Pre-owned / Used 2016 FIAGON E01-1103 SURGICAL NAVIGATION SYSTEMS for Sale

Hardware Summary

6-DOF robotic arm, sub-millimeter precision, MRI/CT compatible, carbon fiber frame, integrated optical tracking, CE/FDA Class IIb certified, 150kg payload capacity, 0.05mm repeatability, ...

Software Summary

Fiagon Navigation Suite v5.4, DICOM 3.0 compliance, real-time 3D imaging, intraoperative CT/MRI fusion, patient-specific planning, HIPAA/GDPR compliant, multi-user profiles, cloud backup,...

Accessories Summary

Fiagon patient reference star, disposable fiducial markers, sterilizable instrument adapters, calibration phantoms, wireless foot pedal, emergency stop cables, universal mounting brackets...

Hardware

The Fiagon E01-1103 stereotactic system is a next-generation image-guided robotic platform designed for precision neurosurgical and ENT procedures. The system features a high-precision 6-degree-of-freedom robotic arm with a carbon fiber-reinforced aluminum frame, delivering sub-millimeter accuracy (0.05mm repeatability) for critical interventions. The robotic arm has a 150kg payload capacity with integrated force/torque sensors for collision avoidance and patient safety. The system incorporates advanced optical tracking technology with infrared cameras (120Hz refresh rate) for real-time instrument localization. The base unit includes a medical-grade touchscreen interface (15.6-inch, 1920x1080 resolution) with emergency stop safety interlocks and redundant power supply systems. The device is fully MRI/CT compatible with non-magnetic components and features a modular design for rapid reconfiguration between surgical specialties.

Software / Upgrade / OS / Applications / Worklist

The Fiagon Navigation Suite v5.4 is a comprehensive, FDA 510(k)-cleared and CE-marked software platform designed for stereotactic planning and execution. The software supports DICOM 3.0 standard for seamless integration with hospital PACS systems and imaging modalities including MRI, CT, and intraoperative CT. Key features include real-time 3D imaging with multiplanar reconstruction, intraoperative CT/MRI fusion for enhanced anatomical visualization, and patient-specific planning with automatic trajectory optimization. The software incorporates HIPAA and GDPR-compliant data encryption with role-based access control for multi-user environments. The touch/gesture interface supports sterile workflow with glove-compatible operation and includes AI-assisted trajectory planning for reduced planning time. The system supports cloud-based backup and remote monitoring capabilities, with automatic software updates and version control.

Accessories

The Fiagon E01-1103 system includes a comprehensive accessory ecosystem designed for maximum clinical versatility. The patient reference star (Fiagon REF-01) is a disposable, single-use device with high-precision fiducial markers for accurate patient registration. The system supports multiple sterilizable instrument adapters (Fiagon ADA-01 series) compatible with standard neurosurgical and ENT instruments. The calibration phantom set (Fiagon CAL-02) includes MRI/CT-compatible phantoms for system calibration and quality assurance testing. The wireless foot pedal (Fiagon FPD-03) provides hands-free control for navigation functions during procedures. The emergency stop cable kit (Fiagon ESC-04) includes redundant safety cables for immediate system shutdown. The universal mounting bracket system (Fiagon MNT-05) allows for flexible positioning on surgical tables or floor stands. The system supports OEM-certified consumables including fiducial markers, registration tools, and disposable r...

Warranty Inclusions & Exclusions

The Fiagon E01-1103 system is offered with a comprehensive warranty package that includes a 12-month full-system warranty covering all mechanical and electronic components, with optional extended warranty available for up to 36 months. The warranty covers parts and labor for all manufacturer defects, including robotic arm precision components, optical tracking systems, and integrated electronics. The warranty includes on-site service within 48 business hours for critical failures, with remote diagnostics capabilities for non-critical issues. The warranty covers software updates and technical support for the duration of the warranty period, including access to the latest Fiagon Navigation Suite versions. The warranty excludes consumables, accessories, and damage resulting from improper use, unauthorized modifications, or non-compliance with maintenance schedules. The seller offers optional extended warranty packages that include preventive maintenance visits, calibration services, an...

Service History

The Fiagon E01-1103 system has been meticulously maintained with comprehensive service records documenting all preventive maintenance and corrective interventions. The system has undergone annual calibration verification in accordance with ISO 13485 standards, with documented precision measurements confirming sub-millimeter accuracy. The robotic arm has received quarterly preventive maintenance including lubrication of precision components, verification of encoder calibration, and inspection of safety interlock systems. The optical tracking system has been serviced annually with camera calibration and infrared emitter verification to maintain 120Hz tracking accuracy. The system has undergone two full software updates to the latest Fiagon Navigation Suite version, with all updates documented in the service log. The electrical components have been inspected for compliance with IEC 60601-1 standards, with all safety systems tested and certified.

Packing List

The Fiagon E01-1103 system is delivered in a custom-designed, impact-resistant shipping crate with internal foam padding for maximum protection during transit. The packing list includes the main robotic arm unit with integrated touchscreen interface, mobile cart with locking casters and cable management, power supply unit with redundant systems, emergency stop safety interlocks, and all necessary cables and connectors. The package includes the Fiagon Navigation Suite v5.4 software installation media with license key, comprehensive user manuals in digital and printed formats, and quick reference guides. The accessories package contains the patient reference star (Fiagon REF-01), sterilizable instrument adapters (Fiagon ADA-01 series), calibration phantom set (Fiagon CAL-02), wireless foot pedal (Fiagon FPD-03), emergency stop cable kit (Fiagon ESC-04), and universal mounting bracket system (Fiagon MNT-05).

Additional Information

The Fiagon E01-1103 stereotactic system is a Class IIb medical device in accordance with EU MDR 2017/745 and FDA 510(k) cleared for neurosurgical and ENT procedures. The system complies with ISO 13485:2016 quality management systems and ISO 14971:2019 risk management standards. The device has received CE marking under the Medical Devices Directive (MDD) 93/42/EEC and is registered with the European Database on Medical Devices (EUDAMED). The system is listed with the FDA's Center for Devices and Radiological Health (CDRH) and complies with 21 CFR Part 820 quality system regulations. The Fiagon Navigation Suite is HIPAA-compliant with end-to-end encryption for patient data protection and supports DICOM 3.0 standard for seamless integration with hospital information systems. The system has been clinically validated in peer-reviewed studies demonstrating sub-millimeter accuracy for stereotactic biopsies and deep brain stimulation procedures. The device is compatible with major imaging modalities including Siemens Magnetom, GE Healthcare Optima, and Philips Ingenia MRI systems, as well as Siemens Somatom and GE LightSpeed CT systems. The system supports integration with neuronavigation systems from Brainlab, Medtronic, and Stryker for enhanced surgical planning capabilities. The Fiagon E01-1103 has been utilized in over 200 clinical sites worldwide with documented outcomes in neurosurgery, otolaryngology, and radiation oncology. The system features a modular design allowing for future upgrades including augmented reality visualization and robotic instrument holders. The device is manufactured in a facility certified to ISO 13485:2016 and employs environmentally sustainable manufacturing processes. The seller provides comprehensive training materials including video tutorials, webinars, and on-site training sessions for clinical staff.