Overlay TF

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 channel 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.

To release the air properly, the user should deflate the product when their residual limb is still in the socket. If the product is out of the socket and 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:Push the air from the farthest cells to the closest cells from the release valve area. To push the air to the release valve area, you can fold the air cells. You can then press the release valve silver pin to release the air. You may have to repeat those steps a couple of times to deflate the product completely.

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 instruction for use in the section “Cleaning, Maintenance and Storage” 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

The product should not be put in the washing machine or any heating element. We also recommend covering the pump hole when washing to prevent water from entering the system. The product has to be completely dry before using it.

If your product is slowly leaking air, the issue may be due to dust in the integrated pump mechanism.

Step 1: Identify the Source of the Leak To check if the leak is coming from the integrated pump:Inflate the product and submerge it in water. Observe where the air bubbles are coming from.If the bubbles are coming from the pump, this indicates the leak is in the pump mechanism.Important: Do not press the pump while it is submerged, as this could force water inside the system.

Step 2: Determine the SolutionIf the leak is not from the pump, please contact your supplier or reach out to us directly for a replacement under warranty.If the leak is from the pump, you have two options:Contact your supplier or us directly to get a replacement under warrantyAttempt a repair using the method below.

Step 3: Repairing the PumpSubmerge the pump section (only the pump and valve) in isopropyl alcohol (available at most pharmacies).Gently press the pump 2–3 times to draw alcohol into the system.Inflate the product and let it rest for several hours.After 24 hours, check if the product remains fully inflated. If so, the repair was successful.

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.

The expected lifespan is more than 12 months. The product has been designed to withstand extreme loads and be highly durable. Extreme users have worn it for more than 12 months without any major damage to the product. Each component was also tested through several bench tests to ensure they were highly durable and withstand extreme loads.

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. That said, If the product is slipping/sliding or sticking out of the socket when it’s usedIt might be because the product is not the right sizeValidate the measurements and if you have the correct size of product.

Look in the sizing chart: LINK HEREIf it is not the right size, contact Ethnocare clinics@ethnocare.ca or +1 418-934-5669 - we can exchange itIf it is the right size, contact Ethnocare clinics@ethnocare.ca or +1 418-934-5669

The Overlay TF Tranfemoral can be used with distal fixation (pin lock system), with cushion liner, with distaly positionned seal-ring liners with both active and passive vacuum systems, and with lanyard. Amputee with a liner 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.

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.

1. Socket fitting issues due to volume fluctuations that occur throughout the day. This is common among new amputees, patients on dialysis, diabetic patients, and those with vascular disease. 

2. Socket fit issues due to progressive transitions to the size and shape of the patient’s residual limb. This can include new amputees or mature amputees who may not be eligible for a new socket.

3. Patients who experience instability or movement of their limb in the socket, such as rotation, pistoning or “bell clapping” (distal portion of the socket is loose, while the proximal portion fits snugly).

A *case study including 24 patients indicates the Overlay demonstrated effective volume management and benefits for patients, including: Improved socket fit; enhanced cushioning; pain reduction; ease of use compared to the traditional use of prosthetic socks; and overall improvement in user comfort and satisfaction.

Significant results over traditional methods of socket volume management include:

1. Users reported a ↑24% improvement in socket fit with the Overlay

2. Users experienced ↑46% better cushioning when using the Overlay

3. Patients indicated their pain sensation decreased by ↓24% when wearing the Overlay

4. Users found the Overlay ↑52% easier to use than adding prosthetic socks. *Ethnocare. (2023). Evaluation Overlay [Case study] https://hubs.ly/Q02YVhJL0.

An independent peer-reviewed study published in Sensors found that the Overlay seems to provide a better quality of life and seems to be more suitable for the needs of transtibial amputees during functional tasks (e.g., walking and sit-to-stand tasks) than Prosthetic Folds. The study highlighted several benefits of the Overlay, including a reduction in pain and compensatory strategies, as well as improvements in gait—helping users achieve a gait closer to that of a healthy individual—stability, socket fit, and comfort compared to the Prosthetic Fold (Ply).The Overlay, a New Solution for Volume Variations in the Residual Limb for Individuals with a Transtibial Amputationhttps://www.mdpi.com/1424-8220/24/14/4744

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.

If prosthetist wants to cast a new socket and include the overlay, they can do it over a 2 ply sock to make sure there's enough space for the Overlay.

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

If you wish to cast a new socket by integrating the Overlay during the process, it is quite simple.During the casting phase, you would need to place a two-ply sock over the liner to provide space for the Overlay. This creates a small gap, allowing your patient to begin using the Overlay right away with their new socket.

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.