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1.Indications for Use: The Carnation Ambulatory Monitor is designed to provide extended duration cardiac monitoring for people who are suspected of having cardiac arrhythmias. Please refer to the Instructions for Use for further information. © 2021 Bardy Diagnostics. All rights reserved. Bardy Diagnostics, Bardy Diagnostics logo, and Carnation Ambulatory Monitor (CAM) are trademarks of Bardy Diagnostics.
Patient Population: The intended patient population includes both males and females not weighing less than 10kg (22 lbs) who may have cardiac arrhythmias.
2. Smith WM., et al. Comparison of diagnostic value using a small, single channel, P-wave centric sternal ECG monitoring patch with a standard 3-lead Holter system over 24 hours. American Heart Journal. March 2017.
3. Romme AG, et al. Feasibility of P wave Centric Ambulatory Electrocardiogram Monitoring in Infants and Young Children. Pediatr Cardiol. 2021 Apr 10. doi: 10.1007/s00246-021-02590-5. Epub ahead of print. PMID: 33837839.
4. Rho R., et al. Comparison of two ambulatory patch ECG monitors: The benefit of the P- wave and signal clarity. American Heart Journal. Manuscript Accepted Online. March 2018.