Orthofix Cervical-Stim 2505CE, Инструкция по эксплуатации

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range of state-of-the-art medical devices for orthopaedics and neurosurgery
that enhance the body's natural healing process, simulate natural function,
protect, restore and heal. Thank you for including Orthofix in your healing
process. To learn more about Orthofix, please visit our website at
www.orthofix.com.
PEMF Stimulation
Pulsed electromagnetic field (PEMF) bone growth stimulation is a safe,
nonsurgical treatment prescribed by a physician to heal nonunion fractures
and promote spinal fusion. Electrical currents have been used to heal bones
since the mid-1800s. However, it wasn’t until the 1950s that scientists made
an important discovery. When human bone is bent or broken, it generates an
electrical field. This low-level electrical field activates the body's own repair
mechanism, which in turn stimulates bone healing.
Orthofix PEMF bone growth stimulators generate a uniform, low-level, pulsed
electromagnetic field similar to the electrical field generated by the body.
The application of PEMF directly to the fusion or fracture site helps activate
and augment the body’s natural healing process to enhance bone fusion.
Prescription Information
Indication
The Cervical-Stim is a noninvasive, pulsed electromagnetic bone growth
stimulator indicated as an adjunct to cervical fusion surgery in patients at
high-risk for non-fusion and nonoperative salvage of failed cervical spine fusion.
Contraindications
There are no known contraindications for the Cervical-Stim.
Warnings
• The Cervical-Stim may interfere with the operation of a cardiac pacemaker
or defibrillator. Consultation with the attending cardiologist is recommended.
• The Cervical-Stim should be removed prior to any imaging procedures
(e.g., CT scan, MRI, etc.).
Precautions
• The Cervical-Stim should not be used if there are mental or physical
conditions that may preclude compliance with physician or device
instructions.
• The Cervical-Stim has not been evaluated in treating patients with the
following conditions: osseous or ligamentous spinal trauma, spondylitis,
Paget’s disease, moderate to severe osteoporosis, metastatic cancer, renal
disease, rheumatoid arthritis, uncontrolled diabetes mellitus, patients prone
to vascular migraine headache, seizure, epilepsy, thyroid conditions or
neurological diseases.
• Animal teratological studies performed with this device did not show any
adverse effects in animals. However, the safety of this device for use on
patients who are pregnant or nursing has not been established.