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©

 2009 Cardiovascular Systems, Inc.  

 

 

 

 

 

90074-00.F 

Appendix B – DISCLAIMER OF WARRANTY 

 
 
 

DISCLAIMER OF WARRANTY 

 
Cardiovascular Systems, Inc. warrants that reasonable care has been used in the manufacture of this 
device.  THIS WARRANTY IS EXCLUSIVE AND IN LIEU OF ALL OTHER WARRANTIES WHETHER 
EXPRESSED OR IMPLIED, WRITTEN OR ORAL, INCLUDING BUT NOT LIMITED TO ANY 
WARRANTIES OF MERCHANTABILITY OF FITNESS FOR A PARTICULAR PURPOSE.  AS A RESULT 
OF BIOLOGICAL DIFFERENCES IN INDIVIDUALS, NO PRODUCT IS 100 PERCENT EFFECTIVE 
UNDER ALL CIRCUMSTANCES.  BECAUSE OF THIS FACT, AND SINCE CARDIOVASCULAR 
SYSTEMS, INC. HAS NO CONTROL OVER THE CONDITIONS UNDER WHICH THIS DEVICE IS 
USED, DIAGNOSIS OF THE PATIENT, METHODS OF ADMINISTRATION OR ITS HANDLING AFTER 
THE DEVICE LEAVES OUR POSSESSION, CARDIOVASCULAR SYSTEMS, INC. DOES NOT 
WARRANT EITHER FOR A GOOD EFFECT OR AGAINST ALL ILL EFFECT FOLLOWING ITS USE.  
 
CARDIOVASCULAR SYSTEMS, INC. (INCLUDING ITS AFFILIATED ENTITIES, OWNERS, 
DIRECTORS, OFFICERS, EMPLOYEES, 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 determined to have 
been defective at the time of shipment. 
 
The exclusions, disclaimers, and limitations set forth in this Disclaimer of Warranty are not intended to, 
and shall not be construed as to, contravene mandatory provisions of any applicable law or regulation.  If 
any part of this Disclaimer of Warranty is held to be illegal or unenforceable by a court of competent 
jurisdiction, the part shall be modified so as to be enforceable to the maximum extent possible. If the part 
cannot be modified, then that part may be severed and the other parts of this 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 

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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