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 Patient Receiving a LIMBER UniLeg Prosthesis
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.
Expectations
Receiving a LIMBER UniLeg Prosthesis
LIMBER provides prosthetic limbs (the LIMBER UniLeg) to medical providers. LIMBER has agreed to work with the on-site provider to give advice and recommendations during the scanning, fitting, and follow-up phases. The duration of these responsibilities is one year from the date of signing.
What are LIMBER’s responsibilities?
The on-site provider is responsible for delivering the prosthesis to the patients. The provider will be responsible for direct contact with the patient, and if necessary, will reach out to LIMBER for questions. The provider is responsible for scheduling follow-up sessions with the patient.
What are the provider’s responsibilities?
The patients who receive a LIMBER UniLeg are responsible for their own safe use of the device and must follow all recommendations in the following pages and all recommendations from their provider and should reach out to their provider immediately with any concerns or questions. Mandatory duties include good hygiene and reporting fitting issues or socket discomforts immediately.
What are the patient’s responsibilities?
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?
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
20-LIM-000007 Rev B
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.