Table of Contents
Advertisement
Quick Links
Advertisement
Table of Contents
Related Manuals for Thoratec HeartMate 3 Coring Tool
Summary of Contents for Thoratec HeartMate 3 Coring Tool
- Page 1 Thoratec Corporation 3™ C EART ORING Instructions for Use...
-
Page 3: Authorized Eu Representative
Specifications may change without notice. Thoratec and the Thoratec logo are registered trademarks. HeartMate 3 Coring Tool is a trademark of Thoratec Corporation. Tyvek is a registered trademark of E. I. duPont de Nemours and Company or its affiliates. - Page 5 INTRODUCTION Preface This manual contains information needed to properly and safely use the HeartMate 3 Coring Tool. New users should read this document in its entirety before using the Coring Tool. For experienced practitioners, this manual may serve as a reference.
-
Page 6: Package Contents
• HeartMate 3 Coring Tool • Instructions for Use for HeartMate 3 Coring Tool The HeartMate 3 Coring Tool is supplied sterile and for single use only. Store components in a cool, dry place. The system is packaged for safe transportation and effective use in an operating room under sterile conditions. - Page 7 • Do modify this device without authorization from Thoratec Corporation. • HeartMate 3 Coring Tool is compatible only with the HeartMate 3 Left Ventricular Assist System. • Do use the HeartMate 3 Coring Tool if the sterile packaging is damaged or open.
- Page 8 Coring Tool system components. If components need service, contact the appropriate Thoratec personnel. • Notify the appropriate Thoratec personnel if there is a change in how the device works, sounds, or feels. • Do use the HeartMate 3 Coring Tool system after the “Use by”...
-
Page 9: Adverse Events
For the HeartMate 3 Left Ventricular Assist System Indications for Use, please refer to the HeartMate 3 Instructions for Use. The HeartMate 3 Coring Tool is intended for use with the HeartMate 3 Left Ventricular Assist System (LVAS). The Coring Tool provides a means to resect a plug of myocardium from the left ventricle, which allows for HeartMate 3 inflow cannula insertion. -
Page 10: Surgical Procedures
This section describes the preimplant, implant, and proce- dures for the HeartMate 3 Coring Tool. Equipment and Supplies Required for Implant CAUTION ! • The HeartMate 3 Coring Tool is supplied sterile and is intended for single use only and should be re-used or re-sterilized. - Page 11 To unpack the Coring Tool from the tray: 1. Peel back and remove the cover from the main packaging tray. 2. Remove the HeartMate 3 Coring Tool inner tray from the main packaging tray. Place the HeartMate 3 Coring Tool inner tray in the sterile work area.
-
Page 12: Directions For Use
HeartMate 3 IFU. The Coring Knife provided in the HeartMate 3 LVAS implant kit is required as the HeartMate 3 Coring Tool provided in this package will be used to core the left ventricle. Coring Procedure... - Page 13 Apical Cuff suturing approach and Mini Apical Cuff Instruc- tions for Use for Mini Apical Cuff installation approaches. 3. Align and insert the guide pin of the HeartMate 3 Coring Tool into the center of the HeartMate 3 Apical Cuff or HeartMate 3 Mini Apical Cuff.
- Page 14 CAUTION ! Depressing the locking tabs may cause the helix to retract with force. Maintain a grip on the locking tabs while deflecting. HeartMate 3 Coring Tool Instructions for Use...
- Page 15 The Coring Tool may be used in a Cut-Then-Sew approach by first creating the ventriculotomy described in steps 3 through 9 and then suturing the HeartMate 3 Apical Cuff to the exterior of the ventricle. HeartMate 3 Coring Tool Instructions for Use...
- Page 16 3. Uncoil cored tissue from the helix using tissue forceps by rotating counter-clockwise. Avoid uncoiling the cored tissue by hand. Removal Note: should be completed using forceps to protect from disen- gagement of the blade and injury to fingers. HeartMate 3 Coring Tool Instructions for Use...
-
Page 17: General Symbols
Serial Number Batch Code (Lot Number) European Conformity Authorized representative in the European community Temperature Limitation Sterilized using Ethylene Oxide Do not use if package damaged Do not reuse. Do not resterilize Peel Tab HeartMate 3 Coring Tool Instructions for Use... - Page 18 SYMBOL DESCRIPTION Caution Refer to instruction manual Use by Keep dry Caution: US federal law restricts this device to sale by or on the order of a physician HeartMate 3 Coring Tool Instructions for Use...
Need help?
Do you have a question about the HeartMate 3 Coring Tool and is the answer not in the manual?
Questions and answers