Cardiovascular Systems, Inc. DIAMONDBACK 360 Peripheral Orbital Atherectomy System Exchangeable Series Instructions For Use Manual page 30

1. Ensure the OAD brake is unlocked and the device is not spinning.
2. If the OAD is in the patient, keep the pump power on.
3. If there is a guidewire in the OAD, remove the guidewire from the proximal end
of the OAD.
4. A 4 French dilator may be inserted into the green strain relief to aid insertion of
the guidewire. Insert the new guidewire through the proximal strain relief.
Warning: The device is designed to track and spin only over the CSI
Peripheral VIPERWIRE ADVANCE Guide Wire or the VIPERWIRE ADVANCE
with FLEXTIP Guide Wire.
CAUTION: Do not attempt to load a guide wire with crossing profile >0.014"
through the proximal end OAD. Guide wire with crossing profile >0.014" will
not fit through the internal components of the OAD.
12.1.2. Exchanging the Cartridge
Note: Each handle can only accept up to three different cartridges. The
Exchangeable Series device has not been tested clinically for extended use in a
single lesion.
To Exchange the cartridge, perform the following:
1. Stop the spinning crown and drive shaft by pressing and releasing the On/Off
button on top of the crown advancer knob.
2. Retract the OAD sheath and drive shaft, from the introducer, guide sheath, or
guide catheter, while monitoring and maintaining guide wire position.
3. Once the OAD drive shaft and sheath are fully retracted, power off the OAS pump
by pressing the green Start button on the OAS pump control panel to stop saline
from flowing through the saline tubing and verify that the green LED, on the OAS
pump control panel, is not illuminated.
4. Disconnect the saline tubing from the cartridge and set aside for use with the next
cartridge.
5. Disconnect the cartridge from the handle:
a) Slide the crown advancer knob to the most distal position on the handle. The
yellow button will align with the rotate symbol on the handle, see Figure 11.
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