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  9. uniprox V18 User manual

uniprox V18 User manual

Valve
V18, V20, V21, V22
unique prosthetic solutions
A company of the Bauerfeind GroupEin Unternehmen der Bauerfeind Gruppe – www.uniprox.de
Rev.3 2021 09_V18,V20,V21,V22_101258
Qualität und Funktion
Gebrauchsanweisung
Instruction Manual
Uniprox GmbH & Co.KG
H. Heine Str.4
07937 Zeulenroda Triebes
Tel. +49 (0) 36628 66 33 00
Fax +49 (0) 36628 66 33 55
E Mail info @uniprox.de
Please read the IFU carefully before fitting Only correct usage will
warrant the function
1 Intended Use
The valves control the expulsion of air between the prosthetic socket and the residual
limb, by this the fixation of the prosthetic limb prosthesis.
2 Technical data
2 1 V18, V20 Valve – with manual air expulsion
•V18: The Contact valve lets the air flow when the button is pressed.
•V20: The Rubber valve is a simple potion for prostheses with flexible inner sockets.
•incl. dummy and nail
•Valve head Ø 33 mm, bore Ø 38 mm
2 2 V21 Jet Contact Valve
•Contact valve: During ambulation the valve allows minimum air flow in and out
•incl. Dummy and nail
•Valve head Ø 33 mm, bore Ø 38 mm
2 3 V22 Valve – with automatic air expulsion
•Contact valve: designed for short residual limbs
•The air is expepelled during gait and can not flow back.
•incl. Dummy and nail
•Valve head Ø 33 mm, bore Ø 38 mm
2 3
2 4 Service parts for V18 – V22
O Ring for valve body V18, V21, V22
Cosmetic ring for V18, V20, V21, V22
Valve body for V18
Valve housing for V18, V20, V21, V22
Dummy for V18, V20, V21, V22
Threaded coupling ring for V18, V20, V21, V22
Sealing ring for V18, V20, V21, V22
Valve body V21 (Jet contact valve)
Valve body for V22 (with automatic air expulsion)
Expulsion push button for V22
Order No Material Valve Opening Article No
V18 Aluminium, Plastic Ø 28 mm 4 233 190 00 00 000
V20 Aluminium, Rubber Ø 28 mm 4 233 200 00 00 000
Order No Material Valve Opening Article No
V21 Aluminium, Plastic Ø 28 mm 4 233 220 00 00 000
Order No Material Valve Opening Article No
V22 Aluminium, Plastic Ø 28 mm 4 233 230 00 00 000
Order No Material Article No
E V12 Rubber 4 233 151 04 00 000
Order No Material Article No
E V14 Plastic 4 233 151 08 00 000
Order No Material Article No
E V21 Aluminium, Plastic 4 233 191 01 00 000
Order No Material Article No
E V22 Aluminium 4 233 191 02 00 000
Order No Material Article No
E V23 Plastic 4 233 191 04 00 000
Order No Material Article No
E V24 Aluminium 4 233 191 05 00 000
Order No Material Article No
E V25 Soft Rubber 4 233 191 06 00 000
Order No Material Article No
E V33 Aluminium, Plastic 4 233 221 01 00 000
Order No Material Article No
E V34 Aluminium, Plastic 4 233 231 01 00 000
Order No Material Article No
E V35 Plastic 4 233 231 02 00 000
4 5
Attention: left-handed thread!
Make sure, that the threaded coupling ring fit uniformly distributed at the surface of
the Thermoflex material before tighten with the Valve Key. After a few hours of use
please control the threading coupling ring, if necessary retighten.
Turn in the Valve head into the Lower part for Standard (righthand thread).
7 Maintenance and Cleaning
As part of regular prosthesis maintenance, the valves must be checked and cleaned
every 6 months at the most.
Cleaning:
•Compressed Air up to 2 bar
•Soap and hand warm water
•Do not use aggressive solvents for cleaning.
8 CE- Conformity
The product satisfies the requirements of Regulation (EU) 2017/745 of the European
Parliament and of the Council (MDR) and bears the CE mark. All major incidents related
to the product needs to be informed to Uniprox and the competence European
Authority.
9 Warranty and Guarantee
With regular maintenance, the valve can be used for the duration of the prosthesis use
(usually 5 years).
Warranty is provided under the terms of sale and supply of Uniprox GmbH & Co. KG
provided that the above conditions are met.
10 Storage and Disposal
The product is disposable with standard household garbage.
Please direct any questions to:
Customer Service: + 49 (0) 36628 66 33 70
Fax: + 49 (0) 36628 66 33 77
E mail: [email protected]
Valve housing for V20
Special wrench for V18, V20, V21, V22
3 Indication/ Contraindicationen
Indication:
•Prosthetic fitting of the lower extremity
Contraindikation:
•not known
4 Side effects
There are no known side effects.
5 General safety instructions
•This medical product is designed for: single patient, multiple use.
•Fitting/service of this medical device is only allowed by a certificated orthopedic
professional.
•Improper modification or application to the product is not allowed. In case of non
observance, the function of the product may be impaired, so that product liability
is excluded.
6 Instruction
For the construction of an AK socket with contact valve use accompanying dummy
E V23. Mark where to place of the valve on the plaster and fix the dummy with the nail.
Heat up Thermoflex material. Apply heated Thermoflex material centrically over
Dummy to achieve an even thickness material around the Dummy. Vaccum form the
Thermoflex material over the plaster, draw off and allow to cool. Thermoflex material
around dummy provided with a hole centrical and remove the nail.
Now you can take off the deep drawing socket from the plaster model. Socket edges
finish as usual. Milling a hole for the lower part for Standard Contact Valve with 38mm
diameter. Overlay the sealing ring through the lower part for Standard and fit it into
the inside from the 38 mm hole.
Screw the threaded ring by hand together with the lower part for Standard carefully.
Order No Material Article No
E V36 Aluminium 4 233 201 01 00 000
Order No Material Article No
E V32 Steel 4 233 240 00 00 000

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