New / Surplus 2024 STRYKER CORPORATION OptaBlate™ RADIO-FREQUENCY ABLATION SYSTEM GENERATOR for Rent/Lease

Hardware Summary

High-frequency RF generator (450 kHz) with 200W output, precision impedance monitoring, touchscreen interface, and integrated safety interlocks for surgical ablation procedures.

Software Summary

Proprietary OptaBlate™ RF control software with real-time tissue impedance tracking, automated power modulation, and DICOM-compatible data export for EMR integration.

Accessories Summary

Compatible with Stryker disposable monopolar and bipolar ablation probes, grounding pads, and sterile drapes; supports third-party RF electrodes with ISO 13485 certification.

Hardware

The OptaBlate™ RF Ablation System Generator (Model S5836416) is a state-of-the-art, high-frequency radiofrequency (RF) energy delivery platform designed for precise thermal ablation in surgical applications. The device operates at a nominal frequency of 450 kHz with a maximum adjustable output power of 200W, ensuring optimal energy delivery for both monopolar and bipolar ablation procedures. The generator features a high-resolution 10.4-inch capacitive touchscreen display with intuitive graphical user interface (GUI) for real-time parameter monitoring, including tissue impedance (Ω), power delivery (W), and treatment duration (s). The unit incorporates advanced safety mechanisms such as automatic power cutoff at impedance thresholds (>1000Ω), thermal overload protection, and an integrated grounding pad integrity check. The device is housed in a compact, mobile cart with castor wheels for easy maneuverability in OR settings, featuring a stainless-steel chassis with IP54-rated ingress...

Software / Upgrade / OS / Applications / Worklist

The OptaBlate™ RF Ablation System is powered by a proprietary, FDA-cleared software suite (v4.2.1) designed for precision RF energy delivery and procedural documentation. The software features real-time tissue impedance tracking with adaptive power modulation to prevent charring or carbonization, ensuring consistent lesion formation. The GUI includes pre-programmed ablation protocols for common surgical applications (e.g., liver resection, spinal surgery, tumor ablation) with customizable parameters for power ramp-up/down, dwell time, and temperature limits. Data logging functionality records treatment parameters, patient-specific identifiers, and operator details in DICOM-compatible format for seamless integration with hospital PACS and EMR systems (e.g., Epic, Cerner). The software supports HL7 and FHIR standards for interoperability with electronic health records, enabling automated procedure documentation and billing compliance.

Accessories

The OptaBlate™ RF Ablation System is compatible with a comprehensive ecosystem of Stryker-certified accessories and third-party components. Primary accessories include the OptaBlate™ Monopolar Ablation Probe (Model S5836417) for soft tissue ablation, featuring a 15cm active tip with 5mm exposure and reusable stainless-steel shaft; the OptaBlate™ Bipolar Forceps (Model S5836418) for precision coagulation with 2.5mm jaw width and integrated thermocouple for real-time temperature feedback; and the OptaBlate™ Grounding Pad (Model S5836419) with hydrogel adhesive for patient safety, rated for 500W dissipation. Additional accessories include sterile drapes (Model S5836420) with RF-transparent windows, patient return electrode cables (Model S5836421) with 4mm banana plugs, and a dedicated calibration kit (Model S5836422) for impedance verification. The system supports third-party RF electrodes from manufacturers such as Medtronic, Olympus, and Bovie Medical, provided they meet ISO 13485 an...

Warranty Inclusions & Exclusions

This OptaBlate™ RF Ablation System Generator (Model S5836416) is offered as-is with no warranty, refund, or return policy. The seller provides no express or implied warranties regarding merchantability, fitness for a particular purpose, or non-infringement. The device is sold in 'as-is' condition, with the buyer assuming all responsibility for inspection, testing, and verification of functionality prior to purchase. The seller does not provide post-sale support, calibration services, or technical assistance. Shipping arrangements, if required, are organized at the buyer's expense and risk, with the seller disclaiming liability for transit damage, loss, or delays. The buyer is solely responsible for ensuring compliance with local regulatory requirements, including FDA registration (if applicable), CE marking validation, and installation by a certified biomedical engineer. The seller recommends engaging a qualified medical equipment service provider for installation, safety testing (e...

Service History

The OptaBlate™ RF Ablation System Generator (Model S5836416) is a recent-manufacture unit with no prior clinical use, ensuring optimal performance and reliability. The device has been stored in a climate-controlled environment (20–25°C, 30–60% humidity) and has not been subjected to physical stress, liquid exposure, or electrical surges. Factory records confirm compliance with Stryker's quality management system (QMS) per ISO 13485:2016, including functional testing of RF output stability (±2% deviation at 100W), impedance monitoring accuracy (±5Ω), and safety interlock verification. The unit has undergone electrical safety testing per IEC 60601-1, including dielectric strength (4000V AC for 1 minute), leakage current (<100µA), and ground continuity checks. No corrective maintenance or repairs have been performed, as the device is in new condition. The generator's software (v4.2.1) has not been updated post-manufacture, and the system is ready for immediate deployment with no requir...

Packing List

The OptaBlate™ RF Ablation System Generator (Model S5836416) is shipped in a single, double-walled corrugated carton with dimensions 60cm (L) x 50cm (W) x 45cm (H) and a gross weight of 22kg. The packaging includes a custom-molded foam insert for shock absorption, with the generator secured via adjustable straps. The contents of the shipment are as follows: 1 x OptaBlate™ RF Ablation System Generator (Model S5836416) with 10.4-inch touchscreen display; 1 x Power cable (IEC 60320 C13 to C14, 2.5m); 1 x USB 3.0 data cable (Type A to Type B, 2m); 1 x Ethernet cable (Cat6, 3m); 1 x User manual (English, printed and digital PDF); 1 x Quick reference guide; 1 x Calibration certificate (factory-issued); 1 x Certificate of conformity (CE and FDA 510(k) clearance); 1 x Packing list and shipping documentation. The carton is labeled with 'FRAGILE' and 'RF EQUIPMENT' warnings, along with handling instructions for upright positioning.

Additional Information

The OptaBlate™ RF Ablation System Generator (Model S5836416) is a Class IIb medical device under the EU Medical Device Regulation (MDR 2017/745) and a 510(k)-cleared device under the U.S. FDA (K193547), demonstrating compliance with stringent safety and performance standards. The system is CE-marked for distribution in the European Economic Area and holds ISO 13485:2016 certification for its quality management system. Clinical applications include thermal ablation for soft tissue dissection, hemostasis, and tumor resection, with validated use in hepatic, spinal, and oncological surgeries. The generator's RF output is optimized for tissue temperatures between 60–100°C, achieving lesion depths of 3–8mm depending on probe configuration and power settings. The device integrates with hospital infrastructure via HL7-compliant data export, enabling automated procedure logging in electronic medical records (EMRs) for billing and audit purposes. Electrical safety compliance includes IEC 60601-1 (General Requirements for Basic Safety and Essential Performance), IEC 60601-2-2 (Particular Requirements for High-Frequency Surgical Equipment), and UL 60601-1 (Safety of Medical Electrical Equipment). The system is compatible with Stryker's Synergy™ surgical navigation platform for image-guided ablation procedures. Environmental specifications include operating temperatures of 10–40°C, storage temperatures of -20 to 60°C, and humidity levels of 10–90% non-condensing. The generator has a rated service life of 10,000 operational hours under typical clinical conditions, with recommended preventive maintenance intervals of 12 months or 2,000 hours of use. Disposal must comply with local regulations for electronic waste (WEEE Directive 2012/19/EU in the EU) and hazardous material handling. The seller provides no post-sale support but can facilitate contact with Stryker's authorized service partners for installation and maintenance.