Product Description; Contraindications For Use; Intended Use - Össur PRO-FLEX LP ALIGN Mode D'emploi

ENGLISH
Pro-Flex LP Align is referred to as the device in the following document.
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.

PRODUCT DESCRIPTION

The device is a prosthetic foot with user adjustable heel height. It is
composed of an integrated hydraulic ankle unit, with a male pyramid and
three composite blades. It features a sandal toe and a full-length
composite blade. The bottom blade is secured with heel bolts.
The device consists of the following components: (Figure 1)
1. Male Pyramid
2. Foot Cover
3. Lock and release button
4. Upper housings
5. Top Blade
6. Middle Blade
7. Bottom Blade bolts
8. Bottom Blade
9. Lower Housings
10. Posterior Spacer
11. Anterior Spacer Wedge
INDICATIONS FOR USE
Lower extremity amputations.

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 (Figure 2)
The following specifications are for a size 24 category 5 foot with foot
cover:
• Product weight with footcover : 703 g / 1.55 lbs
• Foot cover weight: 100 g / 0.22 lbs
• Build height: 116 mm / 4 9/16"
• Maximum user weight: 116 kg / 256 lbs
CATEGORY SELECTION CHART
Please refer to the selection chart below to determine the appropriate
category required according to Össur recommendations.
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