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ABOUT CONFIRM Rx™ ICM
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VISIT ABBOTT.COM

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References

1. AFib Awareness. Heart.org. 2017. http://www.heart.org/HEARTORG/Conditions/Arrhythmia/AFib-Awareness_UCM_476637_SubHomePage.jsp. Accessed 10 Nov, 2017.

2. Chugh, S, Havmoeller, R., Narayanan, K., Singh, D., Rienstra, M., Benjamin, E., … Murray, C. https://doi.org/10.1161/CIRCULATIONAHA.113.005119Circulation. 2014;129:837–847

3. Atrial Fibrillation Fact Sheet|Data & Statistics|DHDSP|CDC. Cdc.gov.2017. https://www.cdc.gov/dhdsp/data_statistics/fact_sheets/fs_atrial_fibrillation.htm. Accessed 10 Nov, 2017.

Abbott
One St. Jude Medical Dr., St. Paul, MN 55117 USA, Tel: 1 651 756 2000
Abbott.com

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

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.

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™ ICM 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™ ICM 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.

™ Indicates a trademark of the Abbott group of companies.
^‡ Indicates a third-party trademark, which is property of its respective owner.
Bluetooth and the Bluetooth logo are registered trademarks of Bluetooth SIG, Inc.
© 2022 Abbott. All Rights Reserved.
MAT-1901148 v1.0 | Item approved for U.S. and OUS use.

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