Abiomed Impella 2.5, Instructions For Use Manual

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I Impella Ventricular Support System s for Use During Cardiogenic Shock
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
®
2.5, 5.0, LD, and Impella CP
®
Catheters during cardiogenic shock. The Impella
System performs life-sustaining functions. To use the system you must
understand and follow these instructions. The Impella
®
System may be used only for its
intended purpose.
MANUAL OVERVIEW
This manual provides instructions for use of the Impella
®
2.5, 5.0, LD, and Impella CP
®
Catheters
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 ® 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
®
Catheter with the Automated Impella
®
Controller.
• Section 3: The Impella
®
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
®
Catheter
provides the procedures for using the Impella ® System.
• Section 6: Clinical Experience provides an overview of clinical studies of the Impella
®
System.
• Section 7: Patient Management Topics provides key information on various topics
related to management of patients with the Impella
®
Catheter and Automated Impella
®
Controller.
•
Section 8: Automated Impella
®
Controller Alarms
provides a listing of Automated
Impella
®
Controller alarms as well as information on what to do to resolve them.
•
Section 9: 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
® Catheter and Automated Impella ® Controller components and
packaging, technical information pertaining to the Impella ® 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 Impella
®
Limited Service Warranty; Abiomed-approved guidewires and
introducers; and the Automated Impella
®
Controller menu structure.
IN
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