Do not use the OAS if the physician does not have experience in coronary angioplasty at their institution.
Do not use the OAS if the physician does not have training on using the OAS.
Do not use other commercially-available guide wires with the OAD. Only use the Model GWC-12325LG-FLP VIPERWIRE ADVANCE Coronary Guide Wire with the coronary OAD. The VIPERWIRE guide wire is designed for use with all coronary OAD crown and shaft configurations.
Never operate the OAD without normal saline and VIPERSLIDE lubricant. Continually flowing saline and VIPERSLIDE lubricant is required for cooling and lubricating the OAD during use in order to avoid overheating and permanent damage to the device and possible injury to the patient.
Do not use the OAD or the VIPERWIRE® guide wire if their sterile package barriers are compromised or damaged.
Do not use device during spasm of the vessel.
Do not re-sterilize or re-use the OAD. If the OAD is re-sterilized or re-used, the OAD may not function properly potentially leading to serious infection and patient harm and/or death.
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.
Immediately stop use of the OAD if the device stalls. Review for complications if a stall condition occurs. Do not change to high speed if a device stalls on low speed.
Initial treatment for each lesion must start at low speed.
Do not continue treatment if the wire or the device becomes subintimal.
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.
Do not start or stop orbiting of the crown when tight in a lesion.
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.
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.