ENGLISH
Medical Device
INTENDED USE
The device is intended to immobilize the knee
The device must be fitted and adjusted by a healthcare professional.
Indications for use
Indications requiring knee immobilization and restrictions to knee range
of motion. These indications may include:
• ACL, PCL, MCL, LCL repairs/injuries
• Meniscal repairs
• Tibial plateau fractures
• Patellar tendon repairs
• Osteochondral repairs
• Condylar fractures
• Sprains/strains of the knee
• HTOs (High Tibial Osteotomy)
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 immediately 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.
FITTING INSTRUCTIONS
Device Application
1. Apply the anti-migration strap (Fig. 1). Cut to size along groove if
necessary (Fig. 1a).
2. Position the device paddles on the leg by aligning the hinge center to
the knee center (Fig. 2).
3. To adjust the length of hinge arms (Fig. 3):
– Push down on the length adjustment button to unlock the paddle
(Fig. 3a).
– Slide paddle to the desired length.
– Repeat adjustment for all paddles. Ensure all length adjustment
buttons are in the locked position.
Note: A healthcare professional should adjust the device length to
provide optimal knee stabilization. Upper hinge arms should extend no
higher than 5 cm from groin level. Lower hinge arms should extend no
lower than calf/Achilles tendon junction.
Note: If necessary, use bending tools to adapt the device to the patient's
leg shape.
4. Fastening Straps (Fig. 4):
5