Orliman 7Н11TK Instrucciones De Uso página 2

7Н11ТK
4-hole female pyramid
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INSTRUCTIONS FOR USE AND MAINTENANCE
Dear Customer,
Please read the instructions carefully. Make sure that the user understands the instructions
for use, paying particular attention to the safety and maintenance warnings.
APPLICATION
The 4-hole female pyramid is used in lower-limb prostheses and serves to fasten modules
and sockets with flat supporting surfaces and four M6 threaded holes, and modules with
spherical surface bearings and pyramid. The 4-hole female pyramid enables angular adjust-
ment on the frontal and sagittal planes.
TECHNICAL CHARACTERISTICS
Code
Support material
Patient weight, kg, no higher than
Temperature range for use
Angular adjustment of the whole
prosthesis on the frontal and sagittal
planes
Warranty period
DESCRIPTION OF THE STRUCTURE
The 4-hole female pyramid consists of support 1 (Fig. 1) and features spherical surface
bearing A and is supplied with two pairs of screws 3 and 4 of 12 and 16 mm in length for
connection to other modules of the prosthesis. This connection enables angular adjustment
on the frontal and sagittal planes in a range of -7.5º to +7.5º.
The opposite side of housing 1 has a flat surface and four screws 2 for connection to other
modules and the socket.
The 4-hole female pyramid is compatible with Orliman's modular lower-limb prosthetic sys-
tems.
3
1
1
Support
2
M6 screw 4 units
ORLIMAN S. L. U.
C/ Ausias March, 3 - Pol. Ind. La Pobla-L´Eliana
Apdo. de correos 49 · C.P.: 46185 - La Pobla de Vallbona Valencia - España (Spain)
Tel.: +34 96 272 57 04 - Fax: +34 96 275 87 00 - Tel. Exportación: +34 96 274 23 33
E-mail: orto@orliman.com · Export mail: export@orliman.com
www.orliman.com
LB-I-7H11TK
EDICIÓN: 09/2017
7Н11ТK
Titanium
150
From -40 to +40°C.
From -7.5 to +7.5°
2 years
2
4
3
1 unit М8 screw, L=12 mm
4
М8 screw, L=16 mm
FITTING THE ITEM TO THE PROSTHESIS
To connect the 4-hole female pyramid to other modules that have a flat surface and four
holes, use screws 2, according to Fig. 1, which protrude 11 mm from the fixing surface.
During assembly through the spherical surface, the screws should be placed according to
Figure 2 as follows: the 12 mm long screws should be placed where the space between the
adapter ring and the pyramid is smaller, and the 16 mm long screws, from the opposite side.
In addition, there should be no direct contact between the pyramid and the housing of the
support adapter with clamp.
1 2
5
)
a), b) - correct connection of the module
c) - incorrect connection of the module
During final assembly of the prosthesis, it is recommended to apply Loctite 243 (or 241)
threadlocker to the threads of screws 2, 3 and 4. Tightening torque for screws 2 - 14 Nm.
Tightening torque for screws 3 and 4 - 15 Nm.
RECOMMENDATIONS - WARNINGS
These products should not be used for purposes other than those described in these instruc-
tions. They should only be used by one person and under the conditions prescribed.
Before use, the product must be adapted by an orthopaedic technician.
When disposing of the product and packaging, strictly comply with the refuse disposal reg-
ulations of your community.
In knee joints, there is risk of entrapment, use caution.
As the product features metal components, use caution in the case of magnetic resonance.
WARRANTY
These products comply with European Medical Devices Directive 93/42/EEC (Spanish Royal
Decree 1591/2009). They have undergone tests in accordance with international standard
EN ISO 22523 for prostheses and orthoses and EN ISO 10328 for lower-limb prostheses.
ORLIMAN, S.L.U. guarantees all of its products, provided that they have not been tampered
with or altered from their original form. The company does not guarantee products whose
characteristics have been altered through any kind of misuse, breakage or defect. If you
notice any defect or abnormality, notify the supplier immediately in order for the product
to be replaced.
2 units
2 units
WARRANTY
2 years from purchase
Reference
Signature and stamp of the
orthopaedic establishment
1 2
5
5
6
6
b)
Batch Date of
no. purchase
For the warranty to be valid, it is
necessary to complete these details.
1 2
6
c)