ottobock 28U50 Malleo Neurexa Pro Ankle Foot Orthosis Instruction Manual
- June 3, 2024
- ottobock
Table of Contents
28U50 Malleo Neurexa Pro
Instructions for use
28U50 Malleo Neurexa Pro Ankle Foot Orthosis
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Foreword
INFORMATION
Date of last update: 2021-07-23
► 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 prob lems.
► 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 28U50 Mal leo Neurexa Pro ankle foot orthosis.
Intended use
2.1 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.
2.2 Indications
- Dorsal flexor weakness, (e.g. after stroke, traumatic brain injury, in multiple sclerosis, neur omuscular atrophy, or peroneal paralysis)
Indications must be determined by the physician.
2.3 Contraindications
2.3.1 Absolute Contraindications
- Moderate to severe spasticity in the lower leg
- Moderate to severe oedema
- 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 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 gener ally be discussed with the patient.
2.5 Lifetime
The product is designed for a maximum lifetime of 1 year.
2.6 Effects
The ankle foot orthosis provides lifting of the foot and limits plantar
flexion.
Safety
3.1 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.
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.
► 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 accidents due to restricted body function
► Observe the applicable legal and insurance regulations for the operation of
motor vehicles and have your driving ability examined and certified by an
authorised agency.
INFORMATION
► The daily duration of use and period of application are generally determined
by the physcian.
► 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).
4.1 Size Selection
► Select the orthosis size based on the shoe size (see sizing table).
4.2 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
Use of the product without shoes
Risk of injury due to slipping on slippery surfaces
► Do not use the product on slippery surfaces.
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.
-
If necessary: Thermoplastically re-form the orthosis by applying gentle heat to a limited extent.
NOTICE! Re-forming the orthosis in cold conditions or at temperatures above 80 °C is not permitted. -
If necessary: Lightly sand the orthosis in the heel area (see fig. 2) and affix the supplied rub ber pad (see fig. 1, item 3) with double-sided adhesive tape (see fig. 3).
-
Attach the calf pad (see fig. 1, item 4) using the supplied hook-and-loop tabs (see fig. 1, item 2) (see fig. 4).
-
Attach the pad (see fig. 1, item 1) to the shin strap.
4.3 Application
CAUTION
Incorrect or excessively tight application
Risk of local pressure and constriction of blood vessels and nerves due to
improper or excess ively tight application
► Ensure that the product is applied properly and fits correctly.
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.).
- Position the foot in the orthosis; note the position of the heel and forefoot (see fig. 5).
- Put the upper hook and loop strap through the loop and fasten it (see fig. 6).
- Fasten the lower hook and loop strap on the forefoot (see fig. 7).
- Pull the middle hook and loop strap from the inside of the foot across the top of the foot, through the outer strap guide loop, and tighten the strap till the heel fits snugly in the shell (see fig. 8).
- Stretch the elastic functional strap and fasten it (see fig. 9).
4.4 Cleaning
NOTICE
Use of improper cleaning agents
Damage to the product due to use of improper cleaning agents
► Only clean the product with the approved cleaning agents. Clean the orthosis
regularly:
- Remove the padding from the orthosis.
- Recommendation: Use a laundry bag or net.
- Hand wash the padding in warm water at 30°C with standard mild detergent. Do not use fab ric softener. Rinse thoroughly.
- Allow to air dry. Do not expose to direct heat sources (e.g. sunlight, stove or radiator).
- Reattach the padding to the orthosis.
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.
6.1 Liability
The manufacturer will only assume liability if the product is used in
accordance with the descrip tions 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
unauthorised modification of the product.
6.2 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.
………………..
Ottobock SE & Co. KGaA
Max-Näder-Straße 15 · 37115 Duderstadt · Germany
T +49 5527 848-0
F +49 5527 848-3360
[email protected]
www.ottobock.com
© Ottobock · 647G1107=all_INT-08-2108