Crown CM-30 Spezifikationen

© 2011 Cardiovascular Systems, Inc. 90168-00.K Diamondback 360® Orbital Atherectomy Device, Solid Crown, 30 µm, with 15 cm Travel Instruc

© 2011 Cardiovascular Systems, Inc. 10 90168-00.K  Rest periods are recommended after 30 to 60 seconds of treatment time with a maximum treatme

© 2011 Cardiovascular Systems, Inc. 11 90168-00.K Troubleshooting Issue SolutionThe Crown stops rotating during the atherectomy procedure. 1.

© 2011 Cardiovascular Systems, Inc. 12 90168-00.K Appendix A – Platform Graphs 1.50mm 30µm Solid Crown Orbit Results1.522.533.540 5 10 15 20 2

© 2011 Cardiovascular Systems, Inc. 13 90168-00.K 2.00mm 30µm Solid Crown Orbit Results22.533.544.555.50 5 10 15 20 25 30 35 40 45 50 55 60 6

© 2011 Cardiovascular Systems, Inc. 14 90168-00.K Appendix B - Maximum Orbit/Resulting Lumen Diameter Table 3 shows the maximum orbit/resulting

© 2011 Cardiovascular Systems, Inc. 15 90168-00.K Appendix C - Recommended Introducer Sheath Sizes Crown Size Diamondback 360 Maximum Outer Dia

© 2011 Cardiovascular Systems, Inc. 16 90168-00.K Appendix D: Symbols Model Number Lot Number Use By Date Refer to the Instructions For Use

© 2011 Cardiovascular Systems, Inc. 17 90168-00.K Appendix E - DISCLAIMER OR WARRANTY DISCLAIMER OF WARRANTY Although Cardiovascular Systems,

© 2011 Cardiovascular Systems, Inc. 2 90168-00.K Table of Contents List of Illustrations and Tables 2 Introduction 3 Diamondback 360 Orbital A

© 2011 Cardiovascular Systems, Inc. 3 90168-00.K Introduction The following Instructions for Use describe the components and use of the Diamondba

© 2011 Cardiovascular Systems, Inc. 4 90168-00.K • Handle the DB 360 and guide wire carefully. A tight loop, kink, or bend in the guide wire ma

© 2011 Cardiovascular Systems, Inc. 5 90168-00.K Clinical Summary The prospective multi-center Clinical Study of the Orbital Atherectomy System f

© 2011 Cardiovascular Systems, Inc. 6 90168-00.K Diamondback 360 Orbital Atherectomy Device (DB 360) The DB 360 includes the following subcompone

© 2011 Cardiovascular Systems, Inc. 7 90168-00.K Crown Size Selection Crown Sizes The eccentric diamond-coated Crown is available in diameters as

© 2011 Cardiovascular Systems, Inc. 8 90168-00.K Diamondback 360 Orbital Atherectomy Procedure Background Information The eccentric diamond-coat

© 2011 Cardiovascular Systems, Inc. 9 90168-00.K Ability to Advance the Crown After setting the correct rotational speed of the Shaft/Crown, prac