Ossur MIAMI J SELECT Gebrauchsanweisung Seite 6

ENGLISH
SYMBOLS
Medical Device
Magnetic Resonance (MR) safe
Product overview (Fig. 1):
a. Front
b. Height Indicator Marks
c. Chin Support
d. Hook Landing Area
e. Tracheal Opening
f. Patient Compliance Lockout
g. Height Adjustment Button
h. Sternum Relief Knob
i. Sternum Contact
j. Back Panel
k. Repeatable Fit Tabs (sold separately)
l. Strap
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
Conditions requiring gross immobilization of the cervical spine. This may
include:
• 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
• Patients with a compromised airway or known spinal deformities such
as ankylosing spondylitis.
• Patients with penetrating trauma injuries.
Warnings 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.
Warning: Use of a cervical collar may increase complexity of airway
management.
Warning: Cervical spine immobilization, including use of a cervical collar,
has been associated with:
• Impaired respiratory effort and forced expiratory volume
• Pneumonia
• Aspiration
• Worsening of existing cervical spine injury
• Severe neurological deterioration in patients with ankylosing
spondylitis
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