Oppo GENU X Instructions For Use

OPPO GENU X
INSTRUCTIONS FOR USE
OP-2935-INS-EN-DEU
Intended Purpose
• This device is a brace for pain relief from osteoarthritis and
degenerative meniscal tears through unicompartmental
unloading of the knee.
Intended User
• This device is intended for people with unicompartmental knee
joint osteoarthritis or meniscal tears.
Indication for Use
• Mild to moderate medial or lateral osteoarthritis
• Degenerative meniscal tears
• Cartilage bone lesions
• Bone bruise
• Other knee conditions that may benefit from unicompartmental
unloading
• Condition after cartilage surgery or cartilage build-up with
necessary medial or lateral postoperative
unloading
Performance Characteristics
The brace adopts a series of advanced product designs. The
ergonomic hinged stays working with the straps build up a
3-point system to provide dynamic support.
This system generates opposite forces on target joint to ease
excessive load on unicompartmental of the knee.
The force adjusted dynamically accompany with the range of
motion to allow more pain-free movement.
Clinical Benefits
The brace provides a targeted relief and stabilization for more
movement with osteoarthritis of the knee.
Contraindication
Bilateral osteoarthritis (medial and lateral)
Warning/Precaution
• The brace provides its unloading effect during physical activity.
• For first time use, we recommend that you gradually increase
the usage time while building up tolerance to the brace.
• Remove your brace during prolonged periods of rest.
• Use the brace only as indicated and in accordance with the
further instructions of the medical professional.
• If used with other products, consult your medical professional.
• Do not make any accidental changes to the product, which may
alter the effect and cause health damage. Warranty and liability
are excluded in such cases.
• Avoid contact with fatty and acidic products, ointments or lotions.
• Outside applied braces may cause local pressure symptoms or,
in rare cases, constrict passing blood vessels or nerves.
• If you notice changes or increasing discomfort while wearing
the product, stop further use and contact your medical
professional.
• Do not use this product if there is any damage on attached
accessories, components, or the device itself.
is a registered trademark of OPPO MEDICAL INC.
Seattle City Center 1420 Fifth Ave., Ste. 220080, Seattle, WA 98101, USA
© OPPO MEDICAL INC. All rights reserved.
www.oppomedical.com
2935
OPPO MEDICAL INC.
• Regular practitioner supervision is recommended for users with:
• Skin diseases/injuries in the treated part of the body,
especially in cases of inflammation, scars with swelling,
redness and overheating
• Varicose veins (varicosis)
• Strong Baker Cyst
Notes on Reuse
This product is intended and tested for use on a single patient.
Use on more than one patient is excluded.
Product Material Content
74% Polyamide, 14% Polyester, 7% Elastane, 5% POM
Storage
Please store at room temperature. Avoid sunlight and/or
exposure to excessive heat or moisture.
Cleaning Instructions
• Close Velcro fasteners before washing.
• Hand wash at 30° with a gentle detergent
• Do not wash with softener
• Do not bleach
• Do not iron
• Do not dry clean
• Air dry, do not dry in the dryer.
• Avoid contact with chlorinated or salt water. In case of contact
rinse thoroughly with tap water.
• Below is a guide for laundry symbols on product care label.
Hand wash Do not bleach
only
Warranty
The legal provisions of the country in which you purchased the
product apply. If you suspect a warranty case, please first contact
your medical professional directly from whom you received the
brace. Please note the instructions for use and care, otherwise
the warranty may be impaired or excluded. The warranty is
excluded in the event of non-indication-compliant use,
non-compliance with the instructions of the medical professional
and in the event of unauthorized product modification.
Duty to Report
Serious incidents that occur in relation to the device should be
reported to the manufacturer and the competent authority of the
Member State in which the user resides. Our contact details can
be found on this brochure.
Environment/Disposal
All product and packaging components should be disposed of in
accordance with the applicable environmental regulations of the
respective country. If you have any questions about recycling or
environmentally sound disposal, please contact the competent
authorities.
AUTHORISED REPRESENTATIVE: MT PROMEDT CONSULTING GMBH
ADDRESS: ALTENHOFSTRAβE 80, D-66386 ST. INGBERT, GERMANY
Do not tumble Do not iron
dry
PUBLICATION: 2022-01-30
VERSION: 02
IMPORTEUR
veomedical GmbH
Enzianweg 8, 50259 Pulheim, Germany
www.veomedical.de hallo@veomedical.de
Do not dry clean