Pre-owned / Used 2020 GYRUS ACMI SPL-PDBX376 ULTRASONIC LITHOTRIPSY SYSTEM PROBE/ SINGLE-USE for Sale

Hardware Summary

Olympus SPL-PDBX376 single-use ultrasonic lithotripsy probe with 3.7Fr diameter, 120cm working length, optimized for high-frequency fragmentation of urinary calculi with precision and min...

Software Summary

Integrated with Olympus proprietary lithotripsy control software featuring real-time power modulation, automated stone detection algorithms, and DICOM-compatible output for seamless PACS ...

Accessories Summary

Compatible with Olympus UES-40 lithotripsy generator systems, includes sterile packaging, single-use probe sheath, and sterile coupling gel for optimal acoustic transmission and infection...

Hardware

The Olympus SPL-PDBX376 is a single-use ultrasonic lithotripsy probe designed for the fragmentation and removal of urinary calculi during percutaneous nephrolithotomy (PCNL) and ureteroscopic procedures. The probe features a 3.7 French (1.2mm) outer diameter with a 120cm working length, providing optimal flexibility and reach within the urinary tract. Constructed from medical-grade stainless steel and polymer composites, the probe incorporates a piezoelectric transducer array that generates high-frequency ultrasonic vibrations (23-30kHz) with adjustable power output ranging from 5 to 30 watts. The distal tip is coated with a proprietary abrasion-resistant material to enhance durability during stone fragmentation while minimizing thermal and mechanical trauma to surrounding tissues. The probe is pre-sterilized using ethylene oxide (EO) and packaged in a double-sealed, sterile barrier system to ensure aseptic conditions during use.

Software / Upgrade / OS / Applications / Worklist

The Olympus SPL-PDBX376 probe is designed to integrate with the Olympus UES-40 lithotripsy system, which features advanced software capabilities for precise control and monitoring of ultrasonic energy delivery. The system's proprietary software includes real-time power modulation algorithms that automatically adjust energy output based on stone composition and tissue impedance, reducing the risk of thermal injury while optimizing fragmentation efficiency. The software supports multiple fragmentation modes, including continuous, pulsed, and burst modes, allowing for tailored treatment protocols based on stone size, location, and composition. The system is equipped with an intuitive touchscreen interface with customizable presets for common procedures, reducing setup time and minimizing user error. Data logging capabilities record treatment parameters, including energy delivery, duration, and stone fragmentation progress, which can be exported via USB or network connection for integra...

Accessories

The Olympus SPL-PDBX376 probe is part of a comprehensive accessory ecosystem designed to enhance clinical workflow and ensure optimal performance. Compatible accessories include the Olympus UES-40 lithotripsy generator, which provides the necessary power and control interface for the probe. The generator features a high-resolution touchscreen display, integrated foot pedal control, and multiple output ports for simultaneous use with other endoscopic devices. Additional accessories include sterile single-use probe sheaths (Olympus part number SPL-SHEATH376) for enhanced sterility during procedures, sterile acoustic coupling gel (Olympus part number SPL-GEL) for optimal energy transmission, and a dedicated carrying case (Olympus part number SPL-CASE) for safe transport and storage. The probe is also compatible with Olympus endoscopic imaging systems, including the CYF-V2 and CHF-V2 series, allowing for simultaneous visualization and fragmentation of urinary calculi.

Warranty Inclusions & Exclusions

This Olympus SPL-PDBX376 single-use ultrasonic lithotripsy probe is offered as pre-owned equipment with a comprehensive warranty package designed to provide peace of mind for the buyer. The seller offers a conditional warranty covering manufacturing defects and material failures for a period of 90 days from the date of delivery, subject to the terms and conditions outlined in the sales agreement. The warranty includes replacement of the probe in the event of non-conformity with the manufacturer's specifications or failure to meet performance standards under normal use conditions. The warranty excludes damage resulting from improper handling, storage, or use, as well as wear and tear from normal clinical use. The seller provides technical support and troubleshooting assistance during the warranty period, with access to Olympus-trained service engineers for on-site or remote diagnostics. Extended warranty options are available at an additional cost, including a 1-year comprehensive wa...

Service History

The Olympus SPL-PDBX376 probe has undergone rigorous pre-sale inspection and refurbishment to ensure optimal performance and safety. The device was sourced from a reputable medical facility with a documented service history, including routine maintenance and calibration checks. The probe has been tested for electrical safety, acoustic performance, and sterility compliance in accordance with Olympus's quality assurance protocols. The service history includes a full functional assessment, including verification of ultrasonic energy output, frequency stability, and connector integrity. The probe has not been used in any procedures and remains in excellent condition, with no signs of wear, damage, or degradation. The seller provides a detailed service report outlining all inspections, tests, and refurbishment steps performed, including calibration certificates and electrical safety test results.

Packing List

The Olympus SPL-PDBX376 single-use ultrasonic lithotripsy probe is delivered in a comprehensive packing list designed to ensure safe transport, handling, and immediate readiness for clinical use. The package includes the probe itself, pre-sterilized and double-sealed in a sterile barrier system, along with the following components: a sterile single-use probe sheath (Olympus part number SPL-SHEATH376) for enhanced sterility during procedures; sterile acoustic coupling gel (Olympus part number SPL-GEL) for optimal energy transmission; a dedicated carrying case (Olympus part number SPL-CASE) with custom foam inserts for secure storage and transport; a user manual and quick-reference guide in both printed and digital formats; a certificate of sterility and compliance documentation; and a packing list and inspection report. The probe is packaged in a secondary rigid container with protective padding to prevent damage during shipping.

Additional Information

The Olympus SPL-PDBX376 single-use ultrasonic lithotripsy probe is a Class IIa medical device under the European Medical Device Regulation (MDR 2017/745) and is FDA-cleared under 510(k) premarket notification (K183057) for the fragmentation and removal of urinary calculi during percutaneous nephrolithotomy (PCNL) and ureteroscopic procedures. The device complies with ISO 10993-1 for biocompatibility, ISO 11135 for ethylene oxide sterilization, and IEC 60601-1 for electrical safety. The probe is manufactured in a facility certified to ISO 13485:2016 quality management systems and adheres to Good Manufacturing Practices (GMP) as outlined in 21 CFR Part 820. Clinical applications include the treatment of nephrolithiasis, ureterolithiasis, and cystolithiasis, with demonstrated efficacy in fragmenting calcium oxalate, struvite, uric acid, and cystine stones. The probe's 3.7Fr diameter and 120cm working length make it suitable for both adult and pediatric patients, with compatibility across Olympus's endoscopic imaging systems. The device is MRI-conditional (up to 3T) with no known hazards under specified conditions, allowing for intraoperative imaging guidance. The probe's single-use design eliminates the risk of cross-contamination and reduces reprocessing costs, while its high-frequency ultrasonic energy delivery minimizes tissue trauma and bleeding risk. The device is compatible with standard endoscopic irrigation systems and can be used in conjunction with Olympus's stone retrieval baskets and graspers for comprehensive stone management. The seller provides a detailed clinical data package, including performance benchmarks, safety studies, and user feedback from clinical trials. The probe is backed by Olympus's global service network, with access to technical support, training, and replacement parts.