Abiomed Impella 2.5, Instructions For Use Manual

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9.7 Impella
®
System for Use During Cardiogenic Shock
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 with the Impella
®
Catheter in place 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.
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