Intended Use; Technical Specifications - Össur PFP0 Serie Instrucciones Para El Uso

ENGLISH
Pro-Flex Pivot
®
This document provides important information on the indications for
use, and handling of the device. This document is intended for a certified
prosthetist and the user of the device. The device may only be fitted by a
qualified practitioner authorized by Össur after completing the
corresponding training. The practitioner must ensure that the user is able
to operate the device.
DEVICE DESCRIPTION
The device is a prosthetic foot with anatomically located ankle pivot joint.
Two supporting joints connect flexible carbon blades and act together with
the main joint to provide progressive energy storing during the whole stance
phase and a powerful push-off in the end of stance.
The device consists of the following components (Figure 1):
1. Male pyramid
2. Chassis
3. Main pivot
4. Upper supporting pivot
5. Supporting link
6. Lower supporting pivot
7. Top blade
8. Main pivot carbon clamp
9. Middle blade
10. Lower supporting pivot carbon clamp
11. Bottom blade
12. Bottom blade bolts
13. Sock
14. Footcover
INDICATIONS FOR USE
Lower extremity amputations, for example due to:
• Trauma
• Vascular Disease
• Cancer
• Congenital Defects
CONTRAINDICATIONS FOR USE
None known.

INTENDED USE

The device is a non-invasive, reusable prosthetic device, designed for
single patient use.
The device is to be used exclusively for the exo-prosthetic fitting of
amputations of the lower limb.
The device supports low to moderate impact levels.

TECHNICAL SPECIFICATIONS

The following specifications are for a size 27 category 5 foot with foot cover:
• Weight with footcover : 922 g
• Foot cover weight: 165 g
is referred to as the device in the following document.
4