Specifications

© 2011 Cardiovascular Systems, Inc. 9 90168-00.K
Ability to Advance the Crown
After setting the correct rotational speed of the Shaft/Crown, practice advancing the Crown while it is rotating.
1. Hold the Sheath a few centimeters from the Crown making sure that the Crown is not in contact with any objects.
2. Depress and release the Foot Pedal. Saline will flow at high pump speed.
3. Within five seconds, depress and hold the Foot Pedal. The Shaft/Crown will rotate.
4. While the Crown is rotating, slowly slide the Crown Control Knob back and forth and note the corresponding
movement of the Crown along the guide wire.
Procedure Steps
1. Gain vessel/shunt access by the operator’s preferred methodology.
2. Access the treatment site with an introducer sheath.
3. Use angiography to locate, visualize, and evaluate the lesion.
4. Approach and cross the lesion with the guide wire.
5. Ensure the Crown Control Knob is pushed fully back (away from the Shaft) and turned fully clockwise.
6. Thread the Shaft over the guide wire, if needed.
7. Activate the Fluid/Pump On/Off switch on the Controller. The saline will flow at low pump speed.
8. Advance the Shaft over the guide wire through a hemostasis valve.
Note: If an adjustable hemostasis valve is used with the introducer sheath, it should be closed just enough to
prevent blood loss around the sheath, but still allow the Shaft to slide through the valve. Excessive tightening of
the hemostasis valve can crush the Sheath around the Shaft and restrict flow of saline through the Sheath. Care
should be taken not to deform the DB 360 Crown/Shaft when inserting or removing it through the hemostasis
valve. See Appendix C for recommended sheath size for the Crown Size selected.
9. Under fluoroscopic guidance, gently advance the Crown over the guide wire to a point immediately proximal to
the lesion.
Note: While advancing or withdrawing the DB 360, rotation at speeds less than 25,000 rpm may facilitate
movement of the Shaft over the guide wire. Grasp the guide wire as it exits the Control Handle to prevent guide
wire rotation.
10. Inject contrast and verify that the size of the Crown is compatible with the vessel/shunt diameter.
11. Verify that the guide wire spring tip is distal to the lesion and is not in danger of contacting the rotating Shaft tip.
Note: A minimum distance of 4 inches (10 cm) must be observed throughout treatment between the proximal
end of the guide wire spring tip and distal tip of the OAD Shaft to prevent damage to the guide wire spring.
Advance the guide wire further proximal if necessary. Never bring the OAD shaft into contact with the guide wire
spring tip.
12. Select the rotational speed beginning with the Low speed setting. See Appendix B for speed settings for each
Crown size.
a. Controller Model OAC-100, turn the Pressure Control Knob clockwise to obtain the desired speed
setting.
b. Controller Model DB-2000, select the appropriate speed as indicated on the handle.
Note: The maximum orbit diameter is primarily a function of Crown size, rotational speed and number of passes
through the lesion. It is recommended that debulking be initiated at the Low speed setting. Frequent
fluoroscopic visualization allows for controlled removal of the lesion. Increase rotational speed, as required, to
increase the orbit diameter.
13. Depress and release the Foot Pedal. Saline will flow at high pump speed.
14. Within five seconds, depress the Foot Pedal again and hold. The Shaft/Crown will rotate.
15. Check the Rotational Speed display and verify that the Shaft/Crown is rotating at the selected speed.
16. Turn the Crown Control Knob counterclockwise to loosen and advance it slowly to begin atherectomy of the
lesion. Always hold the Crown Control Knob during Crown/Shaft rotation. Observe the Crown’s progress
fluoroscopically.
17. Move the Crown Control Knob to move the Crown back and forth across the lesion. Employ a series of
intermittent treatment events and rest periods.