DeRoyal M5168 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
product.
INTENDED USE
The DeRoyal®Gait Belts are intended to be
prescribed by a properly licensed practitioner to
provide caregivers a secure point to hold while
assisting patients with walking and/or transfer.
CAUTION
• A physician or properly licensed practitioner (a
“prescriber”) who is familiar with the use and
purpose of this product must fit it to the user.
The prescriber has a duty to provide wearing
instructions and risks related to the use of this
product 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.
• DO NOT attempt to use this device on an
incoherent patient.
• DO NOT apply the device where any I.V. or wound
site could be compromised.
• Inspect product for damaged or missing
components before use. Discontinue use and
consult your prescriber if the product or its
components break, become damaged or if
cleaning is insufficient.
• Inspect the fit of the product on the patient to
ensure fit is proper. DO NOT OVERTIGHTEN.
• Consult your prescriber immediately if you
experience sensation changes, unusual reactions.
Swelling or increased pain while using this
product. Discontinue use if pressure injuries
develop.
INSTRUCTIONS FOR USE
1. Wrap the belt around the
patient’s waist with the buckle
closure in front.
2. Feed the end of the belt
through the buckle and secure
buckle closure. Make sure the
buckle lever is pressed down
completely.
QUICK-RELEASE BUCKLE
CLOSURE
Insert the male end into the
female end of the buckle. Pull
excess strap to adjust waist
circumference.
NOTE: The product should fit snug,
but remain comfortable.
CLEANING INSTRUCTIONS
Use hospital approved cleaning
wipes. Thoroughly wipe all
surfaces of device. Allow treated
surfaces to remain wet for a full 2
minutes. Air dry completely prior
to use. If the inside of the buckle
becomes contaminated, discard.
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.
WIPEABLE GAIT BELT
NON-STERILE
MAGNETIC RESONANCE SAFE
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.
2A
2B
2C
NOTE
1

Part#0-1819 Revised 3/2021
©2021 DeRoyal Industries, Inc.
All Rights Reserved. DeRoyal, the DeRoyal logo, and Improving
Care. Improving Business. are trademarks or registered
trademarks of DeRoyal Industries, Inc.
Manufactured by:
DeRoyal Industries, Inc.
200 DeBusk Lane
Powell, TN 37849 USA
888.938.7828 or [phone].7828
www.deroyal.com