Cardiovascular Systems, Inc. DIAMONDBACK 360 Peripheral Orbital Atherectomy System Exchangeable Series Instructions For Use Manual page 29

8. Unlock and move the crown advancer knob to the fully proximal position to relieve
any compression in the driveshaft.
9. Press and release the On/Off button on top of the crown advancer knob to activate
crown rotation. The OAD is preset to low speed, and the illuminated LED on the OAD
will indicate that the device is operating at low speed.
10. Audibly verify that the OAD drive shaft and crown are orbiting at a stable speed.
11. Slowly advance the crown advancer knob to begin atherectomy of the lesion at a
travel rate between 1 mm per second and 10 mm per second. Using imaging,
continually verify that the crown and the crown advancer knob are moving 1:1 with
one another. Ensure that the OAD handle remains horizontal during the procedure to
minimize saline leakage from the OAD.
12. Using a series of intermittent treatment intervals and rest periods, slide the crown
advancer knob to move the crown back and forth across the lesion always returning
to the proximal side of the lesion when the interval set is complete.
Warning: Once the OAD has reached full speed (as indicated by a stable pitch), do
not allow the orbiting crown to remain in one location as it may lead to vessel
damage. Continue to maintain a travel rate between 1 mm per second and 10 mm
per second.
A rest period of 30 seconds, is recommended for every 30 seconds of treatment, with
a maximum treatment time of 8 minutes per cartridge. The OAS pump will emit a
beep after every 25 second interval of treatment time. Use contrast injections through
the introducer, guide sheath, or guide catheter only during rest periods to
fluoroscopically evaluate results.
Warning: Maximum total treatment time should not exceed 8 minutes per
cartridge. If maximum total treatment time is exceeded, the OAD shaft, crown, and
VIPERWIRE guide wire may begin to exhibit signs of wear and result in a device
malfunction and possible injury to the patient.
13. If reduction of the stenosis is not adequate, perform one of the following:
• Continue to treat the lesion by moving the crown back and forth across the lesion
per the instructions above.
• Increase the rotational speed of the crown by using the crown rotation speed
buttons on the handle of the device.
14. Evaluate the reduction of the stenosis
15. Perform a final angiogram.
12.1.1. Load a Guidewire through the Proximal End of the OAD
Guidewires with crossing profile <0.014" can be loaded through the proximal end of
the OAD.
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