DeRoyal M8035-I Instructions For Use

ELBOW IMMOBILIZER
SINGLE PATIENT USE
NON STERILE
MRI 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.
IMPORTANT INFORMATION
Please read all instructions, warnings and
cautions before use. Correct application
is essential for proper functioning of the
product. 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® Elbow Immobilizer is intended
to be prescribed by a properly licensed
practitioner to help prevent patients from
disturbing medical treatment.
CONTRAINDICATIONS
DO NOT use on a patient who is or may become
highly aggressive or agitated.
WARNINGS
• A physician or properly licensed practitioner
(a "prescriber") who is familiar with the use
and purpose of this device must fit it to the
user. The prescriber has a duty to provide
wearing instructions and risks related to
the use of this device 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 product for damaged or missing
components before use.
• Discontinue use and consult your prescriber
if the device or its components break or
become damaged.
• Inspect the fit of the device on the patient
to ensure fit is proper. DO NOT OVERTIGHTEN.
Check regularly to ensure circulation is not
compromised.
• Consult your prescriber immediately if the
patient experiences sensation changes,
unusual reactions, swelling or increased
pain while using this device. Discontinue
use if pressure injuries develop.
• 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.
• Avoid using if an I.V. insertion site could be
compromised.
• DO NOT allow patient to ingest product
material.
INSTRUCTIONS FOR USE
1. Reference sizing chart
to ensure correct size for
patient.
2. Open immobilizer by
releasing hook-and-loop
straps.
3. Place the immobilizer under
the patient's arm with the
opening oriented toward
the inside of the arm. Adjust
the immobilizer to the
desired position on the arm,
ensuring that the elbow is
centered lengthwise. (A)
4. Starting with the strap-side,
wrap around the patient's
arm. (B)
5. Starting with the strap closest
to the shoulder, secure the
immobilizer by threading
the hook-and-loop strap
through the plastic buckles
and attaching back onto
itself. (C) Repeat with other
straps. (D) NOTE: For infant
size, secure by attaching hook straps to
corresponding loop.
6. NOTE: DO NOT OVERTIGHTEN. Two fingers should
fit between the device and the patient to
ensure circulation is not compromised.
A
B
C
D