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Idiomas disponibles
Idiomas disponibles
6Н01С - 6Н01Т
Polycentric knee joint
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 polycentric knee joint has been designed for femoral prostheses in cases of unilateral or
bilateral amputation and is recommended for disabled people with low to medium activity
levels.
TECHNICAL CHARACTERISTICS
Code
Material
Item weight, g
For patients weighing
Maximum angle of flexion
Temperature range for use
Enables angular adjustment
(of the whole prosthesis)
Warranty period
DESCRIPTION OF THE STRUCTURE
The polycentric knee joint (Fig. 1) consists of upper and lower supports 1 and 19 linked by
rear connecting rod 2, side connecting rods 18 and two pairs of axes 15 and 17. The axes are
mounted on ball bearings 22.
On the upper support, a stop is located which includes regulating screw 12, nut 21, stop 9,
rubber gasket 10 and washers 13. During the stance phase of the gait cycle, the stop rests
on shock absorber 11 of connecting rod 2. The stop serves to adjust patellar flexion stability.
The stop is closed with protective cover 14 fixed to the upper support with screw 20.
Lower support 19 features a tibial hinging device, spring 4, where one of the ends is
supported by screw 5 connected to bushing 3, and the other end, through protrusion 7 and
pin 6. All of this is supported by connecting rod 2.
The polycentric knee joint is compatible with Orliman's modular lower-limb prosthetic
systems.
A
1
14
18
16
22
19
3
A
1
9
Upper support
Stop
2
10
Rear connecting rod
Rubber gasket
3
11
Bushing
Shock absorber
4
12
Spring
Regulating screw
5
13
Regulating screw
Regulating washers 3 units
6
14
Pin
Cover
7
15
Protrusion
Axis
8
16
Screw
2 unit
Screw
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 - Exports Tel.: +34 96 274 23 33
E-mail: orto@orliman.com · Exports email: export@orliman.com - www.orliman.com
LB-I-6H01
EDITION: 04/2015
6Н01С
6Н01Т
Stainless steel
Titanium
673
465
up to 125 kg
up to 100 kg
135º
From -40 °C to +40 °C
on the frontal and sagittal planes in a range of
not less than ±7.5°
2 years
17
8
2
11
10
9
15
17
Axis
18
Side connecting rods 2 units
19
Lower support
20
Screw
21
Nut
22
Bearing
2 units
8 unit
OPERATION
During the stance phase of the gait cycle, rubber gasket 10 makes contact with shock
absorber 11 and the immediate centre of rotation is located above the reference axis of the
knee and behind the line of application of the load, which provides a stable position for the
disabled person on the sagittal plane.
At the beginning of the swing phase, the knee flexes, causing spring 4 of the tibial hinging
device to compress; the stored energy in spring 4 promotes the extension of the tibia when
the knee straightens.
The module ensures functional shortening of the prosthesis up to 16 mm during the swing
phase, facilitating the movement of the foot on the supporting surface.
FITTING THE ITEM TO THE PROSTHESIS
The assembly diagram for the prosthesis using the polycentric knee joint is shown in Figure
2. The recommended values, ∆L and H, are shown in the accompanying documentation for
the prosthetic foot.
During assembly of the prosthesis and to ensure patellar flexion stability, with the possibility
of subsequent adjustment, it is necessary to position the knee joint so that both lower axes
are located on a horizontal line (line "a" in Fig. 2).
ADJUSTMENT
To adjust patellar flexion stability, remove cover 14, loosen screw 20, unscrew nut 21 and
screw 12. Reducing the number of washers 13 increases patellar flexion stability and
increasing the number of washers 13 decreases patellar flexion stability.
Regulating the speed of the tibia is carried out by changing the compression of spring 4 by
tightening or loosening screw 5. The screw-in depth of screw 5 in bushing 3 should not be
20
greater than 6 mm (maximum compression of the spring).
MAINTENANCE
During the warranty period, the polycentric knee joint does not require preventive
21
maintenance.
In the event of intensive use, it is possible to replace rubber gaskets 10 and shock absorber
12
11.
13
During use or cleaning, do not use talcum powder. Do not put the product into contact
with corrosive or abrasive elements such as fresh or salt water, acids, dust, sand or other
substances.
At least once a year, have the product checked by an orthopaedic technician for proper
7
operation and wear. If you detect any unusual changes in the product's functioning or hear it
6
making noises, stop using it immediately and notify an orthopaedic technician.
RECOMMENDATIONS - WARNINGS
4
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.
5
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
2 units
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
8 units
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.
WARRANTY
years from purchase
Reference
Signature and stamp of the
orthopaedic establishment
Line "a"
Línea "а"
Load line
Línea de carga
Midfood
Mitad del pie
L
Batch
Date of
no.
purchase
For the warranty to be valid, it is
necessary to complete these details.
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