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Idiomas disponibles
Idiomas disponibles
ENGLISH
Medical Device
DESCRIPTION
The device is an auto-expulsion valve with push button for suction release.
Components: (Fig. 1 & 2)
1. Valve Housing
2. Rubber Membrane
3. Cap
4. Cap Key
5. Socket Insert
6. Set Screw
7. Foam Cap
INTENDED USE
The device is intended to connect and release a prosthetic system that
replaces a missing lower limb.
Suitability of the device for the prosthesis and the patient must be
evaluated by a healthcare professional.
The device must be fitted and adjusted by a healthcare professional.
Indications For Use and Target Patient Population
• Lower limb loss, amputation, or deficiency
• No known contraindications
The device is for high impact use, e.g., walking and occasional running.
GENERAL SAFETY INSTRUCTIONS
The healthcare professional should inform the patient about everything in
this document that is required for safe use of this device.
Warning: If there is a change or loss in device functionality, or if the device
shows signs of damage or wear hindering its normal functions, the patient
should stop using the device and contact a healthcare professional.
The device is for single patient use.
ASSEMBLY INSTRUCTIONS
Directly to the socket
1. Fabricate the socket as usual.
2. Mark the position of the valve onto the socket.
3. Using an 8.5 mm drill bit, make a hole perpendicular to the socket wall.
4. Tap the hole using M10x1.5 tap.
5. Ensure the Cap and Rubber Membrane have been removed prior to
shortening the threads to prevent debris lodging in the airways.
6. Measure socket wall thickness at insertion point with a caliper, and
shorten the threads accordingly using a hacksaw and smooth edges.
Warning: Do not shorten the threads beyond 4 mm, as it may affect the
seal and increase the risk of the valve breaking off (Fig. 3).
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