Intended Use; General Safety Instructions; Alignment Instructions - Ossur ASPIRE M2 Gebrauchsanweisung

ENGLISH
Medical Device
DESCRIPTION
The device is a four-bar polycentric mechanical knee. It is designed to
facilitate single cadence ambulation on level ground and small slopes.
Extension of the knee is aided by a spring, which is compressed during
knee flexion.
The device has a Distal Tube Connector and a Proximal Integrated Male
Pyramid Adapter.

INTENDED USE

The device is intended as a part of a prosthetic system that replaces knee
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.
The weight limit for the device is 136 kg.

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.
Warning: Avoid placing hands or fingers near moving joints.
Caution: Do not adjust other screws than described in these instructions.
The device is for single patient use.

ALIGNMENT INSTRUCTIONS

Bench Alignment (Fig. 1)
Alignment Goal
Alignment reference line (B) should:
– pass through midpoint of socket at the ischial tuberosity level (D)
– pass through midtube (A)
– fall at the 1/3 mark on the inside of the foot cover.
Note: Prioritize knee alignment over foot alignment if there is a mismatch.
Alignment Instructions
1. Position the foot so that the alignment reference line (B) falls at the
1/3 mark on the inside of the foot cover (with the foot cover and shoe
on). Consider the external rotation of the foot.
2. Use the applicable adapters to connect the knee to the foot and
establish the correct knee center height.
4