INDICATIONS, SAFETY, AND WARNINGS MANAGING YOUR PATIENTS

Medtronic MyCareLink Patient and CareLink Monitors, MyCareLink Smart Monitoring System (including the MyCareLink Smart Reader and MyCareLink Smart Application), Medtronic CareLink Express Monitor, Medtronic CareLink Network, Medtronic CareLink Mobile Application, and Medtronic MyCareLink Connect Patient Website.

Indications for Use

The MyCareLink™ Patient Monitor, CareLink™ Monitor, MyCareLink Smart™ Monitoring System, CareLink Express™ Monitor, and CareLink™ Network are indicated for use in the transfer of patient data from some Medtronic implantable cardiac devices based on physician instructions and as described in the product manual. The CareLink Express Monitor is for use in a clinical setting with Medtronic implantable cardiac devices. 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 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. 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 Network and MyCareLink Connect Patient website availability and mobile device accessibility 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 MyCareLink Smart Monitoring System and subject to coverage availability. Standard text message and data rates apply. Message frequency depends on account settings and clinic scheduling.

For U.S. Text SMS Messages:

Reply HELP for text message Help (Non-Medical information regarding text messaging).

Reply STOP to cancel the text messages. Alternatively the user can change account settings via the MyCareLink Connect Patient Site: MyCareLinkConnect.com.

User must be 18 years or older or have permission from a parent or guardian to participate. * Terms and Conditions are available at myMedtronicCareLink.net.

Supported Text Message Carriers: Our participating carriers include (but are not limited to): AT&T, Sprint, Boost, Verizon Wireless, U.S. Cellular®, T-Mobile®.

Web browsers currently supported by the MyCareLink Connect Patient Site are: Microsoft® Internet Explorer for Windows Version 8.x and Version 9.x, Mozilla Firefox® for Windows Version 13.x, Google Chrome for Windows Version 20.x.

Contraindications

There are no known contraindications.

Warnings and Precautions

The MyCareLink Patient Monitor, CareLink Monitor, CareLink Express Monitors, and MyCareLink Smart Monitoring System must only be used for interrogating compatible Medtronic implantable devices.

While using the MyCareLink Patient Monitor, CareLink Monitor, and CareLink Express Monitors do not use a cellular phone while the antenna is positioned over the implanted device.

The MyCareLink Smart Patient Monitor may be used internationally. The MyCareLink Patient Monitor, CareLink Monitor, and CareLink Express Monitor are intended for use within the prescribing country.

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 Medtronic's website at medtronic.com.


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 Medtronic's 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 Medtronic's 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 Medtronic's 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.