Contraindications; Intended Use - Ossur RE-FLEX ROTATE Gebrauchsanweisung

ENGLISH
Re-Flex Rotate and Re-Flex Shock are both referred to as the device in this
document. This document provides important information concerning
the indication for use and handling of the device. It is intended for use by
a certified prosthetist and the user of the device.
PRODUCT DESCRIPTION
Re-Flex Rotate is a mechanical foot with an integrate torsion and shock-
absorbing adapter (Rotate module), available with male or female
pyramid options.
Re-Flex Shock is a mechanical foot with an integrated shock-absorbing
adapter (Shock module) and a male pyramid.
The device consists of the following components (Figure 4):
1. Rotate / Shock module
2. Male pyramid
3. Female pyramid
4. Foot module
5. Torsion cell
6. Front spring
7. Spectra sock
8. Foot cover
9. Heel wedge
10. Attachment clamp
11. Collar
12. Bellow
13. Attachment clamp screws
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 fittings of people with lower-limb loss. The device
supports low to high impact levels.
TECHNICAL SPECIFICATIONS (Figure 1, 2 and 3)
The following specifications are for a size 27 category 5 foot with foot cover:
Device weight with foot cover and Spectra sock:
Build height:
Maximum user weight:
CATEGORY SELECTION CHART
Please refer to the selection chart below to determine the appropriate
category required according to Össur recommendations.
Re-Flex Rotate
1105 g / 2436 lb
See figure 1, 2
See category
selection chart
Re-Flex Shock
1076 g / 2372 lb
See figure 3
See category
selection chart
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