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

Cardiovascular Systems, Inc. DIAMONDBACK 360 Peripheral Orbital Atherectomy System Exchangeable Series
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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
____________________________________________________
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
®

Questions and Answers:

Cardiovascular Systems, Inc. DIAMONDBACK 360 Peripheral Orbital Atherectomy System Exchangeable Series Specifications

General IconGeneral
BrandCardiovascular Systems, Inc.
ModelDIAMONDBACK 360 Peripheral Orbital Atherectomy System Exchangeable Series
CategoryMedical Equipment
LanguageEnglish

Summary

System Description

System and Component Descriptions

Orbital Atherectomy Device (OAD) Description

Details the hand-held, over-the-wire device consisting of a handle, cartridge, and saline line.

OAS Pump Description

VIPERWIRE ADVANCE Peripheral Guide Wire Description

Indications for Use

Contraindications

Warnings

Precautions

Storage and Handling

Adverse Events

Equipment Setup and Test

OAS Pump Set Up

Step-by-step guide for setting up the OAS pump on an IV pole and connecting power.

OAD Set Up

Connect the Cartridge to the Handle

Instructions on how to connect the OAD cartridge to the handle, ensuring proper locking.

Connecting the OAD to the OAS Pump

Testing the OAD

Initiating the Atherectomy Procedure

OAS Usage Directions

Performing the Atherectomy Procedure

Detailed steps for performing the atherectomy procedure using the OAS, including crown rotation and advancement.

Cartridge Exchange Procedure

Replacing the OAD Unit

Completing the Atherectomy Procedure

Specifications

System Troubleshooting Guide