, you can view and record magnet operation.
Auto-interrogation – Occurs automatically at the start of a session. The programmer
automatically prints a report of the interrogated information unless this feature is turned off.
Checklist feature – You can advance quickly to the next task to be done in a patient session.
Clinicians can create custom checklists that streamline task selection in follow-up and
implant sessions.
Full page-size reports – You can choose to connect an external printer for printing full
page-size reports.
Live rhythm waveform display – You can quickly tailor a multiple-trace display of the
patient’s ECG, atrial and ventricular EGMs, and Marker Channel signals.
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Saved session data – You can save data from a session on a disk, which allows you to
import session data into a database or review it using Read From Media.
3.2 Automatically adapting parameters
This section lists some of the automatically adapting parameters:
●
Rate Profile Optimization
●
Automatic Implant Detection
●
Capture Management
●
Sensing Assurance
●
Lead Monitor
●
Search AV+
●
Automatic PVARP
3.2.1 Rate Profile Optimization
When Rate Profile Optimization is programmed On, the pacemaker can adapt ADL and
exertion rate response levels once each day by comparing the patient’s current sensor rate
profiles against a prescribed target rate profile. This feature is intended to provide automatic
and independent ADL rate response for moderate activities such as walking and daily
chores, and exertion rate response for vigorous exercise.
3.2.2 Automatic Implant Detection
The Automatic Implant Detection feature does the following:
●
It determines that the pacemaker has been implanted and that its leads are stable, and
it sets lead polarities.
●
At implant it initializes Sensing Assurance, Capture Management, Rate Response, MVP,
and diagnostic data collection.
3.2.3 Capture Management
The Atrial Capture Management and Ventricular Capture Management features check the
patient’s pacing thresholds at regular intervals. Using these threshold measurements, the
pacemaker can determine whether pacing pulses in that chamber are capturing the heart.
Optionally, it makes adjustments to the amplitude and pulse width parameters based on
these measurements.
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3.2.4 Sensing Assurance
The Sensing Assurance feature, when active for a specific chamber, allows the pacemaker
to change the sensitivity threshold for that chamber to track changes in the sensed
amplitude.
3.2.5 Lead Monitor
This feature monitors lead integrity by measuring and recording lead impedance. Optionally,
it can switch either lead (or both leads) from bipolar to unipolar polarity if lead impedance is
out of range.
3.2.6 Search AV+
The Search AV+ feature is intended to promote intrinsic ventricular activation in patients with
intact or intermittent AV conduction and prevent inappropriate therapy in patients without
conduction. Search AV+ is available for dual chamber pacemakers when the operating
mode is DDDR, DDD, DDIR, DDI, DVIR, DVI, or VDD. The pacemaker searches for the
patient’s intrinsic AV conduction time and adjusts the SAV and PAV intervals either longer or
shorter to promote intrinsic activation of the ventricles. When Rate Adaptive AV is active, the
pacemaker also adjusts the SAV and PAV intervals relative to the rate adaptive values. If the
pacemaker does not observe intrinsic ventricular activation during its periodic searches over
the course of a week, it turns off the Search AV+ feature.
3.2.7 Automatic PVARP
When automatic PVARP is programmed, the pacemaker determines a value for the PVARP
based on the mean atrial rate (which is an average of all A-A intervals except those starting
with an atrial sense or atrial refractory sense and ending with an atrial pace). When the
operating mode is DDDR, DDD, or VDD, automatic PVARP is intended to provide a higher
2:1 block rate by shortening the PVARP and SAV (if necessary) at higher tracking rates and
protect against PMTs at lower rates by providing a longer PVARP.
3.3 Starting a patient session
Because the programmer collects and stores data on a session-by-session basis, it is
important to correctly start and end each session. This section describes how to start a
patient session. To end a session, refer to Section 3.14, “Ending a patient session”,
page 64.
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3.3.1 The tool palette during a patient session
Table 3. Tool palette during a patient session
Tool Selecting the tool (button or icon)
Freezes a segment of the live rhythm display.
Accesses the rhythm strips saved since the start of the session.
Opens a window of options for adjusting the live rhythm display.
Displays the following options for retrieving information about the patient’s pacemaker and its operation and for setting up or clearing the data collection functions:
Quick Look II - Initial Interrogation
Graphs and Tables
Battery and Lead Measurements
Data Collection Setup/Clear
Displays the Therapy Parameters screen.
Displays the following pacing system test options:
Magnet
Underlying Rhythm
Threshold
Exercise
Sensing
Temporary
EP Studies
Displays the following options for printing and saving generated reports:
Available Reports
Print Queue
Displays the following options for entering patient information:
TherapyGuide
Patient Information
Key Parameter History
Displays the following options for setting session preferences and saving session data to a diskette or to a USB flash drive:
Preferences
Save To Media…
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3.3.2 Starting a session with the [Find Patient…] button
Figure 14. Select Model screen
1 Task bar
2 Live Rhythm Monitor window
3 Task area
4 Buttons
5 Tool palette
1. With the Select Model screen displayed, position the programming head over the
patient’s pacemaker, and continue to hold it steady.
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Notes:
●
If the programmer is not operating, turn it on. If there is telemetry with the device,
then the session starts and the device is interrogated. (Skip Step 2.) If there is no
telemetry with the device, then after a short self-test sequence, the Find Patient
screen is displayed. Select [Cancel] to display the Select Model screen.
●
If the programmer is operating, but the Select Model screen is not displayed, select
the Select Model icon from the tool palette at the side of the screen.
●
If the Select Model icon is not in the tool palette, the previous patient session was
not ended properly. Refer to Section 3.14, “Ending a patient session”, page 64.
●
If the Select Model screen does not look like the example above, check that the
programmer is on the Medtronic desktop.
2. Select the [Find Patient…] button at the bottom of the screen.
After 40 to 50 s of internal software loading, the programmer displays the first task screen.
Continue to hold the programming head in place until the initial interrogation process is
100% complete.
Refer to Section 3.4, “Proceeding with session tasks”, page 39 for information on selecting
the functions or tasks you have planned for the session.
3.3.3 About automatic interrogation
At the start of a patient session, the programmer automatically attempts to interrogate the
patient’s pacemaker to retrieve most of the data that might be needed during the session.
Note: To take advantage of this automatic interrogation, you must position the programming
head over the pacemaker and continue to hold it in place until the interrogation is complete.
Clinician-selected diagnostic data is not included in the initial interrogation. The programmer
interrogates that data when you choose to view the clinician-selected data on-screen or
when you select the [Interrogate…] button and ensure that the Collected Data check box is
selected on the Interrogate How Much? screen.
The interrogation time may take about a minute because of the amount of information stored
in the pacemaker. A status gauge at the bottom of the screen shows progress of the
interrogation. The [Stop] button lets you cancel the interrogation once it has started.
Note: Except for use of the [Emergency] button or the [Stop] button, you cannot proceed with
session activities until the initial interrogation is 100% complete.
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You can choose to stop interrogation by selecting the [Stop] button or lifting the programming
head before the process is complete. In this case, when data is needed, the programmer will
display a message prompting you to interrogate the pacemaker.
You also can manually interrogate the pacemaker at any time during the patient session (see
Section 3.5, “Interrogating the pacemaker”, page 43).
Warning messages – As a result of an interrogation, a warning message box may be
displayed. Examples of these include:
●
RRT/ERI (Recommended Replacement Time)
●
POR (Power On Reset) or Full Electrical Reset
●
Interrogation interrupted or unsuccessful
●
Lead warnings
You must acknowledge the message before proceeding with other activities. For an
RRT/ERI, POR, or lead message, you can attempt to clear them by following the instructions
in the message. Otherwise, you can close the message box and clear the condition later. For
more information about clearing these conditions, see Section 7.1, “Programming
parameters”, page 153.
3.3.4 Initial Interrogation Report
Following a successful interrogation, a report based on this interrogation is printed
automatically. Session preferences allow you to turn this function on or off. For more
information on session preferences, see Section 3.4, “Proceeding with session tasks”,
page 39). If the function is on, the same preferences allow you to choose whether or not to
include the Arrhythmia Summary and Permanent Parameters sections in the report.
Depending on the programmed status of the implanted pacemaker, this report can include
the following:
●
History (clinical conditions for TherapyGuide)
●
Patient/Pacemaker Information
●
Pacemaker Status
●
Last Measured Threshold
●
P and R-Wave Measurements
●
Threshold Trend
●
Impedance Trend
●
Parameter Summary
●
Clinical Status
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●
Long Term Heart Rate Histograms
●
Pacing % counters
●
Event counters
●
High Rate Episodes Summaries
●
Arrhythmia Summary, including:
– High Rate Episodes Summaries
– V. Rate During Atrial Arrhythmias
– Atrial Arrhythmia Durations
– Atrial Arrhythmia Trend
●
All Permanent Parameters
3.4 Proceeding with session tasks
After you begin a patient session, a short period of internal software loading occurs before
the first task screen appears.
3.4.1 The first task screen
The first task screen to appear is the Quick Look II screen. See Section 3.6, “Taking a quick
look at pacemaker operation”, page 44 for more information.
3.4.2 Selecting another task or function
To proceed with the session, select the desired task or function from the button and icon
options grouped along the edge of the screen. This group of buttons and icons is referred to
as the “tool palette.” It is always available (except during the execution of certain functions)
so that you can quickly and easily display a desired task or function screen.
Note: When some functions are active on the display, selecting a tool button or icon will have
no effect. Closing the active window restores operation of the tool palette.
3.4.3 Consider using Checklist
During a follow-up session, you can use the tool palette to select tasks or functions in any
order as you proceed through the session. However, if you use a particular follow-up routine
or protocol, you can configure and use the Checklist feature to streamline the session. For
more information, see Figure 1, page 9.
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With Checklist, you can advance quickly to each successive task in a follow-up session. You
also can create custom checklists that can be used for task selection during an implant
procedure.
3.4.4 Verifying or changing session preferences
At the start of a patient session, or anytime during the session, you can select the Session
icon to access preference settings that apply to printing reports and viewing waveform traces
during test procedures. Preference settings are saved and will not be canceled when the
session ends.
3.4.4.1 Printing preferences
Printing preferences let you set up how reports are printed when you select the [Print…]
button. You can choose to have the setup window show each time you select the [Print…]
button or have the [Print…] button immediately print the report or send it to the print queue.
You can also enable or disable the printer Trace Mode. With the Trace Mode enabled, the
programmer prints programmed variables and their values.
3.4.4.2 How to set up printing preferences
Figure 15. Printing preferences screen
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1. Select Session > Preferences.
2. Select the check box for “Pop up these options when any Print button is selected” as
follows:
●
If a check mark appears, the print setup window will appear each time you select the
[Print…] button.
●
If there is no check mark, the [Print…] button immediately prints the report or
transfers it to the print queue.
3. Select the Number of copies field to change the number of report copies to be printed.
Options are 1 to 4 copies.
4. Select the desired Printer (Full Size or Programmer Strip).
●
Full Size requires that a compatible, external printer be connected to the
programmer.
Caution: Select the printer field and choose the appropriate printer. The selected
printer type must be compatible with the input requirements of the connected
printer.
●
Programmer Strip prints reports on the programmer’s strip chart printer.
5. Select the desired Print report option (Now or Later from Print Queue).
●
Now: The report prints immediately when you select the [Print…] button.
●
Later from Print Queue: Selecting the [Print…] button sends the report to the print
queue. For information about the Print Queue”, see Section 3.12, “Printing reports”,
page 57.
6. Select the check box for “Print continuously (Trace Mode)” as follows:
●
If a check mark appears, the programmer prints programmed variables and their
values. The data in this case is not printed in a report format.
●
If there is no check mark, the programmer does not print automatically.
3.4.4.3 Initial Report preference
The Initial Report preference lets you choose whether or not an initial interrogation report is
automatically printed at the start of each patient session following a successful interrogation.
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3.4.4.4 How to select your Initial Report preference
Figure 16. Initial Report preferences screen
1. Select the Initial Report option in the Preferences window.
2. Select the check box for “Always print at session start” as follows:
●
If a check mark appears, the programmer automatically prints the initial
interrogation report.
●
If there is no check mark, the programmer does not automatically print the initial
interrogation report.
3. Use the additional check boxes to select whether the initial report will include an
Arrhythmia Summary or Permanent Parameters or both.
3.4.4.5 Tests preference
The Tests preference lets you choose how waveform traces are displayed during a selected
follow-up test. You can choose whether the live rhythm display automatically displays the
EGM for the heart chamber being tested (atrium or ventricle) or does not change the
arrangement of the rhythm traces.
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3.4.4.6 How to select your preference for the trace display
Figure 17. Tests preferences screen
1. Select the Tests option in the Preferences window.
2. Choose the desired option (“Switch EGM to match selected test chamber” or “Do not
change waveform arrangement”).
3.5 Interrogating the pacemaker
At the start of the patient session the programmer performs an automatic interrogation to
retrieve most of the information stored in the pacemaker.
You can also manually interrogate the pacemaker at any time during the patient session. In
some cases, a pop-up window may request that you do so.
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3.5.1 How to interrogate the pacemaker
Figure 18. Interrogate How Much? screen
1. Select the [Interrogate] button at the bottom center of the screen or press the
Interrogate [I] button on the programming head.
2. From the window of options, select the type of information you want to retrieve. You can
select more than one option.
Collected data can be interrogated only once during a patient session. The word
“(AGAIN)” indicates that a previous interrogation has already retrieved this data.
3. Position the programming head and select the [Start] button or press the programming
head Interrogate [I] button.
Hold the programming head steady until the interrogation is 100% complete as shown
by the status gauge at the bottom of the screen. The [Stop] button lets you cancel the
interrogation.
3.6 Taking a quick look at pacemaker operation
Quick Look II provides a summary or overview of pacemaker operation by displaying the
essential information on one screen. This data was retrieved during the initial interrogation of
the session.
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3.6.1 Quick Look II screen
The Quick Look II screen appears automatically when you start a patient session or when
you choose to display it.
Figure 19. Pacemaker information on the Quick Look II screen
1 Remaining longevity
2 Threshold
3 Impedance
4 More...
5 Mode/Lower Rate/Upper Track Rate
6 % Pacing
7 Observations
Note: Each QuickLink [>>] button on the screen provides a direct link to diagnostic data
related to information displayed next to the button.
3.6.2 Viewing data on the Quick Look II screen
The Quick Look II screen displays the following information and information access options.
Remaining Longevity – This is an estimate of the time in years or months remaining until
pacemaker replacement is required. This estimate is based on the programmed parameter
settings and events recorded by the pacemaker since the last patient session. Note the
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following explanation of the longevity estimates, which you can view by selecting the
information icon next to the “Remaining Longevity” heading.
Threshold Trend – The graph shows the average weekly atrial and ventricular pacing
thresholds over the last year. If Capture Management is enabled, the last measured
threshold is shown in the box to the right of the graph. To view detailed Automatic Capture
Management data, select the QuickLink [>>] button. For more information about Capture
Management Trends, see Section 5.3, “Automatically collected data displays”, page 96.
Impedance Trend – The graph shows the average weekly atrial and ventricular measured
impedances over the last year. The lead impedances measured during initial interrogation
are shown in the box to the right of the graph. To view detailed Lead Impedance Data, select
the QuickLink [>>] button. For more information about Impedance Trends, see Section 5.3,
“Automatically collected data displays”, page 96.
P Wave – If Atrial Sensing Assurance is on, this shows the current P Wave amplitude range
measured by the pacemaker within the last week. To view detailed P Wave Amplitude trend
data, select the QuickLink [>>] button. For more information about P Wave Amplitude Trend,
see Section 5.3, “Automatically collected data displays”, page 96.
R Wave – This shows the current R Wave amplitude range if Ventricular Sensing Assurance
is on. To view detailed R Wave Amplitude trend data, select the QuickLink [>>] button. For
more information about R Wave Amplitude Trend, see Section 5.3, “Automatically collected
data displays”, page 96.
Mode – This shows the currently programmed mode.
Lower Rate – This is the slowest rate at which pacing occurs during a mode’s basic
operation. In rate-responsive modes, in the absence of sensor-detected activity, the
sensor-indicated rate is equal to the programmed Lower Rate.
Upper Track Rate – This is the maximum rate at which the ventricle may be paced in
response to sensed atrial events in the DDDR, DDD, and VDD modes.
AT/AF – This shows the average number of hours each day in which atrial arrhythmia
episodes are occurring and the total percentage of patient time that is spent in atrial
arrhythmias. To view the Atrial Arrhythmia Trend, select the QuickLink [>>] button. For more
information about the Atrial Arrhythmia Trend, see Section 5.3, “Automatically collected data
displays”, page 96.
Pacing – Listed under this heading are the pacing and sensing event sequences applicable
to the programmed pacing mode (see Table 4). Shown is the percent of the total number of
heart beats (recorded since the last patient session) that occurred in each category.
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A message below the event sequences indicates whether the pacemaker was operating in
one of the following conditions between the previous session and the current session:
●
MVP On
●
MVP Off
●
Search AV+ On
Note: These messages are not changed by programming during the current session.
To view a recorded heart rate histogram, select the QuickLink [>>] button. For more
information about the histogram displays, see Section 5.3, “Automatically collected data
displays”, page 96.
Note: The data under the Pacing and the Observations headings show data collected by the
pacemaker since the last patient session. This data is automatically cleared from pacemaker
memory after the session has ended. After the data is cleared, it cannot be recalled.
Table 4. Event sequence categories
Dual chamber pacing modes (and ADI, ADIR, VDI, VDIR, VDD)
AS-VS Atrial Sense - Ventricular Sense
AS-VP Atrial Sense - Ventricular Pace
AP-VS Atrial Pace - Ventricular Sense
AP-VP Atrial Pace - Ventricular Pace
Single chamber pacing modes
Paced Atrial or Ventricular Pace
Sensed Atrial or Ventricular Sense
Observations – The information displayed in the field under this heading summarizes the
results of diagnostic data collection since the last patient session. This field lists the number
of significant events recorded by the various diagnostic monitoring functions (see Table 5).
To view a graph or table showing the details associated with an observation, select the event
and then select the QuickLink [>>] button. Refer to Section 5.2, “Viewing the collected data”,
page 94 for information about viewing the data recorded by the various monitoring
functions.
Table 5. Observation monitoring functions
Functions and criteria used for observation reporting
Atrial Lead Monitor Lead impedance outside Min/Max settings
Ventricular Lead Monitor Lead impedance outside Min/Max settings
Atrial High Rate Episodes One or more episodes detected
Ventricular High Rate Episodes One or more episodes detected
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Table 5. Observation monitoring functions (continued)
Functions and criteria used for observation reporting
Rate Drop Response Episodes One or more episodes detected
RRT/ERI Monitor Occurrence of RRT/ERI conditions
Electrical Reset Monitor Occurrence of reset conditions
Capture Management High ventricular or atrial threshold measurement
Abort threshold searches prior to RRT/ERI
Capture Management unable to run
3.7 Viewing Battery and Lead Measurements
By selecting the Battery and Lead Measurements screen, you can view information about
the pacemaker battery and the lead system based on real-time measurements and
calculations made at the time of pacemaker interrogation.
3.7.1 Battery and Lead Measurements screen
The information on this screen provides a detailed status of the pacemaker battery and the
output conditions pertaining to the pacing lead system.
Figure 20. The Battery and Lead Measurements screen
Note: The values measured for the pacemaker battery and the lead system can change from
one measurement to the next.
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3.7.2 Pacemaker Battery and Lead Measurements
The Battery and Lead Measurements screen displays the following information.
Battery Status – Displays an “OK” or “Replace Pacer” message based on battery voltage
and internal impedance measurements. Included below the battery status message is the
date of pacemaker implant, which is based on the most recent operation of the Implant
Detect function.
Remaining Longevity – This is a calculated estimate of the time remaining until pacemaker
replacement will be required. This calculated estimate is based on the programmed
parameter settings and event data accumulated by the pacemaker since the previous
patient session.
For an on-screen explanation of the longevity estimates, select the information button
appearing after the “Remaining Longevity” heading.
Caution: Pacemaker replacement should not be based on the estimated remaining
longevity. For this decision, use only the RRT/ERI (Recommended Replacement Time) or
the “Replace Pacer” battery status message.
Battery Voltage/Current/Impedance – These values show the measured pacemaker
battery voltage, the present current drain on the pacemaker battery averaged over a pacing
cycle, and the battery’s impedance.
Atrial and Ventricular Leads – Lead information includes the following:
Amplitude The measured amplitude of a pacing pulse
Pulse Width Present programmed pulse width setting
Output Energy Output energy contained in a single pacing pulse
Measured Current The measured current in the pacing lead during delivery of a pacing pulse
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Measured Impedance
Pace Polarity The present lead electrode configuration (unipolar or bipolar) used for pacing
The measured electrical impedance presented by the pacing lead and electrode/tissue interface
3.7.3 Updating the displayed data
You can update the data shown on the screen by the following interrogation procedure.
1. Position the programming head and hold it in place.
2. Select the [Measure Again] button.
As indicated by the pop-up window, the interrogation and measurement process takes a few
seconds.
3.8 Checking the present parameter settings
The first step to viewing the parameter settings to which the patient’s pacemaker is presently
programmed is to display the Therapy Parameters screen shown below.
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3.8.1 Therapy Parameters screen
This screen is used to view permanent parameters or to program them to the desired
settings.
Figure 21. The Therapy Parameters screen
The parameter values displayed on this screen are the parameter settings to which the
patient’s pacemaker is presently programmed. If the field for a parameter or option displays
an ellipsis (for example, Rate Response…), there are subordinate parameters that are not
displayed on this screen.
For more information and a table of subordinate therapy parameters, see Section 7.1.5,
“How to program subordinate parameters”, page 157.
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3.9 Viewing and programming patient information stored in the pacemaker
Pacemakers can store patient-related information that you can view and print during a
patient session. This information typically is programmed into the pacemaker at the time of
implant, but it can be revised at any time.
When you select the patient’s clinical conditions (Age and History) and program them into
pacemaker memory, they are available to the TherapyGuide feature. Refer to Section 7.2,
“Using TherapyGuide to select parameter values”, page 162.
Note: Selecting Patient > TherapyGuide displays the Therapy Parameters screen with the
TherapyGuide window opened.
Figure 22. Viewing the Patient Information screen
3.9.1 How to program patient information
1. On the Patient Information screen, select the data field in which you want to enter or
change the data.
This action displays selectable options or the on-screen keyboard for entering data.
2. Select the desired information option, or type the desired information, and then select
the [Enter] button on the on-screen keyboard.
3. Repeat steps 1 and 2 for any field to which you want to add, delete, or change the data.
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4. To define the patient’s clinical conditions, which are made available to TherapyGuide,
take the following actions:
●
Select the data field for Age, and select the patient’s Age range.
●
Select the History field to open the History window. Select the appropriate clinical
conditions, and Select [OK].
5. When you have finished, position the programming head and press the [PROGRAM]
button.
This action programs into the pacemaker all the data as it is presently displayed on the
Patient Information screen.
3.10 Recording an ECG Strip of magnet operation
Positioning the programming head does not cause the pacemaker to operate in its magnet
mode. To record or view magnet operation, you must use the Magnet test.
3.10.1 Magnet Test Setup screen
From the Magnet Test Setup screen, you can start and stop magnet operation in the
pacemaker. Options let you collect an ECG strip of magnet operation and, if desired,
non-magnet operation.
Figure 23. Magnet Test Setup screen
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.
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3.10.2 Procedure for conducting a Magnet Test
1. Display the Magnet Test Setup screen (see Figure 23).
2. To start magnet operation, position the programming head and select the
[START Magnet] button.
Observe that the live rhythm display shows the point at which magnet operation begins
(“DOO, 85 bpm” for example). At this point, the pacemaker performs a Threshold
Margin Test.
If you have chosen to collect an ECG strip (see Section 3.10.3), a pop-up window shows
progress during the collection process. Select the [Stop Collection] button if you want
to stop the ECG collection before it completes. Selecting this button does not stop
magnet operation.
3. To stop magnet operation, select the [STOP Magnet] button.
A pop-up window gives you the option to collect an ECG strip of non-magnet operation.
Select [Yes] to collect a non-magnet strip or select [No] to close the window.
3.10.3 Collecting an ECG strip
The programmer automatically collects an ECG strip during the Magnet test unless you
cancel this option.
●
A check mark appearing in the Magnet Strip check box indicates that a strip will be
collected. This is the default status when you open the screen.
●
To change the length of the strip, select the time field and choose the collection time you
desire.
●
If you do not want automatic strip collection, select the Magnet Strip check box to clear
the check mark.
3.10.4 About the collected ECG strips
If you have chosen to collect a Magnet strip or both a Magnet and Non-Magnet strip, the
strips are stored by the programmer for viewing and printing. A Magnet Strip (and
Non-Magnet Strip) icon appears at the bottom of the screen to indicate when strips are
available for viewing and printing.
To view a collected ECG strip, select the Magnet Strip icon or the Non-Magnet Strip icon near
the bottom of the screen. Refer to Section 4.3, “Waveform strips”, page 87 for information
about using the strip viewing feature and about printing waveform strips and reports.
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To print a Magnet Test report, select the [Print…] button and then choose the desired printing
options.
3.11 Checking the patient’s underlying rhythm
To evaluate a patient’s underlying rhythm or determine the patient’s intrinsic heart rate, use
the Underlying Rhythm test.
Caution: The use of this test function is intended for diagnostic and test purposes. It should
be used only under conditions of careful patient monitoring and control.
3.11.1 Underlying Rhythm Test screen
The Underlying Rhythm Test screen provides the following means for evaluating the patient’s
underlying rhythm:
●
the Inhibit test
●
the Manual Rate Decrease test
Figure 24. Underlying Rhythm Test screen
Note: At any point during use of the Underlying Rhythm test, lifting the programming head
away from the site of the patient’s pacemaker for at least 2 s will restore normal pacemaker
operation. In the event of a programmer malfunction or loss of power, lift the programming
head immediately.
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3.11.2 Procedure for checking the patient’s underlying rhythm
Note: The Inhibit mode shuts off pacemaker output for the test duration.
3.11.2.1 How to check underlying rhythm using Inhibit
1. Display the Underlying Rhythm Test screen (see Figure 24).
2. To stop the output of pacing stimuli:
a. Position the programming head.
b. Press and hold the [INHIBIT Press and Hold] button.
Pacemaker blanking periods are shortened during this test to increase the period
during which cardiac events can be sensed.
3. To restore pacing, release the [INHIBIT Press and Hold] button.
3.11.2.2 How to check underlying rhythm using manual rate decrease
1. Display the Underlying Rhythm Test screen (see Figure 24).
2. Choose the desired test pacing mode and the starting value for Lower Rate:
a. Select the Mode field to display the test mode options.
b. Select the test pacing mode from the options displayed.
c. Select the arrow buttons to adjust the Test Value for Lower Rate to a setting close to
the patient’s present pacing rate.
3. Select the [START Test] button to engage the test mode and rate.
4. Select the down arrow button to gradually decrease Lower Rate until the patient’s
underlying rhythm emerges. (Select the up arrow button to increase Lower Rate as
desired.)
5. To end the test, select the [STOP and Restore] button.
3.11.3 Collected ECG strips
During either type of Underlying Rhythm test, the programmer automatically collects and
saves a 10 s ECG strip. A Test Strip icon appears near the bottom of the screen (after the test
has ended) to indicate its availability.
To view a collected ECG strip, select the Test Strip icon near the bottom of the screen. Refer
to Section 4.3, “Waveform strips”, page 87 for information about using the strip viewing
feature and about printing waveform strips and reports.
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To print an Underlying Rhythm Test report, select the [Print…] button and then choose the
desired printing options.
3.12 Printing reports
You can print the data generated during a patient session using the [Print…] button or by
opening the Available Reports window. You can also print reports that are being held in the
print queue.
3.12.1 Using the Print button
On most task screens, the [Print…] button appears or becomes active as soon as the
execution of a task or function generates the data needed for a report. Selecting the [Print]
button allows you to print a formatted data report associated with the current task. The
[Print…] button appears near the bottom of all task screens except the Parameters screen.
On the Parameters screen, a Print icon appears instead of a [Print] button.
Depending on the Session preference settings (see Section 3.4.4), selecting the [Print…]
button (or the Print icon) does one of the following:
●
Immediately initiates printing of the associated report.
●
Sends the report to the print queue to be printed later.
●
Opens the Print Options window shown below.
For information about session preferences and print options, see Section 3.4, “Proceeding
with session tasks”, page 39.
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Figure 25. Print Options window
3.12.2 Printing from the Available Reports window
During a patient session, the programmer automatically generates and saves the following
reports:
●
The Initial Interrogation report
●
The Final report
●
Reports generated by the use of the Tests functions.
Note: If a test function is used more than once, a report for only the most recent use is
available.
●
Device Memory report (This is a special report intended for use only by Medtronic
technical support personnel.)
At any time during the session, you can view the list of reports that are available for printing,
and select the ones you want to print immediately or save in the print queue for printing later
in the session or after the session has ended.
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3.12.2.1 How to print from the list of Available Reports
Figure 26. Available Reports window
1. Select Reports > Available Reports.
2. From the displayed list of available reports, select the report you want to print.
3. Select the [Print…] button.
3.12.3 Printing reports held in the Print Queue
Whenever you request a report by selecting the [Print…] button, control of the print job is
passed on to the print queue.
By displaying the Print Queue window, you can check the status of any print job and either
print or delete those print jobs that are being held. All print jobs held for printing are displayed
and up to 25 print jobs already printed are reported.
Note: When you end a patient session, the print queue is still available. It lists any reports
held from that session and other previous sessions.
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3.12.3.1 How to print or delete reports from the Print Queue
Figure 27. Session Print Queue window
1. Select Reports > Print Queue.
2. From the list of reports, select the report you want to print or delete.
Caution: Once deleted, a report cannot be recovered.
3. Select the button for the desired action:
●
Select [Print] to print the report.
●
Select [Delete] to delete the report from the Print Queue Report list.
3.13 Saving or transferring session data
Any time during a patient session, you can save data from the session on a diskette or on a
USB flash drive. If you are using a programmer that is configured with SessionSync, you can
also transfer session data from the programmer to a Medtronic Paceart data management
system.
The saved data is listed in Table 6. Saved session data can be reloaded on the programmer
for analysis.
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Table 6. Saved session data
Feature name Information exported
Therapy Parameters Initial interrogated values
Last programmed values
Patient Information Last programmed values
Battery and Lead Measurements Last measured values
Threshold Tests
Sensing Tests
Exercise Test Results for the last test conducted
Automatic Diagnostics Event Counters
Device Memory Retrieved from interrogation performed only for sav-
a
Manual test results are saved only if you have saved the results.
a
a
Last results for each test type conducted (for each
chamber tested)
Last results for each test type conducted (for each
chamber tested)
Atrial High Rate Episodes
Ventricular High Rate Episodes
Mode Switch Episodes
Rate Drop Response Episodes
ing session data
3.13.1 How to save session data on a diskette
The diskette drive is functional only when no USB flash drive is inserted in the programmer.
When no flash drives are inserted, the diskette indicator is green to indicate that the diskette
drive is available for use. Inserting a diskette allows all session data and PDF file saving
operations to take place on the diskette.
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1. Select Session > Save To Media… to display the Save To Media window.
Note: The SessionSync... menu selection appears only on programmers that have the
feature enabled.
Note: A similar procedure allows you to save session data when ending a patient
session, but it requires that you end the session immediately after doing that. For more
information, refer to Section 3.14, “Ending a patient session”, page 64.
2. Insert a 90 mm (3.5 in) computer diskette into the disk drive on the right side of the
programmer. Use a formatted diskette that is IBM-compatible.
3. Position the programming head and select the [Start] button from the Save To Media
window.
This initiates an interrogation and then starts the transfer of data to the media. The
programming head must be held in position until the interrogation is complete.
Depending on the amount of session data being saved, this process may take several
minutes. A gauge on the screen indicates the progress of the data transfer to the media.
Note: If the diskette is full, the programmer will notify you that you need to insert a
different diskette.
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4. When the transfer of data is complete, remove the media from the programmer.
The programmer automatically assigns a unique file name so that it cannot overwrite
any existing session file. To determine which file was saved for a particular session, use
an IBM-compatible computer to view the media file directory. The directory lists the date
and time each file was created.
Optionally, you can continue with the patient session after saving the data.
3.13.2 How to save session data on a USB flash drive
When a USB flash drive is inserted in the programmer, the diskette drive becomes
unavailable. Diskettes may be used when no USB flash drive is inserted.
Any operation that normally uses a diskette to read or write data (such as saving session
data, reloading session data, or saving reports to a PDF file) uses a USB flash drive if it is
inserted.
Insert only one writable flash drive at a time. Inserting additional flash drives results in an
error during data-saving operations. This condition is indicated by the USB indicator being
grayed out.
Notes:
●
While a Save to Media action is in progress, the progress indicator and the message
“Saving Session…” are displayed. The progress indicator displays the completion
percentage. Before removing the flash drive, wait a few seconds after the progress
indicator shows 100%.
●
To ensure the integrity and security of patient information, you should use a flash drive
that is reserved for storage of programmer data.
A USB flash drive should be inserted only if the programmer is powered on. Insert a writable
USB flash drive in the programmer using any available USB port. A slight delay may occur
while the flash drive is authorized. The USB indicator on the task bar will turn green to
indicate that the USB flash drive is available for use, and the diskette icon will become grayed
out to indicate that the diskette drive is not available.
Flash drives should not be inserted or removed during the following operations:
●
programming a device
●
saving data to or reading data from a diskette
●
saving a report as a PDF file
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3.13.3 How to transfer session data with Manual SessionSync
1. Select Session > SessionSync….
Notes:
●
SessionSync may have been disabled outside the patient session. If so,
SessionSync… is not listed in the Session menu, and the SessionSync Status
icon is grayed out.
●
Refer to Section 3.14, “Ending a patient session”, page 64 for a similar procedure
that allows you to transfer session data automatically. After transferring the data,
you must end the session immediately.
2. The following window opens. Interrogation starts automatically.
3. The same window shows the progress of session data being saved automatically on the
programmer’s hard disk after successful interrogation.
The programmer side of the SessionSync Status icon turns blue after the data has been
saved on the programmer’s hard disk.
If the subsequent transfer is successful, the data management system side of the
SessionSync Status icon turns blue.
Refer to Section 2.2.4 for more details about its indications.
Note: If error messages appear during the data transfer process, refer to Table 7.
3.14 Ending a patient session
Note: Before you end a patient session, print a copy of the session data in case the session
data is accidentally cleared without first being saved to media. For more information, refer to
Section 3.12.
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Note: The pacemaker will be unresponsive to the application of a magnet for one hour
following the use of a programmer unless the session is ended with the command option to
immediately clear data collected in the pacemaker. The default command for ending a
session allows the pacemaker to retain collected data for one hour, during which use of a
magnet has no effect. See Section 3.14.4.
Because the programmer collects and stores data on a session-by-session basis, it is
important to correctly end a session when you finish. You should not begin using the
programmer with a different patient until you have completed the procedure described in this
section.
Note: If the programmer detects a serial number that is different from the one acquired
during the initial interrogation, it will automatically end the current session.
Once you end a session, you can still access the Print Queue window to print reports from
the session. Prior to ending the session, you have the following options:
●
Save the session data on a diskette.
●
Save the session data on a USB flash drive.
●
Transfer session data using SessionSync (if using a configured programmer)
●
Change the way the pacemaker clears collected data.
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3.14.1 How to end a patient session
1. Select the [End Session…] button in the command bar at the bottom of the screen. The
End Session window is displayed.
2. Note the “Warnings!” field at the top of the End Session window. It informs you of any
action you should take or any information you should know before you end the session.
To return to the session, select the [Cancel] button.
3. Before ending the session, consider the options available from the End Session
window.
●
To save the session data on a diskette, see Section 3.14.2.1.
●
To save the session data on a USB flash drive, see Section 3.14.2.2.
●
To transfer session data using SessionSync (using a configured programmer), see
Section 3.14.3
●
To change the settings for how collected data is cleared from the pacemaker when
you end the session, see Section 3.14.4.
To accomplish any of these tasks, proceed to its appropriate procedure. Do not select
the [End Now] button in step 4.
4. To end the session now and return to the Select Model screen, select the [End Now]
button.
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3.14.2 Saving session data
Before you end a patient session, you can save data from the session on a diskette or USB
flash drive. For a list of the data saved, see Section 3.13. Saved session data can be
reloaded on the programmer for analysis. For information about reloading session data, refer
to Section 3.13.
3.14.2.1 How to save session data on a diskette
Note: When using this procedure, you must end the patient session after saving session
data on a diskette. If you choose to initiate the save by selecting the Session icon, you can
continue the session (see Section 3.13).
1. Insert a 90 mm (3.5 inch) computer diskette into the disk drive on the right side of the
programmer. Use a formatted diskette that is IBM-compatible.
2. From the End Session window (see Section 3.14.1), select the [Save To Media…]
button.
Note: If the diskette is full, the programmer will notify you that you need to insert a
different diskette.
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3. Position the programming head and select the [Start] button from the Save To Media
window.
This initiates an interrogation and then starts the transfer of data to the diskette. The
programming head must be held in position until the interrogation is complete.
Depending on the amount of session data being saved, this process may take several
minutes. A gauge on the screen indicates the progress of the data transfer to the
diskette.
Note: After session data has been saved, you can change the options for clearing data
(see Section 3.14.4). However, you cannot cancel the End Session sequence and
return to the session.
4. When the transfer of data is complete, select the [End Now] button to end the patient
session. Remove the diskette from the programmer.
Note: The programmer automatically assigns a unique file name so that it cannot
overwrite any existing session file. To determine which file was saved for a particular
session, use an IBM-compatible computer to view the diskette file directory. The
directory lists the date and time each file was created.
3.14.2.2 How to save session data on a USB flash drive
Note: When using this procedure, you must end the patient session after saving session
data on a flash drive. If you choose to initiate the save by selecting the Session icon, you can
continue the session (see Section 3.13).
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1. Insert a USB flash drive in the programmer.
2. From the End Session window (see Section 3.14.1), select the [Save To Media…]
button.
3. Position the programming head and select the [Start] button from the Save To Media
window.
This initiates an interrogation and then starts the transfer of data to the USB flash drive.
The programming head must be held in position until the interrogation is complete.
Note: After session data has been saved, you can change the options for clearing data
(see Section 3.14.4). However, you cannot cancel the End Session sequence and
return to the session.
4. When the transfer of data is complete, select the [End Now] button to end the patient
session.
Note: The programmer automatically assigns a unique file name so that it cannot
overwrite any existing session file. To determine which file was saved for a particular
session, use an IBM-compatible computer to view the contents of the flash drive. The
directory lists the date and time each file was created.
3.14.3 Transferring session data using Automatic SessionSync
SessionSync provides network connectivity between the programmer and the Medtronic
Paceart data management system.
Interrogated data is first saved to the programmer’s hard disk. When a connection to the data
management system is established using SessionSync, the interrogated information is sent
to the data management system.
The programmer can be configured to transfer device data to the data management system
automatically.
Refer to Section 2.2, “Setting up your programmer”, page 13 for configuration options.
Note: SessionSync may have been disabled outside the patient session. If so, the Automatic
SessionSync check box does not appear in the End Session window, and the SessionSync
Status icon is grayed out.
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3.14.3.1 How to transfer session data with Automatic SessionSync
1. Select [End Session…].
2. Select [End Now].
3. The following window opens, and interrogation starts automatically.
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4. The same window shows the progress of session data being saved automatically on the
programmer’s hard disk after successful interrogation.
The programmer side of the SessionSync Status icon turns blue after the data has been
saved on the programmer’s hard disk.
If the subsequent transfer is successful, the data management system side of the
SessionSync Status icon turns blue.
Refer to Section 2.2.4 for more details about its indications.
Note: If error messages appear during the data transfer process, refer to Table 7.
Table 7. SessionSync error messages
Error Message What this means
Ending a Session without Automatic SessionSync
Interrogation Required You must conduct an interrogation before starting a SessionSync
Data Transfer Failed The data cannot be transferred to the data management system.
You have deselected the Automatic SessionSync check box on
the End Session window before selecting the [End Now] button.
data transfer for this device.
Select [OK] to close the window.
The session data has been successfully saved on the programmer’s hard disk but cannot be transferred to the data management
system.
Select [Retry] to retry SessionSync operation.
- or Select [Cancel] to close the window.
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Table 7. SessionSync error messages (continued)
Error Message What this means
Unable to Save Session Data The session data cannot be saved on the programmer’s hard disk.
Select [Save to Disk…] to save the session data on a diskette.
- or Select [End Now] to end the session without saving the device
data.
- or Select [Cancel] to close the window without saving the device
data.
Interrogate - Unsuccessful The programmer cannot interrogate the device. You must repo-
sition the programming head.
Select [Retry] after repositioning the programming head.
- or Select [Cancel] to close the window.
3.14.4 Clearing pacemaker data
By default, the diagnostic data collected in the implanted pacemaker is cleared one hour
after you end a patient session. Collection of new data then starts. You can restart a session
within one hour of ending it and still retrieve the collected data. Alternatively, you can select
Now in the Clear Data window to clear the collected data and start collection of new data
immediately when you end the session and lift the programming head. For more information,
see Section 5.6, “Clearing data from the pacemaker”, page 124.
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4 Viewing the patient’s ECG and EGM traces
4.1 Viewing the ECG and other rhythm waveforms
During a patient session, the programmer continuously displays the patient’s ECG (or other
selected waveform trace) in the Live Rhythm Monitor window at the top of the screen.
On the programmer, the size of the window automatically changes between a dual-trace size
and a triple-trace size.
The instructions on the following pages describe how you can:
●
Expand the monitor window to its full-screen size.
●
Adjust the size, position, and color of the waveform traces.
●
Choose a different sweep speed, display pacing artifacts or turn them off, and engage an
interference filter.
●
Program pacemaker telemetry to a different EGM mode.
4.1.1 Expanding the Live Rhythm Monitor window
To view all of the available waveform traces, you can expand the Live Rhythm Monitor
window to its full size with the touch of a button. The expanded screen covers the task area
of the current screen.
To expand the monitor window to its full size, select the square button in the upper-right
corner of the partial-view window. This action expands the Live Rhythm Monitor window to
its maximum size.
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Figure 28. Live Rhythm Monitor window - expanded view
To return to the partial-view window, select the minimize button in the upper-right corner of
the full-view window. This action collapses the monitor window to its previous size and
displays the task screen as it was prior to expanding the monitor window.
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Figure 29. Live Rhythm Monitor window - partial view
4.1.2 About the waveform traces
The programmer can display the traces described in Table 8. The ECG Leads (I, II, and III)
are always available if the ECG leads are connected. Marker Annotation and Marker
Intervals are displayed if the programming head is positioned over the pacemaker.
The telemetry modes for the traces are programmable. For information about changing
telemetry modes, see Section 4.2, “Adjusting and arranging the waveform traces”,
page 77.
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Figure 30. Waveform trace breakdown
The traces in Figure 30 are shown in a separated fashion for the purpose of explanation.
Typically, the Marker Annotation and Marker Intervals traces are superimposed on an ECG
or EGM trace to facilitate interpretation. Refer to Section 4.2, “Adjusting and arranging the
waveform traces”, page 77.
Note: A programming command or interrogation momentarily interrupts the transmission of
marker annotations. This interruption can result in missing markers on the trace display.
Table 8. Waveform trace information
Trace Description
ECG Lead I
ECG Lead II
ECG Lead III
Marker Annotation
ECG signals are detected via skin electrodes attached to the patient. The
programmer must be connected to these electrodes with the ECG cable
as described in Section 2.4, “Connecting the programmer to skin electrodes”, page 24.
a
Marker annotations depict pacemaker operation by showing events as
they occur within the pacemaker. These annotations, which are coded as
shown below, are intended to facilitate ECG interpretation. The typical
position of the Marker Annotation trace is superimposed on an ECG trace.
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Table 8. Waveform trace information (continued)
Trace Description
Dual Chamber Models
AP - Atrial pace
AS - Atrial sense
AR - Atrial sense during refractory
VP - Ventricular pace
VS - Ventricular sense
VR - Ventricular sense during refractory
Other Markers
TP - Triggered pace (AAT or VVT pacing mode)
MS - Mode Switch episode (marks the beginning and end)
ER - Error marker (indicates a marker signal that could not be decoded)
Marker Intervals
Programmable Trace
(Telemetry Mode)
a
Since these traces depend on telemetry received from the pacemaker, they are not displayed unless the
programming head is positioned over the pacemaker.
a
The programmer automatically measures the interval between pace and
sense markers and displays these intervals (in milliseconds) as one of the
traces. For dual chamber and ADI, ADIR, VDI, and VDIR modes, the trace
displays the A–V interval and the V–V interval. For single chamber modes,
the trace displays the A–A or V–V interval depending on the chamber
being paced.
The Telemetry Mode feature lets you program the pacemaker to transmit
one of the following types of EGM signals to be displayed in the Live
Rhythm Monitor window:
- Atrial EGM
- Ventricular EGM
- Dual EGM
- Summed EGM
Note: The Telemetry Mode feature is not available when the pacemaker is
at RRT/ERI (Recommended Replacement Time). Also, the Telemetry
Mode feature can be programmed Off.
Single Chamber Models
P - Pace
S - Sense
SR - Sense during refractory
4.2 Adjusting and arranging the waveform traces
A button bar associated with each waveform trace (Figure 31) and the viewing options
displayed when you select the [Adjust…] button (Figure 33) provide the controls for tailoring
the Live Rhythm Monitor window.
4.2.1 Changing trace size, source, and print status
The button bar appearing below the source title of each waveform trace provides controls for
adjusting the waveform size, selecting the trace source, and choosing whether or not the
trace will appear on the printed chart recording.
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Figure 31. Waveform trace adjustment buttons
1 Increases waveform size
2 Returns waveform to its default size
3 Decreases waveform size
4 Displays options for selecting the trace
source
5 Indicates the 2 waveform traces selected for
printing (chart recorder)
4.2.1.1 Adjusting trace size (amplitude)
1. To increase or decrease the size (or amplitude) of the trace waveforms, select the up or
down arrow on the associated button bar. ECG and EGM traces can be adjusted by a
maximum of 4 steps.
2. To return the waveform trace to its default size, press the Return button (the button
labeled 2 in Figure 31).
4.2.1.2 Changing the trace source
You can change the order in which traces appear in the monitor window. One method is by
changing the “source” of one or more of the traces as described below. You also can use the
touch pen to “drag” a trace to the desired location as described on Section 4.2.9.
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4.2.1.3 How to change the source of a displayed trace
1. Select the trace source button from the associated button bar.
Note: Traces may be superimposed on one another. For example, as shown below,
both ECG Lead II and Marker Annotation sources make up a single composite trace.
The name of only one source appears at the left edge of the screen.
To display the name of the other source, “tap” the trace name at the left edge of the
screen. It will change to show the source of the other trace. The source name of the
trace you want to change must be displayed.
2. Select the desired source from the drop-down menu of Source options.
The trace for the newly selected source now appears in place of the previously
displayed trace. If the monitor window is fully expanded, you will see that the original
trace and the selected trace have switched positions on the screen.
Note: You can also rearrange the trace positions on screen by dragging the traces with
the touch pen. Refer to Section 4.2.9.
4.2.1.4 Selecting traces to be printed by the chart recorder
Initiating a continuous trace recording on the programmer chart recorder results in a printout
of Marker Channel telemetry and 2 waveform traces based on selections made as described
below. Only ECG and EGM traces can be selected for printing.
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4.2.1.5 How to select an ECG or EGM trace to print
Figure 32. Buttons to enable and disable trace printing
1. Select the printing enabled button next to the print-enabled trace that you do not want
to print. This disables printing for that trace.
2. Select the printing disabled button next to the trace you want to print. This enables
printing for that trace.
4.2.2 Displaying additional adjustment options
The Adjust window contains additional controls that let you tailor the Live Rhythm Monitor to
your specific needs. Once certain display attributes have been adjusted, the programmer
will maintain these settings from one patient session to another.
To open the Adjust window, select the [Adjust…] button near the top of the tool palette. This
action:
●
Expands the Live Rhythm Monitor window (if it is not already expanded)
●
Displays options for changing the trace color coding
●
Opens the Adjust window (see Figure 33).
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Figure 33. Live Rhythm Display and Adjust window
Instructions in the following sections describe using the trace color options and each of the
options in the Adjust window.
Table 9. The Adjust window options
Clipping Select this check box to truncate the tops and bottoms of waveform traces
at a 22 mm boundary (see Section 4.2.4). A check mark indicates that this
option is selected.
ECG Filter Select this check box to turn the ECG filter on or off. A check mark indicates
that the filter is on (see Section 4.2.5).
Show Artifacts Select this check box to enable or disable the pacing artifact enhancement
function. A check mark indicates that the function is enabled (see Section 4.2.6).
Sweep speed Select the Sweep speed field to display options for changing the sweep
speed (see Section 4.2.7). Sweep speed options are 12.5, 25, 50, and
100 mm/s.
Telemetry mode Select the Telemetry Mode field to display options for programming the type
of waveform telemetry transmitted by the device (see Section 4.2.8).
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Table 9. The Adjust window options (continued)
Normalize Select this button to equalize the trace spacing and to adjust the size of each
trace to the default setting.
Calibrate Select this button to calibrate the external device connected to the Analog
Output.
OK Select this button to close the Adjust window.
4.2.3 Color coding the waveform traces
The Live Rhythm Monitor with the Adjust window open provides options for color coding the
displayed traces as described below.
1. Select [Adjust…] to open the Adjust window.
2. Select the color field for the trace you want to change.
3. Select the desired color from the drop-down menu of color options.
4.2.4 Enabling or disabling waveform clipping
The Clipping option in the Adjust window vertically truncates the waveform trace, allowing
you to limit the vertical space that a trace can occupy on the screen and on the chart
recording. With the Clipping option selected, the vertical space allotted to each trace is
22 mm on the screen and 25 mm on the printout. Waveforms that exceed this limit will be
“clipped” as shown below.
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Figure 34. Waveform Clipping option
To enable or disable waveform clipping, select the Clipping check box in the Adjust window.
A check mark indicates that the clipping option is enabled.
4.2.5 Using the ECG Filter option
In the presence of interference, the ECG filter may improve clarity of both the displayed and
printed ECG. The filter affects the ECG detection frequency bandwidth as follows:
●
Filter Off (no check mark) – Bandwidth = 0.05 to 100 Hz
●
Filter On (check mark) – Bandwidth = 0.5 to 40 Hz
To turn the ECG filter on or off, select the ECG Filter check box in the Adjust window. A check
mark indicates that the filter is turned on.
4.2.6 Enabling or disabling artifact enhancement
The Show Artifacts option allows you to enable or disable the artifact enhancement function,
which shows the position of each pacing stimulus on the ECG traces. To enable or disable
the Show Artifacts option, select the Show Artifacts check box in the Adjust window. A check
mark indicates that this function is enabled.
4.2.7 Selecting a different sweep speed
From the Adjust window, you can set the trace sweep speed to one of four settings: 12.5, 25,
50, and 100 mm/s. These sweep speeds apply only to the Live Rhythm Monitor display. The
default setting is 25 mm/s.
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1. Select the Sweep Speed field in the Adjust window.
2. From the drop-down menu of options, select the desired sweep speed.
4.2.8 Programming a different telemetry mode
In contrast to the traces that automatically appear in the Live Rhythm Monitor window (the
ECG, Marker Annotation, and Marker Intervals traces), the EGM trace can be programmed
to any one of the Telemetry Mode options (see Table 10).
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1. Position the programming head over the patient’s implanted device. Observe that
marker annotations are appearing on the screen.
2. Select the Telemetry Mode field in the Adjust window.
3. From the drop-down menu of options, select the desired EGM telemetry (see Table 10).
Table 10. Programmable telemetry modes
Atrial EGM The intracardiac signal detected in the atria by the atrial pacing lead
Ventricular EGM The intracardiac signal detected in the ventricle by the ventricular pacing
lead
Dual EGM Display atrial and ventricular EGM traces. Since the device transmits both
EGMs over a single telemetry channel in a “time-sharing” fashion, resolution
of the EGM signals in this case is reduced.
Summed EGM The atrial and ventricular EGM signals combined (added together) into a
single trace.
Off No EGM trace is displayed.
Note: For single-chamber models, the mode choices are EGM or Off.
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4.2.9 Arranging waveform traces using the touch pen
In addition to arranging waveform traces by selecting the source as described in
Section 4.2.1.3, you can use the touch pen to “drag” a trace to the desired position. The
procedure in the following example shows how to move the Marker Annotation trace from its
position over the ECG Lead II trace to a position over the Ventricular EGM trace.
1. First decide which trace you want to move. If the trace name is not displayed (Marker
Annotation in this case), tap the name of the superimposed trace to display the hidden
name.
2. Press and hold the touch pen against the name of the trace you want to move.
3. Without lifting the touch pen, drag the box now appearing around the trace name to the
desired location.
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4. When you have the box positioned where you want the trace to appear, lift the touch
pen. If you are positioning the trace over another, the trace will “snap” into position.
5. To equalize the spacing between the traces in the new arrangement, select the
[Normalize] button in the Adjust window.
4.3 Waveform strips
4.3.1 Freezing and analyzing a waveform strip
The Freeze feature enables you to “freeze” the last 15 s of all waveform traces that show in
the expanded monitor window. Selecting the [Freeze] button at the top of the tool palette
captures the previous 15 s of the trace signals and opens the frozen trace viewing window
shown below.
Figure 35. Freezing and analyzing a waveform strip
Controls below the viewing window include the caliper controls described on the next page
and the following buttons:
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[Adjust…] Select to open a window of waveform adjustment controls (see Section 4.3.1.3).
[Strips…] Select to view a list of other frozen waveform strips (see Section 4.3.2).
[Save] Select to save the waveform strip presently displayed (see Section 4.3.1.4).
[Delete] Select to delete a saved waveform strip. This button is active only if you are viewing
a saved waveform strip.
[Print…] Select to print the waveform strip presently displayed (see Section 4.3.1.5).
[Close] Select to close the frozen waveform viewing window. If you have not saved the
trace, a pop-up window will remind you to save or delete the trace.
4.3.1.1 Using the on-screen calipers
The control buttons shown below control the frozen trace viewing window by letting you move
each of the 2 vertical cursors appearing in the window to any desired position. The cursors
thus act as calipers allowing you to measure the time interval between events. The caliper
measurement is displayed in milliseconds in the upper-left corner of the window.
Figure 36. The on-screen calipers
To use the caliper positioning buttons, alternately press and release the appropriate button
to make small movements, or press and hold the button to make larger movements.
4.3.1.2 How to view other portions of the frozen waveform display
1. Use the vertical scroll bar to scroll the display up or down to view other waveform traces.
Tap the scroll arrows to scroll the traces up or down in small increments. The scroll box
shows the relative position of the window with respect to the total height of the strip.
Touch and drag the box to scroll the strip up or down.
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2. Use the horizontal scroll bar, which operates like the vertical scroll bar, to move the
display to the right or left to see other portions of the 15 s strip.
4.3.1.3 Adjusting the frozen traces
The button bar next to the trace source name provides options for adjusting the trace size
and selecting a different trace source. Selecting the [Adjust…] button opens the Adjust
window, which provides additional control options. In both cases, these are some of the
same controls available for the Live Rhythm Monitor window. Refer to Section 4.2, “Adjusting
and arranging the waveform traces”, page 77 for information about using the following Adjust
controls:
●
Using the button bar to adjust trace size or select a trace source
●
Using the waveform Clipping option
●
Selecting a Sweep Speed
●
Using the [Normalize] button
3
4.3.1.4 Saving a frozen waveform strip
You can save the frozen waveform strip you are viewing by pressing the [Save] button. You
may then recall the saved strip for viewing or printing later (see Section 4.3.2).
4.3.1.5 Printing the frozen strip
To print a frozen strip, select the [Print…] button near the bottom of the Frozen Strip window.
Depending on the Session preference settings, selecting the [Print…] button does one of the
following:
●
Immediately initiates printing of the selected strip.
●
Sends the strip to the print queue to be printed later.
●
Opens a window of print options.
For more information about session preferences, see Section 3.4, “Proceeding with session
tasks”, page 39.
3
Sweep Speed options for frozen traces are 12.5, 25, 50, 100, and 200 mm/s.
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4.3.2 Recalling and viewing waveform strips
Prior to ending the patient session, you can recall and view any waveform strip collected and
saved during the session. Such strips may be strips saved during a test such as the Magnet
test, Threshold test, or Underlying Rhythm test, or a strip saved during use of the Freeze
feature.
4.3.2.1 How to view a previously collected strip
1. Select the [Strips…] button that appears near the top of the tool palette or the [Strips…]
button in the lower-left corner of the Frozen Strip viewing window.
2. From the Other Strips window now displayed, select the Collected by programmer
option.
3. From the list of strips in the selection field, select the strip you want to view.
It may be necessary to use the scroll bar at the right side of the field if there are more than
five strips available.
4. Select the [Open] button.
For instructions on using the Frozen Strip viewing window, refer to Section 4.3.1.
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5 Collecting diagnostic data
5.1 About diagnostic data collection
To aid in the evaluation of pacemaker operation and delivery of pacing therapy, the
pacemaker records several types of information pertaining to the patient’s heart rate and
certain device operations. This recording process occurs automatically and continuously
during the period between patient sessions.
With the programmer, you can retrieve the recorded information and view it in a graphic
format. You can print the information in its graphic format, with or without a tabular summary
of the numerical data.
This chapter does not list the diagnostics that are offered by each specific pacemaker model.
To find applicable diagnostics for a specific pacemaker model, refer to the Implant Manual
for that pacemaker.
5.1.1 Automatic data collection
Once implanted, the pacemaker automatically records information for several types of data
displays, depending on the programmed pacing mode and the pacemaker model.
●
Patient’s Heart Rate (histogram and data format)
●
Patient’s AV Conduction Status (histogram and data format)
●
Search AV+ Histogram (histogram and date format)
●
Sensor Indicated Rate Profile
●
High Rate Episodes
●
Rate Drop Response Episodes
●
Atrial Arrhythmia Trend
●
Atrial Arrhythmia Durations (printed only, Initial Interrogation Report)
●
Ventricular Rate During Atrial Arrhythmias (histogram and data format)
●
Capture Management Trends
●
Sensitivity Trends
●
Lead Impedance (Chronic Trends and Impedance Data)
●
Key Parameter History
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5.1.2 Clinician-selected data collection
In addition to the automatically collected data, the clinician can choose to have the
pacemaker collect additional data by programming one option from the following list of
options:
●
Custom Rate Trend
●
Atrial Capture Management Detail
●
Ventricular Capture Management Detail
●
High Rate Detail
●
Rate Drop Response Detail
5.1.3 Important points about using the data function
5.1.3.1 Data collection is automatic
Data collection starts automatically at the time of device implant when the device detects the
presence of an acceptable lead impedance. Thereafter, data collection is automatic
throughout the life of the device. If Implant Detection is restarted, data collection is
suspended until implant detection is complete or programmed off.
5.1.3.2 Programmable setup options
The data types listed below have programmable options that allow you to make some
adjustments to the automatic data collection process. Refer to Section 5.5, “Programming
data collection options”, page 121.
5.1.3.3 Time and date notations
The time and date information that appears on the display or printout of the diagnostic data
is based on current settings of the programmer’s clock/calendar function. You can verify that
the programmer time and date are set correctly by selecting the [Freeze] button. The current
settings appear at the top of the strip viewing window. For instructions on setting the
clock/calendar function, see Section 2.2, “Setting up your programmer”, page 13.
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5.1.3.4 Effects of the programming head or a magnet
Data collection is suspended while the programming head or a magnet is positioned over the
implanted device. If data collection is suspended during an episode, the word “Suspended”
appears in the data listed for that episode. If a patient session has been initiated, data
collection is suspended until one hour after the patient session has ended. At this time
histogram and episode data are automatically cleared, and new data collection begins.
For trend data, a dashed vertical line indicates that data collection was suspended at that
time.
5.1.3.5 Automatically cleared diagnostics
The following diagnostics are always cleared automatically following each patient session:
histograms, episode data, sensitivity trend, and clinician-selected diagnostics. By default,
the data are cleared one hour after the end of the patient session, at which time collection of
new data begins. You can choose to start new data collection immediately upon ending the
session (see Section 5.6, “Clearing data from the pacemaker”, page 124).
Note: The minimum action that constitutes a patient session is interrogation of the device.
Note: Sensor Indicated Rate Profile data are cleared only when programming certain rate
response parameters or another rate responsive mode.
5.1.3.6 Manually cleared trend data
Certain types of trend data are not cleared automatically. Unless you choose to manually
clear these specific trends, collection occurs continuously as follows:
●
Chronic lead trend data are collected for the most recent 14 months and typically should
not be cleared unless the lead is replaced. Clearing the lead trend data for a particular
chamber (atrial or ventricular), clears both the Lead Impedance and Capture
Management Trend data for that chamber.
●
The Atrial Arrhythmia Trend can show up to the most recent 6 months of collected data.
See Section 5.6, “Clearing data from the pacemaker”, page 124 for information about
clearing trend data.
5.1.3.7 Effects of reaching RRT/ERI
Data collection stops when the device reaches RRT/ERI (Recommended Replacement
Time). Accumulated data can still be retrieved for viewing and printing. If the RRT/ERI
condition is reset, diagnostic data is cleared and data collection automatically resumes one
hour after the end of the programming session (or immediately, if programmed).
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5.1.3.8 Effect of an electrical reset
In the event of an electrical reset, all diagnostic data recorded before the electrical reset are
lost.
5.1.3.9 Sense events not included in data collection
Data collected for the Rate Histogram, AV Conduction Histogram, High Rate Episodes,
Search AV+ Histogram, and Ventricular Rate During Atrial Arrhythmias include ventricular
paces triggered by the Ventricular Safety Pacing feature. However, the ventricular sense
events that trigger these outputs are not included in the collected data. In the view of an
episode marker strip, for example, the triggering sense (VS) event is not shown, but the
resulting triggered pace is shown.
5.1.3.10 Using the Exercise Test and EP Studies functions
The use of these functions disables and clears data collected for the clinician-selected
diagnostic. You should interrogate the diagnostic data before using these functions. Once
interrogated, the collected data are available on the programmer throughout the patient
session but are lost when you end the session. You should view and print the collected data
before ending the session (seeSection 5.2, “Viewing the collected data”, page 94 ).
●
The procedure for using the Exercise Test includes a step that automatically restores the
data collection settings. If this step is not completed or is not successful, you must
reprogram the clinician-selected diagnostic on the Data Collection Setup screen (see
Section 5.5, “Programming data collection options”, page 121).
●
Conducting an Exercise test clears clinician-selected diagnostic data immediately from
pacemaker memory.
●
Using the EP Studies function clears clinician-selected diagnostic EGM data
immediately from pacemaker memory. The EGM type is set to Off after using the EP
Studies function.
5.2 Viewing the collected data
To display the options for viewing each of the automatically collected types of data, select the
Data icon and then the Graphs and Tables menu option, as shown below.
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Figure 37. Graphs and Tables screen
The range of data types that can be selected for viewing from this screen depends on the
pacemaker model, the programmed pacing mode, and the programmed option for Clinician
Selected data collection. See Section 5.3, “Automatically collected data displays”,
page 96 for more information.
5.2.1 Viewing procedure
From the Graphs and Tables screen, you can select the data you wish to view as follows (see
Figure 37):
1. Select the desired option from the list of Data Types.
2. Select the [Open Data] button.
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5.2.2 Viewing tools
Some data displays allow you to “zoom in” on a selected segment of the plotted data to show
more detailed information.
Figure 38. Viewing tools
Use the arrow buttons to position the zoom region over the data that you want to see in more
detail. These buttons also scroll the data if there is more data than can be displayed at one
time.
Select the Zoom In (+) icon to display details of the zoom region. Select the Zoom Out (–) icon
to return to the full data display screen. For some data displays, the details of the zoom region
are in the form of a recorded strip of event markers. On some screens, selecting the Zoom
In (+) icon has the same effect as selecting the Strip icon.
If applicable, select the Strip icon to display the collected EGM or strip of event markers.
5.3 Automatically collected data displays
5.3.1 Automatic data collection
●
Patient’s Heart Rate (histogram and data format)
●
Patient’s AV Conduction Status (histogram and data format)
●
Search AV+ Histogram (histogram and data format)
●
Sensor Indicated Rate Profile
●
High Rate Episodes
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●
Rate Drop Response Episodes
●
Atrial Arrhythmia Trend
●
Atrial Arrhythmia Durations (printed only, Initial Interrogation Report)
●
Ventricular Rate During Atrial Arrhythmias (histogram and data format)
●
Capture Management Trends
●
Sensitivity Trends
●
Lead Impedance (Chronic Trends and Impedance Data)
●
Key Parameter History
5.3.2 Heart Rate Histograms
5.3.2.1 Description
The Heart Rate Histogram shows at a glance the range of the patient’s heart rate (to a
resolution of 10 bpm) recorded since the last patient session and how the number of heart
beats counted during this period are distributed over that rate range. This histogram is
intended as an aid for evaluating rate response parameter settings and chronotropic
incompetence.
Figure 39. Ventricular Heart Rate Histogram
1 This rate group includes any events that occurred below 40 bpm.
2 This rate group includes any events that occurred above 180 bpm.
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5.3.2.2 Data collection and presentation
The Heart Rate Histograms can be displayed for two intervals of data collection:
●
Short-term heart rate histograms represent data collected over the last 3 to 6 days.
●
Long-term heart rate histograms represent data collected since the last follow-up.
Heart Rate Histograms indicate the percentage of rate events counted during the monitoring
period that fall into 10 bpm segment in the range from 40 bpm to 180 bpm (the “< 40” bpm
group also includes events occurring below 40 bpm; the “180 >” bpm group also includes
events occurring above 180 bpm). Each 10 bpm event group is coded to show the
percentage of paced events and the percentage of sensed events. See Figure 39 and
Figure 40.
Both atrial and ventricular histograms display the pertinent programmed parameter settings.
Ventricular histograms also display the recorded number of single PVCs and PVC runs. Atrial
histograms display the number of PAC runs.
For single-chamber pacemakers, Heart Rate Histograms data is available for the paced
chamber.
5.3.2.3 Atrial and ventricular histograms
If data were collected during device operation in a dual chamber mode (including ADIR, ADI,
VDIR, VDI, and VDD modes), both atrial and ventricular histograms can be viewed by
selecting the Histogram field at the top of the display (Figure 40).
Figure 40. Atrial Heart Rate Histogram
1 This rate group includes any events that occurred below 40 bpm.
2 This rate group includes any events that occurred above 180 bpm.
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5.3.2.4 Setup options
Data collection can be set to include or exclude refractory senses (events sensed during the
refractory period). See Section 5.5, “Programming data collection options”, page 121.
5.3.3 AV Conduction Histograms
5.3.3.1 Description
Like the Rate Histogram, the AV Conduction Histogram indicates the percentage of the total
number of heart beats counted since the last patient session occurred in each of the
displayed 10 bpm rate groups. The AV Conduction Histogram is available only if a dual
chamber mode (including ADIR, ADI, VDIR, VDI, and VDD modes) has been programmed.
Figure 41. AV Conduction Histogram
5.3.3.2 AV conduction sequence categories
Each 10 bpm rate group is coded to show the portion of the events in that group that fall into
the different AV conduction sequence categories. The AV conduction sequence categories
are as follows:
AS–VS Atrial Sense - Ventricular Sense
AS–VP Atrial Sense - Ventricular Pace
AP–VS Atrial Pace - Ventricular Sense
AP–VP Atrial Pace - Ventricular Pace
a
Sequences of AS-VP do not apply to the ADIR and ADI modes.
b
Sequences of AP-VS do not apply to the VDD, VDI, and VDIR modes.
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A rate group on the histogram that represents less than 5% of the counted events may be
coded to the AV sequence with the highest percentage of events.
Short-term AV conduction histograms represent data collected over the last 3 to 6 days.
Long-term AV conduction histograms represent data collected since the last follow-up.
Refer to the Adapta/Versa/Sensia/Relia Pacemaker Reference Guide for additional
information about collecting AV Conduction Histogram data.
5.3.4 Search AV+ Histogram
The Search AV+ Histogram data is automatically collected when Search AV+ is programmed
On. A Search AV+ Histogram shows the percentage of the following intervals versus rate in
every rate range:
●
A–VS: AV sequences ending in a ventricular sense within the programmed paced AV or
sensed AV interval.
●
VS from Search: AV sequences ending in a ventricular sense due to the extension of the
AV interval by Search AV+.
●
A–VP: AV sequences ending in a ventricular pace.
Search AV+ Histogram data can be displayed from the Graphs and Tables screen.
Refer to the Adapta/Versa/Sensia/Relia Pacemaker Reference Guide for additional
information about collecting Search AV+ Histogram data.
5.3.5 Sensor Indicated Rate Profile
The Sensor Indicated Rate Profile records the rate that is derived from activity sensor
operation. Because this diagnostic shows the measured sensor rate profile, it aids in
evaluating the Rate Profile Optimization feature. It indicates the percentage of time spend in
individual rate ranges.
Rates are recorded in 10 bpm ranges from 40 bpm to 180 bpm. Rates outside this range are
recorded in 2 additional ranges. Rates below 40 bpm are counted in the lowest range. Rates
above 180 bpm are counted in the highest range.
The Sensor Indicated Rate Profile can be accessed from the Graphs and Tables screen.
100 Pacemaker Programming Guide
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