DeRoyal SOFT OA KNEE BRACE User manual

IMPORTANT INFORMATION
Please read all warnings and instructions
before use. Correct application is essential for
proper product function and to reduce the risk of
injury or re-injury inherent with the use of any
support.
INTENDED USE
The DeRoyal®Soft OA Knee Brace is intended
for mild to moderate unicompartmental knee
osteoarthritis with ligament instabilities and
increased rehabilitative and functional support for
diagnoses that require medial or lateral joint loads.
WARNING
• Inspect support for damaged or missing
components before use.
• Discontinue use and consult your prescriber if
the support or its components break or become
damaged.
• Prolonged usage can result in muscle atrophy
in the user. The user may require (1) a weaning
period from the support to build muscle strength
(2) regular physical therapy exercises to maintain
the strength of the leg (3) a limitation on duration
of use, or (4) some combination of these.
CAUTIONS
• A physician or properly licensed practitioner (a
“prescriber”) who is familiar with the use and
purpose of this support must fit it to the user.
The prescriber has a duty to provide wearing
instructions and risks related to the use of this
support to other healthcare practitioners treating
the users and the users themselves, including
duration of use. The instructions provided in this
sheet do not supersede hospital protocol or direct
orders of the prescriber.
• Use only as directed by a medical professional.
• Inspect the fit of the support on the patient to
ensure fit is proper. DO NOT OVERTIGHTEN.
Check regularly to ensure circulation is not
compromised.
• Consult your prescriber immediately if you
experience sensation changes, unusual reactions,
swelling or increased pain while using this brace.
Discontinue use if pressure injuries develop.
• Take special care if the user is diabetic or
has poor circulation as these users may have
decreased skin sensitivity and are at greater
risk for poor peripheral circulation and pressure
injuries.
INSTRUCTIONS FOR USE
TO POSITION BRACE:
1. Sit with knee slightly (5° -
10°) bent.
2. Position the brace by
placing the hinge on
the side of the knee
opposite of your affected
compartment.
MEDIAL OA: Place hinge
on OUTSIDE of knee.
LATERAL OA: Place hinge
on INSIDE of knee.
NOTE: The brace needs to
be applied directly to the
skin and should NOT be
worn over clothing.
3. Hold the brace by the
hinge and position the
hinge center (marked by
the grey extension stop)
even with the TOP of
your kneecap and slightly
posterior (towards the
back) to your leg (see
Image 1).
TO FASTEN WRAP:
1. Secure the top and
bottom wrap on your leg
according to the numbers
on the inside of the brace,
maintaining the hinge in
position. (See Image 2 &
Image 2a)
2. Secure the middle two straps according to the
numbers on the inside of the brace above and
below your knee cap (see Image 3).
SOFT OA KNEE BRACE
SINGLE PATIENT USE
NON-STERILE
NOT MADE WITH NATURAL RUBBER LATEX
RX ONLY FEDERAL U.S.A. LAW RESTRICTS THIS DEVICE
TO SALE OR USE BY OR ON THE ORDER
OF A PHYSICIAN OR PROPERLY LICENSED
PRACTITIONER.
2
1
3
2A

TO FASTEN STRAPS:
1. Pull the top strap behind
the knee and secure to the
BOTTOM buckle. Tighten
strap using hook and loop
pull (see Image 4). DO NOT
OVERTIGHTEN.
2. Pull the bottom strap
behind the knee and
secure into the Q-hinge
and turn the hex key either
clockwise or counter-
clockwise until the hinge
has the same shape or
curve as your leg (neutral).
There should be no
pressure at all on the knee
at this time. Walk around
and make sure the brace
is comfortable and that you
don’t feel pressure.
3. Sit back down and bend
knee at least 30°, then
insert the hex key again
into the Q-hinge and turn
away from your body
about a ¼ turn (90°). This
is approximately 3° of
correction and you should
feel gentle pressure, try
another ⅛and ¼ turn.
Stand up and walk around
in the brace. DO NOT
OVERCORRECT as this
will cause discomfort and
may increase your pain
over time.
WEAR TIME
Gradually increase brace wear time to allow your
body to adjust to the brace. Start with 30 minutes
on day one and gradually increase. Pain caused
by osteoarthritis may take time to subside. It is
important that you routinely wear the brace when
your are on your feet as it will reduce joint loading
and allow you to begin feeling relief to become
significant.
CARE INSTRUCTIONS
Hand wash in lukewarm water with a mild detergent.
Air dry prior to wearing. DO NOT machine wash or
dry.
STORAGE AND TRANSPORT CONDITIONS
KEEP DRY
KEEP AWAY FROM SUNLIGHT
WARRANTY
DEROYAL®PRODUCTS ARE WARRANTED FOR
NINETY (90) DAYS FROM THE DATE OF SHIPMENT
FROM DEROYAL AS TO PRODUCT QUALITY
AND WORKMANSHIP. DEROYAL’S WRITTEN
WARRANTIES ARE GIVEN IN LIEU OF ANY
IMPLIED WARRANTIES, INCLUDING WARRANTIES
OF MERCHANTABILITY OR FITNESS FOR A
PARTICULAR PURPOSE.
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Part#0-1948 Revised 12/18
©2018 DeRoyal Industries, Inc.
All Rights Reserved. DeRoyal, the DeRoyal logo and Improving
Care. Improving Business. are trademarks or registered
trademarks of DeRoyal Industries, Inc.
Distributed by:
DeRoyal Industries, Inc.
200 DeBusk Lane
Powell, TN 37849 USA
888.938.7828 or 865.938.7828
www.deroyal.com
Distributed in the US & Worldwide
by DeRoyal Industries, Inc.
DeRoyal B.V.
Kantstraat 19
NL-5076 NP Haaren
The Netherlands