Abiomed Impella RP Manual Del Usuario página 5

CAUTIONS
Handle with care. The Impella RP
packaging, preparation, insertion, and removal. Do NOT bend, pull, or place excess
pressure on the catheter or mechanical components at any time.
Patients with tricuspid or pulmonary valve stenosis or insufficiency, and patients
with prosthetic tricuspid or pulmonary valves, may be compromised by the use of
the Impella RP ®
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 RP
placement guidewire has been removed.
Do NOT remove the Impella RP
guidewire.
When replacing the purge cassette, the replacement process must be completed
within 2 minutes. The Impella RP
longer than 2 minutes.
To prevent malfunction of the Automated Impella
exposure to direct sunlight and excessive heat (40°C).
To prevent overheating and improper operation, do NOT block the cooling vents of
the Automated Impella
Do NOT kink or clamp any part of the Impella RP
Do NOT use the Impella RP
Replace the introducer if a kink is observed.
The Li-Ion batteries must be charged for 5 hours prior to system operation in order
to meet the runtime requirement of 1 hour. Failure to do so will yield a shorter
runtime. After being unplugged, the Automated Impella
at least 60 minutes after the batteries have been fully charged.
Have a backup Automated Impella
Impella RP Catheter available in the unlikely event of a device failure.
®
Do NOT use the bed mount as a handle.
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
If it is in the best interest of the patient to operate the system without heparin, the
dextrose 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
tested with any alternative anticoagulants in the purge solution.
Insertion through the left femoral vein may result in repeated attempts to properly
position the Impella RP
damage. As a result, left femoral insertion should be avoided whenever possible.
Impella RP ® with the Automated Impella
® Catheter can be damaged during removal from
Catheter.
Catheter over the length of the placement
®
Catheter may be damaged if replacement takes
®
Controller while it is operating.
®
Catheter with a damaged or kinked introducer.
®
Controller, purge cassette, connector cable, and
®
, which could cause excessive manipulation and pump
®
® Controller
® Catheter until the
® Controller, avoid long-term
® Catheter.
Controller will operate for
®
System without heparin.
®
Catheter has not been
®
3