Page 2
The OAS is also indicated for removal of stenotic material from artificial arteriovenous dialysis fistulae (AV shunt). Diamondback 360 Orbital Atherectomy System (OAS) Description CSI Supplied Equipment • Orbital Atherectomy Device (OAD) •...
Page 3
• Never connect the Controller to an oxygen cylinder or use oxygen as the compressed gas for the system. Use of oxygen may result in an explosion. Only use compressed air or nitrogen. • Do not operate the Controller with gas pressures in excess of 100 psi (6.9 bar). If a hissing noise is noted from the Controller, check to make sure that the gas pressure supplied to the Controller (located at the rear of the controller) is properly attached via the gas line connector and the supply pressure does not exceed 100 psi (6.9 bar).
Page 4
User Interface The touch screen display of the Controller displays the following: Operation Window The operations window allows user to Turn the pump on, Change IV Bag and Turn the system off Upon selecting “Turn the pump on” display of the Controller displays the following: User Controls Area: Contains controls that allow user to do the following: Pump On/Off button...
Page 5
Saline Pump Power Input Power On/Off Gas Input Controller Front Panel Controller Back Panel Controller Back Panel Power On/Off Switch – The power switch is used to turn the Controller On and Off. The power down sequence is to turn off the user interface first via the touchscreen and then hard power down via controller switch. Power Input –...
Page 6
OAS Assembly and Setup Pre-Procedure Equipment Setup Ensure all components are available for system set up. Note: Hang a full 1-liter bag of saline from the pole on the Controller. Note: Verify the saline tubing is not kinked or damaged and that the tubing is properly inserted into the roller pump. Follow the directions below to set up the OAS.
Page 7
Orbital Atherectomy Device (OAD) Setup Refer to the OAD Instructions for Use for complete instructions related to OAD setup. Connecting the OAD to the Controller: Remove the tubing from the OAD package and pass it out of the sterile field to the circulator or non-sterile personnel.
Page 8
Touch the Turn System Off button in the operation window Touch OK to shut down system When the CSI splash screen is seen turn off the main power to the controller by pressing the On/Off button on the back of the controller.
Page 9
Controller Messages STATUS ACTION MEANING WHEN DISPLAYED USER ACTION MESSAGE MESSAGE PUMP OFF START PUMP Pump is off with no notifications Start pump PUMP ON SET SPEED Pump is on, no speed selected Select speed LOW SPEED NONE Low speed selected MEDIUM SPEED NONE Medium speed selected...
Appendix A – Symbols Attention, Consult Accompanying Documents Equal Potential Terminal Protective Earth Electrical Safety Rating (Type CF Applied Part, IPX1) Fuse Manufacturer MEDICAL EQUIPMENT WITH RESPECT TO ELECTRIC SHOCK, FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH UL 60601-1, IEC/EN 60601-1, CAN/CSA C22.2 No.
Disclaimer of Warranty shall remain in full force and effect. Diamondback 360º and CSI are registered trademarks of Cardiovascular Systems, Inc Cardiovascular Systems, Inc. St. Paul, Minnesota 55112 USA Telephone: 651.259.1600...
Page 13
Do not immerse the Controller, Monitor or Foot Pedal in fluid. Avoid use of solvents or abrasive cleaners, which may damage the Controller System components. Controller Maintenance and Calibration The Controller does not require routine or periodic maintenance or calibration. Contact CSI if questions arise related to Controller function or performance. Controller Repair and Shipping Contact CSI if Controller repairs are required or for shipping instructions.
Page 14
Controller Messages STATUS ACTION MEANING WHEN DISPLAYED USER ACTION MESSAGE MESSAGE PUMP OFF START PUMP Pump is off with no notifications Start pump PUMP ON SET SPEED Pump is on, no speed selected Select speed LOW SPEED NONE Low speed selected MEDIUM SPEED NONE Medium speed selected...
Page 15
Appendix A – Symbols Attention, Consult Accompanying Documents Equal Potential Terminal Protective Earth Electrical Safety Rating (Type CF Applied Part, IPX1) Fuse Manufacturer MEDICAL EQUIPMENT WITH RESPECT TO ELECTRIC SHOCK, FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH UL 60601-1, IEC/EN 60601-1, CAN/CSA C22.2 No.
Page 16
Disclaimer of Warranty shall remain in full force and effect. Diamondback 360º and CSI are registered trademarks of Cardiovascular Systems, Inc Cardiovascular Systems, Inc. St. Paul, Minnesota 55112 USA Telephone: 651.259.1600...
Appendix C – MAINTENANCE AND CALIBRATION STATEMENT Diamondback 360 Model DB-2000 Controller Maintenance & Calibration Statement 13 May, 2008 As outlined in Cardiovascular Systems, Inc. Instructions for Use (IFU) supplied with each unit, the Diamondback 360 DB-2000 controller does not require routine periodic maintenance or calibration.
Need help?
Do you have a question about the Diamondback DB-2000 and is the answer not in the manual?
Questions and answers