PROTEOR 1M01 Notice D'utilisation page 6

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1. COMPONENTS INCLUDED
Designation
Knee
Locking system
Single-piece trim
Extension return
2. DESCRIPTION, PROPERTIES AND ACTION MECHANISM
A. Description
Single-axis lockable knee.
Comes in four versions:
•
1M01 / 1M01-P6: lockable knee with cable (right or left)
•
1M10 / 1M10-P6: lockable knee with release handle
B. Properties
Reference
Weight
Height (H)
Total height (TH)
Design height (DH)
Maximum bend
Maximum patient weight
(Including load borne)
Distal connector tube
This device has been tested as per standard NF EN ISO 10328 for a load level of P5 (i.e. 100 kg) for the 1M01 and 1M10, and for a
load level of P6 (i.e. 125 kg) for the 1M01-P6 and 1M10-P6, 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 lockable knee has a lock with a settable stop, and a joint friction setting.
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 130°. 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 knee friction.
•
Set the lock stop.
•
Set the socket rotation to +/- 15°.
LOCKABLE KNEE – 1M01(-P6) / 1M10(-P6)
User manual for orthopaedic prosthetists
Read before use
Provide the patient with the instructions in § 3, 7, 8, 9
Reference
1M01(-P6) or 1M10(-P6)
1M01100
1G13 / 1G21
1R02
1M01
345 g
This device is designed only for the prosthetic system for a transfemoral amputee, or amputee with hip/knee
disarticulation. It is specifically recommended for low-activity patients (L1), or sedentary patients.
Maximum weight (including load borne):
•
1M01 / 1M10: 100 kg
•
1M01-P6 / 1M10-P6: 125 kg
Not suitable for children.
Included / Sold separately
Included
Sold separately
Sold separately
Sold separately
For 1M01 and 1M10 only
1M10
355 g
13 mm
99 mm
58 mm
130°
100 kg
Ø30 mm
1M01-P6 1M10-P6
375 g 385 g
14 mm
102 mm
59 mm
125 kg
Ø34 mm
1M1099
2021-04