Medtronic D02U001 Instructions for Use

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CareLink SmartSync™ MRI Access Application Help

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

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Medtronic, Medtronic with rising man logo, and Medtronic logo are trademarks of Medtronic. Third-party trademarks (“TM*”) belong to their respective owners. The following list includes trademarks or registered trademarks of a Medtronic entity in the United States and/or in other countries.

Astra™, Azure™, CareLink SmartSync™, CareLink™, Cobalt™, Crome™, Percepta™, Serena™, Solara™, SureScan™

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1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

1.1 Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

1.2 About the MRI Access application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

1.3 Patient session workflow steps . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

1.4 MRI SureScan labeling for implanted devices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

1.5 Device and lead checks performed by the MRI app . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

1.6 MRI app algorithms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

1.7 Intended use of the app . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

1.8 Warnings and precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

1.9 Download or order the instructions for use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

1.10 Notice of Privacy Practices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

1.11 Reporting errors and serious incidents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

2 Important information before using the MRI app . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

2.1 Screening patients . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

2.2 Patient monitoring requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

2.3 Patient comfort . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

2.4 Radiology requirements for transvenous cardiac devices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

3 Using the MRI app . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

3.1 Start a patient session . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

3.2 Turn SureScan mode to ON . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

3.3 Conduct the MRI scan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

3.4 Reconnect to continue . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

3.5 Turn SureScan mode to OFF . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

3.6 Additional workflows to turn SureScan mode to OFF . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

3.7 App messages on the Do Not Scan page . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

3.8 End a patient session . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

3.9 Managing sessions with multiple patients . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

3.10 SureScan mode already turned on . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

3.11 Device reset detected . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

3.12 Multiple implanted devices detected . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

3.13 View or export saved reports and implanted device data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

3.14 Close the app . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

4 Connecting the patient connector . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

4.1 About the app and component connections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

4.2 Connect to the patient connector . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

4.3 Troubleshoot connections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

4.4 Troubleshooting patient connector position . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

5 Managing the MRI app settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

5.1 Manage patient data privacy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

5.2 Manage the profile settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

5.3 Configure rate unit labels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

5.4 Configure filename preferences . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

5.5 Export user preferences . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

5.6 Import user preferences . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

6 Updating the MRI app . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

6.1 IT network, tablet, and data information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

6.2 MRI app updates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

6.3 Install a new version of the app . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

6.4 Install a content update . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

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6.5 Install required software updates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

6.6 Manually check for and install updates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

6.7 Uninstall the app . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

7 Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

7.1 Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

7.2 Service logs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

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1 Introduction

1.1 Description

The CareLink SmartSync MRI Access application (called the “MRI app” or “the app” from now on) is used by a healthcare professional to prepare a compatible Medtronic implanted device for an MRI scan by turning SureScan mode to ON before the patient receives an MRI scan. After the MRI scan is complete, the MRI app is used to turn SureScan mode to OFF and return the implanted device to pre-scan settings.

Before the MRI app is used to turn SureScan mode to ON, the patient must be screened to confirm that the patient has a compatible MR-conditional Medtronic implanted device that is part of a complete MRI SureScan system.

1.2 About the MRI Access application

The CareLink SmartSync MRI Access application is part of a system that includes the following components:

• Model 24967 patient connector (referred to as the patient connector)

• A compatible tablet

• CareLink SmartSync MRI Access application (referred to as “MRI app” or “the app”)

The MRI app includes the following features:

• Bluetooth® connectivity to communicate with the patient connector

• Tablet connectivity tools for sharing and printing reports

• Ability to export data

• Ability to update the MRI app software using an Internet connection

• Ability to communicate with implanted devices

Table 1. MRI app software component model numbers

Software model number Software component name

M01A01 CareLink SmartSync Platform Application M01A02 CareLink SmartSync Common Application D02U001 CareLink SmartSync MRI Access Host Application D00U003 CareLink SmartSync Azure™ Astra™ Application D00U004 CareLink SmartSync Percepta™ Serena™ Solara™ Application D00U005 CareLink SmartSync Cobalt™ Crome™ Application

1.3 Patient session workflow steps

The MRI Access app guides a clinician through the steps to turn SureScan mode to ON in a patient’s device in preparation for an MRI scan, and to turn SureScan mode to OFF after the MRI scan. The following list is an overview of the patient session workflow.

1. The clinician confirms the patient’s system is MR conditional.

2. The clinician initiates interrogation of the implanted device.

3. The MRI app interrogates the implanted device and performs device and lead checks.

4. The clinician ensures that the patient is continuously monitored.

5. The clinician requests that SureScan mode be turned to ON.

6. The MRI app turns SureScan mode to ON and applies the pre-scan algorithm to program appropriate pacing parameters.

7. The clinician confirms that the patient is comfortable and can continue with the scan.

8. The clinician removes the patient connector.

9. The clinician conducts the MRI scan.

10. The clinician re-establishes the connection between the implanted device and the app.

11. The clinician requests SureScan mode be turned to OFF.

12. The MRI app turns SureScan mode to OFF and applies the post-scan algorithm to program appropriate pacing parameters.

1.4 MRI SureScan labeling for implanted devices

Before you scan a patient, you must ensure full compliance with labeling in the MRI technical manual for the implanted device.

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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The MRI app help supplements the MRI technical manual by providing information that pertains to workflow steps, device and lead checks that are performed, and algorithms that are applied when using the MRI app to program SureScan parameters. The MRI app help should be used along with the MRI technical manual.

Refer to the MRI technical manual for the implanted device’s MRI SureScan labeling for the following topics:

• MRI conditions for use.

• MRI warnings, precautions, and potential adverse events.

• Radiology requirements and considerations.

• Cardiology requirements, and in particular screening to ensure the implanted system meets the following requirements: – The patient has no implanted lead extenders, lead adaptors, or abandoned leads. – The device is implanted in the left or the right pectoral region.

• Pre-MRI scan operations, and in particular screening the patient to ensure that the patient does not have additional implanted cardiac devices.

The MRI app help provides information about device and lead checks and algorithms that are performed by the app to automate the programming of SureScan parameters. Refer to the MRI app help for labeling related to the following topics:

• Warnings and precautions related to the use of the app and its components.

• Instructions for turning SureScan mode to ON and OFF using the app.

• Additional device and lead checks that are performed by the app.

• Descriptions of algorithms the app uses to program device parameters when turning SureScan mode to ON and OFF.

• Patient monitoring requirements when using the app to turn SureScan mode to ON.

1.5 Device and lead checks performed by the MRI app

The MRI technical manual for the implanted device outlines a number of required device and lead checks when using the CareLink SmartSync 2090 programmer or the CareLink SmartSync Device Manager for enabling SureScan mode in an MR Conditional cardiac device. The CareLink SmartSync MRI Access app will automatically perform the necessary device and lead integrity checks when the device is being programmed using the app. These may include verifying the device status, the electrical integrity of implanted lead wires connected to the device, as well as relevant implanted device settings. Pre-scan and post-scan tests of the right ventricular (RV) lead pacing capture threshold (PCT) are not required when using the MRI app to program an implanted device into and out of MRI SureScan mode.

The MRI app also performs the following additional device checks before MRI SureScan is turned to ON.

Active VT/VF event – The app checks whether the implanted device detects an active ventricular tachycardia or ventricular fibrillation event. If an active VT/VF event is detected then the app does not allow SureScan mode to be turned ON.

Device reset – The app checks whether the implanted device has undergone a full device reset. If the implanted device has undergone full reset, then the app does not allow SureScan mode to be turned ON. For more information, see Section 3.11, Device reset detected, page 16.

1.6 MRI app algorithms

1.6.1 About MRI app algorithms

The MRI app algorithms are automatic and no interaction from the clinician is necessary.

1.6.2 Pre-scan algorithm

The pre-scan algorithm automatically determines and programs the appropriate device parameters required to turn SureScan mode to ON. The pacing mode and rate will automatically be determined to provide the necessary pacing support for the patient. The pacing mode and rate that the app programs is included in the device report in the app.

1.6.3 Post-scan algorithm

The post-scan algorithm automatically evaluates and programs the appropriate implanted device parameters to return the implanted device to the pre-scan settings. In some cases, if it is determined appropriate for the implanted device, the pacing output of the implanted device may be increased to ensure proper pacing support is maintained after the MRI scan is complete and MRI SureScan mode is disabled. Any changes to the patient’s pacing output are captured in the final device report. The pacing output adjustment is automatic and will continue to be monitored and adjusted by the patient’s implanted device as needed to ensure pacing support is maintained.

1.7 Intended use of the app

1.7.1 Intended use

The intended purpose is to interrogate, program, or execute tests on a Medtronic cardiac device.

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1.7.2 Intended users

The CareLink SmartSync MRI Access app is intended for use by healthcare professionals or Medtronic representatives in a clinical or hospital environment.

1.7.3 Intended patient population

The CareLink SmartSync MRI Access app is intended for use with patients that have a Medtronic implanted cardiac device that is compatible with the app.

1.7.4 Expected clinical benefits

The clinical benefit of the CareLink SmartSync MRI Access app is to prepare a Medtronic implanted device to safely undergo an MRI scan.

1.7.5 Indications for use

For information about the indications for the implanted device, refer to the manual for the implanted device.

1.7.6 Contraindications

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

1.8 Warnings and precautions

These warnings and precautions apply when using the app in combination with the other system components.

Equipment compatibility – The app must be used only with compatible Medtronic implantable devices. If the app is used with other implantable devices, direct stimulation through energy coupling may occur. The app is not compatible with programmable devices of other manufacturers.

Importance of instructions for use – Before using the MRI app, take the following actions:

• Read the instructions for use for the MRI app.

• Read the MRI technical manual for the patient’s implanted device. The MRI app turns on or turns off MRI SureScan mode. When MRI SureScan mode is turned on or turned off, the patient’s implanted device must meet all of the labeling conditions defined in the MRI technical manual.

• To ensure that the implanted device is MR Conditional when part of a complete SureScan system, refer to http://www.mrisurescan.com.

Magnetic interference – Some tablets may be sensitive to magnetic interference. Keep strong magnetic sources (such as magnetic programming heads, patient magnets like the Model 9466 Tachy Patient Magnet, or other strong magnetic field generators) away from direct contact with the tablet when working with the app.

Note that the Model 24967 patient connector does not include a magnet and is not a source of magnetic interference.

Note: MRI magnetic fields that are present in Zone 3, as defined by the American College of Radiology, are not expected to interfere with the operation of the tablet.

Magnetic resonance (MR) unsafe – The tablet used with the MRI app and the patient connector are MR Unsafe. Do not bring any components of the MRI app system into Zone 4 (magnet room), as defined by the American College of Radiology.

Patient screening – Before using the app with a patient, follow your patient screening process to determine the MR-conditionality of the patient’s implanted devices and whether the patient has a complete SureScan system. A complete SureScan system is required for use in the MR environment.

The MRI app does not support cases where the patient has multiple implanted devices. Follow your patient screening process to determine if the patient has multiple implanted devices.

Preparation for patient rescue – In case you need to quickly reconnect to the implanted device to turn SureScan mode to OFF, the MRI app and patient connector should be available nearby whenever the MRI app has been used to turn SureScan mode to ON.

In the event that patient rescue is required, an external defibrillator must be immediately available.

MRI SureScan mode – Do not scan a patient without first turning MRI SureScan mode to ON. Scanning the patient without turning the MRI SureScan mode to ON may result in patient harm or damage to the SureScan system.

• Do not turn MRI SureScan mode to ON until the patient is ready to receive the MRI scan. While MRI SureScan mode is turned to ON, arrhythmia detection and therapies are suspended, leaving the patient at risk of death from untreated spontaneous tachyarrythmia.

• If the implanted device is turned to an asynchronous pacing mode, arrhythmia risk may be increased.

• For CRT (Cardiac Resynchronization Therapy) implanted devices, CRT support may be suspended while MRI SureScan mode is turned to ON. Patients may experience dizziness or shortness of breath without CRT support.

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Turn MRI SureScan mode to OFF as soon as the scan is complete. Do not leave the device in MRI SureScan mode after the scan is complete.

Tablet and app interaction – Due to the dynamic nature of the tablet environment, operating system events such as notifications, alarms, and messaging can take priority and therefore move the app to the background. Tapping, pressing buttons, and using gestures on the tablet can also result in moving the app to the background or closing the app. For example, the app moves to the background if you lock the tablet.

When the app moves to the background or closes, the app pauses communication or loses communication with the implanted device. When you restore the app from the background, the app attempts to re-establish communication with the implanted device and

displays the system status. If the app was closed, you must reconnect the patient connector to the app to re-establish communication with the implanted device.

Tablet language settings – Tablets allow you to change the language used to display information. If you change the language used on your tablet, the tablet automatically closes any apps that are currently running (including the MRI app). You may need to reopen the MRI app after changing the tablet language setting.

Pairing the patient connector – Verify that the app is paired to the correct patient connector. Pairing to a different patient connector can result in confusion during a patient session or the delay of a procedure.

Modification of equipment – Do not modify any hardware or software component of the MRI app system. Modifications may reduce system effectiveness and impact user or patient safety. Modifying any component without the approval of Medtronic could void the user’s authority to operate the equipment.

Radiofrequency (RF) interference – Portable and mobile RF communications equipment can interfere with the operation of components of the MRI app system. There is no guarantee that the MRI app system will not receive interference or that any particular transmission from this system will be free from interference.

Use of wireless devices – The MRI app system incorporates radiofrequency (RF) communications components that 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 compatibility (EMC) compliance testing shows that the components of the MRI app system provide reasonable protection against harmful interference and provide EMC immunity in a typical medical installation. However, there is no guarantee that interference will not occur in a particular installation.

If any component does cause harmful interference to other devices or is negatively impacted by other devices or by the environment, correct the interference by taking one or more of the following measures:

• Reorient or relocate the component and other devices.

• Increase the separation between the component and other devices by at least 2 m (approximately 6 feet).

• Turn off any interfering equipment.

1.9 Download or order the instructions for use

To view, download, print, or order a PDF version of this app help, go to www.medtronic.com/manuals, or contact a Medtronic representative.

The PDF version of this app help can be viewed using a current version of any major internet browser. For best results, use Adobe™* Acrobat™* Reader software with the browser.

Paper copies of this app help are available to customers free of charge. They should arrive in 3 to 7 days. To order, go to www.medtronic.com/manuals or contact a Medtronic representative.

1.10 Notice of Privacy Practices

To read the Medtronic Notice of Privacy Practices, go to medtronic.com/smartsync/us-privacy.

1.11 Reporting errors and serious incidents

If a serious incident related to the app occurs, immediately report the incident to Medtronic and the applicable competent authority or regulatory body.

If you find information in this app help that is incorrect, contact Medtronic.

2 Important information before using the MRI app

2.1 Screening patients

The MRI app does not screen patients or replace your patient screening process. A complete SureScan system is required for use in the MR environment. To verify that components are part of a SureScan system, visit http://www.mrisurescan.com. Any other combination may result in a hazard to the patient during an MRI scan. Verify that requirements in the MRI Conditions for Use and MRI Warnings and Precautions in the MRI technical manual for the implanted device are followed.

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Notes:

• Restrictions may exist for implant position, other nearby implants, accessory components of the system such as lead adaptors or extenders, and abandoned implanted leads. The restrictions should be verified as part of the patient screening process.

• Some electrical device and lead checks indicated in the MRI technical manual are handled automatically when using the MRI app.

Warning: Do not scan a patient without first turning MRI SureScan mode to ON. Scanning the patient without turning MRI SureScan mode to ON may result in patient harm or damage to the SureScan system.

Cautions:

• Before using this app with a patient, follow your patient screening process to determine the MR-conditionality of the patient’s implanted devices and whether the patient has a complete SureScan system. A complete SureScan system is required for use in the MR environment.

• Follow your patient screening process to determine if the patient has multiple implanted devices. The MRI app does not support cases where the patient has multiple implanted devices.

Note: MRI SureScan mode cannot be turned to ON if the device is recommended for replacement.

2.2 Patient monitoring requirements

Proper patient monitoring is required while MRI SureScan mode is ON.

• Maintain continuous visual and verbal contact with the patient

• Continuously monitor the patient’s heart rate, using instrumentation such as pulse oximetry (plethysmography) or electrocardiography

Note: If the patient’s hemodynamic function is compromised or experiences a cardiac arrhythmia during the MRI scan, discontinue the scan, remove the patient from the magnet room, turn MRI SureScan mode to OFF, and take the proper measures to restore the patient’s hemodynamic function.

All devices – The following warnings and cautions are applicable to all implanted devices.

Warning: Arrhythmia risk may be increased for a patient who is programmed to an asynchronous pacing mode while the MRI

SureScan mode is ON. Therefore, proper patient monitoring is required during the entire time when the MRI SureScan mode is ON.

Cautions:

• In case you need to quickly reconnect to the implanted device to turn SureScan mode to OFF, the MRI app and patient connector must be available nearby whenever the MRI app has been used to turn SureScan mode to ON.

• Preparation for patient rescue — In the event that patient rescue is required, an external defibrillator must be immediately available.

Implantable cardioverter defibrillator (ICD) devices – The following warning is applicable to all ICDs.

Warning: While the MRI SureScan mode is ON, tachyarrhythmia detection and therapy are suspended, leaving the patient at risk of

death from untreated spontaneous tachyarrhythmia

Cardiac resynchronization therapy defibrillator (CRT-D), and cardiac resynchronization therapy pacemaker (CRT-P) devices – The following warning is applicable to all CRT-D and CRT-P devices.

Warning: While the MRI SureScan mode is ON, many CRT patients will not receive CRT support. This lack of CRT support might

cause dizziness or shortness of breath. Refer to the MRI technical manual for the implanted device for additional information.

2.3 Patient comfort

The MRI app will adjust the patient’s device pacing settings when appropriate to ensure pacing support is maintained during the MRI scan. Some patients may perceive the change to their device settings when the MRI SureScan mode is turned to ON. Ensure the patient is comfortable after the MRI SureScan mode has been turned to ON. If the patient experiences any prolonged discomfort from the change of device settings, the MRI SureScan mode should be turned to OFF, which resets all settings to the pre-SureScan mode states. Refer the patient to his or her cardiologist in the event of prolonged patient discomfort. The MRI SureScan parameters that were enabled on the implanted device are available for review in the MRI SureScan Parameters report and can be provided to cardiology.

Patient discomfort may be related to the following conditions:

Accelerated heart rate – When appropriate, the MRI app will program a faster pacing rate when turning the MRI SureScan mode to ON in order to provide the necessary pacing support in a safe manner. This can result in a faster heart rate that may be perceptible by the patient.

Pacing sensation – Some patients may rarely experience pacing during normal waking hours. If determined to be appropriate, the MRI app may enable cardiac pacing to ensure proper pacing support is maintained during the MRI scan. In rare cases, patients may feel their cardiac pacing. If any prolonged patient discomfort occurs, turning the MRI SureScan mode to OFF will restore the original device settings.

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Dizziness or shortness of breath – For patients with Cardiac Resynchronization Therapy (CRT) devices, while the MRI SureScan mode is programmed to ON, many will not receive CRT support. This lack of CRT support might cause dizziness or shortness of breath. This form of patient discomfort may not occur immediately. Therefore, proper patient monitoring is required during the entire time when the MRI SureScan mode is programmed to ON. Turning the MRI SureScan mode to OFF will restore CRT Therapy.

Diaphragmatic stimulation – Diaphragmatic stimulation is the stimulation of the patient’s diaphragm, which can result in a hiccup like sensation. In rare circumstances, this could occur due to elevated pacing output settings meant to ensure proper pacing support is maintained during the MRI scan. If this occurs, turning the MRI SureScan mode to OFF will revert the device back to its normal settings and diaphragmatic stimulation should terminate.

Caution: Do not scan patients who are experiencing diaphragmatic stimulation. If the patient is experiencing diaphragmatic stimulation, it may be difficult for the patient to remain still in order to obtain a quality MRI scan.

2.4 Radiology requirements for transvenous cardiac devices

See the Radiology requirements for transvenous cardiac devices table for the radiology requirements for the implantable devices that are listed in the Applicable transvenous cardiac device models table.

If the patient’s product model is not listed in the Applicable transvenous cardiac device models table, then consult the MRI technical manual for the implanted device for the appropriate radiology requirements.

Transvenous pacemaker, ICD, and CRT – A pacemaker, ICD, or CRT device with one or more leads connected to the heart through the venous system.

The safety and reliability of the SureScan system have been evaluated and approved for scanning patients using MRI equipment that has the following operating characteristics:

Table 2. Radiology requirements for transvenous cardiac devices

Scanner type Horizontal field, cylindrical bore, clinical system for hydrogen proton imaging Scanner characteristics • Static magnetic field of one of the following strengths:

– 1.5 T – 3 T

• Maximum spatial gradient of ≤ 20 T/m (2000 gauss/cm)

• Gradient systems with maximum gradient slew rate performance per axis of ≤ 200 T/m/s

Scanner operation 1.5T – MRI radio frequency (RF) power – Normal Operating Mode

• The whole body averaged specific absorption rate (SAR) must be ≤ 2.0 W/kg.

• The head SAR must be ≤ 3.2 W/kg.

3T – MRI radio frequency (RF) power – First Level Controlled Operating Mode or Normal Operating Mode:

• B vertebra.

• Scans can be performed without B C7 vertebra.

must be ≤ 2.8 µT when the isocenter (center of the MRI bore) is inferior to the C7

1+RMS

restriction when the isocenter is at or superior to the

1+RMS

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Figure 1. 3T scan location requirements

1 No B 2 B

1+RMS

restrictions

1+RMS

not to exceed 2.8 µT

Note: Specific models may not be available in your geography.

Table 3. Applicable transvenous cardiac device models

Product name Product model

Astra DR MRI SureScan X1SR01

X1DR01 X2DR01

X3DR01 Astra S SR MRI SureScan X3SR01 Astra XT SR MRI SureScan X2SR01 Azure S DR MRI SureScan W3DR01 Azure S SR MRI SureScan W2SR01 Azure XT DR MRI SureScan W1DR01

W2DR01 Azure XT SR MRI SureScan W1SR01

W2SR01 Cobalt DR ICD MRI SureScan DDPB3D1

DDPB3D4

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Table 3. Applicable transvenous cardiac device models (continued)

Cobalt HF CRT-D MRI SureScan DTPB2D1

DTPB2Q1

DTPB2D4

DTPB2QQ Cobalt VR ICD MRI SureScan DVPB3D1

DVPB3D4 Cobalt XT DR ICD MRI SureScan DDPA2D1

DDPA2D4 Cobalt XT HF CRT-D MRI

SureScan

Cobalt XT VR ICD MRI SureScan DVPA2D1

Crome DR ICD MRI SureScan DDPC3D1

Crome HF CRT-D MRI SureScan DTPC2D1

Crome VR ICD MRI SureScan DVPC3D1

Percepta CRT-P MRI SureScan W1TR01

Serena CRT-P MRI SureScan W1TR02

Solara CRT-P MRI SureScan W1TR03

DTPA2D1

DTPA2Q1

DTPA2D4

DTPA2QQ

DVPA2D4

DDPC3D4

DTPC2Q1

DTPC2D4

DTPC2QQ

DVPC3D4

W1TR04

W4TR01

W4TR04

W1TR05

W4TR02

W4TR05

W1TR06

W4TR03

W4TR06

3 Using the MRI app

3.1 Start a patient session

Before you start a patient session, the app must be connected to a paired patient connector.

For information on pairing a patient connector, see Section 4.2.1, Connect to a patient connector, page 17.

Caution: Before beginning a patient session, ensure the batteries in the patient connector and the tablet are charged or that they are connected to the power mains.

When the app is connected to a patient connector, the first page you will see when you open the app is the Welcome! Before you begin: screen.

To begin a patient session, select the check box after confirming that the patient has been screened properly and will be monitored, then tap CONTINUE.

3.2 Turn SureScan mode to ON

To turn SureScan mode to ON, begin a new patient session and follow the steps presented in the app.

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When you initiate a new patient session, the app interrogates and performs checks on the implanted device and lead or leads. If the implanted device and lead or leads checks pass, the app directs you to a page that identifies the model of the implanted device. Tap TURN SureScan ON.

On the SureScan is ON screen, ensure that the patient is comfortable. If the patient is experiencing prolonged discomfort, tap TURN SureScan OFF. For more information about patient comfort requirements, see Section 2.3, Patient comfort, page 9.

If the patient is comfortable, tap CONTINUE and remove the patient connector from the patient.

3.3 Conduct the MRI scan

When SureScan mode is turned ON, the patient’s implanted device is in SureScan mode. The patient can be moved to Zone 4 (magnet room), as defined by the American College of Radiology, and receive an MRI scan.

Once the MRI scan is complete, remove the patient from Zone 4 (magnet room), where you may proceed to reconnect to the patient’s implanted device to turn MRI SureScan mode to OFF.

3.4 Reconnect to continue

After the patient’s MRI scan is complete, you must reestablish a connection with the implanted device to turn SureScan mode to OFF. To reconnect to the implanted device, use the following steps.

1. Remove the patient from Zone 4 (magnet room), as defined by the American College of Radiology.

2. Place the patient connector over the implanted device.

3. Press the button on the patient connector.

The patient connector will reconnect with the implanted device and the app workflow will proceed to the next step.

If you are having difficulty reconnecting to the implanted device, try the following troubleshooting steps.

• Make sure the patient connector battery is fully charged.

• Reposition the patient connector over the device.

• Confirm the patient and implanted device information for the current session match the patient you are working with.

The MRI app supports one patient session at a time. If there is an active session, the app will only connect to the device that was interrogated at the beginning of the session. The patient name and implanted device from the current session are displayed on the upper left of the app workflow.

If the patient connector is placed over an implanted device that was not interrogated in the open session, the app will remain on the Reconnect to Continue screen. To resume the current patient session, place the patient connector over the implanted device listed in the app session.

3.5 Turn SureScan mode to OFF

Warning: Do not leave the device in MRI SureScan mode after the scan is complete. While the MRI SureScan mode is programmed

to ON, arrhythmia detection and therapies are suspended, leaving the patient at risk of death from untreated spontaneous tachyarrythmia. In addition, if the device is programmed to an asynchronous pacing mode, arrhythmia risk may be increased. Also, if the device is intended to deliver CRT support, while MRI SureScan mode is programmed to ON the patient receives no CRT support. This lack of CRT support might cause dizziness or shortness of breath. Be sure to program MRI SureScan mode to OFF as soon as the scan is complete.

If SureScan mode is not programmed to OFF, the implanted device will remain in SureScan mode until the device’s SureScan mode timeout period automatically expires. The timeout period for SureScan mode is dependent on the device type. It is important to turn SureScan mode to OFF and return the implanted device to the patient’s prescribed settings as soon as possible so that the device’s therapies are available to the patient. Refer to the MRI technical manual for the implanted device for more information about the timeout period.

To turn SureScan mode to OFF, use the following steps.

1. Remove the patient from Zone 4 (magnet room), as defined by the American College of Radiology.

2. Place the patient connector over the patient’s implanted device.

3. Perform one of the following steps.

• If the patient session is still active in the app, on the Patient Ready for MRI screen, tap MRI IS COMPLETE. After the app establishes a connection to the implanted device, tap TURN SureScan OFF.

• If the patient session has been closed, begin a new patient session. When the app interrogates the implanted device and detects that SureScan mode is programmed to ON, the app will redirect you to a page stating that SureScan is ON and ask you if the MRI exam is complete.

4. On the SureScan is OFF screen, tap COMPLETE to end the patient session.

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3.6 Additional workflows to turn SureScan mode to OFF

After SureScan mode is turned to ON, if the patient experiences continued discomfort or an adverse event occurs, be sure to understand how to turn off SureScan mode based on your location in the app workflow.

Caution: In case you need to quickly reconnect to the implanted device to turn SureScan mode to OFF, the MRI app and patient connector should be available nearby whenever the MRI app has been used to turn SureScan mode to ON.

Table 4. Possible app workflow conditions and the method for turning SureScan mode to OFF if an adverse event occurs.

App workflow condition Actions to turn SureScan mode to OFF

App on SureScan is ON screen Tap TURN SureScan OFF. App on Remove Patient Connector screen 1. Tap BACK.

2. Tap TURN SureScan OFF.

Note: If the patient connector was removed, replace it over the implanted device area.

App on Patient Ready for MRI screen 1. Tap MRI IS COMPLETE.

2. Place the patient connector over the implanted device area and press the button on the patient connector.

3. After the app establishes a connection with the implanted device, tap TURN SureScan OFF.

The app patient session is closed 1. On the Welcome! Before you begin: screen, start a new

session by selecting the check box and tap CONTINUE.

2. Place the patient connector over the implanted device area and press the button on the patient connector.

3. The app detects that SureScan mode is turned to ON. From the on-screen options, select YES, TURN SureScan OFF.

3.7 App messages on the Do Not Scan page

If the app determines that SureScan mode cannot be turned on, then it will list the reason on the Do Not Scan screen.

Table 5. Do Not Scan screen messages

App message Action to be taken

The device settings at implant have not been marked as complete.

Lead impedance exceeds limits or cannot be verified. Bipolar pacing is required for MRI SureScan. One or more leads

is currently configured for unipolar pacing. The implanted device has unexpectedly reset since the patient’s

last device check. The device is near its replacement date. The implanted device has invalid or incomplete information

stored on it. The patient’s average heart rate exceeds 95 bpm and the implan-

ted device has invalid information stored on it. The patient’s average heart rate exceeds 120 bpm. If the patient is experiencing anxiety about the scan, try interrog-

The patient is experiencing an arrhythmia that the device is currently treating or monitoring.

Notify the radiologist or other physician supervising the MRI exam.

ating the device again at a later time after the patient has calmed. If the patient continues to have an elevated heart rate and cannot undergo an MRI exam, then notify the radiologist or other physician supervising the MRI exam.

The device is currently treating or monitoring the patient. Closely monitor the patient. Notify the radiologist or other physician supervising the MRI exam.

3.8 End a patient session

Ending a patient session will close the connection between the app, patient connector, and the patient’s implanted device.

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Note: Ending the session does not change the status of MRI SureScan mode in the implanted device. If you end the patient session while SureScan mode is programmed to ON, you must start a new app workflow to re-interrogate the implanted device in order to turn SureScan mode to OFF.

Use the following steps to end a patient session.

1. Tap > End Session.

2. On the confirmation message, tap YES, END SESSION.

3.9 Managing sessions with multiple patients

After you have prepared a patient for an MRI scan and placed the implanted device into SureScan mode, you can use the MRI app to prepare another patient for an MRI scan.

The MRI app can only have one patient session active. You must end the first patient session before you can start a new session with the second patient.

Note: Ending the patient session does not change the SureScan mode in the implanted device.

Caution: The MRI app and patient connector should be available nearby whenever it has been used to turn SureScan mode to ON

in case you need to quickly reconnect to the implanted device to turn SureScan mode to OFF.

To work with multiple patients, use the following steps.

1. With the first patient, follow the MRI app workflow steps to turn SureScan mode to ON and prepare the patient for an MRI scan. Note: Ensure the patient is continuously monitored while SureScan mode is programmed to ON.

2. From the Patient Ready for MRI screen, complete the following steps.

a. Tap > End Session. b. Tap YES, END SESSION.

3. Place the patient connector over the second patient’s implanted device.

4. Using the MRI app, start a new patient session and prepare the second patient for an MRI.

5. After SureScan mode has been programmed to ON for the second patient’s implanted device, from the Patient Ready for MRI screen, complete the following steps.

a. Tap > End Session. b. Tap YES, END SESSION.

6. After the first patient’s MRI scan is complete, place the patient connector over the first patient’s implanted device and restart the MRI app workflow.

Note: Confirm the patient’s name and device serial number in the MRI app banner.

7. The MRI app will interrogate the patient’s device and detect that SureScan mode is programmed to ON and will ask you if the patient’s MRI exam is complete. If the patient’s MRI exam is complete, tap YES, TURN SureScan OFF.

8. Use the following steps to complete the MRI app workflow:

a. Tap > End Session. b. Tap YES, END SESSION. c. Remove the patient connector from the first patient.

9. After the second patient’s MRI scan is complete, place the patient connector over the second patient’s implanted device and restart the MRI app workflow.

Note: Confirm the patient’s name and device serial number in the MRI app banner.

10. The MRI app will interrogate the second patient’s device and detect that SureScan mode is programmed to ON and will ask if the patient’s MRI exam is complete. If the patient’s MRI exam is complete, tap YES, TURN SureScan OFF.

11. Use the following steps to complete the MRI app workflow: and remove the patient connector from the second patient.

a. Tap > End Session. b. Tap YES, END SESSION. c. Remove the patient connector from the second patient.

3.10 SureScan mode already turned on

If the patient’s implanted device is in SureScan mode and you begin a new patient session, the MRI app will display the SureScan is ON. Is the patient MRI exam complete? page with the following options.

• NO, PREPARE FOR MRI EXAM

• YES, TURN SureScan OFF

• VIEW DEVICE REPORT

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SureScan mode may have been enabled by the patient’s cardiologist or a Medtronic representative before he or she arrived for an MRI scan. The device report in the app includes information about the current parameter settings.

If you select NO, PREPARE FOR MRI EXAM, the MRI app will guide you through the steps to prepare the patient to receive an MRI exam.

If the MRI exam is complete, select YES, TURN SureScan OFF to continue with the MRI app workflow to turn SureScan mode to OFF.

The MRI app also displays the remaining time that the implanted device will remain in SureScan mode. The implanted device will automatically turn SureScan mode to OFF after a certain period of time. If the MRI scan has not yet been completed and additional time is necessary, determine if the MRI scan will take longer than the remaining time that the implanted device will have SureScan mode ON. If the MRI scan will take longer than the remaining time and if the MRI app was originally used to turn SureScan mode ON, use the MRI app to turn SureScan mode to OFF and then turn SureScan mode back ON to reset the timeout. If SureScan was originally enabled by cardiology, refer the patient to cardiology for programming SureScan mode to ON.

3.11 Device reset detected

The app will notify you if it detects that the implanted device has reset.

The app can detect a device reset any time it communicates with the implanted device. If a full device reset is detected during the pre-scan device checks, the app will not allow SureScan mode to be programmed to ON.

When a full reset occurs, the implanted device defaults to parameters that are appropriate for the device model. For more information about the default reset values for a device model, refer to the parameter tables in the device manual for that model. For more information about device resets, refer to the implanted device’s manual.

If a full or partial device reset is detected after SureScan mode is programmed to ON, then the app will program SureScan mode to OFF and the app will not apply the post-scan pace output algorithm. Notify the radiologist or other physician supervising the MRI exam. The device report contains information that can be reviewed by the patient’s cardiologist or a Medtronic representative. The device report will be temporarily available in Saved Reports.

3.12 Multiple implanted devices detected

The MRI app does not support cases where a patient has multiple implanted cardiac devices.

When the app detects multiple implanted cardiac devices, it displays the Unsupported Case message.

Caution: The patient connector may not detect another implanted device if its implant location is outside of the patient connector’s telemetry range when interrogating the first detected device. Follow your clinic’s patient screening protocols to determine if the patient has multiple implanted cardiac devices. The MRI app is not intended to replace your patient screening protocols for determining if the patient has multiple implanted cardiac devices.

If the patient has multiple implanted devices, consult the patient’s cardiologist or a Medtronic representative to arrange programming SureScan mode to ON using a supported Medtronic programmer.

Both implanted devices may be MR-conditional and compatible with the MRI app. However, the app only supports cases where the patient has only one implanted cardiac device that is part of a complete SureScan system.

3.13 View or export saved reports and implanted device data

When you generate a report or save implanted device data during a session, the report or data is saved to the SAVED REPORTS window.

Depending on your tablet setup, you can export reports and device data using the following methods:

• Export the reports and device data to various destinations, such as email, network file directories, or cloud storage locations.

• Export the reports to connected printers for printing.

The export options depend on the email, network, and printing apps or connections set up on your tablet.

1. Prepare your tablet. a. Install and configure specific apps, Wi-Fi™* settings, or networking. b. Verify that the tablet shows sufficient signal strength to connect to the network.

For assistance, contact your clinic IT administrator.

2. Tap

3. On the SAVED REPORTS window, tap a session to expand the list, then view reports or export reports and device data:

> SAVED REPORTS / DATA.

• To view a report, tap VIEW next to the report.

• To export reports, select the reports, tap SEND TO…, then select the export option or location. Note: When you select multiple reports to export, the reports export as a single PDF file.

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• To export device data and the reports associated with the device data, select the PKG file, tap SEND TO…, then select the export option or location.

Note: You are responsible for the management of patient and device data that you export from the SAVED REPORTS window. Examples of patient and device data include printed paper reports, data transferred to a hospital network, and emailed attachments.

3.14 Close the app

If there is an active patient session, refer to the instructions for ending a patient session in the app help.

To close the app, swipe away the app using the tablet operating system.

4 Connecting the patient connector

4.1 About the app and component connections

During the app registration process, the app sends your clinic information and account credentials to Medtronic via the Internet for authentication. In response, Medtronic returns configuration files via the Internet. These files complete the installation of the app and update the patient connector software as needed.

To connect and pair to the patient connector, the app uses Bluetooth wireless technology on your tablet. The first time that you connect and pair to the patient connector, the tablet must also have an Internet connection to authenticate the patient connector.

You must first pair the app with the patient connector to enable communication between the app and the patient connector. To pair with the patient connector, the app uses a security key, which ensures that communications are securely transmitted.

After you pair the app to the patient connector, the app can reconnect to the patient connector without the need to reenter the security key or an Internet connection. If the connection between the patient connector and the app is lost, the patient connector and the app automatically attempt to re-establish communication. In certain situations when the connection is lost, the app prompts you to press the button on the patient connector to identify it.

The app can pair with multiple patient connectors, but the app can connect to only 1 patient connector at a time.

To connect to a different patient connector, disconnect from the current patient connector. During a patient session, you are unable to switch between patient connectors.

The app saves the connection information for up to 20 of the most recently connected patient connectors. By saving the connection information, the app allows you to quickly reconnect to a previously paired patient connector without reentering the security keys and without needing an Internet connection.

4.2 Connect to the patient connector

4.2.1 Connect to a patient connector

To connect to a patient connector, complete the following actions:

1. Verify that the patient connector is on and that the app is open and active on the tablet.

2. Turn on the Bluetooth wireless technology.

3. Press the button on the patient connector. The lights on the patient connector flash.

4. Connect the app to the patient connector using the following steps:

a. On the app, tap CONNECT on the Connect Your System screen. b. On the Select An Accessory window, tap the serial number of the previously paired patient connector.

Note: The patient connector serial number is printed on the bottom of the patient connector.

c. To confirm the connection, press the button on the patient connector.

The status bar at the top of the app indicates that the patient connector is connected.

5. To verify that the correct patient connector is connected to the app, tap FLASH on the System Connected! screen. The lights on the connected patient connector flash for several seconds.

Note: To see the lights on the connected patient connector flash again for several seconds, tap FLASH AGAIN. Caution: Verify that the app is paired to the correct patient connector. Pairing to a different patient connector can result in

confusion during a patient session or the delay of a procedure.

4.2.2 Connect to a new patient connector

Connect the app to a new patient connector when needed.

Note: You are unable to change patient connectors during a patient session. If a session is in progress, you must end the session before you begin the following procedure.

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1. Prepare the new patient connector for the connection.

a. Verify that the app is open on the tablet. b. If the app is connected to a patient connector, disconnect the patient connector.

Tap > SYSTEM CONNECTION.

Tap DISCONNECT on the System Connected! screen. c. Ensure that the patient connector is charged or charging. d. Verify that the new patient connector is disconnected from any previously connected app. e. To turn on the Bluetooth wireless technology, press the button on the patient connector.

When the Bluetooth wireless technology is active, the Bluetooth light on the patient connector slowly flashes.

2. Initialize the connection. a. Ensure that the tablet is connected to the Internet. b. On the Connect Your System app screen, tap CONNECT. c. On the Select An Accessory window, tap the serial number of the new patient connector.

Note: The patient connector serial number is printed on the bottom of the patient connector.

3. Enter the security key.

Entering the security key ensures that communications are transmitted securely. To enter the security key, complete one of the following actions:

• On the ENTER SECURITY KEY screen, tap SCAN QR and position the tablet camera over the QR code that is on the bottom of the patient connector.

The app scans the QR code and automatically enters the security key.

• Enter the security key in the text fields. The security key is printed on the bottom of the patient connector near the QR code.

4. To verify that the correct patient connector is connected to the app, tap FLASH on the System Connected! screen. Caution: Verify that the app is connected to the correct patient connector. Connecting to a different patient connector can result

in confusion or the delay of a procedure. The lights on the connected patient connector flash for several seconds.

Note: To see the lights on the connected patient connector flash again for several seconds, tap FLASH AGAIN.

4.3 Troubleshoot connections

4.3.1 App and patient connector are out of sync

The connection information stored in the app can get out of sync with the patient connector. If this occurs, the patient connector serial number does not appear on the Select An Accessory window. To re-establish the connection between the patient connector and the app, you must unpair them, then restart the connection.

1. On the tablet, open the settings, then open the Bluetooth connection settings.

2. Verify the serial number on the patient connector.

3. Select the patient connector, then use the Bluetooth settings to unpair or forget the connection.

4. Return to the app, then restart the connection to the patient connector.

4.3.2 Blue light flashes rapidly but does not connect

When the blue indicator light on the patient connector is flashing rapidly, the patient connector is attempting to automatically reconnect to an app on a specific tablet. To connect to a different tablet, you must make the patient connector available for a different connection.

1. Press and hold the button on the patient connector for at least 5 seconds until the blue light flashes at a slow rate.

2. Return to the app, then restart the connection to the patient connector.

4.4 Troubleshooting patient connector position

When you position the patient connector incorrectly over the implantable device, the telemetry status light changes.

For issues between the patient connector and implanted device, take one of the following actions:

• Confirm that the implanted device is a Medtronic device.

• Confirm that the telemetry light on the patient connector is solid green.

• Reposition or rotate the patient connector.

• Move the patient connector closer to the implanted device.

• Remove any sources of electromagnetic interference (EMI) that can affect the telemetry signal.

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Interference between the patient connector and other electronic equipment can result in reduced quality of service. Reduced quality of service can result in slow data transmission speeds or poor communication strength.

To address possible interference between the patient connector and other electronic equipment, take one or more of the following actions:

• Reorient or relocate the electronic equipment.

• Increase the separation between the patient connector and the electronic equipment.

• Connect the electronic equipment to an outlet on a different circuit, if the patient connector is plugged into the outlet for charging.

• Move the patient connector and tablet closer together.

• For assistance, contact a Medtronic representative.

5 Managing the MRI app settings

5.1 Manage patient data privacy

5.1.1 About patient data privacy management

Manually or automatically remove all protected health information (PHI) from the app.

When you remove PHI, the app deletes the following files:

• Contents of the SAVED REPORTS, unless the files are currently being exported or copied

• Temporary files stored on the app

When a session is in progress or while files are being exported, you are unable to delete PHI. If deletion is interrupted manually, some PHI remains on the app.

Note: You are responsible for the use of this tool, as well as for the management of patient and device data that has already been exported from the app. Examples of patient and device data that can be exported from the app include printed paper reports, reports transferred to a hospital network, or emailed attachments.

5.1.2 Delete protected health information

To manually delete all saved reports, implanted device data (PDD files), and other PHI stored on the app, complete the following actions:

1. Tap

2. Tap DELETE ALL PROTECTED HEALTH INFORMATION.

3. To close the patient data privacy screen, tap > SYSTEM CONNECTION.

5.1.3 Configure the interval to delete protected health information

For added security and convenience, the app can automatically delete saved reports and implanted device data (PDD files). The reports and implanted device data are deleted based on age of the information. You can configure how long reports and implanted device data are retained before they are automatically deleted.

The date and time that a report or implanted device data is created determines its age. When you open the app or restore it from the background, reports or implanted device data that meet the deletion criteria are permanently deleted.

1. Tap > SETTINGS > PATIENT DATA PRIVACY.

2. In the SCHEDULED DELETE configuration area, select one of these options:

3. To close the patient data privacy screen, tap > SYSTEM CONNECTION.

> SETTINGS > PATIENT DATA PRIVACY.

• Reports older than 1 day

• Reports older than 2 days

• Reports older than 7 days

• Reports older than 14 days

5.2 Manage the profile settings

Use the profile tabs to view the following information:

• Location information

• Hardware information

• Software information

1. Tap

2. To view and manage your location information, tap LOCATION INFO and use the following options.

> SETTINGS > PROFILE.

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Option Description Clinic Name of your clinic. Location Description Description of the clinic location. Country Country where your clinic is located. Not editable. Application ID Unique identifier of the MRI app. Not editable. Account # Medtronic account number. Required field. Last Name Last name or surname of your Medtronic representative. First Name First name or given name of your Medtronic representative. Phone # Phone number for your Medtronic representative. Fax # Fax number for your Medtronic representative. Email Email address for your Medtronic representative.

3. To view the hardware information, tap HARDWARE INFO. Note: You are unable to change the HARDWARE INFO fields.

Option Description Tablet Model Model of the tablet where the MRI app is installed. Tablet OS Tablet operating system and version number. Patient Connector Model Model of the patient connector that is currently connected to

the MRI app.

Version Firmware version installed on the patient connector that is

currently connected to the MRI app.

Patient Connector Serial Number Serial number of the patient connector that is currently con-

nected to the MRI app.

4. To view the software information, tap SOFTWARE INFO.

Note: You are unable to change the SOFTWARE INFO fields.

Option Description SOFTWARE COMPONENT Name of each software component installed on the MRI app. VERSION Version of each software component installed on the tablet. SOFTWARE MODEL Software model number. UDI Unique device identifier (UDI) of the component. CHECK FOR UPDATES Tap to check for updates to the MRI app and to the software on

the MRI components.

5. To close the profile settings screen, tap > SYSTEM CONNECTION.

5.3 Configure rate unit labels

The app can display rate values with either the bpm or min-1 unit label.

1. Tap

2. Select the desired unit:

> SETTINGS > PREFERENCES > UNITS.

• To show all rate unit labels in bpm, tap bpm.

• To show all rate unit labels in min-1, tap min-1.

5.4 Configure filename preferences

To help you manage reports and implanted device data, configure the app to include patient information in the filenames of reports and implanted device data. The app includes the patient information in the beginning of the filename when you export the file using one of the tablet operating system export options. The patient information (for example, the patient name and the implanted device serial number) is from the implanted device.

1. Tap > SETTINGS > PREFERENCES > FILENAMES.

2. Select the checkboxes associated with the patient information that you want to include in the filenames.

5.5 Export user preferences

You can export the user preferences from one app installation and import the user preferences to one or more other app installations. The tablet must be connected to the Internet when you export the user preferences. To export the user preferences, complete the following actions:

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1. Tap > SETTINGS > PREFERENCES > USER PREFERENCES.

2. Tap CREATE USER PREFERENCES QR CODE.

3. On the SET NAME OF USER PREFERENCES window, enter a name to describe the user preferences that you are exporting.

4. Tap CREATE QR CODE.

5. On the USER PREFERENCES QR CODE CREATED message, complete one of the following actions:

• To export the QR code, tap SEND TO..., then select the export option or location.

• To view the QR code, tap VIEW QR CODE.

Note: You are responsible for the security and use of all information exported from the app.

5.6 Import user preferences

5.6.1 Import user preferences during installation

If you exported a User Preferences QR Code from an existing app installation, you can import those user preferences to another app installation. To import user preferences when you are installing the app, complete the following actions:

1. On the SETUP COMPLETE screen during system configuration, tap IMPORT USER PREFERENCES.

2. To allow the CareLink SmartSync app to access the tablet camera, tap OK.

3. Scan the User Preferences QR Code.

4. On the USER PREFERENCES IMPORTED message, tap CLOSE.

5. On the SETUP COMPLETE screen, tap START USING THE SYSTEM.

5.6.2 Import user preferences after installation

If you exported a User Preferences QR Code from an existing app installation, you can import those user preferences after the app has been installed. The tablet must be connected to the Internet when you import user preferences. To import user preferences after the app is installed, complete the following actions:

1. Tap > SETTINGS > PREFERENCES > USER PREFERENCES.

2. Tap IMPORT USER PREFERENCES.

3. To allow the CareLink SmartSync app to access the tablet camera, tap OK.

4. Scan the User Preferences QR code.

5. On the USER PREFERENCES IMPORTED message, tap CLOSE.

6 Updating the MRI app

6.1 IT network, tablet, and data information

6.1.1 Required IT network characteristics and configuration

The tablet on which the app is installed must have both Bluetooth wireless technology and access to the Internet.

Bluetooth wireless technology

You must enable Bluetooth wireless technology on your tablet. The patient connector communicates with the app, installed on the tablet, through a Bluetooth connection.

Failure to provide Bluetooth communication access prevents the app components from communicating with each other and with implanted devices. If Bluetooth communication is turned off, the app is unable to establish a Bluetooth connection with the patient connector. The patient connector is used to interrogate and program the implanted device.

Internet

To configure your network, follow the processes and policies of your organization.

To set up or update the app, your network must have Internet access. When your network is configured to access the Internet, you can complete the following actions:

• Download and install the app.

• Register the app.

• Download and install software or updates necessary for the app to function.

Failure to provide information technology (IT) network access prevents the tablet from accessing the Internet, which results in the following limitations:

• Inability to install or update the app and software components

• Inability to download firmware updates for the patient connector

• Inability to receive periodic updates and security enhancements that maintain the security of the app

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• Inability to process app component system logs

• Inability to authenticate the first connection between the app and the patient connector

Note: Internet access is not required during a patient session or to export and print reports. However, failure to provide access to an information technology (IT) network (for example, a Wi-Fi™* or cellular network) results in the inability to export and print reports using a wireless connection.

6.1.2 Supported tablets and technical specifications

The tablet on which the app is installed must meet the requirements in the CareLink SmartSync Tablet Compatibility Technical Manual.

To download or order the CareLink SmartSync Tablet Compatibility Technical Manual, go to medtronic.com/manuals or contact Medtronic.

Note: The app may not always be compatible with the most current version of the tablet operating system.

6.1.3 Intended information flows

System logs are processed through the app components in the following order:

• Patient connector

• MRI app

• Internet

During installation and updates, the app sends your clinic registration and account credentials to Medtronic via the Internet for authentication. In response, Medtronic returns configuration files to the app via the Internet to install or update the app and component software as needed. The configuration files allow the app to connect to and communicate with the implanted device.

6.1.4 Precautions when connecting to your IT network

Connecting the app to an IT network that includes other equipment could result in unforeseen risks to patients, operators, or third parties. Changes to your IT network, such as adding, disconnecting, updating or upgrading equipment, or changing network configurations, could introduce additional risks. Analyze, evaluate, report, and control any risks identified.

6.1.5 Security

Data in the app is protected by encryption. The app is unable to provide data protection for data exported to another destination. Handle and store the data that you export from the app in accordance with the security policy of your clinic.

To protect patient health information, the tablet must be secured with a passcode. The app is unable to function if a passcode is not defined. For more information on securing the tablet with a passcode, refer to the user instructions for your tablet.

To protect the app, Medtronic recommends that you implement the following security measures:

• Use the app and components only on a managed, trusted network. Verify that your Wi-Fi™* networks comply, at minimum, with wireless standard 802.11b, 802.11g, or 802.11n, and use WPA2 or stronger encryption.

• Secure your network with industry best practices, which can include antivirus software, firewalls, and wireless security policies, according to the policies of your IT department.

• When installing or updating the app, if your tablet displays a message indicating that a security certificate is invalid, the installation or update process is unable to continue. For assistance, contact your local Medtronic representative.

The app closes automatically when the app detects a failure to maintain security.

If you suspect that a cybersecurity event has occurred, stop using the app (if possible). Contact your IT security or biomedical department for information on how to confirm and respond to the suspected incident.

6.2 MRI app updates

When updates are available for app components, the app prompts you to install the update.

Medtronic recommends that you install all app updates when they are available.

The installation method varies by the type of update:

• When the app displays a message that a newer version of the app must be installed, go to your tablet’s app store to install the newer version.

• When the app displays a message that new content is available, tap UPDATE to download the content update.

Note: Disable automatic updates from the app store application on the tablet. Automatic app store updates only provide the data for a partial installation of the app.

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6.3 Install a new version of the app

When a new version of the app is available, the app displays an update message.

Note: If you decline an update, the app continues to display the message until you install the update.

Install the new version of the CareLink SmartSync app from your tablet app store:

1. Verify that your tablet is connected to the Internet.

2. Go to the app store for your tablet.

3. Install the new version of the CareLink SmartSync app.

4. Restart the app.

6.4 Install a content update

When a content update is available, the app displays an update message. The tablet must be connected to the Internet to detect that a there is a content update and to install the content update.

If you decline an update, the app continues to send the message until you install the update.

To install the new content, respond to the app message: on the update message, tap UPDATE.

Note: If it has been more than 24 hours since you connected the app to the patient connector, you must connect to the patient connector before you can install the update.

6.5 Install required software updates

If it has been more than a year since you updated the app or connected your tablet to the Internet, the app requires you to update the software. The required update ensures that you have the latest and most secure software.

Note: You are unable to use the app until the update installation is complete.

If it has been more than 6 months since you updated the app or connected your tablet to the Internet, data export functions in the app are disabled until a check for software updates is complete.

6.6 Manually check for and install updates

In addition to automatically checking for updates, the app allows you to manually check for updates.

1. Verify that your tablet is connected to the Internet. If necessary, enable the Wi-Fi™* setting on your tablet and connect to your network, or verify that the cellular data service for

the tablet is connected to the Internet.

2. Verify that the app is connected to a patient connector.

3. Tap

4. Tap SOFTWARE INFO.

5. Tap CHECK FOR UPDATES.

After the update installs, you may be prompted to read and accept the license agreement.

> SETTINGS > PROFILE.

The installation method varies by the type of update:

• If the app displays a message that a newer version of the app is available, go to the app store for your tablet to install the newer version of the app.

• If the app displays a message that new content is available, tap UPDATE to download the content update.

6.7 Uninstall the app

The app data is lost when you uninstall the app. If you want to uninstall the app, contact a Medtronic representative for assistance.

7 Troubleshooting

7.1 Messages

To provide you with important information, the app displays various messages. Pay careful attention to all messages and instructions. If you require further assistance, contact a Medtronic representative.

7.2 Service logs

The app automatically saves information about errors or failures to the service log. When you connect the tablet to the Internet, the app sends the service log to Medtronic.

Medtronic uses the information for the following purposes:

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• Diagnose and resolve errors and failures

• Improve the app components

Note: The service log saves information about performance, errors, and failures of the app components. The service log does not contain any user, device, patient, or protected health information.

When possible, the service log records information about recoverable and nonrecoverable errors and failures.

All service logs are encrypted for security.

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Medtronic, Inc.

*M025566C001*

710 Medtronic Parkway Minneapolis, MN 55432 USA www.medtronic.com +1 763 514 4000

Medtronic USA, Inc.

Toll-free in the USA (24-hour technical consultation for physicians and medical professionals) Bradycardia: +1 800 505 4636 Tachycardia: +1 800 723 4636

Technical manuals

www.medtronic.com/manuals