This document provides information for The LIMBER UniLeg users and should be used in conjunction with advice from a qualified clinical team with experience of the LIMBER UniLeg.
Information for a CPO working with LIMBER UniLeg Prosthesis
Information
About LIMBER
LIMBER Prosthetics & Orthotics, Inc is a B2B business that offers a one-piece 3D printed prosthetic device. A certified prosthetist in your local community is required in order to obtain this unique digital solution.
Who is LIMBER?
The LIMBER UniLeg is a below-knee (transtibial) prosthetic limb, classified as Class II 510(k) Exempt Durable Medical Equipment, that can be 3D printed and is designed based on three-dimensional scan data and measurements. It has multi-axial dynamic performance to enable a high quality of comfort and functionality.
What is the LIMBER UniLeg?
The LIMBER UniLeg is only intended to be used for K1, K2 and K3 activity level patients and should not be used for any higher-level activities. K3 level as defined is broad and generally means the potential ability to ambulate with varied cadence. If a patient's functional needs increase to higher level K3+ and K4 (high activity mobility), those amputees should seek more conventional care.
This device has passed mechanical testing for safety. Every LIMBER UniLeg is designed and manufactured under the supervision of a Certified Prosthetist and Orthotist.
Instructions
Getting Started with Limber
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Contact a LIMBER representative to initiate the account setup process for your clinic.
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The LIMBER representative will create an account not only for your clinic but also for all prosthetists who will be working with LIMBER. This step ensures that your entire team is seamlessly integrated into the LIMBER platform.
Create a Clinic Account:
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Visit your preferred app store, such as the Apple App Store or Google Play Store.
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Search for the "LIMBER" app and click the download button to install it on your mobile device.
Download LIMBER App:
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Open the LIMBER app after it's successfully downloaded and installed.
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You'll be prompted to log in with the account details provided by the LIMBER team during the account setup process.
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Enter your clinic or CPO account credentials to gain access to the LIMBER app, where you can begin utilizing its features and services.
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Similarly, using the same credentials log in into the LIMBER web platform.
Log In to the App and WebPlatform:
Start
A New Patient Order
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When you start a new order you will be able to select from a menu of services such as socket design, bilateral patient, and the 3D printing of the UniLeg.
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Select the services you desired for this order and press continue.
Select Services:
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LIMBER does not collect personal patient information such as name, address, etc. Instead we will create an Order ID that you can use to ensure devices are delivered to the correct patient.
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Begin by entering essential patient information, such as age, height, weight, amputation type, amputation side, functional level and date of amputation.
Basic Info:
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Follow the preparation instructions provided in the app. You will be instructed on how to prepare the residual limb for measurements and scanning.
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Following the instructions in the app, illustrate the important anatomic landmarks.
Preparation Work:
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Utilize the COMB scanning embedded in the LIMBER app using your iPhone to capture the patient's residual limb and sound side for the prosthetic design. Make sure you upload the resulting scans file following the instructions in the app.
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If you prefer using an alternative scanning technology, upload the resulting scan file using the LIMBER web platform.
Scanning:
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Record precise measurements using a tape measure and a set of calipers to ensure proper customized fit for the patient's UniLeg. Measurements include residual limb circumference, length of fibula, tibia and residual limb, as well as caliper measurements of the M-L knee Center and A-P patellar tendon.
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Other additional measurements will be taken from the sound side such as Mid Patella Tendon to floor, foot length, shoe size, heel height, toe-in and toe-out (degrees).
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Finally, following the Thomas Test, record the range of motion for the sound side and residual limb side.
Measurements:
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In order to provide LIMBER CPOs with the proper alignment directions you will be asked to take pictures from a lateral, anterior and posterior view.
Upload the images in the app or web portal following the instructions provided. -
You will also have the opportunity to provide additional design information such as desired modification method, suspension method, tissue level and the percent reduction.
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Finally, you will have the option of selecting coating and foot shell color, as well as any other addons.
Alignment:
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Once all the necessary details are entered, add your delivery address and proceed to checkout.
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Review the checkout screen to ensure the proper options and services were selected.
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If everything is correct, proceed by submitting the order. You will receive a confirmation via email and on the app, as well as in the web-portal with the order ID for your records.
IMPORTANT: The order ID is the only way to track the device delivered to the corresponding patient. This will be the clinic's responsibility as LIMBER does not gather any personal patient information.
Submit Order:
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Keep track of all patient orders using the LIMBER app and web portal.
Track Orders:
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Monitor the shipping and delivery of the UniLeg using the app and web portal.
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In the App and web portal you will be asked to confirm the receipt of orders.
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You will have the option of reviewing each order, and when necessary, order a reprint.
Shipping, Delivery, Reviews and Re-Prints:
Alignment
Via Thermoforming
Thermoforming is a pivotal technique used to adjust the fit and alignment of prosthetic devices such as the UniLeg. It involves the precise heating and shaping of materials to provide final alignments in accordance with a patient's residual limb. This process is essential to ensure that the UniLeg aligns perfectly with the patient's specific needs, providing comfort, stability, and functionality.
Introduction Dynamic Alignment of the UniLeg via Thermoforming:
In the thermoforming process, a specially designed jig plays a crucial role. The jig is a framework created to securely hold the UniLeg during the thermoforming procedure. It is constructed with careful attention to alignment to guarantee that the UniLeg is molded accurately according to the patient's requirements. The jig serves as the foundation for achieving the dynamic alignment of the UniLeg.
The Role of the Jig:
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Preparation: There are two fixing points: One at the ankle/foot connection and one at the socket/pylon connection. To initiate the thermoforming process, ensure that the UniLeg components are securely fastened within the jig at these two locations.
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Heating: The next step involves heating a thermoplastic material to a pliable state using a heat gun. The heating process requires precise control to prevent overheating and ensure safety.
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Moulding/Aligning: Once the thermoplastic material reaches the correct temperature, it can be realigned using the nubs, wheels and handles on the jig for translation and rotation. The heat makes the material pliable, allowing it to translate and rotate without much resistance. The Jig provides scales for precise control of modifications.
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Cooling: The aligned UniLeg is then allowed to cool, which solidifies the shape and ensures the alignment. This step is critical in achieving the desired fit and functionality.
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Fitting: The UniLeg is now ready to fit again to the patient and re-test for proper dynamic gait. This process can be repeated, if necessary.
How to Thermoform:
Device
Instructions
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The UniLeg must always have a gel liner or a custom limber soft insert installed between the UniLeg Socket and residual limb.
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The UniLeg is designed to support specified pin-locking system, expulsion valve and suction liners.
LIMBER UniLeg Fitting
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Gather Your Supplies: Collect mild soap, warm water, a soft cloth or sponge, and a towel.
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Prepare the UniLeg: Do NOT remove components, such as pin-lock, expulsion valve, foot shells, etc, if applicable. Your care provider should be responsible for any removable suspension components.
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Clean with Soapy Water: Wet the soft cloth or sponge with warm, soapy water. It's essential to use mild soap and water that's not too hot, as excessive heat may damage the materials. Gently wipe down the surface of the UniLeg with the soapy cloth or sponge. Pay extra attention to areas with visible dirt or stains.
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Avoid Abrasive Materials: Refrain from using abrasive materials or harsh chemicals during cleaning, as they could potentially harm the UniLeg's surface or components.
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Rinse Thoroughly: Rinse the cloth or sponge thoroughly to ensure you've removed any soap residue. Then, wipe the UniLeg again with the damp cloth to eliminate any lingering soap remnants.
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Dry Thoroughly: Use a clean, dry towel to dry the UniLeg. It's crucial to make sure it's completely dry before use.
How to clean your LIMBER UniLeg
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Keep It Dry: Avoid prolonged exposure to moisture. The UniLeg is water resistant but prolonged exposure to moisture can deteriorate materials. Dry your UniLeg thoroughly if it gets wet.
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Protect from Extreme Temperatures: Store your UniLeg away from extreme heat or cold. High temperatures can weaken plastics, while extreme cold may affect the flexibility of materials. For example: Do not leave the UniLeg inside a car on a hot summer day for prolonged periods of time.
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Prevent Chemical Exposure: Avoid contact with harsh chemicals or solvents, as they can cause damage to the materials. Clean your UniLeg using only mild soap and water as recommended.
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Proper Storage: When not in use, store your UniLeg in a clean, dry place, ideally in a bag or case to protect it from environmental elements.
Environmental conditions
Single Patient – Multiple use
Suitable for submersion
Consult instructions for use
Prescription use only
Unique device identifier
Manufacturer
Expectation
Receiving a LIMBER UniLeg Prosthesis
The risk of using the LIMBER UniLeg is not significantly different from those risks assumed using other lower-limb prosthetic devices. Potential risks include, but are not limited to, acute trauma to the residual limb, including skin breakdown, abrasion, and bruising, falls, and discomfort.
What risks are associated with using a LIMBER UniLeg?
If you so choose, talk with your provider to receive a conventional transtibial prosthesis.
What are the alternatives to receiving a LIMBER UniLeg?
The LIMBER UniLeg will allow you to get back on your feet so you can start on your road to recovery. Like any other prosthetic limb, it will allow you to regain some of your mobility. Receiving a prosthetic limb earlier after your surgery may offer benefits and reduce chances of lost mobility such as from flexion contractures.
What benefits can be reasonably expected?
Information about you collected for the design and manufacturing of your LIMBER UniLeg will be kept confidential to the extent allowed by the law. Your records will be identified in compliance with local law by your patient ID number but not by giving your full name or any address details.
What about your confidentiality?
Please contact your care provider for any questions.
Who can you call if you have questions?
20-LIM-000008 Rev B