Abiomed Impella 5.5, Руководство пользователя

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1 Impella 5.5
®
with SmartAssist
®
Circulatory Support System
INTENDED AUDIENCE
This Instructions for Use and Clinical Reference Manual is designed for healthcare professionals. It contains clinical and technical information to guide healthcare
professionals in their use of the Impella 5.5 ® with SmartAssist ® . To use the system you must understand and follow these instructions. The Impella 5.5 with
SmartAssist may be used only for its intended purpose.
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 for the insertion of the Impella guidewire and
Impella 5.5 with SmartAssist Catheter.
During insertion, avoid manual compression of the inlet, outlet, or
sensor areas of the cannula assembly on the Impella 5.5 Catheter.
The sterile components of the Impella 5.5 System can be used only if
the packaging is not damaged, and the expiration date has not elapsed.
Do
NOT
resterilize or reuse the Impella 5.5 with SmartAssist 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 5.5 with
SmartAssist Catheter is set at P-level P-0.
Do
NOT
use saline in the purge system.
Do NOT use alcohol-based fluids for lubrication.
Do NOT use an Impella 5.5 with SmartAssist System if any part of the
system is damaged.
To prevent the risk of explosion, do
NOT
operate the Impella 5.5 with
SmartAssist System near flammable anesthetics.
If at any time during the course of support with the Impella 5.5 with
SmartAssist Catheter, the Automated Impella Controller alarms “Purge
Pressure Low” or “Purge System Open,” follow the instructions
presented in this manual.
MR Unsafe - Do
NOT
subject a patient who has been
implanted with an Impella 5.5 with SmartAssist Catheter to
magnetic resonance imaging (MRI). The strong magnetic
energy produced by an MRI machine may cause the Impella 5.5
System components to stop working, and result in injuries to the patient.
An MRI may also damage the electronics of the Impella 5.5 System.
During defibrillation, do NOT touch the Impella 5.5 with SmartAssist
Catheter, cables, or Automated Impella Controller.
Avoid overinserting the Impella 5.5 Catheter and possibly impinging the
catheter tip against the walls of the vasculature or ventricles.
Do
NOT
advance or withdraw the Impella 5.5 with SmartAssist
Catheter against resistance without using fluoroscopy to determine
the cause of the resistance. Doing so could result in separation of
the catheter or guidewire tip, damage to the catheter or vessel, or
ventricular perforation.
CAUTIONS
Cautions indicate situations in which equipment may malfunction, be
damaged, or cease to operate. The light gray symbol appears before
caution messages.
INTENDED USE (EU)
INTENDED USE IN THE EUROPEAN UNION
The Impella 5.5
®
with SmartAssist ® heart pump is an intracardiac pump for
supporting the left ventricle. It is intended for clinical use in cardiology and
in cardiac surgery for up to 30 days for the following indications, as well as
others:
• The Impella 5.5 with SmartAssist is a cardiovascular support system
for patients with reduced left ventricular function, e.g., post-
cardiotomy, low output syndrome, cardiogenic shock after acute
myocardial infarction.
• The Impella 5.5 with SmartAssist may also be used as a cardiovascular
support system during coronary bypass surgery on the beating heart,
particularly in patients with limited preoperative ejection fraction with
a high risk of postoperative low output syndrome.
Handle with care. The Impella 5.5 with SmartAssist 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.
Patients with aortic stenosis or other abnormal aortic valve performance
may be compromised by the use of the Impella 5.5 with SmartAssist
Catheter. Patients with aortic valve disease should be observed for aortic
insufficiency.
Use only original accessories and replacement parts supplied by
Abiomed.
To prevent device failure, do NOT start the Impella 5.5 with SmartAssist
Catheter until the placement guidewire has been removed.
Do
NOT
remove the Impella 5.5 with SmartAssist Catheter over the
length of the placement guidewire.
When replacing the purge cassette, the replacement process must be
completed within 90 seconds. The Impella 5.5 with SmartAssist Catheter
may be damaged if replacement takes longer than 90 seconds.
Do NOT kink or clamp any part of the Impella 5.5 with SmartAssist
Catheter.
Have a backup Automated Impella Controller, purge cassette, and
Impella 5.5 with SmartAssist Catheter available in the unlikely event of a
device failure.
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