Senhance Connect

Primary DI

00815440022228

Basic UDI-DI Code

081544002TD007UR

Reference

X9007741

Device Types

None provided

Regulation

Eu Mdr

Classification

Eu Md Class 1

Status

On The Market

Manufacturer

Asensus Surgical Italia S.r.l.

The Senhance Connect is a device designed to aid in telecommunication between local users and remote personnel during laparoscopic procedures. The device mainly consists of two cameras, a cart tower, a speaker, and a medical-grade computer. A video capture card is maintained in the casing behind the monitor of the device to allow for streaming of the endoscopic view of a connected endoscope system or the cockpit view1 of the Senhance system. Video feeds from the endoscopic view and the two cameras of the Senhance Connect are connected to a videoconferencing platform called VSee, alloendoscopic activity. The Senhance Connect is a non-patient contacting device that is supplied to the customer nonsterile and must be thoroughly cleaned and disinfected before the first use and after each use. The Senhance Connect is connected to the endoscope system in use during a surgical procedure, or, if in use, to the Intelligent Surgical Unit (ISU) of the Senhance system in order to enable transmission of the endoscopic view to the VSee interface.

Other on-the-market devices with the same classification (Eu Md Class 1) and regulation (EU MDR).