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Abiomed Impella 5.0 - User Manual

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Impella
®
2.5, 5.0, LD and Impella CP
®
INSTRUCTIONS FOR USE
& CLINICAL REFERENCE MANUAL
(United States only)
Impella Ventricular
Support Systems
for Use During Cardiogenic Shock

Table of Contents

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Summary

1 INDICATIONS, CONTRAINDICATIONS, AND POTENTIAL ADVERSE EVENTS

INDICATIONS (UNITED STATES)

Details the intended use and indications for Impella 2.5, CP, 5.0, and LD catheters for short-term ventricular support.

CONTRAINDICATIONS (UNITED STATES)

Lists conditions and patient factors that contraindicate the use of the Impella System.

POTENTIAL ADVERSE EVENTS (UNITED STATES)

Lists potential adverse events associated with the use of the Impella System.

2 WARNINGS AND CAUTIONS

WARNINGS

Provides critical safety information and warnings to prevent death or serious injury.

CAUTIONS

Details cautions to prevent equipment malfunction, damage, or cessation of operation.

4 USING THE AUTOMATED IMPELLA CONTROLLER

AUTOMATED IMPELLA CONTROLLER FEATURES

Details the features on the front and sides of the Automated Impella Controller.

5 USING THE AUTOMATED IMPELLA CONTROLLER WITH THE IMPELLA CATHETER

PRE-SUPPORT EVALUATION

Guides on evaluating the patient and vasculature before Impella Catheter placement.

STARTUP

Details the necessary supplies and steps for starting up the Impella System.

CASE START

Outlines the procedure for initiating a new case with the Impella System.

IMPELLA 2.5 CATHETER INSERTION (WIRED)

Provides step-by-step instructions for wired insertion of the Impella 2.5 Catheter.

WIRELESS INSERTION OF THE IMPELLA 2.5 CATHETER

Describes an alternative wireless technique for Impella 2.5 Catheter insertion.

IMPELLA CP CATHETER INSERTION

Provides step-by-step instructions for inserting the Impella CP Catheter.

IMPLANTING AND STARTING THE IMPELLA LD CATHETER

Guides on surgically implanting and starting the Impella LD Catheter.

POSITIONING AND STARTING THE IMPELLA 2.5 AND IMPELLA CP CATHETERS

Details positioning and starting procedures for Impella 2.5 and CP catheters.

POSITIONING AND STARTING THE IMPELLA 5.0 CATHETER

Guides on positioning and starting the Impella 5.0 Catheter.

POSITIONING AND STARTING THE IMPELLA LD CATHETER

Guides on positioning and starting the Impella LD Catheter.

REMOVING THE IMPELLA 2.5, 5.0, OR IMPELLA CP CATHETER

Details the procedures for removing Impella 2.5, 5.0, or CP catheters.

EXPLANTING THE IMPELLA LD CATHETER

Provides instructions for explanting the Impella LD Catheter.

6 CLINICAL EXPERIENCE

SAFETY AND EFFECTIVENESS RESULTS

Summarizes the safety and effectiveness findings from clinical studies.

HEMODYNAMIC EFFECTIVENESS RESULTS

Presents data on the hemodynamic benefits observed with Impella support.

7 PATIENT MANAGEMENT TOPICS

USE OF ECHOCARDIOGRAPHY FOR POSITIONING OF THE IMPELLA CATHETER

Details the use of echocardiography for verifying Impella Catheter position.

CORRECT IMPELLA CATHETER POSITION

Describes the correct positioning of the Impella Catheter based on echo findings.

UNDERSTANDING AND MANAGING IMPELLACATHETER POSITION ALARMS

Guides on interpreting and managing Impella Catheter position alarms.

CORRECT POSITION

Illustrates the correct placement screen for Impella Catheters.

IMPELLA 2.5 OR IMPELLA CP CATHETER FULLY IN VENTRICLE

Describes the alarm and actions for Impella 2.5/CP Catheter fully in the ventricle.

IMPELLA 2.5 OR IMPELLA CP CATHETER OUTLET AREA ON OR NEAR AORTIC VALVE

Describes the alarm and actions for Impella 2.5/CP outlet area near the aortic valve.

IMPELLA 5.0 OR LD CATHETER POSITION WRONG

Addresses the alarm and actions for incorrect positioning of Impella 5.0/LD.

IMPELLA 5.0 OR LD CATHETER OUTLET AREA ON OR NEAR AORTIC VALVE

Describes the alarm and actions for Impella 5.0/LD outlet area near the aortic valve.

IMPELLA STOPPED

Provides troubleshooting steps if the Impella Catheter stops suddenly.

EMERGENCY SHUTDOWN PROCEDURE

Provides steps for emergency shutdown of the controller if it becomes unresponsive.

8 AUTOMATED IMPELLA CONTROLLER ALARMS

ALARMS OVERVIEW

Provides an overview of the automated controller's alarm system.

ALARM MESSAGE SUMMARY

Provides a summary of alarm messages, actions, and causes.

Abiomed Impella 5.0 Specifications

General IconGeneral
BrandAbiomed
ModelImpella 5.0
CategoryMedical Equipment
LanguageEnglish

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