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Heartmate II® LVAS LEFT VENTRICULAR ASSIST SYSTEM

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Heartmate II® LVAS LEFT VENTRICULAR ASSIST SYSTEM HeartMate II® LVAS LEFT VENTRICULAR ASSIST SYSTEM OPERATING MANUAL Corporate Headquarters Authorized EU Representative Thoratec Corporation Thoratec Europe Limited 6035 Stoneridge Drive Burnett House, Lakeview Court Pleasanton, CA 94588 Ermine Business Park USA Huntingdon, Cambs PE29 6UA UK Business: Business: Tel.: 925-847-8600 Tel.: +44(0) 1480 455200 Fax: 925-847-8574 Fax: +44(0) 1480 454126 Emergencies: Urgent/24-Hour: 800-456-1477 (USA HeartLine™) +44(0) 7659 877901 925-847-8600 (International) www.thoratec.com 103884.C 12/2009 FOREWORD This manual contains information needed to properly and safely operate the Thoratec HeartMate II® Left Ventricular Assist System (LVAS). The Operating Manual and the Instructions for Use are intended to serve as both clinical textbook and reference; the new user should read both documents in their entirety, before system operation. For experienced practitioners, this manual may serve as a reference for detailed information. Users of the HeartMate II LVAS should have a practical knowledge of the principles of mechanical circulatory assist support (MSC) and should be aware of the physiological and psychological needs of a patient undergoing mechanical ventricular support. Sections 1-3 offer the reader an overall perspective of the system. They also describe the indications for use and the contraindications. Lastly, these sections introduce some of the unique attributes of the HeartMate II LVAS. Sections 4-11 explain how the system works, describe the technical features and operation of each system component and include descriptions of a variety of situations likely to arise during and after pump implantation. Sections 12-13 describe in detail the procedures necessary to support HeartMate II LVAS patients, including equipment cleaning and maintenance requirements. Sections 14-15 are devoted to troubleshooting and answering frequently asked questions. Section 16 contains reference information such as technical specifications and classifications. As with all prescription medical devices, all clinical procedures are under the direction of the prescribing physician. The professional staff at Thoratec regularly provides laboratory training and on-site, in-service programs. Additional training materials are available for independent learning. HeartMate II is a registered trademark of the Thoratec Corporation HeartLine and GoGear are trademarks of the Thoratec Corporation Velcro is a registered trademark of Velcro Industries; Velcro USA Inc. HeartMate II LVAS Operating Manual i Table of Contents 1.0 Introduction to the HeartMate II LVAS ........................................................ 1 1.1 System Overview...................................................................... 1 1.2 System Components ................................................................ 2 1.2.1 Hardware.................................................................................. 2 1.2.2 Primary, Backup, and Optional Components ........................... 4 2.0 Indications for Use ...................................................................................... 8 3.0 Contraindications ........................................................................................ 8 4.0 Warnings and Precautions.......................................................................... 8 4.1 WARNINGS.............................................................................. 8 4.1.1 WARNINGS - Specific Implantation Issues............................ 11 4.1.2 WARNINGS - Patient/System Management Issues............... 13 4.2 PRECAUTIONS...................................................................... 15 4.2.1 PRECAUTIONS - Specific Implantation Issues...................... 18 4.2.2 PRECAUTIONS - Patient/System Management Issues......... 19 5.0 Principles of Operation ............................................................................. 23 6.0 Explanation of Parameters ....................................................................... 26 6.1 Pump Speed........................................................................... 26 6.2 Pump Power........................................................................... 26 6.3 Pump Flow.............................................................................. 26 6.4 Pulsatility Index....................................................................... 27 7.0 HeartMate II LVAD.................................................................................... 28 7.1 Overview................................................................................. 28 7.2 Components ........................................................................... 29 7.2.1 Motor ...................................................................................... 29 7.2.2 Rotor....................................................................................... 29 7.2.3 Inflow Conduit and Outflow Graft ........................................... 30 7.2.4 Percutaneous Lead ................................................................ 30 7.3 Surgical Implantation Site....................................................... 32 7.4 Pump Power Source............................................................... 33 8.0 System Controller ..................................................................................... 34 8.1 Overview................................................................................. 34 8.1.1 Function.................................................................................. 34 8.1.2 Components ........................................................................... 34 8.2 Setup ...................................................................................... 36 8.3 Description of Features .......................................................... 39 8.3.1 Modes of Operation................................................................ 39 8.3.2 Redundant System Operation ................................................ 40 8.3.3 System Performance Monitoring, Interpretation and Response........................................................................ 40 8.3.4 Control Buttons....................................................................... 42 HeartMate II LVAS Operating Manual ii 8.3.5 Battery Charge Level Fuel Gauge Display ............................. 43 8.3.6 Alarms .................................................................................... 45 8.3.7 System Controller Self-Test.................................................... 53 8.3.8 System Controller Alarm Battery Module Replacement ......... 54 8.3.9 System Controller Replacement............................................. 55 9.0 Power Module (PM) .................................................................................. 61 9.1 Overview................................................................................. 61 9.1.1 Function.................................................................................. 61 9.1.2 Components ........................................................................... 63 9.2 Power Module (PM) Setup ..................................................... 63 9.2.1 Connecting the Internal Backup Battery................................. 63 9.2.2 Connecting the PM Power Cord and PM Patient Cable......... 67 9.2.3 Monitoring PM Performance and Performing a PM System Self Test.............................................................. 72 9.3 Description of Features .......................................................... 73 9.3.1 Switching from PM-Power to Batteries................................... 74 9.3.2 Switching from Batteries to PM Power ................................... 76 9.3.3 Power Module (PM) Backup Power........................................ 79 9.3.4 Determining the PM’s Internal Battery Charge Status............ 80 9.3.5 Power Module (PM) Alarms.................................................... 83 9.3.6 Using the PM with the Display Module................................... 86 9.3.7 Using PM with the System Monitor......................................... 90 10.0 Batteries & Battery Clips........................................................................... 97 10.1 Overview................................................................................. 97 10.1.1 Function................................................................................ 101 10.1.2 Components ......................................................................... 101 10.2 Setup for Battery-Powered Operation .................................. 102 10.3 Description of Features ........................................................ 104 10.3.1 Batteries ............................................................................... 104 10.3.2 Battery-Powered Operation.................................................. 105 11.0 Universal Battery Charger (UBC) ........................................................... 113 11.1 Overview............................................................................... 113 11.1.1 Function................................................................................ 114 11.1.2 Components ......................................................................... 114 11.2 UBC Set Up.......................................................................... 114 11.3 Description of Features ........................................................ 119 11.3.1 Determining a Battery’s Charge Status Using the UBC ....... 119 11.3.2 Charging Batteries...............................................................
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