ottobock 50K15 Orthopedic Elastic Knee Brace Instructions
- October 27, 2023
- ottobock
Table of Contents
50K15 Genu Sensa
Instructions for use 
50K15 Orthopedic Elastic Knee Brace
| GrOBe
Size| Umfang
Circumference
---|---|---
A| B| B V-MAX
cm| inch| cm| inch| cm| inch
| XXS| 25-28| 9.1-11.0| 35-38| 13.8-15.0| –| –
XS| 28-31| 11.0-12.2| 38-41| 15.0-16.1| –| –
S| 31-34| 12.2-13.4| 41-44| 16.1-17.3| –| –
M| 34-37| 13.4-14.6| 44-47| 17.3-18.5| 47-50| 18.5-19.7
L| 37-40| 14.6-15.8| 47-50| 18.5-19.7| 50-53| 19.7-20.9
XL| 40-43| 15.8-16.9| 50-53| 19.7-20.9| 53-56| 20.9-22.0
XXL| 43-46| 16.9-18.1| 53-56| 20.9-22.0| 56-59| 22.0-23.2
| Material | Knit Fabric: PA, EL |
|---|
Terry Cloth Covers: Baumwolle
Spiral Springs: verzinkter Federstahl
Pad: viskoelastisches Technogel®
Foreword
INFORMATION
Date of last update: 2021-05-11
- 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 import ant 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 50K15 Genu Sensa knee support.
Intended use
2.1 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.
2.2 Indications
- Feeling of instability
- Irritation (postoperative, posttraumatic and chronic)
- Knee pain due to stress (tendomyopathy, insertion ligamentosis)
- Joint effusion
- Swelling
Indications must be determined by the physician.
2.3 Contraindications
2.3.1 Absolute Contraindications
Not known.
2.3.2 Relative Contraindications
The following indications require consultation with a physician: skin dis
eases/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 area of the lower leg and the foot,
e.g. in case of diabetic neuropathy.
2.4 Effects
The form-knitted support promotes sensorimotor functions and thereby activ
ates muscular stabilisation of the knee joint. The support with integrated
shape-retaining pad offers relief for the kneecap.
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
Contact with oils, salves, lotions or other products that contain oils or
acids
Insufficient stabilisation 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).
4.1 Size Selection
- Measure the circumference of the thigh 14 cm above the centre of the patella.
- Measure the circumference of the lower leg 12 cm below the centre of the patella.
- Determine the size of the support (see size chart).
4.2 Application
CAUTION
Incorrect or excessively tight application
Skin irritation due to overheating, local pressure points due to tight applic
ation 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.
- Grasp the support with both hands on the side and on the upper end of the spiral springs.
- Pull the support over the knee (see fig. 1).
- Position the knee pad so that the kneecap is surrounded without pres sure (see fig. 2).
- Correct the position of the knee pad if required (see fig. 3).
- When providing the support to the patient, the proper fit and positioning of the support must be verified.
4.3 Removal
- Grasp the support with both hands on the side and on the lower end of the spiral springs.
- Pull the support down over the foot.
4.4 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:
-
Recommendation: Use a laundry bag or net.
-
Wash the support in warm water at 30 °C with standard mild detergent.
Do not use fabric softener. Rinse thoroughly. -
Allow to air dry. Do not expose to direct heat (e.g. sunshine, 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.
6.1 Liability
The manufacturer will only assume liability if the product is used in accord
ance 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 unauthor
ised modification of the product.
6.2 CE conformity
The product meets the requirements of Regulation (EU) 2017/745 on medic al
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
[email protected] ·
www.ottobock.com