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Abbott CentriMag User Manual

Abbott CentriMag
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CentriMag
TM
Circulatory Support System Operation Manual (US) Page 1 of 126
© 2019 Abbott Document No PL-0047, Rev 11 (December 2019)
CentriMag
TM
Circulatory Support System
Operation Manual
READ ALL INDIVIDUAL CENTRIMAG CIRCULATORY SUPPORT SYSTEM
COMPONENT INSTRUCTIONS FOR USE (IFU), THE CENTRIMAG CLINICAL
REFERENCE MANUAL, AND THE ENTIRE CONTENTS OF THIS MANUAL
BEFORE USE.
Abbott Medical Clinical & Technical Support Phone number(s)
Emergency HeartLine Support:
Abbott Medical
Main Switchboard:
Tel: +1-800-456-1477
Tel: +1-925-847-8600
Fax: +1-925-847-8574
Manufacturer:
Thoratec Switzerland GmbH
Technoparkstrasse 1
CH-8005 Zürich
Switzerland
US Headquarters:
Abbott Medical
6035 Stoneridge Drive
Pleasanton, CA 94588
USA
www.abbott.com
PL-0047, Rev 11
December 2019
DCO No 19-038

Table of Contents

Other manuals for Abbott CentriMag

Questions and Answers:

Abbott CentriMag Specifications

General IconGeneral
BrandAbbott
ModelCentriMag
CategoryMedical Equipment
LanguageEnglish

Summary

Manual Overview

Indications and Contraindications

Indications for Use

Details the intended use of the CentriMag System and its components.

Contraindications for Use

Specifies conditions where the CentriMag System should not be used.

General Conventions

Warnings and Cautions

Defines and explains warnings and cautions used in the manual.

Patents and Trademarks

Lists patents and trademarks associated with the product.

Conventions Used in This Manual

Explains formatting and text conventions used in the manual.

Warnings and Precautions

Description

General Overview

Provides a general overview of the CentriMag Circulatory Support System.

CentriMagTM Circulatory Support System Components

Details the main and backup system components.

Optional CentriMagTM Circulatory Support System Components

Lists optional accessories for the System.

CentriMag and PediMag Blood Pumps

Describes the electronically-driven, centrifugal blood pumps.

Mag Monitor

Explains the function and use of the Mag Monitor with the system.

2nd Generation CentriMag Primary Console

Details the primary console's capabilities and specifications.

Motor

Describes the CentriMag Motor's function in holding and driving the pump.

Backup Console

Explains the function of the backup console.

System Cart

Describes the custom-designed CentriMag System Cart.

Application Software

Lists compatible software versions for system components.

Required User Supplied Items

Lists items not provided by Abbott Medical but required for system use.

Specifications and General Description

Classification

Details the system's classification based on standards.

Specifications

Provides technical specifications for the Console.

Environmental Conditions

Outlines acceptable conditions for shipping, operation, and storage.

Essential Performance

Details the essential performance characteristics of the System.

EMI Considerations

Discusses electromagnetic interference and its impact.

Permanent Magnet Considerations

Addresses potential interference from permanent magnets.

Console, Monitor, and Flow Probe Controls

Details the features and functions of system controls and indicators.

Alarm and Alert Conditions

Explains how alarms and alerts function and are indicated.

Digital Display Information

Details the information shown on the Console's digital display.

Requirements for Connecting Additional Equipment

Lists requirements for connecting external equipment.

Setting Up the System

Unpacking

Provides steps for unpacking the system components.

Console Mounting

Details how to mount the Console onto the System Cart.

Monitor Mounting

Explains how to mount the Monitor using the Monitor Arm.

Motor Mounting

Describes how to mount the Motor using the Motor Bracket.

Powering Up the Console

Outlines the procedure for powering up the Console.

Self-Test Initiation

Explains the self-test sequence performed upon powering on the Console.

Configuring the Console

Details how to configure system parameters like pump speed and alerts.

Console BIOS

Explains how to access and navigate the Console's BIOS settings.

Setting the Console Max Flow Alert

Guides on setting the maximum flow alert threshold.

Setting the Console Min Flow Alert

Guides on setting the minimum flow alert threshold.

Entering the Pressure Menu

Explains how to access the Pressure Menu.

Setting the Max or Min Pressure Alert Settings for the P1 Transducer

Details setting pressure alerts for the P1 transducer.

Setting the Max or Min Pressure Alert Settings for the P2 Transducer

Details setting pressure alerts for the P2 transducer.

Activating the Pressure Monitoring System (Pressure Display)

Explains how to activate the pressure monitoring system.

Stopwatches

Explains the function and use of the stopwatches.

Flow Range

Details how to change and use the system's flow ranges.

Changing the Flow Recorder Speed

Explains how to adjust the flow graph speed.

Setting the Console Speed Step Resolution

Guides on setting speed increments for the pump.

Selecting Displayed Language

Explains how to change the system's display language.

Setting the Console Flow Limit Sensitivity

Details how to adjust flow limit sensitivity modes.

Setting the Application Mode

Explains how to set the application mode (LVAD/RVAD).

The System Data Logger

Describes the function and use of the system's data logger.

Copy Logger Data to a USB Memory Stick

Details how to copy logged data to a USB stick.

Monitor Connection

Explains how to connect the Monitor to the Console.

Accessing the Monitor Management Application

Guides on accessing the Monitor's management features.

Pump Set-up

Refers to instructions for proper pump setup and operation.

System Operation

Operation of the Pump

Describes how to start and operate the pump.

Starting the Pump

Details the steps for starting the pump.

Adjusting Pump Speed

Explains how to adjust the pump's speed.

Manually Stopping the Pump

Details how to manually stop the pump.

Restarting the Pump

Explains the procedure for restarting the pump.

Console Alarm/Alert Strategy

Explains the console's strategy for handling alarms and alerts.

Alarms

Describes how the system responds to alarm conditions.

Alarm Conditions Requiring Powering Off Before Restarting

Details alarms requiring power cycle before restart.

Alerts

Explains system alerts and their advisory nature.

Response to System Alarms or Alerts

Guides on appropriate operator response to alarms/alerts.

Battery Operation

Details the system's operation on battery power.

Planning for Battery Support

Provides guidance on planning for battery support duration.

Changing from the Main to the backup Console

Details switching to a backup console.

Battery Support Time at Various Operating Levels

Lists estimated battery runtimes.

Patient Transport

Covers considerations for transporting the system with a patient.

Transport Vehicle Qualification

Details vehicle requirements for transport.

Console Considerations

Lists console-specific points for transport.

Shut Down by Operator

Explains the procedure for shutting down the system.

Maintenance

Changing Fuses

Provides instructions for replacing fuses in the console.

Maintenance Following Each Patient Use

Outlines cleaning procedures after patient use.

Recommended Preventive Maintenance

Details a schedule for preventive maintenance tasks.

Battery Maintenance

Explains the procedure for maintaining the system's battery.

Motor Visual Inspection

Guides on visually inspecting the motor cable for damage.

Emergency / Troubleshooting

Switching to Backup Hardware

Details how to switch to backup system components.

Switching to another Pump

Explains how to switch to an alternative pump.

Defibrillation/ Cardioversion

Provides guidance on operating the system during defibrillation/cardioversion.

Electrosurgical Units

Discusses operating the system with electrosurgical units.

Disposal of Equipment

Appendices

Appendix I – Console Alarms and Alerts

Lists console alarms and alerts with system status and operator response.

Appendix II – Technical Specification

Presents detailed technical specifications for the console.

EM-TEC Adult Flow Probe Specifications

Details the technical specifications for the EM-TEC Adult Flow Probe.

EM-TEC Pediatric Flow Probe Specifications

Details the technical specifications for the EM-TEC Pediatric Flow Probe.

Appendix III – Electromagnetic Emissions

Provides guidance on electromagnetic emissions.

Appendix IV – Electromagnetic Immunity

Provides guidance on electromagnetic immunity.

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