Specifications

© 2011 Cardiovascular Systems, Inc. 11 90168-00.K
Troubleshooting
Issue Solution
The Crown stops rotating during
the atherectomy procedure.
1. Discontinue treatment immediately.
2. Retract the Crown.
3. Check the Control Handle for proper connection to the Controller.
4. If the connections are correct, use fluoroscopy to analyze the
situation.
Blood is observed in the Sheath. 1. Discontinue treatment.
2. Verify the saline infusion is properly connected and flowing.
3. If the device is properly connected and blood continues to flow up
the sheath, replace the DB 360.
Crown/Shaft fractures. The coiled tip of the guide wire may keep the Crown/Shaft on the guide
wire. Gently remove the guide wire to retrieve the Crown/Shaft. If the
Crown/Shaft becomes dislodged from the guide wire, use standard
procedures to retrieve the Shaft.
The desired rotational speed
cannot be reached.
1. Discontinue treatment.
2. Verify that the Turbine Gas Intake Hose is not kinked or pinched.
3. Verify that the Gas Intake Hose is not kinked or pinched.
4. Check that the gas cylinder regulator is properly set and the gas
cylinder has adequate volume and pressure.
Variable or unstable rotational
speed is displayed.
1. Discontinue treatment.
2. Verify that the Optical Tachometer Fiber is properly connected to the
Controller.
3. Verify that the end of the Optical Tachometer Fiber is clean.
No Crown activation 1 Discontinue treatment.
2. Verify that the Optical Tachometer Fiber is properly connected to the
Controller.
3. Verify that the end of the Optical Tachometer Fiber is clean.
4. Check that controller is on
No saline flow 1. Discontinue or don’t initiate treatment.
2. Verify the saline infusion is properly connected and flowing.
3. Ensure that saline tubing is installed properly in roller pump
4. Verify the controller saline infusion button is activated
5. If the device is properly connected and no flow is noted, replace the
saline tubing/bag and/or device
Expiration Dating
The Diamondback 360 Orbital Atherectomy Device (DB 360) is provided sterile (ethylene oxide sterilization). It is
intended for single-use only. DO NOT RESTERILIZE. The DB 360 should be used prior to the expiration dating on
the packaging.
Storage and Use Conditions
Each 0.014 platform DB 360 has a functional life of 8 minutes of total operational time.
Storage: 10 to 40 ºC (50 to 104 ºF)