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2009 Cardiovascular Systems, Inc.
90074-00.F
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:
1. Remove the tubing from the OAD package and pass it out of the sterile field to the circulator or non-sterile
personnel.
2. Have the circulator or non-sterile personnel connect the Turbine Gas Intake Hose to the Controller at the Turbine
Gas connector on the front of the Controller.
3. Have the circulator or non-sterile personnel connect the Optical Tachometer Fiber to the Controller at the Optical
Tachometer Fiber connector on the front of the Controller.
Note: Care should be taken to keep the Fiber end clean and free of any material that could interfere with optical
transmissions.
4. The circulator or non-sterile personnel performs the following steps:
a. Ensure the Controller On/Off switch is in the off position.
b. Hang a full 1-liter bag of saline from the pole on the Controller.
c.
Connect the saline tubing to the saline bag 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 On/Off switch on the back of the Controller.
6. Turn on the Pump by touching the Turn Pump On button in the operation window.
a. Note: Controller will default to Test Mode (60kRPM) once pump has been turned on.
7. Purge air from the saline tubing:
a. Press the Foot Pedal to start saline flow at high pump speed.
b. Watch for saline to exit from the saline tubing and ensure there are no air bubbles present in the saline
tubing.
c.
When all the air is purged from the saline tubing, connect the saline line to the OAD saline connection
and repeat steps a through c to purge air from the OAD sheath.
8. Test the system to confirm device operation by depressing the foot pedal to begin spinning the Crown. Hold the
guide wire firmly during the test. When test mode is complete, an operational device is ready to be inserted into
the introducer in the patient.
