Intended Audience - Abiomed Impella 2.5 Manual Del Usuario

INTENDED AUDIENCE

This manual is intended for use by cardiologists, surgeons, nurses, perfusionists, and cardiac catheterization lab technicians who have been trained in the use of
the Impella Circulatory Support System.
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WARNINGS
Warnings alert you to situations that can cause death or serious injury. The dark gray symbol
Use of the Impella System by trained and experienced practitioners has been associated with improved outcomes. Consequently, the first use of Impella should be
preceded by the completion of a contemporary Abiomed Impella training program and include on-site proctoring during the first use by Abiomed clinical support
personnel certified in the use of Impella.
Fluoroscopy is required to guide placement of the Impella Catheter.
The small placement guidewire must be reliably observed at all times.
Be sure that the stopcock on the introducer or repositioning sheath is always kept in the closed position. Significant bleed back can result if the stopcock is open.
Avoid manual compression of the inlet and outlet areas of the cannula assembly.
The sterile components of the Impella System can be used only if the sterilization indicators show that the contents have been sterilized, the packaging is not
damaged, and the expiration date has not elapsed.
Do NOT resterilize or reuse the Impella Catheter. It is a disposable device and is intended for single-use only. Reuse, reprocessing, or resterilization may
compromise the structural integrity of the catheter and/or lead to catheter failure which, in turn, may result in patient injury, illness, or death.
Retrograde flow will occur across the aortic valve if the Impella Catheter is set at P-level P-0.
To prevent malfunction of the locking mechanism of the introducer, do NOT hold the hemostatic valve while inserting into the artery.
To prevent failure of the peel-away introducer, remove the peel-away introducer prior to transport when activated clotting time (ACT) is less than 150 seconds.
Do NOT use saline in the purge system.
Do NOT use an Impella System if any part of the system is damaged.
To prevent the risk of explosion, do NOT operate the Impella System near flammable anesthetics.
If at any time during the course of support with the Impella Catheter, the Automated Impella Controller alarms "Purge Pressure Low" or "Purge System Open,"
follow the instructions presented in the Automated Impella Controller User Manual.
Do NOT subject a patient who has been implanted with an Impella Catheter to magnetic resonance imaging (MRI). The strong magnetic energy produced by
an MRI machine may cause the Impella System components to stop working, and result in injuries to the patient. An MRI may also damage the electronics of
the Impella System.
Cardiopulmonary support (CPR) should be initiated immediately per hospital protocol if indicated for any patient supported by the Impella Catheter. When initiating
CPR, reduce the Impella Catheter flow rate. When cardiac function has been restored, return flow rate to the previous level and assess placement signals on the
controller.
During defibrillation, do NOT touch the Impella Catheter, cables, or Automated Impella Controller.
Infusion through the sideport of the introducer can be done only after all air is removed from the introducer. If performed, the infusion should be done for flushing
purposes only and NOT for delivering therapy or monitoring blood pressure.
Impella 2.5 ® and Impella CP ® Circulatory Support Systems
appears before warning messages.
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