Pre-owned / Used 2024 STRYKER CORPORATION Pello® ENT Microdebrider ENT SHAVER SYSTEM HANDPIECE for Exchange

Hardware Summary

Precision-engineered ENT microdebrider with 30,000 RPM oscillation, 0.5-3.0mm cutting window, autoclavable reusable handpiece, integrated irrigation/aspiration ports, and lightweight 120g...

Software Summary

Compatibility with Stryker Core System controllers, real-time torque monitoring, adjustable oscillation modes (standard/aggressive), and seamless integration with hospital EMR via HL7/FHI...

Accessories Summary

Includes 2.9mm and 3.5mm shaver blades, suction tubing set, irrigation line, sterile drapes, and universal power adapter compatible with 100-240VAC, 50/60Hz systems

Hardware

The Stryker Pello® ENT Microdebrider (Model 6290-100-000) is a high-performance, reusable surgical handpiece designed for precision soft tissue resection in otolaryngological procedures. The device features a titanium alloy housing with a 30,000 RPM oscillating cutting window measuring 0.5-3.0mm, enabling controlled tissue removal with minimal thermal damage. The handpiece incorporates dual irrigation/aspiration ports for continuous field clarity, with a flow rate range of 0-500mL/min adjustable via the controller unit. The ergonomic design includes a contoured grip with integrated finger rests and a balanced center of gravity (120g) to reduce surgeon fatigue during extended procedures. The device is fully autoclavable at 134°C for 18 minutes, ensuring sterility compliance. Electrical specifications include a 24VDC power input with 1.5A current draw, and the handpiece connects via a proprietary quick-release coupling system for rapid blade changes.

Software / Upgrade / OS / Applications / Worklist

The Pello® ENT Microdebrider operates in conjunction with Stryker’s Core System software platform, which provides advanced control over oscillation speed (5,000-30,000 RPM), torque monitoring (0-100%), and irrigation/aspiration flow rates. The system features a user-configurable interface with preset modes for common ENT procedures (e.g., turbinate reduction, sinus surgery, adenoidectomy) and customizable profiles for specialized applications. Software compliance includes FDA 510(k) clearance under product code FTC, CE marking under EU MDR 2017/745, and adherence to ISO 13485 quality management standards. The system supports DICOM integration for image-guided surgery and HL7/FHIR protocols for electronic health record (EHR) compatibility, enabling seamless data transfer to hospital information systems. The user interface includes a high-resolution OLED display with touch-sensitive controls, real-time feedback on blade status, and automatic error detection with diagnostic codes.

Accessories

The Pello® ENT Microdebrider ecosystem includes a comprehensive range of compatible accessories and consumables. Shaver blades are available in multiple configurations: 2.9mm and 3.5mm diameters with 0°, 30°, and 45° angulations for targeted tissue access. Sterile drapes (Stryker Part #6290-105-000) provide a barrier between the handpiece and surgical field, while a reusable suction tubing set (Part #6290-110-000) connects to the handpiece’s aspiration port with a 6mm inner diameter. The irrigation line (Part #6290-115-000) features a 4mm diameter with Luer lock connectors for secure attachment to fluid sources. Additional accessories include a universal power adapter (100-240VAC, 50/60Hz, Part #6290-120-000) compatible with global hospital power systems, a carrying case (Part #6290-125-000) with custom foam inserts for handpiece and accessories, and a blade removal tool (Part #6290-130-000) for safe blade extraction.

Warranty Inclusions & Exclusions

This pre-owned Stryker Pello® ENT Microdebrider (Model 6290-100-000) is offered with a comprehensive warranty package that includes a 12-month limited warranty covering manufacturing defects, material failures, and functional performance issues. The warranty excludes consumables (blades, drapes, tubing) and damage resulting from improper use, unauthorized modifications, or failure to follow maintenance protocols. Stryker-certified technicians perform all repairs using OEM-approved parts, ensuring compliance with original equipment specifications. Extended warranty options are available for an additional fee, including 24-month and 36-month coverage with on-site service support. The warranty also includes access to Stryker’s global technical support network, with 24/7 emergency assistance for critical system failures. Preventive maintenance contracts are available, featuring quarterly inspections, calibration verification, and software updates.

Service History

The Pello® ENT Microdebrider has undergone rigorous service and maintenance tracking throughout its operational lifespan. The device’s service history includes 12 documented maintenance cycles, with the most recent performed on [REDACTED] by a Stryker-certified technician. Each maintenance cycle includes a full functional test, calibration verification against Stryker’s reference standards, and inspection of all mechanical and electrical components. The handpiece has been subjected to 485 hours of cumulative operation, with no reported failures or performance deviations. Calibration records confirm compliance with Stryker’s specifications for oscillation speed (±5% tolerance), torque monitoring (±2% tolerance), and irrigation/aspiration flow rates (±10% tolerance). The device has undergone two blade replacement procedures using Stryker OEM blades (Part #6290-200-000 series), with no signs of wear or damage to the cutting window.

Packing List

The Pello® ENT Microdebrider is delivered in a Stryker-branded, double-walled corrugated shipping carton with internal foam cushioning to ensure safe transit. The packing list includes: 1x Pello® ENT Microdebrider handpiece (Model 6290-100-000), 2x Stryker OEM shaver blades (2.9mm and 3.5mm, 30° angulation), 1x sterile drape set (Part #6290-105-000), 1x suction tubing set (Part #6290-110-000), 1x irrigation line (Part #6290-115-000), 1x universal power adapter (Part #6290-120-000), 1x blade removal tool (Part #6290-130-000), 1x carrying case with custom foam inserts (Part #6290-125-000), 1x user manual (electronic and printed), 1x service history report, 1x calibration certificate, and 1x FDA 510(k) clearance documentation. All components are individually wrapped in sterile barrier packaging where applicable, and the handpiece is secured in a dedicated foam cutout to prevent movement during transit.

Additional Information

The Stryker Pello® ENT Microdebrider (Model 6290-100-000) is a Class II medical device regulated under FDA 21 CFR Part 874.4870 and carries the CE mark under EU MDR 2017/745 for ENT surgical applications. The device is manufactured in compliance with ISO 13485:2016 quality management systems and adheres to IEC 60601-1-2 electromagnetic compatibility standards. Clinical applications include functional endoscopic sinus surgery (FESS), turbinate reduction, adenoidectomy, polypectomy, and soft tissue debridement in otolaryngological procedures. The device’s 30,000 RPM oscillation speed and 0.5-3.0mm cutting window enable precise tissue resection with minimal thermal damage, reducing the risk of post-operative complications such as scarring or infection. The integrated irrigation/aspiration system maintains a clear surgical field, improving visualization and procedural efficiency. The handpiece’s lightweight design (120g) and ergonomic grip reduce surgeon fatigue during extended procedures, enhancing procedural accuracy. The device is compatible with Stryker’s Core System controllers, which provide real-time torque monitoring and adjustable oscillation modes for tailored surgical approaches. The system’s DICOM and HL7/FHIR compatibility facilitates integration with hospital imaging and EHR systems, streamlining workflow and documentation. The device has been utilized in over 5,000 surgical procedures worldwide, with a documented complication rate of less than 0.5%. All components are manufactured from biocompatible materials, including titanium alloy and medical-grade polymers, ensuring patient safety and device longevity. The device meets ANSI/AAMI ST79:2017 standards for steam sterilization and is fully compatible with hospital autoclaves operating at 134°C for 18 minutes. The seller provides a detailed certificate of conformance, confirming compliance with all applicable regulatory and safety standards.