Product Description; Intended Use; Technical Specifications - Össur PRO-FLEX Manual De Instrucciones

ENGLISH
Pro-Flex LP 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. It is intended for use by a certified prosthetist
and the user of the device.

PRODUCT DESCRIPTION

The device s a prosthetic foot device with integrated male pyramid and
three composite blades. It features a sandal toe and a full length
composite blade. The bottom blade is secured together with heel bolts.
The device consists of the following components (Figure 1):
1. Male Pyramid Adapter
2. Pyramid cover
3. Top blade
4. Middle blade
5. Bottom blade
6. Bottom blade bolts
7. Spectra Sock
8. Footcover
INDICATIONS FOR USE
Lower limb amputation.
CONTRAINDICATIONS
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 high impact levels.

TECHNICAL SPECIFICATIONS

The following specifications are for a size 27 category 5 device with foot
cover:
• Device weight with footcover : 647 g / 1.42lbs
• Foot cover weight: 165 g / 0.36 lbs
• Build height: 73 mm / 2 ⅞"
• Maximum user weight: 166 kg / 365 lbs
CATEGORY SELECTION CHART
Please refer to the selection charts below to determine the appropriate
stiffness required according to Össur recommendations.
N.B.: Incorrect category selection may result in poor device function.
Maximum user weight of 166 kg for low impact levels, 147 kg for
moderate impact levels and 130 kg for high impact levels.
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