Bauerfeind Uniprox VA1 User manual

Shifting Adapter
VA1, VA2, VA9
unique prosthetic solutions
A company of the Bauerfeind GroupEin Unternehmen der Bauerfeind Gruppe – www uniprox de
Rev 0-2021-09_VA1,VA2,VA9_101714
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

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Please read the IFU carefully before fitting. Only correct usage will
warrant the function.
1. Intended use
The shifting adapters are for integration into a modular prosthetic limb prosthesis to
enable axial shifting
2. Technical data
2.1 A1 Shifting Adapter
•Pyramid and 30 mm tube-receiver
•10 mm A – P and M – L shifting
•water resistant*
•weight limit: 100 kg
* with specially waterproof coated bolts; not included
2.2 A2 Shifting Adapter
•Pyramid-receiver and 30 mm tube-receiver
•10 mm A – P and M – L shifting
•water resistant*
•weight limit: 100 kg
* with specially waterproof coated bolts; not included
2.3 A9 Shifting Adapter - Only for trial fitting in the workshop!
•25 mm A – P and M – L shifting
•weight limit: 100 kg
Order No. Material Weight Article No.
VA1-Ti Titanium 130 g 4 117 010 99 00 000
Order No. Material Weight Article No.
VA2-Ti Titanium 140 g 4 117 010 77 00 000
Order No. Material Weight Article No.
VA9-Al Aluminium 333 g 4 117 060 00 00 000
2.4 Service Parts for A1, A2
Hex socket head screw:
With waterproof coating
Hexagon socket head cap screw:
With waterproof coating
2.5 Service parts for A9
Base VA9-Al
Sliding unit for VA9-Al
Strips for VA9-Al
Order No. Thread Lenght Units p. package Article No.
M28-12 M8 12 mm 10 4 226 050 00 00 012
M28-16 M8 16 mm 10 4 226 050 00 00 016
Order No. Thread Lenght Units p. package Article No.
E-A11-12 M8 12 mm 4 4 113 018 11 20 612
Order No. Thread Lenght Units p. package Article No.
M33 M5 18 mm 10 4 226 030 05 00 018
Order No. Thread Lenght Units p. package Article No.
E-A12-20 M5 20 mm 1 4 113 018 12 20 520
Order No. Description Article No.
E-VA01 Housing for shifting adapter with 6 cap screws M5 x 10 4 117 069 00 00 001
Order No. Description Article No.
E-VA02 Sliding unit for shifting adapter (with central bore) 4 117 069 00 00 002
Order No. Description Article No.
E-VA03 2 strips for shifting adapter with 6 countersunk screws M3 x 6 4 117 069 00 00 003

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2.6 Recommended Fitting for A9
A87 M36 × 1,5 outside thread and pyramid receiver
A22 Threaded Adapter, M36 × 1,5 and pyramid
A23 Threaded Adapter, M36 × 1,5 and pyramid receiver
3. Indication/ Contraindication
Indication:
•Amputation of lower extremities
Contraindication:
•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
•The maximum weight loads are listed under “2 Technical Data” Additional loads
must be taken into account when calculating the weight
•The sliding adapter VA9-Al is intended solely for use during the trial run in the
orthopedic workshop It is absolutely unsuitable for use in actual prostheses
Order No. Material Weight Limit Weight Article No.
A22-Ti Titanium < 150 kg 40 g 4 114 090 99 33 000
Order No. Material Weight Limit Weight Article No.
A23-Ti Titanium < 100 kg 51 g 4 114 090 77 33 000
Order No. Material Weight Limit Weight Article No.
A87 Steel < 150 kg 55 g 4 620 040 00 00 000
6. Installation
6.1 Installation A1 and A2
The Shifting Adapters VA1-Ti and VA2-Ti have a shifting possibility of approx 10 mm in
sagittal direction
6.1.1 Connection to the Ø 30 mm Tube Adapters
Before fitting the tube, first loosen the Hexagon socket head cap screw (M33) with two
turns Be certain that the cut surface is even and the longitudinal axis of the tube is
rectangular Smoothen the area of the tube cut on the in- and outside Insert the tube
into the clamp adapter until the tube reaches the bottom of the clamp Fix the tube in
the clamp adapter by tightening the clamp screw with a torque wrench
6.1.2 Shifting of the Shifting Adapter
To shift both ends of the Shifting Adapter VA1-Ti against each other, first loosen the
headless screw in which direction you want to shift Reclamp the adapter by tightening
the opposite headless screw Take care to always tighten all headless screws
6.1.3 Instructions of Use - eadless Screws
By using the adjusting screws M28-12 or M28-16, static corrections are possible at any
time When replacing or removing a module, the previously set position is maintained
if only two adjacent adjusting screws (not opposite) are removed, which are screwed in
at the deepest
If the adjusting screws are too long (damage of the foam cover) or too short
(reduced stability) these have to be replaced with appropriate ones
Use a toque wrench to tighten the headless screws
Tightening torque: 12 Nm
When the prosthesis is completed secure thread with Loctite® 222
6.2 Installation A9
The shifting elements enable/ allow adaptation via 4-hole attachment or adapters with
M36 fine thread
Screw the required adaption to the elements of the shifting adapter
Fix the shifting adapter in neutral position
Tighten the six lateral cylinder head screws
Tightening torque: 5 Nm

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Set up the prosthesis in accordance with the usual configuration guidelines During
the trial run, adapt the prosthesis configuration to your patient‘s requirements Make
sure that the slides are always clamped by at least two of the lateral cylinder head
screws
The slides can be shifted max 2 5 cm to each side
Attention by using 4-hole attachment:
Make sure that the adaption surface is even Otherwise the sliding element
may get tense and jam in the adapter housing
7. Maintenance and Cleaning
The adapters must be checked as part of regular prosthetic service/maintenance
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 an Guarantee
We recommend to change/renew 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 with 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: export@uniprox de