CareLink Express Online Help
Instructions for use
CareLink Express Online Help Medtronic
1. Configuration
1.1. About CareLink Express
1.1.1. 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 24965 Patient Connector (called the "patient connector" from now on)
and sends implanted cardiac device data to Medtronic's proprietary CareLink Network for
clinical review. The CL Express app should be used by healthcare personnel only in a
clinical or hospital environment.
1.1.2. Intended Use
The CareLink Express app is intended for interrogating Medtronic cardiac devices and
uploading the data to the CareLink Network.
1.1.3. Contraindications
There are no known contraindications.
1.1.4. Implantable Device Information
During interrogation of the EnPulse/Kappa or Adapta/Versa/Sensia pacemakers, a battery
and lead measurement will temporarily set the pacemaker to asynchronous pacing at 100
ppm 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.
1.1.5. Trademarks
The following list includes trademarks or registered trademarks of Medtronic in the United
States and possibly in other countries. All other trademarks are the property of their
respective owners.
Medtronic, CareLink, CareLink Express
The Bluetooth® word mark is a registered trademark of Bluetooth SIG, Inc. and any use of
this mark by Medtronic is under license.
1.1.6. 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
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Medtronic CareLink Express Online Help
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.
1.1.7. Prescription Statement for the United States
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
1.1.8. CE Mark of Conformity
1.1.9. Medtronic Addresses
Manufacturer
Medtronic, Inc.
710 Medtronic Parkway
Minneapolis, MN 55432
USA
www.medtronic.com
+1 763 514 4000
Authorized Representative in the European Community
Medtronic B.V.
Earl Bakkenstraat 10
6422 PJ Heerlen
The Netherlands
+31 45 566 8000
Europe/Middle East/Africa
Medtronic International Trading Sàrl
Route du Molliau 31
Case Postale 84
CH-1131 Tolochenaz
Switzerland
+41 21 802 7000
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CareLink Express Online Help Medtronic
Australia
Medtronic Australasia Pty Ltd
5 Alma Road
Macquarie Park, NSW 2113
Australia
1800 668 670
Canada
Medtronic of Canada Ltd
99 Hereford Street
Brampton, Ontario L6Y 0R3
Canada
+1 905 460 3800
Japan
1.1.10. Part Number
© Medtronic 2016
M967181A002A
2016-05-17
1.1.11. Applicable Model Numbers
31301
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.
1.1.12. Symbols
For US audiences only
Authorized representative in the European Union
Manufacturer
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Conformité Européenne (European Conformity). This
symbol means that the device fully complies with
applicable European Union Acts.
Menu icon
1.2. IT Network, Mobile Device, and Data Information
1.2.1. 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.
Follow your organization's processes and policies to configure your network.
1.2.2. 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
1.2.3. 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 could also introduce additional risks. Analyze, evaluate and control any risks
identified.
1.2.4. 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
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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.
1.2.5. 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, secured network.
• Secure your network with anti-virus software and/or a firewall 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 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.
1. Ensure that Bluetooth® is enabled on your mobile device. For most mobile devices,
tap Settings > Bluetooth to enable it.
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. When prompted by the app, enter the patient connector model number you are using
and tap CONTINUE.
6. 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.
7. When prompted, select the patient connector you are using from the list.
8. If you are prompted by the mobile device 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.
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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 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.
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.
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 app and the patient
connector. See Adding a Patient Connector.
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.
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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.
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2. Patient Connector
2.1. Adding a Patient Connector
The 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 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.
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. Select the available option:
• Tap SELECT NEW PATIENT CONNECTOR.
• Tap Cancel from the pop-up dialog.
4. When prompted by the CL Express app, enter the patient connector model number
you are using and tap Continue.
5. If prompted, select the patient connector you are using from the list.
6. If prompted, enter the security key code and tap Continue.
7. If you are prompted by the mobile device 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 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 app and the patient
connector. See Adding a Patient Connector.
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 inches (15 centimeters) away from the implanted cardiac
device.
5. The patient connector communicates with the implanted cardiac device. The CL
Express app displays a transmitting signal and a green progress bar.
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.
6. Set the patient connector aside when the communication between the implanted
cardiac device and the patient connector completes.
7. 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.
8. Watch the CL Express app to follow the status of the data transmission from the app
to the Medtronic CareLink Network.
The CL Express app will try to send the data for 15 minutes. If the data has not been
successfully sent after 15 minutes, 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 can not 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.
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5. Troubleshooting
5.1. Issue and System Messages
Issue Messages
Error Code Message Description How to fix
8239 - The implanted cardiac
device is not supported
by the CL Express app
and can not be
interrogated.
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
The Location ID could not
be found or matched.
• Tap Cancel.
• Download the latest
version of the CL
Express app from the
app store and try
again.
• If the issue persists,
contact your
Medtronic
Representative to
determine if the
implanted cardiac
device is compatible
with the CL Express
app.
• 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.
7309 CareLink Maintenance CareLink is temporarily
unavailable due to
maintenance and can not
process the request.
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• Tap Cancel.
• If the data has not
been successfully
sent after 15 minutes,
the session will need
to be repeated.
• Contact your CareLink
Network administrator.
Medtronic CareLink Express Online Help
Error Code Message Description How to fix
5409 No Wi-Fi Connection Certain features of this
software require a
connection to the
Internet. You cannot
transmit data to the
CareLink Network or
receive software updates.
5704 No Cellular Connection Certain features of this
software require a
connection to the
Internet. You cannot
transmit data to the
CareLink Network or
receive software updates.
2108 Transmission Failure Your mobile device was
unable to connect to a
network with access to
CareLink Network to
complete a transmission.
• 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.
3269 Patient Connector Out of
Range
3269 Bluetooth Failure The mobile device can
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The mobile device can
not communicate with the
patient connector.
not connect to the patient
connector using
Bluetooth.
• Move the mobile
device closer to the
patient connector.
• Check your Bluetooth
connection.
• Move the mobile
device closer to the
patient connector.
• Check your Bluetooth
connection.
CareLink Express Online Help Medtronic
Error Code Message Description How to fix
3517 No Device Found No supported implanted
cardiac device was found.
3314 Reading device
interrupted
0056/2316 - An error has occurred in
3230 Bluetooth connection lost Bluetooth pairing failed.
The communication
session between the
patient connector and the
implanted cardiac device
was interrupted.
the CL Express app.
The CL Express app is
unable to connect to the
requested patient
connector at the
beginning of a session.
• 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.
8260 Software update waiting
(Lock Mode).
The CL Express app is in
Lock Mode and is unable
to accept a software
update.
Perform the following
steps:
1. Unlock the CL
2. Accept the update.
System Messages
Message Description How to fix
Application update available You must update the application to
continue.
Patient connector update in
progress
You must wait for the update to
complete.
Tap Update to install the update
and continue. Tap Cancel to close
the CL Express app and install the
update later.
Tap OK and wait for the patient
connector update to complete.
Express app.
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5.2. Charging
Patient Connector Messages
Error Code Message Description How to fix
3248 - The patient connector
battery is low and must
be charged for continued
use.
Connect the patient
connector to the
Medtronic-supplied
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.
5.3.1. 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 CL Express app will close. You can not use the CL Express
app until you accept the app update.
5.3.2. 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.
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 can not cancel the patient connector software update.
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