Prescription Information; Indication; Contraindication; Warnings - Orthofix Physio Stim 5302CE Manuel D'instructions

Prescription Information

Indication

The PhysioStim™ device is indicated for the treatment of an established
nonunion acquired secondary to trauma, excluding vertebrae and all flat bones,
where the width of the nonunion defect is less than one-half the width of
the bone to be treated. A nonunion is considered to be established when the
fracture site shows no visibly progressive signs of healing.

Contraindication

Use of this device is contraindicated where the individual has synovial
pseudarthrosis.

Warnings

• The safety and effectiveness of the use of this device on individuals lacking
skeletal maturity has not been established.
• In the presence of a malaligned nonunion, careful consideration of the use
of this device must be undertaken on an individual basis, as treatment with
this device is not intended to alter or affect the degree of malalignment.
• Demand type pacemaker operation may be adversely affected by exposure
to pulsed electromagnetic fields. Physicians should not prescribe a
PhysioStim device for application which may place the treatment transducer
in close proximity to the pacemaker. Further screening by the attending
cardiologist is recommended (such as with an electrocardiogram).
• Animal studies conducted to date do not suggest any long-term adverse
effects from the use of this device. However, long-term effects in humans
are unknown.
• The safety and effectiveness of this device on individuals with a nonunion
secondary to, or in connection with, a pathological condition has not been
established.

Precautions

• Nonunion fractures with gaps in excess of 1 centimeter (cm) have not been
evaluated.
• Although animal reproductive studies performed with this device
demonstrated no adverse findings, the safety of use of this device during
pregnancy and nursing in humans has not been established.
• This device should not be used if there are mental or physical conditions
which preclude patient compliance with physician and device instructions.
Adverse Events
Rare instances of reversible minor discomfort have been reported. They were:
cumbersome or uncomfortable, tingling or pain and minor skin rash.
Please refer to the Compliance Statements section of the manual for
compatibility information regarding implantable medical devices.
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