ENGLISH
DESCRIPTION OF SYMBOLS
Medical Device
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)
CONTRAINDICATIONS
None known
INTENDED PURPOSE
The device is intended to immobilize the knee.
GENERAL SAFETY INFORMATION
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.
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.
CAUTION
1. The patient should be advised to consult their practitioner before
making any adjustments to the brace.
2. This product is intended to be prescribed and fitted by a licensed
practitioner.
3. Proper rehabilitation and activity modification are also essential parts
of a safe treatment program.
FITTING INSTRUCTIONS
1. Apply anti-migration strap (Figure 1). Cut to size along groove if
necessary (Figure 1a).
2. Position brace paddles on leg by aligning hinge center to knee center
(Figure 2).
3. To adjust length of hinge arms: (Figure 3).
– Push down on length adjustment button to unlock paddle
(Figure 3a).
– Slide paddle to desired length.
– Repeat adjustment for all paddles. Ensure all length adjustment
buttons are in locked position.
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