Medtronic D00U006 Instructions for Use
CareLink SmartSync™ Micra™ VR Application Help
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
Medtronic, Medtronic with rising man logo, and Medtronic logo are trademarks of Medtronic. Third-party trademarks (“TM*”) belong to their respective owners. The
following list includes trademarks or registered trademarks of a Medtronic entity in the United States and/or in other countries.
Capture Management™, CareLink SmartSync™, CareLink™, Micra™, Paceart Optima™, Paceart™, Quick Look™, SessionSync™, SureScan™
Contents
1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
1.1 Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
1.2 Intended use of the implantable device app . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
1.3 Warnings and precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
1.4 Potential adverse events . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
1.5 Download or order the instructions for use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
1.6 IT network, tablet, and data information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
1.7 Reporting errors and serious incidents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
2 Overview of the interface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
2.1 Areas . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
2.2 Status indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
3 Reinterrogating the implanted device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
3.1 Reinterrogate the implanted device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
4 Responding to device status indicator warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
4.1 About device status indicator warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
4.2 Respond to the WARNING – DEVICE ELECTRICAL RESET warning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
4.3 Respond to the SERIOUS DEVICE ERROR warning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
5 Using the Live Rhythm Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
5.1 About the Live Rhythm Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
5.2 Markers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
5.3 Adjust the Live Rhythm Monitor display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
5.4 Freeze live waveform traces . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
6 Using the eStrip recorder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
6.1 About the eStrip recorder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
6.2 Modify the display of waveform traces . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
6.3 Configure waveform strip preferences . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
6.4 Access waveform strips . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
6.5 Change the length of a waveform strip . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
6.6 Measure time intervals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
6.7 Draw notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
6.8 Edit the title of a waveform strip . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
6.9 Use the Holter feature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
7 Viewing summary data using the Quick Look screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
7.1 About the Quick Look screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
7.2 View the Quick Look screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
8 Using emergency VVI pacing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
8.1 Enable emergency VVI pacing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
9 Programming patient information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
9.1 Program the patient information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
10 Programming implantable device settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
10.1 Parameter symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
10.2 Program the parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
10.3 Create custom parameter sets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
10.4 Retrieve parameter sets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
10.5 Program data collection preferences . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
10.6 View parameter changes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
11 Viewing and analyzing diagnostic data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
11.1 View clinical diagnostic data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
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11.2 View device diagnostic data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
12 Performing system tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
12.1 Configure the test preferences for the Live Rhythm Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
12.2 Perform the Device Measurements Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
12.3 Perform a Sensing Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
12.4 Perform an Impedance Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
12.5 Perform a pacing Threshold Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
12.6 Perform a Temporary Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
12.7 Perform an Exercise Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
13 Using the SessionSync feature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
13.1 View the SessionSync connection status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
13.2 Send device data and reports to the Paceart Optima system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
13.3 End the patient session with the automatic SessionSync feature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
14 Using session tools . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
14.1 Connect to the base . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
14.2 Save the implantable device data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
14.3 About Read From File sessions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
14.4 End the patient session . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
15 Working with reports and saved device data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
15.1 Configure the report preferences . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
15.2 Generate reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
15.3 View or export saved reports and implantable device data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
4
1 Introduction
1.1 Description
The CareLink SmartSync Micra VR Application (referred to as the implantable device app) allows you to program the settings of a
Micra VR device and view stored device data.
Use the implantable device app to perform the following tasks:
• Review the presenting rhythm
• Verify the status of the implantable device
• Assess the clinical effectiveness of the implantable device
• View or enter patient information
• Program parameters
• Save or export data
The implantable device app is a component of the CareLink SmartSync device manager.
Note: The CareLink SmartSync Micra VR Application model number is D00U006.
1.2 Intended use of the implantable device app
1.2.1 Intended use
The intended purpose is to interrogate, program, or execute tests on a Medtronic cardiac device.
1.2.2 Intended users
The implantable device app is intended for use by healthcare professionals or Medtronic representatives in a clinical or hospital
environment.
1.2.3 Intended patient population
The implantable device app is intended for use with patients who either have or are receiving a supported implantable device.
1.2.4 Expected clinical benefits
The clinical benefit of the implantable device app is the ability to interrogate and program Medtronic implantable devices.
1.2.5 Indications for use
For information about the indications for the implantable device, refer to the clinician manual for the implantable device.
1.2.6 Contraindications
There are no known contraindications for the use of the implantable device app.
Note: For information about contraindications for the implantable device, refer to the clinician manual for the implantable device.
1.3 Warnings and precautions
These warnings and precautions apply when using the implantable device app in combination with the other device manager
components.
Note: For warnings and precautions about the use of the implantable device, refer to the clinician manual for the implantable device.
Importance of instructions for use – Before using the implantable device app, Medtronic recommends that you do the following:
• Read the implantable device instructions for use.
• Read the device manager instructions for use.
• Carefully assess the patient’s condition and the implantable device system to determine the appropriate settings for tests and
device programming.
Improper use of the implantable device app could result in erroneous programming, inadvertent pacing, improper operation of
telemetry, or incorrect operation of measurement functions.
Tablet and app interaction – Due to the dynamic nature of the tablet environment, operating system events such as notifications,
alarms, and messaging can take priority and, therefore, move the implantable device app to the background. Tapping, pressing
buttons, and using gestures on the tablet can also result in moving the implantable device app to the background or closing the
implantable device app. For example, the implantable device app moves to the background if you lock the tablet.
When the implantable device app moves to the background or closes, telemetry with the implantable device is paused or lost. If a test
is in progress, whether the test continues or stops depends on the type of test. For more information, refer to the section on performing
system tests in this app help.
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When you restore the implantable device app from the background, the implantable device app attempts to re-establish
communication with the implantable device and displays the system status. If the implantable device app was closed, you must
interrogate the implantable device to re-establish communication with the implantable device.
Electromagnetic interference – If electromagnetic interference (EMI) occurs during a telemetry session, EMI can prevent the
proper programming or confirmation of values. For more information about EMI, refer to the clinician manual for the implantable
device.
1.4 Potential adverse events
There are no known potential adverse events related to the use of this implantable device app.
For information about potential adverse events related to the use of the implantable device, refer to the clinician manual for the
implantable device.
1.5 Download or order the instructions for use
To view, download, print, or order a PDF version of this app help, go to www.medtronic.com/manuals, or contact a Medtronic
representative.
The PDF version of this app help can be viewed using a current version of any major internet browser. For best results, use Adobe™*
Acrobat™* Reader software with the browser.
Paper copies of this app help are available to customers free of charge. They should arrive in 3 to 7 days. To order, go to
www.medtronic.com/manuals or contact a Medtronic representative.
1.6 IT network, tablet, and data information
1.6.1 Required IT network characteristics and configuration
To use the implantable device app, your tablet must have Bluetooth® wireless technology1. An Internet connection is optional.
Bluetooth wireless technology
You must enable Bluetooth wireless technology on your tablet. The Bluetooth connection allows the hardware components of the
device manager to communicate with the device manager app that is installed on the tablet.
Failure to provide Bluetooth communication access prevents the device manager components from communicating with each other
and with implantable devices. As a result, the device manager app is unable to establish a Bluetooth connection with the patient
connector. The patient connector is used to interrogate and program the implantable device.
Internet
To configure your network, follow the processes and policies of your organization.
Internet access is not required to export and print reports. However, failure to provide access to an information technology (IT) network
(for example, a Wi-Fi™* or cellular network) results in the inability to export and print reports using a wireless connection.
1.6.2 Supported tablets and technical specifications
The tablet on which the device manager app is installed must meet the requirements in the CareLink SmartSync Tablet Compatibility
Technical Manual. To download or order the CareLink SmartSync Tablet Compatibility Technical Manual, go to
www.medtronic.com/manuals, or contact a Medtronic representative.
Note: The device manager app may not be compatible with the most current version of the tablet operating system.
1.6.3 Intended information flows
Data from the implantable device flows through the device manager components in the following sequential order:
1. Implantable device
2. Patient connector
3. Implantable device app
All information in transit is protected for security.
1.7 Reporting errors and serious incidents
If a serious incident related to the CareLink SmartSync app occurs, immediately report the incident to Medtronic and the applicable
competent authority or regulatory body.
If you find information in this app help that is incorrect, contact a Medtronic representative.
1
The Bluetooth® word mark is a registered trademark of Bluetooth SIG, Inc. Any use of the word mark by Medtronic is under license.
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2 Overview of the interface
2.1 Areas
The implantable device app is divided into 3 areas:
• The 2 status bars at the top of the screen display status information about the device manager components and the patient
session. The top status bar also displays the EMERGENCY button and the
• The Live Rhythm Monitor, which appears below the status bars, displays real-time waveform traces.
• The work area, which is the largest area of the screen, displays the parameters, fields, and controls for the current window.
2.2 Status indicators
The status bar at the top of the screen displays the status of the base, the tablet, the patient connector, and the implantable device.
For more information, tap on the status bar.
Table 1. Base status indicators
Indicator Description
The base is connected to the device manager app.
The base is connected to the device manager app, and an analyzer session is in progress.
There is no base connected to the device manager app.
Note: A green dot indicates that a base was recently connected
to the device manager app, but is not connected now.
(Menu) button.
Table 2. Tablet status indicators
Indicator Description
The tablet is connected to an IT network.
Note: The status indicator shows the remaining percentage of
the tablet battery.
The tablet is not connected to an IT network.
Note: The status indicator shows the remaining percentage of
the tablet battery.
Table 3. Patient connector status indicators
Indicator Description
The patient connector is connected to the device manager app.
The patient connector battery is good.
The patient connector is connected to the device manager app.
The patient connector is charging.
The patient connector is connected to the device manager app.
The patient connector battery is low.
The patient connector is connected to the device manager app.
The patient connector battery is critically low.
There is no patient connector connected to the device manager
app.
Note: A green dot indicates that a patient connector was recently
connected to the device manager app, but is not connected now.
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Table 4. Implantable device status indicators
Indicator Description
The implantable device is connected to the patient connector.
The connection is either strong or moderate. To improve the connection, move the implantable device and the instruments closer
together and away from anything else that causes interference.
The implantable device is connected to the patient connector.
The connection is weak. To improve the connection, move the
implantable device and the instruments closer together and away
from anything else that causes interference.
The connection with the implantable device has been lost. The
device manager attempts to establish the connection and restore
communication. Move the tablet closer to the base or the patient
connector and away from anything else that causes interference.
Table 5. Connection status indicators
Indicator Description
The Bluetooth connection between the device manager app and
the base or the patient connector is strong.
The Bluetooth connection between the device manager app and
the base or the patient connector is moderate.
To improve the connection, move the tablet closer to the base or
the patient connector and away from anything else that causes
interference.
The connection between 2 system components has been lost.
Move the 2 system components closer together and away from
anything else that causes interference. The device manager
attempts to establish the connection and restore communication.
There is a USB connection between the base and the patient
connector.
The connection with the implantable device is weak.
To improve the connection, move the implantable device and the
instruments closer together and away from anything else that
causes interference.
The connection with the implantable device is moderate.
To improve the connection, move the implantable device and the
instruments closer together and away from anything else that
causes interference.
The connection with the implantable device is strong.
3 Reinterrogating the implanted device
3.1 Reinterrogate the implanted device
During a device implant or a patient follow-up appointment, you can reinterrogate the implanted device.
Note: For information on how to perform an initial interrogation, refer to the device manager app help.
To reinterrogate the implanted device, tap > INTERROGATE.
4 Responding to device status indicator warnings
4.1 About device status indicator warnings
The implantable device automatically monitors for internal conditions that affect implantable device operation and require attention.
If any such conditions occur, the implantable device saves the status indicator to its memory. The implantable device app displays the
status indicator warning in a message window when you interrogate the implantable device. The status indicator warning is also
displayed in the OBSERVATIONS area on the Quick Look screen.
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Caution: If the implantable device app displays a status indicator warning for the implantable device, contact a Medtronic
representative.
4.2 Respond to the WARNING – DEVICE ELECTRICAL RESET warning
If the device is not yet implanted, do not implant the device. Contact a Medtronic representative.
A device reset is a safety feature that can automatically change parameter values or clear diagnostic data in response to a problem
with the implantable device memory. If a device status indicator warning for a reset appears, you must clear the device status indicator.
You may need to reprogram the implantable device to the desired parameters.
After a device reset, the device records a status indicator. For a device reset that requires attention, the status indicator warning for
the implantable device describes how the reset affected device data. Read the message accompanying the indicator and follow the
on-screen instructions carefully. If the message indicates that the reset affected implantable device parameters, you must reprogram
the implantable device to restore the previous settings.
1. Respond to the status indicator warning:
a. Remove any sources of electromagnetic interference (EMI).
b. Notify a Medtronic representative.
c. To clear the status indicator, tap CLEAR in the window.
A confirmation window appears, indicating that all previously interrogated data in the implantable device app will be
cleared.
d. 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.
e. Interrogate the implantable device.
2. Determine the events leading up to the device reset:
a. To determine the time and date of the device reset, note the time and date when counter data was last cleared.
b. If the device is implanted, determine what the patient was doing at the time and date of the device reset.
c. Save the implantable device data.
d. Send the implantable device data to a Medtronic representative.
3. Reprogram the implantable device:
a. Verify the programmed device parameters and reprogram them as necessary.
Note: If the reset affected the parameters, the implanted device is automatically programmed to either Device Off or VVI
mode until the parameters are reprogrammed. In VVI mode, the implanted device paces at 65 bpm.
b. Verify that the implantable device date and time are correct. If necessary, reprogram the date and time.
c. To verify that the battery voltage of the implantable device is acceptable, check the BATTERY AND DEVICE
MEASUREMENTS window.
d. Conduct an electrode impedance test, a sensing test, and a pacing threshold test as desired.
4.3 Respond to the SERIOUS DEVICE ERROR warning
If the implantable device app displays a SERIOUS DEVICE ERROR status indicator warning, contact a Medtronic representative. An
immediate new device implant is recommended.
To respond to the SERIOUS DEVICE ERROR status indicator warning, complete the following actions:
1. To clear the status indicator, tap CLEAR in the window.
A confirmation window appears, indicating that all previously interrogated data in the implantable device app will be cleared.
2. Tap CONTINUE.
3. To verify that the battery voltage of the implantable device is acceptable, check the BATTERY AND DEVICE MEASUREMENTS
window.
4. Verify the programmed device parameters and reprogram them as necessary.
Note: The implantable device is automatically programmed to Device Off until the parameters are reprogrammed.
5 Using the Live Rhythm Monitor
5.1 About the Live Rhythm Monitor
The Live Rhythm Monitor displays markers and the telemetered EGM waveform trace from the implanted device. If the device
manager app is connected to the base, the Live Rhythm Monitor displays ECG waveform traces from the base.
During patient sessions, you can view live waveform traces, freeze waveform traces, and access waveform strips.
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