Instructions For Use
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10. Maintenance and Storage
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10.1 Environmental Information
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10.2 Replacement and Repair
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12. Return Materials Authorization (RMA)
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13. Inspection & Cleaning Instructions
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14. Troubleshooting
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14.1 Implant Procedure & Delivery System
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14.2 Pairing and Interrogating the Cordella Sensor
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14.3 Calibrating the Cordella Sensor
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15. Useful Life
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Appendices
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Appendix A: Electromagnetic Compatibility
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Appendix B: Equipment Specifications
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Definition of Symbols
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1. Introduction
The Cordella Pulmonary Artery (PA) Sensor System is intended to measure,
record, and transmit PA pressure data from NYHA Class III heart failure
patients at home to clinicians for assessment and patient-centered heart
failure management. It is designed to be used with the Cordella™ Heart
Failure System to better connect healthcare professionals and patients
with tools for comprehensive heart failure management. The Cordella
Heart Failure System consists of the patient-facing myCordella System
Pack and the clinic-facing myCordella Patient Management Portal (PMP).
The Cordella PA Sensor is an implantable blood pressure monitor
that permanently resides in the patient’s pulmonary artery. With this
innovative Cordella Sensor, PA pressure can be wirelessly measured from
the patient’s home on demand. Changes in PA pressure may indicate
fluid accumulation in the lungs. Active management of a patient using
the Cordella Sensor and the other peripherals of the myCordella System
Pack may improve long-term outcomes in patients with New York Heart
Association (NYHA) Class III heart failure.
1.1 Intended Use
The Cordella PA Sensor System is intended to measure, record, and
transmit pulmonary artery pressure data from NYHA Class III heart failure
patients at home to clinicians for assessment and patient-centered heart
failure management.
1.2 Contraindications
The Cordella PA Sensor System is contraindicated for patients that cannot
tolerate anticoagulation or antiplatelet regimens. The Cordella Sensor is
not recommended for patients with venous peripheral stents, inferior vena
cava filters, or artificial valves in the path of the Delivery System.
