CareLink Express Mobile System Clinician User Guide May 2018

The CareLink Express system for Medtronic implanted cardiac devices allows clinicians in healthcare settings, such as Emergency Rooms, Operating Room procedural areas, and Telemetry Floors to quickly perform device checks and receive a remote technical assessment regarding the status of the device.* This How-to Guide will help you get started using the CareLink Express mobile system. This guide includes instructions on how to use the CareLink Express mobile system and website.

CONTENTS About the CareLink Express Mobile System... 2 How It Works... 3 Instructions for Use... 4 What You Need to Know... 6 Troubleshooting... 7 The CareLink Express Website... 10 CareLink Express Mobile System Information... 16

*The healthcare facility determines who will be the transmission reviewer and/or access the transmission online.

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ABOUT THE CARELINK EXPRESS MOBILE SYSTEM The CareLink Express mobile systems consists of: Patient Connector A handheld telemetry wand called the patient connector.

Mobile Application A Medtronic mobile application downloadable from the Apple App Store.

Tablet An Apple® tablet.

Carrying Case A carrying case that will house both the patient connector and the tablet.

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All patient and clinical data displayed are fictitious and for demonstration purposes only.

ABOUT THE CARELINK EXPRESS MOBILE SYSTEM

 edtronic cardiac device is 1 Minterrogated in a healthcare

 he app will confirm that the 2 Ttransmission was successful.

setting using the Patient Connector and the CareLink Express mobile app on the tablet.

 telephone call is made by the 4 Areviewer to the clinician in the CareLink Express healthcare setting (where the patient’s device was interrogated) to discuss the technical findings.

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representative 3 AorMedtronic device follow-up clinician (configurable by site) is notified of the transmission and reviews the data remotely on the CareLink Express website.

DATA ACCESS OPTIONS § A faxed copy of the interrogation summary reports can be sent back to the facility. § The summary reports are available via the CareLink Express website.

he patient’s follow-up clinic 5 Treceives transmission data for patients currently enrolled in the CareLink network.

INSTRUCTIONS FOR USE

Step 1: Ensure that tablet is connected to the facility’s Wi-Fi network Set up Wi-Fi on Apple tablet 1. C  lick on the Settings icon on your tablet home screen 2. Touch/tap “Wi-Fi” from the list on the left side 3. Make sure the Wi-Fi button is “ON” 4. T  ouch/tap the name of the facility’s Wi-Fi network from the “Choose a Network” drop-down list – You may need to obtain a password from the facility’s IT department to access the network

Step 2: Launch the application

Launch the application by touching/tapping the Carelink Express Mobile app.

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All patient and clinical data displayed are fictitious and for demonstration purposes only.

INSTRUCTIONS FOR USE, cont’d. Step 3: Patient Connector

§ Power on the Patient Connector. When prompted by the application, press and release the POWER ON button. § The BLUE Bluetooth® indicator light on the Patient Connector will flash while searching for a connection with the tablet.

Bluetooth indicator light Power on button

Step 4: Interrogate the Device

The app will prompt you to place the Patient Connector over the Medtronic device. The Telemetry indicator light on the Patient Connector will turn GREEN when a connection is established. § No light = Telemetry not in progress § Solid light = Telemetry in progress The Connection Progress bar provides feedback that the Patient Connector is correctly positioned over the device and the device is being read.

Telemetry indicator light

A telephone call is made by the reviewer to the clinician in the CareLink Express healthcare setting (where the patient’s device was interrogated) to discuss the technical findings.

Step 5: Send Data

A tone will sound and the app will prompt user to put down Patient Connector when the interrogation has finished. Interrogation times vary between 30 seconds and 3 minutes, depending on the amount of data and number of episodes within the device, type of tablet being used, and other factors. The app will now transmit the collected data from the device to the CareLink network. Opening another app on the tablet WILL NOT interrupt the transmitting process. The Transmission Complete screen confirms that the transmission has been successfully received by the CareLink network. A tone will also sound.

The animated send bars will repeat throughout the process. The progress bar will continue to fill throughout the process.

Date and Time when completed transmission was sent to CareLink. Transmission was successful. DONE will take user to Home screen.

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All patient and clinical data displayed are fictitious and for demonstration purposes only.

WHAT YOU NEED TO KNOW CHARGING THE PATIENT CONNECTOR

UPGRADING THE SOFTWARE

The amber battery indicator light will indicate the need to charge the battery. Charging time takes approximately 1 hour.

The first time you pair a patient connector with the app, it will update the firmware on the Patient Connector.

Each full charge should last: § at least 30 sessions (if each lasts about 5 minutes) § at least 5 sessions (if each lasts about 20 minutes) Telemetry indicator light (green) No light = Telemetry not in progress Solid light = Telemetry in progress

Bluetooth indicator light (blue) No light = Telemetry head OFF Flashing light = Establishing Bluetooth connection Solid light = Bluetooth connection is active

Battery indicator light (amber) No light = Battery > 20% Slow flashing light = Battery ≤ 20% Fast flashing light = Charging Solid light = Battery ≤ 5% When solid, the app will require the telemetry head to be plugged in. Power On button

Charging port

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All patient and clinical data displayed are fictitious and for demonstration purposes only.

TROUBLESHOOTING

CONNECTIVITY Message 3269 - Patient Connector Out of Range

Trigger - Temporary interruption of Bluetooth connection Action - Ensure Patient Connector is turned on. Reposition to resume the connection within 30-40 seconds to continue current interrogation or press Cancel to restart device interrogation. Consequences - Any data collected as part of the interrupted interrogation is lost when pressing Cancel

Error 3269 - Bluetooth Failure

Trigger - Interruption of Bluetooth connection, all retry attempts of re-establishing connection exhausted Action - Ensure Patient Connector is turned on. Press Cancel and restart device interrogation. Consequences - Any data collected as part of the interrupted interrogation is lost

Error 3269 - Reposition Screen

Trigger - Temporary interruption of telemetry connection Action - Reposition patient connector over the patient’s device within 2 minutes to resume the connection or press Cancel to restart device interrogation Consequences - Any data collected as part of the interrupted interrogation is lost when pressing Cancel

Home Screen

Trigger - Telemetry connection with patient’s device interrupted for approximately 2 minutes Action - Press Start to retry device interrogation Consequences - Any data collected as part of the interrupted interrogation is lost

Error 3314 - App Interruption

Trigger - When the app is interrupted by a host device function (ex: navigating away from the app or accepting a phone call) Action - Press Cancel and restart the device interrogation Consequences - Press Cancel and restart the device interrogation

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All patient and clinical data displayed are fictitious and for demonstration purposes only.

TROUBLESHOOTING, cont’d.

Errors 5704/5409 - Cellular/Wi-Fi Unavailable

Trigger - When the tablet does not have a functional network connection, prior to downloading data from the device Action - Press Cancel to navigate to Home Screen (or Welcome Screen if in the Setup work flow) Consequences - Unable to successfully complete the interrogation

GENERAL ERRORS Error 8260 - SW Update Required (only shown in LOCK MODE)

Trigger - Software update detected Action - Unlock the app (by tapping the Menu icon and entering the Location ID) and the app will manage the SW update Consequences - This screen will appear until the app is unlocked and updated

Error 3248 - Patient Connector Low Battery

Trigger - Patient connector has less than 5% battery Action - Plug in patient connector, press Cancel, and retry device interrogation Consequences - Patient connector must remain near line power to be used until charged enough to be unplugged (approx. 20 minutes)

Error 3517 - No Device Found

Trigger - No device found with which to communicate OR More than one device found with which to communicate Action - Identify device location (or presence of multiple devices) and try again Consequences - App may not work for patients where the device is hard to communicate with (rare occurrence)

Error 8239 - Device Not Supported

Trigger - User is attempting to interrogate a device that is not supported by this application Action - Cancel button will take user to Home Screen Consequences - Any data collected before failed transmission is lost. Interrogation must be restarted.

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All patient and clinical data displayed are fictitious and for demonstration purposes only.

TROUBLESHOOTING, cont’d.

Error 2108 - Transmission Failure

Trigger - Device data unable to transmit to the CareLink network Action - Tap Cancel. Retry device data interrogation and transmission. Consequences - Any data collected before failed transmission is lost. Interrogation must be restarted.

Error 2112 - Patient Connector Communication Timeout

Trigger - Another tablet attempting to use the same Patient Connector simultaneously Action - Turn off Patient Connector, hold button 5 seconds. Press Cancel in the app, then retry interrogation after 2 minutes. Consequences - Patient Connector may have paired with another tablet. The intended CIED device may not have been interrogated.

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All patient and clinical data displayed are fictitious and for demonstration purposes only.

THE CARELINK EXPRESS WEBSITE The CareLink Express website was designed to provide an exclusive view of recent transmissions from the CareLink Express mobile app. It can be configured according to your CareLink Express facility’s account preferences. Access to the website will be initiated by your Medtronic representative. Access to the CareLink Express website can be found at: www.medtroniccarelink.net. Once on the site, use the login credentials provided by your Medtronic representative to access the CareLink Express website. Detailed information about the CareLink Express website can be found within the Help section of the website.

HOME PAGE After logging into the CareLink Express website you will reach the home page, which has the following three tabs: Transmissions, My Work, and Facility Administration.

TRANSMISSIONS The CareLink Express Transmissions page allows you to view transmission data and notes; you can also open reports. The Transmissions page contains a list of all CareLink Express transmissions from your facility within the last 7 days. Note: After 7 days, the transmission data will be permanently lost. You must print the reports, save them electronically, or export them to a network location in your facility or to your Electronic Health Record (EHR) system. If the patient is enrolled in the CareLink network at a device-following clinic, the transmission information will become part of the patient’s CareLink record.

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All patient and clinical data displayed are fictitious and for demonstration purposes only.

TRANSMISSIONS, cont’d.

3 1 4 6 2

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1 Facility and contact information is listed at the top of the page. 2 The patient name is indicated on the far left column. If the name column says, “not available,” this means that the

patient is not currently enrolled in the CareLink network at a device-following clinic. The device serial number is the patient identifier, or the patient name may be identified within the interrogation reports. 3 The Transmission Search button allows you to search by transmission code or device serial #. 4 The Status column shows you if the transmission has been viewed; if a transmission note was created, you may

open and view the report file. 5 Clicking on the report name next to the PDF symbol under the date, you can open PDF files of the diagnostic

summary reports for the transmission. 6 By clicking on the date, you will be taken to the transmission details page (see below). From here, you can view

additional data from the device interrogation. You may also 7 generate and print custom reports containing additional device interrogation data, 8 create a transmission note.

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All patient and clinical data displayed are fictitious and for demonstration purposes only.

MY WORK From the My Work page, you may access any CareLink Express transmission you have viewed. Transmissions are available on the CareLink Express website for 7 days after they are sent.

Click on the date/time link in the Received column to view transmission details.

FACILITY ADMINISTRATION The Facility Administration section of the CareLink Express website allows facility users to view and edit facility information, set up integration with external systems, and maintain monitor location profiles. Facility Setup There are three sections within the Facility Setup tab: Facility Profile, Facility Users, and Associated Clinics. 9 The Facility Profile section allows CareLink Express facility users to view and edit facility contact information,

and site-wide preferences such as time zone, and whether or not user passwords should expire. To change the information in your facility profile, CareLink Express facility users must have website administration privileges for your facility.

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All patient and clinical data displayed are fictitious and for demonstration purposes only.

FACILITY ADMINISTRATION, cont’d. 10 The Facility Users section can be used to manage facility user accounts, add new users, and set

administrative privileges.

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11 By clicking on the user name (above), the CareLink Express facility users with complete privileges

may update contact information and set administrative privileges for each user.

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All patient and clinical data displayed are fictitious and for demonstration purposes only.

FACILITY ADMINISTRATION, cont’d. 12 The Associated Clinics section provides a list of clinics with access to device transmissions received by

your facility. Please contact your local Medtronic representative to make any changes to this section.

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13 The Monitor Location Profiles section allows CareLink Express facility users with complete privileges to assign

Patient Connector locations within their healthcare facility and assign contact information for each location.

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All patient and clinical data displayed are fictitious and for demonstration purposes only.

FACILITY ADMINISTRATION, cont’d. By selecting Add Location or clicking on the location name (see previous page), Patient Connector location profiles within your facility may be added. Work with your Medtronic representative to order the Patient Connectors and complete the setup. Setup options include:  ransmission Report Communication Setup: This allows CareLink Express facility users with complete privileges 14 T to set communication preferences after sending transmissions with the CareLink Express mobile app and the Patient Connector (fax communications). 15 Transmission Review and Assessment: Your facility has the opportunity to select a reviewer type for CareLink

Express transmissions. Different reviewers may be selected for daytime hours and after-hours.

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All patient and clinical data displayed are fictitious and for demonstration purposes only.

INFORMATION

PATIENT CONNECTOR/MEDTRONIC APP Devices that work with the Patient Connector and the Medtronic CareLink Express mobile app: § Medtronic devices only § 99% of Medtronic devices supported on the CareLink network.* Patient with More than One Implanted Device If the patient has more than one implanted device, contact your Medtronic representative for assistance. Programming Changes The CareLink Express mobile app does not have the ability to change any functions within the devices. The Patient Connector and the Medtronic app are designed to read information and send information only. Reason to Set Device to Specific Location The CareLink Express Patient Connectors are tied to a specific location (i.e., Emergency Department, Hospital Nursing Floor) to allow that location to set Transmission Report Communication Setup specific to that department or floor, such as report fax options or transmission reviewer settings.

WEBSITE SETUP Configure/Modify Communication Preferences Once you are logged onto the CareLink website, click on the Facility Administration tab, then Monitor Location Profiles tab. Click on the Location Name (for an existing Patient Connector) or Add Location (for a new Patient Connector). Communication preferences are unique to each Patient Connector and must be set up or modified individually. Purpose of Associated Clinics Section CareLink Express facility may be associated with a CareLink network clinic. CareLink network users at the associated clinic (with data access privileges) will be able to access device transmission data from the CareLink Express facility. If a new clinic association needs to be added or an existing association needs to be removed, please contact Medtronic. CareLink Technical Services: 1-800-929-4043

TRANSMISSIONS Transmission Is via Hospital Wi-Fi Connection of the Medtronic app with the CareLink Express network is done via the hospital’s secure Wi-Fi. Transmission Data Sent The CareLink Express mobile app will interrogate the device memory and transmit all stored device data. Data presented on reports from a CareLink Express transmission show cumulative counts since the last programmer or home monitor session. Transmission Data Available on the CareLink Express Website *Supported devices on CareLink network. January 2014. Data on file.

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INFORMATION, cont’d.

Transmission data is available on the site for 7 calendar days. § If a patient is not enrolled in the CareLink network, after 7 days the data will be permanently lost. If you have a need to retain data beyond this point, print or save the device diagnostic data as a PDF report. § If a patient is enrolled in the CareLink network at the time of the interrogation or subsequently enrolled, within 7 days of receipt of transmission data, that data will become part of their CareLink record. Transmission Is Successful. What’s Next? § Review of Transmission Data: Notification of the device interrogation and a link to the transmission details is sent to the designated clinician or Medtronic representative for review. § Optional Fax Confirmation: The person responsible for sending the transmission (e.g., clinic or ED) will receive acknowledgement via fax that the transmission was successfully sent (this is optional and can be changed under the section: Transmission Report Communication Setup). § Optional Viewing of Transmission Information: It is not necessary to log into the website after a transmission. You have the option of logging into the website to view the transmission information or notes recorded by the person who reviewed the transmission. Multiple Device Follow-up Clinics The CareLink Express transmission information is sent to the clinic that currently follows the patient on the CareLink network. The reports could be printed, faxed, or sent electronically to additional clinics if desired. CareLink Technical Services is not allowed to fax reports to clinics due to patient data privacy laws. Patient Name Listed as “Not Available” on My Transmission List on the CareLink Express Website This means that these particular patients are not enrolled in the CareLink network at a device follow-up clinic. However, their transmission is still available for viewing by a clinician/Medtronic representative. The device serial number is the patient identifier, or the patient’s name may be visible on the device reports. Creating a Note The benefits of creating a note when a CareLink Express transmission is reviewed is that the transmission assessment note provides an easily accessible summary of the interrogation findings for the facility and device follow-up clinic, and can be configured to be faxed to the facility after the transmission review is completed. More than 1 note can be created for a CareLink Express transmission, but only the most recent note displays on the Transmissions list and in the My Work section. All notes are available from the Actions Taken link on the Transmissions page. Device Memory The CareLink Express mobile does not clear the device memory. It interrogates back to the last programmer session but does not clear the counters or diagnostics; however, it will clear device alerts. Overall Transmission Count For patients enrolled in the CareLink network, the CareLink Express transmissions will be part of the overall transmissions count in the All Sends section of the patient’s profile.

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INFORMATION, cont’d.

ICD Magnet Suspension A manual transmission can be done when the magnet is placed over a wireless or non-wireless pacemaker or ICD, but it will not indicate that detections are suspended due to the magnet placement. If the ICD detection is programmed off/on, the permanent programming will be indicated. § For non-wireless devices, establishing the CareLink Express telemetry session will override the magnet effect and will auto-resume detection until the session is terminated. During the session, it would act as though no magnet was present. Once the session is ended, the device will check the magnet status and suspend/resume detection depending on the state of the magnet. § For wireless devices, the magnet will suspend detection and will work independently of the telemetry session. View Transmission via the CareLink Mobile App Clinicians with CareLink network access will be able to use the CareLink mobile application to access CareLink Express transmissions via the search functionality. If the most recent transmission for a patient is a CareLink Express transmission, it will display on the CareLink mobile application, and be labeled as a CareLink Express transmission. At this time, the CareLink mobile application is not designed for Medtronic representatives to complete reviews of CareLink Express transmissions.

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These products are not a substitute for appropriate medical attention in the event of an emergency. Data availability and alert notifications are subject to Internet connectivity and access, and service availability. The CareLink Express app must be on and in range of the device. Alert notifications are not intended to be used as the sole basis for making decisions about patient medical care. Brief Statement 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 propriety 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.

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