Cardiac monitoring software

MyCareLink Heart™ app

Cardiac monitoring software

MyCareLink Heart™ app

Patients with Medtronic heart devices that have Bluetooth®* wireless telemetry can download the MyCareLink Heart™ app and use it for remote monitoring.

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Indications, Safety, and Warnings

Description

For patients who like using their smartphones or tablets to stay connected, the MyCareLink Heart™ app can be used to automatically send device data, replacing the bedside monitor.

Features

Download the MyCareLink Heart™ mobile app.

Cellphone with a MyCareLink Heart™ app icon

The MyCareLink Heart™ app results in 95% patient transmission adherence¹ and is designed to address 40% of clinic call burden.²
Wireless alerts can now be transmitted via Bluetooth®* using the app, providing patient monitoring — even outside the home.
Patients can view heart device data, including model name and battery longevity.
Push notifications help patients stay connected, transmit on time, and verify that transmissions were sent.
End-to-end security with data encryption keeps heart device data protected.³

®* and TM* Third-party brands are trademarks of their respective owners.

TM* Apple™* and the Apple logo™* are trademarks of Apple Inc. App Store™* is a service mark of Apple Inc.

®* The Bluetooth®* word mark and logos are registered trademarks owned by Bluetooth SIG, Inc. and any use of such marks by Medtronic is under license.

Tarakji KG, Zaidi AM, Zweibel SL, et al. Performance of first in the world pacemaker to use smart device app for remote monitoring. Heart Rhythm O2. 2021;2(5):463–471. doi: 10.1016/j.hroo.2021.07.008.
Van Heel L, Seiler A, Cirocco T, et al. Abstract 11847: Characterization of patient calls at cardiac device clinics: economic implications and opportunities for improved efficiency. Circulation. 2019;140:A11847.
Azure™ XT DR MRI SureScan™ device manual. Medtronic. October 22, 2016.

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Intended Use

The Medtronic CareLink, MyCareLink, MyCareLink Smart patient monitors, MyCareLink Smart application, CareLink network, and the CareLink mobile application are indicated for use in the transfer of patient data from some Medtronic implantable cardiac devices to the Medtronic CareLink network based on physician instructions and as described in the product manual. Medtronic CareAlerts are not intended to be used as the sole basis for making decisions about patient medical care. These products are not a substitute for appropriate medical attention in the event of an emergency and should only be used as directed by a physician. The CareLink mobile application is intended to provide current CareLink network customers access to CareLink network data via a mobile device for their convenience. The CareLink mobile application is not replacing the full workstation, but can be used to review patient data when a physician does not have access to a workstation.

The CareLink mobile application and the MyCareLink Smart mobile application have minimum requirements for the mobile device and operating system. The minimum requirements for the mobile device and operating system are expected to change over time. Periodically, the patient may need to update their mobile device’s operating system, or replace their mobile device to continue to use the app to transfer data to the CareLink network.

The MyCareLink Connect patient site is intended to provide patients, their friends/family, and caregivers messages regarding transmission status of patient device diagnostic data to the CareLink network. The MyCareLink Connect patient website is dependent on certain browser software, and that software is expected to change over time. Patients that are experiencing technical issues with the MyCareLink Connect patient website should contact Medtronic Patient Services at the number below.

Data availability, alert notifications, and patient messages are subject to Internet connectivity, access, and service availability. The CareLink and MyCareLink patient monitors and the MyCareLink Smart Reader must be on and in range of the device. The MyCareLink Smart Reader must also be within range of the patient’s mobile device. The CareLink network and mobile device accessibility to the CareLink network may be unavailable at times due to maintenance or updates, or due to coverage being unavailable in your area. Mobile device access to the internet is required for the CareLink mobile app and the MyCareLink Smart monitoring system and subject to coverage availability. Standard data and text message rates apply. Message frequency depends on account settings and clinic scheduling.

Contraindications

There are no known contraindications.

Warnings and Precautions

The CareLink, MyCareLink, and MyCareLink Smart patient monitors must only be used for interrogating compatible Medtronic implantable devices. While using the CareLink or MyCareLink patient monitor, do not use a cellular phone while the antenna is positioned over the implanted device.

The CareLink and MyCareLink monitors are intended for use within the prescribing country. The MyCareLink Smart patient monitors may be used internationally. Standard mobile device availability and rates apply.

See the device manuals for detailed information regarding the instructions for use, indications or intended uses, contraindications, warnings, precautions, and potential complications/adverse events. For further information, please call Medtronic at 1-800-929-4043 and/or consult the Medtronic website at medtronic.com.

Caution: Federal Law (USA) restricts these devices to sale by or on the order of a physician.

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