PROTEOR 1D111 Notice D'utilisation page 5

2
0
0
1
1. COMPONENTS INCLUDED
Rear shock absorber - Medium
Rear shock absorber - Extra Soft
2. DESCRIPTION, PROPERTIES AND ACTION MECHANISM
A. Description
Multi-axis ankle delivered assembled, and consisting of:
•
Ankle body
•
Front stop - Soft
•
Rear shock absorber - Medium
B. Properties
This device has been tested as per standard 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
The multi-axis ankle adds the dorsal bending, plantar bending, inversion and eversion movements to any compatible foot.
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.
4. CLINICAL BENEFITS
The device will facilitate flattening the foot, and is suited to rough terrain, thanks to its multiple movement options.
A wide range of front stops and rear shock absorbers enables the ankle to be adapted to the patient's activity level and weight.
5. ACCESSORIES AND COMPATIBILITIES
Upper joint
Lower joint
MULTI-AXIS ANKLE – 1D111
User manual for orthopaedic prosthetists
Read before use
Provide the patient with the instructions in § 3, 7, 8, 9
Designation
Multi-axis ankle
Front stop - Soft
Front stop - Medium
Front stop - Hard
Rear shock absorber - Hard
Rear shock absorber - Soft
Setting kit
Weight
Total height
Design height
Maximum patient weight
(Including load borne)
This device is exclusively intended to be used as orthopaedic equipment for an above-knee or below-knee
amputee with low-medium or normal activity level (2 or 3).
Maximum weight (including load borne): 100 kg
Male pyramid
M10 screw
Reference Included / Sold separately
1D111 Included
EE010-1 Included
EE010-2 Sold separately
EE010-3 Sold separately
EE009 Sold separately
EE008 Included
EE007 Sold separately
EE013 Sold separately
Sold separately
1D11150 EE010-2, EE010-3 & EE009
included
250 g
65 mm
53 mm
100 kg
1D11199
2021-07