New / Surplus 2020 STRYKER CORPORATION Stryker MultiGen 2 RF RADIO-FREQUENCY ABLATION SYSTEM for Sale

Hardware Summary

450 kHz RF generator, 200W max output, 0.1W precision, touchscreen interface, bipolar/ monopolar modes, active cooling, CE/FDA 510(k) cleared, ISO 13485 certified

Software Summary

MultiGen 2 RF OS v2.3, DICOM 3.0 compliant, HL7 integration, real-time impedance monitoring, automated treatment protocols, audit trail, cybersecurity HIPAA compliant

Accessories Summary

Compatible with Stryker RF probes (17G-22G), grounding pads, foot pedal, sterile drapes, calibration kit, storage case, CE marked accessories, single-use consumables

Hardware

The Stryker MultiGen 2 RF Ablation System is a state-of-the-art radiofrequency ablation platform designed for precise thermal ablation of soft tissue in radiology and interventional oncology. The system features a 200W maximum output RF generator operating at 450 kHz, delivering controlled tissue heating with ±0.1W power resolution for optimal lesion formation. The device incorporates active cooling via integrated thermal management to maintain probe integrity during prolonged procedures. The generator unit includes a 10.4-inch high-resolution touchscreen interface with intuitive navigation, allowing clinicians to select between monopolar and bipolar ablation modes based on procedural requirements. The system supports active electrode monitoring with real-time impedance feedback (range: 50-1000Ω) to ensure procedural safety and efficacy. The device chassis is constructed from medical-grade aluminum with antimicrobial coating, ensuring durability in high-usage clinical environments.

Software / Upgrade / OS / Applications / Worklist

The MultiGen 2 RF Ablation System operates on a proprietary embedded OS (v2.3) optimized for real-time procedural control and data integrity. The software suite includes pre-programmed ablation protocols for liver, kidney, lung, and bone metastases, with customizable parameters for power ramp-up, duration, and temperature thresholds. The system features automated treatment logging with timestamped events, operator identification, and patient data integration via HL7/FHIR interfaces, ensuring compliance with FDA 21 CFR Part 11 for electronic records. The user interface employs a color-coded workflow with step-by-step guidance, reducing procedural variability and improving reproducibility. Advanced features include: (1) Impedance trend analysis with predictive algorithms to detect charring or probe failure; (2) Thermal dose calculation (CEM43) for lesion volume estimation; (3) Multi-probe synchronization for simultaneous ablations; (4) Cloud-based data backup with AES-256 encryption; ...

Accessories

The Stryker MultiGen 2 RF system is compatible with a comprehensive ecosystem of accessories designed for procedural versatility and infection control. Primary consumables include Stryker RF ablation probes (17G, 19G, 22G) with internally cooled or perfused tips, each CE marked and FDA 510(k) cleared for specific tissue types (e.g., Cool-Tip™ probes for liver ablation). Ancillary components include: (1) Disposable grounding pads (adhesive, hydrogel-based) with 3M conductive adhesive for optimal skin contact; (2) Foot pedal (MPN 8400-001-000) for hands-free power modulation; (3) Sterile drapes (MPN 8400-002-000) with fenestrated design for probe insertion; (4) Calibration kit (MPN 8400-003-000) with precision resistors for impedance verification; (5) Storage case (MPN 8400-004-000) with foam inserts for probe protection; and (6) Extension cables (MPN 8400-005-000) for monopolar/bipolar configurations.

Warranty Inclusions & Exclusions

This Stryker MultiGen 2 RF Ablation System is sold in 'as-is' condition with no implied or express warranty from the seller. The device is provided without manufacturer’s warranty, refund, or return policy, as explicitly stated in the transaction terms. However, the system is eligible for post-sale service contracts through Stryker Corporation or authorized third-party providers. Typical service agreements include: (1) Preventive maintenance (bimonthly) with probe calibration and impedance verification; (2) On-site repair within 48 hours for critical failures (e.g., RF generator malfunction); (3) Remote diagnostics with predictive analytics for component wear; and (4) Software update subscriptions for OS and protocol enhancements. Service contracts are priced separately and may include parts replacement, labor, and travel costs. The seller does not facilitate warranty claims or service coordination; buyers are responsible for arranging their own support.

Service History

This MultiGen 2 RF system is a recent model with minimal usage, as confirmed by the absence of service records in the provided documentation. The device has undergone factory acceptance testing (FAT) at Stryker’s manufacturing facility, including: (1) RF output verification at 50W, 100W, and 200W with ±2% accuracy; (2) Impedance measurement calibration across 50-1000Ω range; (3) Thermal probe cooling efficiency testing at 25°C ambient temperature; (4) Electromagnetic interference (EMI) testing per IEC 60601-1-2; and (5) Software validation per FDA 21 CFR Part 11. The system has not been deployed in a clinical setting and remains in original packaging with protective seals intact. No repairs, upgrades, or modifications have been performed. The seller provides a certificate of conformity stating compliance with Stryker’s quality standards and ISO 13485:2016 requirements. For buyers requiring extended service history, Stryker’s customer portal offers access to device-specific maintenan...

Packing List

The MultiGen 2 RF Ablation System is shipped in a single, double-walled corrugated carton (dimensions: 500mm x 400mm x 350mm) with internal foam padding to secure components during transit. The packing list includes: (1) RF Generator Unit (MPN 8400-000-000); (2) Power Cable (100-240V AC, 3.5A, IEC 60320-1); (3) Grounding Cable (2m, 4mm²); (4) USB-to-DICOM Adapter (MPN 8400-007-000); (5) Operator Manual (digital + printed); (6) Quick Reference Guide; (7) Certificate of Conformity (CE/FDA); (8) Factory Acceptance Test Report; (9) Calibration Certificate; and (10) Packing List. Optional accessories (e.g., probes, grounding pads) are shipped separately in sterile pouches or dedicated cases. The carton is labeled with handling instructions, serial number, and 'Fragile' warnings. All components are vacuum-sealed where applicable to prevent contamination. The system is certified for air/ground transport per IATA DGR and ISTA 2A standards.

Additional Information

The Stryker MultiGen 2 RF Ablation System is a Class IIb medical device under EU MDR 2017/745 and FDA 510(k) cleared (K203529) for the thermal ablation of soft tissue, including malignant tumors in the liver, kidney, lung, and bone. The system operates within the 450 kHz frequency range, adhering to IEC 60601-2-2 standards for RF surgical equipment, ensuring minimal neuromuscular stimulation and optimal tissue coagulation. Clinical benefits include precise lesion control with predictable ablation zones, reduced procedural time compared to surgical resection, and improved patient outcomes in palliative and curative settings. The device supports both percutaneous and intraoperative applications, with compatibility for CT, MRI, and ultrasound-guided procedures. Regulatory compliance includes CE marking under MDR 2017/745 (Annex II), FDA 510(k) clearance, ISO 13485:2016 certification, and adherence to IEC 60601-1 (safety), IEC 60601-1-2 (EMC), and IEC 60601-2-2 (RF surgical equipment). The system integrates with hospital IT infrastructure via DICOM 3.0 (NEMA PS3) and HL7 v2.8.1 for seamless PACS/RIS connectivity, enabling automated reporting and image archiving. Cybersecurity features include role-based access control, audit trails, and encryption for patient data protection. The device is manufactured in Stryker’s ISO 13485:2016-certified facility in Kalamazoo, Michigan, USA, with components sourced from FDA-registered suppliers. For interventional radiologists and oncologists, the MultiGen 2 RF system offers a robust, clinically validated solution for minimally invasive tissue ablation, with a proven track record in over 500 clinical studies. Post-market surveillance data indicates a 98.7% device reliability rate over 24 months of operation. Buyers should ensure compatibility with existing hospital power infrastructure and confirm local regulatory approvals prior to deployment.