2
0
0
4
1. COMPONENTS INCLUDED
Designation
Flexible joints
Reinforced joints
Reinforced and arched
joints
2. DESCRIPTION, PROPERTIES AND ACTION MECHANISM
A. Description
Complete range of strong, lightweight polyurethane ankle joints, in 3 versions
•
Flexible
•
Reinforced
•
Reinforced and arched, in 3 hardnesses (70, 80 and 90 ShA)
B. Properties
Reference
Patient
L x w (mm)
Centre thickness
This device has been tested according to an internal protocol, for 1 million cycles, corresponding to a service life of 1 to 1.5 years,
depending on the patient's mobility.
C. Action mechanism
Their role is to enable:
•
Bending of the joint, and to connect the various orthosis shells, in the flexible version
•
Bending of the joint, in the reinforced straight version
•
Dorsal bending while enabling bending, in the reinforced and arched version, in order to free space for the step.
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.
This device is part of the thermoformed lower and upper limb external orthosis range.
AFLEX – 2C130 / 2C131(-P) / 2C16x
User manual for orthopaedic prosthetists
Read before use
Provide the patient with the instructions in § 3, 7, 8, 9
Reference
2C130 / 2C131 or 2C131-P
2C160 (blue) / 2C160-N (black)
/2C161
2C162-XX/2C163-XX
XX = hardness
2C130
2C131
Adult
Child
49 x 14
42 x 11.7
8 mm
6.5 mm
Included / Sold separately
Included with assembly kit
Or
Included with assembly kit
Or
Included with assembly kit
2C131-P
2C160(-N)
Paediatric
Adult
34 x 11.6
44 x 16
5 mm
9 mm
2C13099
2021-11
2C161
2C162-XX
2C163-XX
Child
Adult
40 x 14
44 x 16
9 mm
Child
40 x 14