Terumo Azur User manual

DETACHABLE IN-SERVICE GUIDE

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Conrm correct coil size Check coil expiration date Open package and remove hoop
Before opening the packaging, conrm correct coil size. Also check the coil expiration date. Open package and
remove hoop.
DIRECTIONS FOR USE
Step 1
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.

54
Gently remove clear cap from the delivery system. Prior to using the device, insert the proximal end of the delivery pusher
into the funnel section of the AZUR® Detachment Controller; DO NOT PRESS BUTTON.
Remove clear cap from the
delivery system
Insert the proximal end of the
delivery pusher into the controller.
If light does not light, replace the
AZUR® Detachment Controller.
If a red light appears, replace the
AZUR® Detachment Controller.
If the indicator light remains solid
green, continue using the AZUR®
Detachment Controller.
Do not press button.
Step 2 Step 3
IMPORTANT: Do not press button at any time during Step 3.

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Step 4:
Pull the AZUR® Peripheral Hydrocoil
Embolization System out of the
housing hoop, until you see the black
shrink lock.
Step 5:
Slide the black shrink lock proximally
to expose the tab on the introducer
sheath. Note: Shrink lock does not
peel away.
Step 6:
Continue to pull the AZUR® Peripheral
Hydrocoil Embolization System out of
the housing hoop.
Slowly advance coil out of the
introducer sheath and inspect distal
tip of coil for any irregularities or
damages.
The following pre-softening procedure is optional. The AZUR® Peripheral Hydrocoil Embolization System may also be used
without pre-softening.
Step 7 (optional):
Prepping techniques include using warm sterile saline solution or steam until coil takes shape; about 5–10 seconds.
Steps 4-6 Step 7
Note: The Hydrogel will not begin to expand until the coil is exposed to blood.

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Step 8:
With the distal end of the introducer sheath pointed downward, gently retract the
coil completely into the introducer sheath about 1-2 cm.
Step 9:
Insert the distal tip of the coil introducer sheath into the microcatheter/
guidecatheter hub.
Note: The coil introducer sheath will not go into the microcatheter/guidecatheter.
If using rotating hemostatic Y valve (RHV), do not over-tighten the RHV around
the introducer. Excessive tightening could damage the coil.
Push the coil into the lumen of the microcatheter/guidecatheter. Use caution to
avoid catching the coil on the junction between the introducer sheath and the hub
of the microcatheter/guidecatheter.
Push the AZUR® Peripheral Hydrocoil Embolization System through the
microcatheter/guidecatheter until the proximal end of the delivery pusher meets
the proximal end of the introducer sheath.
Step 10:
Deliver the coil to the appropriate
location. Verify the coil position
and connect the proximal end of
the delivery pusher to the AZUR®
Detachment Controller.
Step 11:
If a red light appears, wipe the end
of the coil with a saline soaked 4 x 4
gauze to wipe away contrast or blood.
If the indicator light remains solid
green, continue using the AZUR®
Detachment Controller.
Press the button and wait for the
detachment cycle, which consists of
three audible tones accompanied by
three amber lights.
Steps 8-9 Step 10-11

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Step 12
Verify the detachment of the coil under uoroscopy by pulling back slowly on the delivery pusher and conrming 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. The information
presented here is intended only as a summary of key operational
instructions and important considerations related to the system.

RX ONLY. The advertisement is directed to physicians only, and not to consumers. Refer to product
labels and packaging insert for complete warnings, precautions, potential complications, and
instructions for use. Products may not have regulatory approval in all countries. Please contact
your local sales representative if you have questions about the availability of products in your area.
©2019 Terumo Medical Corporation and Terumo Medical Canada Inc. All rights reserved.
All brand names are trademarks of Terumo. PM-02416
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