What if your heart
Could tell your doctor How it's doing?
An irregular heartbeat can be tough to diagnose. Symptoms aren’t always obvious and they can come and go over time. But when your doctor has the right information, and can see what’s happening in your heart, an irregular heartbeat is treatable.
Important safety information
Get LIFE BACK
IN RHYTHM
Abbott’s Confirm Rx ICM heart monitor is revolutionizing how irregular heartbeats are diagnosed. It’s a small, insertable device that continuously monitors your heart’s rhythm.
Important safety information
Important safety information
MAT-2010457 v1.0 | Item approved for global use.
MAT-2010457 v1.0 | Item approved for global use.
Get LIFE BACK
IN RHYTHM
The Confirm Rx ICM continuously collects and analyzes data on your heartbeat while you enjoy your day-to-day activities. Information is then sent to your doctor, wirelessly, through the myMerlin Mobile App so they can see when your heart starts beating differently.
Collecting and analyzing data and sending updates to your doctor wirelessly through the myMerlin Mobile App.
Important safety information
Important safety information
MAT-2010457 v1.0 | Item approved for global use.
INDICATIONS, SAFETY & WARNINGS
Model DM3500
Insertable Cardiac Monitor
Confirm Rx™
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. The Confirm Rx™ ICM has not been specifically tested for pediatric use.
INDICATIONS:
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.
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.
Adverse Events:
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™ mobile app. Review of transmissions is dependent on the clinician and may not happen immediately following delivery of such transmissions.
Additional information:
Patients may use their own Apple‡ or Android‡ mobile 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 enabled and data coverage (cellular or WiFi‡) available. The myMerlin™ 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.
Limitations:
MAT-2010457 v1.0 | Item approved for global use.
MAT-2010457 v1.0 | Item approved for global use.