C. Mechanism of action
The knee contains an oil-filled hydraulic cylinder.
The hydraulic system and the control of its operation provide safe management of the stance phase (transition after the swing phase
and resistance to flexion) and the swing phase (impact at the end of extension and dampening of flexion).
The angle of flexion of the knee is limited mechanically to 120°. This amplitude lets the patient kneel down and ride a bicycle.
It offers four separate adjustments, extension assist and a system for locking the flexion.
The knee's intrinsic characteristics (flexion, braking, hydraulic regulation) allow patients to negotiate slopes and stairs using alternating
feet. As a precautionary measure, it is advisable to hold on to the handrail when walking down stairs.
The braking torque when descending stairs is high (150 Nm) up to a significant flexion angle (75°). This torque gradually reduces as the
flexion angle reduces.
Simply by pressing on a flexion locking button, the knee can be locked to prevent any flexion. With regard to extension, the lock halts
the flexion and allows the knee to extend. The patient can thus lock the knee to make it easier to negotiate obstacles, stand without
tiring and perform activities safely (e.g. climbing up a ladder).
Pressing a second time on the button unlocks the knee.
3. INTENDED USERS/INDICATIONS
This medical device is supplied to healthcare professionals (prosthetists/orthotists) who then instruct the patient in how to use it. The
prescription is drawn up by a doctor. The doctor works with a prosthetist/orthotist to assess whether the patient is suited to using the device.
This device should be used on ONE PATIENT ONLY. It must not be reused on other patients.
The maximum flexion of the knee is 120°. This flexion may, however, be limited by the volume of the socket or by the cosmetic covering.
4. CLINICAL BENEFITS
The device allows:
•
The patient to walk down stairs and slopes by bearing weight on the amputated leg to limit the effort on the sound leg.
•
The knee to be locked in flexion using a manual lock to allow certain activities to be performed safely (e.g. climbing a ladder).
•
The prosthetist/orthotist to adjust certain settings to adapt the knee to the patient.
•
Walking at different speeds thanks to the hydraulic regulation.
•
The hip to do less work since some of the knee extension force is provided by an extension assist spring.
5. ACCESSORIES AND COMPATIBILITIES
Ref.
Proximal adapter
Distal adapter
6. ASSEMBLY AND FITTING TO THE PATIENT
A. Assembly
When tightening, comply with the following sequence and torque for the screws on the 34 mm
diameter tube:
1.
Tighten screw V1 to a torque of 5 Nm
2.
Tighten screw V2 to a torque of 5 Nm
3.
Retighten screw V1 to a torque of 5 Nm
INSTRUCTIONS FOR USE
This device is exclusively intended to be used as prosthetic equipment for patients who have undergone
transfemoral amputation, hip disarticulation or knee disarticulation. It is specifically recommended for active
to very active patients (L3/L4) as it allows them to carry out their everyday activities on all types of terrain
as well as negotiate slopes and stairs.
Maximum weight (including carried load): 150 kg
Not suitable for children.
1P130/ 1P131
1K179+ 1K183 (max. weight 150 kg)
Anchor
1K173 or 1K176 (max. weight 125 kg)
1K177 (max. weight 100 kg)
1K172 or 1K207-HD
Connectors
(max. weight 150 kg)
Tube and
connector
1P130-KD/ 1P131-KD
1K179 (max. weight 150 kg)
1K184 (max. weight 150 kg)
1G01-HD (max. weight 150 kg)
1D52-P6 (max. weight 125 kg)
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V1
V2
5 Nm