DeRoyal PACESETTER 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 brace.
INTENDED USE
The DeRoyal® Pacesetter™Air Walker is
intended for grade 2 and 3 ankle sprains,
stable fractures of tibia, bula, talus and
tarsus, post operative immobilization (soft
tissue reconstructions and open reduction
internal xation), and metatarsal fractures.
CAUTIONS
• A physician or properly licensed practitioner
(a “prescriber”) who is familiar with the use
and purpose of this brace must t 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 by medical
professional.
• 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
foot/ankle (3) a limitation on duration of
use or (4) some combination of these.
• 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.
• Inspect the t of the brace on the patient to
ensure t 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
NOTE: A sock should be worn with this boot.
1. Release hook and loop straps and remove
inner liner/wrap from walker.
2. With patient seated, position foot and lower
leg into liner/wrap making sure that the
heel is positioned at the back of the liner/
wrap. Secure liner/
wrap around foot
and lower leg by
fastening the hook
and loop closures
making sure the
liner/wrap is snug,
but comfortable.
3. Insert foot and lower
leg into walker.
4. Carefully center
the uprights on the
medial and lateral
sides of the ankle to
ensure a comfortable
t and proper
support. Remove
covers from uprights.
Use attached hook
to secure the upright
to the liner/wrap.
5. Fasten hook
and loop straps,
PACESETTER™ AIR WALKER
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.
12
5
6
4
7

beginning from the bottom and working
your way up the leg.
6. To inate the air bladder and increase
compression, turn the air valve clockwise
until secure. Press the air bulb at the top of
the liner/wrap until desired compression
is achieved (see image 6). To deate the air
bladder, turn the air valve counterclockwise
(see image 7). Adjust compression as
needed for a snug, but comfortable t.
CARE INSTRUCTIONS
Liner may be hand washed in lukewarm water
with a mild detergent and air dried prior to
wearing. Plastic/metal portions of uprights
may be wiped with an antibacterial wipe.
STORAGE AND TRANSPORT CONDITIONS
KEEP DRY
KEEP AWAY FROM SUNLIGHT
In addition to the competent authority in the
country where the patient resides, serious
incidents must be reported to DeRoyal
Industries, Inc.
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.
Manufactured by:
DeRoyal Industries, Inc.
200 DeBusk Lane
Powell, TN 37849 USA
888.938.7828 or [phone].7828
www.deroyal.com
PART #1-1578 I `REVISED 1/2023
©2023 DEROYAL INDUSTRIES, INC.
All Rights Reserved. DeRoyal, the DeRoyal logo. and Pacesetter
are trademarks or registered trademarks of DeRoyal Industries, Inc.