ottobock 50S1 Dyna Ankle Bock Foot and Ankle Support Orthosis Instruction Manual
- June 4, 2024
- ottobock
Table of Contents
50S1 Dyna Ankle
Instructions for use
| Shoe size
35 – 37
37 – 39
39 – 41
41 – 44
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Material
PA, PE, PES, PP, PU, TPU, steel
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.
2.2 Indications
- Conservative treatment of lateral ankle ligament ruptures
- Post-operative protection after suturing or reconstruction of the lateral ligaments of the upper ankle joint
2.3 Contraindications
2.3.1 Absolute Contraindications
Not known.
2.3.2 Relative Contraindications
The following indications require consultation with a physician: skin
diseases/injuries, inflamma on, prominent scars that are swollen, reddening,
and hyperthermia of the fitted limb/body area; lymphatic flow disorders,
including unclear soft tissue swelling distant to the body area to which the
medical device will be applied; for sensory and circulatory disorders in the
leg area.
- Condition following deep vein thrombosis of the leg and/or postthrombotic syndrome of the affected leg
2.4 Lifetime
The product is designed for a maximum lifetime of 6 months.
2.5 Effects
The orthosis sets the foot to slight pronation and dorsal extension. The
dynamic restraint limits plantar flexion and supination while pronation and
dorsiflexion movements remain unrestricted. The orthosis relaxes the anterior
talofibular ligament.
Safety
3.1 Explanation of warning symbols
Warning regarding possible serious risks of accident or injury.
Warning regarding possible risks of accident or injury.
Warning regarding possible technical damage.
3.2 General safety instructions
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
authorized agency.
CAUTION
Reuse of 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.
NOTICE
Contact with oils, salves, lotions, or other products that contain oils or
acids
Insufficient stabilization due to loss of material functionality
► Do not expose the product to oils, salves, lotions or other products that
contain oils or acids.
NOTICE
Use of a worn or damaged product
Limited effectiveness
► Before each use, check the product for functional reliability and for
possible wear or dam age.
► Do not continue using a product that is no longer functional, or that is
worn or damaged.
NOTICE
Use without suitable footwear
Restriction of functionality due to insufficient stabilization
► Only use the orthosis with closed footwear, taking the allowable effective
heel height into account.
Handling
INFORMATION
► The daily duration of use and period of application is generally determined
by the physi can.
► 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 Fitting and Application
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 authorized, qualified personnel.
CAUTION
Improper molding 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 excess lively tight application
► Ensure that the product is applied properly and fits correctly.
- Optional: thermoforming the brace: Thermoform the brace to adjust the fit. In order to do so, remove all hook and loop straps, heat the brace to 90 °C max. and reshape it.
- Optional: attach additional pads with hook and loop: In case of pressure sensitivity in the area of the ankle or shin, attach the additional pads with hook and loop straps (see fig. 1 and see fig. 2).
- Optional: apply for anti-slip protection: Clean the bonding surface in the area of the heel, roughen with fine sandpaper and attach the pimple rubber in the heel area using the supplied double-sided adhesive tape.
- Open all hook and loop straps.
- Set the foot into the brace. In doing so, ensure that the heel and forefoot are positioned com fortably.
- Pull the middle hook and loop strap from the inside of the foot across the top of the foot and through the outer loop, and tighten it until the heel fits in the shell. Fasten the hook and look strap in doing so.
- Put the upper hook and loop strap through the loop and fasten it (see fig. 3).
- Put the lower hook and loop strap through the loop and fasten it.
- Stretch the functional strap and fasten it (see fig. 4).
- Open the shoe wide, pull it over the applied brace and lace it.
Cleaning
NOTICE
Use of improper cleaning agents
Damage to the product due to the use of improper cleaning agents
► Only clean the product with the approved cleaning agents.
- Remove the straps from the orthosis.
- Fasten all hook-and-loop closures.
- Hand-wash the straps and pads in warm water at 30 °C (86 °F) using neutral detergent. Rinse thoroughly.
- Allow airing 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.
7.1 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.
7.2 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
unauthorized modification of the product.
7.3 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
healthcare@ottobock.de ·
www.ottobock.com
© Ottobock · 647G1538=all_INT-31-2110
Documents / Resources
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ottobock 50S1 Dyna Ankle Bock Foot and Ankle Support
Orthosis
[pdf] Instruction Manual
50S1, Dyna Ankle Bock Foot and Ankle Support Orthosis, Dyna Ankle Bock Foot,
Bock Foot, Ankle Support Orthosis, 50S1, Support Orthosis
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