8.10
Instructions for Use & Clinical Reference Manual (US)
TRANSPORT BETWEEN HOSPITALS
During transport, the Automated Impella® Controller may be exposed to stronger
electromagnetic disturbance than during in-hospital use. Strong electromagnetic
disturbance may cause the Automated Impella® Controller to display soft button menu
selections that were not selected by the user. Operators should be aware that, under
these conditions, the operating parameters are not affected. No user intervention is
required. Monitor Impella® Catheter flow and patient hemodynamics to confirm
normal operation. The condition will resolve itself once the Automated Impella
®
Controller is no longer exposed to the disturbance.
GUIDELINES FOR PATIENT TRANSPORT
Intra-hospital transport may be required if a patient requires additional resources and specialized
teams located at another hospital. The patient may be transferred to such a location using the
Automated Impella® Controller for hospital-to-hospital transport via ambulance, helicopter, or fixed-
wing aircraft.
Maintaining optimal patient hemodynamic status and correct Impella® Catheter position are two key
factors in managing patients supported with the Impella® System during transport. Steps should be
taken to eliminate or minimize any aspect of the transport that might adversely affect these factors.
The Automated Impella® Controller is designed to operate for 60 minutes on battery power.
Transport teams should take this into consideration when planning the transport. If the total
transport time is expected to include more than 60 minutes during which the system will be
disconnected from AC power, arrangements should be made to use a vehicle with a built-in DC to
AC power inverter.
IMPORTANT TRANSPORT CONSIDERATIONS
1. Planning is critical to success. Abiomed representatives can help with planning for
transport. They can be contacted 24 hours a day at 1-800-422-8666.
2. The Automated Impella® Controller should be fully charged prior to transport. Keep the
Automated Impella® Controller connected to AC power (or an AC inverter) whenever
possible.
3. Do not stress the connector cable from the controller to the Impella® Catheter. Such
tension could move the catheter out of correct position and compromise patient
circulatory support.
4. Carefully monitor purge pressures during changes in altitude.
5. The Automated Impella® Controller should be positioned to allow easy access to the
display screen and soft buttons to view alarms and make any necessary changes.
6. Maintain ACTs between 160 and 180 or at the level recommended by the physician
responsible for the patient.