INDICATIONS, SAFETY, AND WARNINGS MANAGING YOUR PATIENTS

Medtronic CareLink™, MyCareLink™, MyCareLink Smart™ Patient Monitors, MyCareLink Smart™ Application, Medtronic CareLink™ Network, CareLink™ Mobile Application, and Medtronic MyCareLink Connect™ Patient Website

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.

CareLink 2090 Programmer

The Medtronic CareLink™ programmer system is comprised of prescription devices indicated for use in the interrogation and programming of implantable medical devices. Prior to use, refer to the Programmer Reference Guide as well as the appropriate programmer software and implantable device technical manuals for more information related to specific implantable device models. Programming should be attempted only by appropriately trained personnel after careful study of the technical manual for the implantable device and after careful determination of appropriate parameter values based on the patient's condition and pacing system used. The Medtronic CareLink programmer must be used only for programming implantable devices manufactured by Medtronic or Vitatron.

See the device manuals for detailed information regarding the instructions for use, indications, 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

CareLink Encore 29901 Programmer

The Medtronic CareLink Encore™ 29901 programmer system is comprised of prescription devices indicated for use in the interrogation and programming of implantable medical devices. Prior to use, refer to the Programmer Reference Guide as well as the appropriate programmer software and implantable device technical manuals for more information related to specific implantable device models. Programming should be attempted only by appropriately trained personnel after careful study of the technical manual for the implantable device and after careful determination of appropriate parameter values based on the patient's condition and pacing system used. The Medtronic CareLink Encore 29901 programmer must be used only for programming implantable devices manufactured by Medtronic or Vitatron.

See the device manuals for detailed information regarding the instructions for use, indications, 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.  

Medtronic Paceart System

Intended Use
The Paceart™ System is intended for use as a 12-lead electrocardiograph, pacemaker artifact analyzer, and transtelephonic ECG receiving station. It also acts as a database for cardiac patients with or without pacemakers or implantable cardioverter-defibrillators.

Contraindications
There are no known contraindications for the Paceart System.

See the Paceart manuals for more detailed information regarding precautions and use of the system. For further information regarding Paceart, please call Medtronic at 1-800-722-3278 and/or consult the Medtronic website at paceart.com.  

Medtronic Paceart Analytics

Intended Use
Paceart™ analytics is a retrospective reporting and analysis tool intended for use by trained professionals within a clinical network. It contains sub-dashboards for each of the following metric collections: Operations, Clinical, Productivity, and Quality. It provides the ability to view clinical and non-clinical data for monitoring key performance metrics in device populations. It allows the user to filter sub-populations, analyze trends across one or more metrics, and export data sets for further analysis. This product does not modify actual patient data, and is not intended to be used for diagnosis or treatment.

See the device manuals for detailed information regarding the implant procedure, indications, contraindications, warnings, precautions, and potential complications/ adverse events. For further information, please call Medtronic at 1-800- 328-2518 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.

Medtronic Model 24970A CareLink SmartSync™ Device Manager Base and Model 24967 Patient Connector and associated apps    

Indications
The base is intended to be used as part of the CareLink SmartSync Device Manager system. Clinicians use the base to analyze the electrical performance of cardiac leads during device implant or invasive troubleshooting. Clinicians use the base’s ECG connections along with the app display to view, measure, and record live cardiac waveforms. The base is intended to be used by healthcare professionals only in operating environments under direct medical supervision.

Contraindications
The base is not intended for use as an external pulse generator (EPG) outside of the implant procedure. In addition, the patient’s age and medical condition may dictate the lead analyses appropriate for the patient.

See the CareLink SmartSync™ 24970A and Technical Manual and 24967 Patient Connector Technical Manual before using the CareLink SmartSync Device Manager for detailed information regarding the procedure, indications or intended uses, contraindications, warnings, precautions, and potential complications/adverse events. For further information, please call Medtronic at 1-800-328-2518 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.

Medtronic Model 24967 Patient Connector and associated apps:

Indications
The patient connector is intended to be used with Medtronic apps to interrogate, analyze, and/or program implantable Medtronic devices. The patient connector uses Bluetooth® technology to transmit that data to a Medtronic app for further processing. The patient connector is intended to be used by healthcare personnel only in a clinical or hospital environment.

Precautions
Security — 
Maintain adequate physical security of the patient connector to prevent unauthorized use that could lead to harm to patients. Bluetooth communication in the patient connector is encrypted for security. Medtronic inductive telemetry uses short-range communication to protect patient information. If the patient connector should fail, there is no risk of patient harm.

See the 24967 Patient Connector Technical Manual before using the CareLink SmartSync Device Manager for detailed information regarding the procedure, indications or intended uses, contraindications, warnings, precautions, and potential complications/adverse events. For further information, please call Medtronic at 1-800-328-2518 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.