Impella Connect®

Impella Connect transfers a video image of the screen on the Automated Impella Controller™ to an authorized remote user. The transmitted image can be viewed by authorized remote users. The users can include the hospital’s clinicians, Abiomed local support staff, and Clinical Support Center (CSC) team members.

Impella Connect is not intended to provide real-time information for monitoring patient status on the Automated Impella Controller.

During use of the Impella Connect, there will be a delay between when an image appears on the controller screen and when it is displayed at a remote viewing location.

The Impella Connect is not a source of patient alarms, nor is its use intended as a replacement for monitoring the controller’s alarms.

During use of the Impella Connect, receipt of the displayed controller information is not confirmed by the Automated Impella Controller, nor is the delivery of the displayed controller information to the authorized remote users guaranteed.

The Impella Connect is not designed for use during transport.

Radiated and conducted electromagnetic interference can affect the performance of the Impella Connect, causing a temporary loss of connectivity. To clear interference, either increase the distance between system components and the EMI source or turn off the EMI source. Any electromagnetic interference related to the Impella Connect will have no impact on any of the controller functional specifications.

Portable and mobile RF communications equipment can affect medical electrical equipment.

In addition to the risks above, there are other WARNINGS and PRECAUTIONS associated with Impella devices.