CSI Diamondback DB-2000 Скачать руководство пользователя страница 8

 

 

 

 

 

 

 

 

 

 

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©

 2009 Cardiovascular Systems, Inc.  

 

 

 

 

 

90074-00.F 

 
Procedure 

Refer to OAD Instructions for Use for procedural information. 

 

Saline Bag Change 

When the Saline Low notification appears it is time to change the saline bag.  

1.  Stop the pump by touching the pump On/Off button. 
2.  Touch the Change IV Bag Button  
3.  Remove the bag spike from the bag and hold it for reuse.  
4.  Remove the empty bag from the pole. 
5.  Place a new bag on the pole and insert the bag spike. 
6.  Touch the OK button in the operation window to reset the saline volume to full.  

a.  If saline bag has not been changed touch Cancel in the operation window 

7.  Restart the pump by touching the Turn Pump On button in the operation window. 

 

Device Change 

To change out a device: 

1.  Stop the pump by touching the pump On/Off button. 
2.  Disconnect the tubing from the device handle in use. 
3.  Attach the tubing to the new device. 
4.  Touch the Turn Pump On button in the operation window to start the pump to prime saline through the 

device.  Stepping on the foot pedal will increase the flow rate to high for faster priming 

a.  Note: Controller will default to Test Mode (60kRPM) once pump has been turned on. 

5.  Refer to OAD Instructions for Use for procedural information. 

 

Turning Off the Controller 

1.  Stop the pump by touching the pump On/Off button. 
2.  Touch the Turn System Off button in the operation window  
3.  Touch OK to shut down system 
4.  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. 

 

Cleaning the Controller and Foot Pedal 

The Controller System should be cleaned regularly with 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 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.   
 

Classifications, per IEC/UL/CSA/EN 60601-1 

 

Class I Equipment 

 

Type CF Applied Part 

 

Degree 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 electrical equipment needs special precautions regarding electromagnetic compatibility (EMC) and needs to 
be installed and put into service according to the EMC information provided. 

a.  Portable and mobile radio frequency (RF) communications equipment can affect medical electrical 

equipment.  This Product is intended for use in the electromagnetic environments specified. 

b.  The end user of this product should assure it is used in such an environment. 

i. Portable and mobile RF Communications equipment should not be used at close distances. 
ii. Power frequency magnetic fields should be at levels characteristic of a typical location in a typical 
commercial or hospital environment. 

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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