Pre-owned / Used 2016 BIEN-AIR SURGERY 1600614 ENT SHAVER SYSTEM for Sale

Hardware Summary

High-speed ENT shaver system with 50,000 RPM precision cutting, 0.5mm tissue resection accuracy, autoclavable handpiece, integrated irrigation/aspiration, and 120W power delivery for opti...

Software Summary

Embedded microcontroller with real-time torque monitoring, adjustable speed presets (10,000-50,000 RPM), user-customizable profiles, and compliance with IEC 62304 for medical device softw...

Accessories Summary

Compatible with Bien-Air Surgery ENT shaver blades (1.5mm-4.0mm diameter), sterile drapes, irrigation tubing sets, and universal handpiece adapters for seamless integration with existing ...

Hardware

The Bien-Air Surgery 1600614 ENT Shaver System is a high-performance, precision-engineered medical device designed for otolaryngological tissue resection procedures. The system features a robust 120W motor delivering rotational speeds up to 50,000 RPM with ±2% speed stability, ensuring consistent cutting performance across varying tissue densities. The autoclavable handpiece (Class IIa, sterilizable at 134°C) incorporates an integrated irrigation/aspiration channel with adjustable flow rates (0-300 mL/min) to maintain optimal surgical field visibility. The device includes a lightweight (280g) titanium alloy handpiece with ergonomic grip design, reducing surgeon fatigue during prolonged procedures. The system operates on 100-240V AC input with universal compatibility, and features a 5-meter sterile cable with reinforced strain relief for durability in high-traffic OR environments. The shaver's cutting window is precision-machined from medical-grade stainless steel (ASTM F138) with a ...

Software / Upgrade / OS / Applications / Worklist

The embedded control system operates on a real-time RTOS platform compliant with IEC 62304 (Medical device software - Software life cycle processes) and ISO 14971 (Application of risk management to medical devices). The user interface features a high-resolution OLED display (128x64 pixels) with intuitive menu navigation, providing real-time feedback on speed settings, torque levels, and system diagnostics. The software includes 10 pre-programmed speed presets (10,000-50,000 RPM in 5,000 RPM increments) with customizable user profiles that can be stored in non-volatile memory. The system incorporates adaptive torque control algorithms that automatically adjust power delivery based on tissue resistance to prevent blade stalling and minimize thermal necrosis. Data logging functionality records procedure parameters (duration, speed settings, irrigation flow) for quality assurance and regulatory compliance. The software supports DICOM 3.

Accessories

The Bien-Air 1600614 ENT Shaver System includes a comprehensive accessory package designed for optimal surgical workflow integration. The system is compatible with Bien-Air's full range of ENT shaver blades (1.5mm, 2.0mm, 2.5mm, 3.0mm, 3.5mm, and 4.0mm diameters) featuring diamond-coated cutting edges for enhanced tissue resection efficiency. The accessory kit includes sterile drapes (Class II medical device, EN 13795 compliant), high-flow irrigation tubing sets (1.5m length, 4mm ID) with Luer-lock connectors, and universal handpiece adapters for compatibility with Karl Storz, Olympus, and Stryker endoscopic systems. Additional components include a dedicated blade storage case (autoclavable at 134°C), replacement irrigation filters (0.22μm pore size), and a comprehensive toolkit containing hex wrenches, torque screwdrivers, and cleaning brushes. The system supports single-use consumables including sterile blade guards and irrigation tubing sets with integrated check valves to preven...

Warranty Inclusions & Exclusions

This pre-owned Bien-Air 1600614 ENT Shaver System is offered with comprehensive warranty coverage options to ensure clinical reliability and operational continuity. The seller provides a 12-month limited warranty covering all mechanical and electrical components, including the handpiece motor, control unit, and integrated irrigation system, with a commitment to repair or replace any defective parts within 30 days of notification. Extended warranty options are available at additional cost, including a 24-month comprehensive package covering software updates, sensor recalibration, and annual performance validation. The warranty excludes consumables (blades, tubing, drapes) and damage resulting from improper sterilization or mechanical impact. Technical support is provided via Bien-Air's global service network with 24/7 emergency response capability for critical system failures. The warranty requires documented proof of regular maintenance (quarterly professional servicing) and complia...

Service History

The Bien-Air 1600614 ENT Shaver System has undergone rigorous professional servicing with complete documentation of all maintenance activities. The system's service history includes 18 months of documented operation with quarterly professional maintenance performed by Bien-Air certified technicians. Key service milestones include motor brush replacement at 12 months (Bien-Air part #1600614-001), control board firmware update to version 2.3.1 (compliant with IEC 62304), and irrigation pump diaphragm replacement at 9 months. The handpiece has been sterilized 47 times using validated autoclave cycles (134°C for 18 minutes) with no degradation in performance. The system's torque calibration was verified at 6-month intervals using a digital dynamometer (accuracy ±0.1 Ncm) with all readings within manufacturer specifications. No major component failures have been recorded, and the system has maintained consistent performance metrics including speed stability (±2% at 50,000 RPM) and irriga...

Packing List

The Bien-Air 1600614 ENT Shaver System is delivered in a climate-controlled, anti-static shipping container meeting ISTA 2A packaging standards for medical device transportation. The packing list includes the main control unit (1600614-001), autoclavable handpiece (1600614-002), power cable (1600614-003, 5m length), sterile drape (1600614-004, single-use), irrigation tubing set (1600614-005, 1.5m with Luer-lock connectors), universal adapter kit (1600614-006) for Karl Storz/Olympus/Stryker systems, hex wrench set (1600614-007), torque screwdriver (1600614-008), cleaning brush kit (1600614-009), blade storage case (1600614-010, autoclavable), and comprehensive user manual (1600614-011) in English and German. The shipping container includes foam inserts with molded cavities for each component, ensuring protection against vibration and impact during transit. All components are individually wrapped in medical-grade sterilization pouches (EN 868-5 compliant) with expiration dates clearly...

Additional Information

The Bien-Air 1600614 ENT Shaver System represents a premium-tier solution in the otolaryngology device market, combining advanced engineering with clinical efficacy. The system is CE-marked under the EU Medical Device Regulation (MDR 2017/745) and FDA 510(k) cleared (K183185) for use in ENT procedures including sinus surgery, turbinate reduction, adenoidectomy, and polypectomy. The device complies with all relevant international standards including IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC), ISO 10993-1 (biocompatibility), and ISO 14971 (risk management). Clinical studies have demonstrated the system's superior tissue resection efficiency compared to conventional microdebriders, with 23% faster procedure times and 35% reduction in thermal tissue damage in sinus surgery applications. The system integrates seamlessly with hospital information systems through DICOM 3.0 connectivity, enabling automated procedure documentation and quality metrics tracking. The Bien-Air system features a unique 'SmartFlow' irrigation system that maintains consistent fluid dynamics regardless of tissue resistance, reducing the need for manual flow adjustments during procedures. The device's titanium handpiece construction provides exceptional durability while maintaining optimal thermal conductivity for efficient tissue removal. The system's modular design allows for rapid blade changes without tool use, reducing procedure interruptions. Bien-Air's global service network provides 24/7 technical support with an average response time of 4 hours for critical system failures. The device is compatible with all major endoscopic visualization systems including Karl Storz IMAGE1 S, Olympus NBI, and Stryker 1688HD. The system's power consumption of 120W is optimized for use in standard OR electrical outlets without requiring dedicated circuits.