Prescription Information; Indication; Contraindication; Warnings - Orthofix CervicalStim 5505CE Bedienungsanleitung

Prescription Information

Indication

The CervicalStim device is a noninvasive, pulsed electromagnetic bone growth
stimulator indicated as an adjunct to cervical fusion surgery in patients at high-risk
for non-fusion.

Contraindication

There are no known contraindications for the CervicalStim device as an adjunct to
cervical spine fusion surgery.

Warnings

• Do not use the CervicalStim device if you have a cardiac pacemaker or defibrillator
because it may interfere with the operation of your pacemaker or defibrillator.
If you use the CervicalStim device and it affects your pacemaker or defibrillator,
it may injure your heart. Consult your cardiologist before using the CervicalStim
device.
• Remove the CervicalStim device prior to any imaging procedures (e.g., CT scan,
MRI, etc.). If you wear the CervicalStim device during these procedures, you
could be injured, the imaging being produced may be ruined, and/or the
CervicalStim device could be damaged.

Precautions

• Avoid using the CervicalStim device if you do not understand the instructions
your doctor has given you. If you use the CervicalStim device incorrectly, it may
harm you or may not help your healing process.
• The CervicalStim device 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 reproductive studies performed with this device did not show any harmful
effects in animals. However, the safety of this device for use on patients who are
pregnant or nursing has not been established.

Adverse Effects Summary

Adverse effects may be experienced when using the CervicalStim device. These
adverse effects may include increased pain, numbness and tingling, headache,
migraines, and nausea. These effects may or may not be directly related to use of the
CervicalStim device. Any adverse effects that are related to the CervicalStim device
should stop when you discontinue use.
See the Adverse Events Table for a list of all adverse events reported during the
clinical study.
Please refer to the Compliance Statements section of the manual for compatibility
information regarding implantable medical devices.
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