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General| Brand | Otto Bock |
|---|---|
| Model | Harmony P4 4R180 |
| Category | Medical Equipment |
| Language | English |
Describes the mechanical vacuum pumps' role in prosthetic sockets for improved connection.
Details compatibility with Ottobock's modular connectors and untested third-party components.
Specifies the product is exclusively for lower limb exoprosthetic fittings.
Details product performance with MOBIS classification, mobility grades, and TT prostheses.
Lists allowable and prohibited conditions for storage, transport, and use.
States the product was tested for 3 million load cycles, corresponding to a 5-year maximum lifetime.
Requires integration by O&P professionals trained as certified Harmony experts.
Lists conditions that prevent safe product use, such as interim prosthesis or neuromas.
Explains warning symbols, specifically CAUTION for risks of accident or injury.
Provides instructions to prevent injury and product damage, including strain, environment, and use limits.
Instructions for creating the check socket or inner layer of the definitive socket using thermoplastic material.
Guides on roughening, cleaning, and attaching the lamination plate to the vacuum pump.
Steps for securing connections, creating an air-tight surface, and drilling holes for the check socket.
Details the process for creating the final prosthetic socket, including material requirements.
Step-by-step guide for mounting the vacuum pump onto the lamination plate and securing it.
Explains how to adjust vacuum generation and damping using the elastomer rod and set screws.
Procedures to test and verify the proper functioning and vacuum maintenance of the prosthesis.
Instructions for correctly putting on the prosthesis, avoiding wrinkles and air pockets.
Instructions for safely removing the prosthesis from the residual limb.
Guidelines for cleaning the prosthetic socket with a damp, soft cloth.
Refers to the liner's specific instructions for use for cleaning procedures.
Details cleaning methods for qualified personnel and users, including compressed air and water flushing.
States the manufacturer's liability is limited to product use as per instructions, excluding improper use.
Confirms the product meets EU medical device regulations and where to download the declaration.
