Abbott StarClose SE User manual

StarClose SE

Vascular Closure System

Deployment Steps

Clip Applier

Locator Wings

Flex-guide

Deployment

Button

Side-arm

Slot

Finger Loop

Stabilizer

Access Port

Safety

Release

Plunger

Thumb

Advancer

Finger Post

Clip Delivery

Tube

StarClose SE

Vascular Closure System

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StarClose SE

Vascular Closure System

Clip Delivery Tube

A. Clip

B. Clip Delivery Tube

C. Sheath Splitter

A

B

C

2

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

3

StarClose SE

Vascular Closure System

Exchange System

J Tip Guide Wire

Sheath Tube

Exchange Sheath Hub

Dilator

4

Procedural Preparation

StarClose SE

Vascular Closure System

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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• 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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• 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 Wing deployment.Check that the number “2” is completely visible in the number window.

“CLICK” 2 - Locator Wing Deployment

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Vascular Closure System

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• 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

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Vascular Closure System

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• 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

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Vascular Closure System

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• 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

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Vascular Closure System

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Arterial Perspective

StarClose SE

Vascular Closure System

“CLICK” 1 “CLICK” 2

“CLICK” 3 “CLICK” 4

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• 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

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Vascular Closure System

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• 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 that the number “3” on theThumb Advancer exits the number window completely.

• Pull back the Thumb Advancer.

• Slide the Safety Release to collapse theLocator 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 Access Ports

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Vascular Closure System

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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

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Abbott Vascular Australia

Level 8, 15 Talavera Road

North Ryde NSW 2113

Tel: 1800 550 939

Tel: +61 2 8879 2837

Fax: +61 2 8879 2805

Abbot Vascular New Zealand

Level 3, 6 Kingdon Street

New Market Auckland

Tel: 0800 827 285

Tel: +64 524 6580

Fax: +64 9524 6584

Abbott StarClose SE User manual

Abbott StarClose SE User manual

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