Contraindications - Ossur RESOLVE HALO RING Technisches Handbuch

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 Halo system includes a Halo Vest used in combination with a Halo Ring (open or closed back
versions).
INDICATIONS FOR USE
The Halo system 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.
Warning:
MRI CONDITIONAL
The Resolve Halo with ceramic-tipped pins is rated MRI Conditional and is safe to use at 3 Tesla.
The Ossur Halo with titanium-tipped pins is rated MRI Conditional and is safe to use at 1,5 Tesla.
Usage at higher magnetic field strength may result in burns to the skin at the pin sites.

CONTRAINDICATIONS

The Halo system should not be used under any conditions where pressure to the skull would not be tolerated. For
pediatric or geriatric patients with compromised bone integrity a multiple-pin, low-torque technique may be
indicated. Order additional pins and adjustable torque wrench as needed. 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.
This product is for single use only
is guaranteed unless individual package is opened or damaged.
Note: Do not autoclave the Halo components.
Due to the nature of the composite materials used in the Halo Ring, it is not advisable to use high temperature
steam sterilization. The combination of moisture and heat inherent in the autoclave process may cause the device
to temporarily expand resulting in difficulty inserting the skull pins. A blistering of the painted surface may also
result.
PRE-APPLICATION
1. Lay the patient supine.
2. Measure patient's head circumference to determine ring size. Measure at the greatest circumference of the
skull (about 1 cm above the ears) (Figure 1). See sizing chart (Figure 2) for correct size halo ring. The ring
should be large enough to allow for cleaning with approximately 1 to 1,5 cm between the ring and skull.
(Figure 3)
3. Remove pillows from behind the head. Maintain c-spine alignment by supporting the patient's head off the end
of the table using a head positioner (Option 1)(Figure 4a) or by using a bolster (Option 2)
(Figure 4b). Remove pillows from behind the head.
4. Select appropriate pin sites based on "safe zone" recommendations and shave posterior pin sites. Anterior skull
pins should be positioned as low as possible in the lateral one-third area above the eyebrow. Posterior skull
pins should be positioned 1 cm posterior to the tip of the ear (Figure 5).
Caution: Be careful to avoid the supraorbital ridge, supraorbital nerves, temporalis muscle, temporal bone, frontal
sinus, and/or any possible fracture site.
RING APPLICATION
All components used for pin application are provided sterile.
1. Maintain c-spine alignment by supporting the patient's head off the end of the table using a head positioner
. For your convenience, this product has been supplied sterile . Sterility
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