Read Before Use - PROTEOR 4 AXIS Instrucciones De Uso

1M102(-P6) / 1M102V(-P6) / 1M112 / 1M113 / 1M05
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1. COMPONENTS INCLUDED
Designation
Remote unlocking handle
Extension stop
2. DESCRIPTION, PROPERTIES AND ACTION MECHANISM
A. Description
4-axis multi-axis knee, in 7 versions:
•
1M102 / 1M102-P6: 4-axis knee
•
1M102V / 1M102V-P6: lockable 4-axis knee
•
1M112 / 1M113: compact 4 axis-knee
•
1M05: 4-axis knee with short link rods
B. Properties
Reference
Weight
Height (H)
Total height (TH)
Design height (DH)
Maximum bend
Maximum patient weight
(Including load borne)
Distal connector tube
These devices have been tested as per standard NF EN ISO 10328 for a load level of 45 kg for 1M112, 80 kg for 1M113, P5 (i.e. 100
kg) for 1M05, 1M102 and 1M102V, and P6 (i.e. 125 kg) for 1M102-P6 and 1M102V-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
These multi-axis knees stabilise the stance phase through the geometry of the joint system, with a spring extension return system,
with the option of locking in the extended position (for references 1M102V and 1M102V-P6), and without locking in the extended
position (for references 1M05, 1M102, 1M102-P6, 1M112 and 1M113).
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.
User manual for orthopaedic prosthetists

Read before use

Provide the patient with the instructions in § 3, 7, 8, 9
1M102(-P6) / 1M102V(-P6)
Knee 1M112 / 1M113
1M11294 & 1G13
Trim
1M10294 & 1G13 / 1G21
1M102 1M102V
565 g
108 mm
100 kg
Ø30 mm
4-AXIS KNEE
Reference
1M05
For 1M102(-P6) / 1M102V(-P6) only
1X110
1M10270
For 1M102(-P6) / 1M102V(-P6) only
1M11270
1M102-P6 1M102V-P6
575 g 600 g
12 mm
184 mm
113 mm
160°
125 kg
Ø34 mm
Included / Sold separately
Included
Sold separately
For 1M112 / 1M113 only
Sold separately
Sold separately
For 1M102V(-P6) only
Sold separately
Sold separately
For 1M112 / 1M113 only
1M112 1M113
625 g 320 g 340 g
11 mm
155 mm
75 mm
165°
45 kg 80 kg
Ø22 Ø30
mm mm
1M10299
2021-04
1M05
460 g
11 mm
166 mm
85 mm
140°
100 kg
Ø30 mm