Impella® RP with the Automated Impella® Controller
8.11
TRANSPORT WITHIN THE HOSPITAL
Patients supported with the Impella® System may require transport within the hospital.
Considerations for transport within the hospital:
•
The Automated Impella® Controller and Impella® Catheter are designed to operate on
battery power for at least 1 hour.
•
Confirm that the battery capacity displayed on the controller is 100%.
•
If transport time might be longer than 1 hour, bring an extension cord or
confirm that you will be able to connect the controller to AC power once you arrive at
your destination.
•
When rolling the Automated Impella® Controller cart across a threshold, firmly
grasp the cart handle and pull it over the threshold.
•
Pay close attention to all system components and connections when rolling the
Automated Impella® Controller cart over thresholds and through elevator doors.
•
Do not stress the connector cable from the controller to the Impella® Catheter.
FAA ADVISORY
The Automated Impella® Controller has been subjected to, and passed, the EMC/EMI tests as specified
in IEC 60601-1-2 (General requirements for safety—Collateral standard: Electromagnetic
compatibility—Requirements and tests). The Automated Impella® Controller does not, however,
meet the requirements for conducted emissions of RTCA/DO-160G section 21.4 and has not
been tested for radiated emissions per RTCA/DO-160G section 21.5. Abiomed recommends that
air transport carriers follow the guidance FAA Advisory Circular AC No: 91-21.1B. Section 8-a of FAA
Advisory Circular AC No: 91-21.1B states:
“Equipment tested and found to exceed the section 21, Category M, emission levels are
required to be evaluated in the operator’s M-PED selected model aircraft for electromagnetic
interference (EMI) and radio frequency interference (RFI). All navigation, communication,
engine, and light control systems will be operating in the selected aircraft during the
evaluation.”
SLAVE MONITOR CONNECTION
If equipped with a VGA connector, the Automated Impella® Controller can be connected to
a monitor to display the information from the controller to another screen at a resolution of
800 x 600 pixels. The connection between the controller and the monitor can be made using a
cable up to 20 feet in length
