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Always ensure that at least two Azur Detachment Controllers
are available before starting an Azur system procedure.
The coil cannot be detached with any power source other
than an Azur Detachment Controller.
Do NOT place the delivery pusher on a bare metallic
surface.
Always handle the delivery pusher with surgical gloves.
Do NOT use in conjunction with radio frequency (RF)
devices.
Figure 1
– Diagram of Azur System Setup
PREPARATION FOR USE
1.
Refer to Figure 1 for the set-up diagram.
2.
Select a catheter with the appropriate inner diameter for coil
delivery.
3.
Attach a rotating hemostatic valve (RHV) to the hub of the
catheter. Attach a one-way stopcock to the side arm of the RHV
and then connect the flush solution line to the stopcock. If
fluoroscopic roadmapping is being used, an appropriate guide
catheter with attached RHV and flush solution line must be
incorporated as well.
4.
Open the stopcock and flush the catheter with sterile flush
solution and then close the stopcock. To minimize the risk of
thromboembolic complications, it is critical that a continuous
infusion of appropriate sterile flush solution be maintained into the
catheter(s) and femoral sheath.
CATHETERIZATION OF THE LESION
5.
Access the parent vessel or vascular lesion using standard
interventional procedures.
6.
After the catheter has been positioned at the target site, remove
the guidewire.
COIL SIZE SELECTION
7.
Perform fluoroscopic road mapping.
8.
Measure and estimate the size of the lesion to be treated.
9.
For aneurysm occlusion, the diameter of the first and second coils
should never be less than the width of the aneurysm neck or the
propensity for the coils to migrate may be increased.
10. For vessel occlusion, select a coil size that is slightly larger than
the vessel diameter.
11. Correct coil selection increases effectiveness and patient safety.
Occlusive efficiency is, in part, a function of compaction and
overall coil mass. In order to choose the optimum coil for any
given lesion, examine the pre-treatment angiograms. The
appropriate coil size should be chosen based upon angiographic
assessment of the diameter of the target or parent vessel,
aneurysm dome and aneurysm neck.
PREPARATION OF THE AZUR SYSTEM FOR DELIVERY
Figure 2
– Azur Detachment Controller
12. Remove the Azur Detachment Controller from its protective
packaging. Pull the white pull-tab from the side of the detachment
controller. Discard the pull-tab and place the detachment
controller in the sterile field. The Azur Detachment Controller is
packaged separately as a sterile device.
Do not use any power
source other than the Azur Detachment Controller to detach
the coil. The Azur Detachment Controller is intended to be
used on one patient. Do not attempt to re-sterilize or
otherwise re-use the Azur Detachment Controller.
13. Prior to using the device, remove the proximal end of the delivery
pusher from the packaging hoop. Use care to avoid
contaminating this end of the delivery pusher with foreign
substances such as blood or contrast. Firmly insert the proximal
end of the delivery pusher into the funnel section of the Azur
