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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Medtronic CareLink Express Online Help
Conformité Européenne (European Conformity). This
symbol means that the device fully complies with
applicable European Union Acts.
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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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CareLink Express Online Help Medtronic
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.
5 1. Configuration
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