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Information for Use: Custom Made Prosthesis

Product description

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:

Upper Limb

Transradial prosthesis

Elbow-disarticulation prosthesis

Transhumeral prosthesis

Wrist-disarticulation prosthesis

Lower Limb

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.

Indications for use

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.

Contraindications

Patients without the required level of physical fitness to use a prosthesis.

Intended use

The Custom Made Prosthesis is a prosthetic device designed for use by upper or lower limb amputees with low to high impact levels.

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 Custom Made Prosthesis 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.

  • Patients should monitor skin health daily. In case of abnormal symptoms, the user is advised to discontinue the use immediately and contact their prosthetist.
  • 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 Custom Made Prosthesis can be wiped clean with a damp cloth. It should NOT be immersed in water unless it is a specifically designed water activity or waterproof device.
  • The Custom Made Prosthesis should be checked for wear and damage and patients are advised to contact their Prosthetist immediately if any wear or damage is evident.
  • If the patient experiences any change in comfort or function of the Custom Made Prosthesis they should contact their prosthetist immediately for advice, adjustment or repair.
  • Under NO circumstances should a patient attempt to adjust, modify or repair the Custom Made Prosthesis themselves in any way.

Service and Repair

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.

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 Custom Made Prosthesis, the EOS is 3 years from delivery of the device.

Report a serious incident

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.

Liability

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.