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Thoratec HeartMate III User Manual

Thoratec HeartMate III
458 pages
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Instructions for Use

Table of Contents

Other manuals for Thoratec HeartMate III

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Thoratec HeartMate III Specifications

General IconGeneral
BrandThoratec
ModelHeartMate III
CategoryMedical Equipment
LanguageEnglish

Summary

1 Introduction

Preface

Contains essential information for safe operation of the HeartMate III LVAS.

Understanding Warnings and Cautions

Explains the meaning of warnings and cautions used throughout the manual for safety.

Overview

Provides a general description of the HeartMate III LVAS and its components.

Indications

Outlines the intended use of the HeartMate III LVAS for patients with advanced heart failure.

Contraindications

Lists conditions for which the HeartMate III LVAS is not recommended.

Adverse Events

Details potential adverse events associated with the use of the HeartMate III LVAS.

Pre-Use Requirements

Specifies necessary knowledge and training before using the HeartMate III LVAS.

Equipment Overview

Introduces the main components of the HeartMate III LVAS system.

Principles of Operation

Explains how the HeartMate III LVAD functions as a centrifugal pump.

Explanation of Parameters

Defines key operational parameters such as speed, power, and flow.

2 System Operations

HeartMate III Left Ventricular Assist Device Overview

Describes the HeartMate III LVAD, its function, and components.

System Controller Overview

Explains the role of the System Controller as the central hub for power and communication.

Backup System Controller Overview

Details the function and purpose of the backup System Controller for system redundancy.

3 Powering the System

Power Overview

Introduces the different power sources for the HeartMate III LVAS.

Using the Power Module

Provides instructions on how to use the Power Module for system power.

Using the Mobile Power Unit

Explains the usage of the Mobile Power Unit for home or clinical power.

Using HeartMate 14 Volt Lithium-Ion Batteries

Details how to use the HeartMate 14 Volt Lithium-Ion batteries for mobile operation.

Switching Power Sources

Guides on how to switch between different power sources for the system.

Battery Charger Overview

Describes the function and features of the Battery Charger for batteries.

Charging HeartMate Batteries

Provides instructions on how to charge HeartMate 14 Volt Lithium-Ion batteries.

Calibrating HeartMate Batteries

Explains the process for calibrating HeartMate batteries to ensure accuracy.

Checking Battery Power

Details how to check the charge status of batteries using the Battery Charger.

Care and Maintenance of the Battery Charger

Outlines routine care and maintenance procedures for the Battery Charger.

4 System Monitor

Overview

Provides a general overview of the System Monitor and its purpose.

System Monitor Setup

Guides on setting up the System Monitor for use with the Power Module.

System Monitor Interface

Describes the touch-screen interface of the System Monitor.

Clinical Screen

Explains the default screen displaying primary operating parameters.

Settings Screen

Details how to monitor parameters, change settings, and stop the pump.

Alarms Screen

Shows the status of all Hazard and Advisory alarms.

Save Data Screen

Allows changing the rate of periodic data recording and saving to a data card.

Using the History Screen

Explains how to display System Controller event history.

Admin Screen

Used to set date/time and modify technical parameters.

5 Surgical Procedures

Surgical Considerations

Covers preimplant, implant, and explant procedures and critical warnings.

Equipment and Supplies Required for Implant

Lists sterile and non-sterile components needed for the HeartMate III LVAS implant kit.

Preimplant Procedures

Details critical steps and warnings before implanting the device.

Unpacking the Implant Kit

Provides instructions for unpacking the HeartMate III LVAS implant kit.

Unpacking the Pump and Accessories Tray

Guides on how to unpack the pump and its associated accessories.

Unpacking the Sealed Outflow Graft

Instructions for unpacking the sealed outflow graft.

Preparing the Sealed Outflow Graft

Explains how to prepare the sealed outflow graft for implantation.

Unpacking the System Controller

Provides instructions for unpacking the System Controller.

Unpacking the Modular Cable

Details the process of unpacking the modular cable.

Connecting and Initializing the Sterile System Controller

Describes how to connect and initialize the sterile system controller.

Preparing, Operating, and Priming the Pump

Instructions for submerging and operating the pump to verify its function.

Preparing the Coring Knife

Guides on assembling and preparing the coring knife for use.

Implant Procedures

Illustrates the proper orientation and placement of the LVAD during implantation.

Postimplant Procedures

Covers patient transfer and initial setup after implantation.

Device Explant

Provides instructions and warnings for explanting the Left Ventricular Assist Device.

6 Patient Care and Management

Postoperative Patient Care

Details the proper care required for patients supported by the HeartMate III LVAS.

Ongoing Patient Assessment and Care

Covers essential aspects of patient assessment and ongoing care.

Important Clinical Considerations for HeartMate III Patients

Highlights key clinical factors important for patients using the HeartMate III system.

Educating and Training Patients, Families, and Caregivers

Outlines essential topics for training patients and their caregivers on system use.

Ongoing System Assessment and Care

Provides guidelines for regular assessment and maintenance of the system.

Showering

Offers instructions and precautions for showering with the HeartMate III system.

Preparing for Sleep

Details precautions and procedures for sleeping with the HeartMate III system.

Wearing and Carrying System Components

Describes various wearable accessories for carrying system components.

7 Alarms and Troubleshooting

System Controller Alarms

Describes various alarms generated by the System Controller and how to resolve them.

System Monitor Alarms

Lists advisory alarms that appear exclusively on the System Monitor.

Handling Power Module Alarms

Details the types of alarms issued by the Power Module and their resolution.

Mobile Power Unit Alarms

Explains the alarms from the Mobile Power Unit and how to address them.

Using the Charger to Check Battery or Charger Status

Guides on checking battery and charger status using the Battery Charger.

Guidelines for Power Cable Connectors

Provides instructions for correctly connecting and disconnecting power cable connectors.

What Not to Do: Driveline and Cables

Highlights critical precautions regarding the handling of driveline and cables.

8 Equipment Storage and Care

Storage and Transport

Outlines acceptable environmental conditions for storing and transporting equipment.

Cleaning and Maintenance

Provides guidelines for cleaning and maintaining all system components.

Product Disposal

Details considerations for the proper disposal of HeartMate equipment.

A Technical Specifications

Specifications

Lists detailed technical specifications for the HeartMate III LVAS implant kit.

Sterile HeartMate III System Controller

Provides technical specifications for the sterile System Controller.

11 Volt Lithium-Ion Backup Battery

Lists technical specifications for the 11 Volt Lithium-Ion backup battery.

Power Module

Details the technical specifications for the Power Module.

Power Module Patient Cable

Lists technical specifications for the Power Module patient cable.

Mobile Power Unit

Provides technical specifications for the Mobile Power Unit.

HeartMate 14 Volt Lithium-Ion Battery

Lists technical specifications for the 14 Volt Lithium-Ion battery.

14 Volt Lithium-Ion Battery Clip

Details technical specifications for the 14 Volt Lithium-Ion battery clip.

Battery Charger

Lists technical specifications for the Battery Charger.

System Monitor

Provides technical specifications for the System Monitor display unit.

HeartMate Consolidated Bag

Lists technical specifications for the consolidated bag accessory.

HeartMate Shower Bag

Details technical specifications for the shower bag accessory.

HeartMate Battery Holster

Lists technical specifications for the battery holster accessory.

HeartMate Holster Vest

Provides technical specifications for the holster vest accessory.

HeartMate Wearable Accessories Kit

Lists specifications for the wearable accessories kit.

HeartMate Travel Bag

Details technical specifications for the travel bag accessory.

B Safety Testing and Classification

Safety Testing and Classification

Details the safety testing and classification of the HeartMate III LVAS.

Declaration Concerning General Safety Standards

Declares general safety standards applicable to the HeartMate III LVAS components.

Testing and Classification: HeartMate III LVAS

Covers testing and classification for the HeartMate III LVAS regarding EMC.

Testing and Classification: Power Module

Details EMC testing and guidance for the Power Module.

Testing and Classification: Mobile Power Unit

Covers EMC testing and guidance for the Mobile Power Unit.

Testing and Classification: Battery Charger

Outlines safety standards and EMC testing for the Battery Charger.

Testing and Classification: HeartMate 14 Volt Lithium-Ion Batteries

Lists safety standards for the 14 Volt Lithium-Ion batteries.

C Symbols

Description of Labeling Symbols

Explains general symbols used on product labeling and packaging.

Specific 14 Volt Lithium-Ion Battery Symbols

Details symbols specific to the 14 Volt Lithium-Ion batteries.

Specific 11 Volt Lithium-Ion Backup Battery Symbols

Describes symbols specific to the 11 Volt Lithium-Ion backup battery.

Specific System Controller Symbols

Lists symbols found on the System Controller.

Specific Power Module Symbols

Details symbols found on the Power Module.

Specific Mobile Power Unit Symbols

Describes symbols found on the Mobile Power Unit.

Specific System Monitor Symbols

Lists symbols found on the System Monitor.

D Safety Checklists

Daily Safety Checklist

Provides a checklist for daily safety inspections of the system components.

Weekly Safety Checklist

Offers a checklist for weekly safety inspections of the system components.

Monthly Safety Checklist

Details a checklist for monthly safety inspections of system components.

Six Month Safety Checklist

Provides a checklist for six-month safety inspections and readiness assessments.

Yearly Safety Checklist

Outlines a checklist for annual safety inspections and maintenance.

As-Needed Safety Checklist

Lists safety checks to be performed as needed for system components.

Clinic Visit Safety Checklist

Specifies checks to be performed during clinical follow-up visits.

E Glossary

Abbreviations

Lists common abbreviations used in the HeartMate III LVAS documentation.

Terms

Provides definitions for key terms used in the HeartMate III LVAS documentation.

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