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ATTESTA MRI™ SURESCAN™ / SPHERA MRI™
SURESCAN™ SW043
Programmer software
Pacemaker Programming Guide
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
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ATTESTA MRI™ SURESCAN™ / SPHERA MRI™
SURESCAN™ SW043
Pacemaker Programming Guide
A guide to programming the Attesta MRI SureScan and Sphera MRI Surescan pacemakers
using the Medtronic SW043 application software on a Medtronic programmer.
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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, Attesta, Capture Management, Marker Channel, Medtronic, MVP, Quick Look, Relia,
Sensia, Sphera, SureScan, TherapyGuide, Versa
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Contents
1 Introduction .......................................................... 7
1.1 Introduction ......................................................... 7
2 Using the programmer ............................................... 10
2.1 The display screen .................................................. 10
2.2 Setting up your programmer .......................................... 13
2.3 Streamlining implant and follow-up sessions with Checklist ............... 14
2.4 Connecting the programmer to skin electrodes .......................... 16
2.5 Positioning and using the programming head ........................... 17
2.6 Enabling emergency VVI pacing ...................................... 20
2.7 Recording an ECG strip .............................................. 21
3 Conducting a patient session ........................................ 23
3.1 Therapy and programmer features ..................................... 23
3.2 Automatically adapting parameters .................................... 24
3.3 Starting a patient session ............................................ 25
3.4 Proceeding with session tasks ........................................ 29
3.5 Interrogating the pacemaker .......................................... 32
3.6 Taking a quick look at pacemaker operation ............................. 33
3.7 Viewing Battery and Lead Measurements .............................. 35
3.8 Checking the present parameter settings ............................... 37
3.9 Viewing and programming patient information stored in the pacemaker ..... 37
3.10 Recording an ECG Strip of magnet operation ........................... 38
3.11 Checking the patient’s underlying rhythm ............................... 39
3.12 Printing reports ..................................................... 41
3.13 Saving session data ................................................. 43
3.14 Ending a patient session ............................................. 45
4 Viewing the patient’s ECG and EGM traces ............................ 49
4.1 Viewing the ECG and other rhythm waveforms .......................... 49
4.2 Adjusting and arranging the waveform traces ............................ 51
4.3 Waveform strips .................................................... 56
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5 Collecting diagnostic data ........................................... 59
5.1 About diagnostic data collection ....................................... 59
5.2 Viewing the collected data ........................................... 62
5.3 Automatically collected data displays .................................. 63
5.4 Clinician-selected detailed data displays ............................... 72
5.5 Programming data collection options .................................. 78
5.6 Clearing data from the pacemaker ..................................... 80
6 Evaluating parameter settings ........................................ 81
6.1 Measuring stimulation thresholds ...................................... 81
6.2 Determining a sensitivity setting ....................................... 92
6.3 Using temporary programming to evaluate parameter settings ............. 96
7 Programming pacemaker parameters ................................. 98
7.1 Programming parameters ............................................ 98
7.2 Using TherapyGuide to select parameter values ........................ 106
7.3 Saving/retrieving a set of parameter values ............................ 108
7.4 Retrieving Key Parameter History information .......................... 109
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8 Rate Response setup ............................................... 111
8.1 Programming Rate Response parameters ............................. 111
8.2 Using Exercise test to verify Rate Response ........................... 112
9 Using the EP Studies function ....................................... 116
9.1 About the EP Studies function ....................................... 116
9.2 Starting the EP Studies function ...................................... 122
9.3 Setting up and executing a PES protocol .............................. 125
9.4 Setting up and executing a Burst protocol ............................. 128
9.5 Setting up and executing a VOO Burst ................................ 130
9.6 PES parameter definitions and values ................................. 131
9.7 Burst parameter definitions and values ................................ 134
Index ................................................................... 136
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1 Introduction
1.1 Introduction
The information in the Attesta MRI SureScan / Sphera MRI SureScan Pacemaker
Programming Guide (PPG) applies to the following devices:
●
Attesta DR MRI SureScan model ATDR01
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Attesta L DR MRI SureScan model ATDRL1
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Attesta S DR MRI SureScan model ATDRS1
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Attesta SR MRI SureScan model ATSR01
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Sphera DR MRI SureScan model SPDR01
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Sphera L DR MRI SureScan model SPDRL1
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Sphera SR MRI SureScan model SPSR01
1.1.1 How to use this guide
Product information about Attesta MRI SureScan and Sphera MRI Surescan pacemakers
and the associated Medtronic Model SW043 software for the programmer is presented in 2
documents.
The reference manual provides detailed information on the pacemakers.
This pacemaker programming guide contains instructions on how to use the programmer
and the programming software.
1.1.1.1 About the reference manual
The reference manual describes in detail how the pacemakers operate and specifies the
capabilities of the pacemakers. This manual 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.
●
Contains a glossary of terms.
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1.1.1.2 About the pacemaker programming guide
The pacemaker programming guide describes how to program Attesta MRI SureScan and
Sphera MRI Surescan pacemakers using a programmer. The manual 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 Manual conventions
This pacemaker programming guide contains instructions on how to use the programmer
and the programming software. Throughout this manual, the work ’device’ refers to the
implanted pacemaker. The names of screen titles, screen text, and interactive elements are
shown in bold type. Navigation paths to software screens or programmable parameters are
shown with a “>” character betrween steps in the path (for example, Data > Graphs and
Tables > Heart Rate Histograms > Open Data).
1.1.1.4 Additional manuals
Additional manuals and documents with information about the programmer and implanted
device:
MRI technical manual – This manual provides MRI-specific procedures and warnings and
precautions.
Device manual – This manual contains model-specific feature information, indications and
contraindications, warnings and precautions, instructions for implanting the device, quick
reference specifications, and parameter tables.
Explanation of symbols – This document defines the symbols that may appear on the
device package. Refer to the package label to see which symbols apply specifically to this
device.
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Medical Procedure and EMI Warnings and Precautions Manual for Health Care
Professionals – This manual provides warnings, precautions, and guidance for health care
professionals who perform medical therapies and diagnostic procedures on cardiac device
patients. The manual also provides patient education information related to sources of
electromagnetic interference (EMI) at home, at work, and in other environments.
Radio regulatory compliance information – This document provides compliance
information related to the radio components of the device.
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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 displays a partial view of the ECG, Marker Channel, and telemetered EGM
waveform traces. To expand this window to its full size, tap the small square button in the
upper-right corner of the window below the status bar, or tap Adjust….
●
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.
The waveform trace or traces shown 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 49 for information about the Live Rhythm Monitor.
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
Tap buttons with the touch pen to operate the programmer.
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.
A procedure may instruct you to “tap and hold” a button. In such cases you must hold the tip
of the touch pen on the button for a duration determined by the procedure.
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2.1.1.5 The command bar
The bar at the bottom of the screen includes 3 buttons:
●
tap Emergency to program VVI pacing.
●
tap Interrogate… to interrogate the device.
●
tap End Session… to end a patient session
For more information on these functions, see Section 2.6, “Enabling emergency VVI pacing”,
page 20, Section 3.5, “Interrogating the pacemaker”, page 32, and Section 3.14, “Ending
a patient session”, page 45.
2.1.1.6 Active fields
An active field is displayed in bolded text, values, or symbols. It is active by default, or it
becomes active in response to the task or function you select.
Tap an active field to access its range of programmable values, or to select it to be
programmed.
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)
Freeze 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.
Strips… Accesses the rhythm strips saved during the patient session.
No saved strips are available between patient sessions.
Adjust… Opens a window of options for adjusting the Live Rhythm Monitor.
Additional adjustment options are present during a patient session.
Select Model Displays the Select Model screen. Use this screen to select a pacemaker
model and start a patient session.
Print Queue Displays the Print Queue screen. Use this screen to select a printer and to print
or delete print jobs.
< Programmer Displays the programmer setup options, including Preferences, Time and Date,
Artifact Detection, Software, Programmer Profile, Other Software, and Tools.
Analyzer 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 25.
2.2 Setting up your programmer
2.2.1 Adjusting the programmer time and date
Use this procedure if the programmer displays or prints the incorrect time or date:
1. Tap Programmer > Time and Date to navigate to the Programmer Time and Date
screen.
2. Tap the arrows to change the values for Hours, Minutes, Month, Day, and Year. Hold
the touchpen on an arrow to quickly index through the range of available values.
Note: A 24-hour clock is used for the Hours field.
3. Tap Apply to program the corrected time and date.
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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.
2.2.2.1 How to turn the audible tones on or off
1. Tap Programmer > Preferences.
2. Tap Audio ON or Audio OFF as desired.
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.
2.3.1 How to select a checklist
1. Tap Checklist.
Note: When starting a new session, the checklist used during the previous
programming session is active.
2. Review the tasks in the Select Task list for the active checklist.
3. Tap the Checklist field to choose a different checklist.
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2.3.2 How to use a checklist
1. Tap >> Go To Task to perform the first task on the Select Task: list.
Note: If you do not wish to perform the first task on the Select Task: list, tap on your
preferred task and then tap >> Go To Task.
2. Tap >> to the right of the Checklist icon to perform the next task in the Select Task: list.
3. Repeat Step 2 to work through the checklist tasks. To disregard a task, tap >> until your
reach your preferred task on the checklist.
Note: When you reach the final task in a checklist, >> becomes inactive. Tap the
Checklist icon to view the checklist at any time.
Note: The Checklist function displays a check mark next to tasks that you have performed
during the current patient session. If you wish to perform one of these tasks again, tap on that
task then tap >> Go To Task.
2.3.3 How to create a custom checklist
1. Tap Checklist.
2. Tap Create/Edit….
3. Select an existing list from the Copy From: dropdown list.
4. Tap on tasks in the box on the left to copy them to the box on the right. Note that a task
can be added more than once to a custom checklist.
If you do not wish to place a new task at the end of the list in the box on the right, perform
the following procedure:
a. Tap on the task in the box on the right which you want the new task to follow.
b. Tap on the new task in the box on the left. It will be copied below the selected task
in the box on the right.
5. To delete a task, tap the task in box on the right, then tap Delete Item.
6. Tap Save As… to assign a name to the new checklist.
7. Tap Save.
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2.3.4 How to edit a custom checklist
1. Tap the Checklist icon.
2. Select the checklist that you wish to edit from the Checklist: dropdown list.
Note: You cannot edit the Master Checklist.
3. Tap Create/Edit….
4. Tap on tasks in the box on the left in the order that you want them to be copied to the box
on the right.
5. Perform these steps to add tasks to the box on the right that are not in the box on the left:
a. Select Master Checklist from the Copy From: dropdown list.
b. Tap on tasks in the box on the left in the order that you wish them to be copied to the
box on the right.
6. Perform these steps to add a task to a position before the end of your edited checklist:
a. Tap the task in the box on the right that the new task will follow.
b. Tap a task in the box on the left. It will appear under the highlighted task in the box
on the right.
7. To delete a task, tap the task then tap Delete Item.
8. Perform these steps to save the edited checklist:
a. Tap Save As….
b. Tap the checklist name in the Checklist - Save As window.
c. Tap Save.
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.
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( ) = IEC coding
Labeled C on some cables
1
RA (R) LA (L)
V1 (C)
RL (N)
LL (F)
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ATTESTA MRI™ SURESCAN™ / SPHERA MRI™ SURESCAN™
Figure 2. Connecting the programmer to skin electrodes
Refer to your programmer manual for more details on this procedure.
SW043
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.
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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.
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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.
Figure 3. 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.
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Figure 4. Light array indicator
SW043
1 Light array
2 Green
3 Amber/green
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 21. 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.
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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 5. Alternative Program and Interrogate programming head buttons
1 I or Interrogate button
2 Light array
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.
3 P or Program button
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 up to 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.
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MRI SureScan – MRI SureScan feature operation is disabled when emergency VVI pacing
is programmed.
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.
Note: The following procedure applies to programmers that have an on-screen Emergency
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. Tap Emergency.
3. Tap 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 6. Printer buttons on the programmer
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1 50 mm/s
2 25 mm/s
3 12.5 mm/s
4 Paper advance
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.
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.
Programming arrows – The point at which the command occurred is marked above the
ECG trace by a down or up arrow. A down arrow indicates a transmitted command from the
programmer (programming the device); an up arrow indicates a telemetry response from the
pacemaker (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
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 51). 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.
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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 45.
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3.3.1 The tool palette during a patient session
Table 2. 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.
Opens the Checklist screen for simplified navigation through a set of follow-up
tasks. >> navigates to the next task in a Checklist.
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.
SW043
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 Find Patient…
Perform this procedure to start a Medtronic SW043 programmer software session Find
Patient….
Note: Contact your Medtronic representative if your programmer does not have the
Medtronic SW043 programmer software installed on it.
1. With the Select Model screen displayed, position the programming head over the
patient’s pacemaker and hold it in place. If telemetry is established with the device, the
session starts, initial interrogation begins, and you can proceed to Step 3.
Notes:
●
If telemetry is not established with the device, a short self-test sequence takes
place and the Find Patient screen displays. If this occurs, tap Cancel to display the
Select Model screen.
●
If the programmer is operating, but the Select Model screen is not displayed, tap
Select Model.
●
If Select Model does not display, the previous patient session was not ended
properly. Refer to Section 3.14, “Ending a patient session”, page 45.
2. Tap Find Patient… at the bottom of the screen.
After 40 to 50 s of internal software loading, the session starts and initial interrogation
begins.
3. Hold the programming head in place until initial interrogation is 100% complete.
Refer to Section 3.4, “Proceeding with session tasks”, page 29 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 data that might be needed during the session.
Note: You must position the programming head over the pacemaker and hold it in place until
the automatic 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 tap Interrogate… and select the Collected Data on the Interrogate How
Much? screen.
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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. Tap Stop at any time to cancel the interrogation.
Note: Except for use of Emergency or Stop, you cannot proceed with session activities until
the initial interrogation is 100% complete. If you tap Stop or lift the programming head before
the interrogation is complete, the programmer will display a message to interrogate the
pacemaker if it requires pacemaker data that was not collected during the interrogation.
You also can manually interrogate the pacemaker at any time during the patient session (see
Section 3.5, “Interrogating the pacemaker”, page 32).
Warning messages – A warning message may display in response to an interrogation.
Examples of warning messages include:
●
RRT (Recommended Replacement Time)
●
ERI (Elective Replacement Indicator)
●
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 98.
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 29). 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
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●
P and R-Wave Measurements
●
Threshold Trend
●
Impedance Trend
●
Parameter Summary
●
Clinical Status
●
Long Term Heart Rate Histograms
●
Pacing % counters
●
Event counters
●
High Rate Episodes Summaries
●
Arrhythmia Summary, including:
ATTESTA MRI™ SURESCAN™ / SPHERA MRI™ SURESCAN™
– High Rate Episodes Summaries
– V. Rate During Atrial Arrhythmias
– Atrial Arrhythmia Durations
– Atrial Arrhythmia Trend
●
All Permanent Parameters
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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 33 for more information.
3.4.2 Selecting another task or function
To proceed with the session, tap 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 enables you to quickly and easily display a desired task or function screen.
Note: When some functions are active, the tool palette is inactivated. The tool palette is
reactivated when these function windows are closed.
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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 10.
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, tap 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 tap Print…. You can
choose to display the Print - Options window, print the report immediately, or add the report
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
Perform this procedure to set up your printing preferences:
1. Tap 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 tap
Print….
●
If there is no check mark, Print… immediately prints the report or transfers it to the
print queue.
3. Tap the Number of copies: field to select 1, 2, 3, or 4 copies to be printed.
4. Select one of the following options for Printer:
●
Full Size: This option requires that a compatible, external printer be connected to
the programmer.
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Note: Tap the Printer field and choose a printer from the list. The printer you select
must be compatible with the input requirements of your connected printer.
●
Programmer Strip: This option prints reports on the programmer’s strip chart
printer.
5. Select one of the following options for printing the report:
●
Now: The report prints immediately when you tap Print….
●
Later from Print Queue: The report is sent to the print queue when you tap
Print…. For information about the print queue, see Section 3.12, “Printing reports”,
page 41.
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.
3.4.4.4 How to select your Initial Report preference
Perform this procedure to set up your Initial Report preferences:
1. Tap the Session > Preferences > Initial Report.
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. Select the Include: check boxes if you wish to include an Arrhythmia Summary, the
Permanent Parameters (this includes programmed parameter values), or both.
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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.
3.4.4.6 How to select your preference for the trace display
Perform this procedure to set up your trace display preferences:
1. Tap Session > Preferences > Tests .
2. Select either 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.
3.5.1 How to interrogate the pacemaker
1. Tap Interrogate... or press the 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. (AGAIN)
indicates that this data was retrieved in a previous interrogation for this session.
3. Position the programming head and tap Start or press the I button on the programming
head.
Hold the programming head in place until the interrogation is 100% complete as shown
by the status gauge at the bottom of the screen.
Tap Stop to cancel the interrogation.
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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.
3.6.1 Quick Look II screen
The Quick Look II screen appears at the start of a patient session or when you tap Data >
QuickLook II.
Note: Each >> on the Quick Look II screen is a link to diagnostic data related to the
information with which it is associated.
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. For more
information, tap the information icon to the left of the Remaining Longevity label to read the
Explanation of Remaining Longevity Estimates.
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. Tap >> to view threshold trend data in
the Collected Data - Capture Management Trend window. For more information about
Capture Management Trends, see Section 5.3, “Automatically collected data displays”,
page 63.
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. Tap >> to view lead impedance trend data in the
Collected Data - Lead Impedance window. For more information about Impedance
Trends, see Section 5.3, “Automatically collected data displays”, page 63.
P Wave – If Atrial Sensing Assurance is on, this shows the current P Wave amplitude range
measured by the pacemaker within the last week. Tap >> to view P Wave amplitude trend
data in the Collected Data - Sensitivity Trends window. For more information about
P Wave amplitude trend, see Section 5.3, “Automatically collected data displays”,
page 63.
R Wave – This shows the current R Wave amplitude range if Ventricular Sensing Assurance
is on. Tap >> to view R Wave amplitude trend data in the Collected Data - Sensitivity
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Trends window. For more information about R Wave amplitude trend, see Section 5.3,
“Automatically collected data displays”, page 63.
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. Tap >> to view atrial arrhythmia trend data in the Collected Data - Atrial
Arrhythmia Trend screen. For more information about the atrial arrhythmia trend, see
Section 5.3, “Automatically collected data displays”, page 63.
Pacing – The pacing and sensing event sequences applicable to the programmed pacing
mode (see Table 3) are listed under this label. These are shown as the percentage of events
recorded since the last patient session.
An indicator following the event sequences shows 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.
Tap >> to view the Collected Data - Heart Rate Histograms window. For more information
about the histogram displays, see Section 5.3, “Automatically collected data displays”,
page 63.
Note: The information under the Pacing label and the Observations label shows data
collected since the last patient session. This data is cleared from pacemaker memory after
the session has ended. After the data is cleared, it cannot be recalled.
Table 3. 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
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Table 3. Event sequence categories (continued)
Single chamber pacing modes
Paced Atrial or Ventricular Pace
Sensed Atrial or Ventricular Sense
Observations – Observations summarize diagnostic data collected since the last patient
session. Each observation reports the number and category of significant events recorded
by diagnostic monitoring functions (see Table 4).
To view a graph or table showing the details of an observation, tap the observation then tap
>>. Refer to Section 5.2, “Viewing the collected data”, page 62 for information about
viewing the data recorded by the monitoring functions.
Table 4. 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
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
Tap Data > Battery and Lead Measurements to view the Battery and Lead
Measurements screen. This screen captures information about the pacemaker battery and
the lead system based on real-time measurements and calculations made at the time of
pacemaker interrogation.
Note: The values measured for the pacemaker battery and the lead system can change
between interrogations.
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3.7.1 Pacemaker Battery and Lead Measurements
The Battery and Lead Measurements screen includes the following information.
Battery Status – Displays OK or Replace Pacer based on battery voltage and internal
impedance measurements. The Date of Implant is shown below the battery status.
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.
Tap the information icon to the right of the Remaining Longevity label to read the
Explanation of Remaining Longevity Estimates.
Caution: Pacemaker replacement should not be based on the estimated remaining
longevity. For this decision, use only the RRT (Recommended Replacement Time), ERI
(Elective Replacement Indicator), 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 Lead and Ventricular Lead – 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
Measured Impe-
dance
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
3.7.2 Updating the displayed data
It takes a few seconds to update the battery and lead measurements data. Perform this
procedure:
1. Position the programming head and hold it in place.
2. Tap Measure Again.
3. Hold the programming head in place for the duration of measurement as indicated in the
Measure - In Progress pop-up window.
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3.8 Checking the present parameter settings
Tap Params to view the Parameters - Therapy screen. This screen displays the
pacemaker’s programmed parameter settings.
If the label for a parameter or option includes 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 101.
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 program the patient’s clinical conditions (Age and History) into pacemaker
memory, they are available to the TherapyGuide feature. Refer to Section 7.2, “Using
TherapyGuide to select parameter values”, page 106.
Note: Tap Patient > TherapyGuide to display TherapyGuide window.
3.9.1 How to program patient information
1. Tap Patient > Patient Information
2. On the Patient Information screen, tap 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.
3. Tap the desired information option, or type the desired information, and then tap Enter
on the on-screen keyboard.
4. Repeat steps 1 and 2 for any field to which you want to add, delete, or change the data.
5. To define the patient’s clinical conditions, which are made available to TherapyGuide,
take the following actions:
●
Tap the data field for Age, and tap the patient’s age range.
●
Tap the History… field to open the History window. Tap the appropriate clinical
conditions, then tap OK.
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6. When you have finished, position the programming head and tap PROGRAM.
This action programs into the pacemaker all the data that displayed on the Patient
Information screen.
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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
The Magnet test allows you to start and stop magnet operation in the pacemaker. Options let
you collect an ECG strip of magnet operation and, if desired, non-magnet operation.
Note: At any time during a Magnet test, lift the programming head from over the patient’s
pacemaker for at least 2 s to restore pacemaker operation to its permanent status. Take this
action in the event of programmer malfunction, loss of power, or the absence of an
appropriate command confirmation.
3.10.2 Procedure for conducting a Magnet test
1. Tap Tests > Magnet to display the Magnet - Test Setup screen.
2. To start magnet operation, position the programming head and tap START Magnet.
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. Tap Stop Collection if you want to stop the
ECG collection before it completes. Tapping this button does not stop magnet
operation.
3. To stop magnet operation, tap STOP Magnet.
A pop-up window gives you the option to collect an ECG strip of non-magnet operation.
Tap Yes to collect a non-magnet strip or tap No to close the window.
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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, tap the time field and choose the collection time you
desire.
●
If you do not want automatic strip collection, tap 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, tap either icon. Refer to Section 4.3, “Waveform strips”,
page 56for information about using the strip viewing feature and about printing waveform
strips and reports.
To print a Magnet test report, tap Print… and then choose the desired print 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. This test provides two instruments to evaluate the patient’s
underlying rhythm:
●
the Inhibit test
●
the Manual Rate Decrease 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.
Note: At any point during the Underlying Rhythm test, lifting the programming head away
from the site of the pacemaker for at least 2 s will restore normal pacemaker operation. Lift
the programming head immediately in the event of a programmer malfunction or loss of
power.
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3.11.1 Procedure for checking the patient’s underlying rhythm
Note: The Inhibit mode shuts off pacemaker output for the test duration.
3.11.1.1 How to check underlying rhythm using Inhibit
1. Tap Tests > Underlying Rhythm to display the Underlying Rhythm Test (Manual
Rate Decrease or Inhibit) screen.
2. To stop the output of pacing stimuli:
a. Position the programming head.
b. Tap and hold INHIBIT Press and Hold.
Pacemaker blanking periods are shortened during this test to increase the period
during which cardiac events can be sensed.
3. To restore permanent pacing, release INHIBIT Press and Hold.
3.11.1.2 How to check underlying rhythm using manual rate decrease
1. Tap Tests > Underlying Rhythm to display the Underlying Rhythm Test (Manual
Rate Decrease or Inhibit) screen.
2. Choose the desired test pacing mode and the starting value for the lower rate:
a. Tap the Mode field under the Test Value label to display the test mode options.
b. Tap on the desired test mode from the Temp. Mode list.
c. Tap the Lower Rate arrows to adjust the test value to a rate setting close to the
patient’s present pacing rate.
3. Tap START Test to engage the test mode and lower rate.
4. Tap the down arrow to gradually decrease the lower rate until the patient’s underlying
rhythm emerges. (Tap the up arrow to increase the lower rate if desired.)
5. To end the test, tap STOP and Restore.
3.11.2 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.
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To view a collected ECG strip for either the Manual Rate Decrease test or the Inhibit test,
tap the Test Strip icon for the respective test. Refer to Section 4.3, “Waveform strips”,
page 56 for information about using the strip viewing feature and about printing waveform
strips and reports.
To print an Underlying Rhythm Test report for either the Manual Rate Decrease test or the
Inhibit test, tap Print… for that test, then choose the desired print options.
3.12 Printing reports
You can print data generated during a patient session by tapping Print… or by selecting a
report from the Available Reports window. You can also print reports that are in the print
queue.
3.12.1 Using Print…
On most task screens, Print… becomes active when a task is executed or a function
generates report data. Tap Print to print a formatted data report associated with the current
task. Print… appears near the bottom of all task screens except the Parameters - Therapy
screen.
Note: On the Parameters - Therapy screen, an icon of a printer can be found to the right of
Undo.
Tap Print… or the printer icon to perform one of the following tasks, as determined by your
session preferences settings (see Section 3.4.4):
●
print the associated report.
●
send the report to the print queue to be printed later.
●
open the Print - Options window (or the Output Pacemaker Memory window for the
Device Memory Report).
For information about session preferences and print options, see Section 3.4, “Proceeding
with session tasks”, page 29.
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
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●
Reports generated by the use of the Tests functions.
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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.
3.12.2.1 How to print from the list of Available Reports
1. Tap Reports > Available Reports.
2. From the list of available reports, tap the report you wish to print.
3. Tap Print… > Print Now or Print… > Print Later. This will place the report in the print
queue.
3.12.3 Printing reports held in the Print Queue
When you tap Print… > Print Now or Print… > Print Later to print a report, control of the
print job is passed on to the print queue shown in the Session Print Queue window.
The Session Print Queue window shows the status of any print job. You can either print or
delete print jobs in the queue. 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 previous sessions.
3.12.3.1 How to print or delete reports from the Print Queue
1. Tap Reports > Print Queue .
2. From the list of reports, tap the report you want to print or delete.
Caution: A deleted report cannot be recovered.
3. Tap Print to print the report, or tap Delete to delete the report from the Session Print
Queue report list.
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3.13 Saving session data
Any time during a patient session, you can save data from the session on a diskette or on a
USB flash drive.
The saved data is listed in Table 5. Saved session data can be reloaded on the programmer
for analysis.
Table 5. 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.
1. Tap Session > Save to Media… to display the Save To Media - Insert Media window.
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 45.
2. Insert a formatted, IBM-compatible, 90 mm (3.5 inch) diskette into the diskette drive.
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3. Position the programming head and tap Start.
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 to insert another diskette.
4. When the transfer of data is complete, remove the diskette 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.
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… display. 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, use a flash drive that is
reserved to store 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.
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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
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.
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 3.14.3.
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.
●
Change the way the pacemaker clears collected data.
3.14.1 How to end a patient session
1. Tap End Session… 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, tap Cancel.
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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 change the settings for how collected data is cleared from the pacemaker when
you end the session, see Section 3.14.3.
Note: To accomplish any of these tasks, proceed to its listed procedure. Do not tap
End Now in Step 4 at this point if you want to save the session data or change data
collections settings.
4. To end the session now and return to the Select Model screen, tap End Now.
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, “Saving session data”, page 43.
Saved session data can be reloaded on the programmer for analysis. For information about
reloading session data, refer to Section 3.13, “Saving session data”, page 43.
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, “Saving session data”, page 43).
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), tap Save To Media….
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 tap Start 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 3.14.3). However, you cannot cancel the End Session sequence and
return to the session.
4. When the transfer of data is complete, tap End Now 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.
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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 tapping the Session icon, you can
continue the session (see Section 3.13, “Saving session data”, page 43).
1. Insert a USB flash drive in the programmer.
2. From the End Session window (see Section 3.14.1), tap Save To Media….
3. Position the programming head and tap Start 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 3.14.3). However, you cannot cancel the End Session sequence and
return to the session.
4. When the transfer of data is complete, tap End Now 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.
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3.14.3 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 80.
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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 tap of a button. The expanded screen covers the task area of
the current screen.
●
To expand the Live Rhythm Monitor window to its maximum size, tap the maximize
button in the upper-right corner of the partial-view window, displayed to the left of
Freeze.
●
To collapse the Live Rhythm Monitor window to its minimum size, tap the minimize button
in the upper-right corner of the full-view window, displayed to the left of Freeze.
4.1.2 About the waveform traces
The programmer can display the traces described in Table 6. 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 51.
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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 6. Waveform trace information
Trace Description
ECG Lead I
ECG Lead II
ECG Lead III
Marker Annotation
Marker Intervals
a
(ms)
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.
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 16.
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.
Dual Chamber Models
AP - Atrial pace
AS - Atrial sense
AR - Atrial sense during refractory
Single Chamber Models
P - Pace
S - Sense
SR - 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)
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.
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4.2 Adjusting and arranging the waveform traces
Tap Adjust… to display a button bar associated with each waveform trace (Figure 7) and the
options for viewing waveform traces. This button bar provides 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.
Figure 7. 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. Tap the up or down arrow on the associated button bar to increase or decrease the size
(or amplitude) of the trace waveforms. ECG and EGM traces can be adjusted by a
maximum of 4 steps.
2. Tap the return button to return the waveform trace to its default size.
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. Tap the trace source button from the associated button bar.
Note: Traces can be superimposed on each other. For example, both ECG Lead II and
Marker Annotation sources can display as a composite trace, but the name of only
one source appears on the screen.
Tap the trace name to see the trace name behind it. Tap the trace name again to see that
it changes each time you tap.
2. Select the desired source from the drop-down menu of Source options.
The trace for the newly selected source appears in place of the previously displayed
trace. If the monitor window is fully expanded, note that the original trace and the
selected trace have switched positions.
Note: You can also rearrange the trace positions by dragging them 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.
4.2.1.5 How to select an ECG or EGM trace to print
Figure 8. Buttons to enable and disable trace printing
1. Tap the printing enabled button next to the print-enabled trace that you do not want to
print. This disables printing for that trace.
2. Tap the printing disabled button next to the trace you want to print. This enables printing
for that trace.
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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.
Tap Adjust… 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.
Instructions in the following sections describe using the trace color options and each of the
options in the Adjust… window.
Table 7. 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: Tap 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: Tap the Telemetry Mode: field to display options for programming the type
of waveform telemetry transmitted by the device (see Section 4.2.8).
Normalize Tap Normalize to equalize the trace spacing and to adjust the size of each
trace to the default setting.
Calibrate symbol Tap the calibrate symbol to calibrate the external device connected to the
analog output.
OK Tap OK 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. Tap Adjust… to open the Adjust… window.
2. Tap the color field for the trace you want to change.
3. Select the desired color from the drop-down menu of color options.
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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.”
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.
1. Tap 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 8).
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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. Tap the Telemetry Mode: field in the Adjust… window.
3. From the drop-down menu of options, select the desired EGM telemetry (see Table 8).
Table 8. 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.
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 (for
example, Marker Annotation), 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.
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, tap Normalize in
the Adjust… window.
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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. Tapping Freeze 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.
Controls below the viewing window include the caliper controls described in the next section
and the following buttons:
Adjust… Tap to open a window of waveform adjustment controls (see Section 4.3.1.3).
Strips… Tap to view a list of other frozen waveform strips (see Section 4.3.2).
Save Tap to save the waveform strip presently displayed (see Section 4.3.1.4).
Delete Tap to delete a saved waveform strip. This button is active only if you are viewing
a saved waveform strip.
Print… Tap to print the waveform strip presently displayed (see Section 4.3.1.5).
Close Tap 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 caliper positioning buttons 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.
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.
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.
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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 Adjust… 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 51 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
1
4.3.1.4 Saving a frozen waveform strip
You can save the frozen waveform strip you are viewing by tapping Save. 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, tap Print… near the bottom of the Frozen Strip window. Depending on
the Session preference settings, tapping Print… 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 29.
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.
1
Sweep Speed: options for frozen traces are 12.5, 25, 50, 100, and 200 mm/s.
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4.3.2.1 How to view a previously collected strip
1. Tap Strips… near the top of the tool palette or in the lower-left corner of the Frozen
Strip viewing window.
2. From the Other Strips… window now displayed, tap Collected by programmer.
3. From the list of strips in the selection field, tap 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. Tap Open.
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
between patient sessions.
You can retrieve the recorded information and view it in a graphic format. You can also print
the information in its graphic format, with or without a tabular summary of the numerical data.
This chapter does not list the diagnostics available for each 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 records data and presents it in a number of ways,
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 of the following options:
●
Custom Rate Trend
●
A. Capture Management Detail
●
V. 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 at 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 programmer gives you options to adjust how the device collects its various types of data.
For more information, refer to Section 5.5, “Programming data collection options”,
page 78.
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 programmer time settings. You can verify that the programmer time and
date are set correctly by tapping Freeze. 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.
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.
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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 cleared 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 80).
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 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 80 for information about
clearing trend data.
5.1.3.7 Effects of reaching RRT
There is no effect on data collection when the device reaches RRT (Recommended
Replacement Time). Data continues to accumulate, and it can be retrieved for viewing and
printing. There is no effect on diagnostic data if an RRT condition is reset.
5.1.3.8 Effects of reaching ERI
Data collection stops when the device reaches ERI (Elective Replacement Indicator).
Accumulated data can still be retrieved for viewing and printing. If the ERI condition is reset,
diagnostic data is cleared and data collection resumes one hour after the end of the
programming session (or immediately, if programmed).
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5.1.3.9 Effect of an electrical reset
All recorded diagnostic data is lost in an electrical reset.
5.1.3.10 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.
5.1.3.11 Using the Exercise Test and EP Studies functions
The use of the Exercise Test and EP Studies functions disables and clears data collected for
the clinician-selected diagnostic. 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. View and print the collected data
before ending the session (see Section 5.2, “Viewing the collected data”, page 62).
●
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 78).
●
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 see the types of collected data that you can view, tap Data > Graphs and Tables to open
the Collected Data - Graphs and Tables screen.
The list of available collected data varies according to pacemaker model, the programmed
pacing mode, and the programmed option for Clinician Selected data collection. See
Section 5.3, “Automatically collected data displays”, page 63 for more information.
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5.2.1 Viewing procedure
From the Collected Data - Graphs and Tables screen, you can view data as follows:
1. Tap on an item in the Data Type list.
2. Tap Open Data.
5.2.2 Viewing tools
Some data windows allow you to “zoom in” on a selected segment of the plotted data to show
more detailed information.
Use the right and left scroll buttons to position the zoom region over the data that you want
to see in detail.
To display details of the zoom region, tap the Zoom In (+) icon. On some screens, tapping the
Zoom In (+) icon has the same effect as tapping the Strip icon.
If the selected data detail includes more information than can be displayed in the window,
use the scroll buttons to navigate back and forth across the full data detail.
To return to the full data display screen, tap the Zoom Out (–) icon.
For some data, the details of the zoom region are presented as a recorded strip of event
markers.
If the Strip icon is displayed, tap it to view 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
●
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
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Sensitivity Trends
●
Lead Impedance (Chronic Trends and Impedance Data)
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5.3.2 Heart Rate Histograms
5.3.2.1 Description
Heart Rate Histograms 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. The histograms are intended
as an aid for evaluating rate response parameter settings and chronotropic incompetence.
To view the Heart Rate Histograms, tap Data > Graphs and Tables > Heart Rate
Histograms > Open Data.
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.
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), atrial and ventricular histograms can be viewed by tapping the
Histogram: field in the Collected Data - Heart Rate Histograms window.
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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 78.
5.3.3 AV Conduction Histograms
5.3.3.1 Description
Like the Heart Rate Histograms, AV Conduction Histograms indicate 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. AV Conduction Histograms are available only if a dual
chamber mode (including ADIR, ADI, VDIR, VDI, and VDD modes) has been programmed.
To view the A-V Conduction Histograms, tap Data > Graphs and Tables > A-V Conduction
Histograms > Open Data.
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.
a
b
a,b
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 reference manual for additional information about collecting AV Conduction
Histogram data.
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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.
To view the Search AV+ Histogram, tap Data > Graphs and Tables > Search AV+
Histogram > Open Data.
Refer to the reference manual 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.
To view the Collected Data - Sensor Indicated Rate Profile window, tap Data > Graphs
and Tables > Sensor Indicated Rate Profile > Open Data.
Note: Sensor Indicated Rate Profile data is cleared only when programming certain rate
response parameters or another rate responsive mode.
Refer to the reference manual for additional information about collecting Sensor Indicated
Rate Profile data.
5.3.6 High Rate Episodes
High Rate Episodes data include the date and time, the maximum rate in both chambers, the
average ventricular rate, and the duration of episodes. On printed reports, the High Rate
Episodes data will also include the sensor rate at the time the episode was detected.
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The programmed Collection Method determines whether episode data are updated or data
stops when the limit is reached. The options are listed below:
●
Rolling: Data for the first, fastest, longest, and the most recent 13 episodes are collected
until the pacemaker is interrogated.
●
Frozen: Data are collected for the first 16 episodes that occur after the device is
programmed. Data collection stops after 16 episodes; however, the Episodes Detected
count continues.
Episodes are defined by the programmed collected data setup options. For more information
about these options, see Section 5.5, “Programming data collection options”, page 78.
The maximum number of high rate episodes the pacemaker will count is 16,777,215 for atrial
episodes and the same count for ventricular episodes. Once a limit is reached, the count is
frozen.
To view the Collected Data - High Rate Episodes window, tap Data > Graphs and
Tables > High Rate Episodes > Open Data. This window has check boxes that allow you
to view atrial data, ventricular data, or both types. For single-chamber pacemakers, High
Rate Episodes data is available for the paced chamber.
If Mode Switch is programmed On, the atrial data collected will be based on Mode Switch
episodes. If Mode Switch is programmed Off, the atrial data collected will be based on
independent Atrial High Rate detection criteria.
When the clinician-selected data is High Rate Detail, the screen indicates that the applicable
episodes have EGM and/or Trend data. To view the additional data, tap the episode and then
tap Open Episode.
Note: When Mode Switch is programmed On, the diagnostic parameter Collection Delay
sets up a minimum length that mode switching episodes must satisfy to be included in High
Rate data collection. (Collection Delay does not affect Mode Switch therapy, but it allows the
user to filter out short episodes from the high rate episode collection.)
If you tap >>, the Episode Collection Criteria window opens listing the criteria for collection
of atrial and ventricular episodes.
Refer to the reference manual for additional information about collecting High Rate Episodes
data.
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5.3.6.1 Clinician-selected data collection option
High Rate Detail is one of the optional clinician-selected diagnostics discussed in
Section 5.4, “Clinician-selected detailed data displays”, page 72.
5.3.7 Rate Drop Response Episodes
Rate Drop Response Episodes records the operation of the Rate Drop Response function
(no data will be collected if Rate Drop Response function is Off). Depending on the
programmed settings for Rate Drop Response, it will record the number of Low Rate
Episodes, Rate Drop Episodes, or both. Low Rate and Rate Drop Episodes are defined as
follows:
●
Low Rate Episode: When a programmed number of lower rate paced events occurs with
no intervening non-refractory sensed events.
●
Rate Drop Episode: Defined by programmed values for Drop Rate and Drop Size.
– Drop Rate: Intrinsic ventricular rate must decrease to, or falls below, this rate.
– Drop Size: Number of beats per minute the ventricular intrinsic rate must decrease
within the detection window time.
– Detection Window: Maximum allowable time for the rate drop criteria to be met.
If more than 255 Rate Drop Response episodes occur, the Rate Drop Response count stops
recording.
The date/time, type, and intrinsic detection rate of the initial and the 9 most recent episodes
can be accessed from the Graphs and Tables screen.
To view the Additional Data, tap the episode, and then tap Open Episode. Trend data is
collected only when the clinician-selected data is Rate Drop Response Detail.
5.3.7.1 Clinician-selected data collection option
Rate Drop Response Detail is one of the optional clinician-selected diagnostics discussed in
Section 5.4, “Clinician-selected detailed data displays”, page 72.
5.3.8 Atrial Arrhythmia Trend
5.3.8.1 Description
The Atrial Arrhythmia Trend shows a log of how much time each day that the patient spends
in atrial arrhythmias. Collected over a period of weeks or months, this information indicates
when there is an upward or downward trend in this type of cardiac activity.
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The Episode Trigger is Mode Switch if Mode Switch is enabled. Otherwise, it is the
programmed atrial high rate (detection rate) value.
5.3.8.2 Data collection and presentation
This display is a graph of daily measurements of the length of time that the implanted device
detects atrial arrhythmias. Included with the trend display is the time period covered by the
accumulated data, the pertinent programmed parameter settings, and the date of the last
patient follow-up session.
The Atrial Arrhythmia Trend can show up to 6 months of collected data, and it is a rolling trend
that updates continuously. An option allows you to clear the accumulated data if desired (see
Section 5.6, “Clearing data from the pacemaker”, page 80).
To view the Collected Data - Atrial Arrhythmia Trend window, tap Data > Graphs and
Tables > Atrial Arrhythmia Trend
●
Tap >> to the right of High Rate Episodes to open the Collected Data - High Rate
Episodes diagnostic window. See Section 5.3.6 for more details.
●
Tap >> to the right of V. Rate During A. Arrhythmias to open the Collected Data -
Ventricular Rate During Atrial Arrhythmias diagnostic window.
5.3.9 Atrial Arrhythmia Durations
This diagnostic data appears only in the Initial Interrogation Report under Arrhythmia
Summary. Each atrial arrhythmia episode is counted under one of these ranges of episode
duration:
●
72 hr
●
24 hr to <72 hr
●
12 hr to <24 hr
●
4 hr to <12 hr
●
1 hr to <4 hr
●
10 min to <1 hr
●
1 min to <10 min
●
<1 min
To print the Initial Interrogation Report, tap Reports > Available Reports > Initial
Interrogation Report > Print…
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5.3.10 Ventricular Rate During Atrial Arrhythmias
5.3.10.1 Description
The Ventricular Rate During Atrial Arrhythmias histogram shows a profile of ventricular rate
recorded during the atrial arrhythmias that have been recorded since the last patient
session. This information can show how the ventricular rate is controlled during atrial
arrhythmias.
To view the Collected Data - Ventricular Rate During Atrial Arrhythmias window, tap
Data > Graphs and Tables > V. Rate During A. Arrhythmias > Open Data.
5.3.10.2 Data collection and presentation
During each atrial arrhythmia, the implanted device collects ventricular rate data in addition
to atrial data. This histogram shows the percentage of the total number of ventricular beats
counted during these arrhythmias that falls into each of eight 20 bpm rate groups in the
measured rate range. The beats within each rate group are coded to show the proportion of
paced and sensed beats.
Information included with the histogram lists the pertinent programmed parameter settings
and summary information about the recorded atrial arrhythmias during which the ventricular
rate information was recorded.
5.3.10.3 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 78.
5.3.11 Capture Management Trend
Capture Management Trend data are collected automatically when Capture Management is
programmed On. This trend records pacing threshold history for the most recent 14 months.
When VCM and ACM are enabled, the pacemaker collects the following data every 7 days:
●
Maximum Threshold
●
Average Threshold
●
Max Adapted Amplitude
●
Capture Management Setting (Adaptive or Monitor Only)
To open the Collected Data - Capture Management Trend window, tap Data > Graphs
and Tables > Capture Management Trend > Open Data.
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To view Atrial or Ventricular Capture Management Trend data, select Atrial or Ventricular
from the Trend: field.
To open the Ventricular Capture Management - Last Measured Threshold window, tap
>> to the right of the Measured Threshold label. This graph presents the results of the most
recent ambulatory ventricular pacing threshold search. This includes the measured strength
duration curve and the curve corresponding to a 2X Amplitude Margin.
Note: >> is not available when viewing the Atrial Collected Data - Capture Management
Trend window.
Refer to the reference manual for additional information about collecting Capture
Management Trend data.
5.3.11.1 Clinician-selected data collection option
Atrial and Ventricular Capture Management Detail are two of the optional clinician-selected
diagnostics discussed in Section 5.4, “Clinician-selected detailed data displays”, page 72.
5.3.12 Sensitivity Trend
Sensitivity Trend data is collected automatically when Sensing Assurance is programmed
On. The pacemaker records the following information for both chambers every 7 days:
●
Minimum Sensitivity
●
Maximum Sensitivity
●
Whether sensitivity adjustments reached the lower limit (most sensitive)
To view the Collected Data - Sensitivity Trends window, tap Data > Graphs and Tables >
Sensitivity Trend > Open Data.
Tap the Trend: field to view trends for P-Wave Amplitude, R-Wave Amplitude,
Sensitivity - Atrial, or Sensitivity - Ventricular.
Refer to the reference manual for additional information about collecting Sensitivity Trend
data.
5.3.13 Lead Impedance
The Collected Data - Lead Impedance window displays lead impedance trend and
polarity switch data collected for the previous 14 months. Data includes high impedance
paces and low impedance paces from the Lead Monitor function.
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Measurements are taken every 3 hours in each chamber that is being paced. The maximum,
minimum, and average lead impedances are recorded every 7 days. Depending on which
chambers are paced, the following data can be selected from the Trends: field:
●
Atrial Impedance - Chronic
●
Ventricular Impedance - Chronic
●
Atrial Impedance Data
●
Ventricular Impedance Data
Lead impedance trends collection can be programmed On or Off via the Data Collection -
Setup screen.
To view the Collected Data - Lead Impedance window, tap Data > Graphs and Tables >
Lead Impedance > Open Data.
Refer to the reference manual for additional information about collecting lead impedance
data.
5.4 Clinician-selected detailed data displays
Only one type of clinician-selected data can be programmed On at one time. The following
options for clinician-selected data are accessed from the Data Collection - Setup screen:
●
Custom Rate Trend
●
A. Capture Management Detail
●
V. Capture Management Detail
●
High Rate Detail
●
Rate Drop Response Detail
To choose the type of clinican-selected data collected by the device, tap Data > Data
Collection Setup/Clear and then tap the field under Clinician Selected…. Tap an option
from the drop-down list, and configure the settings for that option. Tap PROGRAM to
program any updated settings to the device.
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5.4.1 Custom Rate Trend (rate versus time)
The pacemaker can be set to record the patient’s heart rate for a beat-to-beat, 1-hour, or
24-hour monitoring period, depending on the programmed “duration.”
●
Beat-to-Beat duration: Records beat-to-beat data for several minutes depending on the
mode, rate, and number of refractory events. Shows the maximum, mean, and minimum
rates.
●
1-hour duration: The pacemaker records the patient’s heart rate every 2 s and
accumulates one hour of data.
●
24-hour duration: The pacemaker measures heart rate every 60 s.
5.4.1.1 About displaying Custom Rate Trends
Custom Rate Trends can be displayed by tapping Data > Graphs and Tables > Custom
Rate Trends > Open Data. If data was collected during dual chamber pacing (including
ADIR, ADI, VDIR, VDI, VDD, and ODO modes), atrial and ventricular graphs are recorded.
5.4.1.2 About Zoom-In
Zoom-In lets you view a segment of the Rate vs. Time graph in more detail. If the duration of
recorded data is less than the zoom region, the zoom-in feature automatically is in effect
when the data is displayed.
On the detailed display that shows a segment of the Rate vs. Time graph, the data samples
are coded to indicate the percentage of the beats in each sample that are paced. .
Refer to the reference manual for additional information about collecting Custom Rate Trend
data.
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5.4.1.3 About Custom Rate Trend parameters
Choosing Rate Trend clinician-selected data involves programming the parameters shown
in Table 9.
Table 9. Clinician-selected Rate Trend diagnostic parameters
Parameter Definition Settings
Duration This parameter programs the duration of data
collection to beat-to-beat, 1 hour, or 24 hours.
Collection Method “Rolling” programs the pacemaker to record
continuously, so that new data overwrites the
old data once memory capacity is reached.
“Frozen” programs the pacemaker to record
data until its memory capacity is reached.
Recording then stops, and the collected data
is frozen.
Include Refractory
Senses?
(Refractory Sensed Events) Programs the
pacemaker to include or exclude events
sensed within the refractory period when it
counts heart rate events.
Beat-to-Beat, 1 hr, 24 hr
Rolling, Frozen
Exclude, Include
5.4.2 Atrial Capture Management Detail
Atrial Capture Management Detail data provides a record of the pacing threshold amplitude
at a pulse width of 0.40 ms. The pacemaker records the following information for the most
recent 359 atrial pacing threshold searches:
●
Date and Time
●
Amplitude Threshold
●
Amplitude Margin
●
Adapted or Monitor Only Amplitude
Atrial Capture Management Detail data can be displayed by tapping Data > Graphs and
Tables > Clinician Selected - A. Capture Management > Open Data.
A beat-to-beat trend for the most recent pacing threshold search is available. If you select the
Strip icon, the trend shows the most recent 1000 events in the search.
The results of a pacing threshold search can be displayed by selecting the Zoom In icon. The
pacing threshold search result can be selected from the list on the screen.
Clinicians have the option to record an EGM (atrial, ventricular, or summed EGM). No EGM
is available if the last pacing threshold search was aborted.
Refer to the reference manual for additional information about collecting Atrial Capture
Management Detail data.
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5.4.3 Ventricular Capture Management Detail
Ventricular Capture Management Detail data provide a record of the pacing threshold pulse
width and amplitude. The pacemaker records the following information for the most recent
668 ventricular pacing threshold searches:
●
Date and Time
●
Amplitude Threshold
●
Pulse Width Threshold
●
Amplitude Margin
●
Adapted or Monitor Only Amplitude
Ventricular Capture Management Detail data can be displayed by tapping Data > Graphs
and Tables > Clinician Selected - V. Capture Management > Open Data.
A beat-to-beat trend for the most recent pacing threshold search is available. If you select the
Strip icon, the trend shows the most recent 1000 events in the search.
The results of a pacing threshold search can be displayed by selecting the Zoom In icon. The
pacing threshold search result can be selected from the list on the screen.
Clinicians have the option to record an EGM (atrial, ventricular, or summed EGM). No EGM
is available if the last pacing threshold search aborted before finding the amplitude
threshold.
Refer to the reference manual for additional information about collecting Ventricular Capture
Management Detail data.
5.4.4 High Rate Detail
The pacemaker collects a beat-to-beat trend at the onset and at the termination of selected
episodes. For some episodes, it also collects EGM.
Episode selection depends on the diagnostic parameters for automatic high rate episodes,
which are automatic diagnostics discussed in Section 5.3, “Automatically collected data
displays”, page 63. One of these automatic parameters, Collection Method, controls
whether High Rate data collection is Rolling or Frozen. Rolling data collection continues to
be updated. Frozen data collection stops when a limit is reached.
The specific data collected for High Rate Detail is controlled by these diagnostic parameters:
●
High Rate Type: AHR, VHR, or both
●
EGM Type: AEGM, VEGM, Summed, or Off
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EGM Allocation: how many episodes with EGM collection and how the EGM is aligned
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relative to the episode onset
●
Pre-detection Timeout: the time limit in which pre-onset EGM can be collected
For single-chamber pacemakers, High Rate Detail data is available for the paced chamber.
Trend data is collected whether or not EGM is collected. The number of episodes of trend
data collected depends on Collection Method and High Rate Type:
●
If High Rate Type is AHR or VHR, for Rolling collection, trend data is collected for the first
episode and is updated for the most recent 13 episodes until the pacemaker is
interrogated. For Frozen collection, trend data is collected for the first 16 episodes.
●
If High Rate Type is AHR and VHR, Rolling trend data is collected for the most recent
8 AHR and 8 VHR episodes. Frozen trend data is collected for the first 8 AHR and 8 VHR
episodes.
The choices for EGM Allocation depend on how the Collection Method and High Rate Type
parameters have been set. You should set those parameters before selecting the EGM
Allocation.
When Rolling data collection is used for pre-onset EGM, the total length of EGM collected is
less than it is for the other options:
●
Rolling data collection for post-onset EGM
●
Frozen data collection for pre-onset or post-onset EGM
In Figure 9 you can see an example of the EGM Allocation window with the Collection
Method set to Rolling and High Rate Type set to AHR&VHR. Each value in the window
represents a number of episodes and the number of seconds of pre-onset and post-onset
EGM to be collected for each episode. If High Rate Type set to AHR&VHR, the number of
episodes is split evenly between atrial episodes and ventricular episodes.
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Figure 9. EGM Allocation window: atrial and ventricular collection
1 High rate type is AHR and VHR.
2 4 episodes with 8 s (pre-onset) and 0 s (post-onset).
3 4 episodes with 4 s (pre-onset) and 4 s (post-onset).
Refer to the implant manual for EGM Allocation values related to the settings of High Rate
Type and Collection Method.
Note: If Rolling collection is programmed and several episodes of one type occur before
episodes of the other type occur, EGM collection for the first type will use all allocated EGM
storage until the other episode type occurs. For example, if an allocation of 4 EGM episodes
is programmed and both AHR and VHR High Rate Types are selected, an occurrence of
4 consecutive VHR episodes results in EGM collection for all 4 VHR episodes. If any AHR
episodes subsequently occur, EGM data for the first 2 AHR episodes replaces the EGM data
of the oldest 2 VHR episodes. Thereafter, EGM data are allocated equally between the
2 triggers.
EGM can be collected with a programmable Pre-detection Timeout of 1 to 12 weeks, in
1-week increments, or of 14 to 24 weeks, in 2-week increments. If episodes occur before the
programmable timeout, pre-onset and post-onset EGM can be collected. If episodes occur
after the programmable timeout, only post-onset EGM can be collected.
Note: If pre-onset EGM and Rolling collection are programmed, and the EGM Pre-detection
Timeout expires, EGM collection will occur for an extra episode. For example, if EGM
Allocation is programmed to “4 for 4/4 secs”, the user would go from 4 episodes with EGM
(prior to the timeout) to 5 episodes with EGM (after the timeout).
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5.4.4.1 How to display a High Rate Detail screen
1. Tap Data > Graphs and Tables > High Rate Episodes > Open Data.
2. Select an episode with EGM and Trend data or an episode with Trend data only.
Note: Episodes with EGM data also have Trend data.
3. Tap Open Episode.
4. Tap the Zoom In icon or the Strip icon from the Episode Onset screen to display
episode onset data.
5.4.5 Rate Drop Response Detail
Data is collected only if the Rate Drop Response feature has been programmed On. When
Rate Drop Response Detail is the clinician-selected data, the pacemaker monitors the
designated chamber for activity related to the operation of the Rate Drop Response. A
beat-to-beat trend is collected for the first and the 4 most recent episodes. Each trend can
record a maximum of 680 events and is frozen when the detection criteria are met. Rate Drop
Response episodes are defined by the programmed settings for the Rate Drop Response
feature.
You may include or exclude refractory sensed events from the data.
5.4.5.1 How to display a Rate Drop Response Detail screen
1. Tap Data > Graphs and Tables > Rate Drop Response Episodes > Open Data.
2. Select an episode with Trend data.
3. Tap Open Episode.
5.5 Programming data collection options
The Data Collection - Setup screen displays settings to collect device data. To view this
screen, tap Data > Data Collection Setup/Clear.
Tap the applicable field to display subordinate parameters or information about data
collection.
5.5.1 Setup options for automatic data collection
Data is collected based on the programmed mode, parameter values, and setup options.
Table 10 gives an overview of setup options necessary to collect certain types of data.
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Table 10. Data collection setup options
Data type Setup options Parameters
Rate Histograms
Atrial High
Rate Episodes
(Mode Switch
Off)
Atrial High
Rate Episodes
(Mode Switch
On)
Ventricular
High Rate Episodes
Clinician
Selected
a
# indicates a programmable parameter.
b
The Termination Rate has the same value as the programmable Detection Rate.
c
The Ventricular Rate for ending collection has the same value as the programmable Ventricular Rate (for
collection).
Include or Exclude refractory sensed
events from heart rate histograms.
Include Refractory
Exclude Refractory
Collect if:
Atrial Rate >= #a bpm Detection Rate
For more than #a seconds Detection Duration
End Collection if:
Atrial Rate < #b bpm Termination Rate (not programmable)
for # a beats Termination Beats
Frozen or Rolling Collection Collection Method
Based on programmed Mode Switch
therapy parameters (Mode Switch,
Detect Rate, Detect Duration, and
Blanked Flutter Search)
Filter out short Mode Switch episodes Collection Delay after Mode Switch
Frozen or Rolling Collection Collection Method
Collect if:
Ventricular Rate >= #a bpm Ventricular Rate (for collection)
for #a beats for (X beats)
End Collection if:
Ventricular Rate < #c bpm Ventricular Rate (not programmable)
for #a beats for (Y beats)
Filter out conducted SVT episodes SVT Filter
Frozen or Rolling Collection Collection Method
Select one of the following:
Off
Custom Rate Trend Duration, Collection Method,
Refractory Senses (Include or
Exclude)
Atrial Capture Management Detail EGM Collection
Ventricular Capture Management Detail EGM Collection
High Rate Detail High Rate Type, EGM Type, Allocation,
Predetection Timeout
Rate Drop Response Detail Refractory Senses (Include or
Exclude)
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5.5.2 Programming a clinician-selected data collection option
5.5.2.1 How to program options for data collection
1. Tap Data > Data Collection Setup/Clear.
2. Verify the parameter settings.
3. (optional) Tap the Clinician Selected… field and choose another option. Verify all of
the parameter settings.
4. Tap PROGRAM.
5.6 Clearing data from the pacemaker
Unless another setting is chosen, data is automatically cleared one hour after the end of the
programming session. The End Session window provides access to options that let you
make the following changes to the default settings:
●
The following data is not automatically cleared. However, you can choose to have it
cleared.
– Atrial Lead Trend (Lead Impedance and Pacing Threshold Trends)
– Ventricular Lead Trend (Lead Impedance and Pacing Threshold Trends)
– Atrial Arrhythmia Trend
Note: Chronic lead trend data typically should not be cleared unless the pacing lead
has been replaced.
Selecting the Now option causes the pacemaker to clear the collected data and start
collection of new data immediately when you end the session. New data collection
starts when you lift the programming head.
Open the Clear Data window by tapping Data > Data Collection Setup/Clear. Clearing
data is discussed in more detail in Section 3.14, “Ending a patient session”, page 45.
Chronic Ventricular Lead Trend data should be cleared only if the lead is replaced. Clearing
Ventricular Chronic Lead data also clears automatic Ventricular Capture Management Trend
data.
Note: Sensor Indicated Rate Profile data is cleared only when you program certain rate
response parameters or another rate-responsive mode.
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6 Evaluating parameter settings
6.1 Measuring stimulation thresholds
The Threshold test function allows you to measure the patient’s stimulation thresholds to
determine appropriate settings for amplitude and pulse width. To begin a threshold test, you
must select the desired test type, heart chamber, and test parameter values from the
Threshold Test Setup screen.
6.1.1 The Threshold tests setup screen
To display the Threshold tests setup screen, tap Tests > Threshold.
Note: During the execution of a threshold measurement, lifting the programming head from
over the pacemaker for at least two seconds will return the pacemaker to its programmed
state. This action should be taken in the event of a programmer malfunction, loss of power,
or the absence of an appropriate command confirmation.
6.1.2 Setting up a threshold measurement test
Before you execute a threshold test, choose the test type and parameter options that will
provide appropriate threshold information.
6.1.2.1 How to set up a threshold test
1. Tap Tests > Threshold to display the Threshold tests setup screen.
2. Choose a setting for each of the 3 setup options: Test Type, Chamber, and
Decrement after. Note that not all setup options apply to every test and thus, are not
displayed.
3. Choose a test setting for each displayed parameter (see Table 11).
4. Execute the test you selected in step 2, above:
●
Capture Management: see Section 6.1.4.
●
Strength Duration: see Section 6.1.3.
●
Amplitude - Auto Decrement: see Section 6.1.5.
●
Pulse Width - Auto Decrement: see Section 6.1.5.
●
Manual - Amplitude & Pulse Width: see Section 6.1.6.
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Table 11. Threshold test parameters
Test parameteraValue selection
Mode Select the pacing mode you want to be in effect during the threshold test. The
available mode options depend on the programmed mode.
Lower Rate Select a lower rate value high enough to provide consistent pacing during the
test. Loss of capture cannot be determined if the pacemaker is inhibited.
AV delay If the selected test mode is DDD, DDI, or DOO, select an AV delay value short
enough to provide a consistently paced ventricular rhythm.
If the mode is DDD, the selected value applies to both Paced AV and Sensed AV
intervals.
Amplitude If the selected test type is Amplitude - Auto Decrement, Strength-Duration, or
Manual, select the value at which you want the test to start. The value must be
high enough to provide consistent capture.
If the selected test type is Pulse Width - Auto Decrement, select the value you
want to be in effect during measurement of the pulse width threshold.
Pulse width If the selected test type is Pulse Width - Auto Decrement or Manual, select the
value at which you want the test to start. The value must be high enough to
provide consistent capture.
If the selected test type is Amplitude - Auto Decrement or Strength-Duration,
select the value you want to be in effect during measurement of the amplitude
threshold.
If the selected test type is Strength-Duration, pulse width cannot be less than
0.4 ms.
a
If the Ventricular Capture Management test type is chosen, the test parameters are fixed to pacemaker configured
values.
6.1.3 Executing a Strength Duration threshold test
If you completed the setup steps in Section 6.1.2 and you selected Strength Duration as
the threshold test type, use this procedure to execute the test. The results of this test are
displayed as a strength duration curve, described in Figure 10.
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Figure 10. Strength duration curve
1 The “X” marks the present programmed settings.
2 The square marks the pending amplitude and pulse width settings.
3 The computed strength duration curve based on the threshold test results. Only amplitude and
pulse width values that intersect above the curve are projected to result in capture; any point of
intersection falling in the shaded area below the curve will not result in capture.
6.1.3.1 Test restrictions
Any one of the following conditions will prevent or abort execution of the Strength Duration
threshold test.
●
Implant detection is still operative.
●
Recommended Replacement Time (RRT) is set.
Tap TEST Press and Hold to open a message window that informs you of the restricting
condition.
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6.1.3.2 Test procedure
There are 3 parts to the Strength Duration test. Complete all 3 parts in the order listed.
●
Part I: Measuring the amplitude threshold
●
Part II: Measuring the pulse width threshold
●
Part III: Displaying the strength-duration curve
6.1.3.3 How to measure the amplitude threshold (Part I)
1. Position the programming head, and hold it steady for the duration of this procedure.
2. Press and hold TEST Press and Hold.
The programmer automatically reduces pulse amplitude one programmable value
every 2 to 15 pacing pulses (as set during setup). The programmed value and the point
at which it takes effect shows at the top of the Live Rhythm Monitor.
In cases where pacing is inhibited, the test reduces pulse amplitude one value every
eight seconds.
3. Carefully observe the patient’s ECG for loss of capture.
4. At the moment you see loss of capture, release TEST Press and Hold.
The Strength Duration test screen shows the results of the amplitude threshold
measurement. The point at which capture is recovered is considered the amplitude
threshold.
Tap the Test Strip icon if you want to view or print a 10 s ECG strip starting 8 s before
the test ended. If you want to restart the test, tap Return to Setup.
Note: If the displayed threshold value is not the lowest programmed test value that
maintained capture, tap the Threshold Amplitude field to change the threshold value.
6.1.3.4 How to measure the pulse width threshold (Part II)
1. With the programming head in position, press and hold TEST Press and Hold.
The programmer automatically reduces pulse width one programmable value at a time.
The amplitude setting in effect is twice the threshold value measured in Part I. The
starting pulse width is approximately one-half the value used in Part I or 0.40 ms,
whichever is greater.
2. Carefully observe the patient’s ECG for loss of capture.
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3. At the moment you see loss of capture, release TEST Press and Hold.
The screen now shows the results of both amplitude and pulse width threshold
measurements. The point at which capture is recovered is considered the pulse width
threshold.
Select the Test Strip icon if you want to view or print a 10 ms ECG strip starting 8 ms
before the end of the test.
Note: If the displayed threshold value is not the lowest programmed test value that
maintained capture, adjust the Pulse Width value in the test setup screen.
Tap Return to Setup to restart the test.
6.1.3.5 How to display the strength duration curve (Part III)
1. Tap Draw Curve.
2. This action causes the programmer to calculate and draw the strength-duration curve
based on the amplitude and pulse width threshold test results.
Note: For information about the strength duration curve, see Figure 10.
Options on this screen allow you to:
●
Program amplitude and pulse width values (see Section 6.1.3.6). After a Strength
Duration Test, you can program settings for ambulatory capture management operation
also.
●
View the 10 ms ECG strip collected during either threshold measurement
●
Print a Strength Duration Threshold Test Report, which includes the ECG strips
●
Return to the Test Setup screen, which clears this test data from the screen
Note: If certain pacing parameter values have changed during the session, the programmer
may display a pop-up Warning window advising you that Battery and Lead parameters
should be remeasured. This information is needed for the calculation of the estimated
battery life appearing on the Test Results screen. Tap Yes to allow the programmer to make
these real-time measurements.
6.1.3.6 Selecting and programming amplitude and pulse width values
The programmer displays the pending threshold point on the strength curve based on the
pending amplitude safety margin value or output settings.
From the Strength Duration Test: Curve screen, you can program the suggested
amplitude and pulse width values, or select and program different values.
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If you do not wish to program the suggested values, you can change them:
●
Tap the Amplitude Safety Margin of field. Select an adequate safety margin value that
is above the amplitude and pulse width at the pacing threshold. The programmer then
selects the nearest amplitude value that maintains the lowest possible drain on the
pacemaker to correspond to your selected safety margin. It displays this value under the
Pending column. Note that rounding to the nearest upper value may set a slightly higher
safety margin.
●
Tap the Amplitude or Pulse Width field to display the programmable values. Select the
desired value for pulse width or amplitude. Note that the programmer may recalculate
the amplitude safety margin value to the nearest decimal value to approximate the
selected amplitude value (for example, 3.20 X).
●
Tap the Capture… field (if available) if you want to change Capture Management
parameters.
To program the capture, amplitude and pulse width values, position the programming head,
and tap PROGRAM.
Note: The Estimated battery life of value is an estimate of the average time remaining until
the pacemaker requires replacement. This estimate is based on the amplitude and pulse
width values selected for programming, as well as data accumulated by the pacemaker
since the previous patient session.
Note: The ambulatory capture management feature will discontinue ambulatory threshold
measurements if amplitudes greater than 5.0 V or pulse widths greater than 1.0 ms are
programmed.
6.1.4 Executing a Ventricular Capture Management threshold test
If you selected Ventricular Capture Management as the threshold test type, use this
procedure to execute the test.
6.1.4.1 Test restrictions
Any of the following conditions prevents execution of the Ventricular Capture Management
test. When you tap Tests > Threshold, then select Capture Management and Ventricle,
a message informs you of restricting conditions, if any:
●
Implant detection is still operative.
●
Amplitude is set to a value greater than 5.0 V.
●
Pulse width is set to a value greater than 1.0 ms.
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Pacing mode that does not support ventricular pacing and sensing (these include
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asynchronous modes, non-pacing modes, triggered modes, and atrial modes).
●
Recommended Replacement Time (RRT) is set.
6.1.4.2 Test procedure
The programmer will determine test values for mode and lower rate that are in effect before
determining amplitude and pulse width thresholds.
Note: The patient should be at a resting rate before you execute this test. To verify a resting
rate, the test performs an inactivity check to determine if pacing or sensing is at a low rate.
If a high sensed or paced rate detected, the programmer will stop the test during the first
stage of the test.
6.1.4.3 How to execute a Ventricular Capture Management test
1. Position the programming head and hold it steady for the duration of the test.
2. Tap START Test to start the test sequence, which proceeds automatically (see
Section 6.1.4.4).
Note: To interrupt the test at any time during the automatic execution sequence, tap
Abort & Restore. Previous parameter settings will be restored.
3. Upon successful completion, the test graphically displays the threshold measurement
results as a strength duration curve.
Refer to Figure 10 for information about the strength-duration curve.
6.1.4.4 About the automatic test sequence
The following paragraphs describe each phase of the automatic test sequence, which starts
when you tap START Test in step 2 of the preceding procedure.
The test applies a series of ventricular support cycles and test paces at each amplitude and
pulse width value to determine if capture is present. Each series has 1 to 3 sets of support
cycles, with each set followed by a test pace and a backup pace:
●
The support cycles are at the currently programmed amplitude and pulse width
(including ventricular safety paces and nonrefractory ventricular sensed events).
●
The test pace is at a reduced amplitude or pulse width value, followed 110 ms later by a
backup pace at the programmed amplitude and at a pulse width of 1.0 ms
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During each phase of threshold measurements, the test annotates on the live rhythm window
the test paces and whether each test pace maintained capture (CAP), lost capture (LOC), or
capture could not be determined (Ignore).
Note: The programmer temporarily shortens AV intervals during the test so the pacemaker
predominately paces the ventricle from conducted events.
How amplitude threshold is measured – The test first measures the stimulation threshold
by reducing amplitude at a 0.4 ms pulse width. The test starts at the last ambulatory
amplitude threshold measurement or at 0.75 V if the threshold has not been measured
before.
Amplitude values are automatically reduced by each programmable value until loss of
capture occurs. Amplitude is then increased to regain capture. The point at which capture is
recovered is considered the amplitude threshold. The programmer then plots this point on
the strength-duration graph.
How pulse width threshold is measured – The test next measures the stimulation
threshold by reducing pulse width. The previously determined amplitude threshold value is
doubled and the test starts at the last ambulatory pulse width threshold measurement.
Alternately, the test will start at 0.21 ms if the threshold has not been measured before.
Pulse width values are automatically reduced by each programmable value until loss of
capture occurs. Pulse width is then increased to regain capture. The point at which capture
is recovered is considered the pulse width threshold. This point is plotted on the strength
duration graph.
How test results are displayed – The programmer now displays a strength duration curve
based on the measured amplitude and pulse width thresholds. The programmer also
displays on the strength duration curve the points where the capture threshold exists for
current and pending output settings (amplitude and pulse width).
Options on this screen allow you to:
●
Program settings for ambulatory capture management operation, particularly the
amplitude margin value.
●
View or print the 10 s ECG strip collected during either threshold measurement.
●
Print a Ventricular Capture Management Threshold test report, which includes the ECG
strips.
●
Return to the Test Setup screen, which clears this test data from the screen.
Note: If certain pacing parameter values have changed during the session, the programmer
may display a pop-up Warning window advising you that Battery and Lead parameters
should be remeasured. This information is needed to calculate the estimated battery life. Tap
Yes to allow the programmer to make these real-time measurements.
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Displaying ambulatory test results – Optionally, the programmer can also display a
second strength-duration curve based on the last successful threshold search
measurement taken by the ambulatory capture management feature. This option can be
used to compare the ambulatory threshold results against the in-office test results.
6.1.4.5 Selecting and programming the Amplitude Safety Margin
From the test results screen, you can program the amplitude safety margin value by tapping
Amplitude Margin. You may also program the operation of the ambulatory Capture
Management feature by tapping Capture…. This opens the Capture Management
window, which allows you to select several ambulatory Capture Management parameters.
6.1.4.6 How to change the Amplitude Safety Margin
1. Tap Amplitude Margin to display the safety margin options.
2. Select the desired value.
Note that the programmer displays the nearest amplitude value that corresponds to the
selected safety margin and displays this value along with the pending value for pulse
width under the Pending column.
The programmer also displays the pending threshold point on the strength-duration
curve based on this pending safety margin.
Note: The ambulatory Capture Management feature will discontinue threshold
measurements if amplitudes greater than 5.0 V or pulse widths greater than 1.0 ms are
programmed.
The Ventricular Capture Management Threshold test results provide the following
programmable options:
●
Capture…: select this field to change the operation of the ambulatory capture
management feature.
●
Amplitude Margin: select this field to change the safety margin. Selecting an amplitude
safety margin automatically displays the amplitude value that attains this safety margin.
Note: The Estimated battery life of value is an estimate of the average time remaining until
pacemaker replacement is required. This estimate is based on the amplitude and pulse
width values selected for programming as well as data accumulated by the pacemaker since
the previous patient session.
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6.1.5 Executing an Auto Decrement (Amplitude or Pulse Width) threshold test
If you completed the setup steps on Section 6.1.2 and you selected Amplitude - Auto
Decrement or Pulse Width - Auto Decrement as the threshold Test Type, use this
procedure to execute the test. The test results screen provides the option to program
permanent values for amplitude and pulse width.
6.1.5.1 How to execute an Auto Decrement threshold test
1. Position the programming head and hold it steady in position for the duration of this
procedure.
2. Press and hold TEST Press and Hold.
The programmer automatically reduces the test parameter (amplitude or pulse width)
one programmable step every 2 to 15 pacing pulses (as set during setup). The
programmed value and the point at which it takes effect shows at the top of the live
rhythm display.
3. Carefully observe the patient’s ECG for loss of capture.
4. At the moment you see loss of capture, release TEST Press and Hold.
The Test Results screen shows the results of the threshold measurement.
Tap the Test Strip icon if you want to view or print a 10 s ECG strip starting 8 s before
the test ended.
Note: If the displayed threshold value is not the lowest programmed test value that
maintained capture, tap Threshold to change the threshold value.
Tap Print… to print a Threshold Test Report. The Threshold Test Report includes the
ECG strip.
If you want to restart the test, tap Return to Setup.
6.1.5.2 How to program Amplitude and Pulse Width values
1. Tap Amplitude in the Permanent column and choose the desired setting from the
values displayed.
2. Tap Pulse Width in the Permanent column and choose the desired setting from the
values displayed.
3. Position the programming head and tap PROGRAM.
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6.1.6 Conducting a Manual Threshold test
If you completed the setup steps on Section 6.1.2 and you selected Manual - Amplitude &
Pulse Width as the threshold test type, use this procedure to execute the test.
6.1.6.1 How to execute a Manual Threshold test
1. Position the programming head, and hold it steady for the duration of this procedure.
2. Tap START Test to program the selected test values.
3. Tap the arrows to change the amplitude or pulse width setting.
The newly displayed value is automatically programmed. The value and the point at
which it was programmed show at the top of the live rhythm display.
4. Observe the patient’s ECG for loss of capture as you adjust the amplitude and pulse
width settings.
By raising and lowering the parameter values, you can determine the lowest value or set
of values that maintain capture.
5. To stop the test and return to permanent parameter settings, tap STOP and Restore.
6. Tap Save/Print… to display the Save/Print Test Values screen.
From the Save/Print Test Values screen, you can:
●
View the sequence of all test values programmed during execution of the manual
threshold test.
●
View or print a 10 s ECG strip that starts 8 s prior to the test termination. (Tap the
STOP row from the field of tested values and then tap the Test Strip icon.)
Save one or more of the programmed test values you want to include on the Manual
Threshold Test report.
6.1.6.2 How to save test values for the printed report
1. Select each row to be saved.
Or, select the Select All check box to choose all test values.
If you do not want a selected value to be saved, select that row a second time.
2. Tap Save.
The test values saved are marked in the right-most column.
3. Print the Manual Threshold Test Report. Tap Print….
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6.2 Determining a sensitivity setting
The Sensing (P/R wave amplitude) test lets you determine an appropriate setting for
pacemaker sensitivity. You can select an automatic or a manual test method to determine the
present level of P wave or R wave signals. A Sensing test begins at the Sensing Test Setup
screen.
6.2.1 The Sensing Test setup screen
To display the Sensing Test Setup screen, select Tests > Sensing.
Caution: The Sensing test requires that the pacemaker be programmed temporarily to a
pacing rate that will result in predominantly intrinsic heart activity. This is necessary to allow
sensing during execution of the test. For this reason, use of the Sensing test should be
limited to patients having an intrinsic rhythm that will provide adequate support during
execution of the test.
Note: During the execution of a measurement, lifting the programming head from over the
pacemaker for at least 2 s will return the pacemaker to its programmed state. This action
should be taken in the event of a programmer malfunction, loss of power, or the absence of
an appropriate command confirmation.
6.2.2 Checking the patient’s intrinsic rate
To properly conduct the Sensing test, it is helpful to first evaluate the patient’s intrinsic
rhythm. Refer to Section 3.11, “Checking the patient’s underlying rhythm”, page 39.
When you observe the patient’s intrinsic rhythm, note the rate and whether or not each
intrinsic depolarization is accompanied by a Sense marker (AS or VS). If Sense markers do
not appear, the present setting for pacemaker sensitivity may be too high. A test sensitivity
value that provides consistent sensing is required to successfully run the Sensing test.
6.2.3 Executing an automatic Sensing test
This test automatically measures and reports the present level of R wave or P wave sensing
and includes the option to program a sensitivity value based on the test results.
6.2.3.1 How to execute the sensing measurement
1. Tap Tests > Sensing to display the Sensing Test Setup screen.
2. Choose P Wave Amplitude or R Wave Amplitude from the Test Type field, or choose
the desired Chamber (see Table 12).
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3. Choose a desired Test Value for each of the test parameters listed in Table 13.
4. Position the programming head and tap Start Measurement.
Continue to hold the programming head steady for the duration of the automatic testing
process.
Caution: If the patient’s condition indicates that pacing support is needed, tap
Abort Test or lift the programming head for at least 2 s to terminate the test.
5. Read the messages displayed in the Test Results window. For information about test
result messages, refer to Section 6.2.4.
During execution of the Sensing test, the pacemaker determines whether or not sensing is
lost as it steps sensitivity through a range of programmable settings above the selected test
value. If sensing is lost when the sensitivity is stepped from 2.0 mV to 2.8 mV for example, the
measured amplitude is stated to be between 2.0 and 2.8 mV
Note: Because a special test circuit in the pacemaker performs this test, pacemaker
operating parameters do not vary from the selected test values, unless the intrinsic signal is
significantly larger than the sensitivity test value. In such cases, the test value for sensitivity
is automatically adjusted upward to 1.00 mV for atrial tests and 2.80 mV for ventricular tests.
The ECG and Marker Channel traces will not show any changes in pacemaker operation
during the test.
Table 12. Sensing Test setup options
Setup option Available settings
Test Type Select Test Type to display the following options:
P Wave Amplitude:
Select this test to determine the level of P wave sensing in the atrium.
R Wave Amplitude:
Select this test to determine the level of R wave sensing in the ventricle.
Manual:
Select this test to manually adjust sensitivity to determine the setting at which
sensing is lost.
Chamber Atrium, Ventricle:
You can select these options as an alternative to selecting P Wave Amplitude
or R Wave Amplitude as the test type. For these automatic tests, the test type
and chamber options are linked. If you selected Manual as the test type, select
the chamber in which you want to conduct the test.
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Table 13. Sensing Test parameters
Test parameter Value selection
Mode Select the pacing mode you want to be in effect during the Sensing test. The
available options depend on the programmed pacing mode.
Lower Rate Adjust rate to a value low enough to obtain consistent sensing. The Sensing test
will not run unless the pacemaker is predominately inhibited.
AV Delay If the test mode is DDD or VDD, adjust this interval to a value long enough to
allow normal conduction. If the mode is DDD, the selected value applies to the
paced AV interval and sensed AV interval during execution of the test.
Sensitivity Select a sensitivity value that provides consistent sensing. This setting would
typically be left to the same value as the present programmed value.
6.2.4 Automatic Sensing test results
Test Successful
Measured P Wave Amplitude between:
1.00 mV — 1.40 mV
Retest Required
Measured P Wave Amplitude > 5.60 mV
For more precise measurement, select Return
to Setup button and rerun at a higher sensitivity value.
Measured P Wave Amplitude between:
1.00 mV — 1.40 mV
For more precise measurement, select Return
to Setup button and rerun at a lower sensitivity value.
Test Aborted
No sense markers were received during the
test.
Please lower the test rate or increase the AV
delay to allow patient intrinsic beats and
rerun the test.
The results of a successfully executed test display the P wave or R wave amplitude as being
between 2 sensitivity settings. You can use this
information to determine an appropriate sensitivity setting.
This message indicates that the Test Value
for Sensitivity is too low.
Loss of sensing did not occur within the range of
values tested above the selected test value. In
this case, you should select a higher test value
for sensitivity and conduct the test again.
This message indicates that the Test Value
for Sensitivity is too high.
If the test determines that sensing was lost at
the next setting above the test value, the programmer displays this message. In this case,
select a lower value for sensitivity and conduct
the test again.
This message indicates that Sense markers were not present.
Telemetered Sense markers (AS or VS) were
not present to start the test. Verify on the live
rhythm display that sensing of the patient’s
intrinsic rhythm is occurring. Adjustment of the
lower rate or the Sensitivity test value may be
required.
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6.2.5 Executing a Manual Sensing test
Using this test, you can determine the level of P wave or R wave sensing by manually
adjusting temporarily programmed values of atrial or ventricular sensitivity.
6.2.5.1 How to execute a Manual Sensing measurement
1. Tap Tests > Sensing.
2. Choose Manual as the Test Type, then choose the desired Chamber.
3. Choose a desired Test Value for each of the test parameters.
4. Tap START Test to program the selected test values.
5. Tap the arrows to change the sensitivity setting.
The newly displayed value is automatically programmed. The value and the point at
which it was programmed shows at the top of the live rhythm display.
6. Observe the patient’s ECG for loss of sensing as you adjust sensitivity. Loss of sensing
is indicated by the loss of Sense markers in the chamber being tested.
By raising and lowering the sensitivity setting, you can determine the approximate
sensed P wave or R wave amplitude, which is the range between the highest sensitivity
setting that provided sensing and the one above it.
7. To stop the test and return to permanent parameter settings, tap Stop and Restore.
8. Tap Save/Print… to display the Save/Print Test Values screen.
From the Save/Print Test Values screen, you can:
●
View the sequence of all values programmed during execution of the manual
sensing test.
●
View or print a 10 s ECG strip that starts 8 s prior to the test termination. (Tap the
“Stop” row from the field of tested values and then tap the Test Strip icon.)
●
Save one or more of the programmed test values you want to include on the Manual
Sensing Test Report.
6.2.5.2 How to save test values for the printed report
1. Select each row to be saved.
Or, select the Select All check box to choose all test values.
If you do not want a selected value to be saved, select that row a second time.
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2. Tap Save.
The test values saved are marked in the right-most column.
●
Print the Manual Sensing test report. Tap Print….
Note: Only those rows that are selected or saved are printed.
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6.3 Using temporary programming to evaluate parameter settings
The Temporary test lets you evaluate different parameter settings or use high-rate pacing
while having the option to quickly and easily return to the original settings. The test settings
remain in effect only while you press TEST Press and Hold.
6.3.1 The Temporary Test setup screen
To display the Temporary Test setup screen, tap Tests > Temporary.
Warning: High-rate stimulation of the ventricles could result in ventricular tachycardia or
fibrillation. Application of temporary high-rate pacing should be performed only under
careful patient monitoring and control.
6.3.2 Procedure for conducting a Temporary Test
1. Tap Tests > Temporary to display the Temporary - Test Setup screen.
2. Select the desired test chamber and the parameter settings you want to test. Availability
of temporary pacing mode options depend on the programmed mode setting.
3. Position the programming head and continue to hold it in place for the duration of this
test.
4. To initiate the test values, select and hold TEST Press and Hold.
5. To end the test, release TEST Press and Hold.
6. Tap the Test Strip icon to view or print a 10 s ECG strip starting 8 s before the temporary
test ended.
7. Tap Print… to print a Temporary Test Report, which includes the 10 s ECG strip.
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6.3.3 Programming a high temporary pacing rate
Warning: High-rate stimulation of ventricles could result in ventricular tachycardia or
fibrillation. Application of temporary high-rate pacing should be performed only under
careful patient monitoring and control.
1. Tap Tests > Temporary to display the Temporary - Test Setup screen and select the
desired test chamber and a single chamber test mode.
High pacing rates above 180 bpm are available only if you select a single chamber
pacing mode (AAI/VVI, AOO/VOO, AAT/VVT, ADI/VDI).
2. Tap the Enable Rates > 180 bpm check box so that a check mark shows.
This action displays the High Rate Pacing Warning! window.
3. Tap OK to proceed or Cancel to discontinue this procedure. Tapping OK allows you
access to pacing rates up to 400 bpm.
4. Select the desired rate and any other parameter setting you want to temporarily initiate.
5. Position the programming head and continue to hold it in place for the duration of this
test.
6. To initiate the test values, press and hold TEST Press and Hold.
7. To end the test, release TEST Press and Hold.
8. Tap the Test Strip icon to view or print a 10 s ECG strip starting 8 s before the temporary
test ended.
9. Tap Print… to print a Temporary Test Report, which includes the 10 s ECG strip.
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7 Programming pacemaker parameters
7.1 Programming parameters
7.1.1 Selecting the Therapy Parameters screen
To view the present parameter settings or to program changes, tap Params. This displays
the Parameters - Therapy screen. This screen allows you to select and program new
parameter values applicable to the interrogated pacemaker model.
7.1.2 Programming, printing, and clearing parameter values
Programming parameters – To program pending values for one or more parameters, tap
PROGRAM. This button is active only when one or more parameter values have been made
pending and no parameter values are restricted (see Section 7.1.3).
Similarly, the Program key on the programming head will respond only when PROGRAM is
active on the screen.
Printing parameters – To print the currently displayed parameter values, tap the printer
icon.
Clearing parameters – To clear all pending parameter values and restore the previously
interrogated values on the screen, tap Undo.
Note: On primary and subordinate parameter value windows, tap Undo Pending to clear
only the pending parameter values associated with that window. See Section 7.1.4.1.
7.1.3 Parameter restrictions
Certain combinations of parameter values are restricted because they are invalid or result in
undesirable interactions. The programmer recognizes these combinations and may not
allow programming until all parameter conflicts are resolved and all parameter selection
requirements are met. A symbol that provides the status of a parameter value appears next
to the value in the selection window. The symbols in Table 14 can appear next to a parameter
value.
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Table 14. Symbols that appear with parameter values
Symbol Explanation
Interlock – Indicates that the parameter value conflicts with the setting of another present
or pending value. Select another value or resolve the conflicting parameter value before
programming the parameter.
Warning – Indicates that a warning message is available regarding that value. The message can be viewed either by selecting the message button or by reselecting that parameter. In the latter case, the warning is displayed as a warning note in the selection window.
These parameter values can be programmed.
Adaptive – Indicates that the programmed value can be changed automatically by the
device. The symbol does not necessarily indicate that the parameter value has been
adapted from a previously programmed value, only that it is able to be adapted.
Nominal – Indicates that the value is the Medtronic nominal value.
Programmed – Indicates that the value is the programmed value.
7.1.3.1 Adaptive parameter values
The adaptive symbol appearing next to a parameter value on the Parameters - Therapy
screen indicates that the programmed value can be changed automatically by the
pacemaker. The symbol does not necessarily indicate that the parameter value has been
adapted from a previously programmed value—only that it can be adapted.
For example, the adaptive symbol appears next to the Ventricular Amplitude value, which is
adaptive if Ventricular Capture Management is in the Adaptive mode. This is true whether the
Adaptive mode is programmed or pending for Ventricular Capture Management.
If Ventricular Capture Management is in the Monitor Only mode (which is not adaptive), no
adaptive symbol appears next to the Ventricular Amplitude value.
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7.1.4 How to program parameters
All pacing therapy parameters are changed by selecting the parameter value field (the white
box containing the value).
Notes:
●
If you intend to program a different mode, select the pacing mode first. Selecting a mode
displays the parameters pertinent to that mode.
●
Some parameter value fields open windows that display subordinate parameters. Refer
to Section 7.1.5.
For example, MVP operates when the programmed mode is either AAI<=>DDD or
AAIR<=>DDDR.
7.1.4.1 How to program parameter values
1. Tap the parameter value field next to Mode.
2. From the parameter value window, select the desired value. For MVP operation, select
either the AAI<=>DDD mode or the AAIR<=>DDDR mode.
Selecting a value closes the window. The selected value appears in place of the present
value and is denoted as “pending” by a dashed rectangle.
Note: To clear a pending value from the window, select the parameter value field and
then tap Undo Pending. To close the value window without selecting a value, tap
Close or OK.
3. Repeat steps 1 and 2 to include other parameters you want to program.
4. Position the programming head and tap PROGRAM, or press the program button on
the programming head.
To program all pending parameter values, tap PROGRAM. Hold the programming head
over the pacemaker until the confirmation message appears in the displayed ECG strip.
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