ottobock 8353 Genu Direxa Wraparound Knee Bracing and Supports Instruction Manual
- June 5, 2024
- ottobock
Table of Contents
ottobock 8353 Genu Direxa Wraparound Knee Bracing and Supports Instruction
Manual
1. Foreword
INFORMATION
Date of last update: 2021-01-13
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Please read this document carefully before using the product and observe the safety notices.
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Instruct the user in the safe use of the product.
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Please contact the manufacturer if you have questions about the product or in case of problems.
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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 the fitting and application of the 8356. Genu Direxa and 8353 Genu Direxa wraparound knee joint braces.
2. Intended use
2.1 Indications for use
The brace is intended exclusively for orthotic fittings of the lower limbs and
exclusively for contact with intact skin.
The brace must be used in accordance with the indications.
2.2 Indications
- Knee pain with mild to moderate ligament laxity and/or mild to moderate feeling of instability
- Posttraumatic and postoperative instability and/or feeling of instability
- Gonarthrosis with initial to moderate degenerative ligament instability and/or slight to moderate feeling of instability (mainly involving the cruciate ligament)
- Rheumatoid arthritis
- Patellofemoral pain syndrome (e.g. chondromalacia patellae, chondropathia patellae, retropatellar osteoarthritis)
The indication must be determined by the physician.
2.3 Contraindications
2.3.1 Absolute Contraindications
None known.
2.3.2 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 distant to the body area to which the
medical device will be applied; sensory and circulatory disorders in the leg
area.
2.4 Mechanism of Action
The brace improves neuromuscular function, proprioreception and circulation.
It supports sensorimotor functions and circulation, promotes the resorption of
edemas and can relieve pain.
3. Safety
3.1 Explanation of warning symbols
CAUTION Warning regarding possible risks of accident or injury.
NOTICE Warning regarding possible technical damage.
3.2 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.
4. 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).
4.1 Selecting the Size
- Measure the circumference of the thigh 15 cm above the center of the patella.
- Measure the circumference of the lower leg 15 cm below the center of the patella.
- Determine the size of the brace (see size chart).
4.2 Fitting and Application
NOTICE
Use of a worn or damaged product
Limited effectiveness
- Before each use, check the product for functional reliability and for possible wear or damage.
- Do not continue using a product that is no longer functional, or that is worn or damaged.
4.2.1 Adaptation
The joint bars are fitted individually by trained qualified personnel.
4.2.2 Application
CAUTION
Use with heat-sensitive skin
Skin irritation due to overheating
- Do not use the product in case of a known heat allergy.
- Do not continue to use the product if skin irritation occurs.
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.
8356 Genu Direxa
Open all hook-and-loop closures on the brace.
The patient is sitting on the front edge of a chair.
- Hold the brace on both sides with the donning loops and pull it over the knee until the patella cutout is centered on the patella (see fig. 1 and see fig. 2).
- Close the hook-and-loop straps first below and then above the patella (see fig. 2 and see
fig. 3).
8353 Genu Direxa wraparound
- Open all hook-and-loop closures on the brace.
- The patient is sitting on the front edge of a chair.
- Wrap the brace around the knee from behind (see fig. 4).
- Center the patella cutout over the patella.
- Fasten the hook-and-loop closure below the patella cutout while applying tension. Make sure that the hook-and-loop sections are placed over one another (see fig. 5).
- Fasten the hook-and-loop closure above the patella cutout while applying tension. Make sure that the hook-and-loop sections are placed over one another (see fig. 5).
- Fasten the straps first below and then above the patella. Make sure that the hook-and-loop
sections are placed over one another (see fig. 6 and see fig. 7).
4.3 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.
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Pull the black strap upwards to remove the bracket over the joint bar (see fig. 8).
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Pull the joint bars out of the brace (see fig. 9).
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Fasten all hook-and-loop closures.
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Recommendation: Use a laundry bag or net.
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Wash the brace in warm water at 40 °C (104 °F) with standard mild detergent. Do not use
fabric softener. Rinse well. -
Allow to air dry. Do not expose to direct heat sources (e.g. sunlight, stove or radiator).
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Reinsert the joint bars. INFORMATION: The labelling on the joint bars must be visible from the outside.
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Pull the black strap first upwards and then downwards to position the bracket over the joint
bar (see fig. 8).
5. Disposal
Dispose of the product in accordance with national regulations.
6. Legal Information
All legal conditions are subject to the respective national law of the country
of use and may vary
accordingly.
6.1 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.
6.2 Liability
The manufacturer shall be liable in the event that the product is used in
accordance with the
descriptions and instructions 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.
6.3 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
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