Specifications
Diamondback360®CoronaryOrbitalAtherectomySystem
38
Issue
number
Issue Solution
connected and blood continues to
back into the OAD sheath, replace
the OAD.
3 Crown rotational
speeds are
variable and will
not stabilize
1. Immediately discontinue treatment.
2. Stop the OAD from spinning, but
leave the OAS pump running.
3. Verify that saline is flowing.
4. Verify VIPERSLIDE Lubricant is
present in the saline bag. See the
VIPERSLIDE Lubricant Instructions
for Use for information. Verify that
the saline tubing is properly
connected to the saline bag, that the
saline tubing is routed correctly
through the OAS pump saline tubing
guides, and that the saline tubing is
properly connected to the OAD.
5. Verify that the crown advancer knob
moves smoothly.
6. Retract the crown proximal to the
lesion. Using a maximum travel
rate of 1 cm/second, continue
treatment on low speed.
4 The OAD stops
spinning and both
crown rotation
speed indicator
LEDs on the OAD
handle are
illuminated
Immediately discontinue treatment and
replace the OAD.
5 The crown is not
moving one-to-one
with the crown
advancer knob
During start up in the vessel:
1. Verify the Tuohy valve is not over-
tightened.
2. Verify the crown advancer knob
moves smoothly.
3. Retract the crown advancer knob