Contraindications/ Warnings - Ossur RESOLVE HALO VEST Gebrauchsanweisung

ENGLISH
Instructions do not supercede physician's orders or hospital protocol. The order at which you put the vest and ring
on is left to the physician.
Caution: Federal law restricts this device to sale by, or on the order of, a physician.
A complete ReSolve Halo system includes a ReSolve
®
or Össur Halo Ring (open or closed back versions).
INDICATIONS FOR USE
The ReSolve Halo is recommended for use in traumatic or chronic disorders requiring traction along the cervical
spine to align the vertebral structures (reduce deformities), maintain reduction, or provide stabilization.
Indications include cervical spine trauma or surgery.

CONTRAINDICATIONS/ WARNINGS

The ReSolve Halo should not be used under any conditions where pressure to the skull would not be tolerated.
When used as part of a traction system (i. e. with weights), the halo should also not be used when the stability of
the cervical spine will not permit traction loads.
Caution: Emergency access to chest procedures (located on product label on anterior crossplate) should not be
used for the purpose of daily hygiene. Repeated flexure of vest may lead to material failure.
This product is for single patient use only.
MRI CONDITIONAL/WARNING
The Halo is rated MRI Conditional and is safe to use at either 1.5 or 3 Tesla, depending on which type of skull pins
are used. Usage at higher magnetic field strength may result in burns to the skin at the pin sites. Consult IFU
contained with Halo Ring and Pins for specific MRI safety information.
PRE-APPLICATION
1. Lay the patient supine.
2. Select posterior vest size by measuring the patient's chest circumference at the xyphoid process (Exception:
with pendulous abdomen measure around the widest part of the costal margin) (Figure 1). If patient does not
fit into these sizes or adjustments are needed, please contact Össur Customer Service for custom vest options.
In general patients shorter than 1.75 meters ( 5'9") will be fitted with the short size and patients taller than
1.75 meters (5'9") will be fitted with the tall size. For a properly fitted vest, the chest circvumference at the
xyphoid process measurement must be used. See sizing chart (Figure 2) to choose correct size vest. Note: If
any trimming of the waist stabilizers or liner is necessary, it is best to complete this prior to fitting the vest.
Sharp edges as a result of trimming should be rounded.
3. Maintaining supine position, measure the patient's sternal length to determine anterior vest size. See sizing
chart (Figure 3) to determine correct anterior vest height setting. Detach the liner from the bottom anterior
shell. Adjust height by pushing on the button and sliding the lower anterior vest shell (Figure 4).
CAUTION: YOU MUST APPLY AND TIGHTEN THE THREADED KNOB TO SECURE THE HEIGHT OF THE
ANTERIOR VEST SHELL. FAILURE TO DO SO MAY RESULT IN BODILY INJURY TO THE PATIENT (Figure 5).
Trim excess liner if necessary.
Halo Vest used in combination with a ReSolve
®
Halo Ring
®
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