Image of two hands holding a smartphone with Impella Connect

Impella Connect®

Secure, cloud-based, remote monitoring of Impella® devices' status for better patient outcomes

Overview

Impella Connect enables health care professionals and Abiomed’s clinical support team to view the Automated Impella Controller screen through a secure website, allowing them to track, review, and share that information with the health care team from an internet-capable phone, tablet, or computer.

Indications for Use EU

INTENDED USE EU

Impella Connect is intended to be used to enable remote patient monitoring by providing authorized users with passive viewing of the AIC’s display. This includes information on alarms and data useful for troubleshooting and managing Impella devices to aid in patient management. Impella Connect transfers the video stream from the AIC (via the VGA output) and data stored by the AIC to a cloud-based remote viewing portal. Communication between the AIC and Impella Connect is one-way (AIC to Impella Connect), and the streamed information is limited to Impella device operating parameters and alarm messages with no patient identifiable information. Impella Connect is powered directly by the AIC.

PRECAUTIONS EU

• The Impella Connect is not intended to provide real-time information for monitoring patient status on the AIC.
• During use of the Impella Connect, there will be a delay between when an image appears on the AIC 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 AIC’s alarms.
• During use of Impella Connect, receipt of the displayed controller information is not confirmed by the AIC, nor is the delivery of the displayed AIC information to the authorized remote users guaranteed.
• Impella Connect is not designed for use during transport.
• When Impella Connect is configured to use the hospital’s secured Wi-Fi network, signal quality and strength is dependent on the hospital’s Wi-Fi.
• When Impella Connect is configured to use the hospital’s secured Wi-Fi network, connection may be lost in physical locations of low Wi-Fi signal.
• No modification of this equipment is permitted.
• 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 AIC functional specifications.
• Portable and mobile RF communications equipment can affect medical electrical equipment.
• When in use, the Ethernet cables connecting the Impella Connect to the wall could represent a tripping hazard and should be placed where foot traffic is minimal.
• Keep excess cabling on the cable wrap when not needed.
• Disconnect, when in use, the Ethernet cables from the wall outlet before moving the AIC.
• Impella Connect is not interpretive.
• Impella Connect is not intended to control or interact with any drugs.

ICO-0153