Ottobock 6Y41 Liners Lower Limb Prosthetics Instructions

Ottobock 6Y41 Liners Lower Limb Prosthetics

Other Models

Strain indicators

Product description

INFORMATION

Date of last update: 2023-12-15

• Please read this document carefully before using the product and observe the safety notices.
• Instruct the user in the safe use of the product.
• Please contact the manufacturer if you have questions about the product or in case of problems.
• Report each serious incident related to the product to the manufacturer and to the relevant authority in your country. This is particularly important when there is a decline in the health state.
• Please keep this document for your records.

INFORMATION

• The patient must be fitted with the liner no later than the date printed on the inside of the packaging or on the label (MHD/BBD).

Function

In combination with an appropriate suspension solution, liners increase wearer comfort and improve the suspension of the prosthesis. Together, they reduce the forces that affect the residual limb.

6Y88, 6Y88L, 6Y110, 6Y111, 6Y112
Caleo| 6Y90, 6Y92, 6Y93, 6Y93F, 6Y94, 6Y95
Uneo| 6Y60
Hybrid| 6Y100

Skeo liners

Skeo liners improve shock absorption and wearer comfort. Ottobock recommends a specific weight-bearing prosthetic socket with distal end contact for TT prostheses. The liner used determines the appropriate suspension solution.

The cast technique for TF prostheses can be selected freely. The liner used determines the appropriate suspension solution.

Caleo liners

Caleo liners are made of a thermoplastic gel. They effectively reduce shear forces and contribute to skin care by releasing a medical grade mineral oil.

The cast technique can be selected freely. The liner used determines the appropriate suspension solution.

Uneo liners

Uneo liners are made of a viscoelastic material. It adapts very well to the form and structure of the residual limb and protects very well against impact forces.

Ottobock recommends a total surface weight-bearing socket (the “Harmony” principle) with a suitable vacuum system.

Hybrid

Ottobock recommends a total surface weight-bearing socket (the “Harmony” principle) with a suitable vacuum system.

Combination possibilities

This prosthetic component is compatible with Ottobock’s system of modular connectors. Functionality with components of other manufacturers that have compatible modular connectors has not been tested.

• 6Y94 Caleo liner: The liner has a metal cap at the distal end for connection to the 4R220 Dynamic Vacuum System. The liner is intended exclusively for use in combination with the 4R220 Dynamic Vacuum System.

Intended use

Indications for use

The product is intended exclusively for lower limb exoprosthetic fittings.

Lifetime

The product is a wear part, which means it is subject to normal wear and tear.

2.3 Contraindications

6Y110, 6Y111, 6Y112

• Short residual limb
• Residual limb with pronounced conical shape

3 General safety instructions

WARNING! Risk of severe injuries

• Store the product out of reach of children. There is a risk of suffocation if the product is pulled over the mouth and nose.

CAUTION! Risk of injury and risk of product damage

• Keep the product away from open flames, embers and other sources of heat.
• Do not expose the product to temperatures above +80 °C and below -20 °C.
• Make sure the product is applied properly and fits correctly. Improper or excessively tight application can cause pressure points and constriction of blood vessels and nerves.
• Do not continue to use the product if it does not fit properly

CAUTION! Skin irritation, formation of eczema or infections due to contamination with germs

• The product may only be used by one person; reuse on another person is prohibited.
• Observe the cleaning instructions.
• Only use the product on intact skin.

Scope of delivery

Preparing the product for use

The following technical information is available if needed:

Skeo liner (TT example)| 646T2=1.6,

646T2112

---|---
Skeo liner (TF example)| 647G932
Hybrid liner| 646T217
Caleo liner| 646T215
Uneo liner| 646T2=1.8

Size selection (standard liner only)

INFORMATION

Be sure to select the correct liner size. Possible problems are listed below.

• Liner too small: Feelings of numbness, formation of blisters, pistoning in the prosthetic socket
• Liner too large: Increased perspiration, rotation of the residual limb in the liner, formation of blisters, skin rash

Strain indicators

Some liners have strain indicators. These are markings that indicate the stretch of the liner. The markings look like two transverse letters T and face each other. If the liner is not being worn, the distance between the vertical lines is 35 mm. When the liner is worn and thus stretched, the distance between the vertical lines increases. This is used to determine whether the liner is the right size and the correct shape (standard liner or 3D liner) has been selected (see fig. 1).

1. TF liner: Measure the residual limb circumference 5 cm proximal of the residual limb end.
   TT liner: Measure the residual limb circumference 4 cm proximal of the residual limb end. Additional measurements are required for some liners.

2. Select the next smaller liner size based on the measured residual limb circumference.
   CAUTION! Reduce by a maximum of two liner sizes to avoid excessive compression.

3. Check the fit of the liner

Adapting the liner

INFORMATION

Liners with a threaded connection have an integrated matrix. The matrix prevents excessive expansion of the material. The length of the matrix is based on the liner’s domain of application. Liners with a matrix in the distal are particularly well suited for TT prostheses. Liners with a matrix over the entire length are usually used for TF prostheses.

INFORMATION

Copolymer liners are thermoformable. For this purpose, pull the liner over a dry plaster positive and optionally wrap it in an elastic bandage.

• 6Y90, 6Y92, 6Y94: convection oven, 70° C, 2 h
• 6Y93, 6Y94=*-F, 6Y95: convection oven, 65° C, 15 min
• Recommended tools for liners with textile cover: 719S7 trimming scissors, 719S20 scissors for synthetic fibres or conventional straight edge scissors
• Recommended tools for liners without textile cover: 756L9 trimming device, 756L10 liner trimmer or conventional straight edge scissors
• NOTICE! Do not use wave edge scissors.
  TT liner: Cut the liner horizontally at the required length. Make sure a smooth cutting edge is obtained to prevent the material from tearing.
  TF liner: Cut the liner according to the trim line. The liner always has to end outside the prosthetic socket.

Optional: Installing the pin

INFORMATION

The shape of the prosthetic socket must allow load on the end of the residual limb.

The pin to connect the liner to the shuttle lock is screwed into the thread at the distal end of the liner.

• Required materials: Loctite 636K13

1. Apply Loctite to the thread.
2. NOTICE! Do not shorten flexible pins or pins with an outlet valve. Screw the pin into the thread and carefully tighten it.

Use

Use of powder (e.g. baby powder or talcum)

Skin irritation on the residual limb and loss of function of prosthetic components due to clogging with particles or deprivation of lubricant

• Keep the product away from powders.

NOTICE

Mechanical overload

Impaired functionality due to mechanical damage

• Check the product for damage and readiness for use prior to each use.
• Do not use the product if it is damaged or in a questionable condition. Take suitable measures (e.g. cleaning, repair, replacement, inspection by the manufacturer or a specialist workshop).

INFORMATION

Some liners are treated with the Skinguard Technology additive. Skinguard Technology has an antibacterial effect and prevents the formation of unpleasant odours.

Substances in sweat containing sulphur may cause discolouration.

This discolouration has no effect on the function or durability of the liner but cannot be removed. Sulphur may enter sweat through food, for example, protein products, cabbage, nuts, legumes and sulphured products (e.g. dried fruit).

Discolouration of the liner does not justify customer complaint claims.

INFORMATION

• Liners that have already been worn generally feel softer than new liners.
• Because of the relatively long drying times of Uneo liners, a spare liner is recommended.
• Clean new liners before using for the first time.

INFORMATION

Derma Prevent can damage the coating on liners.

Putting on and taking off the liner

Donning

INFORMATION

Wear the liner directly on the skin. Fabrics between the skin and the liner can cause skin irritation.

If any allergic reaction occurs, immediately discontinue use and contact your medical professional.

1. Check the liner for damage. Also check installed connecting elements (e.g. pin, metal cap).

2. Roll up the liner and place it on the end of the residual limb.

3. Align the liner. Some liners have an orientation aid on the front (visible or tactile) to make them easier to align.

4. NOTICE! Align a distal connecting element (e.g. pin, metal cap) with the longitudinal axis of the residual limb.
   Unroll the liner without leaving wrinkles or displacing soft tissue, and without air pockets.

5. Check the fit and the alignment of the liner.
   → TF liner: The end of the liner must not be inside the prosthetic socket.
   → All liners except 6Y100: Do not fold the liner over the prosthetic socket.

Doffing

1. Roll up the liner and remove it from the residual limb.
2. Recommendation: Clean the liner (see page 11).

Cleaning and Care

NOTICE

Use of improper cleaning agents

Damage to the product due to use of improper cleaning agents

• Only clean the product with the approved cleaning agents.

INFORMATION

If you perspire a lot, clean your skin and the liner/prosthesis more often. Wearing a prosthesis requires daily intensive skin care. Ottobock recommends the Derma care system for this.

1. Turn the liner inside out.
2. Hand wash the liner in warm water (30 °C) using a neutral detergent (e. g. Ottobock Derma Clean 453H10=1).
3. Thoroughly rinse the liner with clear water until all detergent residues have been removed.
4. Turn the liner again so the outer side/textile material is on the outside.
5. Put a towel into the liner and allow the liner to dry lying flat on a drying rack. Alternatively, use a drying stand (5Y100=*).
   NOTICE! Liner with textile cover: To avoid damaging the liner, dry it with the textile material on the outside.

Disposal

Do not dispose of the product with unsorted household waste. Improper disposal can be harmful to health and the environment. Observe the information provided by the responsible authorities in your country regarding return, collection and disposal procedures.

Legal information

All legal conditions are subject to the respective national laws of the country of use and may vary accordingly

Liability

The manufacturer will only assume liability if the product is used in accordance with the descriptions and instructions provided in this document. The manufacturer will not assume liability for damage caused by disregarding the information in this document, particularly due to improper use or unauthorised modification of the product.

CE conformity

The product meets the requirements of Regulation (EU) 2017/745 on medical devices. The CE declaration of conformity can be downloaded from the manufacturer’s website.

Warranty

The manufacturer warrants this device from the date of fitting. The warranty covers defects that can be proven to be a direct result of flaws in the material, production or construction and that are reported to the manufacturer within the warranty period.

Further information on the warranty terms and conditions can be obtained from the competent manufacturer distribution company.

Customer Support

Ottobock SE & Co. KGaA Max -Näder -Straße 15 · 37115 Duderstadt · Germany
T +49 5527 848-0·
F +49 5527 848-3360
healthcare@ottobock.de · www.ottobock.com

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