Description Of Symbols; Intended Purpose; Indications For Use; Warning And Cautions - Össur MIAMI J SELECT Instrucciones Para El Uso

ENGLISH

DESCRIPTION OF SYMBOLS

Medical Device
Magnetic Resonance (MR) safe
Product overview (Figure 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 PURPOSE

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
CONTRAINDICATIONS
• Patients with a compromised airway or known spinal deformities
such as ankylosing spondylitis.
• Patients with penetrating trauma injuries

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.
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
• Triggering of non-compliance or agitation
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