Otto Bock 28U11, Instructions For Use Manual

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3.3 Contraindications
3.3.1 Absolute Contraindications
• Moderate to severe spasticity in the lower leg
• Moderate to severe oedema
• Moderate to severe foot deformities
3.3.2 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.
•
Severe deviations of the leg axis (genu varum/valgum/recurvatum)
• Contractions at the knee and/or ankle joint
3.4 Lifetime
When used as intended, the product is designed for:
Junior
1 year
(shoe sizes EU 24-27, 27-30, 30-33, 33-36)
Adults
2 years
(shoe sizes EU 36-39, 39-42, 42-45, 45-48)
When the end of the lifetime is reached, have the product inspected for functionality by qualified
personnel. Use of the product beyond the specified lifetime is the responsibility of the user.
The doctor decides the daily duration of use for the product.
3.5 Restrictions for use
The orthosis must not be used to prevent contractures.
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.
3.6 Effects
• Supports dorsiflexion
• Promotes dynamic rollover
• Promotes a physiological gait pattern
• Reduces the risk of falling
3.7 Accessories
28U11, 28U22, 28U23
• 28Z10 Lateral pronation strap
4 Safety
4.1 Explanation of warning symbols
WARNING
Warning regarding possible serious risks of accident or injury.
CAUTION
Warning regarding possible risks of accident or injury.
NOTICE Warning regarding possible technical damage.
4.2 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.