Confirm Rx™ Insertable Cardiac Monitor

CARDIOVASCULAR

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THE WORLD’S FIRST SMARTPHONE-ENABLED INSERTABLE CARDIAC MONITOR

Many things can interrupt your life. We believe heart monitoring does not have to be one of them.

THIS DEVICE IS COMMERCIALLY AVAILABLE FOR USE IN SELECT INTERNATIONAL MARKETS.

OVERVIEW

HOW IT WORKS

FAQS

Confirm Rx™ ICM continuously monitors your heart without interrupting your lifestyle. You can enjoy your day-to-day activities, while the ICM makes sure your doctor receives the information needed to create a care plan that's right for you.

ONGOING MONITORING

Episodes can happen over time. That's why Confirm Rx™ ICM continuously monitors your heart rhythm (heartbeat) for up to two years.

EASY-TO-USE-APP

The myMerlin™ mobile app communicates with your Confirm Rx™ ICM. Your doctor can see when your heart starts beating differently. You can also capture your own symptoms, using the app, when something doesn't feel right.

We take data privacy seriously. Your personal information is secure and encrypted.

SLIM PROFILE

With the thin Confirm Rx™ ICM and discreet myMerlin™ mobile app, you'll know you're being monitored - but no one else has to.

myMERLIN^TM MOBILE APP

Download the myMerlin™ mobile app for the Confirm Rx™ ICM today. The app is free and contains a full demo.

REFERENCES

Bluetooth is a registered trademarks of Bluetooth SIG, Inc.
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HOW THE CONFIRM Rx™ INSERTABLE CARDIAC MONITOR WORKS

If your doctor decides long-term monitoring is needed to determine what is causing your irregular heartbeat, a Confirm Rx™ insertable cardiac monitor (ICM) may be selected. The Confirm Rx™ ICM provides valuable information about your heart rhythm to your doctor, for up to two years. This can help your doctor diagnose heart events like an irregular heart rhythm (arrhythmia) or identify a heart-related reason for unexplained fainting (syncope).

Jean's Story: an Animated Patient Experience

Jean is one of the many patients who now use Bluetooth technology and ConfirmRx™ ICM to monitor his condition. This short animation tells his patient story.

SIMPLE INSERTION PROCEDURE AND APP-BASED COMMUNICATION

Placing Confirm Rx™ ICM is an easy procedure that takes very little time. Your chest will be numbed and cleaned before a small cut is made. The monitor is placed under the skin, over your heart. Then the cut is sealed with a stitch or glue.

MONITOR AUTOMATICALLY AND MANUALLY FOR MORE CONTROL

With the Confirm Rx™ ICM and myMerlin™ app (for use with your smartphone), you can:

Know your heart is being monitored around the clock
Automatically transmit heart monitor information nightly, simply by being in range of your smartphone
Be assured your transmitted data is encrypted and secure
Immediately flag health events and symptoms as they occur, and send information to your clinic
Verify your transmissions and view educational resources on your smartphone

HOW TO RECORD AND SEND SYMPTOMS

If something doesn't feel right, you can record your symptoms using the myMerlin™ for Confirm Rx™ ICM mobile app, so your doctor has an even better idea of what's going on. That includes feeling dizzy or faint, or shortness of breath.

IS INSERTABLE CARDIAC MONITORING RIGHT FOR YOU?

Talk to your doctor to determine if insertable cardiac monitoring is right for you or your loved one.

myMERLIN^TM MOBILE APP

Download the myMerlin™ mobile app for the Confirm Rx™ ICM today. The app is free and contains a full demo.

REFERENCES

Bluetooth is a registered trademark of Bluetooth SIG, Inc.
Apple, the Apple logo, iPhone, and iPad are trademarks of Apple Inc., registered in the U.S. and other countries and regions. App Store is a service mark of Apple Inc.

FREQUENTLY ASKED QUESTIONS

HOW DO I TRANSMIT REPORTS?

The unique smartphone technology provided by Abbott with the Confirm Rx ICM and myMerlin™ mobile app automatically checks your device every night and sends relevant information to your clinic. Your app also sends transmissions according to a schedule set up by your clinic. It is easy to stay connected by staying in range of your smartphone. Data is sent securely, without any added action on your part. You can verify that the data was sent using the myMerlin™ for Confirm Rx™ ICM mobile app on your smartphone.

Downloading the myMerlin™ mobile app for your smartphone is simple. The app is free and includes a full demo.

HOW DO I RECORD A SYMPTOM?

Open the myMerlin™ for Confirm Rx™ ICM mobile app on your smartphone and press the “Record Symptom” button. You should keep your smartphone nearby (within 5 feet/1.5 meters) until the “Success” message displays.

CAN I TRAVEL?

Traveling is easy with the myMerlin™ mobile app for use with your smartphone. To send information to your clinic while traveling, you need a strong internet connection. You do not need any additional bulky equipment. Read more about traveling with your device. Before leaving on your trip, make sure to consult your doctor about your plans.

CAN I PAIR MY HEART MONITOR WITH MORE THAN ONE SMARTPHONE?

No. For security reasons, you can only pair your heart monitor to one smartphone at a time. To pair your heart monitor to a different smartphone than the one you originally downloaded the app to, you first need to uninstall the app on your first smartphone.

CAN I GET A MAGNETIC RESONANCE IMAGING (MRI) SCAN WITH MY DEVICE?

The Confirm Rx™ ICM is a MR conditional (also referred to as MRI compatible or MRI ready). This means it is conditionally safe for use in the MRI environment when used in accordance to the instructions in the user manual. You can receive an MRI scan with the Confirm Rx ICM under certain parameters; talk with your doctor prior to having any MRI scan. Prior to having any MRI scan, talk with your doctor about the MRI scan you need and any specific parameters.

If you have an Abbott Cardiovascular MR Conditional device, download your MRI patient ID card.

WHY IS MRI COMPATIBILITY IMPORTANT?

MRI is fast becoming a preferred diagnostic imaging tool used by physicians to diagnose a wide array of medical conditions. Because of its high-resolution image quality and low radiation risk, MRI is often selected over other diagnostic imaging options. The use of MRI continues to grow. By having an MRI conditional device, you will have the option of getting an MRI scan, if the need arises.

WHAT IF I DO NOT HAVE A SMARTPHONE?

If you do not have a smartphone, Abbott Cardiovascular offers a mobile transmitter for you to use.

If you have any more questions about the myMerlin™ for Confirm Rx™ ICM mobile app, please download this comprehensive FAQ list. The PDF covers questions about general usage, connecting with your heart monitor, recording symptoms and traveling.

Find answers to more frequently asked questions.

IMPORTANT SAFETY INFORMATION

Rx Only

Indications: The Confirm Rx™ ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.

Contraindications: There are no known contraindications for the insertion of the Confirm Rx™ ICM. However, the patient’s particular medical condition may dictate whether or not a subcutaneous, chronically inserted device can be tolerated.

Adverse Events: Possible adverse events (in alphabetical order) associated with the device, include the following: Allergic reaction, Bleeding, Chronic nerve damage, Erosion, Excessive fibrotic tissue growth, Extrusion, Formation of hematomas or cysts, Infection, Keloid formation and Migration. Refer to the User’s Manual for detailed indications, contraindications, warnings, precautions and potential adverse events.

Additional information: Clinicians must log onto Merlin.net™ Patient Care Network to view transmissions from patients’ Confirm Rx™ ICM. On Merlin.net™ PCN they can configure transmission schedules and enable or disable features on a patient’s myMerlin™ for Confirm Rx™ ICM mobile app. Review of transmissions is dependent on the clinician and may not happen immediately following delivery of such transmissions.

Limitations: Patients may use their own Apple‡ or Android‡ mobile device to transmit information from their Confirm Rx™ ICM using the myMerlin™ for Confirm Rx™ mobile app. To do so the device must be powered on, app must be installed, Bluetooth^® wireless technology enabled and data coverage (cellular or WiFi‡) available. The myMerlin™ for Confirm Rx™ mobile app provides periodic patient monitoring based on clinician configured settings. Data is resent if the transmission was not sent successfully. However, there are many internal and external factors that can hinder, delay, or prevent acquisition and delivery of ICM and patient information as intended by the clinician. These factors include: patient environment, data services, mobile device operating system and settings, ICM memory capacity, clinic environment, schedule/configuration changes, or data processing.

An Abbott mobile transmitter is available for patients without their own compatible mobile device.

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CONFIRM Rx™ INSERTABLE CARDIAC MONITOR