MEDICAL INDICATIONS
The product is a non-invasive, single patient, reusable system. The system
is not used in direct contact with the body. The device is to be used
exclusively for the exoprosthetic fitting of amputations of the lower limb.
• Unilateral transfemoral amputation
• Bilateral transfemoral amputation
• Unilateral knee disarticulation amputation
• Bilateral knee disarticulation amputation
INDICATIONS FOR USE
This product is recommended for use by above knee amputees with a
high activity level that subject the knee to repeated high impacts or
walking/jogging longer distances on a regular basis.
• Activity level: Moderate to High (K3-K4)
• Impact level: High
• Maximum weight limit: 100 kg (220 lbs)
CONTRAINDICATIONS FOR USE
None
DEVICE SETUP
Refer to the Össur catalog for recommended selection of adapters.
Caution: Always use original Össur adapters. Adapters from other
manufacturer may not fully engage all threads. They may compromise
strength and void the warranty. Never tighten adapters against the
hydraulic head.
Recommended Alignment of the Device
Bench Alignment
For bench alignment refer to Figure 2.
• Assemble prosthetic foot, pylon and knee.
• Establish knee center height, measured from the pivot axis (3)
• Attach socket with selected adapter combination to knee. Tighten to
torque as specified in adapter IFU. Ensure flexion/extension and
abduction/adduction angles are as determined in patient assessment
• Establish vertical pylon for proper knee function. Alignment reference
line (1) from bisection of socket (2) on ischial level should pass
0–10 mm in front of the pivot axis (3) of the knee and an alignment
reference point of the foot (as specified in selected foot IFU)
If alignment reference line (1) is too far anterior to pivot axis (3), more
effort may be required to initiate knee flexion.
Static Alignment
For safety, make initial adjustments with patient standing between
parallel bars.
• Fit prosthesis and check for correct length.
• Make sure the knee is in neutral position and socket angles are correct.
• Evaluate sagittal and coronal alignment for correct position of the
alignment reference line.
Dynamic Alignment
The initial dynamic assessment is important for getting the user familiar
with relying on the prosthesis. The best way to acquire a dynamic
alignment is by having a symmetric gait pattern. Any deviations will be
more pronounced in running gait.
5