Energy storing AFO Fitting Instructions:
We appreciate that you have entrusted us with the fabrication of your patient’s orthosis. Every effort has been made to produce an orthosis that you will be proud to put on your patient. As practitioners have varied manners to fitting their patients, the following are simple guidelines that may be helpful…
Donning the Orthosis:
If you present the orthosis to the posterior of the patient’s leg, keeping the calf section down at mid-tibia height, open the calf shell and bring it forward around the leg. (Do not tighten at this time). Then open the dorsal foot shell and allow the patient’s foot to drop down into the orthosis. Ensure the foot is down but it is not pushed too far back, or posterior, the toe plate should only be about 3/16” longer than the end of the longest toe. Fasten the instep strap, snug, but not so tight as to force the foot posterior. The orthosis will have a looser fit in the heel. With the foot secure; move up the calf. Pull forward on the orthosis at the top back of the calf and this should compress the proximal calf muscle, fasten one then the second calf strap. (Repeat this process to tighten). The Velfoam lining is very compressive. It will seem as if you are tightening the orthosis tighter than is customary. Communicate with the patient to ensure they are comfortable. It is important for the calf section to be secure to the patient as this is where the energy is transferred between the patient and orthosis.
Initial Standing:
It is quite amazing how quickly the patient adjusts to this AFO. Be careful to take appropriate precautions for the patient’s stability. i.e.: gait belt, walker, parallel bars… etc.
Have the patient stand in the orthosis/orthoses. Allow the patient time to become stable standing. Then have the patient attempt to bend their knees a couple of degrees while keeping their heels on the floor. Evaluate if the patient is loading the spring to bend or just shifting weight to the ball of the foot. Have the patient repeat this process a few times increasing the knee bend up to 10-15 degrees.
Initial Walking:
Please ensure the patient is secure.
Have the patient take a few steps and then proceed to walking across the room. Evaluate if the patient is loading the posterior spring. This is evident if the posterior spring is bending. Sometimes this is hard to see. Communicate with the patient as to what they are feeling the orthosis do.
If the patient seems to be only reacting to the pressure of the orthosis, not pushing into or loading the orthosis:
Have the patient perform a calf stretching exercise while wearing the orthosis. Standing an arm’s length from the wall or in parallel bars place hands on the wall, step back a short distance with one foot, and try to put the heel down to the ground. Repeat with other foot. This teaches the patient that they can bend the orthosis.
Then have them walk in the orthosis again.
Skin Evaluation:
Remove the orthosis and evaluate the skin for any concerns in the fit, adjust as needed to be confident in the patient’s safety. You can instruct the patient on your normal break in procedure.
Please be advised that with the high function of this orthosis. The patient will wear it longer and be more aggressive in it than anticipated…
Please adjust your break-in procedure accordingly.
Adjusting the Orthosis:
The orthosis is made with a Pre-Preg Carbon fiber internal structure that is then enveloped into a flexible lamination. You should be able to identify the Carbon structure inside of the orthosis. The core carbon structure is not adjustable and will be damaged if exposed to high temperatures. The design of the orthosis allows for core structure to not extend over boney prominences that may require adjustment. If the core structure extends over an area that requires adjustment, the orthosis will need to be remade.
The flexible lamination that comprises the shell of the orthosis is adjustable. This has a low temp malleability, 180 degrees. This allows for heat adjustments to be made without heating up the core carbon structure to a failure point. Be advised that the edges of the core carbon structure have an additional fiberglass layer, about 1/4’”
Remaking the Orthosis:
As we strive for an excellent fit of each AFO we fabricate; there are a lot of variables in this process.
If we are going to have to remake the orthosis, we would like to get everything fixed at once. We ask that you make any possible adjustments to the orthosis so the patient can wear for a period of time. This will enable you to determine if any other changes in the orthosis, need to be made (resistance strength, alignment, Heel Height… etc.)
We offer to Practitioners, certified to fit our orthosis system, to be able to remake any orthosis we’ve made with only a cost of materials charge.
Composite Warranty
Bio Mechanical Composites has a one-year warranty on its custom pre-preg carbon structure of the orthosis we custom fabricated. This covers any failure due to a flaw in manufacturing during normal use of the orthosis within the normal activities of daily living.
The core pre-preg carbon structure of all our orthosis/ prosthesis are fabricated to produce a 20 million cycle rate, within the normal range of ambulation. 20 million cycles are consistent with 5 years of normal daily walking. As it is common for patients to exceed normal activities, with increased range of motion activities (Hiking, Jogging, Ladders, Stairs and Squatting to get up from the floor). Accordingly, these activities will shorten the cycle rate to failure of the structure. A more immediate failure of the structure can occur with excessive bending of the structure, while on and off the patient.
The Flexible lamination over the pre-preg carbon structure is for the purpose of holding the patient to the carbon structure, and for cosmetics. It is not covered by the warranty. The flexible lamination breaks down with excessive bending, heating for adjustment or being exposed to higher temperatures.
Warranty Re-make Procedure
If you encounter a problem that requires re-making the orthosis, we are not concerned with whether the error was our fault or your fault. We are only concerned with making sure we re-make the orthosis/prosthesis so you will be impressed with what you are fitting your patient with. Accordingly, if you can modify the orthosis/ prosthesis so the patient can wear it long enough to determine if any other changes are needed, please do so.
Bio Mechanical composites does “not” save models after fabrication. If the orthosis/prosthesis needs to be remade, a new cast of the patient is required.
For any reason… you can have the orthosis re-made at a discounted price to cover cost of materials. This requires the following…
The return of the original orthosis/prosthesis
A new cast of the patient in a corrected alignment
A new work order that states specifically what is to be different. Ex. (change of resistance, area of relief).
We will call you to clarify each item that needs to be addressed. When we receive the cast and orthosis if a failure is covered under warranty, we will assess that upon evaluation of the original orthosis/prosthesis and let you know if there are any charges.
We work hard to produce a custom orthosis/prosthesis that you will be proud to fit to your patient and we thank you for trusting us to do so.
We have structured our price to include a re-make at a “cost of materials” discounted price.
Remaking the Orthosis/Prosthesis Without the Original
If you are unable to return the orthosis with the cast for re-making the orthosis, we will invoice it as a new orthosis and issue a credit at a late date, when the original orthosis/prosthesis are returned for evaluation.
In these cases, we still need a work order that clearly states each item that needs to be changed to be sent with the new cast of the patient.
We will do our best to correct any issues during fabrication, but it is always better to have the original orthosis/prosthesis to refer to. The original orthosis/prosthesis follow the job through each stage of fabrication so wecan compare and contrast the new product being fabricated.