Product Description; Indications For Use - Össur PRO-FLEX XC TORSION Instrucciones Para El Uso

ENGLISH
Pro-Flex XC Torsion 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. The device may only be fitted by
a qualified practitioner authorized by Össur after completing the
corresponding training.

PRODUCT DESCRIPTION

The device is a mechanical foot with an integrated torsion and shock
absorbing adapter, and male pyramid.
The device consists of the following components: (Figure 1)
1. Torsion shock assembly
2. Pyramid cover
3. Upper C blade
4. Lower C blade
5. Bottom blade
6. Spectra Sock
7. Foot cover

INDICATIONS FOR USE

The device is a non-invasive, reusable prosthetic device.
The device is designed for single patient use in low to high everyday
activities (e.g. walking).
The device is not designed for use in extreme sports.
The device is tested and validated for exoprosthetic fittings of lower
extremity amputations.
CONTRAINDICATIONS
Not applicable
TECHNICAL SPECIFICATIONS (Figure 2)
The following specifications are for a size 27 category 5 foot with foot
cover:
• Product weight with footcover : 1035 g / 2.28 lbs
• Foot cover weight: 165 g / 0.36 lbs
• Build height: 222 mm / 8 3/4"
• Maximum user weight: 147 kg / 324 lbs
CATEGORY SELECTION CHART
Please refer to the selection chart below to determine the appropriate
category required according to Össur recommendations.
NB: Incorrect category selection may result in poor device function. The
weight limit is 147 kg for low active users, 130 kg for moderate active
users, and 116 kg for high active users.
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