Bauerfeind Uniprox V08 User manual

Socket Valve V08, V13
unique prosthetic solutions
A company of the Bauerfeind GroupEin Unternehmen der Bauerfeind Gruppe – www.uniprox.de
Rev.1 2021 07_V08,V13_110050
Qualität und Funktion
Gebrauchsanweisung
Instruction Manual
Uniprox GmbH & Co.KG
H. Heine Str.4
07937 Zeulenroda Triebes
Tel. [phone]
Fax [phone]
E Mail info @uniprox.de

Please read the IFU care ully be ore itting. Only correct usage will
warrant the unction.
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 V08 Socket Valve – Automatic air expulsion
•The valve is screwed into a specially prepared opening in the socket.
•For flexible sockets
•directs excess air out of the socket while walking automatically
•Valve dummy E V07 and special key are not included
2.1.1 Service parts V08 Socket Valve
Valve body for V08
Dummy for V08
Special key for tightening the valve seat
Patient’s key for V08
2 3
2.2 V13 Socket Valve – With manual air expulsion
•The valve is screwed into a specially prepared opening in the socket.
•Designed for flexible and container sockets
•Allows the air to flow out when the air expulsion button is pressed manually.
•Dummy E V17, Patient’s key E V18 and Spezial wrench are not included
2.2.1 Service parts V13 Socket Valve
Valve housing V13
Valve body V13
Dummy for V13
Patient‘s key V13
Special wrench for V13
3. Indication/ Contraindicationen
Indicationen:
•Prosthetic fitting of the lower extremity
Contraindication:
•Not known
Order No. Material Valve Opening Article No.
V08 Stainless, Steel/Plastic Ø 22 mm 4 233 090 00 00 000
Order No. Material Valve Opening Article No.
E V03 Plastic Ø 22 mm 4 233 091 03 00 000
Order No. Material Article No.
E V07 Aluminium 4 233 091 04 00 000
Order No. Material Article No.
E V08 Aluminium 4 233 091 06 00 000
Order No. Material Article No.
E V09 Plastic 4 233 091 07 00 000
Order No. Material Valve Opening Article No.
V13 Stainless steel/Plastic Ø 20 mm 4 233 140 00 00 000
Order No. Material Valve Opening Article No.
E V15 Stainless steel Ø 20 mm 4 233 141 01 00 000
Order No. Material Valve Opening Article No.
E V16 Plastic Ø 20 mm 4 233 141 03 00 000
Order No. Material Article No.
E V17 Aluminium 4 233 141 05 00 000
Order No. Material Article No.
E V18 Plastic 4 233 141 06 00 000
Order No. Material Article No.
E V19 Aluminium 4 233 141 07 00 000

4. Side e ects
There are no known side effects.
5. General sa ety 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
1. Use the E VO7 valve dummy when setting up a thigh socket with a V08 valve and
the E V17 valve dummy when setting up a thigh socket with a V13 valve.
2. Mark the spot where the valve is to be positioned on the plaster.
3. Drill a 2.5 mm wide hole for the plaster positiv bolt. Secure Dummy 1 (bottom
part) with the plaster positiv bolt to ensure the material around the dummy is of
an even thickness.
4. Draw the heated plate material over the center of the model with Dummy 1,
vacuum, then leave to cool off.
5. Wrap a 4 mm wide strip of deep drawn plate material around Dummy 1.
6. Remove the plaster bolt and bolt Dummy 2 to Dummy 1 using a threaded bolt.
7. Laminate or deep draw the deep drawn model in the usual way.
8. Remove Dummy 1 and Dummy 2 once the outer socket has been made.
9. In order to mount the socket valve, install the inner valve housing, working from
the inside of the socket.
10. Working from the outside of the socket, draw the valve sealing ring over the inner
valve housing. Working from the outside, screw down the outer ring of the valve
housing and tighten with the installation wrench. (E V08 installation wrench for
V08 valve, E V19 installation wrench for V13 valve)
4 5
Scope of delivery: both valves consist of an inner and outer valve housing with a
sealing ring and a valve body with a sealing ring.
Suitable dummies ( or V08: E-V07; or V13: E-V17) are not included in the scope
o delivery.
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-Con ormity
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]