Use Instructions

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Table of Contents
1. Introduction 5
1.1 Intended Use 5
1.2 Contraindications 5
2. Device Descriptions 8
2.1 Cordella™ PA Sensor 8
2.2 myCordella Patient Reader 8
2.3 Delivery System 9
2.4 Calibration Equipment 9
2.5 Cordella Data Analysis Platform (CDAP) 9
2.6 Recommended Accessories 10
3. Safety Information 11
3.1 Warnings: Implantation Procedure 11
3.2 Warnings: Reader and Docking Station 13
3.3 Precautions 15
3.4 Potential Adverse Events 17
3.5 MRI Safety Information 18
3.6 Sterilization 19
4. Instructions for Use 20
4.1 Pre-Procedure Preparation 20
4.2 Pairing and Interrogating the Cordella Sensor in Packaging 21
4.3 Delivery System Package Inspection 22
4.4 Vessel Mapping and Guidewire Placement 23
4.5 Delivery System & Cordella Sensor Insertion 26
4.6 Cordella Sensor Implantation 28
4.7 Calibrating the Sensor 31
5. Transport 33
6. Post-Procedure Antiplatelet Therapy 33
7. Patient Implant Card 33
8. Patient Reader Training 34
9. Reader/Docking Station Audio & Visual Cues 36