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Cloud-based, remote view of the Impella® device

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Impella Connect®

How It Works:

 The Impella Connect enables hospital clinicians and staff, along with Abiomed’s Clinical Support Team to view the Automated Impella® Controller (AIC) screen through a secure website, allowing them to track, review, and share that information from any internet-capable phone, tablet, or computer.

The purpose of the Impella Connect is to enable a connection from the Abiomed AIC to a cloud-based website (HIPAA and GDPR-compliant) accessible by authorized login to certified Abiomed employees and hospital staff, who only see data from their own institution.

Health Insurance Portability and Accountability Act (HIPAA) General Data Protection Regulation (GDPR)

Impella Connect will provide the opportunity for hospital staff to review cases at any time.

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The Impella Connect®:



Automated Impella® Controller

How It Works:

 

The Automated Impella® Controller is the primary user control interface for the Impella® platform featuring a 10-inch high-resolution display. It controls the Impella catheter performance, monitors for alarms, and displays real-time hemodynamic and catheter position information.

The new integrated purge system automatically sets the purge flow to maintain the purge pressure and eliminates the need to actively monitor purge pressures. Step-by-step on-screen procedures allow for quick and simple step-up and purge cassette procedures; featuring automatic priming, detection of connections, and automatic bolus at completion.

The Automated Impella Controller can be powered by AC power or can operate on internal battery power for at least 60 minutes when fully charged.

Intended Use

The Impella Connect® transfers the 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 Customer Support Center (CSC) team members.

Precautions

  • 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 information above, learn more about Abiomed and Impella: Visit www.abiomed.com/important-safety-information