•
Leg ulcers
•
Moderate to severe foot deformities
2.3.2 Relative Contraindications
The following indications require consultation with a physician: skin diseases/injuries, inflamma
tion, prominent scars that are swollen, reddening and hyperthermia of the fitted limb/body area;
lymphatic flow disorders, including unclear soft tissue swelling distal to the body area to which
the medical device will be applied; sensory and circulatory disorders in the lower leg and the foot
area.
2.4 Further Usage Restrictions
The orthosis must not be used for the prevention of contractures (shortening) etc.
The orthosis must not be used for sports activities that involve jumping, sudden movements or
rapid step sequences (e.g. basketball, badminton, riding sports). Sports activities should gener
ally be discussed with the patient.
2.5 Effects
The orthosis enables a more natural gait pattern for the user. In the swing phase, the foot remains
in the neutral position which permits a natural swing-through for the patient without executing
compensating movements for ground clearance.
At heel strike, the carbon spring allows the foot to plantarflex in a controlled and harmonious man
ner preventing foot slap. The force exhibited is used to support the mid-stance phase.
Prior to toe-off, stored energy is released to preserve momentum into swing phase.
3 Safety
3.1 Explanation of warning symbols
Warning regarding possible serious risks of accident or injury.
WARNING
Warning regarding possible risks of accident or injury.
CAUTION
NOTICE
Warning regarding possible technical damage.
3.2 General safety instructions
CAUTION
Reuse on other persons and improper cleaning
Skin irritation, formation of eczema or infections due to contamination with germs
►
The product may be used by one person only.
►
Clean the product regularly.
CAUTION
Contact with heat, embers or fire
Risk of injury (such as burns) and risk of product damage.
►
Keep the product away from open flames, embers and other sources of heat.
CAUTION
Mechanical damage to the product
Injuries due to changes in or loss of functionality
►
Use caution when working with the product.
►
Check the product for proper function and readiness for use.
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