EasyManua.ls Logo

SynCardia Freedom - User Manual

SynCardia Freedom
174 pages
Print Icon
To Next Page IconTo Next Page
To Next Page IconTo Next Page
Loading...
Copyright © 2010-2017 by SynCardia Systems, LLC 900212-001 / F-900013-EN Rev 004
Revision Date: 2017-05
SynCardia temporary Total Artificial
Heart (TAH-t) with the
Freedom
®
Driver System
Operator Manual
SynCardia Systems, LLC
1992 E. Silverlake Road
Tucson, AZ 85713 USA
+1 (520) 545-1234
+1 (866) 771-9437
www.syncardia.com
CAUTION: The 50cc temporary Total Artificial Heart (TAH-t) is an Investigational
Device - Limited by United States Law to Investigational Use.
CAUTION: In the United States, the use of the SynCardia 70cc TAH-t for destination
therapy is investigational.
CAUTION: In the United States, the use of the Freedom Driver System with the 70cc
TAH-t for the destination therapy indication or with the 50cc TAH-t is
investigational.
CAUTION: Federal (USA) law restricts this device to sale by or on order of a
physician.
0086
15 May 2005

Table of Contents

Question and Answer IconNeed help?

Do you have a question about the SynCardia Freedom and is the answer not in the manual?

Summary

1 Device Description

1.1 General Device Information

Overview of the SynCardia TAH-t System, including the Freedom Driver.

1.2 The TAH-t

Details about the SynCardia TAH-t, its function, and versions.

1.3 The Freedom Driver System

Introduction to the Freedom Driver System, its components, and function.

1.3.4 Components of the Freedom Driver System

Lists all parts included in the Freedom Driver System package.

1.3.5 Primary Driver with attached Power Adaptor

Describes the primary Freedom Driver and its attached power adaptor.

1.3.6 Backup Driver with Attached Power Adaptor

Explains the purpose and features of the backup Freedom Driver.

1.3.8 Onboard Batteries

Details the Onboard Batteries, their use, charging, and management.

1.3.9 AC Power Supply

Describes the AC Power Supply units.

1.3.10 Car Charger

Explains the function and connection of the Car Charger.

1.3.11 Battery Charger

Describes the Freedom Battery Charger and its capabilities.

1.3.16 Shoulder Bag and Backpack

Details the Shoulder Bag and Backpack for carrying the system.

1.3.18 Pelican Case

Describes the Pelican Case used for shipping and storage.

1.3.20 Clinician Tool Kit

Lists components of the Clinician Tool Kit.

2 Indications for Use

70 cc TAH-t Indication for Use

Specifies the indications for the 70cc TAH-t.

50 cc TAH-t Indication for Use

Specifies the indications for the 50cc TAH-t.

Freedom Driver System Intended Use

States the intended use of the Freedom Driver System.

2.1 Clinical Trial Results

Summarizes the results of the Freedom Driver System Study.

2.1.3 Additional Analysis

Compares AE rates between high and low volume centers.

2.1.4 Conclusions

Summarizes the findings of the Freedom Driver System Study.

3 Contraindications

4 Warnings

4.1 TAH-t Warnings

Provides critical warnings related to the TAH-t system.

4.2 Driver System Warnings

Lists critical warnings for the Freedom Driver System.

5 Precautions and Recommendations

5.1 Precautions

Lists precautions for using the Freedom Driver System.

5.2 Recommendations

Provides recommendations for optimal system use.

6 Operating Instructions

6.1 Equipment the Patient Needs to Leave the Hospital

Lists equipment required for patient discharge.

6.2 Equipment the Patient Needs to Leave the House

Lists items the patient must take when leaving home.

6.3 Power Management

Details how to manage power sources for the Driver.

6.4 Using External Power through the Power Adaptor

Explains how to use external power sources.

6.4.1 Replacing the Power Adaptor in the Freedom Driver

Provides steps to replace the Power Adaptor.

6.4.2 Using Wall Power through the Power Adaptor

Details connecting to wall power via the adaptor.

6.4.3 Using Vehicle Power through the Power Adaptor

Explains using vehicle power for the Driver.

6.4.4 Charging Onboard Batteries through the Power Adaptor

Details charging batteries via the Power Adaptor.

6.4.6 Removal of External Power

Steps for safely removing external power.

6.5 Using Onboard Battery Power

Details operating the Driver using onboard batteries.

6.5.1 Checking Onboard Battery Charge

How to check the battery charge status.

6.5.2 Inserting the Onboard Batteries

Steps for correctly inserting batteries.

6.5.3 Removing Onboard Batteries

Steps for removing the Onboard Batteries.

6.6 Using the Battery Charger

How to use the Freedom Battery Charger.

6.6.1 To Charge Onboard Batteries

Steps for charging batteries using the charger.

6.6.3 Battery Charger Warnings

Warnings specific to the Battery Charger.

6.7 User Interface

Overview of the Driver's user interface elements.

6.7.1 LCD Screen

Details the Driver's LCD screen and its displays.

6.7.2 Lights and Sounds

Explains the visual and audible alarms.

7 Preparing the Freedom Driver for Patient Use

7.1 General Shipping Information

Information about how the system is shipped and packaged.

7.2 Individual Shipping Units

Lists the components included in the shipping case.

7.3 Packing the Freedom Driver into the Freedom Bags

Instructions for packing the system into bags for patient use.

7.4 Checking and Preparing the Driver

Steps for checking and preparing the Driver before patient use.

7.5 Initial Installation

Steps for the initial setup and installation of the Drivers.

7.6 Starting the Driver

Instructions for starting the Freedom Driver.

7.7 Adjusting the Beat Rate of the Freedom Driver

How to adjust the Beat Rate setting on the Driver.

7.8 Switching to the Freedom Driver

Guidance on switching to the Freedom Driver.

7.9 Moving the Freedom Driver

Instructions for safely moving the Freedom Driver.

7.10 Preparing and Storing the Backup Freedom Driver

Steps for preparing and storing the backup Driver.

9.13 Patient Preparation for Excursions

Steps to prepare a patient for excursions outside the hospital.

8 List of Symbols

9 Freedom Driver Operating Cautions

9.1 Use of SynCardia-Approved Components Only

Emphasizes using only approved system components.

9.3 Observe Alarms

Importance of addressing alarms immediately.

9.4 Use of Backup Driver

Requirements for having and using a backup Driver.

9.5 Maintenance of Electrical Safety

Precautions for maintaining electrical safety.

9.6 Reduction of Explosion Hazard

Warning about flammable gases.

9.7 Maintenance of Patient Safety

General precautions for patient safety.

9.12 Things to Do Before Switching the TAH-t Patient to the Freedom Driver System

Checklist before switching patients to the Freedom Driver.

10 Visual and Audible Alarms

10.1 Battery Alarm

Details the Battery Alarm, its causes, and indicators.

10.2 Temperature Alarm

Details the Temperature Alarm, its causes, and indicators.

10.3 Fault Alarm

Details the Fault Alarm, its causes, and indicators.

11 Switch from Primary Freedom Driver to Backup Freedom Driver

11.3 Driver Switch

Illustrates Driveline to Cannula connection.

11.4 Exchange Driver at Hospital

Procedures for exchanging the Driver at the hospital.

12 Switch from CSS Console to Primary Freedom Driver

12.1 Materials

Lists materials needed for switching from CSS Console.

12.3 Driver Exchange

Shows cutting wire ties on CSS connectors.

13 Switch from Freedom Driver to CSS Console

13.1 Materials

Lists materials needed for switching to CSS Console.

13.2 Preparation to Perform Switch from Freedom Driver to CSS Console

Steps to prepare for switching to CSS Console.

13.3 Driver Exchange

Shows Freedom Driveline to Cannula connection.

14 Switch from CSS Console with Modified Drivelines to Freedom Driver

14.1 Materials

Lists materials for switching from CSS Console with modified drivelines.

14.2 Preparation to Perform Switch from CSS Console with Modified Drivelines to Freedom Driver

Steps to prepare for switching from CSS Console with modified drivelines.

14.3 Driver Exchange

Shows Modified CSS Console Driveline to Cannula connection.

15 Switch from Companion 2 Driver to Freedom Driver

15.1 Materials

Lists materials needed for switching from Companion 2 Driver.

15.2 Preparation to Perform Switch from Companion 2 Driver to Freedom Driver

Steps to prepare for switching from Companion 2 Driver.

15.3 Driver Exchange

Shows Companion Driveline to Cannula connection.

16 Switch from Freedom Driver to a Companion 2 Driver

16.1 Materials

Lists materials needed for switching to Companion 2 Driver.

16.2 Preparation to Perform Switch from Freedom Driver to Companion 2 Driver

Steps to prepare for switching to Companion 2 Driver.

16.3 Driver Exchange

Shows Freedom Driveline to Cannula connection.

17 Equipment Maintenance and Care

17.1 Service

Information on scheduling Freedom Driver servicing.

17.2 Maintenance and Cleaning Instructions

General instructions for maintaining and cleaning the Driver.

17.2.1 Freedom Driver

Specific maintenance and cleaning for the Freedom Driver.

17.2.2 Drivelines

Instructions for inspecting and cleaning Drivelines.

17.2.3 Filter

How to inspect, clean, and replace the filter.

17.2.4 Onboard Batteries

Guidance on caring for Onboard Batteries.

17.2.5 Battery Wells

Instructions for keeping Battery Wells clean.

17.2.6 Battery Charger

Instructions for cleaning and maintaining the Battery Charger.

17.3 Storage Instructions

Guidelines for storing system components.

17.4 Return of the Freedom Driver System

Procedures for returning the system after patient transplant.

18 Freedom Driver System Specifications

18.1 Driver System Safety Standards

Lists safety standards the system complies with.

18.2 Battery Charger Safety Standards

Lists safety standards for the Battery Charger.

18.3 Driver Dimensions (without carrying bag)

Provides physical dimensions and weight of the Driver.

18.4 Power Adaptor Dimensions

Provides physical dimensions and weight of the Power Adaptor.

18.5 Battery Charger Dimensions

Provides physical dimensions and weight of the Battery Charger.

18.6 Environmental Conditions

Lists operating and storage environmental conditions.

18.7 Driver System Power Requirements

Details power requirements for the Driver System.

18.8 Battery Charger Power Requirements

Details power requirements for the Battery Charger.

18.9 Driver Operating Ranges

Lists key operating parameters of the Driver.

18.10 Input; Output Characteristics

Describes the system's input/output characteristics.

18.11 Classification for Freedom Driver System

Classifies the Freedom Driver System according to safety standards.

18.12 Classification for Battery Charger

Classifies the Battery Charger according to safety standards.

18.13 Classification for Hospital AC Power Supply

Classifies the Hospital AC Power Supply.

18.14 Classification for Home AC Power Supply

Classifies the Home AC Power Supply.

18.15 Firmware Versions

Lists the firmware versions for the system.

Appendix 1

Patient Information Card Template

Template for patient information cards.

Appendix 2

Freedom Driver System Test Protocol

Protocol for testing the Freedom Driver System.

FREEDOM DRIVER SYSTEM TEST PROTOCOL

BACKUP FREEDOM DRIVER CHECK

Checklist for verifying the backup Freedom Driver.

POWER REMOVAL ON BACKUP DRIVER

Steps for removing power from the backup Driver.

PRIMARY FREEDOM DRIVER CHECK

Checklist for verifying the primary Freedom Driver.

PATIENT PREPARATION

Steps for preparing the patient for testing.

Freedom Battery Charger Operational Check Form

SET UP

Steps for setting up the Battery Charger for testing.

CHECK OUT

Checkout steps for verifying Battery Charger functionality.

TROUBLESHOOTING INSTRUCTIONS

Troubleshooting steps for the Battery Charger.

SynCardia Freedom Specifications

General IconGeneral
BrandSynCardia
ModelFreedom
CategoryMedical Equipment
LanguageEnglish