OP Navigation system OP Navigation system

OP Navigation system OP Navigation system
In order to do justice to the wide range of services and the medically highly complex range of neurosurgery services at Heidelberg University Hospital, the following criteria must be met for the award: 1. The product must be usable both cranially and spinally and must necessarily meet the following technical requirements a. The system must be able to be used in an interdisciplinary manner for operations on the head, including common image fusion and fiber tract reconstruction procedures as well as third-party examinations (TMS), as well as for instrumentation on the spine as well as for guided biopsies and stereoelectroencephalography (SEEG). b. Integration of the existing Zeiss Kinevo microscope for cranial procedures including the possibility of reflecting planning data from multimodal neuronavigation as semi-transparent structures into the heads-up display. c. Integration of intraoperative MRI and data transfer with the possibility of automatic MRI-based patient registration. 2. Secure integration into the existing and proven IT and server infrastructure of Heidelberg University Hospital must be ensured for smooth and reliable data transmission and planning of surgical interventions via remote access and must meet the following requirements: a. Integration into the existing, centralized server infrastructure for neurosurgery, maxillofacial surgery and ENT including implementation of fail-safe data communication. b. Connection and compatibility of all relevant navigation systems on the UKHD and automatic data synchronization c. Flexible data access to the planning server from the navigation unit as well as for every computer in the hospital network, including the possibility of multiple simultaneous user access d. Possibility of access to extended planning software for installation on a local server infrastructure for spinal and cranial procedures, including module for rigid and elastic image fusion, module for fiber tract reconstruction (probabilistic/deterministic), module for automated planning of pedicle screws based on CT data, as well as a stereotactic planning package including a patient-specific segmentation algorithm for automatic generation and representation of risk structures 3. Taking into account the personnel and spatial conditions On-site integration into the existing navigation infrastructure as well as a modular concept for the needs-based use of the individual components is required in order to maintain user skills and reduce space requirements. The following requirements must be met a. Integration into existing user workflows as well as the software user experience to maintain the existing and long-term established skills of the users. b. Self-sufficient mobile navigation system for spinal and cranial navigated procedures with the possibility of modular connection to existing robotic systems from the same manufacturer and/or imaging units. 4. The possibility of using the individual components together with neighboring departments must be possible taking into account the local conditions (device sharing) a. Interdisciplinary planning server for shared use for cranial, spinal maxillofacial & ENT procedures b. Interdisciplinary navigation system for cranial, spinal & ENT procedures c. Interdisciplinary robotics solution for spinal and cranial indications (including biopsy & SEEG) d. Interdisciplinary 2D & 3D imaging for spinal, cranial, maxillofacial and ENT procedures 5. The manufacturer must have a powerful service network in Germany to ensure high availability of the installation for patient use. The possibility of remote maintenance and remote access must be available. 6. The contractor guarantees compliance with all legal regulations applicable to the device, in particular MDR (EU) 2017/745, MPDG, occupational safety, hygiene, EMC, data protection and radiation protection regulations.