Specifications

© 2011 Cardiovascular Systems, Inc. 2 90168-00.K
Table of Contents
List of Illustrations and Tables 2
Introduction 3
Diamondback 360 Orbital Atherectomy System (OAS) Description 3
Indications For Use 3
Contraindications, Restrictions, Warnings and Precautions 3
Contraindications 3
Restrictions 3
Warnings 3
Precautions 4
Clinical Summary 5
Diamondback 360 Orbital Atherectomy Device (DB 360) 6
Crown Size Selection 7
Diamondback Procedure 8
Background Information 8
Introducer Sheath 8
Guide Wire Placement 8
Equipment Set Up 8
Testing the Diamondback System Prior to Use 8
Procedure Steps 9
Discontinuing the Procedure and Device Removal 10
Troubleshooting 11
Expiration Dating 11
Storage and Usage 11
Appendix A – Platform Graphs 12
Appendix B – Maximum Orbit/Resulting Lumen Diameter 14
Appendix C - Recommended Introducer Sheath Sizes 15
Appendix D – Symbols 16
Appendix E – Disclaimer of Warranty 17
List of Illustrations and Tables
Figure Title Page
1. Diamondback 360 Orbital Atherectomy Device (DB 360) 6
Table Title Page
1. Crown Sizes 7