Detachable In-Service Guide

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DETACHABLE IN-SERVICE GUIDE

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.

Confirm correct coil size Check coil expiration date Open package and remove hoop

2 3
Step 2 Step 3

If light does not light, replace the If a red light appears, replace the If the indicator light remains solid
AZUR® Detachment Controller. AZUR® Detachment Controller. green, continue using the AZUR®
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.

Remove clear cap from the Insert the proximal end of the
delivery system delivery pusher into the controller. IMPORTANT: Do not press button at any time during Step 3.

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

Slowly advance coil out of the


introducer sheath and inspect distal Note: The Hydrogel will not begin to expand until the coil is exposed to blood.
tip of coil for any irregularities or
damages.

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Steps 8-9 Step 10-11
Step 8: Step 10: Step 11:
With the distal end of the introducer sheath pointed downward, gently retract the Deliver the coil to the appropriate If a red light appears, wipe the end If the indicator light remains solid
coil completely into the introducer sheath about 1-2 cm. location. Verify the coil position of the coil with a saline soaked 4 x 4 green, continue using the 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.
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.
Press the button and wait for the
Push the coil into the lumen of the microcatheter/guidecatheter. Use caution to detachment cycle, which consists of
avoid catching the coil on the junction between the introducer sheath and the hub three audible tones accompanied by
of the microcatheter/guidecatheter. three amber lights.
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.

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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. The information
presented here is intended only as a summary of key operational
instructions and important considerations related to the system.

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US: 800.862.4143 US: terumois.com
FIND OUT MORE CA: 833.883.7866 CA: terumocanada.ca

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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