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Ethnocare Overlay Transfemoral on a white background.

Ethnocare Overlay Transfemoral

by Ethnocare

Save $ 550.00 Save $ 550.00
$ 999.00
$ 999.00 - $ 999.00
$ 999.00
$ 449.00
$ 449.00 - $ 449.00
$ 449.00

Eligible for Amplife® Love donation

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Suspension Type: PIN
Length: SH
Circumference: 32

Ethnocare's Overlay is a revolutionary prosthetic device that uses air to manage the changes in limb volume.

This breathable fabric sleeve integrates an air expansion system to create a uniform tightness in the socket.

The Overlay works with most liners and is compatible with distal fixation, suspension sleeves, active and passive vacuum systems.

Sizing Chart
Product Presentation
Overview video
How to use video

Disability Helped

Amputation / Limb Difference

Disabled-Designed

Disabled-Solution

Overview

The Ethnocare Overlay is a prosthetic device that allows users to instantly adjust the fit of their prosthetic socket to accommodate for limb volume fluctuation, and activity level changes throughout the day thus maintaining appropriate socket fit without having to doff the prosthesis.

The Overlay is compatible with most liners and sockets and can be used with different suspension methods, such as distal fixation (pin), sleeve, and both active and passive vacuum systems.

Personalized fit

The Overlay is a stretchy and breathable textile sleeve featuring a unique air expansion system for a customized, comfortable and uniform fit in the socket.

Retrofit sizing

The Overlay incorporates advanced fabric technology with a total thickness of just under one millimeter. It's designed to be compatible with most liners and sockets, allowing you to continue using your existing equipment without disruption.

Air expansion system

The Overlay incorporates an air expansion system as a replacement for prosthetic stockings, enabling more effective residual limb volume management.

The fit can be adjusted without removing the prosthesis, as air is evenly distributed within the socket to adapt to various residual limb morphologies.

The Overlay is intended to be worn over the liner and slid inside the existing socket. It features a breathable circumferential textile structure with an integrated air expansion system, located on the product's posterior, medial and lateral aspects, ensuring proper surrounding and alignment of the limb inside the socket. A proximally positioned built-in pump and release valve enable the patient to effortlessly self-manage the fit quality and comfort of their socket by inflating or deflating the air expansion system. An external air pump is also provided for faster inflation.

The air expansion system consists of a series of interconnected cells that allow air to flow evenly within the socket, filling spaces only where necessary. Since certain regions of the
limb experience greater variability in volume, the use of air, a compressible and easily moveable fluid, effectively compensates for these fluctuations and creates a uniform fit inside the socket.

The Overlay helps clinicians and patients efficiently address fitting issues caused by daily volume fluctuations and/or transitions and variations in the size and shape of the patient’s residual limb. It serves as an effective alternative to prosthetic socks, adjustable sockets, and internal socket padding by filling voids*, improving fit*, enhancing suspension*, relieving pressure points (especially at the distal end), and reducing potential skin irritations and friction. This reduces socket issues that can disrupt ADLs.

*Badaire, P., Robert, M. T., & Turcot, K. (n.d.). The
Overlay: A solution for volume variations in transtibial amputation. (Cirris), Université Laval. https://hubs.ly/Q02BZC570
*Ethnocare. (2023). Clinical Evaluation Report Overlay. https://hubs.ly/Q02BVPxF0

Patient Populations - The Overlay is suitable for patients at all functional levels K1 to K4 (K-levels).

  1. Mature Amputees: Patients often have atrophied limbs with sensitive areas, making socket fit challenging. The Overlay
    provides targeted cushioning and expansion to offload pressure from sensitive areas and apply it to pressure-tolerant ones.
  2. Newly Amputees: Commonly, newly amputated limbs undergo a reduction in size, shape, and volume at an accelerated rate. The Overlay can be used to help manage these more consistent and rapid volume changes as opposed to having
    to make up for this loss with numerous sock layers.
  3. Diabetes or Vascular Disease Patients: Patients with these conditions can experience challenges with the management of prosthetics socks and socket fit. The ease of use of the Overlay can benefit those patients.
  4. Traumatic Amputees: Traumatic amputations often result in more scar tissue and irregularly shaped residual limbs, making optimal socket fitting more challenging.
  5. Dialysis Patients: Dialysis patients experience important limb volume fluctuations between and after dialysis treatments.
  6. Cancer Patients: Patients with amputation due to cancer often return to their pre-diagnosis activity level. However, cancer
    medications often cause fluctuations in limb volume.
  7. Patient that experiences “Bell clapping” (Distal portion of the socket is loose and the proximal portion fits snugly). The Overlay provides targeted cushioning to reposition bony anatomy and accommodate distal limb volume.
Specifications

Materials: Nylon, Elastane, TPU, Spring Steel, Silicone

Suspension method: Distal fixation, Suspension sleeve, Passive and active vacuum

Level of activity: Low, Moderate and High
 (K1 to K4)

Level of limb difference: Transtibial (below knee)

Downloads

Features & Benefits of the Overlay™

Medical Necessity Letter

PDAC Letter

PDAC Approved L5999 - Overlay™ Reimbursement Guide

Shipping & Returns

Ships from:
Montreal, QC

Shipping:
U.S. - Free shipping
International - Standard shipping

Unavailable in these countries:

  • Australia
  • Denmark
  • Finland
  • Germany
  • Norway
  • New Zealand
  • Sweden

It is shipped from when you complete your purchase.
All Ethnocare products are shipped F.O.B. (Freight on Board) from Ethnocare, meaning that once a shipment leaves the Ethnocare facility, it is the customer’s responsibility.

Returns:
No Returns on Opened or Used Products. 
Owing to the singular-patient use and medical application of Ethnocare devices, we cannot accept any returns once the product packaging has been opened or the product has been utilized. This policy is resolute and in place to safeguard the integrity, safety, and hygiene of our products.

Defective or Damaged Items: 
Should you receive a product that is defective or damaged upon arrival, it is imperative that you contact our customer service team without delay. We are committed to resolving any issues expediently and may replace the item free of charge.

Unwavering Commitment to Safety:
This stringent return policy guarantees that every patient receives a new, uncompromised device, upholding the paramount standards of safety and hygiene. As Ethnocare devices are designed for single-patient use, once a product has been opened, it cannot be resold or repurposed.

Reporting Issues or Concerns: 
If there are any concerns or issues with your purchase, we encourage you to reach out to our customer service team at your earliest convenience. We are here to assist you and assure your satisfaction.

Warranty:
The warranty is six months, and it covers the entire product. If a part of the product is damaged, the entire product will be replaced with a new one. Further information on the warranty terms and conditions can be obtained from the manufacturing company. You can reach the Ethnocare support team by mail at clinics@ethnocare.ca or phone at+1 418-934-5669.

Listings sold through amplife.co that do not bear the Amplife® brand name are serviced and supported exclusively by their vendors in accordance with terms and conditions listed with the listing. The Amplife® Limited Warranty does not apply to listings that are not Amplife® branded, even if packaged or sold with Amplife® products. Please reach out to the vendor from the contact form below for technical support and customer service.

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FAQs

Reimbursement

Where can I find the reimbursement support documentation ?

There are four documents that are useful for billing the Overlay:

This document contains:

  1. Details on the MSRP of the Overlay
  2. The suggested coding description to use for the Overlay
  3. Recommendations for electronic and paper claims
  4. Details on the reimbursement amount clinics should expect when billing the Overlay under the L5999 code.
  5. A guide on what to do if there are initial denials or medical reviews.

This is a document that the clinician can use to support the reimbursement claims.

This is the PDAC letter that confirms that our product has been approved under this code.

This is the medical necessity letter that helps you justify the need for our product to insurance companies.

+1 450-626-2273 | 24/7 USA reimbursement support phone line

Clinicians in the USA can call the Reimbursement Support Phone Line at+1 450-626-2273, available 24/7. This dedicated line provides assistance with filing the necessary documentation for L5999 claims and offers expert support in the event of an appeal. Our team is here to help streamline the reimbursement process and address any questions or concerns you may have.

Reimbursement@ethnocare.ca | USA Dedicated Reimbursement Support E-mail

Clinicians in the USA can send an email the Dedicated Reimbursement Support E-mail at reimbursement@ethnocare.ca.This dedicated email provides assistance with filing the necessary documentation for L5999 claims and offers expert support in the event of an appeal. Our team is here to help streamline the reimbursement process and address any questions or concerns you may have.

Warranty

Warranty period | What does it cover?

The warranty is six months, and it covers the entire product. If a part of the product is damaged, the entire product will be replaced with a new one. Further information on the warranty terms and conditions can be obtained from the manufacturing company. You can reach the Ethnocare support team by mail at clinics@ethnocare.ca or phone at +1 418-934-5669.

Product Details

What prevents the product from slipping?

The Overlay is made of a stretchable fabric sleeve that integrates silicone bands on the inside to prevent slipping and ensure a snug fit on the liner.

Does it work with any type of suspension method?

The Overlay works with most suspension methods, such as suspension sleeves, passive and active vacuum, and distal attachment.

As for now, we don’t have a large sample size of enough users with an active vacuum system; therefore, we cannot confirm and assure the efficiency and synergy of the overlay with that type of suspension system.

That said, the patients currently using the Overlay with an active vacuum system enjoy their Overlay as much as the other type of patient. Also, the Overlay might not be suitable for all patients with a supracondylar socket (the data on the compatibility with this type of system is insufficient).

Finally, this device can’t be used on patients with leather thigh straps (Cuffs, Straps and Belts) if they interfere with the pump or valve of the Overlay.

Patients with a sleeve that includes a sealing ring can use the device, however, sometimes the ring takes significant space on the residual limb, and this space, if too proximal, may interfere with the Overlay. In these particular cases, it will be necessary to ensure that all the air cells are inside the socket and that the product does not come into contact with the sealing ring.

For more questions, be sure to get in touch with the Ethnocare support team at the email address: clinics@ethnocare.ca or by phone at +1 418-934-5669.

Which type of activities the Overlay is made for?

You can do any activity besides activities with high water exposure, like swimming.

Installation

How can I inflate the Overlay?

There are two ways to inflate the Overlay; The user can adjust the fit with an external pump for a more significant increment or the integrated pump for smaller increments. To facilitate inflation, the air canal that links the pump and valve to the air cells should be as straight as possible when the user is trying to inflate the product. To achieve that, the user's residual limb should be straight, and the Overlay itself should not be folded.

How do you completely deflate the product, or why is it not deflating well?

To release the air properly, the user should deflate the product when their residual limb is still in the socket. The air canal linking the pump and valve to the air cells should also be as straight as possible when the user is trying to release the air. To achieve that, the leg of the user should be straight, and the Overlay itself should not be folded. If those steps are followed, most of the air should release because of the pressure the socket creates and the user's weight.If the product is out of the socket, like an air mattress, if no pressure is applied to the air expansion system, it won't deflate as easily as within the socket.

To release all the air, you should: Gently push the air from the latest cells to the release valve area to create some pressure below the release valve. To push the air to the release valve area, you can fold the air cells. You can then press the release valve to release the air. You may have to repeat those steps a couple of times to deflate the product completely.

Why is the air expansion system / the air cells positioned at the back?

The Overlay takes volume where there is a need to. Most of the volumetric variation will occur at the back of the leg, so the air expansion system is located posteriorly. It is intended to keep the limb in position with the initial reference point of the socket.

If you have more question about the way the Overlay’s air expansion system works and inflate, feel free to reach the Ethnocare support team by mail at clinics@ethnocare.ca or by phone at +1 418-934-5669.

Does it require any adjustment on the prosthesis?

The Overlay is a retrofit solution; it doesn’t require modifying the existing equipment. However, the patient trying out the Overlay must have a small initial gap (at least 2 plys) in their prosthesis to put it on.

Support

How can I have customer support?

You can reach Ethnocare support team by mail at clinics@ethnocare.ca or by phone at +1 418-934-5669.wers for your most commonly asked questions.

Is the Overlay suitable for use with a particular medical condition or patient population?
  • Do not use the device if there are wounds on the residual limb.
  • Do not use it on patients with neuropathy without physician approbation.
  • Do not use the device if the length of the residual limb is less than 14 cm (vertical measurement in a sitting position between the popliteal fossa and the distal end). If you experience pain, swelling, altered sensation or other abnormal reactions when using this device, contact healthcare professional immediately.
  • Do not over-inflate the air cushion. Improper air cushion inflation may cause skin irritation in patients with diabetic neuropathy or other neurological conditions as determined by prescribing physicians.

The medical specialist determines this condition. Reduce air cushion compression when skin changes occur, or discomfort is felt. Patients with a decrease or loss of normal sensation (i.e., neuropathy, etc.) should be monitored frequently (as determined by the prescribing physician) for skin lesions, skin irritation, or wound management.

See the instruction for use to have more in depth information and or reach Ethnocare support team by mail at clinics@ethnocare.ca or by phone at +1 418-934-5669

What kind of maintenance or cleaning is required for the Overlay and how often must it be performed?

The Overlay should be hand-washed with mild soap every day. It needs to be completely dry before using again. More information about maintenance and cleaning in the instructions for use in the section “Cleaning, Maintenance and Storage”.

If this section is lacking information, feel free to reach Ethnocare support team by mail at clinics@ethnocare.ca or by phone at +1 418-934-5669

Are there any safety considerations or precautions that healthcare professionals and patients should be aware of when using the Overlay?

User and healthcare professionals should always read the Instruction for Use before using the Overlay. You’ll find all the information about safety in the section “general safety instructions”.

If this section lacks information, feel free to reach Ethnocare support team by mail at clinics@ethnocare.ca or by phone at +1 418-934-5669

Can the exit valve break or pierce the suspension sleeve?

Even though we receive this question many times, it never happens to any user of the Overlay even after 6 months of use with highly active users.

If you have any questions or concern, feel free to contact us by mail at clinics@ethnocare.ca or by phone at +1 418-934-5669

What happens if my Overlay Breaks?

You can reach the Ethnocare support team by mail at clinics@ethnocare.ca or by phone at +1 418-934-5669 and we’ll send you a new Overlay.

Ethnocare grants a commercial warranty for this device from the date of fitting. The warranty period is six months. The commercial warranty covers proven defects in material, workmanship or construction. These defects must be reported to the manufacturer within the commercial warranty's validity period.

Further information on the warranty terms and conditions can be obtained from the manufacturing company.