Restrictions; Warnings - Cardiovascular Systems, Inc. DIAMONDBACK 360 Peripheral Orbital Atherectomy System Exchangeable Series Instructions For Use Manual

5. Restrictions

The OAS should only be used by physicians who are experienced in peripheral angioplasty at
their institutions and trained on the use of the OAS. Contact a CSI representative for information
on training.

6. Warnings

•
Do not use the OAD in a vessel that is too small for the crown. The reference vessel
diameter at the treatment area must be at least 2.00 mm in diameter for the 1.25mm micro
crown.
•
If mechanical failure of the OAD occurs before or during the atherectomy procedure,
discontinue use immediately. Do not attempt to use a damaged OAD or other system
component. Use of damaged components may result in system malfunction or patient injury.
•
Do not use the OAD during spasm of the vessel.
•
Only use the approved CSI VIPERWIRE ADVANCE 0.014-inch (0.3556 mm) × 335-cm
guide wires for 75cm and 145 cm length CSI crown and shaft configurations. Only use the
approved CSI VIPERWIRE ADVANCE 0.014-inch (0.3556 mm) x 475 cm guide wires for
180 cm and 200 cm length CSI crown and shaft configurations. See Table 4 and Table 5 for
the appropriate guide wire to use based on the OAD shaft configuration. Follow CSI's
instructions related to guide wire use.
•
Do not continue treatment if the guide wire or the OAD becomes sub-intimal.
•
Immediately stop use if the OAD stalls. Review for complications and mechanical failure if a
stall condition occurs. Do not change to a higher speed if the OAD stalls.
Note: If a stall occurs, the On/Off button is inactive for five seconds. If the On/Off
button is pressed during this five second lockout period, the lockout period will begin
again.
•
Performing treatment in vessels or bifurcations that are excessively tortuous or angulated
may result in vessel damage.
•
Always use fluoroscopy when advancing the guide wire to avoid misplacement, dissection,
or perforation. The OAD tracks over the guide wire, so it is imperative that the guide wire be
initially placed through the stenotic lumen and not in a false channel.
•
Do not inject contrast while OAD crown is spinning. OAD failure or patient harm may occur.
•
Handle the OAD 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 OAD without normal saline and lubricant solution. Flowing saline and
lubricant solution is required for cooling and lubricating the OAD during use to avoid
overheating and permanent damage to the OAD and possible patient injury.
•
The crown at the distal tip of the OAD operates 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 orbiting crown to the point of contact with the guide wire spring tip. Distal
detachment and embolization of the tip may result.
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