This document provides important information on the indications for use, fit and handling of a Custom Made Prosthesis.
There are a number of different types of Custom Made Prostheses depending on the site and level of amputation and the activity for which the prosthesis is to be used.
Each Custom Made Prosthesis is assembled for an individual using component parts to form a functional prosthesis. Where a component part has specific Instructions for Use these are provided in addition to this information.
The following Custom Made Prostheses products are covered by this Information for Use:
Multiple-joint external lower-limb prosthesis system
External lower-limb prosthesis custom-assembly
This document is intended for the user of the Custom Made Prosthesis; 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.
Upper or Lower limb amputation; for the compensation for a disability.
Note: Patients should have an appropriate level of physical fitness to use a Custom Made Prosthesis.
Patients without the required level of physical fitness to use a prosthesis.
The Custom Made Prosthesis is a prosthetic device designed for use by upper or lower limb amputees with low to high impact levels.
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 Custom Made Prosthesis shows signs of damage or wear, the patient should stop using the device and contact their prosthetist at ProActive Prosthetics.
Keep the prosthesis away from open flames, embers or other sources of heat.
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.
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.
The Custom Made Prosthesis is bespoke and is fitted and adjusted to your needs and requirements by the prosthetist.
We advise at least annual reviews of the Custom Made Prosthesis to check they are fitting and functioning correctly.
The ProActive team is here for you, please call to speak to a member of our team.
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 Custom Made Prosthesis, the EOS is 3 years from delivery of the device.
The patient must report any serious incident that has occurred in relation to the Custom Made Prosthesis 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 of any adverse incident relating to the Custom Made Prosthesis.
ProActive Prosthetics does not assume liability for the following.
· A Custom Made Prosthesis not maintained as instructed by the instructions for use.
· A Custom Made Prosthesis used outside recommended conditions, application or environment.