Specifications
Diamondback360®CoronaryOrbitalAtherectomySystem
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9.7. Testing the OAD
9.7.1. 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 rotate the crown during this test.
1. Ensure that the crown advancer knob is in the unlocked position as
this will allow free axial travel of the crown advancer knob.
2. While visually monitoring the crown, slowly move 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 3.3 inches (8.4 cm).
9.7.2. Testing the OAD crown rotation
1. Push the crown advancer knob fully proximal, away from the nose of
the handle, and release the guide wire brake before threading the
VIPERWIRE guide wire through the OAD drive shaft.
2. Grasp the proximal end of the VIPERWIRE guide wire and thread the
VIPERWIRE guide wire through the opening in the OAD drive shaft
distal tip.
Warning: Do not operate the OAD if there is a bend, kink, or tight
loop in the VIPERWIRE guide wire. A bend, kink, or tight loop in the
VIPERWIRE guide wire may cause damage to and malfunctioning of
the OAD during use.
3. Continue feeding the VIPERWIRE guide wire into the OAD drive
shaft until the guide wire appears at the rear of the OAD.
Caution: If using an adjustable hemostasis valve with the guide
catheter, close the hemostasis valve to minimize blood loss from
around the guide catheter while still allowing the OAD sheath to slide
through the hemostasis valve. Avoid excessive tightening of the
hemostasis valve to prevent damaging the OAD catheter sheath.
When inserting or removing the OAD crown or drive shaft through the
hemostasis valve, use care not to deform the drive shaft.