Oppo GENU X User manual

OP-2935-INS-EN-DEU
2935
OPPO GENU X
PUBLICATION: 2022-01-30
VERSION: 02
Intended Purpose
• This device is a brace for pain relief from osteoarthris and
degenerave meniscal tears through unicompartmental
unloading of the knee.
Intended User
• This device is intended for people with unicompartmental knee
joint osteoarthris or meniscal tears.
Indicaon for Use
• Mild to moderate medial or lateral osteoarthris
• Degenerave meniscal tears
• Carlage bone lesions
• Bone bruise
• Other knee condions that may benefit from unicompartmental
unloading
• Condion aer carlage surgery or carlage build-up with
necessary medial or lateral postoperave
unloading
Performance Characteriscs
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
moon to allow more pain-free movement.
Clinical Benefits
The brace provides a targeted relief and stabilizaon for more
movement with osteoarthris of the knee.
Contraindicaon
Bilateral osteoarthris (medial and lateral)
Warning/Precauon
• The brace provides its unloading effect during physical acvity.
• For first me use, we recommend that you gradually increase
the usage me 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 instrucons 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 fay and acidic products, ointments or loons.
• Outside applied braces may cause local pressure symptoms or,
in rare cases, constrict passing blood vessels or nerves.
• If you noce 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 aached
accessories, components, or the device itself.
• Regular praconer supervision is recommended for users with:
• Skin diseases/injuries in the treated part of the body,
especially in cases of inflammaon, scars with swelling,
redness and overheang
• Varicose veins (varicosis)
• Strong Baker Cyst
Notes on Reuse
This product is intended and tested for use on a single paent.
Use on more than one paent 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 Instrucons
• Close Velcro fasteners before washing.
• Hand wash at 30° with a gentle detergent
• Do not wash with soener
• 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
only
Do not iron Do not dry cleanDo not bleach Do not tumble
dry
INSTRUCTIONS FOR USE
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 instrucons for use and care, otherwise
the warranty may be impaired or excluded. The warranty is
excluded in the event of non-indicaon-compliant use,
non-compliance with the instrucons of the medical professional
and in the event of unauthorized product modificaon.
Duty to Report
Serious incidents that occur in relaon 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 regulaons of the
respecve country. If you have any quesons about recycling or
environmentally sound disposal, please contact the competent
authories.
AUTHORISED REPRESENTATIVE:MT PROMEDT CONSULTING GMBH
ADDRESS: ALTENHOFSTRAβE 80, D-66386 ST.INGBERT, GERMANY
OPPO MEDICAL INC.
Seattle City Center 1420 Fifth Ave., Ste.220080, Seattle,WA 98101, USA
www.oppomedical.com
is a registered trademark of OPPO MEDICAL INC.
© OPPO MEDICAL INC. All rights reserved.
IMPORTEUR
veomedical GmbH
Enzianweg 8, 50259 Pulheim, Germany
www.veomedical.de [email protected]

The informaon in this instrucons is applicable to the
following medical device:
2935 OPPO GENU X
Item
Number Product Name
Applicaon Instrucons
Measurement Guide
Measure the circumference of the thigh at 15cm (6 inches) above
the mid-patella and measure the circumference of the calf at 15cm
(6 inches) below the mid-patella with knee fully extended.
Before applicaon
• Open the green and white marked quick fit buckles of the brace.
Push the buckles forward unl you can li it out through the
keyhole. (picture 1&2)
Applicaon
• Bend the leg to about 30°.
• Pull the brace up unl the joint centre is approximately at the
middle of the kneecap. (picture 3)
• Make sure that the brace is straight and not twisted on the leg.
(picture 4)
• Now close the grey marked quick fit buckle. (picture 5)
Now close the green marked quick fit buckle. (picture 6)
• Your Orthost has preset the brace and explained the orientaon
value to you. If you require more or less tension adjust the length
of straps by using the velcro fasteners. (picture 7)
• Take a few steps to verify the correct posion on the leg. If
necessary, opmize the posion again. (picture 8)
Brace removal
• Bend the leg to about 30° and open the two quick fit buckles.
• Pull the brace downwards. (picture 9)
• Close the quick fit buckles. (picture 10)
This instrucons for use are also available as a PDF document and
can be downloaded from www.oppomedical.de. Visually impaired
or blind people can also have the PDF document. Read out to them
by using suitable soware.
1. 2.
3.
4.
5. 6.
7.
8.
9. 10.