Medtronic 31301 Instructions for Use

CareLink Express Online Help
Instructions for Use
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.
Adapta, CareLink, CareLink Express, EnPulse, Kappa, Medtronic, Medtronic CareLink, Sensia, Versa

Contents

1 Configuration .................................... 4
1.1 About CareLink Express ............................. 4
1.3 Initial Setup ..................................... 6
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 ............................ 8
3.1 Conducting a CareLink Express Session ................... 8
4 Lock Mode ...................................... 9
4.1 Lock Mode ..................................... 9
4.2 Enabling Lock Mode ................................ 9
4.3 Disabling Lock Mode ............................... 9
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 24965 Patient Connector or the Medtronic 24967 Patient Connector1 (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.
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 the EnPulse/Kappa or Adapta/Versa/Sensia 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.
CE Mark of Conformity
1
All model numbers may not be available in your geography.
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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.
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.
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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.
Follow your organization’s processes and policies to configure your network.
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
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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
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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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