Medtronic MC1AVR1 Programming Guide

Micra™ AV SW044

Programmer software

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

Micra™ AV SW044

Programming Guide

A guide to programming the Micra™ AV dual chamber transcatheter pacing system using the
Medtronic SW044 application software on a Medtronic programmer

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

Capture Management, CareLink, CareLink Encore, Conexus, Marker Channel, Medtronic,
Medtronic CareLink, Micra, Paceart, Quick Look, SessionSync, SureScan

Medtronic

Micra™ AV SW044

Contents

1 Software overview .................................................... 6

1.1 Introduction ......................................................... 6

1.2 Software description .................................................. 6

1.3 Intended use ........................................................ 7

1.4 Contraindications .................................................... 7

1.5 Warnings and precautions ............................................. 7

1.6 Potential adverse events .............................................. 7

1.7 Data security ........................................................ 8

2 Patient session ....................................................... 9

2.1 Conducting a patient session .......................................... 9

2.2 Starting a patient session ............................................. 9

2.3 Interrogating the device during a patient session ......................... 10

2.4 Responding to device status indicator warnings ......................... 11

2.5 Programmer screen ................................................. 12

2.6 Quick Look II screen ................................................. 19

2.7 Enabling emergency VVI pacing ...................................... 20

2.8 Patient information .................................................. 21

2.9 Parameters ........................................................ 22

2.10 Using a checklist to complete tasks .................................... 25

2.11 Printing reports ..................................................... 27

2.12 Exporting data to the Paceart system .................................. 30

2.13 Saving and retrieving device data ..................................... 31

2.14 Ending a patient session ............................................. 33

3 System tests ........................................................ 35

3.1 Performing the Device Measurements tests ............................ 35

3.2 Conducting the Temporary test ....................................... 41

3.3 Conducting tests to optimize atrial mechanical sensing for AV synchrony .... 42

3.4 Conducting an Exercise test ......................................... 45

Glossary ................................................................. 49

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Micra™ AV SW044

1 Software overview

1.1 Introduction

This manual describes the Medtronic Model SW044 programmer software and explains how
to use a programmer to conduct a patient session.

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

If you have a printed copy of this manual and any part of it is illegible, contact a Medtronic
representative to request a replacement manual.

The following manuals and documents contain additional information about the programmer
and implanted device:

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

Reference manual – This manual provides detailed descriptions of device features.

Programmer reference manual – This manual provides a detailed description of the

Medtronic programmer. There is a programmer reference manual for the Medtronic
CareLink 2090 programmer and a programmer reference manual for the Medtronic CareLink
Encore 29901 programmer.

Device manual – This manual provides summaries of device features, indications and
contraindications, warnings and precautions, instructions for implanting the device, quick
reference specifications, parameter tables, and an explanation of package symbols.

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

1.2 Software description

The Medtronic Model SW044 software runs on the Medtronic CareLink 2090 programmer
and the Medtronic CareLink Encore 29901 programmer and communicates with an
implanted device to program settings and view stored data. The software is compatible with
an implanted Micra AV device.

The programmer and software are for use by healthcare professionals or by Medtronic
personnel in a clinical or a hospital environment.

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1.2.1 Notice

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

For more information on the Patient Information screen, see Chapter 2.

1.3 Intended use

The Medtronic Model SW044 software is used to program device parameters and to
evaluate the performance of the implanted pacing device. See the Micra AV Model
MC1AVR1 device manual for device indications.

1.4 Contraindications

There are no known contraindications for the use of this software. However,
contraindications for the use of the implantable device and the programmers that are
compatible with this software are documented in their respective manuals.

1.5 Warnings and precautions

There are no general warnings or precautions related to the use of this software. See specific
warnings and precautions in the functional sections to which they apply. For warnings and
precautions related to the use of the implantable device or the programmers that are used
with this software, refer to the device manual or the programmer manuals.

1.6 Potential adverse events

There are no known potential adverse events for the use of this software. However, potential
adverse events for the use of the implantable device and the programmers that are
compatible with this software are documented in their respective manuals.

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1.7 Data security

Medtronic has designed safeguards to protect patient information and device data for the
Micra AV Model MC1AVR1 device.

Inductive telemetry communication system – The Medtronic inductive telemetry
communication system is used with the clinician programmer to interrogate and program the
device. It can also be used to interrogate the device for remote monitoring, if available. This
system uses short-range communication that protects patient information and device data.

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2 Patient session

2.1 Conducting a patient session

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

Use the programmer to perform the following tasks:

●

Review the presenting rhythm.

●

Verify the status and the clinical effectiveness of the implanted system.

●

View or enter patient information.

●

Program parameters.

●

Print, save, or export data.

2.2 Starting a patient session

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

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

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

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

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

Note: Emergency programmer functions are available only after the initial interrogation.

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

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

Use the following steps to start a patient session:

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1. Power on the programmer.

2. To establish telemetry between the device and the programmer, place the
programming head over the device.

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

3. To ensure that reliable telemetry has been established, position the programming head
so at least 1 of the green lights illuminates.

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

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

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

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

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

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

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

Micra™ AV SW044

2.3 Interrogating the device during a patient session

The programmer interrogates the device at the start of a patient session. You can also
interrogate the device at any time during a patient session.

To interrogate the device during a patient session, tap Interrogate or press the I button on
the programming head.

The Interrogation In Progress window displays during the device interrogation.

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2.4 Responding to device status indicator warnings

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

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

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

●

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

Indicator warning Action

Warning - Device Elec­trical Reset

SERIOUS DEVICE
ERROR

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

Contact a Medtronic representative. Immediate replacement of

the device is recommended.

2.4.1 Responding to a device reset warning for an implanted device

If the programmer reports that an electrical reset occurred before the device is implanted, do
not implant the device and contact a Medtronic representative.

If the programmer reports that an electrical reset occurred in an implanted device, contact a
Medtronic representative and perform the following steps:

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

2. Tap Clear in the pop-up window to clear the reset indicator. A confirmation window
appears, indicating that all previously interrogated data in the programmer is cleared.

3. Tap Continue.

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

4. Interrogate the device.

a. Note the time and date when counter data was last cleared. The time and date

indicate when the electrical reset occurred.

b. Determine, if possible, what the patient was doing at the time and date the electrical

reset occurred.

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c. Tap End Session > Save to Media….

d. Follow the instructions in the Save To Media - Insert Media window to save the

session data. Give a copy of this saved data file to your Medtronic representative.
The data will help to determine the events that led to the reset.

5. If a full electrical reset occurred, the reprogrammed values are displayed in the error
message. Verify the programmed device parameters and, if necessary, reprogram the
device parameters for your patient.

After a full electrical reset, the device operates in the VVI mode until it is reprogrammed.
For a list of electrical reset parameter settings, see the Medtronic Micra AV Model
MC1AVR1 device manual.

6. Verify that the device date and time are correct. If necessary, reprogram the date and
time.

7. Tap Interrogate to re-interrogate the device.

8. Tap Data > Diagnostics > Battery and Device Measurements to navigate to the

Data - Battery and Device Measurements screen. Check the Data - Battery and
Device Measurements screen to verify that the battery voltage is >2.56 V.

Note: A battery voltage of ≤2.56 V indicates that the Recommended Replacement

Time (RRT) for the device has been reached.

Note: If the device battery no longer has adequate capacity to provide therapy to the
patient, it has reached the End of Service (EOS) condition. The programmer displays
an EOS indicator when the battery reaches the EOS condition, and device deactivates
pacing permanently.

9. If necessary, conduct an electrode impedance test, a sensing test, and a pacing
threshold test.

2.5 Programmer screen

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

The screen includes the following areas:

●

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

●

Status bar below the task bar

●

Live Rhythm Monitor area

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●

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

●

Navigation icons on the right

Micra™ AV SW044

2.5.1 Status bar

When the device has been interrogated, the status bar at the top of the display screen
(located immediately below the task bar) shows the current pacing mode, the device model
name, and any manual operation in progress.

2.5.2 Live Rhythm Monitor window

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

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

●

If telemetry has been established with the device, the heart rate and interval (in ms)
display.

●

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

The Live Rhythm Monitor window appears in partial-screen view by default. To expand the
window to full-screen view, tap the small square button in the upper-right corner of the
window, or tap Adjust….

The display of waveform traces in the Live Rhythm Monitor window varies, depending on
which sources you select during data collection setup and how you arrange traces in the
full-screen view.

2.5.2.1 About the Live Rhythm Monitor

The Live Rhythm Monitor can display up to 5 waveforms during a patient session:

●

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

Note: ECG signals are required to assess AV synchrony.

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●

The EGM signal is telemetered from the device to the programmer. The programmer
cannot display or record an EGM waveform trace until the device has been interrogated.

●

The A. Sensing or A. Sensing: Vector [X] labels show atrial activity in the form of
mechanical signals sensed by the device accelerometer.

– The waveform labelled A. Sensing simply shows sensed atrial activity. It is not used

for any therapeutic purpose.

– The waveform labelled A. Sensing: Vector 1, A. Sensing: Vector 2, or A. Sensing:

Vector 3 indicates that the device is programmed to track the atrial mechanical signal
(that is, atrial systole) to facilitate AV synchronous pacing. See the Medtronic
Micra AV reference manual for a description of AV synchronous pacing.

2.5.2.2 Adjusting the Live Rhythm Monitor display

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

1. Tap Adjust….

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

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

Button Description

Increase the size of the waveform trace.

Restore the waveform trace to its default size.

Decrease the size of the waveform trace.

Opens a list of which waveform trace, marker annotation, or marker intervals can
be displayed on the selected line.

Indicates which waveform traces have been selected for printing. Tap the button
to clear the selection and choose a different trace.

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Button Description

Select the waveform trace for printing. You can select 1 or 2 waveform traces for
printing.

Change the color of the waveform trace.

Micra™ AV SW044

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

Optional adjustment

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

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

Display pacing artifacts superimposed over
waveform traces.

Control how quickly the waveform is drawn
across the display.

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

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

Steps

Tap Clipping.

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

Tap Show Artifacts.

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

Tap Normalize.

Tap (Calibrate).

4. Tap OK.

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

2.5.2.3 Marker Channel data

Markers on the waveform trace indicate events such as pacing and sensing.

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

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Micra™ AV SW044

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

Notes:

●

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

●

The device stops transmitting marker data when you lift the programming head.

●

If Holter Telemetry is programmed to On and telemetry has been established with a
Holter monitor, the device transmits Marker Channel data and supplementary data to the
Holter monitor regardless of the position of the programming head.

2.5.2.4 Live waveform trace recordings

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

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

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

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

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

●

ECG, EGM, and A. Sensing traces

●

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

●

Test values during system tests

●

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

EGM waveform trace

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

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Simultaneous report printing and live waveform trace recording

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

2.5.2.5 Freezing live waveform traces

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

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

1. Tap Freeze.

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

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

Optional task Steps

Open the Adjust… window for the
frozen strip viewer.

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

Measure time intervals on the wave­form trace.

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

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

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

View earlier or later portions of the
strip.

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

Save the on-screen frozen strip. Tap Save.

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

Use the waveform adjustment buttons.

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

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

Tap Delete.

Scroll horizontally using the horizontal scroll bar.

Scroll vertically using the vertical scroll bar.

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

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2.5.2.6 Recalling saved waveform strips

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

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

The Strips… window is displayed.

2. Tap a strip to view.

3. Tap Open.

The frozen strip viewer displays the selected strip.

2.5.3 Navigation icons

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

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

Table 1. Navigation icons

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

Navigates to the next task in the Checklist.

Displays options to display the Quick Look II screen and diagnostic data.

Displays the Parameters screen to view and program device parameters.

Displays options to perform system tests.

Displays options to print reports.

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Table 1. Navigation icons (continued)

Displays the Patient Information screen.

Displays options to adjust preferences, view parameter changes made during the ses­sion, save data, and end the session.

2.6 Quick Look II screen

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

The Quick Look II screen provides the following information:

●

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

●

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

●

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

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

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

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

2.6.1 Information on the Quick Look II screen

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

To view relevant details about a section of the screen or a screen artifact, tap its associated
button, if active.

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

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To access the Battery and Device Measurements screen, tap the button next to the

Remaining Longevity label.

Electrode impedance, capture threshold and sensing amplitude measurements –

The Battery and Device Measurements screen shows the most recent measurements for
electrode impedance, capture threshold, or sensing amplitude. To compare these
measurements to daily measurement trends, tap the button next to the Electrode
Impedance label, the Capture Threshold label, or the Sensing label. To perform manual
tests to measure these device performance variables, see the Medtronic Micra AV reference
manual.

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

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

If you select one of the displayed observations, the button becomes active if observation
details are available. Tap the button to see observation details.

Micra™ AV SW044

2.7 Enabling emergency VVI pacing

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

Note: Operation of the MRI SureScan feature is disabled when emergency VVI pacing is
programmed.

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

2. Tap Emergency.

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

Program - VVI Pacing window.

Note: You can also enable emergency VVI pacing by pressing the red mechanical

emergency VVI button on the programmer.

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

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2.8 Patient information

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

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

●

Clinical conditions (Date of Birth and History) are included in the Save to Media file.

●

Clinical conditions can be printed from the Patient Information screen.

●

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

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

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

2.8.1 Entering and viewing patient information

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

1. Tap Patient.

The Patient Information screen displays.

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

Field

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

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

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

Serial Number Displays the serial number of the implanted device.

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Description

Note: This field cannot be changed.

Medtronic

Field Description

Implant… Enter the test values for R-Wave Amplitude, Electrode Impe-

dance, and Threshold. Also enter the Pulse Width value.

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

acters).

History… Enter the patient’s clinical conditions.

Physician/Phone/Hos­pital

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

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

were programmed into memory. This field is not selectable.

Micra™ AV SW044

3. Tap PROGRAM.

2.9 Parameters

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

All programmable parameters appear as active fields that you can tap. Some active fields
pertain to only 1 parameter, while other active fields provide a pathway to a group or groups
of parameters. If a parameter cannot be programmed, no active field appears next to its
name.

After you select new values for parameters, the new values display as pending values. A field
containing a pending value displays a dashed rectangle around its border. Values remain
pending until you tap PROGRAM to program them to device memory.

2.9.1 Accessing and programming parameters

Use the Parameters screen to view and program parameters.

1. Tap the Params icon.

The Parameters screen displays.

2. Make the desired parameter selections.

The new values display as pending values.

3. Tap PROGRAM.

The pending values are programmed to device memory.

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2.9.2 Parameter symbols

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

Table 2. Symbols that appear with parameter values

Symbol Explanation

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

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

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

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

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

displayed instead of the Nominal symbol.

Programmed – Indicates that the value is the programmed value.

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

Table 3. Symbols that appear on the message button

Symbol Explanation

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

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

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

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

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2.9.3 Parameter sets

Parameter sets are collections of parameter values that have been stored for quick retrieval.
Tap the Get… button to see the list of parameter sets in the Get Parameter Set window.
Available parameters sets include:

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

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

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

2.9.4 Creating a custom parameter set

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

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

1. Tap the Params icon.

The Parameters screen is displayed.

2. Make the desired parameter selections.

3. Tap Save….

The Parameter Set Name window is displayed.

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

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

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

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2.9.5 Retrieving a parameter set

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

1. Tap Params > Get….

The Get Parameter Set window opens.

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

Optional task Steps

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

Program the selected parameter set. 1. Tap Set Pending to use the parameters

from the selected set.

The Get Parameter Set window closes
and the new parameter values appear as
pending values on the Parameters
screen.

2. Tap PROGRAM to program the pending
values to device memory.

Remove an unneeded parameter set from the
list.

1. Tap Get… to display the Get Parameter
Set window.

2. Tap the name of the custom set of param­eters.

3. Tap Delete.

The Delete - Are you sure? window dis-
plays.

4. Tap Delete > Close.

2.10 Using a checklist to complete tasks

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

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

1. Tap the Checklist icon.

The Checklist screen displays.

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

●

Medtronic Standard Followup checklist

●

Medtronic Standard Implant checklist

●

Custom checklists you have created

The tasks included in a selected checklist appear in the Task list.

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

3. Follow these actions to advance through the checklist tasks:

Action Steps

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

Checklist icon. The screen for the first task

appears. Complete the task on the screen.

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

the next.

Return to the Task list. Tap the Checklist icon.

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

Task or tap the
icon.

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

Task or tap the
icon.

button next to the Checklist

button next to the Checklist

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

2.10.1 Creating and editing a custom checklist

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

To create a new checklist, use the following steps:

1. Tap the Checklist icon.

The Checklist screen displays.

2. Tap New….

The Checklist - New window opens.

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

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Optional task Steps

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

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

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

task displays again in the box on the right.

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

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

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

checklist and tap Delete Task.

Micra™ AV SW044

4. Tap Checklist name and enter a name.

5. Tap Save.

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

Use the following options to manage custom checklists:

Optional task Steps

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

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

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

Edit…. Change the name and tap Save.

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

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

it cannot be restored.

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

2.11 Printing reports

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

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

2.11.1 Setting printing preferences

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

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

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

●

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

●

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

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

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

Your preferences take effect immediately.

2.11.2 Enabling printing of an Initial Interrogation Report

You can set preferences to print an initial interrogation report following device interrogation.
You can also specify which data to include in the report.

Preferences for the initial interrogation report take effect at the start of a new session and
remain in effect until you change them.

1. During a patient session, tap Reports > Preferences… > Initial Report to display the
preferences for the Initial Interrogation Report.

2. Select the check box for Print Initial Interrogation Report after first interrogation.
If you select this check box, the report prints at the beginning of a patient session
following device interrogation.

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3. Select the reports to include in the initial interrogation report and tap OK.

The selected preferences are stored and the Preferences window closes. The initial
interrogation report prints following device interrogation.

Note: The Quick Look II Report is always included in the initial interrogation report and
cannot be deselected.

2.11.3 Printing a set of reports during a patient session

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

1. Tap Reports > Available Reports….

2. Select the reports you want to print.

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

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

4. Tap one of the following buttons:

●

Print Now prints the reports immediately.

●

Print Later adds the print request to the print queue.

2.11.4 Printing a Final Report for the patient session

You can print a final report at the end of a patient session. A session summary report is
included in the final report.

Note: Your final report preferences remain in effect between sessions and across all
applications.

Your first final report

Follow these steps the first time you create a final report:

1. Tap Reports > Preferences… > Final Report.

2. Select the reports you want to print in addition to the Session Summary report.

3. Tap OK.

4. Tap Reports > Final Report….

5. Select the Number of Copies and the Printer.

6. Tap Print Now or Print Later.

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Subsequent final reports

Follow these steps if you have created a final report in the past and you know your report preferences:

1. Tap Reports > Final Report….

2. Select the Number of Copies and the Printer.

3. Tap Print Now or Print Later.

Micra™ AV SW044

2.11.5 Print Queue window

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

The Print Queue window during a patient session

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

The Print Queue window outside of a patient session

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

Printing or deleting a print job

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

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

●

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

●

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

●

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

2.12 Exporting data to the Paceart system

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

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

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2.13 Saving and retrieving device data

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

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

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

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

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

Before saving data to a USB flash drive or a disk, interrogate the device. The programmer
saves only the data it has interrogated.

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

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

●

performing a Save To Media operation

●

performing a Read From Media operation

●

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

2.13.1 Saving device data

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

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

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

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

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

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

2. Tap Interrogate to interrogate the device.

3. Tap Session > Save to Media….

4. Tap Save.

While a save-to-media action is in progress, the Save To Media - In Progress window and
progress indicator display.

Micra™ AV SW044

Note: Before you remove a USB flash drive, wait a few seconds after the progress indicator
reaches 100%.

2.13.2 Retrieving device data

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

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

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

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

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

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Use the following steps to retrieve device data:

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

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

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

4. Tap Start.

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

5. Tap OK.

6. Tap Open File….

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

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

2.14 Ending a patient session

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

Note: Session data may be lost once a session has ended. Print session data or save the
session data to a USB flash drive or a disk before you end the session to avoid permanent
loss of the session data.

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

This Session.

Note: Tap Print… to print the list of changes made during this session.

2. Tap End Session….

The End Session? window displays.

3. If you want to change the setting for clearing the session data, select one of the following
options from the Pacemaker Data drop-down list, or proceed to Step 4:

●

Select Clear Now to immediately clear the session data.

●

Select 1 hour after session end to clear session data 1 hour after the end of the
session.

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●

Select Do not clear if you want data collection to continue as if there were no
device interrogation. Data collection will end when the session data is cleared.

4. Choose one of the following options:

●

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

●

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

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3 System tests

3.1 Performing the Device Measurements tests

The Micra AV Model SW044 software provides 3 assessment tools to measure device
electrical performance for your patient. These tests, the sensing test, the impedance test,
and the threshold test, can be performed individually or in an automated sequence from the
Tests - Device Measurements screen.

Tap Tests > Device Measurements to access the Tests - Device Measurements screen.

3.1.1 Performing the device measurement tests in automated sequence

You can perform 2 or 3 of the device measurement tests in an automated sequence.

To prepare for the device measurement tests, follow these steps:

1. Tap Tests > Device Measurements to open the Tests - Device Measurements
screen.

2. Select the 2 or 3 tests that you wish to perform. If you wish to perform only 1 test, see the
procedure for that test in the following sections.

Make your pre-test parameter changes for the sensing test or the threshold test (the
impedance test has no parameters):

●

For more information on the sensing test parameters, see Section 3.1.2.

●

For more information on the threshold test parameters, see Section 3.1.4.

3. Place the programming head over the implanted device to establish the telemetry
between the device and the programmer. Move the programming head over the
patient’s heart until 1 or more of the green indicator lights illuminate on the programming
head.

4. Tap Interrogate.

Wait for the device interrogation to complete.

5. Following the device interrogation, tap START Tests to perform the selected device
measurements tests.

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3.1.2 Performing a Sensing Test

The sensing test allows you to measure R-wave amplitudes. This test can help you assess
sensing performance.

Before you perform the sensing test, you can set temporary values for the test parameters.
These temporary values help ensure that the device does not pace the patient during the
test. The temporary values increase the likelihood that sensed events will occur.

Warning: Before you start the sensing test, select a temporary pacing rate that allows
intrinsic sensed events that can be well tolerated by the patient. If the patient shows poor
tolerance to the selected pacing rate during the test, tap Stop. To complete the sensing test,
the device must detect 2 consecutive ventricular sensed events, and the interval between
them must be at least 500 ms (120 bpm). If after 10 s this interval is not detected between 2
consecutive ventricular sensed events, the device aborts the sensing test. If you cannot
select a pacing rate that is well tolerated by the patient, consider withholding the sensing
test.

3.1.2.1 Considerations for performing the Sensing Test

●

If you need to conduct consecutive sensing tests to collect data, reduce the pacing rate
gradually to avoid or minimize patient symptoms associated with abrupt changes in
heart rate.

●

A successful sensing test ends after a few seconds and restores the programmed
settings. No changes are made to the permanent Lower Rate.

●

Do not adjust the value for RV Sensitivity based on the results of the sensing test. For
more information, refer to the Medtronic Micra AV reference manual.

Comparison to sensing trends – Sensing amplitude measurements taken during a
sensing test may include events that are atypical or a result of oversensing (for example,
noise interference). These events are excluded from the daily measurements of automatic
sensing amplitude that the device collects and reports in the R-wave amplitude trend. Due
to this difference in measurement operations, sensing test results may differ from R-wave
amplitude trend data.

3.1.2.2 How to perform the Sensing Test

Follow this procedure if you are performing a sensing test only. If you are performing the
device measurement tests in an automated sequence, see Section 3.1.1.

Follow these steps to perform a sensing test:

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1. Tap Tests > Device Measurements > Sensing Test.

Note: Make sure that Impedance Test and Threshold Test are not selected.

2. If necessary, change the values for Mode and Lower Rate by tapping the corresponding
Test Value field for each parameter. Select new values.

Note: The pacing modes available under Test Value depend on the programmed
pacing mode, displayed below the Permanent label.

3. Tap START Tests.

4. Observe the Live Rhythm Monitor for an intrinsic rhythm.

5. If you see an intrinsic rhythm at a rate that is within the normal rate range for the patient,
the test is successful. The R-wave measurement value displays in the test results at the
bottom of the Device Measurements screen.

a. If the patient shows poor tolerance to the test pacing rate, tap STOP.

b. Reset the Mode and Lower Rate values as appropriate for the patient.

c. Resume the test beginning with Step 3.

Note: If you are unable to program a test pacing rate that the patient can tolerate,
consider withholding the sensing test.

Micra™ AV SW044

After the sensing test is completed, the measurement value is shown in the R-wave column
in the test results area at the bottom of the Device Measurements screen. Compare the
sensing test R-wave measurement value with the measurement values in the R-Wave

Amplitude window. To see the R-Wave Amplitude window, tap Data > Diagnostics >
R-Wave Amplitude Trend > Open Data.

3.1.3 Performing an Impedance Test

An electrode impedance test tests the integrity of the implanted device by measuring the
impedance of the pacing electrode. Impedance measurements are made by delivering a
pacing pulse. If the intrinsic heart rate is faster than the programmed pacing rate, the device
increases the pacing rate to be slightly faster than the intrinsic rate for 1 interval.

Note: The upper limit for the pacing rate can vary depending on the programmed pacing
mode.

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3.1.3.1 Considerations for the Impedance Test

Sensing measurement pulses – During a sequence of electrode impedance

measurements, the device may pace at a rate faster than the programmed value for the lower
rate for 1 or more pacing cycles.

3.1.3.2 How to perform the Impedance Test

Follow this procedure if you are performing the impedance test only. If you are performing the
device measurement tests in an automated sequence, see Section 3.1.1.

Follow these steps to perform an impedance test:

1. Tap Tests > Device Measurements > Impedance Test.

Note: Make sure that Sensing Test and Threshold Test are not selected.

2. Tap START Tests. The message Impedance Test In Progress… displays.

3. If necessary, tap STOP to end the test.

When the test is complete, the new value for impedance measurement is shown in the
Impedance column in the test results area of the Tests - Device Measurements screen.
You can determine whether the electrode impedance has changed by comparing the
impedance measurement value to the daily impedance measurement values on the
Electrode Impedance Trend window and to the values measured during the previous
follow-up appointments (see the patient’s chart). To see the Electrode Impedance Trend
window, tap Data > Diagnostics > Electrode Impedance Trend > Open Data.

3.1.4 Performing the Threshold Test

The threshold test allows you to measure the pacing stimulation thresholds. The threshold
test provides the option to select an automatic test (Capture Management) or a manual
pacing threshold test (Amplitude – Auto Decrement) to check the pacing stimulation
thresholds.

If you select Capture Management, the programmer checks the pacing stimulation
thresholds at different pacing amplitude settings. If you select Amplitude – Auto
Decrement, you can program your own mode and pacing settings to identify the pacing
stimulation thresholds.

You can use the results of the pacing threshold test to program pacing amplitude and pulse
width to capture the heart and optimize battery longevity.

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3.1.4.1 Considerations for performing the Threshold Test

Selectable and default values – The parameter values available for the pacing threshold

test depend on the permanent (programmed) values for pacing therapy.

Pacing threshold and safety margin – Following a pacing threshold test, make sure that
the programmed value for the RV Amplitude parameter provides an adequate safety margin
above the patient’s pacing threshold.

3.1.4.2 How to perform the automatic Threshold Test

Follow this procedure if you are performing a single automatic (Capture Management)
threshold test. If you are performing the device measurement tests in an automated
sequence, see Section 3.1.1.

1. Tap Tests > Device Measurements > Threshold Test.

2. Select Capture Management from the Threshold Test parameter list.

3. Tap START Tests. The Capture Management test begins. When the test is in progress,
the Marker Channel waveform trace in the Live Rhythm Monitor window shows the
annotations VC (ventricular capture) or VL (ventricular loss) for the delivered test paces.

If you need to end the test, tap STOP.

When the test has finished, the test measurement value displays in the Threshold column in
the test results area of the Tests - Device Measurements screen. To determine if the pacing
threshold measurement has changed, compare the Threshold value to the automatic daily
threshold measurement values on the Capture Threshold Trend screen. To see the

Capture Threshold Trend screen, tap Data > Diagnostics > Capture Threshold Trend >
Open Data.

3.1.4.3 How to perform the manual Pacing Threshold Test

The manual pacing threshold test enables you to determine the patient’s pacing stimulation
thresholds. Pacing threshold information may be used to determine appropriate amplitude
and pulse width settings to ensure capture while minimizing output to maximize battery
longevity.

Considerations for measuring pacing thresholds:

●

The selectable and default values provided by the pacing threshold test depend on the
programmed values for pacing therapy.

●

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

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1. Tap Tests > Device Measurements.

Make sure that Sensing Test and Impedance Test are not checked in the Tests - Device
Measurements window.

2. Select Amplitude - Auto Decrement from the Threshold Test drop-down list.

3. Tap START Tests to display the Tests - Pacing Threshold window.

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

Optional task Steps

Change the value for Decrement after. Tap the field next to the parameter if you wish

to change the test value.

Change the Test Value for Mode, Lower
Rate, RV Amplitude, or RV Pulse Width.

Change the Test Value for V. Pace Blanking. Tap the field next to the parameter if you wish

Tap the fields next to these parameters you
wish to change the test values.

to change the test value.

5. Initiate the pacing threshold test. Press and hold the TEST Press and Hold button.

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

7. When capture is lost, immediately release the TEST Press and Hold button.

The device resumes its original pacing values and displays the RV Amplitude
Threshold Test - Results window.

8. In the Ending Value column, verify the detected RV Amplitude at which loss of capture
occurred.

9. If you want to retest the pacing threshold, use the following options to view or change
data in the RV Amplitude Threshold Test - Results window:

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Optional task Steps

Change the programmed values for RV
Amplitude or RV Pulse Width.

View the ending value and the permanent
value for V. Pace Blanking parameter.

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

Tap the value in the Permanent column to dis­play the RV Amplitude parameters pop-up
window or the RV Pulse Width parameters
pop-up window. Select the desired values and
tap PROGRAM to program the pending val­ues.

—

If the RV Amplitude Threshold Test -
Results window is displayed, tap the Test
Strip icon in the lower left corner of the test
results window to see the test results.
Tap Close in the test strip window to return to
the Tests - Device Measurements window,
or tap Print… to print the report.

Micra™ AV SW044

10. When you have finished viewing or changing data on the Pacing Threshold window,
tap Close to return to the Device Measurements screen.

3.2 Conducting the Temporary test

The temporary test evaluates device operation during temporary changes to parameter
settings. The changes are in effect only while the test is in progress.

The temporary test allows you to evaluate changes to these parameters:

●

Mode

●

Lower Rate

●

Amplitude

●

Pulse Width

●

Sensitivity

3.2.1 How to conduct the Temporary test

Place the programming head over the device to establish telemetry. Move the programming
head until you see 1 or more of the green indicator lights on the programming head, then hold
it in place.

Follow these steps to perform a temporary test:

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1. Tap Tests > Temporary to display the Tests - Temporary screen.

2. To change the parameters for the test, tap the parameters under the Test Value label
and select from the range of temporary values for that parameter.

Note: Be aware of temporary parameter values that can inhibit pacing in
pacemaker-dependent patients.

Warning: High-rate stimulation of the ventricle could result in ventricular tachycardia or
fibrillation. Apply temporary high-rate pacing under careful patient monitoring and
control.

3. To start the test, press and hold TEST Press and Hold.

When the test starts, the annotation Test Started appears above the waveform trace in
the Live Rhythm Monitor.

Continue to hold TEST Press and Hold to observe changes in the waveform.

4. To end the test, release TEST Press and Hold. The annotation Test Ended appears
above the waveform trace in the Live Rhythm Monitor.

5. Remove the programming head.

6. To view the last 10 s of the temporary test ECG test strip, tap the Test Strip icon to see
the Temporary Test, collected [date and time stamp] window.

7. If you want to keep a copy of the ECG test strip, tap Print… to display the Print -
Options window.

Make your print selections.

3.3 Conducting tests to optimize atrial mechanical sensing for AV synchrony

There are 2 ways that the Model MC1AVR1 can be set up for AV synchrony, where the atrial
mechanical signal is properly sensed in order to know when to pace the ventricle:

●

The Atrial Sensing Setup process is automated. It takes place following implant. It
collects atrial sensing data and then sets the atrial sensing parameters to
patient-specific values based on the collected data.

●

The Manual Atrial Mechanical test allows you view the A3 signal and the A4 signal on the
programmer and program the atrial sensing parameters as you choose.

Note: Connect a surface ECG between the patient and the programmer to confirm atrial
sensing.

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3.3.1 Atrial sensing setup

Atrial sensing setup is performed shortly following device implant without clinician
intervention. Following atrial sensing setup, you should interrogate the device to verify AV
synchrony performance.

For more information on atrial sensing setup, see the Medtronic Micra AV reference manual.

3.3.1.1 Starting the atrial sensing setup process

The Atrial Sensing Setup parameter is shipped at On/Restart, so the atrial sensing setup
process will initiate without clinician intervention following device implant if the programmed
mode is VDD.

If you choose to initiate the atrial sensing setup process and the device is programmed,
perform the following steps:

1. Place the programming head over the implanted device to establish telemetry.

2. Program the pacing mode to VDD.

3. Program the Atrial Sensing Setup parameter to On/Restart.

The following events take place:

a. The pacing mode switches to VDI.

b. The message Atrial Sensing Setup Scheduled displays in the upper right corner of

the programmer.

4. Remove the programming head from the patient for at least 3 min.

3.3.1.2 The atrial sensing setup process

During the atrial sensing setup process, if telemetry is re-established, the message Atrial
Sensing Setup in Progress displays in the upper right corner of the programmer.

Process suspension and reversion to scheduled status

If the atrial sensing setup suspends and reverts to the scheduled status, the message Atrial
Sensing Setup Scheduled displays in the upper right corner of the programmer. If the atrial
sensing setup attempts to restart, the message Atrial Sensing Setup In Progress displays in
the upper right corner of the programmer.

Note: Programming parameters or running tests during the atrial sensing setup process will
cause it to suspend. For other suspension causes, see the Medtronic Micra AV reference
manual.

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To stop the atrial sensing setup process at any time, program the Atrial Sensing Setup
parameter to Off/Complete.

Micra™ AV SW044

3.3.1.3 Completing the atrial sensing setup process

When the atrial sensing setup process completes, the device programs the Atrial Sensing
Setup parameter to Off/Complete, and no message displays in the upper right corner of the
programmer.

Note: The device can reprogram some parameters or record relevant Observations in the
Quick Look II screen in response to its analysis of the cardiac cycle collected during the atrial
sensing setup process.

3.3.2 The Manual Atrial Mechanical test

You can observe and program the atrial sensing parameters with the assistance of the
manual atrial mechanical test.

The manual atrial mechanical test displays the patient’s ECG signal and the device
accelerometer signal. Your settings for the A3 Threshold, the A3 Window End, and the A4
Threshold parameters are represented as lines superimposed on the accelerometer
signals. The accelerometer blanking and threshold windows are labeled PVAB, A3, and A4.

The manual atrial mechanical test can be used to adjust the A3 and A4 parameter thresholds
and the A3 Window End relative to the A3 and A4 signals so that the atrial and ventricular
event markers in the test window indicate effective AV synchrony. See the Medtronic
Micra AV reference manual for more details.

Note: The initial parameter settings shown in the Tests - Manual Atrial Mechanical screen
are the current programmed settings.

3.3.2.1 Manual Atrial Mechanical test procedure

Follow these steps to conduct a manual atrial mechanical test:

1. Attach a surface ECG to the patient to monitor and confirm atrial sensing and AV
synchrony.

Note: ECG signals are required to assess AV synchrony.

2. Place the programming head over the device to establish telemetry. Move the
programming head until you see 1 or more of the green indicator lights on the
programming head, then hold it in place.

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3. Tap Tests > Manual Atrial Mechanical.

The Tests - Manual Atrial Mechanical screen displays. The current parameter values
listed in the Permanent column are the same as the values in the Test Value column.

4. Change the Test Value parameter values as you choose.

5. Tap and hold the TEST Press and Hold button for multiple cardiac cycles shown on the
ECG. Collect cycles where the P-wave and R-wave appear to be synchronous and the
A3 and A4 signals can be distinguished from each other.

Note: Up to 10 s of cardiac cycles are recorded.

6. Release the TEST Press and Hold button. The recorded test cardiac cycles display in
the test results window. The cardiac cycles are displayed in the reverse order that they
were recorded. For example, if you record 9 cycles, the first cycle you will see in the test
results window is labeled 9/9.

7. Tap on the left and right arrow icons on the right and left edges on the test results window
to see the collected cardiac cycles.

8. Tap Enable Program > PROGRAM to program your updated parameter settings.

If you are not satisfied with the test results, repeat Step 4 through Step 7 until you are
satisfied with the test results.

If you wish to print the test results, tap Test Strip > Print.

Micra™ AV SW044

3.4 Conducting an Exercise test

The exercise test helps you to assess the patient’s settings for rate-response. The
rate-response settings are applied when the device is operating in either VVIR or VDIR
mode.

Note: VDIR mode is used when the device is programmed to VDD mode and operating
under the Activity Mode Switch.

As an alternative to automatic Rate Profile Optimization, you can conduct an exercise test
from the programmer to set the rate response ranges for the Lower Rate, ADL Rate, and
Upper Sensor Rate. If Rate Profile Optimization is programmed to Off, the rate-response
parameters remain at their programmed values. When Rate Profile Optimization is
programmed to On, this feature adjusts the 3 rate-response parameters once each day. For
more information about rate-responsive pacing, see the Medtronic Micra AV reference
manual.

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The exercise test allows you to evaluate the rate-response settings for the patient and
optimize the rate-response control parameters:

●

The LR Setpoint (lower rate setpoint) determines the activity counts required to pace at
a rate higher than the lower rate.

●

The ADL Setpoint (activities of daily living setpoint) determines the minimum sensor
response to pace at the ADL Rate, which falls within the ADL rate range.

●

The UR Setpoint (upper rate setpoint) determines the minimum sensor response to
pace at the Upper Sensor Rate, which is at the upper limit of the exertion rate range.

●

The Activity Vector determines the accelerometer vector used for rate-response. For
more information about choosing the Activity Vector, see the Medtronic Micra AV
reference manual.

Note: The programmed LR Setpoint setting must be lower than the ADL Setpoint setting,
and the ADL Setpoint setting must be lower than the UR Setpoint setting.

3.4.1 Performing an Exercise test

1. Program the pacing mode to VVIR.

2. Position the programming head over the patient’s device to establish telemetry. Move it
until you see at least 1 green light on the programming head.

3. Tap Tests > Exercise. If test data from a previous exercise test is in the device memory,
this data is shown on the Exercise test screen.

4. Tap the Duration field and select the test duration (5 or 20 min).

5. Tap the Activity Vector field, select from the vector list, and tap PROGRAM.

Note: Do not change the currently programmed values for LR Setpoint, ADL Setpoint,
and UR Setpoint. These values provide a baseline to determine the necessity to adjust
the patient’s rate-response setpoints in consideration of the results of the exercise test.

6. Tap Start. The message “Warning - Data will be lost” warns that you that the current test
results will be overwritten if you start the exercise test.

Note: Print or otherwise record the current values if you want to compare them to the
test values.

7. Tap Continue to start the test or tap Cancel to return to the Exercise test screen.

8. Continue the test until you see the message Test Complete, or stop the test at any time.
The data recorded up to that point will be saved.

9. Re-establish telemetry with the device as explained in Step 2.

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10. Tap Stop and Retrieve to display the test results.

11. See Section 3.4.2 to interpret the test results.

3.4.2 Interpreting Exercise test data and adjusting rate-response setpoints

The device collects and displays the following information on the Tests - Exercise screen:

●

A time stamp when the test data was most recently collected

●

Programmed Activity Vector

●

Exercise test duration

●

Activity count data

Note: In the test printout, activity count data is labelled as “Patient activity”.

●

Heart rate data

●

Sensor rate data

1. The test data is displayed as the Activity Counts graph on the Tests - Exercise test
screen.

2. To view the patient’s heart rate, sensor rate, and the device activity during the exercise
test, tap Activity Counts and select Rate Graph.

3. Examine the exercise test results shown on the Activity Counts graph. Compare the
patient activity count data to the programmed values for LR Setpoint, ADL Setpoint, and
UR Setpoint.

To determine if you need to adjust the rate-response setpoint values, consider the
activity that the patient was engaged in during the exercise test:

●

The LR Setpoint (that is, the lower rate set point) corresponds to when the patient
is at rest at the beginning of the test. Following the test, tap LR Setpoint and select
a value slightly higher than the highest activity count for when the patient is at rest.

●

The ADL Setpoint (that is, the activities of daily living set point) corresponds to
when the patient is engaged in moderate activity. Following the test, tap ADL
Setpoint and select the average activity count for when the patient is engaged in
moderate activity.

●

The UR Setpoint (that is, the upper rate setpoint) corresponds to when the patient
is engaged in vigorous activity. Following the test, tap UR Setpoint and select a
value slightly lower than the average activity count for when the patient is engaged
in vigorous activity.

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4. Tap PROGRAM to program the updated rate-response values.

Note: The rate-response setpoint values can also be programmed when the device is
programmed to VDD mode.

5. To print the results of the exercise test, tap Print….

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Glossary

device reset – automatic device operation to recover from a disruption in device memory

and control circuitry. Programmed parameters may be set to default reset values. This
operation triggers a device status indicator.

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

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

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

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

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

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

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

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

Quick Look II data – overview data summarizing the most important indicators of system

operation and the patient’s condition, including information about device status, pacing
therapy, and system-defined observations.

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

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

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

Programming Guide 49

Medtronic, Inc.

*M991357A001*

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

Medtronic USA, Inc.

Toll-free in the USA (24-hour technical consultation for
physicians and medical professionals)
Bradycardia: [phone]
Tachycardia: [phone]

Technical manuals

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© 2020 Medtronic
M991357A001 B
2020-01-22