Silicone Liner for AK/BK amputee

Silicone Liner for Above Knee amputee without lock/with matrix and lock

Silicone Liner for Below Knee amputee without lock/with matrix and lock

Application
SILICONE LINER is only for prosthetic use. The use of salt water is not intended!

Indication
The SILICONE LINER is unique for the following applications:
– Very few soft tissues covering stumps
– Bony stumps
– Dry skin at the stump
– Sensible skin (skin transplantation, etc.)
– Scary stumps
– Skin adhesion at the Periost
Because of his unique thermoforming character, Liner can be used especially for patients with:
– Patients with blood circulations problems
– Diabetes

Please be careful to stump reduction of diabetes patients. In this case, the special function of the Gel the thermoforming function is the best. Very important is the hygiene of the patient. Besides all this, it is necessary that the patient understand the function and usage of the Liner.

Contraindication
Please see the topic: Applications

How to manufacture the socket
Perfect use of the SILICONE LINER is achieved using a hydrostatic socket type. During the casting, it is important to keep the shape of the stump without any shifting and modifications. The circumferences should be measured with the liner on the stump. Take measures from the Tibia each 2,5 cm. Do a uniform and circular reduction from 4-8% on the positive model. The reduction depends on soft tissue, activity level, and blood circulation, or another disease. The reduction has to be homogeneous.
Doing grooves on the positive model is not allowed, because the gel will be filling it. We are recommending doing a test socket. The patient has to have a constant, compact feeling in the whole socket without any pressure areas. You can see the pressure areas easily. Control with a light if you can see any stretches or buckling of the fabric or seam.
Because of the hydrostatic socket style, it could happen that the stump reduces. This especially could happen when the patient was not wearing a hydrostatic socket before. Before You change the socket, please let the patient wear the liner one week before doing the model for compression and forming the stump. Because of the same reason we advise doing a longer test period of the socket before doing the definitive socket. The definitive socket should have smooth and flowing contours and not any sharp edges.

Use of the Liner
The SILICONE LINER is able to be adjusted following the needs of the patients, it’s important he understands the use.
Variation 1: To provide a first easy dressing of the Liner, please use a clean and dry plaster model with similar measurements and put the liner on the model. Leave the liner for 1 hour on the plaster positive. After this operation, you have to clean the liner and give it to your patient. Because of the first stretching, the liner already has a thermoforming and good shape for the user.

Cutting the Liner
The SILICONE LINER can be cut with a big and sharp cutter. Anyway, it is possible to cut the liner with a sharp knife and using a stop bar for better results. After cutting, please use a drop of second glue to seal the seams.

How to roll on and roll off the liner and storing the liner:
Please, go through every single step of the instruction with Your patient
Please, take care that when you roll on or roll off the liner, no sharp and spiky material is touching the liner (fingernails, rings, pins, etc.).
Roll on the Liners:
1. Put over the liner with the silicon outside
2. Lean the liner on the distal end of the stump and roll on. When You are using a Locking liner, please make sure the umbrella fits the stump correctly.
3. Roll the liner slowly and carefully with the silicon on the skin side. Please take care that there is no air inclusion. Please don’t stretch the liner only roll the liner, otherwise, it could come to skin irritations and so the comfort is constricted
4. In case You are using a Locking liner, please make sure that the pin of the shuttle lock is not damaging the liner during the roll-on process
Please, don’t use additional creams or any lubricant before roll on the liner. Roll on the liner each time on dry and clean skin without any residuum of creams. The use of powder or similar is forbidden and will damage the silicon
Roll-off the Liner:
1. Be sure the gel is on the external side
2. Take the above end and pull slowly from above to down.

Storage: When You are not using the liner, please use the drying stand which is included, and place the liner with fabric out a site on the stand.

Please, don’t dry or place the liner with the gel outside on the stand. This could damage the liner. When you are using the liner, not for a long time, please well dry and clean the liner. To avoid clueing of the silicon, please use, for long-term storage, foam on the inside. After, you should put the liner in a plastic bag.

Care
Daily cleaning of the liner:
The daily cleaning of the liner is very important. As well You should disinfect the liner one time a week.
Please clean the liner right after you took the liner off from your stump and the gel is on the external side
1. Clean the liner with warm water (not hot!) and a mild soap without perfume. Flush the liner with enough water until all the soap is gone. After, dry the liner with a soft cloth. Please don’t use a brush or similar hard utensils.
2. After dry the liner with a soft cloth.
3. Lean the liner onto the dry stand included in the box.
4. After you have to clean your stump and skin.
Don’t use a washing machine for the cleaning of the liner. When you are drying the liner, please, don’t put it on the radiator or drying to the sun.
For don’t ruin the external textile of liners, you have to use socks between liner and socket.
Weekly Disinfection:
In normal use of the liner, you have to disinfect the liner one time a week with Ethyl – or Isopropanalcohol.
1. Do a little bit of alcohol on a clean cloth
2. Grinding the Gel good but carefully with the cloth for 2 minutes
3. Flush the Gel site with warm water (not hot!)
4. Place the liner again with the fabric at the external side on the stand
Use not too much alcohol. This could make damages to the gel and the liner will get harder. Please, don’t use a hairdryer.

Volume shifting
Normally all stumps are shrinking during the day when you wearing a prosthesis. It is important for the long life warranty of the liner that you take care of these changes. For adjusting the volume you can use socks or our special volume pads what provides you the right fitting again of the socket. When the gap between the volume changes is too big, please contact your CPO. The liner can be damaged, when the socket fits not as it should.
Please give your patient the advice to contact You directly, when the socket fits not any longer correct and the CPO has to adjust the socket again, to avoid any damages to the liner.

Perspiration
During the first weeks of using the liner, probably there will be more transpiration of the skin. This will be getting better after a few weeks. If it’s not getting better, please contact your doctor. Please, don’t use too many anti-perspiration products to reduce perspiration. This could damage the liner

Importance for notice:
– Please follow thoroughly the instruction, otherwise, all the warranty is not any longer valid
– Please keep away sharp tools from the liner
– Don’t intermit the liner with hot water or general hot utensils
– Be careful with the transportation and storage of the liner. Don’t leave the liner in the care which is exposed directly to the sun
– ROADRUNNERFOOT recommends using a replacement liner. In this case, the liner will last unloaded and the silicon can relax for 24 hours.
– In the case of using a Locking liner, please prove the tight and fixed fitting of the PIN. Otherwise, the patient can lose the prosthesis.

Warranty
The SILICONE LINER has a warranty time of 6 months. The warranty is applied to material defects or general manufacture mistakes in or during production. When a patient is wearing 2 Liners and changing them each day the liners the warranty is 12 months for each liner. The date of warranty starts at this time when the liner was delivered to the patient. In this case, the customer has to send the warranty documentation to ROADRUNNERFOOT.
No warranty:
– Miss use of the liner in each form.
– Activities from the patients what is not above the activity lever recommended.
– Damage in case of an accident.
– Ignore the instruction.
– Ignore the care.

Liabilities
In case of damage: ROADRUNNERFOOT can only accept reclamations, when there is a copy of invoice, acknowledgment, and written detailed reasons for sending back the liner.

CE-Mark
SILICONE LINER complies with the essential requirements of Annex I of the Medical Devices Directive 93/42/CEE and s.m.i. transposed in Italy by D.Lgs.46/97 and D.Lgs.37/2010.

Compatibility
Skin creams, other products between skin and liner. SILICONE LINER had to be used correctly. Clinical test reports positive compatibility of the SILICONE LINER to the skin if used without any type of medical oil o general medicine on the skin. In addition, there aren’t toxicity problems and full satisfaction.