ottobock 50S1 Dyna Ankle Bock Foot and Ankle Support Orthosis Instruction Manual

: June 4, 2024
: ottobock

Table of Contents

Material
Intended use
Safety
Handling
Cleaning
Disposal
Legal information
Documents / Resources

50S1 Dyna Ankle
Instructions for use

ottobock 50S1 Dyna Ankle Bock Foot and Ankle Support
Orthosis

ottobock 50S1 Dyna Ankle Bock Foot and Ankle Support Orthosis -
FIG

| 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

| ottobock 50S1 Dyna Ankle Bock Foot and Ankle Support Orthosis [pdf] Instruction Manual
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