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 firstname.lastname@example.org or phone at +1 418-934-5669.
What is the lifespan?
The minimal expected lifespan is six months. The product has been designed to withstand extreme loads and be highly durable. Extreme users have worn it for more than eight 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. After several months, the fabric might start to wear out, as is usually the case with liners.
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 sleeve, passive vacuum and distal fixation. 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. Nouvelle version en anglais : "The Overlay works with most suspension methods, such as suspension sleeves, passive and active vacuum, and distal attachment. Moreover, the Overlay might not be suitable for all patients with a supracondylar socket (the data on compatibility with this type of system are insufficient). This device cannot 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: email@example.com 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.
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.
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 firstname.lastname@example.org 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 instruction 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 email@example.com 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 firstname.lastname@example.org 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 email@example.com or by phone at +1 418-934-5669
What happens if my Overlay Breaks?
You can reach the Ethnocare support team by mail at firstname.lastname@example.org 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.