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myMerlin™ Mobile Application
for the Confirm Rx™ Insertable Cardiac Monitor
Models APP1000, APP1001
Software version 1.0
User's Manual

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Summary of Contents for St. Jude Medical myMerlin

  • Page 1 Mobile Application for the Confirm Rx™ Insertable Cardiac Monitor Models APP1000, APP1001 Software version 1.0 User's Manual...
  • Page 2 Unless otherwise noted, ™ indicates that the name is a trademark of, or licensed to, St. Jude Medical or one of its subsidiaries. ST. JUDE MEDICAL and the nine-squares symbol are trademarks and service marks of St. Jude Medical, LLC and its related companies.
  • Page 3: Table Of Contents

    Download the myMerlin™ Mobile Application......13 Set up the myMerlin™ Mobile Application ......14 Keep your Smart Phone or Tablet at your Bedside.
  • Page 4 What type of materials and substances will my device expose me to?..........17 How long will my device last?.
  • Page 5: Important Telephone Numbers

    Important Telephone Numbers Clinician's office Special Instructions...
  • Page 7: Introduction

    Intended Purpose The myMerlin™ mobile application is intended for people who have a Confirm Rx™ ICM and access to a mobile device. The app allows the patient to activate recordings in the implanted device and wirelessly transmit data for physician and clinician review.
  • Page 8: Intended Use

    Intended Use The myMerlin™ mobile application is intended for people who have a St. Jude Medical implanted heart device and access to a mobile device. The app allows the patient to activate recordings in the implanted device and wirelessly transmits data to the Merlin.net™...
  • Page 9 The system design does not rely on input from the clinic or user settings to safeguard the patient information and device data. St. Jude Medical takes the following measures to ensure cybersecurity for this app: ▪...
  • Page 10 St. Jude Medical will provide necessary app software upgrades during the life of the implanted heart device. If you do not maintain the latest version of the app, you risk losing remote monitoring functionality through the app.
  • Page 11: Summary Of Safety And Clinical Performance

    3. Patient 4. Patient Controlled data 5. Mobile Device Application 6. Encrypted Patient Diagnostic data sent over secure channel 7. Merlin.net™ PCN 8. Diagnostic information 9. Clinician 10. Configuration/diagnostic Data 11. Programmer 12. Encrypted Configuration/Diagnostic information sent over secure wireless channel 13.
  • Page 12: What Is The Insertion Procedure Like

    What is the insertion procedure like? The insertion typically involves a simple surgical procedure. The doctor numbs the area with local anaesthesia, makes a small incision, and places the device just under the skin in the chest through the small incision.
  • Page 13 it off will usually allow the device to return to its normal mode of operation. You should always use caution with the following: ▪ ▪ Medical procedures. Although your device should be unaffected by most medical procedures, you should notify your doctor, dentist, physical therapist, chiropractor, or any other health care provider that you have a device.
  • Page 14: What Items Will I Receive

    What items will I receive? You will receive product documentation regarding your monitoring system. In addition, you will need to download the myMerlin™ mobile application onto your smart phone or tablet. You can use your own smart phone or tablet if it meets the system requirements of the app.
  • Page 15: When Can I Begin Using The Mymerlin™ Mobile Application

    To ensure that your app communicates and transmits data properly: ▪ ▪ Do not close or quit the myMerlin™ mobile application. If the app is closed, it is not transmitting. The app needs to be running in the background to be able to perform automatic remote monitoring.
  • Page 16: App Settings

    Make sure your Bluetooth® and Notifications settings are ON and your smart phone or tablet has a strong connection to the internet using Wi-Fi‡ or cellular data. The time it takes for the myMerlin mobile application to transmit data depends on the strength of the cellular or Wi-Fi signal.
  • Page 17: Precautions

    For regulatory statements regarding your smart phone or tablet, refer to the manufacturer's website. Download the myMerlin™ Mobile Application Your clinician will let you know when you can start using the app. You can use the app with smart phones or tablets that meet the following minimum system requirements: ▪...
  • Page 18: Set Up The Mymerlin™ Mobile Application

    To set up the app: 1. Tap the Set up now button on the myMerlin mobile application Welcome screen. 2. Scroll down the screen to review the Terms and Conditions and Privacy Policy.
  • Page 19: Keep Your Smart Phone Or Tablet At Your Bedside

    Make sure your smart phone or tablet is sufficiently charged and keep it at your bedside every night. Do not close or quit the myMerlin™ mobile application. If the app is closed, it is not transmitting. The app needs to be running in the background to perform automatic remote monitoring.
  • Page 20: Additional Features

    NOTE: Your clinician will tell you whether or not you need to record symptoms. Your app will not have the Record Symptoms button if you do not need to record symptoms. To record your symptoms: 1. Tap the Record Symptoms button on the bottom of the Home screen.
  • Page 21: Troubleshooting

    Troubleshooting An error message appears on the screen of your smart phone or tablet when there is an issue with your app. Follow the prompts on the screen to resolve the issue. If you are unable to resolve the issue, contact Technical Support.
  • Page 22: How Long Will My Device Last

    Description European conformity, affixed according to the relevant provisions of European Council Regulation 2017/745 (NB 2797 and RE directive 2014/53/EU Annex III. Hereby, St. Jude Medical declares that this device complies with the relevant provisions of this regulation and directive.
  • Page 23 Symbol Description Unique Device Identifier Importer Malaysian Communication and Multimedia Commission (MCMC) certification mark for products meeting applicable MCMC Technical Codes Date Healthcare center or physician Patient identification Patient identification card label Physician telephone...
  • Page 24: Glossary

    Glossary Application (app) A software application that you download onto your smart phone or tablet. Clinician The person that you see at your doctor's office. This may be your doctor, a nurse, a technician, or someone else that works for your doctor.
  • Page 28 sjm.com 2022-01 ARTEN600140237 B *600140237*...

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