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©

 2009 Cardiovascular Systems, Inc.  

 

 

 

 

 

90074-00.F 

 
 
 
 
 
 
 
 
 
 
 
 

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 – The power cord plugs into the Controller and a conventional 100-240 VAC receptacle, 1A at 50-60 
Hz(as indicated on the label located on the back of the Controller) and provides power to the Controller.  Fuse rating 
is 250 V, 4A Slow Blow, Type T 

 

 
Gas Input – Standard, hospital supplied tubing connects the regulator of the compressed gas cylinder to the 
Controller allowing for gas to be supplied to the Turbine.  
 
Potential equalization terminal - For the purpose of testing the grounding of the controller.  Note: remainder of roll 
stand may not be grounded.

 

 

 
Controller Side Panel 

Roller Pump – Pumps saline from the 1000 ml saline bag through the Sheath and around the Shaft.    
 

 
Foot Pedal 

Foot Pedal Housing – The basket below the Controller houses the Foot Pedal and power cord for storage 

 

Foot Pedal 
The Foot Pedal comes pre-connected to the Controller. When the pump is on and a speed setting selected, 
depressing the electrical Foot Pedal once causes saline to flow at the high pump speed.  Depressing the Foot Pedal 
again (within five seconds) opens the compressed gas line and starts the turbine, which results in Shaft/Crown 
rotation.  Releasing the Foot Pedal closes the compressed gas line and stops Shaft/Crown rotation.  The pump speed 
automatically resets to low pump speed within 7 seconds after release of the foot pedal.     
 

 
Compressed Gas Cylinder and Regulator  

Additional equipment needed to operate the OAS includes a compressed gas cylinder and cylinder pressure regulator 
or a hard plumbed compressed air line set between 85-100 psi.   
 
Compresses Gas System 
A compressed gas system must contain air or nitrogen. A cylinder capacity of at least 80 standard cubic feet (2250 
liter) is recommended and will provide approximately 20 minutes of service with the OAS running at full speed.  
Larger cylinders may be used.  A fully charged spare cylinder should always be available. 
 
Cylinder pressure regulator – The cylinder pressure regulator must be capable of delivering at least 5 scfm (140 
liter/min) at 85-100 psi (5.8-6.9 bar).  A relieving type cylinder pressure regulator is preferred.  The regulator’s 
cylinder filling capability should be compatible with the gas cylinder being used.   
 
Hospital Air System 
A hospital compressed air or nitrogen system can be used in place of a gas cylinder and regulator.  
1.  The compressed gas must be air or nitrogen. 
2.  The gas must be clean, dry, and oil free. 
3.  The gas pressure must be 80-100 psi (5.8-6.9 bar, 551.6-689.6 kPa) at the inlet to the Controller.   
4.  The system must be capable of supplying gas at a rate of 5 scfm (140 liter/min).   

 

Power On/Off 

Gas Input 

Power Input 

Saline Pump 

Summary of Contents for Diamondback DB-2000

Page 1: ... 2009 Cardiovascular Systems Inc 90074 00 F Controller Manual Part I Instructions for Use Model DB 2000 ...

Page 2: ...riate Instructions for Use for recommended guide catheter sheath introducer sizes Compressed Gas Cylinder or house air supply The gas must be air or nitrogen Cylinder Pressure Regulator The regulator must be capable of delivering at least 5 scfm 140 liter min at 85 100 psi 5 8 6 9 bar Normal Saline Solution for Injection At least one full 1 liter bag must be available Other equipment as needed for...

Page 3: ...oller box spill saline or other fluids on the Controller Saline or fluids inside the Controller may result in corrosion or electrical hazard Make sure the cylinder pressure regulator s fitting is compatible with the gas cylinder used Verify the type of gas coupling provided with the Controller prior to procuring a pressure regulator and connecting hose If necessary use suitable adapters to make th...

Page 4: ...m a user perspective about an active notification condition Therapy Status Area The Therapy Status Area displays the following therapy information Speed is the actual speed of the OAD in thousands of RPM Event time is the elapsed time between therapy OAD start and stop for the last therapy session When the turbine is started for the next session the event time is reset to zero Total time is the su...

Page 5: ... opens the compressed gas line and starts the turbine which results in Shaft Crown rotation Releasing the Foot Pedal closes the compressed gas line and stops Shaft Crown rotation The pump speed automatically resets to low pump speed within 7 seconds after release of the foot pedal Compressed Gas Cylinder and Regulator Additional equipment needed to operate the OAS includes a compressed gas cylinde...

Page 6: ...oller 2 Insert the other end of the power cord into a properly rated hospital grade receptacle Compressed Gas Cylinder Setup 1 Setup the compressed gas air or nitrogen regulator and tubing according to standard hospital protocol 2 Connect the gas tubing to the Gas Input connector on the back of the Controller Note Push down on the Release Button to open the connector before inserting the hose conn...

Page 7: ...using standard hospital procedure d Lift the roller pump lever to open the roller pump door e Place the saline tubing into the grooved tubing guides of the roller pump Ensure that the tubing guide located on top of the pump housing is appropriately adjusted for tubing diameter See figure A f Close the roller pump door See Figure B Figure A Figure B 5 Turn the Control Unit on by pressing the Power ...

Page 8: ...h a soft cloth dampened in water and mild detergent Isopropyl alcohol water mix 70 30 or Cydex should be used to clean and disinfect the Controller System from blood or other contaminants 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...

Page 9: ...roller has detected that output pressure exceeded maximum for 10 seconds Reselect lower speed or exchange device MAX SPEED EXCEEDED MAX SPEED EXCEEDED The controller has detected that output speed exceeded maximum for 10 seconds Reselect lower speed or exchange device NO SPEED DETECTED CHECK AND RETRY No Tachometer reading detected 1 Check fiber optic connections 2 Replace fiber optic SYSTEM FAILU...

Page 10: ...panying Documents On Off 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 601 1 3MSP ...

Page 11: ...AGENTS AND VENDORS SHALL NOT BE LIABLE FOR ANY DIRECT INDIRECT INCIDENTAL OR CONSEQUENTIAL LOSS DAMAGE OR EXPENSE ARISING FROM OR RELATED TO THE USE OF THIS DEVICE No person has authority to bind Cardiovascular Systems Inc to any representation warranty or liability except as set forth in this Disclaimer of Warranty Cardiovascular Systems Inc may at its sole discretion replace any device that is d...

Page 12: ... 2009 Cardiovascular Systems Inc 90074 00 F Controller Manual Part II Service and Maintenance Model DB 2000 ...

Page 13: ...ree of protection against the ingress of water IPX1 Controller IPX0 Monitor IPX8 Footswitch Equipment not suitable for use in the presence of flammable anesthetics Operation Mode Continuous Storage Transport and Operating Conditions Storage and Transport 50 C to 60 C 58 F to 140 F 10 to 100 Relative Humidity 5000 to 1060 hPA Operating 10 to 40 C 50 to 104 F Electromagnetic Compliance Medical elect...

Page 14: ...roller has detected that output pressure exceeded maximum for 10 seconds Reselect lower speed or exchange device MAX SPEED EXCEEDED MAX SPEED EXCEEDED The controller has detected that output speed exceeded maximum for 10 seconds Reselect lower speed or exchange device NO SPEED DETECTED CHECK AND RETRY No Tachometer reading detected 1 Check fiber optic connections 2 Replace fiber optic SYSTEM FAILU...

Page 15: ...anying Documents On Off 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 601 1 3MSP ...

Page 16: ...GENTS AND VENDORS SHALL NOT BE LIABLE FOR ANY DIRECT INDIRECT INCIDENTAL OR CONSEQUENTIAL LOSS DAMAGE OR EXPENSE ARISING FROM OR RELATED TO THE USE OF THIS DEVICE No person has authority to bind Cardiovascular Systems Inc to any representation warranty or liability except as set forth in this Disclaimer of Warranty Cardiovascular Systems Inc may at its sole discretion replace any device that is de...

Page 17: ...ation 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 For Questions Please Contact Director of Quality Assurance Cardiovascular Systems Inc St Paul Minnesota 55112 USA Telephone 651 259 1600 ...

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