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Specifies the short-term use of Impella 2.5, CP, 5.0, and LD for cardiogenic shock post-MI or surgery.
Highlights critical warnings to prevent death or serious injury, including MR unsafe conditions and handling precautions.
Illustrates and describes the features on the front, left, and right sides of the controller.
Describes the placement signal and motor current waveforms shown on the placement screen.
Outlines the necessary supplies and steps for turning on and starting up the Impella System.
Provides detailed steps for the wired insertion of the Impella 2.5 Catheter into the femoral artery.
Details the procedure for inserting the Impella CP Catheter, emphasizing safety and technique.
Details the surgical implantation process for the Impella LD Catheter, including preparation and aortic insertion.
Guides the user on positioning the catheter correctly and starting the pump, including modes of operation.
Provides instructions for positioning and starting the Impella 5.0 Catheter, focusing on waveform confirmation and P-level selection.
Details positioning and starting procedures for the Impella LD Catheter, including waveform verification and P-level adjustment.
Addresses common purge system issues like low pressure, open system, high pressure, and blockages.
Details procedures for removing the Impella 2.5, 5.0, or CP Catheter with the introducer or sheath.
Explains the process for explanting the Impella LD Catheter, including preparation and graft closure.
Explains how echocardiography (TEE/TTE) is used to evaluate Impella Catheter position relative to the aortic valve.
Details how the controller monitors position via placement signal and motor current, and how to manage alarms.
Provides actions to take if the Impella Catheter has stopped suddenly, including restart attempts and removal.
Explains suction occurrence due to inadequate volume or restricted flow and provides actions for Impella 2.5/CP and 5.0/LD.
Explains how to manually zero the differential pressure sensor and the effects of sensor failure on flow and position.
Outlines the procedure to restart the controller without stopping the Impella Catheter if software stops responding.
Categorizes alarms into Advisory, Serious, and Critical, detailing audible and visual indicators for each.
Describes the alarm window, priority listing, color coding, and how to use the MUTE ALARM function.
Provides a comprehensive summary of alarm messages, their actions, and potential causes for critical and serious alarms.
| Therapeutic Area | Cardiology |
|---|---|
| Insertion Method | Percutaneous |
| Intended Use | Temporary ventricular support |
| Indication | High-risk PCI and cardiogenic shock |
| Catheter Size | 14 Fr |
| Motor Speed | Variable |
| Power Source | Impella Console |
| Sterility | Sterile |