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Idiomas disponibles
Idiomas disponibles
6Н23
Polycentric pneumatic knee joint
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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 polycentric pneumatic knee joint is intended for patients weighing up to 100 kg with unilateral
or bilateral amputation at any level, including amputation at the knee. The knee joint ensures secure
fastening in the stance phase and adaptation to walking speed. It is recommended for patients with
second and third group activity levels.
TECHNICAL CHARACTERISTICS
Code
Material of the main parts
Item weight, kg
For patients weighing
Flexion angle
Joint in the proximal part
Joint in the distal part
Total height
Device height
Max. speed
Warranty period
DESCRIPTION OF THE STRUCTURE
The knee joint consists of support 1 connected by means of fork 2 and two connections 3 to hous-
ing 4. Axes 5 rotate around bearings 6 creating a closed kinematic loop. In a position of maximum
stretching, the instantaneous axis of rotation of the assembly is located significantly higher than
the knee joint and above the load line, which provides a secure fit for the knee joint in the stance
phase.
Housing 4 features a dual-chamber pneumatic cylinder which ensures control of the knee joint in the
swing phase. Inside the housing, a spring folding device has been included. Located in the central
part of the housing are valves 7 and 8. Valve 7, marked "F", controls flexion resistance and valve 8,
marked "E", controls extension resistance.
For connection to other parts of the prosthesis, support 1 features pyramid 9, and the bottom of
housing 4 is designed in the shape of a bushing extendible by means of connecting screw 10.
The knee joint is compatible with similar lower-limb prosthetic systems made by other manufac-
turers. The connection elements comply with the requirements of Russian standard GOST R 51191.
1
9
2
5
6
3
7
8
E
4
10
7
8
F
E
FITTING THE KNEE JOINT TO THE PROSTHESIS
50%
3°-5°
50%
Adjustment
axis
0
Midline of
the foot
Figure 2a
30mm
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-6H23
EDITION: 09/2015
6Н23
Aluminium alloy
Maximum 0.8
up to 100 kg
Max. 150°
Pyramid
Bushing 30 mm
235 mm
179 mm
4 Km/h
3 years
1
Support
2
Fork
3
Connection
4
Housing
5
Axis
6
Bearing
7
Flexion adjustment valve
8
Extension adjustment valve
9
Pyramid
10
Connecting screw
RECOMMENDATIONS The knee joint maintains all of its
functions when fitted in conjunction with articulated foot
1Н 04У and, for adjusting the length of the leg, use of
joint 3H 01А/400, 3H 01C/400 or 3H 01Т/400 is recom-
mended.
ATTENTION To correctly assemble the prosthesis, follow
the fitting diagram (see Figure 2). Not strictly following
the prosthesis fitting diagram could lead to loss of stabi-
lity in the stance phase, causing the patient to fall over.
The assembly of the prosthesis should be performed in
two stages. In the first, the prosthesis is adjusted and, in
the second, it is fitted directly onto the patient. For the
first stage, a laser level is required.
See Figure 2a for how the knee joint should be fitted to
the prosthesis. The adjustment axis of the prosthesis on
the sagittal plane must pass through the centre of the
proximal area of the side of the receiver socket, through
the anterior axis of rotation 1 of the knee joint, at a dis-
tance of 30 mm from the midline of the foot towards the
heel. This fitting diagram should be used for all types
of foot joint, regardless of the recommended distance
shown in the technical documentation of the foot joint.
On the prosthesis, during adjustment, 5 mm should be added to the height of the heel. The outer
rotation of the knee joint should be approximately 5 degrees (see Figure 2b).
The angle between the line that connects the centres of the proximal and distal parts of the receiver
5º
Figure. 2b
35
LOAD LINE
Pneumatic control of the swing phase prevents the leg with the prosthesis from separating exces-
sively during flexion and ensures smoother extension without sudden jolts.
NOTE The knee joint is supplied from the factory with a pneumatic cylinder setting optimised and
adapted for most patients.
For any modification, follow these instructions:
During the test walk, adjust the leg's flexion damping.
- Rotate valve "F" clockwise to increase resistance and, consequently, reduce the angle of sepa-
ration of the leg.
- Rotate valve "F" anticlockwise to decrease resistance and, consequently, increase the angle of
separation of the leg.
Then, adjust the leg's extension damping.
- Rotate valve "E" clockwise to increase resistance when the prosthesis extends abruptly and in the
event of strong jolts during the final phase of extension of the prosthesis.
- Rotate anticlockwise to decrease resistance when walking, when the prosthesis partially extends.
Carefully adjust the ratio between the flexion and extension values.
ATTENTION Extension can be adjusted as long as complete extension of the knee joint is not imped-
ed. If it is impeded, the patient could fall over.
MAINTENANCE
During the warranty period, the knee joint requires no maintenance.
ATTENTION Inform your patient of the following:
Do not expose the prosthesis to agents that can cause corrosion to its metal components, such as
fresh or salt water, acids or other liquids, or the effects of external environmental factors that could
lead to the deterioration of its components, such as dust and sand.
Usage and environmental conditions can affect the functional characteristics of the knee joint.
In order to avoid risks to the health of the patient, the knee joint should not be used if significant
changes in its functioning are noticed. These significant changes can include partial extension,
difficulty walking, problems controlling the swing phase and stability in the stance phase, squeaking
noises or jolts, etc.
Solution: contact a specialist technical service to check the functioning of the prosthesis.
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 abnor-
mality, notify the supplier immediately in order for the product to be replaced.
WARRANTY
4 Km/h from purchase
Reference
Batch
no.
Signature and stamp of the
orthopaedic establishment
socket with respect to the adjustment axis on the sagittal plane is 3 to
5 degrees, however, the individual characteristics of the patient should
be taken into account and the position of the receiver socket corrected.
Fig. 2b
ATTENTION If the position of the receiver socket is not taken into accou-
nt, the knee joint will excessively incline forwards, causing malfunction
and unnecessary wear and tear to the knee joint.
RECOMMENDATIONS To correct the position of the knee joint and the
receiver socket in the joint, use of adjustable adapter 4Н 16Т, 4Н 16С
or 4Н 24Т, 4Н 24С is recommended.
If the amputation is at knee level, it is necessary to use adapter 4H
13Т or 4H 13S.
In the second stage, the final adjustment of the prosthesis is carried
out in a static position on the same device to balance the weight with
the laser level during the test walk.
The patient is positioned in the device to balance the weight. The height
of both legs is made equal and the load between them is distributed as
evenly as possible. At the same time, the beam of the laser level is ex-
tended along the load line (see Figure 2c). Adjustment of the prosthesis
is governed exclusively by the change in plantar flexion, so that the load
axis reflected by the laser beam passes at a distance of 35 mm from
the axis of rotation of the knee joint.
The final adjustment of the prosthesis is carried out through a test walk
by the patient and adjustment of the pneumatic cylinder. The stride
rate and length of the orthopaedic leg and the healthy leg should be
the same or similar.
To complete the assembly of the prosthesis, screw 10 should be tighte-
ned with a torque of 10 Nm.
ADJUSTING THE PNEUMATIC CYLINDER
Date of
purchase
For the warranty to be valid, it is
necessary to complete these details.
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