Abbott CentriMag - Manual Overview

CentriMag
TM
Circulatory Support System Operation Manual (US) Page 5 of 126
© 2019 Abbott – Document No PL-0047, Rev 11 (December 2019)
1 MANUAL OVERVIEW
This manual provides technical information and use instructions for the CentriMag
TM
Circulatory Support System (System). The Clinical Reference Manual contains clinical use
information on the System to help guide healthcare professionals. The user must
understand and follow both manuals. The following summarizes the content of each
section of this manual.
Section 1: Manual Overview describes the organization of this Manual.
Section 2: Indications & Contraindications describes the intended use of the
System.
Section 3: General Conventions describes warnings, cautions, and conventions
of expression used in this Manual. Also, this section describes the
Patents and Trademarks involved.
Section 4: Warnings & Precautions describes warnings and cautions to be
considered when using the System.
Section 5: Device Description describes the System and each element within the
System.
Section 6: Specifications and General Description describes the product
specifications and physical attributes of the System.
Section 7: Setting up the System describes the procedure for unpacking the
System and configuring it for use.
Section 8: System Operation describes how to operate the Console.
Section 9: Maintenance describes procedures for maintaining and cleaning the
System.
Section 10: Emergency describes procedures for managing the Console during
defibrillation and in the event of equipment malfunction.
Section 11: Disposal of Equipment describes the procedure for proper disposal of
used Console batteries and Consoles that have reached end of useful
service life.
Section 12: Appendices
Appendix I: Alarm/Alert Table lists the Console’s audio/visual alarms and alerts
and the expected System and operator response to each alarm or alert
condition.
Appendix II: Technical Specification lists the product specifications and physical
attributes of the Console.
Appendix III: Electromagnetic Emissions describes the electromagnetic
environmental conditions under which the System may be operated.
Appendix IV Electromagnetic Immunity describes the electromagnetic
environmental conditions under which the System may be operated.