CAUTIONS
Handle with care. The Impella® RP 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 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 Catheter.
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 Catheter until the
placement guidewire has been removed.
Do NOT remove the Impella® RP Catheter over the length of the placement
guidewire.
When replacing the purge cassette, the replacement process must be completed
within 2 minutes. The Impella® RP Catheter may be damaged if replacement takes
longer than 2 minutes.
To prevent malfunction of the Automated Impella® Controller, avoid long-term
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® Controller while it is operating.
Do NOT kink or clamp any part of the Impella® RP Catheter.
Do NOT use the Impella® RP Catheter with a damaged or kinked introducer.
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® Controller will operate for
at least 60 minutes after the batteries have been fully charged.
Minimize exposure of Impella® RP System components to sources of electromagnetic
interference (EMI). Exposure to sources of EMI, such as cell phones and two-way
radios, may cause operational interference. To clear interference, either increase the
distance between system components and the EMI source or turn off the EMI source.
Operation of Impella® RP System components may interfere with the operation of
other devices. If interference occurs, increase the distance between the device and
system components.
Impella
®
RP with the Automated Impella
®
Controller
Cautions
Cautions indicate situations
in which equipment may
malfunction, be damaged, or
cease to operate. The yellow
symbol appears before
caution messages.
2.3
