Specifications

Diamondback360®CoronaryOrbitalAtherectomySystem
7
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 Do not re-sterilize or re-use the VIPERWIRE guide wire or the guide wire torquer. If
the VIPERWIRE guide wire or torquer is re-sterilized or re-used, the guide wire may
not function properly potentially leading to serious infection and patient harm and/or
death.
 Never force the crown if any resistance is felt within the vessel as vessel perforation
may occur. If resistance is felt, retract the crown, while monitoring the cause of the
resistance, and immediately stop treatment. Use fluoroscopy to analyze the situation
and to monitor the cause of the resistance.
 Do not come within 5 mm of the proximal end of the VIPERWIRE guide wire spring tip
with the distal end of the OAD drive shaft. If the distance between the shaft tip and the
VIPERWIRE guide wire spring tip is insufficient, the shaft tip may contact the guide
wire spring tip and result in dislodging the guide wire spring tip. Use fluoroscopy to
monitor movement of the shaft tip in relation to the VIPERWIRE guide wire spring tip.
 Immediately stop using any OAS component should mechanical failure of any
component occur before or during the atherectomy procedure. Using damaged
components may result in OAS malfunction or patient injury.
 Initial treatment for each lesion must start at low speed.
 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 device during use.
 Performing treatment in excessively tortuous vessels or bifurcations may result in
vessel damage.
 Always keep the crown advancing or retracting, while it is rotating, by continually
moving the control knob to ensure 1:1 movement between the control knob and the
rotating crown.
 Once the OAD has reached full speed (as indicated by a stable pitch) do not allow the
rotating crown to remain in one location as it may lead to vessel damage. Continue to
maintain a maximum travel rate of 1 cm per second.
 Maximum total treatment time should not exceed 5 minutes. If maximum total
treatment time exceeds 5 minutes, the OAD shaft, crown, and VIPERWIRE guide wire
may begin to exhibit signs of wear and result in a device malfunction and possible
injury to patient. A team member should track run time during use to verify total run
time is not exceeded.
 Do not advance or retract the rotating crown by advancing the OAD sheath or handle.
Buckling of the VIPERWIRE guide wire may occur resulting in vessel perforation or
vascular trauma. Always advance the rotating crown by using the crown advancer
knob.
 Do not inject contrast solution into the OAD injection port. Device failure or patient
harm may occur.
 Do not allow body parts or clothing to come into contact with rotating components as
the OAD rotates at very high speeds. Physical injury to the user or entanglement of
clothing with the crown may occur.