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Medical Device
DESCRIPTION
The device is a prosthetic foot with a foam core to provide multi-axial
function. It features a sandal toe and a full-length composite blade.
The device consists of the following components (Fig. 1a):
A. Top Plate
B. Bottom Blade
C. Foam Core
D. Straps
This device must be used with a Foot Cover and a Spectra Sock.
D/P Flexion
The D/P Flexion is a hydraulic ankle to be used with K2 Sensation and
Flex-Foot Balance. The device has a range of 4 degrees plantar and 4
degrees dorsal flexion. The ankle motion can be adjusted by the hydraulic
flow in the ankle component.
The device consists of the following components (Fig. 1b):
A. Male Pyramid
B. D-Valve
C. P-Valve
D. O-Ring
E. Hydraulic Housing
F. Lower Housing
G. Pistons
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 impact use, e.g., gentle walking.
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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