User Responsibility - Abiomed ImpellaCP Manuel D'utilisation

USER RESPONSIBILITY

The Impella System will perform in conformity with the description thereof
contained in this manual and accompanying labels and/or inserts, when
assembled, operated, and maintained in accordance with the instructions
provided. A defective system should not be used. Any serious incident
that has occurred in relation to the device should be reported to the
manufacturer and the competent authority of the Member State in which
the user and/or patient is established.
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.
WARNINGS
Warnings alert you to situations that can cause death or serious injury. The
dark gray symbol appears before warning messages.
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
0.018 inch 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 160-
180 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 the Automated
Impella Controller User Manual
Do NOT subject a patient which is supported by 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.
Impella CP with SmartAssist
® ®
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.
CAUTIONS
Cautions indicate situations in which equipment may malfunction, be
damaged, or cease to operate. The light gray
caution messages.
Handle with care. The Impella Catheter can be damaged during removal
from packaging, preparation, insertion, and removal. Do NOT bend, pull,
or 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.
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.
Have a backup Automated Impella Controller, purge cassette 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.
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