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Orliman 6H25 Instrucciones De Uso página 3

Rodilla articulada policéntrica con amortiguador neumático

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6H25
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 125 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
Item weight, g
Maximum patient weight, kg
Total height, mm
Device height, mm
Flexion angle
Temperature range for use
Joint in the proximal part
Joint in the distal part
Warranty period
DESCRIPTION OF THE STRUCTURE
The knee joint consists of support with pyramid 1 connected by means of fork 2 and two
connections 3 to housing 4. The axes rotate around the bearings creating closed kinematic
loop and a pneumatic shock absorber 5. The instantaneous axis of rotation of the knee joint
mechanism is located in the area of the sole of the foot, which provides the patient with
complete confidence in the stance phase. The mediolateral stability of the prosthesis can be
adjusted with the help of stops 9 and 10, making it possible to adapt the knee joint to the
degree of security required by the patient.
Pneumatic shock absorber 5 built into the structure of the knee joint ensures adapted control
in the swing phase. Flexion and extension can be regulated separately by adjustment valves
6 and 7 located on the front of the pneumatic shock absorber.
The proximal area of the knee joint is the location of the pyramid designed to connect to
other prosthesis modules and the lower part of housing 4 designed in the shape of a bushing
extendible with connecting screw 8.
The knee joint is compatible with Orliman's modular lower-limb prosthetic systems.
1
1
A
A
3
3
4
4
8
8
9
9
E
E
Вариант 1
Fig. 1
без клиньев
No stops
1
Support with pyramid
2
Fork
3
Connection
4
Housing
5
Pneumatic shock absorber
6
Flexion adjustment valve
6H25
Aluminum alloy
875
125
208
158
up to 150°
From -30 °C to +40 °C
Pyramid
Bushing ø30 mm
3 years
2
2
7
7
A (2 : 1)
A (2 : 1)
10
10
11
11
Fig. 2
Fig. 3
Stop A installed
Stop B installed
7
Extension adjustment valve
8
Connecting screw
9
Replaceable stop A
10
Replaceable stop B
11
Screw M3x5
FITTING THE ITEM TO THE PROSTHESIS
The knee joints fully maintain their function when they are
installed on the prosthesis together with the 1Н 04Y foot.
To join the knee joint and the foot, it is recommended to use
joint 3H 01А/400, 3Н 01С/400 or 3Н 01Т/400 for patients
weighing up to 100 kg or joint 3Н 02С/400 or 3Н 02Т/400 for
patients weighing up to 125 kg.
ATTENTION: To correctly fit the prosthesis, follow
the fitting diagram (see Figures 2, 3 and 4). Failure
to strictly follow the prosthesis fitting diagram could
lead to loss of stability in the stance phase, causing
the patient to fall over.
The fitting of the prosthesis should be performed in two sta-
ges. 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 fitting axis of the prosthesis on the sagittal
plane must pass through the centre of the proximal area on
the side of the receiver socket, through the anterior axis of
rotation 1 of the knee joint, at a distance of 30 mm from the
midline of the foot towards the heel. On the prosthesis, du-
ring adjustment, 5 mm should be added to the height of the
heel. The outer rotation of the knee joint should be approxi-
mately 5 degrees (see Figure 3).
ATTENTION: If the position of the stump is not taken
into account, the knee joint will excessively incline
forwards, causing malfunction and unnecessary wear
and tear to the knee joint.
To correct the position of the knee joint and the receiver soc-
ket 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 extended along the load line
(see Figure 4). Adjustment of the prosthesis is governed ex-
clusively 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 support 1 of the knee joint.
Final adjustment of the prosthesis is carried out through a
test walk by the patient and adjustment of the pneumatic
shock absorber. The stride rate and length of the orthopae-
dic leg and the healthy leg should be the same or similar.
To complete the fitting of the prosthesis, screw 8 should be
5
5
tightened with a torque of 10 Nm.
ADJUSTING THE PNEUMATIC SHOCK ABSORBER
Pneumatic control of the swing phase prevents the leg with
the prosthesis from separating excessively during flexion
and ensures smoother extension without sudden jolts.
NOTE. The knee joint is supplied with its pneumatic shock
absorber factory set. For any modification, follow these ins-
tructions:
6
During the test walk, adjust the leg's flexion damping
6
• Rotate valve 'F' (6) clockwise to increase resistance and, consequently, reduce the angle
of separation of the leg.
• Rotate valve 'F' (6) anticlockwise to decrease resistance and, consequently, increase the
angle of separation of the leg.
Then, adjust the leg's extension damping
• Rotate valve 'E' (7) 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.
11
11
ATTENTION: Extension can be adjusted as long as complete extension of the knee joint
is not impeded. If it is impeded, the patient could fall over.
ATTENTION: Do not completely close the valves, as this could damage the item and
cause the patient to fall over.
ADJUSTING THE MEDIOLATERAL STABILITY OF THE PROSTHESIS
The mediolateral stability of the knee joint can be adjusted with the help of stops 9 and 10,
which can be installed on fork 2 (Figure 1, location B) with two screws 11. To change medio-
lateral stability, three settings can be used:
1.Without stops - the knee joint ensures the highest degree of security.
2.Installation of stop A (9) - medium degree of dynamism.
3.Installation of stop B (10) - high degree of dynamism.
Manually tighten screws 11 with the 2 mm Allen key.
Fitting axis
0...5 мм
0...5 мм
2/3 L
2/3 L
L
L
35 мм
35 мм
Load line

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