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2009 Cardiovascular Systems, Inc.

90074-00.F

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.

For Questions, Please Contact:

Director of Quality Assurance
Cardiovascular Systems, Inc.
St. Paul, Minnesota 55112 USA
Telephone: 651.259.1600

Содержание Diamondback DB-2000

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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 ...

Страница 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...

Страница 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...

Страница 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 ...

Страница 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...

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

Страница 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...

Страница 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...

Страница 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 ...

Страница 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...

Страница 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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