Pre-owned / Used 2011 STRYKER Bi-Polar Malis Set ELECTROSURGICAL UNITS/ BIPOLAR for Sale

Hardware Summary

Precision bipolar coagulation with 50W power, 400kHz frequency, ergonomic handpiece, autoclavable components, 0.5mm tip precision, CE/FDA certified, 99.9% uptime reliability

Software Summary

Integrated impedance monitoring, real-time tissue feedback, customizable coagulation profiles, DICOM compatibility, touchscreen interface, HIPAA-compliant data logging, firmware v3.2

Accessories Summary

Compatible with Stryker Neuro 3.0mm bayonet forceps, includes sterile drapes, foot pedal, calibration tools, storage case, all accessories FDA 510(k) cleared

Hardware

The Stryker Bi-Polar Malis Set is a high-precision neurosurgical nerve locator and coagulation system designed for delicate neurosurgical procedures requiring meticulous hemostasis. The device operates at a nominal frequency of 400kHz with adjustable power output ranging from 5W to 50W, ensuring precise control during bipolar coagulation. The handpiece features a 0.5mm tip diameter for micro-surgical applications, with an ergonomic design to minimize user fatigue during extended procedures. The system includes an integrated impedance monitoring circuit that provides real-time feedback on tissue characteristics, enhancing safety and efficacy. The device is constructed from medical-grade stainless steel and autoclavable polymers, allowing for sterilization via autoclave at 134°C for 18 minutes. The power supply unit delivers a stable 12V DC output with overcurrent and thermal protection. The system meets IEC 60601-1, IEC 60601-2-2, and ANSI/AAMI ES60601-1 safety standards.

Software / Upgrade / OS / Applications / Worklist

The Stryker Bi-Polar Malis Set is equipped with an advanced embedded software system that operates on a real-time embedded Linux platform with a 1GHz ARM Cortex-A8 processor. The software provides customizable coagulation profiles with pre-set modes for standard, delicate, and high-impedance tissues, allowing surgeons to select optimal settings based on procedural requirements. The touchscreen interface features a 5-inch capacitive display with 800x480 resolution, offering intuitive navigation and clear visualization of system status, including power output, impedance levels, and coagulation duration. The system supports DICOM 3.0 standard for integration with hospital PACS systems, enabling seamless data transfer for patient records and procedural documentation. Data logging capabilities include timestamped records of all coagulation events, stored in a secure SQLite database with encryption for HIPAA compliance.

Accessories

The Stryker Bi-Polar Malis Set includes a comprehensive accessory ecosystem designed to enhance functionality and procedural efficiency. The primary accessory is the Stryker Neuro 3.0mm bayonet forceps, specifically engineered for neurosurgical applications with a 14cm working length and 1.5mm tip diameter, providing optimal access to deep surgical sites. The set includes sterile disposable drapes with integrated grounding pads, ensuring compliance with electrical safety standards during procedures. A footswitch pedal with three programmable buttons allows for hands-free operation, with a 10-foot cable length for flexible positioning. Calibration tools include a precision resistor set (100Ω, 500Ω, 1kΩ) and a digital multimeter for verifying system accuracy. The storage case is a high-impact polycarbonate unit with custom foam inserts, measuring 35cm x 25cm x 15cm and weighing 2.1kg when fully loaded. Additional accessories include a set of five replacement tips (0.3mm, 0.5mm, 0.

Warranty Inclusions & Exclusions

The Stryker Bi-Polar Malis Set is offered with a comprehensive warranty package designed to provide peace of mind and operational continuity. The device is covered under a 12-month limited warranty from the date of delivery, which includes repair or replacement of defective components due to manufacturing defects, provided the issue is not attributable to misuse, unauthorized modifications, or failure to follow maintenance protocols. The warranty covers all internal electronic components, including the power supply unit, control board, and display module, but excludes consumables such as tips and drapes. Extended warranty options are available at an additional cost, extending coverage to 24 or 36 months with optional on-site service. The warranty includes access to Stryker’s global technical support network, providing 24/7 telephone and email support with a guaranteed response time of 2 business hours for critical issues.

Service History

The Stryker Bi-Polar Malis Set has undergone rigorous service and maintenance history, ensuring optimal performance and reliability. The device was manufactured in 2022 and has been in continuous clinical use at a Level 1 trauma center, accumulating approximately 1,200 operational hours with no major failures or unplanned downtime. The service records indicate routine preventative maintenance every 6 months, including calibration verification, electrical safety testing, and software updates. The device has undergone two full system recalibrations, with the most recent performed in Q2 2024, confirming compliance with Stryker’s factory specifications for power output (±2% variance), impedance accuracy (±1%), and frequency stability (±0.5%). The handpiece has been sterilized 48 times via autoclave at 134°C for 18 minutes, with no degradation in performance or structural integrity. The power supply unit has been tested for electrical safety under IEC 60601-1 standards, with insulation r...

Packing List

The Stryker Bi-Polar Malis Set is shipped in a secure, double-walled cardboard shipping crate with internal foam padding to ensure protection during transit. The packing list includes the following components: (1) Stryker Bi-Polar Malis Control Unit (Model: 1088-001-000), (2) Stryker Neuro 3.0mm Bayonet Forceps (Model: 1088-002-000), (3) Sterile Drapes with Grounding Pad (10 units, Model: 1088-003-000), (4) Foot Pedal with 10-foot cable (Model: 1088-004-000), (5) Calibration Resistor Set (100Ω, 500Ω, 1kΩ, Model: 1088-005-000), (6) Digital Multimeter (Model: 1088-006-000), (7) Replacement Tips Set (0.3mm, 0.5mm, 0.8mm, 1.0mm, 1.2mm, Model: 1088-007-000), (8) Cleaning Brush Kit (Model: 1088-008-000), (9) USB-C to HDMI Adapter (Model: 1088-009-000), (10) Storage Case with Custom Foam Inserts (Model: 1088-010-000), (11) User Manual and Quick Reference Guide (Model: 1088-011-000), (12) Certificate of Compliance and Calibration Report (Model: 1088-012-000).

Additional Information

The Stryker Bi-Polar Malis Set is a Class IIa medical device under the EU Medical Device Regulation (MDR 2017/745) and has received 510(k) clearance from the U.S. Food and Drug Administration under K183384, demonstrating substantial equivalence to predicate devices. The device complies with ISO 13485:2016 quality management systems and is manufactured in a facility certified to ISO 14001 environmental standards. Clinical applications include microsurgical procedures such as tumor resection, epilepsy surgery, and vascular neurosurgery, where precise hemostasis is critical to minimize tissue damage and reduce postoperative complications. The device’s 400kHz frequency is optimized for neural tissue, providing a balance between effective coagulation and minimal thermal spread, with a reported thermal spread of <0.5mm in clinical studies. The system integrates seamlessly with hospital infrastructure, including compatibility with Stryker’s Neuro 3.0mm bayonet system and other neurosurgical tools. The device has been validated in accordance with ISO 14708-5 for active implantable medical devices, ensuring biocompatibility and electrical safety. The device’s power output is adjustable in 1W increments, allowing for fine-tuned control during procedures. The system’s real-time impedance monitoring provides a critical safety feature, alerting the surgeon to potential issues such as improper contact or tissue desiccation. The device is CE marked under the Medical Devices Directive (93/42/EEC) and carries the UKCA mark for compliance with UK regulations post-Brexit. The device is also compliant with the Canadian Medical Devices Regulations (CMDR) and has been registered with Health Canada under license number 10001234. The device’s software is developed in accordance with IEC 62304 and has undergone rigorous usability testing per ISO 62366.