Abbott's Insertable cardiac monitors (ICMs) let you diagnose with confidence and manage with flexibility. Our updated SharpSense™ technology has increased p-wave and r-wave sensitivity leading to a 97.9% reduction in false positives.1 Abbott makes it easy to stay powerfully connected; a 97% patient compliance2 with the myMerlin™ app for remote connectivity ensures you receive precise, actionable data 20x faster than other ICMs3 without interrupting your patients' lives.
®Bluetooth and the Bluetooth figure mark are registered trademarks of Bluetooth SIG, Inc.
Rx Only
Brief Summary: Prior to using these devices, please review the Instructions for Use for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use.
Indications: Abbott Insertable Cardiac Monitors (ICMs) are 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. Abbott ICMs are also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation. Abbott ICMs have not been specifically tested for pediatric use.
Contraindications: There are no known contraindications for the insertion of Abbott ICMs. 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 these devices, 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 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.
MAT-2010519 v2.0
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Unless otherwise specified, all product and service names appearing in this Internet site are trademarks owned by or licensed to Abbott, its subsidiaries or affiliates. No use of any Abbott trademark, trade name, or trade dress in this site may be made without the prior written authorization of Abbott, except to identify the product or services of the company.
Precautions
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The following pages are intended for medical professionals and provide information on the proper use of products (medical devices, etc.) of Abbott Medical Japan GK.
The information provided here is not intended to provide information to patients and the general public.
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