ROUX RETRACTOR SET FIG-1-3

ROUX RETRACTOR SET • FIG-1 TO FIG-3 • CE-CLASS I • ISO 13485:2016

Professional Retractor Set for Graduated, Deep Liver and Upper Abdominal Exposure in Visceral and Transplantation Surgery

The ROUX RETRACTOR SET (FIG-1 to FIG-3) is a Class I medical device manufactured according to ISO 13485:2016. This special set of three coordinated, curved retractors is designed for the systematic and gentle exposure of the liver, biliary tract, and deep upper abdomen. Each hook has a specific curvature and size to enable optimal graduated retraction.

Set Product Highlights:

✔ Manufactured in accordance with ISO 13485:2016
✔ CE Marked – Class I (Regulation (EU) 2017/745 – MDR)
✔ Complete 3-piece set (FIG-1, FIG-2, FIG-3) for systematic and deep upper abdominal retraction
✔ Graduated curvatures and sizes: Each hook is optimized for a specific depth and anatomical region
✔ High-quality Surgical Stainless Steel 1.4301 – rust-proof, corrosion-resistant and durable
✔ Atraumatic, wide and rounded blade tips for gentle tissue contact
✔ Ergonomic, closed finger rings for secure guidance
✔ Matte finish to reduce light glare
✔ Sterilizable and reusable
✔ Practical storage: Often as a set in a sterilizable storage tray or case

Benefits of the Roux Retractor Set:

• Systematic and Deep Exposure: Enables stepwise and controlled visualization of deep upper abdominal organs (liver, spleen, gastric fundus, distal esophagus) by using the appropriately curved hooks sequentially or in combination.
• Optimal Adaptation to Anatomy: The varying curvatures (FIG-1: flattest, FIG-3: deepest and most curved) allow perfect adaptation to the convex surface of the liver and the curvature of the diaphragm.
• Reduced Liver Trauma: The wide, blunt blades distribute pressure evenly on the liver parenchyma, minimizing the risk of parenchymal tears or crush injuries.
• Indispensable for Liver Surgery: A standard instrument set for liver resections (hemihepatectomies, segmentectomies), liver transplantations, and complex procedures on the gastric fundus or cardia.
• Improved Team Efficiency: The set provides the entire surgical team with the right instruments for optimized and safe retraction during different phases of the procedure.

Technical Specifications of the Set:

• Type: Roux Retractor Set / Curved Liver-Upper Abdominal Retractors
• Set Contents: 3 retractors (FIG-1, FIG-2, FIG-3) with increasing curvature and size
• Common Features: Wide, curved blades with rounded tips, closed oval handles
• Material: Surgical Stainless Steel 1.4301 (AISI 304)
• Surface Finish: Satin (matte)
• Sterilization: Autoclavable up to 138°C (Steam Sterilization)
• Packaging: Set packed in sterilizable peel pouch or storage tray
• Risk Class: I according to Regulation (EU) 2017/745 (MDR)

Description of Individual Hooks (typical graduation):

• ROUX FIG-1: Flattest and widest curvature. Ideal for initial retraction and exposure of more superficial areas or large flat organs.
• ROUX FIG-2: Medium curvature and size. Versatile for mid-depth retraction, e.g., of the left liver lobe or gastric fundus.
• ROUX FIG-3: Strongest curvature and often longest/deepest hook. For the deepest retraction, e.g., to expose the retrohepatic vena cava, hepatic veins, or the diaphragmatic junction of the esophagus.

Areas of Application for the Set:

• Anatomical and atypical liver resections
• Liver transplantation (backtable preparation and implantation)
• Gastrectomy (especially for exposure of the cardia and distal esophagus)
• Surgery of the distal esophagus and cardia (e.g., fundoplication, myotomy)
• Splenic surgery and left pancreatectomy
• Complex revision and adhesiolysis procedures in the upper abdomen

Important Safety and Handling Information for the Set:

• FOR USE BY EXPERIENCED VISCERAL AND TRANSPLANT SURGEONS ONLY.
• Graduated Retraction: Start with the flatter hook (FIG-1) and switch to the more curved hooks (FIG-2, FIG-3) for deeper layers as needed. This minimizes the risk of excessive tissue stretching.
• Caution with Portal Hypertension and Fragile Liver: In liver cirrhosis or steatosis, the parenchyma is more friable. Retraction force must be reduced accordingly.
• Protection of Major Vessels: When retracting deeply near the liver hilum or retrohepatic vena cava, utmost care is required to avoid vascular injury.
• Cleaning and Care of the Set: After use, all hooks should be individually cleaned thoroughly to remove dried blood and tissue residue. Store the set together to ensure completeness.