English; Overview; Intended Use - Abiomed Impella Connect Mode D'emploi

OVERVIEW

The Impella Connect system consists of two parts:
• A web-based user portal that allows authorized users to remotely view the screen of the Automated Impella
Controller (AIC).
• A small box (0042-4100) attached to the back and side of an Automated Impella Controller (AIC),
as shown below.
The box connects to the VGA output of the AIC and transmits the display of the AIC screen and data stored by the
AIC to a cloud based server. The transmitted information can be viewed by authorized remote users, which may
include hospital clinicians, Abiomed local support staff and Abiomed Clinical Support Center (CSC) team members.
The Impella Connect enables passive viewing the AIC screen. Changes to the controller settings can only be made
using the physical controls on the AIC. Impella Connect may be configured and connected to the hospital's secured
Wi-Fi network or be plugged in directly via Ethernet cable to the secured hospital network in order to transmit the
video image to a web-based portal.

INTENDED USE

Impella Connect is intended to be used to enable remote patient monitoring by providing authorized users with
passive viewing of the AIC's display which 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.
Impella Connect
®
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ENGLISH

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