Cardiovascular Systems, Inc. DIAMONDBACK 360 Peripheral Orbital Atherectomy System Exchangeable... User manual

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DIAMONDBACK 360®Peripheral Orbital Atherectomy
System Exchangeable Series
Including the Orbital Atherectomy Device, Handle, Orbital
Atherectomy Cartridge, Saline Pump, VIPERWIRE ADVANCE®
Peripheral Atherectomy Guide Wire, and VIPERWIRE
ADVANCE®with FLEXTIP Peripheral Atherectomy Guide Wire
Instructions for use
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Caution: Federal Law (USA) restricts this device to sale by or on the order of a
physician.
The following are trademarks of Cardiovascular Systems, Inc.:
CSI®, Cardiovascular Systems®, DIAMONDBACK 360®, VIPERWIRE®, VIPERWIRE
ADVANCE®, VIPERWIRE ADVANCE®with FLEXTIP, VIPERSLIDE®, GlideAssist®

Explanation of Symbols on Package Labels
Refer to the package labels to see which symbols apply to specific products.
Lot number
Model number
Consult IFU www.csi360.com (USA) (Symbol appears in blue when
placed on the device itself)
Caution: Consult IFU www.csi360.com (USA)
Do not reuse.
Do not re-sterilize
Sterilized with Ethylene Oxide
Manufacturer
Use by
Maximum guide wire tip diameter
Maximum guide wire shaft diameter
Guide wire length
Caution: Federal law (USA) restricts this device to sale by or on
the order of a physician.
Contains phthalates

Explanation of Symbols on the Saline Pump
Low saline red LED indicator
Start button and pump ON green LED indicator
Pump status yellow LED indicator
Prime button
Type CF Applied Part
Slow Blow Type T Fuse

Explanation of Symbols on the Handle
Prime button
Low speed button
Medium speed button
High speed button
Rotate Symbol
Eject Symbol
Non-continuous use; spin cycles of 30 seconds on, 30
seconds off with maximum spin time of ≤ 8 minutes per
cartridge using no more than three cartridges per handle

Table of Contents
1. System Description................................................................................................1
2. System and Component Descriptions ...................................................................1
3. Indications for Use.................................................................................................9
4. Contraindications...................................................................................................9
5. Restrictions..........................................................................................................10
6. Warnings.............................................................................................................10
7. Precautions .........................................................................................................11
8. Storage and Handling..........................................................................................13
9. Adverse events....................................................................................................13
10. Clinical Trials Summary.......................................................................................14
11. Equipment, Setup, and Test................................................................................14
12. OAS Directions for Use .......................................................................................22
13.Specifications......................................................................................................32
14. OAS Pump Declaration of Conformity.................................................................34
15. EMC Declaration .................................................................................................34
16. FCC.....................................................................................................................37
17. Disclaimer of Warranty........................................................................................37
Appendix A. System Troubleshooting ...........................................................................39
Appendix B. Introducer, Guide Sheath, or Guide Catheter Size....................................44
Appendix C. Maximum Orbit and Resulting Lumen Diameter.......................................46
Appendix D. Orbit Performance ....................................................................................48