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General| Brand | Bort |
|---|---|
| Model | Generation |
| Category | Medical Equipment |
| Language | English |
Defines the medical device as a shoulder joint brace for immobilisation in a defined position.
Lists conditions for using the brace, including pre-operative, post-operative, and post-traumatic scenarios.
Specifies conditions where the brace should not be used, such as impaired lymphatic drainage or skin diseases.
Highlights precautions, physician consultation, and proper use guidelines for the medical device.
Provides a step-by-step guide for correctly fitting and adjusting the shoulder brace.
Details the procedure for safely removing the shoulder brace by opening fasteners.
Lists the materials used in the shoulder brace, such as polyamide and cotton.
Provides instructions for washing and maintaining the shoulder brace, including temperature and bleach warnings.
Explains warranty terms, expected lifespan, and proper disposal of the medical device.
Outlines reporting obligations for health worsening and confirms compliance with EU regulations.
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