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 spin 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 allow fluid to leak onto electrical connections of 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. Do not spin the crown without a seated and supportive guide catheter. When treating from a larger lumen to a smaller lumen, make sure the guide catheter is coaxial and that the tip of the OAD has entered the coronary artery to control the initial orbit before engaging the crown; engage the OAD tip into the tight stenosis until low speed had reached its treatment potential prior to initiating treatment with high speed. To relieve compression in the driveshaft, lock the crown advancer knob at 1cm from the full back position, advance device over wire to a position proximal from the lesion, deploy the guide wire brake, then unlock the crown advancer knob and move it fully proximal. If the OAD is started with existing compression in the driveshaft it may result in the crown springing forward. Do not flip contents of tray into sterile field as damage may occur. Components within tray must be carefully removed and placed into sterile field to avoid damage. Patients with an ejection fraction (EF) of less than 25% were not evaluated in the ORBIT II clinical study. See the instructions for use before performing DIAMONDBACK 360 coronary orbital atherectomy procedures for detailed information regarding the procedure, indications, contraindications, warnings, precautions, and potential adverse events. For further information call CSI at 1-877-274-0901 and/or consult CSI’s website at www.csihubstage.wpengine.com. Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.