General Safety Instructions; Fitting Instructions - Ossur MIAMI J SELECT Gebrauchsanweisung

• Delay to definitive treatment
• Impaired physical examination/secondary survey
Caution: Cervical spine immobilization, including use of a cervical collar,
has been associated with:
• Increased pain and discomfort, which may lead to increased spinal
movement
• Impaired swallowing
Caution: Perfumes and harsh cleaning agents should not be used on or
under the collar, as they may compromise the integrity of materials.
Caution: Use of a cervical collar for cervical spine immobilization is not
recommended in situations where patients are awake, alert, not
intoxicated, without neck tenderness or pain and without abnormal
sensory or motor findings on examination.
Caution: Regular cleaning of the collar, pads, and the skin beneath along
with inspection of the skin for any signs of irritation is required to reduce
the risk of skin ulceration. Bedridden patients are at an increased risk for
skin ulceration.
Caution: Federal law restricts this device to sale by, or on the order of,
a physician.
Precautions:
• At least two persons are needed for initial collar placement: one to
maintain the patient's head and neck in proper alignment, the second
to fit the collar.
• Collar removal or any adjustments to the collar should be done with
physician permission only and according to the physician's
instructions.
• Unless otherwise specified by the physician, the patient should not
remove the collar except to wash under it and change the pads.
• The patient will need a second person to help when cleaning the
collar.
These instructions do not supersede hospital protocol and/or direct
orders of patient's physician.

GENERAL SAFETY INSTRUCTIONS

The healthcare professional should inform the patient about everything
in this document that is required for safe use of this device.
Any serious incident in relation to the device must be reported to the
manufacturer and relevant authorities.
Patient should immediately contact a healthcare professional:
– If there is a change or loss in device functionality, or if the device
shows signs of damage or wear hindering its normal functions;
– If any pain, skin irritation, or unusual reaction occurs with the use
of the device.
The device is for single patient – multiple use.

FITTING INSTRUCTIONS

Sizing Tips
• Miami J Select is an adjustable collar suitable for most adult and
adolescent patients; some patient phenotypes (Fig. 2) and anatomical
variations may not be accommodated.
– The Miami J Select is suitable for Stout (Fig. 2b), Tall (Fig. 2d),
Regular (Fig. 2e), and Short (Fig. 2f ) patient phenotypes.
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