FAQ Lynk System
Here you will find answers to your questions about the Lynk System.
System
In an orthoprosthesis, components of a prosthesis are combined with components of an orthosis. An orthosis is an orthopaedic appliance for stabilising, relieving, immobilising, guiding or correcting limbs. A prosthesis is an orthopaedic device that attempts to partially or completely replace a body function.
The hand orthoprosthesis consists of a Cuff, an Adapter and various activity Modules. Depending on the activity, the Modules can be easily exchanged.
Yes! The Cuff is a medical device, risk class I, and the Adapter and the Modules are accessories of a medical device, risk class I. We have developed the orthoprosthesis according to ISO-13485 and the Medical Device Regulation.
Target group
The Lynk system can be used for people who suffer from a one-sided restriction of the hand due to paralysis, muscle weakness or joint stiffness. It can also be used if the hand or fingers are completely or partially missing. The system is suitable for people aged 2 and over. For very young users, we recommend clarifying with the parents and doctor whether the child can actually obtain the desired benefit from the aid.
The macu4 Lynk System, like the Explorer System, is a very modular, lightweight and trendy tool. It offers a wide range of possibilities in terms of fit and the activities it can support you in. The Explorer System is suitable for people with amputations or congenital deformities below the elbow. Occasionally it can also be used by people who have a wrist. The Lynk system is suitable for people with a wrist joint and no or limited gripping function of the hand.
The Cuff of the hand orthoprosthesis is not fitted to the arm, but you determine the appropriate size using a simple measuring technique. We try to adapt the design of the cuff so that it is suitable for a wide range of people. However, we cannot always meet all individual requirements. Of course, you are welcome to contact us directly as we are constantly developing new designs. If the Lynk cuff doesn't meet your needs, our next design may offer a suitable solution for you.
The Lynk system can be tested for a fee. Please contact the macu4 support team.
This must be assessed on a case-by-case basis. However, the cuff and components that come into contact with the palm of the hand can always be fitted with additional cushioning material. When using the Lynk system, pressure forces are always transferred directly to the forearm, which protects the wrist. If you are unsure, please contact us so that we can find a comfortable solution together.
The Cuff may not fit properly on the forearm or may be too large if the forearm is shorter than 9cm or the circumference is larger than 35cm. In this case, please contact the macu4 support team.
Application
Depending on the activity Module, different activities can be carried out. Various examples are listed under the heading 'Activities'.
Yes. The macu4 Lynk system consists of a Cuff component, an Adapter and several activity Modules. The activity Modules are designed for specific sporting activities. For example, the Clic Module can be attached to a bicycle handlebar.
Yes. The macu4 Lynk System orthoprosthesis consists of a Cuff component, an Adapter and several activity Modules. The activity Modules are designed for specific activities. For example, the hold Module can be used to hold cutlery and cooking utensils.
We are always happy to receive feedback. If you have any suggestions for further product development, please send them to us via the contact form.
The macu4 hand ortho prosthesis can be used for over two years with an average of 120 minutes per day of daily use.
Our products are passive functional tools and therefore do not require electronics. Electricity or batteries are accordingly not necessary.
The risk of injury when using the macu4 hand orthoprosthesis has been tested and is minimal when used properly. The orthoprosthesis should not be used in case of pain.
Where is the pressure point? Is one edge of the Cuff exposed and pressing on the skin? It can help to loosen the padding material briefly (it is attached to the Cuff with Velcro) and reposition it. Loosening the lacing system or the Velcro straps can also help. If the problem persists, please contact us.
The Lynk system consists of the following components: Adaptable Cuff, Adapter and activity Modules. Additional products are not required.
Application - Modules
No. The bicycle brake cannot be operated with the Clic Module.
The macu4 Lynk activity Modules are specially adapted to the Cuff and are therefore not compatible with any third-party product.
No. All Modules are newly manufactured. Only when it comes to product testing, used components may be provided.
If the system is used correctly according to the instructions for use, then the module cannot come loose from its position in an uncontrolled manner.
If the system is used correctly according to the instructions for use, then the Module cannot come loose from its position in an uncontrolled manner.
Regulatory requirements
The Lynk Cuff and all so-called accessories (e.g.Adapter or Modules) are CE marked and provided with a unique identification number (UDI) as soon as they are officially offered on the market.
The Lynk system is developed according to the highest quality requirements along the Medical Device Regulation and ISO-13485.
Yes, the components are made from biocompatible raw materials. The raw material used for printing the cuff is PA 2200 and approved for direct skin contact. The raw material is biocompatible according to ISO 10993-1, ISO 10993-5 and ISO 10993-12. The colouring material complies with the recognised requirements of OEKOTEX® Standard 100. The colouring material is biocompatible according to ISO 10993-1, ISO 10993-5 and ISO 10993-12.
Measurement
Detailed information on this can be found in the data protection information.
The measurement of the arm can even be done without a photo. For template-based measurement, you can print out the template, cut it out and then read off the size.
Use by professionals
By contacting us via the contact form, we can arrange an appointment to show you the functionality of a sample. If desired, we can also do this in a first step by means of a video call.
The Lynk System Modules are only compatible with the associated Lynk Cuff.
The online configurator of the Lynk system is intuitively designed. There are also specific instructions and videos for explanation. A separate chapter is linked to this in the footer of this website. Professionals have the possibility to configure the Cuff and the Modules directly.
Basically no. But we are always open to ideas and requests.
Proeprties - Material
All materials used that come into contact with the skin have been dermatologically tested.
Almost all components of the Lynk system are made of polyamide-12. This is a material that is often used in medical technology. This material is resistant to water, chlorinated water and salt water. There are individual Modules that are made of polypropylene.
The screws and nuts we use are made of stainless steel. The padding materials are common materials for orthopaedic technology.
Our Hand Ortho Prosthesis is mainly made of polyamide 12. This material is often used in medical technology. The material is resistant to water, chlorinated water and salt water. The screws and nuts we use are also rustproof.
Properties - Comfort
The weight of the macu4 Lynk system is a maximum of 250g (Cuff with activity Module). More detailed information on the individual Modules can be found on the respective Module page on this website or in the instructions for use.
The Lynk system is designed to be very light and airy. Nevertheless, sweating cannot be ruled out, as this depends on many factors such as the ambient temperature or the intensity of an activity.
Properties - Product care
Yes. The padding material is attached to the inner wall of the upper with a Velcro fastener and can be easily removed. We recommend hand washing with mild soapy water. Afterwards, the padding material should air dry. The padding material should always be detached from the Velcro fastener slowly so that the Velcro fastener does not detach from the inner wall of the Cuff. It is best to contact the macu4 support team so that they can give you a few tips and tricks.
Colour wear is a normal sign of use.
The system is best cleaned with water and a cloth. Further information can be found in the instructions for use.
The main component of the orthoprosthesis is made of polyamide-12 (PA12). The post-treatment of the material surface provides little surface for invisible dirt and bacteria to attack. Almost all 3D printed components are made of PA12 - the instructions for use list the specifications per product component
Properties - Configuration
The colour can be selected when ordering. There are different options depending on the product.
The Lynk System Cuff is available in up to 10 size combinations. The length of the adapter and the Modules are available in two sizes. The appropriate adapter or Module length depends on the Cuff size.
The circumference of the Cuff is variable within a certain range. It can be adjusted by means of a lacing system or Velcro straps. The inner wall of the cuff is also lined with a padding material. If necessary, a thicker padding material can be used.
The material used is a thermoplastic. Any modification of the Cuff wall may change the mechanical stability. Therefore, thermoplastic deformation is not recommended. Subsequent thermoplastic deformation is prohibited for sleeves manufactured by macu4.
Please consult the specific Module page. There you can find out which product sizes and configuration options are available for each Module.