Prescription Information; Indications; Contraindication; Warnings - Orthofix SpinalStim 5212CM Manuel D'instructions

Prescription Information

Indications

The SpinalStim device is a noninvasive electromagnetic bone growth stimulator
indicated as a spinal fusion adjunct to increase the probability of fusion success
and as a nonoperative treatment of salvage of failed spinal fusion, where a
minimum of nine months has elapsed since the last surgery.

Contraindication

Cardiac pacemakers may be adversely affected by exposure to PEMF. Use of
this device is contraindicated where the individual has an implanted cardiac
pacemaker.

Warnings

• Although animal teratological studies performed with the device
demonstrated no adverse findings, the safety of use of this device
during pregnancy and nursing in humans has not been established.
• The safety and effectiveness of the use of this device on individuals
lacking skeletal maturity have not been established.
• Animal studies conducted to date do not suggest any long-term adverse
effects from the use of a similar device. However, long-term effects in
humans are unknown.

Precautions

• This device should not be used if there are mental or physical conditions
which preclude compliance with the physician and device instructions.
• This 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, and uncontrolled diabetes mellitus.
• The results of premarketing data from the randomized double-masked
cohort indicate that inconsistent users (defined as those patients that
used the device for less than an average of two hours per day) had
success rates similar to those in the placebo group. Therefore, the use of
the device for less than the minimum recommended usage may result in
lower success rates.

Adverse Effects

Rare instances of reversible minor discomfort have been reported. These
were: cumbersome or uncomfortable, minor tingling or pain, minor skin rash,
insomnia, fainting, nausea/diarrhea, and polymenorrhea.
Please refer to the Compliance Statements section of the manual for
compatibility information regarding implantable medical devices.
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