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.
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
The CareLink Express app is intended for interrogating Medtronic cardiac devices
and uploading the data to the CareLink Network.
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.
1
All model numbers may not be available in your geography.
2
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.
3
Follow your organization’s processes and policies to configure your network.
3
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
CodeMessageDescriptionHow to fix
4514-The implanted cardiac
device has experienced a
flash failure state and has
been reset to its ROM
backup.
8786Registered
Clinic Location ID
Lookup
Failed
7309CareLink
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
CodeMessageDescriptionHow to fix
5409No Wi-Fi Con-
nection
5704No Cellular
Connection
2108Transmission
Failure
3269Patient Con-
nector Out of
Range
3269Bluetooth
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
CodeMessageDescriptionHow to fix
the patient connector.
• Check your
Bluetooth connection.
3517No Device
Found
3314Reading
device interrupted
0056/2316 -An error has occurred in the
3230Bluetooth
connection
lost
8260Software
update waiting (Lock
Mode).
8287Application
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
MessageDescriptionHow 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
CodeMessageDescriptionHow 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.