DIRECTIONS FOR USE Please refer to the IFU for a complete statement of the indications, contraindications, warnings, and instructions for use supplied with each device. Always follow the IFU. Step 1 Before opening the packaging, confirm correct coil size. Also check the coil expiration date. Open package and remove hoop.
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® Gently remove clear cap from the delivery system. Prior to using the device, insert the proximal end of the delivery pusher Detachment Controller. into the funnel section of the AZUR Detachment Controller; DO NOT PRESS BUTTON. ® Do not press button.
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Steps 4-6 Step 7 The following pre-softening procedure is optional. The AZUR ® Peripheral Hydrocoil Embolization System may also be used Step 4: Step 5: Step 6: without pre-softening. Pull the AZUR Peripheral Hydrocoil Slide the black shrink lock proximally...
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AZUR ® and connect the proximal end of gauze to wipe away contrast or blood. Detachment Controller. the delivery pusher to the AZUR ® Detachment Controller. Step 9: Insert the distal tip of the coil introducer sheath into the microcatheter/ guidecatheter hub.
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Step 12 Verify the detachment of the coil under fluoroscopy by pulling back slowly on the delivery pusher and confirming there is no coil movement. Remove the delivery pusher. Repeat steps 1-12 to deliver multiple AZUR detachable coils. ® Note: Please refer to the full Instructions for Use for complete instructions on how to use this medical device.
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