Intended Use; Technical Specifications - Össur PRO-FLEX XC Instrucciones De Uso

ENGLISH
Pro-Flex XC 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.
DEVICE DESCRIPTION
The device is a prosthetic foot with integrated male pyramid. It is
composed of a dual and bottom blade secured using heel bolts. The
bottom blade features a sandal toe and a full length composite blade.
The device consists of the following components (Figure 1):
1. Male Pyramid Adapter
2. Pyramid housing
3. Pyramid cover
4. Upper C blade
5. Lower C blade
6. Bottom blade
7. Bottom blade bolts
8. Drop toe
9. Spectra Sock
10. 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:
• Device weight with footcover : 670 g / 1.47lbs
• Foot cover weight: 165 g / 0.36 lbs
• Build height: 155 mm / 6 ⅛"
• 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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