CareLink SmartSync™ Device Manager 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.
CareLink SmartSync™, CareLink™, Paceart Optima™, Paceart™, SessionSync™
Contents
1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
1.1 Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
1.2 About the device manager . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
1.3 Intended use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
1.4 Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
1.5 Warnings and precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
1.6 Connect to an external monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
1.7 Download or order the instructions for use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
1.8 IT network, tablet, and data information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
1.9 Reporting errors and serious incidents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
1.10 Notice of Privacy Practices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
2 Overview of the interface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
2.1 Areas . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
2.2 Buttons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
2.3 Status indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
3 Connecting the device manager components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
3.1 About device manager app and component connections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
3.2 Connect to the base and patient connector . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
3.3 Troubleshoot connections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
4 Using therapy and documentation tools . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
4.1 Start an analyzer session . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
4.2 Start a patient session . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
4.3 Start a patient session with the last patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
4.4 Open a saved patient session using Read From File . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
4.5 View or export saved reports and implantable device data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
4.6 Using the SessionSync feature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
4.7 Close the device manager app . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
5 Managing the device manager app settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
5.1 Manage patient data privacy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
5.2 Manage the profile settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
5.3 Manage data synchronization with the SessionSync feature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
5.4 Configure filename preferences . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
5.5 Configure rate unit labels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
6 Exporting and importing user preferences . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
6.1 Export user preferences . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
6.2 Import user preferences . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
7 Updating the device manager app . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
7.1 Device manager app updates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
7.2 Install a new version of the device manager app . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
7.3 Install a content update . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
7.4 Install required software updates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
7.5 Manually check for and install updates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
7.6 Uninstall the app . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
8 Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
8.1 Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
8.2 Service logs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
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1 Introduction
1.1 Description
The CareLink SmartSync Device Manager Application (referred to as the device manager app) is installed on a tablet and is the
primary interface for the CareLink SmartSync device manager.
The device manager app includes the following features:
• Bluetooth® connectivity to communicate with the base and patient connector
• Tablet connectivity tools for sharing and printing reports
• Ability to export data
• Ability to update the device manager app software using an Internet connection
• Access to the CareLink SmartSync PSA (Pacing System Analyzer) application (referred to as the analyzer) to assess the pacing
and sensing performance of the cardiac lead system during the implant of an implantable cardiac device
• Access to implantable device apps, which communicate with implantable devices and allow you to program the implantable
device settings and view stored implanted device data
Table 1. Device manager app model numbers
Software model number Software component name
M01A01 CareLink SmartSync Platform
M01A02 CareLink SmartSync Common Application
D00U001 CareLink SmartSync Host Application
1.2 About the device manager
The CareLink SmartSync device manager includes the following components:
• CareLink SmartSync Model 24970A base (referred to as the base)
• Model 24967 patient connector (referred to as the patient connector)
• CareLink SmartSync Device Manager Application (referred to as the device manager app)
The device manager app is the primary interface of the device manager. The device manager app provides access to the implantable
device apps and to the CareLink SmartSync PSA (Pacing System Analyzer) Application (referred to as the analyzer).
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1.3 Intended use
The device manager app is intended to be used as the primary interface of the device manager.
The device manager is intended to be used to interrogate and program Medtronic implantable devices and conduct a cardiac lead
analysis session during Medtronic heart device implant or invasive troubleshooting.
The device manager is intended for use by healthcare professionals in a clinical or hospital environment.
1.4 Contraindications
There are no known contraindications for the use of the device manager app.
1.5 Warnings and precautions
These warnings and precautions apply when using the device manager app in combination with the other device manager
components.
Electrical and patient safety – The device manager is compliant with the requirements of IEC 60601-1 for electrical and patient
safety.
Equipment compatibility – The device manager app must be used only with compatible Medtronic implantable devices. If the device
manager app is used with other implantable devices, direct stimulation through energy coupling may occur. The device manager app
is not compatible with programmable devices of other manufacturers.
Importance of instructions for use – Before using the device manager, Medtronic recommends that you take the following actions:
• Read the device manager instructions for use.
• Read the instructions for use for the leads and implantable device.
• Carefully assess the patient condition and the implantable device system to determine the appropriate settings for tests and
device programming.
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The Bluetooth® word mark is a registered trademark of Bluetooth SIG, Inc. and any use of this mark by Medtronic is under license.
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Improper use of the device manager could result in erroneous programming, inadvertent pacing, improper operation of telemetry, and
incorrect operation of measurement functions.
Magnetic interference – The base includes a magnet under the charge cradle to secure the patient connector and ensure charging.
The symbol on the cradle identifies the location of this magnet. Avoid placing devices or material that may be damaged by the
magnetic field (such as magnetic media, watches, or other electronic devices) on top of the base.
Some tablets may be sensitive to magnetic interference. Keep strong magnetic sources (such as magnetic programming heads,
patient magnets like the Model 9466 Tachy Patient Magnet, or other strong magnetic field generators) away from direct contact with
the tablet when working with the device manager.
Note that the Model 24967 patient connector does not include a magnet and is not a source of magnetic interference.
Magnetic resonance (MR) unsafe – The device manager is MR Unsafe. Do not bring any components of the device manager into
Zone 4 (magnet room), as defined by the American College of Radiology.
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 device manager app to the background. Tapping, pressing buttons,
and using gestures on the tablet can also result in moving the device manager app to the background or closing the device manager
app. For example, the device manager app moves to the background if you lock the tablet.
When the device manager app moves to the background or closes, the device manager app pauses communication or loses
communication with the implantable device or the analyzer hardware within the base.
When you restore the device manager app from the background, the device manager app attempts to re-establish communication
with the implantable device or analyzer and displays the system status. If the device manager app was closed, you must reconnect
the device manager components to the device manager app to re-establish communication with the implantable device and analyzer.
Tablet language settings – Tablets allow you to change the language used to display information. If you change the language used
on your tablet, the device automatically closes any apps that are currently running (including the device manager app). You may need
to reopen the device manager app after changing the tablet language setting.
Modification of equipment – Do not modify any hardware or software component of the device manager. Modifications may reduce
system effectiveness and impact user or patient safety. Modifying any component without the approval of Medtronic could void the
user’s authority to operate the equipment.
Radiofrequency (RF) interference – Portable and mobile RF communications equipment can interfere with the operation of
components of the device manager. There is no guarantee that the device manager will not receive interference or that any particular
transmission from this system will be free from interference.
Use of wireless devices – The device manager incorporates radiofrequency (RF) communications components that may affect
other devices and equipment in the medical environment. The use of wireless devices in the medical environment must be evaluated
and authorized by the responsible organization. RF interference may affect device performance.
Electromagnetic compatibility (EMC) compliance testing shows that the components of the device manager provide reasonable
protection against harmful interference and provide EMC immunity in a typical medical installation. However, there is no guarantee
that interference will not occur in a particular installation.
If any component does cause harmful interference to other devices or is negatively impacted by other devices or by the environment,
correct the interference by taking one or more of the following measures:
• Reorient or relocate the component and other devices.
• Ensure that the base is placed at the level of or on top of tables (and not below table level). Placing the base below table level can
negatively impact communication and connectivity.
• Increase the separation between the component and other devices by at least 2 m (approximately 6 feet).
• Turn off any interfering equipment.
1.6 Connect to an external monitor
To display the device manager app on an external monitor, directly connect the monitor to your tablet with a cable connector.
The method that you use to connect an external monitor depends on how your tablet is set up. For assistance, contact your clinic IT
administrator.
For the best performance, Medtronic recommends that you use a direct cable to connect to an external monitor. Medtronic may offer
for purchase compatible display adaptors and cables. Contact your Medtronic representative for more information.
1.7 Download or order the instructions for use
Download or order the instructions for use from the Medtronic Manual Library.
To download the instructions for use, go to www.medtronic.com/manuals. For best results, use Adobe Acrobat® Reader.
To order paper copies of the instructions for use, go to www.medtronic.com/manuals or contact a Medtronic representative. Paper
copies of the instructions for use are free of charge and arrive in approximately 3 to 7 days.
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1.8 IT network, tablet, and data information
1.8.1 Required IT network characteristics and configuration
To use the device manager, your tablet must have both Bluetooth wireless technology and access to the Internet.
Bluetooth wireless technology
You must enable Bluetooth wireless technology on your tablet. The hardware components of the device manager communicate with
the device manager app, installed on the tablet, through a Bluetooth connection.
Failure to provide Bluetooth communication access prevents the device manager components from communicating with each other
and with implantable devices, which results in the following limitations:
• The device manager app is unable to establish a Bluetooth connection with the base, which prevents access to the analyzer and
prevents the ability to view ECG waveforms.
• 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.
To set up or update the device manager, your network must have Internet access. When your network is configured to access the
Internet, you can complete the following actions:
• Download and install the device manager app.
• Register the device manager app.
• Download and install software or updates necessary for the device manager to function.
Failure to provide information technology (IT) network access prevents the tablet from accessing the Internet, which results in the
following limitations:
• Inability to install or update the device manager app and software components
• Inability to download firmware updates for the base and patient connector
• Inability to receive periodic updates and security enhancements that maintain the security of the device manager app
• Inability to process device manager component system logs
• Inability to authenticate the first connection between the device manager app and the base and patient connector
Note: Internet access is not required to export and print reports. However, failure to provide access to an IT network (for example, a
Wi-Fi™* or cellular network) results in the inability to export and print reports using a wireless connection.
1.8.2 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 your Medtronic representative.
Note: The device manager app may not be compatible with the most current version of the tablet operating system.
1.8.3 Intended information flows
System logs are processed through the device manager components in the following sequential order:
1. Base or patient connector
2. Device manager app
3. Internet
During installation and updates, the device manager app sends your clinic registration and device manager credentials to Medtronic
via the Internet for authentication. In response, Medtronic returns configuration files to the device manager app via the Internet to
install or update the device manager app and component software as needed. The configuration files allow the device manager app
to connect to and communicate with the analyzer and implantable device.
When you are exporting patient data from the implantable device app, data flows to the IT network.
Note: You are responsible for the management of patient and device data that you export from the SAVED REPORTS window.
Examples of patient and device data include printed paper reports, data transferred to a hospital network, and emailed attachments.
1.8.4 Precautions when connecting to your IT network
Connecting the device manager to an IT network that includes other equipment could result in unforeseen risks to patients, operators,
or third parties. Changes to your IT network, such as adding, disconnecting, updating or upgrading equipment, or changing network
configurations, could introduce additional risks. Analyze, evaluate, report, and control any risks identified.
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1.8.5 Security
Data in the device manager app is protected by encryption. The device manager app is unable to provide data protection for data
exported to another destination. Handle and store the data that you export from the device manager app in accordance with the
security policy of your clinic.
To protect patient health information, the tablet must be secured with a passcode. The device manager is unable to function if a
passcode is not defined. For more information on securing the tablet with a passcode, refer to the user instructions for your tablet.
To protect the device manager, Medtronic recommends that you implement the following security measures:
• Use the device manager app and device manager components only on a managed, trusted network. Verify that your Wi-Fi™*
networks comply, at minimum, with wireless standard 802.11b, 802.11g, or 802.11n, and use WPA2 or stronger encryption.
• Secure your network with industry best practices, which can include antivirus software, firewalls, and wireless security policies,
according to the policies of your IT department.
• When installing or updating the device manager app, if your tablet displays a message indicating that a security certificate is
invalid, the installation or update process is unable to continue. For assistance, contact your local Medtronic representative.
The device manager app closes automatically when the device manager app detects a failure to maintain security.
If you suspect that a cybersecurity event has occurred, stop using the device manager app (if possible). Contact your IT security or
biomedical department for information on how to confirm and respond to the suspected incident.
1.9 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 your Medtronic representative.
1.10 Notice of Privacy Practices
To read the Medtronic Notice of Privacy Practices, go to medtronic.com/smartsync/us-privacy.
2 Overview of the interface
2.1 Areas
The device manager app is divided into 3 areas:
• The title bar at the top of the screen displays the name of the device manager app.
• The status bar, which appears below the title bar, displays the status of the device manager components and the
• The work area, which is the largest area of the screen, allows you to connect to a base and patient connector, or start an analyzer
or patient session.
2.2 Buttons
Button Description
Opens the help.
Expands and collapses menus and windows.
Note: These arrows are shown in various sizes and with different
background colors. For example, blue and grey background colors.
2.3 Status indicators
The status bar displays the status of the base, patient connector, and tablet.
The status indicators for the patient connector and the tablet show the remaining percentage of the patient connector or tablet battery.
button.
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