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General| Brand | Otto Bock |
|---|---|
| Model | 3R15 |
| Category | Medical Equipment |
| Language | English |
Provides information and safety notices for document usage and product handling.
Defines CAUTION and NOTICE symbols indicating potential risks and technical damage.
Explains the meaning of numbered pictograms used in illustrations for clarity.
Details key features of the product, including its monocentric prosthetic knee joint.
Specifies the product's exclusive use for lower limb exoprosthetic fittings.
Defines the specific medical conditions and patient types for product application.
Defines allowable mobility grades and body weight limits for product use.
Guidelines for combining prosthetic components and verifying compatibility.
Details allowable and unallowable environmental conditions for product operation and storage.
Information on product reuse limitations and its estimated service life.
Critical safety warnings regarding joint mechanism access and mechanical damage.
Instructions for correct fabrication, alignment, and initial patient use of the prosthesis.
Lists the components included in the product package for assembly.
Provides essential technical specifications such as weight, dimensions, and load capacities.
Detailed steps for aligning the prosthesis on a workbench in sagittal and frontal planes.
Procedures for optimizing static alignment based on load lines and anatomical reference points.
Adjustments made during dynamic fitting to optimize gait and function.
Steps for completing the prosthesis, including protective covers and screw connections.
Information and notices regarding the safe and proper use of the prosthesis.
Guidelines for cleaning the product using approved agents and methods.
Instructions for regular maintenance, lubrication, and component replacement.
Information on proper disposal procedures for the product and environmental considerations.
Covers liability and CE conformity declarations for the product.
Manufacturer's liability conditions based on product usage and adherence to instructions.
Product compliance with EU regulations and availability of conformity declarations.
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