3. PRESCRIBING INFORMATION
Description
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inducing a therapeutic, low level electrical current at the fusion site. Federal law restricts
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intended for re-sale.
Indications for Use
The ActaStim-S Spine Fusion Stimulator is a noninvasive bone growth stimulator indicated
as an adjunct electrical treatment to primary lumbar spinal fusion surgery for one or two
levels. The device is Rx only, and intended for single patient use in adult patients only.
Contraindications
There are no known contraindications.
Warnings
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concomitant use of ActaStim-S and a pacemaker or cardioverter must be assessed on an
individual basis, such as with an electrocardiogram, prior to use. The patient should be
referred to a cardiologist for monitoring of pacemaker function while wearing the active
stimulator device. If there are any observable adverse changes in the pacemaker rhythm or
output, ActaStim-S should not be used.
c©Þ£æüÄąæ¬õÄÞÞË£æ]æ¬Ãɫ]¬Ä×Ú¤ÄÄæöËÃÄ©õÄËæÄÞæê¬ɆÄ
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who is either pregnant or is intending to become pregnant should be referred to her doctor
prior to treatment with ActaStim-S.
Precautions
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•
spondylitis, infection, Paget’s disease
•
cancer, diabetes mellitus, renal disease
INFORMATION & SAFETY
•
trauma of the lumbar spine
•
osteoporosis
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