Cardiovascular Systems, Inc. DIAMONDBACK 360 Peripheral Orbital Atherectomy System Exchangeable Series Instructions For Use Manual page 27

3. Continue feeding the guide wire into the OAD drive shaft until the guide wire
4. Lock the guide wire in place by pressing down on the guide wire brake lever
5. Verify that saline is still flowing freely out of the saline sheath tip. Verify that
6. Hold the OAD sheath a few centimeters from the crown while making sure
7. Press and release the On/Off button located on top of the crown advancer
8. Check that the flow of saline is increasing and that the shaft and crown are
9. Immediately press and release the On/Off button to stop the shaft and crown
11.7. Initiating the Atherectomy Procedure
1. Gain vessel access using the physician's preferred methodology.
2. Access the treatment site with an appropriately sized introducer, guide sheath, or
guide catheter.
Note: For radial access, use a preferred guide catheter or guide sheath of an
appropriate length.
3. Use angiography to locate, visualize, and evaluate the lesion.
4. If desired, use the thumb and index finger to gently impart a slight curve or J-shape to
the distal spring tip of the guide wire.
5. If use of the guide wire torquer is desired, attach the torquer to the guide wire by
holding the distal end of the torquer and rotating the proximal end counterclockwise to
tighten.
6. Approach and cross the lesion, with the guide wire, using the physician's preferred
methodology.
Caution: Do not operate the OAD if there is a bend, kink, or tight loop in the
guide wire. A bend, kink, or tight loop in the guide wire may cause damage
to and malfunctioning of the OAD during use.
appears at the rear of the OAD.
as the crown will not spin if the guide wire brake is unlocked.
the saline tubing is properly connected to the saline bag, that the saline
tubing routes correctly through the saline tubing guides, and that the saline
tubing is properly connected to the OAD.
that the crown is not in contact with any objects. Verify there is no pinching of
the OAD sheath at any time during OAD operation.
knob to activate crown rotation. The OAD is preset to low speed, and the
illuminated LED on the OAD will indicate that the OAD is operating at low
speed.
beginning to spin.
from spinning and to complete the test.
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