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Abiomed Impella CP - 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

Impella Ventricular Support Systems Instructions for Use & Clinical Reference Manual

Indications, Contraindications, and Potential Adverse Events

Indications for Impella Systems

Specifies the short-term use of Impella 2.5, CP, 5.0, and LD for cardiogenic shock post-MI or surgery.

Warnings and Cautions for Impella System Use

General Warnings

Highlights critical warnings to prevent death or serious injury, including MR unsafe conditions and handling precautions.

Impella Catheter and Automated Impella Controller Components

Using the Automated Impella Controller

Automated Impella Controller Features

Illustrates and describes the features on the front, left, and right sides of the controller.

Placement Screen Waveforms

Describes the placement signal and motor current waveforms shown on the placement screen.

Using the Automated Impella Controller with the Impella Catheter

System Startup Procedures

Outlines the necessary supplies and steps for turning on and starting up the Impella System.

Impella 2.5 Catheter Insertion (Wired)

Provides detailed steps for the wired insertion of the Impella 2.5 Catheter into the femoral artery.

Impella CP Catheter Insertion

Details the procedure for inserting the Impella CP Catheter, emphasizing safety and technique.

Implanting and Starting the Impella LD Catheter

Details the surgical implantation process for the Impella LD Catheter, including preparation and aortic insertion.

Positioning and Starting Impella 2.5 and CP Catheters

Guides the user on positioning the catheter correctly and starting the pump, including modes of operation.

Positioning and Starting Impella 5.0 Catheter

Provides instructions for positioning and starting the Impella 5.0 Catheter, focusing on waveform confirmation and P-level selection.

Positioning and Starting Impella LD Catheter

Details positioning and starting procedures for the Impella LD Catheter, including waveform verification and P-level adjustment.

Troubleshooting the Purge System

Addresses common purge system issues like low pressure, open system, high pressure, and blockages.

Removing the Impella Catheter

Details procedures for removing the Impella 2.5, 5.0, or CP Catheter with the introducer or sheath.

Explanting the Impella LD Catheter

Explains the process for explanting the Impella LD Catheter, including preparation and graft closure.

Patient Management Topics

Use of Echocardiography for Positioning

Explains how echocardiography (TEE/TTE) is used to evaluate Impella Catheter position relative to the aortic valve.

Managing Impella Catheter Position Alarms

Details how the controller monitors position via placement signal and motor current, and how to manage alarms.

Impella Stopped Conditions

Provides actions to take if the Impella Catheter has stopped suddenly, including restart attempts and removal.

Suction Management

Explains suction occurrence due to inadequate volume or restricted flow and provides actions for Impella 2.5/CP and 5.0/LD.

Pressure Sensor Drift and Sensor Failure

Explains how to manually zero the differential pressure sensor and the effects of sensor failure on flow and position.

Emergency Shutdown Procedure

Outlines the procedure to restart the controller without stopping the Impella Catheter if software stops responding.

Automated Impella Controller Alarms

Alarm Levels and Indicators

Categorizes alarms into Advisory, Serious, and Critical, detailing audible and visual indicators for each.

Alarm Display and Mute Function

Describes the alarm window, priority listing, color coding, and how to use the MUTE ALARM function.

Alarm Message Summary

Provides a comprehensive summary of alarm messages, their actions, and potential causes for critical and serious alarms.

Abiomed Impella CP Specifications

General IconGeneral
Therapeutic AreaCardiology
Insertion MethodPercutaneous
Intended UseTemporary ventricular support
IndicationHigh-risk PCI and cardiogenic shock
Catheter Size14 Fr
Motor SpeedVariable
Power SourceImpella Console
SterilitySterile

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