Specifications

Diamondback360®CoronaryOrbitalAtherectomySystem
8

 The OAS was only evaluated in severely calcified lesions; therefore the scientific
evidence to support use of the OAS to treat other types of lesions/patients is limited.
5. Precautions
 Do not use the OAD if there is damage to the OAD package or if the OAD has
reached its shelf life expiration date.
 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.
 If 1:1 movement is not observed, retract and re-advance the crown into the lesion.
Repeat retracting and advancing the crown into the lesion until 1:1 movement is
observed. If the knob and the crown are not moving together, the crown may be driven
into the lesion with too much force and lengthening of the OAD driveshaft may occur
on exiting the lesion.
 Follow standard institution atherectomy policies and procedures, including those
related to anticoagulation and vasodilator therapy.
 Always use fluoroscopy while introducing and advancing the VIPERWIRE guide wire
within a vessel.
 A temporary pacing lead may be necessary when treating lesions in the right coronary
and circumflex arteries due to the possible occurrence of electrophysiological
alternations.
 The risk of the occurrence of a dissection or perforation is increased in severely
calcified lesions undergoing percutaneous treatment; therefore, on-site surgical back-
up should be included as a clinical consideration..
 Do not kink or crush the saline tubing as this will reduce the flow of saline and
VIPERSLIDE Lubricant to the OAD.
 Continually monitor and check the saline tubing and connections for leaks during the
procedure.
 Do not rotate the crown while advancing or retracting the crown within a guide
catheter. Damage to the guide catheter and/or OAD may occur.
 Ensure the OAD strain relief remains straight during atherectomy treatment. If the
OAD strain relief does not remain straight, the shaft/sheath can kink. Do not sterilize
the OAS pump. Sterilizing will damage the OAS pump. The OAS pump is intended to
be used and maintained outside of the sterile field. See Section 10.3 for instructions
on cleaning and disinfecting the OAS pump.
 Do not spin the crown when removing the OAD from the body as this can result in
guide catheter or touhy damage.
 Patients with an ejection fraction (EF) of less than 25% were not evaluated in the
ORBIT II clinical study.