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1. COMPONENTS INCLUDED
Designation
Knee
Extension return kit
Single-piece trim
2. DESCRIPTION, PROPERTIES AND ACTION MECHANISM
A. Description
Single-axis knee with stance phase brake and extension return.
Comes in two versions, and has 3 settings:
•
Extension return force
•
Joint friction
•
Load-dependent brake sensitivity
B. Properties
Reference
Material
Weight
Height (H)
Total height (TH)
Design height (DH)
Maximum bend
Maximum patient weight
(Including load borne)
This device has been tested as per standard NF EN ISO 10328 for a load level of P5 (i.e. 100 kg) for 3 million cycles, corresponding to
a service life of 4 to 5 years, depending on the patient's activity level.
C. Action mechanism
This knee with stance phase brake comes with 3 distinct settings and extension return.
During the stance phase, the ground reaction force closes a jaw, which locks the rotation axis.
3. INTENDED USERS/INDICATIONS
This medical device is supplied to health professionals (orthopaedic prosthetists), who will train the patient in their use. The prescription is
drawn up by a doctor, alongside the orthopaedic prosthetist, to assess whether the patient is suited to using it.
This device is for SINGLE-PATIENT use. It must not be reused on another patient.
The knee's maximum bend is 150°. It may however be limited by the socket volume or by the aesthetic
coating.
4. CLINICAL BENEFITS
The device makes it possible to:
•
Set the brake according to the patient's weight and activity.
•
Set the knee friction.
•
Set the extension return.
BRAKE KNEE – 1M115 / 1M149
User manual for orthopaedic prosthetists
Read before use
Provide the patient with the instructions in § 3, 7, 8, 9
Reference
1M115 or 1M149
M11510
1G13
1M115
Stainless steel
485 g
22 mm
This device is designed only for the prosthetic system for a transfemoral amputee, or amputee with hip/knee
disarticulation. It is specifically recommended for medium to low-activity patients (L1/L2).
Maximum weight (including load borne): 100 kg
Not suitable for children.
Included / Sold separately
Included
Included and sold separately
Sold separately
1M149
Titanium
376 g
30 mm
75 mm
50 mm
150°
100 kg
1M11599
2021-07
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