INTRODUCTION
PURPOSE OF MANUAL
This Instructions for Use & Clinical Reference Manual is designed for healthcare professionals. It
contains clinical and technical information to guide healthcare professionals in their use of the
Impella® RP Catheter with the Automated Impella® Controller. The Impella® RP System performs
life-sustaining functions. To use the system you must understand and follow these instructions. The
Impella® RP System may be used only for its intended purpose.
MANUAL OVERVIEW
This manual provides instructions for use of the Impella
®
RP Catheter with the Automated Impella®
Controller. The following summarizes the contents of each section of the manual.
• Section 1: Indications, Contraindications, and Potential Adverse Events discusses
indications for use of the Impella
®
RP Catheter with the Automated Impella
®
Controller,
contraindications, and potential adverse events that may be associated with the use of the
system.
• Section 2: Warnings and Cautions discusses the warnings and cautions pertaining to the
use of the Impella
®
RP Catheter with the Automated Impella
®
Controller.
• Section 3: The Impella® RP Catheter and Automated Impella® Controller provides an
overview of the system and describes its major components and features.
• Section 4: Using the Automated Impella® Controller describes the controls and various
screen types on the Automated Impella® Controller.
• Section 5: Using the Automated Impella® Controller with the Impella® RP Catheter
provides the procedures for using the Impella® RP System.
• Section 6: Clinical Experience provides an overview of the RECOVER RIGHT trial, which
studied the use of the Impella® RP System in a U.S. clinical trial. The results of this trial
were reviewed by the FDA prior to its approval of the Impella® RP System.
• Section 7: Automated Impella® Controller Alarms provides a listing of Automated
Impella® Controller alarms as well as information on what to do to resolve them.
• Section 8: General System Information contains information including definitions for key
terms that appear in the manual, descriptions of the abbreviations and symbols that appear
on Impella® RP Catheter and Automated Impella® Controller components and packaging,
technical information pertaining to the Impella® RP Catheter and Automated Impella®
Controller, and instructions on cleaning and storing system components as well as returning
components to Abiomed.
• Appendices at the end of the manual provide supplemental information about topics
including the Automated Impella® Controller menu structure.
Impella
®
RP with the Automated Impella
®
Controller
I
