The Wonderfu HHL800a Fixer is a Class II medical instrument made from stainless steel, designed to provide reliable fixation in a variety of healthcare and rehabilitation settings. It is intended for use by medical professionals for therapeutic and procedural fixing applications.
Class II indicates the device is subject to specific regulatory controls to ensure safety and effectiveness in medical use. It typically requires compliance with performance standards, quality systems and appropriate labeling; check local regulations for details.
The HHL800a is constructed from stainless steel, which offers enhanced strength, durability and resistance to corrosion. These properties make it suitable for repeated clinical use and common sterilization processes when used according to the manufacturer’s instructions.
The device is CE marked and manufactured under an ISO 13485 quality management system, indicating conformity with applicable European safety requirements and internationally recognized medical device quality standards.
It is designed for a wide range of fixing and stabilization tasks in healthcare and rehabilitation environments, including clinical procedures, patient support and assistive/therapeutic applications. Specific uses depend on clinician judgment and facility protocols.
No. The product description refers to fixation in clinical and rehabilitation settings and does not state it is implantable. For implantable use you must confirm with the manufacturer and applicable regulatory documentation; do not implant unless explicitly authorized by the manufacturer.
Stainless steel instruments are commonly compatible with standard hospital sterilization methods (for example, steam autoclaving), but you must follow the manufacturer’s provided instructions for use (IFU) and your facility’s sterilization protocols to ensure safety and device integrity.
Clean the device promptly after use with compatible detergents and non‑abrasive brushes, rinse thoroughly, and follow validated disinfection/sterilization processes. Inspect regularly for wear, damage or corrosion and remove from service if defects are found. Always follow the manufacturer’s maintenance guidance.
Store in a clean, dry environment away from corrosive chemicals and extremes of temperature or humidity. Protect from mechanical damage and keep in original packaging or dedicated instrument trays when not in use.
The fixer is intended for general fixing applications; compatibility with specific accessories or systems depends on the accessory design. Verify compatibility with the accessory manufacturer or consult the Wonderfu IFU or technical support before combining devices.
The device should be used by trained healthcare professionals or personnel under their supervision, following institutional protocols and the manufacturer’s instructions for safe and effective use.
Follow standard clinical contraindications for fixation procedures and device‑specific warnings in the IFU. Use only for intended indications, ensure proper patient assessment, and inspect the device before use. Do not use if damaged or corroded.
Warranty and service terms are not provided in the basic product description. Contact the manufacturer or your authorized supplier for details on warranty coverage, service plans, repairs and spare parts.
While stainless steel offers long-term durability, actual lifespan depends on frequency of use, maintenance, sterilization cycles and handling. Proper cleaning, inspection and storage will extend service life; refer to the manufacturer’s recommendations for end‑of‑life criteria.
Dispose of medical devices in accordance with local laws and healthcare facility policies. Where possible recycle stainless steel components through appropriate metal recycling channels, and follow any regulations for disposal of medical equipment and contaminated instruments.
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