4
ENGLISH
Medical Device
DESCRIPTION
The device is a prosthetic foot with anatomically located ankle pivot joint.
Two supporting joints connect flexible carbon blades and act together with
the main joint to provide progressive energy storing during the whole
stance phase and a powerful push-off in the end of stance.
The device consists of the following components
(Fig. 1)
:
A. Male Pyramid
B. Chassis
C. Main Pivot
D. Upper Supporting Pivot
E. Supporting Link
F. Lower Supporting Pivot
G. Top Blade
H. Main Pivot Carbon Clamp
I. Middle Blade
J. Lower Supporting Pivot Carbon Clamp
K. Bottom Blade
L. 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 moderate impact use, e.g., 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.
