DeRoyal UNIVERSAL RECOVERY POST-OP KNEE BRACE Quick Start Manual

DEROYAL® UNIVERSAL RECOVERY
POST-OP KNEE BRACE
SINGLE PATIENT USE
NON STERILE
MEDICAL DEVICE
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.
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 brace. Use only on the person it was
provided to by a healthcare professional and only for the use it
was intended.
INTENDED USE
The DeRoyal Universal Recovery Post-Op Knee Brace is used
®
for external fixation or support of the knee.
INDICATIONS
Post-operative stabilization and rehabilitation; post total knee
replacement; Post ORIF; fractures of the femur, tibia, fibula or
patella; ligament reconstructive procedures; meniscal repairs;
post-fracture management.
WARNINGS
• Inspect brace for damaged or missing components before
use.
• Discontinue use and consult your prescriber if the brace 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 brace
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. The
prescriber should communicate these risks to the user and
determine the treatment plan.
CAUTIONS
• A physician or properly licensed practitioner (a "prescriber")
who is familiar with the use and purpose of this brace
must fit it to the user. The prescriber has a duty to provide
wearing instructions and risks related to the use of this
brace 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.
• Inspect the fit of the brace 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.
• While not a contraindication, take special care if the user
is diabetic or has poor circulation. These users may have
decreased skin sensitivity and are at greater risk for poor
peripheral circulation and pressure injuries.
• Once the sizing and range of motion limitations are set,
use caution while wearing to ensure these settings are not
inadvertently adjusted.
• Metal components could cause injury to the user or others.
Exercise care in situations where contact is likely.
INSTRUCTIONS FOR USE
BASIC APPLICATION
1. Open all four straps and press the quick-release button at
the top of each lever buckle to open the brace (FIG 1).
2. Loosen all straps.
3. Disengage all straps from the blue strap lock hook (FIG 2)
and pull the struts apart (FIG 3).
4. Unlock each range of motion (ROM) hinge by sliding the
blue drop lock button upward to the unlocked position.
(FIG 4)
5. Align the hinges of the brace with the knee joint.
POSITIONING CUFFS
1. Adjust the length of the brace by pressing down on the
round adjustment button (FIG 5) and slide the end cuff to
the required length. Release the round adjustment button
to lock the cuff in place. IMPORTANT: Adjust the length of the
brace to provide optimal knee stability. Brace should fit 2"
below groin and above the ankle. Ensure each strut is equal
in length.
2. The cuffs located below and above the ROM hinges can
be moved to accommodate incision sites or for desired
comfort or fit. To move these cuffs, press down on the
round adjustment button and slide cuffs to the desired
position (FIG 5). Once the desired position is achieved,
release the round adjustment button to lock the cuffs in
place.
SECURING TO PATIENT
1. Hold the brace to prevent it from moving. Secure the straps
by engaging the lever buckle (FIG 6).
2. Straps lengths should be adjusted then tightened in the
following order: upper calf, lower thigh, lower calf, then
upper thigh.
STRAP LENGTH ADJUSTMENT
Strap length can be adjusted by removing the Y-tab closure
on the strap ends, trimming straps to desired length, and
reapplying the Y-tab closures to the strap ends. (FIG 7)
IMPORTANT: Applying the straps too tight may lead to slow
blood circulation or downward movement of the brace.
ADJUSTING FIT
From the side view, the hinge should be slightly behind the
midline of the knee. It is normal for the brace to migrate during
use. Adjust the position of the straps and brace if necessary.
ADDITIONAL STRAP PADDING
The DeRoyal Universal Recovery post-operative knee brace
also features additional strap padding to help prevent