ottobock 509 Hallux Valgus Instruction Manual

: June 3, 2024
: ottobock

ottobock 509 Hallux Valgus

Foreword

INFORMATION

Date of last update: 2021-02-23

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 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 provide important information on applying the foot supports 509 Hallux Valgus ComforT and 510 Hallux Valgus Combo ComforT.

Intended use

Indications for use

The support is intended exclusively for fittings of the lower limbs and exclusively for contact with intact skin.
The support must be used according to the indication.

Indications

Hallux valgus (malposition of the metatarsophalangeal joint of the big toe)

Indications must be determined by the physician.

Contraindications

Absolute Contraindications
Not known.

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; pronounced varicose veins, especially with return flow impairment, lymphatic flow disorders, including unclear soft tissue swelling distant to the body area to which the support will be applied; sensory and circulatory disorders in the foot area, e.g. in case of diabetic neuropathy.

Effects

The support promotes the muscular correction of toe positioning and alleviates pain.

Safety

Explanation of warning symbols

CAUTION Warning regarding possible risks of accident or injury.
NOTICE Warning regarding possible technical damage

General safety instructions

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
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.

NOTICE
Improper use and changes
Change in or loss of functionality as well as damage to the product

Use this product with care and only for its intended purpose.
Do not make any improper changes to the product.

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.

Handling

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).

Application

CAUTION
Incorrect or excessively tight application
Skin irritation due to overheating, local pressure points due to tight application to the body.

Ensure that the product is applied properly and fits correctly.
When in doubt, do not continue to use the product if skin irritation occurs.

509 Hallux Valgus Comfort

Open all hook-and-loop closures on the support.
The patient is sitting on the front edge of a chair.
1. Pull the loop over the big toe (see fig. 1).
2. Pull the longer strap underneath the foot at an angle to the outside and wrap it around behind the heel (see fig. 2).
3. Pull the longer strap in the direction of the big toe and fasten it to the short strap with the hook-and-loop (see fig. 3).
4. Optional: Shorten the strap to the desired length (see fig. 4).

510 Hallux Valgus Combo ComforT

Open all hook-and-loop closures on the support.
The patient is sitting on the front edge of a chair.
1. Pull the loop over the big toe (see fig. 5).
2. Pull the longer strap underneath the foot at an angle to the outside and wrap it around behind the heel (see fig. 6).
3. Wrap the longer strap once around the shin (see fig. 7).
4. Pull the longer strap in the direction of the big toe and attach it to the short strap with the hook-and-loop.
5. Optional: Shorten the strap to the desired length (see fig. 8).

Cleaning

Fasten all hook-and-loop closures.
Recommendation: Use a laundry bag or net.
Wash the support in warm water at 40 °C with standard mild detergent.
Do not use fabric softener. Rinse thoroughly.
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.

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.

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