Specifications

© 2011 Cardiovascular Systems, Inc. 8 90168-00.K
Diamondback 360 Orbital Atherectomy Procedure
Background Information
The eccentric diamond-coated Crown of the DB 360 is designed to remove a thin layer of the stenotic lesion with
each pass through the lesion. It is recommended that debulking be initiated at Low speed. Frequent fluoroscopic
visualization allows for controlled removal of the lesion. Increase rotational speed, as required, to increase the orbit
diameter.
Introducer Sheath
An introducer sheath is used to access the target vessel. Care should be taken not to deform the DB 360
Crown/Shaft when inserting or removing it through the introducer’s hemostasis valve. See Appendix C for the
recommended sheath size for the Crown size selected.
Guide Wire Placement
The recommended DB 360 guide wire is used to reach and cross the lesion or stenotic occlusion. It allows for proper
positioning of the Crown and provides a center of rotation for the flexible drive shaft. Follow the instructions related to
guide wire use.
Equipment Set Up
Refer to the Controller Manual for OAS Assembly and Setup instructions including setup of the DB 360. Ensure the
system and all components are setup correctly prior to use.
Testing the Diamondback Orbital Atherectomy System Prior to Use
The DB 360 must be tested with the Shaft/Crown threaded over the guide wire before inserting the DB 360 into the
vessel/shunt and performing the atherectomy procedure.
Test the following prior to use:
• Check the flow of saline
• Set rotational speed of the Shaft/Crown
• Test ability to advance the Crown
Preparation for Testing
1. Ensure the Crown Control Knob is pushed fully proximal (away from the Shaft) and secured by turning it
clockwise before threading the guide wire through the Shaft.
2. Grasp the proximal end of the guide wire and thread it through the hole in the Shaft tip distal to the Crown.
3. Continue feeding the guide wire into the Shaft until the guide wire appears at the rear of the Control Handle.
4. Grasp the exposed guide wire and pull it gently until the distal end of the guide wire spring tip is at least 4 inches
(10 cm) from the end of the shaft.
Note: If difficulty is encountered in guiding the wire through the Control Handle, loosen the Crown Control Knob by
turning it counterclockwise and slide it back and forth while gently pushing the wire. This should ease the wire
through the Control Handle.
5. Attach a wire torquer to the guide wire a few centimeters beyond the end of the Control Handle.
6. Make sure the compressed gas supply is turned on and the roller pump door closed.
Check the Flow of Saline AND Set Rotational Speed of the Shaft/Crown.
1. For Controller Model OAC-100, turn the Pressure Control Knob on the front of the Controller counterclockwise
until it stops. This will prevent the Crown from rapidly spinning if the Foot Pedal is accidentally depressed.
2. Depress the Fluid/Pump On/Off switch on the Controller. Saline will flow at low pump speed.
3. Check that the saline is flowing freely and check the saline tubing and connections for leaks.
Note: Monitor the saline fluid level during the procedure. Saline infusion is critical to safe DB 360 performance.
4. Hold the Sheath a few centimeters from the Crown making sure the Crown is not in contact with any objects.
5. Hold the distal tip of the guide wire (not the guide wire spring tip).
6. For Controller Model OAC-100, turn the Pressure Control Knob clockwise to obtain a reading of 25,000 rpm
For Controller Model DB-2000, press the Test Button.
7. Depress and release the Foot Pedal. Saline will flow at high pump speed.
8. Check that the flow of saline increased.
9. Within five seconds, depress and hold the Foot Pedal. The Shaft/Crown will rotate.
10. Release the Foot Pedal. Rotation of the Shaft/Crown will stop. After five seconds, saline flow will decrease to
low pump speed.