The order to be placed includes the delivery, installation and commissioning of an MRI at Klinikum Bayreuth GmbH, Klinikum Bayreuth.

A high-resolution whole-body MRI system with 70 cm gantry opening of the highest class with a superconducting 1.5 Tesla magnet for imaging diagnostics, spectroscopy and interventional use is required.

The latest available system approved in the EU and Germany must be supplied.

The offered system is equipped with the latest software and hardware version which corresponds to the highest level of technological development.

The necessary interfaces for connection to a DICOM-compatible radiological information system (RIS) and a DICOM-compatible image data archiving and communication system (PACS) are required at the control console.

The offers must include all equipment and equipment components, necessary accessories and additional equipment and software components required for the intended use of the MRI system.

The offer must also include the installation of an HF cabin including viewing window and access door according to room specifications including all shielding components and sound insulation measures. A corresponding sound insulation report for the neighbouring premises must be prepared by the supplier.

The future supplier should take over the introduction and equipment installation. A floor plan is attached. In addition to the usual work planning for the devices, the planning services include the floor plan planning in LP 1-5 HOAI Hochbau and TA, as well as the provision of information on the static necessities of the transport route and the installation location for the MRI and its technology, as well as the planning of the installation of the magnet.

For ongoing maintenance, a full maintenance contract for 10 years after expiry of the warranty of 24 months must be submitted, this contract also includes the patch management of the operating system (OS) and the virus signatures including any necessary hardware updates to IT components over the contract period if an update of the OS alone is no longer possible.

All equipment systems offered by the bidder must comply with the following directives/standards:

• Directive 93/42/EEC on medical devices or MDR, depending on the validity of the

Admission

• Product Safety Act (ProdSG)

• Product must bear the CE mark

• Medical electrical equipment, Part 1: General requirements for safety IEC 60601-1; EN 60601-1

• Electromagnetic compatibility IEC 60601-1-2; EN 60601-1-2