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General| Brand | Abiomed |
|---|---|
| Model | Impella 2.5 |
| Category | Medical Equipment |
| Language | English |
Details the approved uses for Impella 2.5, CP, 5.0, and LD catheters in the US.
Lists conditions where Impella System use is contraindicated, including specific patient factors.
Lists potential adverse events associated with Impella System use.
Alerts to situations that can cause death or serious injury during Impella System use.
Indicates situations where equipment may malfunction, be damaged, or cease to operate.
Provides a general overview of the Impella Catheter and Automated Impella Controller.
Describes the components and features of the Impella Catheter models.
Details the functions and features of the Automated Impella Controller.
Explains the function and components of the Impella Purge Cassette.
Lists and describes accessories used with the Impella Catheter and Controller.
Details the front and side features of the Automated Impella Controller.
Describes the elements and information displayed on the Impella Controller Home Screen.
Explains the Placement Screen for monitoring real-time operating data and waveforms.
Describes the Purge Screen for monitoring purge system data.
Outlines factors to evaluate before Impella Catheter placement.
Details the steps for initiating the Impella System startup.
Guides through the initial steps for starting an Impella case.
Provides instructions for wired insertion of the Impella 2.5 Catheter.
Details the procedure for inserting the Impella CP Catheter.
Describes the surgical implantation and startup of the Impella LD Catheter.
Provides steps to resolve issues related to the Impella purge system.
Offers guidance on weaning patients from Impella support.
Outlines procedures for removing Impella 2.5, 5.0, and CP catheters.
Details the procedure for explanting the Impella LD Catheter.
Presents clinical data for Impella use in patients with AMI-induced cardiogenic shock.
Summarizes key safety and effectiveness findings from clinical studies.
Provides additional data from Impella registries and literature reviews.
Presents clinical data for Impella use in post-cardiac surgery patients.
Provides essential guidelines for ongoing patient care with Impella.
Explains using echocardiography to assess Impella Catheter position.
Details how to interpret and manage Impella Catheter position alarms.
Describes causes and actions for Impella Catheter suction alarms.
Provides guidance for managing hemolysis during Impella support.
Addresses troubleshooting for pressure sensor issues in Impella 5.0/LD.
Outlines the procedure for transferring Impella support to a new controller.
Details the steps for an emergency shutdown of the Impella controller.
Explains the alarm system, its levels, and indicators.
Describes how alarms are displayed and how to mute them.
Provides a summary of alarm messages, their causes, and actions.
Defines key terms, abbreviations, and symbols used in the manual.
Provides mechanical and electrical specifications for the controller.
Details EMC requirements and guidance for the Impella Controller.
Offers guidelines for transporting patients with the Impella system.
Lists key parameters and dimensions for Impella Catheters.
Provides warranty information for the Impella System in the US.
Lists approved guidewires and introducers for Impella 2.5 and CP.
Outlines the structure of the Automated Impella Controller menu system.
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