Abiomed Impella 2.5 Manual Del Usuario página 4

CAUTIONS
Cautions indicate situations in which equipment may malfunction, be damaged, or cease to operate. The light gray symbol
Handle with care. The Impella
place excess pressure on the catheter or mechanical components at any time.
Physicians should exercise special care when inserting the Impella Catheter during active Cardiopulmonary Resuscitation (CPR). In addition, active
CPR maneuvers may change the position of the Impella device. Check that the pump is positioned correctly in the left ventricle after CPR with
echocardiography guidance.
Patients with aortic stenosis or other abnormal aortic valve performance may be compromised by the use of the Impella Catheter. Patients with aortic
valve disease should be observed for aortic insufficiency.
Partial circulatory support with Impella has been associated with more extensive use of rotational atherectomy. Extensive use of rotational atherectomy
has been associated with a periprocedural increase in cardiac biomarkers indicative of myocardial injury. Rotational atherectomy, with or without the use
of hemodynamic support, should be used in accordance with the manufacturer's instructions for use.
Physicians should exercise special care when inserting the Impella Catheter in patients with known or suspected unrepaired abdominal aortic aneurysm
or significant descending thoracic aortic aneurysm or dissection of the ascending, transverse, or descending aorta.
Use only original accessories and replacement parts supplied by Abiomed.
Do NOT use damaged or contaminated connector cables.
To prevent device failure, do NOT start the Impella Catheter until the guidewire has been removed.
Do NOT remove the Impella Catheter over the length of the guidewire.
When replacing the purge cassette, the replacement process must be completed within 90 seconds. The Impella Catheter may be damaged if
replacement takes longer than 90 seconds.
Do NOT kink or clamp the Impella Catheter or the introducer.
During case start, make sure the yellow luer connection between the purge tubing and Y connector is tightened and not leaking.
Have a backup Automated Impella Controller, purge cassette, connector cable, and Impella Catheter available in the unlikely event of a device failure.
Do NOT alter the Impella Introducer kit in any way.
Aspiration and saline flushing of the Impella Introducer kit sheath, dilator, and valve should be performed to help minimize the potential for air embolism
and clot formation.
Indwelling introducer sheaths should be internally supported by a catheter or dilator.
Dilators and catheters should be removed slowly from the sheath. Rapid removal may damage the valve, resulting in blood flow through the valve.
Never advance the guidewire or sheath when resistance is met. Determine the cause of resistance using fluoroscopy and take remedial action
When injecting or aspirating through the sheath, use the sideport only.
Operation of the system without heparin in the purge solution has not been tested. In the event that a patient is intolerant to heparin, due to heparin-
induced thrombocytopenia or bleeding, physicians should use their clinical judgment to assess the risks versus benefits of operating the Impella System
without heparin. If it is in the best interest of the patient to operate the system without heparin, the glucose solution is still required, and physicians
should consider systemic delivery of an alternative anticoagulant. Do NOT add any alternative anticoagulant (such as a direct thrombin inhibitor) to the
purge fluid. The Impella Catheter has not been tested with any alternative anticoagulants in the purge solution.
Do NOT insert the repositioning sheath into the peel-away sheath during catheter insertion; slide the repositioning sheath towards the red pump handle
prior to inserting the device.
Never remove the guidewire when increased resistance is met. Determine the cause of resistance using fluoroscopy and verify the repositioning sheath is
not inserted into the peal-away sheath.
In patients with transcatheter aortic valves position the Impella system carefully to avoid interaction with the TAV prosthesis. In this situation, avoid
repositioning while the device is running; turn the device to P0 during repositioning or any movement that could bring the outlet windows into proximity
to the valve stent structures. If there is low flow observed in a patient implanted with a transcatheter aortic valve prosthesis, consider damage of the
impeller and replace the Impella pump as soon as possible.
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Catheter can be damaged during removal from packaging, preparation, insertion, and removal. Do NOT bend, pull, or
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appears before caution messages.
User Manual