Abbott StarClose SE User manual

StarClose SE
Vascular Closure System
Deployment Steps
©2011 Abbott. All rights reserved. ANZ 080091 10/11

Clip Applier
Locator Wings
Flex-guide
Deployment
Button
Side-arm
Slot
Finger Loop
Stabilizer
Access Port
Access Port
Safety
Release
Plunger
Thumb
Advancer
Finger Post
Finger Post
Finger Post
Clip Delivery
Tube
StarClose SE
Vascular Closure System
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©2011 Abbott. All rights reserved. ANZ 080091 10/11

StarClose SE
Vascular Closure System
Clip Delivery Tube
A. Clip
B. Clip Delivery Tube
C. Sheath Splitter A
B
C
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©2011 Abbott. All rights reserved. ANZ 080091 10/11

StarClose SE
Vascular Closure System
Clip
Material: Nitinol (Nickel Titanium Alloy)
Actual diameter of the closed Clip: 4 mm, Clip thickness: 0.2 mm
4 mm 0.2 mm
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©2011 Abbott. All rights reserved. ANZ 080091 10/11

StarClose SE
Vascular Closure System
Exchange System
J Tip Guide Wire
Sheath Tube
Exchange Sheath Hub
Dilator
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©2011 Abbott. All rights reserved. ANZ 080091 10/11

Procedural Preparation
StarClose SE
Vascular Closure System
Anterior
superior
Iliac crest
Common
femoral
artery
Profunda
artery
External
iliac artery
Inferior
epigastric
artery
Inguinal
ligament
Superficial
femoral
artery
•Perform femoral angiogram
•Re-Prep groin
•Perform nick and spread
External
iliac
artery
Common
femoral
artery
Superficial
femoral
artery
Profunda
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©2011 Abbott. All rights reserved. ANZ 080091 10/11

•With the Exchange Sheath in place, insert the Clip Applier Flex-guide into the Sheath Hub.
•Advance the Flex-guide slowly. Do not bend the Flex-guide excessively during insertion.
•Hold the bottom of the Hub with the left hand. Firmly push the Hub into the Clip Applier.
•A“CLICK”should be heard. Gently pull on the Hub to confirm engagement.
“CLICK” 1 - Connect Exchange Sheath to Clip Applier
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Vascular Closure System
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©2011 Abbott. All rights reserved. ANZ 080091 10/11

•Hold the Stabilizer with the left hand. Stabilize the body of the Clip Applier at the angle of the tissue tract.
•With the right index and middle fingers on the proximal posts, right thumb on the Plunger, retract the Clip Applier out of the tissue 3 to
4 centimeters.
•Using the right thumb, depress the Plunger firmly to deploy the Locator Wings, which advances the Thumb Advancer about
3 centimeters. The initial splitting of the Sheath will be visible above the skin level.
•A“CLICK” should be heard to confirm Locator Wingdeployment.Check thatthenumber“2” is completelyvisibleinthenumber window.
“CLICK” 2 - Locator Wing Deployment
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Vascular Closure System
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©2011 Abbott. All rights reserved. ANZ 080091 10/11

•Keep the left hand on the Stabilizer to maintain the Clip Applier at the angle of the tissue tract.
•Place the right index finger on the distal post, the middle two fingers in the loop, and the right thumb on the Thumb Advancer.
•Gently retract the Clip Applier until the Locator Wings are against the arterial wall, and slight resistance is felt.
•While maintaining the Locator Wing position against the arterial wall, push the Thumb Advancer forward with the pad of the right
thumb until the number “3” can be seen in the number window.
•A“CLICK”should be heard to confirm completion. Check that the number “3” is completely visible in the number window.
“CLICK” 3 - Sheath Split
StarClose SE
Vascular Closure System
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©2011 Abbott. All rights reserved. ANZ 080091 10/11

•While stabilizing the body of the Clip Applier with the right hand, and supporting the Clip Delivery Tube with the left hand, raise the
Clip Applier to a 60 to 75 degree angle.
•Continue to support the Clip Delivery Tube with the left hand. Gently push the Clip Applier down to seat the Clip Delivery Tube on
top of the access site. Pulsation of the artery may be felt.
•While maintaining downward pressure, depress the Deployment Button with the right thumb to deploy the Clip.
•A“CLICK”should be heard to confirm deployment. Maintain the downward pressure for2to 3 seconds.
“CLICK” 4 - Clip Deployment
StarClose SE
Vascular Closure System
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©2011 Abbott. All rights reserved. ANZ 080091 10/11

•Gently push down on the patient’s body with the left hand. Remove the Clip Applier with the right hand.
•Use sterile gauze; firmly depress the area around the puncture site to express any blood in the tissue tract.
•Test for security of the close by having the patient lift their head off the table and cough, and lift their leg against operator’s hand.
Check for Hemostasis
StarClose SE
Vascular Closure System
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©2011 Abbott. All rights reserved. ANZ 080091 10/11

Arterial Perspective
StarClose SE
Vascular Closure System
“CLICK” 1 “CLICK” 2
“CLICK” 3 “CLICK” 4
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©2011 Abbott. All rights reserved. ANZ 080091 10/11

•If excessive resistance is felt while advancing the Thumb Advancer, pull back the Thumb Advancer.
•Slide the Safety Release forward to collapse the Locator Wings.
•Check that the number “2” on the Plunger exits the number window completely.
•Gently push down on the patient’s body with the left hand. Remove the Clip Applier with the right hand without rocking or twisting.
Use of Safety Release
StarClose SE
Vascular Closure System
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©2011 Abbott. All rights reserved. ANZ 080091 10/11

•If resistance is felt upon removal of the Clip Applier, insert the Dilator (or an 18-gauge thin-wall needle) into the Access Ports, one at a
time, to unlock the Thumb Advancer.
•A“CLICK” should be heard to confirm release. Check thatthenumber“3” on theThumbAdvancer exits thenumber window completely.
•Pull back the Thumb Advancer.
•Slide the Safety Release to collapsetheLocator Wings. Check thatthenumber “2” on thePlunger exits thenumber window completely.
•Gently push down on the patient’s body with the left hand. Remove the Clip Applier with the right hand without rocking or twisting.
Use of Access Ports
StarClose SE
Vascular Closure System
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©2011 Abbott. All rights reserved. ANZ 080091 10/11

Please contact your local sales representative for more info.
StarClose SE is a registered trademark of the Abbott Group of Companies.
All drawings are artist's representations only and should not be considered as an engineering drawing or photograph.
Photo(s) on file at Abbott Vascular.
Product is subject to prior training requirement as per the Instruction for Use.
Products intended for use by or under the direction of a physician. Prior to use, it is important to read the package
insert thoroughly for instructions for use, warnings and potential complications associated with use of this device.
Information contained herein is for distribution for Australia and New Zealand only.
For more information, visit our website at www.AbbottVascular.com
©2011 Abbott. All rights reserved. ANZ 080091 10/11
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Abbott Vascular Australia
Level 8, 15 Talavera Road
North Ryde NSW 2113
Tel: [phone]
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Fax: [phone]
Abbot Vascular New Zealand
Level 3, 6 Kingdon Street
New Market Auckland
Tel: [phone]
Tel: [phone]
Fax: [phone]