Streifeneder 20L100 User manual

ortho production
ContexGel-Liner mit Textilbezug
ContexGel-Liner with fabric cover
Anwenderinformation
D
Patient Information
GB
20L100 20L200 ContexGel.basic ohne Außenmatrix without outer matrix
21L100 21L200 ContexGel.soft ohne Außenmatrix without outer matrix
22L100 22L200 ContexGel.soft+ ohne Außenmatrix without outer matrix
25L100 25L200 ContexGel.basic mit Außenmatrix with outer matrix
26L100 26L200 ContexGel.soft mit Außenmatrix with outer matrix
27L100 27L200 ContexGel.soft+ mit Außenmatrix with outer matrix

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Contents
1 Technical Data ............................................................................ 12
2 Description and Function............................................................ 12
2.1 Application ..................................................................................... 12
2.2 Construction................................................................................... 12
3 Indication ................................................................................... 13
4 Contraindication..................................................................13 – 14
5 Putting on the ContexGel-Liner .................................................. 14
6 Perspiration ................................................................................ 15
7 Cleaning and care of the ContexGel-Liner ...........................15 – 16
7.1 Daily Cleaning................................................................................. 15
7.2 Weekly Disinfection......................................................................... 16
8 Storage of the ContexGel-Liner .................................................. 16
9 Service Directions and Recommendations ................................... 16
10 Use ............................................................................................ 16
10.1 Restriction of Use............................................................................ 16
10.2 Misuse of Product ........................................................................... 16
10.3 Product Life Cycle ........................................................................... 16
11 Guarantee...........................................................................17 – 18
11.1 Conditions...................................................................................... 17
11.2 Guarantee and Preclusion period .................................................... 17
11.3 Scope of Guarantee and Exclusion .................................................. 18
11.4 Guarantee service ........................................................................... 18
12 Declaration of Conformity .......................................................... 19
13 Disposal...................................................................................... 19
Please read this instruction manual carefully before applying the
ContexGel-Liner.
This instruction booklet is protected by copyright. Reproduction of the complete instruction booklet, even in abstracts, in any form or by any means,
is only permitted with explicit written authorisation of the Streifeneder ortho.production GmbH. The indicated measurements and weights are guide
values without obligation. Slight deviations in construction, shape, colour or scope of supply may occur. Products are subject to change without prior
notice after press date of this instruction booklet, 2016-09.
Our general terms and conditions apply; they can be viewed anytime at www.streifeneder.com/op.

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Please read this instruction manual carefully before applying the
ContexGel-Liner.
1 Technical Data
Please refer to our latest catalogue „Prosthetics – lower extremities, socket comfort“ for
available ContexGel-Liner sizes and qualities.
2 Description and Function
2.1 Application
Note
The sewn-in label with serial number / EAN Code must NOT be removed!
Important
The inside of the liner must be cleaned thoroughly with lukewarm
water and cleaning lotion Skin-Care 10H2 prior to first skin contact.
2.2 Construction
Due to their construction, the ContexGel-Liners 20L100, 20L200, 21L100, 21L200, 22L100,
22L200, 25L100, 25L200, 26L100, 26L200, 27L100 and 27L200 feature following benefits for
the user:
• Compression of the residual limb (edema prevention, less limb volume changes)
• Protection and care of the skin
• Shock absorption
• Improved adaption and increased safety by locking pin or vacuum system technology
• Protection of protruding areas by pressure distribution
• Simple handling and care (cleaning)
• Prosthetic fit with less restriction of movement (high supracondylar line or additional thigh
corset are not necessary)
• Longevity
• Even for difficult residual limb conditions
• The ContexGel-Liners with outer matrix efficiently reduce the elongation during swing
phase.
Application according to Streifeneder walky-system:
The ContexGel-Liners 20L100, 20L200, 21L100, 21L200, 22L100, 22L200, 25L100, 25L200,
26L100, 26L200, 27L100 and 27L200 are used exclusively for prosthetic care and are approved
for amputees with activity class (walky) 1 to 3.

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3 Indication
The ContexGel-Liner should be used mainly for following residual limb situations:
1. Poor coverage of soft tissue Substitution of soft tissue by elastomer.
2. Bone protuberance The gel flows around these pressure zones
and increases the comfort of the limb
embedding.
3. Burns (skin transplantations) The liner absorbs a big part of the shear
stress during walking, and consequently
protects these sensitive skin areas to a great
extent from mechanical overload.
4. Skin adhesions at the periosteum
The ContexGel-Liner completes the possibilities of standard silicone liner care. The flow ability
of the elastomer provides appropriate care for additional patient groups:
• Patients with arterical circulatory disorders and microangiopathies
• Patients with diabetes mellitus and its dermatological consequences
For these patients, it is important to carefully effect the volume reduction and to benefit from
the good adhesion of the ContexGel-Liner.
4 Contraindication
Please carefully note the following exclusions!
1. Excessive soft tissue or overlapping soft
tissue
The user „swims“ in the socket cup and
shows an unsecure gait pattern.
2. Instable knee joint All kinds of short prostheses will enhance
instabilities of the knee joint and should
only be applied with medical and physio-
therapeutic supervision. A beneficial factor
for these users is the application of soft,
multi-axial foot constructions.
3. Users with high activity level These users will complain about too much
axial lift and too little rotation stability
between socket and limb. Furthermore,
the durability of the liner will be reduced
considerably.
4. No residual limb end load possible If the user cannot put load on the residual
limb end, a ContexGel-Liner cannot be used.
The limb end usually must be able to absorb
20 – 30 % of the body load.
5. Poor hygienic conditions Please consider the instructions for cleaning
the ContexGel-Liner.

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6. Overly sensitive neuroma If the user cannot put load on the residual
limb end, a ContexGel-Liner cannot be used.
The limb end usually must be able to absorb
20 – 30 % of the body load.
7. Allergic reactions / intolerance to the
material(s)
If in doubt, consult your health care supply
store resp. your orthopaedic technician in
order to exclude possible hazards.
8. Contact with irritated or damaged skin
9. Contact with open wounds
5 Putting on the ContexGel-Liner
Attention!
We do not recommend to apply any type of lubricant to the residual limb or to the
ContexGel-Liner. Petroleum jelly will damage the liner and should be avoided.
The limb should be clean, dry, and free of soap residue.
1. Turn the ContexGel-Liner inside out so that the gel side is facing out.
2. With the logo and serial number in the front or anterior surface of the liner, place the end
of the liner against the end of the limb. If you use a ContexGel-Liner with distal connection,
center the pin attachment on the distal end of the limb.
3. Then carefully roll the liner onto the residual limb with the gel side facing the skin.
For optimal comfort, place the seams away from any sensitive areas or bony prominences.
Attention!
Please take care to roll the liner onto the residual limb instead of pulling it onto it,
which could stretch the skin and result in discomfort or skin irritation.
4. If the ContexGel-Liner is being put on for the first time, the user may find it somewhat
tight. In order to achieve a more comfortable fit, proceed as follows:
Fold the upper edge of the ContexGel-Liner, then roll the liner almost all the way down the
limb, so it looks like a thick sausage. Stop rolling down shortly before the distal end and
then roll the line back on the limb. If the ContexGel-Liner still fits too tight, an additional
customisation may become necessary. If in doubt, consult your health care supply store
resp. your orthopaedic technician in order to exclude possible hazards.
5. Avoid wrinkles and air bubbles between residual limb and ContexGel-Liner.
6. If there is still space between the ContexGel-Liner and the socket, you should
• Use a thicker ContexGel-Liner and a protecting stump socket or
• Use an additional soft socket
7. Now let the user put on the prosthetic socket.

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6 Perspiration
During the first weeks of use of a ContexGel-Liner, the user may complain about increased
perspiration. Some orthopaedic technicians have found out that perfume-free antiperspirants
or alum applied to the residual limb prior to putting on the ContexGel-Liner, are effective and
gentle remedies to prevent increased perspiration. Please note the information on the package
accordingly and never use these products on open wounds on the limb.
Attention
If the perspiration does not get back to normal within this time, 4 weeks, the user
should consult an orthopaedic technician or a medical doctor.
7 Cleaning and care of the ContexGel-Liner
Attention!
Proper hygiene is extremely important when using the ContexGel-Liner.
Please review these care instructions very thoroughly with the user.
The ContexGel-Liner must be thoroughly cleaned with cleaning lotion Skin-Care 10H2 at the
end of each day of wear, and should be allowed to dry for at least 24 hours.
The use of two ContexGel-Liners is therefore recommended.
7.1 Daily Cleaning
1. Remove the liner by unrolling it from the residual limb so that it comes off the limb with
the gel side facing out.
2. Immediately after removing the liner, with the gel side still facing outside, clean the
ContexGel-Liner thoroughly with warm tap water and cleaning lotion Skin-Care 10H2 in
order to prevent skin irritations.
Apply the cleaning lotion either by hand or with a clean, soft cloth or sponge.
Attention!
Do not scrub the ContexGel-Liner. Scrubbing can roughen the surface of the liner
which may lead to skin irritations.
3. Take special care to rinse all washing lotion residue from the liner.
4. Dry the gel side of the liner with a clean, lint-free cloth.
5. Turn the liner inside out so that the fabric is on the outside, and the gel is on the inside.
6. Place the liner, with the fabric side out, onto the drying stand delivered with the liner.
7. Clean the residual limb.
Attention
Make sure that the ContexGel-Liner does not get in contact with foreign objects or
substances, as they will settle in the gel and may cause skin irritations. In such cases,
washing the liner may not be sufficient. Return the liner to the prosthetic shop, if it
accidentally has got in contact with foreign objects or chemical substances.
The ContexGel-Liner must be checked daily for damages (tears, material
abrasion).

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7.2 Weekly Disinfection
1. Place a small amount (no more than 2 tbs.) of ethyl or isopropyl alcohol resp. 2 – 3 shots of
Skin-Care-Spray 10H5 onto a soft, clean cloth
2. Lightly wipe the gel side of the liner with the cloth for two minutes. Rinse off any excess
alcohol with water.
3. Place the liner, with the fabric side out, on the drying stand and let it dry.
Attention!
Do not immerse the ContexGel-Liner in ethyl or isopropyl alcohol. Extended contact
with large amounts of ethyl or isopropyl alcohol will cause the ContexGel-Liner to
stiffen.
Attention
It is most important that the ContexGel-Liner is not exposed to corrosive chemicals and
substances such as salt water, acids, dust or sand! If these rules are not obeyed, the
warranty and any claims towards Streifeneder ortho.production GmbH will be void.
8 Storage of the ContexGel-Liner
When the liner is not in use, it should be stored in a cool and dry place. If the ContexGel-Liner is
not in use for a longer time period, we recommend storing it placed on the drying stand while
covered with a clean plastic bag.
9 Service Directions and Recommendations
Generally, a visual and functional check must be done every 6 months.
10 Use
The ContexGel-Liner requires qualified and individual adaption to the patient according to medical
indication. All adjustments must be done by qualified professional staff.
10.1 Restriction of Use
Due to the customisation and for hygienic reasons, please note that the product must only be
used by the wearer it has been customised for and must not be transferred to any other user.
10.2 Misuse of Product
The ContexGel-Liner are exclusively constructed for the activity level (walky) 1-3 and is not
suitable for sportive activities like jumping, running, e. g.
Attention!
We are pointing out, that the ContexGel-Liner are tested and released only
in combination with all other Streifeneder modular parts.
10.3 Product Life Cycle
The product life cycle is limited on 3 years.

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11 Guarantee
The following guarantee bond shall apply in conjunction with any legal statutory warranty
claims and completely independent thereof. It is provided in lieu of any other expressed or im-
plied warranties or suitabilities for a particular purpose (to the extent permitted by law).
11.1 Conditions
Claims resulting from this manufacturers guarantee can only be asserted, if the relevant product
was installed or adjusted by or under the direction of a certified / licensed orthopedic technician
AND if the product has been properly and regularly maintained by a trained technician within
the provided intervals - as far as such maintenance and inspection intervals are predefined by
Streifeneder ortho.production GmbH. The conducted maintenance and service checks must be
confirmed with the date, official stamp and signature of the performing specialist company. The
corresponding verifications shall be submitted to Streifeneder ortho.production GmbH without
request, upon the assertion of claims under this Guarantee.
11.2 Guarantee and Preclusion period
The duration of our manufacturers guarantee varies depending on the product. However, the
duration of the Guarantee starts in any case upon delivery to the customer. The special terms
and conditions of the Guarantee for this particular product are:
Guarantee Duration for the 20L100, 20L200, 21L100, 21L200, 22L100, 22L200, 25L100,
25L200, 26L100, 26L200, 27L100 and 27L200 = 6 months
Claims under this Guarantee must be asserted immediately in writing to Streifeneder ortho.
production GmbH, at the latest within one month after knowledge of the existence of the
preconditions for claims under this Guarantee. Rights to assert guarantee claims are expressly
excluded after the expiry of this time limit.
Note
The sewn-in label with serial number / EAN Code must NOT be removed!

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11.3 Scope of Guarantee and Exclusion
It is guaranteed that the product is free from defective material and / or workmanship.
The Guarantee does not cover damages resulting from
• faulty installation,
• operating errors,
• inappropriate application (especially contrary to existing manufacturer specifications / instruc-
tions)
• normal wear and tear
• external influences such as force majeure or interventions by third parties.
Likewise not included are merely optical impairments without influence on the functionality of
the relevant product, as well as defects arising from the installation of damaged components,
the application of spare parts not approved by Streifeneder ortho.production GmbH and / or
interventions or repair works conducted by distributors / specialist companies not authorized by
Streifeneder ortho.production GmbH.
This Guarantee does not create a liability of Streifeneder ortho.production GmbH with regard to
consequential loss or damage of any kind or other claims for compensation with the exception of
mandatory legal provisions according to which Streifeneder ortho.production GmbH can be held
accountable as
manufacturer beyond the scope of this voluntary Guarantee.
11.4 Guarantee service
If all preconditions of this Guarantee are met, Streifeneder ortho.production GmbH will, at its
sole discretion, either repair or replace the product free of charge.

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12 Declaration of Conformity
Streifeneder ortho.production GmbH declares as manufacturer in sole responsibility, that the
ContexGel-Liner 20L100, 20L200, 21L100, 21L200, 22L100, 22L200, 25L100, 25L200, 26L100,
26L200, 27L100 and 27L200 complies with the requirements of directive 93/42/EWG.
13 Disposal
The product must be disposed of or recycled according to your regional or national regulations.

Streifeneder
ortho.production GmbH
Moosfeldstraße 10
82275 Emmering
Germany
T [phone]
F [phone]
offi[e-mail]
www.streifeneder.de/op
20L-P/G 2016-09