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.

The Confirm Rx™ insertable cardiac monitor (ICM) is the world’s first continuous heart monitor that is compatible with your smartphone and is designed to help you:

Live Life Without Skipping a Beat

  • The slimmest ICM available, Confirm Rx™ ICM combines a smartphone app and integrated symptom recorder to make monitoring your heart's rhythm easy, effective and discreet.
    • The myMerlin™ app allows you to record symptoms on the go and also proactively transmits data to your doctor.

Find Your Rhythm

  • Confirm Rx ICM continuously monitors your heart rhythm.
  • The system proactively transmits information via the myMerlin app on a schedule set by your clinic.
  • Transmissions are encrypted and securely transmitted to help you stay connected to your doctor.

Confirm Rx ICM eliminates the need for a bedside transmitter and separate activator to record symptoms. The myMerlin™ app via your smartphone lets you:

  • Annotate symptoms to give your doctor more insight
  • View your own transmissions and symptom history
  • Record specific symptoms and send them to the clinic without having to wait for a nightly sync with a traditional transmitter

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

 

Visit the Apple‡ App Store.

 

 

Visit Google Play‡.

 

 

Device specifications

Dimensions (mm)
49 x 9.4 x 3.1
Weight (g)
3

REFERENCES
‡ Indicates a third party trademark, which is property of its respective owner. Bluetooth is a registered trademark of Bluetooth ISG, Inc.
Patients may use their own or Android or Apple mobile digital device to transmit information from their Confirm Rx™ ICM using the myMerlin™ mobile app. To do so the device must be powered on, app must be installed, Bluetooth® wireless technology connection enabled and data coverage (cellular or Wi-Fi) available. The myMerlin™ app provides periodic patient monitoring based on clinician configured settings. For further details, refer to the Limitations statement located on the last page
HOW THE CONFIRM Rx™ INSERTABLE CARDIAC MONITOR WORKS

The Confirm Rx™ insertable cardiac monitor (ICM) provides valuable diagnostic information about your heart rhythm to your doctor, allowing your doctor to monitor your heart rhythm over a longer length of time than is provided by other tests. This can help your doctor diagnose heart events, like an irregular heart rhythm (arrhythmia) or identify a heart-related reason for unexplained fainting (syncope).

Easy: a simple insertion procedure and app-based communication

The thin cardiac monitor is inserted just under the skin by your doctor in a quick, simple and safe procedure.

Confirm Rx ICM is the first device with technology that allows information about your heart to be sent from the device securely and automatically to your doctor using a smartphone app and Bluetooth® technology. This gives your doctor continuous insight into your heart’s activity with less interruption to your life.

Effective: 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
  • Transmit nightly data reports automatically, simply by being in range of your smartphone—with no need for additional monitoring equipment
  • Be assured your transmitted data is encrypted and secure
  • Immediately flag health events and symptoms as they occur, and send information to your doctor’s clinic if you feel symptoms
  • Verify your transmissions and view educational resources on your smartphone

Discreet: Use your smartphone to record and send symptoms on command

While Confirm Rx ICM and myMerlin app monitor your heart and record reports automatically, they also let you use your smartphone to record your symptoms on command as you experience them. You can make notes, and send your symptoms to your doctor immediately without the need for a separate patient activator.

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.

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

Visit the Apple‡ App Store.



Visit Google Play‡.

REFERENCES
‡ Indicates a third party trademark, which is property of its respective owner. Bluetooth is a registered trademark of Bluetooth ISG, Inc.
Patients may use their own or Android or Apple mobile digital device to transmit information from their Confirm Rx™ ICM using the myMerlin™ mobile app. To do so the device must be powered on, app must be installed, Bluetooth® wireless technology connection enabled and data coverage (cellular or Wi-Fi) available. The myMerlin™ app provides periodic patient monitoring based on clinician configured settings. For further details, refer to the Limitations statement located on the last page.
Your Confirm Rx™ ICM and the myMerlin™ Mobile App

Learn how the Confirm Rx™ insertable cardiac monitor works and how to use the myMerlin™ mobile app to send information from your monitor to your doctor’s office.

IMPORTANT SAFETY INFORMATION

Confirm Rx™

Model DM3500
Insertable Cardiac Monitor

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. Confirm Rx ICM Model DM3500 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 implantation of the Confirm Rx ICM. However, the patient’s particular medical condition may dictate whether or not a subcutaneous, chronically implanted 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.

Limitations*: Patients may use their own Apple or Android mobile digital device to transmit information from their Confirm Rx ICM using the myMerlin™ mobile app. To do so the device must be powered on, app must be installed, Bluetooth® wireless technology connection enabled and data coverage (cellular or WiFi) available. The myMerlin™ app provides periodic patient monitoring based on clinician configured settings. Transmission data is resent if 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.

SJM-CV WEB-0718-0082

IMPORTANT SAFETY INFORMATION

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