User's Manual

Introduction

This manual provides instructions for operating the RECOVER BP

IABP/VAD System (RECOVER BP System or System). It is intended

to be used in conjunction with the RECOVER BP Intra-Aortic

Balloon Catheter Instructions for Use ****[add document number].

The following information summarizes the contents of each section:

• Section 1 (Warnings and Cautions) lists the warnings and

cautions pertaining to the use of the RECOVER BP System.

• Section 2 (Indications, Contraindications, and Potential

Adverse Events) discusses indications for use of the System

and potential adverse events that may be associated with it.

• Section 3 (The RECOVER BP IABP/VAD System)

provides an overview of the System and associated products.

• Section 4 (Using the RECOVER BP Console) describes

the features, connections, and layout of the RECOVER BP

Console (Console).

• Section 5 (System Status and Settings) describes the

handling of tasks common to both IABP and VAD support.

• Section 6 (IABP Support) describes the procedures for

providing IABP support.

• Section 7 (VAD Support) describes the procedures for

providing VAD support.

• Section 8 (Emergency System Operation [ESO])

describes Emergency System Operation for both IABP and VAD

support.

• Section 9 (Installation and Maintenance) provides

information on installation, cleaning, and preventive

maintenance.

• Section 10 (Abbreviations and Symbols) explains the

symbols and abbreviations used on the System.

• Section 11 (System Specifications) provides technical

information pertaining to the System.