AK Prosthetic Ethnocare Overlay TF Vacuum Suspension Sleeve

AK Prosthetic Ethnocare Overlay TF Vacuum Suspension Sleeve

**If you have been prescribed the Overlay sleeve previously, use code/details/size in the sleeve to order exactly the same size from our size table below**  If you have any questions, please call: +44 7951 762 390 or email: info@cozmedix.co.uk

REQUIREMENT FOR USE & INTENDED USE 

The device must be used between a socket and a prosthetic liner.

This device is a medical device for patients with transfemoral amputations. It is made of fabric and integrates an air cushion that can be activated by a pump integrated on the device and / or a pump external to the device (bulb pump – accessory) as well as a manual release valve in order to allow a daily volumetric adjustment. The device also comes with an elastic band (accessory) to maintain the integrated pump on the socket.

This device is intended for use under the supervision of a healthcare professional. Determination of when to use the device and the frequency and duration of use is at the sole discretion of the treating physician. The device intends to provide additional support for and volumetric fit of a transfemoral exoprosthesis.

The Overlay helps clinicians and patients to 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 (especialy at the distal end), and reducing potential skin irritations and friction.

ABOUT ETHNOCARE OVERLAY SLEEVE

The Overlay TF from Ethnocare is a breathable fabric sleeve with an integrated air expansion system that the wearer can adjust for maximum, personalized comfort. The air expansion system is a replacement for prosthetic socks, enabling more effective residual limb volume management. Allowing a user to quickly modify the pressure within their socket allows them to tailor the fit to their activity or situation. Not only does it improve comfort of a socket, but it also extends the life of that socket; by accommodating up to 15 ply, less socket modifications and replacements are required.

Measuring Guide for Vacuum Sealing Liners – keep liner on and leg at at 90º when taking measurement L (Length)

To measure C = Circumference of the residual limb at H (Height)

• For VAC type liners, the H (Height) is measured 18 cm from the distal end (bottom end of the residual limb). This is point C where you take the circumference to determine your size in cm.

To measure L = Length of the residual limb 

• L = Length is taken from the distal end (bottom end of the residual limb) to the perineum (top end of the residual limb). This is how you determine the length of sleeve required – Take L measurement with the liner on and leg at 90º.

Size Table with Product Code

FEATURES AND BENEFITS

• Improved socket fit
• Increases volume in socket from 2 to 15 ply
• More precise adjustments
• Can be used with cushion, locking and sealing liners
• Quickly increase or decrease pressure as required
• Can be adjusted through clothing

SUSPENSION COMPATIBILITY

The Overlay is compatible with most liners and sockets and can be used with active and passive vacuum systems.  Warranty: 6 months

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 proximaly 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.

OPERATION OF THE DEVICE

The device creates additional support and volumetric fit in a transfemoral exoprosthesis (external limb prosthesis) by creating a uniform tightness using an air cushion. The device needs to be positioned between the prosthesis’s liner and the socket. The device must be used in combination with a liner. It is intended for use with exoprosthesis and liners that are compatible with the device such as any transfemoral liners and sockets approved by a healthcare professional. To inflate the device, the patient or healthcare professional should use the integrated pump or the external pump (accessory), the external pump needs to be connected to the exit valve in order to pump air into the air expansion system. To release the air, the patient or the healthcare professional needs to press on the metal part of the exit valve in order to activate the release mechanism.

STEPS REQUIRED TO REMOVE THE DEVICE

• 1. The patient must first be in a sitting position.
• 2. The patient puts his / her leg straight and uses the release valve to release air from the air cushion and create a gap inside the socket. The patient stops using the release valve when he / she no longer feels any tightness in the socket.
• 3. The patient presses the release mechanism of the fixation system located on the prosthesis.
• 4. The patient removes the residual limb (covered by the liner and device) from the socket.
• 5. The patient removes the device from the liner by pulling it from the distal end.
• 6. The patient can remove the excess air by pressing on the release valve while pressing on the air cushion.

CONTRAINDICATIONS

• Do not use this device if you are allergic to the materials listed – LIST OF MATERIALS: Nylon, Elastane, TPU (Thermoplastic Polyurethane), Spring steel, Silicone. Material applicable standard : ISO 10993-1.
• Do not use this device on any type of amputation other than a transfemoral amputation
• Do not use this device on a patient who is unable to communicate physical discomfort
• For Overlay TF vacuum type (VAC), do not use the device if the length of the residual limb is less than 20 cm (vertical measurement in a sitting position between the perineum and the top of the seal ring).
• For Overlay TF locking type (PIN), do not use the device if the length of the residual limb is less than 19 cm (vertical measurement in a sitting position between the perineum and the distal end).
• If you experience pain, swelling, altered sensation or other abnormal reactions when using this device, contact a healthcare professional immediately.

PS. If you require more information on this product, please contact us.