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

Medtronic Model 24970A CareLink SmartSync Device Manager Base 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 Base 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 Medtronic’s website at www.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.

Precaution

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 Medtronic’s website at www.medtronic.com.

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

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 manual for detailed information regarding the instructions for use, indications, contraindications, warnings, precautions, and potential adverse events. For further information, please call Medtronic at 1-800-328-2518 and/or consult Medtronic’s website at www.medtronic.com.

Medtronic CareLink™ 2090 Programmer and 2290 Analyzer

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.

The Medtronic 2290 Analyzer is an accessory that installs into the Medtronic CareLink programmer. The Analyzer is intended for use by a clinician to analyze the pacing and sensing performance of the cardiac lead system during the implant of a cardiac arrhythmia management device, or during invasive troubleshooting of a cardiac lead system.  There are no known contraindications to the use of a lead analysis device. The patient's age and medical condition, however, may dictate the pacing modes and lead analyses appropriate for the patient.

See the device manuals for detailed information regarding the instructions for use, indications, contraindications, warnings, precautions, and potential adverse events.  For further information, please call Medtronic at 1-800-328-2518 and/or consult Medtronic’s website at medtronic.com.

Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.

Using RemoteView™ for remote control: This section provides general information for using RemoteView for remote control of the programmer.  

Remote control safety: The remote viewer cannot respond to emergency medical conditions that require use of equipment outside of the programmer; neither can the remote viewer provide physical assistance with the programmer. The programmer user must be qualified to respond to emergency medical conditions that may occur during routine use of the programmer. The programmer user also must have the training and ability to perceive patient conditions and react accordingly. The patient care facility has the responsibility to provide appropriate personnel with the patient.

The remote control functionality should not be used with patients for the following situations: 

• Underlying rhythm test with pacer-dependent patients
• Arrhythmia inductions and EP studies
• Cardioversion

See the device manual for detailed information regarding the instructions for use, indications, contraindications, warnings, precautions, and potential 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 this device to sale by or on the order of a physician.

Using RemoteView™ for remote control: This section provides general information for using RemoteView for remote control of the programmer.  

Remote control safety: The remote viewer cannot respond to emergency medical conditions that require use of equipment outside of the programmer; neither can the remote viewer provide physical assistance with the programmer. The programmer user must be qualified to respond to emergency medical conditions that may occur during routine use of the programmer. The programmer user also must have the training and ability to perceive patient conditions and react accordingly. The patient care facility has the responsibility to provide appropriate personnel with the patient.

The remote control functionality should not be used with patients for the following situations: 

• Underlying rhythm test with pacer-dependent patients
• Arrhythmia inductions and EP studies
• Cardioversion

See the device manual for detailed information regarding the instructions for use, indications, contraindications, warnings, precautions, and potential 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 this device to sale by or on the order of a physician

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 www.medtronic.com.

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

Medtronic Paceart™ System (Optima 1.9)

Intended Use 

The Paceart Optima™ system is intended for use as a database to follow cardiac patients with or without cardiac implantable devices.

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.

Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.

Medtronic Paceart System (Optima 1.8 and below)

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.

Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.

TriageHF™

Intended Use

The TriageHF feature can be used with commercially available Medtronic CRT-D, CRT-P, and ICD devices that have the OptiVol™ Fluid Status Monitoring feature. The indications for use of these devices do not change.

The TriageHF feature gives physicians another source of information to use in managing their patients. It does not replace assessments that are part of standard clinical practice or override recommended guidelines for treatment of heart failure patients. Clinicians should not rely exclusively on the TriageHF information to assess a patient’s heart failure risk. The TriageHF information is available to clinicians who monitor their device patients on the Medtronic CareLink Network.

Contraindications

There are no known contraindications for the use of TriageHF information.

See the device manual for detailed information regarding the intended use, contraindications, warnings, precautions, and potential complications / adverse events.  For further information, call Medtronic Technical Services at (800) 328-2518 and/or consult Medtronic’s website at www.medtronic.com.

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

CareLink Express™ Mobile System, including the CareLink Express Apps (Model 31301 and Model 31302) and Patient Connector (Model 24965)

Indications

The CareLink Express app is intended for interrogating Medtronic cardiac devices and uploading the data to the CareLink network. The CareLink Express app is installed on a compatible mobile device with Internet access. The CareLink Express app communicates with the Medtronic Model 24965 Patient Connector and sends implanted cardiac device data to Medtronic’s proprietary CareLink™ network for clinical review. The CareLink Express app should be used by healthcare personnel only in a clinical or hospital environment.

Contraindications

There are no known contraindications for the CareLink Express app or the Patient Connector. 

Warnings and Precautions

Only use the Patient Connector to communicate with the intended implanted device.

Use of wireless devices — The Patient Connector incorporates radiofrequency (RF) communications components which may affect other devices and equipment in the medical environment. The use of wireless devices in the medical environment must be evaluated and authorized by the responsible organization. RF interference may affect device performance. Electromagnetic Compliance (EMC) testing shows that the Patient Connector provides reasonable protection against harmful interference and provides EMC immunity in a typical medical installation. The use of wireless devices in the medical environment must be evaluated and authorized by the responsible organization. However, there is no guarantee that interference will not occur in a particular installation. If the Patient Connector does cause harmful interference to other devices or is negatively impacted by other devices, correct the interference by one or more of the following measures: reorient or relocate the Patient Connector and other devices; increase the separation between the Patient Connector and other devices by at least 2 meters (approximately 6 feet); and/or turn off any interfering equipment.

Radiofrequency (RF) interference — Portable and mobile RF communications equipment can interfere with the operation of the Patient Connector. There is no guarantee that it will not receive interference or that any particular transmission from this system will be free from interference. To avoid interference, do not use the Patient Connector and mobile device within 2 m (6 feet) of other wireless communications equipment.

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.

Environmental precautions — To ensure safe and effective operation, use the device with care to avoid damage to the Patient Connector from environmental factors that may impair its function. Care is exercised in design and manufacturing to minimize damage to devices under normal use. However, electronic devices are susceptible to many environmental stresses. Specifically, the Patient Connector may be affected by electrostatic discharge (ESD). In an environment likely to cause ESD, such as a carpeted floor, discharge any charge collected on your body before touching the device.

Potential Complications

See the device manuals for detailed information regarding the instructions for use, intended use, 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 this system to sale by or on the order of a physician.

Brief Statement for Reveal LINQ™ and LINQ II™ Insertable Cardiac Monitors with Reveal LINQ™ Mobile Manager System

Indications

The Reveal LINQ and LINQ II Insertable Cardiac Monitors (ICMs) are insertable automatically-activated and patient-activated monitoring systems that record subcutaneous ECG and are indicated in the following cases:

• patients with clinical syndromes or situations at increased risk of cardiac arrhythmias
• patients who experience transient symptoms such as dizziness, palpitation, syncope and chest pain that may suggest a cardiac arrhythmia.

The device has not been tested specifically for pediatric use.

Reveal LINQ Mobile Manager System

The Reveal LINQ Mobile Manager app is intended for programming and interrogating the Reveal LINQ and LINQ II Insertable Cardiac Monitors.  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 data to the Reveal LINQ Mobile Manager app for further processing.  The patient connector is intended for use by healthcare professionals in a clinical or hospital environment.
 

Contraindications

There are no known contraindications for the insertion of the Reveal LINQ or LINQ II ICM or for the Reveal LINQ Mobile Manager system. However, the patient’s particular medical condition may dictate whether or not a subcutaneous, chronically implanted device can be tolerated.
 

Warnings and Precautions

Reveal LINQ and LINQ II Insertable Cardiac Monitors

Patients with the Reveal LINQ and LINQ II ICMs should avoid sources of diathermy, high sources of radiation, electrosurgical cautery, external defibrillation, lithotripsy, therapeutic ultrasound and radiofrequency ablation to avoid electrical reset of the device, and/or inappropriate sensing as described in the Medical Procedure and EMI Warnings, Precautions and Guidance manual. MRI scans should be performed only in a specified MR environment under specified conditions as described in the Reveal LINQ or LINQ II MRI Technical Manual. 

Reveal LINQ Mobile Manager System 

Before inserting the device, verify that the patient connector and tablet are fully charged. The patient connector and tablet may run out of power during the insertion procedure if they are not fully charged. You will not be able to program or interrogate the patient's device until the patient connector and the tablet have power.

Only use the patient connector to communicate with the intended implanted device. 

Use of wireless devices – The patient connector incorporates radio-frequency (RF) communications components which may affect other devices and equipment in the medical environment. 

Radio-frequency (RF) interference – Portable and mobile RF communications equipment can interfere with the operation of the patient connector. There is no guarantee that it will not receive interference or that any particular transmission from this system will be free from interference. 

Security -– Maintain adequate physical security of the patient connector to prevent unauthorized use that could lead to harm to patients. 

Environmental precautions -– To ensure safe and effective operation, use the device with care to avoid damage to the patient connector from environmental factors that may impair its function. 
 

Potential Adverse Events or Potential Complications

Potential adverse events of the Reveal LINQ and LINQ II ICMs include, but are not limited to, device rejection phenomena (including local tissue reaction), device migration, infection, and erosion through the skin.  

See the device manual for detailed information regarding the implant procedure, indications/intended use, contraindications, warnings, precautions, and potential complications/adverse events.  For further information, please call Medtronic at 1-800-328-2518 and/or consult Medtronic’s website at www.medtronic.com.

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

CareLink SmartSync™ MRI Access Application Brief Statement

Indications (or Intended Use)

The CareLink SmartSync^™ MRI Access Application (MRI app) is intended for use by a trained healthcare professional or Medtronic representative in a clinical or hospital environment to prepare a compatible Medtronic MR conditional implanted cardiac device for an MRI scan and to return the device to pre-scan settings after the MRI scan is complete. The MRI app is installed on a compatible tablet and communicates with the Medtronic Model 24967 Patient Connector to interrogate the implanted device, perform device checks, and engage the automatic algorithms that program the appropriate device parameters prior to and after the MRI scan.

Contraindications

There are no known contraindications for the use of the MRI app.

Warnings and Precautions

The MRI app does not screen patients or replace the patient screening process. A complete SureScan^™ system is required for use in the MR environment.

The tablet used with the MRI app and the Model 24967 Patient Connector are MR Unsafe and cannot be used in Zone 4 (magnet room), as defined by the American College of Radiology.

See the CareLink SmartSync™ MRI Access Application Help, CareLink SmartSync™ MRI Access Application SureScan Labeling Supplement, and 24967 Patient Connector Technical Manual for detailed information regarding the procedure, indications or intended uses, contraindications, warnings, precautions, and potential complications/adverse events.

Refer to the MRI Technical Manual for the implanted device for information on MRI warnings and precautions and potential adverse events. The MRI app turns on and turns off MRI SureScan mode. When MRI SureScan mode is turned on or turned off, the patient’s implanted device must meet all the labeling conditions defined in the MRI Technical Manual. See the Device Manual for the implanted device for detailed information regarding the implant procedure, indications, contraindications, warnings, precautions, and potential complications/adverse events. 

For further information, call Medtronic at 1-800-328-2518 and/or consult the Medtronic website at www.medtronic.com.

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

Medtronic Model 24967 Patient Connector

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 trained healthcare professionals or Medtronic representatives in a clinical or hospital environment.

Contraindications

There are no known contraindications for the use of the Patient Connector.

Warnings and Precautions

The Patient Connector may experience connectivity or performance issues. See the 24967 Patient Connector Technical Manual for details and troubleshooting instructions.

See the 24967 Patient Connector Technical Manual before using the MRI app for detailed information regarding the indications or intended uses, contraindications,

warnings, precautions, and potential complications/adverse events. For further information, call Medtronic at 1-800-328-2518 and/or consult the Medtronic website at www.medtronic.com.

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