How it Works
Medtronic
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31302
Instructions for Use
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Medtronic 31302 Instructions for Use

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CareLink Express Online Help
Instructions for Use
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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.
Adapta™, Attesta™, CareLink Express™, CareLink™, EnPulse™, Kappa™, Medtronic CareLink™, Sensia™,
Sphera™, Versa™, Vitatron™
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Contents

1.4 Change location ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
2 Patient connector . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
2.1 Adding a patient connector . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
2.2 Charging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
3 CareLink Express session . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
3.1 Conducting a CareLink Express session . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
4 Lock Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
4.1 Lock Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
4.2 Enabling Lock Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
4.3 Disabling Lock Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
5 Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
5.1 Issue and system messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
5.2 Charging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
5.3 Updates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
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1 Configuration

1.1 About CareLink Express

Device description
The CareLink Express™ mobile app (called the “CL Express app” from now on) is installed on a compatible mobile device with Internet access. The CL Express app communicates with the Medtronic 24967 Patient Connector1 (called the “patient connector” from now on) and sends implanted cardiac device data to the proprietary Medtronic CareLink Network for clinical review. The CL Express app should be used by healthcare personnel only in a clinical or hospital environment.
Intended use
Contraindications
There are no known contraindications.
Implantable device information
During interrogation of EnPulse/Kappa, Adapta/Versa/Sensia, Attesta/Sphera, and select Vitatron2 pacemakers, a battery and lead measurement will temporarily set the pacemaker to asynchronous pacing at 100 min–1 for several beats. 2:1 block can be produced in some patients at the time of interrogation in the presence of higher intrinsic atrial rates. Patients with tracked high atrial rates should be observed during initial interrogations to assess their tolerance of a rapid change in heart rate to their programmed Lower Rate.
Patients should be sitting comfortably while the interrogation is performed.
Electronic instructions for use/manuals
To view, download, print, or order manuals for this product, go to www.medtronic.com/manuals, or contact a Medtronic representative.
Software requirements
Manuals can be viewed using a current version of any major internet browser. For best results, use Adobe Acrobat® Reader with the browser.
Paper manuals
Paper manuals are available to customers free of charge. They should arrive in 3 ­7 days. To order, go to www.medtronic.com/manuals, or contact a Medtronic representative.
Prescription Statement for the United States
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
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All model numbers may not be available in your geography.
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Vitatron models Q70A2, Q80A2, G70A2, Q50A2, G20A2, Q20A2. All model numbers may not be available in your geography.
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CE mark of conformity
Applicable model numbers
31302
Select the About screen from the Home menu to determine the model number for your CL Express app. All model numbers may not be available in your geography.
Symbols
For US audiences only
Authorized representative in the Euro­pean Union
Manufacturer
Conformité Européenne (European Conformity). This symbol means that the device fully complies with applicable European Union Acts.
Menu icon
Communication with the device is not available for up to one hour
Communication with the device is not available until midnight

1.2 IT network, mobile device, and data information

Required IT network characteristics and configuration
The use of the CareLink Express system requires your network to have Internet access and Bluetooth® enabled on your mobile device for the following purposes:
• Install and update the CL Express app from the app store.
• Communicate with the CareLink Network.
Failure to provide IT network access results in the following effects:
• Installation and updates to the CL Express app cannot be completed if the mobile device is unable to access the app store.
• Clinical review of the implanted device data cannot be completed if the CL Express app is unable to transmit the data to the CareLink Network.
• Communication with the implantable device cannot occur if the mobile device is unable to establish a Bluetooth connection with the patient connector.
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Follow your organization’s processes and policies to configure your network.
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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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Supported mobile devices and technical specifications
For the list of supported mobile devices, and their specifications including network connectivity specifications, go to the following website:
www.medtronic.com/CLExpressMobile
Precautions when connecting to your IT network
Connecting the CL Express app 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 also introduce additional risks. Analyze, evaluate and control any risks identified.
Intended information flows
Implantable cardiac device data and system logs are sent for processing through the system components in the following sequential order:
1. Implanted cardiac device
2. Patient connector
3. CL Express app installed on the mobile device
4. Internet
5. CareLink Network
In response, a confirmation receipt is sent from the CareLink Network via the Internet to the CL Express app.
The clinic location ID is sent from the CL Express app via the Internet to the CareLink Network for validation. In response, the clinic location ID’s validation status is sent by the CareLink Network via the Internet to the CL Express app to allow clinic location ID to be stored in the CL Express app.
All information in transit is protected for security.
Security
Data in the CL Express app is protected by application level encryption.
It is recommended to use the following security measures to protect the CareLink Express system:
• The CL Express app and patient connector should only be used on a managed, trusted, and secured network.
• Secure your network with anti-virus software, a firewall, or both in-line with your IT department’s policies.
• To help protect patient health information, security measures for your mobile device should include implementation of a passcode and PIN to protect the mobile device.

1.3 Initial setup

During the procedure, you may be asked to enter the security code or serial number of the patient connector. This information is found on the bottom of the patient connector. You can also refer to the instructions for use provided with the patient connector for help in locating this information.
1. Ensure that Bluetooth® is enabled on your mobile device. For most mobile devices, tap Settings > Bluetooth to enable it.
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2. Ensure that your mobile device is connected to the Internet. Consult your IT department for support with connecting your device to the Internet.
3. Open the CL Express app.
4. On the Welcome screen, tap Continue.
5. Press the button on the patient connector to turn it on. The Bluetooth light on the patient connector first flashes when the Bluetooth
is discoverable, and then turns solid when the Bluetooth connection is established.
6. When prompted, select the patient connector you are using from the list.
7. If prompted, allow the CL Express app to use Bluetooth.
8. If prompted to accept a Bluetooth Pairing Request, confirm that the serial number in the request matches the serial number on the back of the patient connector.
• Decline the request if the serial number does not match the serial number on the back of the patient connector.
• Accept the request to pair the patient connector with the CL Express app.
9. Tap Continue.
10. Enter the security key code and tap Continue.
11. The Enter your Location ID screen is displayed. Enter the numerical portion of your Location ID and tap Continue. You can find your Location ID by logging into the CareLink Express website or contacting your CareLink Network administrator.
12. Re-enter the numerical portion of your Location ID and tap Continue.
13. The CL Express app verifies your Location ID with the CareLink Network.
a. Tap Continue if the facility name and location name are correct. b. Tap Cancel if the facility name and location are not correct. If you tap
Cancel, you will be required to repeat the setup process.
The Home screen is displayed. The CL Express app and patient connector are ready to use.

1.4 Change location ID

Under certain circumstances CareLink Express may need to be used at a different location. In those circumstances the Location ID will need to be updated to match the new location as configured in the CareLink Network. To change to a different Location ID, the following steps will be required.
During the procedure, you may be asked to enter the model number, security code, or serial number of the patient connector. This information is found on the bottom of the patient connector. You can also refer to the instructions for use provided with the patient connector for help in locating this information.
To view the current Location ID, tap Menu and refer to the Location ID listing.
1. Tap Menu > Location ID.
2. Ensure that Bluetooth® is enabled on your mobile device. For most mobile devices, tap Settings > Bluetooth to enable it.
3. Ensure that your mobile device is connected to the Internet.
4. Press the button on the patient connector to turn it on. The Bluetooth light on the patient connector first flashes when the Bluetooth
is discoverable, and then turns solid when the Bluetooth connection is established.
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5. The patient connector pairs with the CL Express app. If prompted by the CL Express app, select the patient connector you want to
use from the list. If you are using a new patient connector, you will have to pair the CL Express
app and the patient connector. See Section 2.1.
6. The Enter your Location ID screen is displayed. Enter the numerical portion of your Location ID and tap Continue. You can find your Location ID by logging into the CareLink Express website or contacting your CareLink Network administrator.
7. Re-enter the numerical portion of your Location ID and tap Continue.
8. The CL Express app verifies your Location ID with the CareLink Network.
a. Tap Continue if the facility name and location name are correct. b. Tap Cancel if the facility name and location are not correct. If you tap
Cancel, you will be required to repeat the setup process.
The Home screen is displayed. The CL Express app and patient connector are ready to use.

2 Patient connector

2.1 Adding a patient connector

The CL Express app will guide you through the following steps when you add a new patient connector.
During the procedure, you may be asked to enter the security code or serial number of the patient connector. This information is found on the bottom of the patient connector. You can also refer to the instructions for use provided with the patient connector for help in locating this information.
1. Ensure that Bluetooth® is enabled on your mobile device. For most mobile devices, tap Settings > Bluetooth to enable it.
2. Press the button on the patient connector to turn it on. The Bluetooth light on the patient connector first flashes when the Bluetooth
is discoverable, and then turns solid when the Bluetooth connection is established.
3. Open the CL Express app.
4. If prompted, select the patient connector you are using from the list.
5. If prompted, allow the CL Express app to use Bluetooth.
6. If prompted, enter the security key code and tap Continue.
7. If prompted to accept a Bluetooth Pairing Request, confirm that the serial number in the request matches the serial number on the back of the patient connector.
• Decline the request if the serial number does not match the serial number on the back of the patient connector.
• Accept the request to pair the patient connector with the CL Express app.
The patient connector is paired and ready to use.

2.2 Charging

Medtronic recommends that you charge the patient connector and your mobile device before conducting a CareLink Express session.
For information on charging the patient connector, refer to the instructions for use provided with the patient connector.
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3 CareLink Express session

3.1 Conducting a CareLink Express session

1. Tap Start.
2. Press the button on the patient connector to turn it on.
3. The patient connector pairs with the CL Express app. If prompted by the CL Express app, select the patient connector you want to
use from the list. If you are using a new patient connector, you will have to pair the CL Express
app and the patient connector. See Section 2.1.
4. When prompted, hold the patient connector over the implanted cardiac device. You can hold the patient connector either snugly against the clothing or bare skin.
The telemetry indicator light on the patient connector turns on when you have established telemetry with the implanted device.
Caution: Do not place the mobile device directly over the implanted cardiac device. Keep the mobile device at least 6 in (15 cm) away from the implanted cardiac device.
5. When prompted, select the implanted cardiac device you want to interrogate from the Select a Device list and tap Continue.
• If multiple devices are displayed, use the device model, serial number, or patient name information to select the correct device.
• If the desired implanted cardiac device is not displayed, tap the Continue
Scanning button to update the Select a Device list.
Note: If communication with a device is currently unavailable, a lock icon is
shown next to the device model, and you cannot select the device from the list. By temporarily locking itself, the device can prevent its battery from being depleted from excessive connections. Use the color of the lock icon to determine when to try to reconnect the patient’s device:
• A yellow lock icon indicates communication with the device is unavailable for up to one hour.
• An orange lock icon indicates communication with the device is unavailable until midnight.
6. Continue to hold the patient connector over the implanted cardiac device. The CL Express app displays a transmitting signal icon and a green progress bar while the patient connector communicates with the implanted cardiac device.
Note: The CL Express app clears alerts triggered by implanted cardiac devices at the end of the communication with the patient connector. These triggered alerts are included in the data transmission sent to the Medtronic CareLink Network for review.
7. Set the patient connector aside when the communication between the implanted cardiac device and the patient connector completes.
8. The CL Express app automatically transmits the data to the CareLink Network when the mobile device has adequate connectivity to either a cellular or Wi-Fi network.
Note: You may need to move the mobile device to a location that has an adequate cellular or Wi-Fi network signal to complete the transmission.
9. Watch the CL Express app to follow the status of the data transmission from the CL Express app to the Medtronic CareLink Network.
The CL Express app will try to send the data for 15 min. If the data has not been successfully sent after 15 min, the session will need to be repeated.
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4 Lock Mode

4.1 Lock Mode

Lock Mode restricts the CL Express app to interrogate and transmit data to the CareLink Network only and prevents unauthorized access to the Menu options.

4.2 Enabling Lock Mode

1. Tap Menu > Lock.
2. Enter your Location ID.
3. Tap Lock.
The Home screen is displayed and the CL Express app configuration cannot be changed.

4.3 Disabling Lock Mode

1. Tap the Menu button.
2. Enter your Location ID.
3. Tap Unlock.
The Home screen is displayed. The Menu icon is enabled and the CL Express app settings are available.

5 Troubleshooting

5.1 Issue and system messages

Table 1. Issue Messages

Error Code Message Description How to fix
4514 - The implanted cardiac
device has experienced a flash failure state and has been reset to its ROM backup.
8786 Registered
Clinic Loca­tion ID Lookup Failed
7309 CareLink
Maintenance
The Location ID could not be found or matched.
CareLink is temporarily unavailable due to mainte­nance and cannot process the request.
• Tap Cancel.
• Contact your Medtronic Repre­sentative or the clinician managing the patient.
• Tap Cancel.
• Verify that the Location ID is con­figured correctly.
• Contact your CareLink Network administrator.
• Tap Cancel.
• If the data has not been successfully sent after 15 min, the session will need to be repea­ted.
• Contact your CareLink Network administrator.
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Table 1. Issue Messages (continued)
Error Code Message Description How to fix
5409 No Wi-Fi Con-
nection
5704 No Cellular
Connection
2108 Transmission
Failure
3269 Patient Con-
nector Out of Range
3269 Bluetooth
Failure
Certain features of this soft­ware require a connection to the Internet. You cannot transmit data to the CareLink Network or receive software updates.
Certain features of this soft­ware require a connection to the Internet. You cannot transmit data to the CareLink Network or receive software updates.
Your mobile device was unable to connect to a net­work with access to CareLink Network to complete a transmission.
The mobile device cannot communicate with the patient connector.
The mobile device cannot connect to the patient con­nector using Bluetooth.
• To enable all fea­tures, ensure that Wi-Fi or cellular data service is enabled and con­nected.
• To enable Wi-Fi, tap Cancel, ena­ble the Wi-Fi set­ting on your mobile device and con­nect to your net­work.
• To enable all fea­tures, ensure that Wi-Fi or cellular data service is enabled and con­nected.
• To enable cellular connectivity, work with your IT depart­ment to get the mobile device con­figured.
• Check that your Wi-Fi is enabled and connected to the Internet.
• Contact your CareLink Network administrator.
• Attempt to resend the data later.
• Contact your Medtronic Repre­sentative.
• Move the mobile device closer to the patient con­nector.
• Check your Bluetooth connec­tion.
• Move the mobile device closer to
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Table 1. Issue Messages (continued)
Error Code Message Description How to fix
the patient con­nector.
• Check your Bluetooth connec­tion.
3517 No Device
Found
3314 Reading
device inter­rupted
0056/2316 - An error has occurred in the
3230 Bluetooth
connection lost
8260 Software
update wait­ing (Lock Mode).
8287 Application
Software Update Required to Match Firm­ware/Hard­ware Revision
No supported implanted cardiac device was found.
The communication ses­sion between the patient connector and the implan­ted cardiac device was interrupted.
CL Express app.
Bluetooth pairing failed. The CL Express app is unable to connect to the requested patient connec­tor at the beginning of a session.
The CL Express app is in Lock Mode and is unable to accept a software update.
The app may require an update to support new/updated telemetry hardware.
• Tap Cancel to close the mes­sage.
• Place the patient connector over the implanted cardiac device and attempt the communica­tion session again.
• Contact your Medtronic Repre­sentative.
Restart the communi­cation session between the patient connector and the implanted cardiac device.
Contact your Medtronic Represen­tative and tap Cancel to close the CL Express app.
Tap CANCEL and try pairing again.
Perform the following steps:
1. Unlock the CL Express app.
2. Accept the update.
Connect to the appro­priate app store and update to latest ver­sion.
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Table 2. System Messages

Message Description How to fix
Application update available
Patient connec­tor update in pro­gress
You must update the application to continue.
You must wait for the update to complete.
Tap Update to install the update and continue. Tap Cancel to close the appli­cation update window and continue in the CL Express app. You can install the update at a later time.
Tap OK and wait for the patient connector update to complete.

5.2 Charging

Table 3. Patient Connector Messages

Error Code Message Description How to fix
3248 - The patient connector bat-
tery is low and must be charged for continued use.
Connect the patient con­nector to the Medtronic­supplied charger or switch to a different patient connector and follow the prompts on the app.

5.3 Updates

Medtronic will periodically push updates to the CL Express app on the mobile device and updates to the software on the patient connector.
If a CL Express app update is available, you will be prompted to update the CL Express app unless you have enabled automatic updates on your mobile device. Medtronic requires accepting all CL Express app updates when they are available if automatic updates are not enabled on your mobile device. If you are in a CareLink Express session, updates to the CL Express app will happen either before the device interrogation or after the data has been sent to CareLink Network.
If the CL Express app is in Lock Mode when an app update is detected, unlock the CL Express app and then accept the app update.
CL Express app updates
If the CL Express app displays a message that the CL Express app must be updated, select one of the following options:
• Accept the update to update the CL Express app to the latest version.
• Decline the update to keep the CL Express app at the same version.
If you decline the update, the update display message will close and the CL Express app will continue to run at the same version. You can update the CL Express app at a later time.
Patient connector software updates
When an update to the patient connector software is available, the update begins automatically after the patient connector pairs with the CL Express app.
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The patient connector software update process occurs automatically. You do not need to take any action for the process to start or complete.
When the patient connector software is updating, a software update screen displays and a progress bar shows the status of the software update. When the progress bar fills completely, the patient connector software is updated and the software update screen closes.
If you navigate away from the patient connector software update screen during the software update, the software update continues until the patient connector software update completes. You cannot cancel the patient connector software update.
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Medtronic, Inc.
*M018253C001*
710 Medtronic Parkway Minneapolis, MN 55432 USA www.medtronic.com +1 763 514 4000
Medtronic B.V. Earl Bakkenstraat 10 6422 PJ Heerlen The Netherlands +31 45 566 8000
Canada
Medtronic Canada ULC 99 Hereford Street Brampton, Ontario L6Y 0R3 Canada 1 800 268 5346
Technical manuals
www.medtronic.com/manuals
© 2021 Medtronic M018253C001 A 2021-05-27
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