Germany – Fluorescent microscopes – Surgical microscope with fluorescence imaging Zeiss Kinevo 900S

Opportunity description

The ZEISS KINEVO 900 S surgical microscope is to be procured for the Department and Outpatient Clinic of Neurosurgery at LMU University Hospital Munich. I. Initial situation and procurement need The ZEISS KINEVO 900 S surgical microscope is to be procured for the Department and Outpatient Clinic of Neurosurgery. What is needed is not merely a high-resolution surgical microscope, but an integrated visualization platform for complex procedures in neurovascular, neuro-oncological, skull base and ventricular surgery. The procurement is necessary to ensure continuous care at the level of a university neurosurgical maximum-care facility and to continue performing complex neurovascular, neuro-oncological, skull base and ventricular procedures safely and without avoidable system changes. The purchase has not yet been made and will take place only if this ex ante transparency notice proceeds without challenge. II. Functional and technical requirements The following indispensable requirements are placed on this microscope. The requirements arise from the clinical workflows. Each individual function is required; what is decisive is their combined availability in one system. 1. Optical-digital hybrid visualization The system must enable a direct optical view through eyepieces and a digital 4K 3D display without conversion. During the most delicate dissection steps, the eyepiece view serves as an immediate fallback; the digital display improves ergonomics and co-observation. If either of the two viewing modes is absent, there is no equivalent way to continue within the same system in the event of a malfunction or unsuitable viewing angle. 2. Motorized positioning from the sterile field The surgeon must be able to move the visualization head by motorized means, particularly via a foot control panel. A defined target point must remain centered during pivoting; movement along the optical axis and storable positions are also required. This allows the viewing angle to be changed in deep approaches without losing the surgical corridor or removing the hands from the sterile field. 3. Integrated intracavitary micro-inspection A sterile, angled micro-inspection instrument must make concealed areas behind vessels, cranial nerves, tumor portions or clips visible and must be integrated into the imaging and documentation chain. A separate endoscopy tower would require additional devices, cables, user interfaces and system changes. 4. Three fluorescence modalities 5-ALA-, fluorescein- and ICG-assisted imaging are required in the same configuration. The procedures are needed for different tumor, vascular and perfusion-related questions. Switching to another microscope or an additional imaging chain during the ongoing procedure would not be equivalent. 5. Direct connection to the existing Brainlab neuronavigation system The system must be connected to the existing navigation system and enable navigation-assisted motorized alignment with targets or trajectories. This is particularly necessary for deep or anatomically difficult-to-access lesions to ensure reproducible orientation. 6. Unified image, data and documentation chain DICOM/PACS connectivity, integrated video recording and a 3D display for the surgical team are required. Patient assignment, co-observation and documentation must take place within the same system environment in order to avoid media discontinuities and assignment errors. III. Result of the market analysis: a unique position exists Only the offered ZEISS KINEVO 900 S provides the required overall workflow in the offered configuration. All six clinically required functions are therefore available within one system. No switch to a separate visualization, endoscopy, fluorescence or documentation system is required. The specialist department’s market analysis showed that competitors offer, at most, individual required functions. What is decisive, however, is not an individual feature, but the complete combination. No alternative system was demonstrated to meet all six requirements simultaneously. A combination consisting of another microscope, a separate endoscopy tower and additional fluorescence, navigation or documentation systems would not be functionally equivalent. It would require additional devices, sterile components, cables and user interfaces. During an ongoing procedure, this would result in system changes that are unacceptable from a professional perspective, separate imaging and documentation pathways, and additional space and staffing requirements. The ZEISS KINEVO 900 S fulfills the cumulative combination of functions in the offered configuration. It is therefore the only system identified during the market investigation that provides the required overall clinical workflow without additional individual devices or system changes. From a professional perspective, there is no reasonable equivalent alternative. IV. Public procurement law assessment The professional opinion forms the specialist and technical basis for the public procurement law review. 1. According to the statements of the requesting entity, the conditions for a negotiated procedure without a call for competition pursuant to Section 14(4)(2)(b) VgV (absence of competition for technical reasons due to a unique technical position) are met. The contract can be performed only by Carl Zeiss Meditec Vertriebsgesellschaft mbH because only the KINEVO 900S system fulfills the mandatory criteria. 2. Performance of the contract by Carl Zeiss Meditec Vertriebsgesellschaft mbH is without alternative because only the specified provider, with the specified service, guarantees the mandatory technical characteristics. There is also no reasonable alternative or substitute solution by which the procurement objective could be achieved, so the absence of competition is not the result of an artificial restriction of the procurement parameters (Section 14(6) VgV). Procedure: neg-wo-call. Review the original TED notice for the complete requirement, lots, amendments and attachments.