Cardiovascular Systems, Inc. DIAMONDBACK 360 Peripheral Orbital Atherectomy System Exchangeable Series Instructions For Use Manual page 26

a. Verify that the saline tubing is connected to the OAD.
b. Press the green Start button on the OAS pump control panel to start saline flowing
through the saline tubing. Verify that the green LED illuminates.
c. Press and hold the Prime button on the OAS pump control panel to purge air from
the saline tubing. Continually pressing the Prime button will pump saline through
the tubing at an increasing flow rate. Releasing the Prime button will decrease the
flow to the low flow rate after two seconds.
d. Verify that saline is exiting from the OAD sheath near the crown.
e. Continue priming to ensure there are no air bubbles within the saline tubing and
use standard hospital procedures to aspirate or purge air from the lines.
f. After verifying there are no air bubbles within the saline tubing, discontinue
priming.
11.6. Testing the OAD
11.6.1. Testing OAD Crown Advancement
Before inserting any portion of the OAD into the body, ensure that axial
movement of the OAD crown advancer knob will produce smooth travel of the
crown.
Caution: Do not spin the crown during this test.
1. Ensure that the crown advancer knob is in the unlocked position as this will
2. While visually monitoring the crown, slowly move the crown advancer knob
11.6.2. Optional: Testing OAD Crown Rotation
This test is optional, but is performed chronologically after testing crown
advancement.
Note: Hold the guide wire firmly during the test. When the test is complete, the
OAD is ready for use and the guide wire can be inserted through the introducer,
guide sheath, or guide catheter.
1. Push the crown advancer knob fully proximal, away from the nose of the
2. Grasp the proximal end of the guide wire and thread the guide wire through
allow free axial travel of the crown advancer knob.
in a back and forth motion. The maximum travel of the crown advancer knob,
and the corresponding maximum travel of the shaft tip, is 5.9 inches (15 cm).
handle, and release the guide wire brake before threading the guide wire
through the OAD drive shaft.
the opening in the OAD drive shaft distal tip.
21