Specifications
© 2011 Cardiovascular Systems, Inc. 10 90168-00.K
Rest periods are recommended after 30 to 60 seconds of treatment time with a maximum treatment time
of 90 seconds.
Do not leave the rotating Crown in one location for more than 2-3 seconds.
Use contrast injections through the introducer sheath to evaluate the results angiographically.
Stop Crown rotation by releasing the Foot Pedal.
To begin Crown rotation again:
a. Depress and release the Foot Pedal to start the flow of saline at high pump speed.
b. Within five seconds, depress the Foot Pedal again and hold. The Shaft/Crown will rotate.
18. If luminal patency is not adequate, one or more of the following options may be selected:
Continue to treat the lesion by moving the Crown across the lesion as described above.
Increase the rotational speed of the Shaft/Crown.
19. To increase rotational speed to Medium:
a. Controller Model OAC-100: turn the Pressure Control Knob clockwise to desired speed setting while
closely monitoring the Rotational Speed and Turbine Pressure displays.
b. Controller Model DB-2000, select the appropriate speed as indicated on the handle.
c. Continue to periodically monitor the Rotational Speed and Turbine Pressure displays. Repeat Step 17.
d. For additional treatment, increase speed to the High setting. Repeat Step 17.
20. To increase rotational speed on the DB-2000 by using the Up and Down Arrows, select a Speed setting.
Increase or decrease in increments of 10,000 rpms by selecting the arrows. The selected rpms will read out in
the therapy window.
21. If luminal patency is not adequate, consider selecting and DB 360 with a larger Crown size.
22. Evaluate luminal patency.
23. Perform a final angiogram.
Discontinuing the Procedure and Device Removal
To discontinue treatment:
1. Release the Foot Pedal to stop Shaft/Crown rotation.
2. Retract the Crown proximal to the lesion.
3. Remove the DB 360.
4. Stop the Fluid/Pump.
5. Remove the guide wire and introducer sheath according to standard hospital procedures.
6. Treat the puncture site according to standard hospital procedures.
7. Discard the DB 360 according to hospital protocol.
8. Turn off the Controller following Controller instructions for use.