PROTEOR DYNASTEP Instrucciones De Uso página 5

1
9 Instructions for use for Prosthetists/Orthotists
9
8
Please read before using or working on the device
1. COMPONENTS INCLUDED
2. DESCRIPTION, PROPERTIES AND MECHANISM OF ACTION
A. Description
An energy-returning, prosthetic foot that offers comfort to patients active on normal or uneven terrain, consisting of:
•
A polyurethane foam foot shell 1 overmoulded around two composite blades 2 and 3, with a
sandal toe,
o
o
•
A malleolar clip,
•
A hole through the heel for a screw used to secure an ankle base.
B. Properties
This device has undergone a two-million-cycle test, in accordance with standard NF EN ISO 10328 (at a P4 load level for the 80 kg
version and at P5 for the 100 kg version), which corresponds to a service life of 2 to 3 years, depending on the patient's activity level.
3. INTENDED USERS/INDICATIONS
This medical device is supplied to healthcare professionals (prosthetists/orthotists) who then instruct the patient in how to use it. The
prescription is drawn up by a doctor. The doctor works with a prosthetist/orthotist to assess whether the patient is suited to using the device.
This device should be used on ONE PATIENT ONLY. It must not be reused on other patients.
4. CLINICAL BENEFITS
The device increases an amputee's walking range thanks to the energy efficiency generated by the two foot blades that also allow the
patient to walk on a range of surfaces.
5. ACCESSORIES AND COMPATIBILITIES
Can be connected to any A type ankle base fitted with an M10 screw (A1) (Refer to our catalogue).
The heel height can be adjusted from 5 to 15 mm.
DYNASTEP-1A101
Pass on § 3, 7, 8 and 9 of these instructions to the Patient
Designation
Foot shell
Malleolar clip
Multi-axis ankle
A split, forefoot blade made of fibre glass and epoxy resin 2,
A C-shaped rear blade (3),
Weight (Size 26)
Side
Size
Malleolar clip
Maximum patient weight
(Including carried load)
This device is exclusively intended to be used as orthopaedic equipment for a below-knee or above-knee
amputee whose activity level is low-medium (2).
Maximum weight (including carried load):
•
Sizes 22 to 25: 80 kg
•
Sizes 26 to 29: 100 kg
Designed to accommodate a heel height of 5 to 15 mm.
Ref. Included/Sold separately
1A101-xx Included
1D101 Included
Sold separately
1D111
Included in kit 1E201-xx
510 g
Right or Left
22 to 25
1D101-2225
80 kg
26 to 29
1D101-2629
100 kg
1A10199
2021-04