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Amputation Level | Transfemoral |
---|---|
Product Type | Knee Joint |
Material | Aluminum |
Adjustable Swing Phase | Yes |
Polycentric Design | Yes |
Features | Swing phase control |
Details key technical specifications like part number, weight, system height, and max body weight.
Explains the DVS components and how pistoning between limb and socket generates vacuum.
Details compatible components and limitations for optimal product function and compatibility.
Specifies that the product is intended exclusively for lower limb exoprosthetic fittings.
Information regarding product approval for maximum body weight.
Specifies allowable and unallowable temperature, humidity, and environmental factors.
Details product testing with 3 million load cycles, corresponding to a 5-year lifespan.
Defines the meaning of CAUTION and NOTICE symbols used in the document for risk communication.
Provides essential guidelines for safe product use, handling, and maintenance to prevent damage or injury.
Covers compliance with application, environmental conditions, and product integrity to avoid risks.
Lists items included in the 4R220 Dynamic Vacuum System package for initial setup.
Guides on preparing a plaster model for socket fabrication using specific materials and tools.
Details processes for fabricating the prosthetic socket, including optional check socket and lamination types.
Steps for completing the prosthetic socket, including trimming, sanding, and attaching components.
Instructions for attaching the socket adapter and ensuring secure connection to other components.
Procedure for putting on the prosthesis correctly with the liner and socket.
Procedure for removing the prosthesis correctly from the residual limb.
Manufacturer's liability conditions based on product usage and adherence to instructions.
Statement of product compliance with EU medical device regulations (Regulation (EU) 2017/745).
Details manufacturer's warranty coverage for material, production, and construction defects.