Specifications
Diamondback360®CoronaryOrbitalAtherectomySystem
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verify that the crown and the crown advancer knob are moving 1:1 with one
another. Ensure that the OAD remains horizontal during the procedure to
minimize saline leakage from the OAD handle.
10. 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 OAD has reached full speed (as indicated by a stable pitch)
do not allow the rotating crown to remain in one location as it may lead to
vessel damage. Continue to maintain a maximum travel rate of 1 cm per
second.
For every 30 seconds of treatment, a rest period of equal time is
recommended with a maximum treatment time of 5 minutes per OAD. The
OAS pump will emit a beep after every 25 second interval of treatment time.
Warning: Maximum total treatment time should not exceed 5 minutes. If
maximum total treatment time exceeds 5 minutes, 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 patient. A team member should
track run time during use to verify total run time is not exceeded.
10.1.1. Replacing the bag of saline and VIPERSLIDE Lubricant
The low saline level sensor triggers if there is less than 200 mL (+/- 100
mL) remaining in the bag of saline and VIPERSLIDE Lubricant. Perform
the following to replace the bag of saline and VIPERSLIDE Lubricant:
1. Ensure that the pump is stopped by pressing the green Start button
on the OAS pump control panel and verify that the green LED, on the
OAS pump control panel, is not illuminated.
2. Prepare a new 1000 mL bag of normal saline solution with
VIPERSLIDE Lubricant. Refer to the VIPERSLIDE Lubricant
Instructions for Use for lubricant preparation instructions.
3. Remove the empty bag of saline and VIPERSLIDE Lubricant from
the low saline level sensor on the IV pole.
4. Hang the new bag of saline and VIPERSLIDE Lubricant from the low
saline level sensor on the standard IV pole.
Caution: Do not use glass bottles for the saline solution with
VIPERSLIDE Lubricant or hang multiple saline bags from the low