5
PB
Indications For Use and Target Patient Population
• Lower limb amputation and/or congenital deficiency
• No known contraindications
The device is for moderate impact use, e.g., walking.
The weight limit for the device is 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.
The device is for single patient use.
ASSEMBLY INSTRUCTIONS
Lamination Instructions
. Flatten distal end of Plaster Cast enough to centrally attach Delrin
Tooling Body. Attach with nails provided or double-sided tape
maintaining original pin alignment.
. Apply inner PVA bag. Pull through central hole of Lam/Therm Ring.
Flare bag away from the central hole and attach ring using Delrin
Screw, sealing PVA bag in the process. Note: Ensure that arrow (A) on
Lam/Therm Ring is aligned in AP or ML direction.
. Place some clay in spacing screw heads (B) and in a groove on Delrin
Screw (C).
. Tie in lay-up material. Tie all but first layer beyond Lam/Therm Ring.
Ensure that four spacing (B) screws are embedded evenly in material.
. Apply outer PVA bag and complete lamination.
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