Bauerfeind Uniprox A1 User manual

Tube Clamp Adapters
A1, A2, A40
Reducation Adapter
A30
unique prosthetic solutions
A company of the Bauerfeind GroupEin Unternehmen der Bauerfeind Gruppe – .uniprox.de
Rev.0-2021-09_A1,A2,A40,A30_101713
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

2 3
Please read the IFU carefully before fitting. nly correct usage will
warrant the function.
1. Intended use
The tube clamp adapters connect pyramid adapters or pyramid receiving adapters ith
tube clamps in a modular prosthetic limb prosthesis.
2. Technical data
2.1 A1 Tube Clamp Adapters
•For 30 mm tubes
•With visible measuring scale for rotation adjustments
•Weight limit: 75 – 125 kg
•For 34 mm tubes
•With visible measuring scale for rotation adjustments
•Weight limit: 150 kg
2.2 A2 Tube Clamp Adapters
•10 ° inclination
•For 30 mm tubes
•With visible measuring scale for rotation adjustments
•Weight limit: 100 kg
rder No. Weight Limit Material Weight Article No.
A1-Al < 75 kg (Mobi 2, 3, 4)
<100 kg (Mobi 1)
Aluminium 69 g 4 113 011 30 11 000
A1-St < 100 kg Steel 112 g 4 113 011 30 22 000
A1-Ti < 125 kg Titanium 69 g 4 113 011 30 33 000
rder No. Material Weight Article No.
A1-St34 Steel 136 g 4 113 010 34 22 000
rder No. Material Weight Article No.
A2-Ti Titanium 83 g 4 113 030 30 33 000
2.3 A40 Tube Clamp Adapters
•Pyramid and Clamp
•For 30 mm tubes, height 45 mm
•Weight limit: 100 kg
2.4 A30 Reducation Adapter
•34 mm Clampfit to 30 mm tube
•Usable to all Uniprox Knee Joints ith 34 mm attachment
•Weight limit: 100 kg
2.5 Service parts
A1, A2
Hex socket head scre
A1
Hexagon socket head cap scre
3. Indication/ Contraindication
Indication:
•Amputation of lo er extremities
Contraindication:
•not kno n
rder No. Material Weight Article No.
A40-Ti1 Titanium 76 g 4 116 030 88 00 045
rder No. Material Lenght Weight Article No.
A30 Aluminium 100 mm 91 g 4 610 070 00 00 008
rder No. Thread Lenght Units p. package Article No.
M28-12 M8 12 10 4 226 050 00 00 012
M28-16 M8 16 10 4 226 050 00 00 016
rder No. Thread Lenght Units p. package Article No.
M33 M5 18 10 4 226 030 05 00 018

4 5
4. Side effects
There are no kno n side effects.
5. General safety instructions
•This medical product is designed for: single patient, multiple use.
•Fitting/service of this medical device is only allo ed by a certificated orthopedic
professional.
•Improper modification or application to the product is not allo ed. In case of non-
observance, the function of the product may be impaired, so that product liability
is excluded.
•Only approved scre s may be used.
•The maximum eight loads are listed under “2. Technical Data”. Additional loads
must be taken into account hen calculating the eight.
6. Installation
6.1 A1, A2 und A40 Tube clamp Adapters
Before fitting the tube, first loosen the Hexagon socket head cap scre (M33) ith t o
turns.
Al ays position the tube clamp adapter proximal to the tube adapter. It is
not permitted to pull out the tube from the tube clamp adapter to adjust the
length.
Tighten Hexagon Socket Head Cap Scre (M33) ith a Torque Wrench.
Tightening torque A1 and A2: 10 Nm
Tightening torque A40: 8 Nm
6.1.1 Instructions of Use - Headless Screws (A1 and A2 only)
By using the adjusting scre s M28-12 or M28-16, static corrections are possible at any
time. If a module has to be replaced or removed the previously adjusted position is
maintained if only t o adjacent adjusting scre s (not opposite), the ones scre ed in
at the deepest, are removed.
If the adjusting scre s are, too long (damage of the foam cover) or too short
(reduced stability) these have to be replaced ith appropriate ones.
Use a toque rench to tighten the adjusting scre s.
Tightening torque: 12 Nm.
Secure the various scre s, used for assembly, ith Loctite 222.
6.2 A30 Reducation Adapter
The A30 Reducation Adapter ith the outer tube attachment (ø 34 mm) is inserted into
the distal attachment of a JT09, JT20, JT20S, JT22 or JT22S (Uniprox knee joints) as
far as possible.
The clamp adapter is aligned distally/dorsally and scre ed to the respective tube
clamp adapter of the modular knee. Use the torque rench provided.
The distally aligned 30 mm tube attachment accepts a 30 mm modular tube adapter.
Tightening torque: 8 Nm
The various scre s used for assembly purposes must be secured ith
Loctite Loctite® 243.

6 7
7. Maintenance and Cleaning
The adapters must be checked as part of regular prosthetic service/maintenance.
Cleaning:
•Soap and hand arm ater
•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
We recommend to change/rene the adapter after 5 years of usage.
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 ith standard household garbage.
There are no storage recommendations.
Please direct any questions to:
Customer Service: + 49 (0) 36628-66-33 70
Fax: + 49 (0) 36628-66-33 77
E-mail: [email protected]