YOUR APP-BASED DEVICE MANAGEMENT SOLUTION Reveal LINQ Mobile Manager For the Reveal LINQ Insertable Cardiac Monitor ios 1.03.03 & Android 1.05.03 FOLLOW-UP WORKFLOW
APP-BASED DEVICE MANAGEMENT A Streamlined Solution to Simplify Monitoring The Reveal LINQ Mobile Manager is an innovative, app-based device management system that makes it possible to manage all of your Reveal LINQ work flow needs right from your tablet. SIMPLE An easy-to-use, app-based device management system. SECURE Dedicated protection of patient health data. INTEGRATED A single work flow solution from device activation to follow-up. 2
MOBILE DEVICE MANAGEMENT SYSTEM Reveal LINQ ICM Patient Connector Mobile Manager Application CareLink Network Patient Connector Communicates with the Reveal LINQ ICM and Mobile Manager for: Programming Follow-up Device Checks Mobile Manager Communicates with the Medtronic CareLink Network Wi-Fi or cellular connection required 3
PREPARE Battery Indicator Light (amber light) Connection Status Battery Status Ensure the Patient Connector is charged Ensure your tablet is charged NOTE: The Patient Connector may run out of power during the insertion if the Battery Indicator amber light is on. Ensure connection to Wi-Fi or a cellular network. 4
APP-BASED DEVICE MANAGEMENT Follow-up Workflow Overview 1 2 3 Connect to the Patient Connector Connect to Reveal LINQ Device View Reports Review/Edit Parameters 5
CONNECT TO PATIENT CONNECTOR Press and release the Power on button on the Patient Connector once to turn it on. The blue indicator light will flash, changing to solid when connected to the app. Bluetooth Indicator Light (blue light) Power On button NOTE: If you are using a new Patient Connector that has not previously been paired with the Reveal LINQ Mobile Manager, tap SELECT NEW PATIENT CONNECTOR and follow the prompts to pair the patient connector. 6
CONNECT TO REVEAL LINQ DEVICE Place the patient connector over the Reveal LINQ ICM The Patient Connector light will turn green when a connection is established Reveal LINQ ICM Connection Indicator Light (green light) The Connect to the Reveal LINQ progress bar provides feedback that the patient connector is correctly positioned over the device and the device is being read NOTE: Interrogation times vary between 30 seconds and 3 minutes, depending on the amount of data and episodes within the device, type of tablet being used, and other factors. 7
VIEW REPORTS Quick Look Screen The Quick Look screen provides a summary of Reveal LINQ ICM status and diagnostic information collected since the last confirmed programming session using either the Reveal LINQ Mobile Manager or the 2090/Encore programmer. NOTE: A confirmed programmer session is one that occurred at least 8 hours prior to the current interrogation/session. All patient and clinical data are fictitious and for demonstration purposes only. 8
VIEW REPORTS Workflow Reports To view a report, select the VIEW REPORT button. The Reports dialogue box will display All patient and clinical data are fictitious and for demonstration purposes only. 9
VIEW REPORTS Reports Dialogue After a follow-up device check session using the Reveal LINQ Mobile Manager, both the Quick Look and Full Reports are available. NOTE: Access to the Full Report requires a wireless or cellular connection. If the Full Report option is not available, log onto the CareLink network to view the Full Report. All patient and clinical data are fictitious and for demonstration purposes only. 10
VIEW REPORTS Quick Look Report The Quick Look Report provides a basic overview of the Reveal LINQ ICM status and the patient s condition. Quick Look Report includes: Patient Information Current ECG Key Observations Counters Parameter Settings All patient and clinical data are fictitious and for demonstration purposes only. 11
VIEW REPORTS Full Report Full Report provides an extended overview of a patient s condition and device functionality since the last confirmed programming session. Full Report includes: Patient Information Current ECG Observations Counters Cardiac Compass trends Histograms Longest AF ECG Episode List Episode Details NOTE: A confirmed programmer session is one that occurred at least 8 hours prior to the current interrogation/session from either Reveal LINQ Mobile Manager or 2090/Encore programmer. All patient and clinical data are fictitious and for demonstration purposes only. 12
FULL REPORT VS. QUICK LOOK REPORT FULL REPORT* QUICK LOOK REPORT Available? Content Available? Content Patient Information Yes Values interrogated at the start of the follow-up device check session. Yes Current values saved to Reveal LINQ ICM at the time the View Report button is selected. Current ECG Yes 10-second ECG interrogated at the start of the follow-up device check session. Yes Screenshot ~5 seconds of streaming ECG taken by the Reveal LINQ Mobile Manager at the time the View Report button is selected. Counters Yes Since last clinic transmission and lifetime Yes Since last clinic transmission Observations Yes Since last clinic transmission Yes Since last clinic transmission Only a small set of observations (e.g., Daily Max Episode Count Met) are supported Episode List, Episode Details Yes Since last clinic transmission (max of 30 episodes with ECG) No Programmed Parameters No Values interrogated at the start of the follow-up device check session. Yes Current values saved to Reveal LINQ ICM at the time the View Report button is selected. Cardiac Compass Report Yes 90-day report No * A full report is also available on the CareLink network. See Module 4 for details. Last clinic transmission could be from the Reveal LINQ Mobile Manager or 2090/Encore programmer, whichever is most recent. 13
END FOLLOW-UP WORKFLOW End Workflow To complete the follow-up device check workflow, select the END SESSION button Complete this step to: Ensure that programming changes are transmitted promptly to the patient s CareLink record Avoid draining the Patient Connector s battery All patient and clinical data are fictitious and for demonstration purposes only. 14
FOR ASSISTANCE In-Application Contextual Help Look for the button. Help Menu Look for the HELP option in the Application menu. For questions or concerns with the tablet or connectivity: Contact your hospital s IT help desk. Contact tablet manufacturer. For additional assistance with the application or the Patient Connector: Visit LINQmobilemanager.com. Contact your Medtronic Representative. 15
BRIEF STATEMENT See the device manual for detailed information regarding the instructions for use, the implant procedure, indications, contraindications, warnings, precautions, and potential adverse events. If using an MRI SureScan device, see the MRI SureScan technical manual before performing an MRI. For further information contact your local Medtronic representative and/or consult the Medtronic website at www.medtronic.com. Consult instructions for use at this website. Manuals can be viewed using a current version of any major Internet browser. For best results, use Adobe Acrobat Reader with the browser. Europe Medtronic International Trading Sàrl. Route du Molliau 31 Case postale CH-1131 Tolochenaz www.medtronic.eu Tel: +41 0 21 802 70 00 Fax: +41 0 21 802 79 00 medtronic.eu UC201802664 EE 2018 Medtronic. Minneapolis, MN. All Rights Reserved. 11/2017 United Kingdom/Ireland Medtronic Limited Building 9 Croxley Green Business Park Hatters Lane Watford Herts WD18 8WW www.medtronic.co.uk Tel: +44 0 1923 212213 Fax: +44 0 1923 241004 All rights reserved. Medtronic, Medtronic logo, and Further, Together are trademarks of Medtronic. The Bluetooth word mark and logos are registered trademarks owned by Bluetooth SIG, Inc. and any use of such marks by Medtronic is under license. Other third party brands are trademarks of their respective owners. All other brands are trademarks of a Medtronic company. 16