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Orliman 6H06A1 Instrucciones De Uso página 3

Rodilla monocéntrica con bloqueo manual

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6Н06А1
Single axis knee joint with lock
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 knee joint with lock is designed for patients with unilateral or bilateral femoral
amputation at any level, except for knee disarticulation. This module provides complete
patellar flexion stability and is recommended for patients who require a high degree of
security during movement.
TECHNICAL CHARACTERISTICS
Code
Item weight, g
For patients weighing
Maximum angle of flexion
Temperature range for use
Warranty period
DESCRIPTION OF THE STRUCTURE
The module consists of lower housing 8 (Fig. 1) with a steel support fitted to it and fixed
to lower housing 8 by means of screws 16. Upper housing 5 is attached to lower housing 8
by means of axis 4 and screws 14 and can rotate on the axis with respect to lower housing
8. Upper housing 5 features axis 3 which is fitted with ratchet 9 and spring 11. Fixed by
screw 24 (Fig. 2), on shackle 9, is locking bar 1 (Fig. 1). Upper housing 5 also features shock
absorber 2. On the outside, the module features housing 7 with rubber ring 13. Fixed to the
upper and lower housings are pyramids 10.
The single axis knee joint is compatible with Orliman's modular lower-limb prosthetic
systems.
1
12
14
4
16
3
11
1
7
Locking bar
Cover
2
8
Shock absorber
Lower housing
3
9
Axis
Ratchet
4
10
Axis
Pyramid
5
11
Upper housing
Spring
6
12
Stop
Washer
OPERATION
During the gait cycle, the knee should be in its closed position and cable 22 of the unlocking
assembly (Fig. 2) should be slightly loosened (free).
To activate the unlocking system:
- Position the prosthesis slightly backwards, put weight on the forefoot of the prosthesis and
then pull upwards on trigger 19 of the unlocking device (Fig. 2).
Through cable 22 of the flexible bar and unlocking screw 24, the movement is transmitted
to ratchet 9. Ratchet 9, overcoming the resistance of spring 11, disengages from stop 6 and
enables rotation in axis 4 of upper housing 5 with respect to lower housing 8.
When removing the load from trigger 19, ratchet 9, through the action of spring 11, returns
to its original position and when the surfaces of upper housing 5 and lower housing 8
coincide, and pressure is applied again, the knee is locked.
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-6H06A1
EDITION: 05/2015
6Н06А1
305
up to 125 kg
120º
from -40°С to +40°С
2 years
10
5
7
13
2
15
6
9
8
13
Ring
14
Screw
15
Screw
16
Bearing
FITTING THE ITEM TO THE PROSTHESIS
The diagram for fitting the knee to the prosthesis and fastening the unlocking assembly in
the socket is shown in Fig. 3. The recommended values, ∆L and H, are shown in the prosthetic
foot's accompanying documentation.
The fitting of the unlocking assembly begins with fixing bushing 18 to the socket of the
prosthesis (Fig. 3). Then, on the cable of the flexible bar, a loop is made which is fixed with
screw 20. The cable's PVC covering should firstly be removed for more secure fastening.
The free end of the cable of the flexible bar is placed through aluminium clamp 21 and
then riveted. The cable must not be bent or loose. If necessary, the cable can be shortened.
The possibility of fixing screw 24 to ratchet 9 through the right or left side enables the knee
module to be used in femoral prostheses for the left or right limbs.
During final assembly of the prosthesis, it is recommended to apply Loctite 241 threadlocker
to the threads of screws 20 and 24 and tighten as far as they will go.
The kit includes fastening screw М6×50, which is used for adjusting the prosthesis before
fitting the handle of the locking system to the socket. For this, the technological screw
should be inserted 8÷10 mm into ratchet 9 instead of screw 24 and with its help unlock the
knee module.
Note: Do not remove nerves A from trigger 19.
18
Bushing
19
Trigger
20
Screw
MAINTENANCE
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
años from purchase
Reference
Batch
no.
Signature and stamp of the
orthopaedic establishment
Unlocking
assembly
Load line
Midfood
21
Aluminium clip
6 units
22
Cable
23
Unlocking screw
Date of
purchase
For the warranty to be valid, it is
necessary to complete these details.

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