Otto Bock 2R38-5 User manual

2R38=5
4R21=5
4R52=5
2R38=5/4R21=5/4R52=5
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Instrucciones de uso ���������������������������������������������������������������������� 8

2 | Ottobock
4R21=5 4R52=5
4D4
Single components Single-Component Pack Minimum order quantity
Componentes Kit componentes Cantidad mínima
1
2R38=5
1

Ottobock | 3
23
45
(1)
5 Nm
(2)
15 Nm
(2)
15 Nm

4 | Ottobock
English
Date of the last update: 2013-02-11
• Please read this document carefully.
• Follow the safety instructions.
1 Scope of Delivery (Fig. 1)
1.1 Single Component
–
1.2 Single-Component Pack
4D4 Single-Component Pack (4R21=5 / 4R52=5)
Consisting of: 2 straight pins (3 + 4), 1 cap screw (5).
1.3 Minimum Order Quantity
506G3=M8×12-V Set Screws (2)
4X28=4 (6)
2 Description
2.1 Intended Use
The 2R38=5 Tube Adapter and the 4R21=5, 4R52=5 Clamp Adapters are
to be used exclusively for the prosthetic tting of the lower limbs.
2.2 Field of Application
Field of application according to the Ottobock Mobility System MOBIS®:
Approved for a patient with a weight of up to 136 kg/300 lbs.
≤ 136 kg / 300 lbs
The tube adapter together with the corresponding clamp adapters com-
prise structural components for modular lower limb prostheses. The ad-
apter combinations allow for controlled angular and linear adjustments in
the sagittal and frontal planes, and internal and external rotations in the
transverse plane.
For maximum structural strength the Tube Clamp Adapter must be placed
proximally. The clamping slot must always be positioned anteriorly.

Ottobock | 5
Attention!
To achieve maximum stability for the transtibial prostheses, we
recommend using a 34 mm tube adapter (e.g. 2R57 or 2R76)
together with a 34 mm clamp adapter (e.g. 4R82 or 4R91). This
applies in particular if the prosthesis is to withstand increased
pressure due to higher activity levels, longer foot or transtibial
lever arms or similar factors.
Attention!
Please avoid exposing prosthetic components to corrosive ele-
ments such as fresh water, salt water and acids. Using this medi-
cal product in such environmental conditions will render all claims
against Otto Bock HealthCare null and void.
Please inform your patients.
3 Technical Data
4R21=5 2R38=5 4R52=5
Weight 130 g 275 g 75 g
System height 33 mm 97 mm 33 mm
Material INOX
stainless steel Titanium Titanium
Diameter 30 mm 30 mm 30 mm
Maximum patient weight 136 kg /
300 lbs
136 kg /
300 lbs
136 kg /
300 lbs
Mobility level – – –
4 Handling
4.1 Connection to the Clamp Adapter
The tube adapter must be shortened according to the patient’s measure-
ments. To avoid deforming the tube, care must be taken to carry out the
steps accurately as described below. Given the low tolerances of Ottobock
adapters, a deformed tube will not t easily into the clamp adapter.
Note:
Do not clamp the tube into a vise. This could cause damage or deformation.

6 | Ottobock
The cut surface must be perpendicular to the longitudinal axis of the
tube (Fig. 2). Use of the 719R2 Tube Cutter or equivalent is recommended.
All inner and outer burrs must be removed from the cut edge (Fig. 3).
Use of the 718R1 Reamer or equivalent is recommended.
Note:
To ensure structural solidity, the remaining pieces of the shortened tube
adapter are not to be used as components in the prosthesis.
Loosen the Cap Screw (Fig. 4.1) of the Tube Clamp Adapter by two turns,
check, whether the plastic ring has been inserted into the Tube Clamp Ad-
apter completely and with the chamfer on the ring‘s outer diameter rst,
and then insert the tube 5 mm deep into the Tube Clamp Adapter while
slightly rotating the tube. Next, place the Tube Clamp Adapter with the tube
inserted vertically on the worktop and fully insert the Tube Adapter into
the Adapter until the tube is in contact with the base rim inside the clamp.
Attention!
The interior surface of the Tube Clamp Adapter and the exterior
surface of the Tube Adapter must be cleaned with 634A3 (Aceton)
in the insertion area prior to nal assembly (insertion of the Tube
Adapter into the Tube Clamp Adapter).
Warning
For nal use, the Cap Screw (Fig. 4.1) must be torqued to 5 Nm with
the 710D1 Torque Wrench. Failing to comply with this instruction
may lead to permanent over-extension or breaking of the screw.
4.2 Maintenance Instructions
Information
As a basic principle, all Ottobock modular adapters are subjected to
tests involving three million load cycles. Depending on the amputee's
activity this corresponds to a service life of three to ve years.
We recommend carrying out regular safety checks once a year.
5 Adjustment Screws
Adjustments may be made through adjusting the four 506G3 Adjustment
Set Screws during tting and at any time after the prosthesis has been

Ottobock | 7
completed. The optimal position of the components may be preserved when
exchanging parts or when servicing the prosthesis by removing only the
two most deeply set adjacent screws.
Once positioning has been determined, replace any set screws that are
too long (to prevent foam cover damage) or too short (lacking strength).
Screws are available in the folling sizes:
Article Nr. Lenght
506G3=M8×10 10 mm
506G3=M8×12-V 12 mm
506G3=M8×14 14 mm
506G3=M8×16 16 mm
Use a 710D4 Torque Wrench to tighten screws
Attention!
(Applies to the application of the Tube Adapter 2R38=5 and
Tube Clamp Adapters 4R21=5; 4R52=5)
For testing: with the torque wrench 710D4, screw in the set
screws 506G3 of the Adapter clockwise at 10 Nm (7.4 lbf. ft /
88.5 lbf. in).
For nalizing the prosthesis: secure the set screws 506G3
with Loctite 636K13, tighten the set screws clockwise at 10 Nm
(7.4 lbf. ft / 88.5 lbf. in) rst and then tighten completely at 15 Nm
(11.1 lbf. ft / 133 lbf. in).
6 Liability
The manufacturer recommends using the device only under the specied
conditions and for the intended purposes. The device must be maintained
according to the Instructions for Use. The device must only be operated
with tested modular components in accordance with the Ottobock Mobility
System. The manufacturer is not liable for damage caused by component
combinations that were not authorized by the manufacturer.
7 Warranty
Ottobock warrants this device / these devices from the date of purchase.
The warranty covers defects that can be proven to be a direct result of

8 | Ottobock
aws in the material, production or construction. Because warranty condi-
tions may differ by country, please contact your local Ottobock distribution
company for more information.
8 CE Conformity
This device meets the requirements of the 93 / 42 / EEC guidelines for medi-
cal devices. This device has been classied as a class I device according
to the classication criteria outlined in appendix IX of the guidelines. The
declaration of conformity was therefore created by Ottobock with sole
responsibility according to appendix VII of the guidelines.
Español
Fecha de la última actualización: 2013-02-11
• Lea atentamente este documento.
• Siga las indicaciones de seguridad.
1 Suministro (g. 1)
1.1 Componentes
–
1.2 Kit de componentes
4D4 Kit de componentes (4R21=5 / 4R52=5)
Compuesto por: 2 pivotes cilíndricos (3 + 4), 1 tornillo cilíndrico (5).
1.3 Cantidad mínima
Tornillos prisioneros 506G3=M8×12-V (2)
4X28=4 (6)
2 Descripción
2.1 Uso previsto
Los tubos con adaptador 2R38=5 y los adaptadores con tornillo 4R21=5
y 4R52=5 se utilizan exclusivamente para la protetización de la extremi-
dad inferior.

Ottobock | 9
2.2 Campo de aplicación
Campo de aplicación según el sistema de movilidad MOBIS® de Ottobock:
Peso máximo del usario 136 kg.
≤ 136 kg
El tubo con adaptador (⌀ 30 mm) se utiliza en combinación con los adap-
tadores con tornillo como elemento de ajuste, para prótesis modulares
de pierna. Estas combinaciones facilitan modicaciones de ángulo y de
traslación en el plano sagital y frontal así como la regulación de la rota-
ción interior y exterior.
Siempre debe montar el adaptador con rosca de forma proximal. La ranura
de jación siempre tiene que colocarla de forma anterior.
Nota:
Para conseguir una máxima estabilidad de las prótesis de pantorrilla, se
aconseja un tubo con adaptador de ⌀ 34 (p. ej. 2R57 / 2R76) y un adap-
tador con tornillo de ⌀ 34 (p. ej.4R82 / 4R91) sobre todo en los casos
si se prevean mayores cargas a raíz de un alto nivel de actividad, pies
grandes o pantorrillas con brazo de palanca grande o factores similares.
¡Atención!
Por favor, no exponga las piezas de ajuste de la prótesis a en-
tornos que puedan generar corrosiones en las partes metálicas,
p. ej. agua dulce, agua salada y ácidos. Si se utiliza el producto
médico en estas condiciones del entorno se extingue cualquier
derecho de reposición por Otto Bock HealthCare.
Por favor, informe también a sus pacientes.
3 Datos técnicos
4R21=5 2R38=5 4R52=5
Peso 130 g 275 g 75 g
Altura del sistema 33 mm 97 mm 33 mm
Material INOX
Acero inoxidable Titanio Titanio
Diámetro 30 mm 30 mm 30 mm

10 | Ottobock
Peso máx. del paciente 136 kg 136 kg 136 kg
Grado de movilidad – – –
4 Manejo
4.1 Unión con el adaptador roscado
El tubo con adaptador se suministra como módulo con suciente longitud,
para ser cortado a la medida de la pantorilla. Por favor seguir las siguien-
tes instrucciones para evitar la deformación del tubo. Las tolerancias de
los adaptadores de Ottobock son muy pequeñas y por ello no se puede
introducir un tubo deformado en un adaptador roscado sin problemas.
Nota
No sujetar el tubo en el tornillo del banco de trabajo para no deformar
o dañarlo.
El corte tiene que formar un ángulo recto con el eje longitudinal del
tubo. Aconsejamos utilizar cortatubos 719R2 ó herramienta similar (Fig. 2).
Eliminar las rebabas con la herramienta 718R1 ó con herramienta similar,
tanto del interior del tubo, como del exterior (Fig. 3).
Nota
Por razones de resistencia de la estructura, no utilicen como compo-
nentes para otras prótesis, los trozos sobrantes cortados de los tubos
con adaptador.
Suelte con dos giros el tornillo de cabeza cilíndrica (Fig. 4.1) del adapta-
dor con rosca, compruebe primero, si el anillo de plástico está introducido
totalmente y con el canto del diámetro exterior del anillo en el adaptador
con rosca e introduzca, a continuación el tubo 5 mm en el adaptador con
rosca con un ligero giro. A continuación, coloque verticalmente el adaptador
con rosca con el tubo introducido sobre la mesa de trabajo, e introduzca
el adaptador de tubo en el adaptador hasta que el tubo quede en el fondo
de la abrazadera de sujeción.