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©
2009 Cardiovascular Systems, Inc.
90074-00.F
Introduction
This document describes the components and use of the Diamondback 360º® Orbital Atherectomy Controller
(Controller). The Controller is a component of the Diamondback Orbital Atherectomy System (OAS). Read this
document thoroughly before using the OAS, Controller, or any other components. Review the contraindications,
restrictions, warnings, and precautions carefully. Additional instructions and information are found in the
Diamondback Orbital Atherectomy Device (OAD) Instructions for Use and package inserts included with separately
packaged components. Read all instructions completely before using the OAS or any components.
Indications for Use
The Diamondback Orbital Atherectomy System is a percutaneous orbital atherectomy system indicated for use as
therapy in patients with occlusive atherosclerotic disease in peripheral arteries and who are acceptable candidates for
percutaneous transluminal atherectomy.
The OAS is also indicated for removal of stenotic material from artificial arteriovenous dialysis fistulae (AV shunt).
Diamondback 360 Orbital Atherectomy System (OAS) Description
CSI Supplied Equipment
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Orbital Atherectomy Device (OAD)
•
Controller
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Guide Wire - as specified in the OAD Instructions for Use
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Gas input line and connector – connects from the controller to the air supply
Additional Components
These are independently obtained, as listed below. Follow the original manufacturer’s instructions for each
independently sourced component.
•
Guide Catheter / Sheath Introducer – See the appropriate Instructions for Use for recommended guide catheter
sheath introducer sizes.
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Compressed Gas Cylinder or house air supply – The gas must be air or nitrogen.
•
Cylinder Pressure Regulator – The regulator must be capable of delivering at least 5 scfm (140 liter/min) at 85-
100 psi (5.8-6.9 bar).
•
Normal Saline Solution for Injection – At least one full 1-liter bag must be available.
•
Other equipment as needed for interventional procedures.
Diamondback 360 Orbital Atherectomy Controller
This document explains the function of the Orbital Atherectomy Controller (Controller). Device specific instructions
for use are available separately as packaged with the Orbital Atherectomy Device (OAD).
The Orbital Atherectomy Controller (Controller) is an electro-mechanical control system. The functions of the
Controller include:
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Regulation of gas pressure to the turbine that controls Shaft/Crown rotational speed..
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Recording of operation time including event time, and total time.
•
Regulation of saline flow through the Sheath covering the Shaft.
Contraindications, Restrictions, Warnings and Precautions
Contraindications
Refer to the OAD Instructions for Use for the associated contraindications.
Restrictions
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The OAS should only be used by physicians who are experienced in peripheral angioplasty at his or her
institution and trained on the use of the OAS.
•
Caution:
Federal law (USA) restricts this device to sale by or on the order of a physician.
Warnings
•
If mechanical failure of the Controller occurs before or during the atherectomy procedure, discontinue use
immediately and return the product to Cardiovascular Systems, Inc. Do not attempt to use a damaged OAD,
Controller, or other system component. Use of damaged components may result in system malfunction or
patient injury.
