Otto Bock Agilium Reactive 50K324-US User manual

50K324-US Agilium Reactive
Instructions for use .................................................................... 4
Instructions d'utilisation ............................................................. 9

5431766662
1
2 3
4 5
2

6
aterial I, PP, P , PU, PES, EL, PE Schaum / PE foam, Stahl / steel
3

1 Foreword English
INFORMATION
Last update: 2017-06-20
►Please read this document carefully before using the product.
►Follow the safety instructions to avoid injuries and damage to the prod
uct.
►Instruct the user in the proper and safe use of the product.
►Please keep this document in a safe place.
These instructions for use provide important information on the fitting and
application of the 50K324 Agilium Reactive knee joint brace.
2 Product description
Fig. 1/
Item:
Designation Fig. 1/
Item:
Designation
1 Brace 2 Allen wrench
3 Screwdriver 4 Joint stop for flexion limita
tion
5 Joint stop for extension lim
itation
6 Strap guide loop
7 Condyle pad
3 Intended use
3.1 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.
3.2 Indications
• Unicompartmental knee osteoarthritis
• Post-operative fitting after meniscus reconstruction
• Ligament injuries requiring unilateral relief
The indication must be determined by the physician.
3.3 Contraindications
3.3.1 Absolute Contraindications
None known.
4

3.3.2 Relative Contraindications
The following indications require consultation with a physician: skin dis
eases/injuries; inflammation; prominent, swollen scars; reddening and
hyperthermia of the treated limb; pronounced varicose veins, especially with
impaired return flow; lymphatic flow disorders, including unclear soft tissue
swelling distal to the body area where the device will be applied; sensory
and circulatory disorders in the legs, e.g. associated with diabetic neuropa
thy.
• Planar osteoarthritis
3.4 Mechanism of Action
The brace relieves the medial or lateral compartment of the knee joint using
the three-point principle. In the process, corrective force is applied to the
contralateral condyle.
4 Safety
4.1 Explanation of warning symbols
CAUTION Warning regarding possible risks of accident or injury.
NOTICE Warning regarding possible technical damage.
4.2 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.
CAUTION
Breakage of the brace frame or joint due to improper shaping
Injuries caused by sharp edges, loss of function
5

►Avoid adapting the brace repeatedly.
►Do not make any improper changes to the brace.
►Inform your patient.
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 brace is applied properly and fits correctly.
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
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.
NOTICE
Contact with ointments, lotions, or other products that contain oils
or acids
Insufficient stabilization due to loss of material functionality
►Do not expose the product to ointments, lotions, or other products that
contain oils or acids.
5 Handling
INFORMATION
►The daily duration of use and period of application are generally deter
mined by the physician.
6

►The initial fitting and application of the product must be carried out by
qualified personnel according to the instructions of the treating physi
cian.
►Consult a physician if any exceptional changes are noted (suchas
worsening of the complaint).
5.1 Application
> The patient should be seated.
> The knee joint should be slightly bent and relieved of pressure.
1) Slide the brace over the leg from the front. When doing this, the brace
joint must be on the lateral side of the affected compartment.
2) Position the brace on the leg in such a way that the brace joint is at the
height of the middle of the patella (see fig.2).
3) Fasten the top strap for the lower leg. When doing so, be sure that the
tibia pad is under the fastening strap.
4) Close the rest of the straps in the following order: the bottom lower leg
strap, the bottom upper leg strap, the top upper leg strap. Do this by
pulling the straps through the strap guide loops and fastening them.
5) Ensure that the brace is in a firm and comfortable position.
5.2 Adaptation
Adjusting the corrective force
>Prerequisite: The patient should be seated.
>Prerequisite: The knee joint should be relieved of pressure and slightly
bent.
1) Set the corrective force on the socket screw above the brace joint (see
fig.3). This changes the varus/valgus angle of the brace (see fig.6).
2) Check the corrective force while standing and walking.
3) If necessary, adapt the corrective force until the desired adjustment has
been made.
Optional: shorten the bottom lower leg and upper leg straps
1) Remove the Y-hook-and-loop.
2) Shorten the straps to the required length.
3) Stick the Y-hook-and-loop onto the strap.
7

Optional: shorten the top lower leg strap
1) Loosen the hook-and-loop closure on the strap guide loop.
2) Remove the hook-and-loop circle.
3) Shorten the strap to the desired length.
4) Fasten the hook-and-loop circle to the top lower leg strap.
Optional: limiting the knee flexion and extension
The extension limitation at delivery is 0°. The flexion is not limited.
1) Remove the condyle pad.
2) To limit the extension, remove the anterior screw. To limit the flexion,
remove the posterior screw.
3) Choose the joint stops appropriate for the desired flexion and extension.
4) Insert the joint stops into the brace knee joint. Insert the joint stop for
extension limitation at the front and the joint stop for flexion limitation at
the back. Ensure that the heads of the joint stops are pointing outwards
(see fig.4).
5) Secure the joint stop with the screw (see fig.5).
6) Re-attach the condyle pad.
5.3 Removal
>Prerequisite: The patient should be seated.
>Prerequisite: The knee joint should be relieved of pressure and slightly
bent.
1) Open and unfasten all straps.
2) Pull the brace forwards off the leg.
5.4 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.
1) Remove the straps and pads from the brace.
2) Fasten all hook-and-loop closures.
3) Hand-wash the straps and pads in warm water at 30°C (86°F) using
neutral detergent. Rinse thoroughly.
4) Allow to air dry. Do not expose to direct heat sources (e.g.sunlight,
stove or radiator).
5) If the brace comes into contact with salt water or dirt, rinse with clear
water and allow to air-dry.
8

6 Disposal
Dispose of the product in accordance with national regulations.
7 Legal Information
All legal conditions are subject to the respective national law of the country
of use and may vary accordingly.
7.1 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 unautho
rized modification of the product.
7.2 CE Conformity
This product meets the requirements of the European Directive 93/42/EEC
for medical devices. This product has been classified as a class I device
according to the classification criteria outlined in Annex IX of the directive.
The manufacturer therefore drew up the declaration of conformity on its own
responsibility in accordance with Annex VII of the directive.
1 Avant-propos Français
INFORMATION
Date de la dernière mise à jour: 2017-06-20
►Veuillez lire attentivement l’intégralité de ce document avant d’utiliser le
produit.
►Respectez les consignes de sécurité afin d’éviter toute blessure et en
dommagement du produit.
►Apprenez à l’utilisateur à bien utiliser son produit et informez-le des
consignes de sécurité.
►Conservez ce document.
Les présentes instructions d’utilisation vous apportent des informations im
portantes pour adapter et poser l’orthèse pour articulation de genou Agilium
Reactive 50K324.
9

2 Description du produit
Ill.1/
Pos.:
Désignation Ill.1/
Pos.:
Désignation
1 Orthèse 2 Clé Allen
3 Tournevis 4 Cale pour articulation limi
tation de la flexion
5 Cale pour articulation limi
tation de l’extension
6 Boucle de renvoi
7 Pelote pour condyle
3 Utilisation conforme
3.1 Usage prévu
L’orthèse est exclusivement destinée à un appareillage orthétique de
l’extrémité inférieure et elle est conçue uniquement pour entrer en contact
avec une peau intacte.
Il est impératif d’utiliser l’orthèse conformément aux indications.
3.2 Indications
• Gonarthrose unicompartimentale
• Appareillage post-opératoire après une reconstruction du ménisque
• Blessures du ligament qui requièrent une décharge unilatérale
L’indication est déterminée par le médecin.
3.3 Contre-indications
3.3.1 Contre-indications absolues
Inconnues.
3.3.2 Contre-indications relatives
Les indications suivantes requièrent la consultation d’un médecin: lésions
ou affections cutanées; inflammations; cicatrices exubérantes avec
œdème; rougeurs et hyperthermie dans la zone du corps appareillée; va
rices importantes, en particulier avec troubles du reflux veineux, troubles de
la circulation lymphatique et également œdèmes inexpliqués des parties
molles du côté distal par rapport à l’orthèse; troubles de la perception et de
la circulation sanguine dans la zone des jambes, par exemple en cas de neu
ropathie diabétique.
• Arthrose évoluée stade 4
10