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General| Product Type | Prosthetic Knee Joint |
|---|---|
| Amputation Level | Transfemoral |
| Maximum Body Weight | 125 kg |
| Knee Disarticulation | Yes |
| Material | Aluminum |
| Hydraulic Resistance | Yes |
| Stance Phase Control | Hydraulic |
| Swing Phase Control | Hydraulic |
| Weight Capacity | 125 kg |
| Water Resistance | No |
| Adjustability | Yes |
Details the polycentric design, flexion angle, and pneumatic swing phase control.
Lists compatible prosthetic components for fabrication, including adapters and foam covers.
Specifies the product is for lower limb prosthetic fittings only.
Defines suitability for MOBIS mobility grades 2 and 3, up to 125 kg.
Outlines allowable temperature, humidity, and unallowable conditions.
States product tested for 3 million load cycles, with a 3-5 year service life.
Explains the meaning of CAUTION and NOTICE symbols used in the document.
Provides crucial safety advice, including avoiding reuse on other patients.
Guides on prosthesis fabrication steps: bench alignment, static alignment, and dynamic trial fitting.
Advises on using cosmetic covers, applying silicone spray, and re-testing after cover fitting.
Details the process and equipment for aligning prosthetic components using specific reference points.
Instructions for safely shortening the tube adapter using a tube cutter and deburrer.
Procedures for correctly installing the tube adapter onto the prosthetic knee joint and foot.
Instructions for fabricating both test and definitive prosthetic sockets for specific models.
Steps for creating a test socket using various laminating materials and techniques.
Steps for creating the final prosthetic socket using specified materials and assembly methods.
Describes determining sagittal/frontal load lines and component positioning.
Guides on adjusting settings like flexion and extension damping for optimal patient walking.
How to verify and reset initial flexion and extension damping settings.
Instructions on adjusting the flexion damping valve to control prosthetic foot swing.
Instructions on adjusting the extension damping valve for smooth knee extension.
Procedures for replacing or omitting the compression spring for adjusted extension assist.
Final steps for tightening screws and verifying the overall function of the prosthesis.
General usage guidance, mechanical overload warnings, and patient information needs.
Details how to clean the product for minor dirt, heavy dirt, and with disinfectants safely.
States manufacturer liability conditions and disclaims responsibility for unauthorized modifications.
Confirms product meets European medical device directive requirements and classification.
