Orliman 4Н07TK Instrucciones De Uso página 2

4Н07TK
Female pyramid adapter
|
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 pyramid adapter is used in lower-limb prostheses and serves to interconnect and adjust
the modules, compensating for the shortening of the amputated part of the leg or thigh.
TECHNICAL CHARACTERISTICS
Code
Item length L, mm
Item weight, g
Patient weight, kg, no higher than
Material
Outer diameter of the tube, mm
Temperature range for use
Angular adjustment of the whole
prosthesis on the frontal and sagittal
planes
Warranty period
DESCRIPTION OF THE STRUCTURE
Housing 1 of the pyramid adapter (see Fig. 1) features female spherical surface bearing A
and is supplied with two pairs of screw 2 of 12 mm and two pairs of screw 3 of 16 mm for
connection to the modules of the prosthesis and their adjustment. This connection enables
angular adjustment on the frontal and sagittal planes in a range of -7.5 to ±7.5°.
The back of housing 1 is designed in the shape of a tube with 30 mm outer diameter for
connection to the modules provided in its structure with a retaining clamp. This connection
enables horizontal rotations to be carried out at the desired angle.
The pyramid adapter is compatible with Orliman's modular lower-limb prosthetic systems.
2
1
Housing
2
М8 screw, L=12 mm 2 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-4Н07TK
EDICIÓN: 09/2017
4Н07TK
100
122
150
Titanium
30
From -40 to +40℃.
From -7.5 to +7.5°
2 years
A
3
1
3
1 unit М8 screw, L=16 mm
FITTING THE ITEM TO THE PROSTHESIS
During assembly, through the spherical surface, screws 3 and 4 should be placed according
to Figure 2 as follows: the 12 mm long screws should be placed where the space between
the ring housing and the pyramid is minimal, and the 16 mm long screws from the opposite
side. It is necessary to ensure that the screws protrude from the outer surface of the adapter.
ATENTTION: to avoid annoying friction noises, there should be no contact between the ring
housing and the pyramid of the corresponding part.
The fitting of the pyramid adapter to the corresponding units with clamp and inner cylindrical
surface should be carried out until the stop.
During final assembly of the prosthesis, it is recommended to apply Loctite 243 (or 241)
threadlocker to the threads of screws 2 and 3 and tighten them with a torque of 15 Nm.
RECOMMENDATIONS - WARNINGS
These products should not be used for purposes other than those described in these
instructions. 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
regulations 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
WARRANTY
2 years from purchase
Reference
Signature and stamp of the
orthopaedic establishment
Batch Date of
no. purchase
For the warranty to be valid, it is
necessary to complete these details.
Correct
Correct
Incorrect