ottobock 8360 Genu Carezza Patella Stabilizer Instruction Manual

: June 3, 2024
: ottobock

ottobock 83 60 Genu Carezza Patella Stabilizer

ottobock-8360-Genu-Carezza-Patella-Stabilizer-01

Foreword

INFORMATION
Date of last update: 2021-03-19

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 the fitting and application of the 8360 Genu Carezza patella stabilizer knee support.

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

Patellofemoral pain syndrome (e.g. chondromalacia patellae, chondropathia patellae, retro patellar osteoarthritis)
Patellofemoral malt racking
Following patellar dislocation/subluxation
After lateral release operations
The indication must be determined by the physician.

Contraindications

Absolute Contraindications
None 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/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.

Mechanism of Action

The support stabilizes the kneecap laterally and relieves 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).

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 support (see size chart).

Fitting and 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.

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.

The patient is sitting on the front edge of a chair.
Open all hook-and-loop closures on the support.

Hold the support by the top edge on both sides and pull it over the knee until the patella cutout is centered on the patella.
Fasten the straps first below and then above the patella (see fig. 1). 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.

Fasten all hook-and-loop closures.
Recommendation: Use a laundry bag or net.
Wash the support in warm water at 40 °C (104 °F) 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).

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 support regularly:

Fasten all hook-and-loop closures.
Recommendation: Use a laundry bag or net.
Wash the support in warm water at 40 °C (104 °F) 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 law of the country of use and may vary accordingly.

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.

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.

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.