Product Description; Intended Use - Össur Dynamic L Instrucciones De Uso

ENGLISH
Medical Device

PRODUCT DESCRIPTION

Thank you for choosing an Össur Product
The device is an alignment adapter for Össur sports feet. This document
covers the following products.
Product Name
Dynamic L- Adapter 13°
Bolted L- Adapter 13°
Dynamic - Adapter 10°
Bolted - Adapter 10°
Alignment Adapter
Xpanse
INDICATIONS FOR USE
Lower limb amputation.
CONTRAINDICATIONS
None known.

INTENDED USE

Maximum patient weight is 100 kg (220 lbs)
The adapters are intended to aid alignment of Össur sports feet. They
can be used temporarily to adjust alignment to individual patients before
attaching the sport foot more permanently to the socket. The Bolted
L-Adapter 13° can be used long term. The device service life cannot be
determined since load varies depending on the sport and patient activity
level.
GENERAL SAFETY INSTRUCTIONS
WARNING: The Alignment Adapter Xpanse and Bolted Adapter 10° are
NOT to be used for jumping. Structural failure may occur.
WARNING: In cases of functional change or functional loss, the patient
should stop using the device and contact a healthcare professional.
WARNING: If the device shows signs of damage or wear, the patient
should stop using the device and contact a healthcare professional.
PRODUCT SELECTION / VERIFICATION
The devices can be used with Össur feet that use a lamination
connection.
Intended use
Alignment only
Long term
Alignment only
Short term
Alignment/
short term
Product Patient
Weight Activity
700 g Walk, jog
500 g High activity
720 g Walk, jog
High activity
350 g (NOT
jumping)
High activity
980 g (NOT
jumping)
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