ENGLISH
Medical Device
INTENDED USE
The device is intended for external support or stabilization of the knee.
The device must be fitted and adjusted by a healthcare professional.
Indications for use
• ACL, MCL, LCL, PCL and combined instabilities.
• Conditions requiring unicompartmental load control (Acculign slider
configuration).
No known contraindications.
Warnings and Cautions:
• The use of the device may increase the risk of deep vein thrombosis
and pulmonary embolism.
GENERAL SAFETY INSTRUCTIONS
The healthcare professional should inform the patient about everything in
this document that is required for safe use of this device.
Any serious incident in relation to the device must be reported to the
manufacturer and relevant authorities.
The patient should stop using the device and contact a healthcare
professional:
• If there is a change or loss in device functionality, or if the device
shows signs of damage or wear hindering its normal functions.
• If any pain, skin irritation, or unusual reaction occurs with the use of
the device.
The device is for single patient – multiple use.
This device is a supportive brace only and is not intended or guaranteed to
prevent injury.
FITTING INSTRUCTIONS
While carrying out the following instructions, please refer to the overview
figure for locating components mentioned in the text (Fig. 1).
Device Application
1. Unfasten all straps on the posterior side of the device (Fig. 2).
2. Bend the knee at a 90° angle with the foot flat on the floor and place
the device on the leg such that the patella is centered between the
Condyle Pads (A) (Fig. 2).
Ensure proper alignment of the device on the leg:
• Height positioning: Align the center of the Hinge (B) slightly above
the middle of the patella (Fig. 3).
3. The device is pre-assembled with medium Condyle Pads. There are
also thin and thick Condyle Pads, as well as a hook-and-loop, shim
included with the device. Use any combination of the Condyle Pads
and shim to widen or narrow the width of the device at the knee.
4. The supplied tibial wedge pads can be placed between the liner and
device frame to adjust the fit around the tibia. They can also be used
to position the hinge center forward slightly or removed to position
the hinge further back.
Fasten the straps in the following order. All straps can be adjusted and/or
trimmed to length.
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