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ENGLISH
Medical Device
DESCRIPTION
The device is a prosthetic foot device with a male pyramid and three
composite blades. It features a sandal toe and a full-length composite
blade. The bottom blade is secured together with heel bolts.
The device consists of the following components (Fig. 1):
A. Male Pyramid Adapter
B. Pyramid Cover
C. Top Blade
D. Middle Blade
E. Bottom Blade
F. Bottom Blade Bolts
This device must be used with a Foot Cover and a Spectra Sock.
INTENDED USE
The device is intended as a part of a prosthetic system that replaces the
foot and ankle function of 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 amputation and/or congenital deficiency
• No known contraindications
The device is for low to 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.
DEVICE SELECTION
Verify that selected variant of the device is suitable for the impact level
and weight limit according to the following table.
Warning: Do not exceed weight limit. Risk of device failure.
Incorrect category selection may also result in poor device function.
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