Intended Use; Contraindications - Ossur MIAMI J Gebrauchsanweisung

ENGLISH
DESCRIPTION OF SYMBOLS
Medical Device
Magnetic Resonance (MR) safe
Product Overview (Fig. 1)
a. Front
b. Chin Support
c. Tracheal Opening
d. Sternal Pad
e. Hook and Loop Strap
f. Angulation Buttons
g. Occipital Support
h. Back

INTENDED USE

The device is intended to provide gross immobilization to the cervical
spine.
• X-ray and CT lucent
The device must be fitted and adjusted by a healthcare professional.
INDICATIONS FOR USE
• C-Spine precaution for trauma patients
• Immobilization for pre- and post-c-spine surgery
• Other conditions requiring gross immobilization of the mid-cervical
spine

CONTRAINDICATIONS

None Known.
WARNING AND CAUTIONS
Warning: If an unstable fracture is suspected or unknown, with or
without a sustained trauma, ensure additional spinal precautions are
implemented to immobilize the spine.
Warning: Use of a cervical collar may increase intracranial pressure (ICP)
through jugular venous compression.
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.
Precaution: Unless otherwise specified by the physician, the patient
should not remove the collar except to wash under it and change the
pads.
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.
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