TeslaiV1

Primary DI

04255629200249

Basic UDI-DI Code

42556292001011LS

Reference

1190001

Device Types

None provided

Regulation

Eu Mdr

Classification

Eu Md Class 1

Status

On The Market

Manufacturer

MIPM Mammendorfer Institut für Physik und Medizin GmbH

The TeslaiV1 is an MRI system rack for the operation of one single B. Braun Spaceplus Infusion Pump (Perfusor® or Infusomat®) during MRI examinations (MRI procedures). The TeslaiV1 does not control the operation of the installed infusion pump. The TeslaiV1 is a RF-shielded housing which can optionally mounted on a trolley or attached to an infusion pole. The construction of the housing makes it possible to position the system within the MR environment; it provides a shielded space for one single B. Braun Spaceplus Infusion Pump (Perfusor® or Infusomat®). A window allows for direct viewing of the inserted infusion pump, allowing all pump status and alarm conditions to be observed. The TeslaiV1 provides Infusion Line Guide inlets and outlets. The Spaceplus Infusion Pump (Perfusor® or Infusomat®) can only be installed and removed by authorized service personnel. The TeslaiV1 is MR conditional and intended to be used in the MR environment. The TeslaiV1 contains a Magnetic Field Indicator (MFI) which measures the magnetic field and serves as a positioning support for the trained user to position the TeslaiV1 on its released magnetic field strength. If the released magnetic field strength is exceeded, the trained user is notified in advance via optical and acoustic signals before damage to the devices occur. The TeslaiV1 is not connected to any network.

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