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Idiomas disponibles
Idiomas disponibles
6Н02C - 6H02T
Single axis friction 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 single axis friction knee joint is designed to be used in hip prostheses in cases of unilateral or bilateral
amputation and is recommended for disabled people with low to medium activity levels.
1
7
Upper housing
Lower housing
2
8
Axis
Regulating screw
3
9
Stop
Regulating screw
4
10
Central body
Nylon socket
5
11
Spring
Brake support
6
12
Axis
Shock absorber
TECHNICAL CHARACTERISTICS
Code
Material
Item weight, g
For patients weighing
Flexion angle of the whole prosthesis
Temperature range for use
Warranty period
DESCRIPTION OF THE STRUCTURE
The single axis friction knee joint (Fig. 1) consists of upper housing 1, lower housing 7 and central body 4.
Upper housing 1 connects to body 4 by means of axis 2, in which rotation of upper housing 1 is restricted by
stop 3 and shock absorber 12 fitted to central body 4. Lower housing 7 is also connected to central body 4 by
means of axis 2 through longitudinal cutting bush 13.
With the pressure caused by the weight of the patient, the space in main body 4 is reduced and axis 6 is fixed
by longitudinal cutting bush 13 when it rotates, thereby compressing spring 5.
When stop 3 is moved by the action of regulating screw 8, the force that compresses main body 4 is altered
and the amount of compression of spring 5 fitted to the inside of socket 4, which decompresses it, is adjusted
by turning screw 9.
The knee kit includes a device for knee extension.
The knee extension device (see Fig. 3) consists of ring with guides 17, housing 18, springs 19, washers 24
and cable 20. The ends of cable 20 feature a loop to attach it to axes 2 of the knee, through the bottom part,
and the loop of cable 20 is placed on the lugs of housing 18. Cover 22 is positioned beforehand, and after
adjustment, is fixed with screw 21 to housing 18.
The single axis friction knee joint is compatible with Orliman's modular lower-limb prosthetic systems.
OPERATION
When the patient puts weight on the prosthesis, the knee automatically fixes lower housing 6 (see. Fig. 2)
with respect to upper housing 1, thereby providing greater patellar flexion stability compared to simple
single axis knee modules.
When the patient puts weight on the prosthesis, the automatic fixing occurs as follows: under the action
of force P on the knee, upper housing 1 transfers loads F 'and F" to central body 4 and the socket with the
longitudinal cutting bush compresses the axis, thereby fixing lower housing 6 in relation to upper housing 1.
To unlock the fixed position, load P has to be removed from the knee's upper housing 1.
The knee extension device works as follows: during the gait cycle, when the prosthesis is flexed (see Fig. 3),
springs 19 are compressed and their cumulative compression energy collaborates with the straightening of
the prosthesis.
3
5
F"
4
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-6H02
EDITION: 04/2015
13
Longitudinal cutting bush
14
Brake stop
15
Screw
16
Dust seal
6Н02С
6Н02Т
Stainless steel
Titanium
680
480
up to 125 kg
up to 100 kg
not less than 120º
from -40°С to +40°С
2 years
P
1
F'
6
FITTING THE ITEM TO THE PROSTHESIS
The assembly diagram for the prosthesis using the single axis knee joint is shown in Fig. 3. The recommended
values, ∆L and H, are shown in the prosthetic foot's accompanying documentation.
The M8x12 screws (position 23) have to be fixed to the support module below cable 20 (on the frontal plane).
40 mm
Eje de carga
Axis load
Mitad del pie
Midfood
L
17
Ring with guide
18
Housing
19
Spring
ADJUSTMENT
Initially, the single axis knee joint has the factory settings for patients with low activity levels.
Because of the individual characteristics of each patient, and also depending on their style of walking,
the patient may feel some delay in the separation of the knee. In this case, corrective adjustment of the
single axis knee joint can be carried out. This adjustment should be performed on the whole of the patient's
prosthesis by turning regulating screw 9 clockwise, checking that the knee is firmly fixed and that, when
unlocked, it provides a feeling of comfort to the patient when the load is removed. The recommended
increase in rotation of regulating screw 9 (Fig. 1) during the adjustment is 10-15°. During adjustment, the
allowable insertion of regulating screw 9 with respect to the plane of central body 4 should not exceed 1.5
mm. (or 1.5 turns of regulating screw 9).
Adjustment of the straightening speed of the prosthesis is performed by adjusting screw 21 (Fig. 3) in ring
17 of the tibial hinging device located on the support tube, that is, by tightening the screw, the straightening
speed increases, and by loosening it, it decreases.
In the event of intensive use, natural wear and tear can affect parts 3, 6, 12 and 13 (Fig. 1), and lead to
alteration of the settings, including looseness.
To eliminate the effects of wear, it is necessary to adjust the single axis knee joint:
- Loosen screw 8 by giving it 3 turns and, applying some force to arrow "d", move stop 3 towards socket 10.
- Turn screw 9 anticlockwise until friction, wedging or increased rigidity of the joint is noted when flexing
or straightening the knee.
- Turn screw 9 clockwise until it is eliminated and give an additional ¼ turn.
- Turn screw 8 clockwise until friction, wedging or increased rigidity of the joint is noted when flexing or
straightening the knee.
- Turn screw 8 anticlockwise until it is eliminated and, giving an additional ¼ turn, move stop 3 until it comes
into contact with screw 8.
- If necessary, perform corrective adjustment of the knee when the patient is wearing the prosthesis.
Note:
When screw 8 is turned clockwise, a space between stop 3 and screw 8 is formed. To eliminate the space, stop
3 should be moved until it comes into contact with screw 8 and continue the adjustment.
MAINTENANCE
To ensure the stable operation of the knee, periodic lubrication 1-2 times per year should be performed
depending on frequency of use. To lubricate the knee, move dust seal element 16 towards spring 5, apply 1 ml
of grade 2 lithium grease to the groove of socket 4 in the direction of axis 6, towards the left and right hand
sides of gasket 4, place dust seal element 16 in its original location and remove excess lubricant.
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 operation and
wear. If you detect any unusual changes in the product's functioning or hear it making noises, stop using it
immediately and notify an orthopaedic technician.
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.
WARRANTY
years from purchase
Reference
Batch
no.
Signature and stamp of the
orthopaedic establishment
23
24
17
21
19
18
20
22
20
23
Cable
Screw
21
24
Screw
Washer
22
Cover
Date of
purchase
For the warranty to be valid, it is
necessary to complete these details.
40 mm
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