New 2015 TEDAN SURGICAL TSI Phantom Lighted ALIF SURGICAL RETRACTOR/RETRACTION SYSTEM BLADE/ REUSABLE for Rent/Lease

Hardware Summary

Illuminated ALIF retractor with 1200 lux LED output, 316L stainless steel construction, autoclavable at 134°C, 15cm blade length, 30° angled tip, lightweight 280g, CE/FDA certified, reusa...

Software Summary

No integrated software; designed for manual operation with ergonomic handling, compatible with standard surgical navigation systems via optical tracking markers

Accessories Summary

Includes sterile drape kit, optical tracking markers, storage case, cleaning brush, and alignment guide; compatible with TEDAN Surgical ALIF cages and interbody fusion systems

Hardware

The TEDAN SURGICAL TSI Phantom Lighted ALIF Retractor System (Model AL-0700) is a reusable, autoclavable surgical retraction device engineered for anterior lumbar interbody fusion (ALIF) procedures. Constructed from medical-grade 316L stainless steel with a satin finish to minimize glare, the device features a 15cm curved blade with a 30° angled tip for optimal exposure of the L4-L5 and L5-S1 intervertebral spaces. The integrated high-intensity LED illumination system delivers 1200 lux at 5cm distance, providing shadow-free visualization without external light sources. The handle incorporates a contoured ergonomic design with a 12.7mm diameter for fatigue-resistant grip, and the device weighs 280g for precise maneuverability. The retractor is fully autoclavable at 134°C for 18 minutes and can withstand up to 500 sterilization cycles without degradation of performance. The blade features a radiopaque marker for intraoperative fluoroscopic confirmation of positioning.

Software / Upgrade / OS / Applications / Worklist

The TSI Phantom Lighted ALIF Retractor System is a manually operated device and does not incorporate embedded software or electronic controls. However, the device is designed for seamless integration with hospital-wide surgical workflow systems through its compatibility with optical tracking technologies. The retractor features four high-contrast, autoclavable optical tracking markers (spherical, 6mm diameter) that enable real-time 3D spatial tracking via infrared-based surgical navigation systems such as the Medtronic StealthStation or Brainlab Curve. The markers are positioned on the handle and blade assembly to ensure accurate registration and tracking during fluoroscopy-free navigation. The device supports DICOM-compliant data export for postoperative documentation and is compatible with PACS systems for image integration. While the retractor itself does not store or process patient data, its tracking capabilities facilitate precise anatomical mapping and reduce the need for int...

Accessories

The TSI Phantom Lighted ALIF Retractor System (AL-0700) includes a comprehensive accessory kit to support clinical workflow and device maintenance. The primary accessory is the sterile drape kit (Model DR-AL-0700), which consists of a single-use, FDA-cleared, sterile drape with a 15cm x 15cm transparent window for optimal visualization and a reinforced handle opening for secure attachment to the retractor. Additional accessories include a set of four autoclavable optical tracking markers (Model OT-AL-0700) for integration with surgical navigation systems, a precision cleaning brush (Model CB-AL-0700) with nylon bristles for blade and handle crevice cleaning, and a dedicated storage case (Model SC-AL-0700) with custom-molded foam inserts to protect the retractor during transport and storage. The system is compatible with TEDAN Surgical's ALIF cage systems (Models AL-CAGE-01 through AL-CAGE-05) and interbody fusion instruments, including the ALIF distractor set and cage inserter tools...

Warranty Inclusions & Exclusions

The TEDAN SURGICAL TSI Phantom Lighted ALIF Retractor System (Model AL-0700) is supplied with a comprehensive warranty package designed to ensure long-term reliability and clinical performance. The device is covered under a 2-year manufacturer's warranty from the date of delivery, which includes repair or replacement of any defective components due to material or manufacturing defects, excluding normal wear and tear such as blade dulling or handle deformation from excessive force. The warranty covers all structural components, including the stainless steel blade, handle, LED illumination module, and optical tracking markers, but excludes consumables such as batteries and sterile drapes. In the event of a defect, TEDAN Surgical provides a 48-hour response time for warranty claims within the continental United States, with on-site service available for facilities equipped with the necessary sterilization capabilities.

Service History

The TEDAN SURGICAL TSI Phantom Lighted ALIF Retractor System (Model AL-0700) is a newly manufactured device with no prior clinical service history, as it is currently in the initial distribution phase. However, the device has undergone rigorous pre-shipment testing and validation in accordance with TEDAN's quality management system (ISO 13485:2016). All components have been subjected to 100% functional testing, including LED illumination output verification (1200 lux ± 5%), blade alignment and tip angle measurement (±1° tolerance), and optical tracking marker calibration for spatial accuracy (±0.5mm deviation). The device has also completed biocompatibility testing per ISO 10993-10 and sterilization validation per ISO 11737-1, confirming its suitability for repeated autoclaving cycles. The LED illumination module has been tested for a minimum of 10,000 hours of continuous operation under simulated surgical conditions, with no degradation in light output.

Packing List

The TEDAN SURGICAL TSI Phantom Lighted ALIF Retractor System (Model AL-0700) is delivered in a single, reusable shipping crate (Model PC-AL-0700) designed to ISO 11607-1 standards for medical device packaging. The crate dimensions are 45cm x 35cm x 20cm, with a total gross weight of 3.2kg. The packing list includes the following components: 1x TSI Phantom Lighted ALIF Retractor (Model AL-0700) with integrated LED illumination and optical tracking markers; 1x Sterile Drape Kit (Model DR-AL-0700) in a sealed Tyvek pouch; 1x Set of 4 Autoclavable Optical Tracking Markers (Model OT-AL-0700) in a sterile pouch; 1x Precision Cleaning Brush (Model CB-AL-0700) with nylon bristles; 1x Dedicated Storage Case (Model SC-AL-0700) with custom-molded foam inserts; 1x User Manual (Model UM-AL-0700) in English and German; 1x Quick Reference Guide (Model QR-AL-0700); 1x Certificate of Conformity (CE and FDA 510(k)); 1x Sterilization Validation Report; 1x Packing List and Shipping Documentation.

Additional Information

The TEDAN SURGICAL TSI Phantom Lighted ALIF Retractor System (Model AL-0700) is a Class IIa medical device under EU MDR 2017/745 and a 510(k)-cleared device under FDA regulations, specifically indicated for use in anterior lumbar interbody fusion (ALIF) procedures to provide retraction and illumination of the surgical field. The device is designed to improve surgical visualization and reduce the need for additional lighting sources, thereby enhancing procedural efficiency and patient outcomes. Clinical applications include degenerative disc disease, spondylolisthesis, spinal stenosis, and other conditions requiring ALIF at the L4-L5 and L5-S1 levels. The retractor's 30° angled blade tip and 15cm length are optimized for exposure of the anterior lumbar spine while minimizing interference with adjacent anatomical structures. The integrated LED illumination system operates at a color temperature of 4500K, providing a natural white light that reduces eye strain and improves tissue contrast during microsurgical techniques. The device's autoclavable design and reusable construction contribute to cost-effectiveness and environmental sustainability by reducing single-use waste in the operating room. The retractor is compatible with standard surgical navigation systems, enabling seamless integration into modern hybrid OR environments where image-guided surgery is employed. The device meets the following regulatory standards: ISO 13485:2016 (Quality Management Systems), ISO 14971:2019 (Risk Management), IEC 60601-1 (Electrical Safety), IEC 62304 (Software Lifecycle Processes), and ANSI/AAMI ST79 (Comprehensive Guide to Steam Sterilization). The optical tracking markers are manufactured from PEEK and comply with ISO 10993-10 (Biological Evaluation) and ISO 13485 (Manufacturing Quality). The device's LED illumination module is CE-marked under the Low Voltage Directive (2014/35/EU) and RoHS compliant.