ottobock AFO 28U90 Ankle Foot Orthosis Instruction Manual
- June 5, 2024
- ottobock
Table of Contents
ottobock AFO 28U90 Ankle Foot Orthosis
Foreword
INFORMATION
Date of last update: 2022-02-07
- Please read this document carefully before using the product and observe the safety notices.
- Instruct the user in the safe use of the product.
- Please contact the manufacturer if you have questions about the product or in case of problems.
- Report each serious incident related to the product to the manufacturer and to the relevant authority in your country. This is particularly important when there is a decline in the health state.
- Please keep this document for your records.
These instructions for use contain important information for fitting and setting up your 28U90 ankle foot orthosis.
Intended use
Indications for use
The orthosis is intended exclusively for orthotic fittings of the lower limbs
and exclusively for contact with intact skin. The orthosis must be used in
accordance with the indications.
Indications
- Dorsal flexor weakness, (e.g. after stroke, traumatic brain injury, in multiple sclerosis, neuromuscular atrophy, or peroneal paralysis)
Indications must be determined by the physician.
Contraindications
Absolute Contraindications
- Moderate to severe spasticity in the lower leg
- Moderate to severe oedema
- Leg ulcers
- Moderate to severe foot deformities
Relative Contraindications
The following indications require consultation with a physician: skin
diseases/injuries, inflammation, 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.
Lifetime
The product is designed for a maximum lifetime of 6 months.
Restrictions for use
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 generally be discussed with the patient.
Effects
The ankle foot orthosis provides lifting of the foot and limits plantar
flexion.
Safety
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.
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.
- In case of changes in or loss of functionality, discontinue use of the product and have it checked by authorised, qualified personnel.
NOTICE
Contact with oils, salves, lotions or other products that contain oils or
acids
Insufficient stabilisation due to loss of material functionality
- Do not expose the product to oils, salves, lotions or other products that contain oils or acids.
Handling
WARNING
Operation of motor vehicles
Risk of accident due to limited body function
- The product has not been approved by the manufacturer for the operation of motor vehicles.
- Observe the applicable legal regulations for the operation of motor vehicles and have your driving ability examined by an authorised test centre.
INFORMATION
- The daily duration of use and period of application are generally determined by the physician.
- The initial fitting and application of the product must be carried out by qualified personnel.
- Instruct the patient in the handling and care of the product.
- Instruct the patient to see a physician immediately if any exceptional changes are noted (e.g. worsening of the complaint).
Size Selection
- Select the orthosis size based on the shoe size (see sizing table).
Adaptation
CAUTION
Improper moulding or application
Injuries or damage to the orthosis due to overloading of the material and
improper fit of the orthosis due to breakage of load-bearing components
- Do not make any improper changes to the orthosis.
- Always apply the orthosis according to the information in the instructions.
CAUTION
Incorrect or excessively tight application
Risk of local pressure and constriction of blood vessels and nerves due to
improper or excessively tight application
- Ensure that the product is applied properly and fits correctly.
NOTICE
Use without suitable footwear
Restriction of functionality due to insufficient stabilisation
- Only use the orthosis with closed footwear, taking the allowable effective heel height into account.
Adapting the orthosis size:
- If necessary: Cut or sand down the orthosis to size according to shoe size.
- Then, deburr the worked edges and polish out any notches.
Adapting the orthosis:
-
If necessary: Thermoplastically re-form the orthosis by applying gentle heat to a limited extent.
NOTICE! Re-forming of the orthosis in cold conditions or at temperatures above 80°C is not permitted. -
Attach the calf pad and the hook-and-loop strap (see fig. 2).
INFORMATION: The hook-and-loop strap can be fastened medially or laterally. -
Once fitting is complete, reattach the hook-and-loop strap to the calf pad (see fig. 3).
Final inspection:
- Conduct trial walking with the patient. Testing on inclines, ramps and stairs is mandatory. Fine tune as required.
Application
NOTICE
Mechanical overload
Impaired functionality due to mechanical damage
- Check the product for damage prior to each use.
- Do not use the product if its functionality has been impaired.
- Take any necessary measures (e.g. repair, replacement, inspection by the manufacturer’s customer service, etc.).
- Open the hook-and-loop strap.
- Insert the orthosis into the shoe.
- Put the orthosis on together with the shoe.
- Tighten and close the hook-and-look strap.
Cleaning
Clean the orthosis regularly:
Textile pads
- Remove the textile pads from the orthosis.
- Fasten all hook-and-loop closures.
- Hand wash the textile pads in warm water at 30 °C with standard mild detergent. Rinse thoroughly.
- Allow to air dry. Do not expose to direct heat sources (e.g. sunlight, stove or radiator).
Orthosis frame
- Wipe with a damp cloth as needed.
- Allow to air dry. Do not expose to direct heat sources (e.g. sunlight, stove or radiator).
Disposal
Dispose of the product in accordance with national regulations.
Legal information
All legal conditions are subject to the respective national laws of the country of use and may vary accordingly.
Local Legal Information
Legal information that applies exclusively to specific countries is written in
the official language of the respective country of use after this chapter.
Liability
The manufacturer will only assume liability if the product is used in
accordance with the descriptions and instructions provided in this document.
The manufacturer will not assume liability for damage caused by disregarding
the information in this document, particularly due to improper use or
unauthorized modification of the product.
CE conformity
The product meets the requirements of Regulation (EU) 2017/745 on medical
devices. The CE declaration of conformity can be downloaded from the
manufacturer’s website.