Specifications

© 2011 Cardiovascular Systems, Inc. 4 90168-00.K
• Handle the DB 360 and guide wire carefully. A tight loop, kink, or bend in the guide wire may cause damage and
system malfunction during use.
• Never operate the DB 360 without normal saline solution (saline) infusion. Flowing saline is required for cooling
and lubricating of the DB 360 turbine. Operation of the DB 360 without proper saline infusion may result in over
heating and permanent damage to the DB 360 and possible patient injury.
• The Crown at the distal tip of the DB 360 rotates at very high speeds. Do not allow body parts or clothing to
come into contact with the Crown. Physical injury or entanglement may occur.
• Never advance the rotating Crown to the point of contact with the guide wire spring tip. Distal detachment and
embolization of the tip may result.
• Always advance the rotating, abrasive Crown by using the Crown Control Knob. Never advance the rotating
Crown by advancing the DB 360 Control Handle. Guide wire buckling may occur and perforation or vascular
trauma may result.
• Always keep the Crown advancing or retracting while it is at high rotational speeds. Do not allow the Crown to
remain in one location for more than 2-3 seconds. Maintaining the Crown in one location while it is rotating at
high speeds may lead to excessive tissue removal.
• Never force the Crown when rotational or translational resistance occurs; vessel perforation may occur. If
resistance to motion is noted, retract the Crown and stop treatment immediately. Use fluoroscopy to analyze the
situation.
• When treating a total occlusion – CTO – create a channel at low or medium speed before traversing the lesion at
high speed. Crossing the total occlusion on high speed may cause the shaft and / or the guide wire to fracture
due to excessive force.
• While advancing the Crown through the introducer sheath / guide catheter, do not activate Crown rotation. The
Crown must not rotate while located within the introducer sheath / guide catheter.
• The maximum travel of the Crown Control Knob, and therefore the Shaft tip, is 6.0 inches (15 cm). Moving the
Crown Control Knob forward will move the Shaft tip an equal distance toward the guide wire spring tip. When
moving the Crown Control Knob, make sure there is sufficient distance between the guide wire spring tip and the
distal end of the Shaft. If the distance between the Shaft tip and the guide wire spring tip is insufficient, the Shaft
tip may contact the guide wire spring tip and may result in the guide wire spring tip being dislodged. Use
contrast injections and fluoroscopic observation to monitor movement of the shaft tip in relation to the guide wire
spring tip.
• Do not re-use device. If the device is re-used, the device may not function as intended and serious infection
leading to potential harm and/or death could occur.
Precautions
• If the DB 360 sterile package appears damaged, or shelf life has expired, do not use, return to Cardiovascular
Systems, Inc.
• Follow standard hospital atherectomy policies and procedures including those related to anticoagulation and
vasodilator therapy.
• Safety and effectiveness for the treatment in vessels greater than 4.0 mm in diameter or of lesions greater than 10
centimeters in length has not been established.
• Radiographic equipment for fluoroscopic observation should provide high-resolution images. Guide wires and
catheters should only be manipulated under fluoroscopic observation.
• Due to the torque responsiveness of the ViperWire Guide Wire, it is more difficult to handle than other
commercially available guide wires used in peripheral angioplasty. Care should be exercised when using this
guide wire.
• Use only saline as the infusate. (Drugs, such as vasodilators, can be added to the infusate at the physician’s
discretion). The Control Handle may malfunction if contrast or other substances are injected into the Control
Handle infusion port.
• Do not operate without lubricant at the lubricant manufacturer’s recommended concentrations. Maximum speeds
may not be achieved without lubricant.
• When moving the eccentric diamond-coated Crown back and forth across the lesion, employ a series of
intermittent treatment events and rest periods.
• Rest periods are recommended after 30 to 60 seconds of treatment with a maximum treatment time of 90
seconds.
• When operating the DB 360 at rotational speeds less than 25,000 rpm or in Test mode, always grasp the guide
wire firmly as it exits the Control Handle. Always use the wire Clip torquer or other approved torquer.
• Monitor the saline fluid level during the procedure. Saline infusion is critical to DB 360 performance.
 Do not kink or crush the saline tubing. Flow of saline will be reduced.
 Check the saline tubing and connections for leaks during the procedure.