Specifications
Diamondback360®CoronaryOrbitalAtherectomySystem
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10. OAS directions for use
10.1. Performing the atherectomy procedure
1. Ensure that the OAD guide wire brake lever is open (in the up position).
2. Advance the OAD drive shaft over the VIPERWIRE guide wire and through
the hemostasis valve while keeping VIPERWIRE guide wire placement
stationary.
3. While using fluoroscopy, gently advance the OAD crown over the
VIPERWIRE guide wire to a position approximately 1 cm proximal to the
lesion. Verify that the OAD distal tip is not within the lesion when the crown
and drive shaft begin to rotate.
4. Inject contrast medium, through a port in the hemostasis valve, to verify that
the size of the crown is compatible with the treatment area diameter (see
Appendix B).
5. Verify that the VIPERWIRE guide wire spring tip is distal to the lesion and is
not in danger of coming in contact with the rotating crown and drive shaft tip.
Caution: Maintain at least 5 mm between the proximal end of the
VIPERWIRE guide wire spring tip and the OAD drive shaft tip to prevent
contact of the drive shaft tip with the guide wire spring tip. Further advance
the VIPERWIRE guide wire, as necessary, to maintain the 5 mm minimum
distance.
6. Push down on the VIPERWIRE guide wire brake lever to engage the brake.
The crown will not spin if the guide wire brake is not locked.
7. Press and release the On/Off button
on top of the crown advancer 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.
Warning: Initial treatment for each lesion must start at low speed.
Caution: Continually monitor the saline fluid levels during the procedure.
Continual infusion of saline and VIPERSLIDE Lubricant is critical for safe
coronary OAS operation.
8. Audibly verify that the OAD drive shaft and crown are rotating at a stable
speed as indicated by the OAD frequency (pitch) stabilizing following the 2
second ramp up in speed.
9. Slowly advance the crown advancer knob to begin atherectomy of the lesion
at a maximum travel rate of 1 cm per second. Using fluoroscopy, continually