Product description
A custom made lower limb prosthesis socket is referred to as the ‘socket’ in the following document. This document provides important information on the indications for use, fit and handling of the socket. This document is intended for the user of the socket please keep this document for your records. Please note the most up to date version of the IFU is available on the Proactive Prosthetics website.
Indications for use
Lower-limb amputation
Note: Patients should have an appropriate level of physical fitness to use an external prosthesis.
Contraindications
None known
Intended use
The socket is a custom made non-invasive prosthetic device designed for use by lower limb amputees with low to high impact levels. The socket is the rigid interface between a patients residual limb and prosthetic componentry such as the knee and the foot.
A socket is used for the external prosthetic fitting of an individual with a limb amputation.
General safety instructions
Warnings:
- If the patient has a fall, injury, or skin reaction they should contact their prosthetist at Proactive Prosthetics.
- In the case of a change or functional loss with a prosthesis, the patient should stop using the device and contact their prosthetist at Proactive Prosthetics.
- If the socket shows signs of damage or wear, the patient should stop using the device and contact their prosthetist at Proactive Prosthetics.
Precautions
Keep the prosthesis away from open flames, embers or other sources of heat.
Fitting instructions
Precautions and warnings:
- Patients should make sure the prosthesis is applied and fits correctly. Please contact your Prosthetist if the socket does not fit properly as this could cause injury to the residual limb.
- Wounds or damaged skin should be covered with an appropriate dressing to prevent direct contact between the wound and socket.
- Ensure the socket is clean and free from foreign matter that may cause irritation.
Socket fit
The fit of the socket is based on the measurements and a mould of the residual limb.
Note: If there is a change to body weight, or residual limb shape, this will affect the socket fit. If the socket is not fitting correctly the socket will need adjustment or replacement.
Care and cleaning
Note: daily cleaning of the residual limb is essential. Use of mild, pH balance fragrance and dye free liquid soap is recommended. If skin is dry, apply a pH balance fragrance and dye-free lotion to nourish the skin.
- It is essential to take proper care of the socket and clean it following use with pH balanced and dye-free soap and dry with a lint free cloth.
- If a liner is worn this should be washed daily in accordance with the manufacturer’s instructions.
- The socket should be checked for wear and damage and patients are advised to contact their Prosthetist immediately if any damage is evident.
- Patients should monitor skin health daily. In case of abnormal symptoms, the user is advised to discontinue the use immediately and contact their prosthetist.
- Other common household or bath products may cause or contribute to skin irritation.
Service and Repair
The socket from Proactive Prosthetics is bespoke and is manufactured to fit you at the time the positive mould is taken. We partner with you to keep your socket performing well, however there will be changes to residual limb over time due to swelling, atrophy or changes in body weight which will result in a change to socket fitting.
We advise at least annual reviews of the socket and frequent replacement of interface liners.
The Proactive team is here for you, please call to speak to a member of our team.
Legal information
End of Service Lifetime
Proactive Prosthetics is legally obligated to comply with The European Union Medical Device Regulation of 2017 (EU MDR 2017/745).
In order to ensure its products are compliant with EU MDR 2017/745, effective January 1, 2021, Proactive Prosthetics will adhere to service lifetime standards.
A product’s service lifetime is the amount of time that the manufacturer determines the product to be serviceable and for which it can function safely and effectively. Service and maintenance cannot be provided beyond the product’s designated End of service (EOS) lifetime.
In the case of a prosthetic socket, the EOS is 3 years from delivery of the socket.
Report a serious incident
The patient must report any serious incident that has occurred in relation to the prosthetic device to Proactive prosthetics, which can then be reported to MHRA. Or the user can report it directly to the MHRA.
Please do however inform Proactive Prosthetics or any adverse incident relating to the prosthetic device.
Liability
Proactive Prosthetics does not assume liability for the following.
· A prosthetic device not maintained as instructed by the instructions for use.
· A prosthetic device used outside recommended conditions, application or environment.